Biblioteca para el diseño del cuaderno de recogida de datos en ensayos clínicos en Openclinica / Library for Designing the Case Report Form of Clinical Trials in Openclinica

Introducción: El Centro Nacional Coordinador de Ensayos Clínicos (CENCEC) utiliza el software OpenClinica para diseñar los Cuadernos de Recogida de Datos (CRD) de los ensayos clínicos. Cada ensayo tiene características específicas, pero existen datos comunes a todos los ensayos que pueden ser estandarizados. Objetivo: Desarrollar una biblioteca de plantillas para el diseño de los CRD. Método: Se realizó un análisis documental de los estándares para el manejo de datos en los ensayos clínicos y se analizaron los diseños utilizados en cuatro ensayos desarrollados en OpenClinica. Resultados: Según los tipos de datos que se registran en los ensayos clínicos se diseñaron 14 plantillas. Cada plantilla, es un fichero Excel con cinco hojas de trabajo donde se registran todas las definiciones del CRD. Las plantillas se han utilizado en tres ensayos clínicos con resultados favorables. Conclusión: Las 14 plantillas que componen la biblioteca CRD fueron diseñadas permitiendo su futura reutilización en la gestión de datos de nuevos ensayos clínicos(AU)

Introduction: CENCEC uses OpenClinica software to design the database of the Case Report Forms (CRF) of the clinical trials (CT). Every trial has specific characteristics although some of them are common to all trials which permit to standardize the process. Objective: To develop a library of templates in order to design the CRF. Methods: A documentary analyses of the standards for data management in clinical trials was performed and in addition of that four designs developed at OpenClinica were reviewed. Results: A library of 14 templates according to data types of CT was proposed. Every template is an Excel file with five sheets in which the definitions of the CRF is registered. The templates have been used in three CT. Conclusions: The 14 templates that make up the CRF library were designed allowing their future reuse in the management of data from new clinical trials(AU)

Impact of the introduction of the pneumococcal conjugate vaccine in the Brazilian routine childhood national immunization program.

Brazil introduced the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, Synflorix™, GSK Vaccines) in the routine childhood immunization program in 2010 with a 3+1 schedule (with catch-up for children <2 years-old). This review represents the first analysis of the overall impact of a second-generation pneumococcal conjugate vaccine on nasopharyngeal carriage and all the major pneumococcal disease manifestations in a single, pneumococcal conjugate vaccine-naïve, developing country. A total of 15 published articles and 13 congress abstracts were included in the analysis. In children <5 years-old, studies showed a positive impact of PHiD-CV on the incidence of vaccine-type and any-type invasive pneumococcal disease (including decreases in pneumococcal meningitis morbidity and mortality), on pneumonia incidence and mortality, and on otitis media. Nasopharyngeal carriage of vaccine-type and any-type pneumococci decreased after the primary doses, with no early signs of replacement with other pathogens. Finally, herd protection against vaccine-type invasive pneumococcal disease and pneumonia in unvaccinated subjects was shown in some studies for some age groups. In conclusion, pneumococcal disease decreased after the introduction of PHiD-CV into the Brazilian national immunization program. Further follow-up is needed to evaluate the long-term overall impact of PHiD-CV in the Brazilian population.

Immunogenicity and safety of a booster dose of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine coadministered with the tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers: a randomized trial.

BACKGROUND: This open, randomized clinical trial (NCT00758264) evaluated the coadministration of a booster dose of the 10-valent pneumococcal conjugate vaccine (PHiD-CV) and a single dose of the tetravalent meningococcal conjugate vaccine (MenACWY-TT) in Taiwanese and Mexican toddlers. METHODS: Healthy toddlers aged 12-23 months (N = 363) were randomized (2:1:1) to receive either both vaccines at first visit, MenACWY-TT at first visit and 1 month later PHiD-CV, or PHiD-CV at first visit and 1 month later MenACWY-TT. Immune responses were measured 1 month after MenACWY-TT vaccination by meningococcal serum bactericidal activity (rSBA) assay and 1 month after PHiD-CV vaccination by pneumococcal 22F-inhibition enzyme-linked immunosorbent assay and functional opsonophagocytic activity assay. Solicited and unsolicited symptoms were recorded for days 4 and 31 postvaccination, respectively. Serious adverse events were recorded throughout the study. RESULTS: The prespecified criteria for noninferiority of coadministration versus individual administrations were met for all meningococcal serogroups (in terms of percentages of toddlers with rSBA titer ≥8) and all vaccine pneumococcal serotypes (in terms of antibody geometric mean concentration ratios), except pneumococcal serotype 18C. For each meningococcal serogroup, ≥97.5% of toddlers across the 3 groups had rSBA titers ≥128 at 1 month after MenACWY-TT vaccination. For each pneumococcal serotype, at 1 month after PHiD-CV vaccination, ≥96.0% and ≥92.9% of toddlers across the 3 groups had antibody concentrations ≥0.2 µg/mL and opsonophagocytic activity titers ≥8, respectively. The safety profiles of both vaccines when coadministered were clinically acceptable. CONCLUSIONS: This study supports the coadministration of PHiD-CV and MenACWY-TT in toddlers.

