ANZCTR search results

In Australia, nonalcoholic fatty liver disease (NAFLD) is the most common cause of liver disease, and results in significant healthcare burden from both liver and metabolic complications. NAFLD is defined by the presence of fat in the liver which can cause liver related morbidity and mortality through its progression to liver fibrosis, cirrhosis and increases the risk of developing liver cancer. It is strongly associated with obesity, insulin resistance and the metabolic syndrome, and weight loss is the mainstay of treatment. Weight loss can reduce the amount of fat in the liver, improve the level of liver fibrosis and improve individuals overall metabolic and cardiovascular risk. Current treatment guidelines advise dietary energy restriction, with many recommending a Mediterranean Diet (MD) which has been shown to improve liver fat and reduce the risk of developing T2DM. Despite this current treatment practices are heterogenous, and weight loss is difficult to achieve and maintain. We aim to examine whether the treatment strategies used in the medical management of obesity, such as the use of very low energy diets (VLED) and appetite suppressing (AS) medications, can be adapted to the management of NAFLD which is a related but separate disease entity. This study is a single centre, randomised control trial evaluating the effect of the VLED compared with the standard of care MD in overweight and obese individuals with NAFLD. Participants will be randomised to a 12-week program of either: 1. VLED: a ketogenic 800kcal/day diet utilising meal replacement supplements 2. The standard of care MD: a predominantly plant based diet supplemented with monounsaturated fatty acids (MUFAs) At the end of the 12 week diet, all participants will enter a weight maintenance phase where they will be instructed to follow a calorie controlled but ad-libitum diet in order to maintain their weight, with the VLED group also commenced on low dose Semaglutide as an adjunctive AS medication for 12 weeks. We will compare the impact of these two programs on the severity of NAFLD (change in degree of liver fat on MRI and liver fibrosis on liver biopsy). Other outcome measures include the degree of weight loss and weight maintenance achieved, body composition, and impact on physical activity, mood and quality of life.

Aim of the study: To evaluate the effectiveness of a culturally and contextually informed Aboriginal Diabetes Workforce Training Program (hereafter training program) on Aboriginal primary health care workforce knowledge, attitude, confidence, skill and practice relating to diabetes care. Objectives: 1. To implement the training program in Aboriginal primary health care services across South Australia. 2. To evaluate the effectiveness of the training program on Aboriginal Health Worker, Practitioner and multidisciplinary team knowledge, confidence, skill, practice and attitude related to diabetes care, and secondary outcomes relating to quality of diabetes care and patient outcomes. HYPOTHESIS It is hypothesized that the primary health care services whose workforce participate in the training program will have: - a workforce with increased knowledge, confidence, and skills to manage diabetes within the local primary health care setting, - in the longer term, improvements in the quality of diabetes care provided and patient biomedical outcomes.

The aim of this project is to assess the acceptability, usability and impact of VR in patient education to help improve patients' understanding of head & neck reconstructive surgery and decrease anxiety levels. Who is it for? You may be eligible for this study if you are aged 18 years or older and are scheduled to undergo reconstruction of the mandible for any head and neck pathology (malignant or benign). Study details Participants will undergo a 1-hour session where they will familiarise themselves with the VR technology before receiving a virtual education experience regarding aspects of the surgery and recovery. Following this, they will be asked to complete questionnaires regarding their experience of the VR system, knowledge of the treatment and anxiety levels. It is hoped that this research will help inform the development of VR for managing psychosocial outcomes in patients with head and neck pathologies.

This project aims to determine the impact of Experiential Immersive Education (iED) delivered via Virtual Reality for people with chronic pain. The project will examine the extent and nature of altered pain beliefs and attitudes after the iED treatment, and will explore perceptions of acceptability and utility. Objectives: 1. To quantify change in pain attitudes and beliefs following iED, relative to a weight-list, and minimal intervention control. 2. To establish iED feasibility, acceptability and preliminary efficacy 3. To explore potential mechanism of effect We hypothesise, that: 1. iED will lead to greater positive changes in pain beliefs and attitudes, than either control groups 2. iED will appear feasible, acceptable, and effective; and 3. Improvements in pain and disability will be mediated by fear of pain, pain catastrophising, and self-efficacy.

