ANZCTR search results

To evaluate the safety of LYN-005 extended release capsules containing risperidone in patients with schizophrenia, schizoaffective disorder or bipolar 1 disorder. To perform characterisation of the the pharmacokinetics of risperidone and active metabolite, 9-hydroxyrisperidone, and active moiety administered as a LYN-005 extended-release (ER) capsule of risperidone to immediate-release (IR) risperidone tablets

An open-label, multi-centre study in healthy volunteers: To determine the safety and tolerability of LYN-157 when administered as a single dose to participants on steady-state daily memantine HCl and donepezil HCl. To characterize the pharmacokinetics (PK) of memantine HCl and donepezil when LYN-157 is administered as a single dose to participants on steady-state daily memantine HCl and donepezil HCl. To assess the effect of pre-dose food (i.e., fasted, low and high-fat meals) on memantine HCl and donepezil HCl PK following a single dose of LYN-157 to participants on steady-state daily memantine HCl and donepezil HCl.

Outcomes: The aim of the research study to explore the effectiveness of each of the treatment methods in reducing oedema in the hands following tetraplegia. The quantitative study will identify whether there was a reduction of oedema or not in this sample. The treatment methods will also provide a comparison of the two treatment methods to determine if there is a trend for one to exert a greater effect than the other. The qualitative study will provide findings from the participants’ perception of the oedema and oedema management and their impact on daily function. This aspect of the study will explore participants’ experiences of developing oedema and the management techniques, seeking to explore the potential impact of both on their day to day function.

A single arm feasibility study of an 12-week smoking cessation intervention consisting of varenicline, combination nicotine replacement therapy, and counselling (motivational interviewing) among men at risk or experiencing homelessness and attending a healthcare clinic. The primary aims of the feasibility study is to assess the safety of the intervention (as recorded by number of adverse events, serious adverse events). If the intervention is found to be feasible and safety for this population this intervention could be implemented as part of standard practice and a model for other healthcare clinics treating this high priority population for tobacco smoking.

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.