ANZCTR search results

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO-203 in Healthy Volunteers

Despite the prevalence of insomnia among psychiatric hospital inpatients, few studies have investigated the effectiveness of CBT-I for this population. Furthermore, no known studies have selected a psychiatric inpatient population when examining the impact of CBT-I on suicidality. The current study aims to implement a program of CBT-I adapted for suitability with mental health hospital inpatients, evaluating the effectiveness of this intervention in both the reduction of insomnia symptom severity and suicidal ideation. Participants will be randomly allocated to one of two conditions: i) adapted CBT-I, or ii) treatment as usual at the hospital. The adapted CBT-I will be delivered in group-therapy format across four sessions (twice a week, for two weeks). It is hypothesised that inpatients who receive the sleep intervention will show a larger reduction in their insomnia symptoms and suicidal ideation, compared to patients in the control group. Assessment time points for self-report questionnaires will be at baseline (admission), end of treatment, and a 1-month follow-up.

This study is testing whether a new hormone-based therapy called HAV-088 (a combination of testosterone and an aromatase inhibitor) can help reduce breast cancer risk in premenopausal women. Who is it for? You may be eligible for this study if you are aged between 25 and 50, you are not currently going through menopause or peri-menopause, and you are at-risk of developing breast cancer - defined as meeting one of the following: history of abnormal cell growth in the breasts, known BRCA1/2 or other high-risk gene mutation, or extremely dense breasts. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two treatment groups. Participants allocated to the first group will be asked to take an oral dose of tamoxifen each day for 1 year. Participants allocated to the second group will be asked to have a slow-release HAV-088 pellet injected into soft tissue (with local anaesthetic) near their hips once every 3 months for 1 year. All participants will be asked to attend two MRI scans and will also be asked to provide blood samples and fill out questionnaires about their symptoms and quality of life throughout the study. It is hoped this research will determine that HAV-088 is a safe treatment for women at high-risk of developing breast cancer, while preserving ovarian function and causing fewer side effects than tamoxifen. If this small study is positive, a larger study enrolling a greater number of women at high-risk of developing breast cancer may be undertaken.

P. gingivalis is associated with diseases including periodontitis, cardiovascular disease, diabetes, and AD. This study will assess the safety and immune response to GPV381 in patients who have mild AD.

The REPURPOSE Trial aims to assess the efficacy and safety of oral efavirenz in high grade serous ovarian, fallopian tube and primary peritoneal cancer. Who is it for? You may be eligible for this study if you are an adult female with platinum resistant or potentially platinum sensitive high grade serous ovarian, fallopian tube and primary peritoneal cancer. Study details All participants will receive daily oral efavirenz (600mg) for 24 months or until disease progression by RECIST 1.1 or CA125 GCIG criteria unless the clinician believes that there is a clinical benefit to continue treatment beyond progression and there is no unacceptable toxicity resulting from the treatment. Data will be collected on clinical response and incidence of adverse events. It is hoped that findings from this study will inform researchers and clinicians of the role of efavirenz in the landscape of gynaecological cancer treatment.

This study will look at experiences of family, domestic, and sexual violence in people with multiple sclerosis and other neurological conditions. Participants will complete one-time screening, surveys, and optional interviews about their experiences and care, with this information linked to medical records and the MSBase registry. Outcomes of multiple sclerosis will be followed for three years. The study aims to understand how violence affects health and wellbeing, whether it worsens MS through other illnesses and the psychological impact of trauma, and to improve how neurology recognises and responds to violence. Lessons from MS are expected to inform responses across the wider field of neurology.

The purpose of this study is to understand clinician’s and consumers’ views regarding benchmarking in general and whether and how they would like to see it applied in the Inflammatory Bowel Disease space. The dual aims will be to publish a paper that analyses and discusses the survey’s findings/responses, and ultimately, to use this information to implement safe and effective benchmarking to improve clinical care and patient outcomes in IBD. It will involve an online survey of consumers and clinicians working in IBD.

Primary aim of this research is to evaluate the impact of an integrated supportive care model on health service utilisation and consumer experience for patients living with advanced liver disease who are estimated to be in the last two years of life, and their carers.

This study aims to evaluating the effects of aerobic and resistance exercise in “stiff” heart failure. We will utilize various methods to assess the efficacy of the exercise regime in order to validate it. We postulate this regime will have a favourable effect on the structure and the function of the heart whilst providing symptomatic benefit to the patient.

The Menopausal transition is linked with reduced physical activity and mood disturbances. Microbiome-targeted therapies such as oral Lactobacillus may influence motivation and exercise via the gut-brain axis.