Registry‐based randomized clinical trials in surgery: Working with ACS‐NSQIP and the AHPBA to conduct pragmatic trials

2021 ◽  
Vol 125 (1) ◽  
pp. 89-92
Author(s):  
Brett L. Ecker ◽  
Brian C. Brajcich ◽  
Ryan J. Ellis ◽  
Clifford Y. Ko ◽  
Michael I. D'Angelica
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Pragmatic Trials ◽  
Acs Nsqip

scholarly journals Alternative clinical trial designs

2020 ◽  
Vol 5 (1) ◽  
pp. e000420
Author(s):  
John A Harvin ◽  
Ben L Zarzaur ◽  
Raminder Nirula ◽  
Benjamin T King ◽  
Ajai K Malhotra
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Trauma Centers ◽  
Cluster Randomization ◽  
Stepped Wedge ◽  
Pragmatic Trials ◽  
Clinical Trial Designs ◽  
Cluster Randomized ◽  
Injured Patients

High-quality clinical trials are needed to advance the care of injured patients. Traditional randomized clinical trials in trauma have challenges in generating new knowledge due to many issues, including logistical difficulties performing individual randomization, unclear pretrial estimates of treatment effect leading to often unpowered studies, and difficulty assessing the generalizability of an intervention given the heterogeneity of both patients and trauma centers. In this review, we discuss alternative clinical trial designs that can address some of these difficulties. These include pragmatic trials, cluster randomization, cluster randomized stepped wedge designs, factorial trials, and adaptive designs. Additionally, we discuss how Bayesian methods of inference may provide more knowledge to trauma and acute care surgeons compared with traditional, frequentist methods.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

Ongoing randomized clinical trials for the treatment of thrombosis in the antiphospholipid syndrome

2001 ◽  
Vol 21 (02) ◽  
pp. 77-81 ◽  
Author(s):  
G. Finazzi
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Low Dose ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Collaborative Study ◽  
Clinical Problem ◽  
Vascular Events ◽  
Dose Oral ◽  
Adverse Pregnancy

SummaryThrombotic events are a major clinical problem for patients with antiphospholipid antibodies (APA). However, current recommendations for their prevention and treatment are still based on retrospective studies. Data from large scale, prospective clinical trials are required to ultimately identify the optimal management of these patients. To date, at least four randomized studies are underway. The WAPS and PAPRE clinical trials are aimed to establish the correct duration and intensity of oral anticoagulation in APA patients with major arterial or venous thrombosis. The WARSS-APASS is a collaborative study to evaluate the efficacy and safety of aspirin or low-dose oral anticoagulants in preventing the recurrence of ischemic stroke. The recently announced UK Trial compares low-dose aspirin with or without low-intensity anticoagulation for the primary prevention of vascular events in APA-positive patients with SLE or adverse pregnancy history, but still thrombosis-free. It is hoped that the results of these trials will be available soon since clinicians urgently need more powerful data to treat their patients with the APA syndrome.

ANTERIOR VERSUS POSTERIOR MYOTOMY DURING POEM FOR THE TREATMENT OF ACHALASIA: SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CLINICAL TRIALS

2019 ◽  
Author(s):  
E Rodríguez de Santiago ◽  
N Mohammed ◽  
A Manolakis ◽  
Y Shimamura ◽  
M Onimaru ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis

Cohort Analysis of Randomized Clinical Trials on long acting GLP-1 receptor agonists versus DPP4 inhibitors

2016 ◽  
Author(s):  
Thuy Pham ◽  
Mukunda Singh ◽  
Marvin Dao ◽  
Griselda Herrera ◽  
Katherine Asuncion
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Cohort Analysis ◽  
Receptor Agonists ◽  
Dpp4 Inhibitors ◽  
Long Acting

Oxidative stress does not influence weight loss induced by aerobic training in adults: randomized clinical trials

2020 ◽  
Vol 60 (6) ◽  
Author(s):  
Glêbia A. Cardoso ◽  
Mateus D. Ribeiro ◽  
Ana P. Ferreira ◽  
Yohanna de Oliveira ◽  
Thiago de O. Medeiros ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Weight Loss ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Aerobic Training
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