This is a prospective study that will recruit surgical patients over the age of 60 who will be in hospital for at least 2 days. The objective of this study is to explore the associations between changes in brain biomarkers following surgery and cognition at 1-year post-operative. The study procedures will include a pre-operative baseline cognitive screen, a quality of life questionnaire and some bloods drawn by the anaesthetic doctor on their day of surgery. Following surgery they will be followed up for up to 4 days post-operatively. Delirium assessments will be conducted and on post-operative day 1 some additional blood will be collected. The blood samples will be analysed for brain biomarker levels following recruitment. Additionally, any participants who experience post-operative delirium will have the option to be referred to the Healthy Brain Aging Clinic for ongoing assessment and care.

This study aims to compare the effectiveness of two body image writing interventions in increasing body appreciation in female cancer populations. Who can participate? You may be eligible to participate in this study if you are a female aged 18 years and older, who has a history of a cancer diagnosis, or a current cancer diagnosis. What will participation involve? The study will be completed online via Qualtrics. Participants will be randomly allocated to one of three writing interventions, which may take up to 30 minutes to complete. Participants may be randomly allocated to either; a) writing about appreciating the functions of your body, b) writing about your cancer experience in a caring and supportive way, or c) writing about different rooms in your house as though you were explaining it to someone who has never seen it before. Measures will be taken directly before the writing session, directly after the writing session, one-week later, and two-weeks later. It is hoped that this study will help diversify the range of interventions available for female cancer survivors. In addition, this study may provide important information regarding which intervention is best tailored to target body image distress.

This study is a prospective observational cohort study in males and females, investigating the immune response in people vaccinated with the Neisseria meningitidis serogroup B (MenB) vaccine 4CMenB. Participants will receive 2 doses of 4CMenB vaccine 2 months apart by intramuscular injection. Gonorrhoea-specific immune responses will be measured to characterise possible mechanisms of vaccine-induced protection against gonorrhoea and to identify immunodominant antigens in 4CMenB and potential future gonorrhoea vaccine-candidates.

Dysarthria occurs in up to 40% of people following stroke and brain injury leading to difficulties participating in daily communication activities, social and work roles and wellbeing. Traditionally, people with dysarthria are treated one on one by a speech pathologist which is relatively costly. This pilot study aims to explore the feasibility of implementing a group therapy model compared to individual therapy in inpatients with nonprogressive dysarthria, to inform the implementation of a larger trial. We aim to recruit 24 inpatients with dysarthria who will randomly receive either group therapy or individual therapy in hospital and be assessed before and after their treatment. The results of this pilot study will give us important information about patient, carer and clinician satisfaction, and costs and practicalities of implementing group therapy which would help develop a larger research trial to run across Australia.

This is a Phase 1, open label, multiple oral dose study in healthy adult Japanese, Chinese, and Caucasian volunteers, to compare the single-dose and steady-state pharmacokinetics of a 40 mg PHA-022121 extended-release (XR) tablet administered once daily, and to assess the safety and tolerability of multiple oral doses of PHA-022121.

Overall, 40-60% of youth with Type 1 or Type 2 diabetes have a mental health condition, affecting their lives, ability to self-manage their diabetes and increasing their risk of complications. Limited access to mental health services aggravates the situation. Our project addresses this through a technology-enabled model of care, leveraging access to peer support and a clinically-validated digital platform. A 6-month randomised controlled trial will rigorously test how well this model works in the ‘real world’ across eight hospitals in improving young people’s mental health (particularly distress), well-being and physical health (eg blood glucose), and reducing health care costs and burden.