ANZCTR search results

Text-message based programmes have proven to be an effective public health approach to improve adolescent health behaviours, including tobacco use, and so may have promise as an approach to influence adolescent e-cigarette behaviours. Given this potential, we aim to conduct a randomised controlled trial employing a 2x2 factorial design to examine the potential effect of a text-message program targeting parents and adolescents to prevent adolescent e-cigarette use. Parent-adolescent dyads will receive a series of text messages (1/week for 1 school term, then 1 booster message per term) designed to address the factors associated with e-cigarette use (e.g. to modify perceived social norms, or correct misconceptions of risk). Adolescent intentions to use e-cigarettes will be the primary outcome, assessed via a survey. It is hypothesised that adolescents who receive the text messages (or whose parents receive them) will report lower intentions to use e-cigarettes, than those in the control condition (who don't receive the text messages).

Hepatitis B virus (HBV) infection is one of the most common infectious diseases in the world, with nearly 300 million people chronically infected worldwide. Chronic HBV infection can lead to serious complications such as cirrhosis, liver failure, hepatocellular carcinoma (HCC), and death. Approximately 820,000 people die every year due to consequences of CHB. Hepatitis delta virus (HDV) is the causative agent of chronic hepatitis delta (CHD), the most severe form of viral hepatitis. Infection with HDV is dependent on the presence of HBV infection, as it uses HBV encoded envelope proteins (HBsAg) for infection and replication HDV infection can occur either simultaneously with HBV or, more commonly, as a superinfection in patients already chronically infected with HBV. Relative to CHB infection alone, CHD co-infection is associated with more severe liver disease, causing faster progression to cirrhosis, hepatocellular carcinoma, and liver failure. Developing therapeutic strategies that deplete HBsAg levels, like monoclonal antibodies, may play a role in future regimens targeting functional cure. There is a clear need for additional treatment for CHD, particularly agents that improve response rates, are better tolerated, and simpler to administer than currently available treatments. BlueJay Therapeutics has developed BJT-778, which has the potential to provide anti HBV and anti HDV benefits by neutralizing and clearing HBV and HDV virions as well as by depleting HBsAg containing subviral particles, which may help reconstitute HBV-specific immunity and contribute to functional cure for CHB. BJT-778 is a potent, selective neutralizing monoclonal antibody for the treatment of CHB and CHD. This study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of BJT-778 in patients with CHB.

The primary purpose of this study is to test an intervention with people with Long COVID which promotes hope, activity and participation and differs vastly from current practice in which people receive brief advice only about lifestyle changes. The study adapts ‘Take Charge’ approach, which is a short, early, patient activation intervention, and designed to de-medicalise a condition, improve intrinsic motivation and foster the patient to take charge of their own recovery. The study hypothesises that people who receive the ‘Take Charge’ program (a short, early, patient activation intervention) will have improved medical outcomes (e.g., COVID-19 Yorkshire Rehabilitation Scale, Short Form 36 and other scales), as well as increased rates of return to work or working hours. We anticipate that patients will report higher levels of quality of life, higher levels of hope and increased levels of independence at 3 months after receiving intervention than those who are offered standard advice and care for Long COVID. We hypothesise that the intervention will be acceptable and feasible to provide to patients with Long COVID. The study aims to contribute to the current paucity and urgently needed information on treatment strategies for people with long COVID.

