ANZCTR search results

This study aims to evaluating the effects of aerobic and resistance exercise in “stiff” heart failure. We will utilize various methods to assess the efficacy of the exercise regime in order to validate it. We postulate this regime will have a favourable effect on the structure and the function of the heart whilst providing symptomatic benefit to the patient.

The Menopausal transition is linked with reduced physical activity and mood disturbances. Microbiome-targeted therapies such as oral Lactobacillus may influence motivation and exercise via the gut-brain axis.

The aim of the NODULE study is to assess the safety, efficacy and feasibility of the Prana System for the sampling of small pulmonary (lung) nodules that are suspected of being cancerous. Who is it for? You may be eligible for this study if you are aged between 40 and 75 years and you have a lung nodule that is suspected of being cancerous. Study details All participants who choose to enrol in this study will undergo an initial nodule localisation procedure which involves having their with a localisation wire placed through the lung nodule (under local anaesthesia) during a CT scan. Once the wire has been inserted, participants will then be moved to an operating room where a thoracic surgeon will use the Prana System to take a piece of tissue from the area around the lung nodule. All participants will then be managed as per standard of care for thoracic (chest) surgery and will be asked to stay in hospital for at least 24 hours after the procedure. All participants will then be followed up during their hospital stay and at 14 and 30 days after completion of the procedure. It is hoped this research will determine whether use of the novel Prana system is safe and feasible for use in patients with a lung nodule that requires biopsy to assess if it is cancerous. If the Prana System is found to be safe and effective for biopsy of suspected cancer nodules, there may be scope for further use in the future.

This research program is studying whether giving ketone nutritional supplements to traumatic brain injury (TBI) patients can improve outcomes. To begin this line of research, this project will identify the optimal supplement dose for patients in the intensive care unit and examine the feasibility of using these supplements in TBI patients. Previous studies have used single doses of the supplement in relatively healthy patients. This study will be the first to look at the effect of giving multiple doses of the ketone supplement to critically ill intensive care unit patients. Information obtained from this study is foundational for planned future trials examining the use of ketone supplements in critically ill patients.

This research program is studying whether giving ketone nutritional supplements to traumatic brain injury (TBI) patients can improve outcomes. To begin this line of research, this project will identify the optimal supplement dose for patients in the intensive care unit. In this open-label phase 1 study, 12 patients at Royal Perth Hospital will be given one of 4 dosing regimens of the study intervention (R-1,3-butanediol) over 4 days. This study will be the first to look at the effect of giving multiple doses of the ketone supplement to critically ill intensive care unit patients. Information obtained from this study is foundational for planned future trials examining the use of ketone supplements in critically ill patients.

The treatment of melioidosis is complex; to cure the disease and prevent it from returning, prolonged intravenous antibiotics are given followed by an even longer course of oral antibiotics. The oral antibiotics used for the treatment of melioidosis are prone to causing side effects; over one half of patients will have a side effect and in over 40% this will result in reducing the dose or stopping the antibiotic. This study will investigate if a lower dose of oral antibiotics, given for the same time, will still cure and prevent recurrence of the infection but also cause less side effects than the currently used higher dose.

Tryptophan, an essential amino acid, acts as a precursor to Melatonin production in the brain. Tryptophan is transported across the blood brain barrier by the same transporters as other large neutral amino acids (LNAA) and has to compete with them to cross the barrier, for its availability. Alpha lactalbumin (ALAC), a whey protein, is a good source of tryptophan and has previously been found to increase Tryptophan to LNAA ratio by up to 130%. Thus potentially increasing the tryptophan availability to the brain and associated melatonin production. Through this research our team aims to assess the changes in sleep quality, mood, cognition and urinary metabolite levels of melatonin post ALAC supplementation. The current study also aims to investigate the confounding influence of dietary protein and its amino acid composition on the associated outcomes. Findings from the present study will inform ALAC supplementation strategies for future researchers and clinicians to potentially augment sleep, mood and cognition in active individuals with existing sleep difficulties.

This is a randomized, multicentre, open-label, blinded-endpoint feasibility trial designed to evaluate the safety and efficacy of an anaesthetic regimen incorporating methadone in combination with magnesium, ketamine, lidocaine, and dexmedetomidine in the context of fast-track cardiac anaesthesia (FTCA). It represents the first investigation to assess this specific multimodal protocol in cardiac surgical patients. Eligible participants will be adults (>18 years) undergoing elective, low-risk cardiac surgery requiring cardiopulmonary bypass. Consenting subjects will be randomized to receive either the FTCA intervention protocol or standard anaesthetic care. The primary hypothesis is that the intraoperative administration of intravenous dexmedetomidine and methadone, as part of a multimodal anaesthetic strategy, will reduce time to postoperative tracheal extubation and shorten intensive care unit length of stay, compared with usual care. Secondary outcomes include feasibility measures and safety endpoints relevant to implementing this anaesthetic approach in a multicentre setting. Recruiting hospitals: Austin Hospital, Epworth Eastern Hospital and Warringal Private Hospitals Number of participants planned: 100

The aim of this study is to find out whether KIM can be successfully used across multiple treatment centres so that more than 95% of patients can complete all their planned treatments accurately and within normal treatment times. You may be eligible for this study if you are a male aged 18 or older, have histologically proven prostate adenocarcinoma, ECOG performance status 0-2. Also, suitable for definitive external beam radiotherapy, ability to have fiducial markers inserted in the prostate. Study details: All participants will receive standard-of-care external beam radiotherapy, with the addition of Kilovoltage Intrafraction Monitoring (KIM) at every treatment fraction to continuously track prostate motion in real time using intraprostatic fiducial markers and a gantry-mounted kV imager. If motion greater than 3 mm persists for five seconds or more, KIM signals radiation therapists to pause the treatment beam and apply couch shifts to return the prostate to the planned position before resuming. The intervention therefore consists of continuous monitoring, beam gating, and intra-fraction repositioning throughout beam delivery (approximately 15–25 minutes per fraction), delivered by trained radiation therapists with physicist oversight, across the full prescribed course of radiotherapy. It is hoped that findings from this study will help further validate a new way to make prostate cancer radiotherapy more accurate and reliable in routine clinical practice.

In this project, our research seeks to understand how very high levels of folic acid during pregnancy might contribute to an increased risk of developing gestational diabetes. In previous research, we have found that very high folate levels in early pregnancy may affect the placental hormones of the mother. We think this may increase the risk of developing gestational diabetes. We need to identify and understand how these factors contribute to gestational diabetes.