ANZCTR search results

Endometriosis is an important and common cause for pelvic pain for which laparoscopy provides definitive diagnosis and often symptom relief. There are however many people with pelvic pain who do not have endometriosis in whom laparoscopy poses potential risks and costs without the same possibility for symptom benefit. As yet, there are no validated, symptom-based, patient-reported questionnaires for endometriosis screening. We plan to make a predictive tool that uses questions about a person’s symptoms and medical history and their anogenital distance (AGD – the distance from the vagina to the anus which is associated with chance of endometriosis), to better predict pre-operatively the absence of endometriosis. This could hopefully be used as a tool that women could use to help decide if they want to go on and have a laparoscopy or not. It might result in fewer women having unnecessary surgery and getting more appropriate treatment for their pain instead. In this study we will look at people already planning to have a laparoscopy for investigation of their pelvic pain. We will ask them to fill in a questionnaire about their symptoms and medical history before their operation and then we will check if they had endometriosis at surgery or not. We will also measure their anogenital distance while they are asleep under the anaesthetic for their surgery. We will use this information to develop and validate a predictive tool for absence of endometriosis.

Sodium-glucose co-transporter 2 (SGLT2) inhibitors have been shown to reduce heart failure hospitalisation in patients with type 2 diabetes (T2D) at high cardiovascular risk and in patients with heart failure (HF) with reduced ejection fraction without or without diabetes. However, the mechanisms by which SGLT2 inhibitors reduce the risk of HF remains unclear. Previous studies have demonstrated that SGLT2 inhibitors can reduce left ventricular (LV) mass and improve LV diastolic function in stable outpatients with T2D and in patients with HF with reduced ejection fraction. We recently performed the first study to assess the effects of empagliflozin (an SGLT2 inhibitor) on LV function following an acute coronary syndrome (ACS) in patients with T2D. The observational study found that empagliflozin reduces LV mass and improves LV diastolic function in this cohort, which means that empagliflozin could potentially improve the heart’s pumping function after a heart attack or an angina episode. This had led to the design of the Randomised trial of Empagliflozin and Left Ventricular diastolic function in Acute Coronary Syndrome and Type 2 Diabetes (RELACS-T2D). Following an ACS, 80 participants with T2D at Fiona Stanley Hospital (FSH) will be randomised 1:1 in this open-label trial to either 1) Empagliflozin or 2) no SGLT2 inhibitor therapy. Diastolic stress echocardiography (DSE) using supine bicycle will be performed at baseline and at 6 months follow-up. Echocardiography will be performed by certified sonographers and reported by a consultant Cardiologist who are both blinded to treatment allocation. Results at follow-up will be compared to baseline by a blinded investigator to assess for significant changes in LV function between groups. Non-fasting blood samples will be collected at baseline and follow-up and analysed to detect significant associations. We hypothesise that empagliflozin treatment can reduce adverse LV remodelling and improve LV diastolic function following an ACS in patients with T2D.

This is a 4-year Phase 3 RCT to re-purpose sildenafil citrate - a widely available, off-patent drug that dilates pelvic blood vessels and improves placental blood flow. The trial will evaluate whether, compared to Placebo, sildenafil citrate safely reduces emergency caesarean sections for fetal distress in small or suboptimally grown babies.

This project will test a new intervention that aims to prevent people's social media use from causing them to feel dissatisfied with their body and experience disordered eating. The intervention uses exercises designed to help people reduce their self-criticism and increase their self-compassion when using social media. The project will assess how much participants engage with the intervention, request their feedback on it, and determine whether there is evidence that it may help to prevent disordered eating. Because this intervention has not been tested before, we do not know if it will be effective or acceptable, but we hope that it will reduce appearance comparison, self-criticism, and disordered eating, and increase body image flexibility.

