ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31331 results sorted by trial registration date.
  • A randomised controlled trial comparing the benefits of once to twice weekly aerobic cycling exercise on functional fitness and quality of life in haemodialysis patients.

    The primary aim of this research project is to examine changes in health outcomes following the introduction of a single or two cycling exercise sessions a week to kidney failure patients. We hypothesise that after 12 weeks of either once or twice weekly of cycling sessions per week, health outcomes are improved.

  • WorkplaceAid - A trial on improving mental health and physical first aid skills in the workplace

    This study aims to evaluate whether Mental Health First Aid (MHFA) training, delivered in eLearning or Blended learning (eLearning plus face-to-face) modes, leads to improvements in mental health first aid knowledge, stigmatizing attitudes, confidence in supporting a person in the social network with a mental health problem, and self-reported supportive behaviours if someone in their social network develops a mental health problem. It will also evaluate the effects of the training on the participants’ personal help-seeking if they have a mental health problem and on their own mental health.

  • A study to measure markers in the breath of patients with Chronic Obstructive Pulmonary Disease (COPD)

    We are investigating the effect of Indacaterol on the effect on volatile organic compounds (VOCS) in COPD from exhaled air. VOCS would be initially sampled from healthy controls and COPD. The COPD patients would be randomised to treatment or placebo and VOCS measured. We would then determine whether there are specific VOCS in COPD that changes with treatment. Thsi would give us insights into biomarkers for this disease.

  • The effect of modified night lighting on sleep characteristics, and activity levels among admitted inpatients.

    This study will explore the influence of modified night lighting installed in specific locations within hospital patient rooms and toilets, on how well patients sleep, how they move about at night and the effect of the lighting on other related aspects of the environment (such as the use of other forms of lighting at night). The modified lighting is being implemented as part of a larger study, a cluster randomised controlled trial across six RBWH wards, examining whether improved night lighting reduces the number of patient falls on these wards. By collecting this additional data directly from patients before and after the lighting is installed, the current observational study will allow us to compare whether there are differences at the patient-level between control and intervention environments.

  • A night-lighting intervention to reduce inpatient falls: A stepped-wedge cluster randomised controlled trial

    BACKGROUND Falls among older hospital patients are a concerning and costly problem. While most falls occur during the day, nearly 40% happen outside normal hours; potentially while patients attempt to mobilise to and from the toilet in poorly lit environments. A practical solution for these problems is the installation of targeted low-intensity lighting around key room features without disrupting the dark sleep environment. Previous laboratory research has demonstrated improved postural stability and gait among older people with such lighting. Subsequent evaluations in aged care facilities have confirmed high levels of acceptance among staff and residents. In order to test the clinical acceptability of this solution the investigative team recently completed a multi-site user acceptance study (unpublished). Formal patient and staff feedback after ward demonstrations of the novel lighting confirmed both acceptability and the likelihood of sleep and safety improvements. User feedback has been incorporated into the final intervention design for the present trial. AIM We aim to test the effect of the night lighting intervention on ward level patient fall rates. METHODS The effect of our intervention on the primary outcome will be evaluated through a stepped-wedge cluster randomised controlled trial (RCT) across six inpatient wards at the Royal Brisbane and Women's Hospital over fourteen months. A stepped-wedge cluster RCT design describes a staggered roll-out of the intervention across participating wards such that the order of roll-out is randomly generated. Therefore, participating wards provide control data prior to implementation and intervention data after implementation.

  • Can physical activity prevent the associated vascular dysfunction in type 2 diabetes?

