ANZCTR search results

The primary aim of the study is to define the point-prevalence of a Post-Viral Syndrome (PVS, Long COVID) at 12-24 weeks post SARS Cov-2 infection versus infective (RSV A/B or Influenza A/B) and non-infective controls using an operationalised PVS research case definition in the Australian community. The study will also help to understand: - how often SARS-CoV-2 infection and other respitatory viral infections cause PVS , - what symptoms (and symptom clusters) occur, and - what medical, mental health and functional impact those symptoms may have. We will screen-swab up to 10,000 participants aged 12+ with recent onset (<7 days) respiratory symptoms, to enroll a total of 500 confirmed acute SARS-CoV-2 infection cases, 500 Influenza cases and 500 RSV cases, as well as 500 non-infective control subjects across Australia. Participants will be tested for respiratory viruses including SARS-CoV-2, Influenza A/B, RSV A/B. Up to a total of 2000 participants who are positive for SARS CoV-2, Influenza A/B, RSV A/B and non-infective controls will be followed up at 6, 12, 24 and 48 weeks via self-reported questionnaires to assess for ongoing symptoms and application of a standardised PVS case definition. The OUTPOST cohort will provide a basis for health economic analysis. The cohort will complement a concurrent mapping exercise of existing studies and cohorts on Long COVID in addition to specialist support services and clinics around the country. Together, these project activities will inform better care and support for people experiencing Long COVID in Australia.

AXA-042 is a novel toll-like receptor (TLR) 2/6 agonist designed to re-engage the innate immune system and promote anti-tumour immune responses. In this first-in-human study, researchers will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumour activity of AXA-042 administered as monotherapy in participants with advanced solid tumours. This part of the study (Part C) will use a Simon’s two-stage design to identify early signals of clinical activity while minimising exposure to potentially ineffective treatment. Who is it for? You may be eligible for this study if you are 18 years of age or older, have a diagnosis of a locally advanced or metastatic solid tumour, and your cancer has progressed despite standard treatments or you are intolerant to standard of care therapies. Study details Participants will receive AXA-042 as monotherapy, administered as an intravenous infusion on Day 1 of a 21-day treatment cycle. Treatment will continue until disease progression, withdrawal of consent, unacceptable toxicity, investigator decision, or study completion. The dose of AXA-042 used in this part of the study will be selected based on available safety and pharmacokinetic/pharmacodynamic data from earlier parts of the study and confirmed by the Safety Monitoring Committee. Participants will be monitored closely for adverse events throughout treatment and for at least 30 days after the last dose. Blood samples will be collected to assess pharmacokinetics, immunogenicity, and pharmacodynamic biomarkers, including immune response markers and cytokine profiles. Tumour response will be evaluated using RECIST v1.1, iRECIST, and/or PERCIST criteria, as appropriate. Quality-of-life assessments will also be conducted during the study. It is hoped that this study will help determine whether AXA-042 monotherapy demonstrates sufficient biological and clinical activity in selected solid tumour types to support further clinical development.

The purpose of this Phase 1 study is to evaluate the safety, tolerability and PK profile of Smartech Aspirin, applied daily to the skin for 10 days, compared to topical vehicle control and orally administered immediate release (IR), low dose aspirin in healthy adult participants. The study will be initiated with 2 treatment cohorts as follows: 1. Topical Cohort (randomized, double-blind, vehicle-controlled): up to 10 evaluable participants will be enrolled and randomized to receive Smartech Aspirin (2 pumps of a nominal 179 mg per pump; 358 mg total per day) or vehicle control in a 4:1 ratio (8 active: 2 vehicle control), to be applied topically once daily (QD) for 10 days. 2. Oral Cohort (open-label): up to 8 evaluable participants will be enrolled and treated with oral, IR, low dose aspirin (81 mg) dosed QD for 10 days. Up to 2 additional cohort(s) of 10 participants each; i.e., Cohort A2 and Cohort A3, may be enrolled to further investigate the safety, tolerability and PK/PD of Smartech Topical Aspirin gel.

This study aims to directly compare the laboratory findings from samples collected from 10 healthy volunteers with results from a laboratory bladder infection model, using similar antibiotic therapy dosing. Laboratory testing involves measuring concentrations of amoxicillin and clavulanate in urine, assessing the activity of the antibiotic against E. coli uropathogens, and studying how the antibiotic affect the healthy microorganisms in the urinary tract, called the urobiome. Results from this study will validate the utility of the laboratory bladder infection model and help guide future research. This includes finding the best doses of antibiotics and testing other types of antimicrobials.

