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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.

Paltusotine is an oral somatostain receptor 2 (sst2) agonist being developed for the treatment of acromegaly. This single cohort, 2 period study will evaluate the relative bioavailability of two paltusotine tablet strengths in healthy volunteers. Participants will receive 1 dose of 2 x 30mg and 1 dose of 3 x 20mg of paltusotine, across 2 periods in a randomised format as follows: Period 1: 6 Participants to receive 1 dose of 2 x 30mg, 6 Participants to receive 1 dose of 3 x 20mg. Period 2: Participants to receive the other dose to what was received in Period 1. Participants will receive each dose with approximately 240ml of water, after a 10 hour overnight fast. Participants will then fast for further 4 hours after dosing. There will be 10 to 14 days between doses.

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 gamble less. This app will provide users with in-the-moment support for gambling cravings, high-risk situations, and positive outcome expectancies to prevent gambling episodes. 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: a tailored intervention condition or a no-intervention control condition. Participants who are assigned to a tailored intervention condition continue completing intervention activities in a loop until they indicate they no longer need support or close the app. 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 inform the optimisation of this intervention, evaluate the efficacy of the intervention, and explore when and for whom the intervention is effective.

Hormonal testing can be performed at different stages during ovarian stimulation, either alone or combined with ultrasound (Kwan et al., 2014). Currently, hormonal testing is mostly performed via serum-based hormonal assay in clinical practice. Levels of Estradiol (E2), Luteinizing Hormone (LH) and Progesterone (P4) can provide information on ovarian response to stimulation, risk of ovarian hyperstimulation syndrome (OHSS), drug regimen required (type of gonadotrophin and type of protocol), whether dose adjustment of gonadotrophins is needed during treatment and optimal time to trigger follicular maturation (Kwan et al., 2014; Meyer et al., 2015; The ESHRE Guideline Group On Ovarian Stimulation et al., 2020). Kinder is a non-invasive in vitro diagnostic device for measuring urinary fertility hormones (FSH, LH, Estrone-3-glucuronide (E1-3G) and Pregnanediol-3-glucuronide (PdG)). The assay test system is for use by both health care professionals in a clinical setting and non-professionals in a home care setting under the guidance of a health care professional. Results will be sent, as de-identified data, to be interpreted by a health care professional as an aid to clinical decisions (Planet Innovation Regulatory Strategy Plan version 3.0). Correlation of serum concentration of fertility hormones and their urinary metabolites represents one of the critical data gaps in incorporating the use of Kinder device into the daily practice of ART treatment. This study will provide pilot data on such correlation.

Recent studies on melanoma have shown that survival and response to treatment can related to gut microbiome diversity and richness. All bacteria produce molecules, known as metabolites, that can alter immune cell function. This study aims to assess whether people with melanoma who are being treated with a checkpoint inhibitor (immunotherapy) have any key differences in their bacterial metabolites (metabolome) that may determine whether they are likely to respond to their immunotherapy treatment. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have been diagnosed with resected and unresectable melanoma and you are undergoing checkpoint inhibitor therapy. Study details All participants who choose to enrol in this study will be asked to provide a blood sample and a faecal (stool) sample for testing. This will occur during a clinic appointment lasting no more than 20 minutes. Participants will be asked to provide these samples at the time of enrolment, at 6 weeks and then either (i) at the 6 month mark, or (ii) earlier if the immunotherapy treatment stops working. It is hoped this research will determine if there are any key metabolite differences between melanoma patients who do respond to immune checkpoint inhibitor therapy, and those do not respond to this treatment. We hope to use our research findings to investigate more effective cancer treatments for patients in the future.