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Previous research has demonstrated human exposure to mycotoxins among Guatemalans, with high levels of mycotoxins being found in blood and urine samples as well as in maize for human consumption. Mishandling of crops such as maize during pre- and post-harvest has been associated with mycotoxin contamination. The overarching goal of this study was to identify risk factors for aflatoxin and fumonisin exposure in Guatemala. A cross-sectional survey of 141 women tortilla makers was conducted in the departments of Guatemala, Sololá, Suchitepéquez, Izabal, and Zacapa in February 2022. Maize and tortilla samples were collected and analyzed for aflatoxin B1 (AFB1) and fumonisin B1, B2, and B3 contamination (FB1, FB2, FB3). Urine samples were collected and analyzed for urinary FB1 (uFB1) contamination. A questionnaire was administered to collect data on sociodemographic characteristics, dietary intake of maize-based foods the week prior to the study, and maize handling practices. Descriptive statistics were used to describe common maize handling practices. A univariable analysis was conducted to identify predictors of low/high AFB1, total fumonisins, and uFB1. Multivariable logistic regression was used to calculate adjusted odds ratios (ORs) and 95% confidence intervals (CIs). During tortilla processing, a reduction in the AFB1 and total fumonisin levels was observed. The presence of AFB1 in maize was associated with department and mean total fumonisin level in maize (OR: 1.705, 95% CI: 1.113-2.613). The department where the tortilleria was located was significantly associated with the presence of fumonisins in tortillas. Increased consumption of Tortrix was significantly associated with the presence of FB1 in urine (OR: 1.652, 95% CI: 1.072-2.546). Results of this study can be used in the development and implementation of supply chain management practices that mitigate mycotoxin production, reduce food waste and economic loss, and promote food security.

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INTRODUCTION: Aflatoxin B1 (AFB1) is a carcinogen produced by Aspergillus flavus and Aspergillus parasiticus which grow on maize. Given the high prevalence of child stunting (ie, impaired growth) and other nutritional disorders in low-income and middle-income countries, where maize is consumed, the role of aflatoxin exposure may be significant. Observational reports have demonstrated associations between aflatoxin exposure and impaired child growth; however, most have been cross-sectional and have not assessed seasonal variations in aflatoxin, food preparation and dynamic changes in growth. Biological mechanistic data on how aflatoxin may exert an impact on child growth is missing. This study incorporates a prospective cohort of children from rural Guatemala to assess (1) temporal associations between aflatoxin exposure and child growth and (2) possible mediation of the gut microbiome among aflatoxin exposure, inflammation and child growth. METHODS AND ANALYSIS: We will prospectively evaluate aflatoxin exposure and height-for-age difference trajectories for 18 months in a cohort of 185 children aged 6-9 months at enrolment. We will assess aflatoxin exposure levels and biomarkers of gut and systemic inflammation. We will examine the faecal microbiome of each child and identify key species and metabolic pathways for differing AFB1 exposure levels and child growth trajectories. In parallel, we will use bioreactors, inoculated with faeces, to investigate the response of the gut microbiome to varying levels of AFB1 exposure. We will monitor key microbial metabolites and AFB1 biotransformation products to study nutrient metabolism and the impact of the gut microbiome on aflatoxin detoxification/metabolism. Finally, we will use path analysis to summarise the effect of aflatoxin exposure and the gut microbiome on child growth. ETHICS AND DISSEMINATION: Ethics approval was obtained from Arizona State University Institutional Review Board (IRB; STUDY00016799) and Wuqu' Kawoq/Maya Health Alliance IRB (WK-2022-003). Findings will be disseminated in scientific presentations and peer-reviewed publications.

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ABSTRACT Coral reefs inside Cartagena Bay have disappeared, largely due to the constant discharge of contaminated, sediment-rich freshwater from the Dique Channel. Recently, which might be the last healthy coral reef in the bay was found between Bocachica and Barú. Despite the unfavorable conditions for coral development, this reef exhibits an average coral cover of around 45 %. To study its fish diversity, inventories were made between 2015 and 2019, based on censuses during errant dives, band transects, photographs, and video recordings. A list of all fish species observed at Varadero reef, where 147 species belonging to 49 families have been recorded is presented; seven of those species (5%) are cataloged under threat. This study is the first approach to the fish diversity in this unusual reef, and a starting point for future studies that address the functionality and proper conservation of this ecosystem, currently threatened by projects that seek to dredge it.

