Post-marketing authorisation safety and efficacy surveillance of advanced therapy medicinal products in Brazil, the European Union, the United States and Japan.

Background Aims: Advanced therapy medicinal products (ATMPs) are a class of biological products for human use that are based on gene, tissues or cells. ATMPs have peculiar characteristics when compared with traditional medicines. In this regard, long-term safety and efficacy follow-up systems of individuals treated with ATMPs have become necessary and may present unique challenges, because unlike conventional drugs and biologics, these products can exert their effects for years after administration.

Changes in hippocampal astrocyte morphology of Ruddy turnstone (Arenaria interpres) during the wintering period at the mangroves of Amazon River estuary.

Astrocytes are essential for lipid neuronal metabolism in long-distance uninterrupted migratory flights, when glucose is not available as the main source of energy. We previously demonstrated in Calidris pusilla that after uninterrupted 5 days transatlantic flight, astrocytes shrink and reduce its number in the hippocampal formation. Here we shifted our attention to the wintering period and tested the hypothesis that hippocampal astrocyte morphology of A interpres will change as the wintering period progresses towards the premigration window.

[Prevalence of metabolic syndrome in pubertal stages of female students].

Objective To analyze the prevalence of metabolic syndrome (MS) in pubertal stages of female students. Methods Cross-sectional study of 449 school children between eight and 18 years, stratified by pubertal stage, body mass index (BMI) and body fat percentage (BF %). The MS was classified according to the International Diabetes Federation.

[Quality of clinical studies published in the RBGO over one decade (1999-2009): methodological and ethical aspects and statistical procedures].

Purpose: To evaluate the methodological and statistical design evolution of the publications in the Brazilian Journal of Gynecology and Obstetrics (RBGO) from resolution 196/96.

Methods: A review of 133 articles published in 1999 (65) and 2009 (68) was performed by two independent reviewers with training in clinical epidemiology and methodology of scientific research. We included all original clinical articles, case and series reports and excluded editorials, letters to the editor, systematic reviews, experimental studies, opinion articles, besides abstracts of theses and dissertations.

[Correlation between complaints of stress urinary incontinence and the one-hour pad test in postmenopausal women].

Objective: to correlate complaints of stress urinary incontinence and the results of a one-hour pad test in pre- and postmenopausal women.

Methods: cross-sectional study conducted on 60 postmenopausal volunteers divided into two groups: one consisting of 34 women with involuntary loss of urine due to stress incontinence and the other consisting of 26 women without involuntary loss of urine. A control group of 15 premenopausal women with normal menstrual cycles and no urinary complaints was also used.

[The relationship between the human development index and nutritional variables in Brazilian children].

Objective: This study was aimed at showing the relationship of the Human Development Index (HDI) in different areas of Brazil to body composition variable patterns, thereby indicating these variables' nutritional status and the suitability of their use.

Material And Methods: This was a descriptive, cross-sectional, comparative study. The sample consisted of male and female state school students aged 8 to 10 years old from 3 regions of Brazil .