Trials
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Randomized Controlled Trial Comparative Study
Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial.
The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. ⋯ If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain.
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Randomized Controlled Trial Comparative Study
The effect of mannitol on intraoperative brain relaxation in patients undergoing supratentorial tumor surgery: study protocol for a randomized controlled trial.
The risk of brain swelling after dural opening is high in patients with midline shift undergoing supratentorial tumor surgery. Brain swelling may result in increased intracranial pressure, impeded tumor exposure, and adverse outcomes. Mannitol is recommended as a first-line dehydration treatment to reduce brain edema and enable brain relaxation during neurosurgery. Research has indicated that mannitol enhanced brain relaxation in patients undergoing supratentorial tumor surgery; however, these results need further confirmation, and the optimal mannitol dose has not yet been established. We propose to examine whether different doses of 20% mannitol improve brain relaxation in a dose-dependent manner when administered at the time of incision. We will examine patients with preexisting mass effects and midline shift undergoing elective supratentorial brain tumor surgery. ⋯ The aim of this study is to determine the optimal dose of 20% mannitol for intraoperative infusion. We will examine brain relaxation and outcome in patients undergoing supratentorial tumor surgery. If our results are positive, the study will indicate the optimal dose of mannitol to improve brain relaxation and avoid side effects during brain tumor surgery.
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Randomized Controlled Trial Multicenter Study
Acupressure for agitation in nursing home residents with dementia: study protocol for a randomized controlled trial.
Agitation is prevalent among people with dementia (PWD) in nursing homes. It frustrates both the PWD and their caregivers. Acupressure is a non-pharmacological intervention whose effectiveness is supported by preliminary studies. However, there is still a dearth of evidence to explain its effect for clinical use and further research. The present study is being conducted primarily to investigate the effects of acupressure as compared with sham-acupressure and usual care. ⋯ This trial will provide a higher quality of evidence than previous studies on the use of acupressure for agitation in PWD. It will also provide newer evidence on acupressure in the population of PWD with agitation for clinical application and further research, including the effect on moderating stress, the delayed effect, the added effect on the placebo, and the effect on moderating the participant's use of psychotropic drugs.
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Randomized Controlled Trial Multicenter Study
The INTERVAL trial to determine whether intervals between blood donations can be safely and acceptably decreased to optimise blood supply: study protocol for a randomised controlled trial.
Ageing populations may demand more blood transfusions, but the blood supply could be limited by difficulties in attracting and retaining a decreasing pool of younger donors. One approach to increase blood supply is to collect blood more frequently from existing donors. If more donations could be safely collected in this manner at marginal cost, then it would be of considerable benefit to blood services. National Health Service (NHS) Blood and Transplant in England currently allows men to donate up to every 12 weeks and women to donate up to every 16 weeks. In contrast, some other European countries allow donations as frequently as every 8 weeks for men and every 10 weeks for women. The primary aim of the INTERVAL trial is to determine whether donation intervals can be safely and acceptably decreased to optimise blood supply whilst maintaining the health of donors. ⋯ The INTERVAL trial should yield novel information about the effect of inter-donation intervals on blood supply, acceptability, and donors' physical and mental well-being. The study will generate scientific evidence to help formulate blood collection policies in England and elsewhere.
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Randomized Controlled Trial Multicenter Study
Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial.
The single most distressing symptom for patients with advanced esophageal cancer is dysphagia. Amongst the more effective treatments for relief of dysphagia is insertion of a self-expanding metal stent (SEMS). It is possible that the addition of a palliative dose of external beam radiotherapy may prolong the relief of dysphagia and provide additional survival benefit. The ROCS trial will assess the effect of adding palliative radiotherapy after esophageal stent insertion. ⋯ The ROCS study will be a challenging trial studying palliation in patients with a poor prognosis. The internal pilot design will optimize methods for recruitment and data collection to ensure that the main trial is completed on time. As a pragmatic trial, study strengths include collection of all follow-up data in the usual place of care, and a focus on patient-reported, rather than disease-orientated, outcomes. Exploration of patient experience and health economic analyses will be integral to the assessment of benefit for patients and the NHS.