Search results for "controlled"

Effectiveness of tailored exercise therapy in patients with knee osteoarthritis and comorbidity: a randomized controlled trial

2016

Reperfusion Treatment in an Acute Myocardial Infarction in Patients Older Than 75 Years. Do We Need a Randomized Controlled Trial?

2005

Fibrinolytic therapy in ST-segment elevation acute myocardial infarction (AMI) constitutes one of the most important advances in cardiology in the last 25 years and has influenced the management and evolution of patients as much as the first coronary care units did. The most important limitations of fibrinolytics are the presence of absolute or relative contraindications to their administration in ≤25% of patients, their limited capacity to restore adequate coronary flow and the risk of inducing cerebral hemorrhage. They are at their most efficient in the first 2 hours’ evolution of AMI but lose their efficacy thereafter. 1 Consequently, treatment must be initiated as early as possible and …

AB1367-HPR EFFECTIVENESS OF THE HYPERBARIC TREATMENT ON THE PERCEIVED PAIN, FATIGUE AND FUNCTIONALITY OF WOMEN WITH FIBROMYALGIA

2019

Background Fibromyalgia (FM) is a chronic pain syndrome accompanied by other symptoms such as fatigue or altered functionality1. One of the most common non-pharmacologic treatment is physical exercise because of its known positive influence on pain as a consequence of the physical condition improvement. 2 However, they use to present a lack of adherence to this type of therapeutic programs may be attributable to post-exercise pain 3. For this reason, alternative approaches that do not involve physical efforts, such as hyperbaric therapy, may be effective to reduce pain, fatigue or functionality in women with FM.4 Objectives To compare the effectiveness of hyperbaric therapy and physical exe…

When to use frovatriptan in migraine? A reply

2011

Dear Sir, We read with interest the comments of Dr. Tfelt-Hansen [1] on the two recently published randomized controlled trials comparing patients’ preference (primary end-point) and efficacy (secondary end-points) of frovatriptan with respect to rizatriptan [2] and almotriptan [3]. In both studies, frovatriptan showed similar preference and short-term efficacy outcomes (pain relief and pain free episodes at 2 h) with respect to the other two triptans. The principal concern of Dr. Tfelt-Hansen was the very early use of frovatriptan in these studies, making their results hardly comparable with those of previous randomized controlled trials [4–6], where patients waited until the headache was …

Suggested randomized, controlled trial for frovatriptan: a reply

2011

Dear Sir, We read with interest the comments of Dr. Tfelt-Hansen [1] regarding our three recently published randomized controlled trials comparing patients’ preference (primary endpoint) and efficacy (secondary endpoints) of frovatriptan 2.5 mg versus zolmitriptan 2.5 mg [2], rizatriptan 10 mg [3] and almotriptan 12.5 mg [4], and the meta-analysis of pooled individual data from the three studies [5]. In all studies frovatriptan showed similar preference and short-term efficacy outcomes (pain relief and pain-free episodes at 2 h) with respect to the other three triptans. The questions put by Dr. Tfelt-Hansen sound appropriate. Doubts are raised on the usefulness of head-to-head preference tr…

Comparing the use of patient-reported outcomes in clinical studies in Europe in 2008 and 2018: a literature review

2021

Abstract Purpose Several guidelines for the use of patient-reported outcomes (PROs) in clinical studies have been published in the past decade. This review primarily aimed to compare the number and compliance with selected PRO-specific criteria for reporting of clinical studies in Europe using PROs published in 2008 and 2018. Secondarily, to describe the study designs, PRO instruments used, patient groups studied, and countries where the clinical studies were conducted. Methods A literature search was conducted in MEDLINE to identify eligible publications. To assess the number of publications, all abstracts were screened for eligibility by pairs of reviewers. Compliance with PRO-specific cr…

<tocheading>Original Article</tocheading>

1999

In this double-blind clinical trial 429 patients (217 terbinafine and 212 clotrimazole) were randomized to receive twice daily terbinafine 1% topical solution for 1 week followed by a vehicle application for 3 weeks, or 1% clotrimazole solution for 4 weeks. Patients were evaluated clinically and mycologically at baseline and then at weeks one, two, four (end of treatment), and eight (end of follow-up). To be evaluable the patient needed to have a positive culture for a dermatophyte and positive KOH microscopy and a clinical diagnosis of tinea pedis (interdigital type) at baseline. Effective treatment of tinea pedis was recorded in 181 of 217 (83%) of patients treated for 1 week with terbina…

Effectiveness of a home exercise programme in low back pain: a randomized five-year follow-up study

2007

Background and Purpose. Therapeutic exercise has been shown to be beneficial in decreasing pain and in increasing functioning in patients with chronic low back pain. However, longitudinal follow-up studies are small in number, and often limited in the numbers of subjects due to drop-outs. In addition there is a shortage of real control groups in most cases. The purpose of the present study was to describe long-term changes in intensity of low back pain and in functioning for two study groups five years after undertaking a home exercise programme. Method. This was a randomized follow-up study over five years. Fifty-seven subjects were reassessed with questionnaires five years after their ini…

Adjunctive Brivaracetam in Focal Epilepsy: Real-World Evidence from the BRIVAracetam add-on First Italian netwoRk STudy (BRIVAFIRST)

2021

Background: In randomized controlled trials, add-on brivaracetam (BRV) reduced seizure frequency in patients with drug-resistant focal epilepsy. Studies performed in a naturalistic setting are a useful complement to characterize the drug profile. Objective: This multicentre study assessed the effectiveness and tolerability of adjunctive BRV in a large population of patients with focal epilepsy in the context of real-world clinical practice. Methods: The BRIVAFIRST (BRIVAracetam add-on First Italian netwoRk STudy) was a retrospective, multicentre study including adult patients prescribed adjunctive BRV. Patients with focal epilepsy and 12-month follow-up were considered. Main outcomes includ…

Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regime…

2013

Abstract Background:  Interleukin-17A has major proinflammatory activity in psoriatic lesional skin. Objectives:  Assess the efficacy and safety of secukinumab, a fully human IgG1κ monoclonal anti-interleukin-17A antibody, in moderate-to-severe plaque psoriasis in a phase II regimen-finding study. Methods:  404 patients were randomised to subcutaneous placebo (67 patients) or one of three secukinumab 150 mg induction regimens: Single (week 0; 66 patients), Early (weeks 0, 1, 2, 4; 133 patients), and Monthly (weeks 0, 4, 8; 138 patients). The primary outcome was ≥75% improvement from baseline Psoriasis Area and Severity Index (PASI) score at week 12. PASI 75 responders from active treatment …