85 resultados para Controlled clinical trials
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Background: Blood pressure (BP) within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age. Non-drug interventions to prevent hypertension have had low effectiveness. In individuals with previous cardiovascular disease or diabetes, the use of BP-lowering agents reduces the incidence of major cardiovascular events. In the absence of higher baseline risk, the use of BP agents reduces the incidence of hypertension. The PREVER-prevention trial aims to investigate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target-organ damage.Methods: This is a randomized, double-blind, placebo-controlled clinical trial, with participants aged 30 to 70 years, with pre-hypertension. The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. The primary outcomes will be the incidence of hypertension, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new sub-clinical atherosclerosis, and sudden death. The study will last 18 months. The sample size was calculated on the basis of an incidence of hypertension of 14% in the control group, a size effect of 40%, power of 85% and P alpha of 5%, resulting in 625 participants per group. The project was approved by the Ethics committee of each participating institution.Discussion: The early use of blood pressure-lowering drugs, particularly diuretics, which act on the main mechanism of blood pressure rising with age, may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension. If this intervention shows to be effective and safe in a population-based perspective, it could be the basis for an innovative public health program to prevent hypertension in Brazil.Trial Registration: Clinical Trials NCT00970931. © 2011 Fuchs et al; licensee BioMed Central Ltd.
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Objectives: The objective of this study was to evaluate the clinical performance of 124 non-carious cervical lesion restorations at 12 months. Materials And Methods: Three study groups were formed according to the material and technique used. All teeth received 37% phosphoric acid etching in enamel and dentin. The teeth of Group I received the conventional adhesive system Scotch Bond Multi Purpose, followed by resin composite Filtek Z350; teeth of Group II were restored with resin-modified glassionomer cement Fuji II LC; teeth of Group III were restored with the same resin-modified glass-ionomer cement-however, before it was inserted, 2 coats of primer of the Scotch Bond Multi Purpose adhesive system were applied to dentinal tissue. The teeth were evaluated by 2 examiners with regard to the factors of retention, marginal adaptation, marginal discoloration, color alteration, presence of marginal caries lesion, anatomic shape, and sensitivity. Results: Application of the Kruskal-Wallis test showed no statistically significant difference for anatomic shape, marginal discoloration, color alteration, caries lesion, marginal adaptation, and sensitivity among the three study groups, but the variable retention presented statistically significant difference at 12 months, with Group III presenting a behavior superior to that of Group II but similar to that of Group I. Conclusion: The analyzed restorations of non-carious cervical lesions presented a good clinical performance at 12 months. © 2012 Nova Science Publishers, Inc.
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Aim: The objective of the present study was to investigate the effect of a multimodal exercise intervention on frontal cognitive functions and kinematic gait parameters in patients with Alzheimer's disease. Methods: A sample of elderly patients with Alzheimer's disease (n=27) were assigned to a training group (n=14; aged 78.0±7.3years) and a control group (n=13; aged 77.1±7.4years). Multimodal exercise intervention includes motor activities and cognitive tasks simultaneously. The participants attended a 1-h session three times a week for 16weeks, and the control participants maintained their regular daily activities during the same period. The frontal cognitive functions were evaluated using the Frontal Assessment Battery, the Clock Drawing Test and the Symbol Search Subtest. The kinematic parameters of gait-cadence, stride length and stride speed were analyzed under two conditions: (i) free gait (single task); and (ii) gait with frontal cognitive task (walking and counting down from 20 - dual task). Results and discussion: The patients in the intervention group significantly increased the scores in frontal cognitive variables, Frontal Assessment Battery (P<0.001) and Symbol Search Subtest (P<0.001) after the 16-week period. The control group decreased the scores in the Clock Drawing Test (P=0.001) and increased the number of counting errors during the dual task (P=0.008) after the same period. Conclusion: The multimodal exercise intervention improved the frontal cognitive functions in patients with Alzheimer's disease. © 2012 Japan Geriatrics Society.
