ANZCTR search results

In the intensive care unit (ICU), non-invasive ventilation (NIV) is a treatment option for patients with respiratory failure. NIV involves the delivery of oxygenated air from a ventilator to the patient via a mask. The mask is secured to the patient’s head using straps that sit around the head to hold the mask over the nose and mouth. The purpose of NIV is to reduce the likelihood of invasive mechanical ventilation that requires the insertion of an artificial airway or breathing tube. Traditionally NIV masks cover the entire nose and mouth, resting on the nasal bridge. This can in rare instances lead to the development of pressure injuries on the bridge of the nose and as such facial disfiguration. At Sunshine hospital the Nivairo® mask is routinely used for NIV. This mask sits across the nasal bridge. In this study we would like to determine if the Visairo® mask that does not have a nasal bridge is equivalent to the Nivairo® mask for the delivery of NIV.

This study aims to assess the safety and feasibility of using tranexamic acid (TXA) in patients with cerebral amyloid angiopathy (CAA) and symptomatic brain bleeding to determine if TXA can reduce risk of recurrent intracranial haemorrhage without harmful side effects. We hypothesise TXA to be a safe and well tolerated treatment option for patients with CAA in reducing their risk of recurrent brain bleeding. Participants will be recruited from Alfred Health and Royal Melbourne Hospital, diagnosed with probable CAA, who have had previous brain bleeding within the last 6 months. They will be randomly assigned to take either 1 gram of TXA orally three times per day or an identical placebo for 6 months. All participants will have MRI scans with contrast and blood tests at the start and end of the study to measure biomarkers. Researchers will track participants' compliance with the treatment and any adverse events over the 6-month period. Primary outcomes will include feasibility measures (participation and adherence rates) and safety (monitoring for serious adverse events like clotting conditions, heart attacks, strokes, or death). Secondary outcomes will track the recurrence of various brain haemorrhages, progression of white matter changes, changes in cognitive function, and brain volume loss, as well as the development of new strokes.

This study is a data collection study of the EMVision emu™ brain scanner for patients not suffering from or suspected of suffering from an acute stroke for software algorithm development. This study collects EMVision brain scans and MRI scans from patients receiving a head MRI as part of their routine care. Scans are anonymised and enter the EMVision database for training and developing software algorithms. This study hypothesises that an expanded non-stroke dataset can improve the diagnostic performance of the emu™ brain scanner.

The aim of this study is to test whether MDMA-assisted psychotherapy reduces social anxiety in young autistic people, compared with medication-assisted psychotherapy using: • Dexamfetamine • Lorazepam • Diphenhydramine hydrochloride, and • placebo. We hypothesise that MDMA-assisted psychotherapy will reduce social anxiety more than medication psychotherapy with placebo or the active control medications. Young people with autism, aged 16 to 25 years and experiencing social anxiety can take part in this research. The study will involve assessment for autism if participants have not been diagnosed in the past year. Participation will involve taking part in a medication-assisted psychotherapy program over a period of 12 weeks in addition to participating in a number of research assessments for approximately one year.

Most people diagnosed with dementia will experience at least one type of behavioural and psychosocial symptoms of dementia (BPSD), however the prevalence varies across the literature, with up to 95% of people living with dementia experiencing BPSD during their hospital admission. BPSD may also result in inappropriate psychotropic prescribing, falls, distress, and death. Over the past decade, virtual reality (VR) technologies have gained interest as a novel therapeutic intervention for dementia. VR therapy provides a potential non-pharmacological approach to managing BPSD and minimising distress during an acute hospital admission. To date, no randomised control trial has been done on the use of VR therapy in the acute hospital setting in Australia.

