ANZCTR search results

Earlier recognition and better support for children with mental health problems is an urgent priority in Australian mental health research and policy. "Supporting Child Mental Health (SCMH): A comprehensive program for adults to learn how to provide mental health first aid to children aged 5-12 years" is a new training program designed to increase the mental health literacy and first aid skills of parents and teachers of primary school children. We propose an uncontrolled pilot trial with 100 teachers and 100 parents to establish: 1) initial evidence for the safety and efficacy of the program; 2) the feasibility of the program for community-based dissemination; and 3) the appropriate protocols for conducting a subsequent randomised controlled trial (RCT). The outcome of this pilot evaluation will allow refinements of the SCMH program materials, to ensure it is an effective and feasible program, which will then be subject to a randomised controlled trial (RCT) in 2026. The RCT will establish high-quality evidence of efficacy, allowing the program to be licensed to Industry Partners who will disseminate the program nationally, and internationally--with the aim of improve outcomes in child mental health--should SCMH be found to be an effective and feasible program

The overall aim of this study is to evaluate whether our new osteoarthritis eLearning program designed to facilitate the uptake of evidence-based osteoarthritis care, meets the needs of health professionals and leads to better service delivery.

Revascularisation of large coronary arteries (percutaneous coronary intervention, PCI) may improve blood flow to areas of myocardium previously subtended by a chronically occluded (CTO) vessel. Restoring blood flow in this manner may be associated with an improvement in angina, however despite technically successful PCI a significant proportion of patients will continue to experience angina or suffer from future stent failure (in-stent restenosis and re-occlusion. The reasons for this remain unclear and the influence of PCI on the coronary microcirculation is poorly described. However, it is likely that the presence of ongoing local vascular inflammation (at the site of PCI) and/or the presence of CMD may influence the outcome of PCI. In this study we aim to examine the effect of PCI on the coronary microcirculation. Furthermore, to better understand the influence of vascular inflammation, delayed stent healing / early stent failure with CMD, intravascular imaging (IVUS or OCT) will be performed immediately after PCI. Finally, we aim to measure cOCT at the same time as baseline invasive coronary assessment and again at 3 months, so that temporal changes in peripheral (cutaneous) microvascular reactivity and its association with baseline coronary microvascular reactivity may be described.

This study aims to explore whether a low-carbohydrate/ketogenic diet combined with ketone supplementation can improve kidney and metabolic health in adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD). The study will assess safety, feasibility, and changes in quality of life, kidney function, and metabolic markers. Participants will receive dietary support via a smartphone app, take a ketone supplement, and use continuous glucose monitoring. The hypothesis is that reducing glucose availability and supporting nutritional ketosis may slow disease progression and improve overall wellbeing in people with ADPKD.

The ACTIDIET-PRO study aims to evaluate the feasibility of an exercise and diet intervention in Australian men with metastatic hormone-resistant prostate cancer who are treated at a single centre. Who is it for? You may be eligible to join this study if you are aged 18 years and older, have been diagnosed with adenocarcinoma of the prostate, and are receiving ongoing treatment with androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (ARPI) such as Abiraterone/Prednisone, Apalutamide, Darolutamide or Enzalutamide. To be deemed eligible for this trial, you must have a rising PSA with no evidence of clinical or radiographic progression on imaging evaluation, and your doctor must consider that continuation of your current systemic treatment is feasible. Study details: All participants who meet the eligibility criteria in this study will undertake a 12-week lifestyle intervention of intensified physical activity and a controlled dietary regimen. Exercise prescription will be tailored to each participant’s fitness and comorbidities, and will consist of two supervised sessions per week and one pre-instructed home-session, including cardio and resistance training. The dietary regimen will consist of a balanced diet consisting of low total fat, low saturated fat, high omega-3 fatty acids, optimised protein content and low simple carbohydrates. During and after the completion of the intervention participants will be assessed for prostate-specific antigen (PSA), and questionnaires assessing quality of life and fatigue. Changes in lipid and immune signatures will be assessed through serial blood profiling. It is hoped that this research project will help in understanding whether benefits from of diet and exercise prescription in men with early stage of prostate cancer can be replicated in men who suffer from a more advanced stage of disease.

