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Sample records for superior safety profile

  1. Leflunomide : a manageable safety profile

    NARCIS (Netherlands)

    Riel, P.L.C.M. van; Smolen, J.S.; Emery, P.; Kalden, J.R.; Dougados, M.; Strand, C.V.; Breedveld, F.C.

    2004-01-01

    The safety profile of leflunomide in the treatment of rheumatoid arthritis has been well documented in clinical trials, postmarketing surveillance, and epidemiological studies. Both postmarketing surveillance and epidemiological study results are consistent with the safety profile of leflunomide rep

  2. Triclosan: a safety profile.

    Science.gov (United States)

    DeSalva, S J; Kong, B M; Lin, Y J

    1989-09-01

    Triclosan (2, 4, 4'-trichloro-2'-hydroxydiphenyl ether), an antimicrobial agent, has been used extensively for 20 years in consumer products, principally in deodorants, soaps and other dermatological preparations. Recently, the use of triclosan has been extended to oral health care products such as dentifrices. This paper reviews safety information, both pre-clinical and clinical studies, from the literature, data submitted to the Antimicrobial I OTC Review Panel and unpublished work from the Pharmacology and Toxicology Department of the Colgate-Palmolive Company. The data spans acute, subacute, subchronic and chronic toxicity; mutagenicity, carcinogenicity, reproduction/teratology and pharmacokinetics. Results of these studies show that triclosan is well tolerated by a variety of species including man. In clinical studies with triclosan in solutions and dentifrices, a steady state was reached by day 7 with blood levels in the parts per billion (ppb) range and urine as the main route of excretion. Based on these studies, triclosan can be considered safe for use in dentifrice and mouthrinse products.

  3. 77 FR 45490 - Safety Zone, Barrel Recovery, Lake Superior; Duluth, MN

    Science.gov (United States)

    2012-08-01

    ... [Docket Number USCG-2012-0491] RIN 1625-AA00 Safety Zone, Barrel Recovery, Lake Superior; Duluth, MN..., Duluth, MN. This safety zone is precautionary to protect recreational vessels and marine traffic from any... Superior, Duluth, MN. This safety zone will be in effect and enforced 24 hours a day from on or around July...

  4. 77 FR 37321 - Safety Zone, Barrel Recovery, Lake Superior; Duluth, MN

    Science.gov (United States)

    2012-06-21

    ... SECURITY Coast Guard 33 CFR Part 165 RIN 1625-AA00 Safety Zone, Barrel Recovery, Lake Superior; Duluth, MN..., Duluth, MN. This safety zone is precautionary to protect recreational vessels and marine traffic from any... Brighton Beach, up to approximately 4 miles offshore on Lake Superior, Duluth, MN. This safety zone will be...

  5. Functional Safety Specification of Communication Profile PROFIsafe

    Directory of Open Access Journals (Sweden)

    Jan Rofar

    2006-01-01

    Full Text Available Paper maps the trends in area of safety-related communication within PROFIBUS and PROFINET industry networks. There are analyses safety measures and Fail-safe parameters of PROFIsafe profile in version V2 and their localisation in Safety Communication Layer SCL, which guarantees Safety Integrity Level SIL according to standard IEC 61508. The last chapter analyses the reaction in the event of fault during transmission of messages.

  6. A Profile for Safety Critical Java

    DEFF Research Database (Denmark)

    Schoeberl, Martin; Søndergaard, Hans; Thomsen, Bent

    2007-01-01

    We propose a new, minimal specification for real-time Java for safety critical applications. The intention is to provide a profile that supports programming of applications that can be validated against safety critical standards such as DO-178B [15]. The proposed profile is in line with the Java...... specification request JSR-302: Safety Critical Java Technology, which is still under discussion. In contrast to the current direction of the expert group for the JSR-302 we do not subset the rather complex Real-Time Specification for Java (RTSJ). Nevertheless, our profile can be implemented on top of an RTSJ...

  7. 77 FR 48856 - Safety Zone; Superior Bay, Duluth, MN

    Science.gov (United States)

    2012-08-15

    ... spectators during the Superior Man Triathlon. DATES: This rule is effective from 6 a.m. to 8:30 a.m. on... Triathlon, which are discussed further below. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good... inaugural Superior Man Triathlon will occur along the Bay of Lake Superior. The 1.2 mile swim leg of...

  8. [Safety profile of NO-SPA].

    Science.gov (United States)

    Tar, Attila; Singer, Júlia

    2002-03-17

    The aim of the safety analysis performed by Chinoin Drug Safety Unit was to summarise the safety profile of NO-SPA (drotaverine hydrochloride), the Hungarian spasmolytic well known in Hungary and abroad. Authors collected the safety data from clinical studies between 1964-1998 for the determination of the adverse event frequency. Based on the data of 12111 patients treated with NO-SPA in 37 clinical trials 0.9% frequency of adverse events was found. The value indicates uncommon (0.1-1%) adverse event frequency according to the criteria for frequency categories. The benefit-risk ratio of NO-SPA is favourable, since the therapeutic effect does not include frequent adverse reaction occurrence.

  9. ANTHROPOGENIC COPPER INVENTORIES AND MERCURY PROFILES FROM LAKE SUPERIOR: EVIDENCE FOR MINING IMPACTS

    Science.gov (United States)

    During the past 150 years, the mining indstry discharged more than a billion tons of tailings along Lake Superior shorelines and constructed numerous smelters in the watershed. Given the vast size of Lake Superior, were sediment profiles at locations far offshore impacted by near...

  10. The safety profile of the fluoroquinolones.

    Science.gov (United States)

    Bertino, J; Fish, D

    2000-07-01

    Premarketing trials showed the fluoroquinolone agents to have a favorable side-effect profile, with treatment-related adverse events comprising gastrointestinal, central nervous system, and dermatologic effects that were generally mild and reversible on cessation of treatment. However, postmarketing surveillance studies have identified severe adverse events, including severe anaphylaxis, QTc-interval prolongation, and potential cardiotoxicity, associated with 3 quinolone agents that either resulted in the removal of the agent from the market (temafloxacin and grepafloxacin) or significantly restricted its use due to substantial mortality and morbidity associated with liver toxicity (trovafloxacin). To date, there have been no such significant adverse events associated with the older fluoroquinolone agents, including ciprofloxacin, ofloxacin, norfloxacin, and levofloxacin. However, there are fewer data from postmarketing surveillance studies on the most recently approved agents, such as moxifloxacin and gatifloxacin, or agents awaiting approval, such as gemifloxacin. This paper examines safety data from the premarketing trials and postmarketing surveillance studies of fluoroquinolones available in the United States. A MEDLINE search was performed to identify all English-language studies published since 1980 concerning the safety profiles of the fluoroquinolones. The fluoroquinolone antibacterial agents offer broad-spectrum therapy in patients with a variety of infections. Given similar spectra of activity, the choice between quinolones may be based on differences in efficacy and safety or tolerability profiles. Most drug reactions involving these agents are minor and reversible on discontinuing treatment, but adverse effects can be associated with significant mortality and morbidity, as was seen in the case of trovafloxacin and temafloxacin.

  11. Laser safety at high profile projects

    Science.gov (United States)

    Barat, K.

    2011-03-01

    Laser Safety at high profile laser facilities tends to be more controlled than in the standard laser lab found at a research institution. The reason for this is the potential consequences for such facilities from incidents. This ranges from construction accidents, to equipment damage to personnel injuries. No laser user wants to sustain a laser eye injury. Unfortunately, many laser users, most commonly experienced researchers and inexperienced graduate students, do receive laser eye injuries during their careers. . More unforgiveable is the general acceptance of this scenario, as part of the research & development experience. How do senior researchers, safety personnel and management stop this trend? The answer lies in a cultural change that involves institutional training, user mentoring, hazard awareness by users and administrative controls. None of these would inhibit research activities. As a matter of fact, proper implementation of these controls would increase research productivity. This presentation will review and explain the steps needed to steer an institution, research division, group or individual lab towards a culture that should nearly eliminate laser accidents. As well as how high profile facilities try to avoid laser injuries. Using the definition of high profile facility as one who's funding in the million to billions of dollars or Euros and derives form government funding.

  12. Biologic Therapy in Psoriasis: Safety Profile.

    Science.gov (United States)

    Campanati, Anna; Ganzetti, Giulia; Giuliodori, K; Molinelli, Elisa; Offidani, A

    2016-01-01

    This review focuses on the emerging concepts concerning the efficacy profile of biological drugs in psoriasis ranging from moderate to severe, and attempts to provide the most recent individual positioning of biologics in treating psoriasis. Biologic agents targeting towards specific immune mediators have emerged as treatment options for patients with moderate to-severe plaque psoriasis unresponsive or intolerant to traditional systemic agents. Data on the safety of biologics are available for up to 5 years in psoriasis and are on the whole reassuring. National registries are still evolving and will provide data on safety, to help the long-term monitoring of patients with psoriasis ongoing biological treatment. Although several biologics have demonstrated good efficacy and tolerability in short-term trials, treatment guidelines recommend them as third line therapies due to relative lack of long-term safety data, especially for those who have been commercialized recently. Here, we have reviewed the long-term safety data obtained from National Registries, randomized controlled trials, open-label extension studies and meta-analyses on etanercept, infliximab, adalimumab, and ustekinumab in the treatment of adults with moderate to severe plaque psoriasis.

  13. 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...

  14. Safety and security profiles of industry networks used in safety- critical applications

    Directory of Open Access Journals (Sweden)

    Mária FRANEKOVÁ

    2008-01-01

    Full Text Available The author describes the mechanisms of safety and security profiles of industry and communication networks used within safety – related applications in technological and information levels of process control recommended according to standards IEC 61784-3,4. Nowadays the number of vendors of the safety – related communication technologies who guarantees besides the standard communication, the communication amongst the safety – related equipment according to IEC 61508 is increasing. Also the number of safety – related products is increasing, e. g. safety Fieldbus, safety PLC, safety curtains, safety laser scanners, safety buttons, safety relays and other. According to world survey the safety Fieldbus denoted the highest growth from all manufactured safety products.The main part of this paper is the description of the safety-related Fieldbus communication system, which has to guaranty Safety Integrity Level.

  15. A Semicircular Incision in the Superior Umbilical Fold for SILS Preserves the Umbilical Profile

    Directory of Open Access Journals (Sweden)

    S. C. Blackburn

    2012-01-01

    Full Text Available Background. Single Incision Laparoscopic Surgery (SILS has been highlighted in the recent literature as a means of performing a range of common, minimal access, paediatric surgical procedures. The primary attraction is the absence of visible scarring. Aim. This study aims to describe a cosmetically advantageous means of SILS port placement in children, which preserves the umbilical profile. Methods. We describe a paediatric case series utilising a semicircular incision in the superior umbilical fold for SILS procedures. The linea alba is exposed over 2 cm just superior to the umbilical ring and stay sutures are applied. A vertical incision is made over this distance without entering the umbilical ring. Data were recorded prospectively in a Microsoft Excel database. Results. Twenty-one cases were performed in a 1-year period. Ten appendicectomies, 5 ovarian/paraovarian cystectomies, 2 Palomo procedures, 3 nephrectomy/heminephrectomies, and 1 Meckel’s diverticulectomy were performed. There was 1 wound infection. No incisional hernias occurred. Discussion. We believe that our technique, which maintains the integrity of the umbilical ring and allows preservation of the umbilical profile, offers a distinct cosmetic advantage over other incisions for SILS which distort it. Conclusion. We have demonstrated the aesthetic benefits of utilising a superior umbilical-fold incision for SILS in children.

  16. Non-Additive Transcriptional Profiles Underlie Dikaryotic Superiority in Pleurotus ostreatus Laccase Activity

    Science.gov (United States)

    Castanera, Raúl; Omarini, Alejandra; Santoyo, Francisco; Pérez, Gúmer; Pisabarro, Antonio G.; Ramírez, Lucía

    2013-01-01

    Background The basidiomycete Pleurotus ostreatus is an efficient producer of laccases, a group of enzymes appreciated for their use in multiple industrial processes. The aim of this study was to reveal the molecular basis of the superiority of laccase production by dikaryotic strains compared to their parental monokaryons. Methodology/Principal Findings We bred and studied a set of dikaryotic strains starting from a meiotic population of monokaryons. We then completely characterised the laccase allelic composition, the laccase gene expression and activity profiles in the dikaryotic strain N001, in two of its meiotic full-sib monokaryons and in the dikaryon formed from their mating. Conclusions/Significance Our results suggested that the dikaryotic superiority observed in laccase activity was due to non-additive transcriptional increases in lacc6 and lacc10 genes. Furthermore, the expression of these genes was divergent in glucose- vs. lignocellulose-supplemented media and was highly correlated to the detected extracellular laccase activity. Moreover, the expression profile of lacc2 in the dikaryotic strains was affected by its allelic composition, indicating a putative single locus heterozygous advantage. PMID:24039902

  17. Non-additive transcriptional profiles underlie dikaryotic superiority in Pleurotus ostreatus laccase activity.

    Directory of Open Access Journals (Sweden)

    Raúl Castanera

    Full Text Available BACKGROUND: The basidiomycete Pleurotus ostreatus is an efficient producer of laccases, a group of enzymes appreciated for their use in multiple industrial processes. The aim of this study was to reveal the molecular basis of the superiority of laccase production by dikaryotic strains compared to their parental monokaryons. METHODOLOGY/PRINCIPAL FINDINGS: We bred and studied a set of dikaryotic strains starting from a meiotic population of monokaryons. We then completely characterised the laccase allelic composition, the laccase gene expression and activity profiles in the dikaryotic strain N001, in two of its meiotic full-sib monokaryons and in the dikaryon formed from their mating. CONCLUSIONS/SIGNIFICANCE: Our results suggested that the dikaryotic superiority observed in laccase activity was due to non-additive transcriptional increases in lacc6 and lacc10 genes. Furthermore, the expression of these genes was divergent in glucose- vs. lignocellulose-supplemented media and was highly correlated to the detected extracellular laccase activity. Moreover, the expression profile of lacc2 in the dikaryotic strains was affected by its allelic composition, indicating a putative single locus heterozygous advantage.

  18. Gastrointestinal safety profile of nabumetone: a meta-analysis.

    Science.gov (United States)

    Huang, J Q; Sridhar, S; Hunt, R H

    1999-12-13

    Individual comparative studies suggest that nabumetone has a gastrointestinal (GI) safety profile superior to comparator NSAIDs but lack power to show a statistical difference. The aim of this study was to evaluate systematically the difference in GI adverse events--especially the rate of perforations, ulcers, and bleeds (PUBs)-- between studies, meta-analyses of comparative trials of nabumetone and conventional NSAIDs, and postmarketing, open-label studies of nabumetone meeting predefined inclusion and exclusion criteria. A fully recursive literature search identified 13 studies consisting of 29 treatment arms and 49,501 patients that met the predefined criteria. Tests for heterogeneity found no significant difference between studies of each subgroup. Overall, the dyspeptic symptoms flatulence, constipation, and diarrhea were the most commonly reported adverse events accounting for 98.6% of the total GI adverse events. Significantly more patients treated with a comparator NSAID experienced GI adverse events than did those taking nabumetone (P = 0.007). After adjustment for patient-exposure years, PUBs were 10 to 36 times more likely to develop in patients treated with a comparator NSAID than with nabumetone. This was consistently seen in patients in nonendoscopic (n = 7,468) and endoscopic studies (n = 244). In the analysis of postmarketing or open-label studies of nabumetone, only one PUB was reported per 500 patient-exposure years over 17,502 treatment years (n = 39,389). GI adverse event-related dropouts and hospitalizations were increased by 1.3- and 3.7-fold if patients were treated with a comparator NSAID than with nabumetone. Significantly fewer treatment-related GI adverse events, especially PUBs, are seen in patients treated with nabumetone than with a comparator NSAID. Nabumetone is very safe for the GI tract.

  19. [Combined treatment: regimens, indications and safety profile].

    Science.gov (United States)

    Muñiz Grijalvo, Ovidio; Villar Ortiz, Jose

    2013-01-01

    Statins are the current basis of lipid-lowering therapy, despite which may have limitations on efficacy and safety. In high risk patients who do not achieve current lipid goals, in those intolerant to statins or those with atherogenic dyslipidemia, it is possible combine two or more lipid lowering drugs, including statins, ezetimibe, bile acid sequestrants, fibrates, niacin and prescription omega-3 fatty acids. However, for most of these combination therapies pivotal data on clinical outcomes are still lacking. Copyright © 2013 Elsevier España, S.L. and SEA. All rights reserved.

  20. 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...... to that of the qHPV vaccine; injection-site AEs were more common with 9vHPV vaccine. Its additional coverage and safety profile support widespread 9vHPV vaccination....

  1. Safety Profile of Cough and Cold Medication Use in Pediatrics.

    Science.gov (United States)

    Green, Jody L; Wang, George Sam; Reynolds, Kate M; Banner, William; Bond, G Randall; Kauffman, Ralph E; Palmer, Robert B; Paul, Ian M; Dart, Richard C

    2017-06-01

    The safety of cough and cold medication (CCM) use in children has been questioned. We describe the safety profile of CCMs in children pediatric (75.5%), and single-ingredient (77.5%) formulations were most commonly involved. AEs occurring in >20% of all cases included tachycardia, somnolence, hallucinations, ataxia, mydriasis, and agitation. Twenty cases (0.6%) resulted in death; most were in children pediatric liquid formulations were the most commonly reported products. These characteristics present an opportunity for targeted prevention efforts. Copyright © 2017 by the American Academy of Pediatrics.

  2. [Safety profile of rilpivirine: general and neuropsychiatric tolerability, safety in patients with hepatitis B or C viruses, and lipid profile].

    Science.gov (United States)

    López Cortés, Luis F; Martínez, Esteban; von Wichmann, Miguel Ángel

    2013-06-01

    Currently available data on the safety and tolerability of rilpivirine come from the product information document, a phase IIb, dose-finding clinical trial (TMC278-C204), the phase III ECHO and THRIVE clinical trials, and the preliminary data from the STaR and SPIRIT clinical trials, with a total of 1,728 patients. The comparator has usually been efavirenz. All studies have found a lower incidence and severity of neuropsychiatric adverse effects, a better lipid profile, and a lower number of patients with subclinical transaminase elevation in patients treated with rilpivirine. However, because of the relatively low number of patients coinfected with hepatitis B or C virus, definitive conclusions cannot be drawn. Similarly, experience in patients with mild or moderate liver failure is limited and there are no safety data in patients with advanced liver failure.

  3. 77 FR 35268 - Safety Zone, Fireworks Display, Lake Superior; Cornucopia, WI

    Science.gov (United States)

    2012-06-13

    ... or fatalities. Establishing a safety zone to control vessel movement around the location of the... the fireworks launch site with its center in position 46 51'35'' N, 091 06'10'' W.; at Cornucopia, WI... and the States, or on the distribution of power and responsibilities among the various levels of...

  4. The safety profile of drug treatment of alzheimer's disease

    Directory of Open Access Journals (Sweden)

    V. А. Moroz

    2013-06-01

    Full Text Available Despite the fact that Alzheimer's disease is being intensively studied for many years, its main etiopathogenic mechanisms are still unknown. At the same time, given the prognosis of the disease and its prevalence, the problem of adequate medical treatment is an important medical and social problem. The problem is compounded by the fact that in recent years there has been a tendency of expanding the concept of the disease. The aim of the study was to evaluate the safety profile of drug regimens used for the treatment of Alzheimer's disease with the evidence of controlled clinical trials, completed in 2012, according to the database of the U.S.National Institute of Health and available Cochrane reviews and publications. The safety profile and tolerability of reversible anticholinesterase drugs, memantine, as well as alternative: ginkgo biloba, cerebrolysin, estrogen, idebenone, nicergoline, statins, and neurotrophines, has been evaluated. Analysis of the data has showed that the greatest limiting factor in the use of anticholinesterase drugs in the treatment is their direct dose-related side effects of dangerous dysfunction of the heart, nervous and respiratory systems, dyspepsia, which allows to use the recommended effective dose more than 3 months only in 50-58% of the patients with a minimum of efficiency. At the same time, the use of such drugs, as ginkgo biloba, based on standardized extract, improves cognitive function of the patients and has less side effects. There were also marked results of cerebrolysin, the dangers of using estrogen replacement therapy (vaginal bleeding in 16% of patients, the modest prospects of using idebenone, nicergoline and statins. The author comes to the conclusion that because of the low profile of safety and efficacy for the treatment of Alzheimer's disease anticholinesterase drugs and memantine, as well as the knowledge of the pathogenesis of the disease, the use of alternative schemes of drug therapy can be

  5. Relative safety profiles of high dose statin regimens

    Directory of Open Access Journals (Sweden)

    Carlos Escobar

    2008-06-01

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

  6. Biologic Therapy in Inflammatory Immunomediated Systemic Diseases: Safety Profile.

    Science.gov (United States)

    Moroncini, Gianluca; Albani, Lisa; Nobili, Lorenzo; Gabrielli, Armando

    2016-01-01

    The discovery of some key molecular mechanisms underlying the dysregulation of the immune system responsible for inflammatory systemic diseases as severe as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), and Systemic Vasculitides, led to the development and subsequent introduction into clinical practice of biological drugs which are significantly improving the management of such complex disorders. This novel molecular targeted therapeutics represents in fact a valid alternative or complementary treatment to conventional immunosuppressive strategies, characterized by broad, unspecific actions and severe adverse effects. Main advantages of the use of biologic drugs reside in their steroid-sparing effect and in the ability of inducing remission of refractory disease states or curing specific organ involvements. Aim of this article is to review and briefly discuss the scientific evidence supporting the use of biologics in these diseases, with a particular emphasis on their efficacy and safety profile compared to the canonical drugs.

  7. Brain morphology and neuropsychological profiles in a family displaying dyslexia and superior nonverbal intelligence.

    Science.gov (United States)

    Craggs, Jason G; Sanchez, Juliana; Kibby, Michelle Y; Gilger, Jeffrey W; Hynd, George W

    2006-11-01

    Behavioral research suggests that individuals with dyslexia may have exceptional skills in nonverbal cognitive processes, while genetic studies have noted that giftedness, high IQ and/or special talents tend to run in families. Taken together, these results suggest that persons within families (particularly offspring) may share similar cortical systems supporting those functions. Postmortem and in vivo imaging studies have linked dyslexia to abnormalities in the structures associated with the parietal operculum (PO) (e.g., planum temporale, supramarginal gyrus, and angular gyrus). In this paper we present data on a single family showing a link between dyslexia, superior nonverbal IQ and atypical PO presentation. We consider the psychometric and neurological patterns of this family as a tentative etiological test of the putative dyslexia-talent association.

  8. Safety profile of bilastine: 2nd generation H1-antihistamines.

    Science.gov (United States)

    Scaglione, F

    2012-12-01

    Bilastine is a new H1 antagonist with no sedative side effects, no cardiotoxic effects, and no hepatic metabolism. In addition, bilastine has proved to be effective for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. Pharmacological studies have shown that bilastine is highly selective for the H1 receptor in both in vivo and in vitro studies, and with no apparent affinity for other receptors. The absorption of bilastine is fast, linear and dose-proportional; it appears to be safe and well tolerated at all doses levels in healthy population. Multiple administration of bilastine has confirmed the linearity of the kinetic parameters. The distribution in the brain is undetectable. The safety profile in terms of adverse effects is very similar to placebo in all Phase I, II and III clinical trials. Bilastine (20 mg), unlike cetirizine, does not increase alcohol effects on the CNS. Bilastine 20 mg does not increase the CNS depressant effect of lorazepam. Bilastine 20 mg is similar to placebo in the driving test. Therefore, it meets the current criteria for medication used in the treatment of allergic rhinitis and urticaria.

  9. Intraocular caspofungin: in vitro safety profile for human ocular cells.

    Science.gov (United States)

    Kernt, M; Kampik, A

    2011-07-01

    Endogenous Candida endophthalmitis is sight-threatening, difficult to treat and sometimes leads to loss of the eye. Only a few therapeutic agents are available for its treatment. Caspofungin is the first of a new class of antifungal drugs (echinocandins) with a high activity against Candida species, the most common pathogens found in endogenous endophthalmitis. This study investigates the safety profile of caspofungin for intraocular application in a cell-culture model. Endothelial toxicity of caspofungin was evaluated in cultured human corneas. Possible toxic effects of caspofungin (5-300 μg ml(-1)) in corneal endothelial cells (CEC), primary human trabecular meshwork cells (TMC) and primary human retinal pigment epithelium (RPE) cells were evaluated after 24 h and under conditions of inflammatory stress by treatment with tumour necrosis factor-alpha (TNF-α), lipopolysaccharides (LPS) or interleukin-6 (IL-6) and hydrogen peroxide (H(2)O(2)). Toxicity was evaluated by tetrazolium dye-reduction assay; cell viability was quantified by a microscopic live-dead assay. No corneal endothelial toxicity could be detected after 30 days of treatment with 75 μg ml(-1) of caspofungin. Concentrations up to 75 μg ml(-1) had no influence on CEC, TMC or RPE cell proliferation, or on cell viability when administered for 24 h. Exposure to H(2)O(2) did not increase cellular toxicity of caspofungin at concentrations of 5-50 μg ml(-1). After preincubation with TNF-α, LPS or IL-6 for 24 h followed by treatment with caspofungin for 24 h, no significant decrease in cell proliferation or viability was observed. This study showed no significant toxicity for caspofungin on CEC, TMC or RPE cells, or human corneal endothelium when administered in therapeutic concentrations up to 50 μg ml(-1).

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

    National Research Council Canada - National Science Library

    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...

  11. Prediction of Clinically Relevant Safety Signals of Nephrotoxicity through Plasma Metabolite Profiling

    Directory of Open Access Journals (Sweden)

    W. B. Mattes

    2013-01-01

    Full Text Available Addressing safety concerns such as drug-induced kidney injury (DIKI early in the drug pharmaceutical development process ensures both patient safety and efficient clinical development. We describe a unique adjunct to standard safety assessment wherein the metabolite profile of treated animals is compared with the MetaMap Tox metabolomics database in order to predict the potential for a wide variety of adverse events, including DIKI. To examine this approach, a study of five compounds (phenytoin, cyclosporin A, doxorubicin, captopril, and lisinopril was initiated by the Technology Evaluation Consortium under the auspices of the Drug Safety Executive Council (DSEC. The metabolite profiles for rats treated with these compounds matched established reference patterns in the MetaMap Tox metabolomics database indicative of each compound’s well-described clinical toxicities. For example, the DIKI associated with cyclosporine A and doxorubicin was correctly predicted by metabolite profiling, while no evidence for DIKI was found for phenytoin, consistent with its clinical picture. In some cases the clinical toxicity (hepatotoxicity, not generally seen in animal studies, was detected with MetaMap Tox. Thus metabolite profiling coupled with the MetaMap Tox metabolomics database offers a unique and powerful approach for augmenting safety assessment and avoiding clinical adverse events such as DIKI.

  12. Safety profile of Colgate Platinum Professional Toothwhitening System.

    Science.gov (United States)

    Adam-Rodwell, G; Kong, B M; Bagley, D M; Tonucci, D; Christina, L M

    1994-01-01

    Colgate Platinum, a professional tooth-whitening paste containing 10% urea peroxide as the active ingredient, was evaluated for potential acute oral toxicity, genotoxicity, and irritation to oral mucosa. Oral administration to rats of a single dose of 5 g/kg of Colgate Platinum did not induce any adverse effects. Colgate Platinum was not mutagenic in Ames/Salmonella Plate Incorporation assay and did not induce primary DNA damage in the bone marrow hematopoietic cells of rats that were given oral doses of up to 1 g/kg for 5 consecutive days. Results of the oral mucosa irritation study in rats indicated that Colgate Platinum did not induce damage to soft and hard tissues of oral cavity after repeated applications for 28 days. Collectively, the data from these studies document the safety of the product for the intended use.

  13. Fesoterodine clinical efficacy and safety for the treatment of overactive bladder in relation to patient profiles: a systematic review.

    Science.gov (United States)

    Chapple, Christopher; Oelke, Matthias; Kaplan, Steven A; Scholfield, David; Arumi, Daniel; Wagg, Adrian S

    2015-06-01

    To summarize published evidence on the pharmacology, efficacy, and safety of fesoterodine for the treatment of overactive bladder (OAB) symptoms in relation to patient clinical and demographic profiles. A systematic review of published articles on fesoterodine was conducted via a PubMed search. Articles were identified using the search term fesoterodine, with limits of human species and abstract available. Review and meta-analysis articles, validation studies, articles focused on treatment compliance/adherence, meeting abstracts, and articles not focused on oral fesoterodine administration in human subjects were excluded. Data from retained articles were summarized descriptively. Of 137 articles identified, 61 (15 articles on the pharmacology and 46 articles on the efficacy and/or safety of fesoterodine) met inclusion criteria. Superiority trials demonstrated the additional efficacy of fesoterodine 8 mg versus fesoterodine 4 mg and tolterodine extended release 4 mg in treating OAB. Prospective trials in specific patient populations indicated beneficial effects of fesoterodine in elderly patients, vulnerable elderly patients, patients dissatisfied with or with a suboptimal response to previous antimuscarinic therapy, patients with urge urinary incontinence (UUI) or nocturnal urgency, and men with persistent LUTS during alpha-blocker treatment. With two effective doses, the fesoterodine dose can be adjusted to achieve optimal efficacy and tolerability in individual patients. The most common adverse events during fesoterodine treatment are dry mouth and constipation. Extensive evidence demonstrates the efficacy and safety of fesoterodine in relieving OAB symptoms, including urgency, urinary frequency, UUI, and nocturnal urgency, in patients with various clinical and demographic profiles. Trial results provide valuable information on fesoterodine treatment in specific patient populations, including both elderly and vulnerable elderly patients. Potential

  14. The long-term efficacy and safety profile of barnidipine.

    Science.gov (United States)

    Smilde, J G

    2000-11-01

    Two multicentre trials have investigated the efficacy and tolerability of treatment with once-daily barnidipine, in patients with mild to moderate essential hypertension. The long-term efficacy and safety of barnidipine were demonstrated in a long-term, multicentre, open-label study. In total, 106, 79 and 32 patients were followed for the first, second and third year, respectively. Patients received barnidipine at a dose titrated to achieve a sitting DBP > or = 90 mmHg or a decrease in sitting BDP > or = 10 mmHg. If necessary, another antihypertensive agent was added to achieve normalisation of blood pressure. In the first year, normalisation of blood pressure was achieved in 91% of patients. This was maintained in 91% and 81% of patients in the second and third years, respectively. At the end of treatment in both years, over 60% of patients remained on barnidipine monotherapy (10 or 20 mg/day). A low incidence of adverse events possibly or probably related to barnidipine (10 or 20 mg/day) monotherapy was reported in the first and second years with headache, peripheral oedema and palpitations the most commonly reported. In the third year of follow-up, only one adverse event, an ECG abnormality, was considered to be possibly related to the study medication. The effective 24 hour control of blood pressure with barnidipine monotherapy was confirmed in a randomised, double-blind, placebo-controlled, cross-over study of 20 patients. These patients were given 6 week regimens of both barnidipine (20 mg/day) and placebo. Office and 24 hour ambulatory blood pressures were recorded at the end of each treatment phase. Barnidipine lowered blood pressure to a significantly greater extent than placebo both at night and during the day. Adverse events were classified as mild or moderate and fewer adverse events were reported with barnidipine treatment compared with placebo. Barnidipine monotherapy (20 mg/day) is safe and effective in providing 24 hour control of blood pressure

  15. 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

    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......BACKGROUND: Dyslipidemia and low-grade inflammation are integral in the pathogenesis of atherosclerosis. We aim to compare the effects of a considerable weight loss and intensive exercise training on lipid atherogenicity and low-grade inflammation in a high-risk population with coronary artery...... profile curve. LED was superior to AIT in decreasing atherogenicity reflected by increased LDL (between-group: 1.0 Å {0.4; 1.7},P = 0.003) and high-density lipoprotein (between-group: 1.2 Å {0.2; 2.4},P = 0.026) particle size and a decreased proportion of total lipoprotein constituted by the small, dense...

  16. Nabumetone: therapeutic use and safety profile in the management of osteoarthritis and rheumatoid arthritis.

    Science.gov (United States)

    Hedner, Thomas; Samulesson, Ola; Währborg, Peter; Wadenvik, Hans; Ung, Kjell-Arne; Ekbom, Anders

    2004-01-01

    Nabumetone is a nonsteroidal anti-inflammatory prodrug, which exerts its pharmacological effects via the metabolite 6-methoxy-2-naphthylacetic acid (6-MNA). Nabumetone itself is non-acidic and, following absorption, it undergoes extensive first-pass metabolism to form the main circulating active metabolite (6-MNA) which is a much more potent inhibitor of preferentially cyclo-oxygenase (COX)-2. The three major metabolic pathways of nabumetone are O-demethylation, reduction of the ketone to an alcohol, and an oxidative cleavage of the side-chain occurs to yield acetic acid derivatives. Essentially no unchanged nabumetone and Nabumetone is clinically used mainly for the management of patients with osteoarthritis (OA) or rheumatoid arthritis (RA) to reduce pain and inflammation. The clinical efficacy of nabumetone has also been evaluated in patients with ankylosing spondylitis, soft tissue injuries and juvenile RA. The optimum oral dosage of nabumetone for OA patients is 1 g once daily, which is well tolerated. The therapeutic response is superior to placebo and similar to nonselective COX inhibitors. In RA patients, nabumetone 1 g at bedtime is optimal, but an additional 0.5-1 g can be administered in the morning for patients with persistent symptoms. In RA, nabumetone has shown a comparable clinical efficacy to aspirin (acetylsalicylic acid), diclofenac, piroxicam, ibuprofen and naproxen. Clinical trials and a decade of worldwide safety data and long-term postmarketing surveillance studies show that nabumetone is generally well tolerated. The most frequent adverse effects are those commonly seen with COX inhibitors, which include diarrhoea, dyspepsia, headache, abdominal pain and nausea. In common with other COX inhibitors, nabumetone may increase the risk of GI perforations, ulcerations and bleedings (PUBs). However, several studies show a low incidence of PUBs, and on a par with the numbers reported from studies with COX-2 selective inhibitors and considerably

  17. The Importance of Being Profiled: Improving Drug Candidate Safety and Efficacy Using Ion Channel Profiling

    Directory of Open Access Journals (Sweden)

    Gregory J. Kaczorowski

    2011-12-01

    Full Text Available Profiling of putative lead compounds against a representative panel of relevant enzymes, receptors, ion channels and transporters is a pragmatic approach to establish a preliminary view of potential issues that might later hamper development. An early idea of which off-target activities must be minimized can save valuable time and money during the preclinical lead optimization phase if pivotal questions are asked beyond the usual profiling at hERG. The best data for critical evaluation of activity at ion channels is obtained using functional assays, since binding assays cannot detect all interactions and do not provide information on whether the interaction is that of an agonist, antagonist, or allosteric modulator. For ion channels present in human cardiac muscle, depending on the required throughput, manual- or automated- patch-clamp methodologies can be easily used to evaluate compounds individually to accurately reveal any potential liabilities. The issue of expanding screening capacity against a cardiac panel has recently been addressed by developing a series of robust, high-throughput, cell-based counter-screening assays employing fluorescence-based readouts. Similar assay development approaches can be used to configure panels of efficacy assays that can be used to assess selectivity within a family of related ion channels, such as Nav1.X channels. This overview discusses the benefits of in vitro assays, specific decision points where profiling can be of immediate benefit, and highlights the development and validation of patch-clamp and fluorescence-based profiling assays for ion channels.

  18. The importance of being profiled: improving drug candidate safety and efficacy using ion channel profiling.

    Science.gov (United States)

    Kaczorowski, Gregory J; Garcia, Maria L; Bode, Jacob; Hess, Stephen D; Patel, Umesh A

    2011-01-01

    Profiling of putative lead compounds against a representative panel of relevant enzymes, receptors, ion channels, and transporters is a pragmatic approach to establish a preliminary view of potential issues that might later hamper development. An early idea of which off-target activities must be minimized can save valuable time and money during the preclinical lead optimization phase if pivotal questions are asked beyond the usual profiling at hERG. The best data for critical evaluation of activity at ion channels is obtained using functional assays, since binding assays cannot detect all interactions and do not provide information on whether the interaction is that of an agonist, antagonist, or allosteric modulator. For ion channels present in human cardiac muscle, depending on the required throughput, manual-, or automated-patch-clamp methodologies can be easily used to evaluate compounds individually to accurately reveal any potential liabilities. The issue of expanding screening capacity against a cardiac panel has recently been addressed by developing a series of robust, high-throughput, cell-based counter-screening assays employing fluorescence-based readouts. Similar assay development approaches can be used to configure panels of efficacy assays that can be used to assess selectivity within a family of related ion channels, such as Nav1.X channels. This overview discusses the benefits of in vitro assays, specific decision points where profiling can be of immediate benefit, and highlights the development and validation of patch-clamp and fluorescence-based profiling assays for ion channels (for examples of fluorescence-based assays, see Bhave et al., 2010; and for high-throughput patch-clamp assays see Mathes, 2006; Schrøder et al., 2008).

  19. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

    Science.gov (United States)

    Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

    2017-01-01

    Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features

  20. Demonstration of Risk Profiling for promoting safety in SME´s

    DEFF Research Database (Denmark)

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

    2011-01-01

    observations for external safety experts, and useful for SMEs and for risk profiles for two occupations. Finally some experiences about the needs and difficulties in risk awareness in small enterprises as well as requirements for the employer and the employees. Research limitations......Purpose – The purpose of this paper is to identify and assess the risks and potential risks that may lead to accidents. It aims to look at how to improve risk assessment within SMEs for the benefit of all staff. Design/methodology/approach – The research included results from a Dutch project which...... identifies accident risks and safety barriers that are presented in a huge database and risk calculator. The method was first to develop a simple way of accessing this enormous amount of data, second, to develop a tool to observe risks and safety barriers in SMEs and to investigate the usefulness...

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

    Science.gov (United States)

    2016-01-01

    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. PMID:27689098

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

    Directory of Open Access Journals (Sweden)

    Moataz Alhaj

    2016-01-01

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

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

    OpenAIRE

    Riguelle, F. Eksler, V. Holló, P. Vis, M. 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 comparison of road safety status within and between countries, and the accelerated sharing of best practice in road safety policy. One of the macroscopic road safety related areas that SafetyNet focus...

  4. 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.

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

    Science.gov (United States)

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

    2013-12-01

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

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

    Directory of Open Access Journals (Sweden)

    Gotmi Sharwan

    2016-09-01

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

  7. Safety profile and protocol prevention of adverse reactions to uroangiographic contrast media in diagnostic imaging.

    Science.gov (United States)

    Rossi, C; Reginelli, A; D'Amora, M; Di Grezia, G; Mandato, Y; D'Andrea, A; Brunese, L; Grassi, R; Rotondi, A

    2014-01-01

    The purpose of the study is to examine the incidence of adverse reactions caused by non-ionic contrast media in selected patients after desensitization treatment and to evaluate the safety profile of organ iodine contrast media (i.c.m.) in a multistep prevention protocol. In a population of 2000 patients that had received a CT scan, 100 patients with moderate/high risk for adverse reactions against iodinated contrast agents followed a premedication protocol and all adverse reactions are reported and classified as mild, moderate or severe. 1.7 percent of the pre-treated patients reported a mild, immediate type reaction to iodine contrast; of these five patients with allergy 0.71 percent had received iomeprol, 0.35 percent received ioversol and 0.71 percent received iopromide. The incidence of adverse reactions was reported to be higher (4 out of 5 patients) among those that referred a history of hypersensitivity against iodinated i.c.m. Although intravenous contrast materials have greatly improved, especially in terms of their safety profile, they should not be administered if there isn't a clear or justified indication. In conclusion, even if we know that the majority of these reactions are idiosyncratic and unpredictable we propose, with the aim of improving our knowledge on this subject, a multicenter study, based on skin allergy tests (prick test, patch test, intradermal reaction) in selected patients that have had previous experiences of hypersensitivity against parenteral organ iodine contrast media.

  8. 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 com

  9. 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

  10. 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.

  11. Evaluation of bioavailability, efficacy, and safety profile of doxorubicin-loaded solid lipid nanoparticles

    Science.gov (United States)

    Patro, Nagaraju M.; Devi, Kshama; Pai, Roopa S.; Suresh, Sarasija

    2013-12-01

    We investigated the bioavailability, efficacy, and toxicity of doxorubicin-loaded solid lipid nanoparticles (DOX-SLNs) prepared by a simple modified double-emulsification method. A 3-factor, 3-level Box-Behnken statistical design was adopted in the optimization of DOX-SLN formulation considering dependent factors particle size and entrapment efficiency. Optimized SLN formulation composed of lipid (2 %) consisting of soya lecithin and Precirol ATO 5 (1:3) with Pluronic F68 (0.3 %) resulted in 217.36 ± 3.31 nm particle size and 59.45 ± 1.75 % entrapment efficiency. DOX-SLN exhibited significant enhancement ( p enzyme assay, antioxidant enzyme levels, hematological parameters, effect on body weight and tumor volume, tumor necrosis factor-α level, histopathological examination, and survival analysis confirmed the improved efficacy and safety profile of DOX-SLN in 7,12-dimethyl benzanthracene-induced breast cancer in SD rats.

  12. 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.

  13. 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.

  14. 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.

  15. Safety profiling of pioglitazone and telmisartan combination by sub-chronic toxicity study in rat.

    Science.gov (United States)

    Sengupta, Pinaki; Das, Arindam; Ibrahim, Fuzianna; Mandal, Uttam Kumar; Chatterjee, Bappaditya; Mahmood, Syed; Das, Sreemoy Kanti; Kifayatullah, Muhammad

    2016-11-01

    It has been reported that the major cause of mortality in diabetes is cardiovascular diseases and contribution of hypertension is significant in this context. Pioglitazone, a thiazolidinedione class of therapeutic agent is used to treat type 2 diabetes mellitus. Telmisartan, an angiotensin receptor blocker antihypertensive has been reported to have beneficial effect if co-administered with pioglitazone for the management of diabetes complications. The present research work aims to evaluate the safety/toxicity profile of this combination in rat model. The investigation was carried out after co-administering the drugs to the rats for 28 days at three dose levels of 50, 100 and 150 mg/kg covering low to high dose ranges. Various hematological and biochemical parameters were studied in addition to the histopathology of the major organs in order to evaluate the toxicity profile of the combination. Absence of mortality and histopathological changes as well as unaltered hematological and biochemical parameters was observed. This preliminary investigation concludes that the combination of pioglitazone and telmisartan can primarily be stated as safe in animals, even at the dose level which is several folds higher than the intended human dose. Thus, this combination can be explored in future to develop a rational therapy regimen to treat hypertensive diabetic patients.

  16. Establishment of a new quality control and vaccine safety test for influenza vaccines and adjuvants using gene expression profiling.

    Science.gov (United States)

    Momose, Haruka; Mizukami, Takuo; Kuramitsu, Madoka; Takizawa, Kazuya; Masumi, Atsuko; Araki, Kumiko; Furuhata, Keiko; Yamaguchi, Kazunari; Hamaguchi, Isao

    2015-01-01

    We have previously identified 17 biomarker genes which were upregulated by whole virion influenza vaccines, and reported that gene expression profiles of these biomarker genes had a good correlation with conventional animal safety tests checking body weight and leukocyte counts. In this study, we have shown that conventional animal tests showed varied and no dose-dependent results in serially diluted bulk materials of influenza HA vaccines. In contrast, dose dependency was clearly shown in the expression profiles of biomarker genes, demonstrating higher sensitivity of gene expression analysis than the current animal safety tests of influenza vaccines. The introduction of branched DNA based-concurrent expression analysis could simplify the complexity of multiple gene expression approach, and could shorten the test period from 7 days to 3 days. Furthermore, upregulation of 10 genes, Zbp1, Mx2, Irf7, Lgals9, Ifi47, Tapbp, Timp1, Trafd1, Psmb9, and Tap2, was seen upon virosomal-adjuvanted vaccine treatment, indicating that these biomarkers could be useful for the safety control of virosomal-adjuvanted vaccines. In summary, profiling biomarker gene expression could be a useful, rapid, and highly sensitive method of animal safety testing compared with conventional methods, and could be used to evaluate the safety of various types of influenza vaccines, including adjuvanted vaccine.

  17. SAFETY

    CERN Document Server

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  18. 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.

  19. Profile of ranibizumab: efficacy and safety for the treatment of wet age-related macular degeneration

    Directory of Open Access Journals (Sweden)

    Chen Y

    2012-07-01

    Full Text Available Youxin Chen, Fei HanDepartment of Ophthalmology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, ChinaAbstract: Wet age-related macular degeneration (AMD causes severe vision loss due to the development of choroidal neovascularization (CNV. The critical role of vascular endothelial growth factor in the pathogenesis of CNV is well understood. Ranibizumab plays an inhibitory role with CNV and reduces vascular permeability by binding to vascular endothelial growth factor. Intravitreal ranibizumab reduces the risk of visual acuity (VA loss and increases the chance of VA gain compared with no treatment or photodynamic therapy for CNV in AMD. Some high-quality research has shown that the optimal timing for ranibizumab treating wet AMD is the first 3 months. It is recommended that ranibizumab is intravitreally injected monthly in the initiation for at least 3 months. Subsequent managing of regimens should be made dependent on the VA change, fundus examination, and image of optical coherence topography. An individualized strategy or combined method with photodynamic therapy is beneficial to the active lesion in the consecutive treatment of ranibizumab for CNV, and may be a good choice in order to decrease injection times. Regarding the safety profile, ranibizumab has been well tolerated in clinical trials. The principal ocular adverse event detected in clinical trials is a low frequency of ocular inflammation. Key serious ocular adverse events occurred in <5% of ranibizumab-treated patients in large-scale clinical trials. It appears unlikely that treatment with ranibizumab increases the risk of vascular events significantly. Less frequent injections on an as-needed schedule, based on monthly monitoring may have the most optimal risk:benefit ratio.Keywords: age-related macular degeneration, choroidal neovascularization, ranibizumab, efficacy, safety

  20. Developing awareness profiling force and activities linking safety and quality of foods of animal origin in Bangladesh

    Directory of Open Access Journals (Sweden)

    SM Lutful Kabir

    2012-10-01

    Full Text Available Food safety is an important topic as large number of consumers has become victim of consuming adulterated foods. As the food safety laws, administration and inspection in Bangladesh do not include monitoring the chain of production and comply the recommendation by Codex Alimentarius Commission (CAC, Sanitary and Phytosanitary (SPS Agreement, and Hazard Analysis Critical Control Point (HACCP System, the government is encouraging the private sector to put the food processing and marketing into the context of standard, cost effectiveness, public health issues and global trade. Recommendations came up for strengthening collaboration between Ministries and stakeholders. Since the public health service cannot combat alone the complex situation, the governmental agencies and academic institutions must work together to delineate many of the problems in food safety, consumers protection and zoonoses. In this paper the profiling force linking safety and quality of foods of animal origin in Bangladesh is highlighted.

  1. Safety

    CERN Multimedia

    2003-01-01

    Please note that the safety codes A9, A10 AND A11 (ex annexes of SAPOCO/42) entitled respectively "Safety responsibilities in the divisions" "The safety policy committee (SAPOCO) and safety officers' committees" and "Administrative procedure following a serious accident or incident" are available on the web at the following URLs: Code A9: http://edms.cern.ch/document/337016/LAST_RELEASED Code A10: http://edms.cern.ch/document/337019/LAST_RELEASED Code A11: http://edms.cern.ch/document/337026/LAST_RELEASED Paper copies can also be obtained from the TIS divisional secretariat, e-mail: tis.secretariat@cern.ch. TIS Secretariat

  2. Effectiveness and safety profile of 40% trichloroacetic acid and cryotherapy for plantar warts.

    Science.gov (United States)

    Cengiz, Fatma Pelin; Emiroglu, Nazan; Su, Ozlem; Onsun, Nahide

    2016-09-01

    Plantar warts are one of the most common infectious skin disease caused by the human papillomavirus. In this study, cryotherapy with liquid nitrogen delivered by the physician, up to four treatments 2 weeks apart. Forty percent trichloroacetic acid (TCA) was applied to warts weekly up to four treatments. At the end of 4 weeks, the clinical improvement of the TCA group (n = 30) was six patients (20%) with no change, one patient (3.3%) with a mild response, 13 patients (43.3%) with a moderate response and 10 patients (33.3%) with a good response. In the cryotherapy group, clinical responses were 12 patients (40%) with no change, four patients (13.3%) with a mild response, 12 patients (40%) with a moderate response and two patients (6.7%) with a good response. There was a statistically significant difference in improvement between the two treatment groups (P = 0.027). According to our results, TCA 40% is more effective for clearance of plantar warts with significantly improved long-term safety profile.

  3. Safety profile of the respiratory fluoroquinolone moxifloxacin: comparison with other fluoroquinolones and other antibacterial classes.

    Science.gov (United States)

    Van Bambeke, Françoise; Tulkens, Paul M

    2009-01-01

    Moxifloxacin, a fluoroquinolone with potent activity against respiratory pathogens, is approved and considered as an alternative to beta-lactams and macrolides for the treatment of acute bacterial sinusitis and lower respiratory tract infections. In this review, we critically examine its safety profile in comparison with other fluoroquinolones and other antibacterial classes sharing similar indications. Data were extracted from published clinical trials, meta-analyses, postmarketing studies, spontaneous report systems and case reports for rare effects. Global analysis did not reveal significantly higher incidences of drug-related adverse effects than for comparators. Tendon rupture was infrequent with moxifloxacin, including when used in elderly patients with chronic obstructive pulmonary disease. Severe toxic cutaneous reactions and allergies were very rare. Phototoxicity and CNS adverse effects were less common than with other fluoroquinolones. Although causing a 4-7 msec corrected QT interval prolongation, severe cardiac toxicity was neither seen in large cohorts or clinical trials nor reported to pharmacovigilance systems. Hepatotoxicity was not different from what was observed for other fluoroquinolones (excluding trovafloxacin) and less frequent than reported for amoxicillin-clavulanic acid or telithromycin. The data show that using moxifloxacin, in its accepted indications and following the corresponding guidelines, should not be associated with an excessive incidence of drug-related adverse reactions, provided the clinician takes care in identifying patients with known risk factors and pays due attention to the contraindications and warnings mentioned in the labelling.

  4. Scleral fixation of intraocular lenses using Gore-Tex suture: clinical outcomes and safety profile.

    Science.gov (United States)

    Khan, M Ali; Gupta, Omesh P; Smith, Ryan G; Ayres, Brandon D; Raber, Irving M; Bailey, Robert S; Hsu, Jason; Spirn, Marc J

    2016-05-01

    To report the short-term safety profile and clinical outcomes of scleral fixation of intraocular lenses (IOLs) using Gore-Tex suture. Retrospective, interventional case series. 85 eyes of 84 patients undergoing ab externo scleral fixation of a Bausch and Lomb Akreos AO60 or Alcon CZ70BD IOL using Gore-Tex suture. Primary outcome measures were change in visual acuity and occurrence of intraoperative and postoperative complications with minimum follow-up of 90 days. 85 eyes of 84 patients were identified. Mean logarithm of the minimum angle of resolution visual acuity improved from 1.43±0.72 (20/538 Snellen equivalent) preoperatively to 0.64±0.61 (20/87 Snellen equivalent) postoperatively (pGore-Tex suture was well tolerated in all cases. No suture-related complications were encountered. This procedure led to improvement in visual acuity and was not associated with significant intraoperative or postoperative complications. 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/

  5. Results and safety profile of trainee cataract surgeons in a community setting in East Africa.

    Science.gov (United States)

    Mavrakanas, Nikolaos; Dhalla, Kazim A; Jecha, Jerry; Kapesa, Imani; Odouard, Capucine; Murdoch, Ian

    2016-11-01

    To evaluate the results and safety profile of assistant medical officer ophthalmologists (AMO-O) performing cataract surgery in the last stage of their surgical training, before their appointment to local communities. We retrospectively analyzed the records of patients who underwent cataract surgery by AMO-Os at Dar es Salaam, Comprehensive Community Based Rehabilitation for Tanzania Disability Hospital between September 2008 and June 2011. Surgical options were either extracapsular cataract extraction (ECCE) or manual small incision cataract surgery (MSICS), both with polymethylmethacrylate intraocular lens implantation. Four hundred and fourteen patients were included in the study. Two hundred and twenty-five (54%) underwent ECCE and 189 had MSICS. Mean logarithm of the minimum angle of resolution (logMAR) uncorrected visual acuity (UCVA) improved from 2.4 ± 0.6 preoperatively to 1.3 ± 0.8 1 week postoperatively (t-test, P ECCE and MSICS. 89.5% achieved BCVA better than 6/60 and 57.3% better than 6/18 with a follow-up of 3 months. Posterior capsule rupture and/or vitreous loss occurred in 34/414 patients (8.2%) and was more frequent (P = 0.047) in patients undergoing ECCE (10.2%) compared with MSICS (5.3%). AMO-O cataract surgeons at the end of their training offer significant improvement in the visual acuity of their patients. Continuous monitoring of outcomes will guide further improvements in surgical skills and minimize complications.

  6. Evaluation of antidiabetic, antioxidant effect and safety profile of gomutra ark in Wistar albino rats.

    Science.gov (United States)

    Sachdev, Devender O; Gosavi, Devesh D; Salwe, Kartik J

    2012-01-01

    The effect of Gomutra ark (GoA) on experimental alloxan-induced diabetes in rats was studied. For this purpose, Wistar albino rats of either sex weighing 200-250 g were used. The biochemical parameters like blood sugar, vitamin C, and malondialdehyde release were measured. The safety profile of GoA was evaluated using acute and chronic toxicity studies. GoA significantly lowers blood glucose in diabetic rats although the observed effect was found to be less than glibenclamide. It significantly lowers the level of malondialdehyde and vitamin C in diabetic rats. No toxicity was observed even when cow urine was given 32 times of the study dose in acute toxicity and no significant changes were seen when it was used chronically, which suggests that cow urine is having a very high therapeutic index. This study supports the traditional use of GoA in diabetes and is having a high therapeutic index and is safe for chronic use. However, further studies are needed to elucidate the mechanism of action of Gomutra ark.

  7. Effect of vigabatrin on seizure control and safety profile in different subgroups of children with epilepsy.

    Science.gov (United States)

    Jackson, Michele C; Jafarpour, Saba; Klehm, Jacquelyn; Thome-Souza, Sigride; Coughlin, Francesca; Kapur, Kush; Loddenkemper, Tobias

    2017-09-01

    hypsarrhythmia in most patients. In this series with a median treatment duration of 12.1 months, vigabatrin had a good safety profile with a low rate of discontinuation due to nonophthalmologic and ophthalmologic adverse effects. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  8. Safety profile of orlistat: results of a prescription-event monitoring study.

    Science.gov (United States)

    Acharya, N V; Wilton, L V; Shakir, S A W

    2006-11-01

    'gastrointestinal unspecified' events. A similar pattern of predominately gastrointestinal events was seen for reasons for stopping and suspected adverse drug reactions. Review of selected events for causality revealed 45 events which were assessed as possibly or probably related to orlistat. This study shows that orlistat is fairly well tolerated. The safety profile of orlistat was similar to the prescribing information and experience reported in the literature.

