215 resultados para controlled clinical trial


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Objectives: To examine the change in health-related quality of life (HRQOL) and its determinants in children with juvenile idiopathic arthritis (JIA) treated with methotrexate (MTX). Methods: Patients were extracted from the PRINTO clinical trial which aimed to evaluate the efficacy and safety profile of MTX administered in standard, intermediate or higher doses (10, 15 and 30 mg/m2/week respectively). Children with polyarticular-course JIA, who were less than 18 years and had a complete HRQOL assessment were included. Results: A total of 521 children were included. At baseline, patients with JIA showed poorer HRQOL (p<0.01) than healthy children. In 207/412 (50%) and 63 (15%) children, HRQOL values were 2 standard deviations below the mean of healthy controls in the physical and psychosocial summary scale, respectively. After 6 months of treatment with standard dose MTX, there was a statistically significant improvement in all HRQOL health concepts, particularly the physical ones. Similar improvements were observed in those who did not respond to a standard dose of MTX and were subsequently randomised to a higher dose. The presence of marked disability at baseline was associated with a fivefold increased risk of retaining poor physical health after 6 months of active treatment with standard dose MTX. Other less important determinants of retaining poor physical well-being were the baseline level of systemic inflammation, pain intensity and an antinuclear-antibody-negative status. Conclusions: MTX treatment produces a significant improvement across a wide range of HRQOL components, particularly in the physical domains, in patients with JIA.

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BACKGROUND. This study aimed to evaluate clinical characteristics of epidural anesthesia performed with 0.75% ropivacaine associated with dexmedetomidine. METHODS. Forty patients scheduled for hernia repair or varicose vein surgeries under epidural anesthesia participated in this study. They were assigned to: Control Group (n = 20), 0.75% ropivacaine, 20 ml (150 mg); and Dexmedetomidine Group (n = 20), 0.75% ropivacaine, 20 ml (150 mg), plus dexmedetomidine, 1 μg.kg -1. The following variables were studied: total analgesic block onset time, upper level of analgesia, analgesic and motor block duration time, intensity of motor block, state of consciousness, hemodynamics, postoperative analgesia and incidence of side-effects. RESULTS. Epidural dexmedetomidine did not affect onset time or upper level of anesthesia (p > 0.05) however it prolonged sensory and motor block duration time (p < 0.05) and postoperative analgesia (p < 0.05), and also resulted in a more intense motor block, 1 (p < 0.05). Values of bispectral index were lower in Dexmedetomidine Group (p < 0.05). There was no difference in incidence of hypotension and bradycardia (p > 0.05). Occurrence of side-effects (shivering, vomiting and SpO 2 < 90%) was low and similar between groups (p > 0.05). CONCLUSION. There is clear synergism between epidural dexmedetomidine and ropivacaine, further this drug association does not bring about additional morbidity.

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The purpose of this randomized study was to evaluate EMG spectral, subjective and cardiovascular recovery parameters after isometric lumbar extension contractions. Ten healthy women performed isometric lumbar extensions until exhaustion with 5%, 10%, 15% and 20% of maximal voluntary isometric contraction on 4 different days (random order). One baseline five second contraction was performed before the fatiguing task which was followed by eight submaximal five second extension contractions (until 20 minutes after the end of the fatiguing task) at the same intensity as the trial to evaluate muscle recovery. EMG (Median Frequency, Peak Power, Peak Power Frequency, Total Power and Zero-crossing Rate) and cardiovascular variables did not demonstrate any statistical difference between the 5-second contractions (p > 0.05) performed before and after the fatiguing task, showing a quick EMG recovery. However, the data analysis showed that the perceived effort variable had not recovered even 10 minutes after the fatigue contraction (p < 0.05). Our results represent a data basis for future comparisons and since subjective felling can affect performance, this study shows the importance of its analysis, since the subjective effort rate was not fully recovered after 10 minutes the end of the exhaustion contraction. © 2008 IOS Press. All rights reserved.

