COVID-19 vaccines: a look at the ethics of the clinical research involving children.

Currently, millions of minors are being inoculated against SARS-CoV-2 in many countries in the world. Ethical concerns about clinical research involving children have barely been addressed in the literature, despite the fact that the paediatric population is particularly vulnerable within this context. Children should be included in the research plans for COVID-19 vaccines. Nevertheless, it is necessary to critically assess to what extent clinical trials are being conducted according to methodological and ethical criteria that allow us to conclude that the results are valid and, in consequence, how far the vaccination plans for children are scientifically justified.The principal aim of this article is to analyse critically the process of clinical research on COVID-19 vaccines involving children, highlighting the ethical concerns that arise, including the need to stratify the results from older adolescents separately for analysis before proceeding, if further research is warranted, in descending age order. The development of COVID-19 vaccines is examined, with a special look at the participation of children throughout their clinical development, including a review of the clinical trials registered in three international databases. We also offer some additional considerations about the inclusion of minors in vaccination plans. Finally, we conclude with some recommendations, with particular emphasis on the following ethical duties: research in children should be carried out only once the relevant research in adults has previously been conducted; issues that concern children's needs and rights should be specifically addressed; and, therefore, the highest standards of ethical and scientific quality should be met.

Feline thelaziosis (Thelazia callipaeda) in Spain: state-of-the-art and first prophylactic trial in cats.

OBJECTIVES: Thelaziosis caused by the nematode Thelazia callipaeda (Spirurida, Thelaziidae) affects the eyes of domestic and wild carnivores, lagomorphs and even humans. The role of cats in spreading thelaziosis remains unclear. The present study assesses the current status of feline T callipaeda infection in Spain and presents the results of the first prophylactic trial conducted in this species. METHODS: We retrospectively analysed the occurrence of feline thelaziosis (study 1), examined its prevalence based on cross-sectional sampling of endemic areas (study 2), and assessed the therapeutic/prophylactic benefits of a spot-on (moxidectin) and therapeutic efficacy of an eye drop (ivermectin) formulation (study 3). RESULTS: In study 1, 69 Thelazia-infected cats were examined. Autochthonous cases were detected in 18/26 municipalities surveyed in Spain, which corresponds to 88.4% (n = 61/69) of the total number of cases. In study 2, 74 cats (20 from La Vera region and 54 from Orense province) were examined from 2011 to 2013. Ten of these cats (13.5%) were infected with T callipaeda. The infection prevalence was 40% (n = 8/20) in La Vera and 3.7% (n = 2/54) in Orense. The therapeutic efficacy of ivermectin was assessed over a summer (2011) in 12 cats, while that of moxidectin was examined over a 17-month period in seven cats. Four of these seven cats were subsequently included in an all-year-round prophylaxis trial. Treatment efficacy ranged from 91.7% (ivermectin) on day 28 after treatment to 100% (moxidectin) on day 14. Moxidectin prevented reinfections in cats. CONCLUSIONS AND RELEVANCE: Our data confirm the endemic status of T callipaeda infection in Spain, revealing its high prevalence in cats living in known endemic areas. Moxidectin was effective in treating and preventing infection. We strongly recommend the inclusion of thelaziosis in the differential diagnosis of pets and humans presenting with ocular manifestations, along with adequate preventive measures.

Update on the treatment and prevention of ocular thelaziosis (Thelazia callipaeda) in naturally infected dogs from Spain.

