ANZCTR search results

The study is evaluating the feasibility of hyper-accelerated partial breast irradiation therapy in women with breast cancer. Who is it for? You may be eligible to join this study if you are a woman aged 40 years or above who has been diagnosed with invasive non-lobular breast carcinoma and have had breast conserving surgery. Trial details: All participants in this study will undergo a procedure called hyper-accelerated partial breast irradiation. This involves catheters implantation under general anaesthetic followed by three treatment doses of brachytherapy radiation. All participants will be followed up for a maximum of 10 years to assess for recurrences and quality of life, which will involve performing annual mammogram scan and completing questionnaires (6 weeks, 6 months and annually for 5 years). A peripheral blood sample and the resected tumour sample will also be assessed at the time of commencing therapy (and then 6 weeks,1 year, 5 year and 10 year) to identify potential biomarkers of local disease recurrence. It is hoped that this study may show that hyper-accelerated partial breast irradiation therapy is feasible, safe, and efficacious for the treatment of locally advanced breast cancer. It may also help to identify biomarkers to allow for accurate selection of patients who are suitable for this treatment in future.

Inflammation is a key component in the cause of ischemic stroke. Colchicine is a commonly used anti-inflammatory medication approved for the treatment of gout, Familial Mediterranean Fever, and acute/recurrent pericarditis. There is an increasing body of evidence in the literature supporting a beneficial role of long-term colchicine therapy in prevention of cardiovascular disease. Low-dose colchicine use has also been proven to be safe, well tolerated and is inexpensive and readily available. The aim of this trial is to assess the effect of low-dose colchicine (0.5mg/daily) in addition to optimal medical therapy of cardiovascular outcomes in stroke patients with evidence of persistent coronary inflammation (based on hs-CRP). We hypothesise that addition of colchicine to optimal medical therapy in patients post-stroke, who have biomarker evidence of persistent inflammation will reduce recurrent cardiovascular events.

Cardiovascular disease (CVD) is the main cause of death in women. Current ways to check for CVD in women are unreliable. Breast artery calcification (BAC) is build-up of calcium in the blood vessels of the breast. It can be seen on mammograms and is related to CVD. The way in which CVD develops and progresses is not clear. A cardiac CT scan is a specialised X-ray test that allows you to look at the arteries of the heart. Using a computer software we can measure the plaque which blocks arteries, some of which are 'high risk plaque' meaning they are associated with future heart attacks. We can also measure other markers such as peri-coronary adipose tissue which is indicative of inflammation that can predict the development of plaque. In this study we will recruit patients with previous mammogram and a cardiac CT to have another cardiac CT to look at the change in plaque and compare BAC to no BAC. This will allow us to examine the association of BAC with coronary plaque presence and progression. We expect that patients with BAC will have more plaque, inflammation and high risk plaque on their previously conducted clinical cardiac CT. We also expect patients with BAC to show greater progression of these parameters on their research cardiac CT when compared to their previously conducted clinical cardiac CT.

Seaweeds comprise a diverse range of marine organisms containing biologically active metabolites that are being explored for their therapeutic effect(s) on a range of health conditions. This project provides a novel opportunity to assess the role of inflammatory processes and the microbiome in the oesophagus in Eosinophilic oesophagitis (EoE). The aim of this study is to examine the clinical effectiveness of fucoidan supplementation in alleviating symptoms of Eosinophilic oesophagitis(EoE). To better understand the local immune pathways and responsiveness to supplementation oesophageal biopsy samples will be used to characterise immune and inflammatory signalling and to assess microbiome composition at the mucosal oesophageal surface.

This is a observational prospective cohort study whereby convenient and routine venous bloods are collected prior to commencement (day 2 menses) IVF or ICSI, antagonist treatment and oocyte collection, and analysed for proteomic biomarkers indicative of embryo quality score and clinical pregnancy. The primary objective is to develop a predictive model that facilitates decision-making in the clinic, particularly regarding the choice to proceed to oocyte collection given the subject’s health status and probability of assisted reproduction success.

The aim of this study is to determine whether it is feasible to conduct a study of crushed oral dexamethasone, at a dose of at least 8 mg daily, either with or without daily crushed oral famotidine in the management of inoperable bowel obstruction. Who is it for? You may be eligible for this study if you are aged 18 years or older, have advanced cancer, and have a clinically confirmed inoperable bowel obstruction at any level with vomiting that requires a hospital admission or a change in clinical care. Study details Participants will be randomised (i.e. allocated by chance) to receive 5 days of either 40mg per day of famotidine or placebo as a crushed oral tablet. All participants will also receive a single daily dose of 8mg of dexamethasone for 5 days and intravenous or subcutaneous fluids at 10-20ml/kg/24 hours, as part of standard care. Participants will be assessed daily for the duration of treatment to monitor safety and tolerability, where the study team will visit each day and assess any side effects and improvement. Participants will also complete a number of questionnaires on the last day of treatment, as well as weekly for 4 weeks post-treatment completion. These questionnaires will involve answering questions regarding general well-being and quality of life, vomiting episodes, pain, nausea, side effects, medication use, and use of rescue pain medications. Analysis for cost-effectiveness of the intervention will also occur. It is hoped that this study will help clinicians to further understand the management of of inoperable malignant bowel obstruction.

As two million Australians have prediabetes and the medical expenditures are increasing, prediabetes management is a critical and challenging topic in our healthcare. People with prediabetes have a higher risk for serious health problems such as heart disease, stroke, blindness, kidney failure, loss of toes, feet, or legs. It is necessary to explore a holistic approach to prevent prediabetes from progressing to type 2 diabetes to mitigate the medical and economic burdens. By using laser light as an alternative to needles to stimulate acupuncture points, light acupuncture is a non-invasive, safer, pain-free, and non-infectious alternative to traditional acupuncture. It could be a promising add-on for prediabetes management. This study aims to evaluate the feasibility, short-term therapeutic effects, and safety of light acupuncture in prediabetes management in community settings in Western Australian (WA).

The primary purpose of the ChAP-II Study is to assess the impact of an intervention based on online modules, a webinar, and one-on-one registrar/supervisor contact, on antibiotic prescribing by GP registrars, specifically for acute bronchitis/bronchiolitis. We hypothesise that an appropriately targeted educational intervention will improve adherence to evidence-based guidelines regarding antibiotic prescribing for respiratory infections by GP registrars participating in a vocational training program (that is, a reduction in prescribing of antibiotics for acute bronchitis/bronchiolitis and a number of other non-pneumonia respiratory tract infections).

The aim of this study is to assess the visual performance and wearability of prototype ophthalmic lenses compared to commercially available ophthalmic lenses.

Treatment for haemophilia has improved immensely over the past 30 years which has increased the life expectancy in these patients. As such, comorbidities of ageing and their impact is now an area of importance – in particular musculoskeletal health. Reports have shown that fracture incidence is higher in patients with haemophilia, with disease severity effecting fracture risk. Currently the underlying mechanisms of increased fracture risk in patients with haemophilia is unknown, or what age the bone loss begins and whether or not this is different to the general population. Majority of existing studies have reported low areal bone mineral density (aBMD) measured with dual energy x-ray absorptiometry (DXA), however, other components of bone strength may be compromised, and may also contribute to the increased fracture risk. For example, the separate bone compartments (cortical vs trabecular), bone geometry (shape and size), microarchitecture (organisation of trabecular bone) and bone strength (buckling vs strain). With the advancements in bone imaging technology, these other components of bone strength can now be measured using cutting-edge high-resolution peripheral quantitative computed tomography (HRpQCT). Currently there are no guidelines on bone density screening or osteoporosis treatment for patients with haemophilia. As such, it is unknown when the best “window or age” for bone density screening would be most effective to prevent fracture. The findings from this study will indicate at which age bone density screening will be most beneficial for patients with haemophilia A. Therefore, The Haemophilia Osteoporosis Registry (THOR) is timely as it has been empirically designed and powered to identify the mechanisms of bone loss in patients with haemophilia.