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Among the numerous coadjuvant therapies that could influence the incidence and progression of diabetic complications, antioxidants and flavonoids are currently being tested in clinical trials. We investigated the effect of quercetin on biochemical parameters in streptozotocin-induced (60 mg/kg body mass, by intraperitoneal injection) diabetic rats. A total of 32 female Wistar rats were distributed among 4 groups as follows: control (G1); control treated with quercetin (G2); diabetic (G3); and diabetic treated with quercetin (G4). Quercetin administered to pregnant diabetic rats controlled dyslipidemia and improved lipid profiles in diabetes mellitus, regulated oxidative stress by reducing the generation of lipid hydroperoxides, and increased the activity of the antioxidant enzyme glutathione peroxidase.
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Purpose: To comparatively and prospectively compare in a randomized clinical trial, dentin hypersensitivity after treatment with three in-office bleaching systems, based on hydrogen peroxide at different concentrations, with and without light source activation. Methods: 88 individuals were included according to inclusion and exclusion criteria. Subjects were randomly divided into the following three treatment groups: Group 1 was treated with three 15-minute applications of hydrogen peroxide at 15% with titanium dioxide (Lase Peroxide Lite) that was light-activated (Light Plus Whitening Lase) with five cycles of 1 minute and 30 seconds each cycle, giving a total treatment time of 45 minutes; Group 2 was treated with three 10-minute applications of hydrogen peroxide at 35% (Lase Peroxide Sensy), activated by light (LPWL) same activation cycles than Group 1, with a total treatment time of 30 minutes; Group 3 was treated with only one application for 45 minutes of hydrogen peroxide at 35% (Whitegold Office) without light activation. Each subject underwent one session of bleaching on the anterior teeth according to the manufacturers' instructions. Dentin sensitivity was recorded with a visual analogue scale (VAS) at baseline, immediately after, and at 7 and 30 days after treatment using a stimulus of an evaporative blowing triple syringe for 3 seconds on the upper central incisors from a distance of 1 cm. A Kruskal-Wallis test followed by Mann-Whitney test was performed for statistical analysis. Results: All groups showed increased sensitivity immediately after treatment. Group 1 displayed less changes relative to baseline with no significant differences (P= 0.104). At 7 and 30 days after treatment, a comparison of VAS values indicated no significant differences between all groups (P= 0.598 and 0.489, respectively).
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Anderson-Fabry disease is an X-linked defect of glycosphingolipid metabolism. Progressive renal insufficiency is a major source of morbidity, additional complications result from cardio- and cerebro-vascular involvement. Survival is reduced among affected males and symptomatic female carriers. To evaluate the effectiveness and safety of enzyme replacement therapy compared to other interventions, placebo or no interventions, for treating Anderson-Fabry disease. We searched 'Clinical Trials' on The Cochrane Library, MEDLINE, EMBASE, LILACS and the Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register (date of the most recent search: 11 September 2012). The original search was performed in September 2008.Date of the most recent search of the Cystic Fibrosis and Genetic Disorders Group's Inborn Errors of Metabolism Trials Register: 11 September 2012. Randomized controlled trials of agalsidase alfa or beta in participants diagnosed with Anderson-Fabry disease. Two authors selected relevant trials, assessed methodological quality and extracted data. Six trials comparing either agalsidase alfa or beta in 223 participants fulfilled the selection criteria.Both trials comparing agalsidase alfa to placebo reported on globotriaosylceramide concentration in plasma and tissue; aggregate results were non-significant. One trial reported pain scores, there was a statistically significant improvement for participants receiving treatment at up to three months, mean difference -2.10 (95% confidence interval (CI) -3.79 to -0.41); at up to five months, mean difference -1.90 (95% CI -3.65 to -0.15); and at up to six months, mean difference -2.00 (95% CI -3.66 to -0.34). There was a significant difference in pain-related quality of life at over five months and up to six months, mean difference -2.10 (95% CI -3.92 to -0.28) but not at other time-points. Neither trial reported deaths.One of the three trials comparing agalsidase beta to placebo reported on globotriaosylceramide concentration in plasma and tissue and showed significant improvement: kidney, mean difference -1.70 (95% CI -2.09 to -1.31); heart, mean difference -0.90 (95% CI -1.18 to -0.62); and composite results (renal, cardiac, and cerebrovascular complications and death), mean difference -4.80 (95% CI -5.45 to -4.15). There was no significant difference between groups for death; no trials reported on pain.Only one trial compared agalsidase alfa to agalsidase beta. There was no significant difference between the groups for any adverse events, risk ratio 0.36 (95% CI 0.08 to 1.59), or any serious adverse events; risk ratio 0.30; 95% CI 0.03 to 2.57). Six small, poor quality randomised controlled trials provide no robust evidence for use of either agalsidase alfa and beta to treat Anderson-Fabry disease.
