ANZCTR search results

The time from when a heart is removed from a brain dead organ donor and transplanted into a recipient is known as the ischemic time. This is a critical period of time since the donor heart is not receiving any blood supply, oxygen or nutrition and if the ischemic time becomes prolonged (beyond approximately 4 to 6 hours), the heart may be damaged to the point that it does not work well in the recipient (known as primary graft dysfunction). For the last 50 years of heart transplantation, transportation of the heart during the ischemic time involves stopping the heart by paralysing it chemically and then putting it in ice slush to cool it down and reduce its energy requirements, a technique known as cold static storage (CSS). Recent advances in donor heart preservation have led to the development of a mechanical perfusion system called non-ischemic heart preservation (NIHP). With this system, during the ischemic time, the heart can be continuously perfused with a solution containing hormones, oxygen and some nutrition. Protecting the donor heart using NIHP substantially increases the ischemic time while minimizing the risk of primary graft dysfunction. The aim of the current trial is to investigate the effectiveness of NIHP to increase the ischemic time of donor hearts to 6 to 8 hours. Findings from this study may demonstrate that NIHP is beneficial in preventing primary graft failure. Additionally, countries the size of Australia and New Zealand where donor hearts are often declined because the ischemic time is unacceptably long, NIHP of the donor heart may allow longer ischemic times and hence increase donor heart availability.

The purpose of this study is to test the feasibility of a care model involving haematologists and GPs for lymphoma follow-up care. Who is it for? You may be eligible for this study if you are aged 18 or older, and have lymphoma. Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will receive standard follow-up (haematologist-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 haematologists for up to 2 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 feasibility and usefulness of the new model of care which could influence future lympjhoma follow-up care.

Seasonal influenza infection is a significant cause of morbidity and mortality which can be prevented by vaccination. Notably, pregnant women and babies under 6 months are at significant risk of hospitalisation and adverse health outcomes if infected with influenza. In a retrospective audit, seasonal influenza vaccination rates in pregnant women at the Centenary Hospital for Women and Children at the Canberra Hospital were found to have increased from 35% in 2017 to 79.8% in 2017 with the introduction of a mandatory field in an electronic health record. This study aims to investigate compliance of pregnant women with seasonal influenza vaccination rates at the Centenary Hospital for Women and Children during the Covid-19 pandemic using a follow-up audit.

This purpose of this study is to determine a safe dose for GQ1001 in patients with HER-2 Positive Advanced Solid Tumors Who is it for? You may be eligible to join this study if you are aged 18 years and older, and have pathologically documented solid tumor with HER2 expression Study details All participants in this study will receive the study drug (called GQ1001). There will be 5 groups of patients who each receive a different dose. The drug will be given once intravenously (through the vein) on Day 1 of a 21-day cycle. Participants will be monitored for reactions and treatment effectiveness, and provide blood and urine for analysis. It is hoped that this research will improve the health outcomes of patients with HER2-positive advanced solid tumors.

This study is a randomised controlled trial investigating whether response to TBS can be substantially enhanced through the application of TBS at an individualised frequency. We hypothesised that treatment with an individualised TBS (Ind TBS) protocol will result in greater improvement in depressive symptoms, compared with standard TBS. So we will compare an individualised TBS intervention to standard TBS to evaluate its relative effectiveness in regards to antidepressant effects. Participants will take part in assessments of depression severity before, during and after four weeks of TBS and at another follow-up review at week 8. They will receive a course of 20 treatments of either Ind TBS or standard TBS. All assessments and treatments will take place at Epworth Camberwell.

This study will investigate the psychological impact on healthcare workers who work in the operating theatre environment during the COVID-19 pandemic. This is an important study because operating theatre staff are frontline healthcare professionals, who are working under enormous pressure during this challenging time. There is potentially a significant risk of mental health burden as a result of the pandemic. This study will help to identify any risk factors which may be associated with worse psychological outcomes. This study is a time-series online survey. Participation is voluntary. Data collected are anonymous and unidentifiable. The survey will be repeated every 4 weeks until the end of the pandemic or for 8 months from commencement, whichever is the sooner. Psychological support strategies will be provided to each individual at the end of each survey in the form of written information.

