ANZCTR search results

As the population ages, aortic stenosis (AS, a heart valve disease involving degeneration and obstruction of the aortic valve) is becoming an increasing problem. This condition is often unrecognized until patients present in a crisis. The goal of the ASSURE-ECHO study is to identify the feasibility and value of AI-guided and-interpreted echocardiography for screening for aortic stenosis in the community. The aims of the project are to confirm the feasibility of AI-guided echo acquisition and interpretation in rural and remote communities, and to show greater recognition of AS than through usual care.

Operation Glucose is a clinical trial exploring whether continuous glucose monitors (CGMs) can improve diabetes management in hospitalised patients with insulin-requiring type 2 diabetes who are undergoing surgery. People with diabetes face a higher risk of complications during the surgical period, often due to fluctuations in blood glucose levels. This study aims to assess whether CGMs can help reduce these fluctuations (known as glycaemic variability), to support better blood glucose control and improved clinical outcomes. Participants will be randomly assigned to one of two groups. One group will wear a CGM device (Libre 2 Plus) that displays real-time glucose data to both the patient and the clinical team. This data, alongside regular finger-prick testing, will be used to guide treatment. The other group will wear a blinded CGM device (Libre ProIQ) which does not display glucose data. This group will rely on standard finger-prick testing alone for treatment decisions. The primary outcome will be the percentage of time that a patient's blood glucose levels remain within the healthy target range (4.0 - 10.0 mmol/L).

This is a Phase 1, four-part clinical trial in healthy adult participants to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SPT-320, an investigational oral prodrug of agomelatine. Part B evaluates single ascending doses of SPT-320 compared with placebo. Part D studies multiple ascending doses of SPT-320 given once daily for 7 days, compared with placebo.

This study aims to find out how the body absorbs a powdered form of penicillin called Extencilline® when given by two different injection methods, into the muscle (intramuscular) or under the skin (subcutaneous). Penicillin is the main treatment for syphilis in pregnancy, but the current method (muscle injection) is painful and often requires multiple doses. A new method of giving the medicine under the skin may be less painful and more convenient. In this study, healthy adults will receive doses of penicillin using both routes of delivery at different times, and blood samples will be taken to measure how long penicillin stays in the body. The study will also look at side effects, pain, and participants’ experiences with both types of injection. We hope this research will help develop better ways to give penicillin in future studies involving pregnant women.

The study Sponsor (Parvus Therapeutics) is developing a new drug called PVT201 for the treatment of Primary Biliary Cholangitis (PBC). This research study will examine the safety and tolerability of PVT201 for humans. This registration is for the patient cohort, examining PVT201 in participants with PBC/PSC. All participants will receive a single dose of PVT201 on Day 1 of the study and participants will be followed-up on Day 2 & Day 7 of the study.

This study is a pilot randomised, placebo-controlled clinical trial to determine the impact of a Strawberry sorbet containing Davidson Plum powder on oxidative stress, and muscle recovery following a high-intensity interval training session in long-distance runners. The study incorporates a one week baseline period, 10 day intervention period and 24, 48 and 72 hours follow up.

Have received feedback which we are actively addressing to obtain HREC approval ERM Reference Number: 116499 Monash Health Reference: RES-25-0000-173A This study, called SLUMBER, is investigating whether melatonin—a natural hormone known to help regulate sleep—can improve sleep quality in women with endometriosis, a condition often linked to both pain and sleep disturbance. Participants will take either a placebo, 10 mg, or 20 mg of slow-release melatonin nightly for eight weeks. Researchers will assess changes in sleep, pain, and overall well-being through surveys completed before and after the trial. The study hypothesis is that melatonin use will lead to improved sleep quality, compared to placebo, in women with endometriosis.

This is a first-in-human, multi-center, randomized, double blind, two-part single and multiple ascending dose study to assess the safety of SNT9465, and how this drug acts in the body in healthy volunteers. SNT9465 may be indicated for use in patients with Hypertrophic Scars, but a trial of the drug in healthy volunteers is needed before trials in patients with Hypertrophic Scars can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. Study details: All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single or multiple doses of SNT9465 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with Hypertrophic Scars.

This is a prospective, multi-center, single-arm phased study assessing the efficacy and safety of the ETLA system for the treatment of severe emphysema with hyperinflation. The ETLA System is a minimally invasive bronchoscopic treatment designed to deliver heated normal saline to targeted emphysematous lung regions with hyperinflation to cause tissue ablation and subsequent volume reduction as a means for treating emphysema. The ETLA therapy will be delivered sequentially over two (2) procedures. The magnitude of clinical benefit associated with ETLA is anticipated to correlate with the relative volume of diseased tissue removed/reduced, therefore it is anticipated that a higher relative saline dose may result in greater improvement.

This study intervention proposes EMDR Therapy may facilitate more rapid and effective improvement in mood (anxiety and depression), cognition (attention/concentration, memory) and quality of life for individuals who have experienced a recent concussion when compared to care as usual (CAU). Further aim of the current study intervention is to examine functional connectivity within the Default Mode Network (DMN) and associated neurological changes following EMDR relative to control groups.