Association of socioeconomic status, truncal fat and sICAM-1 with carotid intima-media thickness in adolescents: the HELENA study.

Objective: To measure the carotid intima-media-thickness (cIMT) and to assess its determinant factors in healthy adolescents.

Methods: 319 adolescents aged 12.5-17.

Effect of child health status on parents' allowing children to participate in pediatric research.

Background: To identify motivational factors linked to child health status that affected the likelihood of parents' allowing their child to participate in pediatric research.

Methods: Parents were invited to return their completed questionnaires anonymously to assess motivational factors and factors that might improve participation in pediatric research.

Results: Of 573 eligible parents, 261 returned the completed questionnaires.

Genotype/phenotype analyses for 53 Crohn's disease associated genetic polymorphisms.

Background & Aims: Recent studies reported a role for more than 70 genes or loci in the susceptibility to Crohn's disease (CD). However, the impact of these associations in clinical practice remains to be defined. The aim of the study was to analyse the relationship between genotypes and phenotypes for the main 53 CD-associated polymorphisms.

Safety and immunogenicity of rSh28GST antigen in humans: phase 1 randomized clinical study of a vaccine candidate against urinary schistosomiasis.

Background: Treatment of urinary schistosomiasis by chemotherapy remains challenging due to rapid re-infection and possibly to limited susceptibility to praziquantel treatment. Therefore, therapeutic vaccines represent an attractive alternative control strategy. The objectives of this study were to assess the safety and tolerability profile of the recombinant 28 kDa glutathione S-transferase of Schistosoma haematobium (rSh28GST) in healthy volunteers, and to determine its immunogenicity.

Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries.

Background: In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.

Methods: We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN) countries-Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and United Kingdom-covering approximately 70% of the EU population.

Temporal analysis of heart rate variability as a predictor of post traumatic stress disorder in road traffic accidents survivors.

Background: Road Traffic Accidents (RTA) are most probably the leading cause of post traumatic stress disorder (PTSD) in developed countries. The autonomic nervous system (ANS) disturbances, due to psychological trauma, are part of the pathophysiology of PTSD. The aim of the present study was to determine whether early heart rate variability (HRV) measurement, a biomarker of the ANS function, could act as a predictor of PTSD development after a RTA.

Previous leisure-time physical activity dose dependently decreases ischemic stroke severity.

In the present subanalysis of a cross-sectional study showing the favorable effect of prior transient ischemia, leisure-time physical activity, and lipid-lowering drug therapy on stroke severity, we aimed to evaluate whether previous physical activity was dose dependently associated to minor stroke (NIHSS 0-3) and to identify possible underlying factors. Among 362 consecutive patients, less severe stroke was related to weekly exercise duration prior to stroke (no exercise: 36.1%; <2 hours: 49.

Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries.

Background: 'Compassionate use' programmes allow medicinal products that are not authorised, but are in the development process, to be made available to patients with a severe disease who have no other satisfactory treatment available to them. We sought to understand how such programmes are regulated in ten European Union countries.

Methods: The European Clinical Research Infrastructures Network (ECRIN) conducted a comprehensive survey on clinical research regulatory requirements, including questions on regulations of 'compassionate use' programmes.

Increased intima-media thickness of the carotid artery in childhood: a systematic review of observational studies.

Unlabelled: Increased carotid intima-media thickness (cIMT) in adults may be caused by a childhood exposure to cardiovascular risk factors. We systematically reviewed observational studies to determine whether obesity, insulin-dependent diabetes mellitus (IDDM), dyslipidemia (DL), hypertension (HT), and chronic renal failure (CRF) are associated with increased cIMT in children and adolescent patients compared with control subjects. We performed a PubMed literature search from January 1986 to February 2010.

Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN).

Background: Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states.

Methods: In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey.

Effect of two oral doses of 17beta-estradiol associated with dydrogesterone on thrombin generation in healthy menopausal women: a randomized double-blind placebo-controlled study.

Oral hormone therapy is associated with an increased risk of venous thrombosis. Drug agencies recommend the use of the lowest efficient dose to treat menopausal symptoms for a better risk/ratio profile, although this profile has not been totally investigated yet. The aim of the study was to compare the effect of the standard dose of 17beta-estradiol to a lower one on thrombin generation (TG).

Candida albicans colonization and ASCA in familial Crohn's disease.

Objectives: Anti-Saccharomyces cerevisiae antibodies (ASCAs) are present in 50-60% of patients with Crohn's disease (CD) and in 20-25% of their healthy relatives (HRs). The yeast, Candida albicans, has been shown to generate ASCAs, but the presence of C. albicans in the digestive tract of CD patients and their HRs has never been investigated.

E-selectin gene S128R polymorphism is associated with poor prognosis in patients with stage II or III colorectal cancer.

Some host-related factors may predict the risk of metastasis after surgery of colorectal cancer (CRC). The endothelial adhesion molecule E-selectin is implicated in the metastatic spread of CRC. We postulated that some polymorphisms within the E-selectin gene, especially the S128R polymorphism, may increase the risk of metastases by facilitating adhesion of tumour cells to the endothelium.

