Navegando por Palavras-chave "Clinical trial"

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    A 6-month randomized controlled trial to test the efficacy of a lifestyle intervention for weight gain management in schizophrenia
    (Biomed Central Ltd, 2013-02-18) Attux, Cecilia [UNIFESP]; Martini, Larissa Campagna [UNIFESP]; Elkis, Helio; Tamai, Sergio; Freirias, Andrea; Camargo, Maria das Gracas Miquelutti; Mateus, Mário Dinis [UNIFESP]; Mari, Jair de Jesus [UNIFESP]; Reis, Andre Fernandes [UNIFESP]; Bressan, Rodrigo Affonseca [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Universidade de São Paulo (USP); CAISM Ctr Atencao Integrada Saude Mental Irmandad
    Background: Patients with schizophrenia have lower longevity than the general population as a consequence of a combination of risk factors connected to the disease, lifestyle and the use of medications, which are related to weight gain.Methods: A multicentric, randomized, controlled-trial was conducted to test the efficacy of a 12-week group Lifestyle Wellness Program (LWP). the program consists of a one-hour weekly session to discuss topics like dietary choices, lifestyle, physical activity and self-esteem with patients and their relatives. Patients were randomized into two groups: standard care (SC) and standard care plus intervention (LWP). Primary outcome was defined as the weight and body mass index (BMI).Results: 160 patients participated in the study (81 in the intervention group and 79 in the SC group). On an intent to treat analysis, after three months the patients in the intervention group presented a decrease of 0.48 kg (CI 95% - 0.65 to 1.13) while the standard care group showed an increase of 0.48 kg (CI 95% 0.13 to 0.83; p=0.055). At six-month follow-up, there was a significant weight decrease of -1.15 kg, (CI 95% -2.11 to 0.19) in the intervention group compared to a weight increase in the standard care group (+0.5 kg, CI 95% -0.42-1.42, p=0.017).Conclusion: in conclusion, this was a multicentric randomized clinical trial with a lifestyle intervention for individuals with schizophrenia, where the intervention group maintained weight and presented a tendency to decrease weight after 6 months. It is reasonable to suppose that lifestyle interventions may be important long-term strategies to avoid the tendency of these individuals to increase weight. Clinicaltrials.gov identifier: NCT01368406
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    Avaliação da Terapia Interpessoal de grupo em pacientes com Transtorno do Estresse Pós-Traumático vítimas de violência urbana
    (Universidade Federal de São Paulo (UNIFESP), 2010-11-24) Braga, Rosaly Ferreira [UNIFESP]; Mello, Marcelo Feijó de [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Background: Posttraumatic stress disorder (PTSD) is a highly prevalent condition, yet available treatments demonstrate only modest efficacy. Exposure therapies, considered by many to be the “gold standard” therapy for PTSD, are poorly tolerated by many patients and show high attrition. We evaluated interpersonal therapy, in a group format, adapted to PTSD (IPT-G PTSD), as an adjunctive treatment for patients who failed to respond to conventional psychopharmacological treatment. Methods: Research participants included 40 patients who sought treatment through a program on violence in the department of psychiatry of Federal University of São Paulo (UNIFESP). They had received conventional psychopharmacological treatment for at least 12 weeks and failed to have an adequate clinical response. After signing an informed consent, previously approved by the UNIFESP Ethics Review Board, they received a semistructured diagnostic interview (SCID-I), administered by a trained mental health worker, to confirm the presence of a-PTSD diagnosis according DSM-IV criteria. Other instruments were administered, and patients completed out selfreport instruments at baseline, and endpoint to evaluate clinical outcomes.Results: Thirty-three patients completed the trial, but all had at least one second outcome evaluation. There were significant improvements on all measures, with large effect sizes. Conclusions: IPT-G PTSD was effective not only in decreasing symptoms of PTSD, but also in decreasing symptoms of anxiety and depression. It led to significant improvements in social adjustment and quality of life. It was well tolerated and there were few dropouts. Our results are very preliminary; they need further confirmation through randomized controlled clinical trials.
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    Avaliação de efetividade do biofeedback como estratégia de manejo da síndrome de burnout: um ensaio clínico randomizado
    (Universidade Federal de São Paulo (UNIFESP), 2018-03-29) Vasconcelos, Eduardo Motta de [UNIFESP]; Martino, Milva Maria Figueiredo de [UNIFESP]; http://lattes.cnpq.br/7096939242634758; http://lattes.cnpq.br/7006674371293601; Universidade Federal de São Paulo (UNIFESP)
    Objective: To evaluate the effectiveness of biofeedback conditioning based on heart rate variability to reduce the intensity of burnout in nursing students. Methods: Randomized, twophase clinical trial. Accomplished with nursing academics from a public educational institution. The first phase of the study consisted of 100 participants, who completed the sociodemographic data collection form and the Maslach Burnout Inventory Student Survey. Among the participants of the first phase were selected 32 individuals (16 with burnout and 16 healthy) for the second phase of the research, who were randomly assigned to two groups. The experimental group included eight individuals with burnout and eight healthy subjects, who randomly received two biofeedback sessions with a total duration of 40 minutes. The control group included eight individuals with burnout and eight healthy individuals, who randomly underwent a session of the active control condition lasting 20 minutes. Before initiating the active control condition or intervention, participants' initial condition was established by biofeedback based on heart rate variability in monitoring mode. Finally, the final condition of the academics was established and the Maslach Burnout Inventory Student Survey was completed. Results: The prevalence of academics with the syndrome corresponded to 20% of the sample. Of these, all were single, had no job, no children, and had no income of their own. Academics who were in the second group (p = 0.036) and the third year (p = 0.046), those who used medication (p = 0.002) and those who thought to give up the course (p = 0.001) had a significant association with burnout, and these are considered predictive factors. In the experimental subgroup with burnout, there was a reduction in the emotional exhaustion score (p = 0.004), the dissatisfaction score (p = 0.016) and the total score (intensity) of the Maslach Burnout Inventory (p = 0.011) while in the dimension of professional effectiveness (p = 0.001) there was an increase in the score (intensity). On the variables obtained through cardioEmotion®, the mean heart rate (p = 0.031) and the percentage of time in cardiac noncoherence (p = 0.008) were reduced in the experimental subgroup with burnout. In addition, the mean percentage of time in cardiac coherence (p = 0.001) and mean sympatheticvagal activity scores increased (p <0.001). It was found that the intervention reduced the disbelief score (p = 0.013) more sharply in the students who practiced physical activity in relation to those who did not practice. Conclusion: Biofeedback intervention based on heart rate variability was effective in reducing the intensity of burnout in nursing students.
