Search results for "Randomized"

New-generation drug-eluting stents for left main coronary artery disease according to the EXCEL trial enrollment criteria: Insights from the all-come…

2019

Percutaneous coronary intervention (PCI) has been established as an alternative treatment option to coronary artery by-pass graft (CABG) surgery in patients with left main coronary artery disease (LMCAD). Whether the findings of randomized controlled trials are applicable to a real-world patient population is unclear.We compared the outcomes of PCI with new-generation DES in the all-comer, international, multicenter DELTA-2 registry retrospectively evaluating mid-term clinical outcomes with the historical CABG cohort enrolled in the DELTA-1 registry according to the EXCEL key inclusion or exclusion criteria. The primary endpoint was the composite of death, myocardial infarction, or stroke a…

Deep sclerectomy versus punch trabeculectomy with or without phacoemulsification: a randomized clinical trial.

2004

Purpose: To compare the efficacy of non-penetrating deep sclerectomy without implant with Crozafon-De Laage punch trabeculectomy, and to evaluate the effect of simultaneous temporal approach phacoemulsification on both techniques. Patients and Methods: Setting: Department of Ophthalmology of the University of Palermo. Design: Prospective randomized clinical trial. Patients and intervention procedures: Sixty-five patients (65 eyes) with primary open angle glaucoma (POAG) or pseudoexfoliative glaucoma (PEXG): 32 eyes underwent non-penetrating deep sclerectomy (NPDS), 17 as single procedure and 15 combined with phacoemulsification (phaco- NPDS), and 33 eyes underwent punch trabeculectomy (PT),…

Inverse association between habitual polyphenol intake and incidence of cardiovascular events in the PREDIMED study

2014

Background and aims: Epidemiologic and biological evidence supports an inverse association between polyphenol consumption and the risk of cardiovascular disease (CVD). However, no previous studies have prospectively evaluated the relationship between polyphenol intake and the incidence of CVD in such a comprehensive way. The aim was to evaluate the association between intakes of total polyphenol and polyphenol subgroups, and the risk of major cardiovascular events (myocardial infarction, stroke or death from cardiovascular causes) in the PREDIMED study. Methods and results: The present work is an observational study within the PREDIMED trial. Over an average of 4.3 years of follow-up, there…

A randomized, intraindividual, non-inferiority, Phase III study comparing daylight photodynamic therapy with BF-200 ALA gel and MAL cream for the tre…

2018

Abstract Background The most effective treatment modality for actinic keratosis (AK) is photodynamic therapy (PDT). Major obstacles of PDT are the need of a special illumination device and pain accompanying the illumination. These issues may be overcome by replacing an artificial high‐power light source with natural daylight for more extended illumination at lower light doses. Objective To determine whether BF‐200 ALA (a nanoemulsion gel containing 7.8% 5‐aminolaevulinic acid) is non‐inferior to MAL (a cream containing 16% methyl‐aminolaevulinate) in the treatment of mild‐to‐moderate AK with daylight PDT (dPDT). Non‐inferiority of the primary efficacy variable (total lesion clearance rate p…

The effects of preoperative balance training on balance and functional outcome after total knee replacement: a randomized controlled trial.

2019

Objective: To assess the effects of preoperative balance training on the early postoperative balance and functional outcomes after total knee replacement surgery and to test whether an outpatient intervention may be as effective as a domiciliary intervention. Design: This is a three-arm randomized controlled trial. Setting: University hospital. Subjects: Eighty-six individuals were recruited. Seventy-seven were analysed, aged 72.1 (SD 7.6) years, of which 68% were women. Outcome measures: Overall state of balance, as measured with the Berg Balance Scale, and patient-perceived functionality, as measured with the Knee Injury and Osteoarthritis Outcome Score Function in Activities in Daily Liv…

Influence of the Geriatric Oncology Consultation On the Final Therapeutic Decision In Elderly Subjects With Cancer: Analysis of 191 Patients

2014

International audience; Objectives: evaluate the impact of the Geriatric Oncology consultation on the final therapeutic management of cancer in elderly patients aged 70 and older. Design: retrospective study. Setting: the Pilot coordination unit in Geriatric Oncology of Cote d'Or, Burgundy, France. Participants: From January 2010 to December 2010, 191 patients with cancer aged 70 and older. Measurements: the concordance between the treatments proposed following the tumor Board, those proposed following the Geriatric evaluation (GE) and those actually given to the patients was evaluated using the kappa agreement test. Results: One hundred and ninety-one patients were included. Mean age was 8…

Clinical Relevance of a Balance Training Program on Liver Transplant Patients. A Randomized Controlled Trial

2019

Background. Although some studies have reported significant improvements in physical function and strength after training programs on liver transplant (LT) recipients, there is a lack of knowledge on how it affects in static and dynamic balance, being an important part of these participants' tasks development. The aim of the study was to determine the effects of a 6-month multicomponent circuit training program on static and dynamic balance in LT participants. Methods. Fifty-four participants were randomized at 6 months after LT into 2 groups: exercise (EXER) group and control (CONTROL) group, with repeat testing at 6 (baseline) and 12 months after LT. The intervention consisted of a multic…

Barriers to and facilitators of participation of older adults in a placebo-controlled randomized clinical trial

2013

Domperidone plus Magnesium Hydroxide and Aluminum Hydroxide: A Valid Therapy in Children with Gastroesophageal Reflux: A Double-Blind Randomized Stud…

1994

To evaluate the efficacy of different drug combinations in treating severe gastroesophageal reflux (GER), we studied 80 children with GER. The patients were randomly divided into four groups: group A was treated with domperidone plus magnesium hydroxide and aluminum hydroxide, group B with domperidone plus alginate, group C with domperidone alone, and group D received placebo. At the time of diagnosis and 8 weeks after treatment the patients were clinically evaluated and underwent 24-h continuous esophageal pH monitoring. After treatment a complete regression of symptoms was observed in 16 of 20 patients in group A, in 8 of 20 in group B (A versus B, p < 0.018), in 9 of 20 in group C (A ver…

Effect of a 2-year diet intervention with walnuts on cognitive decline. The Walnuts And Healthy Aging (WAHA) study: a randomized controlled trial

2019

Background Walnut consumption counteracts oxidative stress and inflammation, 2 drivers of cognitive decline. Clinical data concerning effects on cognition are lacking. Objectives The Walnuts And Healthy Aging study is a 2-center (Barcelona, Spain; Loma Linda, CA) randomized controlled trial examining the cognitive effects of a 2-y walnut intervention in cognitively healthy elders. Methods We randomly allocated 708 free-living elders (63-79 y, 68% women) to a diet enriched with walnuts at ∼15% energy (30-60 g/d) or a control diet (abstention from walnuts). We administered a comprehensive neurocognitive test battery at baseline and 2 y. Change in the global cognition composite was the primary…