ANZCTR search results

This randomised controlled trial aims to investigate the efficacy and acceptability of telemedicine vs. traditional in-person follow-up for patients undergoing uncomplicated general surgical procedures. These general surgical procedures include appendectomies, umbilical and inguinal hernia repairs, and cholecystectomies.

Health professionals have long established a link between gum disease and cardiovascular disease. However, whether the treatment of gum disease reduces the risk of having a cardiovascular incident, for example- a heart attack, remains a question mark. Colchicine is a drug that has been shown to reduce cardiovascular risk. This trial aims to help ascertain whether a combination of gum disease therapy and colchicine therapy will reduce the risk of having a cardiovascular incident.

The aim of the National Breathlessness Survey is to evaluate respiratory symptom burden (breathlessness, cough, wheeze and/or chest tightness), treatment, healthcare utilisation and patient attitudes and beliefs in a randomly selected adult population, irrespective of any current diagnostic assignment. Specifically, the National Breathlessness Survey aims to: • Describe the prevalence (and severity) of breathlessness in adults with or without a self-reported, doctor-diagnosed illness of asthma, COPD, bronchiectasis, or cardiac disease. • Describe the frequency of breathlessness and the impact of breathlessness on quality of life in adults with or without a self-reported, doctor-diagnosed illness of asthma, COPD, bronchiectasis or cardiac disease. • Quantify how many people have exposure to known risk factors for developing breathlessness or experiencing adverse health outcomes of contributory conditions, including the presence of comorbidities (e.g. exposure to tobacco products, occupational exposure to fumes, dust and asthmagens, inactivity/obesity). • Assess healthcare utilisation among people with breathlessness.

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.