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    Avaliação de estudos clínicos de tratamentos medicamentosos em pacientes acometidos por COVID-19 (SARS-CoV-2) : uma abordagem estatística crítica de ensaios clínicos fase III
    (Universidade Federal de São Paulo (UNIFESP), 2024-05-23) Santos, Rodolfo Rodrigo Pereira [UNIFESP]; Atallah, Álvaro Nagib [UNIFESP]; http://lattes.cnpq.br/8461078281290598; http://lattes.cnpq.br/3033736457834804
    Contexto: A pandemia de COVID-19 motivou extensas pesquisas sobre tratamentos, incluindo ensaios clínicos com padrões flexíveis. Esta revisão avalia a qualidade dos ensaios clínicos para tratamentos e vacinas contra a COVID-19, com o objetivo de identificar lacunas e limitações. Objetivos: Analisar criticamente ensaios clínicos randomizados de Fase III para tratamentos de COVID-19 referentes a prevenção de infecções, agravamentos da doença e mortalidade. Métodos: Seguindo as diretrizes estabelecidas, foi realizada uma revisão dos ensaios de Fase III. Os estudos elegíveis envolveram adultos e foram pesquisados sem restrições de idioma ou data de publicação. Extração de dados, avaliação de risco de viés e avaliação da estrutura GRADE foram realizadas. As análises estatísticas incluíram poder de teste post-hoc e recálculos do tamanho da amostra. Resultados: A revisão incluiu 46 ensaios de Fase III com aproximadamente 64.000 participantes. Foram encontradas discrepâncias entre tamanhos amostrais empregados e tamanhos recalculados, destacando possíveis limitações. A avaliação do risco de viés identificou vieses significativos, particularmente no cegamento e no desempenho. A qualidade da evidência variou entre os tratamentos, principalmente com níveis moderados a baixos. Conclusão: As considerações metodológicas são cruciais em ensaios clínicos, enfatizando o planejamento cuidadoso, a definição de hipóteses e a determinação do tamanho da amostra. A comunicação transparente de metodologias estatísticas é essencial para a replicação dos resultados. Estudos piloto são propostos como alternativa ética. A ausência de análise de poder de teste e de justificativa para o tamanho da amostra levanta preocupações. A integração de análises estatísticas e perspectivas clínicas possibilita mais resultados confiáveis. O poder estatístico e os recálculos do tamanho da amostra são vitais para práticas baseadas em evidências durante emergências. A combinação do risco de viés e do GRADE facilitaram as avaliações críticas dos estudos encontrados.
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    Avaliação do uso de cateter vesical impregnado com nitrofurazona como medida preventiva de bacteriúrias assintomáticas e infecções urinárias em transplante renal
    (Universidade Federal de São Paulo (UNIFESP), 2017-12-07) Menezes, Fernando Gatti de [UNIFESP]; Camargo, Luiz Fernando Aranha [UNIFESP]; Corrêa, Luci [UNIFESP]; http://lattes.cnpq.br/1034137168719643; http://lattes.cnpq.br/8501165687754582; http://lattes.cnpq.br/6364521254510499; Universidade Federal de São Paulo (UNIFESP)
    Abstract Objective: To evaluate the efficacy of nitrofurazone-coated silicone urinary catheters in the prevention of asymptomatic bacteriuria and urinary infection among living donor renal transplant recipients, to compare nitrofurantoin resistance and other antibiotics, as well as the impact on function and graft survival. Methods: This is an experimental, prospective, pilot, randomized and controlled, open-label study conducted at the Hospital do Rim (affiliated with the Universidade Federal de São Paulo), comparing clinical and epidemiological characteristics between two groups of patients undergoing bladder catheterization for live donor kidney transplantation: 1) 3-way nitrofural-impregnated silicone urinary catheter; 2) 3-way nonimpregnated silicone urinary catheter. The incidence of asymptomatic bacteriuria, urinary infection and sensitivity profile of the isolated etiological agents in the first month after transplantation were compared between the groups, as well as the evaluation of the impact on graft function during one year. In the comparative analysis of baseline characteristics, we used the Fisher’s exact test to verify homogeneity between dichotomous variables, and the chi-square test with Yate’s correction for categorical variables. Depending on their homogeneity, continuous variables were compared using the t test or Mann-Whitney-Wilcoxon test. We performed Mann-Whitney-Wilcoxon test to evaluate the impact on graft function using mean values of estimated glomerular filtration rate collected at 4 moments: discharge, 30 days, 6 months, and 12 months after transplantation. Results: Between March 2013 and December 2014, 214 patients were randomized, of which 176 ended the study (88 patients in each group). There were no differences between groups regarding clinical and epidemiological characteristics, except for the presence of the double J ureteral catheter (p = 0.04), ureteral catheter (P = 0.02), cardiovascular disease prior to renal transplantation (p = 0.002), mean number of blood transfusions prior to transplantation (p = 0.04) and incidence of discomfort with bladder catheter (p = 0.007), being more frequent in the group that used nitrofurazone-coated silicone urinary catheters. Among the groups of