ANZCTR search results

Background Over half of all COPD patients suffer from poor sleep quality which is a major contributor to their reduced quality of life. There is currently a lack of understanding as to the mechanisms underlying poor sleep in COPD. Our pilot data show that more severe hyperinflation is correlated with worse sleep quality in COPD. This suggests that hyperinflation is a novel target for treating poor sleep quality in COPD. Hyperinflation compromises ventilation during sleep in two ways. Firstly, hyperinflation increases the work of breathing because gas trapping imposes a pressure load that must be overcome during inspiration (intrinsic positive end-expiratory pressure, iPEEP). Secondly, hyperinflation comprises diaphragm function, which is the predominant inspiratory muscle during sleep. Half of all patients with chronic obstructive pulmonary disease (COPD) suffer from poor sleep which is a major contributor to their reduced quality of life. However, current treatments focus on sleep apnoea and therefore do not address poor sleep for the majority of COPD patients. In COPD, the destruction of lung tissue leads to gas trapping and hyperinflation, a condition in which patients breathe at abnormally high lung volumes. Hyperinflation reduces the function of the diaphragm, the predominant muscle of breathing during sleep. This means that lung function in COPD patients is particularly vulnerability during sleep. Non-invasive ventilation, in which external pressure is applied to the lung to improve breathing, may reduce hyperinflation in patients with COPD. Therefore, we will determine the effect of ventilator settings on hyperinflation and determine the effect of optimal ventilator settings on sleep quality.

This study aims to find out how well using immunotherapy on its own before starting standard chemotherapy, or starting treatment with immunotherapy at the same time as standard chemotherapy, helps to reduce tumour size before surgery in patients with previously untreated early stage triple negative breast cancer. Who is it for? You may be eligible for this study if you are 18 years or older and have been diagnosed with triple negative breast cancer that is potentially operable and has not spread to other parts of your body. Tumour block/sections from the initial diagnostic core biopsy must be available. Trial Details: Arms A & B (completed recruitment in April 2022) Participants will be randomised 1:1 to either: Arm A: Nivolumab only for 2 weeks, followed by Nivolumab + Carboplatin + Paclitaxel for a further 12 weeks, followed by surgery. Paclitaxel is given weekly; Nivolumab and Carboplatin are given every 3 weeks for 4 cycles. Arm B: Nivolumab + Carboplatin + Paclitaxel for 12 weeks. Paclitaxel is given weekly; Nivolumab and Carboplatin are given every 3 weeks for 4 cycles. After 12 weeks, there will be a further 2 weeks of treatment with Nivolumab only, followed by surgery. All treatments are administered intravenously. The following biological samples will be collected: * Tumour biopsy at diagnosis, after Nivolumab monotherapy lead-in (Arm A) or before Cycle 2 (Arm B), and from the surgical specimen should invasive residual disease remain. * Blood samples at Baseline (before the first dose of study treatment), after Cycle 1 (Arm A) or after Cycle 2 (Arm B) and at the End of Treatment Visit. Arm C: Nivolumab + Relatlimab only for 2 weeks, followed by Nivolumab + Relatlimab (together) + Carboplatin + Paclitaxel for a further 12 weeks, followed by surgery. Paclitaxel and carboplatin are given weekly; Nivolumab + Relatlimab are given every 3 weeks for 4 cycles. You are recommended to continue Nivolumab after surgery every 4 weeks for 9 cycles where pembrolizumab is not available. All treatments are given intravenously. The following biological samples will be collected: * Tumour biopsy at diagnosis, after 2 week lead-in, and from the surgical specimen should invasive residual disease remain. * Blood samples at Baseline (before the first dose of study treatment), after Cycle 1, before surgery, 2-4 weeks after surgery, at the End of Treatment Visit, and 6 months, 12 months after registration and at each Survival Follow up Visit.. All participants (Arms A, B & C) will be regularly monitored throughout treatment to evaluate their health. There will be an end of treatment visit 30 days after surgery. Follow-up visits will occur every 6 months after surgery for up to 3 years post-randomisation. Further treatment will be at the discretion of the participant and their treating clinician. It is hoped this research will provide new treatment options for people with triple negative breast cancer.

The aim of this project is to determine if there is a difference in microbial community between responsive and non-responsive sites. A secondary aim is to determine if there is a difference in microbial community between responded and healthy sites. The objective is to establish the microbial community profile associated with sites that respond poorly to periodontal treatment. The specific hypothesis tested is whether certain subgingival microbial profiles are associated with poor response to periodontal treatment in a prospective longitudinal clinical study in a Melbourne population. Achieving the above aim may assist with a better understanding of the polymicrobial aetiology of chronic periodontitis and its effect on treatment. The establishment of a microbial community profile associated with sites that respond poorly to periodontal treatment may allow for the pre-operative identification and allow more targeted treatment of these sites.

