ANZCTR search results

This is a randomized, double-blind, placebo-controlled, single ascending dose study. Approximately 56 men and women who fulfill the inclusion and exclusion criteria will be enrolled at one or more sites in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2, and return for outpatient visits through Week 24. In Part A, 8 subjects will be randomized in a 3:1 ratio to receive a single dose of BW-00163 (n=6) or placebo (n=2) on Day 1 in a double-blind fashion. Cohorts 1 to 4 will receive BW-00163 doses of 50, 150, 300, and 600mg, or placebo respectively. In Part B,12 subjects will be randomized in a 2:1 ratio to receive a single dose of BW-00163 (n=8) or placebo (n=4) on Day 1 in a double-blind fashion in each cohort. Cohorts 5 and 6 will receive single dose of BW-00163 300 and 600 mg, or placebo respectively.

Adolescent e-cigarette use has drastically increased in recent years, posing several acute and chronic harms, including poisonings, burns, serious lung injury, and - where nicotine e-liquid is used - the potential to impact brain development and lead to dependence. Effective and scalable preventive interventions are urgently needed, and school-based eHealth interventions are an efficient, effective and economical approach. Yet, there are few school-based preventive eHealth interventions targeting e-cigarettes, and none within Australia. To address this need, we developed the OurFutures Vaping Program. Built on the successful ‘OurFutures’ (formerly ‘Climate Schools’) prevention model, the OurFutures Vaping Program involves 4x40 minute online cartoon-based lessons that are delivered during Year 7/8 health education classes. This study will evaluate the OurFutures Vaping Program via a cluster randomised controlled trial among 42 schools across NSW, QLD and WA. It hypothesized that: • H1 (primary outcome): Students who receive the OurFutures Vaping Program will be less likely to commence e-cigarette use at the 12-month follow-up, compared to students in an active control condition. • H2: The OurFutures Vaping Program will achieve superior outcomes to the control condition on secondary outcomes including: uptake of tobacco smoking, frequency/quantity of e-cigarettes use and tobacco smoking, intentions to use e-cigarettes/tobacco cigarettes, knowledge about e-cigarettes and tobacco smoking, mental health, wellbeing, and quality of life. • H3: Benefits of the OurFutures Vaping Program on primary and secondary outcomes will be sustained over the long-term (up to 36-months post baseline). • H4: The OurFutures Vaping Program will demonstrate cost-effectiveness (up to 36 months post baseline).

There are currently no specific guidelines for exercise and mental health conditions, rather the general guidelines to maintain health (150 minutes of moderate intensity exercise per week) is recommended. However, we don’t know whether a higher volume of exercise is required to better manage symptoms. This research project aims to answer the question ‘what volume of exercise is required to decrease symptoms of depression, anxiety, and stress in tertiary students?’ We hypothesise that a higher volume of exercise will improve symptoms of depression, anxiety and/or stress to a greater extent than a lower volume of exercise. Tertiary level students aged 18 years and older, who have completed >1 year of study, exercise <150 minutes per week, and have mild to moderate depression, anxiety and/or stress symptoms will be invited to participate. Participants will be asked to complete a 90-minute initial assessment consisting of initial screening and the Depression, Anxiety and Stress 21-item Scale (DASS-21) to determine depression, anxiety and stress levels and study eligibility. If eligible to continue, a treadmill test, quality of life survey, perceived stress scale and an arm and leg strength test, along with resting blood pressure, heart rate, height, weight, body mass index and waist circumference will also be performed. Participants will then be randomly allocated to one of two groups (150-minute or 300-minute exercise group). Participants will be asked to complete two 60-minute supervised exercise sessions consisting of aerobic and resistance training each week. The remaining 30 or 180 minutes of exercise (dependent upon group allocation) will be unsupervised and self-reported using an adapted Godin Leisure Time Exercise Questionnaire. Following the six week intervention, participants will attend a 90-minute post-intervention assessment to conduct the same tests performed during the initial assessment, to determine intervention effect. All supervised sessions and testing will be provided free of charge. The results of this study will provide evidence as to the effect that higher volumes of exercise have on mild to moderate depression and anxiety symptoms, which could help to inform exercise prescription in this population.

Antioxidant deficiencies (e.g., low vitamin C levels) lead to oxidative stress which is associated with poor cardiovascular and metabolic health including exercise intolerance (inability to exercise), poor blood glucose control, type 2 diabetes (T2D) and cardiovascular disease (CVD). However, findings from antioxidant treatment research aimed at decreasing oxidative stress and improving health in humans have been inconsistent. Our previous research suggests that antioxidant treatment is likely to be only effective in humans when it is personalised towards restoring specific antioxidant deficiencies. Adults with pre-diabetes and T2D will be randomised to undergo 3-months of personalised antioxidant treatment (antioxidants specific to their deficiency), generic antioxidant treatment (antioxidants not specific to their deficiency), or placebo. Cardiovascular and metabolic health will be assessed before and after treatment. We aim to provide evidence that personalised antioxidant treatment is more effective than generic antioxidant treatment and placebo for improving cardiovascular and metabolic health in adults with pre-diabetes and T2D.

