Search results for "Randomized controlled"
showing 10 items of 2220 documents
Efficacy and safety comparison of two amoxicillin administration schedules after third molar removal. A randomized, double-blind and controlled clini…
2009
Objective: The aim of this comparative double-blind, prospective, randomized, clinical trial was to evaluate two amoxicillin administration patterns. The first was a short prophylactic therapy and the second a long postoperative regimen. Study Design: The study population consisted of 160 patients who underwent mandibular third molar extraction. Patients were randomized into two equal groups. In group 1, 2 grams of amoxicillin were administered 1 hour before the procedure and 1 gram 6 hours after surgery. In group 2, patients received 1 gram of amoxicillin 6 hours after surgery followed by 1 gram every 8 hour for 4 days. All patients received the same number of tablets thanks to the use of …
Prospective Randomized Trial of Electrolysis for Chronic Plantar Heel Pain
2018
Background: Chronic plantar heel pain (CPHP) is a common condition with high prevalence rates and a projected cost of treatment of US$192 to US$376 million. There are several therapeutic approaches and there is increased interest in treatments aimed at the regeneration of tissues with poor healing potential. Our purpose was to investigate the effectiveness of ultrasound-guided percutaneous needle electrolysis in chronic plantar heel pain. Methods: A total of 73 patients with a clinical and ultrasonographic diagnosis of plantar heel pain unrelated to systemic inflammatory disease who had not received any other treatment in the previous 6 months on the affected foot were randomly allocated to…
Ropeginterferon alfa-2b versus phlebotomy in low-risk patients with polycythaemia vera (Low-PV study): a multicentre, randomised phase 2 trial.
2021
Summary Background There is no evidence that phlebotomy alone is sufficient to steadily maintain haematocrit on target level in low-risk patients with polycythaemia vera. This study aimed to compare the efficacy and safety of ropeginterferon alfa-2b on top of the standard phlebotomy regimen with phlebotomy alone. Methods In 2017, we launched the Low-PV study, a multicentre, open-label, two-arm, parallel-group, investigator-initiated, phase 2 randomised trial with a group-sequential adaptive design. The study involved 21 haematological centres across Italy. Participants were recruited in a consecutive order. Participants enrolled in the study were patients, aged 18–60 years, with a diagnosis…
Adverse Cardiovascular Response to Aerobic Exercise Training
2015
AB Purpose: Aerobic exercise training in sedentary individuals improves physical fitness and various cardiovascular (CV) biomarkers. Nevertheless, there has been controversy as to whether exercise training may adversely affect some biomarkers in a small segment of the population. The purpose of this study was to investigate whether clinically significant worsening of CV biomarkers was more prevalent among individuals randomized to a supervised endurance training program as compared with those randomized to a control condition. Methods: Baseline and end of study measurements of fasting insulin (FI), triglycerides (TG), resting systolic blood pressure (SBP), and HDL cholesterol (HDL-C) were o…
ACT Internet-based vs face-to-face? A randomized controlled trial of two ways to deliver Acceptance and Commitment Therapy for depressive symptoms: A…
2013
The aim of the present study was to investigate two interventions based on Acceptance and Commitment Therapy (ACT) for depressive symptoms: A face-to-face treatment (ACT group) was compared to a guided self-help treatment delivered via the Internet consisting of two assessment sessions (pre and post) and an ACT-based Internet program (iACT). Outpatients experiencing at least mild depressive symptoms were randomized to either approach. The iACT treatment group received access to an ACT-based Internet program and supportive web-based contact over a period of 6 weeks. The face-to-face group received ACT-based treatment once a week over the same period of time. In both groups, the results showe…
Depression during an acute episode of schizophrenia or schizophreniform disorder and its impact on treatment response
2008
The aim of the present study was to examine the relevance of depressive symptoms during an acute schizophrenic episode for the prediction of treatment response. Two hundred inpatients who fulfilled DSM-IV criteria for schizophrenia or schizophreniform disorders were assessed at hospital admission and after 6 weeks of inpatient treatment using the Positive and Negative Syndrome Scale (PANSS) and the Hamilton Rating Scale for Depression (HAM-D). Depressive symptoms showed positive correlations with both positive and negative symptoms at admission and after 6 weeks, and decreased during 6 weeks of treatment. Pronounced depressive symptoms (HAM-D score> or =16) were found in 28% of the sample a…
Effect of Lanadelumab Compared With Placebo on Prevention of Hereditary Angioedema Attacks: A Randomized Clinical Trial.
2018
Current treatments for long-term prophylaxis in hereditary angioedema have limitations.To assess the efficacy of lanadelumab, a fully human monoclonal antibody that selectively inhibits active plasma kallikrein, in preventing hereditary angioedema attacks.Phase 3, randomized, double-blind, parallel-group, placebo-controlled trial conducted at 41 sites in Canada, Europe, Jordan, and the United States. Patients were randomized between March 3, 2016, and September 9, 2016; last day of follow-up was April 13, 2017. Randomization was 2:1 lanadelumab to placebo; patients assigned to lanadelumab were further randomized 1:1:1 to 1 of the 3 dose regimens. Patients 12 years or older with hereditary a…
Knee arthroscopy and exercise versus exercise only for chronic patellofemoral pain syndrome: a randomized controlled trial.
2007
Abstract Background Arthroscopy is often used to treat patients with chronic patellofemoral pain syndrome (PFPS). As there is a lack of evidence, we conducted a randomized controlled trial to study the efficacy of arthroscopy in patients with chronic PFPS. Methods A total of 56 patients with chronic PFPS were randomized into two treatment groups: an arthroscopy group (N = 28), treated with knee arthroscopy and an 8-week home exercise program, and a control group (N = 28), treated with the 8-week home exercise program only. The arthroscopy included finding-specific surgical procedures according to current recommendations. The primary outcome was the Kujala score on patellofemoral pain and fu…
Long-term sequential deferiprone-deferoxamine versus deferiprone alone for thalassemia major patients: a randomised clinical trial
2009
A multicentre randomized open-label trial was designed to assess the effectiveness of long-term sequential deferiprone–deferoxamine (DFO–DFP) versus DFP alone to treat thalassaemia major (TM). DFP at 75 mg/kg, divided into three oral daily doses, for 4 d/week and DFO by subcutaneous infusion (8–12 h) at 50 mg/kg per day for the remaining 3 d/week was compared with DFP alone at 75 mg/kg, administered 7 d/week during a 5-year follow-up. The main outcome measures were differences between multiple observations of serum ferritin concentrations. Secondary outcomes were survival analysis, adverse events, and costs. Consecutive thalassaemia patients (275) were assessed for eligibility; 213 of these…
Efficacy, safety and quality of life of calcipotriol/betamethasone dipropionate (Dovobet (R)) versus calcipotriol (Daivonex (R)) in the treatment of …
2007
Objective: A clinical trial was performed to evaluate the efficacy, speed of response, side effects and quality of life of patients treated with calcipotriol/betamethasone dipropionate (Dovobet (R)) for 4 weeks followed by maintenance with calcipotriol for 8 weeks (group A) versus calcipotriol (Daivonex (R)) alone for 12 weeks (group B) for the treatment of psoriasis. Materials and methods: A total of 150 patients were enrolled and randomized to groups A and B. PASI and Skindex-29 were considered the outcome measures. Results: Ninety-six patients completed the trial. At weeks 2 and 4, both groups showed a significant clinical improvement compared to baseline; group A demonstrated a higher c…