ANZCTR search results

This research project is being conducted to investigate the safety and tolerability of a single application of a transdermal drug delivery system containing memantine when administered to healthy volunteers.

Chronic physical illness (e.g. diabetes, epilepsy, asthma, autoimmune disease) affects 10-20% of Australian youth and can involve frequent pain, intensive treatment, and major limitations in daily activities. This can have serious impacts on well-being and mental health. In order to address this, we need engaging and accessible interventions to improve well-being and mental health among young people with chronic conditions. We aim to find out whether online self-compassion training improves mental health and well-being in adolescents and young adults with chronic illness. Self-compassion involves treating yourself with the same kindness and understanding as you would a good friend. In self-compassion training, people learn to skills to be kinder to themselves and soothe themselves when they are distressed. This helps them to recover from difficult experiences more quickly. Online programs may be preferable for people with a chronic illness as they are accessible and flexible. We have developed a four-week online program to help people learn self-compassion skills. A We will trial the program with young people (16-25 years) with chronic conditions. We will test whether people doing the program have significant improvements in psychological distress and well-being, compared to people on a waitlist. We will also explore whether any improvements in these outcomes are driven by increases in self-compassion or emotion regulation skills.

To assess the pharmacokinetics of memantine and donepezil in LYN-157 extended release capsules. To evaluate the safety of LYN-157 extended release capsules containing memantine HCl and donepezil HCl in healthy volunteers

This is a pilot study for a new application of robotic assisted surgery for removal of urogynaecological mesh from the vagina or pelvis aiming to reduce incision size and therefore surgical harm.This study will examine the use of this approach in improving visualisation and access in order to remove mesh completely via smaller incisions. Our aim is to confirm that this it is techincally possible to completely remove implanted pelvic mesh with a robot-assisted laparoscopic surgical approach.

This study will evaluate the effects of virtual reality on pain intensity in people with cancer-related pain Who is it for? You may be eligible to join this study if you are aged 18 and above, have a current or previous cancer diagnosis and are experiencing pain for at least a month Study details Participants in this study will receive both immersive and non-immersive virtual reality (VR) experiences but in a random sequence. Participants will attend once only where they undergo two 15-minute VR sessions with a one-hour washout period between sessions. The immersive session will comprise the use of immersive VR exploring a scene using an Oculus headset attached to a laptop. The non-immersive session will comprise viewing the same scene but directly watching the laptop screen. After each session, participants will be asked to answer questionnaires regarding pain intensity. A subset of participants will also undergo linear and non-linear electroencephalogram (EEG) analyses using a wireless EEG during the VR sessions to analyse regions of the brain that may be involved with pain. It is hoped that this research will contribute to the management of cancer-related pain using commercially available, non-pharmacological treatment applications that may improve health outcomes giving patients more control over their symptoms.

The purpose of this study is to test the idea of a new way of using an old drug in men with prostate cancer that has spread. Who is it for? You may be eligible for this study if you have advanced prostate cancer and are eligible to take a medicine called enzalutamide/Xtandi. Study details If a man taking enzalutamide chooses to take part in the study, their oncologist will advise them to pause taking their medication if their PSA blood test falls by over half. If their PSA blood test returns to pre-treatment levels, participants will then be advised to recommence taking the tablets again until again, the PSA blood test has decreased by more than 50%. The idea is to take breaks from the hormone tablets, using them for long enough to control the cancer, but then stopping and saving them up until later to treat the cancer again. The blood tests, scans, and doctors appointments in the trial are almost identical to normal treatments; men on the trial will be asked to complete short questionnaires, and have an extra blood test every three months. It is hoped this study will demonstrate this strategy of treatment will reduce side-effects, and may improve the lives and survival of men with prostate cancer.

Oxaliplatin chemotherapy improves survival but causes acute neuropathy (paraesthesias or dysesthesias) and chronic chemotherapy-induced peripheral neuropathy (CIPN) in almost all patients. CIPN can last for months to years, and can have a major impact on quality of life. It is suggested that ibudilast can prevent and treat this neurotoxicity. The purpose of this study is to determine if ibudilast can safely and effectively decrease neurotoxicity in patients receiving chemotherapy. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with metastatic colorectal cancer, and will be commencing chemotherapy with oxaliplatin. Study details Participants in this study will continue with their prescribed chemotherapy. As part of this study, participants will be randomly allocated to one of two groups: 1. Ibudilast taken twice a day for the duration of oxaliplatin, and 2. Placebo capsules, taken twice a day for the same period. Participants will complete questionnaires and be examined by their usual oncologist. Results of usual blood tests and imaging will be reviewed. It is hoped that this research will help determine if ibudilast can be effective in reducing neurotoxicity in participants. If it is shown to be effective, it may allow more chemotherapy to be delivered, and therefore may improve survival rates in people with colorectal cancer.

We want to determine the effect of regular exercise on cognitive functioning in young adults with Down syndrome. We will compare the effect of a 12-­week exercise intervention on cognitive function against a wait list control group. Participants will complete a weight training program with a mentor to assist them, at a local gym. Exercise sessions will run for one hour, twice a week for 12 weeks. We will recruit a 30 participants aged 15-35 years old with Down syndrome. Baseline data on Executive functioning, Short ­term Memory, Information processing speed and Intellectual ability will be collected at baseline (week 0). Executive functioning, Short ­term Memory and Information processing speed will be measured again during follow­-up (week 13) after having either completed the exercise program or doing their usual activities. We will also collect data on participant demographics.

Primary ciliary dyskinesia (PCD), is a rare, incurable, progressive, serious disorder with a large unmet need in both the diagnosis & treatment. We will test the benefits of a currently used (but unapproved for long term use in PCD) antibiotic (azithromycin) and a novel mucolytic (erdosteine). We plan a parallel, multicentre, double-blinded, double-dummy RCT. Our primary question is: Among children and adults with PCD, does azithromycin or erdosteine reduce acute respiratory exacerbations during 12-mo of treatment? Study sites are Sydney, Brisbane, Melbourne, Darwin, Perth. Our secondary aims are to: 2. Determine the effects of 12-months of the azithromycin or erdosteine on PCD-quality of life (QoL), its cost effectiveness and impact on bacterial type and antibiotic resistance 3. Assess whether whole exome sequencing (WES) can identify known and unknown gene mutations in PCD, and whether knowing this improves the patient's journey

The overall goal of this project is to increase the detection and referral of NAFLD patients with advanced hepatic fibrosis and cirrhosis to the Gastroenterology Departments at the Princess Alexandra and Logan Hospitals and to reduce the number of unnecessary referrals to these specialist outpatient clinics. Referrals to secondary care and evaluation of the outcomes of referrals after introduction of the integrated NAFLD pathway will be performed. Calculation of the costs and potential healthcare savings of the NAFLD pathway in comparison with standard care will be undertaken.