ANZCTR search results

This is an investigational agent within the ALLG AMLM26 INTERCEPT trial platform, which is registered on ANZCTR with ID ACTRN12621000439842. This investigational agent (MBG453 - a new treatment) will be evaluated for its activity alone and in combination with azacitidine in a population of participants with progressive acute myeloid leukemia (AML). Who is it for? You may be eligible for to receive this treatment if you are a part of the AMLM26 Intercept trial which is registered on ANZCTR with ID ACTRN12621000439842 (ie if you are aged 18 or older, you have been diagnosed with progressive acute myeloid leukemia, and are currently in your first or second morphologic remission with a known and trackable minimal residual disease (MRD) marker.). If you are on the AMLM26 Intercept trial you may be eligible for this treatment option if your minimal residual disease (very small amounts of disease) is rising. The trial management committee will review your disease characteristics and determine your best treatment option(s) available on the trial. Study details Participants who choose to enrol in this study may be randomly allocated by chance (similar to flipping a coin), to receive either MBG453 alone or MBG453 with azacitidine or another available treatment option within the Intercept platform which the TMC has indicated are your best treatment options. MBG453 is given intravenously by itself (treatment A) or in combination with azacitidine therapy administered either intravenously or subcutaneously (injections under the skin, Treatment B). Participants who receive Treatment A will have MBG453 administered as a single 800mg intravenous dose on day 1 of a 28 day treatment cycle for 12 cycles. Participants who receive Treatment B will have daily 75mg doses of azacitidine during the first week of a 28 day treatment cycle and 800mg of MBG453 on day 8. This treatment will also continue for 12 cycles. After 100 days on therapy, participants in Treatment A who are not responding to the single therapy may be re-allocated to Treatment B for another 12 cycles (after rescreening for eligibility). Participants will undergo a disease assessment at screening after cycle 1, cycle 3, cycle 6 and then 3 monthly until progression. This will require blood tests and bone marrow biopsies. Safety and tolerability of treatment will be assessed throughout the trial whilst you are receiving treatment. Health related quality of life during treatment will be assessed on the first treatment day of 3 consecutive cycles. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that MBG453 will be well tolerated and may improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

The purpose of this trial is to compare the visual performance of various spectacle films (test) against films without optical features (control). Visual performance will be assessed with vision testing and questionnaires completed by the participant. The films are made of polycarbonate material and have been designed to provide optical features for the use by people with short-sightedness. It is hypothesized the visual performance of test films will be no different to the control film.

Cardiogenic shock (CS) is a clinical syndrome which is characterised by cellular and tissue hypoxia due to either inadequate oxygen delivery, increased oxygen demand, or a combination of these processes. It may present on a clinical spectrum ranging from occult hypoperfusion (with preserved blood pressure) to fulminant circulatory collapse. For patients presenting with CS, approximately 80% of cases can be attributed to an underlying cause of acute coronary syndrome (ACS). In patients with refractory CS that is not responsive to conventional measures such as fluid resuscitation, inotropic or vasopressor supports and revascularisation, mechanical circulatory support (MCS) can represent a reasonable salvage therapy. To date there is no data assessing the impact of various support modalitites on coronary physiology. We aim to characterise coronary perfusion in the shocked state, comparing and contrasting the impact of various support strategies.