the nitrofural-impregnated silicone urinary catheter and nonimpregnated silicone urinary catheter, the incidence of asymptomatic bacteriuria was: 12.5% VS 11.4%, p = 0.99, respectively, and the incidence of urinary infections was: 8% VS 6.8%, p = 0.99, respectively. Regarding the etiological agents of asymptomatic bacteriuria and urinary infection, 42 strains were isolated with Gram-negative bacteria accounting for 95.24%. Escherichia coli was the most frequent Gram-negative bacteria (47.62%), with the extended spectrum beta-lactamase resistance mechanism (ESBL) present in 21.42% of the isolates, as well as 4.76% of the isolates presented resistance to carbapenems (blaKPC gene). Regarding the comparative analysis of bacterial resistance and impact on graft function in the first 12 months after kidney transplantation, there was no significant difference between the catheter groups. Conclusions: The use of nitrofurazone-coated silicone urinary catheters among living donor renal transplant recipients did not prevent asymptomatic bacteriuria and urinary infection, and increased patients' discomfort significantly, but without impact on the development of antimicrobial resistance, and without impact on graft function during 12 months of follow-up.
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    Avaliação do uso terapêutico do extrato de Lafoensia pacari St. Hil. Mangava-Brava na erradicação do Helicobacter pylori: Ensaio Clínico Randomizado Duplo Cego
    (Universidade Federal de São Paulo (UNIFESP), 2006-04-03) Menezes, Valfredo da Mota [UNIFESP]; Atallah, Álvaro Nagib [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Background: The eradication of Helicobacter pylori is easily achieved by combining antisecretory agents and antibiotics; however, the cost of these associations is very high for the population of Third World countries, where the prevalence of the infection is even higher and leads to markedly reduced treatment effectiveness. We tested a plant (Lafoensia pacari) that is used in the central region of Brazil. According to previous studies, this plant has high concentrations of ellagic acid, which presents gastric antisecretory and antibacterial actions. Material and Methods: 100 dyspeptic, urease-positive patients were randomized to receive 500mg of methanolic extract of L. pacari (n= 55) or placebo (n= 45), for 14 days, in a double-blind clinical trial. The main variables assessed were the eradication of H. pylori eight weeks after the intervention and complete symptom relief at the end of the treatment. Results: The exams (urease and histology) showed persistence of H. pylori in 100% of participants. Complete symptom relief was experienced by 42.5% of patients (95% CI: 29.4-55.8) in the intervention group and by 21% (95% CI: 8.8-33.1) in the control group, p=0.020. The side effects were minimum and similar in both groups. Conclusions: The extract of L. pacari as a single agent was not effective to eradicate H. pylori. However, it was well tolerated and many participants reported relief of symptoms. Future studies may test the agent using larger doses and longer periods, in monotherapy or in combination with antibiotics.
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    Brief motivational interview and educational brochure in emergency room settings for adolescents and young adults with alcohol related problems: a randomized single blind clinical trial
    (Associação Brasileira de Psiquiatria - ABP, 2011-09-01) Segatto, Maria Luiza [UNIFESP]; Andreoni, Solange [UNIFESP]; Silva, Rebeca de Souza e [UNIFESP]; Diehl, Alessandra [UNIFESP]; Pinsky, Ilana [UNIFESP]; Universidade Federal de Uberlândia Compulsion Care Sector; Universidade Federal de São Paulo (UNIFESP)
    OBJECTIVE: To evaluate the effectiveness of brief motivational interviewing and an educational brochure when delivered in emergency room to reduce alcohol abuse and related problems among adolescents and young adults. METHOD: a randomized single blind clinical trial with a 3 month follow-up was carried out at three emergency rooms from October 2004 to November 2005; subjects assessed were 16-25 years old treated for alcohol related events up to 6 hours after consumption. Socio-demographic data, quantity, frequency and negative consequences of alcohol consumption, motivation to change habits and future risk preception were evaluated. Statistical analysis was performed on subjects who completed follow up (completers). ANCOVA model was used to analyze the difference between the intervention groups with statistical significance level α = 5% and Confidence Interval (CI) 95%. RESULTS: 186 subjects formed the initial sample, being n = 175 included and randomized to educational brochure group (n = 88) or motivational interviewing group (n = 87). Follow-up assessment was performed in 85.2% sample. No significant difference between groups was observed. However, significant reductions (p < 0.01) in related problems and alcohol abuse were found in both groups. CONCLUSION: In this sample a reduction of alcohol use and related problems was observed. Preliminary data indicates that controlled clinical trials with motivational interviewing, educational brochure and nonintervention should be of future interest among Brazilian adolescent population.
