Trials
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Randomized Controlled Trial
A mobile phone intervention to reduce binge drinking among disadvantaged men: study protocol for a randomised controlled cost-effectiveness trial.
Socially disadvantaged men are at a substantially higher risk of developing alcohol-related problems. The frequency of heavy drinking in a single session is high among disadvantaged men. Brief alcohol interventions were developed for, and are usually delivered in, healthcare settings. The group who binge drink most frequently, young to middle-aged disadvantaged men, have less contact with health services and there is a need for an alternative method of intervention delivery. Text messaging has been used successfully to modify other adverse health behaviours. This study will test whether text messages can reduce the frequency of binge drinking by disadvantaged men. ⋯ This study will assess the effectiveness of a brief intervention, delivered by text messages, aimed at reducing the frequency of binge drinking in disadvantaged men. The process measures will identify components of the intervention which contribute to effectiveness. The study will also determine whether any benefit of the intervention is justified by the costs of intervening.
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Randomized Controlled Trial
Effect of a structured psycho-oncological screening and treatment model on mental health in cancer patients (STEPPED CARE): study protocol for a cluster randomized controlled trial.
High levels of emotional distress in cancer patients often goes unnoticed in daily clinical routine, resulting in severe undertreatment of mental health problems in this patient group. Screening tools can be used to increase case identification, however, screening alone does not necessarily translate into better mental health for the patient. Doctors play a key role in providing basic emotional support and transferring the patients in need of such specific support to mental health professionals. This study investigates whether a stepped care model, combining screening, doctor consultation and professional psycho-oncological service in a structured way, improves the emotional wellbeing of cancer patients. ⋯ Mental health problems not only cause emotional suffering but also direct and indirect costs. This calls for timely and adequate psychosocial support, especially as we know that such support is effective. However, not every cancer patient can and must be treated by a mental health professional. Allocating limited resources most sensibly and economically is of crucial importance for our healthcare system to ensure the best quality of care to as many patients as possible. It is the hope of the STEPPED CARE trial that this model is both effective and efficient, and that it can be implemented in other hospitals as well, if proven to be effective.
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Randomized Controlled Trial
Prevention of post-mastectomy neuropathic pain with memantine: study protocol for a randomized controlled trial.
N-methyl-D-aspartate receptor antagonists are potential therapies for neuropathic pain, and memantine has a good tolerance profile. A preclinical study recently reported that presurgery memantine may prevent neuropathic pain development and cognition dysfunction. Considering the high prevalence of breast cancer and of post-mastectomy neuropathic pain, a clinical trial is carried out to evaluate if memantine may prevent neuropathic pain development and maintain cognitive function and quality of life in cancer patients. ⋯ The hypothesis of this translational approach is to confirm in patients the beneficial prophylactic effect of memantine observed in animals. Such a protective action of memantine against neuropathic pain and cognitive dysfunction would greatly improve the quality of life of cancer patients.
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The Core Outcome Measures in Effectiveness Trials (COMET) Initiative database is an international repository of studies relevant to the development of core outcome sets. By the end of 2013, it included a unique collection of 306 studies. ⋯ There has been a rise in visits from outside the United Kingdom, with 2,405 such visits in 2013 (30% of all visits). By December 2013, a total of 4,205 searches had been completed, with 2,139 in 2013 alone.
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Randomized Controlled Trial
Effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: statistical analysis plan for a randomized controlled trial.
One of the main causes of mortality and morbidity following subarachnoid hemorrhage (SAH) is the development of cerebral vasospasm, a frequent complication arising in the weeks after the initial bleeding. Despite extensive research, no effective treatment of vasospasm exists to date. Prostacyclin is a potent vasodilator and inhibitor of platelet aggregation. In vitro models have shown a relaxing effect of prostacyclin after induced contraction in cerebral arteries, and a recent pilot trial showed a positive effect on cerebral vasospasm in a clinical setting. No randomized clinical trials have investigated the possible pharmacodynamic effects of prostacyclin on the human brain following SAH. ⋯ The primary outcome has been altered slightly since the publication of our study protocol. Global cerebral blood flow is now primary outcome, whereas regional blood flow is a secondary outcome.