ANZCTR search results

This study will evaluate a new model of of care for people with musculoskeletal pain (e.g., back, neck or joint pain) in primary care. It will compare usual GP-led care with a model that also allows patients direct access to publicly funded physiotherapy. The study will involve 16 general practices and their associated physiotherapy clinics across Australia. Adult patients attending these clinics for musculoskeletal pain may be invited to participate by completing online questionnaires about their health, healthcare use, and experiences over 12 months. The study will also collect de-identified information from clinical records about healthcare use, such as healthcare visits, diagnostic imaging referrals, and medication prescriptions related to musculoskeletal pain. The study aims to determine whether direct access to publicly funded physiotherapy provides physical health outcomes that are no worse than usual GP-led care, while improving healthcare use and value for money. Findings will help inform future healthcare policy in Australia.

This study aims to examine possible changes in brain activity in people with alcohol use disorder after receiving focused ultrasound stimulation guided by brain imaging. Stimulation will be applied to the anterior insula, a brain region involved in craving. We will assess changes in brain activation, connections and chemistry, self-reported craving, and cognition and behaviour. We will also assess emotional awareness to better understand how the intervention works. We hypothesise that applying focused ultrasound stimulation to the left anterior insula will facilitate insula connections with the prefrontal cortex, which is a brain region involved in craving regulation.

BMB-105 is a novel, potent, and selective 5-HT2C receptor agonist being developed for the treatment of hyperphagia and associated neurobehavioral symptoms in PWS. Preclinical pharmacokinetic data indicate good oral bioavailability. Part 1 SAD: will be 4 single dose cohorts, consisting of 8 participants each. Dosing will be initiated at 0.8mg/kg (or matching placebo) once. Part 2 Food Effect: 12 participants will have a single dose of BMB-105 with and without a meal 7 days apart (crossover). The dose will be determined following the SRC of Part 1 data. Part 3 MAD: will be 4 cohorts of 8 participants each, using different doses. Dosing will be initiated at 0.8mg/kg (or matching placebo) daily for 7 days.

Intracytoplasmic Sperm Injection (ICSI) was first described in 1992 and has since been routinely used to treat patients with severe male factor infertility with much success. An alternative method of injecting sperm into the oocyte has been described: PIEZO-ICSI. This utilises an actuator in piercing the zona pellucida of oocytes, which allows for microinjections with less physical stress being applied during the procedure. The hypothesis of this study is that using the PIEZO-ICSI technique to inject sperm will result in a higher fertilisation rate compared to conventional ICSI. This will be a sibling oocyte study in patients aged 38 and over.

Research suggests SGLT2 inhibitors may help people with type 1 diabetes by improving blood sugar control and supporting weight management. It is also possible that the heart and kidney benefits seen in people with type 2 diabetes may extend to people with type 1 diabetes. However, they are not approved for people with type 1 diabetes because there are important safety concerns. In people with type 1 diabetes, SGLT2 inhibitors can increase the risk of diabetic ketoacidosis (DKA), a serious and potentially life-threatening condition. Although findings from our clinical trial (PARTNER) has shown that dapagliflozin (an SGLT2 inhibitor) can significantly improve blood glucose control and weight without DKA events with the use of a continuous ketone monitoring device, participants in the trial receive frequent monitoring and support from the study team, which may not reflect routine clinical practice. The aim of this study is to assess the safety of off-label Dapagliflozin use in adults with type 1 diabetes living in the community, supported by continuous ketone monitoring. We hypothesise that similar to the PARTNER study, there will be no DKA events.

The aims of this project are to pilot and test the feasibility, acceptability and efficacy of the RECONNECT ME program, specifically: 1. Examine the impact of the RECONNECT ME program on children’s screen time, wellbeing, social skills, thinking skills and family functioning 2. Explore what factors are associated with these (potential) changes (e.g. home environment, parent role modelling etc). 3. Explore the feasibility and acceptability of the RECONNECT ME strategies

SACHA is an international registry that collects information on innovative cancer treatments used for children and young adults aged 25 years or younger with recurrent or refractory cancer outside of clinical trials. These treatments may be used off-label or through compassionate access. The registry collects treatment and outcome data to better understand their safety and effectiveness in routine care. It is hypothesised that learning from these experiences will improve knowledge of these treatments and help inform future care and research.

This study will evaluate a digital literacy program for older adults aged 60 years and over with hearing and/or vision loss. Trained Digital Mentors will provide one-to-one support to help participants build their digital skills and confidence over 6–8 weeks. The study will assess whether the program is practical and acceptable and explore changes in digital confidence, skills, technology use, social participation and wellbeing. Participants will complete assessments before and after the program and again three months later. The findings will help improve the program and inform a future larger study.

This Phase 1 study is a randomized, placebo-controlled, double-blind, ascending dose, first in human trial of IN-007 vs. placebo in normal healthy volunteer men and women. The study will assess the safety and pharmacokinetics on IN-007. the study drug is being developed for the treatment of mild to moderate COVID-19. The study is designed to enrol normal healthy participants in Part A (2 cohorts) and Part B (2 cohorts) with each cohort testing a different dose and number of doses of IN-007. Participants will be dosed as in-patients at the study site and then will be followed up with multiple follow-up visits over a period of 8-9 weeks.

The aim of this research study is to characterise the acute physiological and exercise-endurance responses to two divergent passive lower-limb heating modalities (hot-water perfused trousers, and infrared leg heating) compared to knee-down water immersion in individuals with HF with reduced ejection fraction (HFrEF). Participants will be asked to visit Griffith University on up to four separate occasions. During the first visit, participants will be familiarised with the study procedures and equipment, and complete the incremental shuttle walk test. In the subsequent three visits (separated by a minimum of 5 days), conducted in a random order, participants will undergo 45 minutes of one of three different lower-limb heating methods: Placing your lower legs, up to knee height, in a circulating warm water bath (42°C); Wearing a pair of trousers through which warm water is circulated; Sitting with your legs positioned within an infrared heating device; and a control condition where no heating is applied. During all experimental sessions, participants heart rate, blood pressure, oxygen saturation, and cardiac output will be continuously monitored. Every 15 mins throughout heating, we will measure the size and blood flow of the the femoral artery using an ultrasound machine. Immediately after each heating session, participants will complete a walking test (the Endurance Shuttle-Walk Test) that measures how long individuals can exercise at a set pace, It is hypothesised that exercise endurance results will vary dependent on the magnitude of femoral artery blood flow increase at end-heating.