Search results for "Randomized controlled"
showing 10 items of 2220 documents
An 18-Month Follow-up, Randomized Comparison of Effectiveness and Safety of Two Hyaluronic Acid Fillers for Treatment of Moderate Nasolabial Folds
2016
Hyaluronic acid (HA) filler injection is a popular nonsurgical aesthetic procedure.To compare the effectiveness and safety of 2 hyaluronic acid fillers (HAEC and HARES) for treatment of moderate nasolabial folds (NLFs).This was an evaluator- and subject-blinded split-face study. HAEC or HARES was randomly assigned to the left or right NLF at baseline. Retreatment was performed after 9 months; follow-up extended to 18 months after baseline (9 months after retreatment). Effectiveness assessments included the Wrinkle Severity Rating Scale (WSRS) and subject preference. Safety assessments included adverse events (AEs) and local tolerability symptoms recorded by subjects during 3 weeks after tre…
Mirtazapine compared with paroxetine in major depression.
2000
Background: The aim was to compare the efficacy and tolerability of mirtazapine with those of paroxetine. Method: 275 outpatients with a diagnosis of major depressive episode (DSM-IV) and a score ≥ 18 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17) were randomly assigned to 6 weeks of treatment with mirtazapine (15-45 mg/day) or paroxetine (20-40 mg/day). Efficacy was assessed by the HAM-D-17, Hamilton Rating Scale for Anxiety (HAM-A), and Clinical Global Impressions scales (Severity and Improvement), and analyses were performed on the intent-to-treat sample (127 mirtazapine-treated patients and 123 paroxetine-treated patients). Results: Mean daily doses were 32.7 mg of mirta…
Botulinum toxin type-A in the prophylactic treatment of medication-overuse headache: a multicenter, double-blind, randomized, placebo-controlled, par…
2011
Medication-overuse headache (MOH) represents a severely disabling condition, with a low response to prophylactic treatments. Recently, consistent evidences have emerged in favor of botulinum toxin type-A (onabotulinum toxin A) as prophylactic treatment in chronic migraine. In a 12-week double-blind, parallel group, placebo-controlled study, we tested the efficacy and safety of onabotulinum toxin A as prophylactic treatment for MOH. A total of 68 patients were randomized (1:1) to onabotulinum toxin A (n = 33) or placebo (n = 35) treatment and received 16 intramuscular injections. The primary efficacy end point was mean change from baseline in the frequency of headache days for the 28-day per…
Prospective randomized trial to evaluate two delayed granulocyte colony stimulating factor administration schedules after high-dose cytarabine therap…
2002
In acute lymphoblastic leukemia (ALL), treatment with granulocyte colony stimulating factor (G-CSF) during remission induction shortens granulocytopenia and may decrease morbidity due to infections. However, the optimal timing of G-CSF administration after chemotherapy is not known. In a prospective randomized multi-center study, adult ALL patients were treated with high-dose ARA-C [HDAC, 3 g/m(2) bid (1 g/m(2) bid for T-ALL) days 1-4] and mitoxantrone (MI 10 mg/m(2) days 3-5). They were randomized to receive recombinant human G-CSF (Lenograstim) 263 micro g/day SC starting either from day 12 (Group 1) or day 17 (Group 2). Fifty-five patients (41 male, 14 female) with a median age of 34 yea…
Orthopaedic manual therapy, McKenzie method or advice only for low back pain in working adults: a randomized controlled trial with one year follow-up.
2009
OBJECTIVE: To examine the effects of 2 manual therapy methods compared with one counselling session with a physiotherapist with "advice-only to stay active" for treating low back pain/leg pain and disability. DESIGN: A randomized, controlled trial with a 1-year follow-up. SUBJECTS: A total of 134 subjects with low back disorders. METHODS: Participants with acute to chronic first or recurrent low back pain, excluding those with "red flag" criteria, were assigned randomly to one of the 3 intervention groups: an orthopaedic manual therapy group (n=45), a McKenzie method group (n=52), and an "advice only to be active" group (advice-only) (n=37). Data on leg and low back pain intensity and disab…
A Prognostic Enrichment Strategy for Selection of Patients With Acute Respiratory Distress Syndrome in Clinical Trials.
2019
Incomplete or ambiguous evidence for identifying high-risk patients with acute respiratory distress syndrome for enrollment into randomized controlled trials has come at the cost of an unreasonable number of negative trials. We examined a set of selected variables early in acute respiratory distress syndrome to determine accurate prognostic predictors for selecting high-risk patients for randomized controlled trials.A training and testing study using a secondary analysis of data from four prospective, multicenter, observational studies.A network of multidisciplinary ICUs.We studied 1,200 patients with moderate-to-severe acute respiratory distress syndrome managed with lung-protective ventil…
Alpha lipoic acid efficacy in burning mouth syndrome: a controlled clinical trial
2014
Background A double-blind placebo-controlled trial was conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. Burning mouth syndrome (BMS) is defined as an oral burning sensation in the absence of clinical signs which could justify the syndrome. Recent studies suggest the existence of neurological factors as a possible cause of the disease. Material and Methods 60 patients with BMS, in two groups: case group with 600 mg/day and placebo as control group; with follow up of 2 months. Results 64% of ALA patients reported some level of improvement, with a level of maintenance of 68.75% one month after treatment.…
Assessing age and gender in studies of breakthrough pain medications
2014
AbstractObjective:The present review was performed to identify possible differences observed between adults and elderly patients and between males and females in randomized clinical trials of breakthrough pain (BTP).Methods:A systematic search of the existing literature from 1998 to September 2013 was performed. Randomized clinical trials reporting data on older patients were selected.Results:Sixteen comparative studies were selected. The age range of inclusion criteria patients was mainly between 18–80 or ≥18 years. In some cases this data was unreported. The mean age of patients was 48–64 years, but information regarding the number of elderly patients was present in three studies only. Ge…
Prevention of haemophilic arthropathy during childhood. May common orthopaedic management be extrapolated from patients without inhibitors to patient…
2008
We recommend prophylaxis in haemophilic children with an inhibitor as a way of preventing the musculoskeletal impairment that is likely to affect them. This approach has been used for children without inhibitors with excellent results. If prophylaxis is not feasible, we suggest that intensive on-demand treatment should be given. Two agents, recombinant activated FVII (rFVIIa) and activated prothrombin complex concentrates (aPCC), are currently used to control haemostasis either for prophylaxis or intensive on-demand treatment. As it is recombinant, rFVIIa would seem more appropriate to be employed in children. aPCC could be used in adults, or in the event of an unsatisfactory response to rF…
Laparoscopy is an available alternative to open surgery in the treatment of perforated peptic ulcers: A retrospective multicenter study
2018
Abstract Background Perforated peptic ulcers (PPU) remain one of the most frequent causes of death. Their incidence are largely unchanged accounting for 2–4% of peptic ulcers and remain the second most frequent abdominal cause of perforation and of indication for gastric emergency surgery. The minimally invasive approach has been proposed to treat PPU however some concerns on the offered advantages remain. Methods Data on 184 consecutive patients undergoing surgery for PPU were collected. Likewise, perioperative data including shock at admission and interval between admission and surgery to evaluate the Boey’s score. It was recorded the laparoscopic or open treatments, the type of surgical …