ANZCTR search results

Atrial Fibrillation (AF) is a type of heart rhythm disturbance which is relatively common in patients admitted to the Intensive Care Units (ICU) especially in people on breathing machines and/or who need drugs to support their blood pressure. Onset of fast AF (>130 beats/minute) in ICU is a clinical problem and usually associated with worsening clinical condition, low blood pressure, and poor outcome. The treatment of fast AF is variable and ranges from giving potassium or magnesium replacement or medications that slow down the heart's rate all the way up to providing an electric shock to "reset" the heart into a normal rhythm. Such invasive treatments are usually associated with significant side effects, and recognising ways to prevent fast AF could improve patient outcomes. Magnesium is also frequent in patients who are admitted to intensive care and I sbeleived to contribute to fast AF. Magnesium replacement via intermittent delivery via a drip in the patient’s vein is common practice in intensive care units. However, an optimal approach to replacing magnesium may be via continuous adminsotration via drip and may decrease the risk of fast AF. This study will aim to establish which of these two methods of administration of magnesium replacement in patients at risk of developing fast atrial fibrillation (AF) is better at preventing early AF in high risk patients.

Diabetes is a progressive, chronic disease characterised by elevated blood glucose levels. Approximately two million Australians are currently at high risk of developing Type 2 Diabetes. There has been increased attention to the effects of individual food items and nutrients on the outcome of Type 2 Diabetes in recent times, including nuts. Regular nut consumption has been shown to improve glucose control and reduce the overall risk of Type 2 Diabetes. The glycaemic response varies for different carbohydrates. In addition to the level of available carbohydrate in foods, the remaining composition of a food item can also influence the glycaemic response. Almonds have been shown to decrease blood glucose levels and increase satiety after eating. Walnuts contribute numerous positive health benefits including lowering cholesterol and reducing inflammation. Both walnuts and almonds contain high amounts of polyphenols. The form in which nuts are consumed (butter vs whole nuts) may lead to differing metabolic responses. Whilst there are several acute feeding studies which have looked at the postprandial glucose and insulin responses of whole walnuts and almonds, very few have looked at almond or walnut butters, (despite widespread commercial availability of such products). The current study design hopes to provide answers to this research gap. Significant outcomes of the research may include: - Understanding the effects of almond and walnut butters on blood glucose and insulin levels - Understanding the subjective satiety measures of almond and walnut butters We hypothesise that consuming almond butter or walnut butter with white bread will lower the resulting glucose and insulin response, as compared to white bread alone.

COPD and OSA are the most prevalent respiratory diseases. Patients with both conditions termed overlap syndrome are at increased risk of dying from cardiac related problems. Positive airway pressure therapy are devices that stabilise the airway and assist with breathing. The aims of this study is to assess whether positive airway pressure therapy can reverse the negative consequences that occur in the heart of people with overlap syndrome and whether it can reduce their cardiovascular risk.

This research will be conducted at four Australian hospitals. This study aims to investigate the effectiveness of an eight-week multidisciplinary rehabilitation intervention (including exercise and nutrition) i in patients 30 days following bone marrow transplant (either from a donor or from yourself), compared to usual care. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have received a bone marrow transplant within the last 30 days and you are able to walk independently. or using a gait aid Study details All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either the intervention program or usual care. Participants who are allocated to the intervention program will firstly undergo a one-on-one session with a dietitian to review their current diet and discuss options to optimise their intake to meet their needs and have their function measured by a Physiotherapist. They will then undertake an 8- week exercise program that will be delivered via telehealth as 2 x 1 hour sessions each week with a face to face session in week 4 replacing one telehealth session. At the end of the program, all participants will be asked to attend a follow-up session to measure their fitness, nutrition, healthcare utilisation and and quality of life. Participants will also be asked to provide these details again at 6 and 12 months after completion of the program/usual care to determine any long term effects. It is hoped this research will demonstrate that delivery of an individualised nutrition and exercise program to patients who have undergone a bone marrow transplant will lead to improvements in their physical function and quality of life.

This study aims to test the acceptability and feasibility of a text message program (TEXT4HealthyHeart) on reducing overweight and obesity for people referred to the Shoalhaven CRP, as well as to assess the preliminary effect of TEXT4HealthyHeart on body mass index (BMI), waist circumference, blood pressure, heart rate, nutrition and physical activity including step count. Participants will receive specifically selected automatic daily text messages for 6 months on weight reduction, nutrition and physical activity. They will also receive a step recording calendar and will be supplied with a step counting device if they do not have one. Objective and self-report measures will be collected directly from the participant at baseline, 3 months and at 6 months.