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    Clinical and radiographic study of orofacial alterations in patients with systemic sclerosis
    (Sociedade Brasileira de Pesquisa Odontológica - SBPqO, 2009-03-01) Marcucci, Marcelo; Abdala, Nitamar [UNIFESP]; Heliópolis Hospital Department of Stomatology and Oral & Maxillo Facial Surgery; Universidade Federal de São Paulo (UNIFESP)
    Systemic sclerosis (SS) is an autoimmune disease with great repercussions on the hard and soft tissues of the orofacial region. The aim of this study was to investigate the relationship between mandibular osteolysis and mouth opening measurements, duration of disease and presence/absence of teeth. Twenty-five subjects were selected: 15 diagnosed with systemic sclerosis and 10 healthy controls. The SS patients were grouped according to the presence (group I) or absence (group II) of mandibular osteolysis. The healthy subjects served as the control group (III). All of them underwent panoramic radiography on Ortophos® equipment (Siemens) and were clinically examined, with mouth opening measurement. We observed that group I had a longer duration of the disease than group II (p = 0.003). Groups I and II presented the same mean mouth opening. There was an increasing correlation between mouth opening and duration of the disease in group I (p = 0.095), but this was not observed in group II (p = 0.596). There was no correlation between presence/absence of teeth and osteolysis (p > 0.999), or between presence/absence of teeth and side of osteolysis (p = 0.143). We could conclude that osteolysis seemed to develop in patients with a longer duration of the disease, but did not modify the degree of mouth opening in relation to patients without osteolysis, and the presence/absence of teeth was not significant. On the other hand, in the osteolysis cases, the longer the duration of the disease, the greater the opening of the mouth.
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    Comparação dos efeitos da estimulação elétrica nervosa transcutânea em pacientes com lombalgia crônica não específica: ensaio clínico randomizado
    (Universidade Federal de São Paulo (UNIFESP), 2007) Facci, Ligia Maria [UNIFESP]; Trevisani, Virgínia Fernandes Moça [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Introdução: Os equipamentos de eletroterapia mais utilizados no tratamento da lombalgia crônica não-específica são a Estimulação Elétrica Nervosa Transcutânea (TENS) e a Corrente Interferencial (CI). Ainda são escassas, porém, as evidências que justifiquem a sua utilização na prática clínica. Objetivos: O objetivo deste estudo foi comparar os efeitos da Estimulação Elétrica Transcutânea (TENS) com os da Corrente Interferencial (CI) em pacientes com lombalgia crônica não-específica. Métodos: Cento e cinqüenta pacientes com lombalgia crônica não-específica foram randomicamente divididos em três grupos: 1)TENS; 2) Corrente Interferencial e 3) Controle. Os pacientes designados à eletroterapia receberam 10 sessões de 30 minutos, em dias consecutivos, enquanto os pacientes do grupo controle permaneceram sem tratamento pelo mesmo período.Todos os pacientes foram avaliados, antes e depois do protocolo de tratamento, quanto à intensidade de dor através da EVA e do Questionário McGill; capacidade funcional, pelo questionário Roland-Morris; e utilização de medicamentos adicionais ao tratamento. Resultados: Cento e trinta e sete pacientes completaram o protocolo de tratamento, sendo 72,7 por cento do sexo feminino e 27,3 por cento do masculino, com média de idade de 47,16 ± 15,93 anos. Com relação à intensidade de dor, houve redução média na EVA de 44,86 mm (IC:- 52,4; -35,6) no grupo 2, de 39,18 mm (IC: -48,7; -29,7) no grupo 1, e de 8,53 mm (IC:-15,7; -01,3) no grupo 3, e no questionário McGill a redução do PPI no grupo 1 foi mais evidente, e do PRI e do NWC no grupo 2. No questionário Roland Morris, o grupo 2 teve redução média de 7,20, o grupo 1 de 6,59 e o grupo 3 de 0,70 pontos. É importante destacar que 84 por cento dos pacientes do grupo 1, 75 por cento do grupo 2 e 34 por cento do grupo 3 deixaram de tomar o medicamento após tratamento. Em todos os desfechos investigados, o grupo Controle apresentou diferença estatisticamente significante com relação aos demais grupos (p<0,0001), mas, apesar dos pacientes que receberam CI terem obtido melhores resultados na redução da dor e na melhora da capacidade funcional, estes não foram estatisticamente significantes quando comparados ao grupo de TENS (p>0,05). Conclusão: No tratamento da lombalgia crônica não-específica, tanto a TENS como Corrente Interferencial melhoram a capacidade funcional, reduzem a dor e diminuem a utilização de medicamentos quando comparados ao controle. Não há diferença, entretanto, entre os efeitos dos dois equipamentos de eletroterapia..
