ANZCTR search results

This study aims to describe real-world clinicopathologic presentation and treatment selection in routine care of patients with recently diagnosed metastatic colorectal cancer that have a biomarker of interest. Who is it for? You may be eligible to join this study if you are aged 18 years and older with any ECOG performance status and with histologically confirmed metastatic colorectal cancer (either de novo metastatic or relapsed) that harbour at least one of these biomarkers of interest after 1st January 2021. Study details All participants who meet the eligibility criteria in this study will have their data collected on specific biomarker. During and after completion of the Metastatic colorectal cancer treatment participants data will be collected on biomarkers, progression free survival, overall survival, medical access, and disease free interval. It is hoped that this research project could help answer research questions around assessing the incidence, clinicopathologic associations, variation in treatment management and outcomes in routine care.

To review oral food challenges in children with Food Protein Enterocolitis Syndrome (FPIES) over a 10 year period (2010 to 2020) at the Women’s and Children’s Health Network (WCHN) and Flinders Medical Centre (FMC) in Adelaide, Australia. We will review safety and clinical outcomes and how practices have changed over this period.

Single site exploratory prospective cohort study involving twenty patients compared against ten healthy controls. Primary endpoint to is study and compare differences in intestinal motility and intestinal gas profiles amongst patients with compensated and decompensated liver cirrhosis with portal hypertension using a gas sensing capsule. We hypothesize that small bowel motility and bacterial metabolism are significantly altered in the setting of portal hypertension, and dynamically change with increasing portal pressure and severity of liver disease. We anticipate that there will be a correlation between intestinal gas profiles, gut transit times and markers of inflammation and/or immune dysfunction.

The Gro-AUS study is a cluster-randomised controlled trial designed to evaluate the effectiveness of the Gro-AUS app, an AI-enhanced digital health intervention for managing Type 2 diabetes. The app provides personalised support, education, and behaviour change strategies to aid self-management. The primary hypothesis is that participants using the Gro-AUS app will experience a statistically significant reduction in HbA1c levels compared to those receiving standard care. The study plans to recruit 240 participants from various GP practices within the Western Sydney Local Health District. This research aims to enhance the understanding of digital health interventions in chronic disease management and inform clinical practice.

A first-in-human, single-ascending dose study to determine the safety, tolerability, pharmacokinetics (PD) and pharmacodynamics (PD) of ABS-101 in healthy adult participants. Results of the study will be used to determine the starting dose for subsequent studies in either healthy volunteers and/or patients. As this is a study in healthy volunteers to evaluate safety and tolerability there is not study hypothesis to evaluate.

This research will evaluate the effectiveness and implementation of the eHEEADSSS digital psychosocial screening tool for young people presenting to 3 Emergency Department sites. The eHEEADSSS identifies patient strengths and risks relevant to Home, Education and Employment, Eating and Exercise, Activities, Drugs and Alcohol, Sexuality and Gender, Suicide, Depression and Self-harm, and Safety. Participant patient administrative data will be used to evaluate the effectiveness and implementation of the eHEEADSSS. Participant consent will be waived to allow for the use of patient data for the purposes of intervention evaluation.

Syphilis is an important public health threat in Australia. Benzathine penicillin G (BPG) is the current treatment of choice of non-CNS syphilis infection. Primary, secondary or early latent syphilis is treated with 2.4 million units (MU) of intramuscular BPG injections, while late latent syphilis requires 2.4MU weekly for 3 consecutive weeks. IM BPG injections are associated with significant pain and discomfort for recipients. Consequently, treatment uptake is low, especially where multiple doses are required. Subcutaneous (SC) delivery of BPG is potentially a more efficacious alternative to the current IM injection. Our team has demonstrated acceptability and a superior pharmacokinetic profile in healthy volunteers. Additionally, a small cohort of patients with syphilis reported SC delivery of BPG as a preferred alternative. This study aims to further demonstrate safety and tolerability of a single 7.2MU dose of BPG given as a subcutaneous infusion for the treatment of syphilis. Secondary objectives include demonstrating efficacy of 7.2MU BPG as subcutaneous infusion for the treatment of syphilis and to estimate the proportion of patients with penicillin concentrations above the target concentration of 18mg/mL. Primary outcome is the assessment of safety and tolerability including serious adverse events and reactions. Secondary outcomes are the change in nontreponemal specific serology at 6 months, plasma penicillin concentrations at 6 weeks and the proportion of participants with treatment failure requiring re-treatment at 6 months. We aim to recruit 35 patients with confirmed syphilis infection or contacts of confirmed syphilis infection who would require empirical treatment, at the M Clinic. This study will incorporate self-guided online surveys exploring participant experiences receiving subcutaneous infusion of BPG for syphilis treatment. Participants will be followed up for 24 weeks from day of treatment.

Hyperglycaemia and post-transplant diabetes mellitus (PTDM) are common in heart and lung transplant recipients. PTDM has been associated with unfavorable transplant-related outcomes including increased rates of infection, rejection, graft dysfunction and mortality. To prevent unnecessary transplant-related morbidity and mortality, accurate and sensitive screening tests are required to optimize the diagnosis of PTDM in heart and lung transplant recipients. The proposed study will examine whether use of a simple and inexpensive CGM (FreeStyle Libre2) is non-inferior to the more cumbersome 75-gram OGTT to diagnose PTDM in transplant recipients without a known diagnosis of diabetes at least 12 months after heart or lung transplantation.

This study observes the vancomycin treatment (up to four days) for 100 critically ill patients who are prescribed the antibiotic in the ICU with the Nutromics Sensor Device. These patients will have blood sampling across their vancomycin treatment period, in line with their prescribed treatment regimen (intermittent or continuous dosing). This study will compare vancomycin concentrations measured in interstitial fluid with the Device to those measured in blood samples, and will characterize the performance (ie: stability and precision) of the Device.

Over the past six years, Northern NSW (NNSW) has experienced three disastrous floods and two seasons of bushfires. Chief amongst the mental health impacts is the extremely disabling condition of post-traumatic stress disorder (PTSD). Previous research has estimated that there are 1000s of people with disaster-related PTSD in NNSW. This reflects a broader trend observed in regions hit by climate-related disasters worldwide, where the psychological aftermath often lingers far beyond the physical recovery period. Hence, there is an urgent need for accessible, effective, and culturally sensitive interventions designed to address the complex manifestations of PTSD in disaster-affected populations. Recent research suggests that teaching compassion skills in a compassion group program can be an effective non-trauma-based approach to addressing PTSD. Group-based compassion programs seem particularly appropriate for people who have been dislocated in post-disaster contexts since social connection is the best predictor of good outcomes post-disaster, and compassion for self and others promotes social connection. Stemming from an innovative adaptation of compassion science principles, the present clinical trial focuses on two compassion-focused interventions Arts-Based Compassion (ABC) and Nature-Based Compassion (NBC) programs, tailored to meet the specific needs of flood-affected individuals in NNSW. These programs are scalable, cost-effective, and able to be delivered on a group basis. Therefore, the primary aim of this 14-week randomised clinical trial is to assess the effectiveness of the ABC and NBC interventions in reducing PTSD symptom severity and promoting wellbeing, social connection, resilience, nature-relatedness, and post-traumatic growth in NNSW residents experiencing climate-related PTSD. Secondary aims are to gather evidence for the development of cost-effective and scalable treatments for natural disaster-related PTSD.