RESUMEN Los arrecifes de coral dentro de la bahía de Cartagena han desaparecido, en gran parte debido a la constante descarga de agua dulce contaminada y rica en sedimentos del Canal del Dique. Recientemente, el que podría ser el último arrecife de coral saludable de la Bahía fue encontrado entre Bocachica y Barú. A pesar de las condiciones desfavorables para el desarrollo de los corales, este arrecife exhibe una cobertura de coral promedio de alrededor del 45 %. Para estudiar su diversidad de peces, se hicieron inventarios entre 2015 y 2019, basados en censos durante buceos errantes, transectos de bandas, fotografías y grabaciones de video. Se presenta una lista de todas las especies de peces observadas en el arrecife de Varadero, donde se han registrado 147 especies pertenecientes a 49 familias; siete de esas especies (5%) están catalogadas como amenazadas. Esta investigación es el primer acercamiento a la diversidad de peces en este inusual arrecife, y un punto de partida para futuros estudios que aborden su funcionalidad y adecuada conservación, actualmente amenazada por los proyectos que pretenden su dragado.

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BACKGROUND: The Center of Molecular Immunology of Cuba has developed a programme for the conducting of multicentre oncology clinical trials in primary healthcare centres since 2009. AIM: To evaluate the ability to conduct oncology clinical trials in primary health care. DESIGN & SETTING: A longitudinal, prospective, analytical study was developed between July 2010 and August 2020 in the Villa Clara province. METHOD: Structure, process, and outcome indicators were evaluated by the methods of a structured interview, direct observation, documentary observation, and databases analysis. The investigators' curricula vitae, the investigator site file, minutes of workshops, the monitoring reports, the clinical trial training records, and databases were employed as sources of information. The following criteria were considered adequate: when the indicator met the standard; and not adequate: when the indicator did not meet the standard. RESULTS: The six structure indicators reached adequate results and showed that the programme has allowed building of capacities to conduct clinical trials in primary care. The eight processes indicators and two outcome indicators were considered adequate too. Trials conducted in primary care showed better indicators of patient recruitment than secondary care. Both scenarios showed similar behaviour for the process indicators: retention, protocol compliance, and safety. Survival and satisfaction with health services were also comparable in both scenarios. CONCLUSION: The evaluation of the programme showed adequate indicators for conducting oncology clinical trials in primary care in Villa Clara and these were comparable to those determined in the secondary care.

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Fumonisin exposure is common in populations where maize is a dietary staple, such as in Guatemala, and has been associated with negative health outcomes including neural tube defects. The objective of this study was to estimate fumonisin B1 (FB1) exposure among Guatemalan reproductive-age women and develop a better understanding of the dietary and sociodemographic risk factors for exposure. A cross-sectional study in 18 municipalities in Guatemala was conducted. Midwives and study nurses enrolled consenting women and collected individual and household demographic and socioeconomic data. A food frequency questionnaire was administered to estimate quantity and types of food products consumed. A urine sample was collected and urinary fumonisin B1 (uFB1) concentration was measured. A univariable analysis was conducted to identify predictors of low/high uFB1. Multivariable logistic regression was used to calculate adjusted odds ratios (ORs) and 95% confidence intervals (CIs). In total, 775 women had analyzable urine samples. Higher uFB1 levels were associated with speaking Mayan (OR = 2.33, 95% CI:1.44-3.77), less than high school education (OR = 1.61, 95% CI:1.12-2.30), increasing dietary proportion of maize-based foods (OR = 1.02, 95% CI:1.01-1.03), and consumption of tostadas (fried tortillas) (OR = 1.11, 95% CI:1.02-1.22). Lower uFB1 levels were associated with consumption of highly processed maize-based foods (OR = 0.93, 95% CI:0.87-0.99). Tortillas were the most frequently consumed maize-based food among study participants and significantly associated with high uFB1 exposure in the univariable but not multivariable analysis. Consumption of >4,750 grams/week of maize-based foods, >5,184 g/week of locally produced maize-based foods, and >110 servings/week of tortillas were also significantly associated with high uFB1 exposure in univariable analysis. Populations with low socioeconomic status/education levels and high consumption of maize-based foods had higher fumonisin exposure. Interventions aimed at reducing the risk of exposure to mycotoxins through maize in Guatemala, including the increased consumption of non-maize-based foods, should be further explored.

