Articles: adult.
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Randomized Controlled Trial
Effects of ethanol on the pharmacokinetics of extended-release oxycodone with sequestered naltrexone (ALO-02).
ALO-02 capsules, intended to deter abuse, contain pellets of extended-release oxycodone hydrochloride (HCl), an opioid agonist, surrounding sequestered naltrexone HCl, an opioid antagonist. The objective of this study was to determine the effects of administration of ALO-02 with 20 or 40 % ethanol on the pharmacokinetics of oxycodone. ⋯ Oxycodone exposures (Cmax) were unaffected when ALO-02 was administered with 20 % ethanol but Cmax increased by 37 % with 40 % ethanol versus water. ALO-02 administered with ethanol under naltrexone block was generally well tolerated.
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Preventive medicine · Apr 2015
Randomized Controlled TrialEfficacy of a tobacco quitline among adult cancer survivors.
The purpose of the study (conducted 2010-2013) was to determine the efficacy of two common types of tobacco quitlines in adult cancer survivors who regularly smoked cigarettes. ⋯ Our results are consistent with other studies indicating that traditional smoking cessation interventions are ineffective among cancer survivors. Moreover, self-reports of cessation were unreliable in cancer survivors participating in a quitline intervention, indicating that future studies should include biochemical verification. Given the importance of smoking cessation among cancer survivors and low cessation rates in the current study, it may be necessary to design alternative interventions for this population. ClinicalTrials.gov identifier: NCT00827866.
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Randomized Controlled Trial
Evaluator-blinded trial evaluating nurse-led immunotherapy DEcision Coaching In persons with relapsing-remitting Multiple Sclerosis (DECIMS) and accompanying process evaluation: study protocol for a cluster randomised controlled trial.
Multiple sclerosis is a chronic neurological condition usually starting in early adulthood and regularly leading to severe disability. Immunotherapy options are growing in number and complexity, while costs of treatments are high and adherence rates remain low. Therefore, treatment decision-making has become more complex for patients. Structured decision coaching, based on the principles of evidence-based patient information and shared decision-making, has the potential to facilitate participation of individuals in the decision-making process. This cluster randomised controlled trial follows the assumption that decision coaching by trained nurses, using evidence-based patient information and preference elicitation, will facilitate informed choices and induce higher decision quality, as well as better decisional adherence. ⋯ This trial will assess the effectiveness of a new model of patient decision support concerning MS-immunotherapy options. The delegation of treatment information provision from physicians to trained nurses bears the potential to change current doctor-focused practice in Germany.
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Health Technol Assess · Mar 2015
Randomized Controlled Trial Multicenter Study Comparative Study Pragmatic Clinical TrialThe ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial - a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults.
Proximal humeral fractures account for 5-6% of all fractures in adults. There is considerable variation in whether or not surgery is used in the management of displaced fractures involving the surgical neck. ⋯ Current surgical practice does not result in a better outcome for most patients with displaced fractures of the proximal humerus involving the surgical neck and is not cost-effective in the UK setting. Two areas for future work are the setting up of a national database of these fractures, including the collection of patient-reported outcomes, and research on the best ways of informing patients with these and other upper limb fractures about initial self-care.
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Randomized Controlled Trial
Distal tourniquet-facilitated radial arterial cannulation in adults--a double-blinded, prospective, randomized and controlled study.
Relatively small radial artery may be challenging for cannulation. We investigated whether a distal tourniquet would inflate the proximal radial artery and therefore facilitate cannulation in adults. ⋯ Distal tourniquet could inflate the proximal radial artery and facilitate palpation of radial artery cannulation.