This study aims to assess whether a single dose of 177 Lutetium-PSMA-targeted therapy is safe and effective as a treatment for men who have developed biochemical failure after having a radical prostatectomy. Who is it for? You may be eligible for this study if you are a male aged 18 years or older who has recently undergone a radical prostatectomy (surgery to remove the prostate) due to a diagnosis of high or very high risk prostate cancer. Participants will undergo blood tests and MR imaging to determine whether they meet the additional criteria of biochemical failure. Study details All participants who choose to enrol in this study will receive a single dose of 177 Lutetium-PSMA-targeted therapy that will be administered intravenously (through a vein). Please note that any participants who are eligible for this study will need to pay out-of-pocket for the study treatment (177-Lu-PSMA-I&T) as well as the post-operative mpMRI (multiparametric Magnetic Resonance Imaging of the prostate). It is anticipated that the single dose will be administered over a 10-minute period followed by a saline (neutral fluid) flush. Participants will then be asked to provide blood samples at 3 months post-dose, and then every 4 months for up to 3 years post-dose. Participants will also be asked to complete a questionnaire about their health at 30 days, and then every 3-6 months for up to 3 years post-dose. Additional imaging scans will also be collected at 3 months post-dose, with the potential for further imaging to be determined by the treating clinician. It is hoped this research will determine whether a single dose of 177 Lutetium-PSMA-targeted therapy is safe and whether it has a positive impact on resistant prostate cancer. If this study does show that the drug is safe and effective, a larger study to examine potential benefits in more patients may proceed.

This study will look at the effects on muscle protein synthesis (rates of building new muscle) when people undertake resistance training while consuming 2 different types of diet for 2 weeks. One will restrict energy intake using an intermittent fasting restriction (2 days per week of severe dietary restriction), and the other will meet individual energy requirements. Generally, energy restriction results in lower muscle protein synthesis, however energy restriction is usually undertaken every day, rather than over 2 days per week. It is hypothesised that that rates of muscle protein synthesis rates will not be significantly different between groups.

EMVision’s EMView study is a 3 stage, multicentre, study of the EMVision Gen 1 Brain Scanner to collect clinical data for hardware verification and software advancement for the imaging of acute stroke. The imaging software, once finalised, will be able to differentiate between stroke/no stroke, classify stroke as either haemorrhagic or ischaemic and localise the stroke event to a specific quadrant of the brain. The first stage of the study will gather data from 30 healthy participants, to establish an age-matched baseline against the target stroke patient population for ‘healthy brain’/no stroke. The second stage will gather data on 150 patients presenting to hospital emergency with symptoms suspected to be stroke, including a minimum of 15 haemorrhagic stroke, 15 ischaemic stroke, 10 stroke mimics with migraine, 10 stroke mimics with seizure and other stroke mimics. Data from the second stage will be used to estimate the final sample size necessary to advance the software algorithms to clinically useful performance levels. The third stage will gather data on up to 30 patients presenting to hospital emergency with symptoms suspected to be stroke and who are confirmed to have had a haemorrhagic stroke. Due to the nature of streamlined code-stroke protocols and timing of diagnosis and EMVision scan, other patients who present to hospital with suspected stroke will continue to be recruited until the haemorrhagic stroke group minimum target is met. The data from all stages of the study will allow the EMVision to finalise software algorithms that identify, classify and localise stroke. It is anticipated that EMView Study will enroll approximately 320 patients with stroke and stroke mimics in the second and third stages of the study.

Background & Aim: Myofascial pain or jaw muscle pain is a common orofacial pain resulting in impairment of jaw function, and high health-care costs. It is most common in the 20–40-year age range. The aim of this study is to evaluate the feasibility, acceptability, and effectiveness of yoga in adult students experiencing myofascial pain. Methods: Subjects were recruited from a university student population and invited to learn more about the study through advertisements by email. Those interested were provided a jaw health screening questionnaire and if self-reporting facial pain they were invited for clinical examination to confirm orofacial myofascial pain (using standardised Research diagnostic criteria for Temporomandibular disorders [RDC/TMD]). 25 students with diagnoses of myofascial pain volunteered for this double-blind randomized controlled study. Participants undergoing other management for facial pain and TMDs were excluded. Participants were randomized to one of two interventions, either a yoga inclusive management programme or an active control standard care programme. Both groups received the intervention for 28 days. The outcome measures analysed were the change in pain intensity on an 11-point numerical rating scale and change in pain location and distribution using digitalized pain mapping software. Jaw mobility, oral health related quality of life and cognitive factors related to the participant’s understanding of pain were determined at baseline, at 14 days and at the end of 28 days. Change in outcome measures between baseline and (outcome points) were analyzed using Mann- Whitney test. Hypothesis That there will be a statistically significant difference in the treatment benefits between a yoga exercise inclusive management program as compared to active control standard care for the management of jaw muscle pain.