Immunogenicity, reactogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Mexican infants.

The immunogenicity and safety of the 10-valent pneumococcal conjugate vaccine, PHiD-CV, have been documented in European and Asian studies. In this open study conducted in Mexico (NCT00489554), 230 healthy infants received three doses of PHiD-CV and DTPa-HBV-IPV/Hib vaccines at 2, 4 and 6 months of age and two doses of oral human rotavirus vaccine at 2 and 4 months. Serotype-specific pneumococcal responses and opsonophagocytic activity (OPA) were measured one month post-dose 3. PHiD-CV's primary vaccination course was highly immunogenic against each of the 10 pneumococcal vaccine serotypes and carrier protein D. Antibody responses against pneumococcal serotypes and protein D were generally higher in Mexican infants compared with European antibody responses, and functional OPA responses were also higher or in the same range. The most frequent solicited local symptom was pain, with high but similar incidences of grade 3 pain reported at both injection sites (up to 15% of all doses). PHiD-CV was well tolerated, with no serious adverse events considered as causally related to vaccination. Most solicited symptoms were mild and there was no increase in incidence of solicited symptoms with successive vaccine doses.

Bebidas energéticas: componentes e custo-benefício / Power drinks: components and cost-benefit

Neste trabalho, foi mostrada uma análise cuidadosa da composição química dos energéticos, observando-se que a grande maioria consiste numa mistura de carboidratos (cerca de 11 g/dl), taurina (400mg/dl), cafeína (cerca de 32mg/dl), glucoronolactona (cerca de 240 mg/dl) e vitaminas do complexo B (100 por cento da necessidade diária). A ação das bebidas energéticas no organismo também foi avaliada nessa revisão.

Bebidas energéticas: componentes e custo-benefício / Power drinks: components and cost-benefit

Neste trabalho, foi mostrada uma análise cuidadosa da composição química dos energéticos, observando-se que a grande maioria consiste numa mistura de carboidratos (cerca de 11 g/dl), taurina (400mg/dl), cafeína (cerca de 32mg/dl), glucoronolactona (cerca de 240 mg/dl) e vitaminas do complexo B (100 por cento da necessidade diária). A ação das bebidas energéticas no organismo também foi avaliada nessa revisão.(AU)

This investigation was showed a careful analyze of chemical composition the energetics, watching that the majority consist of carboidrates mix (about 11 mg/dl), taurine (400 mg/dl), caffeine (about 32 mg/dl) , glucuronolactones (about 240 mg/dl) and complex B vitamins (100% of necessity diary). The action of the "power drinks" in the organism also was valued in the review. (AU)

Determinação espectrofotométrica e amperométrica de compostos fenólicos em urina humana, usando extrato parcialmente purificado de banana nanica (Musa acuminata) / Spectrophotometric and amperometric determination of compounds phenolics in human urine, utilizing purificated partialment extract of banana nanica (Musa acuminata)

