ANZCTR search results

The aim of this project is to evaluate the impact, feasibility, acceptability of a wellbeing and healthy lifestyle program for adults with rheumatoid arthritis (RA). The program is delivered over 20 weeks by a multidisciplinary team and includes individual (in person and online/teleconference) and small group in person sessions to provide education, skills training, feedback, resources and support related to psychological resilience, exercise, healthy eating, cigarette smoking cessation and behaviour change. Assessment is done before and within 1 month after the program using online questionnaires, measures of physical functioning, a dietary interview and food diary, and physical activity monitoring. Questionnaires will be used to assess participant feedback on the program. It is hypothesised that program participants will describe the program positively and show more improvements in wellbeing, healthy lifestyle behaviours and physical functioning than those receiving usual care. The outcomes of this research will be used to review and revise the program and to design a larger trial.

A Clinical Investigation to evaluate safety and performance of APEX KNEE ECiMa Patella and Tibial Insert components in primary Total Knee Arthroplasty. This 10 year study aims to review the two aspects - long term performance of the three ECiMa Tibia and Patella (if inserted) variants in patients receiving Apex Knee System during knee replacement surgery. The study also aims to review the safety of these devices.

The study is a clinical study which aims to review the performance Apex KneeTM Pegged Tibial Baseplate Porous Coated components following primary total knee arthroplasty and to monitor fixation over time. The study also aims to review the safety of the product and assess the Quality of Life of patients after the surgery via assessment of quality of life questionnaires collected before and after the surgery.

Numerous clinical and public health organizations clearly state that children have thermoregulatory impairments that render them more susceptible to heat-related illness. However, other than commenting that children may be at a disadvantage, very few extreme heat policies specifically differentiate between adults and children for the upper environmental limit at which exercise and/or sporting events should be modified or cancelled. The overall aim of the proposed project is to use a novel experimental approach to determine the independent influence of developmental age on the environmental limits (i.e., maximum relative humidity at 35°C) for safe exercise in the heat. The primary research question guiding this project is: Is thermoregulatory strain (and the critical environmental limit) during exercise in the heat different between: Children (ages 10-17 years) and adults (aged 18+). The research hypothesis is that: - Thermoregulatory strain (and the critical environmental limit for safe exercise) will be similar between children and adults when exercising at a fixed metabolic heat production of 220 W/kg.

Type 1 diabetes is one of the most common life-long diseases in childhood. Management is intensive with frequent blood glucose management, insulin administration and monitoring of food intake and exercise and can affect most aspects of the life of the child. Insulin can be administered by multiple injections per day or with insulin pumps. There is growing evidence for improved glycaemic control by using insulin pumps. However, the optimal time to commence pump therapy is yet to be elucidated. Results of studies of pumps at diagnosis are conflicting and complicated by the inclusion of studies with pump therapy commencing at any time in the first year since diagnosis. This randomised controlled study intends to determine the optimal time to commence insulin pump therapy for type 1 diabetes in children. Children over 5 years will be randomised to either commence their pump within days of diagnosis compared to 3 months. The outcomes of interest will be whether an early pump start will result in improved diabetes control and preserve the function of the pancreatic beta cells. Secondary outcomes will include determining the effect on quality of life for the child and their parents and determining whether this approach is cost-effective.

Across Australia every year, children undergoing treatment for cancer experience more than 250 bloodstream infections, 70 deep vein thromboses, and 300 blockages - all caused from their central line. This central venous access device (CVAD) is vital as it administers treatments such as chemotherapy drugs and supportive therapies including blood transfusions and antibiotics, however we need to do more to prevent harm. When the CVAD is not in use, it is locked it with fluid. This fluid lock is an opportunity to prevent CVAD-associated complications. Therefore, the aim of this study is so compare the safety and effectiveness of the locking solutions KiteLock (Tetrasodium-EDTA (T-EDTA)) and heparinised saline with normal saline, which is routinely used in as part of standard care. Who is it for? You may be eligible for this study if you are aged younger than 18 years, have been diagnosed with an oncological or malignant haematological condition, and have a CVAD in place. Study details Participants will be randomised (i.e. allocated by chance) to receive either the normal saline (10ml of 0.9% sodium chloride), heparinised saline (1-2ml of sodium heparin 10units/ml or 100units/ml depending on the device and standard operating procedures), or KiteLock (1-2ml of 4% T-EDTA) administered into the lumen of the CVAD. The solution will be administered at a frequency based on clinical requirement (i.e. if the CVAD is de-accessed), plus during routine management procedures (e.g. needleless connector changes, totally implanted device needling, line cares) with a maximum of one dose per 24 hours. This will continue until the device is removed, the participant withdraws from the study, for up to a maximum of 3 months post-enrolment. Throughout this study period, participants may be assessed by their treating clinicians for bloodstream infections using blood cultures, for CVAD-associated thrombosis (i.e. blood clots) with ultrasound or venography, for blockages of the CVAD with a test of injection and/or aspiration catheter occlusion, and for CVAD failure requiring removal. Participants will also be monitored for any adverse events, with a research nurse contacting them twice weekly across the study period. A questionnaire assessing health-related quality of life will be given to participants at the trial commencement and completion. Participants will additionally be followed up at 1 and 5 years after study completion (using medical records only) to assess for any serious CVAD complications, and for any cause of death. It is hoped that this study may help to identify the locking solution with the least complications and adverse effects, in order to prevent harm in children with a CVAD undergoing treatment for cancer.

