1000 resultados para Ensaios clínicos como assunto
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A Atenção Farmacêutica é uma prática crescente no Brasil, assim como no cenário internacional. O princípio de promoção a saúde e atenção primária, preconizados no fim da década de 70, vem de encontro com essa atuação do farmacêutico, a fim de promover uma melhoria na qualidade de vida do paciente. Nesse âmbito é de extrema importância monitorar a farmacoterapia da gestante, já que são poucos os fármacos relativamente testados quanto à eficácia e a segurança para esse grupo específico. O aparecimento de novos fármacos que não tenham informações completas e totalmente confiáveis no que se refere a segurança para a gestante tem aumentado. Pelo potencial risco que o feto e o neonato podem sofrer durante a exposição ao fármaco, as dificuldades éticas e metodológicas dos estudos e ensaios clínicos são uma problemática. Analisando publicações e trabalhos que tiveram como foco a atenção farmacêutica em gestantes, objetiva-se conseguir informações importantes para que durante a gravidez o uso de medicamentos seja cada vez mais racional e que a prescrição seja feita e forma criteriosa, privilegiando medidas não farmacológicas quando possível.
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
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Pós-graduação em Doenças Tropicais - FMB
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Pós-graduação em Bases Gerais da Cirurgia - FMB
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To understand the perception of the participants in controlled clinical trials (CCTs) about the informed consent and describe the meaning of their participation in the research. Qualitative study using the focus group technique. The sample was composed of 19 patients who participated in clinical trials about hypertension and coronary disease in a specialized cardiologic hospital located in the city of Sao Paulo. The methodological framework used was the content analysis. Some of the participants were aware of the real objective of these studies while others had misperceptions. The reading of the informed consent is not always done and, when it is done, the patient does not understand it. The lack of understanding about the term ''placebo'' was mentioned by some participants. The motivation to participate was the personal benefit. This study shows that obtaining the informed consent in CCTs is complex and that there is the need to adapt the structure and application of this document, in order to protect the participants and improve the quality of clinical trials performed in the country.
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Pós-graduação em Bases Gerais da Cirurgia - FMB
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The granulomatous lesions are frequently founded in infectious diseases and can involve the larynx and pharynx and can cause varying degrees of dysphonia and dysphagia. There is still no systematic review that analyzes effectiveness of speech therapy in systemic granulomatous diseases. Research strategy: A systematic review was performed according to Cochrane guideline considering the inclusion of RCTs and quasi-RCTs about the effectiveness of speech-language therapy to treat dysphagia and dysphonia symptoms in systemic granulomatous diseases of the larynx and pharynx. Selection criteria: The outcome planned to be measured in this review were: swallowing impairment, frequency of chest infections and voice and swallowing symptoms. Data analysis: We identified 1,140 citations from all electronic databases. After an initial shift we only selected 9 titles to be retrieved in full-text. After full reading, there was no RCT found in this review and therefore, we only described the existing 2 case series studies. Results: There were no randomized controlled trials found in the literature. Therefore, two studies were selected to be included only for narratively analysis as they were case series. Conclusion: There is no evidence from high quality studies about the effectiveness of speech-language therapy in patients with granulomatous diseases of the larynx and pharynx. The investigators could rely in the outcomes suggested in this review to design their own clinical trials.
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The purpose of this literature review was to evaluate the use of fibrin tissue adhesive in implant dentistry. Materials and Methods: A literature search of Medline-PubMed for articles published, describing the use of fibrin tissue adhesive in implant dentistry was performed and articles were critically reviewed. Results: The literature review reveals clinical trials and experimental studies with regard to the use of fibrin tissue adhesive in implant dentistry. This material consists of 2 components: highly purified, freeze-dried human fibrinogen with factor XIII and a starter solution containing human thrombin. Clotting factor XIII is admitted for reinforcement of the fibrin network. The components are reconstituted before use and when mixed form a clot by mimicking the terminal phase of the physiological clotting cascade. Several studies showed that fibrin tissue adhesive is fully absorbed by macrophages within 2 weeks of application. Adhesive fibrin tissue may be used for to prevent bone loss, to create contour in the periimplant soft tissue and osseous tissue, to sculpt emergence profile for prosthetic components and to mimic tissue architecture. In the last years fibrin tissue adhesive also find use as material for the controlled delivery of drugs and biologics. Conclusions: The fibrin tissue adhesive presents good properties such as biocompatibility, hemostatic properties and ability to break down like the physiologic clot. This material, alone or associated with other materials, can be used with the implants immediately after extraction. In this condition it brings the necessary anchoring and efficient maintenance of osseous/mucosal contour, which it is important for the clinical success.
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The root resorption is one of the possible sequels of greater complexity to the orthodontist, the difficulty of detection and be asymptomatic. The presence, during the orthodontic treatment, is linked to a multifactorial origin, a complex combination of biological activities, anatomical, physiological, genetic variables and mechanical forces. Thus, the aim of this study was perform to critical literature review related to root resorption in orthodontic movement. Were included articles published between 2004 to 2014, indexed in the PUBMED database. Used descriptors contained in the Mesh, being adopted as inclusion criteria: clinical trials in humans, only articles that had clear ideas and objective, articles with English language. The search strategy used resulted in 24 articles and after applied the inclusion and exclusion criteria, 11 articles remained. Based on the results of this study it was concluded that heavy forces of intrusion, inclination and torque leads to a greater degree of root resorption; its etiology is multifactorial, the periodic radiographic control during treatment is needed and further studies are suggested to identify more specifically the causes and risk factors for root resorption.
