Clinical trial of medicament for craving control in crack users under RAPS care: a case report

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.Introdução: Segundo estimativa da Fundação Oswaldo Cruz (Fiocruz) sobre o uso de crack no Brasil, somente 0,5% da população brasileira faz uso regular de crack. A motivação para o início do uso relatada por 29,2% dos entrevistados foi relativa a problemas familiares, perdas afetivas importantes e pressão social. Como estudos científicos sobre o tema podem ser realizados por meio de diferentes tipos de investigação, em 2016, foi proposto um ensaio clínico randomizado (ECR) entre usuários de crack sob cuidados na Rede de Atenção Psicossocial (RAPS) para investigar a eficácia de um determinado medicamento destinado a amenizar a fissura (crise de abstinência) por crack. Entretanto, no curso de seu desenvolvimento, o estudo encontrou barreiras e enfrentou tantos vieses que se inviabilizou por completo. Objetivos: Essa tese de doutorado teve como objetivo geral realizar um estudo de caso sobre o referido ECR a partir da identificação e discussão dos nós críticos do delineamento de pesquisa originalmente proposto, os desafios relacionados ao cuidado com usuários de crack, assim como os problemas e desafios relacionados à RAPS como espaço para produção de pesquisas científicas. Métodos: Para a análise crítica do ECR foi utilizada a diretriz Consolidated Standards of Reporting Trials (Consort, 2010). Para a análise sobre os sujeitos a quem se destinavam os potenciais benefícios do uso do medicamento e a estrutura da RAPS para o cuidado desses sujeitos, realizou-se uma Revisão Bibliográfica. Resultados: A análise crítica realizada com o auxílio da diretriz Consort (2010), demonstrou que o ensaio clínico proposto não cumpriu 17 dos 25 quesitos baseados em evidências previstas na diretriz. A amostra do ECR deveria contar com 150 pacientes alocados em 2 grupos (controle e experimental), porém, apenas 5 participantes concluíram o protocolo previsto, não sendo possível validar o ECR. Os vieses metodológicos derivaram, basicamente, da escolha e vulnerabilidade da população do estudo. Conclusão: Esta análise crítica convida a uma reflexão sobre as dificuldades e limites envolvidos na realização de um ensaio clínico na RAPS com amostras populacionais sob alta vulnerabilidade. O desenvolvimento e análise de pesquisas deve considerar o mapeamento das redes imperceptíveis desenvolvidas pelos usuários de drogas e outros indivíduos em situação de rua para além dos pontos formais da RAPS e tomar como ponto de partida o usuário em seu contexto de vida, relações e tratamento, tendo como norteador o Projeto Terapêutico Singular.BV UNIFESP: Teses e dissertaçõe

Influence of Microelement Concentration on the Intensity of Alcohol Withdrawal Syndrome

Aims: To establish a nutritional and constitutional profile concerning the micronutrient plasma concentration of patients who suffer from AWS. Method: Observational case control study to determine whether patients who exhibited symptoms of AWS (N = 60) had micronutrient plasmatic concentration deficiencies when compared with healthy controls (N = 34). Results: There were statistically significant differences between the concentrations of nutrients that are correlated with glutamate hyperactivity (zinc, magnesium and folate/vitamin B12/homocysteine). Conclusion: Evidence from literature and our experiment suggests that brain activity, especially the glutamatergic system, might be directly involved in micronutrient concentrations. Therefore, their supplementation to the AWS patient might improve symptom evolution.Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)Associacao Fundo de Incentivo a Pesquisa (AFIP)Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)Universidade Federal de São Paulo UNIFESP, Dept Psychobiol, São Paulo, BrazilCtr Referencia Tratamento Alcool Tabaco & Outras, São Paulo, BrazilUniversidade Federal de São Paulo UNIFESP, Dept Psychobiol, São Paulo, BrazilFAPESP: 2012/06731-4Web of Scienc

Homeopathy in crack-cocaine craving: randomized, placebo controlled, double-blind study (COCACRACK study)

Centro de Atenção PsicossocialCentro de Atendimento à Pessoa DeficienteCentro de Referência de Álcool, Tabaco e Outras DrogasCentro Brasileiro de Informações sobre DrogasFarmácia Homeopática HN-CristianoUniversidade de São Paulo Faculdade de Medicina de Ribeirão PretoUniversidade Federal de São Paulo (UNIFESP)UNIFESPSciEL