This study examines the therapeutic and year-round prophylactic efficacy of different formulations used in dogs in three Spanish areas where canine thelaziosis is endemic. The study was conducted as a Good Clinical Practice, multicentre, randomised field study in privately owned outdoor dogs naturally infected with Thelazia callipaeda. The active pharmaceutical ingredients tested were: an oral formulation of milbemycin oxime 12.5 mg combined with praziquantel 125 mg (A), a subcutaneous sustained-release formulation of moxidectin 10 g (B), a moxidectin 2.5% weight/volume (w/v) spot-on formulation combined with imidacloprid 10% w/v (C), and an eye drop formulation (6 µg) of ivermectin 10 mg/ml diluted 10% in propylene glycol (D). Infected dogs were randomly allocated to treatment Groups A, B, C and D. Dogs testing negative for T. callipaeda inspection in two visits (Day 7/Day 14 and D30) were enrolled in the prophylaxis trial and reallocated to the corresponding study group (A, B, C or D). Treatment efficacy ranged from 70.4% recorded in Group A 1 week after treatment, to 100% recorded in Group C on Day 30 and in Group B on Day 60. Treatment was more efficacious in Group D (85.7% 1 week after treatment) than A, but was never 100% efficacious as in Groups B and C. Year-round prophylactic efficacy was 83.3% in Group A, 100% in Group B, 93.5% in Group C and 87.5% in Group D. In conclusion, products containing moxidectin were highly efficacious both in treating and preventing canine thelaziosis. Milbemycin also emerged as a good option. However, the off-label use of topical or subcutaneous ivermectin should be avoided due to possible adverse reactions such as pruritus, irritation or redness. In endemic areas, monthly prophylaxis to limit the spread of T. callipaeda to new areas across Europe and reduce zoonotic risks is essential.

Spain as a dispersion model for Thelazia callipaeda eyeworm in dogs in Europe.

Thelazia callipaeda (Spirurida, Thelaziidae) causes ocular infection in carnivorous animals and humans. While growing numbers of companion dogs and sometimes cats are being diagnosed with thelaziosis, little is known about its real spread. As it has been also diagnosed in wild animals and human beings, it is considered a potential emerging zoonotic disease. This study provides information about the spread of the parasite in dogs in Spain since its initial description in 2010 until 2018. The first detection of T. callipaeda in the Principality of Andorra in 2017 is also reported. Two different studies were conducted: a) a survey in which clinical cases from veterinary practices were collected and b) a prevalence study in two endemic areas in western and central Spain (Site 1 La Vera region, Cáceres, and Site 2 El Escorial municipality, Madrid). In total, 1114 cases of thelaziosis were detected in 121 municipalities of Spain and 6 municipalities of Andorra. In 92 out these 127 municipalities, reports were of autochthonous cases. Six hundred twenty-three out of 1114 presented data collection sheet and were included in the statistical analysis: 510 cases identified by veterinarians in Spain and Andorra in Study 1, and 113 cases detected among the 234 dogs (48.3 %) examined in the prevalence study (Study 2). Prevalences were 61.3 % (84/137) for Cáceres and 29.9 % (29/97) for Madrid, being Site 1 significantly more risky (P <  0.0001, odds ratio: 3.72, CI: 2.14-4.47 %) compared to Site 2. Our study updates data for canine thelaziosis reported in the last decade in Spain and Andorra. Results highlight the urgent need for prevention strategies to control the spread of this potential zoonotic disease.

Radioembolization of hepatocellular carcinoma activates liver regeneration, induces inflammation and endothelial stress and activates coagulation.

BACKGROUND & AIMS: Radioembolization may rarely induce liver disease resulting in a syndrome that is similar to veno-occlusive disease complicating bone marrow transplantation where inflammation, endothelial cell activation and thrombosis are likely involved. We hypothesized that similar mechanisms could be implicated in radioembolization-induced liver disease (REILD). Moreover, lobar radioembolization may induce hypertrophy of the non-treated hemiliver most probably by inducing liver regeneration. METHODS: In patients with hepatocellular carcinoma, we prospectively studied serum levels of markers of liver regeneration, oxidative stress, pro-inflammatory pathways, endothelial activation and coagulation parameters over 2 months after radioembolization. RESULTS: Although REILD did not occur among 14 treated patients, a decrease in effective liver blood flow was observed. Radioembolization was followed by a persistent increase in pro-inflammatory (interleukin 6 and 8) and oxidative stress (malondyaldehide) markers, an induction of endothelial injury markers (vW factor and PAI-1) and an activation of the coagulation cascade (factor VIII, PAI-1, D-Dimer) as well as a significant increase in factors related to liver regeneration (FGF-19 and HGF). CONCLUSION: Radioembolization activates liver regeneration, produces oxidative stress, activates inflammatory cytokines and induces endothelial injury with partial activation of the coagulation cascade. These findings may have implications in the pathogenesis, prevention and therapy of REILD and in the development of new therapies to enhance hypertrophy with a surgical perspective.