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Due to shortage of time and limited availability of faculty surgeons to teach basic surgical skills during medical graduation, the search for alternative ways of simulated training with feedback is needed. The purpose of this study was to compare the simulated teaching of suture skills to novice medical students by senior medical students and by experienced faculty surgeons. Forty-eight novice medical students were randomly assigned to three practice conditions on bench model (n = 16): self-directed suture training (control), senior medical student-directed suture skills' training, or experienced faculty surgeon-directed suture skills' training. Pre- and post-tests were applied. Global Rating Scale with blinded evaluation and self-perceived confidence based on Likert scale were used to assess all suture performances in pre- and post-training. Effect size was also calculated. The analysis made after training showed that the students who received feedback from the instructors had better performance based on the Global Rating Scale (all p < 0.0000) and felt more confident to carry out sutures (all p < 0.0000) when compared to the control. There was no significant difference (all p > 0.05) between the student-directed teaching and faculty-directed teaching groups. The magnitude of the effect (instructor-directed training suture) was considered large (>0.80) in all measurements. The acquisition of suture skills after student-directed training was similar to the training supervised by faculty surgeon, and the increase in suture performances of trainees that received instructor administered training was superior to self-directed learning. © 2013 Springer-Verlag Italia.
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Pós-graduação em Bases Gerais da Cirurgia - FMB
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Pós-graduação em Anestesiologia - FMB
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Objetivo: Analisar os desfechos aumento/diminuição da pressão intracraniana e/ou queda da pressão de perfusão cerebral, proporcionados pela fisioterapia respiratória em pacientes graves assistidos em unidade de terapia intensiva. Métodos: Por meio de uma revisão sistemática da literatura, foram selecionados ensaios clínicos publicados entre 2002 e 2012. A busca envolveu as bases de dados LILACS, SciELO, MedLine e PEDro, usando os descritores physical therapy, physiotherapy, respiratory therapy e randomized controlled trials em cruzamento com o descritor intracranial pressure. Resultados: Foram incluídos 5 estudos, que somaram 164 pacientes, com média de idade entre 25 e 65 anos, e que indicaram que as manobras de fisioterapia respiratória aumentaram significativamente a pressão intracraniana, sem alterar a pressão de perfusão cerebral. Os artigos abordaram as técnicas de vibração, vibrocompressão, tapotagem, drenagem postural, além da manobra de aspiração intratraqueal. Todos os pacientes estavam sob ventilação mecânica invasiva. Conclusão: A fisioterapia respiratória promove aumento da pressão intracraniana. Os estudos sugerem que não há repercussões hemodinâmicas e respiratórias a curto prazo ou alteração da pressão de perfusão cerebral. Entretanto, não há estudos que avaliem desfechos clínicos e que assegurem a segurança das manobras.
