Search results for "Randomized Controlled Trial"
showing 10 items of 2199 documents
Enhancing the efficacy of treatment for temporomandibular patients with muscular diagnosis through cognitive-behavioral intervention, including hypno…
2011
Objective This study evaluated the efficacy of a cognitive-behavioral therapy (CBT), including hypnosis, in patients with temporomandibular disorders (TMDs) with muscular diagnosis. Study Design Seventy-two patients (65 women and 7 men with an average age of 39 years) were selected according to the Research Diagnostic Criteria for TMD, and assigned to the experimental group (n = 41), receiving the 6-session CBT program, and the control group (n = 31). All patients received conservative standard treatment for TMD. The assessment included pain variables and psychologic distress. Results There were significant differences between the groups, the experimental group showing a higher improvement …
Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis:A Randomized, Placebo-Controlled, Phase II Study
2017
Objective To determine the effect of selexipag, an oral, selective IP prostacyclin receptor agonist, on the frequency of attacks of Raynaud's phenomenon (RP) in patients with systemic sclerosis (SSc). Methods Patients with SSc-related RP were randomized 1:1 to placebo (n = 38) or selexipag (n = 36) in individualized doses (maximum of 1,600 μg twice daily) during a 3-week titration period. The primary end point was the weekly average number of RP attacks during the study maintenance period, analyzed using a Bayesian approach with a negative binomial model adjusted for baseline number of RP attacks. Other outcome measures included Raynaud's Condition Score (RCS), RP attack duration, and treat…
Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: a multicenter, randomized trial.
2011
Objective To evaluate the efficacy and safety of an intraoral electrostimulation device, consisting of stimulating electrodes, an electronic circuit, and a power source, in treating xerostomia. The device delivers electrostimulation through the oral mucosa to the lingual nerve in order to enhance the salivary reflex. Methods The device was tested on a sample of patients with xerostomia due to Sjogren's syndrome and other sicca conditions in a 2-stage prospective, randomized, multicenter trial. Stage I was a double-blind, crossover stage designed to compare the effects of the electrically active device with the sham device, each used for 1 month, and stage II was a 3-month open-label stage d…
Kinetics of plasma biomarkers of inflammation and lung injury in surgical patients with or without postoperative pulmonary complications
2017
Background Postoperative pulmonary complications (PPCs) are common after major abdominal surgery. The kinetics of plasma biomarkers could improve identification of patients developing PPCs, but the kinetics may depend on intraoperative ventilator settings. Objective To test whether the kinetics of plasma biomarkers are capable of identifying patients who will develop PPCs, and whether the kinetics depend on the intraoperative level of positive end-expiratory pressure (PEEP). Design A preplanned substudy of a randomised controlled trial. Setting Operation room of five centres. Patients Two hundred and forty-two adult patients scheduled for abdominal surgery at risk of developing PPCs. Interv…
Deferiprone versus Deferoxamine in Sickle Cell Disease: Results from a 5-year long-term Italian multi-center randomized clinical trial
2014
Blood transfusion and iron chelation currently represent a supportive therapy to manage anemia, vasculopathy and vaso-occlusion crises in Sickle-Cell-Disease. Here we describe the first 5-year long-term randomized clinical trial comparing Deferiprone versus Deferoxamine in patients with Sickle-Cell-Disease. The results of this study show that Deferiprone has the same effectiveness as Deferoxamine in decreasing body iron burden, measured as repeated measurements of serum ferritin concentrations on the same patient over 5-years and analyzed according to the linear mixed-effects model (LMM) (p=0.822). Both chelators are able to decrease, significantly, serum ferritin concentrations, during 5-y…
Long-term treatment with deferiprone enhances left ventricular ejection function when compared to deferoxamine in patients with thalassemia major
2013
Transfusion and iron chelation treatment have significantly reduced morbidity and improved survival of patients with thalassemia major. However, cardiac disease continues to be the most common cause of death. We report the left-ventricular ejection fraction, determined by echocardiography, in one hundred sixtyeight patients with thalassemia major followed for at least 5 years who received continuous monotherapy with deferoxamine (N = 108) or deferiprone (N = 60). The statistical analysis, using the generalized estimating equations model, indicated that the group treated with deferiprone had a significantly better left-ventricular ejection fraction than did those treated with deferoxamine (c…
Therapeutic synergism between hyaluronic acid and dexamethasone in the intra-articular treatment of osteoarthritis of the knee: a preliminary open st…
1992
In vitro studies on the effects of dexamethasone on human synovial cells have shown that with high concentrations of the steroid in the culture medium cellular activity was completely blocked whereas with low concentrations (10(-6)M), cellular density decreased but there was an increase in the synthesis of RNA, DNA, protein and hyaluronic acid. These data, coupled with clinical experience of using intra-articular hyaluronic acid to treat patients with osteoarthritis of the knee, prompted the investigators to carry out an open, randomized study of the use of very small doses of dexamethasone in association with hyaluronic acid in 40 osteoarthritic patients. Twenty patients received a weekly …
Long-term weight loss maintenance after inpatient psychotherapy of severely obese patients based on a randomized study: predictors and maintaining fa…
2006
Abstract Objective The objective of this study was to identify predictors of long-term weight loss after inpatient psychodynamic or behavioral psychotherapy of severely obese patients. Methods In a longitudinal study, obese patients [body mass index (BMI)≥35 kg/m2] were randomly assigned to behavioral or psychodynamic inpatient treatment. The average treatment duration was 7 weeks. Two hundred sixty-seven obese patients, mostly female (85%), with psychiatric and somatic comorbidity (age, 20–64 years; BMI=35–74 kg/m2) were examined with standardized self-report scales at intake, discharge, 1-year follow-up, and 3-year follow-up. Results Overall, 3 years after inpatient psychotherapy, irrespe…
Botulinum toxin vs. topical glyceryl trinitrate ointment for pain control in patients undergoing hemorrhoidectomy: a randomized trial.
2007
PURPOSE: The maximum resting pressure in the anal canal is greatly raised after hemorrhoidectomy. This increase is likely to be the cause of postoperative pain, which is still the most troublesome early problem after hemorrhoidectomy. This study was designed to compare, after hemorrhoidectomy, the effects of intrasphincter injection of botulinum toxin vs. application of glyceryl trinitrate ointment in improving wound heating and reducing postoperative pain at rest or during defecation. METHODS: Thirty patients with hemorrhoids of third and fourth degree were included in the study and randomized in two groups. Anorectal manometry was performed preoperatively and 5 and 40 days after hemorrhoi…
Effect of High-Fidelity Simulation on Medical Students' Knowledge about Advanced Life Support: A Randomized Study
2015
High-fidelity simulation (HFS) is a learning method which has proven effective in medical education for technical and non-technical skills. However, its effectiveness for knowledge acquisition is less validated. We performed a randomized study with the primary aim of investigating whether HFS, in association with frontal lessons, would improve knowledge about advanced life support (ALS), in comparison to frontal lessons only among medical students. The secondary aims were to evaluate the effect of HFS on knowledge acquisition of different sections of ALS and personal knowledge perception. Participants answered a pre-test questionnaire consisting of a subjective (evaluating personal percepti…