ANZCTR search results

Frozen shoulder is a type of shoulder disorder that affects an individual's physical and mental health in daily life. It could cause economic burden to individuals, families, health system, and the society. It is essential to find the best treatment plan to promote frozen shoulder patients' wellness and fasten the recovery time. Laser acupuncture has been used in a few health conditions with positive outcomes. However, the evidence in use laser acupuncture for frozen shoulder is still limited and inconclusive. This study will investigate the feasibility and therapeutic effect of using low-level laser acupuncture to manage frozen shoulder, and provide preliminary evidence in this field.

This study aims to assess whether a test called coronary artery calcium (CAC) score, can help predict the risk of a heart attack in cancer patients who are undergoing radiation therapy. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with any type of cancer, and you will be undergoing a thoracic computed tomography (CT) scan to plan for radiotherapy as part of your cancer treatment. Study details All participants who choose to enrol in this study will undergo their thoracic (chest) CT scan as planned, but the scan images will be used to calculate the CAC score will be completed after the scan. There are no changes to your normal scan for us to measure CAC. The duration of scan will be as per normal and you will not need any additional procedures. The CAC score will be used to identify patients who are at high risk of a heart attack in the future, and we will provide these patients with a referral to see the cardiologist (heart doctor) for management to help reduce this risk. After the scan you will have your radiotherapy treatment as planned. Throughout the study, you will be asked to complete a a series of questionnaires about your overall quality of life and your anxiety levels. You will be asked to complete these at the beginning of the study (Baseline), when you receive your CAC score from your doctor and about 3 months after you finish your radiotherapy treatment. It is hoped this research will demonstrate that the CAC score is able to identify patients who are at high risk of a heart attack in the future and help plan additional care to reduce this risk. We believe that this will have a positive effect on quality of life and reduce anxiety for future cancer patients undergoing radiotherapy.

This study aims to determine the safety, tolerability and pharmacokinetics (drug interactions within the body) of CCX559, a new chemotherapy drug that has not been previously tested in humans. Who is it for? You may be eligible for this study if you are aged 18 or older, you have a solid tumour of any cancer that is considered to be refractory (not responding to treatment), or you are intolerant of other approved treatments including standard chemotherapy, radiotherapy, and/or immunotherapy. Study details All participants who choose to enrol in this study will be given the study drug (CCX559) in either a powder form or as a capsule to be taken each day for 21 day treatment cycles. During each treatment cycle, participants will also be asked to report any side effects they have experienced and will undergo CT imaging at the beginning of every other treatment cycle (Cycles 3,5,7, 9 etc.), and again at the end of the study (7 days after the last dose) and after the safety follow up visit (30 days after the last dose). After taking the first dose, participants will also be asked to provide several [blood] samples over the first 24 hours, on Days 2, 5, 8, 15, 21 of the first treatment cycle and then again at the start and midpoint of each 21-day treatment cycle for the duration of the study. Overall study participation will take up to 2 years. It is hoped this research will determine whether CCX559 is safe and can be tolerated by adult cancer patients. If CCX559 is safe, future studies may be conducted to determine the drug's effect on cancer progression, which may improve health outcomes for future cancer patients

The overall aim of this study is to assess the effects of cognitively demanding resistance training breaks in secondary school classrooms. More specifically, this study will assess the effect of cognitively demanding classroom resistance training breaks on adolescents' executive function, on task behaviour and muscular fitness. The majority of research in physical activity and cognition has investigated the quantitative aspects of physical activity, such as duration and intensity. Alternatively, the qualitative characteristics of physical activity, such as task complexity, novelty and activity context, have received less attention. Emerging research on cognitively demanding physical activity, using the qualitative characteristics of physical activity, seems to promote changes in executive functions. The outcomes from this research will benefit current and future generations of young Australians as physical activity levels decline dramatically during adolescence, and only 15% of Australian adolescents are sufficiently active. Finding ways to promote physical activity in adolescents is particularly important considering that physical inactivity is linked with a range of diseases such as obesity, Type II diabetes, and a range of mental health disorders. Of note, stress and anxiety among youth are increasing in recent decades, particularly among older adolescents. Schools are ideal settings for the promotion of physical activity because they have the necessary facilities, equipment, personnel and are accessible to young people. Our proposed study, focusing on the promotion of physical activity for adolescents has the potential to create new knowledge and reduce the burden of physical inactivity. This project will offer a significant contribution to the field by emphasising the impact of cognitive demanding physical activity.

An open label, cluster randomised controlled trial to determine the comparative efficacy of 2 different insulin regimens for management for dexamethasone induced hyperglycaemia amongst diabetes patients with COVID-19. Patients with COVID-19, with hyperglycaemia when treated with dexamethasone will be eligible. The 2 regimens being compared are morning isophane insulin combined with standard basal bolus insulin therapy versus basal bolus insulin therapy alone. The hypothesis is that the addition of morning isophane insulin will result in superior glucose control, compared to basal bolus insulin therapy alone. The primary outcome is the mean of pre and post meal glucose levels following commencement of the protocol.

