42 resultados para Safety Indicators


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Background: The long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Methods: In two double-blind, 52-week studies, ACCLAIM/COPD I (n = 843) and II (n = 804), patients were randomised to inhaled aclidinium 200 μg or placebo once-daily. Patients were required to have a postbronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio of ≤70% and FEV1 <80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George"s Respiratory Questionnaire (SGRQ) and time to first moderate or severe COPD exacerbation. Results: At 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM/COPD I (by 61 and 67 mL; both p < 0.001) and ACCLAIM/COPD II (by 63 and 59 mL; both p < 0.001). More patients had a SGRQ improvement ≥4 units at 52 weeks with aclidinium versus placebo in ACCLAIM/COPD I (48.1% versus 39.5%; p = 0.025) and ACCLAIM/COPD II (39.0% versus 32.8%; p = 0.074). The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM/COPD II (hazard ratio [HR] 0.7; 95% confidence interval [CI] 0.55 to 0.92; p = 0.01), but not ACCLAIM/COPD I (HR 1.0; 95% CI 0.72 to 1.33; p = 0.9). Adverse events were minor in both studies. Conclusion: Aclidinium is effective and well tolerated in patients with moderate to severe COPD. Trial registration: ClinicalTrials.gov: NCT00363896 ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II).

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Ordered weighted averaging (OWA) operators and their extensions are powerful tools used in numerous decision-making problems. This class of operator belongs to a more general family of aggregation operators, understood as discrete Choquet integrals. Aggregation operators are usually characterized by indicators. In this article four indicators usually associated with the OWA operator are extended to discrete Choquet integrals: namely, the degree of balance, the divergence, the variance indicator and Renyi entropies. All of these indicators are considered from a local and a global perspective. Linearity of indicators for linear combinations of capacities is investigated and, to illustrate the application of results, indicators of the probabilistic ordered weighted averaging -POWA- operator are derived. Finally, an example is provided to show the application to a specific context.

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Designing new teaching programs for both undergraduate and graduate university studies involves integrating concepts and methodologies regarding quality, work safety and hazard prevention, and environmental protection. One of the challenges facing Spanish research within the realm of European Higher Education concerns health and safety issues in the Arts.In the case of Fine Arts, student exploration is one of the fundamental pillars of the study program; therefore it is imperative that art studios be optimized. This optimization affects both designated resources (infrastructures, materials, equipment, etc.) and organization of the teaching force.In this context, the aim of our research is to improve educational practices by designing quality measures that are both friendly to the environment and hazardous free. The aim here is to assure adequate art studio and laboratory management, and provide students with hazard free health and environmentally safe concepts that can be incorporated in their professional lives.The school of Fine Arts at the University of Barcelona is part of a pilot program, where our experience in educational innovation and research is serving as a reference for the implantation of OSHAS 18001 norms.

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Designing new teaching programs for both undergraduate and graduate university studies involves integrating concepts and methodologies regarding quality, work safety and hazard prevention, and environmental protection. One of the challenges facing Spanish research within the realm of European Higher Education concerns health and safety issues in the Arts.In the case of Fine Arts, student exploration is one of the fundamental pillars of the study program; therefore it is imperative that art studios be optimized. This optimization affects both designated resources (infrastructures, materials, equipment, etc.) and organization of the teaching force.In this context, the aim of our research is to improve educational practices by designing quality measures that are both friendly to the environment and hazardous free. The aim here is to assure adequate art studio and laboratory management, and provide students with hazard free health and environmentally safe concepts that can be incorporated in their professional lives.The school of Fine Arts at the University of Barcelona is part of a pilot program, where our experience in educational innovation and research is serving as a reference for the implantation of OSHAS 18001 norms.

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Designing new teaching programs for both undergraduate and graduate university studies involves integrating concepts and methodologies regarding quality, work safety and hazard prevention, and environmental protection. One of the challenges facing Spanish research within the realm of European Higher Education concerns health and safety issues in the Arts.In the case of Fine Arts, student exploration is one of the fundamental pillars of the study program; therefore it is imperative that art studios be optimized. This optimization affects both designated resources (infrastructures, materials, equipment, etc.) and organization of the teaching force.In this context, the aim of our research is to improve educational practices by designing quality measures that are both friendly to the environment and hazardous free. The aim here is to assure adequate art studio and laboratory management, and provide students with hazard free health and environmentally safe concepts that can be incorporated in their professional lives.The school of Fine Arts at the University of Barcelona is part of a pilot program, where our experience in educational innovation and research is serving as a reference for the implantation of OSHAS 18001 norms.

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Inspections of pleasure boats in Spain can be carried out by collaborating entities of inspection, entities that must be authorized by the Maritime Administration. This authorization allows to perform effective inspections and technical controls of recreational crafts. Recreational crafts are subjected to surveys that are based on the registration list and on the material used in the hull. In addition, required safety equipment of the recreational boat depends on the distance that the recreational boat is authorized to navigate. Following data obtained from inspections of recreational craft, this paper aims to analyze information about hulls within dry and afloat conditions, about the equipment for rescue and safety, and about other nautical equipment; as well as to perform and improve different verifications during the inspections. All this information points to several aspects relevant for the optimization of the inspection process, the ultimate target being increasing efficiency and effectiveness, and ensuring more safety in recreational craft.

