Efficacy and Safety of Nifurtimox in Pediatric Patients with Chagas Disease: Results at 4-Year Follow-Up in a Prospective, Historically Controlled Study (CHICO SECURE).

Nifurtimox is recommended for the treatment of Chagas disease; however, long-term follow-up data are scarce. This prolonged follow-up phase of the prospective, historically controlled, CHICO clinical trial evaluated seronegative conversion in pediatric patients aged <18 years with Chagas disease who were followed for 4 years after nifurtimox treatment. Patients were randomly assigned 2:1 to nifurtimox 60-day or 30-day regimens comprising 10 to 20 mg/kg/day for patients aged <12 years and body weight <40 kg, and 8 to 10 mg/kg/day for those aged ≥12 years and body weight ≥40 kg. Anti-Trypanosoma cruzi antibodies decreased during the study period, achieving seronegative conversion in 16 (8.12%) and 8 (8.16%) patients in the 60-day and 30-day nifurtimox regimens, respectively, with corresponding incidence rates per 100 patients/year of seronegative conversion of 2.12 (95% confidence interval [CI]: 1.21 to 3.45) and 2.11 (95% CI: 0.91 to 4.16). Superiority of the 60-day nifurtimox regimen was confirmed by the lower limit of the 95% CI being higher than that (0%) in a historical placebo control group. Children aged <2 years at baseline were more likely to reach seronegative conversion during the 4-year follow-up than older children. At any annual follow-up visit, >90% of evaluable patients had persistently negative quantitative PCR results for T. cruzi DNA. No adverse events potentially related to treatment or caused by protocol-required procedures were documented for either treatment regimen. This study confirms the effectiveness and safety of a pediatric formulation of nifurtimox administered in an age- and weight-adjusted regimen for 60 days to treat children with Chagas disease.

Efficacy of a tetravalent dengue vaccine in healthy children aged 4-16 years: a randomised, placebo-controlled, phase 3 trial.

BACKGROUND: A substantial unmet need remains for safe and effective vaccines against dengue virus disease, particularly for individuals who are dengue-naive and those younger than 9 years. We aimed to assess the efficacy, safety, and immunogenicity of a live attenuated tetravalent dengue vaccine (TAK-003) in healthy children aged 4-16 years. METHODS: We present data up to 18 months post-vaccination from an ongoing phase 3, randomised, double-blind trial of TAK-003 in endemic regions of Asia and Latin America (26 medical and research centres across Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, and Thailand). Healthy children aged 4-16 years were randomly assigned 2:1 (stratified by age and region) to receive two doses of TAK-003 or two doses of placebo, 3 months apart. Investigators, participants and their parents or guardians, and sponsor representatives advising on trial conduct were masked to trial group assignments. Participants presenting with febrile illness were tested for virologically confirmed dengue (VCD) by serotype-specific RT-PCR. In timeframes beginning 30 days post-second dose, the primary endpoint (overall vaccine efficacy) was assessed in the first 11 months, and the secondary endpoints (efficacy by baseline serostatus, serotype, hospitalised dengue, and severe dengue) in the first 17 months. This study is registered with ClinicalTrials.gov, NCT02747927. FINDINGS: 20 099 participants were randomly assigned and vaccinated between Sept 7, 2016, and Aug 18, 2017; 19 021 (94·6%) were included in the per protocol analysis, and 20 071 (99·9%) in the safety set. The primary endpoint was achieved with an overall vaccine efficacy of 80·2% (95% CI 73·3 to 85·3; 61 cases of VCD in the TAK-003 group vs 149 cases of VCD in the placebo group). In the secondary endpoint assessment timeframe, an overall vaccine efficacy of 73·3% (95% CI 66·5 to 78·8) was observed. Analysis of secondary endpoints showed efficacies of 76·1% (95% CI 68·5 to 81·9) in individuals who were seropositive at baseline, 66·2% (49·1 to 77·5) in individuals who were seronegative at baseline, 90·4% (82·6 to 94·7) against hospitalised dengue, and 85·9% (31·9 to 97·1) against dengue haemorrhagic fever. Efficacy varied by individual serotypes (DENV 1, 69·8% [95% CI 54·8 to 79·9]; DENV 2, 95·1% [89·9 to 97·6]; DENV 3, 48·9% [27·2 to 64·1]; DENV 4, 51·0% [-69·4 to 85·8]). Cumulative rates of serious adverse events were similar in TAK-003 (4·0%) and placebo (4·8%) recipients, and were consistent with expected medical disorders in the study population. Infection was the most frequent reason leading to serious adverse events. 20 participants (<0·1% of the safety set) were withdrawn from the trial due to 21 adverse events by the end of part two; 14 of these participants received TAK-003 and six received placebo. INTERPRETATION: TAK-003 was well tolerated and efficacious against symptomatic dengue in children regardless of serostatus before immunisation. Vaccine efficacy varied by serotype, warranting continued follow-up to assess longer-term vaccine performance. FUNDING: Takeda Vaccines.