The ACTnow toolkit was designed for health professionals who were developing physical activity programs for survivors of stroke. This toolkit has completed stage 2 (co-design an ‘Adherence Counselling Toolkit’) and is currently in stage 3 (pilot testing in an inpatient and ambulatory stroke rehabilitation services of Flinders Medical Centre – RAP). Participants (health professionals and survivors of stroke) in stage 3 will provide feedback via a survey and semi-structured interview. This stage, stage 4, proposes to test the ACTnow toolkit in a chronic stroke population at the FMC-RAP outpatient Stroke Clinic as a RCT. It is hypothesised that the intervention group will have improved adherence and self-efficacy as they are using the toolkit which will develop individualised and tailored programs.

This is a randomised, double-blind, placebo-controlled, parallel group study evaluating the safety, tolerability and PK of multiple doses of KAI-7531 in a non-Asian (Cohort 1) and Asian (Cohort 2) participants. The study will also evaluate the effect of food on safety, tolerability, and PK. Who is it for? You may be eligible for this study if you are aged 18 to 55 years with body mass index of 25.0 to 40.0 kg/m2 (inclusive), medically healthy and without clinically significant (CS) abnormalities. Study details All participants who choose to enrol in this study will be assigned by chance to receive multiple doses of KAI-7531 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 tolerated of KAI-7531 that can be administered safely without causing severe reactions. KAI-7531 is intended to be used for the treatment of metabolic diseases such as type 2 diabetes mellitus and obesity or overweight with comorbidities. The data collected will also support dose administration for future clinical studies.

This study is investigating whether a ketone product improves exercise capacity in children with IEMEM, and if the ketone product is acceptable and tolerated by participants. Secondly, to assess quality of life in children with IEMEM, and glean feedback on an IEM-specific quality of life questionnaire for future adaptation in LC-FAOD. We hypothesise that an exogenous ketone product will improve exercise capacity compared to standard therapy, in children with an IEMEM (LC-FAOD or HMG-CoA-lyase deficiency.) Also that quality of life in children with an IEMEM will be negatively impacted, compared to healthy children.

This is a prospective safety and feasibility study of a new device designed to deliver a low electrical pulse to the intestine from inside the body. Candidates for this study will be participants with Type 2 diabetes. This study intends to assess and prove that the device is safe for use for the delivery of energy within the intestine and may be an effective treatment. Participants will be followed up by the study team for up to 1-year post-procedure. This is a powered study, so there is no formal hypothesis. This research will determine whether use of this new system is safe and feasible

This research project is testing an experimental treatment for people with glioblastoma that has returned after treatment with first- or second-line therapy. The experimental treatment that will be tested in this research project is called EGFR-targeted EDV-Dox. The EDV is a delivery vehicle (manufactured from a non-disease-causing salmonella bacteria) that is carrying a drug called Doxorubicin or E-EDV-Dox directly to the tumour via the blood stream. The E-EDV-Dox are mixed with another EDV investigational product, thought to boost the body's own immune system to fight the cancer, consisting of non-targeted EDVs carrying a-galactosyl ceramide or EDV-GC. The combination of these 2 products is known as E-EDV-Dox/GC. Who is it for? You may be eligible to join this study if you are aged 18 years and older, with a Karnofsky performance score of greater than 70. A life expectancy greater than 3 months, measurable disease per RANO 2.0 criteria, adequate haematological, renal, hepatic and cardiac function. Study details In Phase I of the study a safety assessment will be performed on 6 participants. In Phase II the recommended dosing regimen from Phase I will be open to a maximum of 40 participants. The first treatment cycle will involve bi-weekly visits for 4 weeks where a single dose will be administered at each visit (8 doses), after which 2 doses of the Investigational Product will be administered 90 minutes apart during each visit occurring once/week for a further 3 weeks (6 doses). Doses of E-EDV-Dox/GC in 3mL of 0.9% sodium chloride will be administered intravenously over 10 seconds. In week 8, tumour burden will be radiologically re-evaluated in accordance with RANO 2.0 to determine treatment response. Subsequent cycles will consist of weekly visits for 7 weeks where two doses will be administered at each visit 90 minutes apart. Following each 7-week treatment period is a treatment free week in which tumour burden is radiologically re-assessed (Week 8). Treatment may continue until the participant or investigator deems it suitable to stop treatment, for example if serious side effects occur or if the participants disease continues to grow. It is hoped the findings from this study will help determine the safety and efficacy of E-EDV-Dox/GC treatment for recurrent glioblastoma.