ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32107 results sorted by trial registration date.
  • Effect of Ivabradine use on exercise capacity in patients with transposition of the great arteries (TGA) post atrial switch repair

    This is a single centre, randomized, double blind, cross over study designed to assess the effect of Ivabradine (as a heart rate lowering drug) on the exercise capacity of adults with transposition of the great arteries who have had a previous atrial switch repair. Subjects will be randomised to Ivabradine or placebo after undergoing a baseline cardiopulmonary stress test. Repeat testing will be performed after 4 weeks of treatment then at 8 weeks after a crossover at 4 weeks. We hypothesise that heart rate lowering on exercise with improve exercise capacity (VO2 max) in these adults owing to improved blood flow through the heart (ie. improved atrio-ventricular transport).

  • A study to determine the feasibility of a trial investigating the effect of angiotensin II infusion on kidney damage in cardiac surgical patients

    Each year more than 25,000 Australians have cardiac surgery. While the mortality rate is relatively low (around 1-2%), the rate of problems afterwards such as kidney injury is higher (up to 40%). Acute kidney injury (AKI) is a reduction in kidney function over a short period of time. In many cases it resolves, but patients who have had AKI have higher rates of long-term kidney problems and mortality rates. A few will need dialysis. Maintaining blood flow and pressure for the kidney may help prevent injury. Angiotensin II is produced by the body naturally but can also be given as a drug. It has effects that increase blood pressure. Studies in patients with infection have shown that angiotensin II may improve kidney injury. Animal experiments suggest it may be superior to another drug, known as noradrenaline. Our hypothesis is that angiotensin II may reduce kidney injury. In this pilot study we will determine the feasibility of a definitive study comparing angiotensin II to noradrenaline.

  • The implementation and effectiveness of Brief Physical Activity Counselling by Physiotherapists (BEHAVIOUR) on levels of patient physical activity.

    Physical activity counselling increases physical activity when delivered in healthcare settings; however, implementation efforts have been sub-optimal. The BEHAVIOUR trial aims to address this important evidence-practice gap by delivering implementation strategies (education, training, tailored strategies to address community referral barriers, creation of a learning collaborative, and facilitation and audit and feedback) to enable physiotherapists working in South Western Sydney Local Health District to provide physical activity counselling within routine care. It is hypothesised that physical activity counselling will be implemented into practice and that patients receiving treatment from physiotherapists who receive the implementation strategies will be more likely to participate in greater amounts of self-reported planned physical activity at 6-months after baseline assessment compared to patients whose physiotherapist have not received the implementation strategies.

  • Meta-Emotion Therapy for Bulimia Nervosa

    The aim is to build on previous findings and gain some preliminary evidence to the effectiveness of MET within the BN population. Furthermore, it is important to gain feedback on therapy content, process and dosage in order to prepare for future clinical studies. It is hypothesised that the MET intervention will improve participants’ BN as evidenced by primary measure scores, as well as the secondary measure scores. This study employed a single-case multiple baseline design with commencement of the intervention staggered for each participant. Participants intend to include six adults. Following pre-treatment telephone screening, participants will be screened in an initial assessment interview and to ensure a diagnosis of BN consistent with DSM-5 criteria. Participants will also be administered a Structured Clinical Interview for DSM-5 (SCID) (First, 2015) to ascertain that inclusion and exclusion criteria were met. Participants will be referred to another service for treatment if exclusion criteria is met. Following the initial interview, participants will then complete the outcome measures. Participants will also need to be assessed by a general practitioner to identify any physical conditions that precluded full participation and to ensure that their electrolyte levels are all within a safe range. Participants will complete 16 sessions of MET treatment on a weekly basis with each session lasting approximately one hour in duration. The therapist will be a registered provisional psychologist currently undertaking a Masters of Clinical Psychology at QUT. All sessions will be video/audio recorded and discussed during clinical supervision with a supervisor who is an experienced clinical psychologist (20 years).

  • Development, Feasibility, and Efficacy of a Web-Based Intervention to Reduce Psychological Barriers to Insulin Therapy among Adults with Type 2 Diabetes (Stage 3: Full RCT)

    It is estimated that approximately 1.1 million Australians are living with type 2 diabetes (T2D). T2D is characterised by high blood glucose (hyperglycaemia). Prolonged hyperglycaemia increases the risk of developing diabetes-related complications. Managing T2D can involve healthy eating, regular, physical activity, maintaining a healthy weight and taking diabetes medications. These behaviours are all important for maintaining blood glucose levels within the recommended target range. T2D is a progressive condition which means that the type (and/or dose) of medication a person needs to keep their blood glucose levels in target range may change over time. Injecting insulin is a very effective treatment for diabetes. However, around one quarter of adults with T2D report being not at all willing to inject insulin if recommended by their health professional. People with T2D commonly report concerns and negative attitudes about insulin therapy, including a belief that insulin is not effective for T2D, and could negatively affect a person’s health; concerns about injecting insulin, and; feelings of guilt and self-blame about what insulin symbolises about their health and identity. Our research has previously shown that around half of Australians with non- insulin-treated T2D believe that insulin is a punishment or consequence of ‘failing’ to self-manage their diabetes previously. These negative attitudes about insulin are associated with delayed commencement of insulin. Few resources are currently available to people with T2D to help address these negative attitudes about insulin. Existing Australian resources about insulin are not evidence- based and have not been evaluated to test whether they reduce these negative attitudes. Given the size of the Australian population with T2D a resource that is delivered online to enable wide reach is needed. Therefore, this study aims to test if a novel web-based resource (intervention), compared to widely available existing resources (control), is effective for reducing negative attitudes toward insulin therapy, among adults with non-insulin-treated T2D.