Introdução - Extrato parcialmente purificado de banana nanica (Musa acuminata), melhor fonte de enzima Polifenol oxidase (PFO) [EC.1.14.18.1] (Bonfim et al.3, 2000), foi estudado como material biocatalítico para a oxidação aeróbica dos substratos fenólicos usando um biossensor amperométrico com PFO imobilizada. Métodos - Foi estudada a extração da PFO dessa fonte (Bonfim et al.3, 2000), a purificação parcial desse extrato bruto usando sulfato de amônio (40%), que precipita o excesso de enzimas presentes nesse extrato com posterior diálise (Perone15, 2004). A seguir foi determinada a atividade e proteína total nos dois extratos. Um biossensor amperométricofoi construído usando 50 U de PFO proveniente do extrato parcialmente purificado de banana nanica (Perone15, 2004), imobilizada sobre uma membrana de teflon (Celgard 2400) com o uso do reagente bifuncional glutaraldeído 2,5% m/V. Após secagem, essa membrana enzimática foi acoplada na extremidade de um eletrodo de oxigênio. Esse biossensor foi usado na determinação de compostos fenólicos em urina de indivíduos que consomem drogas metabolizando fenólicos, por amperometria e por espectrofotometria. Resultados - Nas amostras de urina observou-se que indivíduos que usam L-dopa apresentaram maior concentração de fenólicos que indivíduos que usam anfetaminas. Conclusões - A porcentagem de erro nas amostras estudadas foi menor que 3%, usando extrato bruto (Perone14, 2003) e parcialmente purificado, usando o método padrão espectrofotométrico (Folin-Denis), mostrando a eficiência do método amperométrico empregado, com ou sem purificação enzimática.

Introduction - Partial purificated extract of stunded banana (Musa acuminata), the best source of enzyme Poliphenol oxidase (PPO) [EC.1.14.18.1] (Bonfim et al.3, 2000), was studied as biocatalitic material to the aerobic oxidation of phenolics substrates using an amperometry biosensor with PPO immobilized. Methods - The extraction of PPO was studied in the source (Bonfim et al.3, 2000), the partial purification of this crude extract using ammonium sulphate (40%), that precipitate the enzyme excess presents in this extract with posterior dialysis. After it was determinated the total activity and proteins in the two extracts. An amperometric biosensor was builded using 50 U of PPO proceeding of purificated partial extract of stunded banana; immobilized on a Teflon membrane (Celgard 2400), with the use of the reagent glutaraldeyde 2,5% m/V. After drying, this enzymatic membrane was copled in the extremity of an oxygen electrode. This biosensor was used in the determination of phenolics in urine samples of persons that use drugs, metabolizing phenols by amperometry and by spectrophotometry. Results - In the urine samples, was possible to notice that persons that use L- Dopa shows greather quantity of phenols than persons that use amphetamines. Conclusions - The percentage of error in the samples studied was minor that 3%, using the crude extract (Perone14, 2003) and purificated partialment, using the spectrophotometric standard method (Folin-Denis), showing the efficiency of the amperometric method used with or without the enzymatic purification.

Determinação espectrofométrica e amperométrica de compostos fenólicos em urina humana, usando extrato parcialmente purificado de banana nanica (Musa acuminata) / Spectrophotometric and amperometric determination of compounds phenolics in human urine, utilizing purificated partialment extract of banana nanica (Musa acuminata)

Introdução - Extrato parcialmente purificado de banana nanica (Musa acuminata), melhor fonte de enzima Polifenol oxidase (PFO) [EC. 1.14.18.1] (Bonfim et al., 2000), foi estudado como material biocatalítico para a oxidação aeróbica dos substratos fenólicos usando um biossensor amperométrico com PFO imobilizada. Métodos - Foi estudada a extração da PFO dessa fonte (Bonfim et al., 2000), a purificação parcial desse extrato bruto usando sulfato de amônio (40%), que precipita o excesso de enzimas presentes nesse extrato com posterior diálise (Perone, 2004). A seguir foi determinada a atividade e a proteína total nos dois extratos. Um biossensor amperométrico foi construído usando 50 U de PFO proveniente do extrato parcialmente purificado de banana nanica (Perone, 2004), imobilizada sobre uma membrana de teflon (Celgard 2400) com o uso do reagente bifuncional glutaraldeído 2,5% m/V. Após secagem, essa membrana enzimática foi acoplada na extremidade de um eletrodo de oxigênio. Esse biossensor foi usado na determinação de compostos fenólicos em urina de indivíduos que consomem drogas metabolizando fenólicos, por amperometria e por espectrofotometria. Resultados - Nas amostras de urina observou-se que indivíduos que usam L-dopa apresentaram maior concentração de fenólicos que indivíduos que usam anfetaminas. Conclusões - A porcentagem de erro nas amostras estudadas foi menor que 3%, usando extrato bruto (Perone, 2003) e parcialmente purificado, usando o método padrão espectrofotométrico (Folin-Denis), mostrando a eficiência do método amperométrico empregado, com ou sem purificação enzimática.