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    A dose-optimization trial of laronidase (Aldurazyme (R)) in patients with mucopolysaccharidosis I
    (Elsevier B.V., 2009-01-01) Giugliani, Roberto; Rojas, Veronica Munoz; Martins, Ana Maria [UNIFESP]; Valadares, Eugnia R.; Clarke, Joe T. R.; Goes, Jose E. C.; Kakkis, Emil D.; Worden, Mary Alice; Sidman, Marisa; Cox, Gerald F.; Univ Fed Rio Grande do Sul; Universidade Federal de São Paulo (UNIFESP); Universidade Federal de Minas Gerais (UFMG); Hosp Sick Children; Hosp Infantil Joana de Gusmao; BioMarin Pharmaceut Inc; Genzyme Corp; Harvard Univ
    Recombinant human alpha-L-iduronidase (Aldurazyme (R) laronidase) is approved as an enzyme replacement therapy to treat the lysosomal storage disorder, mucopolysaccharidosis type I (MPS I) at a dose of 0.58 mg/kg by once-weekly intravenous infusion. To assess whether alternate dosing regimens might provide a better reduction in lysosomal storage, a 26-week, randomized, open-label, multinational dose-optimization trial was conducted. the pharmacodynamic effect and safety of the approved laronidase dose was compared to three alternative regimens (1.2 mg/kg every 2 weeks; 1.2 mg/kg every week; 1.8 mg/kg every 2 weeks) among 33 MPS I patients. the four treatment regimens showed no significant differences in the reduction of urinary glycosaminoglycan excretion or liver volume. Laronidase had an acceptable safety profile in all dose regimen groups. Infusion-associated reactions were the most common drug-related adverse events across dose regimens (by patient incidence), and included pyrexia (21%), vomiting (15%), rash (15%), and urticaria (12%). Patients in the approved dose group had the lowest incidence of drug-related adverse events (38% vs. 63-75%) and infusion-associated reactions (25% vs. 25-63%). There was one death: a patient with acute bronchitis died of respiratory failure 6h after completing the first laronidase infusion. the approved 0.58 mg/kg/week laronidase dose regimen provided near-maximal reductions in glycosaminoglycan storage and the best benefit-to-risk ratio. the 1.2 mg/kg every 2 weeks regimen may be an acceptable alternative for patients with difficulty receiving weekly infusions, but the long-term effects of this regimen are unknown. (C) 2008 Elsevier Inc. All rights reserved.
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    Double-blind evaluation of homeopathy on cocaine craving: a randomized controlled pilot study
    (Elsevier Science Bv, 2018) Adler, Ubiratan Cardinalli; Acorinte, Ana Carolina; Calzavara, Fernando Oliveira; Silva, Adriano Andre da; Cesar, Amarilys de Toledo; Adler, Maristela Schiabel; Martinez, Edson Zangiacomi; Galduróz, José Carlos Fernandes [UNIFESP]
    Background: Brazil is among the nations with the greatest rates of annual cocaine usage. Pharmacological treatment of cocaine addiction is still limited, opening space for nonconventional interventions. Homeopathic Q-potencies of opium and Erythroxylum coca have been tested in the integrative treatment of cocaine craving among homeless addicts, but this setting had not proven feasible, due to insufficient recruitment. Objective: This study investigates the effectiveness and tolerability of homeopathic Q-potencies of opium and E. coca in the integrative treatment of cocaine craving in a community-based psychosocial rehabilitation setting. Design, setting, participants, and interventions: A randomized, double-blind, placebo-controlled, parallel-group, eight-week pilot trial was performed at the Psychosocial Attention Center for Alcohol and Other Drugs (CAPS-AD), Sao Carlos/SP, Brazil. Eligible subjects included CAPS-AD patients between 18 and 65 years of age, with an International Classification of Diseases-10 diagnosis of cocaine dependence (F14.2). The patients were randomly assigned to two treatment groups: psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca (homeopathy group), and psychosocial rehabilitation plus indistinguishable placebo (placebo group). Main outcome measures: The main outcome measure was the percentage of cocaine-using days. Secondary measures were the Minnesota Cocaine Craving Scale and 12-Item Short-Form Health Survey scores. Adverse events were reported in both groups. Results: The study population comprised 54 patients who attended at least one post-baseline assessment, out of the 104 subjects initially enrolled. The mean percentage of cocaine-using days in the homeopathy group was 18.1% (standard deviation (SD): 22.3%), compared to 29.8% (SD: 30.6%) in the placebo group (P < 0.01). Analysis of the Minnesota Cocaine Craving Scale scores showed no between-group differences in the intensity of cravings, but results significantly favored homeopathy over placebo in the proportion of weeks without craving episodes and the patients' appraisal of treatment efficacy for reduction of cravings. Analysis of 12-Item Short-Form Health Survey scores found no significant differences. Few adverse events were reported: 0.57 adverse events/patient in the homeopathy group compared to 0.69 adverse events/patient in the placebo group (P = 0.41). Conclusions: A psychosocial rehabilitation setting improved recruitment but was not sufficient to decrease dropout frequency among Brazilian cocaine treatment seekers. Psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca were more effective than psychosocial rehabilitation alone in reducing cocaine cravings. Due to high dropout rate and risk of bias, further research is required to confirm our findings, with specific focus on strategies to increase patient retention. (C) 2018 Shanghai Changhai Hospital. Published by Elsevier B.V. All rights reserved.
