ANZCTR search results

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.

This study aims to recruit participants with comorbid insomnia and AUD after completing a supervised alcohol withdrawal program (inpatient or outpatient) who are seeking to maintain abstinence post-detoxification. Potential participants will be recruited by advertising in participating hospital clinics, internet, as well as through hospital caseworkers and clinicians. Potentially eligible and interested individuals will then be asked to provide informed consent prior to undergoing a full eligibility assessment at a screening visit with a study medical officer. After eligibility is confirmed, participants will undergo a baseline visit, a study visit 7 days post-baseline, an end-of-treatment visit 14-days post-baseline, and a follow-up visit 21-days post-baseline. Study participants will self-administer suvorexant 20mg each evening for 14 days.

This study will help researchers to understand if supplement FTC0098 improves sperm quality in men undergoing fertility treatment by investigating its safety and efficacy. It is known that for couples who are trying to become pregnant, the male factor can be responsible for up to 50% of these cases. Therefore, this study aims to evaluate the effect of antioxidant supplements on improving semen quality as measured by semen analysis and DNA damage studies. Each participant takes the daily supplement for 16 weeks and will be asked to produce three semen samples throughout the duration of the study. .

The ECHIDNA-01 study is investigating two non-surgical treatments for gallbladder inflammation in patients who are not suitable for surgery. One treatment involves placing a stent inside the body using a camera through the mouth (EUS-GBD), while the other uses a drain tube inserted through the skin (PC). Both procedures are already used in hospitals, but the study aims to find out which one leads to better recovery, improved quality of life, and better overall costs. Patients who need a procedure will be randomly assigned to one of the two options. After treatment, researchers will follow up with each patient by phone over the next year to check on their health and progress. We hypothesise that the EUS-GBD technique will prove superior to PC in recovery, quality of life and overall healthcare cost.

Paediatric spinal cord disorders (SCD) are rare, yet carry severe, lifelong consequences for health and functioning. However, there is very little published research on this population, and clinical practice guidelines are lacking. The aim of this study is to collect a rolling minimum dataset of demographic and medical information of paediatric SCD at all key rehabilitation sites across Australia, to develop a longitudinal registry to improve care and patient outcomes, and facilitate future research for this population.