ANZCTR search results

The purpose of this study is to test the effectiveness and safety of the investigational medication in the threatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) in at risk adults. This is a randomized, double-blind, placebo controlled and parallel group study of GL0034 (Utreglutide) for the treatment of (MASH). Approximately 60 participants will be randomly assigned to receive GL0034/Placebo in a ratio of 2:1. GL0034/Placebo is administered weekly as a subcutaneous injection for a period of 24 weeks, The dose will be increased gradually for a period of 20 weeks (called the Dose Titration Period) and then will remain at a fixed dose for 4 weeks (called the Final Dose Period)

Paramedics worldwide have a higher prevalence of PTSD, anxiety, and depression than the general population. Paramedicine students predominately enter the profession without preventative techniques to manage stress, depression and fatigue. The objective of this study was to examine the effect of Transcendental Meditation Technique (TM) on the well-being and resilience of paramedicine students.

A 2-arm randomised clinically controlled trial to determine if there is a difference in palatal volume and surface area between conventional expander appliance and appliances fabricated by a clear aligner company. The study intervention includes the placement of rapid palatal expander appliances or clear aligner expander appliances. The rapid maxillary expanders are adjusted at home by the participant using a key which expands the device; the clear aligner expanders are removed and replaced at home with sequentially expanded appliances. The palate is then scanned and the palatal volume measured digitally. The palatal volume is used to determine if there are any significant differences in expansion of the palatal between the appliances..

Rising inadequately- or un-treated disruptive disorders are expected to increase family dysfunction and violence, academic underachievement, school drop-out, psychiatric and physical illness, harmful substance use, poor quality of life, and impairing financial, occupational, and relationship difficulties, raising annual societal costs for disruptive disorders that exceed $20.4 billion. This project aims to overcome these major obstacles to improving the mental health and wellbeing of the most vulnerable Australian children by delivering an accessible, comprehensive school-based early intervention—iteratively co-designed with school endusers—to diverse children with disruptive behaviour disorders living in culturally and linguistically diverse (CALD) and rural communities. The effectiveness and cost-effectiveness of this enhanced intervention and its mechanisms of action will be evaluated from baseline, posttreatment and follow-up assessments conducted by clinically trained research staff, within a cluster randomised controlled trial design. A novel technology- and interpreter-assisted intervention protocol will be used to deliver treatment to non-English speaking CALD families for the first time. If successful, the outcomes of this research will provide new knowledge to the field on how to address the critical shortcomings of current gold-standard interventions for child disruptive behaviour problems.

The Chronic Myeloid Leukaemia: Treatment-Free Remission Registry (CML-TFR) is an observational registry for participants with CML in chronic phase who are in molecular remission on Tyrosine Kinase Inhibitor (TKI) treatment and are planning a trial of TKI drug cessation with the objective of Treatment-Free Remission (TFR). Who is it for? Participants may be eligible for this study if they are an adult who has been diagnosed with chronic myeloid leukaemia, have completed a minimum of 3 years TKI therapy, and are intending to stop TKI treatment based on their treating clinician’s advice. Study Details All participants in this study will enter this registry before stopping their TKI treatment. No intervention will be provided to participants as part of this study, participants will stop their TKI treatment as prescribed by their treating clinician. For this study, participants will undergo an informed consent process. Following this the screening process will begin where a series of data including blood test results relating to the participant’s CML diagnosis are collected from participants medical records. A research blood sample will be collected on the day before stopping their current TKI treatment. Results from CML blood tests requested by the treating clinician will be collected from participants medical records every 3 months for up to 5 years unless a participant experiences relapse or requires re-treatment. If a participant requires retreatment with TKI, participants will be followed for a further 1 year from commencing re-treatment. This registry will provide valuable descriptive data on TFR in Australia and will enable the validation of biomarkers to identify patients with a higher chance of achieving long-term TFR, as well as those with a lower chance of TFR in whom investigational approaches might improve the TFR outcome.

