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- ItemSomente MetadadadosAbstracts of the international symposium excitatory amino acids Ten years later held in Manaus, Brazil on November 19-22, 1998(Ios Press, 1998-10-01) Cavalheiro, Esper Abrão [UNIFESP]; Schoepp, Darryle; Turski, Lechoslaw; Univ London Univ Coll; Universidade Federal de São Paulo (UNIFESP); Eli Lilly & Co
- ItemAcesso aberto (Open Access)Coordination of international multicenter studies: Governance and administrative structure(Inst Nacional Salud Publica, 2003-01-01) Bangdiwala, Shrikant I.; Paula, Cristiane Silvestre de [UNIFESP]; Ramiro, Laurie S.; Munoz, Sergio R; Univ N Carolina; Universidade Federal de São Paulo (UNIFESP); Univ Philippines; Univ La FronteraA well-conducted multicenter study needs to assure standardization, uniformity of procedures, high data quality, and collaboration across sites. This manuscript describes the organization and dynamics of multicenter studies, focusing on governance and administrative structures among countries of diverse cultures. the organizational structure of a multicenter study is described, and a system for oversight and coordination, along with roles and responsibilities of participants in the multicenter study, are presented. the elements of a governance document are also reviewed, along with guidelines and policies for effective collaboration. the experience of an ongoing multi-country collaboration, the World Studies of Abuse in the Family Environment (World-SAFE), illustrates the implementation of these guidelines. It is essential that multicenter studies have an objective coordinating center and that the investigators jointly develop a written governance document to enable collaboration and preserve collegiality among participating investigators. the English version of this paper is available too at: http://www.insp.mx/salud/index.html.
- ItemSomente MetadadadosA double-blind, randomized, controlled study of amitriptyline, nortriptyline and placebo in patients with fibromyalgia. An analysis of outcome measures(Clinical & Exper Rheumatology, 2001-11-01) Heymann, Roberto Ezequiel [UNIFESP]; Helfenstein Junior, Milton [UNIFESP]; Feldman, D. [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)Objective To study the efficacy and tolerability of amitriptyline and nortriptyline in a Brazilian population with fibromyalgia and to evaluate the instruments used to measure the efficacy, of the treatment.Methods A total of 118 fibromyalgia patients were randomly assigned to 3 groups: amitripyline (AM, n = 40), nortriptyline (NOR, n = 38) and placebo (PL, n = 40), and were blindly given 25 mg at bedtime of the assigned treatment for 8 weeks. Clinical evaluation before and at the end of the study included the number of tender points (NTP), FIQ score (FIQ), and global improvement as reported by, the patients on a verbal scale (VSGI).Results The 3 groups were comparable at baseline for all the parameters studied. After 8 weeks, the 3 groups improved in all parameters: (36.5% AM, 26.7% NOR and 24% PL patients improved on FIQ; 13.9% AM, 19.5% NOR and 8.57% PL patients improved on NTP; 86.5% AM, 72.2% NOR and 57.6% PL patients improved on VSGI). Only, the AM group differed from the PL group on VSGI Side effects were noted among the groups, but none were serious (16 in the AM group, 31 in the NOR group, and 25 in the PL group).Conclusion All three groups improved after treatment. Only the patient's subjective global assessment of improvement differed between the AM patients and the PL group (p less than or equal to 0.03). In fibromyalgia, placebo groups are important in drug trials. Different measures of therapeutic effect are not better than the patient's self assessment.