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CONTEXTO E OBJETIVO:Gestações complicadas pelo diabetes estão associadas com aumento das complicações neonatais e maternas. A complicação mais grave materna é o risco de desenvolver diabetes tipo 2 após 10-12 anos do parto. Para o controle rigoroso da glicose no sangue, as mulheres grávidas são tratadas de forma ambulatorial ou com internações hospitalares. O objetivo deste estudo é avaliar a efetividade do tratamento ambulatorial versus hospitalização em gestações complicadas por diabetes ou hiperglicemia.TIPO DE ESTUDO E LOCAL:Revisão sistemática conduzida em hospital universitário público.MÉTODOS:Uma revisão sistemática da literatura foi realizada e as principais bases de dados eletrônicas foram pesquisadas. A data da pesquisa mais recente foi 4 de setembro de 2011. Dois autores selecionaram independentemente os ensaios clínicos relevantes, avaliaram a qualidade metodológica e extraíram os dados.RESULTADOS:Apenas três estudos foram selecionados, com tamanho de amostra pequeno. Não houve diferença estatisticamente significativa entre o tratamento ambulatorial versus hospitalização em relação à mortalidade em nenhuma das subcategorias analisadas: mortes perinatais e neonatais, (risco relativo [RR] 0,65; 95% de intervalo de confiança [IC] 0,11-3,84, P = 0,63); morte neonatal (RR 0,29, IC 95% 0,01-6,07, P = 0,43), e óbitos infantis (RR 0,29, IC 95% 0,01-6,07, P = 0,43).CONCLUSÕES:Com base em estudos com risco de viés alto ou moderado, esta revisão demonstrou que não há diferença estatisticamente significante entre o tratamento ambulatorial comparado com o hospitalar na redução das taxas de mortalidade em gestações complicadas por diabetes ou hiperglicemia. Esta revisão sistemática também sugere a necessidade de mais ensaios clínicos randomizados sobre o assunto.
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BackgroundAcute pulmonary embolism (PE) is a common cause of death, accounting for 50,000 to 200,000 deaths annually. It is the third most common cause of mortality among the cardiovascular diseases, after coronary artery disease and stroke.The advent of multi-detector computed tomographic pulmonary angiography (CTPA) has allowed better assessment of PE regarding visualisation of the peripheral pulmonary arteries, increasing its rate of diagnosis. More cases of peripheral PEs, such as isolated subsegmental PE (SSPE) and incidental PE, have thereby been identified. These two conditions are usually found in patients with few or none of the classic PE symptoms such as haemoptysis or pleuritic pain, acute dyspnoea or circulatory collapse. However, in patients with reduced cardio-pulmonary (C/P) reserve the classic PE symptoms can be found with isolated SSPEs. Incidental SSPE is found casually in asymptomatic patients, usually by diagnostic imaging performed for other reasons (for example routine CT for cancer staging in oncologic patients).Traditionally, all PEs are anticoagulated in a similar manner independent of the location, number and size of the thrombi. It has been suggested that many patients with SSPE may be treated without benefit, increasing adverse events by possible unnecessary use of anticoagulants.Patients with isolated SSPE or incidental PE may have a more benign clinical presentation compared with those with proximal PEs. However, the clinical significance in patients and their prognosis have to be studied to evaluate whether anticoagulation therapy is required.ObjectivesTo assess the effectiveness and safety of anticoagulation therapy versus no intervention in patients with isolated subsegmental pulmonary embolism (SSPE) or incidental SSPE.Search methodsThe Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched October 2013) and CENTRAL (2013, Issue 9). MEDLINE, EMBASE, LILACS and clinical trials databases were also searched (October 2013).Selection criteriaRandomised controlled trials of anticoagulation therapy versus no intervention in patients with SSPE or incidental SSPE.Data collection and analysisTwo review authors inspected all citations to ensure reliable selection. We planned for two review authors to independently extract data and to assess the methodological quality of identified trials using the criteria recommended in the Cochrane Handbook for Systematic Reviews of Interventions.Main resultsNo studies were identified that met the inclusion criteria.Authors' conclusionsThere is no randomised controlled trial evidence for the effectiveness and safety of anticoagulation therapy versus no intervention in patients with isolated subsegmental pulmonary embolism (SSPE) or incidental SSPE, and therefore we can not draw any conclusions. Well-conducted research is required before informed practice decisions can be made.
