ANZCTR search results

Evidence supports the use of intra-operative antiseptic rinse in breast implant surgery to minimize the risk of capsular contracture or other complications. However, there is limited consensus or standardization of antiseptic rinse in practice. Having already determined contemporary trends in antiseptic rinse use in primary breast device surgery in Australia, we will use observational Australian Breast Device Registry (ABDR) data to analyse antiseptic rinse effects on clinical outcomes.

Bowel management in the Intensive Care Unit is a generally overlooked issue. Both constipation and diarrhoea appear common in critical care patients. Their causes are multi-factorial and associated with adverse outcomes. In the intensive care unit at the Austin Hospital, two approaches to bowel management are typically used and are reflective of practice in other intensive care units worldwide. These two approaches are either an ‘early aperient use’ or a ‘delayed aperient use’ approach. However, the evidence to support either approach is not of high-quality. Thus, clinicians remain uncertain about which approach is best for critically ill patients. In response, we will perform a single-centre, cluster double crossover trial. We will include all adult patients (aged 18 years or older), who are receiving mechanical ventilation and are enterally fed via a feeding tube. Over a 12-month period, that includes four 3-month treatment periods, pods within the intensive care unit will be allocated to regimen of 'early aperient use' commencing on day 1 of admission or to a 'delayed aperient use' regimen commencing on day 6 of admission. We estimate that 880 patients will be included in the trial. Data collected for this trial will be that of standard routine care data extracted from electronic data sources. Research findings will be used to help reduce practice variation and may be used to inform the design and conduct of future ethically approved research in the area of bowel management for critically ill patients.

Hepatitis B virus (HBV) infection is one of the most common infectious diseases in the world, with nearly 300 million people chronically infected worldwide. Chronic HBV infection can lead to serious complications such as cirrhosis, liver failure, hepatocellular carcinoma (HCC), and death. Approximately 820,000 people die every year due to consequences of CHB. Hepatitis delta virus (HDV) is the causative agent of chronic hepatitis delta (CHD), the most severe form of viral hepatitis. Infection with HDV is dependent on the presence of HBV infection, as it uses HBV encoded envelope proteins (HBsAg) for infection and replication HDV infection can occur either simultaneously with HBV or, more commonly, as a superinfection in patients already chronically infected with HBV. Relative to CHB infection alone, CHD co-infection is associated with more severe liver disease, causing faster progression to cirrhosis, hepatocellular carcinoma, and liver failure. Developing therapeutic strategies that deplete HBsAg levels, like monoclonal antibodies, may play a role in future regimens targeting functional cure. There is a clear need for additional treatment for CHD, particularly agents that improve response rates, are better tolerated, and simpler to administer than currently available treatments. BlueJay Therapeutics has developed BJT-778, which has the potential to provide anti HBV and anti HDV benefits by neutralizing and clearing HBV and HDV virions as well as by depleting HBsAg containing subviral particles, which may help reconstitute HBV-specific immunity and contribute to functional cure for CHB. BJT-778 is a potent, selective neutralizing monoclonal antibody for the treatment of CHB and CHD. This study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of multiple doses of BJT-778 in participants with Chronic HBV Infection (CHB).

Regular exercise helps people with chronic obstructive pulmonary disease (COPD) to remain independent, stay out of hospital and live longer. However, current COPD clinical guidelines don’t provide clear, evidence-based recommendations around what intensity people with COPD should exercise at. Recommendations provided are based on healthy adults and don’t consider the limitations to breathing and high levels of breathlessness experienced by people with COPD. This may mean people with COPD exercise at intensities too high, causing intolerable breathlessness and negative exercise experiences, or too low, not eliciting health benefits. This study will evaluate the benefits of using respiratory-specific parameters to guide exercise prescription in COPD. We will compare the benefits of three, 6-week exercise training groups: (1) usual care, defined as 25 minutes of continuous cycle exercise at a breathlessness intensity of 3 (moderate) to 5 (severe) on Borg's 0-10 category ratio scale; (2) 25 minutes of continuous cycle exercise based on respiratory-specific parameters; (3) high intensity interval exercise training (HIIT, 4 lots of 4 minute exercise periods, interspersed with 3 minute rest periods) based on respiratory-specific parameters. Specifically, this study aims to answer two research questions: 1. Do people with COPD achieve greater adherence and health benefits from 6 weeks of continuous exercise prescribed based on respiratory specific parameters compared with current exercise training practices (usual care)? 2. Is it safe and feasible for people with COPD to perform HIIT prescribed based on respiratory specific parameters, to further maximise health benefits from an exercise training program?

Lung health is mostly measured by “blowing tests”, known as spirometry. These types of tests can give useful information about lung health, but they can’t show exactly where in the lung any disease may be present. Other tests like computed tomography (CT) can give doctors useful and detailed information about the structure of the lungs, but this is different information to measuring how the lung is actually working as you breathe. We are trialing a new test called XV LVAS which will show how well different areas of the lung are working. This test is not currently approved for use in children but might help doctors to treat conditions like cystic fibrosis. We are recruiting children with healthy lungs and children with cystic fibrosis and other chronic lung diseases to decide if this test should be used with other lung tests to help doctors treat lung diseases like cystic fibrosis.

