ANZCTR search results

The purpose of this research is to investigate a new heart therapy device for the treatment of acute decompensated heart failure (ADHF) with worsening renal function (WRF), to evaluate the device for providing support and recovery during unscheduled hospital admissions. This type of heart failure occurs because the heart is not pumping blood effectively leading to a sudden deteriorating or worsening heart failure, often requiring emergency hospital admission. Typically, a patient presents to hospital in an emergency with congestion and fluid retention, resulting in shortness of breath and lower limb swelling. Diuretics are used to remove fluid and reduce congestion which is only effective in around half of the patients treated. The QHeart TARR heart therapy device is a new treatment aiming to support patients who do not respond in a timely manner to diuretics. The QHeart TARR heart therapy device is a small balloon that is deployed inside the descending aorta, the large blood vessel running from of the heart supplying blood to organs and tissues throughout the body, including the kidneys. The TARR balloon device has shown very promising performance and safety data in pre-clinical studies. The TARR heart therapy device uses a small diameter balloon sized for low risk within the aorta. The device is inserted using a standard interventional procedure in under 30 minutes and can be safely removed at any time during use. The device balloon is inflated which then automatically works with your heart allowing your heart to pump more effectively. The study aims to show the TARR device therapy: 1) Provides a clinically significant improvement in heart performance during treatment, and 2) The TARR device and procedures for its insertion, use, and retrieval are as expected and without any adverse events.

This study aims to investigate whether a supervised, online, home-based eccentric resistance exercise program can reduce liver fat and improve liver health in adults with metabolic dysfunction–associated steatotic liver disease (MASLD). Participants will complete five supervised exercise sessions each week for eight weeks, delivered live through Google Meet. Liver fat, liver stiffness, liver enzymes, metabolic markers, and physical fitness will be measured before and after the program. We hypothesise that this home-based eccentric exercise program will be safe, feasible, and effective in reducing liver fat and improving MASLD-related health outcomes.

Fatigue is a common and debilitating symptom of primary biliary cholangitis (PBC), yet no approved treatments currently exist. Creatine, through its beneficial effects on mitochondrial function, muscular metabolism, and neuroprotection, represents a biologically plausible therapeutic option to treat symptoms associated with PBC. This is the first study of its kind with aims to assess whether creatine supplementation improves fatigue, quality of life, liver biochemistry, and muscle function in patients with PBC. If effective, creatine could offer a safe, accessible, and cost-effective strategy for managing fatigue in this population.

This study aims to evaluate whether an online intervention helping people understand the science of pain and self-management strategies for endometriosis can help people with suspected endometriosis in their journey into, and recovery from, their first laparoscopy (surgery to diagnose and treat endometriosis). Previous work in back pain and surgery has shown this type of intervention can help to reduce pain, improve recovery from surgery, and reduce someone's overall healthcare usage after back surgery. We have recently work with people with pelvic pain and endometriosis to understand more about what they value in terms of learning about pain and self-management in order to recover. Now we want to turn these findings into an online intervention and evaluate its feasibility, acceptability, and preliminary efficacy in those with suspected endometriosis about to undergo their first laparoscopy.

The purpose of this study is to determine if an imaging method called laser confocal endomicroscopy can accurately identify the the presence of residual tumour in the margins of head and neck cancer during surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, under the care of the principal investigator with known head and neck cancer limited to the oral cavity, oropharynx or base of the tongue and requiring surgical intervention as standard therapy. Study details Participants in this study will undergo their usual surgical treatment for head and neck cancer. During this procedure the surgeon will image the tissue remaining after the tumour is removed and the researchers will also image the cancerous tissue which has been removed. The standard pathology tests will then be performed. If this study shows that laser confocal endomicroscopy can accurately determine margins in head and neck cancer then this will lead to larger clinical trials. Ultimately the aim is to give surgeons more precise tools for determining surgical margins to improve surgical outcomes for patients.

In the context of ensuring that all clients of a health organisation receive care consistent with the best available evidence, this pilot trial aims to test the feasibility and potential impact of a new approach to integrate evidence into existing models of care, known as “SAIFR” (Systematic Approach to the Implementation of Falls Recommendations). SAIFR will be pilot tested within two sites of the community rehabilitation program at Eastern Health using a stepped-wedge design, with implementation guided by the COM-B Model for Behaviour Change. The feasibility of study methods (e.g. step timing, client recruitment, training feasibility, engagement, falls measurement, progression requirements, drop-out rates and contamination) will be evaluated. The potential impact of applying this systematic approach to implementing the World Guidelines for Falls Prevention and Management for Older Adults and the Australian Preventing Falls and Harm from Falls in Older People: Best Practice Guidelines to the Community Rehabilitation Program will also be evaluated, using the first four elements of the RE-AIM framework – reach, effectiveness, adoption and implementation. Findings related to potential impact and feasibility will determine whether pre-specified progression criteria are met to support progress to a fully powered stepped-wedge, randomised controlled trial of the Systematic Approach to the Implementation of Falls Recommendations (SAIFR).

The human body releases heat by sweating and increasing blood flow to the skin. However, when the temperature gets too hot, or the humidity too great, these processes become impaired. This causes heat to be stored in the body, and the body temperature to increase. Understanding the specific environmental conditions when this occurs is very important to prescribe advice regarding upper environmental limits for older adults engaging in physical activity in the heat. The objective of this study is to determine the ambient temperature and humidity at which age-related impairments can result in greater risk of heat illness. To determine these limits, participants will perform light intensity exercise in various environmental conditions and body temperature will be monitored while the humidity is increased throughout the trial. These data will be used to derive upper environmental limits for older men and women exercising in the heat.

This study seeks to evaluate the efficacy of the Single Session Course, a brief intervention for depression and anxiety for adults, and to explore the impact of a pre-treatment diagnostic interview. The current study hypothesises that the Single Session Course will be more effective than a waitlist control and furthermore receiving a diagnostic interview prior to starting the Course will also be associated with reductions in depression and anxiety.

This research project aims to explore whether i) introducing regular exercise consultations from physiotherapists before and after colorectal cancer surgery and ii) allowing patients to choose when they want to participate in a formal exercise program is feasible and beneficial. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with stages I-III colorectal cancer and is within 6 weeks of planned primary tumour resection surgery for colorectal cancer at Eastern Health. Study details Participants will be randomly assigned to receive either three physiotherapist-led exercise consultations inclusive of an exercise assessment, delivered at key times of their cancer care pathway, or the usual care that people currently receive. Data on feasibility, acceptability, physical activity and health-related quality of life will be collected at key timepoints during the trial. It is hoped that findings from this study will help researchers understand how and when exercise support should be offered to people undergoing treatment for colorectal cancer in the future.

This project aims to measure biomarkers of nitrate metabolism in the body after vegetable and meat intake. To assess this, we will examine biomarkers (nitrate, nitrite and N-nitrosamines) in urine and faecal (stool) samples. The study hypothesis is that eating nitrate-rich vegetables with meats that do not contain added nitrate or nitrite will not increase potentially harmful N-nitrosamines in the body, whereas eating nitrate-rich vegetables with meats that do contain added nitrate or nitrite will increase these compounds, despite the natural protective substances found in vegetables.