ANZCTR search results

This is a first-in-human, Phase 1, single-center study that will evaluate single ascending doses (SAD) and multiple ascending doses (MAD) of EmtinB conducted in 2 parts. Part 1 (SAD) of this study will be conducted in approximately 40 healthy participants in up to 5 groups. Each group will consist of up to 8 participants who will be randomized to receive a single dose of EmtinB or placebo. Part 2 (MAD) of this study will be conducted in approximately 32 healthy participants in up to 4 groups and will commence after safety data for the highest dose in the SAD phase has been evaluated. Each group will consist of up to 8 participants who will be randomized to receive 7 daily doses of EmtinB or placebo.

Vaginal prolapse is a common problem with approximately 1 in 10 women in the developed world requiring prolapse surgery in their lifetime . The problem has a myriad of symptoms ranging from mild discomfort to being very problematic and having a huge impact on quality of life. Surgery is generally seen as a last resort for managing vaginal prolapse, especially if a conservative method has been tried (eg: vaginal pessary device). However, the results of surgery alone are not perfect, and some women will develop recurrent prolapse or not be satisfied with the result. The thought of having a vaginal pessary device inserted at the end of the operation is for the pessary device to take tension away from the native tissue and suture lines and hence improve tissue regeneration, healing without scarring, leading to better surgical results and patient satisfaction. This could revolutionize the way we manage our level 1 and level 2 repairs and may result in better surgical outcomes, lower prolapse recurrence and better quality of life for our women in the long term. This study is to determine if having a vaginal pessary device (shaatz pessary) inserted intraoperatively at the end of vaginal prolapse surgery temporarily for 4 weeks will improve surgical results and patient satisfaction.

Orygen Virtual Worlds (OVW) is a project aimed at developing and testing an innovative and engaging prototype for an online, virtual platform to help the delivery of mental health treatments for young people with mental health difficulties. In a time of increasing reliance on digital delivery of mental health care, we propose this major opportunity to build on previous work to develop a standalone, purpose built, online virtual world. OVW aims to increase engagement and provide therapy to an isolated and disadvantaged patient group. A prototype of the OVW platform has been developed using user centred design principles, alongside a group of 10 - 15 young people and 6 clinicians to ensure it is purpose built to fit their needs. The current trial aims to evaluate the feasibility, acceptability and usefulness of the platform for delivering standard treatments (individual, group and peer therapy).

After a new stroke, the presence of physical disability, loss of employment, inability to participate in pre-stroke activities, social isolation, anxiety and depression make returning to the community difficult. Many people living with stroke have ongoing disability and report extreme problems in their quality of life. The purpose of this project is to develop and evaluate the feasibility of providing a co-designed, hospital-initiated follow-up service to support people living with stroke. This service is designed to prioritise support to people who are registered in the Australian Stroke Clinical Registry and report unmet needs and extreme health problems on a patient-reported outcomes survey collected between 90-180 days of discharge from hospital after a new stroke. Following the design and an initial non-randomised piloting of the intervention components (not registered separately) in up to 5 patients at one hospital to enable refinements to the clinical tools and protocol, we seek to complete a multicentre, randomised controlled pilot trial. In up to 6 hospitals and with approximately 100 eligible patients randomised to either usual care or the intervention we will test the feasibility and acceptability of this proposed follow-up service. Our study includes a process evaluation and cost consequences analysis to inform future scaling of the intervention including providing an understanding of the costs to provide the service in terms of the type of patient benefits may be achieved. The outcomes of this study may also be used to inform undertaking a fully powered effectiveness study. We seek to proactively use registry data to provide more tailored support for survivors of stroke who have reported extreme unmet needs and direct them to relevant services.

This study will determine the feasibility and acceptability (uptake, satisfaction) of the online CIRCUS program; a gender-tailored alcohol and healthy lifestyle program for women. The primary endpoint will be 3-weeks post baseline. The aims of this study are to determine if women are willing and able to use CIRCUS, an eHealth program, for 3-weeks, and to assess their satisfaction with the program. Primary outcomes will focus on recruitment, retention, and adherence to study parameters. Secondary outcomes will examine key health behaviours of alcohol use, nutrition, exercise, sleep and mental well being.

