Medicine
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Randomized Controlled Trial Multicenter Study
Design and Rationale of the APELOT Trial: A Randomized, Open-Label, Multicenter, Phase IV Study to Evaluate the Antiplatelet Effect of Different Loading Dose of Ticagrelor in Patients With Non-ST Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.
Ticagrelor is a direct acting on the P2Y12 receptor blocker, which provides faster and greater platelet inhibition than clopidogrel. However, several studies suggested that in ST-segment elevation myocardial infarction patients undergoing percutaneous coronary intervention (PCI), ticagrelor exhibits initial delay in the onset of antiplatelet action. Unlike ST-segment elevation myocardial infarction, in non-ST-segment elevation acute coronary syndrome (NSTE-ACS), management pathways are highly variable, and some patients may require surgery. ⋯ A total of 250 NSTE-ACS participants will be randomized to receive a ticagrelor LD (360 or 180 mg), followed by a maintenance dose of 90 mg twice a day (bid) starting 12 hours after the LD. The primary endpoint is platelet reactivity index measured by vasodilator-stimulated phosphoprotein phosphorylation 2 hours after the LD, and the secondary endpoints include occurrence of periprocedural myocardial infarction and bleeding events. The AntiPlatelet Effect of different Loading dOse of Ticagrelor trial will provide important information on the risks and benefits of a high LD (360 mg) of ticagrelor in achieving a faster and stronger platelet inhibition compared with the conventional LD (180 mg) in NSTE-ACS patients undergoing PCI.
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Randomized Controlled Trial
Effect of Dexmedetomidine on Heart Rate-Corrected QT and Tpeak-Tend Intervals During Robot-Assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position: A Prospective, Randomized, Double-Blinded, Controlled Study.
Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads to changes in ventricular repolarization. This in turn can result in changes of heart rate-corrected QT (QTc) interval and Tpeak-Tend (Tp-e) interval. Dexmedetomidine is a highly selective α2-receptor agonist and has potential antiarrhythmic properties. ⋯ Continuous infusion of dexmedetomidine at a rate of 0.3 μg/kg/hour significantly attenuated the QTc interval prolongation induced by CO2 pneumoperitoneum with steep Trendelenburg position. Furthermore, dexmedetomidine reduced the Tp-e interval. Thus, dexmedetomidine administration may be effective for patients who are susceptible to the development of ventricular arrhythmia during robot-assisted laparoscopic prostatectomy.
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Review Meta Analysis
The Effect of Subclinical Maternal Thyroid Dysfunction and Autoimmunity on Intrauterine Growth Restriction: A Systematic Review and Meta-Analysis.
The objective of this study was to evaluate the association between maternal subclinical thyroid dysfunction and autoimmunity with the risk for intrauterine growth restriction (IUGR). Design is a systematic review and meta-analysis. A literature search was conducted using PubMed, Embase, and Cochrane database. ⋯ Meta-analysis showed that there was no effect of subclinical hyperthyroidism (odds ratio (OR) = 0.98; 95% confidence interval (CI), 0.40-2.41), TPOAb positivity (OR = 1.57; 95% CI, 0.77-3.18), or isolated hypothyroxinemia (OR = 1.05, 95% CI: 0.37-2.92) on IUGR. However, SCH is associated with IUGR (OR = 1.54; 95% CI, 1.06-2.25). SCH is associated with IUGR; however, subclinical hyperthyroidism, TPOAb positivity, or isolated hypothyroxinemia do not affect the risk of IUGR.
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Review Meta Analysis
Effects of Statins on Bone Mineral Density and Fracture Risk: A PRISMA-compliant Systematic Review and Meta-Analysis.
Although observational studies have identified the protective effect of statins on bone health, the effects remain controversial in randomized controlled trials (RCTs). We conducted a meta-analysis of RCTs to evaluate the effects of statins on bone mineral density (BMD) and fracture risk among adults. We searched electronic databases of Medline, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) and conducted a bibliography review to identify articles published until May, 2015. ⋯ The effect of statins use on bone health among subpopulation could not be identified due to limited number of trials. These findings provide evidence that statins could be used to increase BMD other than decreasing fracture risk in participant with dyslipidemia. In addition, further trials with the primary outcome of bone health-related measurements in subpopulation are warranted to ensure the effect of statins use.
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Controlling for confounders is a crucial step in analytical observational studies, and multivariable models are widely used as statistical adjustment techniques. However, the validation of the assumptions of the multivariable regression models (MRMs) should be made clear in scientific reporting. The objective of this study is to review the quality of statistical reporting of the most commonly used MRMs (logistic, linear, and Cox regression) that were applied in analytical observational studies published between 2003 and 2014 by journals indexed in MEDLINE. ⋯ Reporting of all items assessed was higher in articles published in journals with a higher impact factor. A low percentage of articles indexed in MEDLINE that used multivariable techniques provided information demonstrating rigorous application of the model selected as an adjustment method. Given the importance of these methods to the final results and conclusions of observational studies, greater rigor is required in reporting the use of MRMs in the scientific literature.