916 resultados para major clinical study


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

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Falls among older people is a major clinical problem due to its high incidence, with consequent implications for the health and care costs. Elderly patients with dementia of Alzheimer type (AD) are more susceptible to falls due to the impairment of executive functions and gait, with the risk of falls 3 times higher than non-demented elderly. This study used a longitudinal design and aimed to analyze the effects of a regular and systematized physical activity program on the frequency of falls in patients with AD. Additionally, we aimed to correlate the frequency of falls with the executive functions and equilibrium, after and before the physical activity program. The study included 21 patients with clinical diagnosis of AD, divided into two groups: control group (CG), composed of 11 subjects not engaged in any systematized physical activity and training group (TG): 10 seniors who participated in the Cinesioterapia Functional and Cognitive in Elderly with Alzheimer's disease program (PRO-CDA). The physical activity program lasted four months, with weekly frequency of three times, with each session lasting 60 minutes. Were administered the Mini-Mental State Examination (MMSE) to assess cognitive functioning and global score of the Clinical Dementia Rating (CDR) to classify the severity of dementia. For the evaluation of executive functions were used the Clock Drawing Test (TDR) and Frontal Assessment Battery (FAB). In addition, we used the Functional Balance Scale, Berg test (EEFB) and Timed Up-and-Go (TUG) to assess the equilibrium and risk of falls. Falls were recorded by means of a questionnaire, which included the number of falls in the last four months. Analyzing the results, it was observed that TG obtained significant improvements in equilibrium and in executive functions, highlighting the beneficial effects of physical activity in these variables... (Complete abstract click electronic access below)

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES

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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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Context: The possibility of bleaching vital teeth with peroxide-based products considerably revolutionized esthetic dentistry. Aim: The aim of this clinical study was to evaluate tooth color change and dental sensitivity after exposure to preloaded film containing a 10% hydrogen peroxide whitening system (Opalescence Trθswhite Supreme). Materials and Methods: A total of 13 volunteers, aged 18 to 25 years, participated in this study. The patients used the whitening system once a day for 60 minutes during the 8-day study. For maxillary incisors and canines, the color change was visually evaluated with the Vita color scale before, immediately, and six months after the treatment. Tooth sensitivity was evaluated during the daily gel applications. All whitening applications were done in office and under the supervision of a dental professional. Statistical Analysis Used: The results were analyzed using the Friedman Test (nonparametric repeated measures ANOVA) at a level of 5%, and Dunn's Multiple Comparison Test at the level of 5%. Results: It was verified that the original mean color values observed at the baseline analysis differed significantly from those observed immediately after bleaching, as well as from those seen in the analysis at six months ( P = 0.001). There was no significant difference between the mean color values observed in the immediate time and in the analysis at six months ( P = 0.474). No tooth sensitivity was observed in any patients. Conclusion: It was concluded that the bleaching technique using the 10% hydrogen peroxide system was effective in a short period of time without tooth sensitivity during applications.

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Objective: Based on evidence showing that electrical stimulation of the nervous system is an effective method to decrease chronic neurogenic pain, we aimed to investigate whether the combination of 2 methods of electrical stimulation-a method of peripheral stimulation [transcutaneous electrical nerve stimulation (TENS)] and a method of noninvasive brain stimulation (transcranial direct current stimulation (tDCS)]-induces greater pain reduction as compared with tDCS alone and sham stimulation. Methods: We performed a preliminary, randomized, sham-controlled, crossover, clinical study in which 8 patients were randomized to receive active tDCS/active TENS (""tDCS/TENS"" group), active tDCS/sham TENS (""tDCS"" group), and sham tDCS/sham TENS (""sham"" group) stimulation. Assessments were performed immediately before and after each condition by a blinded rater. Results: The results showed that there was a significant difference in pain reduction across the conditions Of stimulation (P = 0.006). Post hoc tests showed significant pain reduction as compared with baseline after the tDCS/TENS condition [reduction by 36.5% (+/- 10.7), P = 0.004] and the tDCS condition [reduction by 15.5% (+/- 4.9), P = 0.014], but not after sham stimulation (P = 0.35). In addition, tDCS/TENS induced greater pain reduction than tDCS (P = 0.02). Conclusions: The results of this pilot study suggest that the combination of TENS with tDCS has a superior effect compared with tDCS alone.

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Dentine hypersensitivity (DH) is a painful condition and is a clinical challenge due to the different treatment strategies available. High-intensity lasers have been studied as a possible option. The aim of this randomized, controlled, double-blind clinical study was to evaluate the effects of Er:YAG and Er,Cr:YSGG lasers on DH. The study group comprised 28 subjects who met the inclusion criteria. A visual analogue scale was used to quantify sensitivity before treatment as baseline, immediately before and immediately after treatment, and 1 week and 1 month after treatment. Teeth were assigned to four groups: group 1 control (no treatment), group 2 Er:YAG laser treatment (2 Hz/32.4 mJ/5.9 J/cm(2)), group 3 Er,Cr:YSGG laser treatment (0.25 W/4.4 J/cm(2)), and group 4 Er,Cr:YSGG laser treatment (0.50 W/ 8.9 J/cm(2)). Data were collected and submitted to statistical analysis for both evaporative (air) and mechanical (probe) stimulation. For both the air and probe stimulation no differences were observed between the pretreatment sensitivities. With the evaporative stimulus, the pain level immediately after treatment was reduced; however, after this the values remained stable. Irradiation with the Er:YAG laser was associated with the lowest level of pain. With the mechanical stimulus, group 4 showed the most pronounced decrease in pain immediately after treatment; however, by the end of the study, pain levels had increased. Groups 1, 2 and 3 showed a reduction in pain that was significantly different from that in group 4 after the 4 weeks of clinical follow up. Based on the results and within the limits of this study, it can be concluded that none of the laser treatments studied was capable of completely eliminating pain, but the Er:YAG and Er,Cr:YSGG lasers are suitable for the treatment of DH.