  9. A STUDY OF EFFICACY AND SAFETY PROFILE WITH SUB DERMAL SINGLE ROD CONTRACEPTIVE IMPLANT IMPLANON

    Directory of Open Access Journals (Sweden)

    Sapna

    2015-03-01

    Full Text Available INTRODUCTION: The development of sub dermal contraceptive implant has been an important improvement in current contraceptive technology and to a good alternative to offer well established contraceptive method. Hormonal implant must show high efficacy, high acceptabilit y and rapid return of fertility after removal by maintaining a sustained release of progesterone, the contraceptive effect of the implant can be obtained with a much smaller daily dose than when administering the same steroid by an oral or intramuscular ro ute. Sub dermal implant s are also independent of user compliance which remains a determinant factor in the efficacy of most contraceptive methods. In addition after removal of the hormonal implant, fertility returns almost immediately. They contain only pr ogestogen, these implant may also be used by women who cannot tolerate oestrogen or by women for whom oestrogen is contraindicated. The availability of new innovative contraceptive implant system such as implanon is very important to offer couples alternat ive methods to plan size of their family more efficiently. OBJECTIVES: To study efficacy and safety profile of single rod sub dermal contraceptive device implant implanon. To evaluate the vaginal bleeding patterns observed during the use of implanon. To as sess the acceptability of the contraceptive device as indicated by discontinuation rates. MATERIAL AND METHODS: S tudy was carried in OBG department of RMC Kanpur on healthy female volunteers having regular menstruation & at least one living child. RESULT: The result of this study was excellent in terms of contraception with pearl index of 0, almost one third cases were having in frequent bleeding episode. CONCLUSION: The study was conducted on 110 women of age 20 - 35 years with at least one living child and having regular menstrual period, in present study half of cases discontinued implant due to no fix pattern of bleeding and failure was o%, efficacy of this implant

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

    Directory of Open Access Journals (Sweden)

    Abeer Y. IBRAHIM

    2012-02-01

    Full Text Available This study was conducted to investigate the safety profile of Salvadora persica (Salvadoraceae aqueous alcoholic root extract by carrying out acute and sub-chronic toxicity assessment in order to find out any side effect of the traditionally using of these root sticks. Regarding to acute toxicity test, mice were administered the extract up to 5 g kg-1, intraperitoneally. Animals were then observed for behavioural changes; signs of toxicity, and mortality within 24 h. Surviving mice were monitored for 7 days for signs of delayed toxicity. In the sub-chronic toxicity test, rats were daily treated with the extract at a dose of 400 mg kg-1 intraperitoneally, for 30 days. At the end of the test period, hematological and biochemical parameters were determined in blood and serum samples with determination of vital organs weights. In the acute toxicity test, the extract was practically non-toxic showing no mortality and visible signs of delayed toxicity. The LD50, given intraperitoneally, was estimated to be 4 g kg-1. Administration of extract (at a dose of 400 mg Kg-1 b.wt. to male and female rats for 30 days did not produce any significant (P < 0.05 effect on hematological and most biochemical parameters also vital organs weights. The root extract showed adverse effects on sexual hormones, by increasing estrogen secretion and reducing testosterone level in male rats. At the same time, the extract reduces progesterone level in female satellite group. Overall, Meswak aqueous extract is safe concerning liver and kidney functions and hematological assessments; however, it induces reversal effect on sexual hormones levels determined in sera.

  11. 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.

  12. 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.

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

    Institute of Scientific and Technical Information of China (English)

    Mekonnen Haileselassie; Habtamu Taddele; Kelali Adhana; Shewit Kalayou

    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.

  14. Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

    Science.gov (United States)

    Michel, Christiane; Scosyrev, Emil; Petrin, Michael; Schmouder, Robert

    2017-05-01

    Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed. Because disproportionality analysis is based on spontaneous reports submitted for a large number of drugs and adverse event types, one might consider using these data to compare safety profiles across drugs. In fact, recent publications have promoted this practice, claiming to provide guidance on treatment decisions to healthcare decision makers. In this article we investigate the validity of this approach. We argue that disproportionality cannot be used for comparative drug safety analysis beyond basic hypothesis generation because measures of disproportionality are: (1) missing the incidence denominators, (2) subject to severe reporting bias, and (3) not adjusted for confounding. Hypotheses generated by disproportionality analyses must be investigated by more robust methods before they can be allowed to influence clinical decisions.

  15. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines

    NARCIS (Netherlands)

    Pane, J. (Josep); P.M. Coloma (Preciosa); K.M.C. Verhamme (Katia); M.C.J.M. Sturkenboom (Miriam); Rebollo, I. (Irene)

    2017-01-01

    textabstractRecent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our obje

  16. Safety profile of L-arginine infusion in moderately severe falciparum malaria.

    Directory of Open Access Journals (Sweden)

    Tsin W Yeo

    Full Text Available BACKGROUND: L-arginine infusion improves endothelial function in malaria but its safety profile has not been described in detail. We assessed clinical symptoms, hemodynamic status and biochemical parameters before and after a single L-arginine infusion in adults with moderately severe malaria. METHODOLOGY AND FINDINGS: In an ascending dose study, adjunctive intravenous L-arginine hydrochloride was infused over 30 minutes in doses of 3 g, 6 g and 12 g to three separate groups of 10 adults hospitalized with moderately severe Plasmodium falciparum malaria in addition to standard quinine therapy. Symptoms, vital signs and selected biochemical measurements were assessed before, during, and for 24 hours after infusion. No new or worsening symptoms developed apart from mild discomfort at the intravenous cannula site in two patients. There was a dose-response relationship between increasing mg/kg dose and the maximum decrease in systolic (rho = 0.463; Spearman's, p = 0.02 and diastolic blood pressure (r = 0.42; Pearson's, p = 0.02, and with the maximum increment in blood potassium (r = 0.70, p<0.001 and maximum decrement in bicarbonate concentrations (r = 0.53, p = 0.003 and pH (r = 0.48, p = 0.007. At the highest dose (12 g, changes in blood pressure and electrolytes were not clinically significant, with a mean maximum decrease in mean arterial blood pressure of 6 mmHg (range: 0-11; p<0.001, mean maximal increase in potassium of 0.5 mmol/L (range 0.2-0.7 mmol/L; p<0.001, and mean maximal decrease in bicarbonate of 3 mEq/L (range 1-7; p<0.01 without a significant change in pH. There was no significant dose-response relationship with blood phosphate, lactate, anion gap and glucose concentrations. All patients had an uncomplicated clinical recovery. CONCLUSIONS/SIGNIFICANCE: Infusion of up to 12 g of intravenous L-arginine hydrochloride over 30 minutes is well tolerated in adults with moderately severe malaria, with no clinically important changes in

  17. Results and safety profile of trainee cataract surgeons in a community setting in East Africa

    Directory of Open Access Journals (Sweden)

    Nikolaos Mavrakanas

    2016-01-01

    Full Text Available Purpose: To evaluate the results and safety profile of assistant medical officer ophthalmologists (AMO-O performing cataract surgery in the last stage of their surgical training, before their appointment to local communities. Methods: We retrospectively analyzed the records of patients who underwent cataract surgery by AMO-Os at Dar es Salaam, Comprehensive Community Based Rehabilitation for Tanzania Disability Hospital between September 2008 and June 2011. Surgical options were either extracapsular cataract extraction (ECCE or manual small incision cataract surgery (MSICS, both with polymethylmethacrylate intraocular lens implantation. Results: Four hundred and fourteen patients were included in the study. Two hundred and twenty-five (54% underwent ECCE and 189 had MSICS. Mean logarithm of the minimum angle of resolution (logMAR uncorrected visual acuity (UCVA improved from 2.4 ± 0.6 preoperatively to 1.3 ± 0.8 1 week postoperatively (t-test, P < 0.001 and to 1.1 ± 0.7 3 months postoperatively (t-test, P < 0.001. Mean logMAR best-corrected visual acuity (BCVA was 0.7 ± 0.5 1 week postoperatively and 0.6 ± 0.5 3 months postoperatively. There was no significant difference in mean logMAR UCVA (P = 0.7 and BCVA (P = 0.7 postoperatively between ECCE and MSICS. 89.5% achieved BCVA better than 6/60 and 57.3% better than 6/18 with a follow-up of 3 months. Posterior capsule rupture and/or vitreous loss occurred in 34/414 patients (8.2% and was more frequent (P = 0.047 in patients undergoing ECCE (10.2% compared with MSICS (5.3%. Conclusion: AMO-O cataract surgeons at the end of their training offer significant improvement in the visual acuity of their patients. Continuous monitoring of outcomes will guide further improvements in surgical skills and minimize complications.

  18. Safety profile of biologic drugs in the therapy of Crohn disease: A systematic review and network meta-analysis.

    Science.gov (United States)

    Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

    2016-12-01

    Crohn disease (CD) is an inflammatory bowel disease which occurs especially in developed countries of Western Europe and North America. The aim of the study was to compare the safety profile of biologic drugs in patients with CD. A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, until April 27, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, vedolizumab, certolizumab pegol, and ustekinumab) with one another or with placebo in patients with CD. The network meta-analysis (NMA) was conducted for an induction phase (6-10 weeks) and maintenance phase (52-56 weeks) with a Bayesian hierarchical random effects model in the ADDIS(®) software. The PROSPERO registration number was CRD42016032606. Ten RCTs were included in the systematic review with NMA. In the case of the induction phase, the NMA could be conducted for the assessment of the relative safety profile of adalimumab, vedolizumab, certolizumab pegol, and ustekinumab, and in the case of the maintenance phase-of infliximab, adalimumab, and vedolizumab. There were no significant differences in the rate of adverse events in patients treated with biologics. Statistical analysis revealed that vedolizumab had the greatest probability of being the safest treatment in most endpoints in the induction phase and adalimumab-in the maintenance phase. No significant differences between the biologics in the relative safety profile analysis were observed. Further studies are needed to confirm our findings, including head-to-head comparisons between the analyzed biologics. Copyright © 2016 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

  19. 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

    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 we...

  20. Use of speed profile as surrogate measure: Effect of traffic calming devices on crosstown road safety performance.

    Science.gov (United States)

    Moreno, Ana Tsui; García, Alfredo

    2013-12-01

    Urban road safety management is usually characterized by the lack of sufficient, good quality crash data and low budgets to obtain it even though many traffic accidents occur there. For example, 54 percent of road crashes in Spain take place in urban areas, and 10 percent of urban fatal crashes occur on crosstown roads, which are rural roads that traverse small communities. Traffic calming measures (TCMs) are often implemented on these parts of rural roads that traverse small communities in order to reduce both the frequency and severity of crashes by lowering speeds, but evaluation of their effectiveness has been limited. The objective of this study was to develop a methodology using continuous speed profiles to evaluate the safety effectiveness of TCMs on crosstown roads as part of an integrated system in the absence of historical data. Given the strong relationship between speed and crash experience, safety performance can be related to speed. Consequently, speed can be used indirectly as a surrogate safety measure in the absence of crash and speed data. Two indexes were defined in this study as surrogate safety measures based on the continuous speed profile: Ra and Ea. Ra represents the absolute accumulated speed variations relative to the average speed and is inversely related to accumulated speed uniformity; and Ea represents the accumulated speed variations above the speed limit and is directly related to accumulated speeding. Naturalistic data were collected using GPS trackers for 12 scenarios with different TCM spacings. Then, the indexes were applied to individual observed speed profiles (individual analysis) as well as the operating speed profile (global analysis). The values obtained from individual and global analysis were statistically different. Spacing lower than 110m, which was found optimal from previous research, did not allow drivers to modify their speeds as the accumulated speed uniformity was quite similar regardless of the average operating

  1. 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.

  2. 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 lath...

  3. An open-label study to investigate the cardiac safety profile of cabazitaxel in patients with advanced solid tumors

    DEFF Research Database (Denmark)

    Maison-Blanche, Pierre; Dakhil, Shaker; Baron, Ari;

    2014-01-01

    additional ECG parameters (QT, PR and QRS intervals, and heart rate), plasma pharmacokinetics of cabazitaxel and overall clinical safety. RESULTS: The pharmacodynamic (ECG) population included 94 patients. In 63 patients with a full 24-h ECG evaluation, the maximum upper bound of 90 % confidence interval (CI......PURPOSE: This study assessed the cardiovascular safety of cabazitaxel, based on thorough evaluation of QT and non-QT variables, and the relationship between pharmacokinetic and pharmacodynamic electrocardiographic (ECG) profiles and the occurrence of Grade ≥3 cardiovascular adverse events. METHODS......: Patients with advanced solid tumors were treated with cabazitaxel 25 mg/m(2) every 3 weeks. Digital ECG recordings were obtained during Cycle 1 over 24 h after dosing. The primary end point was effect of cabazitaxel on QT interval corrected by the Fridericia formula (QTcF). Secondary end points were...

  4. Approaching low liver iron burden in chelated patients with non-transfusion-dependent thalassemia: the safety profile of deferasirox

    Science.gov (United States)

    Taher, Ali T; Porter, John B; Viprakasit, Vip; Kattamis, Antonis; Chuncharunee, Suporn; Sutcharitchan, Pranee; Siritanaratkul, Noppadol; Origa, Raffaella; Karakas, Zeynep; Habr, Dany; Zhu, Zewen; Cappellini, M Domenica

    2014-01-01

    Objective Patients with non-transfusion-dependent thalassemia (NTDT) often develop iron overload and related complications, and may require iron chelation. However, the risk of over-chelation emerges as patients reach low, near-normal body iron levels and dose adjustments may be needed. In the THALASSA study, the threshold for chelation interruption was LIC <3 mg Fe/g dw (LIC<3); 24 patients receiving deferasirox for up to 2 yr reached this target. A post hoc analysis was performed to characterize the safety profile of deferasirox as these patients approached LIC<3. Methods THALASSA was a randomized, double-blind, placebo-controlled study of two deferasirox regimens (5 and 10 mg/kg/d) versus placebo in patients with NTDT. Patients randomized to deferasirox or placebo in the core could enter a 1-yr extension, with all patients receiving deferasirox (extension starting doses based on LIC at end-of-core and prior chelation response). The deferasirox safety profile was assessed between baseline and 6 months before reaching LIC<3 (Period 1), and the 6 months immediately before achieving LIC<3 (Period 2). Results Mean ± SD deferasirox treatment duration up to reaching LIC<3 was 476 ± 207 d, and deferasirox dose was 9.7 ± 3.0 mg/kg/d. The exposure-adjusted AE incidence regardless of causality was similar in periods 1 (1.026) and 2 (1.012). There were no clinically relevant differences in renal and hepatic laboratory parameters measured close to the time of LIC<3 compared with measurements near the previous LIC assessment. Conclusions The deferasirox safety profile remained consistent as patients approached the chelation interruption target, indicating that, with appropriate monitoring and dose adjustments in relation to iron load, low iron burdens may be reached with deferasirox with minimal risk of over-chelation. PMID:24460655

  5. 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.

  6. SAFETY

    CERN Multimedia

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  7. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  8. Safety profile of Cerebrolysin: clinical experience from dementia and stroke trials.

    Science.gov (United States)

    Thome, J; Doppler, E

    2012-04-01

    The safety of Cerebrolysin has been shown through many years of clinical use, observations from postmarketing surveillance studies, and safety data from randomized, controlled clinical trials. The reported events showed that adverse reactions to Cerebrolysin were generally mild and transient. Most common adverse events included vertigo, agitation and feeling hot. In the controlled clinical trials analyzed for this report, the incidence of adverse events was similar in Cerebrolysin- and placebo-treated groups. Cerebrolysin seems to be safe when used in combination with recombinant tissue-type plasminogen activator or cholinesterase inhibitors such as donepezil or rivastigmine. To our knowledge, Cerebrolysin was not associated with major changes in vital signs or laboratory parameters.

  9. Optimization of the Safety Factor Profile for High Noninductive Current Fraction Discharges in DIII-D

    Energy Technology Data Exchange (ETDEWEB)

    Ferron, J.R. [General Atomics, San Diego; Holcomb, C T [Lawrence Livermore National Laboratory (LLNL); Luce, T.C. [General Atomics, San Diego; Politzer, P. A. [General Atomics, San Diego; Turco, F. [Oak Ridge Associated Universities (ORAU); White, A. E. [Massachusetts Institute of Technology (MIT); DeBoo, J. C. [General Atomics; Doyle, E. J. [University of California, Los Angeles; Hyatt, A. W. [General Atomics, San Diego; La Haye, R. [General Atomics, San Diego; Murakami, Masanori [ORNL; Petrie, T W [General Atomics, San Diego; Petty, C C. [General Atomics, San Diego; Rhodes, T. L. [University of California, Los Angeles; Zeng, L. [University of California, Los Angeles

    2011-01-01

    In order to assess the optimum q profile for discharges in DIII-D with 100% of the current driven noninductively (f(NI) = 1), the self-consistent response of the plasma profiles to changes in the q profile was studied in high f(NI), high beta(N) discharges through a scan of q(min) and q(95) at two values of beta(N). As expected, both the bootstrap current fraction, f(BS), and f(NI) increased with q(95). The temperature and density profiles were found to broaden as either q(min) or beta(N) is increased. A consequence is that f(BS) does not continue to increase at the highest values of q(min). A scaling function that depends on q(min), q(95), and the peaking factor for the thermal pressure was found to represent well the f(BS)/beta(N) inferred from the experimental profiles. The changes in the shapes of the density and temperature profiles as beta(N) is increased modify the bootstrap current density (J(BS)) profile from peaked close to the axis to relatively flat in the region between the axis and the H-mode pedestal. Therefore, significant externally driven current density in the region inside the H-mode pedestal is required in addition to J(BS) in order to match the profiles of the noninductive current density (J(NI)) to the desired total current density (J). In this experiment, the additional current density was provided mostly by neutral beam current drive with the neutral-beam-driven current fraction 40-90% of f(BS). The profiles of J(NI) and J were most similar at q(min) approximate to 1.35-1.65, q(95) approximate to 6.8, where f(BS) is also maximum, establishing this q profile as the optimal choice for f(NI) = 1 operation in DIII-D with the existing set of external current drive sources.

  10. Is 3D technique superior to 2D in Down syndrome screening? Evaluation of six second and third trimester fetal profile markers

    NARCIS (Netherlands)

    Vos, F. I.; Bakker, M.; de Jong-Pleij, E. A. P.; Ribbert, L. S. M.; Tromp, E.; Bilardo, C. M.

    2015-01-01

    ObjectiveThe objective of this article is to investigate whether in the clinical setting of second trimester ultrasound (US) investigations, 3D multiplanar correction prior to the measurement of Down syndrome (DS) facial markers (nasal bone length, prenasal thickness, fetal profile line, maxilla-nas

  11. Long-Term Efficacy and Safety Profile of Lanthanum Carbonate: Results for up to 6 Years of Treatment

    Science.gov (United States)

    Hutchison, Alastair J.; Barnett, M. Edwina; Krause, Rolfdieter; Kwan, Jonathan T.C.; Siami, Ghodrat A.

    2008-01-01

    Background/Aims Lanthanum carbonate (LC, FOSRENOL®) is an effective phosphate binder for which tolerability and a safety profile have been reported in haemodialysis patients. Patients from previous studies entered a 2-year extension, enabling assessment of efficacy and safety for up to 6 years of LC monotherapy. Methods Patients from four previous trials entered this study. Results Ninety-three patients started the extension, with 22 entering a sixth year of LC treatment. Two-thirds of all patients received LC doses of 2,250 or 3,000 mg/day. Reductions in serum phosphate and calcium × phosphate product were maintained for up to 6 years. There were no new or unexpected adverse events (AEs), and no increase in the incidence of events with increasing treatment exposure. Over the complete duration of therapy, treatment-related AEs occurred in 25.8% of patients and were primarily gastrointestinal in nature. No clinically relevant changes in liver function tests were observed and there was no evidence of adverse effects on the liver, bone or the central nervous system. Conclusions LC monotherapy was effective and well tolerated for up to 6 years with no evidence of safety concerns or increased frequency of AEs. PMID:18667837

  12. Functional profiles of SCN9A variants in dorsal root ganglion neurons and superior cervical ganglion neurons correlate with autonomic symptoms in small fibre neuropathy.

    Science.gov (United States)

    Han, Chongyang; Hoeijmakers, Janneke G J; Liu, Shujun; Gerrits, Monique M; te Morsche, Rene H M; Lauria, Giuseppe; Dib-Hajj, Sulayman D; Drenth, Joost P H; Faber, Catharina G; Merkies, Ingemar S J; Waxman, Stephen G

    2012-09-01

    Patients with small fibre neuropathy typically manifest pain in distal extremities and severe autonomic dysfunction. However, occasionally patients present with minimal autonomic symptoms. The basis for this phenotypic difference is not understood. Sodium channel Na(v)1.7, encoded by the SCN9A gene, is preferentially expressed in the peripheral nervous system within sensory dorsal root ganglion and sympathetic ganglion neurons and their small diameter peripheral axons. We recently reported missense substitutions in SCN9A that encode functional Na(v)1.7 variants in 28% of patients with biopsy-confirmed small fibre neuropathy. Two patients with biopsy-confirmed small fibre neuropathy manifested minimal autonomic dysfunction unlike the other six patients in this series, and both of these patients carry the Na(v)1.7/R185H variant, presenting the opportunity to compare variants associated with extreme ends of a spectrum from minimal to severe autonomic dysfunction. Herein, we show by voltage-clamp that R185H variant channels enhance resurgent currents within dorsal root ganglion neurons and show by current-clamp that R185H renders dorsal root ganglion neurons hyperexcitable. We also show that in contrast, R185H variant channels do not produce detectable changes when studied by voltage-clamp within sympathetic neurons of the superior cervical ganglion, and have no effect on the excitability of these cells. As a comparator, we studied the Na(v)1.7 variant I739V, identified in three patients with small fibre neuropathy characterized by severe autonomic dysfunction as well as neuropathic pain, and show that this variant impairs channel slow inactivation within both dorsal root ganglion and superior cervical ganglion neurons, and renders dorsal root ganglion neurons hyperexcitable and superior cervical ganglion neurons hypoexcitable. Thus, we show that R185H, from patients with minimal autonomic dysfunction, does not produce detectable changes in the properties of

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

    Directory of Open Access Journals (Sweden)

    Wenli Zhang

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

  14. Improving health profile of blood donors as a consequence of transfusion safety efforts

    DEFF Research Database (Denmark)

    Edgren, Gustaf; Tran, Trung Nam; Hjalgrim, Henrik

    2007-01-01

    BACKGROUND: Transfusion safety rests heavily on the health of blood donors. Although they are perceived as being healthier than average, little is known about their long-term disease patterns and to which extent the blood banks' continuous efforts to optimize donor selection has resulted in impro...... nature, have successfully refined the selection of a particularly healthy subpopulation Udgivelsesdato: 2007-Nov......BACKGROUND: Transfusion safety rests heavily on the health of blood donors. Although they are perceived as being healthier than average, little is known about their long-term disease patterns and to which extent the blood banks' continuous efforts to optimize donor selection has resulted...... or to the selection criteria for blood donation. Blood donors recruited in more recent years exhibited a lower relative mortality than those who started earlier. CONCLUSION: Blood donors enjoy better than average health. Explicit and informal requirements for blood donation in Scandinavia, although mostly of a simple...

  15. 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...

  16. Intravenous bisphosphonates for postmenopausal osteoporosis: safety profiles of zoledronic acid and ibandronate in clinical practice.

    Science.gov (United States)

    Sieber, Patricia; Lardelli, Patrizia; Kraenzlin, Claude A; Kraenzlin, Marius E; Meier, Christian

    2013-02-01

    Intravenous bisphosphonates are widely used for treatment of postmenopausal osteoporosis. They are associated with transient influenza-like symptoms, predominantly after the first zoledronic acid (up to 32 %) or ibandronate (up to 5 %) administration. The experience in clinical practice suggests that the incidence of post-dose symptoms is higher than has been reported in clinical trials. We assessed the safety of annual infusions of zoledronic acid and 3-monthly injections of ibandronate in women with postmenopausal osteoporosis. In this retrospective study we analysed safety data from 272 postmenopausal women treated with zoledronic acid (n = 127; mean age 68.6 ± 9.4 years) or intravenous (IV) ibandronate (n = 145; mean age 69.1 ± 9.0 years). Safety data (including occurrence of acute-phase reactions and osteonecrosis of the jaw) were gathered in phone call interviews by using a standardized questionnaire. The number of patients with adverse events was significantly higher in zoledronic acid as compared to ibandronate-treated patients, primarily because of a larger number of post-dose symptoms after bisphosphonate administrations (54.3 % vs. 33.1 %, p 3 days in approximately 50 % of patients. The incidence of symptoms decreased after subsequent infusions. The rate of influenza-like symptoms was more frequent after zoledronic acid than after IV ibandronate in bisphosphonate-naïve patients but comparable in patients pretreated with oral bisphosphonates. There were no spontaneous reports of osteonecrosis of the jaw, arrhythmia or delayed fracture healing. Although IV bisphosphonates are generally safe, the occurrence of transient influenza-like symptoms after IV bisphosphonates seems to be more frequent in clinical practice than has been reported in clinical trials.

  17. Myrrh and trematodoses in Egypt: an overview of safety, efficacy and effectiveness profiles.

    Science.gov (United States)

    Abdul-Ghani, Rashad A; Loutfy, Naguiba; Hassan, Azza

    2009-09-01

    Myrrh is an herbal product that has been used since ancient ages for traditional medication and other purposes. The revolution of myrrh as an antiparasitic agent in Egypt began in the 1990s through scientific evidence-based research. The human trematode infections in Egypt were the main focus of research with stories of success and disagreement, at times. The present paper reviewed the antiparasitary activity of myrrh with stress on its possible mode of action, its safety, efficacy and effectiveness on trematode infections in experimental studies and clinical trials in Egypt as well as its molluscicidal effects on the intermediate hosts of trematodes.

  18. Treating Breast Conservation Therapy Defects with Brava and Fat Grafting: Technique, Outcomes, and Safety Profile.

    Science.gov (United States)

    Mirzabeigi, Michael N; Lanni, Michael; Chang, Catherine S; Stark, Ran Y; Kovach, Stephen J; Wu, Liza C; Serletti, Joseph M; Bucky, Louis P

    2017-09-01

    Fat grafting has been demonstrated as a means of reconstructing breast conservation therapy defects. However, there is continued uncertainty regarding its clinical efficacy and oncologic safety. Furthermore, the role of external preexpansion (i.e., with the Brava device) remains unclear in this setting. The purpose of this study was to examine the safety and clinical outcomes of Brava/fat grafting following breast conservation therapy. A retrospective chart review was performed on all patients undergoing fat grafting following breast conservation therapy. Complications were defined as either a clinically palpable oil cyst/area of fat necrosis or infection. The mean time of follow-up was 2.3 years. A total of 27 fat grafting sessions were performed on 20 patients, with an overall complication rate of 25 percent. The mean interval from completion of radiation therapy to fat grafting was 7 years and was not a significant predictor for complications (p = 0.46). Among those who underwent repeated grafting, there was no difference in the complication rates between their first and second encounters (p = 0.56). There was no difference in complication rates between patients with Brava preexpansion and those without preexpansion. Patients undergoing Brava preexpansion had a significantly higher initial fill volume in comparison with those who did not (219 cc versus 51 cc; p = 0.0017). There were no cases of locoregional cancer recurrence following fat grafting. Brava preexpansion was associated with higher initial fill volume in the setting of breast conservation therapy defects.

  19. 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

  20. Safety profile of sural nerve in posterolateral approach to the ankle joint: MRI study.

    Science.gov (United States)

    Ellapparadja, Pregash; Husami, Yaya; McLeod, Ian

    2014-05-01

    The posterolateral approach to ankle joint is well suited for ORIF of posterior malleolar fractures. There are no major neurovascular structures endangering this approach other than the sural nerve. The sural nerve is often used as an autologous peripheral nerve graft and provides sensation to the lateral aspect of the foot. The aim of this paper is to measure the precise distance of the sural nerve from surrounding soft tissue structures so as to enable safe placement of skin incision in posterolateral approach. This is a retrospective image review study involving 64 MRI scans. All measurements were made from Axial T1 slices. The key findings of the paper is the safety window for the sural nerve from the lateral border of tendoachilles (TA) is 7 mm, 1.3 cm and 2 cm at 3 cm above ankle joint, at the ankle joint and at the distal tip of fibula respectively. Our study demonstrates the close relationship of the nerve in relation to TA and fibula in terms of exact measurements. The safety margins established in this study should enable the surgeon in preventing endangerment of the sural nerve encountered in this approach.

  1. Evaluation of in vitro and in vivo safety profile of the Indian traditional medicinal plant Grewia tiliaefolia.

    Science.gov (United States)

    Dicson, Sheeja Malar; Samuthirapandi, Muniasamy; Govindaraju, Archunan; Kasi, Pandima Devi

    2015-10-01

    Grewia tiliaefolia Vahl., is a subtropical tree used in Ayurvedic formulations and also by tribal communities in India for treatment of wounds, urinary infection and skin diseases. Despite of its medicinal use, the plant has not been previously tested for its safety. This study evaluated the toxicological profile of the methanolic extract of G. tiliaefolia leaves (MEGT) through in vitro (cytotoxic, mutagenic, genotoxic) and in vivo (acute and sub-acute) studies. In vitro assays conclude that there is no significant (pcytotoxicity and genotoxicity at the tested concentrations (250-2000 μg/ml) in peripheral blood mononuclear cells. Ames assay in the tested Salmonella typhimurium strains revealed no significant (ptested concentrations and is safe to be used as herbal medicine. Copyright © 2015 Elsevier Inc. All rights reserved.

  2. Evaluation of safety profile of black shilajit after 91 days repeated administration in rats

    Institute of Scientific and Technical Information of China (English)

    Velmurugan C; Vivek B; Wilson E; Bharathi T; Sundaram T

    2012-01-01

    Objective: To evaluate the safety of shilajit by 91 days repeated administration in different dose levels in rats. Methods: In this study the albino rats were divided into four groups. Group I received vehicle and group II, III and IV received 500, 2500 and 5000 mg/kg of shilajit, respectively. Finally animals were sacrificed and subjected to histopathology and iron was estimated by flame atomic absorption spectroscopy and graphite furnace. Results: The result showed that there were no significant changes in iron level of treated groups when compared with control except liver (5000 mg/kg) and histological slides of all organs revealed normal except negligible changes in liver and intestine with the highest dose of shilajit. The weight of all organs was normal when compared with control. Conclusions: The result suggests that black shilajit, an Ayurvedic formulation, is safe for long term use as a dietary supplement for a number of disorders like iron deficiency anaemia.

  3. Safety profile of subjects treated to very low low-density lipoprotein cholesterol levels (JUPITER).

    Science.gov (United States)

    Everett, Brendan M; Mora, Samia; Glynn, Robert J; MacFadyen, Jean; Ridker, Paul M

    2014-12-01

    Recent US guidelines expand the indications for high-intensity statin therapy, yet data on the safety of attaining very low-density lipoprotein cholesterol (LDL-C) levels are scarce. Among 16,304 participants in the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) with on-treatment LDL-C levels, we identified 767 who did and 7,387 who did not achieve LDL-C JUPITER, achieving LDL-C levels <30 mg/dl with high-intensity statin therapy appeared to be generally well tolerated but associated with certain adverse events, including more physician-reported diabetes, hematuria, hepatobiliary disorders, and insomnia. These data may guide the monitoring of patients on intensive statin therapy and adverse events in trials of therapies that lead to very low LDL-C levels.

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

    Science.gov (United States)

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

    2015-06-01

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

  5. Practice-based evidence: profiling the safety of cilostazol by text-mining of clinical notes.

    Science.gov (United States)

    Leeper, Nicholas J; Bauer-Mehren, Anna; Iyer, Srinivasan V; Lependu, Paea; Olson, Cliff; Shah, Nigam H

    2013-01-01

    Peripheral arterial disease (PAD) is a growing problem with few available therapies. Cilostazol is the only FDA-approved medication with a class I indication for intermittent claudication, but carries a black box warning due to concerns for increased cardiovascular mortality. To assess the validity of this black box warning, we employed a novel text-analytics pipeline to quantify the adverse events associated with Cilostazol use in a clinical setting, including patients with congestive heart failure (CHF). We analyzed the electronic medical records of 1.8 million subjects from the Stanford clinical data warehouse spanning 18 years using a novel text-mining/statistical analytics pipeline. We identified 232 PAD patients taking Cilostazol and created a control group of 1,160 PAD patients not taking this drug using 1:5 propensity-score matching. Over a mean follow up of 4.2 years, we observed no association between Cilostazol use and any major adverse cardiovascular event including stroke (OR = 1.13, CI [0.82, 1.55]), myocardial infarction (OR = 1.00, CI [0.71, 1.39]), or death (OR = 0.86, CI [0.63, 1.18]). Cilostazol was not associated with an increase in any arrhythmic complication. We also identified a subset of CHF patients who were prescribed Cilostazol despite its black box warning, and found that it did not increase mortality in this high-risk group of patients. This proof of principle study shows the potential of text-analytics to mine clinical data warehouses to uncover 'natural experiments' such as the use of Cilostazol in CHF patients. We envision this method will have broad applications for examining difficult to test clinical hypotheses and to aid in post-marketing drug safety surveillance. Moreover, our observations argue for a prospective study to examine the validity of a drug safety warning that may be unnecessarily limiting the use of an efficacious therapy.

  6. Inhibition of EGF Uptake by Nephrotoxic Antisense Drugs In Vitro and Implications for Preclinical Safety Profiling

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    Annie Moisan

    2017-03-01

    Full Text Available Antisense oligonucleotide (AON therapeutics offer new avenues to pursue clinically relevant targets inaccessible with other technologies. Advances in improving AON affinity and stability by incorporation of high affinity nucleotides, such as locked nucleic acids (LNA, have sometimes been stifled by safety liabilities related to their accumulation in the kidney tubule. In an attempt to predict and understand the mechanisms of LNA-AON-induced renal tubular toxicity, we established human cell models that recapitulate in vivo behavior of pre-clinically and clinically unfavorable LNA-AON drug candidates. We identified elevation of extracellular epidermal growth factor (EGF as a robust and sensitive in vitro biomarker of LNA-AON-induced cytotoxicity in human kidney tubule epithelial cells. We report the time-dependent negative regulation of EGF uptake and EGF receptor (EGFR signaling by toxic but not innocuous LNA-AONs and revealed the importance of EGFR signaling in LNA-AON-mediated decrease in cellular activity. The robust EGF-based in vitro safety profiling of LNA-AON drug candidates presented here, together with a better understanding of the underlying molecular mechanisms, constitutes a significant step toward developing safer antisense therapeutics.

  7. Safety profile and pharmacokinetic analyses of the anti-CTLA4 antibody tremelimumab administered as a one hour infusion

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    Ribas Antoni

    2012-11-01

    Full Text Available Abstract Background CTLA4 blocking monoclonal antibodies provide a low frequency but durable tumor responses in patients with metastatic melanoma, which led to the regulatory approval of ipilimumab based on two randomized clinical trials with overall survival advantage. The similarly fully human anti-CTLA4 antibody tremelimumab had been developed in the clinic at a fixed rate infusion, resulting in very prolonged infusion times. A new formulation of tremelimumab allowed testing a shorter infusion time. Methods A phase 1 multi-center study to establish the safety and tolerability of administering tremelimumab as a 1-hour infusion to patients with metastatic melanoma. Secondary endpoints included pharmacokinetic and clinical effects of tremelimumab. Results No grade 3 or greater infusion-related adverse events or other adverse events preventing the administration of the full tremelimumab dose were noted in 44 treated patients. The overall side effect profile was consistent with prior experiences with anti-CTLA4 antibodies. Objective tumor responses were noted in 11% of evaluable patients with metastatic melanoma, which is also consistent with the prior experience with CTLA4 antagonistic antibodies. Conclusions This study did not identify any safety concerns when tremelimumab was administered as a 1-hour infusion. These data support further clinical testing of the 1-hour infusion of tremelimumab. (Clinical trial registration number NCT00585000.

  8. Transcriptome profiling of patient-specific human iPSC-cardiomyocytes predicts individual drug safety and efficacy responses in vitro

    Science.gov (United States)

    Matsa, Elena; Burridge, Paul W.; Yu, Kun-Hsing; Ahrens, John H.; Termglinchan, Vittavat; Wu, Haodi; Liu, Chun; Shukla, Praveen; Sayed, Nazish; Churko, Jared M.; Shao, Ningyi; Woo, Nicole A.; Chao, Alexander S.; Gold, Joseph D.; Karakikes, Ioannis; Snyder, Michael P.; Wu, Joseph C.

    2016-01-01

    SUMMARY Understanding individual susceptibility to drug-induced cardiotoxicity is key to improving patient safety and preventing drug attrition. Human induced pluripotent stem cells (hiPSCs) enable the study of pharmacological and toxicological responses in patient-specific cardiomyocytes (CMs), and may serve as preclinical platforms for precision medicine. Transcriptome profiling in hiPSC-CMs from seven individuals lacking known cardiovascular disease-associated mutations, and in three isogenic human heart tissue and hiPSC-CM pairs, showed greater inter-patient variation than intra-patient variation, verifying that reprogramming and differentiation preserve patient-specific gene expression, particularly in metabolic and stress-response genes. Transcriptome-based toxicology analysis predicted and risk-stratified patient-specific susceptibility to cardiotoxicity, and functional assays in hiPSC-CMs using tacrolimus and rosiglitazone, drugs targeting pathways predicted to produce cardiotoxicity, validated inter-patient differential responses. CRISPR/Cas9-mediated pathway correction prevented drug-induced cardiotoxicity. Our data suggest that hiPSC-CMs can be used in vitro to predict and validate patient-specific drug safety and efficacy, potentially enabling future clinical approaches to precision medicine. PMID:27545504

  9. Superior Effects of Eccentric to Concentric Knee Extensor Resistance Training on Physical Fitness, Insulin Sensitivity and Lipid Profiles of Elderly Men

    Science.gov (United States)

    Chen, Trevor Chung-Ching; Tseng, Wei-Chin; Huang, Guan-Ling; Chen, Hsin-Lian; Tseng, Kuo-Wei; Nosaka, Kazunori

    2017-01-01

    It has been reported that eccentric training of knee extensors is effective for improving blood insulin sensitivity and lipid profiles to a greater extent than concentric training in young women. However, it is not known whether this is also the case for elderly individuals. Thus, the present study tested the hypothesis that eccentric training of the knee extensors would improve physical function and health parameters (e.g., blood lipid profiles) of older adults better than concentric training. Healthy elderly men (60–76 years) were assigned to either eccentric training or concentric training group (n = 13/group), and performed 30–60 eccentric or concentric contractions of knee extensors once a week. The intensity was progressively increased over 12 weeks from 10 to 100% of maximal concentric strength for eccentric training and from 50 to 100% for concentric training. Outcome measures were taken before and 4 days after the training period. The results showed that no sings of muscle damage were observed after any sessions. Functional physical fitness (e.g., 30-s chair stand) and maximal concentric contraction strength of the knee extensors increased greater (P ≤ 0.05) after eccentric training than concentric training. Homeostasis model assessment, oral glucose tolerance test and whole blood glycosylated hemoglobin showed improvement of insulin sensitivity only after eccentric training (P ≤ 0.05). Greater (P ≤ 0.05) decreases in fasting triacylglycerols, total, and low-density lipoprotein cholesterols were evident after eccentric training than concentric training, and high-density lipoprotein cholesterols increased only after eccentric training. These results support the hypothesis and suggest that it is better to focus on eccentric contractions in exercise medicine. PMID:28443029

  10. Superior Effects of Eccentric to Concentric Knee Extensor Resistance Training on Physical Fitness, Insulin Sensitivity and Lipid Profiles of Elderly Men.

    Science.gov (United States)

    Chen, Trevor Chung-Ching; Tseng, Wei-Chin; Huang, Guan-Ling; Chen, Hsin-Lian; Tseng, Kuo-Wei; Nosaka, Kazunori

    2017-01-01

    It has been reported that eccentric training of knee extensors is effective for improving blood insulin sensitivity and lipid profiles to a greater extent than concentric training in young women. However, it is not known whether this is also the case for elderly individuals. Thus, the present study tested the hypothesis that eccentric training of the knee extensors would improve physical function and health parameters (e.g., blood lipid profiles) of older adults better than concentric training. Healthy elderly men (60-76 years) were assigned to either eccentric training or concentric training group (n = 13/group), and performed 30-60 eccentric or concentric contractions of knee extensors once a week. The intensity was progressively increased over 12 weeks from 10 to 100% of maximal concentric strength for eccentric training and from 50 to 100% for concentric training. Outcome measures were taken before and 4 days after the training period. The results showed that no sings of muscle damage were observed after any sessions. Functional physical fitness (e.g., 30-s chair stand) and maximal concentric contraction strength of the knee extensors increased greater (P ≤ 0.05) after eccentric training than concentric training. Homeostasis model assessment, oral glucose tolerance test and whole blood glycosylated hemoglobin showed improvement of insulin sensitivity only after eccentric training (P ≤ 0.05). Greater (P ≤ 0.05) decreases in fasting triacylglycerols, total, and low-density lipoprotein cholesterols were evident after eccentric training than concentric training, and high-density lipoprotein cholesterols increased only after eccentric training. These results support the hypothesis and suggest that it is better to focus on eccentric contractions in exercise medicine.

  11. Renal safety profile of STB in virologically suppressed subjects from two randomized phase 3b switch trials

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    Iain Reeves

    2014-11-01

    Full Text Available Introduction: Cobicistat, a component of stribild (STB, is known to inhibit renal creatinine secretion. A detailed analysis of the renal safety profile of STB in two Phase 3b switch studies of virologically-suppressed individuals on stable therapy: STRATEGY(S-PI (STB vs a RTV-boosted protease inhibitor [PI] with emtricitabine and tenofovir DF [FTC/TDF]; and STRATEGY(S-NNRTI (STB versus a non-nucleoside reverse transcriptase inhibitor [NNRTI] with FTC/TDF is herein described. Materials and Methods: Baseline eGFR ≥70 mL/min was an inclusion criterion. The renal safety profile of STB was examined by baseline eGFR through week 48 (i.e., changes in eGFR, renal tubular laboratory abnormalities, investigator-reported renal adverse events leading to discontinuation and unreported subclinical proximal renal tubulopathy [PRT]. Subclinical PRT was defined as a confirmed serum-creatinine increase ≥0.4 mg/dL and two or three markers of renal tubular dysfunction (hypophosphatemia, normoglycemic glycosuria, proteinuria occurring at the same visit at least once and with no alternative etiologies. Results: In S-PI, 433 subjects (STB 293; PI 140 and in S-NNRTI, 434 subjects (STB 291; NNRTI 143 were randomized and treated. Most (>85% STB subjects had a baseline eGFR ≥90 mL/min. STB subjects with baseline eGFR <90 mL/min had smaller declines in eGFR compared to those with baseline eGFR ≥90 mL/min and similar occurrences of renal tubular laboratory abnormalities (Table 1. Rate of renal adverse events leading to study drug discontinuation were similar for the STB group (one PRT in a subject with baseline tubular laboratory abnormalities consistent with underlying PRT and one isolated increase in serum creatinine and PI group (one isolated decrease in eGFR; none in the NNRTI group. The case of PRT improved after study drug discontinuation. There were no cases of unreported subclinical PRT in any group. Conclusions: In this virologically suppressed patient

  12. Practice-based evidence: profiling the safety of cilostazol by text-mining of clinical notes.

    Directory of Open Access Journals (Sweden)

    Nicholas J Leeper

    Full Text Available BACKGROUND: Peripheral arterial disease (PAD is a growing problem with few available therapies. Cilostazol is the only FDA-approved medication with a class I indication for intermittent claudication, but carries a black box warning due to concerns for increased cardiovascular mortality. To assess the validity of this black box warning, we employed a novel text-analytics pipeline to quantify the adverse events associated with Cilostazol use in a clinical setting, including patients with congestive heart failure (CHF. METHODS AND RESULTS: We analyzed the electronic medical records of 1.8 million subjects from the Stanford clinical data warehouse spanning 18 years using a novel text-mining/statistical analytics pipeline. We identified 232 PAD patients taking Cilostazol and created a control group of 1,160 PAD patients not taking this drug using 1:5 propensity-score matching. Over a mean follow up of 4.2 years, we observed no association between Cilostazol use and any major adverse cardiovascular event including stroke (OR = 1.13, CI [0.82, 1.55], myocardial infarction (OR = 1.00, CI [0.71, 1.39], or death (OR = 0.86, CI [0.63, 1.18]. Cilostazol was not associated with an increase in any arrhythmic complication. We also identified a subset of CHF patients who were prescribed Cilostazol despite its black box warning, and found that it did not increase mortality in this high-risk group of patients. CONCLUSIONS: This proof of principle study shows the potential of text-analytics to mine clinical data warehouses to uncover 'natural experiments' such as the use of Cilostazol in CHF patients. We envision this method will have broad applications for examining difficult to test clinical hypotheses and to aid in post-marketing drug safety surveillance. Moreover, our observations argue for a prospective study to examine the validity of a drug safety warning that may be unnecessarily limiting the use of an efficacious therapy.

  13. Human studies on abecarnil a new beta-carboline anxiolytic: safety, tolerability and preliminary pharmacological profile.

    Science.gov (United States)

    Duka, T; Schütt, B; Krause, W; Dorow, R; McDonald, S; Fichte, K

    1993-04-01

    1. Abecarnil (isopropyl-6-benzyloxy-4-methoxymethyl-beta-carboline-3-carboxylate), a beta-carboline with high affinity for benzodiazepine receptors, was tested in healthy male subjects; single doses of abecarnil were given in five dosage levels (1 mg, 5 mg, 10 mg, 20 mg, 40 mg) and in a multiple dose study in four dosage levels (15 mg, 30 mg, 60 mg, 90 mg day-1) for 7 days. On two days following multiple dose treatment, placebo was given in single-blind conditions (follow-up). In each dosage level, in both studies drug was given to 10 subjects (7: verum, 3: placebo). 2. Safety and tolerability were evaluated by changes in vital signs, incidence and severity of adverse reactions and biochemical and haematological screening. Drug effects were estimated utilizing a bipolar visual analogue scale (poles: 'sleepy'-'alert') and a psychomotor task, the digit symbol substitution task. The pharmacokinetics of single and multiple doses were also determined in the multiple dose study. 3. Abecarnil was generally well tolerated. In the single dose study the most frequently reported side effects associated with abecarnil at high doses (20 and 40 mg) were dizziness, unsteady gait, and lack of concentration. A decrement in performance on the digit symbol substitution task was also observed in the two high dosage groups 20 mg and 40 mg. Evaluation of visual analogue scale ratings did not reveal a sedative effect even at higher doses. 4. In the multiple dose study the most frequently reported side effects during the treatment period were dizziness, unsteady gait, and lack of concentration.(ABSTRACT TRUNCATED AT 250 WORDS)

  14. Statin therapy and hepatotoxicity: Appraisal of the safety profile of atorvastatin in hyperlipidemic patients

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    Saeed Kalantari

    2014-01-01

    Full Text Available Background: Statins are one of the most frequently prescribed medications to reduce the risk of cardiovascular events. Statins appear to be safe however, there are contradictory data regarding their adverse effects, which might be due to genetic variation in their metabolism. Hence, this prospective study was aimed to evaluate the effects of atorvastatin on liver transaminase changes in a clinical setting, in north Iran. Materials and Methods: This prospective semi-experimental study was performed on hyperlipidemic adults in 2010-2011. Patients received atorvastatin (5-40 mg/d based on the American National Cholesterol Education Program guidelines. Liver aminotransferases were measured in three occasions of baseline, 8 and 16 weeks period. Results: A total of 206 patients were included in the study. Of which 178 were female and 30 were male. Alanine aminotransferase (ALT and aspartate aminotransferase (AST were in normal range before intervention in the majority, except in 25 (12.1% and 16 (7.8% of patients, respectively. In general, ALT and AST remained in normal range over the study period (23.3 IU/L and 21.8 IU/L, respectively. There was found no relationship between different doses of atorvastatin prescribed and ALT/AST changes in the patients. The males′ ALT means at baseline (26.9 IU/L, 8 weeks (30 IU/L and 16 weeks (28.8 IU/L after statin therapy were significantly higher than females (22 IU/L, 22.2 IU/L and 22.1 IU/L, respectively; P < 0.05 for all. Conclusion: The absence of any hepatic adverse effect in the present study supports safety of atorvastatin and emerging opinion that routine screening of liver function tests is not necessary in patients on statins.

  15. Beliefs and behaviours relevant to the road safety effects of profile lane-marking.

    Science.gov (United States)

    Hatfield, Julie; Murphy, Susanne; Job, R F Soames

    2008-11-01

    Audio-tactile lane-marking (ATLM) is designed to alert inattentive drivers when they deviate from their lane, and appears to reduce crashes. Research into cognitive-behavioural mechanisms underlying, or possibly undermining, the efficacy of ATLM, is limited. We surveyed 775 randomly selected drivers (42% female, up to 75+ years) regarding the profile line-marking (PLM) employed in Australia (and in some European countries). Respondents perceived advantages of PLM in terms of lane-keeping and visibility. Respondents reported avoiding edge-line PLM, so that it may result in driving too close to untreated centre-line. Findings generally allayed concerns, on the basis of risk homeostasis theory, that PLM may increase risky driving. Perceived efficacy of PLM was not associated with increased drink-driving or speeding, but was associated with increased driving while fatigued. Findings suggest that the efficacy of PLM may be increased by employing PLM on both edge- and centre-lines, by exaggerating the audio-tactile effects of PLM that cause drivers to avoid it, and by discouraging the belief that it is safe to drive while fatigued when PLM is present.

  16. 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.

  17. 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.

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

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    Jara M

    2015-12-01

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

  19. Safety profile of HIV-1 attachment inhibitor prodrug BMS-663068 in antiretroviral-experienced subjects: week 24 analysis

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    Jacob Lalezari

    2014-11-01

    Full Text Available Introduction: BMS-663068 is a prodrug of BMS-626529, an attachment inhibitor that binds directly to HIV-1 gp120, preventing initial viral attachment and entry into the host CD4+ T-cell. AI438011 is an ongoing, Phase IIb, randomized, active-controlled trial investigating the safety, efficacy and dose–response of BMS-663068 vs. atazanavir/ritonavir (ATV/r in treatment-experienced (TE, HIV-1-positive subjects. At Week 24, response rates across the BMS-663068 arms were consistent with ATV/r. Materials and Methods: Antiretroviral TE subjects (exposure to ≥1 antiretroviral for ≥1 week with susceptibility to all study drugs (including BMS-626529 IC50 100 nM were randomized equally to four BMS-663068 arms (400 or 800 mg, BID; 600 or 1200 mg, QD and a control arm (ATV/r 300/100 mg QD, with tenofovir disoproxil fumarate (TDF + raltegravir (RAL. The complete safety profile through Week 24 is reported. Results: In total, 251 subjects were treated (BMS-663068, 200; ATV/r, 51. No BMS-663068-related adverse events (AEs led to discontinuation. Grade 2–4 drug-related AEs occurred in 17/200 (8.5% subjects across the BMS-633068 arms; however, these events were mostly single instances and no dose-relationship was seen. Similarly, no noticeable trend for Grade 3–4 laboratory abnormalities was seen and Grade 3–4 hematologic changes and liver chemistry elevations were uncommon (neutropenia, 2.5%; AST/ALT elevations, 1% (n=196. In the ATV/r arm, Grade 2–4 drug-related AEs occurred in 14/51 (27.5% subjects and were mostly secondary to gastrointestinal and/or hepatobiliary disorders. Serious adverse events (SAEs occurred in 13/200 (6.5% and 5/51 (9.8% subjects receiving BMS-663068 and ATV/r, respectively; most were secondary to infections and none were related to study drugs. The most common AE reported for BMS-663068 was headache (28/200, 14%, occurring in 5/51 (10% subjects in the ATV/r arm; in the BMS-663068 arms, this was not dose-related. There were no

  20. Antiretroviral simplification with darunavir/ritonavir monotherapy in routine clinical practice: safety, effectiveness, and impact on lipid profile.

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    José R Santos

    Full Text Available BACKGROUND: Simplification of antiretroviral treatment (ART with darunavir/ritonavir (DRV/r monotherapy has achieved sustained suppression of plasma viral load (pVL in clinical trials; however, its effectiveness and safety profile has not been evaluated in routine clinical practice. METHODOLOGY/PRINCIPAL FINDINGS: We performed a retrospective cohort analysis of HIV-1-infected patients who initiated DRV/r monotherapy once daily with a pVL 50 copies/mL at week 48, and time to VF. Other causes of treatment discontinuation and changes in lipid profile were evaluated up to week 48. Ninety-two patients were followed for a median (IQR of 73 (57-92 weeks. The median baseline and nadir CD4+ T-cell counts were 604 (433-837 and 238 (150-376 cells/mm3, respectively. Patients had previously received a median of 5 (3-9 ART lines and maintained a pVL<50 copies/mL for a median of 76 (32-176 weeks before initiating DRV/r monotherapy. Nine (9.8% patients developed VF at week 48; time to VF was 47.1 (IQR: 36.1-47.8 weeks among patients with VF. Other reasons for changing ART were gastrointestinal disturbances (n = 3, rash (n = 1, and impaired CD4 recovery (n = 2. Median low-density lipoprotein cholesterol levels increased from 116.1 mg/dL at baseline to 137.3 mg/dL at 48 weeks (p = 0.001. CONCLUSIONS/SIGNIFICANCE: Treatment simplification with DRV/r monotherapy seems safe and effective in routine clinical practice. Further research is needed to elucidate the effect of DRV/r monotherapy on cholesterol levels.

  1. Safety Profile of Liver FibroScan in Patients with Cardiac Pacemakers or Implantable Cardioverter-Defibrillators

    Science.gov (United States)

    Pranke, Stephanie; Rashidi, Farid; Nosib, Shravan; Worobetz, Lawrence

    2017-01-01

    Background. Emerging evidence suggests that nonalcoholic fatty liver disease (NAFLD) is associated with coronary artery diseases and arrhythmias. The FibroScan (Echosens, France), a widely available, noninvasive device, is able to detect liver fibrosis and steatosis within this patient population. However, the FibroScan is currently contraindicated in patients with cardiac pacemakers (PM) or implantable cardioverter-defibrillators (ICD). Objective. To determine the safety profile of FibroScan testing in patients with PM or ICD. Methods. Consecutive outpatients undergoing routine device interrogations at a tertiary level teaching hospital underwent simultaneous liver stiffness measurements. PM or ICD performance data, device types, patient demographics, medical history, and previous laboratory and conventional liver imaging results were collected. Results. Analysis of 107 subjects with 33 different types of implanted cardiac devices, from 5 different companies (Medtronic, Sorin, ELA Medical, Boston Scientific, and St. Jude), did not demonstrate any adverse events as defined by abnormal device sensing/pacing or ICD firing. This population included high risk subjects undergoing active pacing (n = 53) and with right pectoral PM placement (n = 1). None of the subjects had any clinical signs of decompensated congestive heart failure or cirrhosis during the exam. Conclusion. TE with FibroScan can be safely performed in patients with PM or ICD.

  2. Glycemic profile and effectiveness and safety of insulin therapy in septic patients: is the blood glucose level sufficient?

    Science.gov (United States)

    Szrama, Jakub; Smuszkiewicz, Piotr; Trojanowska, Iwona

    2009-10-01

    Hyperglycemia in sepsis is managed by intensive insulin therapy, which can cause hypoglycemia. The aim of the study was to evaluate the glycemic profile as well as safety and effectiveness of a nurse-controlled insulin therapy protocol in patients with severe sepsis and septic shock. The study included 16 septic patients who died (nonsurvivors) and 61 septic patients who survived. Glycemia was measured every 4 h, and the dose of insulin infusion was adjusted to maintain glycemia of 4.4 mmol/l to 8.3 mmol/l. We analyzed glycemia levels and daily variations, insulin dose, episodes of hypo- and hyperglycemia. Nonsurvivors and survivors had similar mean glycemia levels (7.38 vs. 7.08 mmol/l; p = 0.20) and insulin requirements (median [Me] = 26.9 vs. 23.9 units/d; p = 0.22; Me = 1.7 vs. 1.4 units/h; p = 0.25). Daily glycemia variation (Me = 4.81 vs. 3.03 mmol/l; p insulin-induced hypoglycemia criteria, and 74.4% of samples met the recommended range of 4.4-8.3 mmol/l. Patients who died experienced more episodes of hyperglycemia, spontaneous hypoglycemia and greater variation in the daily glycemia level. Daily glycemia variation is more reliable than a mean glycemic level in evaluating glucose homeostasis in septic patients. Few episodes of severe insulin-induced hypoglycemia occurred while using the nurse-controlled insulin therapy protocol.

