Search results for "Randomized Controlled Trial"
showing 10 items of 2199 documents
The effect of antenatal intravenous immunoglobulin on ascending intrauterine infection after preterm premature rupture of the membranes: a pilot study
1992
Ascending infection is a serious threat in pregnancies complicated by preterm premature rupture of the membranes (PROM). In a controlled randomized prospective pilot study (n = 18) we have evaluated the effect of intravenous IgM enriched immunoglobulin given to the mothers 24-48 hours after preterm PROM in reducing ascending infection. Using a validated infection score from laboratory and clinical data at birth, we found a significant reduction of probable infection in the neonates of the treatment group compared to the control group (p = 0.0022). Histopathological investigation of the placentas, membranes and umbilical cords revealed significantly lower stages and grades of chorioamnioniti…
Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for Breast MR ima…
2011
To intraindividually compare 0.1 mmol/kg doses of gadobenate dimeglumine and gadopentetate dimeglumine for contrast material-enhanced breast magnetic resonance (MR) imaging by using a prospective, multicenter double-blind, randomized protocol.Institutional review board approval and patient informed consent were obtained. One hundred sixty-two women (mean age, 52.8 years ± 12.3 [standard deviation]) enrolled at 17 sites in Europe and China between July 2007 and May 2009 underwent at least one breast MR imaging examination at 1.5 T by using three-dimensional spoiled gradient-echo sequences. Of these, 151 women received both contrast agents in randomized order in otherwise identical examinatio…
Assessment of tumor microcirculation with dynamic contrast-enhanced MRI in patients with esophageal cancer: initial experience.
2008
PURPOSE: To investigate the feasibility and impact of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) on tumor characterization and response to radiochemotherapy (RCT) in patients with esophageal cancer. MATERIALS AND METHODS: A total of 48 patients underwent DCE-MRI to assess tumor microcirculation based on a two-compartment model function. Effects of RCT on kinetic parameters were studied in 12 patients with squamous cell carcinoma. RESULTS: Tumor microcirculation differs with respect to histological subtype: squamous cell carcinomas showed lower values of amplitude A (leakage space, P = 0.015) and higher contrast agent exchange rates (k(21), P = 0.225) compared with adenoc…
Tacrolimus Monotherapy Without Steroids After Liver Transplantation – A Prospective Randomized Double-Blinded Placebo-Controlled Trial
2007
Early steroid withdrawal after liver transplantation (LT) is desirable in order to reduce steroid side effects. Between February 2000 and August 2004, 110 patients after LT were included in this prospective, randomized, double-blind, placebo-controlled trial. Randomization was performed before LT. In all patients, tacrolimus was used without induction therapy. All patients received methylprednisolon for 14 days, thereafter a double-blinded medication containing either placebo (n = 56) or methylprednisolon (n = 54) for 6 months, which was completely stopped thereafter. End points were patient and graft survival, acute and chronic rejection, and incidence of steroid side effects during the fi…
Morphine versus methadone in the pain treatment of advanced-cancer patients followed up at home
1998
PURPOSE The aim of this study was to evaluate the analgesic and adverse effects and the doses of methadone in comparison to morphine. PATIENTS AND METHODS A prospective randomized study was performed in a sample of 40 patients with advanced cancer who required strong opioids for their pain management. Patients were treated with sustained-release morphine or methadone in doses titrated against the effect administered two or three times daily according to clinical need. Opioid doses, adjuvant medications, symptoms associated with opioid therapy, pain intensity, and pain mechanisms were recorded. The opioid escalation indices in percentage (OEI%) and milligrams (OEImg) were calculated. The eff…
Enhanced rehabilitation guidance after arthroscopic capsulolabral repair of the shoulder : a randomized controlled trial
2020
Objective: To compare the effects of a 12-month home-based exercise program to usual care in patients after arthroscopic capsulolabral repair of the shoulder. Design: Randomized controlled trial. Setting: Outpatient physical and rehabilitation medicine clinic. Subjects: Forty-five patients (mean age: 35 years; standard deviation (SD): 10 years) who underwent arthroscopic capsulolabral repair due to labral lesion were randomized into an exercise group (EG) or a control group (CG). Intervention: The EG received a 12-month home-based additional exercise program with four physiotherapy follow-up visits, while the CG received standard postoperative exercise instructions. Main measures: Self-repo…
Effect of probiotics on vaginal health in pregnancy. EFFPRO, a randomized controlled trial
2016
Background Preterm delivery is a leading cause of neonatal morbidity and death. It often results from chorioamnionitis, which is a complication of bacterial vaginosis. Probiotics are effective in the treatment of bacterial vaginosis in women who were not pregnant; studies in pregnant woman are missing. Objective The purpose of this study was to evaluate whether an oral probiotic food supplement supports the maintenance or restoration of a normal vaginal microbiota during pregnancy. Study Design We conducted a randomized, placebo-controlled, triple-blind, parallel group trial. Oral Lactobacillus rhamnosus GR-1and L reuteri RC-14 (10 9 colony-forming units) or placebo were administered for 8 …
Deferiprone versus deferoxamine in patients with thalassemia major: a randomized clinical trial.
2002
Deferiprone has been suggested as an effective oral chelation therapy for thalassemia major. To assess its clinical efficacy, we compared deferiprone with deferoxamine in a large multicenter randomized clinical trial. One-hundred forty-four consecutive patients with thalassemia major and serum ferritin between 1500 and 3000 ng/ml were randomly assigned to deferiprone (75 mg/kg/day) (n = 71) or deferoxamine (50 mg/kg/day) (n = 73) for 1 year. The main measure of efficacy was the reduction of serum ferritin. Liver and heart iron contents were assessed by magnetic resonance. Liver iron content and fibrosis stage variations were assessed on liver biopsy by the Ishak score in all patients willin…
Intraoperative positive end-expiratory pressure and postoperative pulmonary complications: a patient-level meta-analysis of three randomised clinical…
2022
BACKGROUND: High intraoperative PEEP with recruitment manoeuvres may improve perioperative outcomes. We re-examined this question by conducting a patient-level meta-analysis of three clinical trials in adult patients at increased risk for postoperative pulmonary complications who underwent non-cardiothoracic and non-neurological surgery. METHODS: The three trials enrolled patients at 128 hospitals in 24 countries from February 2011 to February 2018. All patients received volume-controlled ventilation with low tidal volume. Analyses were performed using one-stage, two-level, mixed modelling (site as a random effect; trial as a fixed effect). The primary outcome was a composite of postoperati…
What proportion of chronic obstructive pulmonary disease outpatients is eligible for inclusion in randomized clinical trials?
2013
<b><i>Background and Objective:</i></b> We aimed to explore to what extent an unselected population of chronic obstructive pulmonary disease (COPD) outpatients would be eligible for inclusion in randomized clinical trials (RCTs). <b><i>Methods:</i></b> Retrospective analysis of the clinical records of outpatient subjects with an ascertained diagnosis of COPD. COPD outpatients were assessed against the following inclusion criteria: 40 < age < 80 years, current or former smokers, forced expiratory volume in the first second (FEV<sub>1</sub>) <70% predicted, no long-term oxygen therapy, no other concomitant lung diseases and …