- ItemSomente MetadadadosHomocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients Primary Results From the Folic Acid for Vascular Outcome Reduction in Transplantation Trial(Lippincott Williams & Wilkins, 2011-04-26) Bostom, Andrew G.; Carpenter, Myra A.; Kusek, John W.; Levey, Andrew S.; Hunsicker, Lawrence; Pfeffer, Marc A.; Selhub, Jacob; Jacques, Paul F.; Cole, Edward; Gravens-Mueller, Lisa; House, Andrew A.; Kew, Clifton; McKenney, Joyce L.; Pacheco-Silva, Alvaro [UNIFESP]; Pesavento, Todd; Pirsch, John; Smith, Stephen; Solomon, Scott; Weir, Matthew; FAVORIT Study Investigators; Rhode Isl Hosp; Univ N Carolina; NIDDK; Tufts Med Ctr; Univ Iowa; Brigham & Womens Hosp; Jean Mayer Human Nutr Res Ctr Aging; Univ Toronto; London Hlth Sci Ctr; Univ Alabama; Universidade Federal de São Paulo (UNIFESP); Ohio State Univ; Univ Wisconsin; Duke Univ; Univ MarylandBackground-Kidney transplant recipients, like other patients with chronic kidney disease, experience excess risk of cardiovascular disease and elevated total homocysteine concentrations. Observational studies of patients with chronic kidney disease suggest increased homocysteine is a risk factor for cardiovascular disease. the impact of lowering total homocysteine levels in kidney transplant recipients is unknown.Methods and Results-In a double-blind controlled trial, we randomized 4110 stable kidney transplant recipients to a multivitamin that included either a high dose (n=2056) or low dose (n=2054) of folic acid, vitamin B6, and vitamin B12 to determine whether decreasing total homocysteine concentrations reduced the rate of the primary composite arteriosclerotic cardiovascular disease outcome (myocardial infarction, stroke, cardiovascular disease death, resuscitated sudden death, coronary artery or renal artery revascularization, lower-extremity arterial disease, carotid endarterectomy or angioplasty, or abdominal aortic aneurysm repair). Mean follow-up was 4.0 years. Treatment with the high-dose multivitamin reduced homocysteine but did not reduce the rates of the primary outcome (n=547 total events; hazards ratio [95% confidence interval]=0.99 [0.84 to 1.17]), secondary outcomes of all-cause mortality (n=431 deaths; 1.04 [0.86 to 1.26]), or dialysis-dependent kidney failure (n=343 events; 1.15 [0.93 to 1.43]) compared to the low-dose multivitamin.Conclusions-Treatment with a high-dose folic acid, B6, and B12 multivitamin in kidney transplant recipients did not reduce a composite cardiovascular disease outcome, all-cause mortality, or dialysis-dependent kidney failure despite significant reduction in homocysteine level.
- ItemSomente MetadadadosInternational Field Testing of the Reliability and Validity of the EORTC QLQ-BM22 Module to Assess Health-Related Quality of Life in Patients With Bone Metastases(Wiley-Blackwell, 2012-03-01) Chow, Edward; Nguyen, Janet; Zhang, Liying; Tseng, Ling-Ming; Hou, Ming-Feng; Fairchild, Alysa; Vassiliou, Vassilios; Jesus-Garcia, Reynaldo [UNIFESP]; El-Din, Mohamed A. Alm; Kumar, Aswin; Forges, Fabien; Chie, Wei-Chu; Bottomley, Andrew; European Org Res Treatment Canc; Univ Toronto; Natl Yang Ming Univ; Kaohsiung Med Univ Hosp; Cross Canc Inst; Bank Cyprus Oncol Ctr; Universidade Federal de São Paulo (UNIFESP); Tanta Univ Hosp; Reg Canc Ctr; St Etienne Univ Hosp; Natl Taiwan Univ; Eortc Data CtrBACKGROUND: the objective of this international field study was to test the reliability, validity, and responsiveness of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BM22 module to assess health-related quality of life (HRQOL) in patients with bone metastases. METHODS: Patients undergoing a variety of bone metastases-specific treatments were accrued. the QLQ-BM22 was administered with the QLQ-C30 at baseline and at 1 follow-up time point internationally. A debriefing questionnaire was administered to determine patient acceptability and understanding. RESULTS: Large-scale field testing of the QLQ-BM22 in addition to the QLQ-C30 took place in 7 countries: Brazil, Canada, Cyprus, Egypt, France, India, and Taiwan. A total of 400 patients participated. Multitrait scaling analyses confirmed 4 scales in the 22-item module. the scales were able to discriminate between clinically distinct patient groups, such as between those with a poor and those with a better performance status. the QLQ-BM22 was well received in all 7 countries, and the majority of patients did not recommend any significant changes from the module in its current form. CONCLUSIONS: the final QLQ-BM22 module contains 22 items and 4 scales assessing Painful Sites, Painful Characteristics, Functional Interference, and Psychosocial Aspects. Results confirmed the validity, reliability, cross-cultural applicability, and sensitivity of the 22-item EORTC QLQ-BM22. It is therefore recommended that the QLQ-BM22 be used in addition to the QLQ-C30 in clinical trials to assess HRQOL in patients with bone metastases. (C) Cancer 2012; 118: 1457-65. (C) 2011 American Cancer Society.
