Search results for " control"

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 …

Importancia de la dislipidemia en la enfermedad cardiovascular: un punto de vista

2015

The authors present their view on the prevention of cardiovascular diseases, accepting the European ESC/EAS guidelines. They consider that the aim of the lipid control, based on LDL-C goals, is essential for the prevention and treatment of cardiovascular diseases. In subjects with metabolic syndrome (mainly, abdominal obesity, pre-diabetes and diabetes), the primary objective should be apoB or Non-HDL-C, which are better associated with cardiovascular risk. The treatment must be lifestyle changes and control of other risk factors. After calculating cardiovascular risk, statins are the first therapeutic step, with the strength and dose needed to achieve LDL-C goals. If targets are not achiev…

Potential options to optimize therapy of gastroesophageal reflux disease with proton pump inhibitors.

2007

Proton pump inhibitors (PPIs) are antisecretory agents that are widely used in the short- and long-term management of gastroesophageal reflux disease (GERD) to relieve symptoms, heal esophagitis, and prevent complications, such as strictures and Barrett’s esophagus. The total healthcare costs of GERD are high, especially for maintenance treatment. Therefore, the choice of cost-effective therapeutic options is an ineluctable challenge for public health authorities, third-party payers, and patients. In some European Union countries, a recent trend of public health authorities is to promote the choice of less expensive PPIs, regardless of their antisecretory potency – this in spite of the evid…

Review of: "Teriparatide Promotes Bone Healing in Medication-Related Osteonecrosis of the Jaw: A Placebo-Controlled, Randomized Trial"

2020

Death caused by a chain saw – homicide, suicide or accident?

1999

A 31-year-old farm worker was found dead beside a chain saw. Based on the testimony of a colleague and because of the situation at the site, the police very soon presupposed an accident. It was assumed that the victim had slipped on the sodden ground and had been killed by the subsequent swerving of the saw when starting the engine. The body presented with a deep lacerated wound at the right side of the nape of the neck, including the first cervical vertebra, the medullary canal and the right mandible as well as multiple fissures of the occipital bone, which were attributed to repeated forceful use of the chain by another person. A second wound with relatively sharp edges and a tangential f…