Prognostic factors and prevention of radioembolization-induced liver disease.

UNLABELLED: Radioembolization (RE)-induced liver disease (REILD) has been defined as jaundice and ascites appearing 1 to 2 months after RE in the absence of tumor progression or bile duct occlusion. Our aims were to study the incidence of REILD in a large cohort of patients and the impact of a series of changes introduced in the processes of treatment design, activity calculation, and the routine use of ursodeoxycholic acid and low-dose steroids (modified protocol). Between 2003 and 2011, 260 patients with liver tumors treated by RE were studied (standard protocol: 75, modified protocol: 185). REILD appeared only in patients with cirrhosis or in noncirrhosis patients exposed to systemic chemotherapy prior to RE. Globally, the incidence of REILD was reduced in the modified protocol group from 22.7% to 5.4% and the incidence of severe REILD from 13.3% to 2.2% (P<0.0001). Treatment efficacy was not jeopardized since 3-month disease control rates were virtually identical in both groups (66.7% and 67.2%, P=0.93). Exposure to chemotherapy in the 2-month period following RE and being treated by the standard protocol were independent predictors of REILD among noncirrhosis patients. In cirrhosis, the presence of a small liver (total volume<1.5 L), an abnormal bilirubin (>1.2 mg/dL), and treatment in a selective fashion were independently associated with REILD. CONCLUSION: REILD is an uncommon but relevant complication that appears when liver tissue primed by cirrhosis or prior and subsequent chemotherapy is exposed to the radiation delivered by radioactive microspheres. We designed a comprehensive treatment protocol that reduces the frequency and the severity of REILD.

[Research and protection of personal data in Primary Care]. / Investigación y protección de datos personales en atención primaria.

Research is one of the fundamental functions that have to be carried out in Primary Care. The clinical information stored in different records arising from medical care is a basic tool for this activity. The use of personal data for the purposes of research is legitimate according to our laws; however, this information must be treated confidentially at all times. Two alternatives are available for this. One is to obtain the informed consent of the patient, and the other is to dissociate the handling of the information. But in some situations, the compliance to legal demands when obtaining data for research is not easy, there being a series of obstacles which in many cases makes it impossible to carry out research. In this article, we will give guidance on how to access the information contained in records while respecting the rights of the patient and the current legislation.

[The health and disease from a sociocultural perspective in the first half of the 20th century]. / La salud y enfermedad desde una perspectiva sociocultural en la primera mitad del siglo xx.

The social historians of ends of the 20th century placed in the center of his worries new topics and approaches, between them, the problems linked with the social question called. It is defined as the set of social problems arisen as consequence of the industrialization, the urbanization, the immigration between those who were the conflicts of the work, the poverty, the marginality, the disease, that they returned the protagonism of subjects forgotten as the patients, the madmen, the delinquents between others. The diseases in the society, raise a new historical object of reflection that provides a window to the social reality. To analyze the trilogy disease - health- service of an integrated way is to know an aspect that explains the social problematics. The response to the social problems came from the civil society and from the State, arising institutions of social assistance that were acting in a combined way. The present article approaches the topic of the disease- health- service and the response to this problematics for the State during the period 1900-1940 in Córdoba, seeking to reconstruct how the disease allows us to show the conditions of material and cultural life where they emerged and the social process of constitution of the Social State and the social citizenship, from the continuities, changes and transformations that were demonstrating in the sanitary field.

