Trials
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Randomized Controlled Trial Multicenter Study
Effects of a transitional palliative care model on patients with end-stage heart failure: study protocol for a randomized controlled trial.
Heart failure (HF) is characterized by high rates of readmission after hospitalization, and readmission is a major contributor to healthcare costs. The transitional care model has proven efficacy in reducing the readmission rate and economic outcomes, and increasing satisfaction with care. However, the effectiveness of the transitional care model has not been evaluated in patients with end-stage HF. This study was designed to compare the customary hospital-based care and a comprehensive transitional care model, namely the Home-based Palliative HF Program (HPHP), in terms of readmission rate, quality of life, and satisfaction with care among end-stage HF patients under palliative care. ⋯ This study is original and will provide important information for service development in the area of palliative care. The introduction of palliative care to end-stage organ failure patients is new and has received increasing attention worldwide in the last decade. This study adopts the randomized controlled trial, a vigorous research design, to establish scientific evidence in exploring the best model for end-stage HF patients receiving palliative care.
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Randomized Controlled Trial Multicenter Study
CAMERA2 - combination antibiotic therapy for methicillin-resistant Staphylococcus aureus infection: study protocol for a randomised controlled trial.
Methicillin-resistant Staphylococcus aureus (MRSA) bacteraemia is a serious infection resulting in 20-50 % 90-day mortality. The limitations of vancomycin, the current standard therapy for MRSA, make treatment difficult. The only other approved drug for treatment of MRSA bacteraemia, daptomycin, has not been shown to be superior to vancomycin. Surprisingly, there has been consistent in-vitro and in-vivo laboratory data demonstrating synergy between vancomycin or daptomycin and an anti-staphylococcal β-lactam antibiotic. There is also growing clinical data to support such combinations, including a recent pilot randomised controlled trial (RCT) that demonstrated a trend towards a reduction in the duration of bacteraemia in patients treated with vancomycin plus flucloxacillin compared to vancomycin alone. Our aim is to determine whether the addition of an anti-staphylococcal penicillin to standard therapy results in improved clinical outcomes in MRSA bacteraemia. ⋯ Key potential advantages of adding anti-staphylococcal β-lactams to standard therapy for MRSA bacteraemia include their safety profile, low cost, and wide availability.
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Randomized Controlled Trial Comparative Study
Efficacy and safety of carbetocin applied as an intravenous bolus compared to as a short-infusion for caesarean section: study protocol for a randomised controlled trial.
The two most commonly used uterotonic drugs in caesarean section are oxytocin and carbetocin, a synthetic oxytocin analogue. Carbetocin has a longer half-life when compared to oxytocin, resulting in a reduced use of additional uterotonics. Oxytocin is known to cause fewer cardiovascular side effects when administered as a short-infusion compared to as an intravenous bolus. Based on these findings, we aim at comparing carbetocin 100 mcg given as a slow intravenous bolus with carbetocin 100 mcg applied as a short-infusion in 100 ml 0.9 % sodium chloride in women undergoing a planned or unplanned caesarean delivery. We hypothesise uterine contraction not to be inferior to a bolus application (primary efficacy endpoint) and greater haemodynamic stability to be achieved after a short-infusion than after a bolus administration, as measured by heart rate and mean arterial blood pressure (primary safety endpoint). ⋯ Haemodynamic stability and adequate uterine tone are important outcomes in caesarean sections. The results of this trial may be used to optimise these factors and thereby increase patient safety due to a reduction in cardiovascular side effects.
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Randomized Controlled Trial
Cognitive rehabilitation for Parkinson’s disease dementia: a study protocol for a pilot randomised controlled trial.
There is growing interest in developing non-pharmacological treatments to address the cognitive deficits apparent in Parkinson's disease dementia and dementia with Lewy bodies. Cognitive rehabilitation is a goal-oriented behavioural intervention which focuses on improving everyday functioning through management of cognitive difficulties; it has been shown to be effective in Alzheimer's disease. To date, no studies have assessed its potential efficacy for addressing the impact of cognitive impairment in people with Parkinson's disease or dementia with Lewy bodies. ⋯ This pilot study will evaluate the application of cognitive rehabilitation for the management of cognitive difficulties associated with Parkinson's disease dementia and dementia with Lewy bodies. The results of the study will inform the design of a fully powered randomised controlled trial.
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Adaptive designs have the potential to improve efficiency in the evaluation of new medical treatments in comparison to traditional fixed sample size designs. However, they are still not widely used in practice in clinical research. Little research has been conducted to investigate what adaptive designs are being undertaken. ⋯ In phase III trials, the most popular form of adaptation is the group sequential design. The review failed to capture all trials with adaptive designs, which suggests that the reporting of adaptive designs, such as in clinical trials registers, needs much improving. We recommend that clinical trial registers should contain sections dedicated to the type and scope of the adaptation and that the term 'adaptive design' should be included in the trial title or at least in the brief summary or design sections.