Navegando por Palavras-chave "Clinical Trial"

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    Avaliação da eficácia do nitroprussiato de sódio no tratamento de sintomas negativos da esquizofrenia resistente: um estudo duplo-cego, randomizado, controlado por placebo
    (Universidade Federal de São Paulo (UNIFESP), 2020-08-21) Nunes, Marcel Vella [UNIFESP]; Lacerda, Acioly Luiz Tavares De [UNIFESP]; Universidade Federal de São Paulo
    To evaluate the efficacy, tolerability and safety of the administration of repeated doses of sodium nitroprusside (SNP) for the treatment of negative symptoms in patients with treatment-resistant schizophrenia (TRS). Methods: This is a doubleblind, randomized, placebo-controlled clinical trial. Twenty participants with a diagnosis of schizophrenia according to the DSM-IV-TR criteria were included, with a documented history of non-response to ≥2 antipsychotic treatments, with adequate dose and duration (≥6 weeks). Participants were randomized and received 4-hour sodium nitroprusside or placebo infusions at 0.5 μg / kg / min, which were performed under strict monitoring. Four infusions were performed, with an interval of 2 weeks between infusions for each participant and 4 follow-up evaluations. The primary outcome was the negative subscale of the Positive and Negative Syndrome Scale (PANSS). Secondary measures included changes in the total PANSS score, the Brief Psychiatric Rating Scale (BPRS), the Global Clinical Impression Scale (CGI) and the Udvalg for Kliniske Undersøgelser (UKU), used to assess adverse events. Results: There were no differences between the SNP and placebo groups for changes in total PANSS score (F = 0.525; p = 0.841), or negative PANSS subscale (F = 1.053; p = 0.483). The groups did not differ regarding the change in the BPRS scores (F = 0.615; p = 0.734) or CGI-S (F = 1.11; p = 0.416). The changes in blood pressure and heart rate were not clinically significant, there were no serious adverse events and it was not necessary to suspend the infusion with any participant, that is, SNP had a good tolerability and safety profile. Conclusion: Present findings of this study suggest that the SNP is not efficacious for the treatment of negative symptoms in patients with TRS, therefore it is conceivable to consider that the effectiveness of the SNP may be restricted to the early stages of the disease and to a younger population. Future studies examining larger samples and including patients at different stages of the disease, as well as at different ages, can be particularly clarifying.
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    Efetividade da manta de ar forçado aquecido na redução de complicações da hipotermia após cirurgia de revascularização do miocárdio: ensaio clínico randomizado
    (Universidade Federal de São Paulo (UNIFESP), 2019-12-18) Bezerra, Amanda Silva De Macedo [UNIFESP]; Barros, Alba Lucia Bottura Leite De [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Introduction: Despite intraoperative re-warming of patients undergoing induced hypothermia during on-pump coronary artery bypass grafting (CABG), patients remain hypothermic in the intensive care unit. Postoperative hypothermia in these patients is associated with excessive bleeding, need for blood components transfusion, respiratory failure, unplanned subsequent surgeries, increased length of hospitalization, of mechanical ventilation, and mortality. Objectives: To determine the effectiveness of postoperative use of forced air warming blanket on the reduction of excessive bleeding, arrhythmias, acute myocardial infarction (AMI) and blood product transfusion in hypothermic patients following on-pump CABG and to compare the pattern of the tympanic temperature associated with heated forced air or woolen blanket. Methods: A randomized clinical trial conducted in a public Cardiovascular hospital from January to November 2018. Two hundred patients undergoing isolated on-pump CABG were randomized to the Intervention Group (IG, submitted to postoperative warming with forced air blanket, n=100) and the Control Group (CG, submitted to postoperative warming with a sheet and a blanket, n=100). The tympanic temperature was measured over 24 hours in all participants. The primary outcome was excessive bleeding and the secondary outcomes were cardiac arrhythmias, acute myocardial infarction (AMI), blood component transfusion and the temperature patterns along time. The relationship between the intervention and the outcomes was assessed by means of bivariate logistic regression, with p<0.05 considered significant. Results: Starting two hours postoperatively, the IG had mean temperatures significantly higher than CG, maintaining this trend up to 15 hours. The IG had a 79% lower chance of bleeding compared to the GC (OR=0.21, 95% CI 0.12-0.39, p<0.001). The chance of AMI in was 94% lower in the IG compared to the CG (OR=0.06, 95% CI 0.01-0.48, p<0.001). The IG had a 77% lower chance of arrhythmias compared to the CG (OR=0.23, 95% CI=0.12-0.47, p<0.001). There was no difference between groups regarding blood product transfusion (p<0.279). Conclusions: Postoperative forced air warming decreased the incidence of excessive bleeding, AMI and arrhythmias, but did not alter the incidence of transfusion of blood components. These results indicate that forced air warming can be used after CABG until patients reach normothermia to avoid undesirable clinical outcomes.
