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Masking in Active Comparator Designs in Pharmacovigilance: A Retrospective Bias Analysis on the Spontaneous Reporting of Thiazolidinediones and Cardiovascular Events.
Pharmacoepidemiol Drug Saf
January 2025
School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
Introduction: Masking is a reporting bias where drug safety signals are muffled by elevated reporting of other medications in spontaneous reporting databases. While the impact of masking is often limited, its effect when using restricted designs, such as active comparators, can be consequential.
Methods: We used data from the US Food and Drugs Administration Adverse Event Reporting System (1999Q3-2013Q3) to study masking in a real-world example.
Freeze-dried plasma: Hemostasis and biophysical analyses for damage control resuscitation.
Transfusion
January 2025
Department of Surgery, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
Background: Effective hemorrhage protocols prioritize immediate hemostatic resuscitation to manage hemorrhagic shock. Prehospital resuscitation using blood products, such as whole blood or alternatively dried plasma in its absence, has the potential to improve outcomes in hemorrhagic shock patients. However, integrating blood products into prehospital care poses substantial logistical challenges due to issues with storage, transport, and administration in field environments.
View Article and Find Full Text PDF[Efficacy and safety of intracardiac echocardiography-guided "one-stop" procedures combining radiofrequency catheter ablation and left atrial appendage closure in elderly patients with atrial fibrillation].
Zhonghua Xin Xue Guan Bing Za Zhi
January 2025
Department of Cardiology, General Hospital of Northern Theater Command, National Key Laboratory of Frigid Zone Cardiovascular Diseases, Shenyang110016, China.
To assess the efficacy and safety of "one-stop" procedures combining radiofrequency catheter ablation and left atrial appendage closure by guidance of intracardiac echocardiography(ICE) in elderly patients with atrial fibrillation. A retrospective cohort study was conducted on patients who underwent ICE-guided "one-stop" procedures at the Department of Cardiology, General Hospital of Northern Theater Command between December 2020 and January 2023. Patients were divided into elderly group (age≥60 years old) and non-elderly group (age 18-59 years old).
View Article and Find Full Text PDFTriglyceride-glucose index: carotid intima-media thickness and cardiovascular risk in a European population.
Cardiovasc Diabetol
January 2025
Centro E. Grossi Paoletti, Dipartimento di Scienze Farmacologiche e Biomolecolari "Rodolfo Paoletti", Università degli Studi di Milano, Milano, Italy.
Background: The triglyceride-glucose (TyG) index is now widely recognized as a marker of insulin resistance and has been linked to the development and prognosis of atherosclerotic cardiovascular diseases (ASCVD) in numerous populations, particularly in the Eastern world. Although there are fewer reports from the Western world, and they are sometimes contradictory, the absence of definitive data on the relationship between a raised TyG index and cardiovascular risk suggested the opportunity of testing this biochemical marker against a well-established vascular marker such as the carotid intima media thickness (c-IMT).
Methods: Primary prevention patients were selected from a cohort of individuals who underwent c-IMT measurement between 1984 and 2018 at the Dyslipidemia Center at the ASST Grande Ospedale Metropolitano Niguarda in Milan, Italy.
ECG challenge: Intermittent wide QRS complexes in heterotaxy syndrome.
J Electrocardiol
January 2025
Division of Pediatric Cardiology, Department of Pediatrics, Medical University Graz, Graz, Austria.
We report wide QRS complexes appearing in conjunction with prolonged R-R intervals in a 5- year old patient with situs ambiguous and mirror image dextrocardia, who had undergone ASD and VSD closure at of the age of one. We present differential diagnoses of intermittent spontaneous QRS widening and refer to ECG lead positioning in mirror image dextrocardia patients.
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