BACKGROUND It is often difficult to enrol healthy volunteers into a randomized controlled trial (RCT) as there are barriers to participants' proper understanding of a trial. This study aimed to evaluate degrees of understanding of the informed consent (IC) process among healthy volunteers who participated in an RCT. Additionally, factors associated with degree of understanding were investigated...

OBJECTIVE Ciclosporin and MTX are used in idiopathic inflammatory myopathies (DM and PM) when patients incompletely respond to glucocorticoids. Their effectiveness is unproved in randomized controlled trials (RCTs). We evaluated their benefits in a placebo-controlled factorial RCT. METHODS A 56-week multicentre factorial-design double-blind placebo-controlled RCT compared steroids alone, MTX ...

Cervicogenic headache (CEH) is a secondary headache which affects 1.0-4.6 % of the population. Although the costs are unknown, the health consequences are substantial for the individual; especially considering that they often suffers chronicity. Pharmacological management has no or only minor effect on CEH. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) f...

The efficacy of glucocorticoid for treatment of acute spinal cord injuries remains a controversial topic. Differing medical societies have issued conflicting recommendations in this regard. Here we review the available randomized, controlled trial (RCT) data on this subject and offer a synthesis of these data sets.

Background: To describe the design of a population based randomized controlled trial (RCT), including a cost-effectiveness analysis, comparing participative ergonomics interventions between 2–8 weeks of sick leave and Graded Activity after 8 weeks of sick leave with usual care, in occupational back pain management.

CT computed tomography DGW double guidewire EPBD endoscopic papillary balloon dilation ESGE European Society of Gastrointestinal Endoscopy ERCP endoscopic retrograde cholangiopancreatography NSAID nonsteroidal anti-inflammatory drug PEP post-ERCP pancreatitis PGW pancreatic guidewire RCT randomized controlled trial SOD sphincter of Oddi dysfunction SOM sphincter of Oddi manometry ULN upper limi...

The purpose of this article is to examine the application randomized controlled trial (RCT) methodology for determining efficacy school-based interventions in general and special education. In education science, RCTs are widely acknowledged as gold standard research, with other methodologies relegated a lower level credibility. However, scholars from different disciplines have raised variety is...

BACKGROUND To provide a preliminary estimate of efficacy of constraint-induced aphasia therapy (CIAT) when compared to no-intervention in patients with chronic (>1 year) post-stroke aphasia in order to plan an appropriately powered randomized controlled trial (RCT). MATERIAL AND METHODS We conducted a pilot single-blinded RCT. 24 patients were randomized: 14 to CIAT and 10 to no-intervention....

BACKGROUND Patients with proliferative lupus nephritis are at risk of frequent relapses. Whether low- dose prednisone prevents relapses is uncertain. OBJECTIVES We undertook a pilot RCT to determine the feasibility of a larger trial. DESIGN Pilot randomized controlled trial. SETTING Single center Canadian outpatient nephrology clinic. PATIENTS Participants with systemic lupus erythemato...