- ItemSomente MetadadadosIs it ethical to use placebos in osteoporosis trials?(Elsevier B.V., 2006-07-01) Ragi-Eis, Sergio; Zerbini, Cristiano Augusto F.; Provenza, Jose R.; Griz, Luiz H. M.; Gregorio, Luiz H. de; Russo, Luis A. T.; Silva, Nilzio A.; Borges, Joao L. C.; Souza, Antonio C. A. de; Lazaretti-Castro, Marise [UNIFESP]; Lewiecki, E. Michael; Osteoporosis Diag & Res Ctr Espirito Santo; Hosp Heliopolis; Pontificia Univ Catolica Campinas; Universidade Federal de Pernambuco (UFPE); Clin Res Ctr; Universidade Federal de Goiás (UFG); Universidade de Brasília (UnB); PUC RS; Universidade Federal de São Paulo (UNIFESP); New Mexico Clin Res & Osteoporosis CtrThe use of placebo control groups (e.g., subjects using calcium and vitamin D) in osteoporosis trials with subjects at high risk for fracture has been systematically questioned by institutional review boards (IRBs). Regulatory agencies, on the other hand, continue to not only recommend but also require that placebo-controlled trials be presented for the registration of new drugs for osteoporosis treatment. the Declaration of Helsinki and its updates have upheld the principle that protection of research subjects' rights is of primary concern. Nevertheless, even the Declaration keeps clearly opening the possibility of using placebo-control designs if it is justified for compelling and scientifically sound methodological reasons. the use of intermediary endpoints or surrogates to establish the efficacy or safety of new medications in the management of osteoporosis is currently considered scientifically insufficient. This concept has led regulatory agencies, such as the Food and Drug Administration in the United States and the European Medicines Agency in the European Union, to require fragility fracture reduction as the primary endpoint in clinical trials for the registration of new drugs. Superiority or noninferiority trials are alternatives to placebo-controlled designs. However, factors such as sample size, cost, and statistical limitations render these models impractical for the registration of new medications for osteoporosis. We recommend collaboration among regulatory agencies, IRBs, scientists, and ethicists on the design of clinical trials for the registration of new medications for reduction of fracture risk. Delay in developing mutually acceptable models may impair scientific development in the field and possibly deprive patients of potentially beneficial treatments.
- ItemSomente MetadadadosMapping the Cochrane evidence for decision making in health care(Blackwell Publishing, 2007-08-01) El Dib, Regina P.; Atallah, Alvaro N.; Andriolo, Regis B.; Universidade Federal de São Paulo (UNIFESP)Rationale and aim Over the past 12 years, thousands of authors working with the Cochrane Collaboration around the world have produced systematic reviews to reduce uncertainty in health care decision making. We evaluated the conclusions from Cochrane systematic reviews of randomized controlled trials in terms of their recommendations for clinical practice and research.Methods in our cross-sectional study of systematic reviews published in the Cochrane Library, we randomly selected and analysed completed systematic reviews published across all 50 Cochrane Collaborative Review Groups.Results We analysed 1016 completed systematic reviews. of these, 44% concluded that the interventions studied were likely to be beneficial, of which 1% recommended no further research and 43% recommended additional research. Also, 7% of the reviews concluded that the interventions were likely to be harmful, of which 2% did not recommend further studies and 5% recommended additional studies. in total, 49% of the reviews reported that the evidence did not support either benefit or harm, of which 1% did not recommend further studies and 48% recommended additional studies. Overall, 96% of the reviews recornmended further research.Conclusions Cochrane systematic reviews were about evenly split between those in which the authors concluded that at least one of the interventions was beneficial and those ill which the evidence neither supported nor refuted the intervention tested. the Cochrane Collaboration needs to include clinical trial protocol summaries with a study design optimized to answer the relevant research questions.
- ItemSomente MetadadadosPD-L1 expression as a predictive biomarker in advanced non-small-cell lung cancer: updated survival data(Future Medicine Ltd, 2017) Aguiar, Pedro N., Jr. [UNIFESP]; De Mello, Ramon Andrade; Hall, Peter; Tadokoro, Hakaru [UNIFESP]; de Lima, GilbertoAim: The treatment of non-small-cell lung cancer has changed after the development of the immune checkpoint inhibitors. Although the most studied biomarker is the tumor programmed death ligand one (PD-L1) expression, its clinical significance is still debatable. In this article, we show the updated survival analysis of all published data. Methods: We searched in network and conference data sources for relevant clinical studies of immunotherapy for non-small-cell lung cancer that assessed the PD-L1 expression even as an exploratory analysis. The updated survival hazard ratios (HR) were included in the analysis. Results: 14 studies with 2857 patients were included (2019 treated with immunotherapy). The response rate was as higher among PD-L1-positive patients (RR: 2.19, 95% CI: 1.63-2.94). PD-L1 expression was also related to better progression-free survival (HR: 0.69, 95% CI: 0.57-0.85) and better overall survival (HR: 0.77, 95% CI: 0.67-0.89). Conclusion: PD-L1 overexpression predicts activity as well as better survival for patients treated with immune checkpoint inhibitors.