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    The effectiveness of acupuncture as a treatment for tinnitus: a randomized controlled trial using Tc-99m-ECD SPECT
    (Springer, 2016) Laureano, Maura Regina [UNIFESP]; Onishi, Ektor Tsuneo [UNIFESP]; Bressan, Rodrigo Affonseca [UNIFESP]; Braga Neto, Pedro [UNIFESP]; Vieira Castiglioni, Mario Luiz [UNIFESP]; Batista, Ilza Rosa [UNIFESP]; Reis, Marilia Alves [UNIFESP]; Garcia, Michele Vargas [UNIFESP]; de Andrade, Adriana Neves [UNIFESP]; Sanchez, Maura Ligia [UNIFESP]; Moreira, Hugo Cogo [UNIFESP]; de Almeida, Roberta Ribeiro [UNIFESP]; Garrido, Griselda Jara; Jackowski, Andrea Parolin [UNIFESP]
    Investigate the effect of acupuncture on brain perfusion using ethyl cysteinate dimer single-photon emission computed tomography (Tc-99m-ECD SPECT) in patients with tinnitus. This randomized, single-blind, sham-control study examined patients (18-60 years old) with normal hearing and chronic, idiopathic, continuous tinnitus. Fifty-seven subjects were randomly assigned to true (n = 30) or sham (n = 27) acupuncture (ACP)
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    Effectiveness of physical activity in reducing pain in patients with fibromyalgia: a blinded randomized clinical trial
    (Springer, 2012-08-01) Kayo, Andrea Harumi [UNIFESP]; Peccin, Maria Stella [UNIFESP]; Sanches, Carla Munhoz [UNIFESP]; Moca Trevisani, Virginia Fernandes [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Santo Amaro Univ UNISA
    The purpose of this study was to evaluate and compare the effectiveness of muscle-strengthening exercises (MS) and a walking program (WA) in reducing pain in patients with fibromyalgia. Ninety women, 30-55 years of age, diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria, were randomized into 3 groups: WA Group, MS Group, and control group. Pain (visual analog scale) was evaluated as the primary outcome. Physical functioning (Fibromyalgia Impact Questionnaire, FIQ), health-related quality of life (Short-Form 36 Health Survey, SF-36), and use of medication were evaluated as secondary outcomes. Assessments were performed at baseline, 8, 16, and 28 weeks. Intention-to-treat and efficacy analyses were conducted. Sixty-eight patients completed the treatment protocol. All 3 groups showed improvement after the 16-week treatment compared to baseline. At the 28-week follow-up, pain reduction was similar for the WA and MS groups (P = 0.39), but different from the control group (P = 0.01). At the end of the treatment, 80% of subjects in the control group took pain medication, but only 46.7% in the WA and 41.4% in the MS groups. Mean FIQ total scores were lower for the WA and MS groups (P = 0.96) compared with the control group (P < 0.01). Patients in the WA and MS groups reported higher scores (better health status) than controls in almost all SF-36 subscales. MS was as effective as WA in reducing pain regarding all study variables; however, symptoms management during the follow-up period was more efficient in the WA group.
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    The Emerging Role of Brazil in Clinical Trial Conduct for Transplantation
    (Wiley-Blackwell, 2011-07-01) Tedesco-Silva Junior, Hélio [UNIFESP]; Felipe, Claudia Rosso [UNIFESP]; Abbud-Filho, M.; Garcia, V.; Medina-Pestana, J. O. [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); FAMERP HB FUNFARME; Santa Casa Misericordia
    Brazil is a country with over 190 000 000 inhabitants and a health system composed of a large public, government managed system. Between 1999 and 2010 the number of deceased donors increased by 161%, from 3.8 to 9.9 pmp, and the number of solid organ transplants increased by 121%, from 2891 to 6402. This growth was a consequence of the creation of a well-organized national transplant program. Government funding, decentralization and educational investment in transplant coordinators and related professional were decisive. in 2009 Brazil was the second largest country in the absolute number of kidney transplants (n = 4259). There are significant region disparities in performance which are mainly due to the development status. Improvements in transplant and research regulations resulted in an increasing participation of Brazilian transplant centers in multicenter trials, reaching over 44 studies during the last 11 years. Brazilian centers have been involved in clinical trials using everolimus, sirolimus, fingolimod, mycophenolate mofetyl, mycophenolate sodium, tacrolimus modified-release, sotrastaurin, belatacept, JAK3 inhibitor CP690,550 and valganciclovir. the still increasing number of transplants performed every year along with more efficient regulatory and sanitary analysis, organized clinical research programs and reduction in region performance disparities will eventually increase even more the participation of Brazil in trials worldwide.