This is a bone mineral density (BMD) study using a dedicated analysis protocol to compare bone density around the surgical knee implant. in total knee arthroplasty (TKA). Patients with osteoarthritis will be recruited prior to their TKA operation by their treating surgeon. Patients who participate have an equal chance of being allocated to the Triathlon cemented baseplate or the Triathlon cementless baseplate (Tritanium). Clinical information, such as age, height, weight, ethnicity, general health, medications and medical conditions will be collected. Patient reported outcomes, functional activity, pain and adverse events will also be recorded. The study involves four visits to Monash Medical Centre in Clayton which are additional to routine clinical appointments: before the operation, 6-weeks after, 12 months after and finally 24 months after the operation.

This school trial investigates how family-school partnerships can improve education and mental health outcomes for children in primary school. The project will investigate the effect of family-school partnerships, and how best to increase parent recruitment into evidence-based programs and research studies. Families with children in Grades 2 and 4 in primary schools across Geelong and surrounding municipalities will be asked to participate by completing surveys. We will also gather school-wide (not individual) outcomes related to student academic achievement and readiness using school administrative data. We plan to analyse how family and school influences can improve education and mental health outcomes for primary-school aged children, and how parent engagement can impact these outcomes. The hypotheses are that schools randomised to receive a family-school partnership intervention will show improvements in parent-reports of child academic achievement and parent school engagement (primary outcomes), and in school-wide indicators of student academic achievement, school readiness, and parent-reports of child behaviour problems and child adherence to nutrition and physical activity guidelines (secondary outcomes). We may also conduct further analyses that are aligned to these outcomes in the future using this data.

Undergoing surgery can be a stressful and anxiety provoking process both for parents and the child undergoing surgery. Children are particularly vulnerable to experiencing procedural anxiety in the context of anaesthetic induction, especially due to varying and developing cognitive abilities, inability to self-regulate, and limited knowledge and/or experience of the healthcare environment. Young children are especially unlikely to engage in self-coping strategies, and instead rely on primary attachment figures for emotional regulation and behavioural cues. Previous research has demonstrated that parents’ own responses are influential for paediatric procedural coping and distress. As such, providing parents of children undergoing surgery with psychoeducation resources which can reduce their anxiety and promote coping strategies for both them and their child, may reduce negative experiences and post-operative outcomes (e.g., emergence delirium, pain severity, increased analgesic requirements, and longer-term poor psychological sequelae). The “Take Five” video resource for parents is a newly developed resource for procedural distress, and preliminary data from a study in young children with burn injuries indicates it is effective for improving parent and child experiences of burn wound care. We believe that this resource has the potential to significantly improve anaesthetic induction for parents and children and reduce poor post-operative outcomes.

This is a multi site open label pilot study designed to assess feasibility of further studies looking at the utility of mepolizumab in the treatment of DRESS syndrome. This is an investigator initiated study, with study drug being provided by GlaxoSmithKline. DRESS syndrome is a potentially life threatening, idiosyncratic adverse drug reaction. It is typically accompanied by morbilliform rash, fever, lymphadenopathy, haematological abnormalities including eosinophilia and the presence of atypical lymphocytes, and multiple organ involvement. A number of drugs can cause DRESS syndrome and the common causes include antiepileptic drugs, allopurinol and sulfonamides. We aim to recruit 8 participants over 1.5 - 2 years across the study sites. Mepolizumab, a humanised monoclonal antibody that targets IL5, will be used in conjunction with standard therapy in participants with DRESS syndrome. Mepolizumab is currently approved for use in refractory eosinophilic asthma. Participants will be involved in the study for ~6 months. In addition to standard care investigations/monitoring, blood samples for cytokine analysis and lymphocyte profiling, and patient reported outcome measures will be collected at each visit.

Over half of the people undergoing total knee or total hip arthroplasty (TKA, THA) in Australia have obesity (Body mass index (BMI): 30 kg/m2 or more). Obesity is associated with greater complication rates, lower absolute recovery in mobility and patient-reported pain and function, and higher costs of care following TKA or THA. While weight loss prior to surgery is thought to be beneficial, there is no definitive data to support that this will improve outcomes following surgery, or as to what the most appropriate or effective method of weight loss is. Therefore, this study will test the feasibility and effectiveness of a calorie-restricted partial meal replacement (2 shakes plus a meal, total 1200 Kcal/day) for people with obesity prior to undergoing TKA or THA. This study will assess 30 patients as to whether >50% of people waiting for knee or hip arthroplasty can achieve 5% or more weight loss in 3 months using a clinician-supported partial meal replacement weight loss program.