ANZCTR search results

The CHARISMA trial is a prospective double-blind, placebo-controlled randomised study to evaluate the effect of adding colchicine to standard medical therapy in patients who have non-obstructive but high-risk plaques in their coronary arteries as demonstrated on cardiac CT angiogram (CCTA). A total of 100 participants will be recruited over the study period. Participants will be randomised to either 1) standard medical therapy or 2) standard therapy plus colchicine 0.5mg daily for 12 months. At the end of 12 months, all participants will then undergo a repeat CCTA. We hypothesise that the addition of colchicine to standard medical therapy will have demonstrate a reduction in markers of coronary inflammation as assessed by peri-coronary adipose tissue attenuation.

This study aims to modify and evaluate the feasibility and effectiveness of a highly novel therapy approach that has been trialled with other neurological populations (e.g. stroke, traumatic brain injury). The intervention is predicted to improve the informativeness and efficiency of everyday communication and quality of life in people living with early stage dementia. The study will recruit 15 adults with a diagnosis of dementia and progressive language impairment. Each participant will act as his or her own control. The study will provide pilot data to inform a future large-scale trial, help to optimise the treatment protocol, and discern the most appropriate candidates for the intervention.

This study is a double-blind, single dose, two period crossover study to compare the PK, PD, immunogenicity and safety of three Tocilizumab products (DRL_TC, RP and RMP) in Normal Healthy Volunteers. IP will be given subcutaneosly.

The aim of the RESCUE study is to collect information on the effectiveness of the Pfizer and Astra Zeneca COVID-19 vaccination in patients with AI disease (autoimmune rheumatic and inflammatory bowel disease). In addition, it will help to determine if stopping current therapy for 1 week after the vaccine will make any difference to the effectiveness of the vaccines. The effectiveness of the vaccines shall be measured by the spike protein antibody levels.

The Sleep Course is a remotely-delivered psychological treatment that has been designed to help people improve their sleep and waking patterns, and daytime functioning (e.g. fatigue, emotional wellbeing). It is designed for adults who report sleep difficulty. It involves four lessons delivered over a 6 week period. Participants also receive telephone support from trained psychologists. The aim of our study is to evaluate the efficacy of the Sleep Course in a group of diverse individuals who experience sleep difficulty. We hypothesise that people in the Sleep Course will report greater sleep improvements compared to a participants waiting to receive treatment.

This trial is investigating the feasibility of pre-operative high-dose radiation in early breast cancer patients. Who is it for? You may be eligible for this trial if you are a female aged 60 or over, with unifocal breast cancer graded <3 on core biopsies. You must also be oestrogen and progesterone receptor positive, and clinically node negative. Study details Parents recruited to this study will be offered a high radiation dose delivered in a single treatment using an MRI-guided linear accelerator, 6 weeks prior to surgery. They will be followed up for disease response and progression. It is hoped that this study will help investigators examine the feasibility of pre-operative single dose radiotherapy, which may reduce patient inconvenience as well as potentially decreasing side effects of extended radiation treatment.

Each year, researchers and doctors work to find better tests, treatments, and services for children. They often use questionnaires that ask about a child’s general health (also called ‘health related quality of life’) to understand how these tests, treatments and services improve children’s lives. However, sometimes this can be hard as there is a lack of sound evidence on how well these health related quality of life (HRQoL) questionnaires perform in children. More evidence on the performance of these questionnaires is required in Australia to guide decision making. We hope the results of this work may help us to better measure overall health in children in order to provide better health care to children in the future. This study will compare lots of different HRQoL questionnaires in children (sometimes called a ‘multi-instrument comparison study’). The study will involve an initial and follow-up survey. The follow-up survey will be a simplified version of the initial survey that will be sent out 4 weeks after completion of the first survey. For the small sub-set (N=200) of participants the follow-up survey will be sent two days after the completion of the initial survey. The performance of these various child HRQoL questionnaires will be analysed and compared. We will also look at a subset of disease groups to see how generic HRQoL questionnaires perform compared with disease-specific questionnaires. We plan collect data on 6,500 Australian children (from children who are well through to those that are very sick). The objectives of the study are to: (1) understand how well various child HRQoL questionnaires can be filled out by parents and how well they measure problems and improvements in health (i.e. consistency, acceptability, feasibility, reliability, responsiveness and validity) and (2) provide government, health practitioners and researchers with a practical set of tools that are ‘fit for purpose’ in judging the effectiveness and cost effectiveness of child health interventions.

