832 resultados para Randomized clinical trials


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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: 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.

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Insulin resistance is a common risk factor in chronic kidney disease patients contributing to the high cardiovascular burden, even in the absence of diabetes. Glucose-based peritoneal dialysis (PD) solutions are thought to intensify insulin resistance due to the continuous glucose absorption from the peritoneal cavity. The aim of our study was to analyse the effect of the substitution of glucose for icodextrin on insulin resistance in non-diabetic PD patients in a multicentric randomized clinical trial. This was a multicenter, open-label study with balanced randomization (1:1) and two parallel-groups. Inclusion criteria were non-diabetic adult patients on automated peritoneal dialysis (APD) for at least 3 months on therapy prior to randomization. Patients assigned to the intervention group were treated with 2L of icodextrin 7.5%, and the control group with glucose 2.5% during the long dwell and, at night in the cycler, with a prescription of standard glucose-based PD solution only in both groups. The primary end-point was the change in insulin resistance measured by homeostatic model assessment (HOMA) index at 90 days. Sixty patients were included in the intervention (n = 33) or the control (n = 27) groups. There was no difference between groups at baseline. After adjustment for pre-intervention HOMA index levels, the group treated with icodextrin had the lower post-intervention levels at 90 days in both intention to treat [1.49 (95% CI: 1.23-1.74) versus 1.89 (95% CI: 1.62-2.17)], (F = 4.643, P = 0.03, partial η(2) = 0.078); and the treated analysis [1.47 (95% CI: 1.01-1.84) versus 2.18 (95% CI: 1.81-2.55)], (F = 7.488, P = 0.01, partial η(2) = 0.195). The substitution of glucose for icodextrin for the long dwell improved insulin resistance measured by HOMA index in non-diabetic APD patients.

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To discuss important characteristics of the use of dental implants in posterior quadrants and the rehabilitation planning. An electronic search of English articles was conducted on MEDLINE (PubMed) from 1990 up to the period of March 2014. The key terms were dental implants and posterior jaws, dental implants/treatment planning and posterior maxilla, and dental implants/treatment planning and posterior mandible. No exclusion criteria were used for the initial search. Clinical trials, randomized and non randomized studies, classical and comparative studies, multicenter studies, in vitro and in vivo studies, case reports, longitudinal studies and reviews of the literature were included in this review. One hundred and fifty-two articles met the inclusion criteria of treatment planning of dental implants in posterior jaw and were read in their entirety. The selected articles were categorized with respect to their context on space for restoration, anatomic considerations (bone quantity and density), radiographic techniques, implant selection (number, position, diameter and surface), tilted and pterygoid implants, short implants, occlusal considerations, and success rates of implants placed in the posterior region. The results derived from the review process were described under several different topic headings to give readers a clear overview of the literature. In general, it was observed that the use of dental implants in posterior region requires a careful treatment plan. It is important that the practitioner has knowledge about the theme to evaluate the treatment parameters. The use of implants to restore the posterior arch presents many challenges and requires a detailed treatment planning.

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Pós-graduação em Bases Gerais da Cirurgia - FMB

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The granulomatous lesions are frequently founded in infectious diseases and can involve the larynx and pharynx and can cause varying degrees of dysphonia and dysphagia. There is still no systematic review that analyzes effectiveness of speech therapy in systemic granulomatous diseases. Research strategy: A systematic review was performed according to Cochrane guideline considering the inclusion of RCTs and quasi-RCTs about the effectiveness of speech-language therapy to treat dysphagia and dysphonia symptoms in systemic granulomatous diseases of the larynx and pharynx. Selection criteria: The outcome planned to be measured in this review were: swallowing impairment, frequency of chest infections and voice and swallowing symptoms. Data analysis: We identified 1,140 citations from all electronic databases. After an initial shift we only selected 9 titles to be retrieved in full-text. After full reading, there was no RCT found in this review and therefore, we only described the existing 2 case series studies. Results: There were no randomized controlled trials found in the literature. Therefore, two studies were selected to be included only for narratively analysis as they were case series. Conclusion: There is no evidence from high quality studies about the effectiveness of speech-language therapy in patients with granulomatous diseases of the larynx and pharynx. The investigators could rely in the outcomes suggested in this review to design their own clinical trials.

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The obstructive sleep apnea syndrome affects millions of people around the world. The mandibular repositioning devices have been indicated in cases of mild/moderate syndrome; however in edentulous patients its use is deficient since there is no retention. Therefore the objective of this study was to conduct a review on the use of this treatment method combined to osseointegrated implants. A search on the theme: Dental implant and sleep apnea syndromewas performed in the Medline/PubMed, ISI, Cochrane, Dentistry Oral Science, Clinical Trials, Controlled Trials, and Bireme-BvS, databases, and 22 articles were found. After anevaluation 2 studies were selected and the review was complemented with an analysis of randomized controlled trials in the previous seven bases using the key-words: Sleep apnea syndrome, Oral appliance and Randomized controlled trial. The search returned 37 articles, and after they were submitted to inclusion criteria 17 studies were selected. There are a small number of studies presenting the use of dental implants as a mean to assist the stabilization of the mandibular repositioning appliances; those that are available are case reports that focusing on the effectiveness of the technique. Studies examining the effect these appliances in dentate patients indicate improvement in the levels of apnea and snoring. The use of mandibular repositioning appliances in dentate patients is an effective technique in treatment of patients with obstructive sleep apnea syndrome mild/moderate. Randomized controlled trialsare required in order to enable an analysis of the use of mandibular repositioning devices with the aid of dental implants .

