ANZCTR search results

The aim of this study is to find out if transesophageal echocardiography (TOE) is useful for assessing shock in patients with serious injuries, and helping with treatment and resuscitation of shocked patients. The images of the heart taken by the TOE device may help doctors in diagnosing and treating shock, and therefore in resuscitation efforts.

You are invited to participate in a study using TXI, which is a new imaging software in colonoscopy. This has recently been incorporated within the machine used to process pictures of your bowel during colonoscopy and is available for use in our hospital. TXI enhances the colour and texture characteristics of the bowel lining, making subtle changes and abnormalities more noticeable during colonoscopy. This technology can highlight the contrast between a polyp and the surrounding normal tissue, potentially aiding in the detection of small or flat polyps that may otherwise be missed. Our recent experience with this technology suggests it may increase the ability of endoscopists to detect polyps in the bowel and help us make a decision about which ones may need to be removed. Since you are undergoing a colonoscopy to detect or exclude polyps in your bowel, we would like to invite you to participate in this study.

Hypothesis: Infants and young children 4 months to 5 years of age who are commenced on ETI or IVA will have improved and sustained growth and nutritional outcomes, exocrine pancreatic function and sweat chloride levels. Primary aim: To evaluate longitudinal patterns in growth and nutrition in children 4 months to 5 years of age with CF during the first 2 years of treatment with ETI or IVA. Secondary aim: To describe changes in pancreatic function, clinical outcomes and nutritional interventions in children 4 months to 5 years of age with CF during the first 2 years of treatment with ETI or IVA. Longitudinal, ‘real world’ studies are required to better understand the breadth and significance of CF exocrine pancreatic involvement in children with CF who are exposed to early CFTR correction as infants and children and to better understand the nutritional implications.

Current conservative treatment approaches for persistent low back pain are effective, but significant waiting periods and healthcare resource strain is common. Virtual reality interventions are showing clear potential in individuals with low back pain populations and could facilitate early self-management. Our previous cohort study demonstrated that combining virtual reality with pain education using cognitive behavioural principles (VR-CBT) leads to clinically significant short-term reductions in pain and fear of movement. While these results are promising, the study lacked a control and was conducted over only 2 sessions. This project addresses the next stage. We will undertake a feasibility RCT (VR-CBT and homebased VR gameplay and mindfulness vs usual care) over a longer intervention period (up to 16 sessions over 4 weeks) to determine the feasibility and primary outcome measure of a future, fully powered RCT evaluating the clinical and cost-effectiveness of longer-duration VR-CBT in the management of persistent low back pain.

A multi-center, double blind, placebo controlled, randomized pilot study is proposed to evaluate the effects of daily dapagliflozin given within 3 hours of arrest in comatose out-of-hospital cardiac arrest survivors for 30-days post cardiac arrest. The primary end point selected is the safety of dapagliflozin, measured as the total number of in-hospital adverse events. Adverse outcomes will be a composite of in-hospital mortality, ketoacidosis, need for renal replacement therapy, hypoglycaemia, and genitourinary infection. Secondary end points include post-arrest changes in biomarkers (neurofilament light chain, caspase 3, HIF-1a, VEGF, TNF-a, CRP) at 72 hours from baseline, CT-brain defined HIE changes and infarct size, 30-day mortality, and CPC (cerebral performance score) at time of discharge among survivors. This pilot study will aim to include 120 patients, half (n=60) assigned to the dapagliflozin group and half to the placebo. We expect this study will demonstrate the use of dapagliflozin in this population to be safe and effective at reducing biomarkers associated with hypoxic brain injury, allowing for further larger scale trials to explore the potential clinical benefit in reducing hypoxic brain injury in cardiac arrest.

POSTFIT is an exercise intervention that aims to help women who have recently given birth and want to return to exercise to regain their strength and optimise their long-term health and wellbeing. Specifically, we would like to develop a battery of exercise tests to screen for common postpartum musculoskeletal health issues and examine the effectiveness of a 12-week postpartum specific supervised exercise program that aims to improve pelvic floor function, increase core function and strength, and reduce musculoskeletal pain. Women from the general population are not routinely guided on how to return to exercise safely following birth which puts them at risk of sustaining lifelong irreversible injuries, such as pelvic organ prolapse and incontinence. A multidisciplinary approach to postpartum care with the inclusion of an Accredited Exercise Physiologist could ensure a woman’s return to exercise is safe and effective in treating and preventing these common postpartum related musculoskeletal issues. The results from this study can contribute to evidence based postpartum exercise guidelines to improve the care that postpartum women receive when returning to exercise.

The purpose of this research project is to provide a new alternative to currently approved methods of sealing retinal breaks for participants that are undergoing repair of retinal detachments. The name of the investigational product in this study is PYK-2101. PYK-2101 will be injected during surgery as a retinal sealant to tears/breaks in the retina. Use of the investigational product will prevent subjects from having to remain in a face down position for a number of days, will not limit their ability for air travel for a period of time, nor require an additional surgery to remove the tamponade and may have improved visual clarity as compared to other methods.

The current study aims to reduce the rate of unexplained infertility in couples who test positive for Genital Mycoplasmas by using antibiotic and probiotic treatments. It will recruit couples attending Concept Fertility and City Fertility clinics for investigation of unexplained infertility. Couples will submit semen and vaginal swab samples for analysis; Semen samples will subsequently undergo routine analysis as per World Health Organisation (WHO) guidelines and Lactobacillus and Bifidobacterium spp. will be quantified in vaginal swabs using quantitative PCR (qPCR). Both sample types will undergo qPCR analysis for the presence of Genital Mycoplasmas and where one or more are identified in at least one partner, couples will be treated with either doxycycline (M. hominis and U. urealyticum) and/or azithromycin (M. genitalium) as per standard treatment guidelines. Women will receive a vaginal Lactobacillus sp. probiotic for five weeks post-treatment and then both partners will provide follow-up semen and vaginal swab samples for repeat analysis to assess treatment efficacy in terms of semen parameters and removal or reduction in Genital Mycoplasma DNA titres.

This sub-study is part of the PRAETORIAN registry (ACTRN12622000621718). The PRAETORIAN registry collects information on patients receiving genicular artery embolisation (GAE) to treat pain from knee osteoarthritis. In this sub-study, we will ask participants to provide blood samples at the same time points they complete questionnaires for the PRAETORIAN registry. These samples will be analysed at Queensland University of Technology to study biomarkers, which are indicators of biological processes in the body. By correlating biomarkers with questionnaire responses from the PRAETORIAN registry, we aim to understand how GAE affects the biological mechanisms of osteoarthritis and assess its treatment efficacy.

People with indwelling urinary catheters (IDC) experience frequent complications, particularly when they have an IDC for a long period of time. Hence, it is important that residential aged care staff caring for them are equipped with the knowledge and confidence to deliver person-centred catheter care. Our team has designed a suite of person-centred resources termed the “IDC-IMPROVE Catheter Care Bundle” consisting of a course for residential aged care nurses (RNs and ENs) and personal care workers about person-centred IDC care; a skills-based catheterization workshop for nurses; a toolkit for Managers/Senior Leaders; and online/phone support by health professionals to apply their IDC care skills to practice. Using a multi-centre, facility-level cluster randomised control feasibility trial, we will investigate whether the ‘IDC-IMPROVE Catheter Care Bundle’ is feasible to implement in Australian residential aged care homes.