Rehabilitation is crucial for recovering motor functions after injuries like spinal cord injury (SCI) or stroke. Traditional methods often require a lot of manual effort from therapists, making them time-consuming and less effective for patients with limited or no motor control. Brain-computer interfaces (BCIs) offer a promising alternative by converting brain signals into commands that assist devices, enabling automated therapy without constant manual input. Our study focuses on training individuals, especially those new to BCIs, to use their imagination to control these systems in a virtual reality (VR) environment. This approach could make rehabilitation more efficient, engaging, and accessible for people with severe motor impairments.

The aim of this study is to deliver a new evidence-based education program in hospitals called the Safe Recovery program and to evaluate if it reduces falls and injuries. The study will also measure changes in patient and staff knowledge and motivation about falls prevention and if they are taking actions to reduce falls. Falls education is known to reduce patient falls and injuries in hospital. If effective the program will reduce falls and injuries in the wards that take part in the trial.

PURPOSE The purpose of this study is to assess the feasibility of patient self-administration of daratumumab in patient's own home. WHO IS IT FOR? You may be eligible for this study if you are male or female aged 18 years or older, have a documented diagnosis of multiple myeloma. Have relapsed following first line therapy and require treatment with daratumumab, bortezomib and dexamethasone. STUDY DETAILS Daratumumab, bortezomib and dexamethasone is standard of care. Daratumumab is currently administered in the hospital. Bortezomib can be administered home if your hospital has programs in place for this to happen. Dexamethasone is a tablet that you can take in your own home. The Dara@home trial is to assess the feasibility of implementing a program to allow patients to self-administer daratumumab at home. In addition to standard tests used to treat and monitor your myeloma, this study will have additional questionnaires for you to report your experience with myeloma treatment. There is also an additional blood test to assess the level daratumumab in your blood to ensure that the treatment is working. It is hoped that findings from this study will give insight on the possibility of having daratumumab to be self-administered at home, which can reduce your visits to the hospital.

Anxiety disorders are the earliest emerging, most common and debilitating mental illnesses, yet 40-45% of anxious children do not respond to best-practice psychological treatment, cognitive behavioural therapy (CBT). For the past two decades, we have been examining fear conditioning and extinction (CON-EXT) markers of anxious children’s underlying threat sensitivity, positive valence, and cognitive control systems, and the markers that predict who will recover following CBT. We have developed a CON-EXT Profile to assess markers at the individual patient level and conducted studies of CBT enhancements that allow for personalised treatment. The next and most important step is to examine outcomes from personalised CBT relative to standard CBT. The primary aim of this project is to conduct a Phase III randomised controlled trial, in which anxious children, 7-12 years of age, are randomised to Stratified CBT, in which CBT is personalised to their CON-EXT markers (right CBT for each anxious child), compared to Standard CBT, in which anxious children receive standard CBT (one size fits all). It is hypothesised that a higher proportion of children will be in remission, and acceptability ratings and treatment completions will be higher, in Stratified CBT than Standard CBT at the post-treatment primary endpoint and 6-month follow-up.

Unfulfilled expectations of surgical outcomes are a major factor influencing patient-reported dissatisfaction following Total Knee Arthroplasty (TKA). In Australia, approximately 60,000 TKA procedures are performed annually, with numbers expected to increase over the next decade. Despite advancements in surgical procedures, 10-20% of patients report dissatisfaction with surgical outcomes, indicating a significant number of individuals experience sub-optimal outcomes. In the EXTOKA project, we will develop an educational program for patients focusing on formulating realistic expectations of surgical outcomes following TKA in the private healthcare sector. The success of the program will be assessed by comparing patients’ expectations before and after the program, and by comparing expectations of those who participate in the program to those who receive standard clinical care alone. Additionally, the project will determine if participation is associated with a higher level of expectation fulfilment and satisfaction with surgical outcomes. Project findings will inform efforts to improve patient health literacy associated with TKA, supporting patients to make more informed choices about their recovery journey. By setting meaningful, realistic and achievable expectations of surgical outcomes, there is potential to better target rehabilitation programs to support attaining individual patient goals, thereby connecting them to the right care at the right time.