ANZCTR search results

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.

The early recognition of bronchiectasis (BE) in children is important for immediate and future outcomes, whilst late diagnosis is associated with poorer lung function and more severe bronchiectasis. We plan a consumer co-designed cohort study to develop a diagnostic approach whereby health practitioners can confidently use to refer children with chronic wet cough appropriately. We aim to develop a diagnostic algorithm enriched with systemic (blood) gene expression signatures to enhance accuracy. We will then test our algorithm in an independent cohort, using data from further children recruited to this study plus that from our current MRFF-funded study called LEAP-Cough.

The REFUEL trial is testing whether a multimodal nutrition and gut recovery program is feasible and acceptable for people undergoing colorectal cancer surgery. The study aims to optimise the recovery of gut function and immune health after surgery. Who is it for? You may be eligible to participate in this study if you are male or female, aged 18 years or older, undergoing elective colorectal cancer resection with primary anastomosis. Study details Participants will receive a special program during the perioperative period, including preoperative dietary guidance (high-fibre, antioxidant-rich, and fermented foods), caffeine supplementation after surgery to help bowel recovery, and arginine supplementation to support immune function. Caloric monitoring will be performed on postoperative days 1 and 3, and stool and blood samples will be collected before and after surgery to study the gut microbiome, nutrition, and immune changes. This program will be compared to standard care using a staggered design, and all participants will be monitored closely for adherence, safety, and recovery. It is hoped that the results of this study will be used to inform a future definitive trial.

This study is looking at the efficacy of testosterone cream as a treatment option for men who continue to have low testosterone after prostate cancer treatment. Who is it for? You may be eligible for this study if you are an adult male with clinically localised low-intermediate risk prostate cancer treated with radiotherapy and at least 6 months of androgen deprivation therapy (ADT) with curative intent and have experienced prolonged androgen deficiency more than 6 months after cessation of ADT. Study details Participants will be randomly allocated to either use testosterone cream or a placebo cream daily for 6 weeks. They will undergo blood tests at baseline, 3 and 6 weeks to assess testosterone and other hormone levels, as well as complete questionnaires on quality of life and psychosocial domains. It is hoped that findings from this study will help researchers develop new ways of treating low testosterone levels and associated symptoms in men following prostate cancer treatment.

The purpose of this study is to determine the safety of BMS-986504 in participants diagnosed with glioblastoma (GBM) that has progressed after previous treatment. The study will evaluate the safety prior to and after surgical removal of GBM. BMS-986504 works by attaching to and blocking a molecule called Protein Arginine Methyltransferase 5 (PRMT5). PRMT5 is a protein that has a crucial role in gene expression and repairing damage to deoxyribonucleic acid (DNA). Cancer cells overexpress PRMT5 which allow these cells to survive and multiply. Medicines that block PRMT5 help to selectively destroy the cancer cells and allow normal cells to remain unharmed. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have recurrent MTAP-deleted GBM, and you meet additional criteria relating to your wellbeing and ability to tolerate surgical procedures. Study details Participants who choose to enrol in this study will undergo two brain surgeries; the purpose of the first surgery is to perform a biopsy. A biopsy is a procedure that involves removing a sample of the cancer to be analysed. The purpose of the second surgery is to remove as much of the GBM cancer as safely as possible. Participants will receive BMS-986504 after the biopsy and prior to surgical removal of your GBM. Treatment given prior to surgery is referred to as ‘neoadjuvant treatment’. Following surgery, participants will receive BMS-986504 (treatment given after surgery is referred to as ‘adjuvant treatment’). Blood tests and other assessments will be performed regularly to monitor safety and response to treatment. It is hoped that this study will show that BMS-986504 is safe to deliver to patients with GBM cancer, and that BMS-986504 works to shrink GBM cancers making them easier to remove surgically.

There is currently no clear agreement on the best way to treat certain types of coronary artery narrowings that occur right at a branch point (known as Medina 0,0,1 and 0,1,0 lesions). Two main stenting methods are commonly used, each with pros and cons, but they have never been directly compared in a clinical trial. The PROST trial will, for the first time, compare these two approaches to determine which leads to better outcomes over two years. The results could help standardise treatment, improve patient outcomes, and provide clearer guidance for cardiologists managing this complex type of coronary disease.

This project aims to evaluate the impact of a structured breathwork and resilience building program on the mental health and wellbeing of Australian military veterans. The program, known as Empowering Veterans, is based on the SKY (Sudarshan Kriya Yoga) breathwork model, which has been successfully delivered to veterans in the United States through the Project Welcome Home Troops initiative. The primary objective of this pilot study is to explore whether participation in the Empowering Veterans breathwork program leads to measurable improvements in veterans' mental wellbeing, including symptoms of PTSD, depression, sleep quality, and overall functioning. It will also assess the feasibility and acceptability of delivering this program in an Australian context.