  3. Hepatic safety profile of darunavir with low-dose ritonavir (DRV/r) in HIV/HCV coinfected and HIV monoinfected patients.

    Science.gov (United States)

    Morsica, Giulia; Bianchi, Giampaolo; Bagaglio, Sabrina; Conte, Camilla; Salpietro, Stefania; Porrino, Lucy; Uberti-Foppa, Caterina

    2011-07-01

    The hepatic safety profile of ART including DRV/r was retrospectively evaluated in antiretroviral-experienced HIV-infected patients (18 HIV/HCV coinfected, group A and 29 infected with HIV alone, group B) during a 72 week study. During the study, liver enzyme values were higher in group A, but in the case of abnormal transaminase levels, the median values did not exceed 1.6xULN. This study showed evidence of long-lasting hepatic safety of ART including PI DRV/r in HIV/HCV coinfected and in HIV monoinfected persons.

  4. Post-authorization changes in the safety and efficacy assessment, recommended indications, and drug quality profile of adalimumab: a chronological overview.

    Science.gov (United States)

    Iványi, Gergely; Zelkó, Romána

    2017-02-01

    The intention of the present study was to demonstrate the postauthorization changes of adalimumab (European trade name: Humira), evaluating the variations in its safety, efficacy, and quality profile. Type-II, major variations of the Summary of Product Characteristics (SmPC) from September 8, 2003 to November 19, 2015, were analyzed, which, according to Commission Regulation (EC) No. 1234/2008, have to reflect changes that may have a significant impact on the safety, efficacy, or quality profile of a medicinal product. A unique scoring system was developed to estimate the influence of post-authorization variations in the safety and efficacy assessment, recommended indications, and drug-quality profile of adalimumab. In the past 13 years, adalimumab has been proven to be beneficial in 12 indications. In this time period, the safety-related subsections of the SmPC expanded the most. 27.12% of the total changes were found in subsection 4.8 (Undesirable effects), 19.77% in subsection 4.4 (Special warnings and precautions for use). Section 5 (Pharmacological properties) was also significantly modified (19.77%) thanks to the numerous clinical trials studying the effects of adalimumab. Concerning the total changes in the content of the SmPC, 58.4% was safety, 29.4% efficacy, and only 1.8% was quality-related alteration. The rest, 10.4%, was considered as administrational modification. The extensive postauthorization research (both surveillance and clinical trials) significantly have increased our knowledge about the efficient and safe use of the medicine and have made adalimumab one of the top-10 selling pharmaceuticals worldwide. Regarding ongoing clinical trials, more pediatric indications are expected.

  5. Comparison on the Effects and Safety of Tualang Honey and Tribestan in Sperm Parameters, Erectile Function, and Hormonal Profiles among Oligospermic Males

    Directory of Open Access Journals (Sweden)

    Shaiful Bahari Ismail

    2014-01-01

    Full Text Available Introduction. This study aims to evaluate the effectiveness of Tualang honey on sperm parameters, erectile function, and hormonal and safety profiles. Methodology. A randomized control trial was done using Tualang honey (20 grams and Tribestan (750 mg over a period of 12 weeks. Sperm parameters including sperm concentration, motility, and morphology were analyzed and erectile function was assessed using IIEF-5 questionnaire. Hormonal profiles of testosterone, FSH, and LH were studied. The volunteers were randomized into two groups and the outcomes were analyzed using SPSS version 18. Results. A total of 66 participants were involved. A significant increment of mean sperm concentration (P<0.001, motility (P=0.015 and morphology (P=0.008 was seen in Tualang honey group. In Tribestan group, a significant increment of mean sperm concentration (P=0.007, and morphology (P=0.009 was seen. No significant differences of sperm concentration, motility, and morphology were seen between Tualang honey and Tribestan group and similar results were also seen in erectile function and hormonal profile. All safety profiles were normal and no adverse event was reported. Conclusion. Tualang honey effect among oligospermic males was comparable with Tribestan in improving sperm concentration, motility, and morphology. The usage of Tualang honey was also safe with no reported adverse event.

  6. Safety assessment of transgenic Bacillus thuringiensis rice T1c-19 in Sprague-Dawley rats from metabonomics and bacterial profile perspectives.

    Science.gov (United States)

    Cao, Sishuo; He, Xiaoyun; Xu, Wentao; Luo, YunBo; Yuan, Yanfang; Liu, Pengfei; Cao, Bo; Shi, Hui; Huang, Kunlun

    2012-03-01

    Bacillus thuringiensis rice is facing commercialization as the main food source in the near future. The unintended effects of genetically modified (GM) organisms are the most important barriers to their promotion. We aimed to establish a new in vivo evaluation model for genetically modified foods by using metabonomics and bacterial profile approaches. T1c-19 rice flour or its transgenic parent MH63 was used at 70% wt/wt to produce diets that were fed to rats for ∼ 90 days. Urine metabolite changes were detected using (1)H NMR. Denaturing gradient gel electrophoresis and real-time polymerase chain reaction (RT-PCR) were used to detect the bacterial profiles between the two groups. The metabonomics was analyzed for metabolite changes in rat urine, when compared with the non-GM rice group, where rats were fed a GM rice diet. Several metabolites correlated with rat age and sex but not with GM rice diet. Significant biological differences were not identified between the GM rice diet and the non-GM rice diet. The bacteria related to rat urine metabolites were also discussed. The results from metabonomics and bacterial profile analyses were comparable with the results attained using the traditional method. Because metabonomics and bacterial profiling offer noninvasive, dynamic approaches for monitoring food safety, they provide a novel process for assessing the safety of GM foods.

  7. HOW AUTHENTIC SHOULD A LEARNING CONTEXT BE? USING REAL AND SIMULATED PROFILES IN A CLASSROOM INTERVENTION TO IMPROVE SAFETY ON SOCIAL NETWORK SITES

    Directory of Open Access Journals (Sweden)

    Ellen Vanderhoven

    2015-06-01

    Full Text Available With the rise of social network sites (SNSs, there is an increasing need for safety education within the current cyber society. To this end, a variety of educational materials have been developed to prepare children to be vigilant when interacting on such sites. However, little is known about the critical design aspects necessary to make these materials effective. In this study, we build on the results of two previous studies, in which we found that general instructional principles drawn from constructivism, such as collaborative learning, are not always appropriate to teach children how to behave safely online. This study therefore focuses on the importance of authentic learning and active learning as critical design features. A quasi-experimental study was conducted in secondary schools in order to compare the impact of two classroom interventions about the risks on SNSs. As part of the intervention, students were presented scaffolds towards different risks related to an SNS-profile through a series of questions. In the control condition, these questions concerned a simulated SNS-profile on paper containing signs of many risks. In the experimental condition, students had to answer the same questions about their own SNS-profile on a computer. It was hypothesized that the simulated profile would not be experienced as realistic, and that students would have difficulties identifying with it. On the other hand, teenagers were expected to be able to recognize more risks on the simulated ‘worst-case scenario’ profile than on their own profile, which would facilitate the scaffolding process in the control condition. The results of the study mostly confirmed these hypotheses. Furthermore, the question arose as to whether the intervention based on the student’s own realistic profile was educationally more valuable than the intervention based on the simulated profile, but no such added value was found. On the contrary, the scaffolding questions

  8. 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...

  9. 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...

  10. 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...

  11. Real-World Safety and Patient Profile of Fingolimod in Relapsing-Remitting Multiple Sclerosis: A Prospective Analysis in Buenos Aires, Argentina.

    Science.gov (United States)

    Rojas, Juan Ignacio; Patrucco, Liliana; Miguez, Jimena; Cristiano, Edgardo

    2017-10-02

    The aim was to evaluate fingolimod safety and patient profiles in a real-world setting in Buenos Aires, Argentina. Relapsing-remitting patients with multiple sclerosis who had been prescribed fingolimod and at least 18 months or more of follow-up were included. Demographic, clinical, and safety issues were described during first dose and follow-up. A total of 145 patients were included, 68% female; mean age, 30 ± 10.5 years; mean disease duration, 6.5 ± 3.1 years; mean fingolimod use, 25 ± 13 months. Eleven patients (7.6%) discontinued fingolimod (7 owing to disease activity/4 owing to desire of pregnancy and personal decisions). Forty-two percent of patients experienced adverse events: headache, fatigue, liver enzyme elevation, and lymphopenia were the most commonly found. No serious cardiac event was reported during the first dose. The safety and patient profile of fingolimod in a new real-world setting were consistent with information provided from phase III clinical trials.

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

    OpenAIRE

    Mekonnen Haileselassie; Habtamu Taddele; Kelali Adhana; Shewit Kalayou

    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 assesse...

  13. Hyaluronic Acid-Based Nanogels Produced by Microfluidics-Facilitated Self-Assembly Improves the Safety Profile of the Cationic Host Defense Peptide Novicidin

    DEFF Research Database (Denmark)

    Water, Jorrit J; Kim, YongTae; Maltesen, Morten J

    2015-01-01

    have hampered their commercial development. To overcome these challenges a novel nanogel-based drug delivery system was designed. METHOD: The peptide novicidin was self-assembled with an octenyl succinic anhydride-modified analogue of hyaluronic acid, and this formulation was optimized using...... peptide loading of 36 ± 4%. The nanogels exhibited good colloidal stability under different ionic strength conditions and allowed complete release of the peptide over 14 days. Furthermore, self-assembly of novicidin with hyaluronic acid into nanogels significantly improved the safety profile at least five...

  14. PERFIL DOS DISCENTES (INGRESSANTES E CONCLUINTES DE SECRETARIADO EXECUTIVO: UM ESTUDO COMPARATIVO NAS INSTITUIÇÕES DE ENSINO SUPERIOR (IES PÚBLICAS EXECUTIVE SECRETARIAT STUDENTS´ PROFILE (FRESHMEN AND SENIORS: A COMPARATIVE STYDY IN PUBLIC EDUCATION INSTITUTIONS

    Directory of Open Access Journals (Sweden)

    Vania Souza Bilert

    2012-05-01

    Full Text Available

    O objetivo deste artigo é identificar o perfil dos discentes, ingressantes e concluintes, dos cursos de graduação em secretariado executivo. A pesquisa foi realizada com os discentes de 11 Instituições de Ensino Superior (IES públicas brasileiras, estaduais e federais. O estudo configura-se como descritivo-exploratório, fazendo parte da amostra 507 discentes, sendo 311 ingressantes e 196 concluintes. Os principais resultados indicam que os discentes atuam em empresas de diversos segmentos, com destaque ao comércio e prestação de serviços; 87% são do gênero feminino e a faixa etária predominante é entre 17 a 24 anos. Destaca-se, como fator positivo, a atuação profissional dos discentes desde o início da graduação, exercendo as atribuições pertinentes ao profissional de secretariado executivo, o que revela que os discentes conseguem relacionar o que é aprendido em sala de aula com a prática profissional, o que também evidencia a aceitação do empresariado pelos profissionais de secretariado executivo.

    The objective of this paper is to identify the profile of beginner and graduate students who apply for Executive Secretariat graduation course. This research was carried out with students from 11 Brazilian public undergraduate schools, both federal and state ones. This is considered a descriptive and exploratory study, which analyzed 507 students, 311 beginners and 196 graduate ones. The main results show that students perform in different segment companies, but especially in service companies, 87% are female and the predominant age group is between 17 and 24 years old. In a positive way, this research stands out the factor that these students perform professionally since the beginning of the graduation, exerting the functions which are up to the Executive Secretariat professional. This reveals that the students are able to link what they have learned inside the classroom with the

  15. PERSISTENT LEFT SUPERIOR VENACAVA

    Directory of Open Access Journals (Sweden)

    Devinder Singh

    2014-05-01

    Full Text Available A Persistent Left Superior Venacava (PLSVC is the most common variation of the thoracic venous system and rare congenital vascular anomaly and is prevalent in 0.3% of the population. It may be associated with other cardiovascular abnormalities including atrial septal defect, bicuspid aortic valve, coarctation of aorta, coronary sinus ostial atresia, and cor triatriatum. Incidental rotation of a dilated coronary sinus on echocardiography should raise the suspicion of PLSVC. The diagnosis should be confirmed by saline contrast echocardiography. Condition is usually asymptomatic. Here we present a rare case of persistent left superior vena cava presented in OPD with dyspnoea & palpitations.

  16. 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).

  17. The safety and tolerability profile of therapies for the prevention and treatment of osteoporosis in postmenopausal women.

    Science.gov (United States)

    Komm, Barry S; Morgenstern, Diana; A Yamamoto, Luis; Jenkins, Simon N

    2015-01-01

    At a time when the prevalence of osteoporosis and related fractures is increasing, initiation and continuation of pharmacologic therapies for prevention and treatment of postmenopausal osteoporosis have declined. This decline has been at least in part attributable to concerns about safety of these agents, such as atypical fractures with bisphosphonates and breast cancer with estrogen/progestin therapy, particularly when they are used long term by older women. However, in many cases, absolute risk of serious adverse effects is small and should be balanced against the larger potential for fracture reduction. Here, we review the safety and tolerability of available therapies for postmenopausal osteoporosis. Taking into consideration their relative efficacy, we also provide strategies for optimization of the risk:benefit ratio.

  18. Statin use and lipid profile in relation to safety and functional outcome after thrombolysis in ischemic stroke

    NARCIS (Netherlands)

    Miedema, Irene; Uyttenboogaart, Maarten; Luijckx, Gert-Jan

    Evaluation of: Rocco A, Sykora M, Ringleb P, Diedler J. Impact of statin use and lipid profile on symptomatic intracerebral haemorrhage, outcome and mortality after intravenous thrombolysis in acute stroke. Cerebrovasc. Dis. 33(4), 362-368 (2012). Statins are widely used in the primary and secondary

  19. Air Superiority Fighter Characteristics.

    Science.gov (United States)

    1998-06-05

    many a dispute could have been deflated into a single paragraph if the disputants had just dared to define their terms.7 Aristotle ...meaningful. This section will expand on some key ideology concepts. The phrase "air superiority fighter" may bring to mind visions of fighter... biographies are useful in garnering airpower advocate theories as well as identifying key characteristics. Air campaign results, starting with World

  20. Maintaining Space Superiority

    Science.gov (United States)

    2014-02-01

    owned by the Iridium Corpora- tion. That event sparked international concern as issues of on-orbit safety became a hot topic for international... Attacks on Space Systems," Space and De- fense 4, no. 1 (Winter 2010): 10, http:/ /www.usafa.edu/df/dfe/dfer/centers/ecsds/docs /Space_and_Defense_

  1. Contabilidad Financiera Superior

    OpenAIRE

    Ipiñazar Petralanda, Izaskun

    2013-01-01

    Duración (en horas): De 31 a 40 horas. Destinatario: Estudiante y Docente A través de este material se presentan las pautas necesarias para implementar un aprendizaje basado en problemas en la asignatura de Contabilidad Financiera Superior dentro de los temas “Constitución de S.A. y S.R.L.” (Tema 2), “Ampliaciones de Capital” (Tema 3) y “Reducciones de Capital” (Tema 4). En primer lugar se presentan las guías generales de la asignatura, y a continuación, las diferentes activida...

  2. Contabilidad Financiera Superior

    OpenAIRE

    Ipiñazar Petralanda, Izaskun

    2013-01-01

    Duración (en horas): De 31 a 40 horas. Destinatario: Estudiante y Docente A través de este material se presentan las pautas necesarias para implementar un aprendizaje basado en problemas en la asignatura de Contabilidad Financiera Superior dentro de los temas “Constitución de S.A. y S.R.L.” (Tema 2), “Ampliaciones de Capital” (Tema 3) y “Reducciones de Capital” (Tema 4). En primer lugar se presentan las guías generales de la asignatura, y a continuación, las diferentes activida...

  3. 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.

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

    Science.gov (United States)

    Jennings, Danna; Borchert, Leona; Canale, Lee; Fagan, Nora

    2016-01-01

    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. PMID:28078162

  5. 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.

  6. Statistics of superior records

    Science.gov (United States)

    Ben-Naim, E.; Krapivsky, P. L.

    2013-08-01

    We study statistics of records in a sequence of random variables. These identical and independently distributed variables are drawn from the parent distribution ρ. The running record equals the maximum of all elements in the sequence up to a given point. We define a superior sequence as one where all running records are above the average record expected for the parent distribution ρ. We find that the fraction of superior sequences SN decays algebraically with sequence length N, SN˜N-β in the limit N→∞. Interestingly, the decay exponent β is nontrivial, being the root of an integral equation. For example, when ρ is a uniform distribution with compact support, we find β=0.450265. In general, the tail of the parent distribution governs the exponent β. We also consider the dual problem of inferior sequences, where all records are below average, and find that the fraction of inferior sequences IN decays algebraically, albeit with a different decay exponent, IN˜N-α. We use the above statistical measures to analyze earthquake data.

  7. Frenillo labial superior doble

    Directory of Open Access Journals (Sweden)

    Carlos Albornoz López del Castillo

    Full Text Available El frenillo labial superior doble no sindrómico es una anomalía del desarrollo que no hemos encontrado reportada en la revisión bibliográfica realizada. Se presenta una niña de 11 años de edad que fue remitida al servicio de Cirugía Maxilofacial del Hospital "Eduardo Agramonte Piña", de Camagüey, por presentar un frenillo labial superior doble de baja inserción. Se describen los síntomas clínicos asociados a esta anomalía y el tratamiento quirúrgico utilizado para su solución: una frenectomía y plastia sobre la banda muscular frénica anormal que provocaba exceso de tejido en la mucosa labial. Consideramos muy interesante la descripción de este caso, por no haber encontrado reporte similar en la literatura revisada.

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

    DEFF Research Database (Denmark)

    Martinussen, Laila Marianne

    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......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...... Behaviour Questionnaire (DBQ) within a Danish context was explored, sub-groups of drivers differing in their potential danger in traffic were identified, and the relationship between implicit attitudes towards safe and risky driving and self-reported driving behaviour was explored. The methods applied were...

  9. Conjugated linoleic acid supplementation for 8 weeks does not affect body composition, lipid profile, or safety biomarkers in overweight, hyperlipidemic men.

    Science.gov (United States)

    Joseph, Shama V; Jacques, Hélène; Plourde, Mélanie; Mitchell, Patricia L; McLeod, Roger S; Jones, Peter J H

    2011-07-01

    The usefulness of conjugated linoleic acid (CLA) as a nutraceutical remains ambiguous. Our objective was, therefore, to investigate the effect of CLA on body composition, blood lipids, and safety biomarkers in overweight, hyperlipidemic men. A double-blinded, 3-phase crossover trial was conducted in overweight (BMI ≥ 25 kg/m(2)), borderline hypercholesterolemic [LDL-cholesterol (C) ≥ 2.5 mmol/L] men aged 18-60 y. During three 8-wk phases, each separated by a 4-wk washout period, 27 participants consumed under supervision in random order 3.5 g/d of safflower oil (control), a 50:50 mixture of trans 10, cis 12 and cis 9, trans 11 (c9, t11) CLA:Clarinol G-80, and c9, t11 isomer:c9, t11 CLA. At baseline and endpoint of each phase, body weight, body fat mass, and lean body mass were measured by DXA. Blood lipid profiles and safety biomarkers, including insulin sensitivity, blood concentrations of adiponectin, and inflammatory (high sensitive-C-reactive protein, TNFα, and IL-6) and oxidative (oxidized-LDL) molecules, were measured. The effect of CLA consumption on fatty acid oxidation was also assessed. Compared with the control treatment, the CLA treatments did not affect changes in body weight, body composition, or blood lipids. In addition, CLA did not affect the β-oxidation rate of fatty acids or induce significant alterations in the safety markers tested. In conclusion, although no detrimental effects were caused by supplementation, these results do not confirm a role for CLA in either body weight or blood lipid regulation in humans.

  10. Clinical efficacy and safety of telmisartan versus losartan and their effect on lipid profile in stage 1 hypertension: A randomized, double blind, 12 week trial

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    Anoop Madhukar Salve

    2015-04-01

    Full Text Available The aim of this study was to compare the efficacy and safety of telmisartan and losartan and also to examine their effect on lipid profile in patients of stage 1 hypertension.Method: Sixty three stage 1 hypertensive patients were divided randomly into telmisartan  and losartan  group of 32 and 31 patients respectively. At baseline and 12 weeks, systolic (SBP and diastolic blood pressure (DBP, blood sugar level (BSL, total cholesterol (TC, triglycerides (TG, low density lipoprotein (LDL, very low density lipoprotein (VLDL and high density lipoprotein (HDL were measured. Result: The primary finding of the present study was that telmisartan and losartan significantly decreased SBP and DBP at 12 weeks compared to baseline but there was no significant difference in reduction of blood pressure in between both groups. It was also observed that fasting blood sugar level, serum total cholesterol, triglyceride, VLDL, and LDL decreased significantly and HDL increased significantly (p <0.001 after 12 weeks of treatment in telmisartan group only. No serious adverse effects were reported during the study. Conclusion: It was observed that only telmisartan and not losartan significantly improved lipid profile at 12 weeks.

  11. Effect of database profile variation on drug safety assessment: an analysis of spontaneous adverse event reports of Japanese cases

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    Nomura K

    2015-06-01

    Full Text Available Kaori Nomura,1 Kunihiko Takahashi,2 Yasushi Hinomura,3 Genta Kawaguchi,4 Yasuyuki Matsushita,5 Hiroko Marui,6 Tatsuhiko Anzai,7 Masayuki Hashiguchi,8 Mayumi Mochizuki8 1Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, 2Department of Biostatistics, Nagoya University Graduate School of Medicine, Nagoya, 3Japan Pharmaceutical Information Center, 4Global Pharmacovigilance, Kissei Pharmaceutical Co Ltd, Tokyo, 5Medical Affairs Department, Daiichi Sankyo Co Ltd, 6Drug Safety Division, Chugai Pharmaceutical Co Ltd, 7Data Science Center, EPS Corporation, 8Faculty of Pharmacy, Keio University, Tokyo, Japan Background: The use of a statistical approach to analyze cumulative adverse event (AE reports has been encouraged by regulatory authorities. However, data variations affect statistical analyses (eg, signal detection. Further, differences in regulations, social issues, and health care systems can cause variations in AE data. The present study examined similarities and differences between two publicly available databases, ie, the Japanese Adverse Drug Event Report (JADER database and the US Food and Drug Administration Adverse Event Reporting System (FAERS, and how they affect signal detection.Methods: Two AE data sources from 2010 were examined, ie, JADER cases (JP and Japanese cases extracted from the FAERS (FAERS-JP. Three methods for signals of disproportionate reporting, ie, the reporting odds ratio, Bayesian confidence propagation neural network, and Gamma Poisson Shrinker (GPS, were used on drug-event combinations for three substances frequently recorded in both systems.Results: The two databases showed similar elements of AE reports, but no option was provided for a shareable case identifier. The average number of AEs per case was 1.6±1.3 (maximum 37 in the JP and 3.3±3.5 (maximum 62 in the FAERS-JP. Between 5% and 57% of all AEs were signaled by three quantitative methods for etanercept, infliximab, and

  12. Safety of amisulpride (Solian): a review of 11 clinical studies.

    Science.gov (United States)

    Coulouvrat, C; Dondey-Nouvel, L

    1999-07-01

    We assessed the overall safety profile of amisulpride based on the results from 11 clinical studies performed in patients suffering from schizophrenia with predominance of positive or negative symptoms. A total of 1933 patients were randomly assigned to treatment with amisulpride (n = 1247) or haloperidol (n = 309), risperidone (n = 113), flupentixol (n = 62) and placebo (n = 202). Safety data collection was performed using open reporting, UKU scales or specific extrapyramidal side-effect scales; electrocardiogram recording and vital signs examination; laboratory data collection. Amisulpride demonstrated a satisfactory global safety profile in the range of doses usually prescribed. The number of patients having at least one extrapyramidal side-effect was higher in haloperidol patients compared with both amisulpride and risperidone patients (50% versus 30% in the two latter groups). For endocrine events, a similar rate was observed between amisulpride and risperidone groups (4% versus 6%, respectively) versus 1% in the haloperidol group. Electrocardiogram results were satisfactory, confirmed by the absence of cardiovascular events. The overall laboratory safety profile of amisulpride did not show clinically relevant abnormalities in liver function tests nor haematological abnormalities. Our extensive clinical data confirm the satisfactory safety profile of amisulpride which is superior to standard reference compounds.

  13. Chronic Electromagnetic Exposure at Occupational Safety Level Does Not Affect the Metabolic Profile nor Cornea Healing after LASIK Surgery

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    David Crouzier

    2014-01-01

    Full Text Available LASIK eye surgery has become a very common practice for myopic people, especially those in the military. Sometimes undertaken by people who need to keep a specific medical aptitude, this surgery could be performed in secret from the hierarchy and from the institute medical staff. However, even though the eyes have been previously described as one of the most sensitive organs to electromagnetic fields in the human body, no data exist on the potential deleterious effects of electromagnetic fields on the healing eye. The consequences of chronic long-lasting radar exposures at power density, in accordance with the occupational safety standards (9.71 GHz, 50 W/m2, were investigated on cornea healing. The metabolic and clinical statuses after experimental LASIK keratotomy were assessed on the different eye segments in a New Zealand rabbit model. The analysis methods were performed after 5 months of exposure (1 hour/day, 3 times/week. Neither clinical or histological examinations, nor experimental data, such as light scattering, 1H-NMR HRMAS metabolomics, 13C-NMR spectra of lipidic extracts, and antioxidant status, evidenced significant modifications. It was concluded that withdrawing the medical aptitude of people working in electromagnetic field environments (i.e., radar operators in the navy after eye surgery was not justified.

  14. Chronic Electromagnetic Exposure at Occupational Safety Level Does Not Affect the Metabolic Profile nor Cornea Healing after LASIK Surgery.

    Science.gov (United States)

    Crouzier, David; Dabouis, Vincent; Gentilhomme, Edgar; Vignal, Rodolphe; Bourbon, Fréderic; Fauvelle, Florence; Debouzy, Jean-Claude

    2014-01-01

    LASIK eye surgery has become a very common practice for myopic people, especially those in the military. Sometimes undertaken by people who need to keep a specific medical aptitude, this surgery could be performed in secret from the hierarchy and from the institute medical staff. However, even though the eyes have been previously described as one of the most sensitive organs to electromagnetic fields in the human body, no data exist on the potential deleterious effects of electromagnetic fields on the healing eye. The consequences of chronic long-lasting radar exposures at power density, in accordance with the occupational safety standards (9.71 GHz, 50 W/m(2)), were investigated on cornea healing. The metabolic and clinical statuses after experimental LASIK keratotomy were assessed on the different eye segments in a New Zealand rabbit model. The analysis methods were performed after 5 months of exposure (1 hour/day, 3 times/week). Neither clinical or histological examinations, nor experimental data, such as light scattering, (1)H-NMR HRMAS metabolomics, (13)C-NMR spectra of lipidic extracts, and antioxidant status, evidenced significant modifications. It was concluded that withdrawing the medical aptitude of people working in electromagnetic field environments (i.e., radar operators in the navy) after eye surgery was not justified.

  15. Safety profile of antimicrobial peptides: camel, citropin, protegrin, temporin a and lipopeptide on HaCaT keratinocytes.

    Science.gov (United States)

    Barańska-Rybak, Wioletta; Pikula, Michał; Dawgul, Małgorzata; Kamysz, Wojciech; Trzonkowski, Piotr; Roszkiewicz, Jadwiga

    2013-01-01

    Antimicrobial peptides (AMPs) are an essential part of the innate immunity of the skin and mucosal surfaces. They have a broad spectrum of antimicrobial activity: antibacterial, antifungal, antiviral as well as antiprotozoal. Numerous studies using AMPs as potential agents against different microbes has been performed during the last two decades. Here we investigated antistaphylococcal activity and safety of following AMPs: camel, citropin, protegrin, temporin A and lipopeptide Palm-KK-NH2. The susceptibility of the strains of Staphylococcus aureus isolated from the patients with erythrodermia to conventional antibiotics and AMPs was determined by the broth dilution method. The cytotoxicity assay was performed on HaCaT keratinocytes. Tested peptides turned out to be very effective against all clinical isolates, including strains resistant to conventional antibiotics. The majority of the examined peptides as well as conventional antimicrobials do not exert any toxic effect on HaCaT cells in minimal inhibitory concentration. Peptides are very promising agents for the topical treatment of staphylococcal skin infections. The most promising seem to be citropin 1.1 and temporin A, as they were toxic only in two highest concentration (50 and 100 microg/mL), with relatively low MIC values.

  16. Conhecimento e formação nas IES periféricas perfil do aluno "novo" da educação superior Knwoledge and education in the peripheral higher education institutions: profile of the "new" undergraduate student

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    Luiz Percival Leme Britto

    2008-11-01

    Full Text Available Considerando a forma como se organiza atualmente a Educação Superior no Brasil, num contexto de forte demanda por conhecimento de caráter instrumental e normativo, voltado para a adequação dos sujeitos, de suas condutas e avaliações às exigências da produção e do consumo urbanos, busca-se avançar o reconhecimento das concepções de conhecimento e de desenvolvimento pessoal do estudante universitário. Para tanto, apresentamos neste trabalho uma análise do campo da Educação Superior no Brasil atual, com ênfase na identificação caracterização de IES periférica e do aluno "novo". Este trabalho apresenta resultados parciais de pesquisa que vem sendo realizadas em torno do tema "Educação superior, cultura escrita e conhecimento".Considering the way in which Higher Education is presently structured in Brazil, in a context characterized by strong demands for normative and instrumental knowledge, aiming to adjust the conducts and evaluations of the subjects to the demands of the market-place, this study seeks the advance of the analysis of the concepts of knowledge and personal development of the university student. We present in this paper an analysis of Higher Education in Brazil, emphasizing the characterization and identification of the peripheral Higher Education Institutions and the "new" student. This work presents partial results of a research that is being done on the theme "Higher Education, Literacy and knowledge".

  17. Safety Profile of Anticancer and Immune-Modulating Biotech Drugs Used in a Real World Setting in Campania Region (Italy: BIO-Cam Observational Study

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    Cristina Scavone

    2017-09-01

    expected. Few cases of serious infections occurred, while no case of malignancy did. Overall, the safety profile of biotech drugs used in our population was similar to those observed in pivotal trials. Notwithstanding the positive results of our study, some safety concerns still remain unresolved. In order to collect more effectiveness and safety data on biotech drugs, the collection and analysis of real world data should be endorsed as well as the management of post-authorization studies.

  18. Peptide receptor radionuclide therapy in the management of gastrointestinal neuroendocrine tumors: efficacy profile, safety, and quality of life

    Science.gov (United States)

    Severi, Stefano; Grassi, Ilaria; Nicolini, Silvia; Sansovini, Maddalena; Bongiovanni, Alberto; Paganelli, Giovanni

    2017-01-01

    Peptide receptor radionuclide therapy (PRRT), developed over the last two decades, is carried out using radiopharmaceuticals such as 90Y-DOTA-Tyr3-octreotide and 177Lu-DOTA-Tyr3-octreotate (177Lu-Dotatate). These radiocompounds are obtained by labeling a synthetic somatostatin analog with a β-emitting radioisotope. The compounds differ from each other in terms of their energetic features (due to the radionuclide) and peptide receptor affinity (due to the analog) but share the common characteristic of binding specific membrane somatostatin receptors that are (generally) overexpressed in neuroendocrine neoplasms (NENs) and their metastases. NENs are tumors arising from diffuse neuroendocrine system cells that are classified according to grading based on Ki67 percentage values (Grades 1 and 2 are classed as neuroendocrine tumors [NETs]) and to the anatomical site of occurrence (in this paper, we only deal with gastroenteropancreatic [GEP]-NETs, which account for 60%–70% of all NENs). They are also characterized by specific symptoms such as diarrhea and flushing (30% of cases). Despite substantial experience gained in the area of PRRT and its demonstrable effects in terms of efficacy, safety, and improvement in quality of life, these compounds are still not registered (registration of 177Lu-Dotatate for the treatment of midgut NETs is expected soon). Thus, PRRT can only be used in experimental protocols. We provide an overview of the work of leading groups with wide-ranging experience and continuity in data publication in the area of GEP-NET PRRT and report our own personal experience of using different dosage schedules based on the presence of kidney and bone marrow risk factors. Our results on the retreatment of patients previously administered 90Y-DOTA-Tyr3-octreotide with a low dosage of 177Lu-Dotatate are also included. A comment on potential future developments of PRRT in GEP-NETs is provided. PMID:28203088

  19. Analysis of the safety profile of treatment with a large number of shock waves per session in extracorporeal lithotripsy.

    Science.gov (United States)

    Budía Alba, A; López Acón, J D; Polo-Rodrigo, A; Bahílo-Mateu, P; Trassierra-Villa, M; Boronat-Tormo, F

    2015-06-01

    To assess the safety of increasing the number of waves per session in the treatment of urolithiasis using extracorporeal lithotripsy. Prospective, comparative, nonrandomized parallel study of patients with renoureteral lithiasis and an indication for extracorporeal lithotripsy who were consecutively enrolled between 2009 and 2010. We compared group I (160 patients) treated on schedule with a standard number of waves/session (mean 2858,3±302,8) using a Dornier lithotripter U/15/50 against group II (172 patients) treated with an expanded number of waves/session (mean, 6728,9±889,6) using a Siemens Modularis lithotripter. The study variables were age, sex, location, stone size, number of waves/session and total number of waves to resolution, stone-free rate (SFR) and rate of complications (Clavien-Dindo classification). Student's t-test and the chi-squared test were employed for the statistical analysis. The total rate of complications was 11.9% and 10.46% for groups I and II, respectively (P=.39). All complications were minor (Clavien-Dindo grade I). The most common complications were colic pain and hematuria in groups I and II, respectively, with a similar treatment intolerance rate (P>.05). The total number of waves necessary was lower in group II than in group I (P=.001), with SFRs of 96.5% and 71.5%, respectively (P=.001). Treatment with an expanded number of waves per session in extracorporeal lithotripsy does not increase the rate of complications or their severity. However, it could increase the overall effectiveness of the treatment. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  20. Development of ultrasonic thermometry for high-temperature high-resolution temperature profiling applications in LMFBR safety research

    Science.gov (United States)

    Field, M. E.

    1986-05-01

    Ultrasonic thermometry was developed as a high temperature profiling diagnostic for use in the Liquid Metal Fast Breeder Reactor (LMFBR) Debris Coolability Program at Sandia National Laboratories. These instruments were used successfully in the DC series experiments and the D10 experiment. Temperatures approaching 3000 C with spatial resolution of 10 mm and indicated temperature gradients of 700 C/cm were measured. Instruments were operated in molten sodium, molten steel, and molten UO2 environments. Up to 14 measurement zones on a single instrument in molten sodium were used with 12 mm and 15 mm spatial resolution. Hermetically sealed units operating at elevated temperatures were used. Post-test examination revealed very little systematic calibration drifts (less than 10 C) with random drifts occuring with less than 40 C standard deviation in a 10 to 12 mm measured zone. The stability of the system varies from +/- 1 C to +/- 15 C depending on the sensor design constraints for a particular application. Doped tungsten sensors were developed to permit operation of total measurement zone length of 30 cm at temperatures above 2500 C.

  1. Analytical method evaluation and discovery of variation within maize varieties in the context of food safety: transcript profiling and metabolomics.

    Science.gov (United States)

    Zeng, Weiqing; Hazebroek, Jan; Beatty, Mary; Hayes, Kevin; Ponte, Christine; Maxwell, Carl; Zhong, Cathy Xiaoyan

    2014-04-02

    Profiling techniques such as microarrays, proteomics, and metabolomics are used widely to assess the overall effects of genetic background, environmental stimuli, growth stage, or transgene expression in plants. To assess the potential regulatory use of these techniques in agricultural biotechnology, we carried out microarray and metabolomic studies of 3 different tissues from 11 conventional maize varieties. We measured technical variations for both microarrays and metabolomics, compared results from individual plants and corresponding pooled samples, and documented variations detected among different varieties with individual plants or pooled samples. Both microarray and metabolomic technologies are reproducible and can be used to detect plant-to-plant and variety-to-variety differences. A pooling strategy lowered sample variations for both microarray and metabolomics while capturing variety-to-variety variation. However, unknown genomic sequences differing between maize varieties might hinder the application of microarrays. High-throughput metabolomics could be useful as a tool for the characterization of transgenic crops. However, researchers will have to take into consideration the impact on the detection and quantitation of a wide range of metabolites on experimental design as well as validation and interpretation of results.

  2. Profile of trifluridine/tipiracil hydrochloride in the treatment of metastatic colorectal cancer: efficacy, safety, and place in therapy

    Directory of Open Access Journals (Sweden)

    Sunakawa Y

    2017-09-01

    Full Text Available Yu Sunakawa, Naoki Izawa, Takuro Mizukami, Yoshiki Horie, Mami Hirakawa, Hiroyuki Arai, Takashi Ogura, Takashi Tsuda, Takako Eguchi Nakajima Department of Clinical Oncology, St Marianna University School of Medicine, Kawasaki, Japan Abstract: TAS-102, with its robust survival efficacy and feasible toxicity, is one of the standard salvage-line treatments for patients with metastatic colorectal cancer (mCRC. No definitive data are available to determine which drug should be administered first during salvage-line treatment. Therefore, it is imperative that we establish the sequence of administration by considering drug toxicity profiles based on patient characteristics, such as age, performance status, comorbidities, tolerability to previous treatments, and patient preferences. The identification of predictive biomarkers in response to TAS-102 or its toxicity is urgently needed for better patient selection. Moreover, to strengthen efficacy or relieve toxicity, combinations with other agents, which could potentially emerge as standard treatment regimens, have been investigated and compared to existing active regimens for mCRC. Keywords: TAS-102, metastatic colorectal cancer, regorafenib, biomarker

  3. Parallel functional activity profiling reveals valvulopathogens are potent 5-hydroxytryptamine(2B) receptor agonists: implications for drug safety assessment.

    Science.gov (United States)

    Huang, Xi-Ping; Setola, Vincent; Yadav, Prem N; Allen, John A; Rogan, Sarah C; Hanson, Bonnie J; Revankar, Chetana; Robers, Matt; Doucette, Chris; Roth, Bryan L

    2009-10-01

    Drug-induced valvular heart disease (VHD) is a serious side effect of a few medications, including some that are on the market. Pharmacological studies of VHD-associated medications (e.g., fenfluramine, pergolide, methysergide, and cabergoline) have revealed that they and/or their metabolites are potent 5-hydroxytryptamine(2B) (5-HT(2B)) receptor agonists. We have shown that activation of 5-HT(2B) receptors on human heart valve interstitial cells in vitro induces a proliferative response reminiscent of the fibrosis that typifies VHD. To identify current or future drugs that might induce VHD, we screened approximately 2200 U.S. Food and Drug Administration (FDA)-approved or investigational medications to identify 5-HT(2B) receptor agonists, using calcium-based high-throughput screening. Of these 2200 compounds, 27 were 5-HT(2B) receptor agonists (hits); 14 of these had previously been identified as 5-HT(2B) receptor agonists, including seven bona fide valvulopathogens. Six of the hits (guanfacine, quinidine, xylometazoline, oxymetazoline, fenoldopam, and ropinirole) are approved medications. Twenty-three of the hits were then "functionally profiled" (i.e., assayed in parallel for 5-HT(2B) receptor agonism using multiple readouts to test for functional selectivity). In these assays, the known valvulopathogens were efficacious at concentrations as low as 30 nM, whereas the other compounds were less so. Hierarchical clustering analysis of the pEC(50) data revealed that ropinirole (which is not associated with valvulopathy) was clearly segregated from known valvulopathogens. Taken together, our data demonstrate that patterns of 5-HT(2B) receptor functional selectivity might be useful for identifying compounds likely to induce valvular heart disease.

  4. Stereotactic Radiosurgery for Melanoma Brain Metastases in Patients Receiving Ipilimumab: Safety Profile and Efficacy of Combined Treatment

    Energy Technology Data Exchange (ETDEWEB)

    Kiess, Ana P. [Department of Radiation Oncology, Johns Hopkins University, Baltimore, Maryland (United States); Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Wolchok, Jedd D. [Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Barker, Christopher A. [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Postow, Michael A. [Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Tabar, Viviane [Department of Neurosurgery, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Huse, Jason T. [Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Chan, Timothy A.; Yamada, Yoshiya [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Beal, Kathryn, E-mail: bealk@mskcc.org [Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York (United States)

    2015-06-01

    Purpose: Ipilimumab (Ipi), a monoclonal antibody against cytotoxic T-lymphocyte antigen-4, has been shown to improve survival in patients with metastatic melanoma. In this single-institution study, we investigated the safety and efficacy of stereotactic radiosurgery (SRS) for patients with melanoma brain metastases (BMs) who also received Ipi. Methods and Materials: From 2005 to 2011, 46 patients with melanoma received Ipi and underwent single-fraction SRS for BMs. A total of 113 BMs (91% intact, 9% postoperative) were treated with a median dose of 21 Gy (range, 15-24 Gy). Ipi was given at 3 mg/kg (54%) or 10 mg/kg (46%) for a median of 4 doses (range, 1-21). Adverse events were recorded with the use of the Common Terminology Criteria for Adverse Events 3.0. Kaplan-Meier methods were used to estimate survival, and Cox regression was used to investigate associations. Results: Fifteen patients received SRS during Ipi, 19 received SRS before Ipi, and 12 received SRS after Ipi. Overall survival (OS) was significantly associated with the timing of SRS/Ipi (P=.035) and melanoma-specific graded prognostic assessment (P=.013). Patients treated with SRS during or before Ipi had better OS and less regional recurrence than did those treated with SRS after Ipi (1-year OS 65% vs 56% vs 40%, P=.008; 1-year regional recurrence 69% vs 64% vs 92%, P=.003). SRS during Ipi also yielded a trend toward less local recurrence than did SRS before or after Ipi (1-year local recurrence 0% vs 13% vs 11%, P=.21). On magnetic resonance imaging, an increase in BM diameter to >150% was seen in 50% of patients treated during or before Ipi but in only 13% of patients treated after Ipi. Grade 3 to 4 toxicities were seen in 20% of patients. Conclusion: Overall, the combination of Ipi and SRS appears to be well tolerated. Concurrent delivery of Ipi and SRS is associated with favorable locoregional control and possibly longer survival. It may also cause a temporary increase in tumor size, possibly

  5. A quantitative multiplex nuclease protection assay reveals immunotoxicity gene expression profiles in the rabbit model for vaginal drug safety evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Fichorova, Raina N., E-mail: rfichorova@rics.bwh.harvard.edu [Laboratory of Genital Tract Biology, Department of Obstetrics, Gynecology and Reproductive Biology, Brigham and Women' s Hospital and Harvard Medical School, Boston, MA (United States); Mendonca, Kevin; Yamamoto, Hidemi S.; Murray, Ryan [Laboratory of Genital Tract Biology, Department of Obstetrics, Gynecology and Reproductive Biology, Brigham and Women' s Hospital and Harvard Medical School, Boston, MA (United States); Chandra, Neelima; Doncel, Gustavo F. [CONRAD, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA (United States)

    2015-06-15

    Any vaginal product that alters the mucosal environment and impairs the immune barrier increases the risk of sexually transmitted infections, especially HIV infection, which thrives on mucosal damage and inflammation. The FDA-recommended rabbit vaginal irritation (RVI) model serves as a first line selection tool for vaginal products; however, for decades it has been limited to histopathology scoring, insufficient to select safe anti-HIV microbicides. In this study we incorporate to the RVI model a novel quantitative nuclease protection assay (qNPA) to quantify mRNA levels of 25 genes representing leukocyte differentiation markers, toll-like receptors (TLR), cytokines, chemokines, epithelial repair, microbicidal and vascular markers, by designing two multiplex arrays. Tissue sections were obtained from 36 rabbits (6 per treatment arm) after 14 daily applications of a placebo gel, saline, 4% nonoxynol-9 (N-9), and three combinations of the anti-HIV microbicides tenofovir (TFV) and UC781 in escalating concentrations (highest: 10% TFV + 2.5%UC781). Results showed that increased expression levels of toll-like receptor (TLR)-4, interleukin (IL)-1β, CXCL8, epithelial membrane protein (EMP)-1 (P < 0.05), and decreased levels of TLR2 (P < 0.05), TLR3 and bactericidal permeability increasing protein (BPI) (P < 0.001) were associated with cervicovaginal mucosal alteration (histopathology). Seven markers showed a significant linear trend predicting epithelial damage (up with CD4, IL-1β, CXCL8, CCL2, CCL21, EMP1 and down with BPI). Despite the low tissue damage RVI scores, the high-dose microbicide combination gel caused activation of HIV host cells (SLC and CD4) while N-9 caused proinflammatory gene upregulation (IL-8 and TLR4) suggesting a potential for increasing risk of HIV via different mechanisms depending on the chemical nature of the test product. - Highlights: • A transcriptome nuclease protection assay assessed microbicides for vaginal safety. • Biomarkers were

  6. The use of intravenous immunoglobulin in the treatment of autoimmune neuromuscular diseases: evidence-based indications and safety profile.

    Science.gov (United States)

    Dalakas, Marinos C

    2004-06-01

    Intravenous immunoglobulin (i.v.Ig) has multiple actions on the immunoregulatory network that operate in concert with each other. For each autoimmune neuromuscular disease, however, there is a predominant mechanism of action that relates to the underlying immunopathogenetic cause of the respective disorder. The best understood actions of i.v.Ig include the following: (a) modulation of pathogenic autoantibodies, an effect relevant in myasthenia gravis (MG), Lambert-Eaton myasthenic syndrome (LEMS), Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), and stiff-person syndrome (SPS); (b) inhibition of complement activation and interception of membranolytic attack complex (MAC) formation, an action relevant to the complement-mediated mechanisms involved in GBS, CIDP, MG, and dermatomyositis (DM); (c) modulation of the inhibitory or activation Fc receptors on macrophages invading targeted tissues in nerve and muscle, as seen in CIDP, GBS, and inflammatory myopathies; (d) down-regulation of pathogenic cytokines and adhesion molecules; (e) suppression of T-cell functions; and (f) interference with antigen recognition. Controlled clinical trials have shown that i.v.Ig is effective as first-line therapy in patients with GBS, CIDP, and multifocal motor neuropathy (MMN), and as second-line therapy in DM, MG, LEMS, and SPS. In paraproteinemic IgM anti-MAG (myelin-associated glycoprotein) demyelinating polyneuropathies and inclusion body myositis (IBM), the benefit is variable, marginal, and not statistically significant. i.v.Ig has a remarkably good safety record for long-term administration, however, the following side effects have been observed: mild, infusion-rate-related reactions, such as headaches, myalgia, or fever; moderate but inconsequential events, such as aseptic meningitis and skin rash; and severe, but rare, complications, such as thromboembolic events and renal tubular necrosis. Future studies are needed to (a) find the

  7. Sobredentadura total superior implantosoportada

    Directory of Open Access Journals (Sweden)

    Luis Orlando Rodríguez García

    2010-06-01

    Full Text Available Se presenta un caso de un paciente desdentado total superior, rehabilitado en la consulta de implantología de la Clínica "Pedro Ortiz" del municipio Habana del Este en Ciudad de La Habana, Cuba, en el año 2009, mediante prótesis sobre implantes osteointegrados, técnica que se ha incorporado a la práctica estomatológica en Cuba como alternativa al tratamiento convencional en los pacientes desdentados totales. Se siguió un protocolo que comprendió una fase quirúrgica, procedimiento con o sin realización de colgajo y carga precoz o inmediata. Se presenta un paciente masculino de 56 años de edad, que acudió a la consulta multidisciplinaria, preocupado, porque se le habían elaborado tres prótesis en los últimos dos años y ninguna reunía los requisitos de retención que él necesitaba para sentirse seguro y cómodo con las mismas. El resultado final fue la satisfacción total del paciente, con el mejoramiento de la calidad estética y funcional.

  8. Safety and pharmacokinetic profiles of phosphorodiamidate morpholino oligomers with activity against ebola virus and marburg virus: results of two single-ascending-dose studies.

    Science.gov (United States)

    Heald, Alison E; Iversen, Patrick L; Saoud, Jay B; Sazani, Peter; Charleston, Jay S; Axtelle, Tim; Wong, Michael; Smith, William B; Vutikullird, Apinya; Kaye, Edward

    2014-11-01

    Two identical single-ascending-dose studies evaluated the safety and pharmacokinetics (PK) of AVI-6002 and AVI-6003, two experimental combinations of phosphorodiamidate morpholino oligomers with positive charges (PMOplus) that target viral mRNA encoding Ebola virus and Marburg virus proteins, respectively. Both AVI-6002 and AVI-6003 were found to suppress disease in virus-infected nonhuman primates in previous studies. AVI-6002 (a combination of AVI-7537 and AVI-7539) or AVI-6003 (a combination of AVI-7287 and AVI-7288) were administered as sequential intravenous (i.v.) infusions of a 1:1 fixed dose ratio of the two subcomponents. In each study, 30 healthy male and female subjects between 18 and 50 years of age were enrolled in six-dose escalation cohorts of five subjects each and received a single i.v. infusion of active study drug (0.005, 0.05, 0.5, 1.5, 3, and 4.5 mg/kg per component) or placebo in a 4:1 ratio. Both AVI-6002 and AVI-6003 were safe and well tolerated at the doses studied. A maximum tolerated dose was not observed in either study. The four chemically similar PMOplus components exhibited generally similar PK profiles. The mean peak plasma concentration and area under the concentration-time curve values of the four components exhibited dose-proportional PK. The estimated plasma half-life of all four components was 2 to 5 h. The safety of the two combinations and the PK of the four components were similar, regardless of the target RNA sequence.

  9. Review of the safety, efficacy, and side effect profile of asenapine in the treatment of bipolar 1 disorder

    Directory of Open Access Journals (Sweden)

    Gonzalez JM

    2011-07-01

    Full Text Available Jodi M Gonzalez1, Peter M Thompson1, Troy A Moore1,21University of Texas Health Science Center, San Antonio, TX, USA; 2South Texas Veterans Health Care System, TX, USAObjective: Asenapine is approved for acute manic and mixed states in bipolar disorder. The objective is to review the efficacy of asenapine in bipolar disorder, with a particular focus on acceptability and adherence to treatment.Methods: Five clinical trials were conducted in bipolar disorder manic or mixed states: two 3-week trials (n = 976 comparing asenapine to placebo, a 9-week extension (n = 504, and a 40-week extension (n = 107. One trial was conducted comparing asenapine to placebo (n = 326 as adjunctive therapy for subjects with an incomplete response to lithium or valproate. All trials were conducted in the USA and internationally.Results: Asenapine was found to be efficacious for manic and mixed states in bipolar disorder compared with placebo control, and compares equally well to olanzapine on efficacy measures after 3 weeks of treatment. Asenapine was not found to be efficacious for depression symptoms. Common asenapine side effects in the 40-week extension trial were sedation, insomnia, and dizziness, and 31% reported clinically significant weight gain, compared with 55% reporting clinically significant weight gain with olanzapine. Additionally, 18% had clinically significant changes in fasting blood glucose levels compared to 22% of those on olanzapine. In terms of patient acceptability, one concern may be sublingual administration requiring no liquids or food for 10 minutes after dosing and a twice-daily regimen. Suggestions about addressing barriers to adherence and acceptability are provided.Conclusion: Asenapine is a promising new medication in bipolar disorder. Asenapine in the long-term has a more favorable weight gain profile compared to olanzapine. No benefit was seen for depression symptoms, a major patient-reported concern. Some side effects do not remit

  10. Systemic medications used in treatment of common dermatological conditions: Safety profile with respect to pregnancy, breast feeding and content in seminal fluid.

    Science.gov (United States)

    Brown, S M; Aljefri, K A; Waas, R; Hampton, P J

    2017-01-16

    Prescribing for pregnant or lactating patients and male patients wishing to father children can be a difficult area for dermatologists. There is a lack of review articles of commonly used systemic medications in dermatology with respect to their effects on developing embryogenesis and their potential transfer across the placenta, in breast milk and in seminal fluid. This paper aims to provide an up to date summary of evidence to better equip dermatologists to inform patients about the effects of systemic medications commonly used in dermatology to treat conditions such as atopic dermatitis, psoriasis and acne, on current and future embryogenesis and fertility. We have provided detailed evidence about the safety profile for the use of systemic medication used in the treatment of common dermatological conditions, such as atopic dermatitis, psoriasis and acne with respect to pregnancy, breastfeeding and spermatogenesis. The following medications are completely contraindicated in pregnancy: retinoids, methotrexate, mycophenolate and fumaric acid esters, whilst ciclosporin and hydroxychloroquine are considered safer options. Azathioprine and biologics have been considered on a case by case scenario. There is an association with impaired neonatal immunity and a possible VACTERL association with biologics. There is insufficient evidence to recommend ustekinumab. Dapsone should also be considered on a case by case basis as it is associated with haemolysis and hyperbilirubinaemia in the neonate. The following medications are contraindicated in breastfeeding: retinoids, methotrexate, mycophenolate, fumaric acid esters and ciclosporin. There is conflicting information about the use of azathioprine. Dapsone use during breastfeeding is associated with haemolysis and hyperbilirubinaemia in the neonate. The use of hydroxychloroquine is felt to be safe. The data associated with the use of biologic agents is limited, specific guidance for each biological medication is detailed in

  11. Thiopurines in the Management of Crohn’s Disease: Safety and Efficacy Profile in Patients with Normal TPMT Activity—A Retrospective Study

    Directory of Open Access Journals (Sweden)

    Amine Benmassaoud

    2016-01-01

    Full Text Available Background and Aims. Thiopurines are used in the treatment of Crohn’s disease (CD and thiopurine S-methyltransferase (TPMT activity can guide thiopurine dosing to avoid adverse events. This retrospective study evaluated the safety and efficacy of starting thiopurines at low dose versus full dose in patients with CD and normal TPMT. Methods. This was a single center retrospective study including adult CD patients with normal TPMT levels (≥25 nmol/hr/g Hgb who were followed for 1 year. Patients started at full dose of azathioprine (2–2.5 mg/kg or 6-mercaptopurine (1–1.5 mg/kg were compared to patients started at low dose. Harvey-Bradshaw index, treatment failure, and drug-related adverse events were recorded. Results. Our study included 134 patients. Both groups had similar incidences of drug-related adverse events and discontinuation of therapy due to side effects. Fifty-six percent of all adverse events occurred within 31 days and 92% occurred within 3 months of therapy. Clinical response favored the full-dose group at 6 months (69% versus 27%, p=0.0542. Conclusions. Our study indicates that it is safe to start patients on full-dose thiopurine when they have a normal TPMT given its very similar toxicity profile to patients started on low dose. This may also positively impact efficacy.

  12. Effectiveness and tuberculosis-related safety profile of interleukin-1 blocking agents in the management of Behçet's disease.

    Science.gov (United States)

    Cantarini, Luca; Lopalco, Giuseppe; Caso, Francesco; Costa, Luisa; Iannone, Florenzo; Lapadula, Giovanni; Anelli, Maria Grazia; Franceschini, Rossella; Menicacci, Cristina; Galeazzi, Mauro; Selmi, Carlo; Rigante, Donato

    2015-01-01

    Behçet's disease (BD) is a multi-systemic disorder of unknown etiology characterized by relapsing oral-genital ulcers, uveitis, and involvement of the articular, gastrointestinal, neurologic, and vascular systems. Although the primum movens of this condition remains unknown, a tangled plot combining autoimmune and autoinflammatory pathways has been hypothesized to explain its start and recurrence. In-depth analysis of BD pathogenetic mechanisms, involving dysfunction of multiple proinflammatory molecules, has opened new modalities of treatment: different agents targeting interleukin-1 have been studied in recent years to manage the most difficult and multi-resistant cases of BD. Growing experience with anakinra, canakinumab and gevokizumab is discussed in this review, highlighting the relative efficacy of each drug upon the protean BD clinical manifestations. Safety and tolerability of interleukin-1 antagonists in different doses have been confirmed by numerous observational studies on both large and small cohorts of patients with BD. In particular, the potential for Mycobacterium tuberculosis reactivation and tuberculosis development appears to be significantly lower with interleukin-1 blockers compared to tumor necrosis factor-α inhibitors, thus increasing the beneficial profile of this approach. Copyright © 2014 Elsevier B.V. All rights reserved.