  • The effect of pine bark extract dietary supplement on physical health outcomes in healthy older adults.

    Australia has an ageing population and muscle loss (also known as sarcopenia) is a common condition amongst older adults and is a natural part of the ageing process. Progressive loss of muscle increases the risk of fractures and lowers life expectancy, quality of life as well as limited ability to perform daily tasks with greater levels of fatigue and exhaustion. Changes in the immune system associated with ageing have also been suggested as potential contributing factors to muscle loss and physical frailty. Adequate nutritional intake as well as resistance/balance exercise training and some pharmacological intervention are the current preventative and therapeutic strategies for sarcopenia, however, long-term adherence to complex lifestyle changes that are also physically demanding can be a barrier for some individuals. Therefore, a safe, effective, adjunct therapy with potentially multiple health benefits may improve the well-being of older adults to delay or prevent further muscle loss and potentially improve muscle mass, strength, quality of life and physical function. This study aims to evaluate the health benefits of a dietary supplement containing pine bark extract in healthy older adults. Collection of information and measurements from you will enable us to investigate the health effects of this dietary supplement in older adults to promote healthy ageing.

  • Implementation of a nurse-enabled, shared-care follow-up model for early breast cancer survivors (The IBIS-Survivorship Study)

    The purpose of this study is to test the implementation of a care model involving hospital-based medical teams (medical, surgical and radiation oncologists) and GPs for post-treatment follow-up care for early breast cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, and have breast cancer. Study details Participants in this study will be assigned into two groups. One group will receive standard follow-up (hospital-led) care and information from Cancer Council Australia. The other group will undergo the share-care model. This involves a series of 20 to 60 minute appointments with specialist nurses, GPs and hospital cancer specialists for up to 5 years. As part of the study all participants will answer a series of questionnaires every 6 months for 12 months. It is hoped this research will demonstrate the and effectiveness and cost-effectiveness of the new model of care which could influence future breast cancer follow-up care.

  • Mechanisms of action of SGLT2 inhibitors in patients with heart failure with reduced ejection fraction (HFrEF)

    While SGLT2inhibitor drugs have been demonstrated to favourably affect outcomes in heart failure, the responsible mechanism(s) are completely unknown. We plan to conduct a single centre, phase 2/3, randomised, double blind, placebo-controlled clinical trial with two parallel arms, to investigate the mechanism of action of dapagliflozin (10mg daily), an SGLT2inhibitor, in non-diabetic or diabetic patients heart failure with reduced ejection fraction. By understanding the mode of action, we will then be able to administer these drugs in a personalized manner and to develop better therapies that specific address the key molecular or physiologic targets.

  • Screening for atrial fibrillation in the over-75s with handheld ECG devices

    Patient-led screening for atrial fibrillation (AF) using handheld mobile electrocardiogram (ECG) devices at their homes may help in detecting AF. However, there is no established system to facilitate the diagnosis and management of AF when a suspected case is detected. Therefore, we aim to study whether we can implement an AF screening program using handheld mobile ECG devices integrated with a cardiac centre at Westmead Hospital, New South Wales, that is able to confirm the diagnosis and facilitate appropriate management of new AF. Participants are given a handheld mobile ECG device and they will receive training in using the device. They will involve in the study for a period of 12 months. Participants randomised to the intervention group will commence monitoring straight away while participants in the control group will wait for 6 months to receive the handheld ECG device. During the waiting period, they see their general practitioners (GPs) for usual care. Participants record a 30-second daily ECG on weekdays. ECGs will be automatically transmitted to Westmead Cardiology Department and monitored by trained technicians. Participants and their GPs will be notified of ECG abnormality and GPs can access support from cardiologists involved in this research. The primary outcome at 6-month follow-up (or when AF is diagnosed, whichever occurs first) is the proportion of participants’ reporting being very satisfied/satisfied that their heart rhythm was being monitored in the past 6 months in the intervention group compared to the control group.

  • Evaluation of a peer and clinician co-facilitated group program for people with borderline personality disorder

    To date, there is an absence of specific studies evaluating peer support services for individuals with BPD. This study aims to explore whether a peer support group model is helpful for individuals with BPD. Individuals with BPD will also complete a questionnaire prior to starting the group program to measure mental health symptoms before and after the group program. It is hypothesised that participants in the intervention group will experience an improvement in mental health symptoms and BPD symptoms, and that participants in the waitlist condition will experience no change.

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