Influencia de la familia en la sexualidad adolescente / Family influence on the sexuality in adolescence

INTRODUCCIÓN: La familia es el núcleo más primario del ser humano, en ella el hombre inscribe sus primeros sentimientos, sus primeras vivencias, incorpora las principales pautas de comportamiento y le da un sentido a la vida. OBJETIVO: Conocer el rol de la familia en la esfera sexual de los adolescentes, y la repercusión en la salud reproductiva. MÉTODOS: La muestra fue de 128 alumnos de secundaria básica, residentes en Centrohabana. En grupos focales se les aplicó una encuesta y se entrevistaron los padres en los hogares. RESULTADOS: El 69 por ciento de los adolescentes vive con uno de sus padres. El 52 por ciento pertenece a una familia disfuncional y el 48 por ciento a familias funcionales. Los adolescentes de núcleos disfuncionales recibieron escasa información sobre temas sexuales por parte de sus padres en un 100 por ciento. Los padres, poseen elevados conocimientos sobre temas sexuales, no fue así en el 78 por ciento de los adolescentes. Es inadecuada la comunicación según los adolescentes (57 por ciento) y para los padres, adecuada en el 82 por ciento. El 47 por ciento de los adolescentes se encuentra altamente expuesto a sufrir daño en la reproducción, 63 por ciento de los miembros de familias disfuncionales. Solo el 18 por ciento de los padres reconocieron que el comportamiento de sus hijos era riesgoso. CONCLUSIONES: La información recibida sobre sexualidad fue insuficiente, así como deficientes sus conocimientos a pesar de ser adecuada la comunicación entre padres e hijos. Todos estaban expuestos a factores de riesgo reproductivo y los miembros de familias disfuncionales fueron los más vulnerables

INTRODUCTION: Family is the more primary of human being where the man shows its firsts feeling, its first experiences, adds the main behavior standards giving a sense to the life. OBJECTIVE: To know the role of family in the sexual sphere of adolescents and repercussion on the reproductive health. METHODS: Sample included 128 students of secondary school residents in Centro Habana municipality. In focal groups a survey was applied as well as an at home interview of parents. RESULTS: The 69 percent of adolescents live with one of the parents; the 52 percent come from a dysfunctional family and the 48 percent from a functional family. The adolescents from dysfunctional nuclei had little information on sexual subjects by part of parents in a 100 percent. Parents had high knowledges on above mentioned subjects but not in the 78 percent of adolescents. The communication is inappropriate according the adolescents opinion (57 percent) and for parents it is appropriate in the 82 percent. The 47 percent of adolescents is highly exposed to suffer damage in reproduction and the 63 percent of dysfunctional family members. Only the 18 percent of parents recognized that there was a risky behavior on their children. CONCLUSIONS: All of them were exposed to reproductive risk factor and dysfunctional family members were the more vulnerable

Caracterización de un grupo poblacional con diagnóstico de infección por Treponema Pallidum / Characterization of a population group with a diagnosed of Treponema Pallidum infection

La sífilis es una enfermedad que ha presentado un incremento mundial en los últimos años. OBJETIVOS: Conocer su comportamiento y caracterizar a la población afectada en 3 áreas de salud del municipio Centrohabana. Identificar algunas características sociodemográficas de los pacientes infectados. Reconocer las vías a través de las cuales se realizó el diagnóstico. Establecer relación entre los pacientes con sífilis y la orientación sexual referida. MÉTODOS: Se realizó un estudio descriptivo, retrospectivo, de la incidencia de la sífilis en 3 áreas de salud en el trienio 2007-2009. Se estudiaron distintas variables como, edad, sexo, color de la piel, estado civil, orientación sexual, ocupación y medio de diagnóstico. El universo estuvo constituido por 120 pacientes con serologías cuantitativas positivas a sífilis en 3 áreas de salud la información fue recogida de las tarjetas de enfermedades de declaración obligatoria (EDO). RESULTADOS: Se constató un aumento creciente en las edades de 14 a 30 años. La población de piel negra fue la más afectada ya que se detectó en el 45 por ciento, de la sometida a estudio. Con respecto a las demás variables se pudo constatar que el 70 por ciento mantenía una conducta heterosexual. Dentro de los factores psicosociales estudiados encontramos que más de las tres cuartas partes de los que presentaron serologías reactivas, se declararon solteros. En la distribución ocupacional, más de la mitad de los pacientes estudiados no estaban vinculados a ningún tipo de labor. CONCLUSIONES: Existen indicios de un aumento en el número de casos nuevos diagnosticados por año, la edad, el no tener pareja sexual estable y la desvinculación laboral pueden actuar como un factor de riesgo para adquirir la enfermedad

