ANZCTR search results

This is a multi-centre prospective cohort study to collect data related to management of Hormone Receptor positive, HER2 negative advanced breast cancer in a real-world patient population. Who is it for? You may be elgible for this study if you are aged 18 years or older, of any gender and you have been diagnosed with metastatic, or inoperable histologically confirmed HR+, HER2- breast cancer (either metastatic at diagnosis or relapsed), after 1st January 2020. Study details All enrolled participants will contribute health data to the development of the registry. Participants will not have to attend additional appointments or undergo additional blood tests or scans outside of their routine treatment. Information collected from participants will include duration of therapy, the rationale for any change in treatment and uptake of targeted therapies or immunotherapy. This study will also collect data on any treatment received in the (neo) adjuvant setting, including chemotherapy and endocrine therapy as this does impact subsequent treatment decisions and treatment order in the metastatic setting. It is hoped this research will contribute important information about all patients with HR+, HER2- advanced breast cancer and help to inform future treatment decision-making for clinicians.

This research project is investigating how a right ventricular strain, also known as deformation, obtained during trans-oesophageal echocardiography, may be used to predict kidney failure in patients who are placed on cardiopulmonary bypass for heart and lung surgery. Right ventricular strain may be calculated from echocardiographic images, already taken during heart surgery. Trans-oesophageal ultrasound is an established bedside ultrasound investigation that is used on most patients having heart and lung surgery. Recent technological advancements have allowed us to look at the heart in more detail with the aim of improving the outcomes of these patients. Kidney failure is a major problem after heart and lung surgery and increases post-operative mortality. It also results in longer hospital stays, invasive investigations, invasive treatments, and may result in the patient needing long term dialysis and transplantation. Our understanding of how right ventricular strain relates to kidney dysfunction is currently very poor. This research project will improve our understanding and our aim is that this will enable us to direct treatments to preserve kidney function in at risk patients and improve the burden of kidney failure on the patients affected and on the hospitals taking care of them.

The aim of the Evaluation of the EYI is to determine whether the EYI improved the reach of community supports, programs, and services in the partner communities over the term of the EYI; and how this may have influenced the development, health, and learning of children from conception to age four.

Since 2010, there has been an increase in the prevalence of sleep difficulties in adults which coincides with the use of digital devices (Adams, Appleton, Taylor, McEvoy, & Antic, 2016). This is thought to be due to the time spent surfing the internet and/or to exposure to blue light known to impact circadian entrainment, melatonin secretion, alertness, sleep regulation and the pupillary light reflex (Bauer et al., 2018; Touitou, Touitou, & Reinberg, 2016). There is also a growing body of research investigating the impact of pulse-modulated radiofrequency electromagnetic field exposure on sleep quality, however the majority of these studies involve near head exposures to mobile phones in a sleep laboratory (Loughran, McKenzie, Jackson, Howard, & Croft, 2012; Lustenberger et al., 2013; Lustenberger et al., 2015; Schmid et al., 2012) which do not represent real world scenarios to wireless devices typically used in the home so the clinical significance to the larger population is essentially unknown. It is hypothesized that poorer subjective and objective sleep quality would be found during RF-EMF exposure compared to placebo exposure. Adams, R., Appleton, S., Taylor, A., McEvoy, D., & Antic, N. (2016). Report to the Sleep Health Foundation 2016 Sleep Health Survey of Australian Adults: The Adelaide Institute for Sleep Health: University of Adelaide. Bauer, M., Glenn, T., Monteith, S., Gottlieb, J. F., Ritter, P. S., Geddes, J., & Whybrow, P. C. (2018). The potential influence of LED lighting on mental illness. World J Biol Psychiatry, 19(1), 59-73. doi:10.1080/15622975.2017.1417639 Loughran, S. P., McKenzie, R. J., Jackson, M. L., Howard, M. E., & Croft, R. J. (2012). Individual differences in the effects of mobile phone exposure on human sleep: rethinking the problem. Bioelectromagnetics, 33(1), 86-93. doi:10.1002/bem.20691 Lustenberger, C., Murbach, M., Dürr, R., Schmid, M. R., Kuster, N., Achermann, P., & Huber, R. (2013). Stimulation of the Brain With Radiofrequency Electromagnetic Field Pulses Affects Sleep-Dependent Performance Improvement. Brain Stimulation, 6(5), 805-811. doi:https://doi.org/10.1016/j.brs.2013.01.017 Lustenberger, C., Murbach, M., Tüshaus, L., Wehrle, F., Kuster, N., Achermann, P., & Huber, R. (2015). Inter-individual and intra-individual variation of the effects of pulsed RF EMF exposure on the human sleep EEG. Bioelectromagnetics, 36(3), 169-177. doi:doi:10.1002/bem.21893 Schmid, M. R., Loughran, S. P., Regel, S. J., Murbach, M., Bratic Grunauer, A., Rusterholz, T., . . . Achermann, P. (2012). Sleep EEG alterations: effects of different pulse-modulated radio frequency electromagnetic fields. J Sleep Res, 21(1), 50-58. doi:10.1111/j.1365-2869.2011.00918.x Touitou, Y., Touitou, D., & Reinberg, A. (2016). Disruption of adolescents' circadian clock: The vicious circle of media use, exposure to light at night, sleep loss and risk behaviors. J Physiol Paris, 110(4 Pt B), 467-479. doi:10.1016/j.jphysparis.2017.05.00