  13. Appraising the safety and efficacy profile of left atrial appendage closure in 2016 and the future clinical perspectives. Results of the EAPCI LAAC survey.

    Science.gov (United States)

    Santucci, Andrea; Byrne, Robert A; Baumbach, Andreas; Colleran, Roisin; Haude, Michael; Windecker, Stephan; Valgimigli, Marco

    2016-05-17

    The aim of this study was to determine the opinion of the scientific community regarding percutaneous left atrial appendage closure (LAAC). The main focus of the survey was on concerns and expectations regarding the safety and efficacy profile of LAAC in clinical practice and on current and future clinical perspectives. A voluntary web-based survey was distributed by the European Association of Percutaneous Coronary Interventions (EAPCI) to all individuals registered on the EuroIntervention mailing list (n=21,800). A total of 724 physicians responded to the survey, of whom 31.8% had first operator experience with LAAC. Exclusive use of the Amulet (34.4%) or WATCHMAN (30.3%) was similar, but the former was the most frequently used device in Europe. The majority of respondents (59.3%) deemed LAAC to be as effective as, but safer than oral anticoagulants (OAC) in reducing stroke risk. Periprocedural complications (40.3%) and cost (28.8%) were the major concerns. Most practitioners did not consider novel oral anticoagulants (NOACs) to be a deterrent for performing LAAC procedures. Moreover, a history of serious haemorrhage was not deemed necessary to justify LAAC for 59.8% of physicians. The results of this survey reveal a high level of confidence in percutaneous LAAC amongst surveyed interventional cardiologists, with the majority believing it to be as effective as OAC in terms of stroke prevention and safer in terms of bleeding risk.

  14. Preclinical safety profile of trastuzumab emtansine (T-DM1): Mechanism of action of its cytotoxic component retained with improved tolerability

    Energy Technology Data Exchange (ETDEWEB)

    Poon, Kirsten Achilles, E-mail: achilles.kirsten@gene.com [Genentech, Inc., South San Francisco, CA (United States); Flagella, Kelly; Beyer, Joseph [Genentech, Inc., South San Francisco, CA (United States); Tibbitts, Jay [UCB, Brussels (Belgium); Kaur, Surinder; Saad, Ola; Yi, Joo-Hee; Girish, Sandhya; Dybdal, Noel; Reynolds, Theresa [Genentech, Inc., South San Francisco, CA (United States)

    2013-12-01

    Trastuzumab emtansine (T-DM1) is the first antibody-drug conjugate (ADC) approved for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The therapeutic premise of ADCs is based on the hypothesis that targeted delivery of potent cytotoxic drugs to tumors will provide better tolerability and efficacy compared with non-targeted delivery, where poor tolerability can limit efficacious doses. Here, we present results from preclinical studies characterizing the toxicity profile of T-DM1, including limited assessment of unconjugated DM1. T-DM1 binds primate ErbB2 and human HER2 but not the rodent homolog c-neu. Therefore, antigen-dependent and non-antigen-dependent toxicity was evaluated in monkeys and rats, respectively, in both single- and repeat-dose studies; toxicity of DM1 was assessed in rats only. T-DM1 was well tolerated at doses up to 40 mg/kg (∼ 4400 μg DM1/m{sup 2}) and 30 mg/kg (∼ 6000 μg DM1/m{sup 2}) in rats and monkeys, respectively. In contrast, DM1 was only tolerated up to 0.2 mg/kg (1600 μg DM1/m{sup 2}). This suggests that at least two-fold higher doses of the cytotoxic agent are tolerated in T-DM1, supporting the premise of ADCs to improve the therapeutic index. In addition, T-DM1 and DM1 safety profiles were similar and consistent with the mechanism of action of DM1 (i.e., microtubule disruption). Findings included hepatic, bone marrow/hematologic (primarily platelet), lymphoid organ, and neuronal toxicities, and increased numbers of cells of epithelial and phagocytic origin in metaphase arrest. These adverse effects did not worsen with chronic dosing in monkeys and are consistent with those reported in T-DM1-treated patients to date. - Highlights: • T-DM1 was well tolerated in preclinical studies in rats and cynomolgus monkeys. • T-DM1 is associated with bone marrow/hematologic, hepatic, and neuronal toxicities. • T-DM1 toxicities are related to DM1 mechanisms of action and pharmacologic

  15. An Evaluation of the Honey Bee (Hymenoptera: Apidae) Safety Profile of a New Systemic Insecticide, Flupyradifurone, Under Field Conditions in Florida.

    Science.gov (United States)

    Campbell, Joshua W; Cabrera, Ana R; Stanley-Stahr, Cory; Ellis, James D

    2016-10-01

    Flupyradifurone (Sivanto) is a novel systemic insecticide from the butenolide class developed by Bayer. Based on available data (USEPA 2014), this insecticide appears to have a favorable safety profile for honey bee colonies. As a result, the label permits the product to be applied during prebloom and bloom in various crops, including citrus, except when mixed with azole fungicides during the blooming period. We placed 24 honey bee (Apis mellifera L.) colonies adjacent to eight flowering buckwheat (Fagopyrum esculentum Moench) fields that either had been sprayed with the maximum label rate of flupyradifurone or with water only (control fields), with three colonies placed adjacent to each field. We conducted colony strength assessments during which the number of adult bees, eggs, uncapped brood cells, capped brood cells, food storage cells, and weights of honey supers and brood chambers were determined prior to, during, and after the flowering period. We also analyzed bee-collected pollen and nectar for flupyradifurone residues. Overall, there were no differences in any colony strength parameter for colonies placed at control and flupyradifurone-treated buckwheat fields. Residue analyses showed that pollen (x =  565.8 ppb) and nectar (x  =  259.4 ppb) gathered by bees on fields treated with flupyradifurone contained significantly higher flupyradifurone residues than did bee bread and unprocessed nectar collected by bees from control fields (75% of samples honey bee colonies when following label directions. © The Authors 2016. Published by Oxford University Press on behalf of Entomological Society of America. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  16. A randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, and pharmacokinetics of single enantiomer (+)-mefloquine compared with racemic mefloquine in healthy persons.

    Science.gov (United States)

    Tansley, Robert; Lotharius, Julie; Priestley, Anthony; Bull, Fiona; Duparc, Stephan; Möhrle, Jörg

    2010-12-01

    Racemic mefloquine is a highly effective antimalarial whose clinical utility has been compromised by its association with neuropsychiatric and gastrointestinal side effects. It is hypothesized that the cause of the side effects may reside in the (-) enantiomer. We sought to compare the safety, tolerability and pharmacokinetic profile of (+)-mefloquine with racemic mefloquine in a randomized, ascending-dose, double-blind, active and placebo-controlled, parallel cohort study in healthy male and female adult volunteers. Although differing in its manifestations, both study drugs displayed a substantially worse tolerability profile compared with placebo. The systemic clearance was slower for (-)-mefloquine than (+)-mefloquine. Thus, (+)-mefloquine has a different safety and tolerability profile compared with racemic mefloquine but its global safety profile is not superior and replacement of the currently used antimalarial drug with (+)-mefloquine is not warranted.

  17. Perfil de prescritores e prescrição de antimicrobianos nas infecções das vias aéreas superiores em Pediatria Perfil de prescriptores y prescripción de antimicrobianos en las infecciones de vías aéreas superiores en pediatría Profile of prescribers and prescription of antibiotics in upper respiratory infections in Pediatrics

    Directory of Open Access Journals (Sweden)

    Maria Carolina P. da Rocha

    2012-12-01

    Full Text Available OBJETIVO: Traçar um perfil dos médicos que atendem crianças nos sistemas público (Sistema Único de Saúde e privado de saúde e verificar como são prescritos antimicrobianos nas infecções das vias aéreas superiores. MÉTODOS: Médicos de algumas cidades do interior do Estado de São Paulo receberam via correio ou nas Unidades Básicas de Saúde uma carta explicativa sobre a pesquisa e o questionário, com perguntas sobre: tempo de graduação, residência médica, carga horária e local de trabalho, forma de atualização, fatores que consideram ao prescrever antimicrobianos e casos clínicos sobre as infecções das vias aéreas superiores. Os dados pessoais dos médicos foram relacionados com as respostas aos casos clínicos. Para análise estatística, foram aplicados os testes Z e de Tukey-Kramer, sendo pObjetivo: Esbozar un perfil de los médicos que atienden a niños en el sistema público (SUS y privado de salud y ve­rificar cómo se prescriben antimicrobianos en las infecciones de vías aéreas superiores (IVAS. Métodos: Los médicos de algunas ciudades del interior de la Provincia de São Paulo recibieron por correo o en las Unidades Básicas de Salud una carta explicativa sobre la in­vestigación y cuestionario con preguntas sobre: hace cuánto tiempo se ha graduado, internado, carga horaria y local de trabajo, forma de actualización, factores que tienen en cuenta al prescribir antimicrobianos y casos clínicos sobre IVAS. Los datos personales de los médicos fueron relacionados a las respuestas a los casos clínicos. Para el análisis estadístico, se aplicó la prueba Z y prueba de Tukey-Kramer, siendo significante pOBJECTIVE: To describe the profile of physicians that care for children in Brazilian public and private health systems, and to verify how antimicrobials for upper respiratory airway infections are prescribed. METHODS: Physicians in some cities of the state of São Paulo (Southeast Brazil received an

  18. Safety profile and probe placement accuracy of intraspinal pressure monitoring for traumatic spinal cord injury: Injured Spinal Cord Pressure Evaluation study.

    Science.gov (United States)

    Phang, Isaac; Zoumprouli, Argyro; Saadoun, Samira; Papadopoulos, Marios C

    2016-09-01

    OBJECTIVE A novel technique for monitoring intraspinal pressure and spinal cord perfusion pressure in patients with traumatic spinal cord injury was recently described. This is analogous to monitoring intracranial pressure and cerebral perfusion pressure in patients with traumatic brain injury. Because intraspinal pressure monitoring is a new technique, its safety profile and impact on early patient care and long-term outcome after traumatic spinal cord injury are unknown. The object of this study is to review all patients who had intraspinal pressure monitoring to date at the authors' institution in order to define the accuracy of intraspinal pressure probe placement and the safety of the technique. METHODS At the end of surgery to fix spinal fractures, a pressure probe was inserted intradurally to monitor intraspinal pressure at the injury site. Postoperatively, CT scanning was performed within 48 hours and MRI at 2 weeks and 6 months. Neurointensive care management and complications were reviewed. The American Spinal Injury Association Impairment Scale (AIS) grade was determined on admission and at 2 to 4 weeks and 12 to 18 months postoperation. RESULTS To date, 42 patients with severe traumatic spinal cord injuries (AIS Grades A-C) had undergone intraspinal pressure monitoring. Monitoring started within 72 hours of injury and continued for up to a week. Based on postoperative CT and MRI, the probe position was acceptable in all patients, i.e., the probe was located at the site of maximum spinal cord swelling. Complications were probe displacement in 1 of 42 patients (2.4%), CSF leakage that required wound resuturing in 3 of 42 patients (7.1%), and asymptomatic pseudomeningocele that was diagnosed in 8 of 42 patients (19.0%). Pseudomeningocele was diagnosed on MRI and resolved within 6 months in all patients. Based on the MRI and neurological examination results, there were no serious probe-related complications such as meningitis, wound infection, hematoma

  19. The European Food Safety Authority scientific opinion on a risk profile related to production and consumption of insects as food and feed

    DEFF Research Database (Denmark)

    Finke, Mark D; Rojo, S; Roos, Nanna;

    2015-01-01

    Background: The need for an opinion. The increased attention to the use of farmed insects as a novel protein source has raised the question of the safety of insects as human food and as animal feed. This was the background for the European Union (EU) Commission to mandate the European Food Safety...

  20. Safety profile of bone marrow mononuclear stem cells in the rehabilitation of patients with posttraumatic facial nerve paralysis-a novel modality (phase one trial).

    Science.gov (United States)

    Aggarwal, Sushil Kumar; Gupta, Ashok Kumar; Modi, Manish; Gupta, Rijuneeta; Marwaha, Neelam

    2012-08-01

    Objectives The objectives of this study were to study the safety profile and role of mononuclear stem cells in the rehabilitation of posttraumatic facial nerve paralysis not improving with conventional treatment. Study Design This is a prospective nonrandomized controlled trial. Study Setting This study is conducted at Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh between July, 2007 and December, 2008. Patients We included eight patients of either sex aged between 18 and 60 years of posttraumatic facial nerve paralysis not improving with conventional treatment presented to PGIMER, Chandigarh between July 2007 and December 2008. Methods All patients underwent preoperative electroneuronography (ENoG), clinical photography, and high-resolution computed tomography (HRCT) temporal bone. All patients then underwent facial nerve decompression and stem cell implantation. Stem cells processing was done in well-equipped bone marrow laboratory. Postoperatively, all patients underwent repeat ENoG and clinical photography at 3 and 6 months to assess for objective and clinical improvement. Clinical improvement was graded according to modified House-Brackmann grading system. Intervention Done All patients of posttraumatic facial nerve paralysis who were not improving with conventional surgical treatment were subjected to facial nerve decompression and stem cell implantation. Main Outcome Measures All patients who were subjected to stem cell implantation were followed up for 6 months to assess for any adverse effects of stem cell therapy on human beings; no adverse effects were seen in any of our patients after more than 6 months of follow-up. Results Majority of the patients were male, with motor vehicle accidents as the most common cause of injury in our series. Majority had longitudinal fractures on HRCT temporal bone. The significant improvement in ENoG amplitude was seen between preoperative and postoperative amplitudes on

  1. Effects and safety profile of betahistine in patients in the Russian contingent of OSVaLD, an open-label observational study in vestibular vertigo

    Directory of Open Access Journals (Sweden)

    Morozova SV

    2015-01-01

    Full Text Available Svetlana Vyacheslavovna Morozova,1 Natalia Stepanovna Alekseeva,2 Sergey Vasilyevich Lilenko,3 Eduard Ivanovich Matsnev,4 Oleg Anatol'evich Melnikov51Department of Ear, Nose, and Throat, State Budgetary Educational Institution of Higher Professional Training, IM Sechenov First Moscow State Medical University of the Ministry of Healthcare and Social Development of the Russian Federation, Moscow, 2Federal State Budgetary Institution, Scientific Neurology Center of the Russian Academy of Medical Sciences, Moscow, 3St Petersburg Research Institute of Ear, Throat, Nose and Speech, St Petersburg, 4Department of Physiology and Pathology of Auditory and Vestibular Systems, Federal Scientific Center (FSC, Institute for Biomedical Problems, Russian Academy of Sciences (RAS, Moscow, 5ANO Guta Clinic, Moscow, Russian Federation Background: We report here data from the >200 patients recruited in Russia to take part in OSVaLD, a 12-week, open-label, post-marketing surveillance study of the response to betahistine 48 mg/day in vertigo of peripheral vestibular origin carried out in a total of 13 countries.Methods: The primary efficacy endpoint was change in the Dizziness Handicap Inventory (DHI; 100-point scale. Changes in Hospital Anxiety and Depression Scale (HADS and Medical Outcomes Study Short-Form 36, version 2 (SF-36v2® scores were a priori secondary Outcomes.Results: Total DHI score improved by 43 points during betahistine treatment. This aggregate improvement was equally distributed across the three domains of the DHI (physical, emotional, and functional; P<0.0001 for main and subscore changes from baseline. Statistically significant improvements versus baseline were also observed in mean HADS scores for anxiety and depression (both P<0.0001, and in the Physical Component Summary and Mental Component Summary scores of the SF-36v2 (both P<0.0001 versus baseline. Only one suspected adverse drug reaction was recorded in the Russian safety population (n

  2. Pancreaticoduodenectomy with early superior mesenteric artery dissection

    Institute of Scientific and Technical Information of China (English)

    Yu-Fei Xu; Zuo-Jin Liu; Jian-Ping Gong

    2010-01-01

    BACKGROUND: Pancreatic adenocarcinoma remains the fourth leading cause of cancer-related death and is one of the most aggressive human tumors. At present, surgical resection is the only potentially curative treatment. Early neck division is inadequate when invasion of the superior mesenteric artery (SMA) is suspected or in cases of replaced or accessory right hepatic artery. Malignant periampullary tumors often invade retroperitoneal peripancreatic tissues and a positive resection margin is associated with a poor long-term survival. DATA SOURCES: English-language medical databases, PubMed, ELSEVIER and SPRINGERLINK, were searched for articles on"posterior approach pancreaticoduodenectomy","superior mesenteric artery ifrst approach", "retroperitoneal tissue","hanging maneuver", and related topics. RESULTS:The modiifcation allowed the surgeon to early identify the nonresectability of a replaced right hepatic artery if present, enabling complete dissection of the right side of the SMA and portal vein as well as complete excision of the retroportal pancreatic lamina. CONCLUSION: Pancreaticoduodenectomy with early retro-pancreatic dissection is a useful and safe technical variant, which is indicated for the improvement of the safety and curative effect of the procedure.

  3. 75 FR 28542 - Superior Resource Advisory Committee

    Science.gov (United States)

    2010-05-21

    ... orient the new Superior Resource Advisory Committee members on their roles and responsibilities. DATES... of the roles and responsibilities of the Superior Resource Advisory Committee members; Election of... Forest Service Superior Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice...

  4. [The superior laryngeal nerve and the superior laryngeal artery].

    Science.gov (United States)

    Lang, J; Nachbaur, S; Fischer, K; Vogel, E

    1987-01-01

    Length, diameter and anastomoses of the nervus vagus and its ganglion inferius were measured 44 halved heads. On the average, 8.65 fiber bundles of the vagus nerve leave the retro-olivary area. In the area of the jugular foramen is the near superior ganglion of the 10th cranial nerve. In this area were found 1.48 (mean value) anastomoses with the 9th cranial nerve. 11.34 mm below the margo terminalis sigmoidea branches off the ramus internus of the accessory nerve which has a length of 9.75 mm. Further anastomoses with the 10th cranial nerve were found. The inferior ganglion of the 10th nerve had a length of 25.47 mm and a diameter of 3.46 mm. Five mm below the ganglion the 10th nerve had a width of 2.9 and a thickness of 1.5 mm. The mean length of the superior sympathetic ganglion was 26.6 mm, its width 7.2 and its thickness 3.4 mm. In nearly all specimens anastomoses of the superior sympathetic ganglion with the ansa cervicalis profunda and the inferior ganglion of the 10th cranial nerve were found. The superior laryngeal nerve branches off about 36 mm below the margo terminalis sigmoidea. The width of this nerve was 1.9 mm, its thickness 0.8 mm on the right and 1.0 mm on the left side. The division in the internal and external rami was found about 21 mm below its origin. Between the n. vagus and thyreohyoid membrane the ramus internus had a length of 64 mm, the length of external ramus between the vagal nerve and the inferior pharyngeal constrictor muscle was 89 mm. Its mean length below the thyreopharyngeal part was 10.7 mm, 8.6 branchlets to the cricothyroid muscle were counted. The superior laryngeal artery had its origin in 80% of cases in the superior thyroideal artery, in 6.8% this vessel was a branch of the external carotid artery. Its average outer diameter was 1.23 mm on the right side and 1.39 mm on the left. The length of this vessel between its origin and the thyreohyoid membrane was 34 mm. In 7% on the right side and in 13% on the left, the superior

  5. 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

    2017-07-27

    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

  6. What are Millian Qualitative Superiorities?

    Directory of Open Access Journals (Sweden)

    Jonathan Riley

    2008-04-01

    Full Text Available In an article published in Prolegomena 2006, Christoph Schmidt-Petri has defended his interpretation and attacked mine of Mill’s idea that higher kinds of pleasure are superior in quality to lower kinds, regardless of quantity. Millian qualitative superiorities as I understand them are infinite superiorities. In this paper, I clarify my interpretation and show how Schmidt-Petri has misrepresented it and ignored the obvious textual support for it. As a result, he fails to understand how genuine Millian qualitative superiorities determine the novel structure of Mill’s pluralistic utilitarianism, in which a social code of justice that distributes equal rights and duties takes absolute priority over competing considerations. Schmidt-Petri’s own interpretation is a non-starter, because it does noteven recognize that Mill is talking about different kinds of pleasant feelings, such that the higher kinds are intrinsically more valuable than the lower. I conclude by outlining why my interpretation is free of any metaphysical commitment to the “essence” of pleasure.

  7. Isolated superior mesenteric artery dissection

    Directory of Open Access Journals (Sweden)

    Lalitha Palle

    2010-01-01

    Full Text Available Isolated superior mesenteric artery (SMA dissection without involvement of the aorta and the SMA origin is unusual. We present a case of an elderly gentleman who had chronic abdominal pain, worse after meals. CT angiography, performed on a 64-slice CT scanner, revealed SMA dissection with a thrombus. A large artery of Drummond was also seen. The patient was managed conservatively.

  8. A escrita no Ensino Superior

    Directory of Open Access Journals (Sweden)

    Maria Conceição Pillon Christofoli

    2013-01-01

    Full Text Available http://dx.doi.org/10.5902/198464445865 O presente artigo trata de apresentar resultados oriundos de pesquisa realizada no Ensino Superior, enfocando a escrita em contextos universitários. Depoimentos por parte dos acadêmicos evidenciam certa resistência ao ato de escrever, o que acaba muitas vezes distanciando o sujeito da produção de um texto. Assim sendo, mesmo que parciais, os resultados até então analisados dão conta de que: pressuposto 1 – há ruptura da ideia de coerência entre o que pensamos, o que conseguimos escrever, o que entende nosso interlocutor; pressuposto 2 – a autocorreção de textos como exercício de pesquisa é imprescindível para a qualificação da escrita; pressuposto 3 – os diários de aula representam rico instrumento para a qualificação da escrita no Ensino Superior; pressuposto 4 – há necessidade de que o aluno do Ensino Superior escreva variados tipos de escrita, ainda que a universidade cumpra com seu papel, enfatizando a escrita acadêmica; pressuposto 5 – o trabalho com a escrita no Ensino Superior deve enfatizar os componentes básicos da expressão escrita: o código escrito e a composição da escrita. Palavras-chave: Escrita; Ensino Superior; formação de professores.

  9. Vaccine Safety

    Science.gov (United States)

    ... Vaccine Safety Shingles (Herpes Zoster) Vaccine Safety Smallpox Vaccine Safety Common Concerns Adjuvants Autism CDC Statement: 2004 Pediatrics Paper on MMR and Autism Fainting (Syncope) Febrile ...

  10. Safety and pharmacokinetic profile of rufinamide in pediatric patients aged less than 4 years with Lennox-Gastaut syndrome: An interim analysis from a multicenter, randomized, active-controlled, open-label study.

    Science.gov (United States)

    Arzimanoglou, Alexis; Ferreira, Jose A; Satlin, Andrew; Mendes, Shannon; Williams, Betsy; Critchley, David; Schuck, Edgar; Hussein, Ziad; Kumar, Dinesh; Dhadda, Shobha; Bibbiani, Francesco

    2016-05-01

    A good knowledge of safety and age group-specific pharmacokinetics (PK) of antiepileptic drugs (AEDs) in young pediatric patients is of great importance in clinical practice. This paper presents 6-month interim safety and PK from an ongoing 2-year open-label study (Study 303) of adjunctive rufinamide treatment in pediatric subjects ≥ 1 to < 4 years with inadequately controlled epilepsies of the Lennox-Gastaut syndrome (LGS) spectrum. Subjects (N = 37) were randomized to either rufinamide or any other approved AED chosen by the investigator as adjunctive therapy to the subject's existing regimen of 1-3 AEDs. Interim safety results showed that treatment-emergent adverse events (TEAEs) were similar between the rufinamide (22 [88.0%]) and any-other-AED group (9 [81.8%]), with most events considered mild or moderate. A population PK analysis was conducted including plasma rufinamide concentrations from Study 303 and two other study populations of LGS subjects ≥ 4 years. The rufinamide PK profile was dose independent. The apparent clearance (CL/F) estimated from the PK model was 2.19 L/h; it was found to increase significantly as a function of body weight. Coadministration of valproic acid significantly decreased rufinamide CL/F. CL/F was not significantly affected by other concomitant AEDs, age, gender, race, hepatic function, or renal function. No adjustments to body weight-based rufinamide dosing in subjects ≥ 1 to < 4 years are necessary. Rufinamide was safe and well tolerated in these pediatric subjects. Results from the interim analysis demonstrate that rufinamide's safety and PK profile is comparable in subjects ≥ 1 to < 4 and ≥ 4 years with LGS. Study 303 (clinicaltrials.gov: NCT01405053). Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  11. Pensamiento Superior y Desarrollo Territorial

    Directory of Open Access Journals (Sweden)

    Víctor Manuel Racancoj Alonzo

    2015-04-01

    Full Text Available Esta reflexión pretende explicar el papel, fundamental, que juega el pensamiento superior, en la formulación y la práctica de modelos de desarrollo territorial local; para que contribuyan de forma sustantiva, en la transformación de las condiciones socioeconómicas adversas que hoy viven comunidades indígenas y rurales de muchos países, como Guatemala, situación que puede resumirse en altos índices de pobreza y desnutrición. Pero, el pensamiento superior, debe ser competencia de la población con pertenencia a lo local, pues si y solo si esta condición existe, se dará validez y viabilidad al desarrollo territorial. Para alcanzar competencias de pensamiento superior, en los espacios locales, se tiene que superar obstáculos en el modelo de universidad, que hoy estamos familiarizados a ver y pensar; modelos que tienen las características de: herencia colonial, disfunción con la problemática económica, cultural, social y política de la sociedad y la negación de los saberes ancestrales.

  12. Superior sulcus tumors (Pancoast tumors).

    Science.gov (United States)

    Marulli, Giuseppe; Battistella, Lucia; Mammana, Marco; Calabrese, Francesca; Rea, Federico

    2016-06-01

    Superior Sulcus Tumors, frequently termed as Pancoast tumors, are a wide range of tumors invading the apical chest wall. Due to its localization in the apex of the lung, with the potential invasion of the lower part of the brachial plexus, first ribs, vertebrae, subclavian vessels or stellate ganglion, the superior sulcus tumors cause characteristic symptoms, like arm or shoulder pain or Horner's syndrome. The management of superior sulcus tumors has dramatically evolved over the past 50 years. Originally deemed universally fatal, in 1956, Shaw and Paulson introduced a new treatment paradigm with combined radiotherapy and surgery ensuring 5-year survival of approximately 30%. During the 1990s, following the need to improve systemic as well as local control, a trimodality approach including induction concurrent chemoradiotherapy followed by surgical resection was introduced, reaching 5-year survival rates up to 44% and becoming the standard of care. Many efforts have been persecuted, also, to obtain higher complete resection rates using appropriate surgical approaches and involving multidisciplinary team including spine surgeon or vascular surgeon. Other potential treatment options are under consideration like prophylactic cranial irradiation or the addition of other chemotherapy agents or biologic agents to the trimodality approach.

  13. Hurricane Safety

    Science.gov (United States)

    ... English Hurricane Safety Checklist - Arabic Hurricane Safety Checklist - Chinese Hurricane Safety Checklist - French Hurricane Safety Checklist - Haitian ... Cross serves in the US, its territories and military installations around the world. Please try again. Your ...

  14. Safety profiles and efficacy of infliximab therapy in Japanese patients with plaque psoriasis with or without psoriatic arthritis, pustular psoriasis or psoriatic erythroderma: Results from the prospective post-marketing surveillance.

    Science.gov (United States)

    Torii, Hideshi; Terui, Tadashi; Matsukawa, Miyuki; Takesaki, Kazumi; Ohtsuki, Mamitaro; Nakagawa, Hidemi

    2016-07-01

    A large-scale prospective post-marketing surveillance was conducted to evaluate the safety and efficacy of infliximab in Japanese patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. This study was conducted in all psoriasis patients treated with infliximab after its Japanese regulatory approval. Infliximab was administrated at 5 mg/kg at weeks 0, 2 and 6, and every 8 weeks thereafter. Patients were serially enrolled and observed for 6 months to evaluate the safety and efficacy. The safety and efficacy were evaluated in 764 and 746 patients, respectively. Incidences of any and serious adverse drug reactions were 22.51% and 6.94%, respectively, and those of any and serious infusion reactions were 6.15% and 1.31%, respectively, which were comparable with the results in the post-marketing surveillance with 5000 rheumatoid arthritis patients in Japan. Major adverse drug reactions during the follow-up period were infections (5.10%) including pneumonia, cellulitis and herpes zoster, however, no tuberculosis was observed. The safety profiles were equivalent, regardless of the psoriasis types. No new safety problems were identified. The response rates on global improvement and median improvement rate of Psoriasis Area and Severity Index in all patients were 88.0% and 85.0%, respectively. Of note, the efficacy was equivalent for each psoriasis type as well as for each body region. Infliximab was also effective in pustular psoriasis symptoms, joint symptoms and nail psoriasis, as well as improvement of quality of life. Infliximab was confirmed to be highly effective and well tolerated in treating refractory psoriasis, including pustular psoriasis and psoriatic erythroderma. © 2015 Japanese Dermatological Association.

  15. Characteristics, resource utilization and safety profile of patients prescribed with neuropathic pain treatments: a real-world evidence study on general practices in Europe - the role of the lidocaine 5% medicated plaster.

    Science.gov (United States)

    Katz, Pablo; Pegoraro, Valeria; Liedgens, Hiltrud

    2017-08-01

    To identify characteristics, resource utilization, and safety profile of patients prescribed with lidocaine 5% medicated plaster, pregabalin, gabapentin, amitriptyline and duloxetine when experiencing pain in the real-world setting of general practitioners (GPs) in Europe. Retrospective analysis on real world data from IMS Health Longitudinal Patient Database. Patients with at least one prescription of the drugs of interest during 2014 were selected and those with a non-neuropathic pain-related diagnosis were excluded. Patients' demographic and clinical characteristics, resource utilization data and adverse drug reactions (ADRs) as described in the leaflet were extracted. The association between treatments and ADR occurrence was evaluated applying multivariate logistic models. A total of 70,515 patients were selected from Italy, Germany, the UK, Spain and Belgium. Lidocaine 5% medicated plaster patients were the oldest in Italy, the UK and Spain and the most health impaired in Italy, Spain and Belgium. No relevant differences in the number of co-prescriptions, specialist visits, examinations and hospitalizations were found. Significantly less lidocaine 5% plasters patients experienced ADRs, with odds ratios in favor of lidocaine 5% medicated plasters ranging from 3.41 (p = .036) to 52.33 (p plaster patients showing a better safety profile, but also a comparable level of resource utilization. A possible re-evaluation of the scientific value coming from this retrospective study in building up a diagnostic as well as a therapeutic algorithm is suggested.

  16. Entidades fiscalizadoras superiores y accountability

    OpenAIRE

    Estela Moreno, María

    2016-01-01

    OBJETIVOS DE LA TESIS: El objetivo general del trabajo es establecer el nivel de eficacia de las Entidades Fiscalizadoras Superiores (EFS) como agencia asignada y herramienta de accountability horizontal, a través de la valoración de su diseño institucional y de la calidad de sus productos finales, los informes de auditoría, estableciéndose los siguientes objetivos específicos: 1. Relevar las nociones de accountability, actualizando el Estado del Arte de la cuestión. 2. Analizar la ...

  17. Efeitos da redução de peso superior a 5% nos perfis hemodinâmico, metabólico e neuroendócrino de obesos grau I Effects of greater-than-5% weight reduction on hemodynamic, metabolic and neuroendocrine profiles of grade I obese subjects

    Directory of Open Access Journals (Sweden)

    Kelly Biancardini Gomes Barbato

    2006-07-01

    Full Text Available OBJETIVO: Avaliar os efeitos da redução de peso superior a 5% nos perfis hemodinâmico, metabólico e neuroendócrino de obesos grau I. MÉTODOS: Estudo observacional com 47 obesos grau I, média de idade de 33 anos, submetidos a orientação mensal quanto a dieta, exercício físico e comportamento alimentar, durante quatro meses. A pressão arterial, pelo método auscultatório, e a freqüência cardíaca, pelo método palpatório, foram avaliadas mensalmente, enquanto as seguintes variáveis (e respectivos métodos foram medidas no início e final do estudo: colesterol total, triglicerídeos, HDL-colesterol (enzimático, LDL-colesterol (fórmula de Friedwald, glicemia (enzimático hexoquinase, leptina, adiponectina, renina, aldosterona, insulina (radioimunoensaio e índice de resistência à insulina (HOMA. RESULTADOS: Observamos, após ajuste para outras variáveis, reduções significativas de 6 mmHg na pressão arterial diastólica, 7 pg/ml na renina, 13 mg/dl no colesterol total e 12 mg/dl no LDL-colesterol, no grupo com redução de peso superior a 5%. Notamos, também nesse grupo, tendência ao aumento de maior magnitude da adiponectina ao final do estudo, bem como diminuição três vezes maior dos níveis de glicemia, insulina e HOMA, e seis vezes maior da leptina. CONCLUSÃO: Medidas não-farmacológicas capazes de promover redução de peso superior a 5% produzem efeitos hemodinâmicos, metabólicos e neuroendócrinos que melhoram o risco cardiovascular de obesos.OBJECTIVE: To evaluate the effects of a greater-than-5% weight reduction in hemodynamic, metabolic, and neuroendocrine profiles of grade I obese subjects. METHODS: Observational study with 47 grade I obese subjects, with mean age of 33 years who received monthly orientation regarding diet, physical exercises, and eating behavior for four months. Blood pressure using the auscultatory method and pulse rate were assessed monthly, whereas the following variables (and

  18. The European Food Safety Authority scientific opinion on a risk profile related to production and consumption of insects as food and feed

    DEFF Research Database (Denmark)

    Finke, Mark D; Rojo, S; Roos, Nanna

    2015-01-01

    Background: The need for an opinion. The increased attention to the use of farmed insects as a novel protein source has raised the question of the safety of insects as human food and as animal feed. This was the background for the European Union (EU) Commission to mandate the European Food Safety......, 2014; NVWA, 2014). However, in the EU, existing regulations constitute legal barriers for marketing insects for human consumption and as protein in animal feed for food producing animals....... Authority (EFSA) to conduct a review of the current knowledge about biological, chemical and environmental risks associated with production and consumption of insects. National authorities in some EU member states (Belgium, the Netherlands and France) have conducted national assessments (ANSES, 2015; FASFC...

  19. The sentence superiority effect revisited.

    Science.gov (United States)

    Snell, Joshua; Grainger, Jonathan

    2017-11-01

    A sentence superiority effect was investigated using post-cued word-in-sequence identification with the rapid parallel visual presentation (RPVP) of four horizontally aligned words. The four words were presented for 200ms followed by a post-mask and cue for partial report. They could form a grammatically correct sentence or were formed of the same words in a scrambled agrammatical sequence. Word identification was higher in the syntactically correct sequences, and crucially, this sentence superiority effect did not vary as a function of the target's position in the sequence. Cloze probability measures for words at the final, arguably most predictable position, revealed overall low values that did not interact with the effects of sentence context, suggesting that these effects were not driven by word predictability. The results point to a level of parallel processing across multiple words that enables rapid extraction of their syntactic categories. These generate a sentence-level representation that constrains the recognition process for individual words, thus facilitating parallel word processing when the sequence is grammatically sound. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. 78 FR 21116 - Superior Supplier Incentive Program

    Science.gov (United States)

    2013-04-09

    ... Department of the Navy Superior Supplier Incentive Program AGENCY: Department of the Navy, DoD. ACTION... policy that will establish a Superior Supplier Incentive Program (SSIP). Under the SSIP, contractors that..., performance, quality, and business relations would be granted Superior Supplier Status (SSS). Contractors...

  1. superior en México

    Directory of Open Access Journals (Sweden)

    César Mureddu Torres

    2008-01-01

    Full Text Available El presente artículo desarrolla algunos de los retos que ha traído consigo el acceso a la información existente en la red de Internet y lo que ello supone. Se abordan principalmente las consecuencias de la presencia actual de una sociedad llamada del conocimiento, si se mantiene la confusión entre conocimiento e información. Por ello, la sola gestión de la información no puede ser tomada como definitoria respecto a la función de educación superior confiada a las universidades. Hacerlo sería cometer un error aún más grave que la confusión teórica entre los términos mencionados.

  2. The correlation between CYP2D6 isoenzyme activity and haloperidol efficacy and safety profile in patients with alcohol addiction during the exacerbation of the addiction

    Science.gov (United States)

    Sychev, Dmitry Alekseevich; Zastrozhin, Mikhail Sergeevich; Smirnov, Valery Valerieevich; Grishina, Elena Anatolievna; Savchenko, Ludmila Mikhailovna; Bryun, Evgeny Alekseevich

    2016-01-01

    Background Today, it is proved that isoenzymes CYP2D6 and CYP3A4 are involved in metabolism of haloperidol. In our previous investigation, we found a medium correlation between the efficacy and safety of haloperidol and the activity of CYP3A4 in patients with alcohol abuse. Objective The aim of this study was to evaluate the correlation between the activity of CYP2D6 and the efficacy and safety of haloperidol in patients with diagnosed alcohol abuse. Methods The study involved 70 men (average age: 40.83±9.92 years) with alcohol addiction. A series of psychometric scales were used in the research. The activity of CYP2D6 was evaluated by high-performance liquid chromatography with mass spectrometry using the ratio of 6-hydroxy-1,2,3,4-tetrahydro-beta-carboline to pinoline. Genotyping of CYP2D6 (1846G>A) was performed using real-time polymerase chain reaction. Results According to results of correlation analysis, statistically significant values of Spearman correlation coefficient (rs) between the activity of CYP2D6 and the difference of points in psychometric scale were obtained in patients receiving haloperidol in injection form (Sheehan Clinical Anxiety Rating Scale =−0.721 [P<0.001] and Udvald for Kliniske Undersogelser Side Effect Rating Scale =0.692 [P<0.001]) and in those receiving haloperidol in tablet form (Covi Anxiety Scale =−0.851 [P<0.001] and Udvald for Kliniske Undersogelser Side Effect Rating Scale =0.797 [P<0.001]). Conclusion This study demonstrated the correlations between the activity of CYP2D6 isozyme and the efficacy and safety of haloperidol in patients with alcohol addiction. PMID:27695358

  3. Practical Patient Safety

    CERN Document Server

    Reynard, John; Stevenson, Peter

    2009-01-01

    Following recent high profile cases of surgical error in the UK and USA, patient safety has become a key issue in healthcare, now placed at heart of junior doctor's training. Errors made by doctors are very similar to those made in other high risk organisations, such as aviation, nuclear and petrochemical industries. Practical Patient Safety aims to demonstrate how core principles of safety from these industries can be applied in surgical and medical practice, in particular throughtraining for health care professionals and healthcare managers.Whilst theoretical aspects of risk management form

  4. A comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the PROFIL register

    Directory of Open Access Journals (Sweden)

    A. V. Zakharova

    2016-01-01

    Full Text Available Aim. To study the efficacy and safety of generic orlistat in comparison with the original drug in obese patients.Material and methods. Patients with obesity degree 1-3 (n=60; 11.7% men and 88.3% women were included into the open comparative randomized controlled study in parallel groups. After randomization 40 patients received of generic orlistat and 20 – the original orlistat. The duration of follow-up was 12 weeks. Changes in body weight, body mass index, and waist circumference were assessed, as well as the proportion of patients with a weight loss of 5-10% or more from baseline.Results. Weight loss >5% was observed in 28 and 25% of patients in the groups of generic and original orlistat, respectively, and weight loss >10% - in 7.7% of patients only in the group of generic drug. No significant changes in blood pressure and heart rate were found. A significant reduction in total cholesterol and low density lipoprotein cholesterol was revealed. 11 (27.5% adverse events were observed in the group of generic orlistat and 5 (25% – in the group of original orlistat.Conclusion. Generic orlistat 120 mg in capsules showed clinical equivalence to the original drug. Safety and tolerability of treatment with both drugs were comparable.

  5. Safety and Efficacy Profile of Echinacea purpurea to Prevent Common Cold Episodes: A Randomized, Double-Blind, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    M. Jawad

    2012-01-01

    Full Text Available Objective. To investigate the safety (risk and efficacy (benefit of Echinacea purpurea extract in the prevention of common cold episodes in a large population over a 4-month period. Methods. 755 healthy subjects were allocated to receive either an alcohol extract from freshly harvested E. purpurea (95% herba and 5% root or placebo. Participants were required to record adverse events and to rate cold-related issues in a diary throughout the investigation period. Nasal secretions were sampled at acute colds and screened for viruses. Results. A total of 293 adverse events occurred with Echinacea and 306 with placebo treatment. Nine and 10% of participants experienced adverse events, which were at least possibly related to the study drug (adverse drug reactions. Thus, the safety of Echinacea was noninferior to placebo. Echinacea reduced the total number of cold episodes, cumulated episode days within the group, and pain-killer medicated episodes. Echinacea inhibited virally confirmed colds and especially prevented enveloped virus infections (P<0.05. Echinacea showed maximal effects on recurrent infections, and preventive effects increased with therapy compliance and adherence to the protocol. Conclusions. Compliant prophylactic intake of E. purpurea over a 4-month period appeared to provide a positive risk to benefit ratio.

  6. Safety and Efficacy Profile of Echinacea purpurea to Prevent Common Cold Episodes: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Jawad, M; Schoop, R; Suter, A; Klein, P; Eccles, R

    2012-01-01

    Objective. To investigate the safety (risk) and efficacy (benefit) of Echinacea purpurea extract in the prevention of common cold episodes in a large population over a 4-month period. Methods. 755 healthy subjects were allocated to receive either an alcohol extract from freshly harvested E. purpurea (95% herba and 5% root) or placebo. Participants were required to record adverse events and to rate cold-related issues in a diary throughout the investigation period. Nasal secretions were sampled at acute colds and screened for viruses. Results. A total of 293 adverse events occurred with Echinacea and 306 with placebo treatment. Nine and 10% of participants experienced adverse events, which were at least possibly related to the study drug (adverse drug reactions). Thus, the safety of Echinacea was noninferior to placebo. Echinacea reduced the total number of cold episodes, cumulated episode days within the group, and pain-killer medicated episodes. Echinacea inhibited virally confirmed colds and especially prevented enveloped virus infections (P Echinacea showed maximal effects on recurrent infections, and preventive effects increased with therapy compliance and adherence to the protocol. Conclusions. Compliant prophylactic intake of E. purpurea over a 4-month period appeared to provide a positive risk to benefit ratio.

  7. Safety culture

    Energy Technology Data Exchange (ETDEWEB)

    Keen, L.J. [Canadian Nuclear Safety Commission, Ottawa, Ontario (Canada)

    2003-07-01

    Safety culture has become a topic of increasing interest for industry and regulators as issues are raised on safety problems around the world. The keys to safety culture are organizational effectiveness, effective communications, organizational learning, and a culture that encourages the identification and resolution of safety issues. The necessity of a strong safety culture places an onus on all of us to continually question whether the safety measures already in place are sufficient, and are being applied. (author)

  8. Escuela Superior de Palos Verdes

    Directory of Open Access Journals (Sweden)

    Neutra, Richard J.

    1965-02-01

    Full Text Available Before initiating the building operations for the «Palos Verdes» School, the site was divided into two large horizontal surfaces, at different levels. The lower one served to accommodate the playing fields, a car park, the physical training building, and shop and ancillary buildings. On the higher of these two surfaces, and to the West of the access road, there is a car park and also the building and plot of ground devoted to agricultural technology, as well as the literary studies and general purpose buildings. As a complement to these, there is a series of blocks, arranged in parallel rows, which house the administrative offices, the art school, the craft's school, the general classrooms, and those devoted to higher education. The fascinating aspect of this school is the outstanding penetration of the architect's mind into the essential function of the project. Its most evident merit is the sense of comradeship and harmony that permeates the whole architectural manifold.Antes de construir el complejo escolar «Palos Verdes» se comenzó por crear, en el terreno, dos grandes mesetas a niveles diferentes. Sobre el inferior se organizaron: los campos de juegos, de deportes, un aparcamiento, el edificio para educación física y los destinados a tiendas y servicios. Sobre la meseta superior, al oeste de la vía de acceso, se dispuso un aparcamiento y el edificio y campo para adiestramiento agrícola; al este, otro aparcamiento, el edificio dedicado a materias literarias, y el destinado a usos múltiples. Completan las instalaciones de la escuela una serie de bloques paralelos: la administración, la escuela de arte, las clases de trabajos manuales, las aulas de enseñanzas generales, y las de los cursos superiores. Lo fascinante de este complejo escolar es la perfecta y magistral compenetración del arquitecto con el tema proyectado, y su mayor mérito, la sensación de cordialidad y armonía con el ambiente.

  9. The correlation between CYP2D6 isoenzyme activity and haloperidol efficacy and safety profile in patients with alcohol addiction during the exacerbation of the addiction

    Directory of Open Access Journals (Sweden)

    Sychev DA

    2016-09-01

    Full Text Available Dmitry Alekseevich Sychev,1 Mikhail Sergeevich Zastrozhin,1–3 Valery Valerieevich Smirnov,4 Elena Anatolievna Grishina,1 Ludmila Mikhailovna Savchenko,1 Evgeny Alekseevich Bryun1,2 1Russian Medical Academy of Postgraduate Education, Ministry of Health of the Russian Federation, 2Department of Public Health, Moscow Research and Practical Centre for Narcology, 3Peoples’ Friendship University of Russia, 4National Research Center, Institute of Immunology Federal Medical-Biological Agency of Russia, Moscow, Russia Background: Today, it is proved that isoenzymes CYP2D6 and CYP3A4 are involved in metabolism of haloperidol. In our previous investigation, we found a medium correlation between the efficacy and safety of haloperidol and the activity of CYP3A4 in patients with alcohol abuse.Objective: The aim of this study was to evaluate the correlation between the activity of CYP2D6 and the efficacy and safety of haloperidol in patients with diagnosed alcohol abuse.Methods: The study involved 70 men (average age: 40.83±9.92 years with alcohol addiction. A series of psychometric scales were used in the research. The activity of CYP2D6 was evaluated by high-performance liquid chromatography with mass spectrometry using the ratio of 6-hydroxy-1,2,3,4-tetrahydro-beta-carboline to pinoline. Genotyping of CYP2D6 (1846G>A was performed using real-time polymerase chain reaction.Results: According to results of correlation analysis, statistically significant values of Spearman correlation coefficient (rs between the activity of CYP2D6 and the difference of points in psychometric scale were obtained in patients receiving haloperidol in injection form (Sheehan Clinical Anxiety Rating Scale =-0.721 [P<0.001] and Udvald for Kliniske Undersogelser Side Effect Rating Scale =0.692 [P<0.001] and in those receiving haloperidol in tablet form (Covi Anxiety Scale =-0.851 [P<0.001] and Udvald for Kliniske Undersogelser Side Effect Rating Scale =0.797 [P<0.001].Conclusion

  10. Biological and haematological safety profile of oral amodiaquine and chloroquine in healthy volunteers with or without Plasmodium falciparum infection in northeast Tanzania

    DEFF Research Database (Denmark)

    Massaga, J J; Lusingu, J P; Makunde, R

    2008-01-01

    morbidity in infants. Volunteers were stratified according to parasitaemia status and randomly assigned 20 participants each arm to three days treatment with either AQ or chloroquine (CQ). The level of difference of selected haematological and hepatological values pre-and post-trial were marginal and within......-immune healthy adult male volunteers with and without malaria parasites. The objective was to collect data on biological and haematological safety, tolerability, and parasitological efficacy to serve as baseline in the evaluation of the effectiveness of AQ preventive intermittent treatment against malaria......-treated volunteers. The findings indicate that there was no agranulocytosis or hepatic toxicity suggesting that AQ may pose no public health risk in its wide therapeutic dosage uses. Larger studies are needed to exclude rare adverse effects....

  11. Safety reporting and adverse-event profile of mirtazapine described in randomized controlled trials in comparison with other classes of antidepressants in the acute-phase treatment of adults with depression: systematic review and meta-analysis.

    Science.gov (United States)

    Watanabe, Norio; Omori, Ichiro M; Nakagawa, Atsuo; Cipriani, Andrea; Barbui, Corrado; McGuire, Hugh; Churchill, Rachel; Furukawa, Toshi A

    2010-01-01

    Mirtazapine has a unique mechanism of antidepressant action, and thus is thought to have a different profile of adverse events from that of other antidepressants. To present a methodologically rigorous systematic review of the adverse event profile of mirtazapine and point to possible problems with safety reporting in randomized controlled trials (RCTs) of the acute-phase treatment of major depression in adults with mirtazapine in comparison with other types of antidepressant. The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register was electronically searched using the following search terms: 'depress*', 'dysthymi*', 'adjustment disorder*', 'mood disorder*', 'affective disorder', 'affective symptoms' and 'mirtazapine'. Pharmaceutical companies and experts in this field were contacted, and the reference lists of the relevant RCTs were checked, for additional data. No language restriction was imposed. Two authors independently assessed the quality of trials for inclusion in the review. Disagreements were resolved by consensus. Two authors independently extracted data on adverse events. Disagreements were resolved by consensus. The adequacy of safety reporting was assessed by one author. Regarding the adequacy of safety reporting, the qualitative and quantitative parameters of safety reporting were determined. Regression analyses were conducted to assess characteristics of trials influencing safety reporting. The primary and secondary outcomes in the systematic review of the adverse events associated with mirtazapine were defined as the proportion of patients having each of 43 adverse events listed in the modified version of the WHO Adverse Reaction Terminology, and the proportion of patients experiencing at least one adverse event, respectively. Meta-analyses were conducted for these outcomes. Twenty-five RCTs involving 4842 patients were identified as meeting our inclusion criteria. With regard to safety reporting, only two trials and

  12. Sobredentadura total superior implantosoportada Superior total overdenture on implants

    Directory of Open Access Journals (Sweden)

    Luis Orlando Rodríguez García

    2010-06-01

    Full Text Available Se presenta un caso de un paciente desdentado total superior, rehabilitado en la consulta de implantología de la Clínica "Pedro Ortiz" del municipio Habana del Este en Ciudad de La Habana, Cuba, en el año 2009, mediante prótesis sobre implantes osteointegrados, técnica que se ha incorporado a la práctica estomatológica en Cuba como alternativa al tratamiento convencional en los pacientes desdentados totales. Se siguió un protocolo que comprendió una fase quirúrgica, procedimiento con o sin realización de colgajo y carga precoz o inmediata. Se presenta un paciente masculino de 56 años de edad, que acudió a la consulta multidisciplinaria, preocupado, porque se le habían elaborado tres prótesis en los últimos dos años y ninguna reunía los requisitos de retención que él necesitaba para sentirse seguro y cómodo con las mismas. El resultado final fue la satisfacción total del paciente, con el mejoramiento de la calidad estética y funcional.This is the case of a total maxilla edentulous patient seen in consultation of the "Pedro Ortíz" Clinic Implant of Habana del Este municipality in 2009 and con rehabilitation by prosthesis over osteointegration implants added to stomatology practice in Cuba as an alternative to conventional treatment in patients totally edentulous. We follow a protocol including a surgery or surgical phase, technique without or with flap creation and early or immediate load. This is a male patient aged 56 came to our multidisciplinary consultation worried because he had three prostheses in last two years and any fulfilled the requirements of retention to feel safe and comfortable with prostheses. The final result was the total satisfaction of rehabilitated patient improving its aesthetic and functional quality.

  13. The pharmacokinetic and safety profiles of blonanserin in healthy Chinese volunteers after single fasting doses and single and multiple postprandial doses.

    Science.gov (United States)

    Chen, Xia; Wang, Hongyun; Jiang, Ji; Chen, Rui; Zhou, Ying; Zhong, Wen; Liu, Hongzhong; Hu, Pei

    2014-03-01

    Blonanserin is a novel atypical antipsychotic drug acting as a mixed serotonin 5-HT2A and dopamine D2 receptor antagonist. This study investigated the pharmacokinetics and safety of blonanserin in healthy Chinese males. This was an open-label trial with two parts. Twenty-four subjects were enrolled in part A to receive a single fasting dose of 4 or 8 mg blonanserin (each n = 12); part B recruited 12 subjects and administered single and sequentially twice-daily multiple postprandial doses of blonanserin 2 mg for 9 days. Serial blood samples were taken for the bioassay of plasma blonanserin and its four metabolites during both sub-studies. Safety was assessed, including repeat measurements of fasting serum prolactin, insulin, triglyceride and cholesterol. Blonanserin was rapidly absorbed, accompanied with immediate plasma concentration elevation of the N-oxide form (M2) and gradual rises of the N-deethylated form (M1) and its downstream metabolites. The mean elimination half-life of blonanserin (7.7-11.9 h) was much longer than that of M2 (1.2-1.3 h) but shorter than that of M1 (26.4-31.4 h) after single fasting doses. After food intake, a single dose of 2 mg blonanserin resulted in total exposure and peak concentrations of blonanserin similar to those observed with a single fasting dose of blonanserin 4 mg. Moreover, the relationship of metabolite over parent compound ratio was different between M1 and M2 after single and multiple postprandial administrations (single dose vs multiple dose: M1, 0.33 vs 0.75; M2, 0.13 vs 0.067). Mild but transient increases of prolactin, insulin and triglyceride were observed. The pharmacokinetics of blonanserin in Chinese subjects were similar to those observed in Japanese subjects. This study suggested that food intake not only increases the bioavailability of blonanserin but differently affects the pharmacokinetics of its metabolites as well. The drug was safe and well tolerated in healthy Chinese males.

  14. Obviating much of the need for insulin therapy in type 2 diabetes mellitus: A re-assessment of insulin therapy's safety profile.

    Science.gov (United States)

    Schwartz, Stanley S; Jellinger, Paul S; Herman, Mary E

    2016-08-01

    Current processes of care for diabetes mellitus (DM) were shaped during the era when insulin therapy was considered inexorable to the management of advanced stage type 2 (T2DM), though this no longer appears to be categorically true. There are also dashed hopes that insulin therapy can prevent or stall diabetes. While exogenous insulin remains a life-sparing tool for fully insulin-dependent DM, insulin therapy-induced hyperinsulinemia now appears to contribute to serious safety issues beyond hypoglycemia and weight gain. Iatrogenic and compensatory hyperinsulinemia are metabolic disruptors of β-cells, liver, muscle, kidney, brain, heart and vasculature, inflammation, and lipid homeostasis, among other systems. This may compromise β-cells, exacerbate insulin resistance (IR), and increase risk of cardiovascular (CV) disease. Striking associations between exogenous insulin and risks of CV events, cancer, and all-cause mortality in clinical trial and real-world cohorts caution that insulin may pose more harm than previously evidenced. At our disposal are numerous alternate tools that, alone or in combination, efficaciously manage hyperglycemia and glucolipotoxicity, and do so without inducing hypoglycemia, weight gain, or hyperinsulinemia. Moreover, these new tools support true precision therapy, as modern day drug classes can be aligned with the various mediating pathways of hyperglycemia at work in any given patient. Some also appear to promote β-cell survival, with intriguing data being presented for newer agents, such as incretins. As such, we encourage preferential use of non-insulin antidiabetic agents to injected insulin for the management of non-insulin-dependent patients with T2DM, including in advanced stage T2DM. The goal of this article is to augment existing literature to 1) correct misconceptions on the rationale and necessity for insulin therapy in T2DM, 2) discuss emerging negative safety data with insulin therapy, and, 3) offer a practical means to

  15. Effect of reduced dose schedules and intramuscular injection of anthrax vaccine adsorbed on immunological response and safety profile: a randomized trial.

