ANZCTR search results

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.

This study aims to investigate the effect of a single dose of guanfacine on cognition and brain function in people with Parkinson's disease. The purpose of the study is to determine the potential effectiveness of guanfacine in treating cognitive symptoms in Parkinson's disease. This study will involve 25 participants with Parkinson's disease, who will take part in 2 study visits at least one week apart. Each participant will receive either guanfacine (active treatment) or a placebo at one visit and the opposite at the other, in a randomised order, without knowing which one they are receiving. The effects of the medication will be measured using cognitive tests, brain scans and blood tests.

Staff education and training resources on how to address sexual function and wellbeing after Traumatic Brain Injury (TBI) are being co-designed with clinicians, and will be launched at the Epworth ABI rehabilitation unit. The goal is to reduce the barriers that clinicians face in addressing this sensitive but important topic with patients, which is often neglected in healthcare. This trial will investigate the benefits and changes for both clinician and patient outcomes at the rehabilitation unit through the use of questionnaires and interviews.

The goal of this project to is explore the immediate response of sitting balance and trunk stability to electrical stimulation used to activate the abdominal muscles in people with chronic SCI. This type of electrical stimulation, called functional electrical stimulation, is used on the abdomen or other areas of the body to help people with SCI and other neurological conditions to perform tasks, cough, work out, or strengthen muscles. We plan to study whether functional electrical stimulation activating or turning on the abdominal muscles can alter the sitting balance response compared to having no functional electrical stimulation. We are targeting the abdominal muscles because they are part of the core musculature and play an important role in balance control. Improving balance and trunk stability is a high priority for people with SCI. Balance and trunk stability are crucial to independence in functional activities or activities that people perform every day like dressing, grooming, eating, toileting, and completing transfers. If there is a positive response to abdominal functional electrical stimulation during balance activities, it could be implemented into daily routines of people with SCI because it is a safe and relatively low-cost intervention.