Heart failure is a major burden in Australia in terms of morbidity, mortality and healthcare expenditure. While multiple guideline-based therapies are recommended for heart failure with reduced ejection fraction (HFrEF), they are underutilised and thus ineffective. This study will develop, deploy and evaluate a digital solution, to improve adherence to guideline-based therapies at time of discharge and decrease admissions and mortality in recently admitted HFrEF patients. The BANDAID digital health solution is comprised of a Clinical Decision Support System (CDSS). Physicians will enter specific patient inputs into the CDSS, which will aide in the identification of recommended therapies for hospital inpatients. The primary objective is to determine if use of the Clinical Decision Support System (CDSS) will improve practitioner adherence to guideline-based therapies in recently admitted HFrEF patients, when compared to rates documented in a quality assurance audit in the same institutions.

This project will advance understanding and use of remote patient monitoring devices on top of standard care. The project will facilitate improved patient satisfaction and might also help in better intervention using blood pressure and vital signs data collected through remote patient monitoring devices (wearable/adhesive). The project outcomes will assist in developing future protocols that might be used along with standard care.

Ankle osteoarthritis is a debilitating condition that affects individuals of working age and is characterised by high levels of pain and disability. However, very little is known about how to manage ankle osteoarthritis. While education and exercise interventions have been shown to be successful in the management of hip and knee osteoarthritis, such an intervention has not been investigated in ankle osteoarthritis. The proposed study will establish the feasibility and credibility of a combined education and exercise intervention for ankle osteoarthritis. Secondary outcomes will explore whether education and exercise can improve pain, stiffness, function, and quality of life in this population. This study will determine the feasibility of conducting a full-scale randomised clinical trial investigating education and exercise in people with ankle osteoarthritis and inform the selection of outcome measures. It is an essential first step in determining the effectiveness of an education and exercise intervention for individuals with ankle osteoarthritis. Study findings have the capacity to change the way ankle osteoarthritis is managed and inform the development of clinical practice guidelines to help clinicians make evidence-based decisions when managing people with ankle osteoarthritis.

Administration of antenatal corticosteroids to women prior to preterm birth has been one of the greatest success stories of modern pregnancy and newborn care. Multiple studies have demonstrated a reduction in the rate of breathing problems in newborn babies after this treatment. More recently, several studies have reported benefits when antenatal corticosteroids are given to women who give birth by elective caesarean section after 35 weeks. Elective CS, as opposed to vaginal birth (or even CS in labour) is associated with greater risks of breathing problems in newborn infants and this results in longer hospital stays and separation from the mother. Women with diabetes were specifically excluded from the studies that have demonstrated improvements in the rate of newborn breathing problems, hence, whether these benefits are the same for infants born to women with diabetes is uncertain. Further research in the subgroup of women with diabetes during pregnancy is urgently needed.

Peripheral artery disease (PAD) can result in extensive functional alterations including vascular dysfunction, reduced capacity to exercise, and reduced quality of life. The progression and cause of PAD is thought to be associated with increased oxidative stress and tissue injury related to increased production of reactive oxygen species (ROS) and a decrease in antioxidant defenses. Oxidative stress and inflammation are major features in the development of atherosclerosis and are therefore extremely relevant in the development of PAD. Several important enzymatic antioxidant defenses have been shown to be deficient in the muscle of PAD individuals compared to controls. Endogenous antioxidants function as defenses to remove or regulate ROS production. Therefore, antioxidant deficiencies can lead to a state of excess oxidative stress which contributes to vascular dysfunction, decreased exercise capacity, and the development of PAD, cardiovascular disease, and cerebrovascular disease. However, few studies have adequately explored antioxidant treatment in PAD patients, and none have explored antioxidant treatment and the effects on the extensive vascular network during exercise. The aims of this developmental work are to directly test whether antioxidant treatment (via the intravenous infusion of an antioxidant) can acutely improve vascular function and exercise capacity in patients with PAD.

The aim of this study is to determine the feasibility of implementing a telehealth dermatology service (‘teledermatology’) for melanoma and skin cancer care in Regional Australia, by first piloting in a single general practice (Bendigo Primary Care Centre). Who is it for? You may be eligible to join this study if you are aged 18 years or older, are presenting to Bendigo Primary Care Centre for assessment of a skin lesion of concern, and are willing to undergo clinical photography of the skin lesion of concern. Study details All consenting participants presenting to Bendigo Primary Care Centre during a 6-month period will have their skin cancer referral process managed through the teledermatology platform. GPs will submit an electronic referral containing basic information from participant medical records. and photographs of any skin lesions of concern to the Regional Care Navigator (RCN), a nurse at Bendigo Health. The RCN will assess the quality of photos, and if deemed sufficient, forward them to a reporting dermatologist. The dermatologist will complete a remote assessment and provide a report of preferred diagnosis and recommended management within 48 hours back to the RCN and referring GP. It is hoped that this study will show that teledermatology is a feasible and acceptable method of providing melanoma and skin cancer care in regional Australia. If so, this may provide evidence to facilitate implementation of teledermatology services in other regional general practices in Australia.