- ItemSomente MetadadadosPrevention of deep venous thrombosis and pulmonary embolism following stroke: a systematic review of published articles(Wiley-Blackwell, 2007-01-01) Andre, C.; Freitas, G. R. de; Fukujima, M. M.; Universidade Federal do Rio de Janeiro (UFRJ); Universidade Federal de São Paulo (UNIFESP)We performed a systematic review of the literature on venous thromboembolism (VTE) prophylaxis following cerebral infarct (CI) and haemorrhagic stroke. MEDLINE, Cochrane, LILACS and SciELO databases were scanned, and the Abstracts from Brazilian, American and European Neurology and Stroke Congresses were scrutinized for clinical trials. Moreover, the reference lists of articles and reviews were searched. A pooled analysis of two large studies with aspirin was made. Both unfractionated heparin and low molecular weight heparins/heparinoids (LMWH) are partially effective for VTE prophylaxis after CI, and should be routinely used in patients with motor deficit and reduced mobility and no contraindications. Reduction of deep venous thrombosis is better established than the effect over pulmonary embolism or mortality. Some evidence points to a greater efficacy of LMWH. the available evidence does not support the use of mechanical methods or dextran. Aspirin may have a mild protective effect. Low-dose Warfarin might be useful in the rehabilitation setting. Strict recommendations cannot be made in patients with haemorrhagic stroke but intermittent pneumatic compression merits further study. There are important limitations of current VTE preventive strategies following stroke. Additional studies on the combination of methods after CI and of low doses of anticoagulants following cerebral haemorrhage are urgently needed.
- ItemSomente MetadadadosThe role of PD-L1 expression as a predictive biomarker in advanced non-small-cell lung cancer: a network meta-analysis(Future Medicine Ltd, 2016) Aguiar Junior, Pedro [UNIFESP]; Santoro, Ilka Lopes [UNIFESP]; Tadokoro, Hakaru [UNIFESP]; Lopes, Gilberto de Lima; Filardi, Bruno Andraus [UNIFESP]; Oliveira, Pedro; Mountzios, Giannis; de Mello, Ramon AndradeBackground: Tumor programmed death ligand one (PD-L1) expression has been studied in several trials in non-small-cell lung cancer. Methods: We assessed the potential role of PD-L1 expression according to Cochrane Collaboration's Guidelines. Results: 13 studies with 1979 patients were included. Among 915 PD-L1 negative patients this rate was 13% (RR 2.08
- ItemSomente MetadadadosSingle-dose aprepitant vs ondansetron for the prevention of postoperative nausea and vomiting: a randomized, double-blind Phase III trial in patients undergoing open abdominal surgery(Oxford Univ Press, 2007-08-01) Diemunsch, P.; Gan, T. J.; Philip, E. K.; Girão, Manoel João Batista Castello [UNIFESP]; Eherharts, L.; Irwin, M. G.; Pueyo, J.; Chelly, J. E.; Carides, A. I.; Reiss, T.; Evans, J. K.; Lawson, F. C.; Aprepitant PONV Protocol 091 Study; CHU Strasbourg; Duke Univ; Brigham & Womens Hosp; Universidade Federal de São Paulo (UNIFESP); Univ Marburg; Univ Hong Kong; Univ Navarra Clin; Univ Pittsburgh; Merck Res LabsBackground. the neurokinin(l) antagonist aprepitant is effective for prevention of chemotherapy-induced nausea and vomiting. We compared aprepitant with ondansetron for prevention of postoperative nausea and vomiting.Methods. Nine hundred and twenty-two patients receiving general anaesthesia for major abdominal surgery were assigned to receive a single preoperative dose of oral aprepitant 40 mg, oral aprepitant 125 mg, or i.v. ondansetron 4 mg in a randomized, double-blind trial. Vomiting episodes, use of rescue therapy, and nausea severity (verbal rating scale) were documented for 48 h after surgery. Primary efficacy endpoints were complete response (no vomiting and no use of rescue therapy) 0-24 h after surgery and no vomiting 0-24 h after surgery. the secondary endpoint was no vomiting 0-48 h after surgery.Results. Aprepitant at both doses was non-inferior to ondansetron for complete response 0-24 h after surgery (64% for aprepitant 40 mg, 63% for aprepitant 125 mg, and 55% for ondansetron, lower bound of 1-sided 95% CI > 0.65), superior to ondansetron for no vomiting 0-24 h after surgery (84% for aprepitant 40 mg, 86% for aprepitant 125 mg, and 71 % for ondansetron; P < 0.001), and superior for no vomiting 0-48 h after surgery (82% for aprepitant, 40 mg, 85% for aprepitant, 125 mg, and 66% for ondansetron; P < 0.001). the distribution of peak nausea scores was lower in both aprepitant groups vs ondansetron (P < 0.05).Conclusions. Aprepitant was non-inferior to ondansetron in achieving complete response for 24 h after surgery. Aprepitant was significantly more effective than ondansetron for preventing vomiting at 24 and 48 h after surgery, and in reducing nausea severity in the first 48 h after surgery. Aprepitant was generally well tolerated.
