Central statistical monitoring can both optimize on-site monitoring and improve data quality and as such provides a cost-effective way of meeting regulatory requirements for clinical trials.

Our objectives were to investigate and compare the effects of supplemental Mg, Trp, vitamin E (vit E), and vitamin C (vit C) on stress responses of pigs undergoing transport simulation. In this study, 126 pigs (25.1 +/- 4.4 kg BW) were allocated to one of the six following treatments: 1) negative control (no supplementation); 2) positive control (i.m. injection with 0.5 mg of carazolol/20 kg BW 12 h before vibration, beta-blocker); 3) Trp (additional amount of 6 g/kg of feed for 5 d, as-fed basis); 4) Mg (3 g/L drinking water for 2 d); 5) vit E (additional amount of 150 mg/kg of feed for 21 d, as-fed basis); 6) or vit C (additional amount of 300 mg/kg of feed for 21 d, as-fed basis). Pigs were treated in groups of three, and each treatment was replicated seven times. Feed and water intake were not different among treatments. Heart rate variables (mean, peak, and minimum heart rate, ventricular ectopic beats, and ST elevation of Channels A and B) and heart rate variability were registered from the night before vibration. Pigs were subjected to vibration in a transport simulator (8 Hz, 3 m/s) for 2 h and allowed to recover for 2 h. Generally, the positive control pigs had the lowest heart rate values (mean, peak, minimum heart rate, ST elevation of Channel A; P < 0.05), whereas Mg and Trp decreased ventricular ectopic beats and ST elevation of Channel B, respectively. The effect of vit C and E as vagal stimulators was clearly visible, whereas carazolol and Mg clearly blocked the sympathetic pathways of the autonomic nervous system. During vibration, the negative control pigs lay the least, and Mg pigs the most (P < 0.05). Salivary cortisol concentrations (taken before and after vibration and after recovery) showed that vit E pigs produced the least cortisol during stress periods. Intermediary metabolites (glucose, lactate, creatine kinase, and NEFA) were analyzed in plasma from blood taken before and after vibration. At the two sampling points, the vit E and Mg pigs had the lowest NEFA concentrations (P < 0.05), and the vit E pigs also had the lowest lactate concentrations before vibration. Urine samples were collected before and after vibration to determine catecholamine concentrations; only negative control pigs had an increase (P = 0.04) in epinephrine concentration, despite large individual variation. In general, these results indicate that the supplementation of Trp, Mg, vit E, or vit C improved coping ability of pigs during vibration comparison with the negative control treatment. A muscular injection of carazolol influenced only the heart rate variables.

The Province of Luxembourg is an area in Belgium with a high prevalence of risk factors for cardiovascular disease and non-insulin-dependent diabetes mellitus among adults. In the present study, children in the age groups 6-8, 8-10, and 10-12 years were selected at random from school classes (n = 1,028), with a participation rate of 70.3%. Anthropometric factors, blood pressure, and fasting blood glucose, plasma cholesterol, triglyceride, and insulin levels were measured in 1992. All anthropometric and metabolic variables increased with age, except for waist: hip circumference ratio in boys and cholesterol in girls. In the oldest group, girls who had passed menarche were taller and heavier and had greater skinfold, body mass index, insulin, and systolic blood pressure values but lower total cholesterol levels and waist: hip ratios than girls who had not passed menarche. Boys had lower skinfolds and higher waist: hip ratios than girls in all age groups, and were significantly shorter and lighter in the oldest age group. There was no difference in body mass index between the two sexes. Girls had higher triglyceride and insulin levels in the 10- to 12-year age group, lower blood glucose values in the 8-10 and 10-12 age groups, and lower diastolic blood pressures in the 8-10 age group. Obesity, blood glucose, triglycerides, insulin, and blood pressure were highly interrelated. Cholesterol, triglycerides, insulin, and blood pressure values were all among the highest of values previously reported in other studies. The deciles of body mass index above 50 appeared to be particularly elevated, suggesting that obesity, when present, was pronounced in this population of children. These findings suggest an accumulation of genetic susceptibility to cardiovascular disease and non-insulin-dependent diabetes mellitus in this stable, ethnically homogeneous, and rather isolated part of continental Europe.

This study was undertaken to assess the co-administration of an experimental measles-mumps-rubella-varicella vaccine (MMRV, GlaxoSmithKline Biologicals) with a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate (DTPa-HBV-IPV/Hib) vaccine in healthy children. Healthy children aged 12-23 months (N = 451) were randomised to one of three parallel groups to receive one dose of MMRV vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine (co-administration group), or one dose of MMRV vaccine alone (MMRV group), or a booster dose of DTPa-HBV-IPV/Hib vaccine alone (DTPa-HBV-IPV/Hib group). No differences in seroconversion rates for measles (>95%), mumps (>80%), rubella (>99%) and varicella (>98%) were seen between the co-administration group and the MMRV group. No differences in geometric mean titres (GMTs) were observed between the two groups with the exception of anti-measles titres, which were observed to be higher in the MMRV group than in the co-administration group (4,419.2 vs. 3,441.8 mIU/ml respectively). Immune response to the booster dose of DTPa-HBV-IPV/Hib vaccine was observed to be similar in the co-administration group and the DTPa-HBV-IPV/Hib group. Co-administration of the MMRV vaccine with a booster dose of DTPa-HBV-IPV/Hib vaccine was well-tolerated and did not exacerbate the reactogenicity profile of either vaccine. In summary, GlaxoSmithKline Biologicals' experimental MMRV vaccine was immunogenic and well-tolerated when administered with a booster dose of DTPa-HBV-IPV/Hib vaccine during the second year of life. The ability to co-administer the MMRV vaccine at the same time as other routine childhood immunisation vaccines could increase compliance with varicella vaccination in countries where this vaccine is already recommended and may facilitate implementation of varicella vaccination elsewhere.

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