ANZCTR search results

Untreated obstructive sleep apnea (OSA) can lead to serious health, safety, and economic problems. Continuous Positive Airway Pressure (CPAP) therapy is the main treatment and it helps improve sleep quality and daytime alertness. However, about half of all people prescribed CPAP stop using it within the first year, often within the first month. Early interventions to make CPAP more effective can help improve health and quality of life. People with a low respiratory arousal threshold (who wake up easily due to minor airway narrowing) are at higher risk of not sticking with CPAP therapy. Cognitive Behavioural Therapy for Insomnia (CBTi) can help increase the arousal threshold and improve CPAP effectiveness, but it has limitations like the need for trained therapists and time commitment. Using common sleep (hypnotic) medications like zopiclone might be a cost-effective way to help promote sleep (increase the arousal threshold) and improve CPAP adherence. However, more research is needed to confirm the effectiveness of combining hypnotics with CPAP for people who wake up easily. The research project aims to test whether a medication that promotes sleep can help reduce the severity of OSA by improving the effectiveness of the first-line treatment for OSA, Continuous Positive Airway Pressure (CPAP).

IB409 is a drug being developed as a novel approach for the treatment of Myocardial Infarction (MI). Many patients who survive the initial MI event are left with heart damage, leading to a substantial risk for future cardiovascular events such as recurrent MI, death, and heart failure. Existing treatments aim to restore blood flow but fail to prevent ischemia-induced tissue damage. IB409 would offer the potential to protect cardiac tissue from ischemia/reperfusion injury before and during blood flow restoration. In this study, we will look at the safety and tolerability of IB409 in healthy volunteer participants. This study will also determine the levels of IB409 in the bloodstream when given intravenously.

The aim of this study to assess the feasibility of a functional imaging-guided short course radiotherapy boost dose for adults with locally advanced rectal cancer. Who is it for? Patients older than 18 years of age, with rectal cancer confirmed on biopsy, undergoing curative-intent radiotherapy prior to surgery may be eligible for this study. Study details Participation in this trial will require undergoing an additional MRI scan prior to starting treatment; one extra day of radiotherapy treatment prior to the usual 1 weeks of radiotherapy; and completion of brief quality of life questionnaires before, during and after treatment. Participants will also be asked if the research team may review their medical information collected as part of their treatment. A key part of the study is also to assess any treatment-related side effects and your quality of life during and after treatment to ensure the additional dose does not have any adverse effects. It is hoped that this research will help to improve proportion of patients that completely respond to radiation treatment prior to surgical removal of bowel cancer, which may reduce the need for this invasive surgery for patients in future.

Patients who experience atrial fibrillation (AF) have an elevated risk of cognitive impairment and/ or stroke, heart failure and death. Recently, early rhythm control has been shown to reduce stroke and mortality in patients with AF. This retrospective and prospective observational study seeks to characterise intracardiac anatomic and electrical connections in patients undergoing ablation for AF. The primary objective of our study is to analyse electro-anatomic data to improve understanding of AF and AF ablation.

Unmet Need: Acute Myeloid Leukaemia (AML) remains a challenging disease with poor long-term outcomes despite intensive chemotherapy. While venetoclax has shown benefit in older or unfit patients, its role in fit adults receiving intensive chemotherapy is not yet defined. Who is it for: This study is for fit adults aged 18 and over with newly diagnosed AML who are suitable for intensive chemotherapy. Study Design: This is a phase III, multicentre, randomised (1:1) controlled trial comparing standard intensive chemotherapy (IC) with a modified regimen combining IC and venetoclax (IC-VEN). A total of 390 patients will be recruited across participating sites. It is hoped this study will: Determine whether adding venetoclax to a shortened course of intensive chemotherapy improves event-free survival (EFS), measurable residual disease (MRD) clearance, and other clinical outcomes. The trial also aims to establish a new standard of care for fit adults with AML.

The OPERATE project is aimed at improving health care and outcomes, and decreasing the reliance of attending the Emergency Department (ED) for patients aged 65 years or over. The project will study patients who are presenting to EDs requiring acute care, at risk of presenting, or requiring an emergency ambulance. Phase I of the OPERATE project aims to evaluate existing clinical and health services (interventions) that provide care pathways for WA older patients (aged 65 years or above). Following the evaluation processes, a proof-of-concept model of acute aged care will be designed for future implementation.

A randomised, double-blind, crossover trial will investigate motility patterns, fermentation profiles, and symptom responses to varying lipid doses in 10 patients with functional dyspepsia – postprandial distress syndrome (FD-PDS) and 10 healthy controls. Participants will be randomly assigned in a crossover design manner to either ingest a low fat (3g), moderate fat (6g), or high fat (16 g) meal. This study aims to determine the effect of dietary lipid content on gastrointestinal transit times and regional fermentation gas dynamics (H2, CO2) in individuals with FD (PDS subtype) compared to healthy controls, using the Atmo gas-sensing capsule.

This study aims to tackle a big problem in Australia's rheumatology healthcare system. Even though national guidelines and experts emphasise the importance of having a team of specialists, including podiatrists (foot care experts), podiatry services are missing in public rheumatology clinics. This is a major issue because foot problems are common and very painful for people with rheumatological conditions. Our proposed trial aims to show if it is worthwhile conducting a larger trial about whether adding a specialised podiatry service in rheumatology clinics can work and make a positive difference for people with foot problems due to rheumatological conditions.

Double-blind, Randomized, Placebo-controlled, Crossover study to assess the safety and efficacy of cilnidipine (20 mg) alone. Participants will be randomized to drug first, or placebo first, followed by the alternate treatment in a subsequent dosing period. Medications will be dispensed during the preceding in-clinic study visit for self-administration by the participant. Each Dosing Period will last for 12 days (allowing for a variance window of ±2 days [d10-d14]) in which participants will take daily doses of assigned treatment in the morning. For each day of dosing, participants will take active drug or matching placebo to blind the active therapy being received.

This study aims to determine whether the use of artificial intelligence for polyp detection during colonoscopy has additional benefit when used in combination with texture and colour enhancement imaging (TXI) - a new form of advanced endoscopic imaging technology. In our previous study comparing TXI to usual endoscopic imaging we demonstrated significant improvement in polyp detection with TXI (ACTRN12621000708853). Artificial intelligence has been shown in clinical trials to improve polyp detection. We are aiming to assess whether there is a glass ceiling on polyp detection where additional technology may not be of incremental benefit.