Industrial workers and bullying: a systematic review and meta-analysis of workplace violence.

Workplace violence is a significant problem in industry, especially among rank-and-file workers, known as "blue-collar workers". This systematic review and meta-analysis aim to evaluate the suitability of the reduced Negative Acts Questionnaire (NAQ-R) as an instrument to measure workplace violence in this type of population and synthesize the results of studies that have used it in different industrial sectors. A systematic review was conducted in accordance with the PRISMA 2020 statement. Publications describing populations of industrial workers were identified and included in the meta-analysis. For meta-analysis, we extracted data that allowed us to estimate the effect size of the included studies. We used a random-effects model to estimate the overall effect size and assessed heterogeneity between studies using the I² statistic. The global effect size test showed that the overall effect size was significantly different from zero (3.00, t=22.28, p<0.001), indicating an overall effect in relation to workplace violence measured by the NAQ-R in industrial workers. Our results support the claim that the NAQ-R is an effective tool for assessing workplace violence among industrial workers. These findings have important implications for practitioners and researchers working in the field of industrial psychology and occupational health.

Traffic Noise Annoyance in the Population of North Mexico: Case Study on the Daytime Period in the City of Matamoros.

Aim: The presence of noise in urban environments is rarely considered a factor that causes damage to the environment. The primary generating source is transportation means, with vehicles being the ones that affect cities the most. Traffic noise has a particular influence on the quality of life of those who are exposed to it and can cause health alterations ranging from annoyance to cardiovascular diseases. This study aims to describe the relationship between the traffic noise level and the perceived annoyance in the inhabitants of a city on the Northern Border of Mexico. The work carried out in a city represents the vulnerability characteristics: economic, social, and migratory of its sizable portion of the inhabitants. Due to that, it is impossible to identify precisely the number of residents as the number of vehicles in circulation. Methods: The streets and avenues with an annual average daily traffic of more than 1,000 vehicles were considered for the measurement of traffic noise. The equipment used was a vehicle gauge with non-invasive speed radar; type I integrating sound level meters, with their respective gauges and tripods. A questionnaire was applied to people living within 250 m of the streets and avenues in which the noise was measured. Results: The noise measurement found a parameter of LAeq estimated for 12 h during the day, exceeding 70 dBA. The data received from the questionnaire were statistically tested by using Pearson's correlation tests. A total number of 2,350 people were participated, of whom 1,378 were women (58.6%) and 972 were men (41.4%). The age of participants is ranged from 18 to 75 years. The overall perception of traffic noise annoyance identified that 1,131 participants (48.1%) responded "Yes" as they considered the noise annoying. Participants who responded "No" as well as those who responded "Do not know" resulted in a total of 1,219 people (51.9%). Conclusion: The results show that the population is desensitized to traffic noise and does not perceive it as an annoyance. The flow of vehicles and the type of vehicles are the significant factors for the propagation and increase in the traffic noise levels. Women present a considerable appreciation of traffic noise perception instead of younger people who demonstrate a higher tolerance to high-level exposure. This reflects the lack of information of the population around the noise problem and its effects.