This study is evaluating the quality of cancer shared follow-up care for colorectal and breast cancer using an e-care plan. Cancer shared follow-up care is shared between the patient’s specialist and their GP. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older who has completed their active treatment for colorectal or breast cancer at a cancer service in South Eastern Sydney Local Health District within the past 4 years. You will also need to discuss whether you are suitable for this study with your cancer specialist. Study details The study is being implemented at cancer services in the South Eastern Sydney Local Health District. Participants who choose to enrol in this study will be allocated to one of two treatment groups. Participants who are allocated to the first treatment group will be given access to a new shared follow-up care service provided through an electronic care plan (e-care plan). The e-care plan sets out the schedule of appointments, what needs to be done and who is responsible. Results and other information can be shared through the e-care plan. The participant, specialist and GP have access to it and other care team members can be added. Participants who are allocated to the second treatment group will continue to receive their usual follow-up care which is often provided directly from their specialist and will not access the e-care plan for the duration of 9 months. After enrolling, participants in the second group will then be given access to the e-care plan for shared follow-up care. All participants will be asked to complete a questionnaire at the start of the study, at 9 months and the second treatment group at 18 months. A sample of participants will be asked to complete an interview at 9 months and 18 months after enrolling. It is hoped this research will determine whether implementing a shared follow-up model of care for colorectal and breast cancer patients provides any changes to the participants' quality of care and health outcomes. If this study finds that the shared follow-up model of care is beneficial for patients, it may be expanded for use in more cancer patients in the future.

Motor neuron disease (MND) is a rapidly-progressive and fatal neurological condition. There is no cure. Riluzole, the only available treatment, has a very modest benefit at best. Diagnosis is often delayed. CuATSM (‘copper ATSM’) is a compound that has been shown to protect against a type of newly-described cell death known as ferroptosis in animal models of MND. The results of a recent phase 1 trial of CuATSM in humans with MND were promising. Additionally, radiolabelled CuATSM was detected via PET imaging in parts of the brain involved in MND in a pilot study. CuATSM may therefore be disease modifying as well as localising to areas of active disease, showing promise both as a treatment and diagnostic agent. This project is an imaging study which aims to further explore the role of CuATSM in diagnostic imaging. We aim to use radiolabelled 64CuATSM PET in conjunction with a type of MRI scanning called quantitative state mapping, which detects iron in the brain, another potential marker of ferroptosis. Participants will have these scans at baseline. Clinical data, including neurological examination and cognitive testing results, will be collected. We aim to explore whether both types of imaging demonstrate involvement of the same brain regions. Positive results would 1) provide evidence that the type of cell death known as ferroptosis is occurring in humans with MND, 2) support ongoing clinical trials of anti-ferroptotic agents such as CuATSM, and 3) support future exploration of these imaging techniques in diagnosis and monitoring of disease progression.

The study will be a prospective, randomised placebo controlled 3x6x3 cross over trial that will examine the effect of an isometric wall squat on pain sensitivity and clinical pain intensity when compared to a true control (quiet rest) in 30 individuals with non-specific chronic low back pain. Participants will receive each of the three interventions over a period of three weeks. The sequence of intervention exposure will be randomized according to the Williams randomised allocation sequence. This study will also evaluate the suitability of a novel placebo exercise intervention for maintaining participant blinding of intervention allocation. The hypothesis is that the isometric exercise intervention will lead to reduced pain sensitivity (exercise induced hypoalgesia) and reduced low back pain intensity when compared to the control group. A total of 4 individuals have been screened as potentially eligible. As of 09/01/2023, 3 participants have been enrolled. It is anticipated that data collection for the first participant will commence on the 16/01/2023.