ANZCTR search results

Research into improved management and treatment for patients with infection is essential for reducing such mortality. Individuals who present to the Emergency Department with severe infections are treated with fluids in the vein to maintain optimal blood volume, keep the heart working properly, and keep tissues well oxygenated. There are a number of fluids that Emergency Physicians can provide to patients, including crystalloids (water-based fluids that include salts and other water-soluble molecules), and albumin (a fluid manufactured from human plasma). Within this study, we will randomise patients with severe infection to receive either albumin or crystalloids. The aim is to determine whether albumin improves the patient’s outcome.. The results of the study will provide emergency doctors with important information about how to best treat patients with infections and potentially reduce the number of deaths.

The study will evaluate the impact of MHFA training on the workers' ability to recognise mental health problems and stigmatising attitudes, along with their shared stories about their confidence in having conversations about mental health issues and perceptions of the value of MHFA training. It is hypothesised that the prevalence of workers who can recognise mental health problems immediately after the training is 5% more than those who were not trained, and such ability to recognise mental health problems remains after 3 months of the MHFA training.

The purpose of this study is to test the safety and effectiveness of the investigational medication in the threatment of Non-alcoholic Fatty Liver Disease (NAFLD) in obese adults. This is a randomized, double-blind, placebo controlled and parallel group study of GL0034 (Utreglutide) for the treatment of (NAFLD). Approximately 48 participants will be randomly assigned to receive GL0034/Placebo in a ratio of 3:1. GL0034/Placebo is administered weekly as a subcutaneous injection for a period of 13 weeks, The dose will be increased gradually for a period of 10 weeks (called the Dose Titration Period) and then will remain at a fixed dose for 3 weeks (called the Final Dose Period)

Liver transplantation offers a cure for Australians with end-stage liver failure. Cardiovascular disease remains a leading cause of death following this procedure, with rates of post-transplant cardiac events remaining high over the past 20 years despite improvements in overall complication rates. This may be due to undetected cardiac dysfunction, termed cirrhotic cardiomyopathy, however our ability to diagnose and treat this condition in clinical practice remains limited. Using a novel, validated method for identifying this condition using stress testing, we aim to evaluate whether cirrhotic cardiomyopathy increases the risk of post-transplant cardiovascular events, and determine whether liver transplantation leads to a reversal of this condition. Based on the outcome of this study, the long-term goal is to assess whether use of early treatments in patients with cirrhotic cardiomyopathy can reduce the risk of post-transplant cardiovascular events and improve patient outcomes.

Instrumented posterolateral lumbar fusion surgery involves the fixation and posterolateral grafting of two or more adjacent lumbar vertebrae. Traditionally, local bone sourced from the patient’s hip has been viewed by surgeons as the gold standard for grafting material. However, studies have demonstrated that a significant number of patients report pain at the graft site for up to 6-month post-surgery. To mitigate this, medical device companies have developed synthetic bone graft substitutes which can be used in place of the patient’s local bone. One such material is Bioactive Glass, which is a synthetic bone graft substitute that is designed to mimic the body’s natural healing process. It achieves this role by promoting the growth of new bone cells, and acts as a scaffold that mimics natural bone and promotes cell attachment. Due to the known benefits of synthetic bone graft substitutes, the Johnson & Johnson Medical Device Company have worked to develop FIBERGRAFT Bioactive Glass, which has previously been shown to be a safe and effective bone graft substitute in other procedures involving spinal fusion. The aim of this study is to gain a deeper understanding of the radiological and clinical effectiveness of FIBERGRAFT Bioactive Glass in patients undergoing instrumented posterolateral lumbar fusion surgery. The significance of this research lies with its practical application, in that our results will provide clinicians with the information they need in order to make more informed decisions regarding the selection of bone graft substitutes in this surgical procedure.

A single-blind, superiority randomised controlled trial encompassing an adaptive multi-arm multi-stage design will be conducted to determine whether the My Back Exercise App is effective for improving self-reported physical function when compared to an app-based standard LBP education for people with chronic non-specific LBP at six weeks after randomisation. Eligible participants will be randomly assigned in a 1:1:1:1:1 ratio to either the control group receiving education alone or one of four intervention arms (1: education, notifications, and exercise modules; 2: education, notifications, exercise, and sleep modules; 3: education, notifications, exercise, and diet modules; and 4: education, notifications, exercise, sleep, and diet modules) through the app. The study consists of two stages with the possibility of dropping arms for futility using pre-specified decision rules at the end of the first stage. A total of 370 participants aged 18 years or older, with chronic non-specific LBP, will be recruited Australia-wide from the general community. The primary endpoint will be self-reported physical function, measured by the Patient-Specific Functional Scale (PSFS), at 6 weeks post-randomisation (i.e., immediate post-intervention). If shown to be effective, the My Back Exercise app will be an innovative digital health solution that could facilitate self-management of LBP at scale and in a timely and convenient manner.

Frailty is present in 3 out of 10 people who undergo TAVI. However, there's limited evidence for managing frailty, which worsens outcomes in patients post TAVI. This trial aims to assess the feasibility of implementing a tailored Frailty Response Program for frail aortic stenosis patients undergoing TAVI. Using a cluster randomised controlled trial design, it will compare this program to standard care in hospitals. The multicomponent program (nutrition, patient information, GP notification, geriatric assessment and rehabilitation) adjusted to the patient's frailty status, will commence pre-TAVI and patients will be followed up for 12-months post procedures. This project aims to determine the impact of evidence-based frailty management on aortic stenosis patient outcomes post TAVI.

This research study focuses on evaluating ocular (eye) comfort and tear proteins, with the use of daily disposable contact lenses. Contact lenses provide improved vision and daily convenience for many people around the world. However, about half of new contact lens wearers stop contact lens wear within the first few months. One of the most common reasons is because of challenges with the comfort of the lenses. Recent research has shown that some people who experience discomfort with contact lenses have different levels of certain proteins associated with inflammation in their tears. This study aims to examine the changes to pro-inflammatory proteins (cytokines) in tears in people new to wearing contact lenses, over a period of six months. The primary aim of this project, is to determine whether the presence of certain proteins in the tears can be predictive of people who are more likely to experience discomfort with contact lens wear.

This randomized, double-blind, placebo-controlled, multicenter study aims to evaluate the effects of DONQ52 in CeD patients when they are given a gluten challenge. DONQ52 is expected to be a safe and effective treatment for CeD patients. This study consists of a part of gluten challenge for HLA-DQ2.5 genotype (without HLA-DQ2.2 and/or HLA-DQ8) (Part A) and for atypical HLA-DQ genotype (HLA-DQ2.2 and/or HLA-DQ8 in the absence or the presence of HLA-DQ2.5) (Part B). All parts of this study are designed to investigate a single subcutaneous (SC) dose of DONQ52 with a 3-day gluten challenge in well-controlled CeD patients. All participants must maintain a gluten-free diet (GFD) throughout the study (by the study completion/early termination visit) except for the instructed and controlled gluten challenge.

This study will pilot and evaluate the feasibility and efficacy of 10-session cyberscam adjustment program ("Smooth Sailing After Scams"). The structured but flexible program will focus on cybersafety, and adjusting to the impact on finances, emotions, relationships and lifestyle. Participants will be monitored while they wait for the intervention to start, with evaluations during this baseline period, at the start of the intervention, at the end of the intervention, and at 2-month follow-up. Participants will be randomly assigned to 2, 4 or 6 weeks waitlist baseline lengths before starting. The intervention will be provided as a small group or 1:1. Findings will inform a larger trial in order to translate it into clinical practice.