- ItemAcesso aberto (Open Access)Tratamento com antiinflamatórios tópicos na osteoartrite de joelho(Sociedade Brasileira de Reumatologia, 2006-06-01) Pereira, Helena Lúcia Alves [UNIFESP]; Ribeiro, Sandra Lúcia Euzébio [UNIFESP]; Ciconelli, Rozana Mesquita [UNIFESP]; Universidade Federal do Amazonas Hospital Universitário Getúlio Vargas; Universidade Federal de São Paulo (UNIFESP); UFAM Departamento da Clínica Médica da Disciplina de ReumatologiaOral non-steroidal anti-inflammatories drugs (NSAIDs) are effective in pain relief in osteoarthritis (OA), but are also associated with risks of adverse systemic side effects. In order to reduce its toxicity, it would be desirable to decrease the plasmatic levels of NSAIDs since those side effects are dose-dependent. Topical NSAIDs would be a therapeutic alternative in theory, because while they reach high levels in local tissues, they also produce low plasmatic levels. Our review analyzed clinical randomized and shown that topical NSAIDs were superior to placebo and have similar efficacy to oral NSAIDs, but due a few number of trials and methodological weaknesses we can't make definitive conclusions. Further well designed, long term studies are required.
- ItemSomente MetadadadosViés de publicação em ensaios clínicos sobre anticorpos monoclonais e repercussão jurídica do direito fundamental à saúde baseada em evidências(Universidade Federal de São Paulo (UNIFESP), 2014-12-31) Santos, Douglas Henrique Marin dos [UNIFESP]; Atallah, Alvaro Nagib Atallah [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)Aims: We aimed to assess the proportion of publication and reporting of results of clinical trials on monoclonal antibodies adalimumab, bevacizumab, rituximab, trastuzumab and infliximab registered at ClinicalTrials.gov. We also aimed to evaluate the circumstances associated to publications bias and the effectiveness of FDAAA legislation in controlling it. Methods: In this cross-sectional, we searched ClinicalTrials.gov for protocols of interventional studies, phases III and IV, on monoclonal antibodies adalimumab, bevacizumab, rituximab, trastuzumab and infliximab, interventional (n = 243). After, we searched Pubmed, Embase, Lilacs, Cochrane Central and Google Scholar in order to evaluate and find published papers. Results: Among the 243 trials that comprised our initial sample, 178 (?73,2%) were published and 73 (?30%) had results reported at ClinicalTrials.gov. Industry sponsored trials were 169 (? 69.5%). Regarding the methodological quality of protocols, 159 (?65,4%) trials were designed with two or more comparison groups (intervention versus control), 149 (?61,3%) were randomized and 84 (?34,5%) were masked. Only 82 trials (?33,7%) were cumulatively designed with control groups, randomized allocation of participants, and masking. Among published studies (n=178), 118 (?66,3%) reported positive results, 18 (? 10%) reported negative results, 11 (?6,2%) found neutral or inconclusive results, and 24 (?13,5%) were partially positive. In the subsample of trials under FDAAA mandatory reporting (n=57), 48 (?84.2%) were published and 40 (?70,2%) had their results disclosed at ClinicalTrials.gov. Placebo-controlled trials were significantly more common among industry-funded trials when compared with independent trials (n=44/169 [26%] versus 9/74 [?12,2%]; p=0,025). Treatment as usual controlled trials were significantly more common among independent studies when compared to industry-funded trials (n=36/74 [?48.6%] versus 44/169 [?26%]; p<0,001). Conclusions: Publication bias in clinical trials is intense, despite the nature of intervention investigated (in this case, monoclonal antibodies). The source of funding (independent or industry) did not change the patterns of publication, suggesting that publication bias is evenly spread among different sponsors. However, studies involving placebo or single arm studies were more common in industry-funded trials. Our findings also suggest a higher prevalence of positive results among published trials. Lack of transparency, therefore, goes beyond selective publications and encompasses poor designed and biased protocols. Clinical trials subject to the FDAAA legislation had a greater proportion of published studies and disclosed results at ClinicalTrials.gov, suggesting the effectiveness of U.S. law in controlling publication bias and expanding in clinical research.