ANZCTR search results

This trial will test whether advice alone compared to advice and a pillow device best supports non-supine sleep using the Night Shift as an objective measure of both sleep duration and position. This design could also be employed in the future for a roll out of sleep position interventions, but crucially the optimum intervention would need to be properly validated, which is what this trial aims to do.

This is a randomized, double-blind, placebo-controlled, parallel-group, single ascending dose study in healthy subjects. LPT99, the study drug is an Apaf1 inhibitor that can permeate the cochlea. LPT99 is being developed as a locally administered otoprotective agent that would specifically block apoptosis in the ear without interfering with anti-tumor activity of the platinum-based chemotherapeutic agent delivered systemically. There are four sequential doses: 25 µg (200 µM), 50 µg (400 µM), 75 µg (600 µM) and 100 µg (797 µM). Approximately 32 healthy male and female subjects with normal baseline hearing will be enrolled, with 8 subjects planned for each dose cohort. Each Subject will receive a dose of LPT99 or matching placebo by transtympanic (TT) administration. In all subjects, study drug will be unilaterally delivered (ie, 1 ear will remain untreated, serving as the control ear for that subject). The study will include sentinel subjects in the initial cohort and all subsequent dose escalation cohorts.

The project team, including computer analysts and expert clinicians, will refine and continue to develop facial analysis tools using precise 3-dimensional photography to develop ways to assess treatment response. The hypothesis is: Subtle facial changes associated with treatment response can be assessed and measured by 3D facial analysis

Blood collected from volunteers, also known as allogeneic blood, is donated, processed and made available for patients requiring transfusion, such as during surgery. This is an expensive process; according to the National Blood Authority, the estimated cost associated with blood transfusion in Australia is over $1 billion per year. While the safety of allogeneic blood transfusions has improved over decades, life-threatening risks remain. For example, 617 transfusion-related adverse events were reported in Australia in 2013-2014. These adverse events include wrong blood to wrong patient, transfusion-related lung injury, allergic reaction, infection, cancer recurrence, organ failure and death. Research has linked some of these outcomes to a post-transfusion impairment of the patient’s immune responses. In order to better understand how this happens, the Australian Red Cross Blood Service has developed a series of tests to characterise how transfusion impairs these immune responses. Intraoperative cell salvage is a process where blood lost during surgery is collected, processed and given back to the patient. Use of intraoperative cell salvage may provide a cost-effective and safer alternative to allogeneic blood transfusion. In particular, because patients aren’t exposed to blood from another person, it seems likely that the impairment of immune responses that occurs following allogeneic blood transfusion will be prevented. However, whether or not this assumption is true remains to be investigated. Therefore this research project aims to investigate whether the process of intraoperative cell salvage affects the immune responses of patients. To do so, this research project will use the existing series of assays already developed by the Australian Red Cross Blood Service. This project will be highly significant to the health care system as we anticipate that intraoperative cell salvage, as an alternative to allogeneic blood transfusion, results in better patient care, less harm to patients and a decrease in costs. This important research is led by Dr Michelle Roets, a senior anaesthetist at the Royal Brisbane and Women’s Hospital who has been researching improvements in blood management over the past 10 years. Her work has resulted in authorship of the ‘Guidance for the Provision of Intraoperative Cell Salvage’ National documents with the National Blood Authority in Australia. Dr Roets has teamed up with the Australian Red Cross Service to co-ordinate an expert team and evaluate the association between immune suppression and infection risk after allogeneic blood transfusion compared to intraoperative cell salvage. These results hope to significantly improve current blood administration practice.