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    Eficácia Da Redução No Tempo De Imobilização No Leito Em Pacientes Com Síndrome Coronariana Aguda Após Angioplastia Coronariana:Ensaio Clínico Randomizado
    (Universidade Federal de São Paulo (UNIFESP), 2018-02-22) Santos, Vinicius Batista [UNIFESP]; Barros, Alba Lucia Bottura Leite De [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Introduction: Percutaneous Coronary Intervention (Pci) Is The Treatment Performed In Patients With Coronary Artery Disease, Especially In Patients With Acute Coronary Syndrome (Acs). The Nursing Care In These Patients After Performing This Treatment Is The Maintenance Of The Supine Position For An Average Period Of Four Hours After Removal Of Femoral Artery Sheath. This Care Has The Purpose Of Preventing Vascular Complications, But This Immobility Time May Cause Discomfort (Back Pain, Low Back Pain, Paresthesia And Difficulty In Urination) And Greater Need For Analgesic Drugs, But There Is No Consensus Concerning The Ideal Time Of Immobility In Acs Patients Who Underwent Pci By The Femoral Artery. Objective: To Evaluate The Efficacy Of Reduction In The Immobility Time In Bed From Four To Two Hours After Sheath Removal Of The Femoral Artery In Patients With Acs Undergoing Pci. Method: This Was A Randomized Clinical Trial, Including Patients With Acs Who Underwent Pci Through Femoral Artery, Being Randomized By
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    Impact of extended lymphadenectomy on morbidity, mortality, recurrence and 5-year survival after gastrectomy for cancer: meta-analysis of randomized clinical trials
    (Sociedade Brasileira para o Desenvolvimento da Pesquisa em Cirurgia, 2008-12-01) Lustosa, Suzana Angélica Silva [UNIFESP]; Saconato, Humberto [UNIFESP]; Atallah, Álvaro Nagib [UNIFESP]; Lopes Filho, Gaspar de Jesus [UNIFESP]; Matos, Delcio [UNIFESP]; UNIFOA Clinical Epidemiology and Surgery; Universidade Federal de São Paulo (UNIFESP)
    PURPOSE: To compare morbidity, mortality, recurrence and 5-year survival between D1 and D2 or D3 for treatment of gastric cancer. METHODS: Systematic review and meta-analysis of RCTs. Metaview in RevMan 4.2.8 for analysis; statistical heterogeneity by Cochran's Q test (P<0.1) and I² test (P>50%). Estimates of effect were calculated using random effects model. RESULTS: D2 or D3 was associated with higher in-hospital mortality, with RR = 2.13, p=0.0004, 95% CI, 1.40 to 3.25, I²=0%, P=0.63; overall morbidity showed higher incidence in D2 or D3, RR = 1.98, p<0.00001, 95% CI, 1.64 to 2.38, I² = 33.9%, P=0.20; operating time showed longer duration in D2 or D3, weighted mean difference of 1.05, p<0.00001, 95% CI, 0.71 to 1.38, I² = 78.7%, P=0.03, with significant statistical heterogeneity; reoperation showed higher rate in D2 or D3, with RR = 2.33, p<0.0001, 95% CI, 1.58 to 3.44, I² = 0%, P=0.99; hospital stay showed longer duration in the D2 or D3, with weighted mean difference of 4.72, p<0.00001, 95% CI, 3.80 to 5.65, I² = 89.9%, P<0.00001; recurrence was analyzed showed lower rate in D2 or D3, with RR = 0.89, p=0.02, 95% CI, 0.80 to 0.98, I² = 71.0%, P = 0.03, with significant statistical heterogeneity; mortality with recurrent disease showed higher incidence in D1, with RR = 0.88, p=0.04, 95% CI, 0.78 to 0.99, I² =51.8%, P=0.10; 5-year survival showed no significant difference, with RR = 1.05, p=0.40, 95% CI, 0.93 to 1.19, I² = 49.1% and P=0.12. CONCLUSIONS: D2 or D3 lymphadenectomy procedure is followed by higher overall morbidity and higher in-hospital mortality; D2 or D3 lymphadenectomy shows lower incidence of recurrence and lower mortality with recurrent disease, when analysed altogether with statistical heterogeneity; D2 or D3 lymphadenectomy has no significant impact on 5-year survival.
