ANZCTR search results

Sleep is an important activity for ensuing health and recovery from illness. Sleep deprivation is known to be associated with several comorbidities including obesity, diabetes, anxiety and depression, hypertension, heart disease and stroke and increased risk of death. Sleep deprivation is also known to be associated with impaired cognition, impaired immune function and could make people less morally aware. Sleep in intensive care unit (ICU) was shown to be of a poor quality by several studies including from our group. However many of these studies assessed sleep using subjective tools such as Richard Campbell Sleep Questionnaire, self-reported sleep quality by patients and nurse, or clinician observations. These subjective tools, while they are simpler to use, are not reliable and can over- or underestimate the sleep quality and duration. Some objective tools such as Actigrapy and Bispectral Index were used for sleep evaluation but are not gold standard to evaluate sleep. In this study we propose to use Polysomnography which is considered to be gold standard for studying sleep. We aim to study the sleep of patients who are on a mechanical ventilator and receiving some of the commonly used drugs to promote sleep.

The purpose of this study is to assess the efficacy of an intervention for grief and loss in adolescents aged 13-17 living in Australia. The selected intervention is a cognitive behavioural approach aiming to assist adolescents to deal with grief and loss. It is an online, unguided intervention consisting of eight modules across four weeks. Adolescents self-pace themselves through two modules per week engaging in cognitive and behavioural activities. We predict that treatment will improve symptoms of anxiety, depression, post-traumatic stress disorder and prolonged grief, and improve well-bring.

The Take Control - Live Well program is a self-management program for adults living with at least one chronic condition. We have based the program on the Flinders Program which was designed for use in one-on-on consultations. This study is to explore the effectiveness of applying the Flinders Program to a group program setting in providing self-management support for adults living with chronic conditions. We hypothesise that the Flinders Program will be feasible and effective in a group setting.

Endometriosis is an oestrogen-dependent, chronic inflammatory condition characterised by the presence of endometrial-like tissue outside of the uterus in the form of lesions, affecting around 1 in 7 women and those assigned female at birth in Australia. Endometriosis has a significant impact on one's physical, psychological, and social wellbeing. Unfortunately many of the pharmaceutical medications for endometriosis have bothersome side effects or should only be used for a short period of time due to concerns related to dependence and addiction. Medicinal cannabis has well described analgesic, anti-inflammatory, anxiolytic, anti-depressant, and anti-emetic actions. Cannabis use in other chronic pain conditions has resulted in “substitution” of pharmaceuticals, commonly opioid analgesics, for cannabis. Our previous research has shown that women with endometriosis in Australia are using mostly illicit sources of cannabis to manage their pain and other symptoms. We hypothesise that either a balanced THC:CBD oil or CBD alone will reduce pelvic pain and other symptoms in women with endometriosis. The primary aim of this study is to determine the efficacy and safety of two medicinal cannabis products compared to placebo in women with endometriosis.

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.