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RESUMEN Introducción: La retinopatía diabética es una microangiopatía retiniana. Provoca cambios anatómicos progresivos en la retina de pacientes diabéticos de larga evolución, es la tercera causa de ceguera a nivel mundial y primera en personas de edad productiva en países en vías de desarrollo, que conlleva a pérdida irreversible de la visión si no se diagnostica y se trata a tiempo. Objetivo: Describir el comportamiento de los factores de riesgo en los pacientes con retinopatía diabética que asistieron a la consulta de retina. Métodos: Se realizó un estudio observacional, descriptivo, transversal en 115 pacientes que acudieron a la consulta de retina con diagnóstico de retinopatía diabética en el periodo de octubre 2020 a febrero 2021 y cumplieron con los criterios de inclusión, se aplicó un formulario para recoger los datos. Los resultados se relacionaron con las variables: tipo de diabetes (tipo I, tipo II), tratamiento actual, control glucémico, factores de riesgo de retinopatía diabética y severidad de esta. Resultados: Fueron más frecuente los pacientes con diabetes tipo II y la retinopatía diabética proliferativa, en pacientes con diabetes tipo I. El tratamiento con hipoglucemiantes orales fue más frecuente seguido de la insulina, la mayor cantidad de pacientes presentaron control glucémico deficiente, el mayor número de pacientes tenían más de 15 años de enfermedad como factor de riesgo, seguida de la hipertensión arterial. Solo la nefropatía no se comportó como factor de riesgo. Conclusiones: La diabetes tipo II fue más prevalente. La retinopatía diabética proliferativa fue más frecuente en pacientes con diabetes tipo I. Los hipoglucemiantes orales constituyen el tratamiento más utilizado. La insulina se utilizó en pacientes con retinopatía diabética no proliferativa severa y retinopatía diabética proliferativa. Predominó el deficiente control glucémico. A mejor control glucémico menos severidad de la retinopatía diabética. Existió asociación estadística entre retinopatía diabética y la mayoría de los factores de riesgo.

ABSTRACT Introduction: Diabetic retinopathy is a retinal microangiopathy that provokes anatomical progressive changes in the retina of the patients with diabetes mellitus of long evolution, it is the third worldwide cause of blindness but the first in old fellows productive in developing countries, that it entails an irreversible loss of vision if one does not diagnose and he talks to each other in good timing. Objective: To describe the behavior of the risk factors in the patients with diabetic retinopathy that attended the retinal consultation of the Hospital Universitario Manuel Ascunce Domenech. Methods: A descriptive transverse study, in diabetic patients that attended the retinal consultation with the diagnosis of diabetic retinopathy was carried out in the period understood of October from 2020 to February 2021. The population was composed of 115 diabetic patients that attended the consultation, and they fulfilled the criteria of inclusion, they were applied a fill-out form to pick up data. The results related with the following variables: Type of diabetes (type 1, type 2), present-day treatment, glycemic control and risk factors of diabetic retinopathy and severity of the same. Results: It was more frequent the patients with diabetes type 2, and the proliferative diabetic retinopathy in patients with diabetes type 1. The treatment with hypoglycemic pray to them it was more frequent in frequent users of insulin, the most patients presented glycemic deficient control, the bigger number of patients they had more of 15 years of disease as risk factor, followed of high blood pressure. Only nephropathy did not entail itself as risk factor. Conclusions: Diabetes type 2 was more frequent than diabetes type 1. The proliferative diabetic retinopathy was frequent in the patients with diabetes type 1. The treatment more used was the oral hypoglycemic ones. Insulin was the treatment used in patients with diabetic retinopathy not proliferative severe and proliferative diabetic retinopathy. The bigger group presented deficient glycemic control. To better glycemic control less severity of her diabetic retinopathies. There was statistical association between diabetic retinopathy and most of the risk factors.

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RESUMEN Introducción: La retinopatía diabética es la complicación microvascular más común de la diabetes mellitus. Niveles elevados de glucosa en sangre inducen cambios estructurales, fisiológicos y hormonales que afectan a los capilares de la retina. La retinopatía inicia su desarrollo al menos siete años antes del diagnóstico de diabetes mellitus tipo 2. Objetivo: Describir el comportamiento dela retinopatía diabética en pacientes atendidos en la consulta de Retina del Hospital Universitario Manuel Ascunce Domenech de la provincia Camagüey. Métodos: Se realizó un estudio descriptivo, longitudinal en pacientes con el diagnóstico de retinopatía diabética. La población la conformaron 330 pacientes que acudieron a la consulta, en el periodo de enero a noviembre 2019 y que cumplieron con los criterios de selección. Se diseñó un formulario de recolección de datos y se estudiaron variables independientes: edad, sexo, factores de riesgo, tiempo de evolución de la enfermedad y como variable dependiente la severidad de la retinopatía. Resultados: El comportamiento de los grupos de edades entre 41 y 60 años, fue más frecuente, seguido de pacientes entre 20 y 40 año que padecieron de retinopatía diabética proliferativas. El mal control glucémico fue el factor de riesgo más frecuente, seguido de la hipertensión arterial. Entre 17 y 21 años de enfermedad, se encontraron la mayor cantidad de pacientes, seguido de los pacientes de 22 a 27 años de enfermedad. Conclusiones: Predominó en el estudio la edad entre 41 y 60 años. Todos los pacientes presentaron más de un factor de riesgo. El mal control glucémico y la hipertensión arterial fueron los factores de riesgo más frecuente en el estudio. El tiempo de evolución de la enfermedad predominó entre 17 y 21 años. Existió relación entre edad del paciente, factores de riesgo y tiempo de evolución de la enfermedad con la severidad de la retinopatía diabética, donde predominó la retinopatía diabética proliferativa.

