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.

Misleading associations between cholesterol and vascular outcomes in dialysis patients: the need for randomized trials.

Abstract: Higher cholesterol is strongly associated with an increased risk of coronary heart disease (CHD) in nonrenal populations, so the lack of a clear positive association between total cholesterol and mortality among dialysis patients is unexpected. This review of prospective studies of the association between total cholesterol and mortality among dialysis patients suggests that there is a negative association at below average cholesterol levels and a flat or weakly positive association at higher levels. In nonrenal populations total cholesterol is not positively associated with vascular causes of death other than CHD, so the lack of a strongly positive association at above average cholesterol concentrations in dialysis patients may be explained by the high proportion of deaths due to non-CHD vascular causes. The observation of a negative association between total cholesterol and mortality at below average cholesterol concentrations in some studies is consistent with confounding by both vascular and nonvascular morbidity (i.e., reverse causality). We argue that evaluating the importance of cholesterol for vascular disease risk in dialysis patients can only be achieved through the eradication of confounding by randomization, and that ongoing trials of cholesterol-lowering therapy will provide a definitive answer to this question.

Biliary Tract and Liver Complications in Polycystic Kidney Disease

Abstract: Polycystic liver disease is a well described manifestation of autosomal dominant polycystic kidney disease (ADPKD). Biliary tract complications are less well recognized. We report a 50-year single-center experience of 1007 patients, which raised a hypothesis that ADPKD is associated with biliary tract disease. We tested this hypothesis using all England Hospital Episode Statistics data (1998-2012), within which we identified 23,454 people with ADPKD and 6,412,754 hospital controls. Hospitalization rates for biliary tract disease, serious liver complications, and a range of other known ADPKD manifestations were adjusted for potential confounders. Compared with non-ADPKD hospital controls, those with ADPKD had higher rates of admission for biliary tract disease (rate ratio [RR], 2.24; 95% confidence interval [95% CI], 2.16 to 2.33) and serious liver complications (RR, 4.67; 95% CI, 4.35 to 5.02). In analyses restricted to those on maintenance dialysis or with a kidney transplant, RRs attenuated substantially, but ADPKD remained associated with biliary tract disease (RR, 1.19; 95% CI, 1.08 to 1.31) and perhaps with serious liver complications (RR, 1.15; 95% CI, 0.98 to 1.33). The ADPKD versus non-ADPKD RRs for biliary tract disease were larger for men than women (heterogeneity P<0.001), but RRs for serious liver complications appeared higher in women (heterogeneity P<0.001). Absolute excess risk of biliary tract disease associated with ADPKD was larger than that for serious liver disease, cerebral aneurysms, and inguinal hernias but less than that for urinary tract infections. Overall, biliary tract disease seems to be a distinct and important extrarenal complication of ADPKD.

Trans-ethnic Mendelian-randomization study reveals causal relationships between cardiometabolic factors and chronic kidney disease.

Abstract: Background This study was to systematically test whether previously reported risk factors for chronic kidney disease (CKD) are causally related to CKD in European and East Asian ancestries using Mendelian randomization. Methods A total of 45 risk factors with genetic data in European ancestry and 17 risk factors in East Asian participants were identified as exposures from PubMed. We defined the CKD by clinical diagnosis or by estimated glomerular filtration rate of Results Eight risk factors showed reliable evidence of causal effects on CKD in Europeans, including genetically predicted body mass index (BMI), hypertension, systolic blood pressure, high-density lipoprotein cholesterol, apolipoprotein A-I, lipoprotein(a), type 2 diabetes (T2D) and nephrolithiasis. In East Asians, BMI, T2D and nephrolithiasis showed evidence of causality on CKD. In two independent replication analyses, we observed that increased hypertension risk showed reliable evidence of a causal effect on increasing CKD risk in Europeans but in contrast showed a null effect in East Asians. Although liability to T2D showed consistent effects on CKD, the effects of glycaemic phenotypes on CKD were weak. Non-linear Mendelian randomization indicated a threshold relationship between genetically predicted BMI and CKD, with increased risk at BMI of >25 kg/m2. Conclusions Eight cardiometabolic risk factors showed causal effects on CKD in Europeans and three of them showed causality in East Asians, providing insights into the design of future interventions to reduce the burden of CKD.

