8 resultados para safety monitoring
em Repositório Institucional UNESP - Universidade Estadual Paulista "Julio de Mesquita Filho"
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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
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This is a qualitative-quantitative study based on hospital records of female patients of reproductive age, presenting sexual dysfunction, and treated with 250 mg Tribulus terrestris extract (1 tablet thrice daily for 90 days). Safety monitoring included vital signs, physical examination, laboratory tests, and occurrence of adverse events. Efficacy analysis included results of the Female Sexual Function Index (FSFI), dehydroepiandrosterone (DHEA) levels together with total and free testosterone, and the patient and physician assessments. There was a statistically significant improvement in total FSFI scores (P < 0.0001) post-treatment, with improvement among 106 (88.33%) subjects. There was a statistically significant (P < 0.0001) increase in the level of DHEA, while the levels of both serum testosterone (P = 0.284) and free testosterone decreased (P < 0.0001). Most adverse events recorded were related to the gastrointestinal tract. Physical examination showed no significant changes post-treatment. Based on the results, it is concluded that the T. terrestris extract is safe and effective in the treatment of female sexual dysfunction.
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Background: Treatment of deep-vein thrombosis (DVT) with a once-daily regimen of enoxaparin, rather than a continuous infusion of unfractionated heparin (UFH) is more convenient and allows for home care in some patients. This study was designed to compare the efficacy and safety of these two regimens for the treatment of patients with proximal lower limb DVT. Methods: 201 patients with proximal lower limb DVT from 13 centers in Brazil were randomized in an open manner to receive either enoxaparin [1.5 mg/kg subcutaneous (s.c.) OD] or intravenous (i.v.) UFH (adjusted to aPTT 1.5-2.5 times control) for 5-10 days. All patients also received warfarin (INR 2-3) for at least 3 months. The primary efficacy endpoint Was recurrent DVT (confirmed by venography or ultrasonography), and safety endpoints included bleeding and serious adverse events. The rate of pulmonary embolism (PE) was also collected. Hospitalization was at the physician's discretion. Results: Baseline patient characteristics were comparable between groups. The duration of hospital stay was significantly shorter with enoxaparin than with UFH (3 versus 7 days). In addition, 36% of patients receiving enoxaparin did not need to be hospitalized, whereas all of the patients receiving UFH were! hospitalized. The treatment duration was slightly longer with enoxaparin (8 versus 7 days). There was a nonsignificant trend toward a reduction in the rate of recurrent DVT with enoxaparin versus UFH, and similar safety. Conclusions: A once-daily regimen of enoxaparin 1.5 mg/kg subcutaneous is at least as effective and safe as conventional treatment with a continuous intravenous infusion of UFH. However, the once daily enoxaparin regimen is easier to administer (subcutaneous versus intravenous), does not require aPTT monitoring, and leads to both a reduced number of hospital admissions and an average 4-day-shorter hospital stay. (C) 2004 Elsevier Ltd. All rights reserved.
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The computational program called GIS_EM (Geographic Information System for Environmental Monitoring), a software devised to manage geographic information for monitoring soil, surface, and ground water, developed for use in the Health, Safety, and Environment Division of Paulinia Refinery is presented. This program enables registering and management of alphanumeric information pertaining to specific themes such as drilling performed for sample collection and for installation of monitoring wells, geophysical and other tests, results of chemical analyses of soil, surface, and groundwater, as well as reference values providing orientation for soil and water quality, such as EPA, Dutch List, etc. Management of such themes is performed by means of alphanumeric search tools, with specific filters and, in the case of spatial search, through the selection of spatial elements (themes) in map view. Documents existing in digital form, such as reports, photos, maps, may be registered and managed in the network environment. As the system centralizes information generated upon environmental investigations, it expedites access to and search of documents produced and stored in the network environment, minimizing search time and the need to file printed documents. This is an abstract of a paper presented at the AIChE Annual Meeting and Fall Showcase (Cincinnati, OH 10/30/2005-11/4/2005).
