Search results for "double-blind"
showing 10 items of 662 documents
Long-Term Effects of Dietary Sodium Intake on Cytokines and Neurohormonal Activation in Patients With Recently Compensated Congestive Heart Failure
2009
Abstract Background A growing body of evidence suggests that the fluid accumulation plays a key role in the pathophysiology of heart failure (HF) and that the inflammatory and neurohormonal activation contribute strongly to the progression of this disorder. Methods and Results The study evaluated the long-term effects of 2 different sodium diets on cytokines neurohormones, body hydration and clinical outcome in compensated HF outpatients (New York Heart Association Class II). A total of 173 patients (105 males, mean age 72.5±7) recently hospitalized for worsening advanced HF and discharged in normal hydration and in clinical compensation were randomized in 2 groups (double blind). In Group …
Glycemic Durability of Rosiglitazone, Metformin, or Glyburide Monotherapy
2006
BACKGROUND: The efficacy of thiazolidinediones, as compared with other oral glucose-lowering medications, in maintaining long-term glycemic control in type 2 diabetes is not known. METHODS: We evaluated rosiglitazone, metformin, and glyburide as initial treatment for recently diagnosed type 2 diabetes in a double-blind, randomized, controlled clinical trial involving 4360 patients. The patients were treated for a median of 4.0 years. The primary outcome was the time to monotherapy failure, which was defined as a confirmed level of fasting plasma glucose of more than 180 mg per deciliter (10.0 mmol per liter), for rosiglitazone, as compared with metformin or glyburide. Prespecified secondary…
Efficacy of mandibular advancement device in the treatment of obstructive sleep apnea syndrome: A randomized controlled crossover clinical trial
2015
Background Evaluation of the efficacy and safety of a mandibular advancement device (MAD) (KlearwayTM) in the treatment of mild-to-moderate obstructive sleep apnea and chronic roncopathy. Material and Methods A randomized, placebo-controlled, double blinded, and crossover clinical trial was conducted. Placebo device (PD) defined as a splint in the centric occlusion that did not induce a mandibular advancement served as a control. The mandible was advanced to the maximum tolerable distance or to a minimum of 65% of the maximum protrusion. After each sequence of treatment, patients were assessed by questionnaires, conventional polysomnography, and objective measurement of snoring at the patie…
Microvascular effects of the inhibition of dipeptidylpeptidase IV by linagliptin in nondiabetic hypertensive patients
2015
Recent studies suggest vascular benefits of dipeptidylpeptidase IV (DPP-IV) inhibition in patients with diabetes mellitus. Only little is known about potential vascular effects of DPP-IV inhibitors in nondiabetic individuals. The aim of this study was to investigate the effect of DPP-IV inhibition in a nondiabetic hypertensive population.This was a double-blinded, randomized, placebo-controlled, mechanistic study, comparing microvascular effects of the DPP-IV inhibitor linagliptin with placebo in nondiabetic individuals with a history of arterial hypertension. Twenty-one patients received 5 mg linagliptin (5 women; age 67.6 ± 6.0 years; mean ± SD), whereas 22 patients were randomized to pla…
Intraoperative tramadol reduces shivering but not pain after remifentanil–isoflurane general anaesthesia. A placebo-controlled, double-blind trial
2008
Background and objective Postoperative shivering and pain are frequent problems in patients recovering from anaesthesia with particularly high incidences being observed after remifentanil–isoflurane-based general anaesthesia. The opioid tramadol is generally effective in preventing shivering and treating pain, but its effects are not characterized after remifentanil-based general anaesthesia. This randomized, placebo-controlled, double-blind study evaluated the effects of intraoperative intravenous tramadol on postoperative shivering and pain after remifentanil-based general anaesthesia. Methods After Ethics Committee approval, 60 patients scheduled for lumbar disc surgery were included. Su…
Insights from Experiences on Antiplatelet Drugs in Stroke Prevention: A Review
2020
Reduction of hazard risk of cerebral ischemic event (stroke, transient ischemic attack (TIA)) represents the hard point to be achieved from primary or secondary preventive strategy in the best clinical practice. However, results from clinical trials, recommendations, guidelines, systematic review, expert opinions, and meta-analysis debated on the optimal pharmacotherapy to achieve the objective. Aspirin and a number of antiplatelet agents, alone or in combination, have been considered from large trials focused on stroke prevention. The present review summarizes, discusses results from trials, and focuses on the benefits or disadvantages originating from antiplatelet drugs. Sections of the r…
Fine Structural Evaluation of the Iris After Unilateral Treatment With Latanoprost in Patients Undergoing Bilateral Trabeculectomy (The Mainz II Stud…
2003
Objective To investigate by masked electron microscopy whether 6 months of topical latanoprost caused pathological changes in the peripheral iris of patients with glaucoma. Methods Seventeen patients with bilateral primary open-angle glaucoma requiring trabeculectomy were recruited for this study. The iridectomy taken during surgery on the first eye served as a control. The second test eye was treated topically with latanoprost for 6 months before its trabeculectomy. Fourteen patients completed the treatment arm of the study, and 1 of these underwent marked color change. As a result, 31 iridectomy specimens were fixed, coded, and evaluated. Results The specimens were evaluated for evidence …
Predictive value of heidelberg retina tomograph parameters for the development of glaucoma in the European glaucoma prevention study
2015
Purpose To determine whether baseline Heidelberg Retina Tomograph (HRT) measurements of the optic disc are associated with the development of open-angle glaucoma (OAG) in individuals with ocular hypertension in the European Glaucoma Prevention Study (EGPS). Design Retrospective analysis of a prospective, randomized, multicenter, double-masked, controlled clinical trial. Methods There were 489 participants in the HRT Ancillary Study to the EGPS. Each baseline HRT parameter was assessed in univariate and multivariate proportional hazards models to determine its association with the development of OAG. Proportional hazards models were used to identify HRT variables that predicted which partici…
Postoperative analgesic efficacy of peripheral levobupivacaine and ropivacaine: a prospective, randomized double-blind trial in patients after total …
2008
BACKGROUND: Several previous trials have characterized the intra- and postoperative effects of the recently introduced local anesthetics, levobupivacaine and ropivacaine, for a variety of continuous peripheral nerve blocks. METHODS: We compared the analgesic efficacy of levobupivacaine 0.125% versus ropivacaine 0.2% via patient-controlled femoral nerve analgesia after total knee arthroplasty. In a double-blind, randomized, prospective design, 60 patients received femoral infusion with either substance. We analyzed postoperative local anesthetic consumption, pain scores, motor block, and opioid requirements over 72 h. RESULTS: Pain scores, motor block incidence, and opioid requirements were …
Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II)
2010
SummaryThis trial compared the efficacy and safety of oral dabigatran, a direct thrombin inhibitor, versus subcutaneous enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty. A total of 2,055 patients were randomised to 28–35 days treatment with oral dabigatran, 220 mg once-daily, starting with a half-dose 1–4 hours after surgery, or subcutaneous enoxaparin 40 mg once-daily, starting the evening before surgery. The primary efficacy outcome was a composite of total venous thromboembolism [VTE] (venographic or symptomatic) and death from all-causes. The main secondary composite outcome was major VTE (proximal deep-vein thrombosis or non-fatal pulmonary embol…