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    Endoscopic surgery for the antenatal treatment of myelomeningocele: the CECAM trial
    (Mosby-Elsevier, 2016) Pedreira, Denise A. L.; Zanon, Nelci [UNIFESP]; Nishikuni, Koshiro; Moreira de Sa, Renato Augusto; Acacio, Gregorio L.; Chmait, Ramen H.; Kontopoulos, Eftichia V.; Quintero, Ruben A.; Universidade Federal de São Paulo (UNIFESP)
    BACKGROUND: A recent randomized clinical trial named Management of Myelomeningocele Study (MOMS trial) showed that prenatal correction of open spina bifida (OSB) via open fetal surgery was associated with improved infant neurological outcomes relative to postnatal repair, but at the expense of increased maternal morbidity. OBJECTIVE: We sought to report the final results of our phase I trial (Cirurgia Endoscopica para Correcao Antenatalda Meningomielocele [CECAM]) on the feasibility, safety, potential benefits, and side effects of the fetoscopic treatment of OSB using our unique surgical technique. STUDY DESIGN: Ten consecutive pregnancies with lumbosacral OSB were enrolled in the study. Surgeries were performed percutaneously under general anesthesia with 3 ports and partial carbon dioxide insufflation. After appropriate surgical positioning of the fetus, the neuro-placode was released with scissors and the skin was undermined to place a biocellulose patch over the lesion. The skin was closed over the patch using a single running stitch. Preoperative, postoperative, and postnatal magnetic resonance imaging were performed to assess hindbrain herniation. Neurodevelopmental evaluation was performed before discharge and at 3, 6, and 12 months. All cases were delivered by cesarean delivery, at which time the uterus was assessed for evidence of thinning or dehiscence. RESULTS: The median gestational age at the time of surgery was 27 weeks (range 25-28 weeks). Endoscopic repair was completed in 8 of 10 fetuses. Two cases were unsuccessful due to loss of uterine access. The mean gestational age at birth was 32.4 weeks with a mean latency of 5.6 weeks between surgery and delivery (range 2-8 weeks). There was 1 fetal and 1 neonatal demise, and 1 unsuccessful case underwent postnatal repair. Of the 7 infants available for analysis, complete reversal of hindbrain herniation occurred in 6 of 7 babies. Three babies required ventriculoperitoneal shunting or third ventriculostomy. Functional motor level was the same or better than the anatomical level in 6 of 7 cases. There was no significant maternal morbidity and no evidence of myometrial thinning or dehiscence. However, surgeries were complicated by premature rupture of membrane and prematurity. CONCLUSION: Our study suggests that the antenatal treatment of OSB using a fetoscopic approach and our unique surgical technique can result in a watertight seal, reversal of the hindbrain herniation, and better than expected motor function. Our technique differs substantially from the classic repair of OSB used in prior open fetal surgery and fetoscopic studies, in which the dura mater is dissected and the defect is closed in multiple layers. Instead, we use a biocellulose patch placed over the lesion and simple closure of the skin. As such, our technique is an alternative to the current paradigms in the antenatal treatment of OSB. Our clinical outcomes are in line with the results of our extensive prior animal work. Maternal benefits of our approach and technique include minimal morbidity and no myometrial legacy. Current limitations of the approach include potential loss of access, premature rupture of membranes, and attendant prematurity. Phase II trials are needed to prevent these complications and to further assess the risks and benefits of our distinct surgical approach and technique.
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    Ensaio clínico de medicamento para controle da fissura em usuários de crack sob cuidados na RAPS: um estudo de caso
    (Universidade Federal de São Paulo (UNIFESP), 2019) Jezierski, Marta Ana [UNIFESP]; Rios, Ademar Arthur Chioro dos [UNIFESP]; http://lattes.cnpq.br/9454572596499303; http://lattes.cnpq.br/4844930507147288; Universidade Federal de São Paulo (UNIFESP)
    Introduction: According to data from the Fundação Oswaldo Cruz (Fiocruz) on crack use in Brazil, only 0.5% of the Brazilian population use crack cocaine regularly. The motivation to start using reported by 29.2% of the interviewees was related to family problems, important affective losses and social pressure. As scientific studies on the subject can be carried out through different types of research, in 2016, a randomized clinical trial (RCT) was proposed among crack users under Mental Health Services (MHS) care to investigate the efficacy of a drug designed to relieve fissure (abstinence crisis) by crack. However, in the course of its development, the study encountered barriers and faced so many biases that it became completely unfeasible. Objectives: The objective of this doctoral was to carry out a case report on the RCT from the identification and discussion of the critical nodes of the originally research design, the challenges related to care with crack users, as well as the problems and challenges related to MHS as a space to produce scientific research. Methods: The Consolidated Standards of Reporting Trials (Consort, 2010) was used for the critical analysis of the RCT. A Bibliographic Review was performed for the analysis on the subjects to whom the potential benefits of the drug’s use were destined and the MHS structure for the care of these subjects. Results: The critical analysis carried out with Consort, showed that the proposed RCT failed to fulfill 17 of the 25 evidence-based requirements set out in the guideline. The RCT sample should have 150 patients allocated in 2 groups (control and experimental), but only 5 participants concluded the protocol, and it is not possible to validate the RCT. The methodological biases were basically derived from the choice and vulnerability of the study population. Conclusion: This critical analysis invites a reflection on the difficulties and limits involved in conducting an RCT in the MHS with population samples under high vulnerability. The development and analysis of research should consider mapping the imperceptible networks developed by drug users and other street individuals beyond the formal points of the MHS and taking as a starting point the user in their life context, relationships and treatment, having as guiding the Individual Therapeutic Project.
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    Estudo da influência dos ácidos graxos poli-insaturados na dependência e no craving pelo álcool
    (Universidade Federal de São Paulo (UNIFESP), 2011-11-24) Fogaça, Marina Neves [UNIFESP]; Galduróz, José Carlos Fernandes [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Introdução: A fração lipídica das membranas celulares consiste de ácidos graxos poliinsaturados (PUFAS) e o uso crônico do álcool altera sua composição, modificando a permeabilidade. Portanto, a administração de PUFAS pode ser um potencial tratamento para evitar a compulsão pelo álcool. Metodologia: Este foi um estudo placebo controlado, duplo-cego, randomizado, onde, "PUFAS”, “Naltrexone”, “Naltrexone + PUFAS" e "Placebo", foram administrados por 90 dias, sendo aplicadas escalas para avaliar o craving pelo álcool (OCDS) e a severidade da dependência do álcool (SADD) no início e 90 dias após a administração das substâncias. Resultados: Após 3 meses de seguimento, houve uma melhora significativa ao longo do tempo em relação aos "dias de ingesta", SADD e OCDS em todos os grupos (p <0,001) dentre os 43 pacientes que completaram o estudo. A comparação entre os grupos quanto aos "dias de ingesta" não demonstrou diferença estatisticamente significante (F = 0,71, p = 0,69). O mesmo efeito foi observado para a compulsão (OCDS) (F = 1,08, p = 0,37) e escala de severidade da dependência (SADD) (F = 0,73, p = 0,53). Conclusões: A administração de n-3 e n-6 PUFAS por 3 meses não diferiu significativamente do placebo na redução da quantidade de ingesta de álcool, ou dos escores de OCDS e SADD em um grupo de pacientes dependentes de álcool. Estudos posteriores com mais participantes, ou com tratamento mais prolongado são necessários para avaliar o possível benefício da administração de ácidos graxos poli-insaturados para pacientes dependentes de álcool, quer como monoterapia ou em combinação com o Naltrexone.