ABSTRACT Introduction: Diabetic retinopathy isthemostcommonmicrovascularcomplication of diabetes mellitus. Elevatedlevels of glucose in theblood induce structural, physiological and hormonal changesthataffectthecapillaries of the retina. Retinopathy beginsitsdevelopment at leastsevenyearsbeforethe diagnosis of type 2 diabetes mellitus. Objective: To describe thebehavior of diabetic retinopathy in patientstreated at the Retina clinic of the Manuel Ascunce Domenech University Hospital in Camagüey province. Methods: Adescriptive, longitudinal study in patientswiththe diagnosis of diabetic retinopathy wascarriedout. 330 patientsthatattendedtheretinalconsultation in theperiodfromJanuarytoNovember, 2019 and thattheyfulfilledtheselectioncriteria, conformedthepopulation. A collectingfill-outform of data wasdesigned and independent variables: Age, sex, risk factors, time of evolution of disease and likedependent variable theseverity of retinopathy, werestudied. Results: Thebehavior of theagegroupsbetween 41 and 60 years, was more frequent, followedbypatientsbetween 20 and 40 yearthattheysufferedfromproliferative diabetic retinopathy. Thebadglycemic control wasthemostfrequent risk factor, followedbyhighbloodpressure. Thegreatestquantity of patientshadbetween 17 and 21 years of disease, followedbythosepatientsbetween 22 and 27 years of disease. Conclusions: Theagebetween 41 and 60 yearsprevailed in thestudy. Allpatientshad more thanone risk factor. Poor glycemic control and arterial hypertensionwerethemostfrequent risk factors in thestudy. Thedisease'sevolution time between 17 and 21 years of illnesspredominated. Therewas a relationshipbetweenthepatient'sage, risk factors and time of evolution of thediseasewiththeseverity of diabetic retinopathy, whereproliferative diabetic retinopathy predominated.

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Quinoa is a promising raw material for the production of foods with high nutritional quality. This study used quinoa flour (Chenopodium quinoa Willd.), egg white, and yucca starch to obtain an extruded pasta. By means of a proximate analysis, the nutritional content of the raw materials, uncooked and cooked pasta, was evaluated. The effects of quinoa flour on the protein composition, physical properties (color, texture, loss through cooking, water absorption, and swelling indices), moisture, DSC, and SEM were evaluated through its comparison with a commercial pasta (control) formulated with quinoa (PCQ). The values obtained during the study were subjected to a simple analysis of variance (ANOVA) to determine the interaction between the factors and the variables by using a statistical program. Incorporation of quinoa flour in the formulations (F1, F2, and F3) increased notoriously the protein content (p < 0.05) and decreased the carbohydrate content, and no significant differences were observed for lipids and ash. The energy value increased due to the essential amino acids present in quinoa. The values obtained for L∗, a∗, and b∗ increased with the increase in quinoa flour, and significant differences for b∗ (p < 0.05) were attributed to the characteristic color of quinoa, drying time, and moisture content. The lack of molecular interaction between starch and protein due to the conditions used in the extrusion process influenced the decrease in rupture strength, increase in the water absorption and swelling indices, and losses due to cooking (8 g/100 g) within an acceptable range. Consequently, affected by the enthalpy of fusion, the starch granules of the quinoa flour did not gelatinize, as observed in the SEM micrographs. The results obtained and the parameters used in the extrusion process influenced the characteristics of the pasta, indicating that quinoa flour is a promising raw material for obtaining gluten-free products.

