Trials
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Randomized Controlled Trial Multicenter Study
The Stroke Oxygen Study (SO2S) - a multi-center, study to assess whether routine oxygen treatment in the first 72 hours after a stroke improves long-term outcome: study protocol for a randomized controlled trial.
Mild hypoxia is common in stroke patients and may have significant adverse effects on the ischemic brain after stroke. The use of oxygen treatment is rapidly increasing in European stroke units but is not without side effects. It impedes early mobilization, could pose an infection risk, and may encourage the formation of toxic free radicals, leading to further damage to the ischemic brain. In the Stroke Oxygen Pilot Study (2 or 3 L/min for 72 hours) neurological recovery at one week was better in the oxygen group than in controls, and after correction for difference in baseline stroke severity and prognostic factors, there was a trend to better outcome with oxygen at six months. Oxygen was as effective in mild as in severe strokes.Oxygen saturation is lower at night than during the day, and episodes of oxygen desaturation are common during sleep. Nocturnal oxygen supplementation is likely to reduce the burden of hypoxia without interfering with daytime mobilization and rehabilitation.Before wider use of oxygen supplementation becomes established it is important to obtain better evidence on which patients benefit from such treatment. ⋯ This study will provide evidence on the effectiveness of oxygen supplementation for the treatment of stroke and whether nocturnal oxygen is a potentially beneficial therapy regimen.
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Randomized Controlled Trial Multicenter Study Comparative Study
Use of comparative effectiveness research for similar Chinese patent medicine for angina pectoris of coronary heart disease: a new approach based on patient-important outcomes.
The practice of traditional Chinese medicine (TCM) has a profound history in many Asian countries. TCM syndrome is a set of characteristic physical signs and symptoms shared by a group of patients. Syndrome diagnosis and treatment assignment according to the identified TCM syndrome is a long-held practice of Chinese medicine. Owing to its distinctive way of interpreting illness and administering care, medical practitioners not well educated in TCM theories and practices are generally incapable of giving out prescriptions for Chinese patent drugs. Currently, the existence of a multitude of Chinese patent drugs marked with largely identical indications is further complicating this situation. ⋯ The goal of the study is to establish a methodology for the precise identification of the characteristic indications for which a Chinese patent drug is most effective. The findings of this study will inform the practicality of the proposed evaluation method.
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Randomized Controlled Trial Multicenter Study
Evaluation of a tailored intervention to improve management of overweight and obesity in primary care: study protocol of a cluster randomised controlled trial.
In the UK around 22% of men and 24% of women are obese, and there are varying but worrying levels in other European countries. Obesity is a chronic condition that carries an important health risk. National guidelines, for use in England, on the management of people who are overweight or obese have been published by the National Institute for Health and Clinical Excellence (NICE, 2006). NICE recommendations for primary care teams are: determine the degree of overweight and obesity; assess lifestyle, comorbidities and willingness to change; offer multicomponent management of overweight and obesity; referral to external services when appropriate. This study investigates a tailored intervention to improve the implementation of these recommendations by primary care teams. ⋯ Although often recommended, the methods of tailoring implementation interventions to account for the determinants of practice are not well developed. This study is part of a programme of studies seeking to develop the methods of tailored implementation.