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Aim: The present randomized, controlled prospective study evaluated the histomorphological response of human dental pulps capped with two grey mineral trioxide aggregate (MTA) compounds. Methodology: Pulp exposures were performed on the occlusal floor of 40 human permanent pre-molars. The pulp was capped either with ProRoot (Dentsply) or MTA-Angelus (Angelus) and restored with zinc oxide eugenol cement. After 30 and 60 days, teeth were extracted and processed for histological examination and the effects on the pulp were scored. The data were subjected to Kruskal-Wallis and Conover tests (α = 0.05). Results: In five out of the 40 teeth bacteria were present in pulp tissue. No significant difference was observed between the two materials (P > 0.05) in terms of overall histological features (hard tissue bridge, inflammatory response, giant cells and particles of capping materials). Overall, 94% and 88% of the specimens capped with MTA-Angelus and ProRoot, respectively, showed either total or partial hard tissue bridge formation (P > 0.05). Conclusions: Both commercial materials ProRoot (Dentsply) and MTA-Angelus (Angelus) produced similar responses in the pulp when used for pulp capping in intact, caries-free teeth. © 2009 International Endodontic Journal.

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BACKGROUND AND OBJECTIVES: The objective of the present study was to evaluate the degree of sedation, intraocular pressure, and hemodynamic changes with premedication with low doses of oral clonidine, 100 μg and 200 μg, in outpatient cataract surgeries. METHODS: This is a randomized, double-blind, clinical study undertaken at the Universidade Federal de São Paulo with 60 patients of both genders, physical status ASA 1 and 2, ages 18 to 80 years. Patients were separated into three groups: placebo, clonidine 100 μg, and clonidine 200 μg. Intraocular pressure, heart rate, and blood pressure besides assessment of sedation were measured before and 90 minutes after the administration of clonidine. Sedation levels were classified according to the Ramsay sedation scale. RESULTS: Patients who received placebo and 100 μg of clonidine did not show reduction in heart rate, while a reduction in heart rate was observed in patients who received 200 μg of clonidine, and this difference was statistically significant. Patients who received 200 μg of clonidine also had a reduction in systolic and diastolic blood pressure (p < 0.05). One patient who received 200 μg of clonidine developed severe hypotension, with systolic pressure < 80 mmHg. Patients treated with clonidine had a reduction in intraocular pressure (p < 0.05). Ninety minutes after the oral administration of placebo and 100 μg and 200 μg of clonidine, 25%, 60%, and 80% of the patients respectively were classified as Ramsay 3 or 4. CONCLUSIONS: Clonidine 100 μg can be indicated as premedication for fasciectomies, being effective in sedation and reduction of intraocular pressure, without adverse effects on blood pressure and heart rate.

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The aim of this study was to evaluate the influence of chlorhexidine gluconate, sodium fluoride and sodium iodine on mutans streptococci counts in saliva of irradiated patients. Forty-five patients were separated into three experimental groups and received chlorhexidine (0.12%), sodium fluoride (0.5%) or sodium iodine (2%), which were used daily during radiotherapy and for 6 months after the conclusion of the treatment. In addition, a fourth group, composed by 15 additional oncologic patients, who did not receive the mouthwash or initial dental treatment, constituted the control group. Clinical evaluations were performed in the first visit to dental clinic, after initial dental treatment, immediately before radiotherapy, after radiotherapy and 30, 60, 90 days and 6 months after the conclusion of radiotherapy. After clinical examinations, samples of saliva were inoculated on SB20 selective agar and incubated under anaerobiosis, at 37oC for 48 h. Total mutans streptococci counts were also evaluated by using real-time PCR, through TaqMan system, with specific primers and probes for S. mutans and S. sobrinus. All preventive protocols were able to reduce significantly mutans streptococci counts, but chlorhexidine gluconate was the most effective, and induced a significant amelioration of radiotherapy side effects, such as mucositis and candidosis. These results highlights the importance of the initial dental treatment for patients who will be subjected to radiotherapy for head and neck cancer treatment.

