Search results for "Double-Blind"
showing 10 items of 662 documents
Single shot spinal anaesthesia with hypobaric bupivacaine for hip fracture repair surgery in the elderly. Randomized, double blinded comparison of 3.…
2014
Arterial hypotension is the most frequent adverse effect of subarachnoid anaesthesia in the elderly sustaining a femoral proximal fracture. Decreasing the local anaesthetic dose reduces the incidence of hypotension but shortens sensory block duration that could be insufficient in some surgical procedures. Sensory block duration could be prolonged using hypobaric local anaesthetics. We evaluated whether low hypobaric bupivacaine doses were adequate for this type of surgery while maintaining the haemodynamic stability.A prospective, randomized, double blinded study was designed. Patients over 65 years old, sustaining traumatic hip fracture, were assigned to one of two groups: B0.5 group, hypo…
Single shot spinal anesthesia with very low hyperbaric bupivacaine dose (3.75mg) for hip fracture repair surgery in the elderly. A randomized, double…
2014
Single shot spinal anesthesia is used worldwide for hip fracture repair surgery in the elderly. Arterial hypotension is a frequent adverse effect. We hypothesized that lowering local anesthetics dose could decrease the incidence of arterial hypotension, while maintaining quality of surgical anesthesia.In a randomized double blinded study, 66 patients over the age of 65 years, with hip fracture needing surgical repair, were assigned to B0.5 group 7.5mg hyperbaric bupivacaine 5mg/ml (control group), and B0.25 group 3.75mg hyperbaric bupivacaine 2.5mg/ml (study group). Sensory and motor block level, and hemodynamic parameters including blood presure, heart rate and vasopressor dose administrat…
Re-treatment of Patients With Chronic Hepatitis C Who Do Not Respond to Peginterferon-[alpha]2b: A Randomized Trial
2009
BACKGROUND Many patients with chronic hepatitis C have not responded to therapy with pegylated interferon plus ribavirin. OBJECTIVE To evaluate use of peginterferon-alpha2a plus ribavirin to re-treat nonresponders to peginterferon-alpha2b plus ribavirin. DESIGN Randomized, parallel-group trial conducted between September 2003 and February 2007. Patients and researchers were not blinded to intervention assignment. Random assignment was centralized, computer-generated, and stratified by geographic region, hepatitis C virus (HCV) genotype, and histologic diagnosis. SETTING 106 international centers. PATIENTS 950 nonresponders to 12 or more weeks of therapy with peginterferon-alpha2b plus ribav…
Influenza Vaccination After Myocardial Infarction:A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
2021
Background: Observational and small, randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. Methods: We conducted an investigator-initiated, randomized, double-blind trial to compare inactivated influenza vaccine with saline placebo administered shortly after myocardial infarction (MI; 99.7% of patients) or high-risk stable coronary heart disease (0.3%). The primary end point was the composite of all-cause death, MI, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary end points: all-cause death, cardiovascular death, MI, and stent thrombosis. Results: Because of the COV…
Effects of a phytosterol-enriched dairy product on lipids, sterols and 8-isoprostane in hypercholesterolemic patients: a multicenter Italian study.
2009
Abstract Background and aims Plant sterols, added to several food sources, lower serum cholesterol concentrations. Plant sterol-induced cholesterol lowering is paralleled by a mild decrease in plasma levels of the antioxidant β-carotene, the amount of this decrease being considered clinically non-significant. Whether the effect on lipid profile of daily consumption of plant sterol-enriched low-fat fermented milk (FM) is paralleled by a concomitant variation in a reliable marker of the oxidative burden like plasma isoprostane levels is unresolved. Methods and results The effect of plant sterol consumption on plasma lipid and isoprostane levels of hypercholesterolemic patients was evaluated i…
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…
Functional principal component analysis as a new methodology for the analysis of the impact of two rehabilitation protocols in functional recovery af…
2014
[EN] Background: This study addressed the problem of evaluating the effectiveness of two protocols of physiotherapy for functional recovery after stroke. In particular, the study explored the use of Functional Principal Component Analysis (FPCA), a multivariate data analysis in order to assess and clarify the process of regaining independence after stroke. Methods: A randomized double-blind controlled trial was performed. Thirteen subjects with residual hemiparesis after a single stroke episode were measured in both in- and outpatient settings at a district hospital. All subjects were able to walk before suffering the stroke and were hemodynamically stable within the first week after stroke…
Training Effects of Alternated and Pulsed Currents on the Quadriceps Muscles of Athletes
2018
AbstractThe aim of the study was to evaluate the effects of 6 weeks training with different neuromuscular electrical stimulation (NMES) currents (medium alternated and low-frequency pulsed current) on muscle architecture and neuromuscular performance of competitive athletes. A double-blind controlled and randomized experimental study was carried out with 33 athletes (22.2±2.6 yrs, 74.7±9.8 kg, 176.8±6.0 cm), divided into 3 groups: mid-frequency current (MF, n=12), pulsed current (PC, n=11) and the control group (CG, n=10). Quadriceps maximal voluntary peak torque (PT) and corresponding vastus lateralis electromyographic activity, evoked torque (PT-NMES), vastus lateralis muscle thickness, f…
Brinzolamide/brimonidine fixed-dose combination bid as an adjunct to a prostaglandin analog for open-angle glaucoma/ocular hypertension.
2019
Purpose: To evaluate the additive intraocular pressure–lowering effect of twice-daily brinzolamide 1%/brimonidine 0.2% fixed-dose combination (BBFC) as an adjunct to a prostaglandin analog (PGA) in patients with open-angle glaucoma or ocular hypertension insufficiently controlled with PGA monotherapy. Methods: In this Phase 4, double-masked trial, patients aged ⩾18 years, with a mean intraocular pressure of ⩾19 and <32 mm Hg in at least one eye were randomized (1:1) to receive BBFC + PGA ( n = 96) or vehicle + PGA ( n = 92) for 6 weeks. The primary endpoint was the mean change in diurnal intraocular pressure from baseline (averaged over 09:00 and 11:00 h) at Week 6. Results: The mean diu…
Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study.
2021
Background In prior unblinded studies, cardiac neuromodulation therapy (CNT) employing a sequence of variably timed short and longer atrioventricular intervals yielded sustained reductions of systolic blood pressure (SBP) in patients with hypertension. The effects of CNT on SBP were investigated in this double‐blind randomized pilot study. Methods and Results Eligible patients had daytime ambulatory SBP (aSBP) ≥130 mm Hg and office SBP ≥140 mm Hg despite taking ≥1 antihypertensive medication, and an indication for a dual‐chamber pacemaker. Patients underwent Moderato device implantation, which was programmed as a standard pacemaker during a 1‐month run‐in phase. Patients whose daytime aSBP…