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RESUMEN Fundamento: la degeneración macular relacionada con la edad está entre las causas más comunes de pérdida visual severa e irreversible en pacientes mayores de 60 años en el mundo industrializado. Es considerado el aumento de la esperanza de vida en la población de los adultos mayores, la necesidad de un diagnóstico temprano y oportuno, es obvio para esta enfermedad que constituye un problema de salud a resolver. Objetivo: describir los resultados de la cicatrización con el uso del bevacizumab en la degeneración macular relacionada con la edad húmeda. Métodos: se realizó un estudio descriptivo, longitudinal en pacientes con el diagnóstico de degeneración macular relacionada con la edad húmeda. La población la conformaron 25 pacientes que acudieron a la consulta de retina en el periodo de octubre 2018 a abril 2019 y que cumplieron con los criterios de selección. Se les aplicó una encuesta y se estudiaron variables como: edad, sexo, antecedentes patológicos personales, número de inyecciones intravitreas colocadas a cada paciente, complicaciones post inyección y cicatrización de la lesión macular. BMMEM Resultados: según el comportamiento de los grupos de edades y el sexo, se encontró que la edad entre 60 y 69 fue de diez pacientes y el sexo femenino 15 pacientes fueron los más frecuentes. La hipertensión ocular fue la complicación que predominó. El antecedente patológico personal más frecuente fue la hipertensión arterial con cuatro pacientes. La mayor cantidad de ojos cicatrizaron con la administración de una y dos dosis del medicamento. Conclusiones: predominó el grupo de edad de 60 a 69 años y el sexo femenino. La hipertensión ocular fue la complicación más frecuente. Se constató la hipertensión arterial como el antecedente patológico personal más habitual. La cicatrización de los ojos ocurrió con la administración entre una y dos dosis.

ABSTRACT Background: the age-related macular degeneration is among the most common causes of harsh and irreversible visual loss in patient elders of 60 years in the industrialized world. Considering the increase of life expectancy and the rise in population of the senior citizens, the need of an early and opportune diagnosis, it is obvious for this disease that constitutes a health problem we have to solve. Objective: to describe the results of the cicatrization with the use of the bevacizumab in the age-related humid macular degeneration. Methods: a descriptive, longitudinal study in patients with the diagnosis of age-related humid macular degeneration was carried out. 25 patients that attended the retinal consultation in the period October, 2018 to April, 2019 and who fulfilled the criteria constituted the population of selection. They were applied an opinion poll and they studied variables were: Age, sex, pathological personal background, number of intravitreous injections placed to each patient, complications after injection and cicatrization of the macular injury. B Results: according to the age groups and the sex, it was shown that the age between 60 and 69, ten patients and the feminine sex 15 patients were the most frequent. The ocular hypertension was the complication that predominated with four patients. The greatest amount of eyes healed with the administration of one and two doses of the medication. Conclusions: the age group from 60 to 69 years and the feminine sex predominated. The ocular hypertension was the most frequent complication. It was verified high blood pressure as the most frequent pathological antecedent. The cicatrization of the eyes happened with the administration between one and two doses.

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Background and Objectives: Hemodynamic stress during resistance training is often a reason why this training method is not used in cardiac patients. A lifting protocol that imposes rests between repetitions (IRRT) may provide less hemodynamic stress compared to traditional resistance training (TT). The aim of this study was to verify differences between set configurations on hemodynamic stress responses in resistance training. Materials and Methods: We compared hemodynamic (heart rate (HR), systolic blood pressure (SBP), and rate pressure product (RPP)) responses assessed with the auscultatory method in elderly (age = 75.3 ± 7.3 years) coronary male patients who were participating in a cardiac rehabilitation program allocated to either TT or IRRT with the same load (kg) and total number of repetitions (24) in the bilateral leg extension exercise. Results: IRRT resulted in significant lower values than TT for RPP at repetitions 8 (p = 0.024; G = 0.329; 95% CI: 0.061, 0.598) and 16 (p = 0.014; G = 0.483; 95% CI: 0.112, 0.854). Conclusions: IRRT appears to be a viable method of reducing the hemodynamic response (i.e., RPP) to resistance training and, thus, may contribute to the safety of cardiac rehabilitation programs. Further studies with more cardiac patients and other measurement techniques should be conducted to confirm these important findings.

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Recent evidence supports the hypothesis that aflatoxin exposure from maize can influence malnutrition rates among children. Therefore, in Guatemala we investigated two questions; which maize sources exposed households to higher risk of aflatoxin exposure symptoms and what the risk factors were for each maize source, pre- and post-maize harvest. Survey data and household maize samples were collected in October 2016 (pre-harvest) and February 2017 (post-harvest) in San Vicente, Guatemala. Structural equation modeling (SEM) and odds ratios were used to assess the data. The results suggested that households which purchased maize from the market had 3.64 higher odds of high levels of aflatoxin. The models identified that good market purchase habits were significant for market-based maize sources while improved post-harvest practices and improved types of maize storage were significant for subsistence-based maize sources. Cumulative results suggest multiple interventions may be effective but are dependent on time of year and source of maize.

