926 resultados para Phase-1 Clinical-trial


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This study evaluated whether the use of continuous positive airway pressure (CPAP) in the delivery room alters the need for mechanical ventilation and surfactant during the first 5 days of life and modifies the incidence of respiratory morbidity and mortality during the hospital stay. The study was a multicenter randomized clinical trial conducted in five public university hospitals in Brazil, from June 2008 to December 2009. Participants were 197 infants with birth weight of 1000-1500 g and without major birth defects. They were treated according to the guidelines of the American Academy of Pediatrics (APP). Infants not intubated or extubated less than 15 min after birth were randomized for two treatments, routine or CPAP, and were followed until hospital discharge. The routine (n=99) and CPAP (n=98) infants studied presented no statistically significant differences regarding birth characteristics, complications during the prenatal period, the need for mechanical ventilation during the first 5 days of life (19.2 vs 23.4%, P=0.50), use of surfactant (18.2 vs 17.3% P=0.92), or respiratory morbidity and mortality until discharge. The CPAP group required a greater number of doses of surfactant (1.5 vs 1.0, P=0.02). When CPAP was applied to the routine group, it was installed within a median time of 30 min. We found that CPAP applied less than 15 min after birth was not able to reduce the need for ventilator support and was associated with a higher number of doses of surfactant when compared to CPAP applied as clinically indicated within a median time of 30 min.

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Contextualização:Ações concêntricas apresentam maior estresse cardiovascular quando comparadas às excêntricas. Entretanto, não se sabe a influência desses tipos de ações no comportamento da modulação autonômica cardíaca durante o processo de recuperação pós-esforço.Objetivo:Comparar o efeito de um treinamento resistido para o grupo extensor do joelho realizado com ênfase concêntrica vs excêntrica sobre a força muscular e a recuperação pós-exercício considerando índices de variabilidade de frequência cardíaca (VFC) em jovens saudáveis.Método:Cento e cinco homens, com idades entre 18 e 30 anos, foram randomizados em quatro grupos: controle concêntrico (CCONC), controle excêntrico (CEXC), treinamento concêntrico (TCONC) e treinamento excêntrico (TEXC). Os grupos CCONC e CEXC realizaram uma sessão de exercício reduzido (ER) para o grupo extensor do joelho [três séries de uma repetição a 100% de uma repetição máxima (1RM)], e os grupos TCONC e TEXC realizaram dez sessões de treinamento. A VFC foi analisada no momento basal e na recuperação após as sessões (T1, T2, T3 e T4).Resultados:Observou-se aumento da força muscular para o grupo TEXC. Em relação à modulação autonômica cardíaca, observou-se, em comparação ao momento basal, aumento dos índices SDNN e SD2 no momento T1 nos grupos CCONC e CEXC e aumento dos índices RMSSD, SD1 e AF (ms2) nos momentos T1, T2 e T4 no grupo TEXC.Conclusões:Conclui-se que o treinamento resistido realizado com ênfase em contrações excêntricas promoveu ganho de força e aumento da modulação vagal cardíaca durante o processo de recuperação em relação à condição basal.

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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)

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Objective: The aim of this study was to evaluate the 2-year clinical performance of class II restorations made with a composite resin with two different viscosities.Methods: 47 patients received two class II restorations (n = 94), one made with GrandioSO (conventional viscosity CV), and the other with GrandioSO Heavy Flow (flowable viscosity FV), subjecting both materials to the same clinical conditions. The self-etching adhesive Futurabond M was used for all restorations. The composites were inserted using the incremental technique. The restorations were evaluated using the modified USPHS criteria according to the periods: baseline, 6 months, 1 year and 2 years after restorative procedures.Results: After 24 months, 40 patients attended the recall and 78 restorations were evaluated. In all periods, no secondary caries was observed. After 6 months, there were slightly overall changes of scores for most parameters. After 24 months, the higher number of changes from score Alfa to Bravo was observed for marginal discolouration (32.5% CV and 39.5% FV) and colour match (15% CV and 31.6% FV), followed by proximal contact (25% CV and 23.7% FV) and marginal adaptation (20% CV and 21.1% FV). For wear, surface texture and postoperative sensitivity the changes were very small. Just two restorations were lost during the 24-month follow up. Less than 5% of all restorations showed postoperative sensitivity. Chi-square test showed no significant differences between the two materials for all parameters analysed.Conclusion: After 2 years of clinical service, no significant differences were observed between GrandioSO conventional and GrandioSO Heavy Flow for the parameters analysed. Both materials provided acceptable clinical behaviour in class II restorations. Clinical Significance: This study presents the possibility of using a flowable composite with high filler content, for performing class II restorations. (C) 2014 Elsevier Ltd. All rights reserved.