Prognostic importance of Sudan Black positivity: a study of bone marrow slides from 1,386 patients with de novo acute myeloid leukaemia.

Abstract: Analysis of bone marrow slides from 1,386 patients entered into the Medical Research Council's 8th and 9th trials in Acute Myeloid Leukaemia confirmed that features associated with differentiation in blast cells, in particular increasing Sudan Black (SB) positivity, were the most important morphological features for predicting remission achievement (P = 0.002) and hence survival (P less than 0.0001). SB positivity was also weakly predictive of remission duration (P = 0.05). A low complement of maturing granulocytes was associated with early induction death and a high percentage of blasts with shorter remissions. The few patients with acute promyelocytic leukaemia (FAB M3) had a high haemorrhagic death rate during induction and a low relapse rate. Apart from this, lineage involvement was not predictive of outcome. Multiple lineage leukaemias, in particular those with megakaryocytic and/or erythroid involvement, which had been reported previously to have a poor prognosis, did not have any worse remission rates in this series. When more than one cell line was involved, no combination with particularly good or poor prognosis could be identified. Multivariate analysis suggested that percentage SB positivity was adequate on its own to divide granulocytic leukaemias into poorly differentiated (less than 50% SB +ve) and well-differentiated groups (50% or more SB +ve) without the need for further measurements. This simple and reproducible test was strongly predictive of resistant disease but not of induction deaths. It was of considerably greater prognostic value--and was less open to inter-observer disagreement--than the FAB criteria which are usually used to classify granulocytic lineage leukaemias into the M1 and M2 subgroups. It is proposed that greater than or equal to 50% of blasts with SB positivity should replace blasts greater than 10% of maturing myeloid cells for this sub-categorization between M1 and M2.

Binge drinking and associated factors among school students: a cross-sectional study in Zhejiang Province, China

Abstract: Objective To investigate the prevalence and correlating factors of binge drinking among middle and high school students in Zhejiang Province, China. Methods We performed a cross-sectional study using data from a school-based survey. A total of 23 543 (response rate=97.5%) eligible adolescents from 442 different schools (including middle schools, academic high schools and vocational high schools) were asked to fill in an anonymous self-administered behaviour questionnaire between April and May 2017. Multivariable logistic regression models were used to examine the associations of sociodemographic and behavioural factors with binge drinking. Results The mean (SD) age of participants was 15.6 (1.7) years and 51.3% were boys. The proportions of students from middle schools, academic high schools and vocational high schools were 51.9%, 27.5% and 20.6%, respectively. In total, 22.8% (95% CI 21.6 to 23.9) of students reported drinking alcohol in the past 30 days and 9.2% (95% CI 8.5 to 10.0) of students reported binge drinking (defined as drinking four or more alcoholic drinks in 1–2 hours period among girls and five or more alcoholic drinks among boys) during the past month. The prevalence of binge drinking was highest among vocational high school students (17.9% vs 6.3% and 7.7% among middle school and academic high school students, respectively). Older age, studying at high school, poor academic performance, higher levels of physical activity, excessive screen-time, loneliness, insomnia, previous suicide attempt, cigarette smoking, fighting, being bullied and sexual experience were found to be positively associated with adolescent binge drinking. Conclusions Binge drinking is common among middle and high school students in Zhejiang, China. Efforts to prevent binge drinking may need to address a cluster of sociodemographic and behavioural factors. Our findings provide information to enable healthcare providers to identify students at high-risk of binge drinking and to inform planning of intervention measures for at-risk students.