    The incidence of type 2 diabetes mellitus (T2DM) is growing rapidly, in part because of the aging population, sedentary lifestyle and diet habits. In 2010, an estimated 257 million people worldwide had T2DM, representing an important global public health issue. Non-healthy diet is commonly accompanied by consumption of sugar-sweetened beverages (SSB), reported to provide little (if any) other nutrition or health benefit. The last 2010 National Nutrition Survey in Australia found that 58% of young adults drink an average of 2.1 cans per day (800mL), which is the first everyday source of sugar. In this context, several studies reported in children and adults high correlation between SSB consumption and risk to develop T2DM due to its effects on weight gain and glucose metabolism. These drinks represent 70 to 120g of sugar per litre and lead to acute transient hyperglycaemia (high level of glucose in blood), reported as a precursor of insulin-resistance but also responsible of endothelial dysfunction in the whole arterial tree. The endothelium is the thin layer of cells that lines the interior surface of heart and blood vessels and helps to control blood pressure through vasodilation and vasoconstriction, the widening and constricting of the blood vessels respectively. However, very few studies have investigated the underlying mechanisms involved in endothelial dysfunction in response to SSB -induced acute hyperglycemia. Briefly, endothelial dysfunction in this context has been demonstrated as an impairment of the capacity of blood vessels vasodilation, probably associated with a reduction in nitric oxide (NO) synthesis or biodisponibility. Previous results from our team has reported for the first time in cutaneous microcirculation the implication of oxidative stress and lower activity of endothelial nitric oxide synthase (eNOS, which is responsible of NO synthesis) in endothelial dysfunction after an acute hyperglycemia in healthy rats. On the top that, our works and other demonstrated that patients with T2M or patients in pre-diabetic state (obese or metabolic syndrome) have chronic NO related endothelial dysfunction even without environmental stress. Thus, the first objective of the present study is to explore the effect of SSB consumption on endothelial function in large as well as in small vessels in healthy and T2M subjects, with a focus on underlying mechanisms of the NO pathway. To improve cardiovascular dysfunction in several diseases, physical exercise is a well-known non pharmacological strategy. The higher antioxidant status in cardiovascular and muscular tissues are likely to account for the positive effects of this strategy for disease prevention or rehabilitation. Physical Exercise exercise training is also reported to improve the NO pathway with higher eNOS expression. Thus, the second objective of the present work will be to investigate the potential preventive effects of physical activity on endothelial dysfunction following acute hyperglycemia in healthy and T2DM participants.

  • A Phase I, open label, randomised, single dose, two-way crossover study to determine the pharmacokinetics of two transdermal oxymorphone patch formulations.

    The purpose of this study is to understand how well oxymorphone in combination with tocopheryl phosphate mix (TPM), is absorbed through the skin and into the bloodstream, with the use of two patches.

  • A Phase I/II Study of the Tolerability, Safety and Pharmacokinetics of Oral Monepantel (MPL) in Individuals with Treatment-Refractory Solid Tumours.

    This study is evaluating the tolerability, safety and pharmacokinetics of Oral Monepantel (MPL) in patients with advanced solid tumours that do not respond to standard treatments. Who is it for? You may be eligible to joint this study if you have progressing and unresectable tumours, and have a life expectancy of greater than three months. All standard treatments need to have been exhausted or are contraindicated. Study details Following enrolment in the study, participants will receive an oral liquid dose of MPL once daily for 28 days. The first three participants enrolled in the study will receive 5mg /kg of body weight in each dose. If there are no toxicities or safety events observed in the first three participants, another three participants will be enrolled and receive 25 mg/kg of body weight in each dose. An additional three participants will be enrolled at 62.5 mg/kg body weight per dose if no toxicities/safety events are observed at 25 mg /kg body weight. If dose-limiting toxicities are observed at any dose level, an additional three participants will be enrolled at the same dose level, before the next dose level is initiated. This study design aims to determine whether there is a safe maximum dose that can be provided to patients with this condition. The results of the study will contribute towards the development of MPL as an anticancer treatment.

  • Recruitment of brown fat in overweight adult humans with high blood pressure

    The primary aim of the study is to investigate the impact of telmisartan treatment on brown fat in humans. The hypothesis is that telmisartan recruits brown fat in humans, thereby improving glucose metabolism.

  • Improving medicine adherence in kidney transplantation

    More people require kidney transplants which are in short supply. It is imperative that people who have kidney transplants take their medicines as prescribed. Poor adherence to prescribed medicines can cause a 60% increased risk of kidney transplant failure. Rejection requires costly hospitalisations, laboratory tests and anti-rejection therapies with associated poor outcomes. This project will develop and test an intervention to help adults requiring a kidney transplant to take their medicines as prescribed. Better medicine adherence results in improved graft life, general well-being, and reduced health care expenditure. Our industry partners share this vision of improved health for people requiring kidney transplantation.

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