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The recent context of global food emergency and ecological crisis has increased the relevance of people’s struggle for food sovereignty (FSv), which promotes the transformation of the dominant food system and claims ‘the right of peoples to healthy and culturally appropriate food produced through ecologically sound and sustainable methods, and their right to define their own food and agriculture systems’. Revisiting two Spanish and Catalan articles developing FSv indicators, this article aims at discussing the need and utility of developing FSv indicators at different territorial levels. Confronting these two territorial scales, the paper also identifies common steps that can facilitate other future processes of building FSv indicators. As a conclusion, the paper suggests that these processes of building indicators can contribute to providing political direction at different geographical scales for the implementation of the FSv proposal. At the same time, they favor the movement’s self-reflexivity in its practices while supporting the collective shaping of future actions

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In Europe, the safety evaluation of cosmetics is based on the safety evaluation of each individual ingredient. Article 3 of the Cosmetics Regulation specifies that a cosmetic product made available on the market is to be safe for human health when used normally or under reasonably foreseeable conditions. For substances that cause some concern with respect to human health (e.g. colorants, preservatives, UV-filters), safety is evaluated at the Commission level by a scientific committee, presently called the Scientific Committee on Consumer Safety (SCCS). According to the Cosmetics Regulations, in the EU, the marketing of cosmetics products and their ingredients that have been tested on animals for most of their human health effects, including acute toxicity, is prohibited. Nevertheless, any study dating from before this prohibition took effect is accepted for the safety assessment of cosmetics ingredients. The in vitro methods reported in the dossiers summited to the SCCS are here evaluated from the published reports issued by the scientific committee of the Directorate General of Health and Consumers (DG SANCO); responsible for the safety of cosmetics ingredients. The number of studies submitted to the SCCS that do not involve animals is still low and in general the safety of cosmetics ingredients is based on in vivo studies performed before the prohibition.

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The use of tolls is being widespread around the world. Its ability to fund infrastructure projects and to solve budget constraints have been the main rationale behind its renewed interest. However, less attention has been payed to the safety effects derived from this policy in a moment of increasing concern on road fatalities. Pricing best infrastructures shifts some drivers onto worse alternative roads usually not prepared to receive high traffic in comparable safety standards. In this paper we provide evidence of the existence of this perverse consequence by using an international European panel in a two way fixed effects estimation.

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Purpose The purpose of the present study was to evaluate the retinal toxicity of a single dose of intravitreal docosahexaenoic acid (DHA) in rabbit eyes over a short-term period. Methods Sixteen New Zealand albino rabbits were selected for this pre-clinical study. Six concentrations of DHA (Brudy Laboratories, Barcelona, Spain) were prepared: 10 mg/50 µl, 5 mg/50 µl, 2'5 mg/50 µl, 50 µg/50 µl, 25 µg/50 µl, and 5 µg/50 µl. Each concentration was injected intravitreally in the right eye of two rabbits. As a control, the vehicle solution was injected in one eye of four animals. Retinal safety was studied by slit-lamp examination, and electroretinography. All the rabbits were euthanized one week after the intravitreal injection of DHA and the eyeballs were processed to morphologic and morphometric histological examination by light microscopy. At the same time aqueous and vitreous humor samples were taken to quantify the concentration of omega-3 acids by gas chromatography. Statistical analysis was performed by SPSS 21.0. Results Slit-lamp examination revealed an important inflammatory reaction on the anterior chamber of the rabbits injected with the higher concentrations of DHA (10 mg/50 µl, 5 mg/50 µl, 2'5 mg/50 µ) Lower concentrations showed no inflammation. Electroretinography and histological studies showed no significant difference between control and DHA-injected groups except for the group injected with 50 µg/50 µl. Conclusions Our results indicate that administration of intravitreal DHA is safe in the albino rabbit model up to the maximum tolerated dose of 25 µg/50 µl. Further studies should be performed in order to evaluate the effect of intravitreal injection of DHA as a treatment, alone or in combination, of different retinal diseases.

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Helicobacter pylori (H. pylori) is a gram negative bacteria that represents a considerable global burden in the world and is related to many gastrointestinal diseases (peptic ulcer, gastric MALT lymphoma or gastric cancer). Currently the triple standard therapy is less used as there is an increase of the clarithromycin resistance. Therefore patients have to receive several lines of treatment with the consequence of adverse events and the possibility to interrupt the treatment. This is why the main objective is to determine if making a culture and antibiogram to do a targeted treatment cause less adverse events with the same eradication than making an empirical treatment to eradicate H. pylori. The secondary objective is to determine the prevalence of resistance to clarithromycin in the province of GironaThis is a multicentre clinical trial without blinding; patients are selected by non-probabilistic sampling, with a total sample of 868 patients randomized in two equal groups of 434 patients in each group. The study will last 2 years. The endpoints will be to evaluate the adverse events and eradication of each group of patients. Also it will be evaluated the resistance to clarithromycin

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A research about the quality of life of the older persons of a municipality starting from the analysis of the perceptions, evaluations and expectations related to concrete spheres of their lives (familiar characteristics, housing, health, nearby environment, activities, needs and dependencies and persons helping them to satisfy needs) is presented. Answers to 1988 questionnaires obtained from two representative samples of older per - sons living in private homes in the city have been analysed: persons over 65 years old and a specific one composed by a sub-sample of the general one, with persons over 75 years living alone. Data shaping contextual indicators related to housing have been analysed. The auto - nomy to drive and the evaluation of on’s health seem to be positive indicators to take in account while sutying quality of life at these ages. Sentinel indicators of the physical and relational conditions in the family and indicators of dependency are analysed as well. The evaluations of the older persons about their own life conditions are also analysed through psychosocial indicators connected to housing, nearby environmenent, their activities andincomes. The results obtained are applicable in order to improve the decision making process in social intervention programmes developed in the field of ageing aiming to take into account their perspectives