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Data shows that the use of the medicinal plants in industrialized countries represents around 20% of the total medical prescriptions. Considering the need to establish a safe phytotherapic practice, specially when the evidence based medicine is a current tendency, phytotherapic medicines can no longer justify any doubts regarding its safety and efficacy. So, proof of efficacy and safety must result preferably from properly conducted clinical trials, although the legislation exempts such studies for traditional or well established phytotherapics. In this article, benefits and advantages of standardized dry extracts used in phytotherapic medicines instead of powder drugs and dry extracts are analyzed and discussed. The study reveals as main conclusive remark, that adequate clinical trials are essential to promote this therapeutical practice.
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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
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Pós-graduação em Anestesiologia - FMB
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Background: Previous studies show that chronic hemiparetic patients after stroke, presents inabilities to perform movements in paretic hemibody. This inability is induced by positive reinforcement of unsuccessful attempts, a concept called learned non-use. Forced use therapy (FUT) and constraint induced movement therapy (CIMT) were developed with the goal of reversing the learned non-use. These approaches have been proposed for the rehabilitation of the paretic upper limb (PUL). It is unknown what would be the possible effects of these approaches in the rehabilitation of gait and balance. Objectives: To evaluate the effect of Modified FUT (mFUT) and Modified CIMT (mCIMT) on the gait and balance during four weeks of treatment and 3 months follow-up. Methods: This study included thirty-seven hemiparetic post-stroke subjects that were randomly allocated into two groups based on the treatment protocol. The non-paretic UL was immobilized for a period of 23 hours per day, five days a week. Participants were evaluated at Baseline, 1st, 2nd, 3rd and 4th weeks, and three months after randomization. For the evaluation we used: The Stroke Impact Scale (SIS), Berg Balance Scale (BBS) and Fugl-Meyer Motor Assessment (FM). Gait was analyzed by the 10-meter walk test (T10) and Timed Up & Go test (TUG). Results: Both groups revealed a better health status (SIS), better balance, better use of lower limb (BBS and FM) and greater speed in gait (T10 and TUG), during the weeks of treatment and months of follow-up, compared to the baseline. Conclusion: The results show mFUT and mCIMT are effective in the rehabilitation of balance and gait. Trial Registration ACTRN12611000411943.
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PURPOSE: To evaluate the efficacy of radiotherapy (RT) with total dose of 20 Gy (RT 20 Gy) in the treatment of Graves' ophthalmopathy. METHODS: A systematic review and meta-analysis of randomized controlled trials was performed comparing RT 20 Gy with or without glucocorticoid to clinical treatments for Graves' ophthalmopathy. The MEDLINE, EMBASE, Cochrane Library databases and recent relevant journals were searched. Relevant reports were reviewed by two reviewers. Response to radiotherapy was defined as clinical success according to each trial. We also evaluated the quality of life and whether RT to produce fewer side effects than other treatments. RESULTS: A total of 8 randomized controlled trials (439 patients) were identified. In the subgroup analysis, the overall response to treatment rates was better for: RT 20 Gy plus glucocorticoid vs glucocorticoids alone, OR=17.5 (CI95% 1.85-250, p=0.04), RT 20 Gy vs sham RT, OR= 3.15 (CI95%1.59-6.23, p=0.003) and RT 20Gy plus intravenous glucocorticoid vs RT 20Gy plus oral glucocorticoid, OR=4.15(CI95% 1.34-12.87, p=0.01). There were no differences between RT 20 Gy versus other fractionations and RT 20 Gy versus glucocorticoid alone. RT 20 Gy with or without glucocorticoids showed an improvement in diplopia grade, visual acuity, optic neuropathy, lid width, proptosis and ocular motility. No difference was seen for costs, intraocular pressure and quality of life. CONCLUSION: Our data have shown that RT 20 Gy should be offered as a valid therapeutic option to patients with moderate to severe ophthalmopathy. The effectiveness of orbital radiotherapy can be increased by the synergistic interaction with glucocorticoids. Moreover, RT 20 Gy is useful to improve a lot of ocular symptoms, excluding intraocular pressure, without any difference in quality of life and costs.
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O ingurgitamento mamário afeta a amamentação e causa o desmame precoce. A literatura apresenta técnicas de tratamento do ingurgitamento, entretanto há conflitos quanto à melhor terapêutica. O objetivo desta pesquisa é identificar e analisar as evidências encontradas na literatura da terapêutica não-farmacológica para alívio de sintomas de ingurgitamento mamário durante a amamentação. Foi realizada uma revisão integrativa da literatura com estudos publicados a partir de 1990, nas bases de dados MEDLINE e LILACS utilizando as palavras chaves: aleitamento materno, transtorno da lactação e terapia. Foram encontrados dez estudos, sendo dois de revisão sistemática da literatura, sete ensaios clínicos controlados randomizados e um estudo quase-experimental. Os estudos analisados apresentam resultados divergentes e não há evidências suficientes para recomendar a implementação dos tratamentos avaliados. São necessários mais estudos controlados randomizados para verificar terapias eficazes para o tratamento do ingurgitamento mamário.