Trials
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Pain reduction with oral methotrexate in knee osteoarthritis, a pragmatic phase iii trial of treatment effectiveness (PROMOTE): study protocol for a randomized controlled trial.
Osteoarthritis (OA) is the fastest growing cause of disability worldwide. Current treatments for OA are severely limited and a large proportion of people with OA live in constant, debilitating pain. There is therefore an urgent need for novel treatments to reduce pain. Synovitis is highly prevalent in OA and is associated with pain. In inflammatory arthritides such as rheumatoid arthritis, methotrexate (MTX) is the gold standard treatment for synovitis and has a well-known, acceptable toxicity profile. We propose that using MTX to treat patients with symptomatic knee OA will be a practical and safe treatment to reduce synovitis and, consequently, pain. ⋯ The PROMOTE trial is designed to examine whether MTX is an effective analgesic treatment for OA. The MRI substudy will address the relationship between synovitis and symptom change. This will potentially provide a much needed new treatment for knee OA.
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Randomized Controlled Trial
Safety and feasibility of xenon as an adjuvant to sevoflurane anaesthesia in children undergoing interventional or diagnostic cardiac catheterization: study protocol for a randomised controlled trial.
Xenon has minimal haemodynamic side effects when compared to volatile or intravenous anaesthetics. Moreover, in in vitro and in animal experiments, xenon has been demonstrated to convey cardio- and neuroprotective effects. Neuroprotection could be advantageous in paediatric anaesthesia as there is growing concern, based on both laboratory studies and retrospective human clinical studies, that anaesthetics may trigger an injury in the developing brain, resulting in long-lasting neurodevelopmental consequences. Furthermore, xenon-mediated neuroprotection could help to prevent emergence delirium/agitation. Altogether, the beneficial haemodynamic profile combined with its putative organ-protective properties could render xenon an attractive option for anaesthesia of children undergoing cardiac catheterization. ⋯ Children undergoing diagnostic or interventional cardiac catheterization are a vulnerable patient population, one particularly at risk for intra-procedural haemodynamic instability. Xenon provides remarkable haemodynamic stability and potentially has cardio- and neuroprotective properties. Unfortunately, evidence is scarce on the use of xenon in the paediatric population. Our pilot study will therefore deliver important data required for prospective future clinical trials.
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Randomized Controlled Trial Multicenter Study
Recruiting to inpatient-based rehabilitation trials: lessons learned.
Effective recruitment is central to successful trials but is often problematic. This article reports the lessons learnt while recruiting stroke rehabilitation patients to a multi-centre randomised control trial. As intended, 94 participants were recruited from 12 inpatient stroke rehabilitation services in Northwest England over 12 months; however, recruitment rates were highly varied (from 0.6 to 2.5 participants per site per month) as were the nature of the stroke services and the personnel available. Consequently, bespoke recruitment procedures were needed at each site. As the assessment skills needed to screen for the selection criteria were specific to therapists, our most common strategy was for the hospital therapists to screen patients and make referrals directly to the trial team. However, we identified several strategies undertaken by the research nurse in the highest recruiting site that appeared to positively impact on recruitment. These strategies included involving the whole multidisciplinary team, being part of the stroke team, facilitating contact between the clinical and trial teams and using inclusive recruitment and watchful waiting strategies. Rehabilitation trials frequently require skilled assessments by therapists, rather than by doctors or nurses to identify potential participants. Thus, research support models need to include suitably skilled trial therapists. Recruitment can be enhanced by enthusiastic, regular and structured engagement with the entire stroke multidisciplinary team and by using inclusive recruitment and 'watchful waiting' strategies to identify and monitor potential participants.