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    Exploratory calcineurin inhibitor-free regimens in living-related kidney transplant recipients
    (Associação Brasileira de Divulgação Científica, 2007-04-01) Garcia, Riberto [UNIFESP]; Machado, Paula Goulart Pinheiro [UNIFESP]; Felipe, Claudia Rosso [UNIFESP]; Park, Sung In [UNIFESP]; Spinelli, Glaucio Amaral [UNIFESP]; Franco, Marcello Fabiano de [UNIFESP]; Tedesco-Silva Junior, Hélio [UNIFESP]; Pestana, Jose Osmar Medina [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Chronic allograft nephropathy is among the major causes of graft loss even in low-risk kidney transplant recipients and correlates with acute nephrotoxic events during the first year post-transplant. Therefore, calcineurin inhibitor-free regimens may improve patient and graft survival among recipients of living-related kidney transplants. To confirm this hypothesis, we evaluated the efficacy and safety of two calcineurin inhibitor-free regimens in 92 low-risk recipients of one-haplotype living-related kidney transplants. Immunosuppression consisted of tacrolimus, azathioprine and prednisone (group I, GI, N = 38), 2 doses of daclizumab, mycophenolate mofetil (MMF), and prednisone (GII, N = 33) and 2 doses of daclizumab, MMF, sirolimus and prednisone (GIII, N = 21). At 12 months, treatment failure (biopsy-confirmed acute rejection, graft loss or death) was higher in GII compared to GIII and GI (54.5 vs 24.0 vs 13.1%, P < 0.01, respectively). In patients of black ethnicity the incidence of acute rejection was 25 vs 83.3 vs 20% (P = 0.055), respectively. Patient and graft survival was comparable. There were no differences in mean creatinine or calculated creatinine clearance at 12 months. Overall incidence of post-transplant diabetes mellitus (3.3%) and cytomegalovirus disease (4.3%) was similar in all groups. Further development of effective calcineurin inhibitor-free regimens should exclude patients of black ethnicity and may need full-induction therapy, perhaps with depleting agents, and concentration-controlled use of sirolimus and MMF.
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    Fluticasone/formoterol dry powder versus budesonide/formoterol in adults and adolescents with uncontrolled or partly controlled asthma
    (W B Saunders Co Ltd, 2013-09-01) Cukier, Alberto; Jacob, Cristina Miuki Abe [UNIFESP]; Rosario Filho, Nelson Augusto; Fiterman, Jussara; Vianna, Elcio Oliveira; Hetzel, Jorge Lima; Neis, Marcio Abreu; Fiss, Elie; Castro, Fábio Fernandes Morato; Fernandes, Ana Luisa Godoy [UNIFESP]; Stirbulov, Roberto; Pizzichini, Emilio; AIR Brazilian Study Grp; Universidade de São Paulo (USP); Univ Fed Parana; Pontificia Univ Catolica Rio Grande do Sul; Univ S Paulo; Santa Casa Misericordia Porto Alegre; Ctr Paulista Invest Clin; Fac Med ABC; Inst Pesquisa Clin Med Avancada; Universidade Federal de São Paulo (UNIFESP); Santa Casa Sch Med Sci São Paulo; Universidade Federal de Santa Catarina (UFSC)
    This 12-week study compared the efficacy and safety of a fixed combination of fluticasone propionate plus formoterol (FL/F) 250/12 mu g b.i.d. administered via a dry powder inhaler (DPI) (Libbs Farmaceutica, Brazil) to a combination of budesonide plus formoterol (BD/F) 400/12 mu g b.i.d. After a 2-week run-in period (in which all patients were treated exclusively with budesonide plus formoterol), patients aged 12-65 years of age (N = 196) with uncontrolled asthma were randomized into an actively-controlled, open-labeled, parallel-group, multicentre, phase III study. the primary objective was to demonstrate non-inferiority, measured by morning peak expiratory flow (mPEF).The non-inferiority was demonstrated. A statistically significant improvement from baseline was observed in both groups in terms of lung function, asthma control, and the use of rescue medication. FL/F demonstrated a statistical superiority to BD/F in terms of lung function (FEV1) (p = 0.01) and for asthma control (p = 0.02). Non-significant between-group differences were observed with regards to exacerbation rates and adverse events.In uncontrolled or partly controlled asthma patients, the use of a combination of fluticasone propionate plus formoterol via DPI for 12-weeks was non-inferior and showed improvements in FEV1 and asthma control when compared to a combination of budesonide plus formoterol. (Clinical Trial number: ISRCTN60408425). (C) 2013 Elsevier B.V. All rights reserved.
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    How to design and write a clinical research protocol in Cosmetic Dermatology
    (Soc Brasileira Dermatologia, 2013-01-01) Bagatin, Edileia [UNIFESP]; Miot, Helio Amante [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Universidade de São Paulo (USP)
    Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment.