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The aim of this study is to evaluate the efficacy and safety of SVT-6A4710 as a treatment for active Rheumatoid Arthritis. The treatment consists of a combination of carefully selected bacteria. Bacteria are naturally found in the digestive tract and are a research focus for their important role in many health conditions. Bacteria play an important role in the function of the immune system, digestive health, inflammation and have anti-microbial properties. Several research studies have found treatment with beneficial bacteria to relieve Arthritic symptoms. This study will help determine how safe and effective SVT-6A4710 is as an adjunct therapy to synthetic disease-modifying anti-rhuematic drugs (DMARDs) in treating symptoms of Rheumatoid Arthritis.

Purpose of Study In Australia, asthma affects >10% of adults and costs $28 billion per year. The highest burden occurs in obese, older women, with non-Type 2 (T2), non-eosinophilic severe asthma, which is resistant to corticosteroids. Severe, steroid-resistant disease is the biggest unmet need in asthma therapy, as patients have greatly reduced quality of life, with poor asthma control, frequent exacerbations and side effects from high-dose steroids. Severe asthma also disproportionately contributes to the economic burden of the disease, accounting for >50% of asthma costs. There are no effective therapies for non-T2 obesity-associated asthma, as the underlying mechanisms are largely unknown. We have pilot data showing that the oral contraceptive pill (OCP) may be more effective than corticosteroids in controlling asthma in women, via effects on inflammation and metabolism (immunometabolism). We will extend upon these findings by examining the relationships between sex hormones, immunometabolism and asthma control in a well-defined clinical population of women with and without obesity. Hypothesis Female sex hormones play a major role in asthma control and asthma severity in women with comorbid asthma and obesity. Aims Aim 1 – Observational cross-sectional study: To characterise the association between female sex hormone levels, inflammatory and metabolic markers, and asthma control in women with and without obesity. Aim 2 – Observational longitudinal study: To examine the effect of hormonal fluctuations on asthma control in pre-menopausal women with and without obesity.

The proposed pilot study is a multi-center, prospective, double-blinded, randomized controlled trial comparing standard surgical fixation of ankle fractures with and without local topical antibiotics at the time of wound closure. The null hypothesis is that there will be no difference in post-operative rates of infection despite the addition of local topical antibiotics to the surgical wound at the time of closure. We will test our hypothesis by randomizing one group of patients to receive topical vancomycin and gentamicin solution to the wound at the time of closure and the other group to not receive additional topical antibiotics. Routine follow-up of patients will be completed under the standard of care, to assess whether or not the addition of topical antibiotics at the time of wound closure will reduce the rate of post-operative wound infection in ankle fracture surgery.

The overall aim of this project is to characterise pathways through which individual and everyday contextual factors affect food choices at eating occasions and their role in cardiometabolic health. Participants aged 18 to 64 years will be asked to complete an online survey, and attend a research clinic where blood pressure and anthropometry will be measured. They will also be instructed to complete seven days of data collection including fasting blood sampling, online dietary recalls using ASA24-Australia, and the use of a wearable camera and SenseWear armband. This study will help us understand the pathways through which everyday contexts influence eating behaviours and health. Understanding these complex pathways will help inform the development of realistic and practical intervention strategies that tailor to everyday eating situations and promote heart healthy eating patterns.

Regular physical activity has been clearly demonstrated to have a range of beneficial effects in people with and without diabetes, although in those people with type 1 diabetes this may come at the expense of increased risk of low blood sugar (or a hypo). This increased risk during exercise in individuals with type 1 diabetes occurs as insulin concentration cannot be decreased rapidly at the start of exercise, generally causing blood glucose levels to fall. On the other hand, very hard or intense exercise may cause blood glucose levels to rise. These differing responses to exercise of varying intensities makes generalizing recommendations for exercise difficult in people with type 1 diabetes. A number of strategies are currently recommended to reduce the risk of exercise-induced low blood sugar (hypo), including reducing the meal-time insulin dose for meals close in timing to the beginning of exercise, or eating carbohydrates prior to and during exercise. However, these strategies often require the person with diabetes to actively plan in advance their exercise, and predict its intensity and duration, which is not always possible. Current guidelines for insulin delivery via an artificial pancreas suggest reducing insulin delivery by setting a temporary increased glucose target 60-120min prior to exercise (ie. Increasing the target on the pump from 5.5mmol to 8.3mmol). However, it is important to consider the optimal timing for setting a temporary elevated glucose target using artificial pancreas systems. If good glucose control with very little high or low blood sugar can be achieved when the temporary glucose target is initiated closer to, or at the beginning of exercise, then this would make planning and undertaking exercise easier in people with type 1 diabetes. The purpose of this research study is to collect data that can help to answer questions about the performance of the Medtronic 780G artificial pancreas system during and post-exercise when a temporary glucose target is set at different time points pre-exercise. The study will compare glucose control in adults with type 1 diabetes in response to short-duration (40min) moderate intensity exercise, short-duration (40min) high-intensity exercise and long-duration (90min) moderate intensity exercise, when a temporary glucose target is set 60min pre-exercise, 20min pre-exercise, 0min pre-exercise, or when no temporary target is set.

Prostate cancer continues to be one of the most commonly diagnosed cancer in men and a leading cause of cancer related death worldwide. When prostate cancer is in its early stages, meaning that it has not spread outside the prostate gland, surgical excision of the prostate and radiation to the pelvis have been shown to be effective treatments. However, these treatments frequently leave men with side effects. The main two being erectile dysfunction and urinary incontinence. Over the last decade, new treatment strategies have been aimed at delaying or mitigating the need for prostate excision or radiation therapy to save men from these side effects. Irreversible electroporation (IRE) is a new form of technology which uses electrical pulses to kill cancer cells within the prostate. These electrical pulses are applied through metal probes placed strategically around the cancer in the prostate. The heat generated is kept below “thermal” levels to ensure important structures that surround the prostate (nerves and blood vessels) are not damaged by the treatment. For the moment, studies on IRE have been limited by numbers and short term follow up data. This study will follow and analyse men undergoing IRE. It will include men who have newly diagnosed localised prostate cancer and also men who have localised recurrent prostate cancer after radiotherapy. We aim to assess cancer outcomes through a series of imaging (MRI and PSMA PET/CT), blood tests and biopsies (TP biopsy). Additionally, we aim to analyse functional outcomes through questionnaires. Our study will add the growing evidence of men undergoing IRE around the world. Who is it for? You may be eligible to participate if you are aged 18 years or older, and have been diagnosed with prostate cancer - either newly diagnosed localised prostate cancer, or localised recurrent prostate cancer after radiotherapy. Study details: All participants will undergo IRE surgery, conducted under general anaesthesia. The surgery will take around 30-60mins. Follow up will consist of a 3, 6 and 12 months review. This will be done in clinic with the treating Urologist. At 3 months, participants will be assessed with a serum PSA, and completed EPIC-26 Quality of Life questionnaire. At 6 months, participants will be assessed with a PSA, EPIC-26 Quality of Life questionnaire and prostate MRI. At 12 months, participants will be assessed with a PSA, EPIC-26 Quality of Life questionnaire, PSMA PET and prostate biopsy. It is hoped that this research will improve understanding of IRE treatment, and lead to better treatment for men with prostate cancer.