This is a randomised, double-blind, placebo-controlled study investigating the effects of the herb ashwagandha on cognition, sleep, and energy in children with parent-reported concerns in attention, memory, and concentration. In this 8-week, multi-national study comprising a total of 80 participants (40 participants recruited in Australia and 40 in India) participants will take two gummies a day containing 150mg of ashwagandha or placebo. We will assess changes in cognitive performance through the completion of a computer-based test that assesses various cognitive skills (e.g., attention, working memory, and episodic memory), and parent-report questionnaires that assess children’s mood, cognitive/executive function, fatigue, and sleep. It is hypothesised that, compared to the placebo, ashwagandha supplementation will be associated with greater improvements in cognitive function, sleep and energy levels.

This is a randomised, double-blind, placebo-controlled, multi-national study investigating the effects of the herb ashwagandha on cognition, energy, and mood in adults presenting with self-reported cognitive complaints and low energy. In this 8-week, study comprising a total of 80 participants (40 participants recruited in Australia and 40 in India) participants will take two capsules a day containing 300mg of ashwagandha or placebo. We will assess changes in cognitive performance through the completion of a computer-based test that assesses various cognitive skills (e.g., attention, working memory, and episodic memory), and self-report questionnaires that assess, mood, cognitive/executive function, and fatigue. It is hypothesised that, compared to the placebo, ashwagandha supplementation will be associated with greater improvements in cognitive function, mood, and energy levels.

Estimated to affect one in eight adults, osteoarthritis (OA) is a highly disabling disease resulting in the unsurpassed risk for mobility disability, especially in those above 65 years of age. Medical treatments for OA have mainly targeted the symptoms of the disease, rather than the underlying pathologies responsible. Pain management with analgesics and steroidal and non-steroidal anti-inflammatory drugs (NSAIDs) were, and still remain, the mainstay of treatment with joint replacement the only option for end-stage OA. There is no evidence that steroidal or NSAIDs provide any beneficial effects on the underlying pathologic abnormalities which exist in OA joints. Dyslipidaemia is the presence of abnormal concentrations of lipoproteins in the blood; more specifically, high levels of low-density lipoproteins (LDLs) and, usually, low levels of high-density lipoproteins (HDLs). Hypercholesterolemia was associated with both unilateral and bilateral knee OA and high serum cholesterol and/or triglycerides were associated with both knee and generalized OA. PPS mediates the release, from endothelial cells and the liver, of lipoprotein lipases which split triglycerides into free fatty acids and glycerol providing a lipolytic effect. PPS has other useful properties for the amelioration of the pathophysiology and symptoms of OA. It inhibits the formation of activated factor Xa resulting in a limited anti-coagulant activity. In human patients, a recent pilot open-label study (ACTRN12619000047190) conducted by the University of Sydney aimed to target dyslipidemia in OA participants by oral administration of PPS. Pain and function information from participants were collected to determine if improvements in dyslipidemia would also result in clinical improvements of symptoms associated with knee osteoarthritis. The study outcomes revealed oral PPS significantly improved pain, stiffness, and other functional measures in these patients. The study's secondary outcomes also showed a statistically significant decrease in total and LDL cholesterol and a positive change in self-reported outcomes and severity knee pain score, measured using KOOS and NRS scale together. The self-reported pain, stiffness, and functional outcomes show a significant positive improvement. This indicates good potential for the further randomized double-blinded placebo-controlled study to demonstrate the beneficial effects of PPS in knee osteoarthritis clinical outcomes.