Road risk behaviors: Pedestrian experiences.

Objective: The objective of this study was to identify pedestrian risk behaviors that result in traffic accidents and characterization of the accidents experienced by participants in this study to provide information for the generation of integral preventive strategies. Methods: The study was correlational, descriptive, and transversal and followed a quantitative approach divided into 2 stages. In the first stage, an observational study was performed to identify the manifested risk behaviors of pedestrians, which served as a basis for the construction and design of a questionnaire. In the second stage, the questionnaire was applied to a group of 1,536 participants. Pearson's correlation coefficient was applied to establish associations between gender and age with respect to risk behaviors. Results: The 3 behaviors that participants reported performing always or very often include using electronic gadgets (except mobile phones), not using a pedestrian crosswalk, and using a mobile phone. In addition, 18.5% were involved in at least one road accident as a pedestrian in the last 5 years. Of the total number of registered accidents, 21% resulted in pedestrian injuries, 48.3% of which were serious. These were due to external causes not related to human factors or unidentified (58.5%) and behavior factors as a whole (41.4%, 31.5% of which were caused by pedestrians). Pearson's correlation coefficient showed evidence of a correlation between age and risk behaviors. Conclusions: All subjects in this study performed several risky actions as pedestrians, at least occasionally, and at least one fifth had been involved in a road accident as a pedestrian. It is known that the surroundings can positively or negatively influence individuals' behaviors; therefore, once prevention measures are identified, it is possible to influence risk behaviors. Therefore, road safety education and the physical environment must be considered together, and efforts focused on optimum infrastructure also need to consider road safety education.

Long-term Immunogenicity and Safety of the AS04-adjuvanted Human Papillomavirus-16/18 Vaccine in Four- to Six-year-old Girls: Three-year Follow-up of a Randomized Phase III Trial.

BACKGROUND: The burden of human papillomavirus (HPV) diseases is high in Latin America. HPV vaccines licensed from 2006 onwards offer protection against most HPV-related cancers, especially when introduced into national immunization programs. Barriers to optimal vaccine uptake are, however, lowering the impact of adolescent HPV vaccination programs. Immunization of children might overcome these barriers and be a strategy of choice for some countries. METHODS: This multicenter phase III randomized, controlled, single-blind study (NCT01627561) was conducted in Colombia, Mexico and Panama to assess safety and immunogenicity of 2-dose vaccination with AS04-adjuvanted HPV-16/18 vaccine in girls 4-6 years of age. We report safety outcomes and anti-HPV-16/18 antibody titers measured by enzyme-linked immunosorbent assay in HPV-vaccinated girls that were followed over a 36-month period. RESULTS: Over 36 months (ie, 30 months after the second vaccine dose), among 74 girls included in the HPV group, 1 serious adverse event unrelated to vaccination has been reported. No withdrawal because of (serious) adverse events has been reported. At month 36, all girls in the per-protocol-cohort were still seropositive for anti-HPV-16 and anti-HPV-18 with geometric mean concentrations of 1680.6 and 536.4 enzyme-linked immunosorbent assay units/mL, respectively. CONCLUSIONS: The AS04-adjuvanted HPV-16/18 vaccine administered according to a 2-dose schedule to girls 4-6 years of age induced a high and sustained immunologic response with an acceptable safety profile during the 30 months following vaccination.

Safety and Immunogenicity of the HPV-16/18 AS04-adjuvanted Vaccine in 4-6-year-old Girls: Results to Month 12 From a Randomized Trial.

