ANZCTR search results

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.

This study aims to evaluate the efficacy of a new approach to radiation therapy to the head and neck region at reducing the incidence of dry mouth toxicity. Who is it for? You may be eligible for this study if you are undergoing radical or high dose palliative intent primary radiation therapy with or without chemotherapy for primary carcinoma of the head and neck region with an intention to spare one or more major salivary glands. Study details An MRI scan will be used to plan an avoidance region within the parotid gland to be spared during radiation therapy. Participants will be asked to complete surveys assessing dry mouth toxicity and quality of life up to 5 years post-completion of radiation treatment. It is hoped that findings from this study will help inform dose optimisation of radiation therapy to the head and neck to address dry mouth, which still remains one of the most debilitating side effects of radiation in head and neck cancer patients.

Who is it for? You may be eligible for this trial is you are a female over the age of 50 who has been diagnosed with early-stage breast cancer and will be undergoing radiotherapy following surgery for early-stage breast cancer. Study details All participants in this study will receive a type of breast cancer treatment called Accelerated Partial Breast Irradiation (APBI) using a method called Volumetric Modulated Arc Therapy (VMAT). Only the part of the breast where the cancer has been surgically removed will receive radiotherapy (partial breast irradiation or “PBI”) rather than the whole breast (whole breast irradiation). This approach can reduce the toxic effects of radiotherapy. The treatment starts within 12 weeks after breast-conserving surgery and involves a planning session with a CT scan to help plan the treatment, which takes about an hour. After this, participants will take part in five daily 15-minute treatment sessions over one week. Participants in this study will be randomly allocated to receive one of two doses of treatment (26 Gy or 30 Gy). All participants will then be followed up for 3 years to assess quality of life and if there are any recurrences of cancer. It is hoped that this study will help determine if participant quality of life is the same with a higher dose compared to a slightly lower dose. This will then help decide the best dose for future patients with early breast cancer.

This RCT aims to assess the feasibility and efficacy of delivering an 8-week peer-led, individually tailored exercise program to university students experiencing mental health difficulties. Participants in the intervention group will complete one exercise session each week with their mentor. Subjective and objective data will be collected at baseline, middle and end of the project.