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Multicenter Study Clinical Trial
Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial.
One- and 2-year evaluation of a feasibility trial (clinicaltrials.gov registration numbers NCT01057992, NCT01058070, and 01058564) to assess the safety and efficacy of a laparoscopically implanted sphincter augmentation device for the treatment of gastroesophageal reflux disease (GERD). ⋯ The new laparoscopically implanted sphincter augmentation device eliminates GERD symptoms without creating undue side effects and is effective at 1 and 2 years of follow-up.
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J. Thorac. Cardiovasc. Surg. · Jan 1993
Multicenter Study Clinical TrialSurgical resection of stage IIIA and stage IIIB non-small-cell lung cancer after concurrent induction chemoradiotherapy. A Southwest Oncology Group trial.
Recent studies suggest that preoperative induction chemotherapy +/- radiotherapy can improve the historically poor resectability and survival of patients with stage IIIA non-small-cell lung cancer, but sometimes with significant associated morbidity and mortality. Such treatment has not been studied in stage IIIB non-small-cell lung cancer, usually considered unresectable. This multiinstitutional phase II trial tested the feasibility of concurrent preoperative chemoradiotherapy for stages IIIA and IIIB non-small-cell lung cancer. ⋯ This combined modality therapy has been well tolerated and has been associated with high response and resectability rates in both stage IIIA and stage IIIB non-small-cell lung cancer. Current survival is significantly better than survivorship among historical control patients and provides a firm basis for subsequent phase III clinical trials.
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Randomized Controlled Trial Multicenter Study
Effect of adenosine-regulating agent acadesine on morbidity and mortality associated with coronary artery bypass grafting: the RED-CABG randomized controlled trial.
Ischemia/reperfusion injury remains an important cause of morbidity and mortality after coronary artery bypass graft (CABG) surgery. In a meta-analysis of randomized controlled trials, perioperative and postoperative infusion of acadesine, a first-in-class adenosine-regulating agent, was associated with a reduction in early cardiac death, myocardial infarction, and combined adverse cardiac outcomes in participants undergoing on-pump CABG surgery. ⋯ In this population of intermediate- to high-risk patients undergoing CABG surgery, acadesine did not reduce the composite of all-cause mortality, nonfatal stroke, or SLVD.
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Multicenter Study
Association between human immunodeficiency virus serostatus and the prevalence of atrial fibrillation.
Atrial fibrillation (AF) leads to increased risk for stroke. Human immunodeficiency virus (HIV) is associated with cardiovascular disease (CVD), although it is unclear if HIV is associated with AF. The purpose of this study was to evaluate the association between HIV serostatus and the prevalence of AF in the Multicenter AIDS Cohort Study. ⋯ There were no associations between AF and HIV serostatus after adjusting for demographic factors (odds ratio 0.76; 95% CI 0.37 to -1.58; P = .47) or after further adjustment for CVD risk factors (odds ratio 0.84; 95% CI 0.39 to -1.81; P = .66). We found no association between HIV and AF in this cohort in which viral replication among the HIV+ men is generally suppressed. The overall prevalence of AF was low and was rare in African-American men.
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Randomized Controlled Trial Multicenter Study
An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial.
Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. ⋯ The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life.