177 resultados para double-blind method


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Objective: The aim of this study was to evaluate the effect of carbohydrate or glutamine supplementation, or a combination of the two, on the immune system and inflammatory parameters after exercise in simulated hypoxic conditions at 4500 m.Methods: Nine men underwent three sessions of exercise at 70% VO2(peak) until exhaustion as follows: 1) hypoxia with a placebo; 2) hypoxia with 8% maltodextrin (200 mL/20 min) during exercise and for 2 h after; and 3) hypoxia after 6 d of glutamine supplementation (20 g/d) and supplementation with 8% maltodextrin (200 mL/20 min) during exercise and for 2 h after. All procedures were randomized and double blind. Blood was collected at rest, immediately before exercise, after the completion of exercise, and 2 h after recovery. Glutamine, cortisol, cytokines, glucose, heat shock protein-70, and erythropoietin were measured in serum, and the cytokine production from lymphocytes was measured.Results: Erythropoietin and interleukin (IL)-6 increased after exercise in the hypoxia group compared with baseline. IL-6 was higher in the hypoxia group than pre-exercise after exercise and after 2 h recovery. Cortisol did not change, whereas glucose was elevated post-exercise in the three groups compared with baseline and pre-exercise. Glutamine increased in the hypoxia + carbohydrate + glutamine group after exercise compared with baseline. Heat shock protein-70 increased post-exercise compared with baseline and pre-exercise and after recovery compared with pre-exercise, in the hypoxia carbohydrate group. No difference was observed in IL-2 and IL-6 production from lymphocytes. IL-4 was reduced in the supplemented groups.Conclusion: Carbohydrate or glutamine supplementation shifts the T helper (Th)1/Th2 balance toward Th1 responses after exercise at a simulated altitude of 4500 m. The nutritional strategies increased in IL-6, suggesting an important anti-inflammatory effect. (C) 2014 Elsevier Inc. All rights reserved.

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Purpose - The purpose of this paper is twofold: to analyze the computational complexity of the cogeneration design problem; to present an expert system to solve the proposed problem, comparing such an approach with the traditional searching methods available.Design/methodology/approach - The complexity of the cogeneration problem is analyzed through the transformation of the well-known knapsack problem. Both problems are formulated as decision problems and it is proven that the cogeneration problem is np-complete. Thus, several searching approaches, such as population heuristics and dynamic programming, could be used to solve the problem. Alternatively, a knowledge-based approach is proposed by presenting an expert system and its knowledge representation scheme.Findings - The expert system is executed considering two case-studies. First, a cogeneration plant should meet power, steam, chilled water and hot water demands. The expert system presented two different solutions based on high complexity thermodynamic cycles. In the second case-study the plant should meet just power and steam demands. The system presents three different solutions, and one of them was never considered before by our consultant expert.Originality/value - The expert system approach is not a "blind" method, i.e. it generates solutions based on actual engineering knowledge instead of the searching strategies from traditional methods. It means that the system is able to explain its choices, making available the design rationale for each solution. This is the main advantage of the expert system approach over the traditional search methods. On the other hand, the expert system quite likely does not provide an actual optimal solution. All it can provide is one or more acceptable solutions.

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We assessed the effect of the topical application of epsilon-aminocaproic antifibrinolytic acid (EACA) on the pericardium of patients submitted to coronary artery bypass graft (CABG) without the use of cardiopulmonary bypass (CPB). This is a prospective, randomized, and double-blind study. We evaluated 26 patients with chronic coronary heart disease indicated for CABG without CPB (EACA and placebo groups). The analysis of the postoperative hematological results showed no difference between groups in hemoglobin and hematocrit. There was no difference between the groups regarding the postoperative bleeding through the drains in the first 24 hours, 48 hours, and accumulated loss until removal of drains. The use of EACA in patients undergoing CABG without CPB presented no difference in the reduction of the amount of bleeding and the need for blood transfusions.

