ANZCTR search results

This study will profile the gut and the oral microbiome of highly trained athletes before and after a 21-d block of intensified training to determine if changes in the community profile occur with highly controlled exposure to three different training diets (high-carbohydrate [CHO], high-fat low-CHO, and a periodised diet combining high- and low-CHO). The aim of this study is to profile the normal gut and oral microbiome of highly-trained athletes and determine if changes in diet result in concomitant change in gut microbiome community in this population, dependant on the type of diet followed. We hypothesise that the change in dietary pattern along with intensified training will have a pronounced impact on the oral and stool microbial communities.

The aim of the research is to evaluate the feasibility and preliminary efficacy of a 3-month eHealth intervention for women (aged 18-45 years) with a history of pre-eclampsia (within 4 years of diagnosis). Participants (n=90) will be randomly allocated to the intervention (Be Healthe for your Heart) or the control group. Be Healthe for your Heart supports participants to make changes to key lifestyle behaviours associated with cardiovascular risk, using evidence-based behaviour change techniques (e.g. self-monitoring, goal setting). The Be Healthe for your Heart program resources are tailored to women of childbearing age and delivered via website and email newsletters. Outcomes will be measured at baseline and 3-months, including the Framingham Cardiovascular Disease 30-year risk score, cardiovascular disease risk markers (BMI, waist circumference, blood pressure, biochemical markers), lifestyle risk factors (dietary intake, physical activity, stress levels) and general health and well-being. Intervention acceptability will be evaluated using objective usage data and intervention participant feedback via a process evaluation questionnaire.

A recent study has shown that pre-operative carbohydrate loading in adults undergoing laparoscopic surgery can reduce symptoms of nausea, vomiting and pain. A similar trial on the effect of pre-operative carbohydrate loading in children has not been conducted. Our trial aims to determine if pre-operative carbohydrate loading in children has a positive effect on post-operative recovery.

The primary aim of this study is to derive prediction models from baseline variables from the biological and psychosocial domains to identify responders and non-responders to the UPLIFT program. The secondary aim is to gain insight into what characteristics from the biological and psychosocial domains change following completion of the UPLIFT program and at 6 months follow-up. Considering the patient population referred to the program and the characteristics of the UPLIFT program, we hypothesise that the prediction model for success will include baseline variables such as high fear avoidance behaviours, low pain self-efficacy and matched treatment expectations. We hypothesise that the prediction model for non-success will include baseline variables such as high pain catastrophising, high perceived injustice and high scores on the disability and anxiety stress scale. We hypothesise that the derived prediction models will be significantly better at predicting responders and non-responders than the current 55%:45% ratio for treatment success versus non-success from pilot data.

A Phase 1, randomized, 0pen-label study of the relative bioavailability and effect of food on the pharmacokinetics of a novel formulation of PRN2246 compared to a reference formulation. The study will be performed at a single-centre in healthy adult participants. This is a complete-crossover study where each participant will receive all three treatments.

Polymyalgia rheumatica (PMR) is the most common inflammatory rheumatic condition in the elderly, and is typically treated with glucocorticoids (commonly known as 'cortisone' or 'steroids'). This study aims to examine the possible side effects of standard glucocorticoid therapy in people with a new diagnosis of PMR, with a particular focus on changes to muscle and bone health, including the incidence and prevalence of sarcopenia. People with a recent diagnosis of PMR, as well as people who have never been diagnosed with PMR, will undergo a series of assessments including questionnaires, physical examination, blood tests, imaging tests and physical tests in a dedicated exercise laboratory. Assessments will be repeated in all participants after 78 weeks, in order to examine the changes that occur. It is hypothesised that participants with PMR will demonstrate a greater decline in their muscle and bone health, and a higher incidence of sarcopenia, compared to participants without PMR. Ultimately, this would lead to a greater awareness of the need to address muscle and bone health during treatment of PMR.

This study is designed to develop accurate digital diagnostic tests, used on a smart device, for common respiratory illnesses in children and adults including asthma, croup, bronchiolitis, COPD and pneumonia. These tests can then be used in resource-poor communities, emergency departments or via telehealth applications. The aim is to develop tests that are as accurate as an expert clinical assessment but do not need a clinical examination or other investigations such as x-rays to be performed.

This is a prospective randomized controlled trial (RCT) comparing the outcome of patients undergoing primary anterior cruciate ligament reconstruction (ACLR) with either a hamstring tendon (HT) or a quadriceps tendon (QT) autograft. Patient outcomes will be collected and compared between the two surgical cohorts over a 24 month post-operative period, and will include a range of subjective and functional outcomes, knee movement and laxity measures, patient satisfaction, and kneeling tolerance.

Approximatey 50, 000 Australians suffer a new stroke each year. Survivors of stroke often leave hospital unprepared for life back in the community and without support to assist in their transition from hospital to home and self-managing the sequelae of stroke. Using a randomised controlled design, this pilot study will test a novel personalised electronic self-management support intervention consisting (a) standardised patient-centred goal setting (b) integrated e-health self-management support following stroke. Significance: We will determine the feasibility of the proposed intervention in a sample of survivors of stroke and obtain data to inform the design of Phase II and Phase III studies targeting patients with acute stroke who are discharged home from hospital.

Otitis Externa (swimmers ear) is inflammation of the ear canal and leads to significant pain. The current treatment involves ear drops which are difficult to insert and requiring regular insertion. This leads to decreased patient compliance and a notably increasing level of antimicrobial resistance. This project involves the initial assessment of a newly created thermoresponsive ear gel (a gel that is drops at room temperature and changes to a gel a body temperature) in healthy individuals. We hypothesis the ear gel will gelate in the ear canal causing minimal adverse events.