BACKGROUND: The burden of cervical cancer caused by human papillomavirus (HPV) is high in Latin America. The suboptimal HPV vaccination coverage in adolescents could be improved by pediatric immunization. HPV vaccination has not yet been reported in girls <9 years of age. METHODS: This ongoing phase III, controlled, randomized, single-blind, multicenter study conducted in Colombia, Mexico and Panama (NCT01627561) evaluated the safety and immunogenicity of AS04-HPV-16/18 vaccine in 4-6-year-old girls. Healthy girls (randomized 1:1) received either 2 doses of AS04-HPV-16/18 vaccine (HPV group, N=74) or 1 dose of each measles-mumps-rubella and diphtheria-tetanus-acellular-pertussis vaccines (control group, N=74) 6 months apart. We report the safety and serum anti-HPV-16 and anti-HPV-18 antibodies (measured by enzyme-linked immunosorbent assay) up to 6 months postvaccination, that is, month (M) 12. RESULTS: Injection site pain was the most frequently reported solicited local symptom in HPV vaccinees. The incidence of other solicited and unsolicited symptoms after each vaccination was similar between the HPV and control group. Until M12, 1 girl in the HPV group and 2 in the control group reported serious adverse events; all serious adverse events were assessed as unrelated to study vaccines. No potential immune-mediated diseases were identified. All girls seroconverted for both antigens after 2 doses of AS04-HPV-16/18. In initially seronegative girls, anti-HPV-16 geometric mean concentrations were 20080.0 enzyme-linked immunosorbent assay units (EU)/mL at M7 and 3246.5 EU/mL at M12; anti-HPV-18 geometric mean concentrations were 10621.8 EU/mL at M7 and 1216.6 EU/mL at M12. CONCLUSIONS: Two-dose vaccination with AS04-HPV-16/18 was well tolerated and induced adequate antibody responses in 4-6-year-old girls.

Inteligencia emocional y su relación en el consumo de alcohol en universitarios mexicanos / Emotional intelligence and its relationship in the alcohol consumption in mexican university students / Inteligência emocional e sua relação no consumo de álcool em estudantes universitários mexicanos

RESUMENObjetivo: determinar la relación entre la inteligencia emocional y la prevalencia del consumo de alcohol en jóvenes universitarios. Método: diseñodescriptivo, transversal y correlacional, muestreo no probabilístico por conveniencia con una muestra de 365 estudiantes de una institución pública de educación superior en el periodo 2021-2022, en H. Matamoros, Tamaulipas, México, se utilizó estadística descriptiva y correlacional. Resultados: el género femenino fue mayor (76.7%), con un rango de edad de 18 a 24 años, donde la prevalencia de consumo de alcohol en la vida fue de 77% y la edad de primer consumo se ubicó entre 15 y 18 años (56.4%). El consumo lapsico fue en el último año 38.8%. Las dimensiones inteligencia emocional de atención de los sentimientos y reparación de emociones presentaron en ambos géneros valores similares, en su mayoría un nivel adecuado y excelente. La correlación en mujeres entre edad de consumo de alcohol y las dimensiones la inteligencia emocional, fue significativa e inversa. Conclusión:los estudiantes presentan altas prevalencias de consumo y inteligencia emocional, se encontró que para el género masculino la claridad emocional requiere estrategias que permitan mejorarla.

Objective:to determine the relationship between emotional intelligence and the prevalence of alcohol consumption in university students. Method: descriptive, cross-sectional and correlational design, non-probabilistic convenience sampling with a sample of 365 students from a public institution of higher education in the period 2021-2022, in H. Matamoros, Tamaulipas, Mexico, descriptive and correlational statistics were used. Results: the female gender was higher (76.7%), with an age range of 18 to 24 years, where the prevalence of alcohol consumption in life was 77% and the age of first consumption was between 15 and 18 years. (56.4%). The lapsique consumption was in the last year 38.8%. The emotional intelligence dimensions of attention to feelings and repair of emotions presented similar values in both genders, mostly an adequate and excellent level. The correlation in women between the age of alcohol consumption and the emotional intelligence dimensions was significant and inverse. Conclusion: the students present high prevalences of consumption and emotional intelligence, it was found that for the male gender, emotional clarity requires strategies that allow it to be improved.