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

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Pós-graduação em Bases Gerais da Cirurgia - FMB

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Objective: To compare the efficacy of the mouthwashes 0.12% chlorhexidine, Listerine, and 0.5% and 2% Melaleuca Alternifolia oil against the salivary levels of Streptococcus mutans and total microorganisms. Methods: This study was double-blind controlled and paired clinical assay. Twenty-six volunteers aged 21 to 35 years old were enrolled. At baseline, 1 mL of unstimulated saliva was collected from each subject, 1 and 15 min after mouthrinsing with the following solutions: sterile distilled water, 0.12% chlorhexidine digluconate, Listerine (©Johnson & Johnson do Brasil), 0.5% and 2% concentrations of Melaleuca Alternifolia (Sigma-Aldrich). The volunteers used all the evaluated mouthrinses with a 15-day interval between the solutions. Immediately after rinsing, saliva was collected and serial dilutions were performed, followed by plating in blood agar culture medium for growth of total microorganisms and SB-20 (Sucrose-Bacitracin agar) for growth of S. mutans, and incubation at 37 °C for 48 h in microaerophilia. After incubation, the number of colonies was counted and expressed as colony forming units (UFC/mL). Results: Chlorhexidine showed antimicrobial action by reducing total microorganisms and S. mutans, while the action of 0.5% Melaleuca Alternifolia was similar to that of distilled water. Listerine and 2% Melaleuca Alternifolia oil reduced total microbial counts by 11% and 9% respectively, and S. mutans by 20% and 11%. Conclusion: A single rinse with 0.12% chlorhexidine is effective in reducing the levels of total microorganisms and S. mutans present in saliva. Under the same testing conditions, Listerine and 0.5% and 2% Melaleuca Alternifolia oil presented lower efficacy than chlorhexidine.

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The aim of this double-blind clinical trial was to assess the longevity of repairs to localized clinical defects in composite resin restorations that were initially planned to be treated with a restoration replacement. Methods Twenty-eight patients aged 18–80 years old with 50 composite resin restorations (CR) were recruited. The restorations with localized, marginal, anatomical deficiencies and/or secondary caries adjacent to CR that were “clinically judged” to be suitable for repair or replacement according to the USPHS criteria were randomly assigned to Repair (n = 25) or Replacement (n = 25) groups, and the quality of the restorations was scored according to the modified USPHS criteria. The restorations were blind and two examiners scored them at baseline (Cohen Kappa agreement score 0.74) and at ten years (Cohen Kappa agreement score 0.87) restorations. Wilcoxon tests were performed for comparisons within the same group (95% CI), and Friedman tests were utilized for multiple comparisons between the different years within each group. Results Over the decade, the two groups behaved similarly on the parameters of marginal adaptation (MA) (p > 0.05), secondary caries (SC) (p > 0.05), anatomy (A) (p < 0.05), and colour (C) (p > 0.05). Conclusions Given that the MA, SC, A and C parameters behaved similarly in both groups, the repair of composite resins should be elected when clinically indicated, because it is a minimally invasive treatment that can consistently increase the longevity of restorations. Clinical significance The repair of defective composite resins as an alternative treatment to increase their longevity proved to be a safe and effective treatment in the long term.

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This study aimed to evaluate saliva and plaque as indicators of intraoral fluoride (F) levels after the use of conventional and high-fluoride dentifrices.Subjects were randomly assigned to brush their teeth with conventional (1000 ppm F), high-fluoride (5000 ppm F), and placebo dentifrices (fluoride free) for 10 days, following a double-blind, crossover protocol. Saliva and plaque samples were collected on the morning of the 5(th) and 10th days, respectively at 1 and 12 h after brushing, and analyzed with an ion-selective electrode after HMDS-facilitated diffusion. Data were analyzed by two-way repeated measures ANOVA, Tukey's test and Spearman's correlation coefficient (p < 0.05).Plaque and salivary F levels were significantly increased after the use of conventional and high-fluoride dentifrices when compared to values obtained for placebo, except plaque 12 h after the use of conventional dentifrice. A positive and significant correlation was found between fluoride concentrations in plaque and saliva for both times of sample collection.Both indicators assessed were able to detect significant differences among treatments and between times after brushing. The use of a high-fluoride dentifrice is able to significantly increase intraoral fluoride levels throughout the day, being therefore a useful therapy for patients at high caries risk.A dentifrice with high fluoride concentration could be regarded as a useful therapy of F delivery for high caries-risk patients, since intraoral F levels were sustained throughout most of the day after using this formulation.

