ANZCTR search results

This project is testing the safety and pharmacokinetics of single and multiple oral doses of a new drug called GBP-088. GBP-088 is being developed for the treatment of recurrent kidney stones. You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old. In Part 1, participants will be randomised (assigned randomly, like flipping a coin) to receive single oral dose(s) of either the active study drug or placebo. In Part 2, participants will be randomised (assigned randomly, like flipping a coin) to receive multiple oral dose(s) of either the active study drug or placebo. It is hoped that this research will help determine the safety of GBP-088 when given to healthy men or women so that it can be tested in patients with recurrent kidney stone disease

As the population ages, the prevalence of chronic health conditions is on the rise. There is a need for early diagnosis and intervention for ageing related chronic conditions, with increased health promotion, continuity of care, and care planning to address the physical, social and lifestyle factors influencing healthy ageing. Primary care-based health assessments and care planning (led by GPs and general practice nurses) provide a personalised approach enabling coordinated care for chronic condition management with a focus on early intervention and prevention. This research will involve 12 general practices within Adelaide to support older adults (aged 65+ years) with one or more chronic conditions involved in an early intervention bundle of care. Practices will be encourage their patients to complete a pre-assessment tool, participate in in chronic condition care planning, health assessments, with recommendations for advanced care directive planning and social prescribing. General practice team members and patients involved in this project will be invited to participate in qualitative interviews and/or focus groups. This mixed methods research will evaluate implementation outcomes (reach, effectiveness, adoption, implementation, maintenance) and patient outcomes (quality of life and social connection). Findings will inform sustainability of the project and strategies for scale up to more practices and patient population groups. The project will be conducted from July 2026- July 2027 with patient recruitment and implementation of the early intervention bundle of care from July 2026-April 2027.

This study aims to compare the safety and effectiveness of delivering focused radiotherapy (stereotactic radiosurgery or SRS) in either one session or three sessions before surgery in people with brain metastases. The goal is to find out whether spreading the radiation dose over multiple sessions before surgery improves cancer control and reduces side effects. Who is it for? You may be eligible for this study if you are aged 18 or over, have a confirmed diagnosis of a solid cancer that has spread to the brain, and your medical team has recommended SRS and surgery to remove at least one brain metastasis. Study details Participants in this study will receive focused radiotherapy (SRS) before undergoing surgery to remove brain metastases. All participants are randomly allocated to one of two treatment groups: a single session of SRS, or three smaller sessions of SRS on consecutive days before surgery. Tests may include imaging scans and other routine assessments to monitor treatment effects and side effects. This research hopes to improve how we treat brain metastases and reduce long-term complications, ultimately leading to better quality of life for people with advanced cancer.

Chronic respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD) cause a major burden in Australia, particularly following an exacerbation that can lead to emergency department visits and hospital admissions. This study will evaluate whether the ENGAGEMENT model of care can help people better manage their condition, improve quality of life, and reduce healthcare use. The ENGAGEMENT program combines support from trained nurses with a personalised action plan, telehealth consultations, electronic monitoring of inhaler use, and a mobile phone app to track symptoms and medicines. Adults with asthma or COPD who have recently experienced an exacerbation will be recruited through hospitals and general practices in Victoria. A total of 400 participants will be randomly allocated to receive either the ENGAGEMENT intervention in addition to usual care or usual care alone. We hypothesise that participants receiving the ENGAGEMENT intervention will have improved health-related quality of life, better disease control and self-management, and fewer hospitalisations and emergency department presentations than those receiving usual care.

Relative Energy Deficiency in Sport (REDs) is a condition that can occur when athletes do not consume enough energy to support their training and the body's normal functions. REDs can affect health, performance, recovery, hormones, and bone health. This study will evaluate and compare a range of existing and emerging tools used to identify athletes at risk of REDs. Participants will complete questionnaires, dietary assessments, body composition measurements, blood tests, imaging scans, and physical performance assessments during a single study visit. The findings will help determine which tools are most useful for accurately identifying REDs in athletes.

In this study we will record on video laparoscopic gastric bypass procedures whilst using a new laparoscopic instrument holder, Surgirack. This device has been approved by the Therapeutic Goods Administration (TGA) which is the Australian government organisation tasked with making sure medical devices are safe. Surgirack has been used since January 2025 over 3000 times across 10 different hospitals and by 45 different surgeons within Adelaide. Surgirack has been used in laparoscopic gastric bypass close to 200 times since January 2025. We will also record laparoscopic gastric bypass using standard instrument holders. We will then compare the videos to see if there is a difference in instrument exchange time between the two different instrument holders. We believe that instrument exchange time is significantly reduced which would then reduce operating time.

This study will compare a needle-free device (J-Tip®) with standard care (topical numbing cream) in children aged 8-18 years requiring IV cannulation. The aim is to determine whether a larger trial is feasible by assessing recruitment, study processes, safety, and acceptability. Children's pain during cannulation will also be measured to inform a future trial testing whether the J-Tip® reduces pain.

The purpose of this research project is to determine whether treatment with semaglutide may help maintain control of psoriasis and reduce the risk of relapse after stopping biologic therapy in people with chronic plaque psoriasis (CPP) who are overweight or living with obesity. The study will also examine whether semaglutide improves weight and metabolic health. Participants will receive semaglutide and will be monitored over 12 months following discontinuation of biologic therapy to assess relapse rates, weight change, metabolic health, quality of life and inflmmatory markers in blood and skin. Participation in this study involves the following three phases: Screening, Treatment, and Study Completion (no additional follow-up after 12 months). In the treatment phase, participants will commence once-weekly subcutaneous semaglutide injections beginning at 0.25 mg and gradually increasing to 2.4 mg per week over 16 weeks. During the dose escalation phase, participants will need to attend clinic monthly, then every 8-10 weeks during the maintenance phase. The trial will involve weight, waist circumfrence and blood pressure measurements, blood samples, physical examinations and quality of life questionnaires.

Chronic suppurative otitis media (CSOM) is the most severe form of middle ear disease, characterised by a hole in the eardrum, though which discharge drains (for longer than two weeks). CSOM disproportionally impacts children living in low socioeconomic conditions, including remote-living First Nations children. This trial will compare topical hydrogen peroxide followed by topical ciprofloxacin with ciprofloxacin alone to manage CSOM that has failed to resolve with standard treatment.

- This study is testing a new medicine called IDB-1829 for advanced prostate cancer that no longer responds to standard hormone treatments. Who is it for? - You may be eligible for this study if you are an adult with prostate cancer, where the cancer has stopped responding to hormone therapy. Participants in this study must have also received at least one prior treatment for resistant prostate cancer. Study details - All participants in this study will be asked to take a dose of the new medicine daily in 21-day cycles. The number of cycles will depend on how the participant is responding to the treatment. - Participants will also be asked to provide blood samples throughout the treatment and be followed up for review of safety and via scans to assess changes in the cancer. - It is hoped that this research will help determine if the new medicine is a viable option for the treatment of hormone resistant prostate cancer.