Search results for "Randomized controlled trial"
showing 10 items of 2199 documents
Randomised controlled trial of lipiodol transarterial chemoembolisation with or without amiodarone for unresectable hepatocellular carcinoma.
2011
Abstract Background There is no consensus about the most effective method for transarterial chemoembolisation of hepatocellular carcinoma. Aim The aim of this phase II trial was to compare the efficacy and toxicity of lipiodol transarterial chemoembolisation with amiodarone in association with pirarubicin or doxorubicin versus lipiodol transarterial chemoembolisation with anthracycline alone in a control group. Methods Patients with unresectable hepatocellular carcinoma and Child-Pugh A/B7 were considered eligible for the trial. transarterial chemoembolisation was repeated every 6 weeks for a maximum of 4 sessions. Results Thirteen patients were randomised in the amiodarone group, and 14 we…
A Phase 3 Trial of Sebelipase Alfa in Lysosomal Acid Lipase Deficiency
2015
BackgroundLysosomal acid lipase is an essential lipid-metabolizing enzyme that breaks down endocytosed lipid particles and regulates lipid metabolism. We conducted a phase 3 trial of enzyme-replacement therapy in children and adults with lysosomal acid lipase deficiency, an underappreciated cause of cirrhosis and severe dyslipidemia. MethodsIn this multicenter, randomized, double-blind, placebo-controlled study involving 66 patients, we evaluated the safety and effectiveness of enzyme-replacement therapy with sebelipase alfa (administered intravenously at a dose of 1 mg per kilogram of body weight every other week); the placebo-controlled phase of the study was 20 weeks long and was followe…
Efect of periodontal disease and non surgical periodontal treatment on C-reactive protein. Evaluation of type 1 diabetic patients
2011
Objectives: The purpose of this study was to analyze how anti-infectious periodontal treatment affects C reactive protein (CRP) values in patients with type 1 diabetes, and correlate baseline CRP levels with periodontal disease severity. Study Design: A cohort of fifty three subjects with type 1 diabetes and moderate to severe periodontitis were recruited. Periodontal parameters were measured, and blood samples were obtained to evaluate high-sensitivity C-reactive protein (hs-CRP). Group 1 was treated with scaling, root planning, and systemic administration of doxycycline. Group 2 received only scaling and root planning. Results: Hs-CRP was reduced after periodontal treatment in group 1 (-0…
Mycophenolate plus methylprednisolone versus methylprednisolone alone in active, moderate-to-severe Graves' orbitopathy (MINGO): a randomised, observ…
2018
BACKGROUND: European guidelines recommend intravenous methylprednisolone as first-line treatment for active and severe Graves' orbitopathy; however, it is common for patients to have no response or have relapse after discontinuation of treatment. We aimed to compare the efficacy and safety of add-on mycophenolate to methylprednisolone in comparison with methylprednisolone alone in patients with moderate-to-severe Graves' orbitopathy.METHODS: MINGO was an observer-masked, multicentre, block-randomised, centre-stratified trial done in two centres in Germany and two in Italy. Patients with active moderate-to-severe Graves' orbitopathy were randomly assigned to receive intravenous methylprednis…
Influence of exercise training on physiological and performance changes with weight loss in men.
1999
The purpose of this study was to examine the physiological effects of a weight-loss dietary regimen with or without exercise.Thirty-five overweight men were matched and randomly placed into either a control group (C; N = 6) or one of three dietary groups; a diet-only group (D; N = 8), a diet group that performed aerobic exercise three times per week (DE; N = 11); and a diet group that performed both aerobic and strength training three times per week (DES; N = 10).After 12 wk, D, DE, and DES demonstrated a similar and significant (Por = 0.05) reduction in body mass (-9.64, -8.99, and -9.90 kg, respectively) with fat mass comprising 69, 78, and 97% of the total loss in body mass, respectively…
A prospective randomized trial of high and standard dosages of recombinant factor VIIa for treatment of hemarthroses in hemophiliacs with inhibitors.
2006
Summary. Aim: A multicenter randomized open-label crossover prospective trial was designed to compare the efficacy, safety, and cost of standard and high dosages of recombinant factor VIIa (rFVIIa) for home treatment of hemarthroses in hemophiliacs with inhibitors. Methods: Patients were instructed to treat, within 6 h from the onset of bleeding, four consecutive hemarthroses of ankles, knees, or elbows, either with the rFVIIa standard dose of 90 μg kg−1 (repeated as necessary every 3 h) or with a single high dose of 270 μg kg−1. Patients who did not achieve a clinical success within 9 h continued rFVIIa treatment with repeated standard doses. Response to treatment was assessed for up to 48…
Controlled trial comparing two types of enteral nutrition in treatment of active Crohn's disease: elemental versus polymeric diet.
1991
International audience; To determine whether an elemental diet or a polymeric defined formula diet would be more effective for treating active Crohn's disease, we conducted a prospective randomised clinical trial in 30 patients with active Crohn's disease unresponsive to steroids and/or complicated by malnutrition. They received a four to six week enteral nutrition course with either an elemental diet or a polymeric diet. Clinical remission occurred in 10 of the 15 patients on elemental diet compared with 11 of the 15 patients assigned to polymeric diet. Both groups showed similar improvements in nutritional status, biological inflammation, alpha 1 antitrypsin clearance, and colonoscopic le…
In vivo endomicroscopy improves detection of Barrett’s esophagus–related neoplasia: a multicenter international randomized controlled trial
2013
Background Confocal laser endomicroscopy (CLE) enables in vivo microscopic imaging of the GI tract mucosa. However, there are limited data on endoscope-based CLE (eCLE) for imaging Barrett's esophagus (BE). Objective To compare high-definition white-light endoscopy (HDWLE) alone with random biopsy (RB) and HDWLE + eCLE and targeted biopsy (TB) for diagnosis of BE neoplasia. Design Multicenter, randomized, controlled trial. Setting Academic medical centers. Patients Adult patients with BE undergoing routine surveillance or referred for early neoplasia. Intervention Patients were randomized to HDWLE + RB (group 1) or HDWLE + eCLE + TB (group 2). Real-time diagnoses and management plans were r…
Hemostatic Agents in Periapical Surgery: A Randomized Study of Gauze Impregnated in Epinephrine versus Aluminum Chloride
2016
Abstract Introduction Adequate bleeding control is essential for the success of periapical surgery. The aim of this study was to evaluate the effects of 2 hemostatic agents on the outcome of periapical surgery and their relationship with patient and teeth parameters. Methods A prospective study was designed with 2 randomized parallel groups, depending on the hemostatic agent used: gauze impregnated in epinephrine (epinephrine group) and aluminum chloride (aluminum chloride group). The analysis of the hemorrhage control was judged before and after the application of the hemostatic agents by the surgeon, and 2 examiners independently recorded it as adequate (complete hemorrhage control) or in…
Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of moderate nasolabial folds: 6-month interim results of a randomized, ev…
2011
Hyaluronic acid (HA) fillers such as Restylane(®) are frequently used for the correction of facial soft tissue defects.To compare the efficacy and safety of a novel HA filler, Emervel(®) Classic, with those of Restylane in the treatment of moderate nasolabial folds.This was a split-face, randomized and evaluator-blinded comparison study. Subjects were randomized to receive an injection of Emervel Classic or Restylane on their left or right side. Efficacy was evaluated based on the change in Wrinkle Severity Rating Score (WSRS) from baseline. Local tolerability was assessed based on subject diary, which recorded the severity of erythema, oedema/swelling, bruising, pain/tenderness and pruritu…