ANZCTR search results

In this randomised, double-blind, placebo-controlled study, 80 women aged 50 to 70 years experiencing comorbid depressive symptoms and sleep disturbances will be randomly assigned to receive a saffron extract (14mg twice daily) or a placebo for 12 weeks. Changes in depressive symptoms and sleep quality will be examined over time. Moreover, changes in self-evaluations of physical appearance and self-esteem will be examined. Using photos of participants, a skin age application using AI technology will also be used to evaluate changes in facial skin age over time. It is hypothesised that compared to the placebo, saffron supplementation will be associated with greater reductions in depressive symptoms, sleep disturbances, self-esteem and self-evaluations of physical appearance. Moreover, a reduction in facial skin age is also predicted.

This pilot trial will explore the acceptability, feasibility and outcomes of a blended care group program which combines 8 group therapy sessions with a smartphone app, called MyNewWay. The purpose is to evaluate the short-term outcomes of this new blended care intervention for adults with anxiety disorders.

This study aims to evaluate the diagnostic performance of PB-CT in a real-world clinical setting and compare the scans to the standard of care (mammography). Who is it for? You may be eligible to join this study if you are a woman aged 50 - 70 years old, have had a mammogram in the past 6 months with no detected breast cancer and have no metal clips in your breasts. You will need to be able to go to the ANSTO facility in Clayton Victoria and able to lie face-down for a couple of minutes. Study details All participants who meet the eligibility criteria in this study will undergo Propagation-Based Phase-Contrast CT (PB-CT) (intervention) for breast imaging. After the intervention, image quality metrics of the scan will be assessed and participants will be surveyed regarding the comfort of the scan. It is hoped that this research project will help us understand how acceptable this new test is for patients, provide imaging data sets to teach radiologists how to read PB-CT scans, and allow diagnostic quality assessments to be made. Together, this research will help guide future improvements in breast screening and diagnostic imaging for cancer detection and treatment planning.

This study aims to assess the feasibility of a mediterranean meal box for people living with Huntington's disease and their family. We hypothesise the meal box will be safe and feasible for this community. We also expect it to improve cooking behaviours and quality of life.

What is the purpose of this research? The PROXIMITY study is a national, multi-site research project aiming to better understand how prostate cancer develops, progresses, and responds to treatment. By collecting clinical data, patient-reported outcomes, and optional biological samples, the study seeks to improve the care and outcomes of men with prostate cancer. The study follows a master protocol, with flexible sub-studies introduced over time to address specific research questions. This registration describes the overall PROXIMITY study and its first two sub-studies: HOROSCOPE and PROCAP. Who can take part? You may be eligible to participate if you are aged 18 years or older and have been diagnosed with prostate cancer. Each sub-study will have its own eligibility criteria to determine who can take part. What’s involved? If you agree to take part, depending on your eligibility and consent for specific sub-studies, you may be asked to: Allow researchers to access your prostate cancer-related medical records Complete online surveys about your health, symptoms, and quality of life Optionally provide blood or tissue samples, if available via your treating team Participation in the PROXIMITY master study allows for the possibility of being invited to future sub-studies over the 10-year study period. You can choose to join any sub-study you are eligible for given they would be available at your treating site. What are the sub-studies about? HOROSCOPE investigates how changes in specific DNA repair genes (such as BRCA1, BRCA2, and other homologous recombination repair genes) affect treatment outcomes in patients with metastatic or high-risk localised prostate cancer. This involves retrieving archived tissue for genomic testing—no extra visits or procedures are required. PROCAP looks at how cultural background and language preferences influence prostate cancer care. It involves completing surveys over a 2-year period to understand how different patient experiences and backgrounds may impact care and quality of life. Please note: All PROXIMITY sub-studies are observational only. No treatments are provided through participation. Why is this research important? Your participation will help researchers understand the diverse experiences of men with prostate cancer, including how different treatments affect quality of life. The findings may lead to more personalised, culturally responsive care in the future.

This is a phase 1, open-label, study to evaluate the safety, pharmacokinetics, and pharmacodynamics 225 IU GB-hMG over 7 consecutive days in healthy premenopausal women. Up to twenty eligible, healthy volunteers will receive one (1) subcutaneous (SC) injection of 225 international units (IU) per day for seven (7) consecutive days to evaluate the safety, pharmacokinetics, and pharmacodynamics of GB-hMG.

This study will evaluate the efficacy of a blended care intervention (which combines a smartphone app called myNewWay with up to 10 psychological therapy sessions) for adults with anxiety disorders compared to a usual care control group, and a group who receives a self-guided version of myNewWay. The primary aim of the trial is to compare the efficacy of the blended care and usual care control groups in the reduction of anxiety. The secondary aims are to compare the efficacy of blended care to the control group in changing other symptoms and outcomes (eg quality of life, depression), compare the blended and self-guided groups in reducing anxiety, and other outcomes, as well as compare the acceptability, engagement and satisfaction of blended care versus self-guided care. Participants will be assessed at baseline, week 6, week 12, and week 24 on self-report outcome measures. People randomised to the control group will receive the self-guided myNewWay program after completing the week 12 self-report outcome measures. The study is Australian based, done online, so recruitment will cover all states and territories of Australia.

The study aims to examine the impact of dietary fibre on markers of gastrointestinal integrity, function, and symptoms in response to physical exertion. This will be done by comparing the effects of consuming a low- or high-fibre diet for two days before running in hot temperatures. Additionally, the study will assess how consuming a kiwiberry gel (containing carbohydrates, fibre, and FODMAPs) during exercise influences gastrointestinal integrity, function, and symptoms. Markers of gastrointestinal perturbations and perceptive gastrointestinal symptoms will be measured to better understand how these dietary factors impact gut health and performance during exercise in the heat.

This project aims to evaluate the efficacy, fiesability and acceptability of conducting a 12-session imagery rescripting intervention (an emotion-focused, cognitive-behavioural technique) with a sample of individuals diagnosed with hoarding disorder, in order to inform the suitability and design of a larger, future randomized controlled trial. It is hypothesised that the imagery rescripting intervention will produce reductions in clinical symptom severity among individuals with a primary diagnosis of hoarding disorder. The research questions that this study seeks to address are: 1. Do participants with hoarding disorder report any benefits of participation, particularly in terms of symptom reduction? 2. What are the estimated recruitment and retention rates during the intervention and follow up periods? 2. Is the intervention credible and acceptable to participants? 3. Do participants report any harms or adverse events associated with imagery rescripting?

Breathing and coughing difficulties are extremely distressing for people living with MND, and therapies that improve breathing capacity and related symptoms are needed. This research project will evaluate whether combining two breathing therapies together (lung volume recruitment with expiratory muscle strength training) is feasible and acceptable to people living with MND and clinicians (e.g. physiotherapists trialing the intervention with people). This observational study will also collect information about whether the combined therapy improves breathing and cough symptoms in people affected by MND.