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Introduction: Denosumab, a fully human anti-RANKL monoclonal antibody, reduces the incidence of skeletal-related events in patients with bone metastases from solid tumors. We present survival data for the subset of patients with lung cancer, participating in the phase 3 trial of denosumab versus zoledronic acid (ZA) in the treatment of bone metastases from solid tumors (except breast or prostate) or multiple myeloma. Methods: Patients were randomized 1:1 to receive monthly subcutaneous denosumab 120 mg or intravenous ZA 4 mg. An exploratory analysis, using Kaplan-Meier estimates and proportional hazards models, was performed for overall survival among patients with non-small-cell lung cancer (NSCLC) and SCLC. Results: Denosumab was associated with improved median overall survival versus ZA in 811 patients with any lung cancer (8.9 versus 7.7 months; hazard ratio [HR] 0.80) and in 702 patients with NSCLC (9.5 versus 8.0 months; HR 0.78) (p = 0.01, each comparison). Further analysis of NSCLC by histological type showed a median survival of 8.6 months for denosumab versus 6.4 months for ZA in patients with squamous cell carcinoma (HR 0.68; p = 0.035). Incidence of overall adverse events was balanced between treatment groups; serious adverse events occurred in 66.0% of denosumab-treated patients and 72.9% of ZA-treated patients. Cumulative incidence of osteonecrosis of the jaw was similar between groups (0.7% denosumab versus 0.8% ZA). Hypocalcemia rates were 8.6% with denosumab and 3.8% with ZA. Conclusion: In this exploratory analysis, denosumab was associated with improved overall survival compared with ZA, in patients with metastatic lung cancer.

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There is no consensus in the literature about the impact of complete denture wear on obstructive sleep apnea (OSA). The goal of this randomized clinical study was to assess if complete denture wear during sleep interferes with the quality of sleep. Elderly edentulous OSA patients from a complete denture clinic were enrolled and received new complete dentures. An objective sleep analysis was determined with polysomnography performed at the sleep laboratory for all patients who slept either with or without their dentures. Twenty-three patients (74% females) completed the study with a mean age of 69.6 years and a mean body mass index of 26.7 kg/m(2). The apnea and hypopnea index (AHI) was significantly higher when patients slept with dentures compared to without (25.9 +/- 14.8/h vs. 19.9 +/- 10.2/h; p > 0.005). In the mild OSA group, the AHI was significantly higher when patients slept with the dentures (16.6 +/- 6.9 vs. 8.9 +/- 2.4; p < 0.05), while in moderate to severe OSA patients, the AHI was not significantly different when sleeping with dentures (.30.8 +/- 15.6 vs. 25.7 +/- 7.5; p = 0.2). The supine AHI in mild patients was related to a higher increase in AHI while wearing dentures (12.7 +/- 8.4/h vs. 51.9 +/- 28.6/h; p < 0.001). A limitation of the study is that the mild OSA patients had a higher BMI when compared to the moderate to severe OSA patients. Ten out of 14 patients who preferred to sleep with their upper and lower dentures showed an increase in their AHI while wearing dentures to sleep. Contrary to previous studies, we found that OSA patients may experience more apneic events if they sleep with their dentures in place. Specifically, in mild OSAS patients, the use of dentures substantially increases the AHI especially when in the supine position.

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The aim of this study was to evaluate the effectiveness of photodynamic therapy (PDT) for the disinfection of complete dentures. Biofilm samples were collected from dentures of 60 denture users who were randomly divided into four experimental groups (n = 15 each): subjects whose maxillary dentures were sprayed with 50 and 100 mg/l of PhotogemA (R) suspension (groups P50S and P100S) and patients whose maxillary dentures were treated with 50 and 100 mg/l of PhotogemA (R) gel (groups P50G and P100G). Dentures with photosensitizers were left in the dark for 30 min (pre-irradiation time) and then irradiated with blue LED light at 37.5 J/cm(2) (26 min). Denture samples were taken with sterile cotton swab before (left side surfaces) and after (right side surfaces) PDT. All microbial material was diluted and plated on selective media for Candida spp., Staphylococcus mutans spp., streptococci and a non-selective media. After incubation (48 h/37A degrees C), the number of colony-forming units (cfu/ml) was counted. Microorganisms grown on selective media were identified using biochemical methods before and after PDT. The data were submitted to McNemar and Kruskal-Wallis tests (alpha = 0.05). No growth after PDT was observed in 60, 53, 47, and 40% of dentures from P100G, P50G, P100S, and P50S groups, respectively. When evidence of microorganisms' growth was observed, PDT regimens eliminated over 90% of microorganisms on dentures. This clinical study showed that PDT was effective for disinfecting dentures.