ANZCTR search results

This study aims to investigate whether 3 newly developed brief online interventions are acceptable to young people with chronic health conditions, and pilot the methods for a larger scale randomized control trial. Young people (aged 18-25) with chronic conditions will choose one of three modules to complete and provide feedback on. Each module teaches a different skill (self-compassionate, self-efficacy, and optimism) that has been linked to healthy emotion regulation and mental health in young people with chronic conditions. Modules run for less than 60 minutes, are self-guided and designed to be completed in a single setting. Modules contain a mixture of video content, stories from other young people, psychoeducation on the targeted skills, and interactive activities including guided self-reflection. The trial will assess whether young people perceive changes in their skills and emotions from pre-to-post module completion, as well as their feedback on the module content. It will also explore which modules young people choose to complete, rates of completion across modules, and changes in mental health using validated measures.

Type 2 diabetes mellitus (T2DM) is a chronic disease, the prevalence of which is rapidly growing world-wide. As a result of historical concerns of the safety of available glucose-lowering therapies, cardiovascular outcome trials (CVOTs) were mandated by the Food and Drug Administration (FDA) in 2008 to ensure that new anti-diabetic therapies coming onto the market were safe from a cardiovascular perspective. Out of the recently studied drug classes, GLP-1 receptor agonists (GLP-1 RAs) and sodium-glucose co-transporter 2 (SGLT2) inhibitors have both shown to provide cardiovascular benefits, not just safety/non-inferiority compared to the more traditional glucose-lowering agents they have been compared to. Both are currently recommended in guidelines for use in patients with a cardiac history, however, it is not clear whether one would confer a greater benefit than the other in patients who have recently had an acute coronary syndrome (ACS), nor whether they can slow plaque progression, as a possible mechanism of their cardiovascular benefit. Given patients in Australia can only access one therapy at a time on the PBS, any information regarding their direct comparison in this patient population would be useful. This will be a prospective, randomised, open, blinded end-point (PROBE)-designed trial that will evaluate the effect of semaglutide and empagliflozin on coronary plaque, as assessed by computer tomography coronary angiography (CTCA) at baseline and following 12 months of treatment with either semaglutide or empagliflozin in participants with diabetes and known coronary artery disease who have presented with an acute coronary syndrome. We hypothesise that participants prescribed semaglutide will have a slower progression in coronary plaque development as compared with participants on empagliflozin.

This study aims to explore the relationship between adherence to four key components of the PIVC Clinical Care Standard: use of extension tubing, adequate securement, use of a semi-permeable dressing, and avoidance of areas of flexion where possible. It also aims to explore the relationships between these factors and patient-reported sleep quality and sleep disturbance. We hypothesise that pain and sleep disturbance experienced by patients may be lower and sleep quality higher if compliance with CCS indicators related to PIVC placement and securement is high.

The overarching aim of this quality improvement project is to assess whether an Integrated Model of Osteoporosis Management (the Model) improves GP investigation and management of patients determined from radiology reports or a hospital-based Fracture Liaison Service to have a potential osteoporotic fracture. The study design is a Cluster Randomised Controlled Trial (cRCT) with randomisation at the GP practice level, to compare outcomes amongst practices allocated to the Model versus usual care. Specifically, this study hypothesises that GP practices randomised to the model (intervention group), compared to GP practices randomised to the control (usual care) group, will: • Refer a greater proportion of patients with a potential osteoporotic fracture for a bone density scan and/or prescribe a greater proportion of patients with osteo-protective pharmacotherapy within three months of an initial diagnostic report. • Refer a greater proportion of patients with a potential osteoporotic fracture for a blood test related to bone health within three months of the initial diagnostic report. • Initiate a chronic disease management plan for a greater proportion of patients should investigations confirm the fracture being due to osteoporosis. • Prescribe osteo-protective pharmacotherapy for a greater proportion of patients with a potential osteoporotic fracture at 10 months post initial diagnostic report.

This study aims to find out if adding the medications olaparib, or olaparib + durvalumab together, to standard chemotherapy given to premenopausal women with HR-positive, HER2-negative, HRD-positive breast cancer before surgery will do a better job of controlling the cancer. Who is it for? You may be eligible for this study if you are a pre-menopausal woman between 18 and 44 years of age, have been diagnosed with HR-positive, HER2-negative early breast cancer, and a sample of the tumour is shown to be HRD-positive. Trial Details. Researchers will test the cancer to find out if it is HRD-positive. Being HRD-positive could make the tumour more sensitive to the treatments in the main OLIO study. Only about 20% of cancers are expected to be HRD-positive. Whilst the sample is tested, participants will have standard treatment (4 cycles of anthracycline-based chemotherapy). Participants with HRD-positive tumours will be randomised 1:1 to receive: Arm A: An olaparib tablet twice per day with water for 12 weeks, plus have an infusion of paclitaxel into a vein once per week. Arm B: An olaparib tablet twice per day with water for 12 weeks, plus have an infusion of durvalumab into a vein once every 4 weeks for 3 infusions (Week 1, Week 5 and Week 9), plus have an infusion of paclitaxel into a vein once per week. Participants will have surgery within 6 weeks after their last dose of study treatment. The following biological samples will be collected: * Tumour sample at surgery, if any tumour remains * Blood samples before starting study treatment and just after surgery. All participants will be regularly monitored throughout treatment to evaluate their health. There will be end of treatment visits 30 days & 90 days after the last dose of study treatment. Follow-up visits will occur every 6 months after surgery for years 1-3 years post-surgery (6 visits), then every 12 months for years 4-5 (2 visits). Further treatment will be at the discretion of the participant and their treating clinician. It is hoped this research will provide new treatment options for young women with HR-positive, HER2-negative breast cancer, particularly among those selected for a high HRD score.

