ANZCTR search results

CTCAs have become increasingly utilised non-invasive modality to assess the presence of coronary artery disease for patients with stable coronary syndromes. Despite this, patients who undergo optimal medical therapy based on CTCA will require invasive management 1/3 of the time, meaning that the parameters used in CTCA assessment currently fail to accurately predict patients who need invasive angiograms and subsequent pressure wire investigations. Pressure wire studies are linked to cardiovascular outcomes. This study aims to apply novel measurements, including aggregated plaque volume, to predict the hemodynamic (and therefore ischaemic) burden of coronary disease based on pressure wire studies.

Parkinson's disease (PD) is the second most common neurodegenerative condition globally and its prevalence is increasing exponentially due to ageing and industrialisation. There is no cure but there is preliminary evidence to suggest high-intensity aerobic exercise may help slow down PD progression. To benefit, people with PD need to perform regular, high intensity aerobic exercise for the long term. The primary aim of this study is to examine the feasibility, acceptability, and sustainability of a pragmatic, individualised, high intensity aerobic exercise program. Secondary aims are to quantify effects of high intensity aerobic exercise on clinical, physiological, and neuroimaging outcomes, including potential disease modifying effects. People with PD will perform high intensity aerobic exercise 3 times per week for 6 to 12 months. The type (e.g., continuous and/or interval training, e.g., fast walking/jogging/running, elliptical cross-training, rowing, stairs climbing) and location (e.g., home, gym, local park) of exercise will be tailored to meet individual needs and preferences. Participants will also receive health coaching via regular phone/video calls to support them to exercise. At the end of the study, participants will be interviewed to explore their experiences of their program.

This study is looking to perform a double blinded randomised controlled trial for patients with primary colon adenocarcinoma (cancer) with the use of a monoclonal antibody (Labetuzumab) targeting receptors in the liver which may form liver metastases. Who is it for? You may be eligible for this study if you are an adult with suspected or confirmed colon adenocarcinoma (on histopathology) who is undergoing surgical resection at St George Hospital, Sydney. Study details Participants will undergo blood and tissue testing to determine if they are at low or high risk for developing liver metastases of their colon adenocarcinoma. Patients in the high-risk group will be randomly allocated to either an active treatment group, who will receive an intravenous infusion of Labetuzumab every other day during the month following their surgical resection, or a placebo group who will receive infusions of normal saline only. Data regarding the development of metachronous (> 6 months from primary operation) liver metastases related to their primary colon cancer will be collected from all patients in this study. It is hoped that findings from this study will help inform a multicentric, multinational trial investigating this treatment for patients affected by colon cancer that are at risk of it spreading to their liver and causing unresectable or terminal disease to follow.

This research study aims to evaluate the effectiveness, (including cost-effectiveness), maintenance and scalability of a novel youth specific aftercare service designed to reduce self-harm and suicide in young people aged 12-25. The program being evaluated is a brand-new youth suicide prevention service – the HOPE aftercare. The aftercare provides intensive, person-centred psychological, psychosocial, family and peer support tailored to the young persons’ unique needs and circumstances using the Relational Clinical Care model. The aftercare is delivered weekly, for up to three months, by a multi-disciplinary team of health professionals, peer support workers. Psychological interventions include, but are not limited to: safety planning, behavioural activation, emotion regulation, substance use interventions, problem solving and relapse prevention. Psychosocial interventions include housing and employment assistance, or referral to support services (e.g., education and training).

Self-Regulated Learning (SRL) is described as a process whereby learners actively take control of their learning by setting goals, planning, monitoring, evaluating, and adjusting their learning strategies to improve performance and achieve desired outcomes. SRL proficiency has been shown to predict educational success and lifelong outcomes, such as income and health. While SRL is recognized as a key lifelong competency, there remain questions regarding how educators can best develop and promote SRL in school settings. A scalable, low-cost intervention targeted at grade 1 students (6-7 years old) in Germany was found to have substantial effects on impulse control and self-regulated learning, with sustained impacts on long term academic success. This study seeks to adapt the Schunk et al (2022) randomised trial to the Australian content and extend it to grades levels 2, 4 and 6

This study will be a single-site, randomized, controlled, blinded study at the Royal Prince Alfred Hospital to examine changes in High definition-electroencephalogram (HD-EEG) correlates of cognition and consciousness during waking and sedation. Our study will address the neural correlates of consciousness and modulate these neural correlates through low frequency Transcranial alternating current stimulation (tACS).

