Search results for "Randomized controlled"
showing 10 items of 2220 documents
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 …
Are Asthmatics Enrolled in Randomized Trials Representative of Real-Life Outpatients?
2014
<b><i>Background/Objective:</i></b> This study was aimed at exploring to what extent populations enrolled in randomized controlled trials (RCTs) of inhalation combination treatment for mild/moderate asthma in adults are fully representative of ‘real-life' populations. The following is a retrospective analysis of the clinical records of outpatient subjects with an ascertained diagnosis of asthma. <b><i>Methods:</i></b> A retrospective analysis was performed. Stable conditions, such as smoking habit and chronic diseases other than asthma, were identified as exclusion criteria for RCTs. The selected criteria were then applied to asthmatic outpati…
Cytokeratin-18 fragments predict treatment response and overall survival in gastric cancer in a randomized controlled trial
2018
Background:Gastric cancer is common malignancy and exhibits a poor prognosis. At the time of diagnosis, the majority of patients present with metastatic disease which precludes curative treatment. Non-invasive biomarkers which discriminate early from advanced stages or predict the response to treatment are urgently required. This study explored the cytokeratin-18 fragment M30 and full-length cytokeratin-18 M65 in predicting treatment response and survival in a randomized, placebo-controlled trial of advanced gastric cancer.Methods:Patients enrolled in the SUN-CASE study received sunitinib or placebo as an adjunct to standard therapy with leucovorin (Ca-folinate), 5-fluorouracil, and irinote…
Tralokinumab did not demonstrate oral corticosteroid-sparing effects in severe asthma
2018
Long-term oral corticosteroid (OCS) use in patients with severe asthma is associated with significant adverse effects.This 40-week, randomised, double-blind trial evaluated the OCS-sparing potential of tralokinumab in patients with severe, uncontrolled asthma requiring maintenance OCS treatment plus inhaled corticosteroids/long-acting β2-agonists. Overall, 140 patients were randomised to tralokinumab 300 mg or placebo (n=70 in each group) administered subcutaneously every 2 weeks. The primary end-point was percentage change from baseline in average OCS dose at week 40, while maintaining asthma control. Secondary end-points included proportion of patients with a prescribed maintenance OCS do…
Topical azithromycin for the prevention of Lyme borreliosis: a randomised, placebo-controlled, phase 3 efficacy trial
2017
Summary Background Lyme borreliosis develops in 1–5% of individuals bitten by ticks, but with a diagnostic gap affecting up to 30% of patients, a broadly applicable pharmacological prevention strategy is needed. Topical azithromycin effectively eradicated Borrelia burgdorferi sensu lato from the skin in preclinical studies. We assessed its efficacy in human beings. Methods In this randomised, double-blind, placebo-controlled, multicentre trial done in 28 study sites in Germany and Austria, adults were equally assigned to receive topical 10% azithromycin or placebo twice daily for 3 consecutive days, within 72 h of a tick bite being confirmed. Randomisation numbers, which were stratified by …
Dietary inflammatory index and all-cause mortality in large cohorts: The SUN and PREDIMED studies
2019
[Background]: Inflammation is known to be related to the leading causes of death including cardiovascular disease, several types of cancer, obesity, type 2 diabetes, depression-suicide and other chronic diseases. In the context of whole dietary patterns, the Dietary Inflammatory Index (DII®) was developed to appraise the inflammatory potential of the diet. [Objective]: We prospectively assessed the association between DII scores and all-cause mortality in two large Spanish cohorts and valuated the consistency of findings across these two cohorts and results published based on other cohorts.
Aluminum Chloride versus Electrocauterization in Periapical Surgery: A Randomized Controlled Trial
2019
The aim of this study was to evaluate the efficacy of 2 hemostatic agents in periapical surgery and its relationship with patient- and tooth-dependent variables.A prospective study was designed with 2 randomized parallel groups established according to the hemostatic agent used: aluminum chloride or electrocauterization. The surgeon and 2 independent blinded observers examined the initial and final bleeding and recorded it as 0 (no hemorrhage control), 1 (slight but apparent intermittent bleeding), or 2 (complete hemorrhage control). The following patient- and tooth-dependent variables were collected: sex, age, smoking habit, plaque index, and position.Sixty patients with a periapical lesio…
Is telephone follow-up really effective in early diagnosis of inflammatory complications after tooth extraction?
2018
Background To establish whether telephone follow-up is really able to intercept post-extraction complications and to evaluate the degree of patient satisfaction with this kind of post-surgical monitoring. Material and Methods Six hundred and thirty-eight patients were enrolled and randomly assigned to a test or control group. Test group patients were monitored by telephone follow-up 24 and 72 hours after surgery to investigate the presence of local symptoms that are frequently associated with surgical wound infection and inflammation. Both test and control group patients were examined 7 days at suture removal. Patients with systemic diseases, those in which intra-operative accidents occurre…