ANZCTR search results

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.

Before some patients have a CT scan of the heart's arteries (called a CT coronary angiogram), they are given medication to slow their heart rate down. A slower, steadier heart rate produces clearer pictures and helps the scan work well. The medication used is a type called a beta-blocker. At present, this medication is usually given as a tablet taken by mouth. Tablets take time to work, and some patients' heart rates do not slow down enough, which can delay the scan or mean it has to be postponed. Another option is to give the same type of medication through a drip into a vein, which may work more quickly. This study aims to find out whether giving the heart-rate medication through a drip, rather than by tablet, gets patients ready for their scan sooner. We will compare the two approaches in patients coming in for a CT scan of the heart's arteries. Everyone taking part will be randomly placed into one of two groups: one group will receive the tablet approach currently used, and the other will receive the medication through a drip. We will mainly measure the time it takes each patient to be ready for their scan, and we will also look at how well each approach controls the heart rate, the quality of the scan pictures, the dose of medication needed, and whether any side effects occur. We think that giving the medication through a drip will prepare patients for their scan more quickly than tablets, without affecting their safety or the quality of the scan. If this is correct, it could mean shorter waits, fewer cancelled scans, and a smoother experience for patients.

This study is investigating the safety and skin effects of a new hyaluronic acid-based treatment called Functional Ligand–Hyaluronic Acid Cross-Linked (Fli-HAXL) in healthy adults with facial wrinkles and signs of skin aging. The treatment is applied to the skin and delivered into the superficial layers of the skin using a microneedling device. Each participant will receive the investigational treatment on one cheek and a comparator vehicle treatment on the other cheek. The study aims to determine whether the investigational treatment is safe and well tolerated, with particular focus on skin reactions, vascular occlusion events, and visual symptoms. The study will also assess whether the treatment improves the appearance of facial wrinkles and participant satisfaction with their skin appearance. The hypothesis is that treatment with Functional Ligand–Hyaluronic Acid Cross-Linked delivered by microneedling will have a safety profile comparable to the comparator treatment while improving the appearance of facial wrinkles in adults with signs of skin aging.

Brief description of the study purpose: This study is investigating a personalised mRNA vaccine for children and young people with high risk central nervous system tumours. The vaccine is made individually for each participant using information from their tumour and is designed, based on laboratory and preclinical research, to help the immune system recognise proteins associated with the tumour. Who is it for? You may be eligible if you are male or female 6 months to 25 years old, have a high-risk central nervous system tumour, and are enrolled in the ZERO Childhood Cancer molecular profiling program, you have measurable disease (with some exceptions for newly diagnosed cases), a Karnofsky/Lansky score equal to or above 50, a life expectancy of at least 12 weeks, have recovered from prior therapy according to required washout periods, and have adequate blood counts, kidney function, liver function, and coagulation. You must not have a known hypersensitivity to mRNA vaccines, not be pregnant or breastfeeding and have no underlying congenital immunodeficiency. You must not be taking corticosteroids other than physiologic replacement doses and have no live vaccines within 3 months of starting protocol therapy. What is involved for participants? Study participants will be required to have periodic physical examinations, sample collections (blood and urine tests), completion of quality of life questionnaires, a heart function check and brain imaging to check the tumour. Study details Participants will receive the recommended Phase II dose (RP2D) of the personalised mRNA vaccine for eight doses, followed by a booster dose at six months. Phase II participants will be enrolled into two strata. Phase II Stratum A will include participants with newly diagnosed DMG and Phase II Stratum B will include participants with other high-risk brain tumours.

A randomised cross-over feeding study conducted in free-living adults (aged 18 years and older) with high blood pressure and type 2 diabetes or pre-diabetes living in the local Hunter region. Participants will be enrolled in an 8-week dietary intervention consisting of a 2-week run-in period (habitual/usual diet) followed by 2 x 2-week dietary intervention periods that include a 2-week washout between them. The 2-week diet periods will consist of a ‘Healthy Australian Diet’ (HAD) and the “Healthy Australian Dietary pattern + bioactive foods” (HAD+). The HAD+ will have foods from the 5 core food groups from the current Australian Dietary Guidelines for adults with the addition of high bioactive foods that have been associated with reducing BP. The key foods in the HAD+ diet will include oats, beetroot, leafy green vegetables, flaxseeds, citrus fruit, and mixed nuts. These two diets will be allocated in a randomised order. During the 2-week washout period the participant returns to their / usual diet). The entirety of the diet (i.e., 3 main meals and snacks per day) will be provided to participants during dietary period 1 and 2. Participants will supply their own meals and foods during the run-in and washout periods. Study participation involves completing self-administered questionnaires (e.g., food frequency, health, demographic, physical activity questionnaire); collection of biosamples (fasted blood sample, urine and faecal sample) and physical measurements such as blood pressure, arterial stiffness, anthropometry and body composition.

The ZenZone Trial will test whether an eight-week dairy study is practical, safe, and acceptable for 14-year-old girls experiencing elevated depressive symptoms. Participants will be randomly assigned to consume either a yoghurt containing added BB-12, conventional yoghurt, or flavoured milk each day. The main aim is to assess recruitment, retention, adherence, completion of study activities, protocol compliance, and safety. The study will also explore changes in mood, sleep, thinking, gastrointestinal symptoms, diet, the gut microbiome, saliva biomarkers, and, for some participants, brain imaging measures. We expect the study procedures to be workable and acceptable, and will examine whether probiotic yoghurt shows more promising changes than conventional yoghurt or milk to inform a larger future trial.