ANZCTR search results

Patients who are planned to undergo bariatric surgery will typically undertake a Very Low Calorie Diet (VLCD) for two weeks prior to surgery to reduce the size of the liver and improve intraoperative laparoscopic access. VLCD are effective as they create a state of Ketosis. Ketosis leads to an unpleasant taste in the mouth and patients often struggle with this symptom whilst they are on the diet and can be one reason that they are not compliant with the treatment. We have chosen this group to study rather than our gastroparesis and post-surgical patients as there are currently no other effective treatments that can be offered. We propose a double blinded randomised controlled trial to test the effectiveness of enterically delivered peppermint oil (Breath Pearls™) to improve the perception of breath quality for patients who are on a VLCD. If this trial confirms that patients have the perception of improved breath quality, we will plan to further investigate the mechanism by which this occurs and also extend the study to other cohorts that may benefit from this treatment.

For people with sleep and breathing problems, wearing a breathing machine and mask (non-invasive ventilation, NIV) when sleeping makes them less sleepy during the day and helps them have a better quality of life. Our team led research showing that using NIV when sleeping reduces the rate of decline in breathing function and can improve the life expectancy in people with Motor Neurone Disease. Motor Neurone Disease (MND) is a rare progressive terminal neurological disease with an average life expectancy of two to five years. The benefits of NIV are relatively largest in MND, but it is believed that all people who need NIV will benefit from its’ use. For patients to receive the greatest benefit from NIV, it is recommended the breathing machine and mask are worn for more than four hours a night. Currently, people with sleep and breathing problems referred to the Victorian Respiratory Support Service are set up with a breathing machine and mask during an admission to the Austin Hospital. These admissions can be burdensome and time consuming for patients, their families and carers. An ever-increasing demand for inpatient beds can also further delay access to NIV and increase burden and anxiety. Once on NIV, troubleshooting usually involves going to the hospital or a nurse from the Victorian Respiratory Support Service Outreach nursing team visiting the patient’s home. Additionally, in light of the coronavirus pandemic (COVD-19), research studies investigating alternative models of care that do not require patients to visit the hospital (telehealth) are needed. In this study we will allocate people to one of two groups (50/50 chance) and each group will receive a different model of care: 1) current model of care (usual care) which involves starting non-invasive ventilation at Austin Hospital or 2) NIV@Home (intervention) which involves starting non-invasive ventilation at home with follow up phone calls from a physiotherapist. We will compare the results to see if the NIV@Home model of care results in similar non-invasive ventilation use.

Anxiety and depression are common and often occur together. Both conditions are associated with a range of negative outcomes, including suicide and substance abuse. Yet, current treatments (e.g., cognitive behavioural therapy or CBT) are suboptimal, and treatments which target both disorders (i.e., transdiagnostic) are urgently needed. Cognitive models of anxiety and depression suggest that cognitive biases underpin both disorders. For example, individuals with anxiety and depression are more likely to interpret ambiguous information negatively (known as "interpretation bias"), and to ignore positive information. Cognitive bias modification training of interpretation (CBM-I) directly targets these interpretation biases to reduce anxiety and depression. Yet, despite promising evidence of CBM-I, few studies have targeted biases associated with both anxiety and depression. This study addresses this gap in the research by investigating the effectiveness and acceptability of a modified CBM-I training program for adults with high levels of symptoms of both anxiety and depression. Individuals will be randomly allocated to either a training or control condition. The training condition involves modifying biases associated with both anxiety and depression. Specifically, individuals will be trained to interpret ambiguous information more positively and to attribute positive outcomes to themselves. The training will be compared to a control condition which trains individuals to neutral interpretations of scenarios (i.e., no training). Compared to the control condition, we expect that the training will result in significant decreases in biases associated with both anxiety and depression from pre- to post-training and pre- to follow-up. We also expect that changes in biases will be associated with decreases in anxiety and depressive symptoms.

