ANZCTR search results

Brief description of the study purpose This study aims to evaluate the safety, tolerability, pharmacokinetics, and food effect of a new investigational medicine called SCB0020160 in healthy adult men. This is the first time SCB0020160 will be administered to humans. Who is it for? Healthy adult men aged 18 to 65 years who meet the study eligibility criteria. Study details Participants will be randomly assigned to receive either SCB0020160 or placebo. The study includes single-dose and multiple-dose treatment periods, as well as an assessment of the effect of food on the absorption of SCB0020160. Participants will undergo safety assessments including physical examinations, vital signs, ECGs, blood and urine tests, and monitoring of adverse events. The study will also assess how SCB0020160 is processed by the body. There is no direct health benefit expected from participation. The results may help determine safe dose levels and support future clinical development of SCB0020160.

This study has undergone initial ethics review by the Edith Cowan University Human Research Ethics Committee and is currently under revision. Once revised and approved, it will be approved under the following ethics protocol number REMS No. 2025-07121-LEOW. Participants are healthy adults recruited voluntarily via the ECU and Curtin University SONA participant pools, campus flyers, and community advertising. Informed consent is obtained after participants have had unlimited time to review the Participant Information Letter and ask questions. A pre-screening questionnaire is completed prior to scheduling to ensure participant safety; participants are not required to specify which exclusion criteria apply to them, protecting privacy. All data are de-identified upon collection, stored on secure password-protected university servers, and retained for a minimum of 15 years in accordance with ECU's Data Management Policy for clinical trials.

This study evaluates whether the use of a block room (parallel processing model) for regional anaesthesia is associated with improved operating theatre efficiency in orthopaedic surgery. Using routinely collected theatre management system data from a tertiary hospital, patients are classified into three groups based on anaesthetic pathway: block before surgery, theatre block, and no block. The primary outcome is anaesthetic-controlled time, with secondary outcomes including time to readiness for surgery, post-anaesthesia care unit duration, and theatre turnover time. The study is a retrospective observational cohort analysis of cases performed between January 2023 and November 2025. Findings aim to provide contemporary Australian data to inform perioperative workflow optimisation and service planning.

The proposed research determines the effectiveness of an intervention to support nursing staff to share more meals in socially engaging ways as a strategy for reducing burnout. The main intervention comprises providing staff with “family”-size meal kits, that are healthy and encourage staff to share the meal with family or friends.

Medications can sometimes cause serious problems, like ending up in hospital or even death. People living in rural and deprived areas are more vulnerable to these problems. We aim to work with rural consumers and healthcare providers to develop a new computer support tool that will help health professionals find people who might be at risk because of their medicines. Then, doctors, nurses, and pharmacists can check these medications and make necessary changes to keep rural Australians safe.

This pilot study will test whether a single faecal microbiota transplantation (FMT) enema can be delivered safely and feasibly to adults with alcohol use disorder and compensated alcohol-associated liver disease. Participants will be randomly allocated to receive either FMT or a matched placebo enema and will be followed for 12 weeks, with extended safety follow-up to 6 months. The main outcomes are feasibility of conducting the trial, including recruitment, retention, intervention completion and biospecimen collection, and safety/tolerability, including adverse events and serious adverse events. The study will also explore changes in alcohol use, craving, liver-related measures and gut microbiome features. This trial is designed to inform whether a larger definitive trial of microbiome-targeted therapy in alcohol-related disease is justified.

Compared to other myopia interventions, Repeated Low-level Red-Light therapy has shown superior effectiveness in pre-myopia and high myopia as well as, small but significant shortening of axial length. Currently, there is no evidence that once-daily RLRL therapy is as effective as twice-daily standard therapy. If once-daily treatment proves equally effective, it would reduce exposure by half, potentially minimising long-term side effects.

This study is testing whether a surgical robot called the Toumai® MT-1000 can be used to perform bowel (colorectal) and abdominal wall surgery safely and effectively at Concord Repatriation General Hospital, where it has been newly introduced. Who is it for? You may be eligible for this study if you are an adult patient undergoing an elective colorectal or abdominal wall reconstructive procedure, including patients who have been diagnosed with cancer and are suitable for minimally-invasive surgery. Study details Participants will have their operation performed using the robot by experienced, specially credentialled robotic surgeons, with the operation itself unchanged from what they would normally have. Participants complete short quality-of-life questionnaires before surgery and at 6 weeks, 3 months and 6 months afterwards, while the research team collects routine information about the operation and recovery from the medical record. The two main things being measured are how often the robotic operation needs to be converted to open surgery (a measure of feasibility) and how often serious complications occur (a measure of safety), with results for bowel cancer patients compared against similar past patients who had standard keyhole (laparoscopic) surgery. It is hoped that findings from this study will help inform clinicians and researchers whether the Toumai® MT-1000 is a feasible and safe system for such operations.

Autosomal dominant polycystic kidney disease (ADPKD) is the most common inherited kidney disorder, characterized by the progressive formation and enlargement of fluid-filled cysts in the kidneys, which can lead to chronic kidney disease and ultimately end-stage renal disease (ESRD). Investigational Product: GV-100 Dose Form: Suspension Route of Administration: Oral This randomized, placebo-controlled study is designed to evaluate safety and tolerability, as well as pharmacokinetics (PK) and pharmacodynamics (PD), and is conducted in two parts: Part 1 (Single Ascending Dose [SAD]), Part 2 (Multiple Ascending Dose [MAD]).

When men have surgery for a blocked prostate (called TURP), they often notice that they no longer ejaculate during orgasm. This is commonly assumed to be because semen travels backwards into the bladder instead of forwards, a condition called retrograde ejaculation. However, it is possible that the cause is actually that semen is not produced at all during orgasm (anejaculation). These two conditions look the same from the outside but have different implications, particularly for men who wish to have children in the future. This study will use a simple urine test after orgasm to objectively determine which of these two conditions is occurring in men who have had TURP. It will also assess whether this urine test is practical enough to be used routinely in clinical care.