Pneumothorax, commonly called a collapsed lung, occurs when air leaks out of the lung and accumulates between the lung and the chest wall. This condition can affect individuals with healthy lungs and those with underlying conditions such as emphysema. It can also result from trauma or complications from procedures like lung biopsies. Patients with pneumothorax may remain asymptomatic or have trouble breathing due to the collapsed lung, reduced lung capacity from underlying diseases, or interference with diaphragm function caused by the accumulated air. The exact cause of these symptoms can sometimes be unclear. Treatment may involve inserting a chest tube between the ribs to remove the air and reinflate the lung, which helps alleviate symptoms. Currently, no formal lung function assessments are specifically for patients with pneumothorax. Traditional lung function tests, such as spirometry, require forceful breathing manoeuvres and are contraindicated in patients with pneumothorax as they can exacerbate the air-leak and increase symptoms. The Forced Oscillation Technique (FOT) assesses the mechanical function of the airways and lungs without requiring patient effort. Patients can breathe at rest, while FOT measures the mechanical properties of the lungs. FOT is safe in infants, pregnant women and in sick patients admitted to the intensive care unit. This pilot study aimed to explore the feasibility of performing FOT in patients with pneumothorax and provide insights into the respiratory mechanics of the lungs in pneumothorax. We will correlate FOT parameters with patient symptoms and radiological findings and evaluate if FOT can be a surrogate method to monitor pneumothorax recovery.

This research will pilot a new virtual reality (VR) intervention to support youth with depression and anxiety. While VR has shown promise for adult mental health, little is known about its use in youth or routine clinical care. The VR intervention is based on Acceptance and Commitment Therapy (ACT) and immerses young people in fun, engaging environments to teach practical coping skills for managing distress. The study will evaluate both the preliminary effectiveness of the VR intervention for improving youth mental health, as well as real-world implementation outcomes to understand how it can be successfully adopted in clinical settings. The trial will use a single-group, pre-post design, with treating clinicians delivering the intervention to up to 50 young people seeking treatment for depression and anxiety over a 12-week period. Assessments will be conducted at baseline, immediately after the intervention (12 weeks), and four weeks post-intervention (16 weeks).

This study will evaluate the safety and clinical effectiveness of the M-Finity femoral stem used in total hip arthroplasty. This will be achieved by assessing survivorship and collecting patient reported outcome measures from patients receiving the M-Finity stem. Patient clinical and radiographic outcomes will be analysed pre-implantation and post-implantation through to 2 years and clinical outcomes continued to 10 years. The survivorship data will be compared to the cementless stems currently on the market using the Australian Orthopaedic Association National Joint Registry (AOANJRR) data. The hypothesis is that the 2-year cumulative percent revision of the M-Finity cementless femoral stem is not inferior to the performance of other femoral stems currently on the Australian market.

A new residential in-reach program has been introduced in the Grampians region. The purpose of this project is to examine the effects of this new program in the region. The program will provide medical care to people who live in residential aged care homes when they experience a rapid deterioration in their health without the need to go to hospital if it is not necessary, and receive any care in their place of residence. This project will monitor hospital presentation for 14 months as the program is rolled-out in the region to evaluate its effects. It is hypothesised that this program will reduce emergency department and urgent care centre presentations from residential aged care facilities.

People with epilepsy suffer not only from the effects of their chronic and disabling condition but also the uncertainty surrounding when and how it will affect them. New Australian technology that is currently under investigation - the Epiminder system - is designed to allow for continuous recording of brainwave activity (electroencephalography, or EEG) for months to years, using an implant under the scalp. This technology has the potential to offer unprecedented insights and certainty for patients and the clinicians who care for them. This project will evaluate this new 'subscalp' monitoring technology, to see how it can improve the lives of people with epilepsy. Specifically, we hypothesise (believe) that this new long-term subscalp brainwave monitoring will be more accurate than traditional methods of (people recording seizures in diaries), and that this increased accuracy will lead to better outcomes for people with epilepsy. NB: The Epiminder system is for investigational use only and it’s not approved in any geography.