Objetivo:determinar a relação entre a inteligência emocional e a prevalência do consumo de álcool em estudantes universitários. Método: desenho descritivo, transversal e correlacional, amostragem não probabilística de conveniência com 365 estudantes de uma instituição pública de ensino superior no período de 2021 a 2022, em H. Matamoros, Tamaulipas, México. Aplicou estatística descritiva e correlacional. Resultados: o sexofeminino foi maior (76,7%), com faixa etária de 18 a 24 anos, onde a prevalência de consumo de álcool na vida foi de 77% e a idade do primeiro consumo foi entre 15 e 18 anos (56,4%). O consumo lapsico foi no ano passado 38,8%. As dimensões da inteligênciaemocional de atenção aos sentimentos e reparação de emoções apresentaram valores semelhantes em ambos os sexos, na sua maioria um nível adequado e excelente. A correlação das mulheres entre a idade de consumo de álcool e as dimensões da inteligência emocional foi significativa e inversa. Conclusão: os alunos apresentam altas prevalências de consumo e inteligência emocional, e verificou-se que para o gênero masculino, a clareza emocional requer estratégias que permitam melhorá-la.

Riesgo de hipertensión arterial en población adulta en Matamoros, Tamaulipas, México / Risk of arterial hypertension in the adult population in Matamoros, Tamaulipas, México / Risco de hipertensão arterial na população adulta em Matamoros, Tamaulipas, México

Objetivo: conocer el riesgo de hipertensión en la población adulta de la ciudad de Matamoros, Tamaulipas. Método: el diseño fue de tipo descriptivo y transversal, una muestra de 1004 adultos. Se utilizó una cedula de datos sociodemográficos, donde se realizaron 3 mediciones de la presión arterial, de acuerdo a la Norma Oficial Mexicana NOM-030-SSA2-2009. Resultados: El género estuvo conformado del 38.7% de hombres y 61.3% de mujeres. Se observó una prevalencia de hipertensión arterial en 8.6% de la población. Fue mayor en el género masculino con 12.3% que el femenino de 6.3%. El grupo de 60 y más años (14.1%) presenta mayor prevalencia de hipertensión, seguido de 50 a 59 (13.8%) y finalmente el de 40 a 49 con 11.7%. El riesgo de hipertensión es de 87 (8,7%) de la muestra total; la alta presión arterial sistólica con 52 (5,1%), y alta presión arterial diastólica con 56 (5,5%) también deben ser consideradas hipertensión. Cuando se analizan en conjunto, los tres criterios de inclusión para hipertensión arterial suman el 19,4% de riesgo. Conclusión: el riesgo de hipertensión arterial en población adulta está latente, la prevalencia se ubica dentro de la más alta a nivel mundial.(AU)

Objective: To know the risk of hypertension in the adult population of the city of Matamoros, Tamaulipas. Method: The design was descriptive and transversal in a sample of 1004 adults. A sociodemographic data questionnaire was used and three blood pressure measurements were performed according to the Official Mexican Standard NOM-030-SSA2-2009. Results: The gender was made up of 38.7% of men and 61,3% of women. A prevalence of hypertension was observed in 8.6% of the population. It was greater in the masculine gender with 12.3% than the feminine one of 6.3%. The group of 60 and over (14.1%) had a higher prevalence of hypertension, followed by 50 to 59 (13.8%) and finally the group of 40 to 49 with 11.7%. The risk of hypertension is 87 (8.7%) of the total sample; high systolic blood pressure with 52 (5.1%), and high diastolic blood pressure with 56 (5.5%) should also be considered hypertension. When analyzed together, the three inclusion criteria for hypertension add up to a 19.4% risk. Conclusion: the risk of hypertension in the adult population is latent, the prevalence is among the highest in the world.(AU)