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Food raw materials can contain the mycotoxin ochratoxin A (OTA). Thermal processing of these materials may result in decreased OTA levels but also in the formation of the thermal isomerization product 2'R-ochratoxin A (2'R-OTA). So far, only 2'R-OTA levels reported from 15 coffee samples in 2008 are known, which is little when compared to the importance of coffee as a food and trading good. Herein, we present results from a set of model experiments studying the effect of temperatures between 120 °C and 270 °C on the isomerization of OTA to 2'R-OTA. It is shown that isomerization of OTA starts at temperatures as low as 120 °C. At 210 °C and above, the formation of 25% 2'R-OTA is observed in less than one minute. Furthermore, 51 coffee samples from France, Germany, and Guatemala were analyzed by HPLC-MS/MS for the presence of OTA and 2'R-OTA. OTA was quantified in 96% of the samples, while 2'R-OTA was quantifiable in 35% of the samples. The highest OTA and 2'R-OTA levels of 28.4 µg/kg and 3.9 µg/kg, respectively, were detected in coffee from Guatemala. The OTA:2'R-OTA ratio in the samples ranged between 2.5:1 and 10:1 and was on average 5.5:1. Besides coffee, 2'R-OTA was also for the first time detected in a bread sample and malt coffee powder.

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Aflatoxin B1 (AFB1) is a known human hepatocarcinogen and a recent study reported elevated AFB1 levels, measured by serum albumin biomarkers, among Guatemalan adults. While AFB1 can contaminate a variety of foodstuffs, including maize, Guatemala's main dietary staple, the relationship of maize intake to serum AFB1-albumin adducts levels in Guatemala has not been previously examined. As a result, a cross-sectional study was conducted among 461 Guatemalan adults living in five geographically distinct departments of the country. Participants provided a serum sample and completed a semi-quantitative food frequency questionnaire and a sociodemographic questionnaire. Multiple linear regression analysis was used to estimate the least square means (LSQ) and 95% confidence intervals (95% CI) of log-transformed AFB1-albumin adducts by quintiles of maize consumption in crude and adjusted models. Additionally, analyses of tortilla consumption and levels of maize processing were conducted. The median maize intake was 344.3 g per day [Interquartile Range (IQR): 252.2, 500.8], and the median serum AFB1-albumin adduct level was 8.4 pg/mg albumin (IQR: 3.8, 22.3). In adjusted analyses, there was no association between overall maize consumption and serum AFB1-albumin levels. However, there was a statistically significant association between tortilla consumption and AFB1-albumin levels (ptrend = 0.01). The LSM of AFB1-albumin was higher in the highest quintile of tortilla consumption compared to the lowest quintile [LSM:9.03 95%CI: 7.03,11.70 vs 6.23, 95%CI: 4.95,8.17, respectively]. These findings indicate that tortilla may be an important source of AFB1 exposure in the Guatemalan population. Therefore, efforts to control or mitigate AFB1 levels in contaminated maize used for tortillas may reduce overall exposure in this population.

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BACKGROUND: The management of drug safety with the collection of reliable safety data during the conduction of clinical trials conduct is essential for the registry and marketing of products. The systematic evaluation of this process, based on objective measures, requires the application of quality instruments. This study was aimed to design and validate eight instruments through the components of quality (structure, process, and results), for characterizing and assessing the process of drug safety management, during the conduction of clinical trials. METHODS: The eight instruments were designed according to the international recommendations for Good Clinical Practice (GCP) and comprise a knowledge survey for professionals at the investigational sites, a satisfaction scale of internal and external clients and a satisfaction survey for patients with the treatment of the adverse events. The instruments also include a checklist to evaluate the safety management infrastructure (human, material and organizational resources) in the sponsoring center, a checklist to evaluate the same criterion at the investigational sites and three checklists that evaluate adherence to regulatory requirements of essential documents (investigator's brochure, protocol, and informed consent form). The content validity was evaluated by Delphi method and the reliability was determined by Cronbach α test. RESULTS: All the items were valued as very adequate after the second round of the expert panel. The instruments were deemed as appropriate and understandable in the pre-test performed. All responders agreed with the options given and the accessibility of the application. Only 10% of professionals at the research sites suggested that the knowledge survey was too long. Cronbach α values between .66 and .93 were obtained. CONCLUSION: The structure, process, and outcome framework allowed for the characterization of drug safety management during clinical trials, providing a useful approach for the promoter to systematically measure and evaluate the process. The eight instruments were deemed as reliable, feasible and easy to be used for examining drug safety management while carrying out clinical trials.