    Science.gov (United States)

    Wright, Jennifer G; Plikaytis, Brian D; Rose, Charles E; Parker, Scott D; Babcock, Janiine; Keitel, Wendy; El Sahly, Hana; Poland, Gregory A; Jacobson, Robert M; Keyserling, Harry L; Semenova, Vera A; Li, Han; Schiffer, Jarad; Dababneh, Hanan; Martin, Sandra K; Martin, Stacey W; Marano, Nina; Messonnier, Nancy E; Quinn, Conrad P

    2014-02-12

    We evaluated an alternative administration route, reduced schedule priming series, and increased intervals between booster doses for anthrax vaccine adsorbed (AVA). AVA's originally licensed schedule was 6 subcutaneous (SQ) priming injections administered at months (m) 0, 0.5, 1, 6, 12 and 18 with annual boosters; a simpler schedule is desired. Through a multicenter randomized, double blind, non-inferiority Phase IV human clinical trial, the originally licensed schedule was compared to four alternative and two placebo schedules. 8-SQ group participants received 6 SQ injections with m30 and m42 "annual" boosters; participants in the 8-IM group received intramuscular (IM) injections according to the same schedule. Reduced schedule groups (7-IM, 5-IM, 4-IM) received IM injections at m0, m1, m6; at least one of the m0.5, m12, m18, m30 vaccine doses were replaced with saline. All reduced schedule groups received a m42 booster. Post-injection blood draws were taken two to four weeks following injection. Non-inferiority of the alternative schedules was compared to the 8-SQ group at m2, m7, and m43. Reactogenicity outcomes were proportions of injection site and systemic adverse events (AEs). The 8-IM group's m2 response was non-inferior to the 8-SQ group for the three primary endpoints of anti-protective antigen IgG geometric mean concentration (GMC), geometric mean titer, and proportion of responders with a 4-fold rise in titer. At m7 anti-PA IgG GMCs for the three reduced dosage groups were non-inferior to the 8-SQ group GMCs. At m43, 8-IM, 5-IM, and 4-IM group GMCs were superior to the 8-SQ group. Solicited injection site AEs occurred at lower proportions in the IM group compared to SQ. Route of administration did not influence the occurrence of systemic AEs. A 3 dose IM priming schedule with doses administered at m0, m1, and m6 elicited long term immunological responses and robust immunological memory that was efficiently stimulated by a single booster vaccination at

  16. Conscious Sedation Procedures Using Intravenous Midazolam for Dental Care in Patients with Different Cognitive Profiles: A Prospective Study of Effectiveness and Safety

    Science.gov (United States)

    Collado, Valérie; Faulks, Denise; Nicolas, Emmanuel; Hennequin, Martine

    2013-01-01

    The use of midazolam for dental care in patients with intellectual disability is poorly documented. This study aimed to evaluate the effectiveness and safety of conscious sedation procedures using intravenous midazolam in adults and children with intellectual disability (ID) compared to dentally anxious patients (DA). Ninety-eight patients with ID and 44 patients with DA programmed for intravenous midazolam participated in the study over 187 and 133 sessions, respectively. Evaluation criteria were success of dental treatment, cooperation level (modified Venham scale), and occurrence of adverse effects. The mean intravenous dose administered was 8.8±4.9 mg and 9.8±4.1 mg in ID and DA sessions respectively (t-test, NS). 50% N2O/O2 was administered during cannulation in 51% of ID sessions and 61% of DA sessions (NS, Fisher exact test). Oral or rectal midazolam premedication was administered for cannulation in 31% of ID sessions and 3% of DA sessions (p<0,001, Fisher exact test). Dental treatment was successful in 9 out of 10 sessions for both groups. Minor adverse effects occurred in 16.6% and 6.8% of ID and DA sessions respectively (p = 0.01, Fisher exact test). Patients with ID were more often very disturbed during cannulation (25.4% ID vs. 3.9% DA sessions) and were less often relaxed after induction (58.9% ID vs. 90.3% DA) and during dental treatment (39.5% ID vs. 59.7% DA) (p<0.001, Fisher exact test) than patients with DA. When midazolam sedation was repeated, cooperation improved for both groups. Conscious sedation procedures using intravenous midazolam, with or without premedication and/or inhalation sedation (50% N2O/O2), were shown to be safe and effective in patients with intellectual disability when administered by dentists. PMID:23940729

  17. Conscious sedation procedures using intravenous midazolam for dental care in patients with different cognitive profiles: a prospective study of effectiveness and safety.

    Directory of Open Access Journals (Sweden)

    Valérie Collado

    Full Text Available The use of midazolam for dental care in patients with intellectual disability is poorly documented. This study aimed to evaluate the effectiveness and safety of conscious sedation procedures using intravenous midazolam in adults and children with intellectual disability (ID compared to dentally anxious patients (DA. Ninety-eight patients with ID and 44 patients with DA programmed for intravenous midazolam participated in the study over 187 and 133 sessions, respectively. Evaluation criteria were success of dental treatment, cooperation level (modified Venham scale, and occurrence of adverse effects. The mean intravenous dose administered was 8.8±4.9 mg and 9.8±4.1 mg in ID and DA sessions respectively (t-test, NS. 50% N₂O/O₂ was administered during cannulation in 51% of ID sessions and 61% of DA sessions (NS, Fisher exact test. Oral or rectal midazolam premedication was administered for cannulation in 31% of ID sessions and 3% of DA sessions (p<0,001, Fisher exact test. Dental treatment was successful in 9 out of 10 sessions for both groups. Minor adverse effects occurred in 16.6% and 6.8% of ID and DA sessions respectively (p = 0.01, Fisher exact test. Patients with ID were more often very disturbed during cannulation (25.4% ID vs. 3.9% DA sessions and were less often relaxed after induction (58.9% ID vs. 90.3% DA and during dental treatment (39.5% ID vs. 59.7% DA (p<0.001, Fisher exact test than patients with DA. When midazolam sedation was repeated, cooperation improved for both groups. Conscious sedation procedures using intravenous midazolam, with or without premedication and/or inhalation sedation (50% N₂O/O₂, were shown to be safe and effective in patients with intellectual disability when administered by dentists.

  18. Conscious sedation procedures using intravenous midazolam for dental care in patients with different cognitive profiles: a prospective study of effectiveness and safety.

    Science.gov (United States)

    Collado, Valérie; Faulks, Denise; Nicolas, Emmanuel; Hennequin, Martine

    2013-01-01

    The use of midazolam for dental care in patients with intellectual disability is poorly documented. This study aimed to evaluate the effectiveness and safety of conscious sedation procedures using intravenous midazolam in adults and children with intellectual disability (ID) compared to dentally anxious patients (DA). Ninety-eight patients with ID and 44 patients with DA programmed for intravenous midazolam participated in the study over 187 and 133 sessions, respectively. Evaluation criteria were success of dental treatment, cooperation level (modified Venham scale), and occurrence of adverse effects. The mean intravenous dose administered was 8.8±4.9 mg and 9.8±4.1 mg in ID and DA sessions respectively (t-test, NS). 50% N₂O/O₂ was administered during cannulation in 51% of ID sessions and 61% of DA sessions (NS, Fisher exact test). Oral or rectal midazolam premedication was administered for cannulation in 31% of ID sessions and 3% of DA sessions (p<0,001, Fisher exact test). Dental treatment was successful in 9 out of 10 sessions for both groups. Minor adverse effects occurred in 16.6% and 6.8% of ID and DA sessions respectively (p = 0.01, Fisher exact test). Patients with ID were more often very disturbed during cannulation (25.4% ID vs. 3.9% DA sessions) and were less often relaxed after induction (58.9% ID vs. 90.3% DA) and during dental treatment (39.5% ID vs. 59.7% DA) (p<0.001, Fisher exact test) than patients with DA. When midazolam sedation was repeated, cooperation improved for both groups. Conscious sedation procedures using intravenous midazolam, with or without premedication and/or inhalation sedation (50% N₂O/O₂), were shown to be safe and effective in patients with intellectual disability when administered by dentists.

  19. Oral sildenafil (Viagra™ in male erectile dysfunction: use, efficacy and safety profile in an unselected cohort presenting to a British district general hospital.

    Directory of Open Access Journals (Sweden)

    Boustead Gregory

    2002-04-01

    Full Text Available Abstract Introduction Sildenafil (Viagra® is one of the drugs used in the first line therapy of male erectile dysfunction (MED. We have recorded outcomes, adverse events and acceptability of Sildenafil (Viagra therapy in an unselected group of men presenting with ED to a British district general hospital. Methods In this prospective observational study, 147 men with ED were seen since Oct 1999. Study patients were reviewed at 4, 12 and 52 weeks. All the patients filled the International Index of Erectile Function (IIEF questionnaire and were asked about their willingness to pay (WTP for treatment. Results All suitable men accepted Viagra as first line therapy. 91% of our patients found sildenafil treatment successful. 80% of these patients were willing to continue with sildenafil therapy. Side effect profile of sildenafil was different in this study with much higher incidence of headache, dyspepsia, flushing and abnormal vision. 92% of men with ED expect to be treated by the NHS. Of those men eligible for treatment in the NHS, 30% qualify under the clinical categories and 18% under the 'distress' category. Only 55% of those with cardiovascular risk factors qualify for NHS treatment. Conclusions Sildenafil is widely accepted as first line therapy among British men with ED and has a success rate of 91%. Nearly half of men with ED qualify for NHS treatment. Nearly half of those with vascular risk factors do not qualify for NHS treatment. Most men with ED could possibly be managed in primary care.

  20. [Examination of the hypothesis 'the factors and mechanisms of superiority'].

    Science.gov (United States)

    Sierra-Fitzgerald, O; Quevedo-Caicedo, J; López-Calderón, M G

    INTRODUCTION. The hypothesis of Geschwind and Galaburda suggests that specific cognitive superiority arises as a result of an alteration in development of the nervous system. In this article we review the co existence of superiority and inferiority . PATIENTS AND METHODS. A study was made of six children aged between 6 and 8 years old at the Instituto de Belles Artes Antonio Maria Valencia in Cali,Columbia with an educational level between second and third grade at a primary school and of medium low socio economic status. The children were considered to have superior musical ability by music experts, which is the way in which the concept of superiority was to be tested. The concept of inferiority was tested by neuropsychological tests = 1.5 DE below normal for the same age. We estimated the perinatal neurological risk in each case. Subsequently the children s general intelligence and specific cognitive abilities were evaluated. In the first case the WISC R and MSCA were used. The neuropsychological profiles were obtained by broad evaluation using a verbal fluency test, a test using counters, Boston vocabulary test, the Wechster memory scale, sequential verbal memory test, super imposed figures test, Piaget Head battery, Rey Osterrieth complex figure and the Wisconsin card classification test. The RESULTS showed slight/moderate deficits in practical construction ability and mild defects of memory and concept abilities. In general the results supported the hypothesis tested. The mechanisms of superiority proposed in the classical hypothesis mainly involve the contralateral hemisphere: in this study the ipsilateral mechanism was more important.

  1. Comparison of the circulating metabolite profile of PF-04991532, a hepatoselective glucokinase activator, across preclinical species and humans: potential implications in metabolites in safety testing assessment.

    Science.gov (United States)

    Sharma, Raman; Litchfield, John; Bergman, Arthur; Atkinson, Karen; Kazierad, David; Gustavson, Stephanie M; Di, Li; Pfefferkorn, Jeffrey A; Kalgutkar, Amit S

    2015-02-01

    A previous report from our laboratory disclosed the identification of PF-04991532 [(S)-6-(3-cyclopentyl-2-(4-trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid] as a hepatoselective glucokinase activator for the treatment of type 2 diabetes mellitus. Lack of in vitro metabolic turnover in microsomes and hepatocytes from preclinical species and humans suggested that metabolism would be inconsequential as a clearance mechanism of PF-04991532 in vivo. Qualitative examination of human circulating metabolites using plasma samples from a 14-day multiple ascending dose clinical study, however, revealed a glucuronide (M1) and monohydroxylation products (M2a and M2b/M2c) whose abundances (based on UV integration) were greater than 10% of the total drug-related material. Based on this preliminary observation, mass balance/excretion studies were triggered in animals, which revealed that the majority of circulating radioactivity following the oral administration of [¹⁴C]PF-04991532 was attributed to an unchanged parent (>70% in rats and dogs). In contrast with the human circulatory metabolite profile, the monohydroxylated metabolites were not detected in circulation in either rats or dogs. Available mass spectral evidence suggested that M2a and M2b/M2c were diastereomers derived from cyclopentyl ring oxidation in PF-04991532. Because cyclopentyl ring hydroxylation on the C-2 and C-3 positions can generate eight possible diastereomers, it was possible that additional diastereomers may have also formed and would need to be resolved from the M2a and M2b/M2c peaks observed in the current chromatography conditions. In conclusion, the human metabolite scouting study in tandem with the animal mass balance study allowed early identification of PF-04991532 oxidative metabolites, which were not predicted by in vitro methods and may require additional scrutiny in the development phase of PF-04991532.

  2. Paso superior en una ladera

    Directory of Open Access Journals (Sweden)

    Bender, O.

    1965-07-01

    Full Text Available The Redwood highway, through the Californian forest, runs on a viaduct, as it crosses a mountain slope of about 45° inclination. The firm ground is fairly deep, and as an additional constructional difficulty, it was necessary to respect the natural beauty of the countryside. A structure of portal frames were built, forming a number of short spans. These spans were bridged with metal girders, on which a 19 m wide deck was placed. The columns are hollow and have a transversal cross beam, to join each pair. There was difficulty in excavating the foundations for the columns, as it was necessary to dig through the soft top soil, and also prevent this soil from hurting the trunks of the forest trees. Another significant difficulty in the construction of this viaduct was the access to the working site, since there were no suitable platforms from which to operate the appropriate machinery. This made it necessary to do a lot of the work by manual operation. As one of the edges of the deck is very close to the mountain side, a supporting beam was erected on this side. It was made of concrete, on metal piles. The formwork for the deck structure was placed on the concrete stems of the supporting piles.La autopista denominada Redwood (California salva, con un paso superior, la ladera de un bosque cuya pendiente es del 1/1. El terreno firme se halla a bastante profundidad, añadiéndose, a los naturales problemas de la construcción, el imperativo de respetar la belleza agreste del paraje. La solución adoptada consiste en una estructura porticada, con varios tramos de pequeñas luces, salvados con vigas metálicas, sobre los que se coloca la losa del tablero, de 19 m de anchura total. Los soportes están constituidos por pórticos de dos montantes huecos (con bases de hormigón en masa por debajo del suelo, hasta el firme coronados por un cabezal. La perforación de pozos para el hormigonado de los montantes presentaba la dificultad de atravesar el terreno

  3. Profile Viewer (ProVu)

    Data.gov (United States)

    Department of Transportation — ProVu is a viewer which allows Federal, State, and private industry users to electronically analyze standard motor carrier safety profile reports available from the...

  4. Hand Safety

    Science.gov (United States)

    ... Gardening Safety Turkey Carving Removing a Ring Español Artritis de la base del pulgar Dedo en gatillo ... Gardening Safety Turkey Carving Removing a Ring Español Artritis de la base del pulgar Dedo en gatillo ...

  5. Water Safety

    Science.gov (United States)

    ... Old Feeding Your 1- to 2-Year-Old Water Safety KidsHealth > For Parents > Water Safety Print A ... best measure of protection. previous continue Making Kids Water Wise It's important to teach your kids proper ...

  6. SAFETY FIRST

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    Ensuring safety while peacefully utilizing nuclear energy is a top priority for China A fter a recent earthquake in Japan caused radioactive leaks at a nuclear power plant in Tokyo, the safety of nuclear energy has again aroused public attention.

  7. Safety Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The Swan Lake National Wildlife Refuge Safety Plan discusses policies for the safety of the station employees, volunteers, and public. This plan seeks to identify...

  8. The tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic with a clinically acceptable safety profile in subjects previously vaccinated with a tetravalent polysaccharide vaccine.

    Science.gov (United States)

    Dbaibo, Ghassan; Van der Wielen, Marie; Reda, Mariam; Medlej, Fouad; Tabet, Carelle; Boutriau, Dominique; Sumbul, Anne; Anis, Sameh; Miller, Jacqueline M

    2012-08-01

    The immunogenicity and safety of the tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine (MenACWY-TT) were evaluated in subjects previously vaccinated with a tetravalent meningococcal polysaccharide vaccine and in subjects without previous meningococcal vaccination. In this phase II, open, controlled study (NCT00661557), healthy subjects aged 4.5-34 years received one dose of MenACWY-TT at month 0. Subjects in the MPS group (n=192) had received polysaccharide vaccine in a study conducted 30-42 months earlier; age-matched subjects in the noMPS control group (n=79) had received no meningococcal vaccination within the past 10 years. Serum bactericidal activity using rabbit complement (rSBA) was measured at month 0 and month 1. At month 1, ≥97.0% of subjects had rSBA titers ≥1:128. Post-vaccination rSBA geometric mean titers (GMTs) were ≥3.9-fold higher than pre-vaccination in both treatment groups. Exploratory analyses showed no statistically significant differences between groups in percentages of subjects with rSBA titers ≥1:8 and ≥1:128, but significantly lower rSBA GMTs and vaccine response rates for each serogroup in the MPS versus the noMPS group. MenACWY-TT had an acceptable safety profile in both groups. These results suggest that MenACWY-TT could be used in vaccination programs irrespective of the pre-vaccination status with polysaccharide vaccine. Copyright © 2012 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  9. Pseudodisplacements of superior vena cava catheter in the persistent left superior vena cava

    Energy Technology Data Exchange (ETDEWEB)

    Jantsch, H.; Draxler, V.; Muhar, U.; Schlemmer, M.; Waneck, R.

    1983-01-01

    Pseudodisplacement of a left sided superior vena cava catheter in a persistent superior vena cava may be expected in adults in 0,37% and in a group of children with congenital heart disease in 2,5%. Embryology, anatomy and clinical implications is discussed on the basis of our own cases. The vena cava superior sinistra persitents is depending on a sufficient calibre a suitable vessel for a superior cava catheter.

  10. Efficacy and safety profile of LCR35 complete freeze-dried culture in irritable bowel syndrome: A randomized,double-blind study

    Institute of Scientific and Technical Information of China (English)

    Michel Dapoigny; Thierry Piche; Philippe Ducrotte; Bernard Lunaud; Jean-Michel Cardot; Annick Bernalier-Donadille

    2012-01-01

    AIM:To assess the effects and safety of lactobacillus casei rhamnosus LCR35 complete freeze-dried culture (LCR35) in patients suffering from irritable bowel syndrome (IBS).METHODS:A randomized,double-blind pilot study was performed in 50 patients complaining of IBS symptoms complying with Rome Ⅲ criteria.Patients were allocated to receive either LCR35 (n =25) at a minimum daily dose of 6 x 108 colony forming units or placebo (n =25) for 4 wk.At inclusion,after treatment and2 wk later,patients completed the IBS severity scale.Change from baseline in the IBS severity score at the end of treatment was the primary efficacy criterion.Changes were compared between groups in the whole population and in IBS subtypes (IBS with predominance of constipation,IBS with predominance of diarrhoea,mixed IBS,unsubtyped IBS).The presence of lactobacillus casei rhamnosus in stools was investigated at inclusion and at the end of treatment.The gastrointestinal quality of life questionnaire and the hospital anxiety and depression (HAD) scale were also completed.RESULTS:Both groups were balanced for baseline characteristics.In 85% of patients,stool analyses showed that lactobacillus casei rhamnosus able to survive in the digestive tract.In the whole population,improvements in the IBS severity score did not differ significantly between treatments with a 25% decrease after 4-wk treatment,and a 15% decrease from baseline 2 wk later in both groups.In IBS subgroups,statistical analysis could not be performed due to small sample size,but a clinical response in favour of LCR35 was observed in IBS patients with predominance of diarrhoea:no change in the symptom severity score was seen with the placebo after 4 wk treatment,whereas a clinically relevant decrease occurred with LCR35 (-37%vs-3%).Furthermore,in spite of an increase in symptom intensity,the IBS severity score was maintained below the baseline value 2 wk later with LCR35 (-19%from baseline),whilst a slight 5% increase

  11. Superiority in value and the repugnant conclusion

    DEFF Research Database (Denmark)

    Jensen, Karsten Klint

    2007-01-01

    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...... 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....

  12. An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix™ hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children.

    Science.gov (United States)

    Knuf, Markus; Pantazi-Chatzikonstantinou, Anna; Pfletschinger, Ulrich; Tichmann-Schumann, Irmingard; Maurer, Hartwig; Maurer, Lothar; Fischbach, Thomas; Zinke, Henrike; Pankow-Culot, Heidemarie; Papaevangelou, Vassiliki; Bianco, Veronique; Van der Wielen, Marie; Miller, Jacqueline M

    2011-06-06

    Tetravalent meningococcal serogroups ACWY conjugate vaccines will provide an advantage to those at most risk of invasive meningococcal disease; namely young children. Co-administration of ACWY-TT with DTaP-HBV-IPV/Hib was assessed in a randomized trial in 793 children aged 12-23 months. Pre-specified criteria for non-inferiority of immunogenicity following co-administration versus separate ACWY-TT and DTaP-HBV-IPV/Hib administration were reached. One month post-vaccination, ≥ 97.3% of ACWY-TT vaccinees had rSBA titres ≥ 1:8 (all serogroups). Seroprotection/seropositivity rates against DTaP-HBV-IPV/Hib antigens were ≥ 98.2%. The safety profile of co-administration was similar to that of DTaP-HBV-IPV/Hib alone. ACWY-TT and DTaP-HBV-IPV/Hib co-administration during the second year would facilitate introduction of ACWY-TT into routine toddler vaccination schedules.

  13. Millian superiorities and the repugnant conclusion

    DEFF Research Database (Denmark)

    Jensen, Karsten Klint

    2008-01-01

    James Griffin has considered a form of superiority in value that is weaker than lexical priority as a possible remedy to the Repugnant Conclusion. In this article, I demonstrate that, in a context where value is additive, this weaker form collapses into the stronger form of superiority. And in a ......James Griffin has considered a form of superiority in value that is weaker than lexical priority as a possible remedy to the Repugnant Conclusion. In this article, I demonstrate that, in a context where value is additive, this weaker form collapses into the stronger form of superiority...... 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....

  14. Measuring Financial Gains from Genetically Superior Trees

    Science.gov (United States)

    George Dutrow; Clark Row

    1976-01-01

    Planting genetically superior loblolly pines will probably yield high profits.Forest economists have made computer simulations that predict financial gains expected from a tree improvement program under actual field conditions.

  15. 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

  16. National Safety Council

    Science.gov (United States)

    ... Defensive Driving Workplace Training NSC University International Knowledge Knowledge Introduction Safety at Home Safety at Work Safety on ... or contact us . Measure Measure Safety Measure Safety Introduction Safety Management Systems Workplace Safety Consulting Employee Perception Surveys Research ...

  17. Leiomyosarcoma of the superior vena cava.

    Science.gov (United States)

    de Chaumont, Arthus; Pierret, Charles; de Kerangal, Xavier; Le Moulec, Sylvestre; Laborde, François

    2014-08-01

    Leiomyosarcoma of the superior vena cava is a very rare tumor and only a few cases have been reported, with various techniques of vascular reconstruction. We describe a new case of leiomyosarcoma of the superior vena cava in a 61-year-old woman with extension to the brachiocephalic arterial trunk. Resection and vascular reconstruction were performed using, respectively, polytetrafluoroethylene and polyethylene terephtalate vascular grafts.

  18. Superior mesenteric artery compression syndrome - case report

    OpenAIRE

    Paulo Rocha França Neto; Rodrigo de Almeida Paiva; Antônio Lacerda Filho; Fábio Lopes de Queiroz; Teon Noronha

    2011-01-01

    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 wi...

  19. Superior oblique surgery: when and how?

    Directory of Open Access Journals (Sweden)

    Taylan Şekeroğlu H

    2013-08-01

    Full Text Available Hande Taylan Şekeroğlu,1 Ali Sefik Sanac,1 Umut Arslan,2 Emin Cumhur Sener11Department of Ophthalmology, 2Department of Biostatistics, Hacettepe University Faculty of Medicine, Ankara, TurkeyBackground: The purpose of this paper is to review different types of superior oblique muscle surgeries, to describe the main areas in clinical practice where superior oblique surgery is required or preferred, and to discuss the preferred types of superior oblique surgery with respect to their clinical outcomes.Methods: A consecutive nonrandomized retrospective series of patients who had undergone superior oblique muscle surgery as a single procedure were enrolled in the study. The diagnosis, clinical features, preoperative and postoperative vertical deviations in primary position, type of surgery, complications, and clinical outcomes were reviewed. The primary outcome measures were the type of strabismus and the type of superior oblique muscle surgery. The secondary outcome measure was the results of the surgeries.Results: The review identified 40 (20 male, 20 female patients with a median age of 6 (2–45 years. Nineteen patients (47.5% had Brown syndrome, eleven (27.5% had fourth nerve palsy, and ten (25.0% had horizontal deviations with A pattern. The most commonly performed surgery was superior oblique tenotomy in 29 (72.5% patients followed by superior oblique tuck in eleven (27.5% patients. The amount of vertical deviation in the fourth nerve palsy and Brown syndrome groups (P = 0.01 for both and the amount of A pattern in the A pattern group were significantly reduced postoperatively (P = 0.02.Conclusion: Surgery for the superior oblique muscle requires experience and appropriate preoperative evaluation in view of its challenging nature. The main indications are Brown syndrome, fourth nerve palsy, and A pattern deviations. Superior oblique surgery may be effective in terms of pattern collapse and correction of vertical deviations in primary

  20. Safety; Avertissement

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-07-01

    This annual report of the Senior Inspector for the Nuclear Safety, analyses the nuclear safety at EDF for the year 1999 and proposes twelve subjects of consideration to progress. Five technical documents are also provided and discussed concerning the nuclear power plants maintenance and safety (thermal fatigue, vibration fatigue, assisted control and instrumentation of the N4 bearing, 1300 MW reactors containment and time of life of power plants). (A.L.B.)

  1. Visit safety

    CERN Multimedia

    2012-01-01

    Experiment areas, offices, workshops: it is possible to have co-workers or friends visit these places.     You already know about the official visits service, the VIP office, and professional visits. But do you know about the safety instruction GSI-OHS1, “Visits on the CERN site”? This is a mandatory General Safety Instruction that was created to assist you in ensuring safety for all your visits, whatever their nature—especially those that are non-official. Questions? The HSE Unit will be happy to answer them. Write to safety-general@cern.ch.   The HSE Unit

  2. Medication safety.

    Science.gov (United States)

    Keohane, Carol A; Bates, David W

    2008-03-01

    Patient safety is a state of mind, not a technology. The technologies used in the medical setting represent tools that must be properly designed, used well, and assessed on an on-going basis. Moreover, in all settings, building a culture of safety is pivotal for improving safety, and many nontechnologic approaches, such as medication reconciliation and teaching patients about their medications, are also essential. This article addresses the topic of medication safety and examines specific strategies being used to decrease the incidence of medication errors across various clinical settings.

  3. Whisker-related afferents in superior colliculus.

    Science.gov (United States)

    Castro-Alamancos, Manuel A; Favero, Morgana

    2016-05-01

    Rodents use their whiskers to explore the environment, and the superior colliculus is part of the neural circuits that process this sensorimotor information. Cells in the intermediate layers of the superior colliculus integrate trigeminotectal afferents from trigeminal complex and corticotectal afferents from barrel cortex. Using histological methods in mice, we found that trigeminotectal and corticotectal synapses overlap somewhat as they innervate the lower and upper portions of the intermediate granular layer, respectively. Using electrophysiological recordings and optogenetics in anesthetized mice in vivo, we showed that, similar to rats, whisker deflections produce two successive responses that are driven by trigeminotectal and corticotectal afferents. We then employed in vivo and slice experiments to characterize the response properties of these afferents. In vivo, corticotectal responses triggered by electrical stimulation of the barrel cortex evoke activity in the superior colliculus that increases with stimulus intensity and depresses with increasing frequency. In slices from adult mice, optogenetic activation of channelrhodopsin-expressing trigeminotectal and corticotectal fibers revealed that cells in the intermediate layers receive more efficacious trigeminotectal, than corticotectal, synaptic inputs. Moreover, the efficacy of trigeminotectal inputs depresses more strongly with increasing frequency than that of corticotectal inputs. The intermediate layers of superior colliculus appear to be tuned to process strong but infrequent trigeminal inputs and weak but more persistent cortical inputs, which explains features of sensory responsiveness, such as the robust rapid sensory adaptation of whisker responses in the superior colliculus. Copyright © 2016 the American Physiological Society.

  4. Evaluation of the safety, immunogenicity, and pharmacokinetic profile of a new, highly purified, heat-treated equine rabies immunoglobulin, administered either alone or in association with a purified, Vero-cell rabies vaccine.

    Science.gov (United States)

    Lang, J; Attanath, P; Quiambao, B; Singhasivanon, V; Chanthavanich, P; Montalban, C; Lutsch, C; Pepin-Covatta, S; Le Mener, V; Miranda, M; Sabchareon, A

    1998-07-30

    A clinical evaluation of a new, purified, heat-treated equine rabies immunoglobulin (PHT-Erig), F(ab')2 preparation, was carried out in Thailand and in the Philippines-two countries where rabies is endemic. An initial prospective, randomised, controlled trial (Study 1), compared the safety and pharmacokinetics (serum concentrations of rabies antibodies) after administration either of PHT-Erig or of a commercially-available, equine rabies immune globulin (Erig PMC). A second trial (Study 2) simulated post-exposure rabies prophylaxis by using a reference cell culture vaccine, the purified Vero-cell rabies vaccine (PVRV), administered in association with either Erig PMC or PHT-Erig. In Study 1, 27 healthy, Thai adults received a 40 IU kg(-1) dose of either Erig PMC (n = 12) or PHT-Erig (n = 15) via the intramuscular (i.m.) route; half of the dose was injected into the deltoid area and the other half into the buttocks. Serum for rabies antibody determination and F(ab')2 concentration was collected at hours (H) 0, 6 and 12, and on day (D) 2, 3, 4, 6, 8, 10, 12 and 15. Both products were safe, with no serious adverse events, and in particular, no anaphylactic reactions or serum sickness was reported. A statistical comparison of the pharmacokinetic parameters did not demonstrate bioequivalence of the two products. Nonetheless, the relative bioavailability of 93% and the similar absorption rates suggest the pharmacokinetic profiles of Erig and PHT-Erig are similar. The antibody level in either group were low throughout the 15-day study period. The geometric mean titer (GMT) values ranged from group 0.027-0.117 IU ml(-1) in the Erig group and from 0.029 to 0.072 IU ml(-1) in the PHT-Erig. There was no significant difference between the evolution of GMT values for the two groups. In Study 2, 71 healthy volunteers received 40 IU kg(-1) via the intramuscular route of either Erig PMC (n = 36) or PHT-Erig (n = 35) on D0, in association with five doses of PVRV on D0, D3, D7, D14

  5. Safety Systems

    Science.gov (United States)

    Halligan, Tom

    2009-01-01

    Colleges across the country are rising to the task by implementing safety programs, response strategies, and technologies intended to create a secure environment for teachers and students. Whether it is preparing and responding to a natural disaster, health emergency, or act of violence, more schools are making campus safety a top priority. At…

  6. Safety Instructions

    CERN Multimedia

    2003-01-01

    Please note that the Safety Instructions N0 37 rev. 3 (IS 37 rev. 3) entitled ""LEVEL-3" SAFETY ALARMS AND ALARM SYSTEMS" Is available on the web at the following URL: http://edms.cern.ch/document/335802 Paper copies can also be obtained from the TIS divisional secretariat, e-mail: tis.secretariat@cern.ch TIS Secretariat

  7. Efficacy and safety profile of a novel technique, ThuLEP (Thulium laser enucleation of the prostate) for the treatment of benign prostate hypertrophy. Our experience on 148 patients.

    Science.gov (United States)

    Iacono, Fabrizio; Prezioso, Domenico; Di Lauro, Giovanni; Romeo, Giuseppe; Ruffo, Antonio; Illiano, Ester; Amato, Bruno

    2012-01-01

    Over the past years laser technology has played a predominant role in prostate surgery, for the treatment of benign prostate hypertrophy (BPH). Various laser devices have been introduced in clinical practice, showing good results in terms of complications and urodynamic outcomes efficacy compared with TURP and Open Prostatectomy.In this study we describe the efficacy and the safety profile of a novel laser technique, ThuLEP (Thulium Laser Enucleation of Prostate) that permits a complete anatomical endoscopic enucleation of prostatic adenoma independently to prostate size. 148 patients with a mean age of 68.2 years were enrolled between September 2009 and March 2012 (36 months), and treated for BPH with ThuLEP. Every patient was evaluated at base line according to: Digital Rectal Examination (DRE), prostate volume, Post-Voided volume (PVR), International Prostate Symptoms Score (I-PSS), International Index of Erectile Function-5 (IIEF-5), Quality of Life (QoL), PSA values, urine analysis and urine culture, uroflowmetry. The same evaluation was conducted after a 12 month follow-up. ThuLEP was performed by 2 expert surgeons. Our data showed a better post-operative outcome in terms of catheter removal, blood loss, TURP syndrome, clot retention and residual tissue compared to large series of TURP and OP. Only 1.3% of patients had bladder wall injury during morcellation. I-PSS, Qmax, Prostate Volume, QoL and PVR showed a highly significant improvement at 12 month follow-up in comparison to preoperative assessment. ThuLEP represent an innovative option in patients with BPH. It is a size independent surgical endoscopic technique and it can be considered the real alternative, at this time, to TURP and even more to Open Prostatectomy for large prostate, with a complete removal of adenoma and with a low complication rate.

  8. Chemically characterized Mentha cardiaca L. essential oil as plant based preservative in view of efficacy against biodeteriorating fungi of dry fruits, aflatoxin secretion, lipid peroxidation and safety profile assessment.

    Science.gov (United States)

    Dwivedy, Abhishek Kumar; Prakash, Bhanu; Chanotiya, Chandan Singh; Bisht, Deepa; Dubey, Nawal Kishore

    2017-08-01

    The study reports Mentha cardiaca essential oil (EO) as plant based preservative against fungal and aflatoxin contamination of stored dry fruits. Mycoflora analysis of the dry fruits revealed Aspergillus favus LHP-PV-1 as the most aflatoxigenic isolate with highest Aflatoxin B1 content. M. cardiaca EO showed broad fungitoxic spectrum inhibiting the tested moulds contaminating dry fruits. It's minimum inhibitory concentration (MIC), minimum aflatoxin inhibitory concentration (MAIC) and minimum fungicidal concentration (MFC) against A. favus LHP-PV-1 were recorded to be 1.25, 1.0 and 2.25 µL/mL respectively. The EO caused decrease in ergosterol content and enhanced leakage of Ca(2+), K(+) and Mg(2+) ions from treated fungal cells, depicting fungal plasma membrane as the site of antifungal action. The EO showed promising DPPH free radical scavenging activity (IC50 value:15.89 µL/mL) and favourable safety profile with LD50 value (7133.70 mg/kg body wt.) when estimated through acute oral toxicity on mice. Carvone (61.62%) was recorded as the major component of the oil during chemical characterisation through GC-MS. Based on strong antifungal, antiaflatoxigenic and antioxidant potential, the chemically characterised M. cardiaca EO may be recommended as safe plant based preservative and shelf life enhancer of food items. This is the first report on antifungal and antiaflatoxigenic activity of M. cardiaca EO. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. Superior-subordinate relations as organizational processes

    DEFF Research Database (Denmark)

    Asmuss, Birte; Aggerholm, Helle Kryger; Oshima, Sae

    Since the emergence of the practice turn in social sciences (Golsorkhi et al. 2010), studies have shown a number of institutionally relevant aspects as achievements across time and by means of various resources (human and non-human) (Taylor & van Every 2000, Cooren et al. 2006). Such a process view...... on organizational practices relates closely to an increased focus on communication as being constitutive of the organization in general and the superior-subordinate relationship in specific. The current study aims to contribute to this line of research by investigating micro-practices involved in establishing...... superior-subordinate relations in a specific institutionalized setting: performance appraisal interviews (PAIs). While one main task of PAIs is to manage and integrate organizational and employee performance (Fletcher, 2001:473), PAIs are also organizational practices where superior-subordinate relations...

  10. Lake Superior Aquatic Invasive Species Complete Prevention Plan

    Science.gov (United States)

    The Lake Superior Aquatic Invasive Species Complete Prevention Plan is an expression of the best professional judgment of the members of the Lake Superior Task Force as to what is necessary to protect Lake Superior from new aquatic invasive species.

  11. [Opioids in chronic noncancer pain-are opioids superior to nonopioid analgesics? A systematic review and meta-analysis of efficacy, tolerability and safety in randomized head-to-head comparisons of opioids versus nonopioid analgesics of at least four week's duration].

    Science.gov (United States)

    Welsch, P; Sommer, C; Schiltenwolf, M; Häuser, W

    2015-02-01

    Some leading German pain medicine experts postulate that there is a type of chronic non-cancer pain (CNCP) with an opioid requirement. We tested whether opioids are superior to nonopioid analgesics in the management of CNCP in studies of at least 4 week's duration. We screened MEDLINE, Scopus and the Cochrane Central Register of Controlled Trials (CENTRAL) up until October 2013, as well as the reference sections of original studies and systematic reviews of randomised controlled trials (RCTs) of opioids in CNCP. We included double-blind RTCs comparing opioids to nonopioid analgesics of at least 4 week's duration. Relative risks differences (RD) of categorical data and standardized mean differences (SMD) of continuous variables were calculated using a random effects model. We included 10 RCTs with 3046 participants. Median study duration was 6 weeks (range 4-12 weeks). Five studies compared tramadol with nonsteroidal anti-inflammatory drugs (NSAIDs) in osteoarthritis pain and one trial compared tramadol to flupirtine in low back pain. Morphine was compared to antidepressants (two studies), an anticonvulsant (one study) and an antiarrhythmic (one study) in different neuropathic pain syndromes. There was no significant difference between opioids and nonopioid analgesics in pain reduction (SMD 0.03 [95 % confidence interval, CI - 0.18, 0.24]; p = 0.76). Nonopioid analgesics were superior to opioids in improving physical function (SMD 0.17 [95 % CI 0.02, 0.32]; p = 0.03). Patients dropped out due to adverse events more frequently with opioids than with nonopioid analgesics (RD 0.09 [95 % CI 0.06, 0.13]; p SpringerLink (under "Supplemental").

  12. Endovascular treatment of superior vena cava syndrome

    DEFF Research Database (Denmark)

    Duvnjak, Stevo; Andersen, Poul Erik

    2011-01-01

    Abstract AIM: The aim of this study was to report our experience with palliative stent treatment of superior vena cava syndrome. METHODS: Between January 2008 and December 2009, 30 patients (mean age 60.7 years) were treated with stents because of stenosed superior vena cava. All patients presented...... there was an immediate clinical improvement with considerable reduction in the edema of upper extremities and head. There was, however, continous dyspnea in five patients (17%) and two patients (7%) had persistent visible collateral venous circulations on the upper chest. There were no stent associated complications...

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

    Science.gov (United States)

    Simão, Marcelo Novelino; Vinson, Emily N.; Spritzer, Charles E.

    2016-01-01

    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. PMID:27777474

  14. 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.

  15. Nuclear Safety

    Energy Technology Data Exchange (ETDEWEB)

    Silver, E G [ed.

    1989-01-01

    This document is a review journal that covers significant developments in the field of nuclear safety. Its scope includes the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials, and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated.

  16. SUPERIOR MESENTERIC AND PORTAL VEIN THROMBOSIS WITH HYPERHOMOCYSTEINEMIA

    Directory of Open Access Journals (Sweden)

    Tumma

    2015-02-01

    Full Text Available Superior mesenteric venous thrombosis is a rare & life threatening condition. We report a case of 18 years old boy presented to emergency department with pain abdomen, fever, Melena for almost week duration. Bowel sounds were absent since two days. With a preoperative diagnosis of peritonitis Patient was taken up for emergency laparotomy. Resection of gangrenous small bowel and end to end anastomosis was done. Intra operatively thrombus in SMV was found. Coagulation profile was normal except for elevated homocystine levels. Early postoperative period was stormy. Patient was started on LMV Heparin from day - 1. Pregangrenous changes were seen in contrast CT abdomen on Day - 4. We managed conservatively with anticoagulation therapy in the postoperative period. Pregangrenous changes disappeared with conservative management. Patient was shifted to oral warfarin and discharged on 3 rd week. Follow up Doppler USG abdomen revealed a portal vein of normal size & caliber with no evidence of thrombus. On postoperative follow up for one year, patient is doing well. Hyperhomocycteinemia is an independent predisposing factor to superior mesenteric venous thrombus.

  17. 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.

  18. Designing functionally graded materials with superior load-bearing properties.

    Science.gov (United States)

    Zhang, Yu; Sun, Ming-Jie; Zhang, Denzil

    2012-03-01

    Ceramic prostheses often fail from fracture and wear. We hypothesize that these failures may be substantially mitigated by an appropriate grading of elastic modulus at the ceramic surface. In this study, we elucidate the effect of elastic modulus profile on the flexural damage resistance of functionally graded materials (FGMs), providing theoretical guidelines for designing FGMs with superior load-bearing property. The Young's modulus of the graded structure is assumed to vary in a power-law relation with a scaling exponent n; this is in accordance with experimental observations from our laboratory and elsewhere. Based on the theory for bending of graded beams, we examine the effect of n value and bulk-to-surface modulus ratio (E(b)/E(s)) on stress distribution through the graded layer. Theory predicts that a low exponent (0.15graded materials with various n values and E(b)/E(s) ratios can be fabricated by infiltrating alumina and zirconia with a low-modulus glass. Flexural tests show that graded alumina and zirconia with suitable values of these parameters exhibit superior load-bearing capacity, 20-50% higher than their homogeneous counterparts. Improving load-bearing capacity of ceramic materials could have broad impacts on biomedical, civil, structural, and an array of other engineering applications.

  19. Home Safety

    Science.gov (United States)

    ... October 2015) Preventing accidental injuries to children in India. Video Changing the News with Neal McDonough: Fire ... Our Mailing List Global Road Safety Sponsors Recalls Media Center Blog Videos Newsletter facebook twitter instagram pinterest ...

  20. Safety first!

    CERN Multimedia

    2016-01-01

    Among the many duties I assumed at the beginning of the year was the ultimate responsibility for Safety at CERN: the responsibility for the physical safety of the personnel, the responsibility for the safe operation of the facilities, and the responsibility to ensure that CERN acts in accordance with the highest standards of radiation and environmental protection.   The Safety Policy document drawn up in September 2014 is an excellent basis for the implementation of Safety in all areas of CERN’s work. I am happy to commit during my mandate to help meet its objectives, not least by ensuring the Organization makes available the necessary means to achieve its Safety objectives. One of the main objectives of the HSE (Occupational Health and Safety and Environmental Protection) unit in the coming months is to enhance the measures to minimise CERN’s impact on the environment. I believe CERN should become a role model for an environmentally-aware scientific research laboratory. Risk ...

  1. 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.

  2. SAFETY INSTRUCTION AND SAFETY NOTE

    CERN Multimedia

    TIS Secretariat

    2002-01-01

    Please note that the SAFETY INSTRUCTION N0 49 (IS 49) and the SAFETY NOTE N0 28 (NS 28) entitled respectively 'AVOIDING CHEMICAL POLLUTION OF WATER' and 'CERN EXHIBITIONS - FIRE PRECAUTIONS' are available on the web at the following urls: http://edms.cern.ch/document/335814 and http://edms.cern.ch/document/335861 Paper copies can also be obtained from the TIS Divisional Secretariat, email: TIS.Secretariat@cern.ch

  3. 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 hea

  4. 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

  5. Superior-subordinate relations as organizational processes

    DEFF Research Database (Denmark)

    Asmuss, Birte; Aggerholm, Helle Kryger; Oshima, Sae

    Since the emergence of the practice turn in social sciences (Golsorkhi et al. 2010), studies have shown a number of institutionally relevant aspects as achievements across time and by means of various resources (human and non-human) (Taylor & van Every 2000, Cooren et al. 2006). Such a process view...... superior-subordinate relations in a specific institutionalized setting: performance appraisal interviews (PAIs). While one main task of PAIs is to manage and integrate organizational and employee performance (Fletcher, 2001:473), PAIs are also organizational practices where superior-subordinate relations...... are shaped, (re)confirmed and re-evaluated. This paper pursues the better understanding of the latter aspect by looking at one substantial and recurrent activity in PAIs: the evaluation of employee performance. One resource for doing the evaluation work is making assessments (e.g. Goodwin & Goodwin, 1987...

  6. Exploring the word superiority effect using TVA

    DEFF Research Database (Denmark)

    Starrfelt, Randi

    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. It is unclear, however, if this is due to a lower threshold...... for perception of words, or a higher speed of processing for words than letters. We have investigated the WSE using methods based on a Theory of Visual Attention. In an experiment using single stimuli (words or letters) presented centrally, we show that the classical WSE is specifically reflected in perceptual...... processing speed: words are simply processed faster than single letters. It is also clear from this experiment, that the word superiority effect can be observed at a large range of exposure durations, from the perceptual threshold to ceiling performance. Intriguingly, when multiple stimuli are presented...

  7. Monitoring product safety in the postmarketing environment

    OpenAIRE

    Sharrar, Robert G; Dieck, Gretchen S

    2013-01-01

    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 dispr...

  8. Safety and tolerability of antipsychotics: focus on amisulpride

    Directory of Open Access Journals (Sweden)

    Mario F Juruena

    2010-10-01

    Full Text Available Mario F Juruena1, Eduardo Pondé de Sena2, Irismar Reis de Oliveira31Stress and Affective Disorders Programme, Department of Neuroscience and Behaviour, Faculty of Medicine of Ribeirao Preto, University of Sao Paulo, Sao Paulo, Brazil; 2Department of Pharmacology, Institute of Health Sciences, Federal University of Bahia, Salvador; 3Department of Neurosciences and Mental Health, School of Medicine, Federal University of Bahia, Salvador, BA, BrazilAbstract: The introduction of the atypical antipsychotic drugs represents an important advance in the treatment of schizophrenia, because the therapeutic efficacy, tolerability, and safety profiles of these agents seem to be superior to that of the classical neuroleptics. As would be predicted from the pharmacologic profile of a pure D2/D3 receptor blocker, amisulpride is an atypical antipsychotic agent, effective for positive and negative symptoms, which can bring about additional improvement in the social functioning and quality of life of patients with schizophrenia. Amisulpride is effective in acute schizophrenia as determined by Clinical Global Impression scores. The major concern regarding the safety of the atypical antipsychotics is related to their propensity to induce weight gain and alter glucose and lipid metabolism. Amisulpride has one of the lowest potentials for weight gain of all the antipsychotic agents, and is associated with clearly lower use of antiparkinsonian medication and with fewer dropouts due to adverse events than conventional antipsychotics. Amisulpride is well tolerated with regard to anxiety and insomnia, and not notably different from placebo. Amisulpride has a pronounced prolactin-elevating effect which appears to be independent of dosage and duration of administration. Hyperprolactinemia rapidly reverses following amisulpride discontinuation. Amisulpride benefits patients with negative symptoms, and is the only antipsychotic to demonstrate efficacy in patients with

  9. Resolution of superior oblique myokymia with memantine.

    Science.gov (United States)

    Jain, Saurabh; Farooq, Shegufta J; Gottlob, Irene

    2008-02-01

    We describe a novel treatment of superior oblique myokymia. A 40-year-old woman was treated with gabapentin for this disorder with partial success and reported significant side effects including loss of libido and weight gain. After a drug holiday, memantine therapy was initiated resulting in a substantial improvement in her symptoms with far fewer side effects and stability on long-term maintenance therapy.

  10. Locked Superior Dislocation of the Acromioclavicular Joint

    Directory of Open Access Journals (Sweden)

    Salma Eltoum Elamin

    2013-01-01

    Full Text Available Acromioclavicular (AC joint injuries account for approximately 3–5% of shoulder girdle injuries (Rockwood et al., 1998. Depending on severity of injury and direction of displacement these are classified using Rockwood classification system for AC joint dislocation. We present an unusual case presenting with locked superior dislocation of the AC joint highlighting the presentation and subsequent successful surgical management of such case. To our knowledge this has not been reported previously in literature.

  11. Reperfusion hemorrhage following superior mesenteric artery stenting.

    LENUS (Irish Health Repository)

    Moore, Michael

    2012-02-03

    Percutaneous transluminal angioplasty and stent placement is now an established treatment option for chronic mesenteric ischemia and is associated with low mortality and morbidity rates. We present a case of reperfusion hemorrhage complicating endovascular repair of superior mesenteric artery stenosis. Although a recognized complication following repair of carotid stenosis, hemorrhage has not previously been reported following mesenteric endovascular reperfusion. We describe both spontaneous cessation of bleeding and treatment with coil embolization.

  12. [Mitral surgery by superior biatrial septotomy].

    Science.gov (United States)

    Saade, A; Delepine, G; Lemaitre, C; Baehrel, B

    1995-01-01

    The superior biatrial septotomy approach consists of two semicircular right atrial and septal incisions joined at the superior end of the interatrial septum and extended across the dome of the left atrium, allowing exposure of the mitral valve by reflecting the ventricular side using stay sutures. From 1991 to 1993, 81 patients underwent mitral valve surgery by this technic. Mitral valve operation was combined with other cardiac procedures in 30 patients (37%) and was performed as a second operation in 21 patients (25.9%). Duration of cardiopulmonary bypass and aortic occlusion was not significantly different from that of patients operated via a conventional left atrial approach. The five hospital deaths (6.2%) were not related to this operative approach. Only 2 patients (3.3%) with preoperative in sinus rythm were discharged in atrial fibrillation after operation. In one patient (1.6%), atrioventricular block appeared at late follow-up. There were no cases of bleeding, atrioventricular nodal dysfunction or intra-atrial shunting related to the approach. This approach provides excellent exposure of the mitral valve even in unfavorable situations such as a small left atrium, dense adhesions from previous procedures or a previously implanted aortic prosthesis, without damage to various cardiac structures due to excessive traction. No retractor or vena cava repair are required. These data support a wide application of the superior biatrial septotomy approach in mitral valve surgery.

  13. First Aid and Safety

    Science.gov (United States)

    ... Playground Safety Preventing Children's Sports Injuries Safety Tips: Baseball Safety Tips: Basketball Safety Tips: Hockey Safety Tips: ... it a Medical Emergency? Knowing Your Child's Medical History Nosebleeds Seizures Serious Allergic Reactions (Anaphylaxis) Teaching Your ...

  14. Lipid Profile

    Science.gov (United States)

    ... AACC products and services. Advertising & Sponsorship: Policy | Opportunities Lipid Profile Share this page: Was this page helpful? Also ... as: Lipid Panel; Coronary Risk Panel Formal name: Lipid Profile Related tests: Cholesterol ; HDL Cholesterol ; LDL Cholesterol ; Triglycerides ; ...

  15. Triclosan: applications and safety.

    Science.gov (United States)

    Bhargava, H N; Leonard, P A

    1996-06-01

    Triclosan (2,4,4'-trichloro-2'-hydroxydiphenyl ether) is a nonionic, broad spectrum, antimicrobial agent that, because of its favorable safety profile, has been incorporated into a variety of many personal care products, including deodorant soaps, underarm deodorants, shower gels, and health care personnel handwashes. Triclosan exhibits a moderate degree of substantivity to the skin, and, in many products, it imparts a remnant antimicrobial effect. Although direct contact with the material under exaggerated exposure conditions causes dermal irritation in laboratory animals, it has only rarely been associated with skin irritation or sensitization in human being in formulated products. Acute, subacute/subchronic, and chronic toxicity profiles have been established to determine that triclosan is neither an acute oral toxicant nor that it acts as a carcinogen, mutagen, or teratogen. A new application for triclosan is in oral dentifrices for plaque control. Currently under investigation in the United States, it is approved for oral care application in Canada and many European countries.

  16. Data Profiling

    OpenAIRE

    Hladíková, Radka

    2010-01-01

    Title: Data Profiling Author: Radka Hladíková Department: Department of Software Engineering Supervisor: Ing. Vladimír Kyjonka Supervisor's e-mail address: Abstract: This thesis puts mind on problems with data quality and data profiling. This Work analyses and summarizes problems of data quality, data defects, process of data quality, data quality assessment and data profiling. The main topic is data profiling as a process of researching data available in existing...

  17. 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

  18. BWR AXIAL PROFILE

    Energy Technology Data Exchange (ETDEWEB)

    J. Huffer

    2004-09-28

    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.

  19. Electrical safety during transplantation.

    Science.gov (United States)

    Amicucci, G L; Di Lollo, L; Fiamingo, F; Mazzocchi, V; Platania, G; Ranieri, D; Razzano, R; Camin, G; Sebastiani, G; Gentile, P

    2010-01-01

    Technologic innovations enable management of medical equipment and power supply systems, with improvements that can affect the technical aspects, economics, and quality of medical service. Herein are outlined some technical guidelines, proposed by Istituto Superiore per la Prevenzione e la Sicurezza del Lavoro, for increasing the effectiveness of the power supply system and the safety of patients and surgeons in the operating room, with particular focus on transplantation. The dependence of diagnoses and therapies on operation of the electrical equipment can potentially cause great risk to patients. Moreover, it is possible that faulty electrical equipment could produce current that may flow through the patient. Because patients are particularly vulnerable when their natural protection is considerably decreased, as during transplantation or other surgery, power supply systems must operate with a high degree of reliability and quality to prevent risk, and must be designed to reduce hazards from direct and indirect contact. Reliability of the power supply system is closely related to the quality of the project, choice of materials, and management of the system (eg, quality and frequency of servicing). Among the proposed guidelines, other than normal referencing, are (1) adoption of a monitoring system to improve the quality of the electrical parameters in the operating room, (2) institution of emergency procedures for management of electrical faults, (3) a procedure for management of fires in the operating room, (4) and maintenance interventions and inspections of medical devices to maintain minimal requirements of safety and performance.

  20. Water Safety

    Science.gov (United States)

    ... Families International Services Who We Are Mission & Values History Governance Red Cross Stories Celebrity Supporters News & Events ... use. Alcohol impairs judgment, balance and coordination; affects swimming and diving skills; and ... and use barriers around your home pool or hot tub . Safety covers and pool alarms ...

  1. SAFETY BULLETIN

    CERN Multimedia

    TIS Secretariat

    2002-01-01

    Please note that the Safety Bulletin no 4 (TIS 2002-04) entitled 'KNOW THE RISKS' is available on the web. Paper copies can also be obtained from the TIS Divisional Secretariat, e-mail: TIS.Secretariat@cern.ch TIS Secretariat

  2. Online Safety.

    Science.gov (United States)

    Levine, Elliott

    2001-01-01

    Describes provisions of Children's Internet Protection Act, which school districts are required to implement on or before October 31, 2001, involving the development and public dissemination of federally mandated Internet-safety policy to prevent minors from accessing inappropriate and harmful material. Provides suggestions to protect children…

  3. Safety Resources.

    Science.gov (United States)

    Hoot, James L.; Bartkowiak, Elaine T.

    1994-01-01

    Lists 72 organizations and programs that deal with child safety, grouped by the following categories: (1) general; (2) general violence; (3) gun violence; (4) media violence; (5) drugs and alcohol; (6) child abuse and at-risk children; (7) parenting programs; (8) community service programs; (9) leadership programs; (10) peer counseling; (11)…

  4. Karolinske psychodynamic profile (KAPP)

    DEFF Research Database (Denmark)

    Mathiesen, Birgit Bork; Søgaard, Ulf

    2006-01-01

    psykologiske testmetoder, assesment, Karolinska psychodynamic profile (KAPP), psykodynamisk profil......psykologiske testmetoder, assesment, Karolinska psychodynamic profile (KAPP), psykodynamisk profil...