The aim of this study is to evaluate the state-wide dissemination of the RT for Teens program, This revised intervention was previously evaluated via cluster RCT in 16 secondary schools (ACTRN12615000360516; Kennedy et al., 2018). This trial saw improvements in students' muscular fitness, resistance training skill competency and resistance training self-efficacy. To improve the health behaviours of NSW students, the program was then delivered across the state. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework was be utilised to evaluate the program. We hypothesis that the modified, flexible design of the RT for Teens program will maximise adoption and implementation potential in schools, leading to enhanced program reach - whilst still effectively improving student outcomes as in the RCT. Citation: Kennedy, S. G., Smith, J. J., Morgan, P. J., Peralta, L. R., Hilland, T. A., Eather, N., ... & Lubans, D. R. (2018). Implementing resistance training in secondary schools: a cluster randomized controlled trial. Medicine & Science in Sports & Exercise, 50(1), 62-72.

The study will be a multi-center, open-label, single-dose, parallel-arm evaluation of the ocular effect and safety of NVK031 in healthy volunteers with brown eyes and non-brown eyes. In this study, four test products of NVK031 will be evaluated. Approximately 44 eligible subjects will be healthy volunteers who are 18 to 55 years old and free of clinically significant ocular pathology. The primary objectives are to identify a MED and to assess the overall effect of NVK031 on the change from baseline (pre-dose at Visit 2) in mesopic pupil diameter for subjects receiving the MED.

The primary aim of this study is to determine whether peripheral blood flow differs according to the approach used to prescribe training pressures for blood flow restricted exercise (BFRE). A secondary aim is to explore associations between self-reported tolerability and cuff pressures. The specific research questions posed for this study of older adults are: 1) Does peripheral blood flow rate after cycling differ between cuff pressure prescription approaches? 2) Are sensations of discomfort, breathlessness and tightness intensity related to cuff pressure? We hypothesise that in older adults: 1) Peripheral blood flow rate will be significantly lower when the cuff is inflated and higher following cuff release when percent of systolic blood pressure, perceived cuff tightness or an arbitrary pressure are compared to the recommended percent of limb occlusion pressure (LOP) approach for prescribing blood flow restricted training pressure. 2) Significant positive associations will exist between cuff pressures and a) sensations of peripheral muscle discomfort and tightness under the cuff during cuff occlusion and b) intensity of breathing discomfort upon cuff release.

The proposed study aims to answer an important clinical question: can subthreshold psychotic manifestations be effectively treated with cannabidiol (CBD), a non-psychoactive compound of the plant Cannabis sativa? The question has taken on increased clinical importance in the wake of recent evidence questioning the need and efficacy of specific interventions in the UHR group. This study will test CBD for the first time in the UHR phase of psychotic disorder.

Behavioural eHealth and mHealth interventions have been moderately successful in increasing physical activity. Therefore, there is still room for further improvement. Chatbots equipped with natural language processing can effectively interact and engage with users. Chatbots can also help continuously self-monitor physical activity levels using data from wearable body sensors and smartphones. However, there is lack of studies evaluating effectiveness of chatbot interventions on physical activity. The aim of this study was to investigate the feasibility, acceptability and effectiveness of an interactive machine learning based chatbot that uses natural language processing and adaptive goal setting to improve physical activity among inactive adults living in Australia.

Over 400,000 community and hospital patients in Australia have chronic wounds, posing an estimated annual burden of $3 billion in treatment costs. These patients risk longer hospital stays and 30-day readmission as a result of wound complications. Pressure injuries (PI) and lower leg ulcers, are the most common chronic wounds, with PI accounting for 84% of chronic wounds. With COVID-19, use of telehealth consultations is a timely intervention for patients with chronic wounds. However, research in this area is scarce. This translational research study will determine the efficacy of the Virtual wound Care command Centre (VATICAN) in four settings and three health districts. The project will reduce face-to-face visits between staff and patients, promote timely clinical intervention and prevent deterioration of wounds necessitating re-admission, thereby alleviating demand on services. This application, through leveraging off an existing pilot study, provides the opportunity to test a virtual wound care model, enhancing transferability and scalability.