scholarly journals Objective Real-World Outcomes of Patients Suffering from Painful Neurogenic Claudication Treated with the mild® Procedure: Interim 6-Month Report of a Randomized Controlled Trial

2021 ◽  
Vol Volume 14 ◽  
pp. 1687-1697
Author(s):  
Timothy Deer ◽  
Christopher Kim ◽  
Sayed Emal Wahezi ◽  
Huaguang Qu ◽  
Dawood Sayed
Keyword(s):  
Randomized Controlled Trial ◽  
Real World ◽  
Controlled Trial ◽  
Neurogenic Claudication ◽  
Randomized Controlled

scholarly journals Varenicline and Bupropion for Long-Term Smoking Cessation (the MATCH Study): Protocol for a Real-World, Pragmatic, Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Laurie Zawertailo ◽  
Tara Mansoursadeghi-Gilan ◽  
Helena Zhang ◽  
Sarwar Hussain ◽  
Bernard Le Foll ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Real World ◽  
Smoking Status ◽  
Controlled Trial ◽  
Health Study ◽  
Open Label ◽  
Randomized Controlled

BACKGROUND Varenicline and bupropion are efficacious, prescription-only pharmacotherapies for smoking cessation; however, their real-world impact is limited by prescriber knowledge, affordability, and accessibility. OBJECTIVE The primary objective of the MATCH (Medication Aids for Tobacco Cessation Health) study was to evaluate the real-world, long-term effectiveness of mailed bupropion and varenicline in a sample of interested smokers with the utilization of Web-based recruitment and follow-up. In addition, the study aims to investigate the genotypic and phenotypic predictors of cessation. METHODS This is a two-group, parallel block, randomized (1:1) open-label clinical trial. This study will be conducted online with the baseline enrollment through the study’s website and follow-up by emails. In addition, medication prescriptions will be filled by the study contract pharmacy and couriered to participants. Individuals who smoke ≥10 cigarettes per day and intend to quit within the next 30 days will be recruited through Public Health Units and Tobacco Control Area Networks throughout Ontario by word-of-mouth and the internet. Eligible participants will receive an email with a prescription for 12-week assigned medication and a letter to take to their physician. The recruitment and randomization will continue until 500 participants per arm have received medication. All participants will receive weekly motivational emails during the treatment phase. The primary outcome measure is the smoking status after 6 months, biochemically confirmed by mailed-in salivary cotinine. Follow-ups will be conducted through emails after 4, 8, 12, 26, and 52 weeks of starting the treatment to assess the smoking prevalence and continuous smoking abstinence. In addition, mailed-in saliva samples will be used for genetic and nicotine metabolism analyses. Furthermore, personality characteristics will be assessed using the Big Five Aspect Scales. RESULTS The project was funded in 2014 and enrollment was completed in January 2017. Data analysis is currently underway. CONCLUSIONS To the best of our knowledge, this is the first randomized controlled trial to mass distribute prescription medications for smoking cessation. We expect this method to be logistically feasible and cost effective with quit outcomes that are comparable to published clinical trials. CLINICALTRIAL ClinicalTrials.gov NCT02146911; https://clinicaltrials.gov/ct2/show/NCT02146911 (Archived by WebCite at http://www.webcitation.org/72CZ6AvXZ) REGISTERED REPORT IDENTIFIER RR1-10.2196/10826

scholarly journals The Investigations of Atrial Fibrillation Burden after Cryoballoon Ablation Detected by Insertable Cardiac Monitor in Patients with Paroxysmal Atrial Fibrillation: A Study Protocol for a Multicenter Randomized Controlled Trial (Cryo-ICM AF study)

2021 ◽  
Author(s):  
Di Luo ◽  
Yanhong Liu ◽  
yue zhang ◽  
Gang Xu ◽  
Enzhao Liu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Randomized Controlled Trial ◽  
Real World ◽  
Paroxysmal Atrial Fibrillation ◽  
Controlled Trial ◽  
Cryoballoon Ablation ◽  
Randomized Controlled ◽  
Cardiac Monitor ◽  
Multicenter Randomized Controlled Trial ◽  
Insertable Cardiac Monitor

Abstract Background: With the increasing number of aged population in China, the mortality and disability caused by atrial fibrillation (AF) and its complications lead to serious social burden and becoming more prominent. Due to the high false-negative rates of AF detected by routine ECG, the results on the recurrent rate and AF burden after cryoballoon ablation (CBA) in real world are inconsistent so far. Since the extension of monitoring time, the increased detection of AF in patients, insertable cardiac monitor (ICM) has its unique merits. Methods: Cryo-ICM AF study is a prospective, multicenter randomized controlled trial with 200 participants with paroxysmal atrial fibrillation from 4 centers. Monitoring AF load after CBA though two monitoring methods— ICM and 24 hours holter during the 1 years follow-up of the two groups. All data will be observed and recorded in baseline, 30th days and 3 th , 6 th , 9 th and 12 th months after CBA, which including incidence rates of postoperative complications and recurrence conditions, cardioelectrical indexes from 24-hours holter in all subjects and ICM in ICM group, UCG parameters about atrium/ventricular size and diastolic/systolic function, and biochemical indicators. Disucssion: This is the first study design to confirm the effectiveness of cryoballoon in real world, monitoring AF load with ICM in patients with paroxysmal AF after CBA.Trial registration: Chinese Clinical Trial Registry, No. ChiCTR1900026364. Registered 9 Oct 2019, http://www.chictr.org.cn/index.aspx

scholarly journals A Randomized Controlled Trial in Second-Generation Zotarolimus-Eluting Resolute Stents Versus Everolimus-Eluting Xience V Stents in Real-World Patients

2012 ◽  
Vol 59 (15) ◽  
pp. 1350-1361 ◽  
Author(s):  
Clemens von Birgelen ◽  
Mounir W.Z. Basalus ◽  
Kenneth Tandjung ◽  
K. Gert van Houwelingen ◽  
Martin G. Stoel ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Real World ◽  
Second Generation ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals PCV2 Characterizing Patients Treated with Macitentan: Real-World Evidence and a Randomized Controlled Trial Cohort

2020 ◽  
Vol 23 ◽  
pp. S486
Author(s):  
N. Kim ◽  
K.M. Chin ◽  
V.V. McLaughlin ◽  
C. Zhao ◽  
M. Flynn ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Real World ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Real World Evidence
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