Effect of Yeast protein compared to whey protein and a placebo on muscle mass and performance in an Adult Population – A double blind, randomised controlled trial. The aim of this study is to assess the effectiveness of yeast protein for increasing muscle mass and strength compared to whey protein and a placebo in otherwise healthy adults aged over 40 years old. Yeast protein supplementation is hypothesised to result in equivalent muscle gains when compared to whey protein and superior gains when compared to a placebo.

The PERKS-International trial, which has received funding from the Australian National Health and Medical Research Council (application ID APP1182071), will be of 4 years (2021-2024) duration and involve 790 participants who will be recruited and followed for at least 12 months. The Menzies Institute for Medical Research, University of Tasmania will be responsible for co-ordination of the PERKS-International trial. This is a Phase III, prospective, pragmatic, open-label, single blinded endpoint 2 arm randomised controlled trial (RCT) including 790 participants across Australia and New Zealand. Participants will be adults aged >35 and <=75 years with two or more modifiable risk factors (smoking, overweight, low physical activity, poor diet, high blood pressure, high total cholesterol or high blood glucose). Participants will be randomised using a stratified block approach to either the intervention or usual care group. After undergoing a detailed health assessment, participants will be randomised to receive feedback on their risk factors for stroke in one of two ways. Our hypothesis is that those who receive feedback using one method (intervention group - IG) will have better improvements in their risk factors as compared to people who receive the information about their risk factors using the other method (usual care group - UCG). Blinded assessments will be conducted face-to-face at baseline and 6 months and by online or telephone assessment at 3 and 12 months. The primary outcome is the change in the total combined cardiovascular risk factor score (LS7 score) from baseline to 6 months post-randomisation in the intervention group compared to usual care group.

The study will take place over 7 days in a free living environment. It will involve toddlers between the ages of 2 and 7 who have had type 1 diabetes for greater than 1 year. During this 7 day time period we will monitor their blood glucose levels through the use of a continuous glucose monitor, along with the amount of exercise they undertake which will be done using accelerometers. At the end of the 7 day period parents will be asked two complete two surveys, one around the fear of hypoglycaemia and the other around the barriers to physical activity. Accelerometer data will then be compared to an aged matched population group. This will help us gather information young children with type 1 diabetes and how they are participating in exercise.

This project will compare leading methods for technology-assisted dietary assessment. Excessive cost and questionable accuracy limit the routine use of dietary assessment and undermine decision making in Australia. Three technology 24-hour recall methods of assessing diet will be compared . The approach will confirm if the use of food images and automated methods provide new approaches to improve accuracy and consumer acceptability. The outcomes of this project will lead to more accurate and acceptable methods to assess dietary intake to inform effective government decision making about the types, amounts and drivers of food consumption of the population.

Atrial fibrillation (AF) is the most common arrhythmia in Australia and confers a significant risk of stroke, heart failure and death. Furthermore, patients with symptomatic AF represent a growing burden on the Australian healthcare system. In view of this epidemic, new approaches to preventing and managing the symptoms and complications of AF are required. Sodium-glucose co-transporter-2 (SGLT2) inhibitors are new class of medications designed with diabetes in mind via the renal excretion of glucose. However, in addition to lowering blood glucose, these agents also appear to have significant pleiotropic effects on multiple cardiometabolic factors that are associated with AF.There is strong rationale for the potential benefit of SGLT2 inhibition in patients with AF. However, this class of medications have not been previously tested in these individuals. This study is a Phase II, investigator-initiated, multicenter, randomised controlled trial, investigating the use of Empagliflozin, a SGLT2 inhibitor in patients with AF. It is anticipated that SGLT2 inhibition with Empagliflozin will significantly reduce AF symptoms and arrhythmia burden. A total of 300 participants with symptomatic paroxysmal or persistent AF will be recruited and randomised in 1:1 ratio to Empagliflozin or Placebo. Participants will attend follow up clinic visits every 3 months for a 1-year period.

The aim of this study is to examine whether subgroup classification of chronic low back pain patients results in differing effects from a device based isolated, targeted and progressive resistance strength rehabilitation programme (24 Sessions) on respective measures of spinal strength, range of motion and pain and disability. The sustainability of the results will be examined in a 12 month followup. It is hypothesized that all groups will respond positively to the device based rehabilitation as the specific nature of the exercise addresses the underlying weak spinal musculature as a major factor in all patients with chronic low back pain.