The aim of this RCT is to investigate whether a written self-compassion intervention can improve affect and pregnancy wellbeing in women with GDM. For this study, participants will be randomly allocated to either the self-compassion or positive distraction group. It is anticipated that participants allocated to the self-compassion reflective writing task (using expressions of self-warmth and self-kindness) will report lower levels of affect, and enhanced pregnancy wellbeing at post-intervention relative to participants allocated to the positive distraction group. The outcome measures will include self-compassion, positive and negative affect, pregnancy wellbeing, and intentions to engage in self-care and help-seeking behaviours.

This study will help us assess the effect of a high-fat meal on our blood vessels (cardiovascular health) and how naturally occurring polyphenolic compounds in plant foods could potentially affect this beneficially. An important marker of cardiovascular health is the flexibility of the blood vessels such as arteries, their ability to dilate and constrict when needed. Endothelial function can be measured using a non- invasive technique called “flow mediated dilatation” abbreviated to FMD. The health and function of an artery can be assessed by measuring someone’s FMD in the morning, after fasting overnight. Poor diet can adversely affect artery health. There is evidence that consumption of excess dietary fat contributes towards the dysfunction of our arteries. Consumption of a single, high fat meal impairs post-meal FMD and the typical western diet is characterised by a high frequency of high-fat content meals. Polyphenols are micronutrients mainly found in plant-based foods. Recently, clinical and experimental trials have focused on exploring whether polyphenols can have a beneficial effect on health. Polyphenols can protect blood vessels due to their antioxidant properties, acting directly on the endothelium. The researchers will assess how foods rich in polyphenols (blueberries and cocoa) could play a protective role in the arteries during a high-fat meal challenge by measuring FMD.

This project will evaluate two new single session interventions (SSI) designed to improve body image and compare them to an existing SSI and a control group. The two new SSIs are focused on body neutrality and body positivity, while the existing SSI is on the growth mindset. Because neither the body neutrality or body positivity SSIs have been tested before, we unsure if they will be beneficial or acceptable. However, in particular we hypothesise both will improve body image, hope, mood, and self-efficacy and decrease eating disorder psychopathology and that body neutrality will demonstrate greater effect sizes as compared to body positivity.

This is a multi-site registry-based observational study across regional Victoria for people receiving immunotherapy treatment for an unresectable locally advanced or metastatic tumour. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with advanced cancer that presents as a solid tumour and you have been receiving immunotherapy for at least 12 weeks, and the cancer has started growing again in a small number of areas. Study details Participants who choose to enrol in this study will be asked to consent to having their health information reviewed and collected in a de-identified manner by a member of the research team. Participants will not be asked to attend any additional clinic appointments as part of their involvement in this study nor will they receive specific treatments as part of the study. All treatment(s) received will be the standard treatment(s) otherwise recommended irrespective of participation on this study. It is hoped this research will determine the proportion of patients who do not have cancer progression 6 months after they have completed local therapy, including surgery and/or radiotherapy, but continuing on immunotherapy. If immunotherapy is shown to have a beneficial impact on cancer progression for patients, the information gathered by this study may then be used to optimise treatment options for future cancer patients.

This study is investigating a new cancer treatment drug, ELVN-002, that may be used for patients with lung cancer. Who is it for? You may be eligible for this study if you are a healthy adult aged 18 to 60 years old. Please note that this study will not be enrolling patients with lung cancer. Study details This registration is for Part C of a 3-part study investigating ELVN-002. There are two arms in Part C of the study. Participants enrolled into the CYP3A4 Inhibitor Arm will receive two single dose of ELVN-002 (in capsule form) on separate days. First dose on Day 1 and second dose on Day 7. Participants will also be asked to take a daily dose of itraconazole for 7 days (from Day 4- Day 10). Participants enrolled into the CYP3A4 Inducer Arm will receive two single dose of ELVN-002 (in capsule form) on separate days. First dose on Day 1 and second dose on Day 17. Participants will also be asked to take phenytoin 3 times daily for 17 days (from Day 3- Day 19). Total participation will last up to 10 days for CYP3A4 Inhibitor Arm and 20 days for CYP3A4 Inducer Arm to the clinic for physical examination and vitals assessments and to collect blood and urine samples. It is hoped that this research will help determine the dose that ELVN-002 can be safely given to patients with lung cancer.