ANZCTR search results

Preliminary evidence shows that low-dose naltrexone (LDN) has a clinically beneficial impact on fibromyalgia pain, function and quality of life. However, only a few small clinical trials with high risk of bias have investigated the effect of LDN on fibromyalgia symptoms. The primary aim of this double-blind, randomised, controlled trial is to evaluate the efficacy of LDN in reducing pain in patients with fibromyalgia over a 12-week period.

People often have poor balance and trunk stability after they have a spinal cord injury, but the ability to maintain an upright position when sitting is important for their function. There is no gold standard assessment to measure this type of balance in people with an acute spinal cord injury. We plan to test three assessments (1. the Function in Sitting Test for people with spinal cord injury (FIST-SCI), 2. the modified FIST (mFIST), and 3. the Trunk Control Test (TCT)), used by physiotherapists in a clinical setting, and identify which assessments are the most valid and reliable assessments for people with acute spinal cord injury. Once identified, the researcher involved in this study will educated clinicians and other researchers on the best assessment to use, helping to improve clinical care and future research studies.

Maternal immunisation, a low cost/high efficacy intervention is recommended for its pathogen specific protection. We believe maternal immunisation has another, massive impact: reduction of preterm birth (PTB). Our overarching question is: how does maternal immunisation alter the immune system in pregnant women and/or their newborn to reduce adverse pregnancy outcomes and enhances the newborn infant’s capacity to protect from infectious diseases during early childhood? To answer this question and potentially impact on the single greatest cause of childhood mortality globally we are conducting a multi-site, prospective observational cohort study collecting maternal and infant biosamples at defined time points during pregnancy and post partum from nulliparous women. We plan to enrol 400 women and apply systems biology to determine the immune trajectory in pregnancy and the impact of maternal immunisation (including influenza, pertussis and/or COVID-19 vaccines) on this trajectory. We also plan to delineate the impact of maternal immunisation on the immune trajectory of the infant.

Introduction: You are invited to take part in this research project, Systemic fibrinolytic Activity of Intrapleural Alteplase in Pleural Infection. This is because you have a pleural infection (which means that fluid has collected around the lung and is infected) and you are to have Intrapleural Alteplase as part of your standard of care. The research project is aiming to test if a common treatment for pleural infection (Alteplase), will enter the bloodstream and circulate around the body after it is given into the pleural fluid. Purpose: The lung and the inside of the chest wall are both covered by a thin lining called the pleura. Under normal circumstances, this lining produces a very small amount of fluid to lubricate the lung during breathing. Sometimes there can be a build-up of fluid in the space between the pleural linings which gets infected, which is called a pleural infection. These occur in up to 50% of people who have pneumonia (infection of the lung), but are often very small and can’t be seen on a chest x-ray. In many cases, they clear up with antibiotics; less commonly, a chest tube is required to drain the fluid. Sometimes chest drainage is not enough to clear the fluid as a mesh of protein locks away the infected fluid in pockets which the chest tube may not reach. When these protein-pockets happen, people are said to have a complex pleural effusion. To help break down these protein-pockets, sometimes a medication called Alteplase is given through the chest tube. Alteplase has been proven to help people with pleural infection that also have complex pleural effusions, to get better and avoid surgery. It doesn’t appear to be absorbed into the body when given into the pleural space but this hasn’t been proven. We are doing this project to see if this is true or not. It is important to know if Alteplase given into the pleural space enters the blood-stream as it can cause bleeding in other parts of the body if this happens. What does participation involve: There is a list of criteria that must be met in order to participate in the study. The study team believe you meet the study criteria and that is why you have been approached about it. If you agree to the study, you will be participating in a prospective study. You will have 1 additional blood tests per dose of Alteplase compared to normal treatment, taking about 20mls of blood from your veins each time. This will be done 45 minutes after receiving Alteplase. The blood will be taken either by a lung specialist or a specialist nurse. If it is anticipated that there will be difficulty taking these blood sample, a lung specialist will acquire the blood with the help of an ultrasound machine.

This is a mixed methods prospective cohort study aiming to assess the impact of introducing a safety bundle for all operative vaginal birth (OVB) at Monash Health. This will include up-skilling obstetric staff in the use of intrapartum ultrasound, which they will be encouraged to use routinely prior to OVB. Additionally, we will introduce a routine team time out and procedural checklist to be performed at all OVB. We hypothesize that this bundle will reduce composite maternal and neonatal morbidity and mortality for women where OVB is considered during their clinical care. Secondarily we will assess uptake of all aspects of the bundle, rates of incorrect determination of fetal head position, unsuccessful instrumental birth attempts, mode of delivery and healthcare worker uptake and experience of the bundle. Our primary outcome is composite neonatal morbidity and mortality, which we will compare the 18months following safety bundle intervention to a historical cohort 18months preceding role out of the safety bundle.

