5 resultados para Multicenter Studies as Topic

em Biblioteca Digital da Produção Intelectual da Universidade de São Paulo


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OBJETIVO: Avaliar as condições de uso dos esfigmomanômetros em hospitais públicos e privados. MÉTODOS: Estudo descritivo de abordagem- quantitativa realizado em quatro hospitais de grande porte do Estado de São Paulo, no período entre 2009 e 2010. Os manômetros aneroides foram- testados contra manômetro de mercúrio calibrado. Foram considerados descalibrados quando as diferenças foram > a 4 mmHg. RESULTADOS: Foram avaliados 162 esfigmomanômetros, (78 de um hospital público e 84 de instituições filantrópicas e privada) e 98,1% eram do tipo aneróide.- Verificou-se que 56,2% dos manômetros estavam descalibrados (48,6% do hospital privado e 63,1% dos hospitais públicos). Analisando-se as- médias das diferenças negativas da descalibração, houve diferença significativa entre os manômetros do hospital privado e os dos hospitais públicos- (-6,14±2,66 mmHg vs -8,97±6,74 mmHg, respectivamente, p<0,05). Observou-se ainda que em 70,2% não era feita avaliação periódica; 26,7%- tinham extensão de borracha envelhecida; 20,5% das válvulas apresentaram vazamento; e 27% dos manômetros não estavam com o ponteiro na- marca zero. CONCLUSÃO: A descalibração dos esfigmomanômetros aneróides foi expressiva e pode acarretar avaliação incorreta da pressão arterial.

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Background: Factor analyses indicate that hoarding symptoms constitute a distinctive dimension of obsessive-compulsive disorder (OCD), usually associated with higher severity and limited insight. The aim was to compare demographic and clinical features of OCD patients with and without hoarding symptoms. Method: A cross sectional study was conducted with 1001 DSM-IV OCD patients from the Brazilian Research Consortium of Obsessive-Compulsive Spectrum Disorders (CTOC), using several instruments. The presence and severity of hoarding symptoms were determined using the Dimensional Yale-Brown Obsessive-Compulsive Scale. Statistical univariate analyses comparing factors possibly associated with hoarding symptoms were conducted, followed by logistic regression to adjust the results for possible confounders. Results: Approximately half of the sample (52.7%, n = 528) presented hoarding symptoms, but only four patients presented solely the hoarding dimension. Hoarding was the least severe dimension in the total sample (mean score: 3.89). The most common lifetime hoarding symptom was the obsessive thought of needing to collect and keep things for the future (44.0%, n = 440). After logistic regression, the following variables remained independently associated with hoarding symptoms: being older, living alone, earlier age of symptoms onset, insidious onset of obsessions, higher anxiety scores, poorer insight and higher frequency of the symmetry-ordering symptom dimension. Concerning comorbidities, major depressive, posttraumatic stress and attention deficit/hyperactivity disorders, compulsive buying and tic disorders remained associated with the hoarding dimension. Conclusion: OCD hoarding patients are more likely to present certain clinical features, but further studies are needed to determine whether OCD patients with hoarding symptoms constitute an etiologically discrete subgroup. (C) 2012 Elsevier Ltd. All rights reserved.

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Background Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation include prolonged dual antiplatelet therapy (DAPT) with aspirin and clopidogrel >= 12 months. However, the impact of such a regimen for all patients receiving any DES system remains unclear based on scientific evidence available to date. Also, several other shortcomings have been identified with prolonged DAPT, including bleeding complications, compliance, and cost. The second-generation Endeavor zotarolimus-eluting stent (E-ZES) has demonstrated efficacy and safety, despite short duration DAPT (3 months) in the majority of studies. Still, the safety and clinical impact of short-term DAPT with E-ZES in the real world is yet to be determined. Methods The OPTIMIZE trial is a large, prospective, multicenter, randomized (1: 1) non-inferiority clinical evaluation of short-term (3 months) vs long-term (12-months) DAPT in patients undergoing E-ZES implantation in daily clinical practice. Overall, 3,120 patients were enrolled at 33 clinical sites in Brazil. The primary composite endpoint is death (any cause), myocardial infarction, cerebral vascular accident, and major bleeding at 12-month clinical follow-up post-index procedure. Conclusions The OPTIMIZE clinical trial will determine the clinical implications of DAPT duration with the second generation E-ZES in real-world patients undergoing percutaneous coronary intervention. (Am Heart J 2012;164:810-816.e3.)