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Aflatoxin exposure has been proposed to affect child height-for-age. The following hypothesized associations were tested in Guatemala: (1) aflatoxin (B1, B2, G1, G2) exposure and environmental enteric dysfunction (EED) and child height-for-age z-score; and (2) aflatoxin exposures and subsequent symptoms of aflatoxins. Maize consumption data, health data, and samples of maize from households were collected from mothers and their children - under five - in October 2016 (n = 320) and February 2017 (n = 120). Maize samples were tested for aflatoxin levels and maize consumption data were used to compute an aflatoxin exposure level. Results suggest that there was a significant negative correlation between the putative aflatoxin exposure level and child height-for-age z-score (-0.073, p = 0.030), but not for EED. Furthermore, aflatoxin exposure was significantly correlated with aflatoxin symptoms only at the same time point (0.123, p = 0.026). These results support the potential need for engineered solutions to household aflatoxin transmission problems in rural communities of Guatemala.

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Liver cancer is an emerging global health issue, with rising incidence in both the United States and the economically developing world. Although Guatemala experiences the highest rates of this disease in the Western hemisphere and a unique 1:1 distribution in men and women, few studies have focused on this population. Thus, we determined the prevalence and correlates of aflatoxin B1 (AFB1) exposure and hepatitis virus infection in Guatemalan adults. Healthy men and women aged ≥40 years (n = 461), residing in five departments of Guatemala, were enrolled in a cross-sectional study from May-October of 2016. Serum AFB1-albumin adducts were quantified using isotope dilution mass spectrometry. Multivariate linear regression was used to assess relationships between AFB1-albumin adduct levels and demographic factors. Biomarkers of hepatitis B virus and hepatitis C virus infection were assessed by immunoassay and analyzed by Fisher's exact test. AFB1-albumin adducts were detected in 100% of participants, with a median of 8.4 pg/mg albumin (range, 0.2-814.8). Exposure was significantly higher (p<0.05) in male, rural, low-income, and less-educated participants than in female, urban, and higher socioeconomic status participants. Hepatitis B and C seropositivity was low (0.9% and 0.5%, respectively). Substantial AFB1 exposure exists in Guatemalan adults, concurrent with low prevalence of hepatitis virus seropositivity. Quantitatively, AFB1 exposures are similar to those previously found to increase risk for liver cancer in Asia and Africa. Mitigation of AFB1 exposure may reduce liver cancer incidence and mortality in Guatemala, warranting further investigation.

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Fundamento: la rubeosis del iris se asocia generalmente con diferentes enfermedades que producen falta de oxígeno en la retina. La falta de oxígeno hace que se liberen sustancias que estimulan la formación de nuevos vasos sanguíneos (angiogénesis) en un intento del organismo por solucionar la isquemia. La rubeosis de iris es la complicación más frecuente y precoz de muchas enfermedades vasculares del segmento posterior, que conlleva a una pérdida irreversible de la visión si no se diagnostica y se trata oportunamente. Objetivo: describir el comportamiento de la rubeosis de iris luego del tratamiento con triamcinolona intravítrea. Métodos: se realizó un estudio descriptivo de corte longitudinal, en pacientes con rubeosis de iris que acudieron a la consulta de retina del Centro Oftalmológico Carlos J Finlay, desde junio 2013 a junio 2014. El universo de estudio estuvo constituido por 25 pacientes y la muestra no probabilística estuvo formada por 30 ojos que cumplieron los criterios de inclusión, se les aplicó un formulario para recoger los datos. Los resultados se relacionaron con las siguientes variables: tensión ocular, síntomas, enfermedades que provocaron rubeosis de iris, grados de rubeosis. Resultados: la tensión ocular se estabilizó con el tratamiento empleado, el síntoma más frecuente fue el dolor. La retinopatía diabética proliferativa fue la afección más frecuente en el 40 % de los pacientes, seguido de la trombosis de la vena central de la retina. El estado de la rubeosis mejoró en más de la mitad de los pacientes, algunos con regresión completa. Conclusiones: la tensión intraocular mejoró después del tratamiento con triamcinolona intravítrea. Los síntomas desaparecieron en más de la mitad de los pacientes. La retinopatía diabética proliferativa fue la enfermedad más frecuente que provocó rubeosis de iris. Este signo desapareció en más de la mitad de los pacientes después del tratamiento.

