Trials
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Randomized Controlled Trial
Inhaled nitric oxide for the adjunctive therapy of severe malaria: protocol for a randomized controlled trial.
Severe malaria remains a major cause of global morbidity and mortality. Despite the use of potent anti-parasitic agents, the mortality rate in severe malaria remains high. Adjunctive therapies that target the underlying pathophysiology of severe malaria may further reduce morbidity and mortality. Endothelial activation plays a central role in the pathogenesis of severe malaria, of which angiopoietin-2 (Ang-2) has recently been shown to function as a key regulator. Nitric oxide (NO) is a major inhibitor of Ang-2 release from endothelium and has been shown to decrease endothelial inflammation and reduce the adhesion of parasitized erythrocytes. Low-flow inhaled nitric oxide (iNO) gas is a US FDA-approved treatment for hypoxic respiratory failure in neonates. ⋯ Noteworthy aspects of this trial design include its efficient sample size supported by a computer simulation study to evaluate statistical power, meticulous attention to complex ethical issues in a cross-cultural setting, and innovative strategies for safety monitoring and blinding to treatment allocation in a resource-constrained setting in sub-Saharan Africa.
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Randomized Controlled Trial Comparative Study
Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial.
Perforated diverticulitis is a condition associated with substantial morbidity. Recently published reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised study has published any results. ⋯ HP is associated with a high rate of complication. Not only does the primary operation entail complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe, minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer re-operations, decreased morbidity, mortality, costs and increased quality of life.
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Randomized Controlled Trial
Transfusion of red cells in hematopoietic stem cell transplantation (TRIST): study protocol for a randomized controlled trial.
Insight regarding transfusion practices in Hematopoietic Stem cell Transplantation (HSCT) are lacking and the impact of red cell transfusion in this high risk group on outcomes following HSCT are not well appreciated. Red blood cell transfusion can be life-saving, however, liberal use of transfusion in critically ill patients failed to demonstrate significant clinical benefit. A large number of other observational studies have also demonstrated an association between red blood cell transfusions and increased morbidity such as infections and multi organ failure as well as increased mortality. The role of red cell transfusion on the clinical outcomes observed in patients undergoing HSCT remains poorly understood and a prospective randomized study of transfusion is required to gain insight and knowledge on best transfusion practices in this high risk population. ⋯ Upon completion, this pilot trial will provide preliminary insight into red cell transfusion practice and its influence in hematopoietic stem cell transplant outcomes. The results of this trial will inform the conduct of a larger study.
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Randomized Controlled Trial Comparative Study
A comparison of specialist rehabilitation and care assistant support with specialist rehabilitation alone and usual care for people with Parkinson's living in the community: study protocol for a randomised controlled trial.
Parkinson's Disease is a degenerative neurological condition that causes movement problems and other distressing symptoms. People with Parkinson's disease gradually lose their independence and strain is placed on family members. A multidisciplinary approach to rehabilitation for people with Parkinson's is recommended but has not been widely researched. Studies are needed that investigate cost-effective community-based service delivery models to reduce disability and dependency and admission to long term care, and improve quality of life. ⋯ The trial investigates components of recent national policy recommendations for people with long term conditions, and Parkinson's Disease in particular, and will provide guidance to inform local service planning and commissioning.
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Randomized Controlled Trial
The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial.
The serious mental illness Health Improvement Profile [HIP] is a brief pragmatic tool, which enables mental health nurses to work together with patients to screen physical health and take evidence-based action when variables are identified to be at risk. Piloting has demonstrated clinical utility and acceptability. ⋯ The results of the trial and process observation will provide information about the effectiveness of the HIP Programme in supporting MHNs to address physical comorbidity in serious mental illness. Given the current unacceptable prevalence of physical comorbidity and mortality in the serious mental illness population, it is hoped the HIP trial will provide a timely contribution to evidence on organisation and delivery of care for patients, clinicians and policy makers.