This study will be a Phase IIB trial to look at the safety, tolerability and acceptability of the off-licence use of Dornase alfa into the ear post-ventilation tube insertion ("grommets") in children with chronic otitis media with effusion ("glue ear") and recurrent acute otitis media. We believe that DNA plays a role in maintaining an infectious reservoir in which bacteria can form biofilms and be protected from clearance from the middle ear space. Targeting this DNA scaffolding may improve bacterial clearance from the middle ear and render those bacteria present more susceptible to antimicrobial treatments and the host immune response. From earlier research in our laboratory, we expect that Dornase alfa will help to increase effectiveness of treating middle ear infections and stop new infections from occurring. This would help reduce the number of children who need to have repeat grommet surgeries.

The iCOMP collaboration aims to perform a systematic review and network meta-analysis, using individual participant data, of trials that have assessed different cord management strategies at preterm birth, e.g. delayed cord clamping, cord milking, etc. We are bringing together all completed, ongoing and planned trials on this topic to synthesise all the available data. This work will be crucial in identifying optimal cord management strategies for key subgroups of preterm infants.

Blood sampling to inform decision making is an important aspect of intensive care. Repeated blood sampling either via phlebotomy or VADs can result in blood wastage and contamination, which can lead to iatrogenic anaemia and systemic infection. A range of clinical practice strategies and technologies (including closed-loop system) exist to facilitate safe and conservative arterial sampling, but their impact on blood sampling volumes and infection outcomes has not been rigorously tested. The aim of this study is to test the feasibility of conducting a randomised controlled trial (RCT) to evaluate the impact of a closed-loop blood sampling system on infection outcomes and blood sample volumes. The main outcomes of interest are larger trial feasibility, changes in blood sample volumes and infection outcomes. Preventing hospital acquired complications is a priority area in modern healthcare.

Depression is a common and serious complication after stroke with extensive implications for mental health, functional recovery and health service utilisation (Hackett and Pickles, 2014). Pharmacological therapy has no clear effect on prevention or treatment of post-stroke depression (Hackett et al., 2008), suggesting alternative approaches are required. One novel intervention generating interest is non-invasive brain stimulation (NIBS), with studies reporting some beneficial effects of stimulating hypoactive frontal brain regions; the dorsolateral prefrontal cortex (DLPFC) (Shiozawa et al., 2014). However, few studies have been conducted in people with post-stroke depression so we do not know if this is a viable therapy. We primarily aim to investigate whether NIBS improves post-stroke depression in a pilot RCT

Only a small proportion of available mental health apps have any research backing up claims of efficacy. The present research will use a methodology that will provide timely results using a rigorous scientific process in a manner that can potentially offer valuable information prior to running larger randomised controlled trials, and/or enrich the results of larger randomised controlled trials. This research will also add to the paucity of independent research that currently exists in this area, something that has been called for in the literature. This research is important, because the advent of efficacious mental health apps has the following potential benefits: portability and accessibility (having immediate access to help any time); a convenient way of doing homework activities from face-to-face sessions; ability to set reminders for any number of things, e.g. taking medication; people on waiting lists for face-to-face services may be able to get help via a mobile app; increased anonymity; improved access to treatment for people in rural and remote areas; access difficult to reach groups such as teenagers; and reduce the burden on primary care health services. Research questions/aims/objectives/hypothesis: 1. Do the apps in this study provide clinically significant improvements in symptoms of anxiety and/or depression? 2. What individual characteristics of participants influence the results in this regard? 3. Are there any characteristics of the apps themselves that may influence the results? We will examine a total of five mental health apps for their effectiveness in reducing symptoms of anxiety and/or depression. All apps have published evidence of their effectiveness in peer-reviewed journals, and all five are freely and publicly available in the major app stores for both iOS and Android devices.

This study seeks to show that Remission of T2D may be achieved by following a VLCD combined with lifestyle education over a 1 year period. Participants will undergo a meal replacement diet (VLCD) for 3 months with a gradual reintroduction to healthy eating. This will be done under the care of an Endocrinologist, dietitian and diabetes nurse. It is expected that participants will have an improvement in glycemic control with some achieving diabetes remission, leading to a reduction or cessation in diabetes medications after completion of the 1 year study

The aims of this pilot study are to investigate the feasibility and efficacy of an eHealth program in 20 participants with diabetes with clinically symptomatic diabetic sensory polyneuropathy (DSPN). The e-Health program uses a smartphone app that collects data from a wrist-worn heart rate monitoring device and calculates a weekly Physical Activity Intelligence (PAI) score. PAI is an innovative, scientifically valid and easily understood metric that informs individuals about the quantity and intensity of physical activity needed to obtain or sustain good health. The primary aims of this study were to investigate the feasibility, acceptability and safety of the PAI e-health program in people with DPN. The secondary aims were to explore the clinical impact of the PAI e-Health program on physical activity, sleep and symptoms including the intensity of DPN symptoms and quality of life. It was hypothesised that participants who attended the program would be satisfied with the e-health program and PAI technology, be able to achieve health-enhancing levels of physical activity and not experience major adverse events.