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We are currently facing a global pandemic of COVID-19, caused by the novel coronavirus, SARS-CoV-2. Frontline healthcare workers, especially anaesthetic staff, are particularly vulnerable because of frequent performance of aerosolized-generated procedures, such as bag-mask ventilation and intubation. N95 filtering facepieces are recommended for use by healthcare workers who come into contact with airborne or aerosolized infectious diseases. The protection that is provided by these devices is dependent on the filter’s efficiency and seal quality. According to the recommendations by Standards Australian (AS/NZS 1715-2009), healthcare workers should undergo regular fit testing. Australian Guidelines for the Prevention and Control of Infection in Healthcare (2019) recognises that fit testing is a valuable practice, which provides an opportunity to educate healthcare professionals. There are two types of N95 mask examinations — fit check and fit test. Fit checks, also known as the user seal checks, are fast and simple. It is performed by the wearer, who detects if a gross leak is present. Quantitative fit tests are more objective but require the use of specialised equipment by a trained operator. We would like to compare the fit testing results between the two types of N95 masks, namely the Halyard* N95 Particulate Filter Respirators and the ProShield® N-95 masks. There has been no published literature on the performance of these two types of masks. We would also like to compare the fit check with the fit testing results.

An advanced hybrid closed-loop (A-HCL) insulin delivery system has shown safety and high time-in-range in a previous study. The use of a faster acting insulin aspart (FiASP) with a more rapid onset and shorter duration of insulin action compared to standard insulin aspart could improve the responsiveness of a HCL system. Limited data is available regarding the use of FiASP in HCL systems, in particular in 'free-living' conditions. The aim is to compare glucose control using A-HCL delivering FiASP vs. insulin aspart in this observational study. All participants will undertake the study over a 12-month study duration in a 'free-living' protocol with A-HCL active. Participants are free to undergo their normal daily activities. There will be no specific interventions from the study team. Participants will be free to utilize insulin aspart or FiAsp with the pump based upon their personal preference. Outcome measures include CGM time-in-range and time in hyperglycaemic and hypoglycaemic ranges; safety and system performance outcomes.

STUDY AIM This study will evaluate the feasibility of a web-based system of patient reported outcomes (PROs) assessment to identify and address unmet needs of cancer patients. WHO IS IT FOR? Patients: You may be eligible to join this study if you are aged 18 years or more, and have been diagnosed with any type of cancer for which you are receiving care from Flinders Medical Centre. Staff: You may be eligible to join this study if you are employed by Flinders Medical Centre and provide care for patients with cancer. STUDY DETAILS: Patients and staff participants in this study will provide feedback via a survey and interview or focus group regarding their experience using a web-based portal, called iScreen, to provide PRO data. Patients will be asked to engage in qualitative interviews and complete a survey at least 3 months after their first use of the system to indicate its acceptability. Data on feasibility, cost and safety will also be collected throughout the 16 month implementation period. It is hoped that results from this study will indicate that the iScreen system is feasible, safe and acceptable. It is anticipated that further funding will be sought in order to evaluate the effectiveness of the system and to ultimately roll out the system permanently within Flinders Medical Centre and perhaps across other health institutions.

This project is testing the safety, tolerability, pharmacokinetics (PK, the amount of study drug in your blood) and pharmacodynamics (PD, how the study drug affects your body) of both single and multiple oral doses of a new drug called NT-0167. Up to eighty (80) healthy men or women of non-child-bearing potential (WNCBP), aged between 18-55 will be enrolled in this study in up to six SAD and up to four MAD cohorts comprising 8 subjects each. This study will enrol approximately 80 participants, in two parts: Part A: will involve a single ascending (increasing) dose (SAD) where approximately 48 participants (6 groups of 8) will be randomised (assigned randomly, like flipping a coin) to receive a single dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine. Part A (Food Effect): One group from Part A will return for an additional dose to determine the effect of food on the pharmacokinetics (PK) of the study drug. Part B: will involve a multiple ascending (increasing) dose (MAD) where approximately 32 participants (4 groups of 8) will receive one dose of the study drug or placebo daily for 14 consecutive days (14 doses in total). The study is placebo controlled, meaning that some participants will receive capsule(s) containing the active study drug, and some will receive capsule(s) containing placebo. For Part A your total participation will last about 8 weeks, of which you will spend 4 days (3 nights) in the clinic. For Part B your total participation will last about 10 weeks, of which you will spend 17 days (16 nights) in the clinic.

Background: The aim of this study was to explore the impact of exercise intensity on aerobic fitness and autonomic cardiac regulation (heart rate variability (HRV)) and salivary biomarkers of the stress systems (HPA-axis, cortisol; sympathetic nervous system, a-amylase) and mucosal immunity (secretory(s)-IgA), in breast cancer survivors. Methods: Seventeen participants (62 ± 8 years) were randomly assigned to; 1) high intensity interval training (HIIT; n = 6); 2) moderate-intensity, continuous aerobic training (CMIT; n = 5); or 3) a wait-list control (CON; n = 6) for a 12-week (36 session) stationary cycling intervention. Cardiorespiratory fitness (VO2peak), resting HRV and salivary biomarkers were measured at baseline 2-4 d pre-intervention and 2-4 d post the last exercise session. Results: A significant improvement (p = 0.05) was observed for VO2peak in the HIIT group; 19.3% (B = 3.98, 95%CI = [1.89 ; 4.02]) and a non-significant increase in the CMIT group; 5.6% (B = 1.96, 95%CI = [-0.11; 4.03]), compared with a 2.6% (B = -0.64, 95%CI = [-2.10; 0.82]) decrease in the CON group. Post intervention improvements in HRV markers of vagal activity (log(ln)LF/HF, LnRMSSD) and sympathetic nervous system (a-amylase waking response) occurred for individuals exhibiting outlying (> 95% CI) levels at baseline compared to general population. Conclusion: High intensity interval training improved cardiovascular fitness in breast cancer survivors and improved cardiac regulation, and sympathetic nervous system (stress) responses in some individuals. High-intensity interval training was safe and effective for breast cancer survivors to participate in with promising results as a time efficient intensity to improve physical health and stress.

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.