ANZCTR search results

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.

AMLM28/A2 is part of the ADAPT platform trial (ACTRN12623000900617), which is testing new ways to treat acute myeloid leukaemia (AML). The study is looking at whether adding a new drug called Pelcitoclax to usual treatment is safe and more effective. Who is it for? Patients enrolled on the ADAPT platform trial who are stratified to: · Domain 1) TP53 mutated acute myeloid leukaemia (AML), and · Domain 2) Minimal residual disease (MRD) persistence after 3 cycles of Azacitidine and Venetoclax (AZA-Ven) treatment with less than <5% blasts, will be enrolled into the A2 treatment arm. Study Details. This is a phase 1b/2, open label study to investigate the feasibility and efficacy of adaptive therapeutic intervention. Patients will receive Pelcitoclax, a dual BCL-2/BCL-XL inhibitor, in addition to their AZA-VEN treatment. The trial will begin with a dose-finding phase (n=12) to assess the safety of adding Pelcitoclax to AZA-VEN treatment, and to determine the recommended Phase 2 dose. This will be followed by an expansion phase, recruiting a total of 50 patients. This study aims to determine if the addition of Pelcitoclax to standard of care AZA-VEN treatment is a safe and more effective strategy for the treatment in newly diagnosed AML patients unfit for intensive chemotherapy.

The Iron Heart Study will evaluate patient reported quality of life measures after administration of intravenous iron supplement in post-operative, anaemic, cardiac surgery patients. Post cardiac surgery patients (n = 80) who have a hemoglobin of less the 100mg/L on day 4 post-operative are eligible for this trial. Once consented, participants will be randomised to receive either an intravenous iron supplement infusion (ferric carboxymaltose 1000mg) or intravenous placebo (normal saline 0.9%) on Day 4 post cardiac surgery. Participants will be asked to complete an EQ-5D-5L Questionnaire on day 4 postoperatively prior to the infusion, and week 6 post-operatively. Participants will also be asked to have blood collected at weeks 2, 4 and 6 post-operatively. Blood results and questionnaire responses will be compared between the two groups to assess quality of life measures.

The purpose of this project is to determine the effectiveness of two types of dental implants. We have two types of dental implants that are used routinely. The two types of dental implants differ in the amount of smooth area. The research project is testing which type of dental implant is better to keep the bone and soft tissue around the dental implants healthy so the dental implants can survive for a long time. Who is it for? You may be eligible to join this study if you are aged 18 years and older, have head and neck cancer and will undergo Osseous free flap reconstruction of the jaw requiring dental rehabilitation with endosteal dental implants. Study Details: You will receive both types of dental implants (if you need more than one dental implant). Your dental implants will be randomly chosen for implant location in your mouth and type at each location. You will have head and neck reconstructive surgery as planned and dental implants will be placed. Following your surgery, bone loss and soft tissue assessments will be conducted every 3 months for 1 year after your operation as routine standard of care. However, these appointments are longer to assess bone loss (15 to 30 minutes) and soft tissue health (15 to 30 minutes) around dental implants for trial purpose. Quality-of-life patient reported data will also be collected using the FACE-Q Head and Neck Module questionnaire and the European Quality of Life-5 Dimensions (EQ-5D-5L) at the first appointment and 3,6,9,12 months post-op. Participation in this clinical trial is voluntary. It is hoped this research will generate new information about dental implants and therefore improve the outcomes of future patients undergoing head and neck reconstructive surgery.