Exercise has been shown to improve the health of people with chronic liver disease. It may improve a person’s strength and endurance and help them manage their weight. Exercise programs for conditions like chronic liver disease are often provided at hospitals or community centres which can be inconvenient for people to attend and incur costs associated with travel and parking. Telerehabilitation is an alternative treatment which involves completing an exercise program at home, with exercise guidance provided through a video call with the exercise supervisor. The aim of this study is to investigate the effects of a telerehabilitation program on the health and fitness of people with chronic liver disease. If shown to be effective, telerehabilitation will make an exercise program much easier to access for people with chronic liver disease. This project is being conducted by a student and will form the basis of a Physiotherapy with Honours degree at Curtin University, under the supervision of an experienced Fiona Stanley Hospital Exercise Physiologist and Gastroenterologist. We hypothesise that participants that complete a telerehabilitation program over 8 weeks will improve their strength, endurance, muscle mass and quality of life, while reducing their body fat content when compared to control participants that receive usual care and do not complete a formal exercise program.

Endogenous testosterone has been associated with increased lean mass and exercise performance in young and elderly women and testosterone therapy increased lean mass in two pilot randomized controlled trials. However, our systematic review and meta-analyses found no effect of exogenous testosterone on muscle strength or performance, as prior studies have been small (<20 participants per group) and of short duration (6-16 weeks). The aim of this two-arm parallel-group randomized placebo-controlled trial is to determine whether testosterone therapy results in significant gains in muscular power over placebo in postmenopausal women. Participants will be randomly allocated to receive either transdermal testosterone or identical placebo for 26 weeks. The primary outcome will be body weight-corrected power (watts/kg) determined from the maximal vertical jump test on a Leonardo Mechanography Ground Reaction Force Platform (Novotec Medical GmbH). This innovative technology allows for measurement of force, velocity and centre of gravity/sway. It is reproducible and appropriate for older women. Secondary outcomes include grip strength, balance, proprioception, coordination, performance, endurance, and fatiguing (all measured using Leonardo Mechanography), body composition, bone mineral density (BMD), and health-related quality of life. This study addresses the conditions highlighted in the National Women’s Health Strategy 2020-2030 as being of the greatest significance and urgency for older women, who are notably underrepresented in research. It will generate new knowledge in testosterone action and therapy in relation to the preservation of muscle mass and function in postmenopausal women, and potentially provide evidence for novel approaches to prolong the morbidity-free life span of Australian women. This study will provide much needed reference data, presently lacking, for the effect of transdermal testosterone on preservation of muscle mass and function, which will inform the design of future studies of testosterone and other potential therapies. The findings will lead to high impact publications, and potentially transformative interventions ensured by Prof Davis’s standing as the world expert on testosterone in women.

This proof-of-concept randomised double-blind placebo-controlled crossover study will determine the effects of transdermal testosterone supplementation in post-menopausal females with stage B heart failure with preserved ejection fraction (HFpEF) on attenuation of heart failure risk. We seek to do this based on the previously demonstrated efficacy of this approach in female patients with chronic HF as our epidemiological evidence that suggests low testosterone in females is associated with increased risk of major cardiovascular events and there is an urgent need to identify effective prevention and treatment strategies for the patients with HFpEF. Our hypothesis is that transdermal testosterone, versus placebo, will result in a clinically meaningful improvement in V02peak, which is a strong prognostic indicator for future HF risk in postmenopausal women with stage B HFpEF. The improvement will be due to improvements in central cardiac function and structure. The study will provide high-quality evidence as to whether testosterone, as a novel intervention, will improve cardiorespiratory fitness in women at risk of HFpEF, and therefore whether testosterone therapy has the potential and feasibility as a treatment for this condition, for which there is currently no known treatment.

Laboratory polysomnography (PSG) is costly and labour intensive and therefore cannot adequately deal with the large burden of Obstructive sleep apnoea (OSA) in the community. With technological developments there has been a global trend to home-based sleep testing, both with full PSG at home and limited channel home sleep apnoea testing (HSAT) devices, in order reduce the cost and increase the access to OSA diagnosis. The WatchPAT is a simplified, wrist and finger worn device, which measures peripheral arterial tonometry (PAT), a marker of autonomic tone. WatchPAT and similar devices can measure oxygen saturation and from the PAT signal derive measures of sleep staging and sleep apnoea severity. The WatchPAT is in common clinical use and has been validated against laboratory PSG, but there is limited validation against home based PSG in a general sleep clinic population. This multicentre study aims to assess the diagnostic accuracy of the WatchPAT compared to home based polysomnography in sleep clinic patients referred for the diagnosis of OSA.

The primary aim of this study is to understand the associations between "Things You Do" activities and changes in mental health symptoms. In this two-phase project, participants will be encouraged to restrict the frequency of these behaviours for 4-weeks and then increase these behaviours for the next 4-weeks. In Phase 2, all participants will receive access to the "Things You Do Course", a one-lesson course alongside daily text message reminders. We expect that people will report a increase in depression and anxiety symptoms during Phase 1 (restriction) and then a decrease in these symptoms during Phase 2 (treatment).