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    Investigação da superioridade de um programa de fortalecimento muscular combinado dos músculos do quadril e do quadríceps em relação ao fortalecimento isolado do músculo quadríceps em indivíduos com luxação lateral da patela: um ensaio clínico unicego, paralelo, randomizado e controlado
    (Universidade Federal de São Paulo, 2022-06-27) Arrebola, Lucas Simões [UNIFESP]; Pinfildi, Carlos Eduardo [UNIFESP]; Smith, Toby Oliver; http://lattes.cnpq.br/6370481853776867; http://lattes.cnpq.br/9878119321655526; Universidade Federal de São Paulo (UNIFESP)
    Introdução: A recomendação para a adição do fortalecimento dos músculos do quadril (extensores, abdutores e rotadores laterais) ao fortalecimento isolado do músculo quadríceps para o tratamento da luxação patelar (LP) é baseada em estudos prévios realizados com indivíduos com dor patelofemoral (DPF) e sua eficácia não foi investigada para LP. Objetivo: Investigar a superioridade de um programa de fortalecimento combinado dos músculos do quadril (extensores, abdutores e rotadores laterais) e do músculo quadríceps em relação ao fortalecimento isolado do músculo quadríceps em indivíduos com LP. Método: Foi realizado um ensaio clínico de superioridade, unicego, paralelo, randomizado e controlado, com 40 indivíduos com idade entre 16 e 40 anos, de ambos os sexos, com histórico de pelo menos um episódio de LP documentado. Estes receberam seus programas de fortalecimento muscular correspondente ao grupo de alocação: fortalecimento isolado do músculo quadríceps (20 indivíduos) ou fortalecimento combinado dos músculos do quadril e do quadríceps (20 indivíduos), durante 8 semanas. O desfecho primário do estudo foi o questionário Lysholm. Os desfechos secundários incluíram a escala numérica de dor (END) ao repouso e ao esforço, o questionário Norwich Patellar Instability Score (NPIS), o questionário Kujala, o questionário Lower Extremity Functional Scale (LEFS), o questionário WHOQOL-Bref e o número de recidivas de LP. As avaliações foram realizadas antes do início do tratamento, na quarta semana, na oitava semana, na décima segunda semana, na vigésima quarta semana e na quadragésima oitava semana. Os dados foram analisados por meio do teste de ANOVA de medidas repetidas com o teste de post-hoc de Tukey. Resultados: Não houve diferença significante entre os grupos para os escores patelofemorais (questionário Lysholm: p=0,22, effect size (ES)=0,39; NPIS: p=0,11, ES=0,52; questionário Kujala: p=0,68, ES=0,12), END ao repouso e ao esforço (p=0,30, ES=0,34; e p=0,16, ES=0,46), LEFS (p=0,16, ES 0,46) WHOQOL-Bref (domínio físico: p=0,89, ES=0,02; domínio psicológico: p=0,98, ES=0,01; domínio social: p=0,63, ES=0,27; domínio ambiental: p=0,40; ES= 0,28). e número de recidivas de LP (p=0,39; ES=0,28). Conclusão: O programa de fortalecimento combinado dos músculos do quadril e do quadríceps não é superior ao fortalecimento isolado do músculo quadríceps para o tratamento da LP.
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    Omega-3 levels and nicotine dependence: a cross-sectional study and clinical trial
    (Karger, 2016) Zaparoli, Jucara X. [UNIFESP]; Sugawara, Eduardo K. [UNIFESP]; de Souza, Altay A. L. [UNIFESP]; Tufik, Sergio [UNIFESP]; Galduroz, Jose Carlos F. [UNIFESP]
    Background: High oxidative stress, which is caused by smoking, can alter omega-3 fatty acid concentrations. Since omega-3 fatty acids play a role in dopaminergic neurotransmission related to dependence, it is important to understand their effects on nicotine dependence. Methods: This research comprised 2 studies. The first one consisted of a cross-sectional evaluation, in which the levels of the most important omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), were compared between smokers and non-smokers in a sample of 171 individuals
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    Optimal search strategy for clinical trials in the Latin American and Caribbean Health Science Literature Database (LILACS)
    (Associação Paulista de Medicina - APM, 1997-06-01) Castro, Aldemar Araujo [UNIFESP]; Clark, Otávio Augusto Câmara [UNIFESP]; Atallah, Álvaro Nagib [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Brazilian Cochrane Center
    OBJECTIVE: To define and disseminate the optimal search strategy for clinical trials in the Latin American and Caribbean Health Science Literature (LILACS). This strategy was elaborated based on the optimal search strategy for MEDLINE recommended by Cochrane Collaboration for the identification of clinical trials in electronic databases. DESIGN: Technical information. SETTING: Clinical Trials and Meta-Analysis Unit, Federal University of São Paulo, in conjunction with the Brazilian Cochrane Center, São Paulo, Brazil. (http://www.epm.br/cochrane). DATA: LILACS/CD-ROM (Latin American and Caribbean Health Science Information Database), 27th edition, January 1997, edited by BIREME (Latin American and Caribbean Health Science Information Center). LILACS Indexes 670 journals in the region, with abstracts in English, Portuguese or Spanish; only 41 overlap in the MEDLINE-EMBASE. Of the 168.902 citations since 1982, 104,016 are in human trials, and 38,261 citations are potentiality clinical trials. Search strategy was elaborated combining headings with text word in three languages, adapting the interface of the LILACS. We will be working by locating clinical trials in LILACS for Cochrane Controlled Trials Database. This effort is being coordinated by the Brazilian Cochrane Center.