ANZCTR search results

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.

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.