ANZCTR search results

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.

This study aims to measure how much muscle (fat-free mass) and fat patients lose in the months after metabolic weight loss surgery and whether simpler, non-invasive tools such as bioelectrical impedance spectroscopy (BIS) and ultrasound can accurately measure these body composition changes compared to the reference method (DEXA scan). We hypothesise that BIS and ultrasound will provide measurements of body fat and muscle that are close to those obtained from DXA scans, making them reliable and practical methods for tracking body composition changes after surgery. We also hypothesise that those that lose the greatest fat and least muscle will have better metabolic outcomes after surgery.

This study will assess the safety and tolerability of a new anti-cancer drug, AN8025, to determine the safest dose that can be given to adults with advanced or metastatic solid tumours. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with an advanced or metastatic cancer, this may be non-small cell lung cancer, melanoma (skin cancer) or another type of cancer that presents as solid tumours. Participants will also need to complete additional health checks by a doctor to determine if it is safe for them to enter this study. Study details All participants who choose to enrol in this study will be given AN8025 once every 3 weeks. Treatment will continue until the body can no longer tolerate the drug, the disease progresses, or the participant decides to stop taking part in the study. Different groups of participants will be enrolled to test higher doses of AN8025, once the starting dose has been determined to be safe. Participants will be asked to provide blood samples and keep a diary of any side effects that they experience after taking AN8025. It is hoped this research will determine that use of AN8025 is safe and tolerable for patients with advanced or metastatic cancer, and that this study will determine the highest safe dose for patients with cancer. Once the safest dose is determined, a larger study enrolling a greater number of cancer patients may go ahead.

This study is for people who have recently been diagnosed with mild to moderate ulcerative colitis. In addition to their usual treatment, participants will take part in a 12-week program combining dietary support with faecal microbiota transplant (FMT) therapy. The aim is to find out whether this combination (diet plus FMT) can help improve the disease or even bring about remission. As part of the program, participants will have 2–3 sessions with a specialist dietitian, who will provide meal plans and recipes. The FMT will be delivered first through a colonoscopy, followed by a series of enemas over the 12 weeks. The main goal of the study is to assess how effective this approach is in the short term and whether there are benefits that last longer.

Achalasia is an uncommon disorder of oesophageal motility characterized by failure of relaxation of the Lower Oesophageal Sphincter (LES) resulting in regurgitation of undigested food; chest pain; and weight loss. The mainstay of treatment involves pneumatic dilation, laparoscopic Heller’s myotomy and more recently Per-Oral Endoscopic Myotomy (POEM). Confounders exist in current data comparing oesophageal myotomy length in POEM and optimizing technique. Therefore this study aims to assess myotomy length outcomes. Lay summary: Achalasia is a rare oesophageal disorder where the lower esophageal (feeding tube) sphincter muscle fails to relax, preventing food from entering the stomach properly. The main symptoms are difficulty swallowing (dysphagia), chest pain, and regurgitation of undigested food. It is treated through interventions such as surgery (like Heller myotomy) or endoscopic procedures like balloon dilation or POEM (per oral endoscopic myotomy). Regarding myotomy in particular, a shorter myotomy or cutting of the muscle may result in shorter procedure times. Therefore this study is researching whether this would be a safe approach with similar outcomes to the standard procedure.

The purpose of this study is to evaluate how effective the ZYMOT® device is in enhancing sperm selection before fertilisation. ZYMOT® device, commonly used in IVF to prepare and select sperm cells for fertilisation, relies on the sperm’s natural swimming ability to help select the best sperm cells for either IVF or Intracytoplasmic sperm injection (ICSI) fertilisation. Embryo development arrest at the cleavage stages of embryo development may be due to suboptimal sperm quality. We aim to assess the benefits of ZYMOT® for couples who have had a previous IVF cycle marked by a low number of viable embryos.

The administration of furosemide (a diuretic drug designed to increase production of urine) has been shown to predict a critically ill patient's requirement for dialysis (CRRT). This has been termed the frusemide stress test (FST). Critically ill patients often require dialysis in ICU for severe injury to the kidneys. There is a large amount of evidence around when to start, however there is little to guide clinicians on when the optimal time to stop dialysis is. This is important as whilst dialysis may be life saving, once the kidneys have started to recover it can result in harm. We aim to seek the proportion of patients who respond to the FST and identify whether a future randomised trial to aid clinicians in stopping dialysis at an appropriate time is feasible.