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SynopsisBackgroundCellulite refers to skin relief alterations in womens thighs and buttocks, causing dissatisfaction and search for treatment. Its physiopathology is complex and not completely understood. Many therapeutic options have been reported with no scientific evidence about benefits. The majority of the studies are not controlled nor randomized; most efficacy endpoints are subjective, like not well-standardized photographs and investigator opinion. Objective measures could improve severity assessment. Our purpose was to correlate non-invasive instrumental measures and standardized clinical evaluation.MethodsTwenty six women presenting cellulite on buttocks, aged from 25 to 41, were evaluated by: body mass index; standardized photography analysis (10-point severity and 5-point photonumeric scales) by five dermatologists; cutometry and high-frequency ultrasonography (dermal density and dermis/hypodermis interface length). Quality of life impact was assessed. Correlations between clinical and instrumental parameters were performed.ResultsGood agreement among dermatologists and main investigator perceptions was detected. Positive correlations: body mass index and clinical scores; ultrasonographic measures. Negative correlation: cutometry and clinical scores. Quality of life score was correlated to dermal collagen density.ConclusionCellulite caused impact in quality of life. Poor correlation between objective measures and clinical evaluation was detected. Cellulite severity assessment is a challenge, and objective parameters should be optimized for clinical trials.
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Background: The management of aggressive periodontitis (AgP) represents a challenge for clinicians because there are no standardized protocols for an efficient control of the disease. This randomized controlled clinical trial evaluated the effects of repeated applications of antimicrobial photodynamic therapy (aPDT) adjunctive to scaling and root planing (SRP) in patients with AgP. Methods: Using a split-mouth design, 20 patients with generalized AgP were treated with aPDT + SRP (test group) or SRP only (control group). aPDT was applied at four periods. All patients were monitored for 90 days. Clinical, microbiologic, and immunologic parameters were statistically analyzed. Results: In deep periodontal pocket analysis (probing depth [PD] >= 7 mm at baseline), the test group presented a decrease in PD and a clinical attachment gain significantly higher than the control group at 90 days (P < 0.05). The test group also demonstrated significantly less periodontal pathogens of red and orange complexes and a lower interleukin-1 beta/interleukin-10 ratio than the control group (P < 0.05). Conclusion: The application of four sessions of aPDT, adjunctive to SRP, promotes additional clinical, microbiologic, and immunologic benefits in the treatment of deep periodontal pockets in single-rooted teeth in patients with AgP.
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Background: Pulmonary embolism (PE) is a common life-threatening cardiovascular condition, with an incidence of 23 to 69 new cases per 100,000 people per year. Outpatient treatment instead of traditional inpatient treatment in selected non-high-risk patients with acute PE might provide several advantages, such as reduction of hospitalizations, substantial cost saving and an improvement in health-related quality of life. Objectives: To compare the efficacy and safety of outpatient versus inpatient treatment for acute PE for the outcomes of all-cause and PE-related mortality; bleeding; and adverse events such as hemodynamic instability, recurrence of PE and patients'satisfaction.Search methodsThe Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched October 2014) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 9). The TSC also searched clinical trials databases. The review authors searched LILACS (last searched November 2014). Selection criteria: Randomized controlled trials of outpatient versus inpatient treatment in people diagnosed with acute PE. Data collection and analysis: Two review authors selected relevant trials, assessed methodological quality, and extracted and analyzed data. Main results: We included one study, involving 339 participants. We ranked the quality of the evidence as very low due to not blinding the outcome assessors, the small number of events with imprecision in the confidential interval (CI), the small sample size and it was not possible to verify publication bias. For all outcomes, the CIs were wide and included clinically significant treatment effects in both directions: short-term mortality (30 days) (RR 0.33, 95% CI 0.01 to 7.98, P = 0.49), long-term mortality (90 days) (RR 0.98, 95% CI 0.06 to 15.58, P = 0.99), major bleeding at 14 days (RR 4.91, 95% CI 0.24 to 101.57, P = 0.30) and 90 days (RR 6.88, 95% CI 0.36 to 134.14, P = 0.20), recurrent PE within 90 days (RR 2.95, 95% CI 0.12 to 71.85, P = 0.51) and participant satisfaction (RR 0.97, 95% CI 0.92 to 1.03, P = 0.30). PE-related mortality, minor bleeding, and adverse course such as hemodynamic instability and compliance were not assessed by the single included study. Authors' conclusions: Current very low quality evidence from one published randomized controlled trial did not provide sufficient evidence to assess the efficacy and safety of outpatient versus inpatient treatment for acute PE in overall mortality, bleeding and recurrence of PE adequately. Further well-conducted research is required before informed practice decisions can be made.