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Sickle Cell Disease (SCD) is one of the most prevalent hematological diseases in the world. Despite the immense progress in molecular knowledge about SCD in last years few therapeutical sources are currently available. Nowadays the treatment is performed mainly with drugs such as hydroxyurea or other fetal hemoglobin inducers and chelating agents. This review summarizes current knowledge about the treatment and the advancements in drug design in order to discover more effective and safe drugs. Patient monitoring methods in SCD are also discussed. © 2011 Bentham Science Publishers Ltd.
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Microparticles found in the air may be associated with organic matter that contains several compounds, such as Polycyclic Aromatic Hydrocarbons (PAHs) and nitro-PAHs, and may pose a significant risk to human health, possibly leading to DNA mutations and cancers. This study associated genotoxicity assays for evaluating human exposure with the atmospheric air of two urban areas in southern Brazil, that received different atmospheric contributions. Site 1 was under urban-industrial influence and the other was a non-industrial reference, Site 2. Organic extracts from the airborne particulate matter were tested for mutagenicity via the Salmonella/microsome assay and analyzed for PAH composition. Cells samples of people residing in these two cities were evaluated using the comet and micronucleus assay (MN).Concentrations of the individual PAHs ranged from 0.01ng/m3 (benzo[a]anthracene) to 5.08ng/m3 (benzo[ghi]perylene). As to mutagenicity analysis of airborne, Site 1 presented all the mutagenic responses, which varied from 3.2±1.22rev/m3 (TA98 no S9) to 32.6±2.05rev/m3 (TA98, S9), while Site 2 ranged from negative to minimal responses. Site 1 presented a high quantity of nitro and amino derivatives of PAHs, and peaked at 56.0±3.68rev/μg (YG1024 strain). The two groups presented very low DNA damage levels without intergroup difference. Although Site 1 presented high mutagenic responses in the air samples, high PAH levels, healthy people exposed to this environment did not show significative damage in their genetic material. However, the evaluation of different environmental and genetic damage in such population is necessary to monitor possible damages. © 2013 Elsevier Inc.
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
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Context. The giant anteater, Myrmecophaga tridactyla, is a large insectivorous mammal from Cerrado which is classified as vulnerable by the IUCN's red list. In spite of frequent giant anteater casualties, there continues to be a lack of published data on how road and landscape attributes affect road-kill rates - information that could prove useful in guiding mitigation measures.Aims. We seek to determine whether road and landscape attributes influence the incidence of road-kills of the giant anteater.Methods. From February 2002 to December 2012 (except for 2004), five roads in two regions in south-eastern Brazil were surveyed twice each month by car. We recorded temporal road-kill data for the giant anteater and related spatial road variables. These variables were also recorded at regular control sites every 2 km. We also took traffic volume data on stretches of the two roads to correlate with road-kills.Key results. Of the 45 anteater casualties recorded, there was a predominance of adult males. On roads MG-428 and SP-334, we found anteater road-kills were more common in the dry season, negatively correlated with traffic volume and related to the presence of native vegetation. Accordingly, road-kill sites tended to occur near the cerrado and grasslands and also appeared more frequently on some straight stretches of roadways. Although it was not shown to influence road-kill rates, topography data does point to regular overpass/underpass locations allowing population connectivity. Termitaria or ant nests were present at all road-kill sites, with 86% having signs of feeding.Conclusions. Native vegetation along roadways, together with straight road design, increases the probability of anteater road-kills by 40.1%.Implications. For mitigation, mowing and removing insect nests on roadsides, as well as roadside wildlife fencing in cerrado and grassland areas is suggested. Warning signs and radar to reduce vehicle speed are recommended for both human safety and anteater conservation. With regard to population connectivity, the absence of aggregated anteater road-kill data in this study meant that there were no particular crossing locations identified. However, the collected topography data do show places that could be used for roadway crossings. The measures indicated may apply to similar species and types of topography on other continents.