Search results for "Randomized"
showing 10 items of 2323 documents
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…
The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population.
2019
International audience; Background: The COMPASS trial assessed the impact of adding low dose rivaroxaban to aspirin in selected patients (pts). After an acute myocardial infarction (MI), when dual antiplatelet treatment is no longer needed, patients might be eligible for aspirin/rivaroxaban co-therapy. The characteristics and risks of such a population are unclear.Methods: Data were extracted from the FAST-MI 2005, 2010 and 2015 nationwide French registries. Characteristics and long-term mortality were compared according to COMPASS eligibility and between registry and trial populations.Results: Among 9954 patients alive and free of events at one year, 4402 (44%) were classified as COMPASS-L…
Exercise for depression in older adults: a meta-analysis of randomized controlled trials adjusting for publication bias
2016
OBJECTIVE: To evaluate the antidepressant effects of exercise in older adults, using randomized controlled trial (RCT) data. METHODS: We conducted a meta-analysis of exercise in older adults, addressing limitations of previous works. RCTs of exercise interventions in older people with depression (≥ 60 years) comparing exercise vs. control were eligible. A random-effects meta-analysis calculating the standardized mean difference (SMD) (95% confidence interval [95%CI]), meta-regressions, and trim, fill, and fail-safe number analyses were conducted. RESULTS: Eight RCTs were included, representing 138 participants in exercise arms and 129 controls. Exercise had a large and significant effect on…
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…
Clinical trials with a new atypical antipsychotic (Aripiprazole): gender specific information analysis.
2008
In 1993, the Food and Drug Administration (FDA) published a guideline for the study and evaluation of gender-related differences in clinical trials. However, the extent of the implementation of these recommendations has not been systematically reviewed.To determine the proportion of women in clinical trials of Aripiprazole, a new atypical antipsychotic, and to analyze the resulting information on a gender-specific basis.A systematic review was conducted in Medline to identify randomized trials that compared this new antipsychotic drug with placebo or with typical or atypical antipsychotics in patients diagnosed with schizophrenia. The FDA Guideline was followed for the study and evaluation …
Radical cystectomy or bladder preservation with radiochemotherapy in elderly patients with muscle-invasive bladder cancer: Retrospective Internationa…
2017
IF 3.156; International audience; Background: Radical cystectomy (RC) and radiochemotherapy (RCT) are curative options for muscle-invasive bladder cancer (MIBC). Optimal treatment strategy remains unclear in elderly patients.Material and methods: Patients aged 80 years old and above with T2-T4aN0-2M0-Mx MIBC were identified in the Retrospective International Study of Cancers of the Urothelial Tract (RISC) database. Patients treated with RC were compared with those treated with RCT. The impact of surgery on overall survival (OS) was assessed using a Cox proportional hazard model. Progression included locoregional and metastatic relapse and was considered a time-dependent variable.Results: Be…
Ten-year outcome after coronary angioplasty in patients with single-vessel coronary artery disease and comparison with the results of the Coronary Ar…
2000
The 10-year results of randomized trials comparing percutaneous transluminal coronary angioplasty (PTCA) in patients with single-vessel coronary artery disease (CAD) with coronary artery bypass grafting (CABG) and medical treatment are not available yet. The aim of this evaluation was to compare our 10-year follow-up results after PTCA in patients with single-vessel CAD with the 10-year follow-up results after CABG and medical treatment in the Coronary Artery Surgery Study (CASS) trial. We evaluated the clinical outcome of 509 patients with single-vessel CAD 10 years after coronary angioplasty. The data were compared with the results of 214 patients with single-vessel CAD after CABG or medi…
Impact of regional femoral nerve block during general anesthesia for hip arthoplasty on blood pressure, heart rate and pain control: A randomized con…
2015
Background Adequate pain management is essential for preventing hemodynamic instability which can affect the perfusion of vital organs during the perioperative period, particularly in geriatric patients. For hip arthroplasty, peripheral nerve block is frequently used, limiting the adverse effects of opioid and non-opioid analgesics. Objective The aim was to survey the impact of a supplementary single shot femoral nerve block (FNB) on hemodynamic stability and pain level. Methods After registration at German Clinical Trial Register (DRKS-ID): DRKS00000752. and Ethics Committee approval (University Hospital of Marburg), 80 patients who underwent elective hip surgery were included. Half of the…
5-Year Outcome of Pulmonary Vein Isolation by Loss of Pace Capture on the Ablation Line Versus Electrical Circumferential Pulmonary Vein Isolation
2017
This study sought to compare long-term arrhythmia-free survival between electrical circumferential pulmonary vein isolation (PVI) and PVI with the endpoint of unexcitability along the ablation line.PVI is the standard ablation strategy of paroxysmal atrial fibrillation, although arrhythmia recurrence in long-term follow-up (FU) is high. The endpoint of unexcitability along the ablation line results in decreased arrhythmia recurrence compared to electrical PVI in 1-year FU.Seventy-four consecutive patients (age 62.5 ± 10.6 years; 70.3% male) with de novo paroxysmal atrial fibrillation who were initially included in our randomized trial and underwent catheter ablation at our institution were …
Three-Year Results of Repaired Barlow Mitral Valves via Right Minithoracotomy versus Median Sternotomy in a Randomized Trial
2012
<b><i>Objectives:</i></b> To clarify whether the results of repair of a complex mitral lesion (Barlow valve) at the intermediate-term follow-up are independent of the mode of surgical access [minithoracotomy vs. median sternotomy (MS)]. <b><i>Methods:</i></b> In a prospective randomized study of mitral repair for Barlow disease using either a minimally invasive (MI) approach or MS, we achieved an average follow-up of 3 years (echocardiography, physical examination and quality of life). Mitral repair was achieved with polytetrafluoroethylene chordal implantation for both leaflets. <b><i>Results:</i></b> Both groups inclu…