Background: rubeosis iridis is generally associated to different diseases that produce lack of oxygen in the retina. It is the most frequent and early complication of many vascular diseases of the posterior segment that causes irreversible loss of vision if it is not early diagnosed and treated. Objective: to describe the behavior of rubeosis iridis after the treatment with intravitreous triamcinolone. Method: a descriptive, longitudinal study was conducted in patients with rubeosis iridis who came to the retina consultation of Carlos J. Finlay Ophthalmology Center from June 2013 to June 2014. The universe of the study was composed of 25 patients and the non-probabilistic sample by 30 eyes that matched the inclusion criteria. A form was applied to collect the data. The results were related to the following variables: ocular tension, symptoms, diseases that cause rubeosis iridis and rubeosis degrees. Results: ocular tension stabilized with the treatment applied. The most frequent symptom was pain. Proliferative diabetic retinopathy was the most frequent disease in the 40 % of the patients, followed by thrombosis of the central retinal vein. More than the half of the patients improved their condition, some of them with a complete regression. Conclusions: intraocular tension improved after the treatment with intravitreous triamcinolone. Symptoms disappeared in more than the half of the patients. Proliferative diabetic retinopathy was the most frequent disease that caused rubeosis iridis. This sign disappeared in more than the half of the patients after the treatment.

RESUMO

SCOPE: Fumonisin (FB) occurs in maize and is an inhibitor of ceramide synthase (CerS). We determined the urinary FB1 (UFB1 ) and sphingoid base 1-phosphate levels in blood from women consuming maize in high and low FB exposure communities in Guatemala. METHODS AND RESULTS: FB1 intake was estimated using the UFB1 . Sphinganine 1-phosphate (Sa 1-P), sphingosine 1-phosphate (So 1-P), and the Sa 1-P/So 1-P ratio were determined in blood spots collected on absorbent paper at the same time as urine collection. In the first study, blood spots and urine were collected every 3 months (March 2011 to February 2012) from women living in low (Chimaltenango and Escuintla) and high (Jutiapa) FB exposure communities (1240 total recruits). The UFB1 , Sa 1-P/So 1-P ratio, and Sa 1-P/mL in blood spots were significantly higher in the high FB1 intake community compared to the low FB1 intake communities. The results were confirmed in a follow-up study (February 2013) involving 299 women living in low (Sacatepéquez) and high (Santa Rosa and Chiquimula) FB exposure communities. CONCLUSIONS: High levels of FB1 intake are correlated with changes in Sa 1-P and the Sa 1-P/So 1-P ratio in human blood in a manner consistent with FB1 inhibition of CerS.

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OBJECTIVE: To estimate the number of new cases of cleft lip and cleft palate in the department (state) of Alta Verapaz, Guatemala, in 2012. DESIGN: Cross-sectional survey of midwives from communities identified through a two-stage cluster-sampling process. Midwives were asked how many babies they had delivered in the past year and how many of those newborns had various types of birth defects, as illustrated in pictures. SETTING: Indigenous Mayan communities in rural north-central Guatemala. PARTICIPANTS: Midwives (n = 129) who had delivered babies in the previous year. MAIN OUTCOME MEASURE: Reports of babies born with cleft lip and cleft palate. RESULTS: A 1-year prevalence rate of 18.9 per 10,000 for cleft lip and 4.7 per 10,000 for cleft palate was estimated for Alta Verapaz. None of the cases of cleft lip also had cleft palate. CONCLUSION: The indigenous communities in north-central Guatemala might have a relatively high cleft lip prevalence rate compared with the global average.

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RESUMO

SCOPE: Fumonisin (FB) intake can be high when maize is a dietary staple. We determined (i) urinary FB (UFB) in women consuming maize in high- and low-exposure communities in Guatemala, (ii) the FB levels in maize, (iii) the relationship between UFB and FB intake, and (iv) the relative excretion of UFB1 , UFB2 , and UFB3 . METHODS AND RESULTS: Urine and maize were analyzed for FB for 1 year in three departments. Maize consumption was estimated by an interview questionnaire. Fumonisin B1 , B2 , and B3 (FB1 , FB2 and FB3 ), were detected in 100% of maize samples. FB1 in maize and urine was significantly higher in Jutiapa compared to Chimaltenango or Escuintla. The FB intake paralleled UFB1 in a dose-dependent manner but UFB1 was present in much higher levels than UFB2 or UFB3 compared to maize. CONCLUSION: In Jutiapa, agroecological conditions favored FB production. UFB1 mirrored the estimated FB intake. UFB1 > 0.1 ng/mL resulted in a dose-dependent increase in the risk of exceeding FB intake of 2 µg/kg b.w./day compared to women with no detectable UFB1 . More than 50% exceeded 2 µg/kg b.w./day when UFB1 was >0.5 ng/mL. UFB2 and UFB3 were rarely detected confirming that FB1 is either absorbed better or preferentially excreted in urine.

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