ANZCTR search results

Imagery Rehearsal Therapy (IRT) is a psychological treatment which is thought to reduce the frequency and intensity of trauma-related nightmares. Experiencing nightmares is common after being exposed to stressful life event and these typically subside over time. However, some people who have been exposed to a traumatic event will experience ongoing and frequent nightmares. The aim of this study is to determine whether IRT is an effective intervention in reducing the frequency and intensity of post-traumatic nightmares as well as overall Posttraumatic Stress Disorder (PTSD) symptoms.

Endometriosis is a common condition that affects around 1 in 10 Australian women. The condition is highly burdensome for sufferers, causing debilitating chronic pain; symptom recurrence; compromised fertility; impaired sexual function, and a substantial reduction in quality of life (QOL). Gastrointestinal (GI) symptoms similar to those seen in irritable bowel syndrome (IBS) are particularly common among women with endometriosis, affecting up to 90% of patients. Despite this, we have poor understanding regarding the physiological mechanisms driving these GI symptoms. Candidate mechanisms include changes in gut microbiota, co-morbid psychological disorders, chronic inflammation and/or visceral hypersensitivity. This study will examine whether GI symptoms in patients with endometriosis are associated with the presence of visceral hypersensitivity and/or chronic subclinical inflammation. Understanding the physiological mechanisms driving GI symptoms in endometriosis is essential to the development of treatments targeting these pathways.

Corneal ectasia such as keratoconus, post-LASIK ectasia and pellucid marginal degeneration induce irregular astigmatism which degrades visual quality. Often people with these conditions cannot achieve normal or functional vision in spectacles or soft contact lenses because of their irregular nature. The rigid anterior surface of a scleral contact lens provides an optical interface that regularises vision. However, even with a scleral contact lens some irregular astigmatism remains uncorrected and contributes to degradation of visual quality. By mapping the irregular astigmatism left over with a conventional scleral contact lens on the eye we can reduce irregular astigmatism even further with ‘aberration control’. The purpose of this study is to investigate the effect of aberration control on the front surface of scleral lenses on visual performance and on the reduction of irregular astigmatism in corneal ectasia.

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.