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Abstract Background The occurrence of preterm birth remains a complex public health condition. It is considered the main cause of neonatal morbidity and mortality, resulting in a high likelihood of sequelae in surviving children. With variable incidence in several countries, it has grown markedly in the last decades. In Brazil, however, there are still difficulties to estimate its real occurrence. Therefore, it is essential to establish the prevalence and causes of this condition in order to propose prevention actions. This study intend to collect information from hospitals nationwide on the prevalence of preterm births, their associated socioeconomic and environmental factors, diagnostic and treatment methods resulting from causes such as spontaneous preterm labor, prelabor rupture of membranes, and therapeutic preterm birth, as well as neonatal results. Methods/Design This proposal is a multicenter cross-sectional study plus a nested case-control study, to be implemented in 27 reference obstetric centers in several regions of Brazil (North: 1; Northeast: 10; Central-west: 1; Southeast: 13; South: 2). For the cross sectional component, the participating centers should perform, during a period of six months, a prospective surveillance of all patients hospitalized to give birth, in order to identify preterm birth cases and their main causes. In the first three months of the study, an analysis of the factors associated with preterm birth will also be carried out, comparing women who have preterm birth with those who deliver at term. For the prevalence study, 37,000 births will be evaluated (at term and preterm), corresponding to approximately half the deliveries of all participating centers in 12 months. For the case-control study component, the estimated sample size is 1,055 women in each group (cases and controls). The total number of preterm births estimated to be followed in both components of the study is around 3,600. Data will be collected through a questionnaire all patients will answer after delivery. The data will then be encoded in an electronic form and sent online by internet to a central database. The data analysis will be carried out by subgroups according to gestational age at preterm birth, its probable causes, therapeutic management, and neonatal outcomes. Then, the respective rates, ratios and relative risks will be estimated for the possible predictors. Discussion These findings will provide information on preterm births in Brazil and their main social and biological risk factors, supporting health policies and the implementation of clinical trials on preterm birth prevention and treatment strategies, a condition with many physical and emotional consequences to children and their families.

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Abstract Background: Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and more recently in clinical trials. Method/Design: We have designed clinical trials to test for the efficacy of autologous bone marrow derived mononuclear cell therapies in four different cardiopathies: acute and chronic ischemic heart disease, and Chagasic and dilated cardiomyopathy. All trials are multicenter, randomized, double-blind and placebo controlled. In each trial 300 patients will be enrolled and receive optimized therapy for their specific condition. Additionally, half of the patients will receive the autologous bone marrow cells while the other half will receive placebo (saline with 5% autologous serum). For each trial there are specific inclusion and exclusion criteria and the method for cell delivery is intramyocardial for the chronic ischemic heart disease and intracoronary for all others. Primary endpoint for all studies will be the difference in ejection fraction (determined by Simpson's rule) six and twelve months after intervention in relation to the basal ejection fraction. The main hypothesis of this study is that the patients who receive the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean increase of 5% in absolute left ventricular ejection fraction in comparison with the control group. Discussion: Many phase I clinical trials using cell therapy for cardiac diseases have already been performed. The few randomized studies have yielded conflicting results, rendering necessary larger well controlled trials to test for efficacy of cell therapies in cardiopathies. The trials registration numbers at the NIH registry are the following: Chagasic cardiomyopathy (NCT00349271), dilated cardiomyopathy (NCT00333827), acute myocardial infarction (NCT00350766) and Chronic Ischemic Heart Disease (NCT00362388).