This study is designed to address the issue of smoking in Crohn's Disease patients. It has been well established that smoking has an negative impact on patients with IBD, particularly Crohn’s disease (CD). Smoking increases the risk of disease flares, Crohn's disease reoccurrence after surgery and most recently, has been demonstrated as a risk factor for Loss of response to IBD medications. Considering this, it is essential to ensure IBD patients quit smoking to improve their disease outcomes, improve their quality of life and ensure optimal use of medication. As most major IBD centres have access to IBD nursing services, whose role is largely to support patient education and managing helplines to prevent adverse outcomes. The IBD nurse has the most contact with IBD patients thus, the IBD nurse is well placed to assist smoking cessation interventions. The hypothesis of this study is that a nurse-led service that utilises motivational interviewing and nicotine replacement therapy will assist patients suffering with Crohn's disease to stop smoking.

Recently sarcopenia has been used as a surrogate for frailty. Patients undergoing cardio-thoracic surgery may be particularly susceptible to the risks associated with frailty. In cardiothoracic surgical patients objective measurements of sarcopenia has been difficult and not fully investigated. The hypothesis of this study is that reduced cross sectional area of the rectus femoris muscles as assessed by ultrasound will be associated with poorer outcomes amongst cardio-thoracic patients undergoing major surgery.

Frozen shoulder or adhesive capsulitis is a relatively common condition which results in significant pain and loss of function. Despite its prevalence it is poorly understood. The cause of frozen shoulder is unknown, and treatment options are limited. Additionally the impact on individuals suffering from a frozen shoulder is poorly characterised. Anecdotally the impact of this condition can be severe with marked pain experience and prolonged loss of function, potentially resulting in significant psychological and socioeconomic impacts for individuals effected by the condition. This study aims to better understand the impact of frozen shoulder on people who have recently suffered from the condition. By interviewing individuals using a phenomenological approach we aim to get a deeper understanding of the lived experience of people who have recently suffered from this poorly understood disease.

Already, there are five clinical trials registered at Monash Health to assess the safety and efficacy of allogeneic amniotic epithelial cells for (i) bronchopulmonary dysplasia; (ii) acute ischaemic stroke; (iii) compensated liver cirrhosis; and (iv) Crohn’s related perianal fistulas. To date, 27 individuals (17 neonates, 10 adults) have received allogeneic amniotic epithelial cells intravenously. No serious adverse events associated with cell administration or tumorigenesis have been reported. Preclinical biodistribution studies indicate that the AECs do not engraft and are not detected in any tissues after 5 days. Intravenous infusions of up to 8 million cells per kilogram have been well tolerated in extremely premature babies. Based on our extensive preclinical and clinical expertise with AEC, we propose a Phase 1b/2a trial to assess the safety and efficacy of allogeneic AECs for the treatment of COVID-19 related respiratory illness and multi-organ complications.

This single-center, two-part, Phase 1 clinical trial will assess the safety, tolerability, pharmacokinetics (PK) and PD of multiple-ascending doses of PRAX-944 in healthy male and female participants aged 18 to 55 years, inclusive.

This study is being conducted to look at the safety and immune response (how the immune system of the human body reacts) to a vaccine for SARS-CoV-2 (the virus responsible for COVID-19 infection) when administered as an intramuscular injection (an injection directly into the muscle) to the upper arm of healthy participants, on two occasions at least 28 days apart.

It is well-established that persons with serious mental illness (SMI) do not receive the comprehensive treatment and support that they need. Therefore, greater efforts and resources have been directed towards integrating mental health services in the community. MyCare is a step-down, community-based mental health program developed in Australia that provides assertive outreach support to individuals aged 18-64 years old with SMI. A controlled trial is necessary to determine the impact of MyCare on hospital readmissions and psychosocial functioning in comparison to control participants who will be on a treatment order receiving standard Mental Health Services from the Tasmanian Department of Health. Hospital readmissions, psychosocial functioning, and fidelity data will be collected by MyCare Care Coordinators at multiple time points throughout the study. It is expected that those who engage with MyCare for the duration of the program will have lower readmission rates and improved psychosocial functioning in comparison to participants in the control group.