  5. Exploring the word superiority effect using TVA

    DEFF Research Database (Denmark)

    Starrfelt, Randi

    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. It is unclear, however, if this is due to a lower threshold for perc...... simultaneously we find a different pattern: In a whole report experiment with six stimuli (letters or words), letters are perceived more easily than words, and this is reflected both in perceptual processing speed and short term memory capacity....

  6. de educación media superior

    Directory of Open Access Journals (Sweden)

    Enrique Cerón Ferrer

    2007-01-01

    Full Text Available El trabajo presenta los resultados obtenidos en relación al conocimiento y manejo que sobre matemáticas tienen los estudiantes de educación media superior, de los Centros de Estudios Tecnológicos y de Servicios del Distrito Federal, de diferentes carreras que se imparten en estos centros escolares, durante el año 2005. El instrumento de análisis es un cuestionario que contestaron los alumnos, la metodología utilizada es de tipo longitudinal y comparativa.

  7. Radiation treatment of superior sulcus lung carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Millar, J.; Ball, D.; Worotniuk, V.; Smith, J.; Crennan, E.; Bishop, M. [Peter MacCallum Cancer Inst., East Melbourne, VIC (Australia)

    1996-02-01

    The survival of patients with superior sulcus lung carcinoma and the effects of treatment were reviewed. From a prospective database of 4123 consecutive new patients with lung carcinoma, 131 (3.2%) cases of superior sulcus lung carcinoma were identified. Seventy-four patients were planned to receive radiation with palliative intent, 53 radical radiotherapy and one was observed only. The remaining three patients, with small-cell carcinoma, were treated with chemotherapy with or without radiotherapy. Of the 53 radically treated patients, nine were treated with pre-operative radiation prior to intended radical resection. Analysis was carried out on the effect on survival of performance status, nodal involvement, weight loss, vertebral body or rib involvement, treatment intent and radical combined modality treatment compared with radical radiation alone. The estimated median survival for the whole group was 7.6 months; for those treated radically it was 18.3 months, while for the palliatively treated patients it was 3.7 months. Radically treated patients with no initial nodal involvement had an estimated median survival of 22 months, while radically treated patients with nodal involvement had an estimated median survival of 8.4 months (P = 0.003). There were no statistically significant differences in survival between radically treated patients grouped according to initial weight loss, performance status, or vertebral body and rib involvement. Patients treated with pre-operative radiation did not survive significantly longer than patients treated with radiation alone, although the numbers are small. 33 refs., 2 tabs., 4 figs.

  8. Studies on zooplankton of Lago Paione Superiore

    Directory of Open Access Journals (Sweden)

    Patrizia COMOLI

    1999-08-01

    Full Text Available We report here the results of a three year study on the zooplankton of Lago Paione Superiore, an acid sensitive lake above the tree line in the Italian Alps. The research was carried out within MOLAR, an EC-founded Project on “Measuring and Modeling the dynamic response of remote mountain lakes ecosystems to environmental change”. This study comes after a series of investigations on the effects of acidification, in which we documented the changes occurred with decreasing water pHs, by comparing the recent situation with that in the literature of the 40s, and reconstructed the beginning of anthropogenic disturbance through an analysis of the past cladocera assemblages archived in the lake sediments. A characteristic pattern in seasonal periodicity is a transition from a community dominated by small zooplankton (August to a community where the large particle-feeder Daphnia longispina dominates. This is a typical pattern observed in fishless, copepod-cladocera lakes. Regardless from which food is able to exploit, Daphnia population of Lago Paione Superiore is composed by well-fed organisms, visually rich in lipids, able to produce more than one generation/ year of parthenogenetic females at density levels which are rather high in an oligotrophic high mountain lake.

  9. Safety Note

    CERN Multimedia

    SC Secretariat

    2004-01-01

    Please note that the Safety Note no 29 (NS 29) entitled 'Fire Prevention for Insulating Core (Sandwich) Panel Structures for Inside Use Guidelines for Selection, Installation and Use' is available on the web at the following url: https://edms.cern.ch/document/475438/LAST_RELEASED Paper copies can also be obtained from the SC Unit secretariat, e-mail : sc.secretariat@cern.ch SC Secretariat

  10. Results from a geophysical investigation of Lake Superior's ring structures

    Science.gov (United States)

    Wattrus, N. J.; Gustafson, D.

    2010-12-01

    Ring shaped depressions are widely developed on the lake floor of Lake Superior. They have not been widely reported elsewhere. The rings are typically between 200 and 300 m across and up to 5 m deep. The width of the depression ranges between 10 to 30 m. They often occur in closely spaced groups or networks but can also occur as isolated features. Several mechanisms have been proposed to explain the formation of these features; they include syneresis of the fine-grained lake floor sediments, polygonal faulting and dewatering of the lake floor sediments. High resolution bathymetric surveying with a multibeam sonar has revealed that they are comprised of pockmarks arranged in irregular polygonal patterns. Sidescan sonar images of the pockmarks often exhibit increased backscatter about the pock which could be interpreted as evidence of a lag-surface. High-resolution CHIRP sub-bottom profiling across the pocks occasionally reveal chimney-like structures below the lake floor pock. This evidence suggests that the rings were produced by the expulsion of fluid from the lake floor. This appears to have been a basin-wide event. The timing, duration and origin of this are not well known. Neither is the structure of the subsurface plumbing below these features. Here we present results from a geophysical survey conducted in northwestern Lake Superior off the western coast of Isle Royale where both isolated and grouped lake floor rings are well developed. The objectives of the survey were to define the geometry of the sub-surface plumbing below the rings and to possibly gain some insight into how these systems develop. The data collected included two high-resolution pseudo-3D single-channel seismic reflection datasets, one acquired with a small airgun and a second acquired with a CHIRP profiler. Multibeam and sidescan sonar data were also acquired as part of the survey. A 9 m piston core was collected in close proximity to a ring feature. This is used to determine the physical

  11. Cochlear implant outcomes in patients with superior canal dehiscence

    NARCIS (Netherlands)

    Puram, Sidharth V.; Roberts, Daniel S.; Niesten, Marlien E F; Dilger, Amanda E.; Lee, Daniel J.

    2015-01-01

    Objective: To determine whether adult cochlear implant (CI) users with superior canal dehiscence syndrome (SCDS) or asymptomatic superior semicircular canal dehiscence (SCD) have different surgical, vestibular, and audiologic outcomes when compared to CI users with normal temporal bone anatomy. Meth

  12. Global UAS Proliferation Challenges USAF Air Superiority

    Science.gov (United States)

    2016-01-18

    According to Caleb Weiss from Threat Matrix, in early 2015 ISIS released video showing their assault on the Baiji, Iraq oil refinery complex.45 The 8...one to provide live overhead video coverage of recovery efforts in Nepal following an earthquake .49 Further non-military uses include overhead...at a rate faster than aviation safety can regulate. For decades, U.S. remote control aircraft hobbyists enjoyed flying gas -powered aircraft and

  13. The Superior Transvelar Approach to the Fourth Ventricle and Brainstem

    OpenAIRE

    Ezer, Haim; Banerjee, Anirban Deep; Bollam, Papireddy; Guthikonda, Bharat; Nanda, Anil

    2012-01-01

    Objective The superior transvelar approach is used to access pathologies located in the fourth ventricle and brainstem. The surgical path is below the venous structures, through the superior medullary velum. Following splitting the tentorial edge, near the tentorial apex, the superior medullary velum is split in the cerebello-mesencephalic fissure. Using the supracerebellar infratentorial, transtentorial or parietal interhemispheric routes, the superior medullary velum is approached. Splittin...

  14. 14 CFR 385.7 - Exercise of authority by superiors.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Exercise of authority by superiors. 385.7... Exercise of authority by superiors. Any assignment of authority to a staff member other than the Chief... Department's principle of management responsibility, the superior may choose to exercise the assigned power...

  15. Superiority: China Mobile in the competition

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    The market share between China Mobile and China Unicom has stabilized since 2002.It is found that China Mobile has the superiority in the competition, for example, the scissors movement between its revenue and cost indicates that it has a strong profit generating ability and there is enough room for it to reduce the price.The ratio between its price (marginal income) and marginal cost indicates that there is a very distant limit for it to reduce the price.Its demand is obviously flexible with the price, but it does not use the price weapon abundantly.The reason for the stabilization of the market is that China Mobile withdrew from the competition.

  16. MRI manifestations of enlarged superior ophthalmic vein

    Institute of Scientific and Technical Information of China (English)

    WEI Rui-li; MA Xiao-ye; CAI Ji-ping; ZHU Huang

    2002-01-01

    Objective:To assess MRI in the evaluation of enlarged superior ophthalmic vein (SOV). Methods: MRI manifestations and etiology of forty-six patients with enlarged SOV were analyzed. Results: SOV enlargement was noted to occur in carotid-cavernous fistula, ophthalmic Graves'disease, Tolosa-Hunt syndrome, inflammation at the apex of the orbit, orbital pseudotumor and thrombosis of cavernous sinus. The dilated vein appeared as signal void tubular shadows on both T1 and T2 weighted images. The diameter of the enlarged vein was 3.5-6.0 mm. Extraocular muscle enlargement, orbital pathologies, enlarged carotid cavernous sinus etc were also revealed by MRI. Conclusion: The dilated SOV may be well demonstrated by MRI. The etiological diagnosis of enlarged SOV can be made in combination with the associated findings.

  17. Lightning activity during the 1999 Superior derecho

    Science.gov (United States)

    Price, Colin G.; Murphy, Brian P.

    2002-12-01

    On 4 July 1999, a severe convective windstorm, known as a derecho, caused extensive damage to forested regions along the United States/Canada border, west of Lake Superior. There were 665,000 acres of forest destroyed in the Boundary Waters Canoe Area Wilderness (BWCAW) in Minnesota and Quetico Provincial Park in Canada, with approximately 12.5 million trees blown down. This storm resulted in additional severe weather before and after the occurrence of the derecho, with continuous cloud-to-ground (CG) lightning occurring for more than 34 hours during its path across North America. At the time of the derecho the percentage of positive cloud-to-ground (+CG) lightning measured by the Canadian Lightning Detection Network (CLDN) was greater than 70% for more than three hours, with peak values reaching 97% positive CG lightning. Such high ratios of +CG are rare, and may be useful indicators of severe weather.

  18. Analgesia em modelo animal superior para ortopedia

    OpenAIRE

    Oliveira MT, Maria Teresa; Potes, José Alberto; Queiroga, Cristina; Castro, José António; Pereira, Alfredo; Reis, Joana

    2015-01-01

    O teste de novos biomateriais para aplicações clínicas em ortopedia, ou noutras áreas da medicina, em modelos animais vivos e sencientes, em prol do benefício humano, deve ser objecto de planeamento cuidado e ponderado, dado o conflito ético que se coloca. Compete-nos a nós, enquanto investigadores, garantir que as condições de vida, saúde e bem-estar são asseguradas. O uso de ovinos como modelo superior pré-clínico, para investigação em Ortopedia, tem-se evidenciado devido às suas caracterís...

  19. Superior vena cava syndrome in hemodialysis patient

    Directory of Open Access Journals (Sweden)

    Azeb Molhem

    2011-01-01

    Full Text Available Obstruction of blood flow in the superior vena cava (SVC results in symptoms and signs of SVC syndrome. SVC obstruction can be caused either by invasion or external compression of the SVC by contagious pathologic processes involving the right lung, lymph nodes, and other mediastinal structures, or by thrombosis of blood within the SVC. Occasionally, both mechanisms co-exist. We hereby report a case of a 28-year-old male, Saudi patient who was diagnosed with end-stage renal disease and was maintained on regular hemodiaysis via right jugular vein dual lumen catheter for ten months. Three years later, the patient presented with signs and symptoms suggestive of SVC obstruction that was successfully managed with SVC stenting.

  20. [Surgical treatment of superior thoracic outlet syndrome].

    Science.gov (United States)

    Gaibov, A D; Kakhorov, A Z; Sadriev, O N; Yunusov, Kh A

    2015-01-01

    The authors present immediate and long-term results of treatment of 117 patients with superior thoracic outlet syndrome (STOS). There were different reasons for compression of neu- rovascular fascicle in outlet of the thorax. The costaclavicular syndrome was a reason in 48 patients, additional cervical ribs had 36 patients. Skalenus syndrome was noted in 26 cases, rudimentary cervical ribs or hypertrophy of cervical vertebrae C7 had 7 patients. Raynaud's syndrome took place in 19 cases. The required volume of diagnostic procedures and surgical treatment of STOS were determined according to the cause of the syndrome. Differentiated approach to the different forms of STOS was used in relation to dominant symptoms of the disease and reasons for compression of neurovascular fascicle. This allowed getting positive results in majority of patients (90,4%) in long- term period.

  1. ANATOMIC RESEARCH OF SUPERIOR CLUNIAL NERVE TRAUMA

    Institute of Scientific and Technical Information of China (English)

    1999-01-01

    In order to find the mechanism of superior clunial nerve (SCN) trauma, we dissected and revealed SCN from 12 corpses (24 sides). Combining 100 sides of SCN trauma, we inspected the course of SCN, the relation between SCN and it's neighbour tissues with the situation of SCN when being subjected to force. We found that the following special anatomic characteristics and mechanical elements such as the course of SCN, it's turning angles, the bony fibrous tube at the iliac crest, the posterior layer of the lumbodorsal fascia and SCN neighbour adipose tissue, are the causes of external force inducing SCN trauma. The anatomic revealment is the guidance of SCN trauma treatment with edged needle.

  2. Superiorization: An optimization heuristic for medical physics

    CERN Document Server

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

    2012-01-01

    Purpose: To describe and mathematically validate the superiorization methodology, which is a recently-developed heuristic approach to optimization, and to discuss its applicability to medical physics problem formulations that specify the desired solution (of physically given or otherwise obtained constraints) by an optimization criterion. Methods: The underlying idea is that many iterative algorithms for finding such a solution are perturbation resilient in the sense that, even if certain kinds of changes are made at the end of each iterative step, the algorithm still produces a constraints-compatible solution. This property is exploited by using permitted changes to steer the algorithm to a solution that is not only constraints-compatible, but is also desirable according to a specified optimization criterion. The approach is very general, it is applicable to many iterative procedures and optimization criteria used in medical physics. Results: The main practical contribution is a procedure for automatically p...

  3. A Product Safety Primer

    Science.gov (United States)

    Brown, Mary Anne Symons

    1975-01-01

    The article offers an overview of the product safety issue and offers ideas for helping students develop product safety awareness. The role of the Consumer Product Safety Commission and safety legislation are discussed. (MW)

  4. Superior calcium homeostasis of extraocular muscles.

    Science.gov (United States)

    Zeiger, Ulrike; Mitchell, Claire H; Khurana, Tejvir S

    2010-11-01

    Extraocular muscles (EOMs) are a unique group of skeletal muscles with unusual physiological properties such as being able to undergo rapid twitch contractions over extended periods and escape damage in the presence of excess intracellular calcium (Ca(2+)) in Duchenne's muscular dystrophy (DMD). Enhanced Ca(2+) buffering has been proposed as a contributory mechanism to explain these properties; however, the mechanisms are not well understood. We investigated mechanisms modulating Ca(2+) levels in EOM and tibialis anterior (TA) limb muscles. Using Fura-2 based ratiometric Ca(2+) imaging of primary myotubes we found that EOM myotubes reduced elevated Ca(2+) ˜2-fold faster than TA myotubes, demonstrating more efficient Ca(2+) buffering. Quantitative PCR (qPCR) and western blotting revealed higher expression of key components of the Ca(2+) regulation system in EOM, such as the cardiac/slow isoforms sarcoplasmic Ca(2+)-ATPase 2 (Serca2) and calsequestrin 2 (Casq2). Interestingly EOM expressed monomeric rather than multimeric forms of phospholamban (Pln), which was phosphorylated at threonine 17 (Thr17) but not at the serine 16 (Ser16) residue. EOM Pln remained monomeric and unphosphorylated at Ser16 despite protein kinase A (PKA) treatment, suggesting differential signalling and modulation cascades involving Pln-mediated Ca(2+) regulation in EOM. Increased expression of Ca(2+)/SR mRNA, proteins, differential post-translational modification of Pln and superior Ca(2+) buffering is consistent with the improved ability of EOM to handle elevated intracellular Ca(2+) levels. These characteristics provide mechanistic insight for the potential role of superior Ca(2+) buffering in the unusual physiology of EOM and their sparing in DMD.

  5. The management of superior sulcus tumors

    Energy Technology Data Exchange (ETDEWEB)

    Komaki, Ritsuko; Cox, J.D.; Putnam, J.B. Jr [Texas Univ., Houston, TX (United States). Anderson Cancer Center] (and others)

    2001-09-01

    Superior sulcus tumors are a rare type of lung cancer arising in the apex of the lung above the sulcus and cause specific symptoms and signs depending on the location and whether the tumor extends into the surrounding structures. Because of the closeness of critical structures to the tumor (e.g., the subclavian artery for anterior lesions, the brachial plexus for lesions in the middle location, and the sympathetic stellate ganglion causing Horner's syndrome [Pancoast's tumor], the vertebral bodies, nerve foramen, and spinal cord for posterior lesions), superior sulcus tumors were often considered marginally respectable or unresectable. Therefore, for many years, preoperative radiation therapy was considered routine treatment for those tumors. However, with the evolution in our understanding of these tumors and modern imaging techniques such as computerized tomography (CT) and magnetic resonant imaging (MRI) and surgical techniques, there is now considerable debate about the roles and timing of surgical resection, radiation therapy, and chemotherapy in the treatment of patients with these tumors. If mediastinoscopy reveals microscopic mediastinal lymph node involvement, the patient can be treated with preoperative concurrent chemoradiotherapy followed by surgery. If there was a gross mediastinal lymph node involvement (N2) on CT, N3 or T4 lesions, the patient can be treated with concurrent chemoradiotherapy with a curative intent; the outcome of such treatment appears to be better than that of sequential chemotherapy followed by radiation therapy. Whenever possible, without compromising the patient's quality of life, surgery should be considered to improve outcome. (author)

  6. STEREO Superior Solar Conjunction Mission Phase

    Science.gov (United States)

    Ossing, Daniel A.; Wilson, Daniel; Balon, Kevin; Hunt, Jack; Dudley, Owen; Chiu, George; Coulter, Timothy; Reese, Angel; Cox, Matthew; Srinivasan, Dipak; hide

    2017-01-01

    With its long duration and high gain antenna (HGA) feed thermal constraint; the NASA Solar-TErestrial RElations Observatory (STEREO) solar conjunction mission phase is quite unique to deep space operations. Originally designed for a two year heliocentric orbit mission to primarily study coronal mass ejection propagation, after 8 years of continuous science data collection, the twin STEREO observatories entered the solar conjunction mission phase, for which they were not designed. Nine months before entering conjunction, an unforeseen thermal constraint threatened to stop daily communications and science data collection for 15months. With a 3.5 month long communication blackout from the superior solar conjunction, without ground commands, each observatory will reset every 3 days, resulting in 35 system resets at an Earth range of 2 AU. As the observatories will be conjoined for the first time in 8 years, a unique opportunity for calibrating the same instruments on identical spacecraft will occur. As each observatory has lost redundancy, and with only a limited fidelity hardware simulator, how can the new observatory configuration be adequately and safely tested on each spacecraft? Without ground commands, how would a 3-axis stabilized spacecraft safely manage the ever accumulating system momentum without using propellant for thrusters? Could science data still be collected for the duration of the solar conjunction mission phase? Would the observatories survive? In its second extended mission, operational resources were limited at best. This paper discusses the solutions to the STEREO superior solar conjunction operational challenges, science data impact, testing, mission operations, results, and lessons learned while implementing.

  7. Diseño de nuevos planes de estudios en el contexto del Espacio Europeo de Educación Superior (II: Perfil profesional del graduado en Medicina The design of new medical curricula in the context of the European Higher Education Area (II: Professional profile of the medical doctor

    Directory of Open Access Journals (Sweden)

    J. Carreras

    2008-09-01

    Full Text Available En España, para ejercer la profesión médica como médico especialista y para ocupar un puesto de trabajo, público o privado, con dicha denominación se requiere poseer la titulación de la correspondiente especialidad médica. Además, desde el año 1995, por directiva de la Unión Europea, para el ejercicio de las funciones de médico generalista en el marco del régimen público de la Seguridad Social se requiere una formación específica, que proporciona la especialidad en Medicina Familiar y Comunitaria. De acuerdo con ello, el objetivo de la actual licenciatura en Medicina es proporcionar la denominada ‘formación médica de base'; aquella formación que debe adquirir todo graduado en medicina con independencia de su orientación futura. Sin embargo, desde la Ley de Ordenación Universitaria del año 1943, la legislación española ha determinado que el título de Licenciado en Medicina habilita para el ejercicio de la medicina, en cualquier ámbito o especialidad, con tal de que no se ejerza con el carácter de especialista. Esta inconsistencia, que según parece va a perpetuarse en la futura titulación de Médico adaptada a los requerimientos del Espacio Europeo de Educación Superior, supone una gran dificultad para el diseño de un plan de estudios coherente basado en competencias establecidas de acuerdo con el perfil profesional del graduado. No son las mismas las competencias que requiere ‘todo graduado en medicina', que las competencias que requiere un graduado legalmente habilitado para ‘ejercer en cualquier ámbito o especialidad de la medicina', auque sea ‘sin el carácter de médico especialista'.In Spain, to practice as a physician in any medical speciality, it is necessary to possess the corresponding specific academic title. And since 1995, following the European Union directives, to exert as medical generalist in the public Social Security System it is required a specific academic formation that is provided by

  8. Professores e Gestores: análise do perfil das Competências Gerenciais dos coordenadores de pós-graduação das Instituições Federais de Ensino Superior (IFES do RS [Lecturers and Managers: an analysis of the profile of managerial competencies of the post-graduation coordinators of Federal Institutions of Higher Education (IEFS in Rio Grande do Sul, Brazil

    Directory of Open Access Journals (Sweden)

    Breno Augusto Diniz Pereira

    2011-06-01

    Full Text Available A área educacional universitária tem buscado maior profissionalização de seus cargos administrativos a partir da necessidade de conciliar a gestão administrativa, pedagógica, acadêmica e científica. Dessa forma, o presente estudo tem como objetivo verificar o perfil de Competências Gerenciais dos coordenadores dos Programas de Pós-Graduação das Instituições Federais de Ensino Superior (IFES do Rio Grande do Sul, identificando se os mesmos possuem características que de acordo com a teoria são as consideradas ideais para administrar as atribuições do cargo que deverão desempenhar. Para tal, foi utilizado o modelo teórico de Gary Yukl, publicado em 1998. Esse modelo divide o perfil de Competências Gerenciais entre administrar tarefas e administrar relações. Foi construído um questionário com base na referida teoria. Esse questionário foi validado por meio de uma análise fatorial exploratória. O total de cursos de pós-graduação no Rio Grande do Sul, nas modalidades lato sensu e stricto sensu, foi pesquisado. O questionário foi enviado para 261 coordenadores, obtendo um retorno de 163 questionários, sendo 161 considerados válidos para a análise. As análises estatísticas da relação entre a área de conhecimento e o perfil de Competência Gerencial demonstraram que as áreas com características mais racionais e “científicas” estão mais relacionadas aos construtos que direcionam para administração do trabalho e/ou execução de tarefas. Enquanto que as áreas com características mais subjetivas, como as Humanas, apresentam uma relação mais forte com os construtos sobre administrar relações interpessoais. Já os testes sobre a relação entre as universidades e o perfil de competências identificaram características específicas entre administração de relações ou administração do trabalho. --- Lecturers and Managers: an analysis of the profile of managerial competencies of the post

  9. O Ensino Superior Tecnológico em Gastronomia em São Paulo: Um Estudo sobre Formação, Perfil do Egresso e Áreas de Atuação / The Technological Higher Education in Gastronomy in São Paulo: A Study on Training, Graduates' profile and Areas of Practice

    Directory of Open Access Journals (Sweden)

    Luciana Moura de Abreu

    2015-04-01

    Full Text Available Normal 0 21 false false false PT-BR X-NONE X-NONE MicrosoftInternetExplorer4 Diante das necessidades do novo mercado de trabalho para a área de alimentos e bebidas, que necessita de um profissional articulado, com capacidade crítica e possibilidade de interação com o meio com o qual se relaciona, torna-se importante a reflexão sobre a formação do aluno egresso dos Cursos Tecnológicos em Gastronomia, pensando-se numa educação abrangente que valorize a experiência individual, as expectativas do mercado que se reflitam no conteúdo dos currículos. O presente trabalho teve como objetivo investigar, com base em pesquisa exploratório-descritiva, a matriz curricular de três cursos tecnológicos presenciais do Estado de São Paulo, analisando a proposta de formação contida nos seus documentos, o perfil dos egressos e a visão dos coordenadores, aos quais se aplicou roteiro de entrevista semiestruturada. Apresenta-se, ainda, a contextualização e trajetória da educação formal e do ensino tecnológico em Gastronomia, no Brasil. Como principais resultados observou-se que a pressão do mercado é bastante forte na elaboração dos currículos dos cursos, assim como a percepção dos coordenadores deixa entrever as limitações para a formação mais abrangente de um profissional oriundo dos cursos tecnológicos em Gastronomia. The Technological Higher Education in Gastronomy in São Paulo: A Study on Training, Graduates' profile and Areas of Practice - The job market for the field of foods and beverages requires a professional that is articulated, critical and with ability to interact with the environment. In that way, it is important to reflect about the formation of Food Technology Courses in terms of education, individual experience, market expectations and curriculum. The present study investigated based on an exploratory-descriptive research, the curriculum of three technology courses in the State of São Paulo, analyzing its

  10. SAFETY NOTES

    CERN Document Server

    TIS Secretariat

    2001-01-01

    Please note that the revisions of safety notes no 3 (NS 3 Rev. 2) and no 24 (NS 24 REV.) entitled respectively 'FIRE PREVENTION FOR ENCLOSED SPACES IN LARGE HALLS' and 'REMOVING UNBURIED ELV AND LVA ELECTRIC CONDUITS' are available on the web at the following urls: http://edmsoraweb.cern.ch:8001/cedar/doc.download?document_id=322811&version=1&filename=version_francaise.pdf http://edmsoraweb.cern.ch:8001/cedar/doc.download?document_id=322861&version=2&filename=version_francaise.pdf Paper copies can also be obtained from the TIS Divisional Secretariat, email tis.secretariat@cern.ch

  11. Safety training

    CERN Multimedia

    SC Unit

    2009-01-01

    Habilitation électrique A course entitled "Habilitation électrique pour personnel de laboratoire" (electrical safety qualification for laboratory personnel) will be held on 22 and 23 June. Registration by e-mail to isabelle.cusato@cern.ch. Explosion Hazards in the handling of flammable solvents and gases A course entitled "Explosion Hazards in the handling of flammable solvents and gases" given in French will be held on 18-19 June 2009. This course is obligatory for all FGSOs at CERN, and it is recommended for anyone handling flammable gas or solvents. To sign up please visit this page. For more information please contact Isabelle Cusato, tel. 73811.

  12. 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...

  13. 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...

  14. Re-formulating non-inferiority trials as superiority trials: The case of binary outcomes.

    Science.gov (United States)

    Durkalski, Valerie L; Berger, Vance W

    2009-02-01

    Non-inferiority trials are conducted for a variety of reasons including to show that a new treatment has a negligible reduction in efficacy or safety when compared to the current standard treatment, or a more complex setting of showing that a new treatment has a negligible reduction in efficacy when compared to the current standard yet is superior in terms of other treatment characteristics. The latter reason for conducting a non-inferiority trial presents the challenge of deciding on a balance between a suitable reduction in efficacy, known as the non-inferiority margin, in return for a gain in other important treatment characteristics/findings. It would be ideal to alleviate the dilemma on the choice of margin in this setting by reverting to a traditional superiority trial design where a single p -value for superiority of both the most important endpoint (efficacy) and the most important finding (treatment characteristic) is provided. We discuss how this can be done using the information-preserving composite endpoint (IPCE) approach and consider binary outcome cases in which the combination of efficacy and treatment characteristics, but not one itself, paints a clear picture that the novel treatment is superior to the active control. 2009 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  15. Safety first

    CERN Multimedia

    2012-01-01

    Safety is a priority for CERN. That is a message I conveyed in my New Year’s address and that I reiterated at one of the first Enlarged Directorate meetings of 2012 when I outlined five key safety objectives for the year, designed and implemented according to accepted international standards.   As we move from spring to summer, it’s time to take stock of how we are doing. Objective number one for 2012, which overarches everything else, is to limit the number of incidents in the workplace. That means systematically investigating and acting on every incident that involves work stoppage, along with all the most frequent workplace accidents: falls, trips and slips. The performance indicator we set ourselves is the percentage of investigations and follow-ups completed. Year on year, these figures are rising but we can never be complacent, and must strive to reach and sustain 100% follow-up. The second objective is to improve hazard control, with a focus in 2012 on chemical ha...

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

    Directory of Open Access Journals (Sweden)

    Meyer B

    2015-02-01

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

  17. Safety for Users

    CERN Document Server

    HR Department

    2008-01-01

    CERN welcomes more than 8000 Users every year. The PH Department as host to these scientific associates requires the highest safety standards. The PH Safety Office has published a Safety Flyer for Users. Important safety topics and procedures are presented. Although the Flyer is intended primarily to provide safety information for Users, the PH Safety Office invites all those on the CERN sites to keep a copy of the flyer as it gives guidance in matters of safety and explains what to do in the event of an emergency. Link: http://ph-dep.web.cern.ch/ph-dep/Safety/SafetyOffice.html PH-Safety Office PH Department

  18. Safety for Users

    CERN Document Server

    HR Department

    2008-01-01

    CERN welcomes more than 8000 Users every year. The PH Department as host to these scientific associates requires the highest safety standards. The PH Safety Office has published a safety flyer for Users. Important safety topics and procedures are presented. Although the flyer is intended primarily to provide safety information for Users, the PH Safety Office invites all those on the CERN sites to keep a copy of the flyer as it gives guidance in matters of safety and explains what to do in the event of an emergency. The flyer is available at: http://ph-dep.web.cern.ch/ph-dep/Safety/SafetyOffice.html PH-Safety Office PH Department

  19. Safety first

    Energy Technology Data Exchange (ETDEWEB)

    Harvie, W.

    1997-06-01

    Expansion of international business opportunities for Canadian producers and service companies brings with it a dimension almost never considered on home base - security. It was pointed out that once abroad, safety and defence of people and equipment can become significant problems in many parts of the world. The nature of the security risks involved, and how best to deal with them, were discussed. The use of consultants, mostly foreign ones to date, and the kind of assistance they can provide, everything from written reports on the local situation to counter surveillance training, and bodyguard services, have been described. Examples of recent involvements with guerilla groups demanding `revolutionary war taxes`, kidnapping executives for ransom, due diligence investigations of potential partners, and the like, have been provided to illustrate the unique character of the problem, and the constant need for being alert, educated to risks, and being prepared to react to risk situations.

  20. Construction safety

    CERN Document Server

    Li, Rita Yi Man

    2013-01-01

    A close-to-ideal blend of suburb and city, speedy construction of towers of Babylon, the sparkling proportion of glass and steel buildings’ facade at night showcase the wisdom of humans. They also witness the footsteps, sweats and tears of architects and engineers. Unfortunately, these signatures of human civilizations are swathed in towering figures of construction accidents. Fretting about these on sites, different countries adopt different measures on sites. This book firstly sketches the construction accidents on sites, followed by a review on safety measures in some of the developing countries such as Bermuda, Egypt, Kuwait and China; as well as developed countries, for example, the United States, France and Singapore. It also highlights the enormous compensation costs with the courts’ experiences in the United Kingdom and Hong Kong.

  1. Lake Superior Coastal Wetland Fish Assemblages and ...

    Science.gov (United States)

    The role of the coastal margin and the watershed context in defining the ecology of even very large lakes is increasingly being recognized and examined. Coastal wetlands are both important contributors to the biodiversity and productivity of large lakes and important mediators of the lake-basin connection. We explored wetland-watershed connections and their relationship to wetland function and condition using data collected from 37 Lake Superior wetlands spanning a substantial geographic and geomorphic gradient. While none of these wetlands are particularly disturbed, there were nevertheless clear relationships between watershed landuse and wetland habitat and biota, and these varied consistently across wetland type categories that reflected the strength of connection to the watershed. For example, water clarity and vegetation structure complexity declined with decreasing percent natural land cover, and these effects were strongest in riverine wetlands (having generally large watersheds and tributary-dominated hydrology) and weakest in lagoon wetlands (having generally small watersheds and lake-dominate hydrology). Fish abundance and species richness both increased with decreasing percent natural land cover while species diversity decreased, and again the effect was strongest in riverine wetlands. Lagoonal wetlands, which lack any substantial tributary, consistently harbored the fewest species of fish and a composition different from the more watershed-lin

  2. Leadership Profiles.

    Science.gov (United States)

    Morgan, Robert M.; And Others

    1992-01-01

    Presents profiles of three leaders in the field of educational media and technology: Robert Mills Gagne, Florida State University; Robert Heinich, Indiana University; and Charles Francis Schuller, University of Georgia. (SLW)

  3. Profiling cancer

    DEFF Research Database (Denmark)

    Ciro, Marco; Bracken, Adrian P; Helin, Kristian

    2003-01-01

    In the past couple of years, several very exciting studies have demonstrated the enormous power of gene-expression profiling for cancer classification and prediction of patient survival. In addition to promising a more accurate classification of cancer and therefore better treatment of patients......, gene-expression profiling can result in the identification of novel potential targets for cancer therapy and a better understanding of the molecular mechanisms leading to cancer....

  4. Profiling cancer

    DEFF Research Database (Denmark)

    Ciro, Marco; Bracken, Adrian P; Helin, Kristian

    2003-01-01

    In the past couple of years, several very exciting studies have demonstrated the enormous power of gene-expression profiling for cancer classification and prediction of patient survival. In addition to promising a more accurate classification of cancer and therefore better treatment of patients......, gene-expression profiling can result in the identification of novel potential targets for cancer therapy and a better understanding of the molecular mechanisms leading to cancer....

  5. Gender differences in the adverse events’ profile registered in seven observational studies of a wide gender-medicine (MetaGeM project: the MetaGeM safety analysis

    Directory of Open Access Journals (Sweden)

    Colombo D

    2016-09-01

    Full Text Available Delia Colombo,1 Emanuela Zagni,1 Mihaela Nica,1 Sara Rizzoli,2 Alessandra Ori,2 Gilberto Bellia1 1Patient Access, Novartis Farma S.p.A., Origgio, Varese, 2MediNeos Observational Research, Modena, Italy Background: MetaGeM is a wide gender-medicine project comprising post hoc and meta-analyses by gender of clinical outcomes, therapeutic approaches, and safety data from previously conducted observational studies to explore possible gender differences in real-life clinical settings. We report the results of the safety meta-analysis of seven MetaGeM studies, evaluating gender differences in adverse event (AE incidence and severity. Methods: Data were collected between February 2002 and July 2013. Male and female patients were compared for the main safety variables, using Student’s t-test, χ² test, or Fisher’s exact test as appropriate. As supportive analysis, a logistic regression model was estimated to evaluate associations between gender and outcome. Results: In total, 4,870 patients (46% females, 54% males were included in the analysis; age was higher for females (mean ± standard deviation 61.2±18.3 years than males (56.3±16.6 years. Overall, 264 AEs were reported (59.1% in males. There were no significant gender differences in the percentage of patients with at least one AE: 3.0% for females versus 3.9% for males, χ² test P>0.05. According to the logistic regression model results, no association between gender and AEs occurrence seems to exist. A statistically significant gender difference in the percentage of drug-related AEs emerged (37.6% in females vs 20.8% in males, χ² P=0.0039. Slightly significantly more AEs in females were addressed with treatment compared with males (78.1% vs 66.7%, χ² P=0.0485. Total serious AEs (SAEs were 47 (72% in males. The frequency of patients with ≥1 SAE was 0.6% in females versus 1.2% in males (χ² test P=0.0246. Conclusion: This safety analysis on a large sample of almost 5,000 patients with

  6. 77 FR 35857 - Safety Zone, Fireworks Display, Lake Superior; Duluth, MN

    Science.gov (United States)

    2012-06-15

    ... fireworks display will occur in the vicinity of Duluth Harbor in Duluth, MN. Based on accidents that have... Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions...

  7. Carbon phosphide monolayers with superior carrier mobility

    Science.gov (United States)

    Wang, Gaoxue; Pandey, Ravindra; Karna, Shashi P.

    2016-04-01

    Two dimensional (2D) materials with a finite band gap and high carrier mobility are sought after materials from both fundamental and technological perspectives. In this paper, we present the results based on the particle swarm optimization method and density functional theory which predict three geometrically different phases of the carbon phosphide (CP) monolayer consisting of sp2 hybridized C atoms and sp3 hybridized P atoms in hexagonal networks. Two of the phases, referred to as α-CP and β-CP with puckered or buckled surfaces are semiconducting with highly anisotropic electronic and mechanical properties. More remarkably, they have the lightest electrons and holes among the known 2D semiconductors, yielding superior carrier mobility. The γ-CP has a distorted hexagonal network and exhibits a semi-metallic behavior with Dirac cones. These theoretical findings suggest that the binary CP monolayer is a yet unexplored 2D material holding great promise for applications in high-performance electronics and optoelectronics.Two dimensional (2D) materials with a finite band gap and high carrier mobility are sought after materials from both fundamental and technological perspectives. In this paper, we present the results based on the particle swarm optimization method and density functional theory which predict three geometrically different phases of the carbon phosphide (CP) monolayer consisting of sp2 hybridized C atoms and sp3 hybridized P atoms in hexagonal networks. Two of the phases, referred to as α-CP and β-CP with puckered or buckled surfaces are semiconducting with highly anisotropic electronic and mechanical properties. More remarkably, they have the lightest electrons and holes among the known 2D semiconductors, yielding superior carrier mobility. The γ-CP has a distorted hexagonal network and exhibits a semi-metallic behavior with Dirac cones. These theoretical findings suggest that the binary CP monolayer is a yet unexplored 2D material holding great

  8. Absent right superior caval vein in situs solitus

    DEFF Research Database (Denmark)

    Lytzen, Rebekka; Sundberg, Karin; Vejlstrup, Niels

    2015-01-01

    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......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...

  9. The Business Value of Superior Energy Performance

    Energy Technology Data Exchange (ETDEWEB)

    McKane, Aimee; Scheihing, Paul; Evans, Tracy; Glatt, Sandy; Meffert, William

    2015-08-04

    Industrial facilities participating in the U.S. Department of Energy’s (US DOE) Superior Energy Performance (SEP) program are finding that it provides them with significant business value. This value starts with the implementation of ISO 50001-Energy management system standard, which provides an internationally-relevant framework for integration of energy management into an organization’s business processes. The resulting structure emphasizes effective use of available data and supports continual improvement of energy performance. International relevance is particularly important for companies with a global presence or trading interests, providing them with access to supporting ISO standards and a growing body of certified companies representing the collective knowledge of communities of practice. This paper examines the business value of SEP, a voluntary program that builds on ISO 50001, inviting industry to demonstrate an even greater commitment through third-party verification of energy performance improvement to a specified level of achievement. Information from 28 facilities that have already achieved SEP certification will illustrate key findings concerning both the value and the challenges from SEP/ISO 50001 implementation. These include the facilities’ experience with implementation, internal and external value of third-party verification of energy performance improvement; attractive payback periods and the importance of SEP tools and guidance. US DOE is working to bring the program to scale, including the Enterprise-Wide Accelerator (SEP for multiple facilities in a company), the Ratepayer-Funded Program Accelerator (supporting tools for utilities and program administrators to include SEP in their program offerings), and expansion of the program to other sectors and industry supply chains.

  10. Linking Safety Analysis to Safety Requirements

    DEFF Research Database (Denmark)

    Hansen, Kirsten Mark

    the same system model and that this model is formalized in a real-time, interval logic, based on a conventional dynamic systems model with a state over time. The three safety analysis techniques are interpreted in this model and it is shown how to derive safety requirements for components of a system.......Software for safety critical systems must deal with the hazards identified by safety analysistechniques: Fault trees, event trees,and cause consequence diagrams can be interpreted as safety requirements and used in the design activity. We propose that the safety analysis and the system design use...

  11. CERN's new safety policy

    CERN Multimedia

    2014-01-01

    The documents below, published on 29 September 2014 on the HSE website, together replace the document SAPOCO 42 as well as Safety Codes A1, A5, A9, A10, which are no longer in force. As from the publication date of these documents any reference made to the document SAPOCO 42 or to Safety Codes A1, A5, A9 and A10 in contractual documents or CERN rules and regulations shall be deemed to constitute a reference to the corresponding provisions of the documents listed below.   "The CERN Safety Policy" "Safety Regulation SR-SO - Responsibilities and organisational structure in matters of Safety at CERN" "General Safety Instruction GSI-SO-1 - Departmental Safety Officer (DSO)" "General Safety Instruction GSI-SO-2 - Territorial Safety Officer (TSO)" "General Safety Instruction GSI-SO-3 - Safety Linkperson (SLP)" "General Safety Instruction GSI-SO-4 - Large Experiment Group Leader In Matters of Safety (LEXGLI...

  12. 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.

  13. Fire safety

    Energy Technology Data Exchange (ETDEWEB)

    Keski-Rahkonen, O.; Bjoerkman, J.; Hostikka, S.; Mangs, J. [VTT Building Technology, Espoo (Finland); Huhtanen, R. [VTT Energy, Espoo (Finland); Palmen, H.; Salminen, A.; Turtola, A. [VTT Automation, Espoo (Finland)

    1998-07-01

    According to experience and probabilistic risk assessments, fires present a significant hazard in a nuclear power plant. Fires may be initial events for accidents or affect safety systems planned to prevent accidents and to mitigate their consequences. The project consists of theoretical work, experiments and simulations aiming to increase the fire safety at nuclear power plants. The project has four target areas: (1) to produce validated models for numerical simulation programmes, (2) to produce new information on the behavior of equipment in case of fire, (3) to study applicability of new active fire protecting systems in nuclear power plants, and (4) to obtain quantitative knowledge of ignitions induced by important electric devices in nuclear power plants. These topics have been solved mainly experimentally, but modelling at different level is used to interpret experimental data, and to allow easy generalisation and engineering use of the obtained data. Numerical fire simulation has concentrated in comparison of CFD modelling of room fires, and fire spreading on cables on experimental data. So far the success has been good to fair. A simple analytical and numerical model has been developed for fire effluents spreading beyond the room of origin in mechanically strongly ventilated compartments. For behaviour of equipment in fire several full scale and scaled down calorimetric experiments were carried out on electronic cabinets, as well as on horizontal and vertical cable trays. These were carried out to supply material for CFD numerical simulation code validation. Several analytical models were developed and validated against obtained experimental results to allow quick calculations for PSA estimates as well as inter- and extrapolations to slightly different objects. Response times of different commercial fire detectors were determined for different types of smoke, especially emanating from smoldering and flaming cables to facilitate selection of proper detector

  14. Coronary artery bypass and superior vena cava syndrome.

    OpenAIRE

    Thomas, T V; Masrani, K; Thomas, J.L.

    1999-01-01

    Superior vena cava syndrome is the obstruction of the superior vena cava or its main tributaries by benign or malignant lesions. The syndrome causes edema and engorgement of the vessels on the face, neck, and arms, nonproductive cough, and dyspnea. We discuss the case of a 48-year-old obese diabetic woman who was admitted with unstable angina. She had previously been diagnosed with superior vena cava syndrome. Urgent coronary artery bypass grafting was necessary Although thousands of coronary...

  15. Superiorization of incremental optimization algorithms for statistical tomographic image reconstruction

    Science.gov (United States)

    Helou, E. S.; Zibetti, M. V. W.; Miqueles, E. X.

    2017-04-01

    We propose the superiorization of incremental algorithms for tomographic image reconstruction. The resulting methods follow a better path in its way to finding the optimal solution for the maximum likelihood problem in the sense that they are closer to the Pareto optimal curve than the non-superiorized techniques. A new scaled gradient iteration is proposed and three superiorization schemes are evaluated. Theoretical analysis of the methods as well as computational experiments with both synthetic and real data are provided.

  16. Gender differences in the adverse events’ profile registered in seven observational studies of a wide gender-medicine (MetaGeM) project: the MetaGeM safety analysis

    Science.gov (United States)

    Colombo, Delia; Zagni, Emanuela; Nica, Mihaela; Rizzoli, Sara; Ori, Alessandra; Bellia, Gilberto

    2016-01-01

    Background MetaGeM is a wide gender-medicine project comprising post hoc and meta-analyses by gender of clinical outcomes, therapeutic approaches, and safety data from previously conducted observational studies to explore possible gender differences in real-life clinical settings. We report the results of the safety meta-analysis of seven MetaGeM studies, evaluating gender differences in adverse event (AE) incidence and severity. Methods Data were collected between February 2002 and July 2013. Male and female patients were compared for the main safety variables, using Student’s t-test, χ2 test, or Fisher’s exact test as appropriate. As supportive analysis, a logistic regression model was estimated to evaluate associations between gender and outcome. Results In total, 4,870 patients (46% females, 54% males) were included in the analysis; age was higher for females (mean ± standard deviation 61.2±18.3 years) than males (56.3±16.6 years). Overall, 264 AEs were reported (59.1% in males). There were no significant gender differences in the percentage of patients with at least one AE: 3.0% for females versus 3.9% for males, χ2 test P>0.05. According to the logistic regression model results, no association between gender and AEs occurrence seems to exist. A statistically significant gender difference in the percentage of drug-related AEs emerged (37.6% in females vs 20.8% in males, χ2 P=0.0039). Slightly significantly more AEs in females were addressed with treatment compared with males (78.1% vs 66.7%, χ2 P=0.0485). Total serious AEs (SAEs) were 47 (72% in males). The frequency of patients with ≥1 SAE was 0.6% in females versus 1.2% in males (χ2 test P=0.0246). Conclusion This safety analysis on a large sample of almost 5,000 patients with different diseases and treated with a wide range of different drugs provides a useful overview on possible gender differences in drug tolerability, which may be helpful in more accurately designing future clinical trials

  17. Patient safety: Safety culture and patient safety ethics

    DEFF Research Database (Denmark)

    Madsen, Marlene Dyrløv

    2006-01-01

    and interviews with staff and management in four hospital departments. The appendix contains the Patient Safety Culture Questionnaire tool that I have developed, tested and revised for use in theDanish hospital setting based on the research projects on safety culture described in papers 3, 4 and 5. Paper 6......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...... the problems, and suggest possible solutions for improving patient safety through the promotion of safety culture and ethics. I seek to illuminate theissues of patient safety from several perspectives; the organizational healthcare system, in particular the healthcare workers perspectives and experiences...

  18. 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.

  19. Superior Vena Cava Thrombosis in a Case of Lung Adenocarcinoma

    Directory of Open Access Journals (Sweden)

    Santanu Ghosh

    2013-01-01

    Full Text Available Superior vena cava syndrome is a common presentation of bronchogenic carcinoma. The mechanism of obstruction is by compression of superior vena cava by the bronchogenic tumor itself or enlarged mediastinal lymph nodes. However obstruction due to intravascular thrombosis is extremely uncommon. Here, we report a rare case of a 65-year-old male smoker who presented with superior vena cava syndrome and bilateral pleural and pericardial effusion with thrombotic occlusion of the superior vena cava in adenocarcinoma of the lung. He was given chemotherapy with carboplatin and gemcitabine with anticoagulant therapy.

  20. Attentional bias toward safety predicts safety behaviors.

    Science.gov (United States)

    Xu, Yaoshan; Li, Yongjuan; Wang, Guangxi; Yuan, Xiao; Ding, Weidong; Shen, Zhongxiang

    2014-10-01

    Safety studies have primarily focused on how explicit processes and measures affect safety behavior and subsequent accidents and injuries. Recently, safety researchers have paid greater attention to the role of implicit processes. Our research focuses on the role of attentional bias toward safety (ABS) in workplace safety. ABS is a basic, early-stage cognitive process involving the automatic and selective allocation of attentional resources toward safety cues, which reflect the implicit motivational state of employees regarding safety goal. In this study, we used two reaction time-based paradigms to measure the ABS of employees in three studies: two modified Stroop tasks (Studies 1 and 2) and a visual dot-probe task (Study 3). Results revealed that employees with better safety behavior showed significant ABS (Study 2), and greater ABS than employees with poorer safety behavior (Studies 1 and 2). Moreover, ABS was positively associated with the perceived safety climate and safety motivation of employees, both of which mediate the effect of ABS on safety behavior (Study 3). These results contributed to a deeper understanding of how early-stage automatic perceptual processing affects safety behavior. The practical implications of these results were also discussed. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. Effects of eight weeks of an alleged aromatase inhibiting nutritional supplement 6-OXO (androst-4-ene-3,6,17-trione on serum hormone profiles and clinical safety markers in resistance-trained, eugonadal males

    Directory of Open Access Journals (Sweden)

    Kreider Richard

    2007-10-01

    Full Text Available Abstract The purpose of this study was to determine the effects of 6-OXO, a purported nutritional aromatase inhibitor, in a dose dependent manner on body composition, serum hormone levels, and clinical safety markers in resistance trained males. Sixteen males were supplemented with either 300 mg or 600 mg of 6-OXO in a double-blind manner for eight weeks. Blood and urine samples were obtained at weeks 0, 1, 3, 8, and 11 (after a 3-week washout period. Blood samples were analyzed for total testosterone (TT, free testosterone (FT, dihydrotestosterone (DHT, estradiol, estriol, estrone, SHBG, leutinizing hormone (LH, follicle stimulating hormone (FSH, growth hormone (GH, cortisol, FT/estradiol (T/E. Blood and urine were also analyzed for clinical chemistry markers. Data were analyzed with two-way MANOVA. For all of the serum hormones, there were no significant differences between groups (p > 0.05. Compared to baseline, free testosterone underwent overall increases of 90% for 300 mg 6-OXO and 84% for 600 mg, respectively (p 0.05 and clinical safety markers were not adversely affected with ingestion of either supplement dose (p > 0.05. While neither of the 6-OXO dosages appears to have any negative effects on clinical chemistry markers, supplementation at a daily dosage of 300 mg and 600 mg for eight weeks did not completely inhibit aromatase activity, yet significantly increased FT, DHT, and T/E.

  2. [Catheter in the superior vena cava for hemodialysis as a last resort in superior hemithorax].

    Science.gov (United States)

    Restrepo Valencia, C A; Buritica Barragán, C M; Arango, A

    2010-01-01

    We report four patients with chronic kidney disease undergoing haemodialysis therapy, which had exhausted conventional venous access (internal jugular, subclavian) and non-conventional access (axillary, innominate) in the upper hemithorax for haemodialysis. This was primarily due to thrombosis of these veins caused by previous catheterisation. These patients did not qualify for peritoneal dialysis. Using the technique recommended by Archundia et al., 4 indwelling catheters were implanted directly in the superior vena cava in each of the patients with subsequent subcutaneous tunneling. The catheters operated correctly and are currently permeable after being used for an average of 19 months.

  3. Profile summary.

    Science.gov (United States)

    2003-01-01

    All drugs appearing in the Adis Profile Summary table have been selected based on information contained in R&D Insight trade mark, a proprietary product of Adis International. The information in the profiles is gathered from the world's medical and scientific literature, at international conferences and symposia, and directly from the developing companies themselves. The emphasis of Drugs in R&D is on the clinical potential of new drugs, and selection of agents for inclusion is based on products in late-phase clinical development that have recently had a significant change in status.

  4. A major safety overhaul

    CERN Multimedia

    2003-01-01

    A redefined policy, a revamped safety course, an environmental project... the TIS (Technical Inspection and Safety) Division has begun a major safety overhaul. Its new head, Wolfgang Weingarten, explains to the Bulletin why and how this is happening.

  5. Bromine Safety

    Energy Technology Data Exchange (ETDEWEB)

    Meyers, B

    2001-04-09

    The production and handling in 1999 of about 200 million kilograms of bromine plus substantial derivatives thereof by Great Lakes Chemical Corp. and Albemarle Corporation in their southern Arkansas refineries gave OSHA Occupational Injury/Illness Rates (OIIR) in the range of 0.74 to 1.60 reportable OIIRs per 200,000 man hours. OIIRs for similar industries and a wide selection of other U.S. industries range from 1.6 to 23.9 in the most recent OSHA report. Occupational fatalities for the two companies in 1999 were zero compared to a range in the U.S.of zero for all computer manufacturing to 0.0445 percent for all of agriculture, forestry and fishing in the most recent OSHA report. These results show that bromine and its compounds can be considered as safe chemicals as a result of the bromine safety standards and practices at the two companies. The use of hydrobromic acid as an electrical energy storage medium in reversible PEM fuel cells is discussed. A study in 1979 of 20 megawatt halogen working fluid power plants by Oronzio de Nora Group found such energy to cost 2 to 2.5 times the prevailing base rate at that time. New conditions may reduce this relative cost. The energy storage aspect allows energy delivery at maximum demand times where the energy commands premium rates. The study also found marginal cost and performance advantages for hydrobromic acid over hydrochloric acid working fluid. Separate studies in the late 70s by General Electric also showed marginal performance advantages for hydrobromic acid.

  6. Profile of paliperidone palmitate once-monthly long-acting injectable in the management of schizophrenia: long-term safety, efficacy, and patient acceptability – a review

    Directory of Open Access Journals (Sweden)

    González-Rodríguez A

    2015-05-01

    Full Text Available Alexandre González-Rodríguez,1 Rosa Catalán,1–4 Rafael Penadés,1–4 Clemente Garcia-Rizo,1,3,4 Miquel Bioque,1,4 Eduard Parellada,1,3–5 Miquel Bernardo1–4 1Barcelona Clinic Schizophrenia Unit (BCSU, Neuroscience Institute, Hospital Clinic of Barcelona, 2Department of Psychiatry and Clinical Psychobiology, University of Barcelona, 3Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS, Barcelona, Spain; 4Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM, Madrid, Spain; 5Department of Pharmacology, University of Barcelona, Barcelona, Spain Background and objectives: Short-term studies focused on once-monthly paliperidone palmitate (PP at doses of 25 mg eq, 50 mg eq, 75 mg eq, 100 mg eq, or 150 mg eq have shown its efficacy and tolerability in the treatment of schizophrenia patients. However, few open-label and long-term studies are available regarding this new pharmacological formulation. Thus, our main aim was to review the scientific evidence on efficacy, safety, tolerability, and preference of PP in these populations. Method: Electronic searches were conducted by using PubMed and ISI Web of Knowledge databases. All relevant studies published from 2009 until January 2015 were included without any language restriction if patients met diagnostic criteria for schizophrenia, and adequate information on efficacy, safety, and tolerability of once-monthly PP was available. Results: Nineteen studies were identified irrespective of the study design and duration of the follow-up period. Randomized, double-blind, placebo-controlled trials found that schizophrenia patients receiving PP showed a significant improvement in psychotic symptoms and similar adverse events compared to placebo and suggested that all doses of PP were efficacious and well tolerated. Other studies demonstrated noninferiority of PP compared to risperidone long-acting injectable in recently diagnosed schizophrenia patients, chronically

  7. Farm Health and Safety

    Science.gov (United States)

    ... jobs in the United States. Farms have many health and safety hazards, including Chemicals and pesticides Machinery, ... equipment can also reduce accidents. Occupational Safety and Health Administration

  8. Nuclear criticality safety guide

    Energy Technology Data Exchange (ETDEWEB)

    Pruvost, N.L.; Paxton, H.C. [eds.

    1996-09-01

    This technical reference document cites information related to nuclear criticality safety principles, experience, and practice. The document also provides general guidance for criticality safety personnel and regulators.

