ANZCTR search results

This study will assess the effect of ANPA-0073 on the PK of sildenafil (and vice versa) using a single sequence, 3-period design. Participants will receive a single dose of 50 mg sildenafil on Day 1, ANPA-0073 on each Day 2 to 7, single dose of 50 mg sildenafil + single dose of ANPA-0073 on Day 8. The total maximum study duration for participants is 44 days, inclusive of screening and visit windows. For each participant, the confinement period will commence on Day -1, with dosing commencing on Day 1 and continuing to Day 8, and discharge on Day 11. Participants will return to the clinic on Day 15 (± 1 day) for a final EoS visit. It is anticipated that ANPA-0073 will help treat patients with pulmonary arterial hypertension (PAH),. The results from this study will form the basis for further evaluation of ANPA 0073 and dose and formulation selection for future studies.

In Australia, 60% of adults have low health literacy. This means that they lack the skills needed to perform health tasks (such as reading medicine labels) and making health decisions (such as deciding when to access the Emergency Department). Having low health literacy puts people at greater risk of illness and death, and results in increased healthcare costs. When parents have low health literacy, their children have poorer health and are more likely to visit the emergency department and to be admitted to the hospital. Our team has developed a health literacy program to improve parents’ health literacy skills, known as ‘Parenting+’. In 2018, we delivered the Parenting+ program to 73 new parents in western Sydney. We found that the program could be successfully delivered by trained nurses in existing New Parents Groups, including groups for disadvantaged parents. We will now conduct a cluster randomized controlled trial to evaluate the impact Parenting+ has on parents’ health literacy, health outcomes and use of health services compared to standard parenting groups.

This project seeks to enhance women’s access to primary care provision of LARC and EMA by addressing healthcare practitioner barriers and integrating these aspects of reproductive health into locally-available, community-based services. Lack of familiarity with LARC among health professionals and misperceptions about their use (e.g. many GPs falsely believe that IUDs are contraindicated in nulliparous women) have a profound effect on the advice given to women and limit women’s options. Lack of education and training for GPs and other health professionals and lack of follow-up support after training (e.g. supervision, mentoring) are also real issues. Further to this, integration of EMA into general practice has recognised barriers – some GPs feel EMA is beyond their scope of practice or that they would be stigmatised. Many feel isolated and speak of the need for peer support and referral pathways to assist them. It is anticipated with this intervention that primary care clinicians will benefit from the increased support and education, enhanced teamwork and networking with colleagues in the community, and connection to services and service providers to help women achieve their reproductive goals.

Aboriginal and Torres Strait Islander people want to quit smoking and make frequent quit attempts, however these are often unsupported and not sustained. Providing various resources may improve quit attempts and quitting. This study will provide a more flexible, and potentially low-cost access to evidence-based smoking cessation support for Aboriginal and Torres Strait Islander people. This study will test the feasibility and acceptability of Koori Quit Pack, a mailed out smoking cessation package, including optional NRT, smoking cessation pamphlets, MyQuitBuddy app, iCanQuit app, Koori Quitline Facebook page, Aboriginal Quitline webpage, and proactive Quitline referral for Aboriginal and Torres Strait Islander people in NSW, ACT and VIC.

This will be a randomized, placebo-controlled, double-blinded study to evaluate the effects of a multi-strain synbiotic formulation on measures of physical performance, strength and muscle health in older populations. The study aims to investigate the effects of a multi-strain synbiotic supplement on muscle strength, mass and quality and functional performance in older individuals. Approximately 74 male and female participants aged between 60 - 85 will be randomized to receive in a double-blinded fashion either a synbiotic (Pro- + Pre-biotic) or placebo for 16 weeks. Participants will complete 5 visits: Screening (day-14), Baseline (day 1), mid-intervention (week 8), end of intervention (week 16), and a follow-up visit at 20 weeks. Participants will complete a range of tests at each visit that will assess muscle grip strength and functional performance (Short Physical Performance Battery), body composition and muscle quality (Dual X-Ray Absorptiometry and ultrasonography) and self-reported indicators on quality of life, mood and sleep quality via questionnaire. Blood and fecal samples will be collected from participants at each visit to assess clinical blood chemistry and gut microbiota composition. The expected outcomes are that 16 weeks of daily synbiotic supplementation will result in statistically greater 1) improvements in muscle strength, functional performance and muscle quality and 2) increases in microbial diversity compared to placebo.