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The long-term efficacy and safety of intravenous abatacept in patients (pts) with juvenile idiopathic arthritis (JIA) have been reported previously from the Phase III AWAKEN trial ([1, 2]). Here, we report efficacy, safety and pt-reported outcomes from the open-label, long-term extension (LTE) of AWAKEN, with up to 7 years of follow-up. Pts entered the LTE if they were JIA ACR 30 non-responders (NR) at the end of the 4-month lead-in period (abatacept only), or if they received abatacept or placebo (pbo) in the 6-month double-blind (DB) period. The Child Health Questionnaire was used to evaluate health-related quality of life (HRQoL); physical (PhS) and psychosocial (PsS) summary and pain scores were analyzed. Pain was assessed by parent global assessment using a 100 mm visual analog scale. Efficacy and HRQoL evaluations are reported up to Day 1765 (~ Year 5.5). Safety is presented for the cumulative period (lead-in, DB and LTE), for all pts who received abatacept during the LTE. Of the 153 pts entering the LTE (58 from DB abatacept group, 59 from DB pbo group, 36 NR), 69 completed the trial (29 abatacept, 27 pbo, 13 NR). For pts treated in the LTE, mean (range) exposure to abatacept was 53.6 (5.6–85.6) months. During the LTE, incidence rates of AEs and serious AEs per 100 pt-years were 209.1 and 5.6. Thirty pts (19.6%) had serious AEs; most were unrelated and were musculoskeletal (8.5%) or infectious events (6.5%). No malignancy was reported. There was one death (accidental; unrelated). At Day 169, JIA ACR 50 and 70 response rates were 79.3% and 55.2% in the abatacept group, and 52.5% and 30.5% in the pbo group; 31.0% and 10.2% of pts in the abatacept and pbo groups, respectively, had inactive disease. By Day 1765, JIA ACR 50 and 70 response rates were 93.9% and 78.8% in the abatacept group, and 80.0% and 63.3% in the pbo group; 51.5% and 33.3% had inactive disease. In the NR group, 69.2% and 53.8% of pts achieved JIA ACR 50 and 70 responses at Day 1765, and 30.8% had inactive disease. In pts who entered the LTE, mean baseline PhS scores were below the range for healthy children (abatacept 30.2, pbo 31.0, NR 29.5). At Day 169, 38.3% of pts had reached a PhS score >50 ((1). By the end of the LTE, 43.5% of pts had reached a PhS score >50. At baseline, mean PsS scores for those who entered the LTE were slightly lower than the mean for healthy children (abatacept 43.5, pbo 44.2, NR 47.0). At Day 169, 54.9% of pts had a PsS score >50 (1). By Day 1765, 58.1% of pts had reached a PsS score >50. At baseline, the mean pain score was 42.9. By Day 169, 13.9% of pts were considered pain free (pain score = 0); this was maintained over the LTE (1).

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The objective of this study was to assess the effect of 0.05% sodium fluoride solutions containing 2.5% or 12.5% xylitol on the number of Streptococcus mutans in the human mouth. Fifty boys between 8 and 16 years of age participated in this double-blind crossover study. Of the original 50 boys, 33 finished the study. Participants were randomly divided into four groups. The following solutions were employed: placebo solution; 0.05% sodium fluoride solution; 0.05% sodium fluoride + 2.5% xylitol + 2% sorbitol; 0.05% sodium fluoride + 12.5% xylitol + 2% sorbitol. Each solution was used for a 28-day period (20 mL/day, twice a day), with a 10-day washout period between solutions. There were no significant differences (P = 0.32) between the two xylitol-containing solutions (2.5% vs. 12.5%) concerning the number of Streptococcus mutans. However, there was a significant difference between these two xylitol-containing solutions and the sodium fluoride and placebo solutions (P < 0.001). Our results suggest that the 0.05% sodium fluoride solutions containing either 2.5% or 12.5% xylitol caused a significant reduction in the number of Streptococcus mutans.

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)