A two-year follow-up of oral antioxidant supplementation in primary open-angle glaucoma: an open-label, randomized, controlled trial

2014 ◽  
Vol 93 (6) ◽  
pp. 546-554 ◽  
Author(s):  
Jose Javier Garcia-Medina ◽  
Manuel Garcia-Medina ◽  
Pablo Garrido-Fernandez ◽  
Jose Galvan-Espinosa ◽  
Carlos Garcia-Maturana ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Open Angle Glaucoma ◽  
Open Angle Glaucoma ◽  
Controlled Trial ◽  
Open Angle ◽  
Antioxidant Supplementation ◽  
Open Label ◽  
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 Phacotrabeculectomy versus Phaco with Implantation of the Ex-PRESS Device: Surgical and Refractive Outcomes—A Randomized Controlled Trial

2021 ◽  
Vol 10 (3) ◽  
pp. 424
Author(s):  
Joanna Konopińska ◽  
Anna Byszewska ◽  
Emil Saeed ◽  
Zofia Mariak ◽  
Marek Rękas
Keyword(s):  
Randomized Controlled Trial ◽  
Visual Acuity ◽  
Open Angle Glaucoma ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Refractive Outcomes ◽  
Postoperative Astigmatism ◽  
Prospective Randomized Controlled Trial ◽  
Refractive Change

The aim of this study was to compare surgical and refractive outcomes between phacotrabeculectomy (P-Trab) and phaco with Ex-PRESS (P-Ex-PRESS) for glaucoma at a 6-month follow-up. This prospective randomized controlled trial included 81 eyes; 43 eyes (53%) and 38 eyes (47%) were assigned to the P-Ex-PRESS and P-Trab groups, respectively. Refraction, intraocular pressure (IOP), and best-corrected visual acuity were measured. Refractive change was analyzed using the cylinder’s magnitude, and polar analysis assessed the change in the trend of astigmatism [with-the-rule, against-the-rule (ATR), oblique (OBL)], evaluating mean astigmatism in centroid form. All patients showed a statistically significant postoperative decrease in IOP (P < 0.05). There were no differences between the groups in terms of postoperative IOP and visual outcomes or in astigmatism preoperatively or postoperatively (P = 0.61, P = 0.74). In both groups, the mean preoperative and postoperative astigmatism were ATR and OBL, respectively. Preoperative and postoperative centroids in the P-Ex-PRESS group were 0.44 ± 1.32 D at 177° and 0.35 ± 1 D at 8°, respectively, (P = 0.5) and in the P-Trab group were 0.16 ± 1.5 D at 141° and 0.39 ± 1.38 D at 29°, respectively (P = 0.38). Both P-Ex-PRESS and P-Trab showed comparable antihypertensive efficacy in treating open-angle glaucoma over 6 months. Preoperative and postoperative astigmatism did not differ between groups. The groups showed comparable results for final visual acuity.

scholarly journals Efficacy of two-week quadruple bismuth treatment versus levofloxacin concomitant Helicobacter Pylori infection regimen as empirical first-line therapy Syrian patients. A randomized controlled trial.

2020 ◽  
Author(s):  
Marouf Muhammad Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha
Keyword(s):  
Randomized Controlled Trial ◽  
Helicobacter Pylori ◽  
Controlled Trial ◽  
Helicobacter Pylori Infection ◽  
First Line ◽  
Open Label ◽  
Randomized Controlled ◽  
First Line Therapy ◽  
Line Therapy

Abstract Introduction: Antibiotic-resistant reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, lead to varying treatment protocols according to locations.Aim: Primary outcome was eradication rates of bismuth quadruple (BQ) and levofloxacin concomitant (LC) as empirical first-line treatment by intention to treat (ITT) in a referral hospital in Syria.Design: an open‑label parallel blind randomized controlled trial.Materials and Methods: We randomly assigned seventy-eight naïve who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to receive either BQ (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice daily for two weeks), or LC (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice daily for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test by eight weeks.Results: Thirty-nine patients were allocated in each group. In the BQ group, thirty-eight patients completed the follow-up, thirty patients were cured. While in the LC group, thirty-nine completed the follow-up, thirty-two patients were cured. The ITT eradication rates of the BQ and LC groups were 76.92%, and 82.05%, respectively. Odds ratio with 95% confidence interval according to ITT was 1.371 [0.454-4.146]. We didn’t report serious adverse effects.Conclusions:Both therapy regimens had acceptable rates of eradication. we suggest using both regimens as empirical first-line therapy in the treatment of Helicobacter Pylori infection in the Syrian population.Clinicaltrial.gov, NCT04348786

A multicenter randomized controlled trial to evaluate the efficacy of surgery vs. radiofrequency ablation for small hepatocellular carcinoma (SURF trial).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4002-4002 ◽  
Author(s):  
Namiki Izumi ◽  
Kiyoshi Hasegawa ◽  
Yujiro Nishioka ◽  
Tadatoshi Takayama ◽  
Naoki Yamanaka ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Randomized Controlled Trial ◽  
Radiofrequency Ablation ◽  
Early Stage ◽  
Controlled Trial ◽  
Small Hepatocellular Carcinoma ◽  
Open Label ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

4002 Background: Surgery (SUR) and radiofrequency ablation (RFA) are both known to be effective therapy for treating patients with small oligonodular hepatocellular carcinoma (HCC), however there is only insufficient evidence about which therapy is more preferred approach. This randomized controlled trial was designed to prospectively compare the efficacy of SUR and RFA as the first approach to primary HCC. Methods: In this open-label trial undertaken at 49 hospital in Japan, we recruited patients having primary HCC with tumor foci numbering less than 3, each measuring 3 cm or less, Child-Pugh score of 7 or less, ages between 20 and 79 year. Before randomization, technical and liver functional feasibility for both treatment arms were confirmed by joint chart review by surgeons and hepatologists. Patients were then randomly assigned in a 1:1 ratio to undergo SUR or RFA, stratified by age, infection of hepatitis-C virus, number of tumors, tumor size and institution. The primary endpoint was recurrence free survival (RFS) and overall survival (OS). Results: Between April 2009 and August 2015, total 308 patients were enrolled to this trial. Because of ineligibility 15 patients were excluded, therefore 145 patients underwent SUR and 148 patients underwent RFA finally. There was no perioperative mortality. Under the median follow-up of 5 years, the 3-year RFS of patients underwent SUR and RFA was 49.8%, 47.7%, respectively (hazard ration [HR] 0.96, 95% CI 0.72-1.28; p = 0.793). OS will be analyzed and published after two years. Conclusions: SUR and RFA were both safe therapeutic approaches and provided equally RFS for early stage HCC smaller than 3 cm. Clinical trial information: UMIN000001795.

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