Health care professionals (HCP) working in neonatal intensive care units (NICUs) experience high levels of physical and psychological stress. Nijland and colleagues investigated the ease of use and immediate effect of virtual reality relaxation/ VRRelax (360º immersive environments) to reduce perceived stress in intensive care nurses. After using VRelax, stress levels decreased by 40% and 62% of the ICU nurses thought VRelax was helpful in reducing stress. This study concluded that VR is easy to use and is an effective intervention to reduce immediate stress in ICU nurses. Given these potential benefits, we aim to conduct a pilot study to examine the use of VR to reduce perceived stress in our neonatal intensive care staff during their work shifts.

The study is a pharmacokinetic study on 20 volunteers assessing blood and urine pharmacokinetics and excretion for a 98% CBD product with no THC. The same product is available in a soft gel capsule and a liquid oil. Twenty participants will undergo 24 hour testing for each drug around 2-3 weeks apart. Blood and urine will be taken at 0,1,2,3,4,5,6,8 and 24 hours. They do not have to stay overnight but do need to come back to the clinic for their 24 hour testing.

This study aims to determine the effectiveness of a practice change intervention in increasing the provision of recommended smoking cessation care by antenatal services. Relative to usual antenatal appointments, it is hypothesised that the intervention will achieve increases in the proportion of post intervention appointments in which smoking cessation care is consistent with guideline recommendations: assessment using CO monitors (predicted 7.2% increase); brief advice (predicted 17.6% increase); referral (predicted 21.8% increase). The study will be conducted as a stepped-wedge controlled trial, with staggered implementation of the intervention across maternity services in three health sectors within Hunter New England Local Health District, New South Wales, Australia. The intervention will consist of evidence-based, locally tailored practice change strategies including guidelines and procedures, prompts and reminders, leadership support, training, and audit and feedback. The prevalence of woman-reported assessment, advice and referral for smoking will be the primary outcomes of interest. Cross-sectional measurement of outcomes will occur via telephone interviews with a random sample of women who attend the services each week. An intervention effect will be determined by an increase in recommended care delivery across the sites. Economic analyses will be undertaken to assess the cost, cost effectiveness and budget impact of the practice change intervention. Acceptability of the intervention to women will also be measured.

Babies often require help to breath from a breathing machine (mechanical ventilation with a ventilator). While this keeps babies alive, it may damage their lungs. To minimise this damage, we use gentle methods of mechanical ventilation. High frequency oscillatory ventilation (HFOV) is an alternative type of mechanical ventilation thought to cause less lung damage. To use this type of breathing support safely, a baby’s lungs need to be properly inflated. We usually find out this information by using x-rays of a baby’s lungs, oxygen levels, and measurements we get from the ventilator. Babies whose lungs are not fully inflated need more pressure from the ventilator to open up their lungs, but it can be hard to know when we have given enough pressure. Lung x-rays give us some information about how well inflated the lungs are, but they use radiation and only provide a picture at one point in time. As a result, we rely on a baby’s oxygen levels and measurements from the ventilator to guide how we open the lungs with pressure. These are not very accurate. Ultrasound and electrical impedance tomography (EIT) are forms of imaging that do not use radiation. Ultrasound uses reflected sound to create an image of different parts of the body. EIT uses changes in electrical resistance to create images of the lung. Both are safe, painless and can be used to assess lung inflation over a period of minutes rather than a single time point like x-rays do. We are exploring whether a lung ultrasound performed during a procedure to inflate the lungs called a “recruitment manoeuvre” can help us find the best pressure to use to keep the lungs properly inflated. In this study, we will perform ultrasounds of a baby’s lungs at each step during a recruitment manoeuvre. We will compare the lung ultrasound findings to the usual ways we measure the lung inflation and also to measurements of lung inflation from EIT. These findings may help us better use HFOV in the future.

We aimed to show that a peanut-enriched weight loss diet would improve markers of diabetes compared with a standard low far weight loss diet. We expected given the same degree of energy restriction that both diets would provide a similar weight loss outcome