ANZCTR search results

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.

This study aims to assess if a device called ‘Preemietest’ is more accurate than the current assessment for maturity after birth, called the Ballard score, in determining gestational age. The Preemietest is a light-based device that assesses the baby’s gestational age by placing it on the sole of the foot for a few seconds. The device will provide us with an instant result, and this will be compared to the early dating scan to assess the accuracy of the Preemietest.

This study aims to explore the acceptability of combining robotic training using KinArm Exoskeleton device and functional training. By exploring the acceptability of this training protocol, it would provide the necessary steps to improve the implementation of a robotic training for people with arm and hand weakness after stroke. Also, we would also aim to investigate if combining robotic and functional training for 10 sessions can improve arm/hand strength and function of people who had stroke.

To determine if arterial reflection measures can be used as a risk and monitoring tool for heart disease in Australians with chronic kidney disease. We hypothesise that arterial reflections measures are correlated with current heart disease risk measures.

Ankle osteoarthritis is a serious health problem that causes disabling pain and limits performance of daily, recreational and occupational activities; however, little is known about how to manage it. The aim of this study is to establish the feasibility of conducting a full-scale randomised controlled trial investigating the addition of foot orthoses and education to usual care, compared to usual care alone for people with ankle osteoarthritis, and to collect quantitative and qualitative data to inform a future RCT. Key feasibility outcomes include consent rate, participant attendance at initial orthoses and education appointment, intervention fidelity and rate of completion of 3-month outcome measures. Findings from this study will improve the management of ankle osteoarthritis by establishing the feasibility of running a full-scale randomised controlled trial to investigate foot orthoses and education in this population.

A Phase 1, First-in-Human, Single and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral administration of RTX-101, RTX-010 and RTX-111 in Healthy Subjects. The current study is the first clinical co-administration of combinations of RTX-101, RTX-010 and RTX-111 to be conducted in healthy adult subjects. The study includes Part 1A: single ascending dose (SAD) and Part 1B: multiple ascending dose (MAD).

This early clinical study is being conducted to understand how a new intravenous (IV) form of cannabidiol (CBD), called IPI-201, behaves in the body and how well it is tolerated when given to healthy volunteers. IPI-201 is designed to provide a rapid and precisely controlled dose of CBD through an IV infusion, which may be useful for managing acute pain or other short-term conditions in future patients. In this study, small groups of healthy adult males will each receive a single IV dose of IPI-201 at different strengths, given over 15 minutes. Researchers will carefully monitor safety, check for any side effects, and measure CBD levels in the blood over time. The results will help determine safe dose ranges and how quickly the body absorbs and clears IPI-201. No placebo or comparison drug will be used in this study.