This study aims to assess a new cancer drug, GRWD5769, in patients with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have a cytologically or histologically confirmed locally advanced or metastatic solid malignancy not considered for further treatment, and have progressive disease after treatment with other agents. Study details All participants will receive treatment with GRWD5769. After an initial single dose, GRWD5769 will be administered as an oral capsule throughout the study twice a day. Treatment will continue until participants withdraw from the study or their disease progresses. During the treatment period, participants will undergo study visit for screening and an initial confinement period commencing up to 2 days prior to the first dose until Day 2 of Cycle 1 (minimum of 2 nights). Further confinement periods are required for assessments on Day 14 & 15 of Cycle 1. Participants will also undergo imaging every 56 days for the duration of the study to assess for their response to treatment. It is hoped that this study will show that GRWD5769 is safe, tolerable, and effective for the treatment of advanced solid cancers. This study will also help to define the dose of GRWD5769 that may be used for treatment of similar individuals in future.

This is a prospective observational cohort study seeking recruitment of up to 150 SARS-CoV-2 positive individuals within the Alfred Hospital care pathway. Study participants will have a clinical encounter across two timepoints, the first time point occurring within 5 days after testing positive for COVID-19 (acute-phase) and the second time point occurring when negative; at least 3 weeks after testing positive for COVID-19 (convalescent phase). Study participants will provide two swabs at the acute-phase encounter and two swabs at the convalescent-phase encounter. Each swab is used to obtain an oropharyngeal (throat) and bilateral mid-turbinate (nasal) sample (i.e., combined throat and nasal swab). Samples will be self-collected. All samples will be labelled with a Participant ID number, date of collection and year of birth, but will not have any other identifying information. The samples will be used for optimisation and clinical validation of the ZiP-CoVx-P2 point-of-care test platform. For both study visits; one swab sample will be used for the test under evaluation (ZiP-CoVx-P2 test) and the other swab will be used for gold-standard comparator test (laboratory-based RT-qPCR) analysis. This study will help to optimise and undertake clinical validation of the new ZiP-CoVx-P2 test, including estimates of test sensitivity and specificity. The negative swabs collected in the convalescent phase will be used as a control for sample related variables, thus aiding the assessment of test specificity.

Hepatitis B virus (HBV) infection is one of the most common infectious diseases in the world, with nearly 300 million people chronically infected worldwide. Chronic HBV infection can lead to serious complications such as cirrhosis, liver failure, hepatocellular carcinoma (HCC), and death. Approximately 820,000 people die every year due to consequences of CHB. Hepatitis delta virus (HDV) is the causative agent of chronic hepatitis delta (CHD), the most severe form of viral hepatitis. Infection with HDV is dependent on the presence of HBV infection, as it uses HBV encoded envelope proteins (HBsAg) for infection and replication HDV infection can occur either simultaneously with HBV or, more commonly, as a superinfection in patients already chronically infected with HBV. Relative to CHB infection alone, CHD co-infection is associated with more severe liver disease, causing faster progression to cirrhosis, hepatocellular carcinoma, and liver failure. Developing therapeutic strategies that deplete HBsAg levels, like monoclonal antibodies, may play a role in future regimens targeting functional cure. There is a clear need for additional treatment for CHD, particularly agents that improve response rates, are better tolerated, and simpler to administer than currently available treatments. BlueJay Therapeutics has developed BJT-778, which has the potential to provide anti HBV and anti HDV benefits by neutralizing and clearing HBV and HDV virions as well as by depleting HBsAg containing subviral particles, which may help reconstitute HBV-specific immunity and contribute to functional cure for CHB. BJT-778 is a potent, selective neutralizing monoclonal antibody for the treatment of CHB and CHD. This study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of BJT-778 in participants with Chronic HBV Infection (CHB) and Chronic HDV Infection (CHD).

This is a multicentre Phase I clinical trial to establish if Deflexifol is safe and effective in children, adolescents and young adults with recurrent or refractory brain tumours. Who is it for? Participants may be eligible for this study if they are older than 12 months and up to 21 years old and have a recurrent or refractory brain tumour; or newly diagnosed diffuse intrinsic pontine glioma (DIPG) or diffuse midline glioma (DMG) participants after completion of radiotherapy. Study details Participants will receive Deflexifol every 2 weeks for up to approximately one year, if there is ongoing clinical benefit. Deflexifol will be administered via an injection over 3-5 minutes (bolus), followed by a continuous intravenous infusion over 46 hours. Pharmacokinetics will be measured during the first 4 weeks and safety will be assessed throughout the course of treatment and during follow up visits. Participants will have physical examinations, blood tests, urine tests, echocardiogram, electrocardiogram (ECG) and MRI scans. This study will test the safety and effectiveness of this new drug in children and adolescents in cases where treatment options are limited.

Problem: Goals of Australian antenatal education include promoting appropriate parenting, enhancing parental capacities for relationship with their child and supporting parents with their preparation. Although many programs exist there has been limited examination of effectiveness. Background: ‘Bringing Baby Home’ (BBH) is one such program. Designed as antenatal education, the US developers’ 2005 randomised control ‘efficacy’ study demonstrated benefit on multiple measures at 12 months post-birth. Aim: In the original study participants were American. While that study demonstrated very positive workshop outcomes, in that study the workshop was run by its creators who are recognised world experts, supported by their research team. The current study was run to see if the workshops were still effective when run by a general antenatal educator with no additional back-up, and delivered to Australian rather than US participants.. The current study also had longer follow-up than the original. Methods: 60 couples attending a suburban public hospital maternity service were randomised to either a) the then-standard antenatal education program or b) standard program + BBH workshop. Measures were self-report surveys used in the US study, collected on recruitment and time points up to 8-10 years later.