  9. New Safety rules

    CERN Multimedia

    Safety Commission

    2008-01-01

    The revision of CERN Safety rules is in progress and the following new Safety rules have been issued on 15-04-2008: Safety Procedure SP-R1 Establishing, Updating and Publishing CERN Safety rules: http://cern.ch/safety-rules/SP-R1.htm; Safety Regulation SR-S Smoking at CERN: http://cern.ch/safety-rules/SR-S.htm; Safety Regulation SR-M Mechanical Equipment: http://cern.ch/safety-rules/SR-M.htm; General Safety Instruction GSI-M1 Standard Lifting Equipment: http://cern.ch/safety-rules/GSI-M1.htm; General Safety Instruction GSI-M2 Standard Pressure Equipment: http://cern.ch/safety-rules/GSI-M2.htm; General Safety Instruction GSI-M3 Special Mechanical Equipment: http://cern.ch/safety-rules/GSI-M3.htm. These documents apply to all persons under the Director General’s authority. All Safety rules are available at the web page: http://www.cern.ch/safety-rules The Safety Commission

  10. 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

  11. 33 CFR 117.495 - Superior Oil Canal.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Superior Oil Canal. 117.495 Section 117.495 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY BRIDGES DRAWBRIDGE OPERATION REGULATIONS Specific Requirements Louisiana § 117.495 Superior Oil Canal. The draw of the S82 bridge, mile 6.3, in Cameron...

  12. [Superior vena cava syndrome--surgical solution--case report].

    Science.gov (United States)

    Galie, N; Vasile, R; Savu, C; Petreanu, C; Grigorie, V; Tabacu, E

    2010-01-01

    The patient of 52-year-old smoker was admitted in emergency with headaches, dyspnea, oedema and cyanosis of the cephalic extremity and of the superior members. This signs and symptoms suggest a superior vena cava sindrom. Thoracic CT scan shows the thrombosis of the superior vena cava and a tumor localized in the Bariety's Lodge of about 30/40 mm witch is around the right lateral wall of the traheea.This tumor is also tangent to the superior the superior vena cava. The patient was operated by total median sternotomy. By this approach we performed a complete excision of the mediastinal tumor mass. After that we effected a longitudinal cavotomy, we took out the endoluminal clot and we sutured the superior vena cava. The histological diagnosis of the mediastinal tumor was adenocarcinoma tubular-papillary moderately differentiated. The evolution post operative period was favorable the superior vena cava sindrom was a complet remission. The thoracic CT scan control after 9 months later didn't show a local relapse and blood flow was normally throw the superior vena cava.

  13. 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

  14. A Test Suite for Safety-Critical Java using JML

    DEFF Research Database (Denmark)

    Ravn, Anders Peter; Søndergaard, Hans

    2013-01-01

    Development techniques are presented for a test suite for the draft specification of the Java profile for Safety-Critical Systems. Distinguishing features are: specification of conformance constraints in the Java Modeling Language, encoding of infrastructure concepts without implementation bias...

  15. [Duplex scanning of hemodynamic parameters of the celiac trunk and superior mesenteric artery in healthy volunteers].

    Science.gov (United States)

    Kuntsevich, G I; Shilenok, D V

    1993-07-01

    The possibility of studying the hemodynamics in the visceral arteries of the abdominal aorta by duplex scanning was demonstrated. The results of examination of 30 healthy persons are discussed. Characteristic features of the blood flow spectrogram of the celiac trunk and superior mesenteric artery were revealed. According to the spectrogram, the flow of blood in the celiac trunk is characterized by rapidly increasing peak systolic rate and slowly diminishing diastolic rate to approximately 1/3 of the maximal value of systole. The character of the blood flow in the superior mesenteric artery is distinguished by a lesser peak systolic rate and the presence of a short-lived reverse rate before the sloping diastolic curve. Normal values of the blood flow volume rate were determined, it was 649 +/- 25.4 ml/min in the celiac trunk and 395 +/- 20.5 ml/min in the superior mesenteric artery. Among the advantages of the duplex scanning method are noninvasiveness and safety and the possibility of dynamic study of the hemodynamic parameters.

  16. Superior appetite hormone profile after equivalent weight loss by gastric bypass compared to gastric banding.

    Science.gov (United States)

    Bose, Mousumi; Machineni, Sriram; Oliván, Blanca; Teixeira, Julio; McGinty, James J; Bawa, Baani; Koshy, Ninan; Colarusso, Antonia; Laferrère, Blandine

    2010-06-01

    The goal of this study was to understand the mechanisms of greater weight loss by gastric bypass (GBP) compared to gastric banding (GB) surgery. Obese weight- and age-matched subjects were studied before (T0), after a 12 kg weight loss (T1) by GBP (n = 11) or GB (n = 9), and at 1 year after surgery (T2). peptide YY(3-36) (PYY(3-36)), ghrelin, glucagon-like peptide-1 (GLP-1), leptin, and amylin were measured after an oral glucose challenge. At T1, glucose-stimulated GLP-1 and PYY levels increased significantly after GBP but not GB. Ghrelin levels did not change significantly after either surgery. In spite of equivalent weight loss, leptin and amylin decreased after GBP, but not after GB. At T2, weight loss was greater after GBP than GB (P = 0.003). GLP-1, PYY, and amylin levels did not significantly change from T1 to T2; leptin levels continued to decrease after GBP, but not after GB at T2. Surprisingly, ghrelin area under the curve (AUC) increased 1 year after GBP (P = 0.03). These data show that, at equivalent weight loss, favorable GLP-1 and PYY changes occur after GBP, but not GB, and could explain the difference in weight loss at 1 year. Mechanisms other than weight loss may explain changes of leptin and amylin after GBP.

  17. The superior transvelar approach to the fourth ventricle and brainstem.

    Science.gov (United States)

    Ezer, Haim; Banerjee, Anirban Deep; Bollam, Papireddy; Guthikonda, Bharat; Nanda, Anil

    2012-06-01

    Objective The superior transvelar approach is used to access pathologies located in the fourth ventricle and brainstem. The surgical path is below the venous structures, through the superior medullary velum. Following splitting the tentorial edge, near the tentorial apex, the superior medullary velum is split in the cerebello-mesencephalic fissure. Using the supracerebellar infratentorial, transtentorial or parietal interhemispheric routes, the superior medullary velum is approached. Splitting this velum provides a detailed view of the fourth ventricle and its floor. Materials and Methods A total of 10 formalin-fixed specimens were dissected in a stepwise manner to simulate the superior transvelar approach to the fourth ventricle. The exposure gained the distance from the craniotomy site and the ease of access was assessed for each of the routes. We also present an illustrative case, operated by the senior author (AN). Results The superior transvelar approach provides access to the entire length of the fourth ventricle floor, from the aqueduct to the obex, when using the parietal interhemispheric route. In addition, this approach provides access to the entire width of the floor of the fourth ventricle; however, this requires retracting the superior cerebellar peduncle. Using the supracerebellar infratentorial route gives a limited exposure of the superior part of the fourth ventricle. The occipital interhemispheric route is a compromise between these two. Conclusion The superior transvelar approach to the fourth ventricle provides a route for approaching the fourth ventricle from above. This approach does not require opening the posterior fossa in the traditional way, and provides a reasonable alternative for accessing the superior fourth ventricle.

  18. STUDYING OF SAFETY CLIMATE ASSESSMENT: A CASE STUDY AT STEEL INDUSTRY

    Directory of Open Access Journals (Sweden)

    Hassan DARVISH

    2011-01-01

    Full Text Available Evolution of safety climate used as a practical means has determined and assessed potential problems relevant to safety issues in an organization and can be used in individuals’ performance and work efficiency and decreasing rate of incidents ;as well as; guidance to provide safety organization policy and comparison of safety performance in different organizations. The study wants to determine and prepare safety climate profile and application of its results in improving safety situation. In this study, applied tools presented by Loughborough University are used to evaluate safety climate in one of steel industries and data is collected through questionnaire, group discussions or purposeful interviews and observations, and safety climate score was obtained in 17 scopes. Calculating the score of each safety climate domain and preparing the profile indicated there is the average rate (4.89 2 in the safety climate of the industry.

  19. Safety against flooding: Progress report Autumn 2007

    NARCIS (Netherlands)

    Mosselman, E.

    2007-01-01

    This document reports the progress of Delft Cluster project CT04.30 "Safety against flooding" till June 2009. Fundamental knowledge from the project has resulted in a large number of scientific publications, PhD theses and MSc theses. Work package A 1 in particular has resulted in high-profile scien

  20. 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.

  1. Safety: Preventive Medicine.

    Science.gov (United States)

    Kotula, John R.; Digenakis, Anthony

    1985-01-01

    Underscores the need for community colleges to practice safety within the institutions and to instruct students in workplace safety procedures and requirements. Reviews Occupational Safety and Health Act (OSHA) regulations and their impact on industry and education. Looks at the legal responsibilities of colleges for safety. (DMM)

  2. Network meta-analysis of success rate and safety in antibiotic treatments of bronchitis

    Science.gov (United States)

    Wang, Jinghua; Xu, Haiyang; Liu, Pan; Li, Mingxian

    2017-01-01

    The purpose of this study was to compare the relative efficacy and safety of different antibiotic drugs and recommend superior regimens in the treatment of bronchitis. With respect to the antibiotic comparisons against quinolones in terms of intention-to-treat patients, we concluded that quinolones had advantages over placebo, β-lactams, sulfonamides, and double β-lactams. Concerning treatment methods for clinically evaluable patients, quinolones demonstrated better performance than β-lactams and sulfonamides. The secondary effects of macrolides, quinolones, and double β-lactams were significantly more adverse than β-lactams with odds ratios (ORs) of 1.5 (95% credible interval [CrI] =1.1–2.0), 1.7 (95% CrI =1.2–2.3), and 2.7 (95% CrI =1.8–4.1), respectively. Significant differences in the prevalence of diarrhea as a secondary effect were only identified among the comparisons of double β-lactams against β-lactams and macrolides (OR =5.0, 95% CrI =2.1–12.0; OR =3.0, 95% CrI =1.7–5.4, respectively). Quinolones can be recommended as the superior treatment for bronchitis, in accordance with our cluster analysis with surface under the cumulative ranking curve. The primary outcomes of network meta-analysis indicated that quinolones showed the best performance among the 8 treatments studied, although β-lactams showed the lowest risk of adverse side effects. Quinolones are recommended as the primary treatment option for bronchitis patients, having taking into account the success rates and safety profiles of the eight drugs studied here. PMID:28848340

  3. Safety at CERN

    CERN Multimedia

    2009-01-01

    Safety is an integral part of our working lives, and should be in our minds whatever job we do at CERN. Ultimately, safety is the responsibility of the Director General – your safety is my concern. That’s why I have this week appointed a new Safety Policy Committee (SAPOCO) that reflects the new Organizational structure of CERN. CERN’s Staff Rules and Regulations clearly lay out in chapter 3 the scope of safety at CERN as well as my responsibilities and yours in safety matters. At CERN, safety is considered in the broadest sense, encompassing occupational Health and Safety, environmental protection, and the safety of equipment and installations. It is my responsibility to put appropriate measures in place to ensure that these conditions are met. And it is the responsibility of us all to ensure that we are fully conversant with safety provisions applicable in our areas of work and that we comply with them. The appointment of a n...

  4. Efficacy and safety of micafungin for invasive candida infections:a meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    CHEN Qian; LIN Mao-hu; CHEN Meng-li; LIU Zhe-yuan; CHAI Dong; WANG Rui

    2012-01-01

    Background Invasive fungal infections such as candidiasis and mold infections cause significant morbidity and mortality in seriously ill patients.Micafungin is an echinocandin antifungal agent with potent activity against most species of Candida and Aspergillus.We did this meta-analysis to clarify whether micafungin offers superior efficacy and safety compared with other antifungal agent for treating infections associated with invasive candidiasis.Methods We did a meta-analysis of randomized controlled trials to examine whether micafungin has superior efficacy and safety compared with other antifungal agents recommended by the treatment guidelines for fungal infection.Seven trials involving 2913 patients were included in this analysis.Odds ratios (OR) and 95% confidence intervals (CI) were calculated.Results Micafungin was associated with significantly better treatment success compared with the comparator antifungal agents (modified intention to treat,2851 patients; random-effects model,OR 1.20,95% CI 1.00-1.45,P=0.0487).In addition,micafungin was more effective than the comparators for antifungal prophylaxis of neutropenic patients undergoing hematopoietic stem cell transplantation (OR 1.47,95% CI 1.08-2.00,P=0.01).Although there was no significant difference between the compared regimens in terms of the incidence of adverse drug effects (OR 0.94,95% CI 0.77-1.11),fewer patients treated with micafungin withdrew from the studies because of adverse events (OR 0.64,95% CI 0.44-0.94).Conclusions Micafungin has a good safety and tolerability profile,with an efficacy at least comparable to the other antifungal agents.Micafungin offers advantages over other agents for antifungal prophylaxis.Micafungin offers an appropriate alternative for antifungal prophylaxis rather than the treatment of invasive candida infections.

  5. Regulation of molecular components of the synapse in the developing and adult rat superior cervical ganglion

    Energy Technology Data Exchange (ETDEWEB)

    Wu, K.; Black, I.B.

    1987-12-01

    Rat superior cervical sympathetic ganglion was used to begin studying the regulation of molecular components of the synapse. Ganglionic postsynaptic densities (PSDs) exhibited a thin, disc-shaped profile electron microscopically, comparable to that described for brain. Moreover, the presumptive ganglionic PSD protein (PSDp) was phosphorylated in the presence of Ca/sup 2 +/ and calmodulin, bound /sup 125/I-labeled calmodulin, and exhibited a M/sub r/ of 51,000 all characteristic of the major PSD protein of brain. These initial studies indicated that ganglionic PSDp and the major PSD protein of brain are comparable, allowing the study synaptic regulation in the well-defined superior cervical sympathetic ganglion. To obtain enough quantities of ganglionic PSDp, the authors used synaptic membrane fractions. During postnatal development, calmodulin binding to the ganglionic PSDp increased 411-fold per ganglion from birth to 60 days, whereas synaptic membrane protein increased only 4.5-fold. Consequently, different synaptic components apparently develop differently. Moreover, denervation of the superior cervical sympathetic ganglion in adult rats caused an 85% decrease in ganglionic PSDp-calmodulin binding, but denervation caused no change in synaptic membrane protein 2 weeks postoperatively. The observations suggest that presynaptic innervation selectively regulates specific molecular components of the postsynaptic membrane structure.

  6. Acquired Brown Syndrome Treated With Traction of Superior Oblique Tendon.

    Science.gov (United States)

    Shin, Kwang Hoon; Paik, Hae Jung; Chi, Mijung

    2016-03-01

    Brown syndrome is a rare strabismic disease characterized by a limited elevation in adduction of the eye. The lengthening/weakening of superior oblique muscle is the main way of surgical intervention for this disease. A 7-year-old boy was diagnosed as having acquired Brown syndrome in his right eye after injury in his face. We experienced successful release of this Brown syndrome through mere pulling outward of superior oblique tendon during surgical exploration. We briefly discuss why this manipulation of superior oblique tendon that we performed was successful.

  7. 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.)

  8. 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'.

  9. China's Work Safety Report

    Institute of Scientific and Technical Information of China (English)

    Liang Jiakun

    2005-01-01

    @@ General Situation of China's Work Safety in 2004 In 2004, the national work safety situation remained stable as a whole and gained momentum to improve. The totality of accidents held the line and began to drop. The safety conditions in industrial,mining, and commercial/trading enterprises improved. Progress was made in ensuring work safety in the relevant industries and fields. The safety situation in most provinces (autonomous regions, municipalities directly under the Central Government) kept stable.

  10. Profile of blonanserin for the treatment of schizophrenia

    Directory of Open Access Journals (Sweden)

    Tenjin T

    2013-04-01

    Full Text Available Tomomi Tenjin, Seiya Miyamoto, Yuriko Ninomiya, Rei Kitajima, Shin Ogino, Nobumi Miyake, Noboru YamaguchiDepartment of Neuropsychiatry, St Marianna University School of Medicine, Kawasaki, Kanagawa, JapanAbstract: Blonanserin was developed as an antipsychotic drug in Japan and approved for the treatment of schizophrenia. It belongs to a series of 4-phenyl-2-(1-piperazinylpyridines and acts as an antagonist at dopamine D2, D3, and serotonin 5-HT2A receptors. Blonanserin has low affinity for 5-HT2C, adrenergic α1, histamine H1, and muscarinic M1 receptors, but displays relatively high affinity for 5-HT6 receptors. In several short-term double-blind clinical trials, blonanserin had equal efficacy as haloperidol and risperidone for positive symptoms in patients with chronic schizophrenia and was also superior to haloperidol for improving negative symptoms. Blonanserin is generally well tolerated and has a low propensity to cause metabolic side effects and prolactin elevation. We recently reported that blonanserin can improve some types of cognitive function associated with prefrontal cortical function in patients with first-episode and chronic schizophrenia. Taken together, these results suggest that blonanserin may be a promising candidate for a first-line antipsychotic for acute and maintenance therapy for schizophrenia. Further comparative studies are warranted to clarify the benefit/risk profile of blonanserin and its role in the treatment of schizophrenia.Keywords: blonanserin, schizophrenia, pharmacology, pharmacokinetics, efficacy, safety

  11. Pharmacotherapy for Pediatric Generalized Anxiety Disorder: A Systematic Evaluation of Efficacy, Safety and Tolerability

    Science.gov (United States)

    Dobson, Eric T.; Strawn, Jeffrey R.

    2016-01-01

    Background Randomized controlled trials consistently support the efficacy of antidepressants in treating youth with generalized anxiety disorder (GAD), although integrated examinations of efficacy, safety, and tolerability of psychotropic medications in GAD specifically are rare. With this in mind, we sought to describe the efficacy, safety and tolerability of psychopharmacologic interventions in youth with GAD. Methods Randomized, double-blind, placebo-controlled, prospective trials of psychopharmacologic interventions in youth with GAD were identified through a PubMed/Medline (1966–2015) search. Both authors manually reviewed trials and, to evaluate comparative efficacy and tolerability across medications, numbers needed to treat (NNT) (based on Pediatric Anxiety Rating Scale (PARS) remission criteria (PARS ≤8 [1]), and number needed to harm (NNH) for selected treatment-emergent adverse events (TEAEs) were calculated. Finally, treatment-emergent suicidality and taper-emergent/post-study adverse events are reported descriptively. Results Five trials that involved 1,186 patients and evaluated four medications were reviewed and efficacy data were extracted with regard to dimensional measures of anxiety. SSRI/SNRIs demonstrated efficacy in the reduction of anxiety symptoms with NNTs ranging from 2.8 to 9.3. TEAEs varied considerably between studies but tended to be mild and generally did not lead to discontinuation. Conclusions Data from five trials of SSRI/SNRI in youth with GAD, many of whom had co-occurring separation and social anxiety disorders, suggest superiority to placebo and favorable tolerability profiles. PMID:26660158

  12. Efficacy and safety profile of combination of tramadol-diclofenac versus tramadol-paracetamol in patients with acute musculoskeletal conditions, postoperative pain, and acute flare of osteoarthritis and rheumatoid arthritis: a Phase III, 5-day open-label study

    Science.gov (United States)

    Chandanwale, Ajay S; Sundar, Subramanian; Latchoumibady, Kaliaperumal; Biswas, Swati; Gabhane, Mukesh; Naik, Manoj; Patel, Kamlesh

    2014-01-01

    Objective We aimed to evaluate the safety and efficacy of a fixed-dose combination (FDC) of tramadol and diclofenac versus a standard approved FDC of tramadol and paracetamol, in patients with acute moderate to severe pain. Methods A total of 204 patients with moderate to severe pain due to acute musculoskeletal conditions (n=52), acute flare of osteoarthritis (n=52), acute flare of rheumatoid arthritis (n=50), or postoperative pain (n=50) were enrolled in the study at baseline. Each disease category was then randomized to receive either of two treatments for 5 days: group A received an FDC of immediate-release tramadol hydrochloride (50 mg) and sustained-release diclofenac sodium (75 mg) (one tablet, twice daily), and group B received an FDC of tramadol hydrochloride (37.5 mg) and paracetamol (325 mg) (two tablets every 4–6 hours, up to a maximum of eight tablets daily). The primary efficacy end points were reductions in pain intensity from baseline at day 3 and day 5 as assessed by a Visual Analog Scale (VAS) score. Results Group A showed a significant reduction in the VAS score for overall pain from baseline on day 3 (P=0.001) and day 5 (P<0.0001) as compared with group B. The combination of tramadol-diclofenac resulted in few mild to moderate adverse events (nausea, vomiting, epigastric pain, and gastritis), which required minimal management, without any treatment discontinuation. The number of adverse events in group A was nine (8.82%) compared with 22 (21.78%) in group B, after 5 days of treatment. Conclusion An FDC of tramadol-diclofenac showed a significantly greater reduction in pain intensity and was well tolerated compared with tramadol-paracetamol, resulting in better analgesia in patients suffering from moderate to severe pain due to acute musculoskeletal conditions, postoperative pain following orthopedic surgery, or acute flare of osteoarthritis and rheumatoid arthritis. PMID:25152629

  13. Risk of Hippocampal Metastases in Small Cell Lung Cancer Patients at Presentation and After Cranial Irradiation: A Safety Profile Study for Hippocampal Sparing During Prophylactic or Therapeutic Cranial Irradiation

    Energy Technology Data Exchange (ETDEWEB)

    Kundapur, Vijayananda, E-mail: Vijayananda.kundapur@saskcancer.ca [Saskatoon Cancer Center, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan (Canada); Ellchuk, Tasha [Department of Radiology, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan (Canada); Ahmed, Shahid [Saskatoon Cancer Center, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan (Canada); Gondi, Vinai [Cadence Health Brain Tumor Center and Cadence Health Proton Center, Chicago, Illinois (United States)

    2015-03-15

    Purpose: Neurocognitive impairment (NI) in patients with small cell lung cancer (SCLC) after whole brain radiation treatment (WBRT) is a significant cause of morbidity. Hippocampal avoidance (HA) during WBRT may mitigate or prevent NI in such patients. However, this has not been tested in SCLC patients. The estimated risk of metastases in the HA region (HM) in patients with SCLC at diagnosis or after WBRT is unknown. Our study aimed to determine the risk of HM in patients with SCLC and to assess correlated clinical factors. Methods and Materials: Patients with SCLC who experienced brain metastases (BM) at presentation (de novo) or after WBRT treated at the Saskatoon Cancer Centre between 2005 and 2012 were studied. Relevant neuroimaging was independently reviewed by a neuroradiologist. HM was defined as metastases within 5 mm of the hippocampus. Logistic regression analysis was performed to assess correlation between various clinical variables and HM. Results: Seventy eligible patients were identified. Of 59 patients presenting with de novo BM, 3 patients (5%, 95% confidence interval [CI]: 0%-10.7%) had HM. Collectively there were 359 (range, 1-33) de novo BM with 3 (0.8%, 95% CI: 0%-1.7%) HM deposits. Twenty patients experienced progression of metastatic disease in the brain after WBRT. Of the 20 patients, only 1 patient (5%, 95% CI: 0%-14.5%) experienced HM. On logistic regression, no factors significantly correlated with HM. Conclusion: The overall incidence of HM before or after WBRT in SCLC patients is low, providing preliminary support for the safety of HA during planned clinical trials of HA-WBRT for SCLC.

  14. Automated design of ligands to polypharmacological profiles

    Science.gov (United States)

    Besnard, Jérémy; Ruda, Gian Filippo; Setola, Vincent; Abecassis, Keren; Rodriguiz, Ramona M.; Huang, Xi-Ping; Norval, Suzanne; Sassano, Maria F.; Shin, Antony I.; Webster, Lauren A.; Simeons, Frederick R.C.; Stojanovski, Laste; Prat, Annik; Seidah, Nabil G.; Constam, Daniel B.; Bickerton, G. Richard; Read, Kevin D.; Wetsel, William C.; Gilbert, Ian H.; Roth, Bryan L.; Hopkins, Andrew L.

    2012-01-01

    The clinical efficacy and safety of a drug is determined by its activity profile across multiple proteins in the proteome. However, designing drugs with a specific multi-target profile is both complex and difficult. Therefore methods to rationally design drugs a priori against profiles of multiple proteins would have immense value in drug discovery. We describe a new approach for the automated design of ligands against profiles of multiple drug targets. The method is demonstrated by the evolution of an approved acetylcholinesterase inhibitor drug into brain penetrable ligands with either specific polypharmacology or exquisite selectivity profiles for G-protein coupled receptors. Overall, 800 ligand-target predictions of prospectively designed ligands were tested experimentally, of which 75% were confirmed correct. We also demonstrate target engagement in vivo. The approach can be a useful source of drug leads where multi-target profiles are required to achieve either selectivity over other drug targets or a desired polypharmacology. PMID:23235874

  15. Aliskiren: a clinical profile

    Directory of Open Access Journals (Sweden)

    Roland E Schmieder

    2006-06-01

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

  16. TWRS safety program plan

    Energy Technology Data Exchange (ETDEWEB)

    Calderon, L.M., Westinghouse Hanford

    1996-08-01

    Management of Nuclear Safety, Industrial Safety, Industrial Hygiene, and Fire Protection programs, functions, and field support resources for Tank Waste Remediation Systems (TWRS) has, until recently, been centralized in TWRS Safety, under the Emergency, Safety, and Quality organization. Industrial hygiene technician services were also provided to support operational needs related to safety basis compliance. Due to WHC decentralization of safety and reengineering efforts in West Tank Farms, staffing and safety responsibilities have been transferred to the facilities. Under the new structure, safety personnel for TWRS are assigned directly to East Tank Farms, West Tank Farms, and a core Safety Group in TWRS Engineering. The Characterization Project Operations (CPO) safety organization will remain in tact as it currently exists. Personnel assigned to East Tank Farms, West Tank Farms, and CPO will perform facility-specific or project-specific duties and provide field implementation of programs. Those assigned to the core group will focus on activities having a TWRS-wide or programmatic focus. Hanford-wide activities will be the responsibility of the Safety Center of Expertise. In order to ensure an effective and consistent safety program for TWRS under the new organization program functions, goals, organizational structure, roles, responsibilities, and path forward must be clearly established. The purpose of the TWRS Safety Program Plan is to define the overall safety program, responsibilities, relationships, and communication linkages for safety personnel under the new structure. In addition, issues associated with reorganization transition are addressed, including training, project ownership, records management, and dissemination of equipment. For the purpose of this document ``TWRS Safety`` refers to all safety professionals and technicians (Industrial Safety, Industrial Hygiene, Fire Protection, and Nuclear Safety) within the TWRS organization, regardless of their

  17. MPI Profiling

    Energy Technology Data Exchange (ETDEWEB)

    Han, D K; Jones, T R

    2005-02-11

    The Message Passing Interface (MPI) is the de facto message-passing standard for massively parallel programs. It is often the case that application performance is a crucial factor, especially for solving grand challenge problems. While there have been many studies on the scalability of applications, there have not been many focusing on the specific types of MPI calls being made and their impact on application performance. Using a profiling tool called mpiP, a large spectrum of parallel scientific applications were surveyed and their performance results analyzed.

  18. Quantum profiles

    CERN Document Server

    Bernstein, Jeremy

    1991-01-01

    For the prominent science writer Jeremy Bernstein, the profile is the most congenial way of communicating science. Here, in what he labels a "series of conversations carried on in the reader's behalf and my own," he evokes the tremendous intellectual excitement of the world of modern physics, especially the quantum revolution. Drawing on his well-known talent for explaining the most complex scientific ideas for the layperson, Bernstein gives us a lively sense of what the issues of quantum mechanics are and of various ways in which individual physicists approached them.The author begins this se

  19. Profile of secukinumab in the treatment of psoriasis: current perspectives

    Directory of Open Access Journals (Sweden)

    Roman M

    2015-12-01

    Full Text Available Michael Roman, Vandana K Madkan, Melvin W Chiu Division of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA Abstract: Secukinumab (Cosentyx™ is a human monoclonal IgG1k antibody that has been developed to target and block the actions of IL-17A. It is known that this cytokine is elevated in lesions of psoriasis. Interleukins in the Th17 pathway play a pivotal role in the pathogenesis of psoriasis and have thus become targets for recent biologic drug development. As a monoclonal antibody immune modulator, secukinumab exhibits the expected pharmacokinetic properties of slow subcutaneous absorption, low clearance, and long half-life, although formal studies examining the impact of impaired hepatic or renal function on the overall pharmacokinetic profile have not been conducted. Both Phase II and III clinical trials have demonstrated the effectiveness of secukinumab in the treatment of moderate-to-severe plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, and noninfectious uveitis. In June 2015, secukinumab was approved by the US Food and Drug Administration for the treatment of adults with moderate-to-severe plaque psoriasis, with a wealth of clinical trials showcasing its efficacy in improving psoriasis area and severity index scores, and it is superior to other comparable biologics on the market, including the TNF inhibitor etanercept. As such, this review focuses on the marquee clinical trials involving secukinumab treatment of plaque psoriasis, while also exploring this drug’s efficacy in treating patients with psoriatic arthritis, a disease that has a well-documented comorbidity in patients diagnosed with moderate-to-severe plaque psoriasis. Finally, the safety and tolerability of this drug in a variety of clinical trials to date have also been reviewed, and will undoubtedly have a large impact on this drug’s postmarketing surveillance and future studies regarding its long

  20. 2010 Great Lakes Restoration Initiative Bathymetric Lidar: Lake Superior

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The data contained in this file contain hydrographic and topographic data collected by the Fugro LADS Mk II system along the Lake Superior coast of Minnessota,...

  1. 28 CFR 2.60 - Superior program achievement.

    Science.gov (United States)

    2010-07-01

    ... OF PRISONERS, YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2... or a case with both superior program achievement and minor disciplinary infraction(s)). Advancements...

  2. Coronary artery bypass and superior vena cava syndrome.

    Science.gov (United States)

    Thomas, T V; Masrani, K; Thomas, J L

    1999-01-01

    Superior vena cava syndrome is the obstruction of the superior vena cava or its main tributaries by benign or malignant lesions. The syndrome causes edema and engorgement of the vessels on the face, neck, and arms, nonproductive cough, and dyspnea. We discuss the case of a 48-year-old obese diabetic woman who was admitted with unstable angina. She had previously been diagnosed with superior vena cava syndrome. Urgent coronary artery bypass grafting was necessary Although thousands of coronary artery bypasses are performed every year, there are not many reports on patients with superior vena cava syndrome who successfully undergo cardiopulmonary bypass and coronary artery grafting with an internal mammary artery as the conduit. The results of the case and alternative recommended methods are discussed.

  3. Occupational safety motivation

    DEFF Research Database (Denmark)

    Pedersen, Louise; Kines, Pete

    2010-01-01

    . At the same time many motivation questionnaire items are seldom founded on theory and/or do not account for the theories’ ontological and epistemological differences, e.g. of how knowledge, attitude and action are related. Present questionnaire items tap into occupational safety motivation in asking whether...... or not respondents ‘are’ motivated and whether they feel that safety is important or worthwhile. Another important aspect is ‘what’ motivates workers to comply to and participate in safety. The aim of this article is to introduce a new theory-based occupational safety motivation scale which is validated......Background: Motivation is one of the most important factors for safety behaviour and for implementing change in general. However, theoretical and psychometric studies of safety performance have traditionally treated safety motivation, safety compliance and safety participation unidimensionally...

  4. Occupational safety motivation

    DEFF Research Database (Denmark)

    Pedersen, Louise; Kines, Pete

    2010-01-01

    . At the same time many motivation questionnaire items are seldom founded on theory and/or do not account for the theories’ ontological and epistemological differences, e.g. of how knowledge, attitude and action are related. Present questionnaire items tap into occupational safety motivation in asking whether...... or not respondents ‘are’ motivated and whether they feel that safety is important or worthwhile. Another important aspect is ‘what’ motivates workers to comply to and participate in safety. The aim of this article is to introduce a new theory-based occupational safety motivation scale which is validated......Background: Motivation is one of the most important factors for safety behaviour and for implementing change in general. However, theoretical and psychometric studies of safety performance have traditionally treated safety motivation, safety compliance and safety participation unidimensionally...

  5. Safety of statins

    Directory of Open Access Journals (Sweden)

    Debasish Maji

    2013-01-01

    Full Text Available Statins are an established class of drugs with proven efficacy in cardiovascular risk reduction. The concern over statin safety was first raised with the revelation of myopathy and rhabdomyolysis with the use of now withdrawn cerivastatin. Enhanced understanding of the mechanisms behind adverse effects of statins including an insight into the pharmacokinetic properties have minimised fear of statin use among clinicians. Studies reveal that occurrence of myopathy and rhabdomyolysis are rare 1/100000 patient-years. The risk of myopathy/rhabdomyolysis varies between statins due to varying pharmacokinetic profiles. This explains the differing abilities of statins to adverse effects and drug interaction potentials that precipitate adverse effects. Higher dose of rosuvastatin (80 mg/day was associated with proteinuria and hematuria while lower doses were devoid of such effects. Awareness of drugs interacting with statins and knowledge of certain combinations such as statin and fibrates together with monitoring of altered creatine kinase activity may greatly minimise associated adverse effects. Statins also asymptomatically raise levels of hepatic transaminases but are not correlated with hepatotoxicity. Statins are safe and well tolerated including more recent potent statins such as, rosuvastatin. The benefits of intensive statin use in cardiovascular risk reduction greatly outweigh risks. The present review discusses underlying causes of statin-associated adverse effects including management in high risk groups.

  6. 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.

  7. Superior memorizers employ different neural networks for encoding and recall.

    Science.gov (United States)

    Mallow, Johannes; Bernarding, Johannes; Luchtmann, Michael; Bethmann, Anja; Brechmann, André

    2015-01-01

    Superior memorizers often employ the method of loci (MoL) to memorize large amounts of information. The MoL, known since ancient times, relies on a complex process where information to be memorized is bound to landmarks along mental routes in a previously memorized environment. However, functional magnetic resonance imaging data on groups of trained superior memorizer are rare. Based on the memorizing strategy reported by superior memorizers, we developed a scheme of the processes successively employed during memorizing and recalling digits and relate these to brain activation that is specific for the encoding and recall period. In the examined superior memorizers several regions, suggested to be involved in mental navigation and digit-to-word processing, were specifically activated during encoding: bilateral early visual cortex, retrosplenial cortex, left parahippocampus, left visual cortex, and left superior parietal cortex. Although the scheme suggests that some steps during encoding and recall seem to be analog, none of the encoding areas were specifically activated during the recall. Instead, we found strong activation in left anterior superior temporal gyrus, which we relate to recalling the sequential order of the digits, and right motor cortex that may be related to reciting the digits.

  8. Superior Memorizers Employ Different Neural Networks for Encoding and Recall

    Directory of Open Access Journals (Sweden)

    Johannes eMallow

    2015-09-01

    Full Text Available Superior memorizers often employ the method of loci (MoL to memorize large amounts of information. The method of loci, known since ancient times, relies on a complex process where information to be memorized is bound to landmarks along mental routes in a previously memorized environment. However, fMRI data on groups of trained superior memorizer are rare. Based on the memorizing strategy reported by superior memorizers we developed a scheme of the processes successively employed during memorizing and recalling digits and relate these to brain activation that is specific for the encoding and recall period. In the examined superior memorizers several regions, suggested to be involved in mental navigation and digit-to-word processing, were specifically activated during encoding: bilateral early visual cortex, retrosplenial cortex, left parahippocampus, left visual cortex, and left superior parietal cortex. Although the scheme suggests that some steps during encoding and recall seem to be analog, none of the encoding areas were specifically activated during the recall. Instead, we found strong activation in left anterior superior temporal gyrus, which we relate to recalling the sequential order of the digits, and right motor cortex that may be related to reciting the digits.

  9. Differential diagnosis of cervical radiculopathy and superior pulmonary sulcus tumor

    Institute of Scientific and Technical Information of China (English)

    GU Rui; KANG Ming-yang; GAO Zhong-li; ZHAO Jian-wu; WANG Jin-cheng

    2012-01-01

    Background The result would be disastrous if the superior pulmonary sulcus tumor (Pancoast tumor) was misdiagnosed as degenerative cervical spine diseases.The aim of this study was to investigate the differential diagnosis methods of cervical radiculopathy and superior pulmonary sulcus tumor.Methods Clinical manifestations,physical,and radiological findings of 10 patients,whose main complaints were radiating shoulder and arm pain and later were diagnosed with superior pulmonary sulcus tumor,were reviewed and compared with those of cervical radiculopathy.Results Superior pulmonary sulcus tumor patients have shorter mean history and fewer complaints of neck pain or limitation of neck movement.Physical examination showed almost normal cervical spine range of motion.Spurling's neck compression test was negative in all patients.Anteroposterior cervical radiographs showed the lack of pulmonary air at the top of the affected lung in all cases and first rib encroachment in one case.The diagnosis of superior pulmonary sulcus tumor can be further confirmed by CT and MRI.Conclusions By the method of combination of history,physical examination,and radiological findings,superior pulmonary sulcus tumor can be efficiently differentiated from cervical radiculopathy.Normal motion range of the cervical spine,negative Spurling's neck compression test,and the lack of pulmonary air at the top of the affected lung in anteroposterior cervical radiographs should be considerad as indications for further chest radiograph examinations.

  10. Effectiveness and safety of 1 vs 4 h blood pressure profile with clinical and laboratory assessment for the exclusion of gestational hypertension and pre-eclampsia: a retrospective study in a university affiliated maternity hospital.

    Science.gov (United States)

    McCarthy, Elizabeth Anne; Carins, Thomas A; Hannigan, Yolanda; Bardien, Nadia; Shub, Alexis; Walker, Susan P

    2015-11-18

    We asked whether 60 compared with 240 min observation is sufficiently informative and safe for pregnancy day assessment (PDAC) of suspected pre-eclampsia (PE). A retrospective study of 209 pregnant women (475 PDAC assessments, 6 months) with routinely collected blood pressure (BP), symptom and laboratory information. We proposed a 60 min screening algorithm comprising: absence of symptoms, normal laboratory parameters and ≤1high-BP reading (systolic blood pressure, SBP 140 mm Hg or higher or diastolic blood pressure, DBP 90 mm Hg or higher). We also evaluated two less inclusive screening algorithms. We determined short-term outcomes (within 4 h): severe hypertension, proteinuric hypertension and pregnancy-induced hypertension, as well as long-term outcome: PE-related diagnoses up to the early puerperium. We assessed performance of alternate screening algorithms performance using 2×2 tables. 1 in 3 women met all screen negative criteria at 1 h. Their risk of hypertension requiring treatment in the next 3 h was 1.8% and of failing to diagnose proteinuric hypertensive PE at 4 h was 5.1%. If BP triggers were 5 mm Hg lower, 1 in 6 women would be screen-negative of whom 1.1% subsequently develops treatment-requiring hypertension and 4.5% demonstrate short-term proteinuric hypertension. We present sensitivity, specificity, negative and positive likelihood ratios for alternate screening algorithms. We endorse further research into the safest screening test where women are considered for discharge after 60 min. Safety, patient and staff satisfaction should be assessed prospectively. Any screening test should be used in conjunction with good clinical care to minimise maternal and perinatal hazards of PE. 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/

  11. Safety profile, efficacy, and biodistribution of a bicistronic high-capacity adenovirus vector encoding a combined immunostimulation and cytotoxic gene therapy as a prelude to a phase I clinical trial for glioblastoma

    Energy Technology Data Exchange (ETDEWEB)

    Puntel, Mariana [Department of Neurosurgery, The University of Michigan School of Medicine, MSRB II, RM 4570C, 1150 West Medical Center Drive, Ann Arbor, MI 48109-5689 (United States); Department of Cell and Developmental Biology, The University of Michigan School of Medicine, MSRB II, RM 4570C, 1150 West Medical Center Drive, Ann Arbor, MI 48109-5689 (United States); Gene Therapeutics Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048 (United States); Ghulam, Muhammad A.K.M. [Gene Therapeutics Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048 (United States); Farrokhi, Catherine [Department of Psychiatry and Behavioral Neurosciences, Cedars Sinai Medical Center, Los Angeles, CA 90048 (United States); VanderVeen, Nathan; Paran, Christopher; Appelhans, Ashley [Department of Neurosurgery, The University of Michigan School of Medicine, MSRB II, RM 4570C, 1150 West Medical Center Drive, Ann Arbor, MI 48109-5689 (United States); Department of Cell and Developmental Biology, The University of Michigan School of Medicine, MSRB II, RM 4570C, 1150 West Medical Center Drive, Ann Arbor, MI 48109-5689 (United States); Kroeger, Kurt M.; Salem, Alireza [Gene Therapeutics Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048 (United States); Lacayo, Liliana [Department of Psychiatry and Behavioral Neurosciences, Cedars Sinai Medical Center, Los Angeles, CA 90048 (United States); Pechnick, Robert N. [Department of Psychiatry and Behavioral Neurosciences, Cedars Sinai Medical Center, Los Angeles, CA 90048 (United States); Department of Psychiatry and Behavioral Neurosciences, David Geffen School of Medicine, University of California, Los Angeles, CA (United States); Kelson, Kyle R.; Kaur, Sukhpreet; Kennedy, Sean [Gene Therapeutics Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048 (United States); Palmer, Donna; Ng, Philip [Department of Molecular and Human Genetics, Baylor College of Medicine, Houston, TX 77030 (United States); and others

    2013-05-01

    acute and chronic time points. ► Doses up to 1 × 10{sup 9} vp of HC-Ad-TK/TetOn-Flt3L can be safely delivered in the brain. ► Efficacy and safety of HC-Ad-TK/TetOn-Flt3L merits its use in a GBM Phase I trial.

  12. 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

  13. 胶囊内镜检查失败原因分析和安全性评估%An analysis of failure and safety profiles of capsule endoscopy

    Institute of Scientific and Technical Information of China (English)

    卫炜; 戈之铮; 高云杰; 胡运彪; 萧树东

    2008-01-01

    目的 分析胶囊内镜(capsule endoscopy,CE)因技术和临床因素导致检查失败的原因及其对诊断的影响,评估其在特殊人群中使用的安全性.方法 回顾性分析2002年5月至2006年5月4年间在上海仁济医院因可疑小肠疾病接受CE检查的300例患者.技术问题为与仪器设备相关的问题,临床问题为与患者相关的问题.分析上述两类问题发生情况及对诊断的影响并评估CE检查在儿童组、高龄组、安置起搏器者、胃毕-Ⅱ式术后者、肠道憩室者、小肠克罗恩病者及小肠息肉病者中使用的安全性.结果 共出现4次技术问题(1.3%)(胶囊未被激活1例,胶囊内部电池电量<6 h2例,图像下载失败1例),其中2次影响到CE的诊断;临床问题共出现99次(33.0%)(正常电池电量维持时间内CE未达回盲部95次,吞咽胶囊失败4次),35次(35.4%)影响诊断结果.儿童组6例中胶囊吞咽不能发生3例,外套管下胃镜辅助送入法可成功解决此问题;高龄组13例中CE滞留于食管内3例(23.0%);2例安置心脏起搏器患者CE检查中未发现仪器间互相干扰;2例胃毕-Ⅱ式术后者未发生CE滞留;16例肠道憩室者中1例发生滞留;42例克罗恩病者5例发生CE滞留,但无一发生急性肠梗阻;5例息肉病者中无一例发生CE滞留及肠梗阻.结论 因CE自身技术因素导致检查失败者在临床应用中极少出现,所遇常见临床问题为正常电池电量维持时间内CE未达回盲部.CE对于小肠疾病而言是一项安全有效的检查方法.%objective To analyse the incidence of technical breakdown and clinical problem leading to the failure of capsule endoscopy examination and their influence on the diagnosis and to evaluate its feasibility and safety in special patient population.Methods A retrospective study of 300 consecutive patients referred to Renji Hospital for evaluation of suspected small bowel diseases between May 2002 and May 2006 was done.This included

  14. Safety-barrier diagrams

    DEFF Research Database (Denmark)

    Duijm, Nijs Jan

    2007-01-01

    are discussed. A simple method for quantification of safety-barrier diagrams is proposed, including situations where safety barriers depend on shared common elements. It is concluded that safety-barrier diagrams provide a useful framework for an electronic data structure that integrates information from risk......Safety-barrier diagrams and the related so-called "bow-tie" diagrams have become popular methods in risk analysis. This paper describes the syntax and principles for constructing consistent and valid safety-barrier diagrams. The relation with other methods such as fault trees and Bayesian networks...... analysis with operational safety management....

  15. Safety-in-numbers

    DEFF Research Database (Denmark)

    Elvik, Rune; Bjørnskau, Torkel

    2017-01-01

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

  16. Beyond safety accountability

    CERN Document Server

    Geller, E Scott

    2001-01-01

    Written in an easy-to-read conversational tone, Beyond Safety Accountability explains how to develop an organizational culture that encourages people to be accountable for their work practices and to embrace a higher sense of personal responsibility. The author begins by thoroughly explaining the difference between safety accountability and safety responsibility. He then examines the need of organizations to improve safety performance, discusses why such performance improvement can be achieved through a continuous safety process, as distinguished from a safety program, and provides the practic

  17. Safety KPIs - Monitoring of safety performance

    Directory of Open Access Journals (Sweden)

    Andrej Lališ

    2014-09-01

    Full Text Available This paper aims to provide brief overview of aviation safety development focusing on modern trends represented by implementation of Safety Key Performance Indicators. Even though aviation is perceived as safe means of transport, it is still struggling with its complexity given by long-term growth and robustness which it has reached today. Thus nowadays safety issues are much more complex and harder to handle than ever before. We are more and more concerned about organizational factors and control mechanisms which have potential to further increase level of aviation safety. Within this paper we will not only introduce the concept of Key Performance Indicators in area of aviation safety as an efficient control mechanism, but also analyse available legislation and documentation. Finally we will propose complex set of indicators which could be applied to Czech Air Navigation Service Provider.

  18. Safety climate and safety behavior in the passenger ferry context.

    Science.gov (United States)

    Lu, Chin-Shan; Yang, Chung-Shan

    2011-01-01

    This research empirically evaluates safety climate and safety behavior in the passenger ferry context. Using survey data collected from 155 respondents working for passenger ferry companies in Taiwan, hierarchical regression analysis was used to examine the effects of safety climate on self-reported safety behaviors. Confirmatory factor analysis identified five main dimensions of safety climate as measured on a passenger ferry safety climate scale: safety policy, safety motivation, emergency preparedness, safety training, and safety communication. Further, safety training and emergency preparedness were found to positively affect self-reported safety behaviors with respect to safety compliance and safety participation. The study also revealed positive associations among respondents' age, ferry capacity, and safety compliance. Implications of the study findings for increasing safety in ferry operations and their contribution to the development of safety management are discussed. Copyright © 2010 Elsevier Ltd. All rights reserved.

  19. Water safety and drowning

    Science.gov (United States)

    ... among people of all ages. Learning and practicing water safety is important to prevent drowning accidents. ... Water safety tips for all ages include: Learn CPR Never swim alone Never dive into water unless ...

  20. Gun Safety (For Parents)

    Science.gov (United States)

    ... Teaching Kids to Be Smart About Social Media Gun Safety KidsHealth > For Parents > Gun Safety Print A ... unloaded, and the ammunition should be stored separately. Guns and Pretend Play Allowing kids to play with ...

  1. Water Safety Quiz

    Science.gov (United States)

    ... Prepare for Emergencies Types of Emergencies Take the Water Safety Quiz Trivia quiz loading... Please enable javascript. Stay Safe Around Water Download water safety tips in English or Spanish ...

  2. Medicine safety and children

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/patientinstructions/000619.htm Medicine safety and children To use the sharing features ... especially careful if you have toddlers around. Keep Medicines out of Reach and Sight Safety tips: DO ...

  3. Refrigeration and Food Safety

    Science.gov (United States)

    ... Standard Forms FSIS United States Department of Agriculture Food Safety and Inspection Service About FSIS District Offices Careers ... Viewer (JSR 286) Actions ${title} Loading... Refrigeration and Food Safety History of Refrigeration Importance of Refrigeration Types of ...

  4. Fires and Food Safety

    Science.gov (United States)

    ... Standard Forms FSIS United States Department of Agriculture Food Safety and Inspection Service About FSIS District Offices Careers ... Viewer (JSR 286) Actions ${title} Loading... Fires and Food Safety Fire! Few words can strike such terror. Residential ...

  5. A predictable Java profile - rationale and implementations

    DEFF Research Database (Denmark)

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

    2009-01-01

    , 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......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...

  6. Electrical safety guidelines

    Energy Technology Data Exchange (ETDEWEB)

    1993-09-01

    The Electrical Safety Guidelines prescribes the DOE safety standards for DOE field offices or facilities involved in the use of electrical energy. It has been prepared to provide a uniform set of electrical safety standards and guidance for DOE installations in order to affect a reduction or elimination of risks associated with the use of electrical energy. The objectives of these guidelines are to enhance electrical safety awareness and mitigate electrical hazards to employees, the public, and the environment.

  7. DOE handbook electrical safety

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-01-01

    Electrical Safety Handbook presents the Department of Energy (DOE) safety standards for DOE field offices or facilities involved in the use of electrical energy. It has been prepared to provide a uniform set of electrical safety guidance and information for DOE installations to effect a reduction or elimination of risks associated with the use of electrical energy. The objectives of this handbook are to enhance electrical safety awareness and mitigate electrical hazards to employees, the public, and the environment.

  8. Safety of probiotics

    OpenAIRE

    Gueimonde, Miguel; Ouwehand, Arthur C.; Salminen, Seppo

    2004-01-01

    The use of probiotics in foods has increased significantly and there are more and more products available with high numbers of viable probiotics. This article reviews the safety information on probiotic microorganisms. A literature search and assessment of safety data on current probiotics were undertaken. No significant safety concerns for current probiotics were observed. The available data attest to the safety of Lactobacillus and Bifidobacterium probiotics. In conclusion, current probioti...

  9. Generic safety documentation model

    Energy Technology Data Exchange (ETDEWEB)

    Mahn, J.A.

    1994-04-01

    This document is intended to be a resource for preparers of safety documentation for Sandia National Laboratories, New Mexico facilities. It provides standardized discussions of some topics that are generic to most, if not all, Sandia/NM facilities safety documents. The material provides a ``core`` upon which to develop facility-specific safety documentation. The use of the information in this document will reduce the cost of safety document preparation and improve consistency of information.

  10. Prospective multicentre randomised, double-blind, equivalence study comparing clonidine and midazolam as intravenous sedative agents in critically ill children: the SLEEPS (Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedation) study.

    Science.gov (United States)

    Wolf, Andrew; McKay, Andrew; Spowart, Catherine; Granville, Heather; Boland, Angela; Petrou, Stavros; Sutherland, Adam; Gamble, Carrol

    2014-12-01

    Children in paediatric intensive care units (PICUs) require analgesia and sedation but both undersedation and oversedation can be harmful. Evaluation of intravenous (i.v.) clonidine as an alternative to i.v. midazolam. Multicentre, double-blind, randomised equivalence trial. Ten UK PICUs. Children (30 days to 15 years inclusive) weighing ≤ 50 kg, expected to require ventilation on PICU for > 12 hours. Clonidine (3 µg/kg loading then 0-3 µg/kg/hour) versus midazolam (200 µg/kg loading then 0-200 µg/kg/hour). Maintenance infusion rates adjusted according to behavioural assessment (COMFORT score). Both groups also received morphine. Primary end point Adequate sedation defined by COMFORT score of 17-26 for ≥ 80% of the time with a ± 0.15 margin of equivalence. Secondary end points Percentage of time spent adequately sedated, increase in sedation/analgesia, recovery after sedation, side effects and safety data. The study planned to recruit 1000 children. In total, 129 children were randomised, of whom 120 (93%) contributed data for the primary outcome. The proportion of children who were adequately sedated for ≥ 80% of the time was 21 of 61 (34.4%) - clonidine, and 18 of 59 (30.5%) - midazolam. The difference in proportions for clonidine-midazolam was 0.04 [95% confidence interval (CI) -0.13 to 0.21], and, with the 95% CI including values outside the range of equivalence (-0.15 to 0.15), equivalence was not demonstrated; however, the study was underpowered. Non-inferiority of clonidine to midazolam was established, with the only values outside the equivalence range favouring clonidine. Times to reach maximum sedation and analgesia were comparable hazard ratios: 0.99 (95% CI 0.53 to 1.82) and 1.18 (95% CI 0.49 to 2.86), respectively. Percentage time spent adequately sedated was similar [medians clonidine 73.8% vs. midazolam 72.8%: difference in medians 0.66 (95% CI -5.25 to 7.24)]. Treatment failure was 12 of 64 (18.8%) on clonidine and

  11. General safety considerations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-09-01

    This document presents the full filling of the Brazilian obligations under the Convention on Nuclear Safety. The Chapter 4 of the document contains some details about the priority to safety, financial and human resources, human factors, quality assurance, safety assessment and verification, radiation protection and emergency preparedness.

  12. General safety considerations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-09-01

    This document presents the full filling of the Brazilian obligations under the Convention on Nuclear Safety. The Chapter 4 of the document contains some details about the priority to safety, financial and human resources, human factors, quality assurance, safety assessment and verification, radiation protection and emergency preparedness.

  13. Revitalizing Nuclear Safety Research.

    Science.gov (United States)

    National Academy of Sciences - National Research Council, Washington, DC.

    This report covers the general issues involved in nuclear safety research and points out the areas needing detailed consideration. Topics included are: (1) "Principles of Nuclear Safety Research" (examining who should fund, who should conduct, and who should set the agenda for nuclear safety research); (2) "Elements of a Future…

  14. 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.

  15. 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 .

  16. Leadership and safety culture. Leadership for safety

    Energy Technology Data Exchange (ETDEWEB)

    Fischer, Erwin; Nithack, Eckhard [PreussenElektra GmbH, Hannover (Germany)

    2016-08-15

    The meaning of leadership for safety in the nuclear industry is pointed out. This topic has became an increasing rank since the German ''Energiewende''. Despite the phase-out of the German NPP's nuclear safety and the belonging safety culture needs to be well maintained. A challenge for the whole organisation. Following the challenge to operate nuclear power plants towards Operational Excellence a highly skilled and motivated organisation is needed. Therefore Leadership is a valuable success factor.

  17. 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

    2017-06-22

    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.

  18. Safety survives privatisation

    Energy Technology Data Exchange (ETDEWEB)

    Cunnigham, P. [Health and Safety Executive, Sheffield (United Kingdom)

    1995-01-01

    The privatisation of British Coal will have no effect on safety standards in the industry since the new companies will still be governed by the same safety regulations. The Health and Safety Executive does not just inspect, it relies also on information exchange, in the surface mining sector particularly through the quarries National Interest Group, since good health and safety working practices save money. Future trends include compliance with the European Community directives on health and safety, although much of this is covered already. 3 figs.

  19. Safety Study in Aviation

    Directory of Open Access Journals (Sweden)

    Marek Štumper

    2016-07-01

    Full Text Available The objective of this article is to provide a brief look at safety studies, which are a necessary part of every change of system or a new system in aviation. The main focus is put on the area of air traffic management, because it affects most of the aviation stakeholders. The article begins with a description of safety and safety assessment of changes in systems. Then it discusses analysis of processes, hazard identification and risk assessment. Main part focuses on Safety studies and briefly describes the elements of the study. At the end, possible ways of safety study evaluation are mentioned.

  20. Nuclear safety in perspective

    DEFF Research Database (Denmark)

    Andersson, K.; Sjöberg, B.M.D.; Lauridsen, Kurt

    2003-01-01

    The aim of the NKS/SOS-1 project has been to enhance common understanding about requirements for nuclear safety by finding improved means of communicat-ing on the subject in society. The project, which has been built around a number of seminars, wassupported by limited research in three sub......-projects: Risk assessment Safety analysis Strategies for safety management The report describes an industry in change due to societal factors. The concepts of risk and safety, safety management and systems forregulatory oversight are de-scribed in the nuclear area and also, to widen the perspective, for other...