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The aim of this study was to review the literature in order to discuss the main and the most effective therapeutic activities to control the nocturnal bruxism. To identify the studies included in this review, it was conducted a detailed and advanced search strategy in the PubMed and Medline databases. It was used as KEY WORDS: bruxism, therapeutics and drug therapy. Inclusion criteria were: case reports, randomized controlled trials, in vitro studies, literature reviews and systematic reviews with or without meta-analysis of the past 10 years that addressed the theme. Exclusion criteria were: articles without abstract, animal studies, articles whose first language was not English and articles from journals that do not belong to the dentario field. From a total of 83 articles, after an analysis according to the inclusion and exclusion criteria, 33 articles were selected. Despite the fact that there is a small number of prospective clinical studies with high degree of reliability and most studies that evaluated the alternative treatments effectiveness are isolated case reports, the current literature shows that the use of botulinum toxin has been shown to be effective in the control of nocturnal bruxism. On the other hand, important aspects such as transitory effect, safe dosage and application technique are still little discussed, then, further studies are needed to have these doubts clarified.

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OBJECTIVE: The aim of this study was to gather information and discuss the predictability of implant-supported prostheses in patients with bruxism by performing a literature review. METHODS: In order to select the studies included in this review, a detailed search was performed in PubMed and Medline databases, using the following key words: bruxism, dental implants, implant supported prosthesis, and dental restoration failure. Items that were included are: case reports, randomized controlled trials, in vitro studies, literature and systematic reviews, with or without meta-analysis, of the last 20 years that addressed the theme. Articles without abstracts, animal studies, articles in languages other than English and articles from journals unrelated to the dental field were excluded. RESULTS: after analysis according to inclusion and exclusion criteria, 28 articles were selected from a total of 54. It is known from the array of scientific articles which have assessed, either through retrospective, prospective or experimental studies, that the biomechanical and biological impact of bruxism on implant-supported prostheses is small, and that the literature has contributed little to exemplify the prosthetic limits of safety for the specialist from a clinical point of view. CONCLUSION: Although there is still no general consensus on this matter, most of the literature review articles do provide clinical guidelines that contribute to implant supported prostheses longevity and stability in patients with bruxism.

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The aim of this study was to review the current scientific literature to discuss the biomechanical behavior and characteristics inherent to both cast post and core and the prefabricated posts used in the practice of restoring endodontically treated teeth. To identify studies of this review, it was performed a detailed and advanced search strategy to the databases PubMed and Medline. It was used as descriptors: endodontically treated teeth, post, core, fiber post and metal post. Inclusion criteria were: clinical trials, randomized controlled trials, in vitro studies, literature reviews and systematic reviews with or without meta-analysis of the last 10 years that addressed the theme. Exclusion criteria were: articles without abstracts, animal studies, articles whose language was not English and articles from journals that do not belong to the Dentistry field. Of a total of 35 articles, after an analysis according to inclusion and exclusion criteria, 23 articles were selected. Most of the current scientific literature indicates that the prefabricated fiber reinforced and ceramic posts should be appointed for endodontically treated teeth that have a minimum height of 2mm ferrule. As for the cast metal cores, along with pre-fabricated metal represent a good prosthetic option, when weakened teeth have to be restored for any reason. Despite the large number of studies, there is still a lack of longterm prospective studies that evaluate the effectiveness of these posts in the treatment of endodontically treated teeth.

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

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Noninvasive brain stimulation (NIBS) techniques are being increasingly investigated as a therapeutic approach for neuropsychiatric disorders. One method is to combine NIBS with pharmacotherapy to enhance the clinical effects or avoid an increase in drug dosages to decrease the incidence of side effects. However, few studies to date have investigated the relative and combined efficacy of NIBS with pharmacotherapy. Based on a literature review of previous studies and meta-analyses for major depression, we identified four randomized, controlled trials that tested the combination of NIBS with a new drug and two trials that directly compared NIBS versus pharmacotherapy. There was no study designed to address the relative efficacy of each intervention against placebo and against combined therapy. We discuss the methods and rationale of NIBS-pharmacotherapy trials, addressing some methodological aspects, including factorial design, recruitment, blinding, blinding assessment, placebo effect and quantitative aspects, such as power analysis, statistics and interaction effects. Our review of the methodology underlying NIBS-drug trials provides insights for the further clinical research development of NIBS in major depression.

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Cediranib is a potent inhibitor of the VEGF family receptor tyrosine kinases, and a new agent in cancer treatment. The drug has shown promising activity in a variety of solid malignancies, in preclinical models and in clinical trials. Its pharmacokinetics allow for a convenient once-daily administration, with a toxicity profile that is very similar to other VEGF inhibitors. Its main side effects include hypertension, nausea, dysphonia, fatigue and diarrhea. Adverse events seem to be manageable, especially when used in doses lower than 45 mg/day. Studies have shown some activity as a single agent or in combination in advanced tumors, but not enough to secure its approval for routine use up to now. Clinical trials are still evaluating the role of cediranib in combination chemotherapy with cytotoxic agents.