The proposed study will comprise a 2-armed, 2-site, data-analytic blind clinical trial to determine the clinical effectiveness of the Wandi Nerida program. The data management site will be at the WSU Macarthur Clinical School. The recruitment and treatment sites will be at the Wandi Nerida program and the Royal Brisbane Hospital Day program. The project will be informed by a co-design and Participatory Action Research (PAR) approach. Over a 24-month period we have been advised to anticipate 120 Wandi Nerida participant and 46 Day Program participant separations. Continued recruitment for an additional 6 months would ensure a minimum of 60 participants per group. This estimate this will allow for a mean difference medium effect size of .5 for eating disorder symptoms severity or other continuous outcomes using Cohen’s table. The number who do not engage with and/or do not complete (leave within 4 weeks of treatment) at the Wandi Nerida program is unknown at this stage.The data set for the Clinical Evaluation will include but is not limited to measures on: eating disorder diagnosis prior to residential treatment; body mass index; psychopathology; ability to complete daily activities; related mental health and wellbeing scores (comorbidities); and QALY estimates. The research will extend upon the minimum data set developed by the Federal Technical Advisory Group (TAG) to also include measures that assess outcomes related to (1) the unique aspects of the B-FREEDT model of care through qualitative exploration, (2) the testing of key indicators for measuring change, (3) changes in concurrent and ongoing healthcare utilisation, (4) stakeholders other than the clients themselves and extending to family members and clinicians inside and external to Wandi Nerida, and (4) the monitoring of clinical outcomes of clients and their families over six months from start of treatment. Notably only the data pertaining to primary outcomes will be collected a the control site.

Rotator cuff tendinopathy is a common type of shoulder pain that can severely impact work and general function. It is not currently known whether exercise and education which is recommended care can be delivered via telehealth for this condition. Telehealth has huge advantages including convenience for the patient, ability to reach people in remote regions, and potential healthcare cost savings. The aim of this trial is to compare active control (online education leaflet only ARM 1) with exercise and education delivered via one session (ARM 2) or six sessions (ARM 3). We hypothesis that pain and function outcome will be superior in ARM 2 and 3 versus ARM 1 at 12 weeks. The primary outcome measure will be the Shoulder Pain and Disability Index (SPADI) at 3 months (enough to see an effect of the intervention on clinical outcomes) post randomization, a well validated, reliable and region-specific measure of shoulder pain and disability. This parallel group three-arm trial will randomise 333 people into the three trials arms. The education and exercise in arms 2 and 3 will be delivered via telehealth (Zoom) and in groups (3 participants to 1 physiotherapist). In Arm 3 follow up will occur at week 2, 4, 6, 9 and 12. Outcomes including pain, function, psychological status, sleep, quality of life, global rating of change, worse pain over the last 7-days, working alliance, adherence, health care use, exercise adherence, productivity, adverse events, and telehealth acceptability will be assessed at baseline, 6 weeks and 3 and 12 months.

Theory of mind is a social cognitive domain impaired in people with schizophrenia and has significant impact on functioning including difficulty in social interactions, poor interpersonal relationships and reduced conflict resolution ability. Current interventions are highly intensive, require significant resources and have only modest effects on functional outcomes and new innovative treatments are needed. Virtual reality (VR) and transcranial alternating current stimulation (tACS) will be combined to engage the rTPJ while undergoing theory of mind tasks and use electrical currents to further engage and enhance abnormal neural firing patterns simultaneously. Forty-six participants (23 schizophrenia, 23 controls) will attend 3 research sessions. One comprehensive baseline assessment completing a short interview and cognitive and social cognitive tasks as well as two VR social cognition tasks with simultaneous tACS. At the end of session three participants will have received one sham tACS and one active tACS session simultaneously with VR. We are investigating the effects of combining tACS with VR in single sessions on brain activity to inform future research and potential treatment. Participants will also complete short questionnaires regarding their experience.

Who is it for? You may be eligible to join this study if you are aged 18 years or above, male, and have a new diagnosis of prostate cancer that is being managed through active surveillance. Study details All participants in this study will undergo the usual monitoring processes of mpMRI and confirmatory biopsy. In addition, all participants will undergo one PSMA PET scan at the time of their repeat mpMRI, and, if applicable, one PSMA-targeted biopsy at time of their confirmatory biopsy. The repeat mpMRI and PSMA PET/CT will occur at Epworth Medical Imaging, Freemasons. The results of the scans and biopsies will be used by a panel of experts to make recommendations as to whether the participant should remain on active surveillance for their prostate cancer, or receive active treatment. It is hoped that this research will improve the accuracy of prostate cancer monitoring, and lead to better outcomes for patients who are in active surveillance.