The overall aim of this project is to investigate the feasibility of implementing facial taping via a hybrid model of care (in-person and telehealth) to inform the design of a larger randomized control effectiveness trial. This is a nonrandomised pilot and feasibility study which will consist of two study arms; a treatment arm consisting of participants recruited from GCUH and PAH sites, and a control arm recruited from ACH. Several validated assessment tools will be used to define facial palsy. Recruitment to the treatment arm will be of adults with central facial palsy resulting from stroke who reside within 50km from either tertiary hospital site and meet inclusion criteria; 6-8 speech pathologists working either PAH or GCUH. Following recruitment and consent, baseline assessment will be performed with all participants (treatment arm and control arm). Participants in the treatment arm (and significant others where applicable) will then receive training in the application of facial taping. The facial taping will be applied daily for three weeks with guidance provided by an experienced speech pathologist via a combined telehealth model. The assessment battery will be repeated at the conclusion of the intervention period and at a month following this timepoint. In addition, participants will be interviewed at both post-intervention timepoints. Significant others will also be interviewed at the conclusion of the intervention period. Speech pathologists involved in the care of participants will be invited to participate in a focus group at the end of recruitment. Data collection for the research questions addressed in each study will be undertaken concurrently across a range of focus areas including: - Appropriateness of recruitment methods; - Suitability of assessment tools, data collection procedures, and outcome measures; - Acceptability of assessment and intervention protocols; - Adherence to intervention protocol; - Measurement of health resource utilization and service impact (e.g., cost benefit analysis); - Preliminary impact of intervention on participants. Feasibility outcome measures have been developed from relevant literature. Data will be analysed using a combination of descriptive statistics and qualitative content analysis.

In patients with diseased aortic valves, catheter-based replacement of the sick valve (TAVI) is a less invasive alternative for surgical valve replacement. TAVI has become the procedure of first choice in patients with increased operative risk. Because the valve is implanted through a catheter from the groin, there is no need for open heart surgery and recovery is much quicker. However, there remains a risk of major or life-threatening bleeding from the access site, especially because patients require blood-thinners (heparin) during the valve implantation. At the end of the procedure, when blood-thinners are no longer required, the effect of heparin can be reversed by protamine injection, but routine use of protamine has not been tested in TAVI patients in a randomised trial. In this study we will evaluate if routine use of protamine reduces the risk of major bleeding and improves outcomes for patients who underwent TAVI. We will compare safety and effectiveness of routine use of protamine in a randomised controlled trial and will compare outcomes after 30 days. The results of this study will help to improve the safety of the TAVI procedure and its outcomes for patient (reduced morbidity and mortality) and society (reduced demand on constrained economic resources).

We are hoping to develop an accurate and reliable fetal ECG device. In this application we will examine our fetal ECG device against current technology used, the CTG. We will also examine the accuracy of our device to detect a fetal heart rate over 24 hours. We will compare the accuracy of our device against the Monica device, a fetal ECG available for research purposes.

This trial consists of two parts, 1) an observational part, in which we assess the Vitamin D levels in Australian adults, and 2) an interventional part consisting of Vitamin D supplementation for those with insufficient and deficient levels. A large body of studies have shown Vitamin D levels to be of great importance in the prevention and severity of acute respiratory infections. Vitamin D protects against pathogens including viruses via the innate and adaptive immune system, involving white blood cells and T-cells. It is known, that a large proportion of Australians are Vitamin D deficient, specifically older people. Research has proven Vitamin D supplementation to be a key to alleviate Vitamin D deficiency. In this cross-sectional study, we propose to measure serum Vitamin D levels. If vitamin D deficiency is present, adequate supplementation will be provided, and a follow-up blood test scheduled. In addition, we will assess the frequency of respiratory infection in relation to Vitamin D levels, and before and after supplementation.

Adolescent sleep health is, or lack of, is slowly becoming more recognised as a widespread health issue. Many adolescents are not achieving the recommended sleep time of at least 8 hours each night. This study will therefore look at the potential for a brief gratitude intervention to reduce sleep onset latency in adolescents through reducing negative pre-sleep arousal.

