ANZCTR search results

Around 12 participants will follow a fixed treatment plan to study how GV-100 interacts with other medicines. After screening, they will stay at the study site for about 2 weeks and return for a follow-up visit. They will first receive two medicines to check how their body processes them, then take GV-100 daily for 7 days. Later, the same medicines will be given again along with GV-100 to see if it changes how other drugs are handled in the body.

We recently collaborated with seven Australian adults living with HPP, and a carer of an adult living with HPP, to co-design a DVA-delivered health tool aimed at meaningfully supporting self-management of HPP. The participatory project explored the perspectives of those with lived experience of HPP, following the first three steps of the four-step Design Council Double Diamond Framework (Discover, Define, Develop, Deliver). In the Discover and Define phases, three priorities were identified: providing connection with peers, coordinating care, and supporting self-management. The most important features addressing each priority were then determined using structured prioritisation (i.e. video calls with peers, community noticeboard, health diary/ monitoring, healthcare professional database, education sessions, artificial intelligence-supported question and answer function, and nutrition/mental health support). During the Develop phase, the prioritised features were prototyped and presented for feedback. To address the final Deliver step of the Double Diamond framework, we will test the feasibility and preliminary effectiveness of using the DVA-delivered self-management program in a 12-week trial of adults living with HPP.

The aim of this study is to assess the amount of new bone volume that can be achieved using an established surgical technique know as guided bone regeneration (GBR). The regenerated bone will be used for the purpose of replacing missing teeth with dental implants. The study will be performed at a private specialist periodontal practice. In addition to assessing the volume of newly created bone, potential side effects such as swelling, pain and gum infection around the dental implants will be assessed for a period of up to 10 years from the GBR procedure.

The purpose of this study is to test whether MRI scans using non-standard imaging techniques can identify areas of prostate cancer that have low oxygen levels. Tumours with regions of low-oxygen may be at greater risk of metastatic spread and hence this project aims to build imaging biomarkers that may identify patients that may require additional treatment strategies to manage this risk. Who is it for? Participants may be eligible if aged 18 years or older, have localised intermediate- or high-risk prostate cancer, and have not yet started treatment. Study details Participants will be recruited and participate in this study before receiving their planned (standard of care) prostate cancer treatment. Before treatment starts, participants will undergo two additional MRI scans for research purposes, including one scan with a standard MRI contrast injection. For some participants, leftover tissue from their routine diagnostic biopsy will also be analysed. The researchers will compare the MRI results with the tissue findings to determine whether MRI can accurately identify low-oxygen areas within prostate cancer. The additional scans are not expected to delay initiation of standard-of-care treatment.

Left bundle area pacing is an emerging modality. The importance of continuous electrical monitoring during LBBAP pacemaker implantation has not been established. The CAPTURE trial analyses the principle that continouous electrical monitoring will improve acute implant physiological characteristics, and assesses the impact of implant electrical monitoring on clinical outcomes of pacemaker implantation.

This research project will assess the cardio-respiratory responses to an acute bout of whole-body heating in healthy young (18-40 years) and older adults (60-80 years). Specifically, we will use a water-perfused suit model of passive heating to increase core temperature, while we use a cardiac assessment and respiratory psychophysical assessments to determine what the ‘normal’ change in cardiac function and respiratory sensation is and how this may be augmented by healthy aging. This research will lead to a better understanding of the physiological responses to heat exposure to support future work looking at individualised cooling strategies during hot weather and heat extremes.

Low back pain affects 4 million Australians and creates considerable health service delivery challenges in Australia. Most guidelines advise that low back pain is best managed in primary care with advice and education to support self-management, and effective physical and psychological therapies. Despite this, referrals to spine surgeons are common. In many cases these patients have not tried effective non-surgical care, and while they wait 1-2 years to see a surgeon, they develop health concerns which are complex and costly to manage. In response to this, we co-designed a physiotherapist-led triage and management model of care in spine surgery clinics that could help patients with 'non-urgent’ conditions receive non-surgical care sooner and those with more complex presentations to see a surgeon sooner (Virtual or In-person Physiotherapist-led Evaluation of Referrals to spine surgeons, VIPER). VIPER was informed by a co-design phase which involved assessing and addressing key stakeholders (i.e., patients and health professionals) needs and empowering them to be partners in designing and evaluating the proposed model of care. We hypothesise that the Virtual or In-person Physiotherapist-led Evaluation of Referrals to spine surgeons (VIPER) model of care will reduce disability at 6-months (primary outcome) compared to usual care (i.e. joining the wait list for an in-person appointment with a surgeon) for patients with non-specific low back pain and/or lumbar spine-related leg pain who are referred to a spine surgeon at public hospitals in New South Wales. We also hypothesise that the proposed model of care will be cost-effective and have strong potential to be implemented Australia-wide as it has been co-designed to be acceptable, user-centred, and feasible within the Australian healthcare context.

