Search results for "Randomized Controlled Trial"
showing 10 items of 2199 documents
Acute Aortic Dissection Type A : Age-related Management and Outcomes Reported in the German Registry for Acute Aortic Dissection Type A (GERAADA) of …
2013
To determine the association between age and clinical presentation, management and surgical outcomes in a large contemporary, prospective cohort of patients with acute aortic dissection type A (AADA).AADA is one of the most life-threatening cardiovascular diseases, and delayed surgery or overly conservative management can result in sudden death.The perioperative and intraoperative conditions of 2137 patients prospectively reported to the multicenter German Registry for Acute Aortic Dissection Type A were analyzed.Of all patients with AADA, 640 (30%) were 70 years or older and 160 patients (7%) were younger than 40 years. The probability of aortic dissection extension to the supra-aortic ves…
Stratified Care vs Step Care Strategies for Migraine
2000
ContextVarious guidelines recommend different strategies for selecting and sequencing acute treatments for migraine. In step care, treatment is escalated after first-line medications fail. In stratified care, initial treatment is based on measurement of the severity of illness or other factors. These strategies for migraine have not been rigorously evaluated.ObjectiveTo compare the clinical benefits of 3 strategies: stratified care, step care within attacks, and step care across attacks, among patients with migraine.Design and SettingRandomized, controlled, parallel-group clinical trial conducted by the Disability in Strategies Study group from December 1997 to March 1999 in 88 clinical cen…
Side-effects of extracorporeal shock wave therapy (ESWT) in the treatment of tennis elbow
2002
Apart from a few observational reports, there are no studies on the side-effects of extracorporeal shock wave therapy (ESWT) in the treatment of insertion tendopathies. Within the framework of a randomised, placebo-controlled, single-blind, multicentre study to test the effectiveness of ESWT in the case of lateral epicondylitis (LE), side-effects were systematically recorded. A total of 272 patients from 15 centres was allocated at random to active ESWT (3 x 2000 pulses, energy flux density ED(+) 0.04 to 0.22 mJ/mm(2) under local anaesthesia) or placebo ESWT. In all, 399 ESWT and 402 placebo treatments were analysed. More side-effects were documented in the ESWT group (OR = 4.3, CI = [2.9; …
Effectiveness of high dose sublingual immunotherapy to induce a stepdown of seasonal asthma: a pilot study
2009
There is ample evidence to support the efficacy of sublingual immunotherapy (SLIT) on allergic rhinitis, while there is less solid data regarding asthma. We evaluated the effects of a high dose birch SLIT on birch-induced rhinitis and asthma in a controlled study.This double-blind, placebo-controlled, randomised, single centre trial on SLIT with birch pollen allergen extract (Stallergenes, Antony, France) included 24 patients presenting severe rhinitis and slight to moderate asthma, 14 actively and 10 placebo treated. SLIT was performed by a pre-coseasonal protocol, and was repeated for 2 years. The study plan included a selection visit, a visit at the start of the first and the second trea…
Systemic moxifloxacin vs amoxicillin/metronidazole adjunct to non-surgical treatment in generalized aggressive periodontitis
2014
Background: The objective of this randomized clinical study was to evaluate the effect of systemic administration of moxifloxacin compared to amoxicillin and metronidazole, combined with non-surgical treatment in patients with generalized aggressive periodontitis (GAgP) in a 6-month follow-up. Material and Methods: A total of 39 systemically healthy patients with GAgP were evaluated in this randomized clinical trial. Periodontal parameters were recorded at the baseline during the 1 st , 3 rd and 6 th month. Patients received either 400 mg of moxifloxacin per os once daily or 500 mg of metronidazole and 500 mg amoxicillin per os three times daily for 7 days consecutively. Results: No signifi…
"Baseline physical functioning status of metastatic colorectal cancer patients predicts the overall survival but not the activity of a front-line oxa…
2010
BACKGROUND: No differences in response rate (RR), progression-free survival (PFS), overall survival (OS) and quality of life (QoL) were seen in patients randomly treated with biweekly oxaliplatin plus either fluorouracil/folinic acid or capecitabine. METHODS: We investigated the independent effect of baseline clinical characteristics and physical functioning (PF) domain on RR, PFS, and OS in 310 patients who completed the EORTC QLQ-C30 questionnaire. Multivariate analyses stratified by treatment were performed. An exploratory analysis was done by grouping patients with a PF score superior or equal to the highest quartile (n = 111), included between the highest and the lowest quartiles (n = …
A comparative study of naproxen gel and flufenamic acid gel in the treatment of soft tissue injuries.
1990
One hundred patients were enrolled in a single-blind, randomized, parallel group study to compare naproxen gel (10%) with flufenamic acid gel (3%) for the treatment of soft tissue injuries. Demographic variables, the distribution of diagnoses (tendinitis, bursitis/synovitis, synovitis, periarthritis, epicondylitis) and initial severity of the complaint were similar between the two groups. The gels were applied 2 to 6 times per day, as required, and conventional clinical indices were evaluated at Day 1 (on entry to the study), Day 3 and Day 7. Global assessments of efficacy were made by both physicians and patients at the end of the study. By Day 7 both treatments had produced a highly signi…
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…