Piano training using creative improvisation provides opportunities for autonomy-supportive learning where participants can self-direct and express themselves through their musical play. Piano training using traditional methods often requires precise replication of music notation. This study aims to investigate the cognitive and wellbeing benefits experienced by older adults who participate in piano improvisation training compared to those who engage in traditional piano instruction, with particular attention to individuals who report memory concerns, formally referred to as subjective cognitive decline.

This study aims to improve how anticancer drugs and blood transplant and cellular therapy (BTCT) treatments are given to patients. Many of the medications used—such as chemotherapy agents and immune-modulating drugs—can affect people differently depending on their age, body composition, organ function, and genetics. Some of these drugs stay in the body for a long time and may cause serious side effects or influence how well the treatment works. Who is it for? You may be eligible for this study if you are a male or female of any age scheduled to receive precision medicine drugs as part of cancer treatment or BTCT therapy for both malignant or non-malignant disease. Study details For those who chose to participate in this study no changes will be made to the prescribed treatment regimen by the study team. Drug infusion rates are guided by drug-specific prescribing information, clinical guidelines, and may also be protocol-driven. This study will measure drug levels in the blood over time (called pharmacokinetics) and look at how those levels relate to side effects and treatment success or failure. Researchers will also study how a person’s genes affect how their body handles these medications (called pharmacogenomics). By combining drug level data with genetic information, the study hopes to find better ways to personalize treatment—so each patient gets the right dose for their body from the beginning of treatment. It is hoped that the results from this study will help to reduce harmful side effects, improve transplant success, and help doctors make more informed decisions about dosing. Ultimately, this research will support safer, more personalised cancer and transplant care for future patients.

The purpose of this pilot study is to preliminarily evaluate the efficacy of Integrative Attention and Somatic Processing (IASP), a customised therapeutic approach, developed to support women who have received a diagnosis of ADHD in adulthood. It is hypothesised that this therapeutic approach will reduce the psychosocial burden of ADHD and increase psychological wellbeing of women with a late diagnosis of ADHD.

Motor neurone disease (MND) is a progressive neurological disorder that results in profound disability and eventual death. Respiratory failure is the leading cause of death in MND due to declining respiratory muscle strength. Non-invasive ventilation, to support breathing, is the most effective treatment available for people living with MND. Polysomnography (PSG) is currently the gold standard for diagnosing sleep-disordered breathing and determining when to commence non-invasive ventilation in people living with motor neurone disease (MND) as it offers comprehensive monitoring of cardiac, respiratory, musculoskeletal, and neurological functioning. However, PSGs pose a significant challenge for people with MND as they require significant effort to travel to hospital and stay overnight. Also, as PSGs only collect data on the night they are conducted, they are not able to monitor the deterioration in respiratory status that is synonymous with MND. This study aims to explore the feasibility and acceptability of the use of a minimally invasive on-mattress device capable of recording body position, acoustic, respiratory and cardiac signals to identify breathing issues during sleep by people with MND and carers of people with MND. If feasible and acceptable to people with lived experience of MND, use of this device may simplify and improve the monitoring of sleep-disordered breathing in people living with motor neurone disease.

Poor balance and mobility are consistently associated with increased risk of falling among people in hospitals. This study aims to implement and evaluate SureStep, an evidence-based group standing balance exercise program designed to help hospital patients improve their balance, mobility and reduce their risk of falls. The program is delivered by physiotherapists as part of new standard care and involves supervised group exercise sessions held on the recruited wards. Using a stepped wedge type III hybrid design, recruited hospital wards will begin the program at randomly assigned times, allowing comparison between the original usual care and the SureStep program as new standard care primarily on the exercise dose and physical level of patients on ward. The study will assess feasibility, acceptability, cost-effectiveness and sustainability of the program. We hypothesise that SureStep will be feasible, safe and cost-effective to deliver, which will be sustained over time to support better mobility for hospitalised adults.

The Body Project is an ED prevention program targeting young females with self-identified body dissatisfaction, aiming to challenge and reduce the unrealistic pursuit of thin idealisation. This study will implement and evaluate the Body Project in the Queensland tertiary environment, by recruiting females aged equal to or greater than 18 years up to 30 years of age enrolled at Griffith University with self-reported body image dissatisfaction (n=80). Participants will be randomised into either 4 sessions of the Body Project or a control group directed to watch a documentary. All participants will be asked to complete online surveys that measure changes in body dissatisfaction, psychosocial functioning, quality of life, service use and dietary intake before and after the intervention, 4 weeks apart for both groups. The groups will be facilitated by trained female peer educators. Following completion of all sessions, participants, peer educators and counsellors will be invited to take part in an individual interview to discuss their participation experiences, perceptions of the Body Project and its value.