Clinical Trial Service Unit

About: Clinical Trial Service Unit is a based out in . It is known for research contribution in the topics: Population & Stroke. The organization has 428 authors who have published 1387 publications receiving 181920 citations.

Cardiovascular outcomes among participants with diabetes in the recent large statin trials.

Abstract: Purpose of reviewDespite their increased cardiovascular risk and its continuous relationship with cholesterol, until recently only diabetic patients with marked dyslipidaemia were routinely offered lipid-lowering therapy. The secondary prevention statin trials led to more widespread cholesterol lowe

Quality of life in chronic lymphocytic leukemia: 5-year results from the multicenter randomized LRF CLL4 trial.

Abstract: Health-related quality of life (HRQoL) is a key issue for patients with chronic lymphocytic leukemia. The multicenter LRF CLL4 trial, in which 777 patients were randomized to receive chlorambucil or fludarabine, alone or with cyclophosphamide (FC), assessed HRQoL at baseline, months 3, 6 and 12, then annually until 5 years, using the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC-QLQ-C30). While on treatment, some HRQoL impairment was seen in patients receiving fludarabine, particularly FC, compared with chlorambucil. Thus at 3 months, role/social functioning and fatigue were ≥ 10 points worse than baseline in 41%/46%/56%, respectively, of patients receiving fludarabine alone and 48%/54%/60% receiving FC, compared with only 29%/31%/40% of those receiving chlorambucil. Thereafter HRQoL appeared similar between treatment groups. Sustained remissions were associated with long-term HRQoL benefit. In the primary HRQoL domains patients still in complete or partial remission at each time-point had scores close to those reported in general population studies, while patients whose disease had progressed had mean scores up to 22 points worse, in spite of subsequent treatments. These data offer support for the use of primary treatment regimens likely to achieve and sustain remission in otherwise medically fit patients of all ages, including those aged > 70 years.

Anthropometric characteristics as predictors of coronary heart disease in women.

Abstract: Objectives. Obesity and other anthropometric measures are clearly related to risk of coronary heart disease (CHD), although debate remains as to which measures are most important and how the impact of obesity varies over the life course. Aim. We aimed to investigate these issues in a large cohort of Swedish women. The Women's Lifestyle and Health Cohort Study includes 49 259 women, aged 30-50 years at baseline (1991-1992) when an extensive questionnaire was completed. Methods. Women were given standard instructions for self-measurement of anthropometric characteristics. Women were followed through linkages to national registries until December 2003, during which time 256 cases of incident fatal CHD or nonfatal myocardial infarction occurred. Results. Waist circumference was associated with increased CHD risk after multivariate adjustment for confounders (HR = 1.9; 95% CI:1.1-3.3; highest versus lowest quartile), whereas height, weight and hip circumference were not. Measures of obesity were strongly related to CHD, and after mutual adjustment, waist-hip ratio (HR = 1.9, 95% CI: 1.2-3.2) was more closely related to CHD risk than BMI (HR = 1.5, 95% CI: 1.0-2.4). Risk of CHD was increased in women who remained heavy, those who were heavy at age 18, and those with low birth weight. Conclusions. In conclusion, there is strong evidence for supporting control of obesity, in particular avoidance of abdominal obesity, as a strategy to prevent CHD.

The association of betaine, homocysteine and related metabolites with cognitive function in Dutch elderly people

Abstract: The importance of the one-carbon metabolites, choline and homocysteine, to brain function is well known. However, the associations between the one-carbon metabolites choline, betaine, methionine and dimethylglycine with cognition in elderly are unclear. We therefore examined the associations of these metabolites with cognition in a double-blind, placebo-controlled trial. Individuals (n 195) were randomized to receive daily oral capsules with either 1000 microg cobalamin (vitamin B12), or 1000 microg cobalamin plus 400 microg folic acid, or placebo for 24 weeks. Concentrations of homocysteine, methionine, choline, betaine and dimethylglycine were assessed before and after 12 and 24 weeks of treatment. Cognitive function, including domains of attention, construction, sensomotor speed, memory and executive function, was assessed before and after 24 weeks of treatment. At baseline, elevated plasma homocysteine was associated with lower performance of attention, construction, sensomotor speed and executive function. In addition, betaine was positively associated with better performance of construction, sensomotor speed and executive function, whereas elevated concentrations of methionine were positively associated with sensomotor speed. Daily combined supplementation with cobalamin plus folic acid decreased total homocysteine concentrations by 36%, and increased betaine concentrations by 38%. Participants with the largest increases in betaine concentrations showed a borderline significant (P = 0.07) higher memory performance compared to those without it. Although this trial observed associations of homocysteine and betaine with cognitive domains prior to supplementation, decreased concentrations of homocysteine were not related to improved cognitive performance. There was a tendency of participants with the largest increases in betaine concentrations to show the greatest improvement in memory function.

Could antioxidants play a role in high rates of coronary heart disease in the Czech Republic

Abstract: Objectives: To compare plasma levels of antioxidant vitamins in the Czech population with those in a western European population, and to investigate whether plasma levels of antioxidant vitamins in Czech population are related to risk of MI. Design: The study has two parts: a cross-sectional survey and a population based case-control study. Setting: Adult population in two districts of the Czech Republic, and London based civil servants group as the comparison. Subjects: A random sample of men and women aged 25–64 y resident in two districts were selected for the cross- sectional survey. Subjects in the age group 40–49 y were compared to a sample of British civil servants of the same age enrolled in the Whitehall II Study. Men in the Czech sample served as controls to 52 male cases of first non-fatal myocardial infarction (MI) which occurred in the same population. Plasma samples were obtained from venepuncture during an interview in hospital in the population sample and immediately after hospitalization in the MI cases. Main outcome measures: Plasma levels of β-carotene and α-tocopherol, and the event of MI. Identical protocol and one laboratory was used for all analyses. Results: The mean plasma levels of β-carotene and α-tocopherol in healthy Czech men and women were substantially lower than in a subsample of British civil servants examined in the same laboratory. Smoking was strongly related to β- carotene in both populations but differences between Czechs and Brits were present in both smokers and non-smokers. In the case-control study among Czech men, low levels of the vitamins were strongly related to an increases risk of MI. Age-adjusted odds ratios for concentrations below the median were 3.33 (95% confidence interval 1.43–8.33) for β-carotene and 1.89 (0.94–3.45) for α-tocopherol; further adjustment for a range of variables reduced these estimates only slightly. Conclusions: Plasma concentrations of antioxidants in the Czech population appeared to be very low, and men with low levels of these substances are at increased risk of MI. This indicates that sub-optimal intake of antioxidants or related dietary factors may have played a role in the high rates of coronary heart disease in this population. Sponsorship: This study was supported by grants from the Wellcome Trust, Czech Ministry of Health and the British Heart Foundation. MB was a Wellcome Trust fellow in clinical epidemiology.