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Painful bladder syndrome associated with interstitial cystitis (PBS/IC) is a clinical condition characterized pelvic pain, urinary urgency, and urinary frequency. In this study, 22 patients were assigned to make two visits over a three weeks period. The patients were randomly, double-blinded assigned in two groups. The first group received Cystex® capsules. The second group received placebo capsules. Two capsules were taken three times a day away from meals. The change from baseline in the O’Leary-Sant IC symptom and problem index was the primary outcome parameter. Changes in functional bladder capacity and intensity of pain and urgency have been chosen as secondary outcome parameters. Mood as well as physical and sexual activity were rated by 10 questions on a scale 0 to 6. The ratings were analyzed and the average for each patient in both groups Cystex® and placebo was determined as the quality of life index. For the primary outcome there was a statistically significant difference between the groups. Mean symptom score-sum decreased from 28.4 to 20.5 in the Cystex® group compared with 29.5 to 26.8 in the placebo group (p<0.05). For the secondary end points, pain and urgency intensity improved statistically significantly in the Cystex® group compared with the placebo group (p<0.05). The frequency and functional bladder capacity improved to greater degree in the Cystex® group. The differences were statistically significant for comparison of frequency (p<0.05) and not for functional bladder capacity (p>0.05). In our study, Cystex® enhanced quality of life over the placebo showing a statistically significant. This trial have shown that the efficacy and safety of therapy with Cystex® in the treatment of interstitial cystitis and is an alternative for patients suffering from this pathology. Therefore, it can be concluded that the composition of Cystex®, increased the quality of life in treated patients.

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

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Objective: To investigate the effects of elastic tubing training compared with conventional resistance training on the improvement of functional exercise capacity, muscle strength, fat-free mass, and systemic inflammation in patients with chronic obstructive pulmonary disease.Design: A prospective, randomized, eight-week clinical trial.Setting: The study was conducted in a university-based, outpatient, physical therapy clinic.Subjects: A total of 49 patients with moderate chronic obstructive pulmonary disease.Interventions: Participants were randomly assigned to perform elastic tubing training or conventional resistance training three times per week for eight weeks.Main measures: The primary outcome measure was functional exercise capacity. The secondary outcome measures were peripheral muscle strength, health-related quality of life assessed by the Chronic Respiratory Disease Questionnaire (CRDQ), fat-free mass, and cytokine profile.Results: After eight weeks, the mean distance covered during six minutes increased by 73 meters (69) in the elastic tubing group and by 42 meters (+/- 59) in the conventional group (p < 0.05). The muscle strength and quality of life improved in both groups (P < 0.05), with no significant differences between the groups. There was a trend toward an improved fat-free mass in both groups (P = 0.05). After the first and last sessions, there was an increase in interleukin 1 (IL-1) and interleukin 10 (IL-10) in both groups, while tumour necrosis factor alpha (TNF-) was stimulated only in the conventional training group.Conclusion: Elastic tubing training had a greater effect on functional exercise capacity than conventional resistance training. Both interventions were equally effective in improving muscle strength and quality of life.