Sampling and processing of fresh blood samples within a European multicenter nutritional study: evaluation of biomarker stability during transport and storage.

Introduction: Analysis of several biological markers improves the quality and physiologic comprehension of data obtained in epidemiological nutritional studies.

Aim: To develop a methodology that guarantees the centralized analysis and quality assurance of the most relevant blood parameters from fresh blood samples in adolescents in a European multicenter study.

Materials And Methods: Stability of selected nutrients and biomarkers (vitamins, fatty acids, iron metabolism and immunological parameters) chosen with respect to time and temperature of sample transport and storage was evaluated as part of the pilot study of the Healthy Lifestyle in Europe by Nutrition in Adolescence (HELENA) project.

Socioeconomic questionnaire and clinical assessment in the HELENA Cross-Sectional Study: methodology.

Rationale: Environmental factors such as dietary habits, breastfeeding, socioeconomic conditions and educational factors are strong influences on nutritional and puberty status, physical activity, food choices and their interactions. Several diseases of adulthood seem to be linked to, or to originate from, lifestyle in childhood and adolescence.

Objective: The aims of this study are to describe birth parameters and socioeconomic factors and to assess clinical status in adolescents aged 13-16 years from 10 European countries participating in the Healthy Lifestyle in Europe by Nutrition in Adolescence (HELENA) Cross-Sectional Study (CSS).

Quality assurance of ethical issues and regulatory aspects relating to good clinical practices in the HELENA Cross-Sectional Study.

Rationale: Research involving humans is regulated by regulatory authorities through their specific requirements and controls. The Healthy Life Style in Europe by Nutrition in Adolescence Cross-Sectional Study (HELENA-CSS) is a multicenter biomedical research study of adolescents in several representative European cities, which requires satisfying medico-regulatory requirements including Independent Ethics Committee (IEC) approval and agreement by the national or local regulatory authorities. To achieve a high level of quality assurance relating to ethical issues, we followed the good clinical practices (GCP) described at the International Conference on Harmonisation (ICH), which we adapted to the national and local situations of each of the 11 participating cities in 10 European countries.

Healthy lifestyle by nutrition in adolescence (HELENA). A new EU funded project.

The key to health promotion and disease prevention in the 21st century is to establish an environment that supports positive health behaviour and healthy lifestyle from childhood. The HELENA project includes cross-sectional, crossover and pilot community intervention multi-centre studies, as an integrated approach to the above-mentioned problem. Dietary intake, nutrition knowledge and eating attitudes, food choices and preferences, body composition, biochemical, physical activity and fitness and genotype (to analyse gene-nutrient and gene-environment interactions) assessment will provide the full information about the nutritional and lifestyle status of the European adolescents.

Effects of two marine dietary supplements with high calcium content on calcium metabolism and biochemical marker of bone resorption.

Background/objective: Calcium is essential for the bone metabolism but daily calcium requirements are not met in a significant proportion of the population. Fortunately, oral calcium supplementation can help to meet these needs; however, the calcium bioavailability depends on the calcium sources. The calcium absorption and bioavailability of dietary supplements from marine sources are not known.

Incidence of early adverse events surrounding direct current cardioversion of persistent atrial fibrillation. A cohort study of practices.

Aims: To establish the incidence of early adverse events surrounding direct current (DC) cardioversion of persistent atrial fibrillation in an unselected patient cohort and to describe and analyse these complications.

Methods: Prospective study over a three-month period (February, March and April 2000). Outcome measures included all serious adverse events during the hospitalisation for DC cardioversion.

Effect of training and detraining on heart rate variability in healthy young men.

The purpose of this study was to investigate the effect of twelve weeks of aerobic training and eight weeks of training cessation on Heart Rate Variability (HRV). Ten healthy young men (Age: 21.7 +/- 2.

Diazepam impairs temporal dynamics of visual attention.

The effect of benzodiazepines on attention has been the object of few investigations. Studies using the spatial cueing paradigm (Posner's paradigm) have reported inconsistent results, which are likely due to methodological and/or dose differences but suggest impaired disengagement of attention from the cue to the target. The authors investigated the effect of a benzodiazepine (diazepam) on attentional shifting in the temporal domain.

Prior TIA, lipid-lowering drug use, and physical activity decrease ischemic stroke severity.

Objective: To determine clinical and pharmacologic factors that could influence the initial severity and short-term outcome of cerebral ischemia.

Methods: In a cross-sectional hospital-based study of patients with acute supratentorial ischemic stroke, we systematically collected medical history, previous leisure-time physical activity, current and previous treatments, blood pressure, temperature, blood glucose, fibrinogen, NIH Stroke Scale (NIHSS) score at admission, and outcome at day 8. Factors potentially associated with initial stroke severity and outcome were selected by univariate analyses and then validated in logistic regression analyses with lower severity of stroke at admission (NIHSS 0 to 5) or good outcome at day 8 (modified Rankin Scale 0 to 1, Barthel Index 95 to 100) as dependent variables.