ANZCTR search results

This study aims to explore how a slow, controlled breathing technique (developed in a previous study ACTRN12625000101482) affects the body’s stress response during a high-pressure simulated clinical scenario. Participants who previously completed the breathwork program will be compared to those who did not, to see if the breathing practice helps regulate heart rate, breathing, and other physiological responses under stress. We hypothesise that those who practiced the breathwork regularly will show improved autonomic regulation—specifically more stable heart rate variability (HRV), lower heart rate, and more efficient breathing—during a stressful simulation, compared to those who did not receive the intervention.

The social determinants of health are the everyday things in life that all families need to thrive including childcare and schooling; government benefits and vouchers; housing; food; money to pay bills; and transport. Research from Australia has shown that many parent/carers of children with a neurodisability want help with these everyday things in life and have trouble finding the right supports and services for their family. Adverse social determinants of health are experienced by families as unmet social needs. Studies from the United States of America with parent/carers of children have tested different programs to help families with unmet social needs. These studies have found that providing families with a resource pack containing information about local supports and services can help them address problems they are having with their unmet social needs. These studies have also found that providing families with a resource pack and connecting parent/carers with a person called a “Community Linker” can help. The Community Linker provides 1:1 support to help families access supports and services for their unmet social needs. Together with parents/carers of children with a neurodisability and their health care professionals, we have designed a resource pack and Community Linker program that aims to be suitable for the unique needs of families of children with a neurodisability. We have tested these two programs (resource pack; resource pack plus Community Linker) in a pilot research study of parent/carers of children with cerebral palsy. Our pilot has found that parent/carers find this program helpful, acceptable, and easy to engage with. In this current study we will test the long-term effectiveness of the Community linker with a resource pack against the resource pack only in a wider population. We will also see how cost effective the program is and how we can implement it in other settings. We predict that parents/carers who receive the Community Linker program will report greater improvements, compared to parents/carers who receive the resource pack.

This study examines how artificial sweeteners affect fuel utilisation at rest and during exercise. Participants will consume water, artificially sweetened sports drinks, or full-sugar sports drinks across three sessions in a randomised, double-blind crossover trial. Metabolic responses, including fat and carbohydrate oxidation, will be measured using indirect calorimetry and blood sampling. The findings will help determine whether artificial sweeteners impact energy metabolism similarly to sugar.

People with a mental health condition experience increased morbidity and mortality, with the majority of this burden attributable to chronic disease. This is largely due to a high incidence of key modifiable risk behaviours (smoking, poor nutrition, excessive alcohol consumption, physical inactivity). Mental health community managed organisations are well positioned to provide preventive care for these behaviours, however currently care is not comprehensive or routine in the sector. A new model of providing preventive care for key chronic disease risk behaviours will be implemented. Practice change strategies will be delivered over 6 months to build the capacity of services and their staff in implementing the new model of preventive care. The model of care and implementation strategies have been co-developed in workshops with the participating CMO. The research team will evaluate this new approach in a cluster randomised controlled trial across 12 sites in New South Wales, Queensland and South Australia. Primary outcome will be the proportion of consumers that received an offer from their support worker to facilitate access to services or resources.

The aim of this study is to determine whether it is feasible within an electronic medical record platform to screen, randomise, and direct the administration of intravenous phenobarbital, as an alternative to usual care, As well as the effect of phenobarbital administration in critically ill patients who are withdrawing from alcohol and are admitted to the Intensive Care Unit. We believe it is feasible to use an electronic medical record platform to guide this study intervention and that, based on current literature, phenobarbital is more effective than current usual care in the setting of alcohol withdrawal requiring ICU admission.

This study will aim to establish whether dietary fibre added to normal tube feeding food can increase bacterial diversity in the GI tract in people who are critically ill and are receiving treatment with a breathing machine in the ICU. Information on GI bacteria will be collected from stool samples or cotton swabs that have wiped the bottom. It will also aim to collect information on whether the use of use of dietary fibre can lead to patients improving more quickly, such as by enabling liberation from the breathing machine earlier or having fewer infections caught in hospital. This study aims to investigate if "good bacteria" in the intestines can be increased during critical illness adding fibre to food.

Out of hospital cardiac arrest (OHCA) is the leading cause of death in otherwise healthy adults affecting ~25,000 Australians per year. Even with conventional cardiopulmonary resuscitation (CCPR), survival decreases quickly. After 15 minutes of CCPR the arrest is deemed "refractory", the probability of good functional recovery falls 30 minutes <1% at 30mins. Extracorporeal membrane oxygenation (ECMO) is circulatory support technology. When ECMO is implemented during a cardiac arrest it is termed – Extracorporeal CardioPulmonary Resuscitation or ECPR. Currently, ECPR is implemented at a few large hospitals (5 in Sydney). The best outcomes with ECPR occur when the time from cardiac arrest to ECMO flow are minimised. Pre-hospital ECPR is implementing ECMO at the scene of cardiac arrest and reduces the time from cardiac arrest to ECMO flow. Pre-hospital ECPR services exist in Paris, London, Netherlands, Minnesota and New Mexico and is being trialled in Melbourne. The hypothesis for the trial is that compared with usual care (including hospital-based ECPR), scene-based ECPR is feasible and will increase the rate of neurologically intact survival at discharge in patients with refractory OHCA.

This study is a clinical trial evaluating an online, guided self-help intervention called Couple HOPES (i.e., Helping Overcome PTSD and Enhance Satisfaction). It was adapted from Cognitive Behavioural Conjoint Therapy and designed for couples seeking to address PTSD symptoms and enhance relationship satisfaction. Couple HOPES has been piloted in Canada and the US, and a waitlist clinical trial has been registered in Canada. We aim to understand whether Couple HOPES is effective at improving the health and wellbeing of Australian first responders with symptoms of PTSD and their partners. We are also interested in couples' views regarding whether it is an acceptable approach and how it might be tailored to the Australian context.

To assess and improve our renal biopsy service, we aim to conduct a randomised study comparing automated 16g full core and side-notch needles for adult transplant renal biopsies. The two needle types have a similar safety profile however the difference in the yield and diagnostic value has not been previously assessed. Renal transplant patients referred to the Radiology Department for standard of care renal biopsies will be recruited into the study. Standard of care biopsy procedure and follow-up of patients will be conducted during the trial. Data will be prospectively collected, de-identified and analysed. The findings will be presented at Alfred multidisciplinary meetings, local and/or international conferences and published in the medical peer reviewed literature.

This is a phase 1 first in human study to assess the safety of OZ-001 and how this drug acts in the body in adults with triple negative breast cancer (TNBC). OZ-001 may be indicated for use in patients with TNBC, but a trial to test the amount of OZ-001 that is safe is needed before a trial into the effectiveness of OZ-001 in cancer patients can proceed. Who is it for? You may be eligible for this study if you are aged over 18 years and have a diagnosis of TNBC that is advanced/metastatic and refractory or intolerant to standard therapies or have refused standard therapy. Study details All patients who choose to enrol in this study will receive a single dose of OZ-001 daily for 28 days. All patients 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 of OZ- 001 that can be administered safely without causing severe reactions. Once the dose of OZ-001 has been determined, a trial investigating the effectiveness of OZ-001 as a treatment for patients with TNBC may proceed.