The major aim of this project is to test the effectiveness of Cardiac Prehabilitation aimed at reducing anxiety, depression and distress in patients with aortic stenosis undergoing either sAVR or TAVI as cardiac interventions. This will be assessed by comparing each group against their control arm of cardiac patients in the surgery waitlist. In addition, we will examine whether prehabilitation has been more effective in either sAVR or TAVI. It is expected that those undergoing sAVR will demonstrate higher rates of baseline psychological distress than those undergoing TAVI. A secondary aim is to gauge whether undertaking a web-based intervention has resulted in higher rates of cardiac rehabilitation uptake than is usually seen in this population. This research will contribute to the current lack of research in the area of early interventions in cardiac patients with aortic stenosis.

The primary purpose of this research is to evaluate the feasibility, acceptability, and efficacy of integrating mentalization principles into a cognitive behavioural intervention for childhood anxiety. In light of the evidence that reflective functioning enhances parenting self-efficacy, coupled with the evidence on the effectiveness of CBT in reducing and managing anxiety in children, it is hypothesized that this integrated cognitive behavioural intervention will demonstrate: (a) feasibility, acceptability, safety and tolerability (b) a reduction in clinical levels of anxiety and anxiety symptoms in children and, (c) an increase in self-reported parental self-efficacy in managing their child’s anxiety.

This is a FIH, randomized, double-blind, placebo-controlled, dose-escalation study to investigate the safety, tolerability, PK, and PD of ENN0403 after single and multiple oral dose administration in healthy adult subjects. The study will include 2 parts which will proceed in a parallel staggered manner: Part A, a single ascending dose (SAD) study and Part B, a multiple ascending dose (MAD) study. Approximately 80 healthy adult subjects will be enrolled at a single site in Australia, in up to 6 cohorts in Part A (SAD study), including a Food Effect (FE) study, and up to 4 cohorts in Part B (MAD study). Part A is for the single dose use of IP, while Part B is once daily use for 14 consecutive days. Each cohort will include 8 subjects (6 receiving ENN0403 and 2 receiving placebo). Each subject will be enrolled in only 1 cohort and receive only one dose regimen in this study. Dosing will be escalated in a sequential fashion, contingent on a review of safety, tolerability, and available PK data of the previous dose level by a Safety Review Committee (SRC). The proposed dose levels/dosing frequency of ENN0403 may be adjusted over the course of the whole study and cohorts may be added or removed depending on the emerging safety, tolerability, and available PK data.

Indigenous children and adolescents experience profound levels of preventable dental disease. These impact on Indigenous children and young people’s ability to eat, speak, socialise and learn. It is a leading cause of child malnutrition and overall poor quality of life and SEWB. Trajectories of dental disease among Indigenous children/adolescents are increasing at a rate far greater than for non-Indigenous children/adolescents, with severe cases requiring care under a hospital-based general anaesthetic. Poor oral health in childhood is the leading cause of poor oral health in adulthood, and has associations with other systemic conditions including diabetes, cardiovascular disease and chronic kidney disease. Effective interventions to reduce dental disease among Indigenous children and adolescents are rare, and certainly not included in the current suite of management recommendations for the health and wellbeing of this vulnerable population. This study will test the hypothesis that Indigenous children and young people in 6 Australian states and territories can be provided with appropriate dental care in local Indigenous settings using the AgF approach, without specialist intervention and avoiding the need for treatment under hospital-based general anaesthetic. Our study has 6 major strengths: (1) it will evaluate the extent, prevalence and severity of dental disease in Indigenous children and young people in each state and territory; (2) it will test the efficacy of a simple and culturally safe AgF initiative, which could be easily implemented into the training program of Indigenous Health Workers to be included in their remit of care; (3) we will have capacity to comprehensively assess the cost-effectiveness of the intervention, meaning uptake into clinical guidelines will be much swifter than if no cost-effective analysis was undertaken; (4) the intervention will likely lead to SEWB improvements in Indigenous children and young people; an important strategic priority given current commitments to improving child health and wellbeing, with the Australian Government launching, in Oct 2021, the world’s first National Children's Mental Health and Wellbeing Strategy;1 (5) we have engaged and consulted considerably with the 9 participating ACCHOs, using their feedback to shape the research questions; (6) our researchers are world-class experts in their respective specialties and have experience working with Indigenous child and adolescent populations. Half our study team are Indigenous and include the CEOs and research officers of all ACCHOs involved. Our findings have potential to change the way in which the oral health of Indigenous children and young people is managed, with desired impacts including cost-savings on expensive dental treatments; improved SEWB, nutrition, social and learning outcomes; and improved quality of life for both children/young people and their carers/broader Indigenous community.

The study is designed to assess the safety, tolerability, plasma concentration and efficacy of ABI-2280 Vaginal Tablet, self-administered to participants with intravaginal applicator Part A of the study is consists of 3 Cohorts (A1, A2 and A3) Each cohort will enroll 3 participants Total of approximately 9 participants will be enrolled. The study includes Screening, Baseline Visit, Safety follow-up visit.