Fetal Alcohol Spectrum Disorder (FASD) is a chronic disability with costly impact on families, as well as educational, health, and justice services. The prevalence of FASD ranges from 1-10%, and is as high as 19% in some remote areas. However, many affected children go undetected. Better early detection systems are needed to deliver interventions that can effectively support structural and functional brain development. Current diagnostic practices involve a lengthy assessment process that extends to multiple days per child and requires specialist expertise. Capacity to identify FASD is restricted because specialist teams are expensive, have 2-year waitlists, and exist only in urban areas. Innovative, flexible solutions are needed to ensure that children in remote Indigenous communities have access to early diagnostic services. Through extensive pilot work and strong partnerships with remote Indigenous communities, our team has co-created an innovative, culturally sensitive, tiered neurodevelopmental assessment that can be conducted in routine primary care. The current project will compare the accuracy of a rapid, tiered assessment protocol to a comprehensive assessment protocol used in Queensland specialist FASD clinics. The cost effectiveness of the tiered assessment will be assessed to further extend translation. The outcome will be (i) an expedient, validated FASD screening and assessment protocol, (ii) a culturally-sensitive protocol that has widespread applicability to remote Indigenous communities, and (iii) reduced costs and economic net benefits for families and health services.

The aim of this cutting-edge micro-randomised trial is to evaluate the effectiveness of a new Just-In-Time Adaptive Intervention delivered via a smartphone app for people who want to adhere to their gambling expenditure limits. This implementation intention app intervention will use in-the-moment information about personal gambling intentions and corresponding barriers (e.g., strong cravings) to promote adherence to gambling intentions in real-time. Participants will complete very brief real-time assessments three times per day via the app, which will be used to determine their eligibility for a real-time intervention. Participants who are eligible to receive an intervention at each assessment time point will be micro-randomised to one of two conditions: an intervention condition or a control condition. Participants will also complete pre-intervention, post-intervention, and 6-month follow-up evaluations to determine change over time. In so doing, this trial will evaluate the efficacy of the app intervention and when and for whom the intervention is effective.

The purpose of this study is to assess how practical it is to run a self-compassionate body image intervention for people with endometriosis. The "My Changed Body" intervention was originally designed for breast cancer survivors but has shown success in improving self-compassion and body image in other sub-groups of the population. The program involves people in the self-compassionate condition completing six writing activities that encourage self-compassion towards the body and the self. As this is a feasibility study, it is exploratory in nature and without hypothesis. The focus of the study is therefore on how practicable it is to conduct the program for people with endometriosis, e.g., how easy is it to recruit the necessary sample, how many participants complete the program, how many participants drop-out at different time points, how satisfied participants are with the program, and if the program is associated with a change in self-compassion.

The purpose of this study is to compare the immune responses within cancer tumours which have and have not been treated with stereotactic ablative body radiotherapy (SBRT). Who is it for? You may be eligible to join this study if you are aged 18 years or older, and have cancer in the head or neck regions. Study details All patients undergo SBRT to tumour sites, which delivers a high dose of radiotherapy to the tumour. This will occur across 1-8 treatment sessions (fractions), and most likely 3-5 fractions for one tumour site, and one fraction will be given each day over 30 minutes. Depending on the tumour site, fractions can be given on consecutive weekdays or every 2nd weekday. Your treatment sessions will depend on the number of tumour sites that the doctor considers can be safely treated with SBRT. Before and after SBRT, there will be PET imaging using novel tracer 89Zr-Df-IAB22M2C to track immune cells in the tumour and in the whole body. Blood tests will also be performed before and after SBRT. It is hoped that this research will provide information on how to best deliver immunotherapy with SBRT radiotherapy, thus improving treatment of head and neck cancer.