ANZCTR search results

CRN00808 is an oral somatostain receptor 2 agonist (sst2) being developed for the treatment of acromegaly. This multi cohort single dose study will assess the relative bioavailability, performance and safety of two novel oral formulations of CRN00808. Cohort 1 and Cohort 2 are identical in their design except for the CRN00808 formulation used. CRN00808 Novel Formulation 1 and CRN00808 Novel Formulation 2 will be evaluated in Cohorts 1 and 2 respectively, over 4 periods. For Cohort 3 the test formulation used will be based on data and performance of the two test formulations evaluated in Cohorts 1 and/or 2. The cohort will consist of 4 periods. In Period 1, subjects will be administered the CRN00808 Reference Formulation. In the remaining periods, a single dose of CRN00808 Novel Formulation 2 will be administered orally after fasting to determine the food effect of CRN00808. Cohort 4 will consist of 3 periods, with subjects being administered a single dose of CRN00808 Novel Formulation 2 in each after fasting to determine the optimal dose of CRN00808 and optimal post dose fasting. Dose level and post dose fasting Period 2 and 3 was based on the data obtained in Cohort 4 Period 1 and 2 respectively. Cohort 5 will consist of 3 periods, with subjects being administered a single dose of CRN00808 Novel Formulation 2 in each period. In Period 1 and 2 CRN00808 will be administered after an overnight fast, and will be followed by the consumption of a low fat meal. In Period 3 the low fat meal will be consumed within 30 minutes prior to the administration of CRN00808.

This is a safety trial looking at a powder that produces ketones in the body. Ketones are naturally occurring modules that are produced when someone is fasting or haven't eaten for 6 hours or longer. The body can use them as an energy source when blood glucose is low. This project will be recruiting 10 healthy individuals and will test 2 doses of the powder given to them on one day. This will be compared to their blood glucose, ketone level and blood safety markers 2 days later to see if there are any changes. The aim of the project is ensure the safety of the product in humans so it can be used in clinical trials.

Liver disease affects over 5 million Australians. In patients with advanced liver disease, liver transplantation is a valuable yet scarce resource with the ability to transform the lives of patients. Our research at Austin Health has shown that cardiovascular disease is a leading cause of early and late adverse outcomes after liver transplantation. The development of cardiovascular disease may limit the benefit of liver transplantation. A proposed mechanism for this observation is accelerated development of plaque build-up in coronary arteries, also known as atherosclerosis. Atherosclerosis is a condition that can increase the risk of heart attack in patients after liver transplantation. Computed Tomography (CT) imaging of coronary arteries can be performed in patients to assess their cardiac risk before liver transplantation. Plaque build-up in coronary arteries identified on CT imaging has been shown to adversely impact outcomes at the time of transplantation. However, no studies have evaluated the progression of plaque build-up in patients after transplantation. If liver transplantation causes accelerated atherosclerosis in coronary arteries, the current algorithms for surveillance and therapy of cardiovascular risk may need to be redefined. We propose to undertake repeat CT imaging of the coronary arteries at least two years after liver transplantation, in patients who had CT imaging before transplantation. The aim is to assess whether transplantation is a risk factor for progression of plaque build-up, which can predispose to future heart attack. The CT imaging of liver transplant patients will be compared to a control group of liver disease patients who did not undergo transplantation.

This study aims to answer the following research question: Is metformin pharmacotherapy for 12 months as an adjunctive therapy to a 12-week lifestyle behavioural intervention program targeting physical activity, diet and sleep hygiene practices effective in improving clinical cardiometabolic health parameters and affective symptoms of young people with a clinically diagnosed mood or psychotic syndromes? The study will run for approximately 3 years. The total duration for each participant is 52 weeks involving 52 weeks of metformin/placebo, 12 weeks of lifestyle behavioural intervention, intermittent actigraphic assessments, and follow up at 12, 26, 38, and 52 weeks. Investigators expect to enrol 266 people in this trial.

We anticipate that participants recovering from stroke will be able to participate in inpatient and home-based ELEMENTS-T therapy effectively and will show enhanced motivation to engage in therapy as a result of their involvement. This will fulfil the principle that rehabilitation methods that encourage intense interaction are most beneficial. With the ELEMENTS-T system, intensity is ‘given for free’ because the therapy is fun and the benefits accrue incidentally as a function of active and playful interaction. We expect that the user interaction afforded by the system will enable inpatients to make significant gains in motor and cognitive function, compared to treatment as usual.

