ANZCTR search results

This pilot randomised controlled clinical trial will explore the feasibility of delivering a new, telehealth intervention to individuals with a stimulant use disorder and traumatic brain injury. It aims to generate exploratory data on treatment engagement, change in stimulant use, community participation, and healthcare utilisation/costs that could inform hypotheses for a larger clinical trial.

Diabetic patients are at higher risk of stent failure and heart attacks following percutaneous coronary intervention (PCI). Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are second-line therapy in diabetes and certain SGLT2i (empagliflozin) have been shown to reduce cardiovascular events. Observational data have suggested reduced coronary restenosis rates with SGLT2i following PCI, regardless of glycaemic control. An animal model study demonstrated the plaque-stabilising effects of SGLT2i through the reduction in lipid core and increasing fibrous cap thickness. This study explores the role of empagliflozin in reducing the risk of coronary stent restenosis in diabetic patients. Diabetic patients undergoing PCI in a non-emergency setting will be randomised to either empagliflozin or standard of care (non-SGLT2 inhibitor treatments for diabetes). All patients will receive intravascular imaging at baseline and at 9 months following PCI. The primary outcome of this study is the degree of lumen loss at follow-up, a marker of stent restenosis. Other markers that will be examined include strut coverage, stent mal-apposition and neo-intimal growth. In the world’s first study, we will also examine the impact of empagliflozin on coronary plaque morphology such as fibrous cap thickness, lipid plaque volume and plaque regression over time. This will provide additional knowledge on the impact of SGLT2i on vascular healing and plaque stabilisation.

This randomised controlled trial aims to determine the effect of Expiratory Muscle Strength Training (EMST) on treating dysphagia in critical illness. Early research has suggested that strengthening the swallowing and respiratory musculature, through a type of treatment called “Expiratory Muscle Strength Training (EMST)”, might be helpful in improving swallowing function to assist the transition back to eating and drinking after a period of not having any food or drink by mouth. However, what is currently not known is that if this is any better than our “usual care”.

This study aims to determine whether infusing platelet-rich plasma (PRP) into the cavity of the womb can improve the chances of pregnancy for women who have experienced repeated unsuccessful in vitro fertilisation (IVF) attempts. PRP is derived from a small sample of the woman’s own blood and contains concentrated natural substances (growth factors) that promote healing and tissue regeneration. PRP has been successfully applied in other areas of medicine to support healing. This study will explore whether it can help prepare the uterus for a successful pregnancy. Participants will include women undergoing IVF who have experienced repeated unsuccessful implantation despite using high-quality embryos. They will be randomly assigned to one of two groups: one will receive PRP, and the other will have a similar procedure without PRP. For those in the PRP group, a small blood sample will be taken and processed to produce PRP, and the PRP will be gently infused into the uterus, two days before the embryo transfer. The study will span approximately five years to enable monitoring of pregnancy outcomes, including implantation, clinical pregnancy, miscarriage, and live birth rates. The research team is committed to ensuring participant safety, with all procedures performed by trained professionals. This study explores a potential new treatment option for women who have experienced repeated IVF failures.

What is the purpose of this clinical trial? The main goal of this study is to assess how well a new imaging agent, called 68Ga-3BP-6146, can detect solid tumour lesions in people with advanced cancer. Who is it for? You may be eligible to take part in this study if you are an adult who has been diagnosed with non-small-cell lung cancer, breast cancer, or gastrointestinal cancer (excluding neuroendocrine tumours). What does the study involve? All participants will receive a single injection of the imaging agent 68Ga-3BP-6146, which binds to a protein called uPAR that may be present on some cancer cells. Participants will then undergo PET/CT scans at 1 hour and 4 hours after the injection. Each scan will take approximately 16 minutes. You will also be monitored for any possible side effects during the imaging process and for 48 hours after the injection. [If applicable: Additional blood tests or safety assessments may be performed during this time.] What is the potential benefit? It is hoped that this study will help determine whether this new imaging agent can effectively detect tumours, which may assist in future research and clinical care.

This pilot study will investigate whether consuming purple and red-rich fruits can improve inflammation, oxidative stress, adiponectin levels, and memory in adults living with obesity. Over six weeks, participants will be randomly assigned to consume red dragon fruit juice (rich in betalains), Queen Garnet plum extract (rich in anthocyanins), or a placebo drink. Blood samples will be analysed for markers of inflammation (e.g. TNF-a, IL-6), oxidative stress, and adiponectin. Cognitive function, mood, and clinical health indicators will also be assessed. The results may help clarify the potential benefits of natural fruit compounds for metabolic and brain health.

This study aims to evaluate the effectiveness, cost-effectiveness and implementation of a digital rehabilitation intervention to improve physical function in adults aged >50 years requiring hospital or community rehabilitation for lower body function. Participants will enrol in a 6-month randomised controlled trial of either usual care control, or usual care plus digital rehabilitation program - consisting of the StandingTall application and a personalised walking program (via a smartphone app and smartwatch). Both groups will receive health education. The intervention group will also receive behavioural change strategies to promote rehabilitation adherence. We hypothesise that our intervention will lead to improved physical function at 6-months. We will also evaluate key implementation outcomes for healthcare professionals. Intervention and implementation components were co-designed with older adults and healthcare professionals to optimise usability and ensure integration into existing rehabilitation workflows

This project aims to determine whether a 6 week respiratory muscle training (RMT) program is a well-tolerated, feasible and acceptable intervention in patients with malignant pleural effusion (MPE) after undergoing respiratory procedures. Who is it for? You may be eligible for this study if you are an adult with an MPE requiring definitive intervention (talc pleurodesis or indwelling pleural catheter). Study details Participants will be given a Power Breathe Plus RMT device and receive training from physiotherapists so they know how to use this. They then commence a 6-week training program involving 30 rapid inspired deep breaths through the Power Breathe Plus RMT device, repeated twice daily. The pressure that they are breathing against will be gradually increased by the physiotherapist during regular telehealth follow-up, in an individualised manner. It is hoped that findings from this study help develop this RMT program for use in patients with MPE.

HIDE-SA is a state-wide multi-centre interventional prospective study with a historical control arm. Clinicians will be prompted and reminded during clinics to adopt universal HDV screening of all chronic hepatitis B (CHB) patients. This will be combined with the concurrent introduction of an electronic prompt within the centralised laboratory testing system to remind clinicians to perform reflexive HDV RNA testing on all HDV seropositive patients.. This intervention will run for a 12-month period aiming to increase HDV testing and linkage to care in South Australia. Testing results will be compared to a historical control arm, that will audit HDV testing data during the the preceding 12 month period of standard of care.

Lung cancer is the leading cause of cancer-related mortality globally, and non-small cell lung cancer (NSCLC) accounts for approximately 85% of these cases. There has been recent interest in understanding the textbook outcomes after non small cell lung cancer patients undergo lung resection. The aim of this study is to provide a detailed overview of the number of patients who have a textbook outcome after a lung resection for NSCLC. The ‘textbook outcome' is a patient-centred quality measure, which integrates multiple clinical and perioperative outcomes into a single, readily interpretable indicator capturing the ideal postoperative scenario. Who is it for? You may be eligible for this study if you are an adult with NSCLC who underwent any type of lung resection. Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent lung resection surgery at the Austin Hospital between 1 January 2011 and 31st December 2023. It is hoped that this research will help to provide a better understanding of the outcomes associated with any type of lung resection surgery.