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Introduction: Orofacial pain and pain in the muscles of mastication are frequent symptoms of temporomandibular disorder. The masseter is the closet masticatory muscle to the surface and has the function of raising and retracting the mandible. This muscle has considerable strength and is one of the main muscles involved in the shredding of food It is therefore of utmost importance in the masticatory cycle and generally the most affected by pain and spasms. Objectives: The aim of the present study was to analyze the effect of manual therapy with transversal and circular movements on pain and spasm in the masseter muscle, using electromyography and a visual analogue pain scale (VAPS). Eight women who experienced pain upon palpation of the masseter greater than 6 on the VAPS were selected for participation in the study, which employed electromyography and a VAPS for assessment, followed by manual oral physiotherapy and reevaluation. Results: The statistical analysis revealed a reduction in pain, but there was no significant difference in electromyographic activity (p < 0.05). Conclusion: It was concluded that massage therapy was effective on pain symptoms, but was not capable of altering the electrical activity of the masseter muscle.

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Aim: This study aimed to evaluate the efficacy of a new topical drug (EF028) in two separate presentations (aerosol and cream) in a comparative way with the already registered medication, Andolba® (benzocaine, benzoxiquina chloride benzeconio, menthol) and the negative control (hygiene), in the analgesic efficacy after episiotomy wound, reducing the requirement for systemic medication. Methods: 60 patients were voluntary post normal vaginal childbirth with episiotomy, were divided into four groups to comparatively assess the action of the product EF028 (cream and aerosol), Andolba® and soap, the efficacy of decreasing painful symptoms from daily use for 2 times a day for seven days. Clinical assessments and subjective pain occurred daily until the third postoperative day and on the 7th postoperative day. Results: The results showed that the drugs promoted a reduction of painful symptoms and there was no statistically significant difference (p <0.05) between presentations of drug EF028 (cream and aerosol) and Andolba® and the three products were significantly higher (p <0.05) to the control. Conclusions: The evaluated drugs EF028 aerosol, EF028 cream and Andolba® had similar efficacy in relieving the painful symptoms of the perineal region in postoperative episiotomy can be considered as indication for postoperative episiotomies. © Copyright Moreira Jr. Editora.

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Aim: This study aimed to compare the safety and analgesic efficacy of a new topical drug (in two different presentations: cream and aerosol) consisting of benzocaine, menthol and triclosan, in the curettage of molluscum contagiosum. Method: The study included 296 volunteers in different stages: 256 healthy adult volunteers for the safety evaluation, and 40 volunteers between 2 and 12 years old who presented Molluscum contagiosum, for the evaluation of tolerability and efficacy. Each volunteer represented two experimental units (left and right) where it was applied randomly the tested products (cream or aerosol) 30 minutes before the dermatological curettage, immediately after and twice a day during 7 days. Dermatological evaluations of safety and efficacy were performed immediately after the procedure, 3 and 7 days after the curettage. Results: During safety evaluation, the tested products showed no irritant, sensitizing, phototoxic or photosensitizing potential. Both presentations, cream and aerosol, were considered safe with no statistically significant differences between them. With respect to analgesic efficacy, the results showed that the medication promoted the reduction of painful symptoms and there was no statistically significant difference (p <0.05) between the two presentations. Conclusion: The tested product, in two different presentations, was considered safe and effective in controlling pain symptoms during and after the curettage of molluscum contagiosum. © Copyright Moreira Jr. Editora.

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Background & Aims Patients infected with hepatitis C virus (HCV) genotype 1, body weight <85 kg, and high baseline viral load respond poorly to standard doses of pegylated interferon (peginterferon) and ribavirin. We evaluated intensified therapy with peginterferon alfa-2a plus ribavirin. Methods This double-blind randomized trial included HCV genotype 1-infected outpatients from hepatology clinics with body weight <85 kg and HCV RNA titer <400,000 IU/mL. Patients were randomized to 180 μg/wk peginterferon alfa-2a for 48 weeks plus 1200 mg/day ribavirin (standard of care) (group A, n = 191) or 1400/1600 mg/day ribavirin (group B, n = 189). Additional groups included 360 μg/wk peginterferon alfa-2a for 12 weeks then 180 μg/wk peginterferon alfa-2a for 36 weeks plus 1200 mg/day ribavirin (group C, n = 382) or 1400/1600 mg/day ribavirin (group D, n = 383). Follow-up lasted 24 weeks after treatment. Results Sustained virologic response rates (HCV RNA level <15 IU/mL at end of follow-up) in groups A, B, C, and D were 38%, 43%, 44%, and 41%, respectively. There were no significant differences among the 4 groups or between pooled peginterferon alfa-2a regimens (A + B vs C + D: odds ratio [OR], 1.08; 95% confidence interval [CI], 0.831.39; P = .584) or pooled ribavirin regimens (A + C vs B + D: OR, 1.00; 95% CI, 0.791.28; P = .974). Conclusions In patients infected with HCV genotype 1 who are difficult to treat (high viral load, body weight <85 kg), a 12-week induction regimen of peginterferon alfa-2a and/or higher-dose ribavirin is not more effective than the standard regimen. © 2010 AGA Institute.