When someone in intensive care is sedated or cannot communicate, doctors cannot rely on the usual bedside neurological examination to tell whether blood flow to the brain is becoming compromised. Problems such as a blocked artery, narrowed blood vessels after a brain bleed, or rising pressure inside the skull can therefore go unnoticed until damage has already occurred. When the brain's blood supply is threatened, blood is redirected through smaller back-up arteries in the head and neck. If those changes could be measured continuously and non-invasively at the bedside, they might provide an early warning. Before that idea can be tested in unwell patients, we need to understand what these arteries normally do in healthy people. This study asks a simple question: when we deliberately and safely change a healthy person's circulation for a few seconds at a time, how does blood flow in the arteries of the head and neck respond, how quickly, and how is flow shared between the different vessels? We will recruit up to 20 healthy adults aged 18 to 45 years at a single site in Melbourne. Each participant attends a screening visit and one main recording session lasting about two to four hours. During the session, small ultrasound probes are held gently against the temples, near the eyes and on the neck by a lightweight head frame, and record blood flow continuously. Heart rhythm, oxygen levels, blood pressure and breathing are monitored throughout. Participants then complete five short, standardised tasks, each repeated three times: brief gentle pressure on an artery at the temple; a short breath-hold; blowing gently against a pressure gauge; a period of faster paced breathing; and a very brief, carefully supervised compression of an artery in the neck lasting no more than five seconds. Clear stopping rules apply to every task, and any task is stopped immediately if the participant feels unwell. A safety phone call follows the next day. Up to five participants are also invited to have a single MRI scan of the head's arteries, which is optional. The first five participants form a run-in group. The study only continues to the full group if the recordings are of adequate quality and no safety concerns have arisen. Our hypothesis is that these standardised tasks produce measurable, repeatable and characteristic patterns of blood flow change across the different arteries, and that the pattern differs depending on which task is performed. This is an early-stage physiological study in healthy volunteers. It is not designed to diagnose or treat any condition, it does not test whether any device works, and no participant receives any treatment. The ultrasound and monitoring equipment used is standard commercially available clinical equipment, used in its normal way purely to take measurements. The results are intended to describe normal responses and to inform the design of future, larger studies in patients.

RLS-2202 is an intravenous formulation of oral SEROQUEL® tablet and is being tested for treatment of delirium and acute agitation in critically ill patients. The study is designed to characterise the pharmacokinetics (PK) and safety profile of the formulation RLS-2202, which is an intravenous formulation of quetiapine fumarate and compare it to the approved, oral tablet of quetiapine fumarate, which has the trade name SEROQUEL®. This trial is designed in two parts. The first is a pharmacokinetic assessment, where 4 healthy volunteers are given a single oral dose of 25mg tablet. Blood sampling will occur at timepoints pre-dose, 15, 30, 60,90 minutes and then at 2, 4 an 8 hours. These samples will be tested to observe how long it takes for the medication to be absorbed and metabolised by the body. The healthy volunteers will undergo a wash out period to ensure that there is no medication remaining in circulation. After the washout period, the healthy volunteers will be given an intravenous dose of the RLS-2202. Blood samples will be taken at same timepoints and the samples will be tested in exactly the same way as the first blood samples to see how long the intravenous RLS-2202 takes to be absorbed and metabolised by the body. These results will be compared and the dose for the second part of the study will be determined by a panel of doctors and scientists. The second part involves 12 health volunteers, where a single dose, determined from results of part 1, will be given intravenously and blood sampling will occur over 48 hour period. The healthy volunteers will then undergo a wash out period before being given a dose of oral Seroquel 50mg. Blood sampling will be conducted over the 48 hour period. All samples will then be analysed, as previously described. It is hypothesized that this intravenous formulation will be fast-acting, easier to administer to critically ill patients and significantly reduce the number of side effects, compared to the oral tablet.

Exercise is known to support mental well-being during and after pregnancy as well as in times of grief. However, there is very little research on how exercise may support individuals after pregnancy loss. This study will explore the safety and feasibility of a 10-week, group-based exercise program for individuals following pregnancy loss. It compares a supervised, instructor led progressive exercise program with individualised prescription, to a standardised, in-person stretching program with no individualisation or progression. Thirty-two individuals who have recently experienced pregnancy loss will be invited to take part in a 10-week program run by an accredited exercise professional, combining physical activity with education and peer support. The aim of this research is to better understand how exercise and connection with others can help to improve emotional well-being and reduce isolation after pregnancy loss, and to address critical gaps in current research and practice.