With a large proportion of people with mental ill-health not engaged with professional services, the role of providing care to these individuals often sits with relatives, friends and social networks. Researchers commonly referred to these individuals as ‘carers’. The most recent data estimates showed that the number of Australians who identified as informal carers of someone living with a mental health condition was between 225,421 and 1.5 million people (Diminic, Hielscher, Lee, Harris, Schess, Kealton & Whiteford, 2016). Based on these number estimates, carers make a significant contribution to the Australian economy in terms of lowering Government health expenditure. Therefore, keeping carers healthy not only makes humane sense but also good economic sense. While caring can be very rewarding, carers also experience higher mental ill-health, depression, and anxiety rates than non-carers (Foster 2011; Butterworth et al., 2010; Aggar, 2016). Other risk factors for carers include financial hardship, reduced education and employment opportunities and social isolation (Aggar 2016; Berecki-Gisolf, Lucke, Hockey & Dobson, 2008; Broady & Stone, 2015). Mental health focussed supports for carers to date typically target carers of people with conditions such as cancer, dementia, and diabetes. While some interventions have been developed for health carers specifically, they usually require the care recipient to have a formal diagnosis of a condition, such as bipolar, schizophrenia and depression. This is despite evidence of challenges associated with symptoms of depression or anxiety that do not meet the threshold for diagnosis. Recent studies highlight the benefits of online carer interventions and their capacity to improve self-efficacy, self-esteem, and feelings of depression (McKechnie, Barker and Stott, 2014). Results from these studies have also demonstrated the many advantages of online support compared to face-to-face interventions such as ease of accessibility, time convenience, physical convenience and a lack of stigma relating to professional help-seeking (White, 2001). However, a systematic review of the literature did not identify any evidence-based interventions for people supporting someone with symptoms of depression or anxiety. The following study builds on a previous feasibility study that aimed to explore the feasibility and acceptability of the online program. This two-arm full-scale RCT will assess carers' clinical outcomes in the program condition, compared to the program paired with the social forum condition. Specifically, the study will assess carer burden, coping self-efficacy and social connectedness and compare participants outcomes in each condition, across three time points (baseline, post and 3-month follow-up). The study will also measure the economic value of the program alone compared to the program paired with the social forum.

With a large proportion of people with mental ill-health not engaged with professional services, the role of providing care to these individuals often sits with relatives, friends and social networks. Researchers commonly referred to these individuals as ‘carers’. The most recent data estimates showed that the number of Australians who identified as informal carers of someone living with a mental health condition was between 225,421 and 1.5 million people (Diminic, Hielscher, Lee, Harris, Schess, Kealton & Whiteford, 2016). Based on these number estimates, carers make a significant contribution to the Australian economy in terms of lowering Government health expenditure. Therefore, keeping carers healthy not only makes humane sense but also good economic sense. While caring can be very rewarding, carers also experience higher mental ill-health, depression, and anxiety rates than non-carers (Foster 2011; Butterworth et al., 2010; Aggar, 2016). Other risk factors for carers include financial hardship, reduced education and employment opportunities and social isolation (Aggar 2016; Berecki-Gisolf, Lucke, Hockey & Dobson, 2008; Broady & Stone, 2015). Mental health focussed supports for carers to date typically target carers of people with conditions such as cancer, dementia, and diabetes. While some interventions have been developed for health carers specifically, they usually require the care recipient to have a formal diagnosis of a condition, such as bipolar, schizophrenia and depression. This is despite evidence of challenges associated with symptoms of depression or anxiety that do not meet the threshold for diagnosis. Recent studies highlight the benefits of online carer interventions and their capacity to improve self-efficacy, self-esteem, and feelings of depression (McKechnie, Barker and Stott, 2014). Results from these studies have also demonstrated the many advantages of online support compared to face-to-face interventions such as ease of accessibility, time convenience, physical convenience and a lack of stigma relating to professional help-seeking (White, 2001). However, a systematic review of the literature did not identify any evidence-based interventions for people supporting someone with symptoms of depression or anxiety. The following study explores the feasibility of a Randomised Controlled Trial (RCT) comparing online support for carers of people with depression/anxiety to a waitlist control. The study also explores participant acceptability of the Minds Together program. Feasibility was assessed using adherence and attrition rates. Acceptability was assessed using participant feedback through surveys and interviews. The study also explored the effects of the program on carer burden and coping self-efficacy.