Metacognitive training (MCT) targets ‘thinking errors’ underlying different forms of mental illness and is effective at reducing symptom severity in people with psychosis, depression, borderline personality disorder, and obsessive-compulsive disorder. Importantly, the literature suggests that MCT is not only effective at reducing the severity of a diverse range of psychiatric symptoms (e.g., delusions, depressed mood, compulsive thoughts), but that participants consistently report that the training is engaging, with high applicability to daily life and low attrition rates. However, the approach has not yet been applied to people with anorexia nervosa (AN), despite the high prevalence of ‘thinking errors’ in this population (e.g., belief inflexibility; weak central coherence or difficulty seeing the ‘forest for the trees’). MCT may be particularly beneficial to adolescents with AN, as it aims to improve cognitive flexibility in a non-confrontational manner by targeting the biased thinking styles that contribute to disordered eating symptoms. This project, the first randomised controlled trial to investigate MCT in individuals with eating disorders, specially aims to: 1) determine the feasibility of the MCT programme for adolescents with anorexia nervosa (e.g., subjective evaluation of the programme’s effectiveness and applicability to daily life). 2) determine the therapeutic benefit of MCT for adolescents with AN when added to an inpatient refeeding program, including eating disorder symptom severity (e.g., concerns about weight, shape, and eating). 3) generate knowledge of the psychological processes that contribute to the onset and maintenance of AN (e.g., belief inflexibility, perfectionism). By developing a greater understanding of the psychological processes responsible for disordered eating, this project is expected to improve current models for preventing and treating this serious mental health condition. As the study is a feasibility trial, we are primarily interested in the qualitative feedback participants in the MCT condition provide. We are also interested in group (MCT/control) differences across several secondary measures. We hypothesise that the MCT group will experience greater improvements on biased thinking styles associated with eating disorders (e.g., improved cognitive flexibility, lower perfectionism) and greater increases in global eating disorder psychopathology than the control group at 3-month follow-up.

The pathophysiology of ARDS and sepsis involves a dysregulated response of the immune system to infection. NET-associated proteins, particularly histones play very important role and cause significant tissue damage, which correlate highly with death as an outcome. Our hypothesis is to use STC3141 to neutralize the extracellular histone/NETs. Continuous infusion STC3141 up to 5 days while the patients are on ventilators in ICU compare to standard care.

This randomised control trial (RCT) will examine how an increase in the consumption of dietary fibre, in the form of BarleyMax, affects body composition (including weight loss) and health in overweight and obese individuals. This study will be conducted at QUT and recruit 150 males and females aged 18-50 years old, who will be randomly assigned to one of three conditions at study entry: (1) Receive daily servings of 32 grams of additional fibre for 12 weeks. (BARLEYsupermax condition); (2) Receive daily servings of 16 grams of additional fibre for 12 weeks (BARLEYmax) or (3) Receive 16 grams of placebo product (control). The primary outcome measure for this project is body composition changes (body weight, fat mass, fat distribution, Body Mass Index (BMI), waist to hip ratio (WHR), Blood pressure (BP) and waist circumference). Secondary outcome measures will include biological factors including the gut microbiome, blood analytes relevant to health outcomes, quality of life, appetite, satiety, gastrointestinal discomfort and assessment of facilitators and barriers to completing the intervention programme and its acceptability. All outcome measurements besides those taken from interviews will be performed at baseline, then repeated at the end of the 12 weeks intervention. This RCT aims to examine how an increase in dietary fibre (in the form of BarleyMax) in an ad libitum diet affects body composition (including weight loss) and blood indicators relevant to chronic disease outcomes in obese and overweight individuals. Two recent systematic reviews and meta-analysis both argue that more research is required to examine the efficacy of increased fibre on body composition with studies required of longer duration (> 8 weeks) and higher daily doses (> 30 grams day) (Reynolds et al., 2019; Jovanovski et al., 2020).

The proposed study is a non- blinded, randomised, cross-over trial to be conducted at John Hunter Children's Hospital, Newcastle under free living conditions. The aim of this study is to determine if a smartphone insulin bolus calculator, “OptimAAPP” which calculates insulin for carbohydrate, fat and protein improves glycaemia in people with type 1 diabetes (aged 12- 18 yrs) in comparison to usual care (insulin dosing for carbohydrate only). Participants (n= 48) will be randomised to use OptimAAPP to calculate their meal- time insulin doses or continue to use carbohydrate counting to calculate their meal- time insulin doses (usual care) for 3 months and then cross-over to the alternate condition. To assess the relative efficacy of each method of insulin dosing in managing glycaemia participant interstitial glucose levels will be measured remotely using a continuous glucose monitor for six- non continuous weeks (3 weeks/study arm).