  1. Design of a fifth generation air superiority fighter

    Science.gov (United States)

    Atique, Md. Saifuddin Ahmed; Barman, Shuvrodeb; Nafi, Asif Shahriar; Bellah, Masum; Salam, Md. Abdus

    2016-07-01

    Air Superiority Fighter is considered to be an effective dogfighter which is stealthy & highly maneuverable to surprise enemy along with improve survivability against the missile fire. This new generation fighter aircraft requires fantastic aerodynamics design, low wing loading (W/S), high thrust to weight ratio (T/W) with super cruise ability. Conceptual design is the first step to design an aircraft. In this paper conceptual design of an Air Superiority Fighter Aircraft is proposed to carry 1 crew member (pilot) that can fly at maximum Mach No of 2.3 covering a range of 1500 km with maximum ceiling of 61,000 ft. Payload capacity of this proposed aircraft is 6000 lb that covers two advanced missiles & one advanced gun. The Air Superiority Fighter Aircraft was designed to undertake all the following missions like: combat air petrol, air to air combat, maritime attack, close air support, suppression, destruction of enemy air defense and reconnaissance.

  2. Temporal Bone Fracture Causing Superior Semicircular Canal Dehiscence

    Directory of Open Access Journals (Sweden)

    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.

  3. 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.

  4. Isolated abscess in superior rectus muscle in a child

    Directory of Open Access Journals (Sweden)

    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.

  5. 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.

    2017-06-01

    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.

  6. 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).

  7. 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.

  8. 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.

  9. A note on some measures of profile agreement.

    Science.gov (United States)

    McCrae, Robert R

    2008-03-01

    Profile similarity or agreement is increasingly used in personality research and clinical practice and has potential applications in many other fields of psychology. I compared 4 measures of profile agreement--the Pearson r, Cattell's (1949) r(p), McCrae's (1993) r(pa), and an intraclass correlation coefficient (double entry), ICC(DE)--using both broad factor and specific facet profiles. Matched versus mismatched self-ratings/other ratings on the NEO Personality Inventory-3 (McCrae, Costa, & Martin, 2005) were used as criteria. At the factor level, r(pa) and ICC(DE) were comparable, and both were superior to r(p) in distinguishing matched versus mismatched profiles. At the facet level, ICC(DE) was superior to the other coefficients. The Pearson r performed better than expected.

  10. 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.

  11. 16 CFR Figure 9 to Subpart A of... - Flux Profile Data Log Format

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Flux Profile Data Log Format 9 Figure 9 to Subpart A of Part 1209 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT... to Subpart A of Part 1209—Flux Profile Data Log Format EC03OC91.039...

  12. Safety & Regulatory Strategy : Food Safety and Innovation

    NARCIS (Netherlands)

    Kalk, C.

    2013-01-01

    Food and feed safety is strictly regulated within the EU. Our team of toxicologists, risk assessors and consultants offers strategic advice and valuable expertise in regulatory affairs and health risk assessment.

  13. Safety in Cryogenics – Safety device sizing

    CERN Document Server

    CERN. Geneva

    2016-01-01

    The calculation is separated in three operations: o The estimation of the loads arriving on the component to protect, o The calculation of the mass flow to evacuate, o And the sizing of the safety device.

  14. Pediatric safety pin ingestion.

    Science.gov (United States)

    Sarihan, H; Kaklikkaya, I; Ozcan, F

    1998-08-01

    Fifteen consecutive children with ingested safety pins were evaluated retrospectively. Eight patients were males and seven were girls. The mean age of the patients was 5.4 years ranging from 7 months to 16 years. Two of 15 patients were mentally retarded Seven safety pins ingestion were noted by parents, three older children applied with safety pin swallowing. Three infants referred with hypersalivation and swallowing difficulty. One of two mentally retarded patients had recurrent aspiration pneumonia, the other had neck abscess. These patients' lesions were detected incidentally by thoracic X-ray. Nine safety pins were at the level of the cricopharyngeus, one at the level of the aortic arch and five at the esophagogastric junction. A right esophagoscopy was used for extraction of safety pins under general anesthesia and endotracheal intubation were used. Before esophagoscopy control plain X-ray was obtained for location of safety pin. Nine safety pins were extracted by esophagoscopy. Three safety pins spontaneously and three during anesthesia induction passed through the esophagus falling down the stomach. Five of these six safety pins were spontaneously extracted without complication. However one open safety pin lodged at the duodenum and laparotomy was required. In this article, etiology and management of safety pin ingestion in children are discussed.

  15. Patient Safety Culture

    DEFF Research Database (Denmark)

    Kristensen, Solvejg

    of health care professional’s behaviour, habits, norms, values, and basic assumptions related to patient care; it is the way things are done. The patient safety culture guides the motivation, commitment to and know-how of the safety management, and how all members of a work place interact. This thesis......Patient safety is highly prioritised in the Danish health care system, never the less, patients are still exposed to risk and harmed every day. Implementation of a patient safety culture has been suggested an effective mean to protect patients against adverse events. Working strategically...... with assessment and development of the patient safety culture is in early days in Denmark. It depends upon valid, reliable and effective methods. The patient safety culture represents a wide range of social phenomena permeating the way of life in a health care. In essence, the safety culture is an aggregation...

  16. The postdiction superiority effect in metacomprehension of text.

    Science.gov (United States)

    Pierce, B H; Smith, S M

    2001-01-01

    Metacomprehension accuracy for texts was greater after, rather than before, answering test questions about the texts-a postdiction superiority effect. Although postdiction superiority was found across successive sets of test questions and across successive texts, there was no improvement in metacomprehension accuracy after participants had taken more tests. Neither prediction nor postdiction gamma correlations with test performance improved with successive tests. Although the results are consistent with retrieval hypotheses, they contradict predictions made by test knowledge hypotheses, which state that increasing knowledge of the nature of the tests should increase metacomprehension accuracy.

  17. Imaging Evaluation of Superior Labral Anteroposterior (SLAP) Tears.

    Science.gov (United States)

    Grubin, Jeremy; Maderazo, Alex; Fitzpatrick, Darren

    2015-10-01

    Superior labral anteroposterior (SLAP) tears are common injuries that are best evaluated with magnetic resonance arthrography (MRA), as it provides the most detailed evaluation of the bicipital labral complex. Given the variety and complexity of SLAP tears, distention of the joint with intra-articular dilute gadolinium contrast properly separates the intra-articular biceps tendon, superior labrum, glenoid cartilage and glenohumeral ligaments to optimize assessment of these structures. This allows for increased diagnostic confidence of the interpreting radiologist and provides a better road map for the surgeon prior to arthroscopy. Indirect MRA and high-field magnetic resonance imaging are sensitive and specific alternative modalities if MRA cannot be performed.

  18. SUPERIOR MESENTERIC ARTERY SYNDROME - AN UNUSUAL CAUSE OF DUODENAL OBSTRUCTION

    OpenAIRE

    Sahu SK, , , , , , ,; Singh PK; Ray J; Uniyal M; Sharma C; Sekhar C; Kapruwan H; Sachan PK

    2012-01-01

    Superior mesenteric artery (SMA) arising from aorta at the level of first lumbar vertebra usually takes an angular downward course from ventral surface of aorta. It is through this vascular angle that the 3rd part of duodenum passes at the level of 4th lumbar vertebra. Fat and lymphatics around SMA maintains the angle at 25° to 60° with a mean of 450 and provide protection against duodenal compression. In Superior Mesenteric Artery Syndrome, the SMA-aorta angle in narrowed down to 7° to 22° w...

  19. 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%.

  20. Síndrome de veia cava superior Superior vena cava syndrome

    Directory of Open Access Journals (Sweden)

    SAMUEL ZUÍNGLIO DE BIASI CORDEIRO

    2002-09-01

    Full Text Available A obstrução ao fluxo sanguíneo na VCS e suas manifestações clínicas têm hoje como causa principal o câncer de pulmão. A história relata que no século XVIII a sífilis e a tuberculose eram responsáveis por 40% dos casos conhecidos. O conhecimento das alterações hemodinâmicas compreendidas nesta síndrome assim como a apuração das técnicas de diagnóstico de imagem e de citopatologia permitem hoje que o médico possa tratar de seu paciente com mais segurança e conforto do que há 10 anos. A TC contrastada e a RM auxiliam no diagnóstico de localização da obstrução e técnicas mais antigas como a cavografia puderam ser abandonadas. O diagnóstico de obstrução da VCS e o estudo por Doppler realizado à beira do leito em muito contribuem para a realização de procedimentos de desobstrução como a angioplastia transluminal percutânea nos casos de trombose ou estenose do vaso. Também a utilização de próteses como PTFE é de importância fundamental na condução de casos de lesão traumática da VCS durante cirurgias para câncer pulmonar ou mediastinal. No campo da radioterapia, a técnica de fracionamento permite que altas doses de irradiação sejam administradas aos pacientes portadores de neoplasias malignas, com benefícios em 70% dos casos.Lung cancer is now the main cause of blood flow obstruction in the superior vena cava and of its clinical manifestations. History tells that in the 18th Century, syphilis and tuberculosis were responsible for 40% of the known cases. The knowledge of hemodynamic changes seen in this syndrome and the improvement of diagnostic and cytopathologic techniques allow for a safer and more comfortable treatment of the patient than 10 years ago. Contrast CT and MR added to the identification and location of the obstruction, and older techniques such as cavography could be abandoned. SVC obstruction diagnosis and Doppler studies carried out at the bed of the patient contribute to

  1. Safety and the Human Factor.

    Science.gov (United States)

    Smith, Ann

    1982-01-01

    Discusses four elements of safety programs: (1) safety training; (2) safety inspections; (3) accident investigations; and (4) protective safety equipment. Also discusses safety considerations in water/wastewater treatment facilities focusing on falls, drowning hazards, trickling filters, confined space entry, collection/distribution system safety,…

  2. 16 CFR Figure 8 to Subpart A of... - Standard Radiant Heat Energy Flux Profile

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Standard Radiant Heat Energy Flux Profile 8 Figure 8 to Subpart A of Part 1209 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard Pt. 1209...

  3. Principles of safety pharmacology.

    Science.gov (United States)

    Pugsley, M K; Authier, S; Curtis, M J

    2008-08-01

    Safety Pharmacology is a rapidly developing discipline that uses the basic principles of pharmacology in a regulatory-driven process to generate data to inform risk/benefit assessment. The aim of Safety Pharmacology is to characterize the pharmacodynamic/pharmacokinetic (PK/PD) relationship of a drug's adverse effects using continuously evolving methodology. Unlike toxicology, Safety Pharmacology includes within its remit a regulatory requirement to predict the risk of rare lethal events. This gives Safety Pharmacology its unique character. The key issues for Safety Pharmacology are detection of an adverse effect liability, projection of the data into safety margin calculation and finally clinical safety monitoring. This article sets out to explain the drivers for Safety Pharmacology so that the wider pharmacology community is better placed to understand the discipline. It concludes with a summary of principles that may help inform future resolution of unmet needs (especially establishing model validation for accurate risk assessment). Subsequent articles in this issue of the journal address specific aspects of Safety Pharmacology to explore the issues of model choice, the burden of proof and to highlight areas of intensive activity (such as testing for drug-induced rare event liability, and the challenge of testing the safety of so-called biologics (antibodies, gene therapy and so on.).

  4. 78 FR 20423 - Oil and Gas and Sulphur Operations in the Outer Continental Shelf-Revisions to Safety and...

    Science.gov (United States)

    2013-04-05

    ... Management (PSM) program will provide a superior approach to attaining process safety compared to the SEMS approach. The commenters stated that if PSM data shows a significant and meaningful reduction in process safety accidents, BSEE should consider implementing PSM requirements or incorporate elements of such...

  5. The quality/safety medical index: implementation and analysis.

    Science.gov (United States)

    Reiner, Bruce I

    2015-02-01

    Medical analytics relating to quality and safety measures have become particularly timely and of high importance in contemporary medical practice. In medical imaging, the dynamic relationship between medical imaging quality and radiation safety creates challenges in quantifying quality or safety independently. By creating a standardized measurement which simultaneously accounts for quality and safety measures (i.e., quality safety index), one can in theory create a standardized method for combined quality and safety analysis, which in turn can be analyzed in the context of individual patient, exam, and clinical profiles. The derived index measures can be entered into a centralized database, which in turn can be used for comparative performance of individual and institutional service providers. In addition, data analytics can be used to create customizable educational resources for providers and patients, clinical decision support tools, technology performance analysis, and clinical/economic outcomes research.

  6. Efficacy and safety of alternating norfloxacin and rifaximin as primary prophylaxis for spontaneous bacterial peritonitis in cirrhotic ascites: a prospective randomized open-label comparative multicenter study.

    Science.gov (United States)

    Assem, M; Elsabaawy, M; Abdelrashed, M; Elemam, S; Khodeer, S; Hamed, W; Abdelaziz, A; El-Azab, G

    2016-03-01

    Primary prevention of spontaneous bacterial peritonitis (SBP) is an important strategy to reduce morbidity and mortality in cirrhotic patients with ascites. Efficacy and safety of alternating rifaximin and norfloxacin as primary prophylaxis is questionable. Three hundred thirty-four cirrhotic patients with high SAAG (≥1.1) ascites, protein level in ascitic fluid less than 1.5 g/dL with advanced liver disease (Child-Pugh score >9 points with serum bilirubin level >3 mg/dL) or renal impairment (serum creatinine level >1.2 mg/dL, blood urea nitrogen level >25 mg/dL, or serum sodium level norfloxacin and rifaximin vs. norfloxacin or rifaximin alone as primary prophylaxis for SBP. Both intention-to-treat and per-protocol efficacy analyses were done after 6 months of treatment by assessment of ascitic fluid neutrophil count. Safety analysis was done for all intention-to-treat populations. Alternating norfloxacin and rifaximin showed superior prophylaxis by intention-to-treat (74.7 vs. 56.4% vs. 68.3%, p norfloxacin-based regimen in intention-to-treat (p = 0.016) and per protocol analysis (p = 0.039). There was no difference among the studied groups regarding the incidence and severity of adverse events reported. Alternating norfloxacin- and rifaximin-based primary prophylaxis for SBP showed higher efficacy with the same safety profile when compared with monotherapy of norfloxacin.

  7. Biological Motion Task Performance Predicts Superior Temporal Sulcus Activity

    Science.gov (United States)

    Herrington, John D.; Nymberg, Charlotte; Schultz, Robert T.

    2011-01-01

    Numerous studies implicate superior temporal sulcus (STS) in the perception of human movement. More recent theories hold that STS is also involved in the "understanding" of human movement. However, almost no studies to date have associated STS function with observable variability in action understanding. The present study directly associated STS…

  8. O MARKETING NO ENSINO SUPERIOR: COMPARATIVO BRASIL-PORTUGAL

    Directory of Open Access Journals (Sweden)

    Helena Alves

    2010-12-01

    Full Text Available Ao abordar o marketing aplicado ao ensino superior, este estudo tem como objetivos discutir os conceitos teóricos do marketing educacional e aplicálos aos contextos brasileiro e português. Tendo em consideração que o marketing educacional tem a sua maior expressão nos E.U.A., a sua aplicação a diferentes realidades e culturas requer adaptações. Inicialmente, fez-se uma revisão dos conceitos tradicionais de marketing educacional, com ênfase nas vantagens, desvantagens e no marketing-mix aplicado à educação. Posteriormente realizou-se uma caraterização dos contextos atuais do ensino superior no Brasil e em Portugal, e fez-se uma comparação da aplicação do marketing educacional nas realidades brasileira e portuguesa, focando as análises no marketing-mix educacional. Percebeu-se que o ensino superior no Brasil tem caraterísticas muito diversas do ensino superior em Portugal e ambos divergem na aplicação dos conceitos mais tradicionais do marketing à educação. Desta forma, faz-se necessária a construção de abordagens teóricas específicas para a aplicação do marketing educacional a diferentes nações.

  9. Organizational Self-Awareness in the Key to Knowledge Superiority

    Science.gov (United States)

    2015-12-01

    a divisionalized bureaucracy (Mintzberg 1981). Designed as an innovation center, it is responsible for, among other things, forecasting and...the system, which prioritizes the needs and selection criteria for that system. 14. SUBJECT TERMS knowledge superiority, innovation , organizational...competitive advantage, knowledge is the critical element needed for any organization to innovate and succeed (Porter and Millar 1985). Its timely and

  10. Radiologic classification of superior canal dehiscence : Implications for surgical repair

    NARCIS (Netherlands)

    Lookabaugh, Sarah; Kelly, Hillary R.; Carter, Margaret S.; Niesten, Marlien E F; McKenna, Michael J.; Curtin, Hugh; Lee, Daniel J.

    2015-01-01

    Objective: Surgical access to repair a superior canal dehiscence (SCD) is influenced by the location of the bony defect and its relationship to surrounding tegmen topography as seen on computed tomography. There are currently no agreed-upon methods of characterizing these radiologic findings. We

  11. Mnemonic Training Reshapes Brain Networks to Support Superior Memory

    NARCIS (Netherlands)

    Dresler, M.; Shirer, W.R.; Konrad, B.N.; Muller, N.C.J.; Wagner, I.; Fernandez, G.S.E.; Czisch, M.; Greicius, M.D.

    2017-01-01

    Memory skills strongly differ across the general population; however, little is known about the brain characteristics supporting superior memory performance. Here we assess functional brain network organization of 23 of the world's most successful memory athletes and matched controls with fMRI

  12. Perturbation resilience and superiorization methodology of averaged mappings

    Science.gov (United States)

    He, Hongjin; Xu, Hong-Kun

    2017-04-01

    We first prove the bounded perturbation resilience for the successive fixed point algorithm of averaged mappings, which extends the string-averaging projection and block-iterative projection methods. We then apply the superiorization methodology to a constrained convex minimization problem where the constraint set is the intersection of fixed point sets of a finite family of averaged mappings.

  13. Measurement of ocular torsion variation following superior oblique tenectomy

    Directory of Open Access Journals (Sweden)

    Bruna Lana Ducca

    2014-12-01

    Full Text Available Purposes: To objectively evaluate the torsional effect of the superior oblique muscle-weakening surgery using the tenectomy technique proposed by Souza-Dias. Methods: The present prospective study included 10 patients (20 eyes with horizontal strabismus, bilateral superior oblique overaction and A-pattern of 15 to 30 prism diopters who underwent superior oblique tenectomy. Objective assessment of ocular torsion was performed by retinography immediately before and one month after surgery. The amount of ocular torsion was determined by measuring the angle formed by a horizontal line drawn across the geometric center of the optic disc and a second line connecting this point to the fovea. Results: The median preoperative angle was 5.56° in the right eyes and -3.43° in the left eyes. The median postoperative angle was 1.84° in the right eyes and -3.12° in the left eyes. The angle variation was statistically significant in both eyes (p=0.012 and p=0.01, respectively. Conclusion: The present study suggests that superior oblique tenectomy has an extorter effect, decreasing the intorsion detected on overaction of this muscle.

  14. Superior Mesenteric Artery Syndrome in a Young Military Basic Trainee

    Science.gov (United States)

    2013-03-01

    patients with severe anorexia nervosa .10 Severe cases may require surgery or parenteral feeding because of food avoidance leading to further loss of...2012. 10. Gwee K, Teh A, Huang C: Acute superior mesenteric artery syndrome and pancreatitis in anorexia nervosa . Australas Psychiatry 2010; 18(6): 523

  15. Morphological variation of siscowet lake trout in Lake Superior

    Science.gov (United States)

    Bronte, C.R.; Moore, S.A.

    2007-01-01

    Historically, Lake Superior has contained many morphologically distinct forms of the lake trout Salvelinus namaycush that have occupied specific depths and locations and spawned at specific times of the year. Today, as was probably the case historically, the siscowet morphotype is the most abundant. Recent interest in harvesting siscowets to extract oil containing omega-3 fatty acids will require additional knowledge of the biology and stock structure of these lightly exploited populations. The objective of this study was to determine whether shape differences exist among siscowet populations across Lake Superior and whether these shape differences can be used to infer stock structure. Morphometric analysis (truss protocol) was used to differentiate among siscowets sampled from 23 locations in Lake Superior. We analyzed 31 distance measurements among 14 anatomical landmarks taken from digital images of fish recorded in the field. Cluster analysis of size-corrected data separated fish into three geographic groups: The Isle Royale, eastern (Michigan), and western regions (Michigan). Finer scales of stock structure were also suggested. Discriminant function analysis demonstrated that head measurements contributed to most of the observed variation. Cross-validation classification rates indicated that 67–71% of individual fish were correctly classified to their region of capture. This is the first study to present shape differences associated with location within a lake trout morphotype in Lake Superior.

  16. El contexto virtual en la educación superior

    National Research Council Canada - National Science Library

    Vera Quintana, Mercedes

    2015-01-01

    ... técnicos, organizativos y metodológicos, por tanto, la virtualización de la educación superior durante su relativa corta vida, ha sido ese nuevo paradigma educativo resultante del uso de las tecnologías...

  17. 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.

  18. The effect of superior auditory skills on vocal accuracy

    Science.gov (United States)

    Amir, Ofer; Amir, Noam; Kishon-Rabin, Liat

    2003-02-01

    The relationship between auditory perception and vocal production has been typically investigated by evaluating the effect of either altered or degraded auditory feedback on speech production in either normal hearing or hearing-impaired individuals. Our goal in the present study was to examine this relationship in individuals with superior auditory abilities. Thirteen professional musicians and thirteen nonmusicians, with no vocal or singing training, participated in this study. For vocal production accuracy, subjects were presented with three tones. They were asked to reproduce the pitch using the vowel /a/. This procedure was repeated three times. The fundamental frequency of each production was measured using an autocorrelation pitch detection algorithm designed for this study. The musicians' superior auditory abilities (compared to the nonmusicians) were established in a frequency discrimination task reported elsewhere. Results indicate that (a) musicians had better vocal production accuracy than nonmusicians (production errors of 1/2 a semitone compared to 1.3 semitones, respectively); (b) frequency discrimination thresholds explain 43% of the variance of the production data, and (c) all subjects with superior frequency discrimination thresholds showed accurate vocal production; the reverse relationship, however, does not hold true. In this study we provide empirical evidence to the importance of auditory feedback on vocal production in listeners with superior auditory skills.

  19. Visuospatial Superiority in Developmental Dyslexia: Myth or Reality?

    Science.gov (United States)

    Brunswick, Nicola; Martin, G. Neil; Marzano, Lisa

    2010-01-01

    Anecdotal evidence indicates that dyslexia is positively associated with superior visuospatial ability but empirical evidence is inconsistent. We explicitly tested the hypothesis that dyslexia is associated with visuospatial advantage in 20 dyslexic and 21 unimpaired adult readers using paper-and-pencil measures and tests of "everyday"…

  20. Early detection of non-indigenous fishes in Lake Superior

    Science.gov (United States)

    Invasive species pose a serious threat to the ecological stability of the Great Lakes warranting continual monitoring for the arrival of new species. Three locations in Lake Superior were identified as “high risk” for new introductions: St. Louis River near Duluth, M...

  1. Preference for concentric orientations in the mouse superior colliculus

    NARCIS (Netherlands)

    Ahmadlou, Mehran; Heimel, J Alexander

    2015-01-01

    The superior colliculus is a layered structure important for body- and gaze-orienting responses. Its superficial layer is, next to the lateral geniculate nucleus, the second major target of retinal ganglion axons and is retinotopically organized. Here we show that in the mouse there is also a

  2. Funciones superiores en pacientes con accidente cerebro vascular

    National Research Council Canada - National Science Library

    Felipe Rodríguez; Alfonso Urzúa

    2009-01-01

    .... Con base a esto el objetivo de esta investigación fue elaborar un perfil de deterioro neuropsicológico de las diversas funciones cerebrales superiores causado por un ACV, en un grupo de 50 pacientes de la Unidad de Medicina...

  3. Absence of the superior petrosal veins and sinus: Surgical considerations

    Directory of Open Access Journals (Sweden)

    Ken Matsushima

    2015-01-01

    Conclusions: In cases in which the superior petrosal sinus and veins are absent, care should be directed to preserving the collateral drainage through the galenic and tentorial tributaries. Although surgical strategies for intraoperative management and preservation of venous structures are still controversial, knowledge of the possible anatomical variations is considered to be essential to improve surgical outcomes.

  4. Safety of Topical Dermatologic Medications in Pregnancy.

    Science.gov (United States)

    Patel, Viral M; Schwartz, Robert A; Lambert, W Clark

    2016-07-01

    Dermatologic drugs should be employed with caution in women of childbearing age who are pregnant or considering pregnancy. Topical drugs have little systemic absorption. Therefore, they are deemed safer than oral or parenteral agents and less likely to harm the fetus. However, their safety profile must be assessed cautiously, as there is limited available data. In this article, we aggregate human and animal studies and provide recommendations on using topical dermatologic medications in pregnancy. J Drugs Dermatol. 2016;15(7):830-834.

  5. Formal Safety versus Real Safety: Quantitative and Qualitative Approaches to Safety Culture – Evidence from Estonia

    Directory of Open Access Journals (Sweden)

    Järvis Marina

    2016-10-01

    Full Text Available This paper examines differences between formal safety and real safety in Estonian small and medium-sized enterprises. The results reveal key issues in safety culture assessment. Statistical analysis of safety culture questionnaires showed many organisations with an outstanding safety culture and positive safety attitudes. However, qualitative data indicated some important safety weaknesses and aspects that should be included in the process of evaluation of safety culture in organisations.

  6. 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

    2016-01-01

    ABSTRACT 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. PMID:27565435

  7. Lake Superior supports novel clusters of cyanobacterial picoplankton.

    Science.gov (United States)

    Ivanikova, Natalia V; Popels, Linda C; McKay, R Michael L; Bullerjahn, George S

    2007-06-01

    Very little is known about the biodiversity of freshwater autotrophic picoplankton (APP) in the Laurentian Great Lakes, a system comprising 20% of the world's lacustrine freshwater. In this study, the genetic diversity of Lake Superior APP was examined by analyzing 16S rRNA gene and cpcBA PCR amplicons from water samples. By neighbor joining, the majority of 16S rRNA gene sequences clustered within the "picocyanobacterial clade" consisting of freshwater and marine Synechococcus and Prochlorococcus. Two new groups of Synechococcus spp., the pelagic Lake Superior clusters I and II, do not group with any of the known freshwater picocyanobacterial clusters and were the most abundant species (50 to 90% of the sequences) in samples collected from offshore Lake Superior stations. Conversely, at station Portage Deep (PD), located in a nearshore urbanized area, only 4% of the sequences belonged to these clusters and the remaining clones reflected the freshwater Synechococcus diversity described previously at sites throughout the world. Supporting the 16S rRNA gene data, the cpcBA library from nearshore station PD revealed a cosmopolitan diversity, whereas the majority of the cpcBA sequences (97.6%) from pelagic station CD1 fell within a unique Lake Superior cluster. Thus far, these picocyanobacteria have not been cultured, although their phylogenetic assignment suggests that they are phycoerythrin (PE) rich, consistent with the observation that PE-rich APP dominate Lake Superior picoplankton. Lastly, flow cytometry revealed that the summertime APP can exceed 10(5) cells ml-1 and suggests that the APP shifts from a community of PE and phycocyanin-rich picocyanobacteria and picoeukaryotes in winter to a PE-rich community in summer.

  8. Safety advice sheets

    CERN Multimedia

    HSE Unit

    2013-01-01

    You never know when you might be faced with questions such as: when/how should I dispose of a gas canister? Where can I find an inspection report? How should I handle/store/dispose of a chemical substance…?   The SI section of the DGS/SEE Group is primarily responsible for safety inspections, evaluating the safety conditions of equipment items, premises and facilities. On top of this core task, it also regularly issues “Safety Advice Sheets” on various topics, designed to be of assistance to users but also to recall and reinforce safety rules and procedures. These clear and concise sheets, complete with illustrations, are easy to display in the appropriate areas. The following safety advice sheets have been issued so far: Other sheets will be published shortly. Suggestions are welcome and should be sent to the SI section of the DGS/SEE Group. Please send enquiries to general-safety-visits.service@cern.ch.

  9. Safety objectives for 2014

    CERN Multimedia

    HSE Unit

    2014-01-01

    This is the third year in which the CERN Management has presented annual safety objectives for the Organization, the “HSE Objectives”.   The HSE objectives for 2014, which were announced by the Director-General at his traditional New Year’s address to the staff and were presented at the first Enlarged Directorate meeting of the year, have been drawn up and agreed in close collaboration between the DSOs, the HSE Unit and the DG himself. From safety in the workplace to radiation and environmental protection, the document emphasises that “Safety is a priority for CERN” and that safety policy is a key element in how the Organization is run. And, like all policies, it generates objectives that “serve as a general framework for action”. The HSE objectives are broken down into the following fields: occupational health and safety on sites and in the workplace, radiation protection, radiation safety, environmental protection, emerge...

  10. Reliability and safety engineering

    CERN Document Server

    Verma, Ajit Kumar; Karanki, Durga Rao

    2016-01-01

    Reliability and safety are core issues that must be addressed throughout the life cycle of engineering systems. Reliability and Safety Engineering presents an overview of the basic concepts, together with simple and practical illustrations. The authors present reliability terminology in various engineering fields, viz.,electronics engineering, software engineering, mechanical engineering, structural engineering and power systems engineering. The book describes the latest applications in the area of probabilistic safety assessment, such as technical specification optimization, risk monitoring and risk informed in-service inspection. Reliability and safety studies must, inevitably, deal with uncertainty, so the book includes uncertainty propagation methods: Monte Carlo simulation, fuzzy arithmetic, Dempster-Shafer theory and probability bounds. Reliability and Safety Engineering also highlights advances in system reliability and safety assessment including dynamic system modeling and uncertainty management. Cas...

  11. Lisdexamfetamine dimesylate in the treatment of attention-deficit/hyperactivity disorder: pharmacokinetics, efficacy and safety in children and adolescents

    Directory of Open Access Journals (Sweden)

    Paulo Mattos

    2014-03-01

    Full Text Available Background Psychostimulants (methylphenidate and amphetamines are considered first-line therapy for attention-deficit/hyperactivity disorder (ADHD. Lisdexamfetamine dimesylate (LDX is a new psychostimulant approved for the treatment of ADHD in Brazil. The pharmacologically active fraction, d-amphetamine, is gradually released by hydrolysis of the LDX prodrug. Objectives To perform a systematic review of the literature of the efficacy and safety of LDX in the treatment of ADHD in children and adolescents. Methods Medline/PubMed searches for “d-amfetamine”, “lisdexamfetamine” and “lisdexamfetamine dimesylate” were conducted including articles available from January 2000 to November 2013. Additional references were identified using references listed in those articles. Further data on LDX were requested from its manufacturer. Results Thirty-one papers were found related to ADHD treatment in children and adolescents. Discussion The therapeutic benefits of LDX in children with ADHD are achieved as early as 1.5 hours after its administration and last for up to 13 hours, with efficacy comparable or superior to that of other available psychostimulants. The literature also reports efficacy in long-term treatment, with safety and tolerability profiles comparable to those of other stimulants used for the treatment of ADHD. Most of the adverse events associated with LDX are considered to be mild or moderate in severity, with the most common being loss of appetite and insomnia.

  12. TWRS safety management plan

    Energy Technology Data Exchange (ETDEWEB)

    Popielarczyk, R.S., Westinghouse Hanford

    1996-08-01

    The Tank Waste Remediation System (TWRS) Safety Management Program Plan for development, implementation and maintenance of the tank farm authorization basis is described. The plan includes activities and procedures for: (a) Updating the current Interim Safety Basis, (b) Development,implementation and maintenance of a Basis for Interim Operations, (c) Development, implementation and maintenance of the Final Safety Analyses Report, (d) Development and implementation of a TWRS information Management System for monitoring the authorization basis.

  13. Hydrogen Technologies Safety Guide

    Energy Technology Data Exchange (ETDEWEB)

    Rivkin, C. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Burgess, R. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Buttner, W. [National Renewable Energy Lab. (NREL), Golden, CO (United States)

    2015-01-01

    The purpose of this guide is to provide basic background information on hydrogen technologies. It is intended to provide project developers, code officials, and other interested parties the background information to be able to put hydrogen safety in context. For example, code officials reviewing permit applications for hydrogen projects will get an understanding of the industrial history of hydrogen, basic safety concerns, and safety requirements.

  14. Food Safety & Standards

    Institute of Scientific and Technical Information of China (English)

    2005-01-01

    @@ An increasing number of people have realized that food safety is an important issue for public health. It not only concerns public health and safety, but also has direct influence on national economic progress and social development. The development and implementation of food safety standards play a vital role in protecting public health, as well as in standardizing and facilitating the sound development of food production and business.

  15. Principles of electrical safety

    CERN Document Server

    Sutherland, Peter E

    2015-01-01

    Principles of Electrical Safety discusses current issues in electrical safety, which are accompanied by series' of practical applications that can be used by practicing professionals, graduate students, and researchers. .  Provides extensive introductions to important topics in electrical safety Comprehensive overview of inductance, resistance, and capacitance as applied to the human body Serves as a preparatory guide for today's practicing engineers

  16. Thermal reactor safety

    Energy Technology Data Exchange (ETDEWEB)

    1980-06-01

    Information is presented concerning new trends in licensing; seismic considerations and system structural behavior; TMI-2 risk assessment and thermal hydraulics; statistical assessment of potential accidents and verification of computational methods; issues with respect to improved safety; human factors in nuclear power plant operation; diagnostics and activities in support of recovery; LOCA transient analysis; unresolved safety issues and other safety considerations; and fission product transport.

  17. COMPENDEX Profiling Guide.

    Science.gov (United States)

    Standera, Oldrich

    This manual provides instructions for completing the COMPENDEX (Computerized Engineering Index) Profile Submission Form used to prepare Current Information Selection (CIS) profiles. An annotated bibliography lists nine items useful in searching for proper profile words. (AB)

  18. A study on urban road traffic safety based on matter element analysis.

    Science.gov (United States)

    Hu, Qizhou; Zhou, Zhuping; Sun, Xu

    2014-01-01

    This paper examines a new evaluation of urban road traffic safety based on a matter element analysis, avoiding the difficulties found in other traffic safety evaluations. The issue of urban road traffic safety has been investigated through the matter element analysis theory. The chief aim of the present work is to investigate the features of urban road traffic safety. Emphasis was placed on the construction of a criterion function by which traffic safety achieved a hierarchical system of objectives to be evaluated. The matter element analysis theory was used to create the comprehensive appraisal model of urban road traffic safety. The technique was used to employ a newly developed and versatile matter element analysis algorithm. The matter element matrix solves the uncertainty and incompatibility of the evaluated factors used to assess urban road traffic safety. The application results showed the superiority of the evaluation model and a didactic example was included to illustrate the computational procedure.

  19. Bathroom safety - children

    Science.gov (United States)

    ... sure your child's daycare also follows these guidelines. Images Child safety References American Academy of Pediatrics: Committee on Injury, Violence, and Poison Prevention. Policy statement -- prevention of drowning. ...

  20. Light water reactor safety

    CERN Document Server

    Pershagen, B

    2013-01-01

    This book describes the principles and practices of reactor safety as applied to the design, regulation and operation of light water reactors, combining a historical approach with an up-to-date account of the safety, technology and operating experience of both pressurized water reactors and boiling water reactors. The introductory chapters set out the basic facts upon which the safety of light water reactors depend. The central section is devoted to the methods and results of safety analysis. The accidents at Three Mile Island and Chernobyl are reviewed and their implications for light wate

  1. Safety Study in Aviation

    OpenAIRE

    2016-01-01

    The objective of this article is to provide a brief look at safety studies, which are a necessary part of every change of system or a new system in aviation. The main focus is put on the area of air traffic management, because it affects most of the aviation stakeholders. The article begins with a description of safety and safety assessment of changes in systems. Then it discusses analysis of processes, hazard identification and risk assessment. Main part focuses on Safety studies and briefly...

  2. Lift truck safety review

    Energy Technology Data Exchange (ETDEWEB)

    Cadwallader, L.C.

    1997-03-01

    This report presents safety information about powered industrial trucks. The basic lift truck, the counterbalanced sit down rider truck, is the primary focus of the report. Lift truck engineering is briefly described, then a hazard analysis is performed on the lift truck. Case histories and accident statistics are also given. Rules and regulations about lift trucks, such as the US Occupational Safety an Health Administration laws and the Underwriter`s Laboratories standards, are discussed. Safety issues with lift trucks are reviewed, and lift truck safety and reliability are discussed. Some quantitative reliability values are given.

  3. Improved safety at CERN

    CERN Multimedia

    2006-01-01

    As announced in Weekly Bulletin No. 43/2006, a new approach to the implementation of Safety at CERN has been decided, which required taking some managerial decisions. The guidelines of the new approach are described in the document 'New approach to Safety implementation at CERN', which also summarizes the main managerial decisions I have taken to strengthen compliance with the CERN Safety policy and Rules. To this end I have also reviewed the mandates of the Safety Commission and the Safety Policy Committee (SAPOCO). Some details of the document 'Safety Policy at CERN' (also known as SAPOCO42) have been modified accordingly; its essential principles, unchanged, remain the basis for the safety policy of the Organisation. I would also like to inform you that I have appointed Dr M. Bona as the new Head of the Safety Commission until 31.12.2008, and that I will proceed soon to the appointment of the members of the new Safety Policy Committee. All members of the personnel are deemed to have taken note of the d...

  4. FOOD SAFETY TESTING LABORATORY

    Data.gov (United States)

    Federal Laboratory Consortium — This laboratory develops screening assays, tests and modifies biosensor equipment, and optimizes food safety testing protocols for the military and civilian sector...

  5. Training safely, Training safety

    Directory of Open Access Journals (Sweden)

    Jianjun Wu

    2014-09-01

    Full Text Available It is the basic requirement of maritime safety education to guarantee the safety of teaching operation while training the crew's occupation safety capability. Marine Training Center of Shanghai Maritime University has undertaken the practical teaching of "marine survival" for many years and come up with the whole safety procedures of training. Based on the requirements of SOLAS convention and regulations of STCW over crew training, this paper introduces the safety allocation, utilization and maintenance of teaching equipments. Through the investigation of the safety situation of students' practical operation, the safety teaching method named "four in one" has been put forward, which includes the pre-teaching safety precaution, the whole monitor during the teaching process, the post-teaching summary evaluation, and the reset and standby of teaching facilities. Finally, during the learning and training of "marine survival", crews and students are called on to place priority on personal safety rather than acquisition of knowledge and skills. Only in this way can they be capable of self-protection and protection of others in the career of seafaring.

  6. Evaluation of safety profile of homoeopathic mother tinctures

    Directory of Open Access Journals (Sweden)

    Surender Singh

    2014-01-01

    Methods: Toxicity studies were conducted to assess the level to which substances are toxic for humans and animals. In acute oral toxicity study, different homoeopathic mother tinctures were administered orally (a single dose of 4 ml/kgand animals were observed for toxic symptoms till 14 days as per OECD (Organisation for Economic Co-operation and Development - 423 guidelines. For sub-acute toxicity study, 28 day oral toxicity of mother tinctures (4 ml/kg daily was carried out according to the OECD guidelines for testing of chemicals - 407. At the end of 28 days, the animals were sacrificed and toxicity was assessed on parameters such as blood, biochemistry and histopathology. Results: Results indicate that there were no toxic symptoms observed in tested animals. Results of sub-acute toxicity study did not show any change in body weight, haematological and biochemical parameters as compared to control. The histopathological examination of kidney and liver also did not reveal any organ toxicities.

  7. Nanoparticles skin absorption: New aspects for a safety profile evaluation.

    Science.gov (United States)

    Larese Filon, Francesca; Mauro, Marcella; Adami, Gianpiero; Bovenzi, Massimo; Crosera, Matteo

    2015-07-01

    Nanoparticles (NPs) skin absorption is a wide issue, which needs to be better understood. The attempt of this review is to summarize the scientific evidence concerning open questions, i.e.: the role of NPs intrinsic characteristics (size, shape, charge, surface properties), the penetration of NPs through the intact or impaired skin barrier, the penetration pathways which should be considered and the role of NPs interaction in physiological media. The outcomes suggest that one main difference should be made between metal and non-metal NPs. Both kinds have a secondary NPs size which is given after interaction in physiological media, and allows a size-dependent skin penetration: NPs⩽4nm can penetrate and permeate intact skin, NPs size between 4 and 20nm can potentially permeate intact and damaged skin, NPs size between 21 and 45nm can penetrate and permeate only damaged skin, NPs size>45nm cannot penetrate nor permeate the skin. Other aspects play an important role, mostly for metal NPs, i.e., dissolution in physiological media, which can cause local and systemic effects, the sensitizing or toxic potential and the tendency to create aggregates. This paper suggests a decision tree to evaluate the potential risk for consumers and workers exposed to NPs.

  8. Exploitation of molecular profiling techniques for GM food safety assessment

    NARCIS (Netherlands)

    Kuiper, H.A.; Kok, E.J.; Engel, K.H.

    2003-01-01

    Several strategies have been developed to identify unintended alterations in the composition of genetically modified (GM) food crops that may occur as a result of the genetic modification process. These include comparative chemical analysis of single compounds in GM food crops and their conventional

  9. Profiles in patient safety: when an error occurs.

    Science.gov (United States)

    Hobgood, Cherri; Hevia, Armando; Hinchey, Paul

    2004-07-01

    Medical error is now clearly established as one of the most significant problems facing the American health care system. Anecdotal evidence, studies of human cognition, and analysis of high-reliability organizations all predict that despite excellent training, human error is unavoidable. When an error occurs and is recognized, providers have a duty to disclose the error. Yet disclosure of error to patients, families, and hospital colleagues is a difficult and/or threatening process for most physicians. A more thorough understanding of the ethical and social contract between physicians and their patients as well as the professional milieu surrounding an error may improve the likelihood of its disclosure. Key among these is the identification of institutional factors that support disclosure and recognize error as an unavoidable part of the practice of medicine. Using a case-based format, this article focuses on the communication of error with patients, families, and colleagues and grounds error disclosure in the cultural milieu of medial ethics.

  10. Safety profile of amateur kickboxing among military and civilian competitors.

    Science.gov (United States)

    Buse, George J; Wood, Robert M

    2006-05-01

    The purpose of this study was to identify match-ending injuries in amateur kickboxing (KB) among military and civilian competitors. A total of 148 competitors, of whom 5 were on active duty in the U.S. Air Force or Marine Corps, participated in amateur KB matches (N = 74) from 1999 to 2001. Match-ending injuries were observed and managed from ringside by one author (G.J.B.). Of all matches, 23 (31.1%) were stopped because of injury. Of the 23 matches, 15 (65.2%) ended because of traumatic brain injury, 4 (17.4%) because of orthopedic trauma, 3 (13.0%) because of thoracoabdominal trauma, and 1 (4.4%) because of ocular trauma. The incidence of traumatic brain injury was greater than that of all other match-ending injuries combined (p < 0.01). Because of the incidence and potentially serious sequelae of injuries associated with competitive KB, military commanders should exercise operational risk management in an attempt to safeguard personnel from unnecessary hazard.

  11. Exploitation of molecular profiling techniques for GM food safety assessment

    NARCIS (Netherlands)

    Kuiper, H.A.; Kok, E.J.; Engel, K.H.

    2003-01-01

    Several strategies have been developed to identify unintended alterations in the composition of genetically modified (GM) food crops that may occur as a result of the genetic modification process. These include comparative chemical analysis of single compounds in GM food crops and their conventional

  12. Safety profile of grepafloxacin compared with other fluoroquinolones

    National Research Council Canada - National Science Library

    Stahlmann, R; Schwabe, R

    1997-01-01

    .... The photosensitizing effect of grepafloxacin was relatively weak and similar to that of ciprofloxacin. Grepafloxacin did not cause convulsions in mice when administered in conjunction with the non-steroidal anti-inflammatory drug fenbufen...

  13. Clozapine safety, 35 years later.

    Science.gov (United States)

    Raja, Michele

    2011-07-01

    Clozapine is the best treatment option in several clinical circumstances, including treatment-resistant schizophrenia, non treatment-resistant schizophrenia, suicide risk in schizophrenia spectrum disorders, aggressiveness or violence in psychiatric patients, psychosis in Parkinson's disease, prevention and treatment of tardive dyskinesia. However, clozapine is associated with many serious side effects. Furthermore, monitoring requirements, i.e., frequent blood draws and frequent visits, discourage clozapine use. Therefore, the drug is underused. The only way to avoid the underuse of clozapine is full awareness of its side effects and competence to minimize them. The aim of the paper is reviewing the safety profile of clozapine and the suggested strategies in the management of its side effects, including neutropenia, eosinophilia, seizures, myocarditis, weight gain, diabetes, metabolic syndrome, hypersalivation, fever, constipation, ileus, urinary incontinence, sweating. The neuropsychiatric side effects of clozapine are not discussed in this review.

  14. Tolerance and safety of enalapril.

    Science.gov (United States)

    McFate Smith, W; Davies, R O; Gabriel, M A; Kramsch, D M; Moncloa, F; Rush, J E; Walker, J F

    1984-01-01

    Enalapril is the result of a targeted research programme to develop a non-mercapto converting enzyme inhibitor with a long duration of action and an improved safety profile for use in the therapy of hypertension and congestive heart failure. Over 3500 patients world-wide have received enalapril or enalaprilat. Long-term experience at present includes over 2500 patients. While enalapril and captopril produce similar efficacy, enalapril is better tolerated and appears not to be associated with occurrence of captopril-type side-effects, particularly the skin rash, taste loss, leukopenia and proteinuria. Enalapril and other converting enzyme inhibitors may be associated with renal insufficiency when given to patients with bilateral renovascular hypertension.

  15. Bioaccumulation of toxaphene congeners in the lake superior food web

    Science.gov (United States)

    Muir, D.C.G.; Whittle, D.M.; De Vault, D. S.; Bronte, C.R.; Karlsson, H.; Backus, S.; Teixeira, C.

    2004-01-01

    The bioaccumulation and biotransformation of toxaphene was examined in the food webs of Lake Superior and Siskiwit Lake (Isle Royale) using congener specific analysis as well as stable isotope ratios of carbon and nitrogen to characterize food webs. Toxaphene concentrations (calculated using technical toxaphene) in lake trout (Salvelinus namaycush) from the western basin of Lake Superior (N = 95) averaged (±SD) 889 ± 896 ng/g wet wt and 60 ± 34 ng/g wet wt in Siskiwit Lake. Major congeners in lake trout were B8-789 (P38), B8-2226 (P44), B9-1679 (P50), and B9-1025 (P62). Toxaphene concentrations were found to vary seasonally, especially in lower food web organisms in Lake Superior and to a lesser extent in Siskiwit Lake. Toxaphene concentrations declined significantly in lake herring (Coregonus artedii), rainbow smelt (Omerus mordax), and slimy sculpin (Cottus cognatus) as well as in zooplankton (> 102 &mn;m) and Mysis (Mysis relicta) between May and October. The seasonal variation may reflect seasonal shifts in the species abundance within the zooplankton community. Trophic magnification factors (TMF) derived from regressions of toxaphene congener concentrations versus δ15N were > 1 for most octa- and nonachlorobornanes in Lake Superior except B8-1413 (P26) and B9-715. Log bioaccumulation factors (BAFs) for toxaphene congeners in lake trout (ng/g lipid/ng/L dissolved) ranged from 4.54 to 9.7 and were significantly correlated with log octanol-water partition coefficients. TMFs observed for total toxaphene and congener B9-1679 in Lake Superior were similar to those in Arctic lakes, as well as to previous studies in the Great Lakes, which suggests that the bioaccumulation behavior of toxaphene is similar in pelagic food webs of large, cold water systems. However, toxaphene concentrations were lower in lake trout from Siskiwit Lake and lakes in northwestern Ontario than in Lake Superior possibly because of shorter food chains and greater reliance on zooplankton or

  16. A Silent Safety Program

    Science.gov (United States)

    Goodin, James Ronald

    2006-01-01

    NASA's Columbia Accident Investigation Board (CAIB) referred 8 times to the NASA "Silent Safety Program." This term, "Silent Safety Program" was not an original observation but first appeared in the Rogers Commission's Investigation of the Challenger Mishap. The CAIB on page 183 of its report in the paragraph titled 'Encouraging Minority Opinion,' stated "The Naval Reactor Program encourages minority opinions and "bad news." Leaders continually emphasize that when no minority opinions are present, the responsibility for a thorough and critical examination falls to management. . . Board interviews revealed that it is difficult for minority and dissenting opinions to percolate up through the agency's hierarchy. . ." The first question and perhaps the only question is - what is a silent safety program? Well, a silent safety program may be the same as the dog that didn't bark in Sherlock Holmes' "Adventure of the Silver Blaze" because system safety should behave as a devil's advocate for the program barking on every occasion to insure a critical review inclusion. This paper evaluates the NASA safety program and provides suggestions to prevent the recurrence of the silent safety program alluded to in the Challenger Mishap Investigation. Specifically targeted in the CAM report, "The checks and balances the safety system was meant to provide were not working." A silent system safety program is not unique to NASA but could emerge in any and every organization. Principles developed by Irving Janis in his book, Groupthink, listed criteria used to evaluate an organization's cultural attributes that allows a silent safety program to evolve. If evidence validates Jams's criteria, then Jams's recommendations for preventing groupthink can also be used to improve a critical evaluation and thus prevent the development of a silent safety program.

  17. Eficácia e segurança de Sultamicilina (Ampicilina/Sulbactam e Amoxacilina/Clavulanato no tratamento das infecções de via aéreas superiores em adultos: um estudo multicêntrico, aberto e randomizado Efficacy and safety of Sultamicillin (Ampicillin/Sulbactan and Amoxicillin/Clavulanic Acid in the treatment of upper respiratory tract infections in adults: an open-label, multicentric, randomized trial

    Directory of Open Access Journals (Sweden)

    João Batista Ferreira

    2006-02-01

    pro-drug of Ampicillin/Sulbactan, is a potent beta-lactamase inhibitor which can face this challenge. AIM: evaluate efficacy, safety and tolerability of Ampicillin/Sulbactan compared to Amoxicillin/Clavulanate in upper respiratory tract infections in adults. METHODS: 102 patients were enrolled and randomized to receive Ampicillin/Sulbactan or Amoxicillin/Clavulanate during 10 days. They were evaluated 10 and 30 days after treatment to learn about the therapeutic response. RESULTS: There were no differences between the two groups respecting cure at the end of treatment (visit 2 or at the end of the study (visit 3. Cure ratio was 61.7% and 93.2% (visits 2 and 3 in the Amoxicillin/Clavulanate group compared to 64.4% and 97.4%, respectively, in Ampicillin/Sulbactan group. The adverse events ratio for the two groups was the same (p=0.940. The number of patients with diarrhea was greater in the group of patients receiving Amoxicillin/Clavulanate (70.6% than in the group receiving Ampicillin/Sulbactan (29.4% (p=0.0164. CONCLUSIONS: Ampicillin/Sulbactan is as safe and efficient as Amoxicillin/Clavulanate in the empiric treatment of upper respiratory infections in adults. The low occurrence of diarrhea in the group receiving Ampicillin/Sulbactan needs confirmation in other studies.

  18. Perawatan Ortodontik menggunakan Teknik Begg pada Kasus Pencabutan Satu Gigi Insisivus Inferior dan Frenectomy Labialis Superior

    Directory of Open Access Journals (Sweden)

    Shella Indri Novianty

    2014-12-01

    Full Text Available Pencabutan gigi insisivus rahang bawah merupakan salah satu cara yang digunakan untuk mendapatkan ruang pada perawatan ortodontik. Seleksi kasus yang ketat harus dilakukan sebelum menentukan pencabutan gigi tersebut, agar mendapatkan hasil perawatan yang baik. Artikel ini memaparkan hasil perawatan menggunakan alat cekat teknik Begg pada kasus maloklusi Angle klas I disertai dengan spacing anterior rahang atas dan pencabutan satu gigi insisivus sentralis rahang bawah, serta frenektomi frenulum labialis superior pada seorang wanita berumur 47 tahun yang datang dengan diagnosa kasus maloklusi Angle klas I, skeletal klas I disertai protrusif bimaksiler, bidental protrusif, spacing anterior rahang atas, crowding anterior rahang bawah dan beberapa malposisi gigi individual pada kedua rahang. Frenektomi pada frenulum labialis superior dan pencabutan insisivus sentralis kiri rahang bawah dilakukan untuk mencapai tujuan perawatan. Perawatan aktif dimulai pada bulan September 2012 menggunakan alat cekat teknik Begg dan berakhir pada bulan September 2013. Retraksi anterior dilakukan pada rahang atas sebesar 5,0 mm dan rahang bawah sebesar 2,5 mm. Observasi pada hasil akhir perawatan terlihat ada perubahan yang baik pada profil, susunan gigi geligi dan analisis sefalometri. Pada pemeriksaan studi model diperoleh hasil bahwa overjet akhir 3,5 mm, overbite 3,0 mm, interdigitasi baik, dan median line rahang atas dan rahang bawah tidak segaris. Pencabutan satu gigi insisivus sentralis rahang bawah pada kasus maloklusi Angle klas I dengan spacing anterior rahang atas dan dilakukan perawatan dengan alat cekat teknik Begg, memberikan hasil perawatan yang cukup memuaskan.   Orthodontic Treatment Using Begg Technique In The Case of Extraction of One Inferior Incisor Tooth and Superior Labial Frenectomy. Extraction of lower arch incisive was the alternative way for space gaining on orthodontic treatment. Case selection is needed before deciding the

  19. Patient safety in otolaryngology: a descriptive review.

    Science.gov (United States)

    Danino, Julian; Muzaffar, Jameel; Metcalfe, Chris; Coulson, Chris

    2017-03-01

    Human evaluation and judgement may include errors that can have disastrous results. Within medicine and healthcare there has been slow progress towards major changes in safety. Healthcare lags behind other specialised industries, such as aviation and nuclear power, where there have been significant improvements in overall safety, especially in reducing risk of errors. Following several high profile cases in the USA during the 1990s, a report titled "To Err Is Human: Building a Safer Health System" was published. The report extrapolated that in the USA approximately 50,000 to 100,000 patients may die each year as a result of medical errors. Traditionally otolaryngology has always been regarded as a "safe specialty". A study in the USA in 2004 inferred that there may be 2600 cases of major morbidity and 165 deaths within the specialty. MEDLINE via PubMed interface was searched for English language articles published between 2000 and 2012. Each combined two or three of the keywords noted earlier. Limitations are related to several generic topics within patient safety in otolaryngology. Other areas covered have been current relevant topics due to recent interest or new advances in technology. There has been a heightened awareness within the healthcare community of patient safety; it has become a major priority. Focus has shifted from apportioning blame to prevention of the errors and implementation of patient safety mechanisms in healthcare delivery. Type of Errors can be divided into errors due to action and errors due to knowledge or planning. In healthcare there are several factors that may influence adverse events and patient safety. Although technology may improve patient safety, it also introduces new sources of error. The ability to work with people allows for the increase in safety netting. Team working has been shown to have a beneficial effect on patient safety. Any field of work involving human decision-making will always have a risk of error. Within

  20. Lanthanum carbonate: safety data after 10 years

    OpenAIRE

    Hutchison, Alastair J.; Wilson, Rosamund J.; Garafola, Svetlana; Copley, John Brian

    2016-01-01

    Abstract Despite 10 years of post‐marketing safety monitoring of the phosphate binder lanthanum carbonate, concerns about aluminium‐like accumulation and toxicity persist. Here, we present a concise overview of the safety profile of lanthanum carbonate and interim results from a 5‐year observational database study (SPD405‐404; ClinicalTrials.gov identifier: NCT00567723). The pharmacokinetic paradigms of lanthanum and aluminium are different in that lanthanum is minimally absorbed and eliminat...