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Statement of problem Masticatory performance analysis of conventional complete denture wearers who use denture adhesives is scarce in the dental literature. Purpose The purpose of this study was to assess the effect of the use of 2 denture adhesives on the masticatory performance of conventional complete denture wearers by means of a crossover study. Material and methods Forty individuals who were edentulous received new maxillary and mandibular complete dentures, and, after an adaptation period, were submitted to masticatory performance analysis without denture adhesive (control). The participants were randomly divided and assigned to 2 protocols: protocol 1, denture adhesive 1 (Ultra Corega cream tasteless) use during the first 15 days, followed by no use of denture adhesive over the next 15 days (washout), and then use of denture adhesive 2 (Ultra Corega powder tasteless) for 15 days; protocol 2, denture adhesive 2 (Ultra Corega powder tasteless) use during the first 15 days, followed by no use of denture adhesive during the next 15 days (washout), and then use of denture adhesive 1 (Ultra Corega cream tasteless) for 15 days. The masticatory performance was assessed immediately after the use of denture adhesive by means of the sieve method, in which participants were instructed to deliberately chew 5 almonds for 20 chewing strokes. Masticatory performance was calculated by the weight of comminuted material that passed through the sieves. Data were analyzed by a 1-way ANOVA for paired samples and the multiple comparison of means by using the Bonferroni test (α=.05). Results A significant increase in masticatory performance was noted after using the Ultra Corega cream (mean, 32.6%) and Ultra Corega powder (mean, 31.2%) when compared with the control group (mean, 19.8%) (P<.001). No significant difference was found between the 2 denture adhesives evaluated. Conclusion The use of denture adhesive improved the masticatory performance of conventional complete denture wearers. No difference was found in masticatory performance with the use of cream or powder denture adhesive.

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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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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

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Prolonged intermittent renal replacement therapy (PIRRT) has emerged as an alternative to continuous renal replacement therapy in the management of acute kidney injury (AKI) patients. This trial aimed to compare the dialysis complications occurring during different durations of PIRRT sessions in critically ill AKI patients. We included patients older than 18 years with AKI associated with sepsis admitted to the intensive care unit and using noradrenaline doses ranging from 0.3 to 0.7 mu g/kg/min. Patients were divided into two groups randomly: in G1, 6-h sessions were performed, and in G2, 10-h sessions were performed. Seventy-five patients were treated with 195 PIRRT sessions for 18 consecutive months. The prevalence of hypotension, filter clotting, hypokalemia, and hypophosphatemia was 82.6, 25.3, 20, and 10.6%, respectively. G1 was composed of 38 patients treated with 100 sessions, whereas G2 consisted of 37 patients treated with 95 sessions. G1 and G2 were similar in male predominance (65.7 vs. 75.6%, P=0.34), age (63.6 +/- 14 vs. 59.9 +/- 15.5 years, P=0.28) and Sequential Organ Failure Assessment score (SOFA; 13.1 +/- 2.4 vs. 14.2 +/- 3.0, P=0.2). There was no significant difference between the two groups in hypotension (81.5 vs. 83.7%, P=0.8), filter clotting (23.6 vs. 27%, P=0.73), hypokalemia (13.1 vs. 8.1%, P=0.71), and hypophosphatemia (18.4 vs. 21.6%, P=0.72). However, the group treated with sessions of 10h were refractory to clinical measures for hypotension, and dialysis sessions were interrupted more often (9.5 vs. 30.1%, P=0.03). Metabolic control and fluid balance were similar between G1 and G2 (blood urea nitrogen [BUN]: 81 +/- 30 vs. 73 +/- 33mg/dL, P=1.0; delivered Kt/V: 1.09 +/- 0.24 vs. 1.26 +/- 0.26, P=0.09; actual ultrafiltration: 1731 +/- 818 vs. 2332 +/- 947mL, P=0.13) and fluid balance (-731 +/- 125 vs. -652 +/- 141mL, respectively) . In conclusion, intradialysis hypotension was common in AKI patients treated with PIRRT. There was no difference in the prevalence of dialysis complications in patients undergoing different durations of PIRRT.

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