The aim of this study is to determine the effect of increased sugar consumption on the composition of breast milk and to assess variations in breast milk composition across the day. The intervention within this study includes two different diets; one control and one higher in sugar. A cross-over design will be used where control and higher sugar diets will be provided in a random order to each woman across two days. Women will be asked to manually express small amounts of breast milk each hour throughout the day (alongside consumption of the provided diets). Breast milk will be analysed for triglyceride, lactose, protein and fatty acid concentrations.

This project will aim to reverse T2DM in Aboriginal women with sustained HBA1c above 6.5% and prevent T2DM in Aboriginal women who are considered pre-diabetic with HBA1c between 5.6 and 6.4%. This will be achieved by co-designing culturally and scientifically responsive materials and information by and for Aboriginal women to be delivered by a GP, Aboriginal Health Worker and Diabetes Educator through a procedure called Medical Yarn Ups. The project will address trauma, eating and nutrition, physical activity and other lifestyle determinants of T2DM. Performance indicators will include: sustained reductions in HBA1c to below 5.5%.; development, testing, satisfaction with and adoption of culturally and scientifically responsive materials and procedures that can be used sustainably in practice.

This project's primary aim is to test the feasibility and acceptability of a self-management package that was specifically designed to support people with PF. The secondary aim is to collect preliminary data on clinical outcomes of using the self-management package, which include self-efficacy, health-related quality of life, dyspnoea, physical activity level, treatments for PF, and health care ultilisation. The outcome measures will be compared between two groups: the intervention group (which receives the PF self-management package and support to facilitate the use of the package); and the control group (which receives standardised information about PF and attention control calls). It is a randomised controlled trial that will help to determine the feasibility and acceptability to deliver the self-management package using the current study protocol. In addition, it will provide preliminary data that will inform larger trials in the future.

A spinal cord injury (SCI) results in disruption of the neural connections between the brain and spinal cord causing muscle paralysis and loss of sensation below the injury. Therapeutic acute intermittent hypoxia (AIH) is currently an emerging topic in the SCI research field because of its potential to restore function to muscles paralysed after SCI through ‘neuroplasticity’. This means the therapy changes the way the brain and spinal cord connect to improve muscle function. Treatment with AIH involves breathing air with an oxygen content equivalent to standing on top of a mountain at 6000 m (20,000 ft) altitude. It is safe to do this as the low oxygen air is breathed for short periods at a time (i.e. 1 minute) and is alternated with a short period (i.e. 1 minute) of breathing “normal” air (i.e. level of oxygen the same as sea level). In many previous studies of the breathing muscles in animals with SCI and some studies in limb muscles in humans with SCI, it has been shown that just one 30-minute session of therapeutic AIH can boost the function of previously paralysed and partially paralysed muscles for more than an hour. This study aims to understand the mechanisms of action of this therapy in people with SCI so that we will be able to identify the best way forward to target, tailor and apply this treatment clinically for people with both chronic and acute SCI.

A 6 month Interventional study enrolling 150 women participants between the ages of 30-55 years. To evaluate and assess the effectiveness of a Women only Heart Clinic in reducing Cardiovascular risk and improving cardiovascular outcomes. The study reviews women with a > 1year past obstetric history of gestational diabetes, pre eclampsia, gestational hypertension, small for gestational age babies and placental abruption. The study is based on normal care offered to women with identified traditional CVD risk factors as well as Non traditional risk factors.