Acute ischemic stroke (AIS) is the most frequent pathological subtype of stroke affecting millions of people worldwide. Timely reperfusion treatment with the intravenous (IV) thrombolytic agent, recombinant tissue plasminogen activator ([rtPA] or alteplase) in carefully selected patients, offers them the potential benefit of surviving free of major disability. Clinical practice guidelines recommend that post-rtPA patients are closely observed and monitored over at least the subsequent 24 hours to allow early detection. However, it is unclear whether the standard intensive nursing monitoring protocol that forms the basis of guideline recommendations for the last 20 years should continue to be routinely applied to stable ‘low-risk’ post-rtPA patients with mild neurological deficits who do not require critical care intervention. OPTIMISTmain is an investigator-initiated and conducted, international, multicentre, stepped wedge cluster randomized controlled trial to determine whether compared to standard monitoring, less-intense monitoring is at least as effective ('non-inferior') on the functional recovery of acute ischaemic stroke patients post-rtPA infusion with mild-moderate neurological deficit. The study also aims to establish that less-intense monitoring can be safe, provides economic and resource benefits, relative to standard monitoring.

This research is being conducted to investigate the impact of a brief meditation on brain function using a functional MRI process. The benefits of this study will include determining the impact of Ecomeditation (a brief 22 minute meditation) on neural brain changes - participants will be asked to have a 10 minute brain scan then engage in listening to a meditation track for 4 weeks (daily) and then have another brain scan to see if there are any changes. Validating brief meditation as a physiological method of meditation that can be rapidly and reliably induced, may make brief meditation accessible to many who have found it difficult in the past. We will compare both experienced meditators and non-meditators (in order to ascertain whether non-meditators are able to achieve sustaining a meditative state over the 4 weeks and to see any changes it has on brain regions indicative of deep meditative states, such as the dorsolateral prefrontal cortex, the ventromedial prefrontal cortex, the thymus, and the hippocampus. It is hypothesized that changes in activity patterns and maybe connectivity will be observed).

The study is designed to assess cervical tissue penetration of Topical ABI-1968 Gel after multiple weekly dosing in participants with and without cervical cap. Participants who meet all inclusion and none of the exclusion criteria will be evaluated throughout the study. Up to 12 participants may be enrolled into one of the following four groups (3 participants per group). • Group 1: Four weekly dosing of up to 1% of Topical ABI-1968 Gel with cervical cap • Group 2: Four weekly dosing of up to 1% of Topical ABI-1968 Gel without cervical cap • Group 3: Up to 4 weekly dosing up to 1% of Topical ABI-1968 Gel (with or without cervical cap) • Optional Group 4: Repeat the same dosing regimen used in previous groups or test a different regimen (but not to exceed a dose up to 1% Topical ABI-1968 Gel and no more than four weekly dosing). • Group 5: Up to 4 weekly dosing just 1% gel of topical ABI-cream with a cervical cap.

Recommendations to increase intakes of foods rich in flavonoids have the potential to improve population health and reduce cardiovascular disease-related mortality. Flavan-3-ols are the most abundant subclass of flavonoids in the diet and are found in abundance in cocoa, apples, and tea. Currently, flavan-3-ol intake is estimated from food frequency questionaires. There is a crucial need for quality biomarkers of intake as a means of overcoming food questionnaire and food database limitations. Recently, a microbiome-derived flavan-3-ol catabolite, gamma-valerolactone (gVL), has emerged as a promising candidate. The primary aim of the proposed project is to establish the suitability of gVLs as biomarkers of flavan-3-ol intake.

This study is a randomised, crossover, double-blinded, single-dose experimental trial investigating the dose-dependent effects of purified, oral cannabidiol (CBD) on simulated car driving performance in healthy individuals. Participants will complete four experimental sessions involving different CBD treatments: (1) Placebo (0mg); (2) Low dose (15mg); (3) Moderate dose (300mg); and (4) High dose (1500mg). Trials will be conducted at the Woolcock Institute of Medical Research. We hypothesise that no dose of CBD will affect simulated car driving performance. Findings may assist to inform the development of guidelines and/or laws relating to the use of CBD drug therapies by drivers.