Since Tinlarebant has not yet been approved, the purpose of this study is to continuously provide Tinlarebant to patients who have completed the 24 months of treatment with Tinlarebant in the previous study (i.e., LBS-008-CT02) with no safety issues.

Epilepsy is one of the most common, complex, and disabling neurological conditions worldwide. Mental health conditions are highly prevalent among people with epilepsy (PWE), with approximately 1 in 3 developing lifetime diagnoses of depression and anxiety disorders. However, there are significant barriers to accessing effective psychological treatment for PWE, including high costs, travel and mobility restrictions, cognitive difficulties (e.g. poor memory), and low involvement of mental health professionals in the routine care of PWE. As a digital mental health intervention, the Wellbeing Neuro Course offers an innovative solution to these barriers and aims to improve access to effective psychological care for adults with epilepsy within the Australian healthcare system. The Course uses the principles of cognitive behaviour therapy and compensatory cognitive rehabilitation to target several domains of mental health and cognitive function, and was designed specifically for people with neurological conditions. Digital mental health can be provided in both clinician-guided and unguided models, each with their own potential strengths and weaknesses. Guided models may be more expensive and complex given that trained clinicians must be recruited, yet previous research suggests they may be more efficacious than unguided models. In contrast, unguided models have more public health potential as they involve lower costs and are easier to implement into routine care settings, but may be less efficacious for those with complex presentations who would benefit from clinician support. The primary aim of this research project is to examine the comparative efficacy, cost-effectiveness, acceptability, safety, and long-term outcomes of the Wellbeing Neuro Couse when delivered under two different models of care (clinician-guided vs. unguided) for PWE experiencing emotional difficulties. The secondary aim of this research is to provide critical data of the characteristics of patient’s response to treatment to inform the wider dissemination of the program, including examination of the demographic and clinical predictors and moderators of treatment acceptability and efficacy. Consistent with previous trials, we hypothesise that: 1. Both the guided and unguided groups will result in substantial improvements in primary outcomes of depression and anxiety compared to the treatment-as-usual waitlist control (TAI-WLC) group. 2. There will be non-inferiority in clinical efficacy between the guided and unguided groups across the primary outcomes. 3. Both the unguided group and guided group will be cost-effective compared to TAU-WLC, but the unguided group will be more cost-effective relative to the guided group due to lower intervention costs.

This is an open-label, non-randomised pilot study to evaluate the safety and infectivity of a Plasmodium knowlesi parasite bank. Up to 4 participants will be enrolled in cohorts of 1 participant each. The monkey parasite Plasmodium knowlesi is an important cause of human malaria in South East Asia. This parasite now accounts for all cases of locally-acquired malaria in Malaysia, and has prevented Malaysia from being able to eliminate malaria. Malaria volunteer infection studies (VIS) have provided key insights into the biology of other causes of human malaria, including P. falciparum, P. vivax and P. malariae, and have provided a model for evaluating antimalarial therapeutics against these species. However, a VIS for P. knowlesi has not been established. Using similar methods utilized for other Plasmodium parasites, we have recently developed a P. knowlesi parasite bank. In this pilot study, we will now evaluate the safety and infectivity of this new P. knowlesi parasite bank in up to 4 healthy human volunteers. This study will provide valuable information on P. knowlesi replication rates, host response to disease, and pharmacodynamic response to artemether-lumefantrine, in addition to establishing a model to evaluate novel antimalarials and vaccines against this emerging parasite.

This will be a phase 1 first-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PTC607 at various doses in healthy volunteers. Participants will be undergo screening for up to 28 days. Eligible participants will then be admitted to an inpatient unit for up to 19 days, where they will be taking study medication as directed by the unit staff and will undergo the following but not limited to procedures: vital sign measurements, physical examinations, collection of blood and urine samples, electrocardiograms. Once discharged from the unit, participants will have a follow up phone call approximately 30 days after the last dose of study drug.