We developed a smartphone-based cardiac rehabilitation programme that provides participants with 1) real-time exercise monitoring and coaching from rehabilitation specialists, and 2) educational and social support to make heart healthy lifestyle changes, regardless of where they live. This overcomes key accessibility issues that stop many people participating in traditional hospital-based programmes.. This study will compare health effects and costs of smartphone-based and traditional rehabilitation programmes. We expect the accessibility of the smartphone-based programme will increase participation, improve health outcomes, and reduce costs. Exercise training is a central component of global guidelines for the secondary prevention of ischaemic heart disease and traditional programs delivered in face-to-face settings result in numerous health and wellness benefits. However, uptake and adherence to these programs is low. Accessibility barriers are among the key factors limiting participation rates, especially in regional and rural areas. Our trial will assess the effectiveness of a telerehabilitation program that uses mobile and internet technologies to emulate face-to-face exercise supervision and coaching, and deliver education and strategies to support healthy lifestyle behaviours. 220 participants will receive 1) 24 weeks of usual care (i.e. face-to-face) cardiac rehabilitation or 2) 24 weeks of telerehabilitation in addition to usual care. We will compare physical fitness, risk factors associated with heart disease, lifestyle behaviours, program adherence, and costs between these two groups. This telerehabilitation delivery model has potential to improve the reach and accessibility of cardiac rehabilitation services, and satisfy the unique preferences of many people who are currently unable or unwilling to attend face-to-face programs.

The aim of this study is to demonstrate the effects of 28-days supplementation with a novel probiotic formulation on mental fatigue following a cognitive load in healthy adults. Half of the participants will receive the probiotic formulation while the other half will receive placebo.

Cardiovascular disease (CVD) is the leading cause of death worldwide. Dyslipidaemias and insulin resistance have been associated with the development of CVD. In addition, elevated levels of chronic inflammation has also been shown to play a key role in the pathobiology of CVD. Targeting blood lipid levels, insulin sensitivity and chronic inflammation in high risk individuals may help to ameliorate these modifiable risk factors and reduce the overall risk of developing CVD. Phytosterols are well-known cholesterol-lowering agents, resulting in 10% reductions in LDL-C in only 3-4 weeks of supplementation. Oat beta-glucan is a rich source of soluble fibre which has been shown to lower cholesterol levels with implications for glucose control. This project aims to investigate if combined dietary supplementation with plant sterols and beta-glucan reduces blood cholesterol and to a larger extent than either of the treatments alone.It is expected that participants will have improved levels of blood cholesterol as well as an overall reduced 10-year risk of developing CVD.

Several types of material are commonly used in anterior cruciate reconstruction (ACLR) with the majority of these coming from around the knee. Harvesting tendons may, however in itself cause pain and dysfunction. It is therefore desirable to identifly a harvesting method which does not lead to additional injury and possible dysfunction of the already injured knee while at the same time minimising such problems in other areas of the body. In recent years a small number of studies have been published regarding the use of peroneus longus (a tendon on the outside of the leg) autograft (PLA). These studies suggests PLA is a safe graft choice for ligament reconstruction and causes minimal dysfunction at the harvest site (the ankle). Our hypothesis is that PLA will perform as well as a hamstring tendon in ACLR while not causing pain and loss of strength in the knee nor significant dysfunction at the ankle . The project may potentially lead to the identification of peroneus longus as a suitable graft choice for ACLR. After the pilot study is completed we plan to conduct a randomised trial of peroneus longus versus standard graft (hamstring) to identify whether peroneus longus is superior to standard technique. These studies may lead to an improvement in the standard of care for patients with ACL rupture.

The Mums on the Move study aims to explore the feasibility of a multi-component 12-week home-environment pilot intervention delivered to first-time mothers at risk of PND for increasing physical activity, with the view to inform the development of a larger intervention trial in future. The study also aims to examine changes in depressive symptoms as a result of participating in the intervention.

This proposal will determine whether a beta-adrenoceptor agonist can reduce hepatic fat content and improve metabolic control in obese humans. Accumulation of hepatic fat is an early onset and causative factor in liver and obesity-related metabolic diseases and reversal can delay or prevent sequelae. However there are currently no drugs available on-label to treat fatty liver. Increasing daily energy expenditure decreases liver fat independent of weight loss in rodents. Beta-adrenoceptor activation increases energy expenditure in rodents and humans. This proposal will therefore employ a randomised, placebo-controlled, parallel study design in combination with clinically relevant metabolic endpoints to test whether chronic treatment with a beta-adrenoceptor agonist can decrease liver fat in humans.