ANZCTR search results

The associated morbidity from rheumatic heart disease (RHD) is the leading driver of cardiovascular inequality for Indigenous Australians. Across the Tasman, its precursor acute rheumatic fever (ARF) and RHD almost exclusively affect Maori and Pacific children and young adults living in socio-economically deprived areas of the North Island of New Zealand. For 70 years, the only proven way to prevent ARF progression has been benzathine penicillin G (BPG), given as a monthly intramuscular (IM) injection. The effectiveness of this approach is limited by pain and the frequency of injection which leads to sub- optimal adherence in these vulnerable groups. There is an urgent need to improve penicillin formulations for all children living with ARF/RHD. Based on a randomised cross-over trial conducted by our team, we hypothesise that BPG could be repurposed as an ‘implant’ if given as a high-dose subcutaneous (SC) infusion of penicillin (SCIP). By providing sustained penicillin concentrations for >3 months, this approach would fulfil the ideal product characteristics for the next generation of long-acting penicillins. This 3-year multiphase program begins with a phase 1 study, assessing the safety, tolerability and pharmacokinetics of SCIP in healthy adults (SCIP-I). If SCIP appears tolerable and provides sustained penicillin concentrations, we will perform an observational study of SCIP in children living with ARF (SCIP-II). Concurrently, we will implement mixed-methods studies to identify acceptability, barriers and benefits of SCIP RHD, both from consumer and health care provider perspectives (SCIP-IIa).

Virtual reality (VR) shows promise in rehabilitation. With the advent of new technologies, such as the Oculus Quest, immersive technologies have become more available and cost effective. We plan to compare VR rehabilitation therapy to standard therapy for older adults who are undergoing inpatient rehabilitation. Our hypothesis is that the use of VR exercises is feasible, acceptable to therapists and patients, improves the experience of rehabilitation, as well as improve functional performance in rehabilitation patients.

The purpose of the feasibility pilot is to assess the ease of use of Remote Check on Android smart phones when used by adult Cochlear Implant recipients, in terms of usability and software issues, for the completion of primary tasks. Usability will be assessed using a ranking scale and questionnaire. Software issues/bugs relevant to the use of Remote Check on Android will be logged and used to inform any product enhancements required. The study will also characterise the test retest difference of Aided Threshold Test (AAT) and Digit Triplet Test (DTT) when streamed via Android smart phones.

Road crashes are a major cause of death and disability for young Australians. Fatigue is a major contributor to road crash, and is primarily due to insufficient sleep. Young adults frequently lose sleep due to developmental, social, work, and education demands. This project uses a brief but potentially powerful behavioural program to extend habitual sleep, reduce sleepiness while driving, and reduce driving risk. The program could reduce the very high medical, social, and individual costs of road trauma.

This research project is being conducted to look at the safety, tolerability and pharmacokinetics (PK, how the human body processes a substance) of TTI-0102 when given to healthy volunteers orally as a single dose, compared with a single oral dose of the marketed product Cystagon (registered trademark). It is proposed that TTI-0102 could be used as a treatment for acute respiratory distress syndrome (ARDS) related to COVID-19 infection.

This study will seek to evaluate the generation of droplets and aerosol during high intensity exercise. We will characterise the droplet and aerosol size, volume and direction in an indoor environment during high intensity exercise in athletes. These measurements will be done with the participants wearing no mask or a surgical mask and sampling will happen at different distances and locations. We will compare the concentration of droplets/aerosol at 3 different distances of .3, 1.5 and 3 metres from the participant with and without a surgical mask.

The aim of the current study is to explore the effect of an online mindfulness program (iMindTime) on depression, anxiety and stress. The iMindTime program is a digital health program that comprises six sessions delivered over three weeks. It is designed to enhance mindfulness and increase awareness of moment-to-moment experiences. Adults aged 18 years or older, fluent in English, will be recruited to participate in this randomised controlled trial. Participants will complete baseline questionnaires that will explore their levels of depressive, anxious and stress symptoms, alongside their levels of state and trait mindfulness. Subsequently, participants will be randomised to the iMindTime program or a waitlist control condition. Individuals assigned to the iMindTime program will complete ‘post-intervention’ testing after the program ends. Participants in the waitlist control will continue their usual activities and will complete ‘post-intervention’ testing after a three-week post-enrolment delay, after which they will be given access to iMindTime. It is hypothesised that the iMindTime program will decrease anxiety, depression and stress symptoms in comparison to usual activities.

In Australia, at least half of women aged 18 to 45 are overweight or obese. Women who are overweight or obese are at increased risk of some pregnancy complications. Babies of women who are overweight or obese are more likely to have birth weight above 4kg, which can put them at increased risk of childhood obesity. Our aim is to conduct a randomised trial of a dietary & lifestyle intervention prior to conception • To improve maternal nutrition, physical activity and healthy behaviours and • To evaluate the impact on maternal, newborn and child health outcomes. Our hypotheses are that this innovative public health approach will • Improve health outcomes for women, and their babies and children, who are otherwise at risk of chronic metabolic disease • Reduce health care costs and • Provide an evidence-based tool that can be readily scaled up for implementation in the community.

This study will assess the safety and effectiveness of an investigational agent (MSH2TR) used to detect lymph node spread of cancer in patients with a specific type of breast cancer, HER2-positive breast cancer. Who is it for? You may be eligible for this study if you are a female aged 18 or older, you have histologically confirmed HER2-positive primary breast cancer which you haven't had any prior treatment for (including surgery, radiotherapy, or systemic treatment) and you are scheduled for surgical intervention with lymph node detection by a specific diagnostic agent injection procedure being part of the surgical plan, or scheduled for a core biopsy of a lymph node that is clinically suspicious. Study details All enrolled participants will receive a subareolar (the pigmented area around the nipple) injection of the investigational agent after a baseline magnetic resonance imaging (MRI) scan on Day 1. The scan will last approximately 45 minutes. Participants will return for another MRI in 24 hours (Day 2) and on Day 4 to detect the lymph node spread. Also on Day 4, participants will have a tissue sample (biopsy) taken from a cancerous lymph nodes for further examination. The biopsy will be investigated for standard of care as well as a new imaging technique called magnetic relaxometry (MRX). As this study is investigating the safety of the investigational agent, participants will be asked to attend a series of seven (7) clinic visits where they will provide up to three (3) blood and urine samples. It is hoped this research will demonstrate that a single dose of MSH2TR is safe and well tolerated. It is also hoped that MSH2TR is an effective method for detecting HER-2 positive breast cancer that has spread to lymph nodes using MRI and MRX.

Bionomics Limited is developing BNC210 for the treatment of anxiety, and trauma- and stressor-related, disorders including Post-Traumatic Stress Disorder (PTSD). This single-centre study conducted in healthy volunteers, will evaluate the pharmacokinetics as well as the safety and tolerability, of multiple doses of an oral tablet formulation of BNC210, given over a 7-day period,