The Polish Media System: 1989-2011

Praca recenzowana / peer-reviewed pape

Polski system medialny 1989-2011

Praca recenzowana / Peer-reviewed paperPublikacja składa się z trzech części. Pierwsza, zatytułowana „U źródeł transformacji systemu medialnego Polski”, została poświęcona okresowi przemian systemu medialnego zapoczątkowanych w 1989 r. Druga część publikacji omawia media „głównego nurtu”. Na trzecią część publikacji składają się rozdziały poświęcone mediom spoza głównego nurtu, często niszowym i mało znanym, co nie znaczy, że mniej ważnym

Evaluation of concrete resistance to chloride ions penetration by means of electric resistivity monitoring

The chlorideâ€induced corrosion of reinforcing steel is the major reason for the premature deterioration and degradation of field concrete structures built in a saltâ€laden environment. The results of investigation of the bituminous addition effect on Portland cement concrete resistance to chloride ions penetration are presented in this paper. Chloride penetration was simulated by subjecting samples to cyclic loading with salt solution and drying. Concrete resistivity development was monitored during 12 months. The test results have been analysed to verify the effect of addition content, the time of exposure in aggressive environment, as well as the sort of cement on chloride ion permeability of Portland cement concrete. The statistical analysis showed that bituminous addition significantly improves the concrete resistance to chloride salt solution penetration. Betono atsparumo chloro Jonų skvarbai įvertinimas stebint elektrinÄ—s varžos kitimÄ… Santrauka Betono ir gelžbetonio atžvilgiu chloro jonai yra agresyvus veiksnys, skatinantis armatÅ«rinio plieno ir betono korozijÄ…. Pateikiami bituminio priedo betone įtakos tyrimų rezultatai chloro jonų skvarbai jame. Siekiant įvertinti betono pasiprieÅ¡inimÄ… tokiems difuzijos procesams, remtasi eksperimentiniais medžiagos elektrinÄ—s varžos matavimo rezultatais. Taikant statistinius tyrimų metodus, atlikta rezultatų dispersinÄ— ir regresinÄ— analizÄ—, aiÅ¡kinantis betono elektrinÄ—s varžos kitimo tendencijas priklausomai nuo panaudoto cemento rÅ«Å¡ies, bituminio priedo kiekio, NaCl vandeninio tirpalo, skirto bandiniams įmirkyti, koncentracijos, ir agresyvaus priedo poveikio trukmÄ—s. StatistinÄ— analizÄ— patvirtino gana teigiamÄ… ir naudingÄ… bituminio priedo betone poveikio įtakÄ… ribojant chloro druskų tirpalų skvarbÄ… į betonÄ…. Raktiniai žodžiai: betonas, chloro jonai, elektrinÄ— varža, struktÅ«rinÄ— apsauga, bituminis priedas, dispersinÄ— analizÄ—, regresija. First Published Online: 14 Oct 201

The effect of the Glu342Lys mutation in α1−antitrypsin\alpha_{1}-antitrypsin on its structure, studied by molecular modelling methods

The structure of native α1-antitrypsin, the most abundant protease inhibitor in human plasma, is characterised primarily by a reactive loop containing the centre of proteinase inhibition, and a β-sheet composed of five strands. Mobility of the reactive loop is confined as a result of electrostatic interactions between side chains of Glu342 and Lys290, both located at the junction of the reactive loop and the β structure. The most common mutation in the protein, resulting in its inactivation, is Glu342→Lys, named the Z mutation. The main goal of this work was to investigate the influence of the Z mutation on the structure of α1-antitrypsin. Commonly used molecular modelling methods have been applied in a comparative study of two protein models: the wild type and the Z mutant. The results indicate that the Z mutation introduces local instabilities in the region of the reactive loop. Moreover, even parts of the protein located far apart from the mutation region are affected. The Z mutation causes a relative change in the total energy of about 3%. Relatively small root mean square differences between the optimised structures of the wild type and the Z mutant, together with detailed analysis of 'conformational searching' process, lead to the hypothesis that the Z mutation principally induces a change in the dynamics of α1-antitrypsin