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This study quantified alterations in root dentin permeability after exposure to different acid beverages. Twenty-five third molars were sectioned below the cementoenamel junction, the root segment was collected, and the pulp tissue was removed. The root segments were connected to a hydraulic pressure apparatus to measure the permeability of root dentin after the following sequential steps, with 5 specimens in each: 1) phosphoric acid etching for 30 s (maximum permeability), 2) root planning to create new smear layer, 3) exposure to different acid substances for 5 min (orange, cola drink, vinegar, white wine, lemon juice), 4) toothbrushing with sonic toothbrush for 3 min, 5) toothbrushing with sonic toothbrush plus dentifrice for 3 min. Considering step I as 100%, the data were converted into percentage and each specimen was its own control. Data were analyzed statistically by Kruskal-Wallis and Dunn's post test at 5% significance level. All acidic substances increased dentin permeability significantly after scraping (p<0.05). Toothbrushing after exposure to acid substances decreased dentin permeability and the association with dentifrice accentuated the decrease (p<0.05), except for the specimens treated with cola drink. Thus, it may be concluded that all tested acid fruit juices increased dentin permeability, and toothbrushing with or without dentifrice can decrease root dentin permeability after dentin exposure to acid diet.

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The objective was to evaluate the effects of plasma progesterone (P4) concentrations and exogenous eCG on ovulation and pregnancy rates of pubertal Nellore heifers in fixed-time artificial insemination (FTAI) protocols. In Experiment 1 (Exp. 1), on Day 0 (7 d after ovulation), heifers (n = 15) were given 2 mg of estradiol benzoate (EB) im and randomly allocated to receive: an intravaginal progesterone-releasing device containing 0.558 g of P4 (group 0.5G, n = 4); an intravaginal device containing 1 g of P4 (group 1G, n = 4); 0.558 g of P4 and PGF2α (PGF; 150 μg d-cloprostenol, group 0.5G/PGF, n = 4); or 1 g of P4 and PGF (group 1G/PGF, n = 3). On Day 8, PGF was given to all heifers and intravaginal devices removed; 24 h later (Day 9), all heifers were given 1 mg EB im. In Exp. 2, pubertal Nellore heifers (n = 292) were treated as in Exp. 1, with FTAI on Day 10 (30 to 36 h after EB). In Exp. 3, pubertal heifers (n = 459) received the treatments described for groups 0.5G/PGF and 1G/PGF and were also given 300 IU of eCG im (groups 0.5G/PGF/eCG and 1G/PGF/eCG) at device removal (Day 8). In Exp. 1, plasma P4 concentrations were significantly higher in heifers that received 1.0 vs 0.588 g P4, and were significantly lower in heifers that received PGF on Day 0. In Exp. 2 and 3, there were no significant differences among groups in rates of ovulation (65-77%) or pregnancy (Exp. 2: 26-33%; Exp. 3: 39-43%). In Exp. 3, diameter of the dominant ovarian follicle on Day 9 was larger in heifers given 0.558 g vs 1.0 g P4 (10.3 ± 0.2 vs 9.3 ± 0.2 mm; P < 0.01). In conclusion, lesser amounts of P4 in the intravaginal device or PGF on Day 0 decreased plasma P4 from Days 1 to 8 and increased diameter of the dominant follicle on Day 9. However, neither of these nor 300 IU of eCG on Day 8 significantly increased rates of ovulation or pregnancy. © 2011.

