ANZCTR search results

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.

This is a double-blind, placebo-controlled study to assess the safety of GB-7624 and how this drug acts in the body in healthy volunteers. GB-7624 may be indicated for use in patients with atopic dermatitis, but a trial of the drug in healthy volunteers is needed before trials in atopic dermatitis patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive single or multiple doses of GB-7624 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc). and will provide blood and urine samples for testing. It is hoped this research will determine the maximum dose of GB-7624 that can be administered safely without causing severe reactions. Once the dose of GB-7624 has been determined in healthy volunteers, a trial investigating the efficacy of GB-7624 as a treatment for patients with atopic dermatitis may proceed.

Background and Rationale: Clinical trials are pivotal in advancing stroke care, yet participation remains low, exacerbating disparities, especially across age and gender demographics. This study aims to investigate the barriers to and facilitators of participation in clinical trials to enhance person-centred approaches in stroke research. Objectives: 1.To analyse the trends in age, gender, and rationales for non-participation in clinical trials among adult patients with stroke over the past 6 years at a tertiary Hospital in a large metropolitan area of Australia. 2.To develop and refine frameworks for patient recruitment that reduce barriers and enhance facilitation in stroke clinical trials. Study Design: A retrospective observational study complemented by a qualitative analysis of existing data from stroke patients who were eligible for clinical trial participation from January 2019 to January 2025.

This is an open-label, phase II study for treatment of high-risk myelodysplastic syndromes (MDS) or Acute Myeloid Leukaemia (AML). The purpose of this study is to evaluate the safety, response and survival of Imetelstat treatment in patients that do not respond to Hypo-Methylating Agent (HMA)-based therapy. This multi-centre study will recruit participants across Australia, Germany and France. A total of up to 46 subjects will be recruited for this study. You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with MDS or AML. People with high-risk myelodysplasia (MDS) currently have limited treatment options. This group of patients often rely on blood transfusions and unfortunately, some standard of care therapies are not often successful as a treatment option. Participants who meet the eligibility criteria for this study will receive 2-hour intravenous (IV) infusion with Imetelstat twice in a 28-day cycle (once every 14 days) for at least 4 cycles. After 4 treatment cycles (8 administrations of Imetelstat) response assessment will be performed on all patients. Non-responding patients will discontinue Imetelstat treatment, undergo End of Treatment and enter the follow-up phase of the trial. Patients who are categorized as responders according to the primary endpoint definition and have Bone Marrow blasts =>5% at the response assessment (Visit 9) will continue Imetelstat treatment every 14 days until loss of response/disease progression. Patients who are categorized as responders according to the primary endpoint definition and have Bone Marrow blasts <5% will continue Imetelstat treatment every 28 days until loss of response/disease progression. During and after completion of the treatment participants will be assessed for overall response using response assessment, safety and toxicity using adverse events, overall survival and progression free survival from medical records, and quality of life questionnaires. It is hoped that this research project will contribute to the field of Myelodysplastic Syndromes and that it may be used to improve health outcomes.