In past years, syphilis is an increasing disease at world scale. OBJECTIVES: To know its behavior ad to characterize the involved population in three health areas from the Centro Habana municipality and to identify some sociodemographic features of infected patients, as well to recognize the routes by which diagnosis was made and to establish the relation between the patients with the syphilis and de reference sexual orientation. METHODS: A retrospective and descriptive study was conducted on the syphilis's incidence in three health areas during 2007-2009. Different variables were studied including age, sex, skin color, marital status, sexual orientation, job and diagnostic mean. Universe included 120 patients with quantitative serology positives to syphilis in three health areas; information was obtained from the obligate statement diseases cards (OSDC). RESULTS: There was an increasing rise in ages from 14 to 30 years. The black population was the more involved since it was detected in the 45 percent of study persons. Regarding the other variables it was possible to verify that the 70 percent had a heterosexual behavior. Within the study psychosocial factors we found that more of the three quarter of those with positive serology was singles. In occupational distribution more than a half of study patients are not linked with any type of job. CONCLUSIONS: There are clues of an increase in the figure of new cases diagnosed per year; that the age, a no stable sexual partner and non work link may to act as a risk factor to acquire the disease

Estudio del bajo peso al nacer en Cayo Hueso / Study of low birthweight in Cayo Hueso

El bajo peso sigue constituyendo un problema de salud, analizamos el comportamiento de este indicador en 6 años (2004 a 2009) en el área de salud del Policlínico Joaquín Albarrán del Municipio Centro Habana; se hace un estudio transversal retrospectivo revisando variables como: edad gestacional al parto, edad materna, rango de peso fetal y morbimortalidad .Se analizaron en tablas los datos obtenidos de forma comparativa. Disminuyen los nacimientos sin descenso en el índice de bajo peso, el CIUR aparece en 73 por ciento de los casos identificándose como la principal condición de los desfavorables resultados, la edad promedio de las madres no se encontraba incluida en los grupos de riesgo conocidos, más de la mitad de los nacimientos ocurrieron posterior a las 37 semanas y en 74 por ciento de los niños el peso sobrepasaba los 2 000 gramos, se comprobó que 60 por ciento de los fallecidos en etapa neonatal correspondían a niños con peso inferior a los 2500 gramos(AU)

The low birthweight continues constituting a problem of health, we analyze the behavior of this indicator in 6 years (2004 at 2009) in the area of health of Policlínico Joaquín Albarrán of the Municipality Center Havana, a traverse retrospective study is made revising variables as: age gestacional to the childbirth, maternal age, range of fetal weight and morbimortalidad .Se analyzed in charts the obtained data in a comparative way. They diminish the births without descent in the index of under weight, CIUR appears in 73 percent of the cases identifying you as the main condition of the unfavorable results, the age average of the mothers was not included in the well-known groups of risk, more than half of the births they happened later to the 37 weeks and in 74 percent of the children the weight surpassed the 2000 grams, he/she was proven that 60 percent of the deceaseds in stage neonatal corresponded children with inferior weight to the 2500 grams(AU)

La amniocentesis como técnica de diagnóstico prenatal / Amniocentesis as a technique for prenatal diagnosis

Se ofrece una revisión teórica actualizada sobre la técnica de amniocentesis utilizada, desde 1882, para el diagnóstico prenatal de un sinnúmero de animalías congénitas, a partir de la información obtenida en las bases de datos MEDLINE, LILCAS y de la Literatura Cubana de Medicina, de los años 1988 a 1994, localizadas en los órganos de información del Sistema Nacional de Información de Ciencias Médicas. Se dan a conocer los procedimientos generales para aplicar esta técnicas, sus riesgos y beneficios, así como las variantes de amniocentesis que existen de acuerdo con la semana de gestanción en que se realicen. Se informan los 4 tipos de análisis de laboratorio que se le aplican a los distintos compenentes del líquido amniótico. Se concluye que a pesar de ser una técnica de gran complejidad y riesgo obstétrico es de gran utilidad para el diagnóstico precoz de determinadas anomalias