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Two experiments evaluated an operant procedure for establishing stimulus control using auditory and electrical stimuli as a baseline for measuring the electrical current threshold of electrodes implanted in the cochlea. Twenty-one prelingually deaf children, users of cochlear implants, learned a Go/No Go auditory discrimination task (i.e., pressing a button in the presence of the stimulus but not in its absence). When the simple discrimination baseline became stable, the electrical current was manipulated in descending and ascending series according to an adapted staircase method. Thresholds were determined for three electrodes, one in each location in the cochlea (basal, medial, and apical). Stimulus control was maintained within a certain range of decreasing electrical current but was eventually disrupted. Increasing the current recovered stimulus control, thus allowing the determination of a range of electrical currents that could be defined as the threshold. The present study demonstrated the feasibility of the operant procedure combined with a psychophysical method for threshold assessment, thus contributing to the routine fitting and maintenance of cochlear implants within the limitations of a hospital setting.

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The aim of this paper was to compare the dentin-pulp complex response to cavity preparation in human teeth using ultrasonic chemical vapor deposition (CVD) diamond tip and high-speed diamond bur. Class V buccal cavities were randomly prepared in 40 premolars from 14 patients aged 11 to 15 years. The cutting time was recorded and the cavities had the axial walls protected with gutta-percha and were filled with glass ionomer cement. The teeth were extracted at intervals of 0, 5, 10 and 20 days, and were decalcified, sectioned and stained by Hematoxylin & Eosin, Masson's Trichrome and Brown & Brenn techniques. The inflammatory response and cell disorganization were blindly evaluated by two examiners. The remaining dentin thickness (RDT) was measured by a linear scale using computer software. Statistical analysis by one-way ANOVA showed no statistically significant difference (P≤0.05) among the cavities prepared with either type of instrument, with mean RDT of 1132.50 mm. Cutting time and the pulp-dentin complex responses were analyzed statistically by Kruskal-Wallis and Dunn tests (P≤0.05). The ultrasonic CVD diamond tip took 5 times longer to prepare the cavities and there were no typical inflammatory pulp responses in cavities prepared with either type of cutting instrument, only mild to moderate cell disorganization was present. Even taking longer to cut the dental substrate, the ultrasonic CVD diamond tip produced similar pulp response compared to the conventional high-speed diamond bur.

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Objectives: This study aimed to measure pH changes during 14 days intracoronal bleaching with hydrogen peroxide/sodium perborate and carbamide peroxide/sodium perborate. Materials and methods: Twenty patients presenting endodontically treated central maxillary incisors with color alterations were divided in two groups (n = 10): Group CP + SP: 37% carbamide peroxide + sodium perborate paste; Group HP + SP: 30% hydrogen peroxide + sodium perborate paste. The pH values were measured using a digital microprocessor at different times: Baseline, 2, 7 and 14 days. Data were analyzed with two-way ANOVA followed by Tukey's test (α = 0.05). Results: ANOVA showed p < 0.00 which indicated significant difference between the groups. The mean values (± sd) and the results of the Tukey's test were: HP + SP/14 days-7.98 (±0.58)a; HP + SP/7 days-8.59 (±0.18)b; HP + SP/2 days-8.83 (±0.32)bc; HP + SP/Baseline-8.83 (±0.01)bc; CP + SP/Baseline-8.89 (±0.01)bc; CP + SP/14 days-9.11 (±0.58)cd; CP + SP/7 days-9.54 (±0.16)de; CP + SP/2 days-9.66 (±0.08) de. The group HP + SP resulted in significantly lower pH values compared with group CP + SP. Conclusion: It can be concluded that both associations showed alkaline pH values; however, there was significant reduction in the pH values of the 30% hydrogen peroxide associated with sodium perborate after 14 days. Clinical Significance: The association of hydrogen peroxide and carbamide peroxide with sodium perborate paste presented alkaline characteristics during the 14-day evaluated period. Thus, regarding pH changes, both associations can be considered safe as intracoronal bleaching agents.