Objetivo: conhecer o risco de hipertensão na população adulta da cidade de Matamoros, Tamaulipas. Método: O desenho foi descritivo e transversal, em uma amostra de 1004 adultos. Utilizou-se um questionário de dados sociodemográficos e foram realizadas três medidas de pressão arterial conforme a Norma Oficial Mexicana NOM-030-SSA2-2009. Resultados: O gênero foi composto por 38.7% de homens e 61,3% de mulheres. Prevalência de hipertensão arterial foi observada em 8,6% da população. Foi maior no gênero masculino com 12,3% do que no feminino com 6,3%. O grupo de 60 anos ou mais (14,1%) apresentou maior prevalência de hipertensão, seguido pelo de 50 a 59 (13,8%) e, finalmente, o grupo de 40 a 49, com 11,7%. O risco de hipertensão é de 87 (8,7%) da amostra total; alta pressão arterial sistólica com 52 (5,1%) e alta pressão arterial diastólica com 56 (5,5%) também devem ser consideradas hipertensão. Quando analisados em conjunto, os três critérios de inclusão para hipertensão somam um risco de 19,4%. Conclusão: o risco de hipertensão na população adulta é latente, a prevalência está entre as mais altas do mundo.(AU)

Violencia en el noviazgo en jóvenes y adolescentes en la frontera norte de México / Dating violence in young people and adolescents in the northern border of Mexico / Violência no namoro de jovens e adolescentes na fronteira norte do México

Objetivo: el objetivo principal del estudio es conocer la prevalencia de los diferentes tipos de violencia en el noviazgo en jóvenes, y como objetivos específicos: analizar la asociación entre la violencia el nivel educativo, la edad y sexo de los participantes. Método: se realizó un estudio de tipo cuantitativo, transversal y correlacional, en el periodo de mayo a diciembre de 2016. Se evaluó a un total de 432 estudiantes de ambos sexos, provenientes de cinco instituciones educativas de la ciudad de Matamoros, Tamaulipas, México, mediante el CUVINO. Se consideraron tanto escuelas públicas como privadas de los niveles secundaria y preparatoria. El 53% de la muestra participante fue de estudiantes de nivel secundaria, el restante 47% de preparatorias. Resultados: se encontró una correlación positiva aunque baja entre la variable edad, y los diferentes subtipos de violencia. Se encontraron diferencias significativas en cuanto a sexo para casi todos los subtipos de violencia. No se encontraron diferencias significativas en cuanto a nivel educativo entre los diferentes tipos de violencia. Conclusión: se discute la complejidad del fenómeno de la violencia en parejas jóvenes, con relación a factores sociodemográficos e implicaciones para líneas de investigación futuras.(AU)

Objective: The main objective of the study is to know the prevalence of different types of dating violence in young people, and as specific objectives: to analyze the association between violence, educational level, age and sex of the participants. Method: a quantitative, cross-sectional and correlational study were carried out in the May-December 2016 period. 432 students of both sexes from five educational institutions from Matamoros, Tamaulipas, Mexico, were evaluated through the CUVINO. Public and private institutions from middle and high school levels were considered. 53% of the participating sample was middle-school students, the remaining 47% high school students. Results: among the findings of the study, a positive low correlation between the age variable, and the different subtypes of violence was found. Significant differences regarding sex for almost all subtypes of violence were found. No significant differences in educational level between the different types of violence were found. Conclusion: the complexity of the phenomenon of violence in young couples, in relation with sociodemographic factors and its implications for future lines of research are discussed.(AU)

Objetivo: O principal objetivo do estudo é conhecer a prevalência de diferentes tipos de violência no namoro em jovens; e como objetivos específicos: analisar a associação entre violência, escolaridade, idade e sexo dos participantes. Método: estudo quantitativo, transversal e correlacional, realizado no período de maio a dezembro de 2016. Foram avaliados 432 estudantes de ambos os sexos, de cinco instituições de ensino da cidade de Matamoros, Tamaulipas, através do CUVINO. Foram consideradas escolas públicas e privadas dos níveis secundário e preparatório. 53% da amostra participante eram de estudantes do ensino secundário, os restantes 47% do ensino médio. Resultados: entre os achados do estudo, encontrou-se uma correlação positivo, embora baixe entre a variável idade e os diferentes subtipos de violência. Diferenças significativas foram encontradas em relação ao sexo para quase todos os subtipos de violência. Não foram encontradas diferenças significativas no nível educacional entre os diferentes tipos de violência. Conclusão: discute-se a complexidade do fenômeno da violência em jovens casais, em relação aos fatores sociodemográficos e suas implicações para futuras linhas de pesquisa.(AU)