ANZCTR search results

The main objective of this study is to evaluate the safety and feasibility of the OcuDyne Ophthalmic Micro Balloon Angioplasty System in subjects with dry age-related macular degeneration (AMD). Currently there is no treatment available for dry AMD and this device system may offer a potentially effective treatment. The study is first in human and is a prospective, open label, feasibility clinical trial. This multi-center trial will be conducted at up to six sites in Australia and aims to enroll and treat up to 30 subjects. This study involves a 60 day screening period, study procedure, overnight observation, and follow-up visits (Day 2, Week 1, Week 4, Months 3, Months 6). The study duration for each participant is approximately 8 months. The feasibility of the procedure is presented due to the historically successful use of small artery cerebral angioplasty and ophthalmic artery (OA) angioplasty for acute ischemic retinopathy using like instrumentation. The OcuDyne #OC-1901 project is an effort to confirm the feasibility of establishing the presence of OA ostium narrowing intraoperatively and further, to establish the ability to treat the condition of dry AMD.

Healthcare providers may be vulnerable to psychological trauma in the aftermath of an adverse critical clinical incident, particularly if it is associated with a poor patient outcome. This may be especially evident amongst the medical fraternity, who often lead the management of the acutely deteriorating patient, and there is evidence of stress within this cohort in the literature, and the need for upstream preparation. This project will involve interviewing experienced intensive care doctors about adverse critical clinical incidents whereby patient management was potentially compromised secondary to human error. The aims of the interview will be to explore the impact of the events on them, in terms of their thoughts and feelings and also to explore the coping mechanisms they applied to enable them to emerge from the event with some deeper understanding and resolution. These personal recounts will be transcribed, reviewed and qualitatively analysed in order to identify common human factor gaps in clinical management during adverse critical clinical incidents, and the manner in which the personal effects of these events were mitigated. Results will inform the development of a framework of human factor training, possibly utilising simulation-based training that will aid in the upstream preparation of future critical care doctors.

Better Together will investigate the processes and outcomes of a group-based, peer-led mental health self-stigma program across multiple mental health settings. The objectives of the trial are as follows: Primary objective 1) Guided by the Consolidated Framework for Implementation Research (CFIR), identify the characteristics of the intervention, outer and inner settings, individuals and processes that influence the implementation of peer work roles using qualitative methods. Secondary objectives 2) Using qualitative methods and checklists of adherence, establish the feasibility, acceptability, fidelity and sustainability of peer worker roles in three diverse mental health settings. 3) Examine the service level outcomes of the implementation of peer workers: safety, person-centeredness and effectiveness, using qualitative methods. 4) Evaluate the effect of the peer-delivered Honest, Open, Proud Program on individuals’ self-stigma, empowerment, recovery, quality of life and satisfaction with services using both qualitative and quantitative methods. Whilst the trial is primarily exploratory, , we hypothesise that the Honest, Open, Proud Program will reduce participants' perceptions of self-stigma, and improve their perceptions of their own empowerment, recovery, quality of life and satisfaction with services. "Honest, Open, Proud" is a peer-led self-stigma reduction program, developed by renowned mental health consumer and principal investigator on the National Consortium for Stigma and Empowerment, Professor Patrick Corrigan. The program focuses on identity and disclosure as a means for reducing internalised stigma and promoting empowerment. "Honest, Open, Proud" peer facilitators guide participants through a workbook and activities that explore whether they identify as someone with a mental illness (or other similar terms), the pros and cons of disclosure and how to construct their story in a way that is safe for everyone if they do choose to disclose, particularly if they choose to be completely open such as through public speaking. The program will be delivered face-to-face, in a small group of approximately 8 participants. The delivery format is delivered in 3 x weekly 2-hour sessions, plus a 2-hour ‘booster’ session approximately 3-4 weeks later. Total participation time, including program sessions, outcome measures and the feedback session is approximately 10-12 hours across 8 weeks.

The is a pilot trial to test this initial prototype of the Shift app. We intend for 30 Junior Medical Officers (JMOs) to use the app for a period of 30 days. Using baseline and follow-up questionnaires and app usage data, the app’s usability, feasibility, and acceptability will be examined. The results from this pilot study will enable us to modify and optimise the app as necessary prior to testing its effectiveness in reducing depression in a large-scale randomised control trial.

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.