ANZCTR search results

This study is being done to test the safety and tolerability of a new oral drug called FT2109 and to assess how the body processes FT2109 and a formulated FT2109 capsule compared with the API capsule in healthy participants. FT2109 is being developed as a potential treatment for inflammatory diseases. The study will examine how the drug behaves in the body after single oral doses of two different capsule formulations. The information from this study will help researchers determine whether FT2109 is safe and how it is absorbed compared with the reference formulation. Results will support further development of FT2109 for use in people with inflammatory conditions.

This is a two-part, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RT-312 following single (Part 1) and multiple (Part 2) ascending dose administration in healthy participants. Part 1 will also explore the effect of food on a single oral dose of RT-312 (Food Effect cohort). Up to 80 participants between 18 and 45 years of age at the time of providing informed consent, will be enrolled in this study across the two parts. RT-312 or placebo will be administered as an oral tablet.

Aims This pilot study aims to assess the feasibility, acceptability, and safety of delivering 60 sessions of hyperbaric oxygen therapy (HBOT) at two differing pressures to ex-serving members of the ADF diagnosed with post-traumatic stress disorder (PTSD), while exploring preliminary effects on brain function (fMRI) and psychological outcomes. This will generate effect size estimates and refine the design and methodology of a future large-scale randomised controlled trial. 2 hypotheses are: 1. It is hypothesized, based on the current available research, that HBOT is effective in treating ex-serving members of the ADF diagnosed with PTSD, providing long term changes. 2. Different levels of ATA and total oxygen dose will affect the degree of symptomatic improvements.

This study aims to evaluate a new package of care designed to improve menstrual health literacy and support earlier identification of heavy menstrual bleeding (HMB). Participants will track their menstrual symptoms using a digital diary, access educational resources, and attend a specialist medical assessment. The study will assess whether this approach is acceptable, feasible, and safe for individuals experiencing possible HMB. It will also explore whether the program improves help-seeking behaviour, symptom management, and understanding of menstrual health. We hypothesise that this integrated approach will support better recognition of symptoms and encourage timely access to appropriate care.

People with obstructive sleep apnoea (OSA) experience sleep fragmentation and demonstrate impairments in next-day functioning. OSA is associated with an increased risk of developing dementia. While continuous positive airway pressure (CPAP) therapy continues to be the first-line of treatment for OSA, compliance is poor. Hence, alternative interventions are needed to target sleep disturbance and cognitive deficits in OSA. This study aims to evaluate the effects of low current brain stimulation of different brain regions on sleep and sleep-related cognition in a middle to late aged OSA population. Participants will attend three overnight visits at the Woolcock Institute of Medical Research where they will receive either the active frontal, active parietal or sham stimulation condition during sleep in random order. Participants will complete cognitive tasks and have blood samples taken before and after sleep.

Currently, we don't know enough about how PBC affects people in Australia, or if everyone is getting the very best care. Doctors also want to understand how new and existing treatments are working in real life. This project will help us gather important information to: • Improve care: Make sure people with PBC get the best possible care. • Understand treatments: See how different medicines are working and if there are better ways to use them. • Spot problems: Identify any areas where care can be improved for people with PBC. • Help the future: This information will help doctors, hospitals, and even the government make better decisions about PBC care.

This study aims to investigate whether wearing cyan (blue-green) light-emitting glasses can produce short-term changes in eye structure in children with myopia, specifically by reducing eyeball length and increasing the thickness of the choroid (an inner layer of the eye). These two measurements are well-established biomarkers of myopia, meaning they are predictable changes used to monitor the effects of myopia control treatments. The trial will compare two interventions: wearing the cyan light glasses over regular single-vision spectacles versus wearing single-vision spectacles alone. Each intervention will last 4 weeks, with a one-week break in between. The study will measure eyeball length and choroidal thickness, and will also monitor participants’ comfort, safety, and the impact on daily activities. We hypothesise that cyan light exposure may lead to measurable changes in these eye parameters compared with standard spectacles alone, helping to inform future strategies for myopia control.

This study aims to evaluate a trauma-informed group intervention designed to promote posttraumatic growth in adults with a history of trauma exposure. Participants will attend weekly group sessions and complete questionnaires and interviews to assess the feasibility, acceptability, and potential benefits of the program. The study hypothesises that participation in the intervention will lead to increased posttraumatic growth over time.

The aim of our pilot study is to assess the feasibility of direct non-invasive brain stimulation (transcranial direct current stimulation) use during an exercise intervention to improve pain and functional outcomes in people with Achilles tendinopathy. Specifically, we seek to examine the integrity of the study protocol, the acceptability of the intervention and to inform sample size calculations for a future large scale randomised controlled trial.

This is an open-label, formulation bridging and food-effect study which will compare 2 formulations in 3 separate crossover steps, as well as the effect of food (low-fat vs. high-fat diet). Who is it for? You may be eligible for this study if you are aged 18 to 65 years living with overweight or obesity, have a with a body mass index of greater than or equal to 27kg and less than 45kg without clinically significant (CS) medical history. Study details The aim of this study will be to assess the relative bioavailability of 2 formulations of aleniglipron in overweight or obese participants.