ANZCTR search results

This project aims to examine whether a 10-week multidisciplinary group exercise, nutrition, and self-management program or individual telehealth counselling for older adults with type 2 diabetes (T2D) and osteoarthritis (OA) improves cardiometabolic health, fitness, quality of life and pain. The Meta-Health Clinic will be delivered within the UNSW Medicine & Health Lifestyle Clinic, as part of usual clinical service, with the aim of improving T2D and OA management through increased participation in healthy lifestyle behaviours. The research hypotheses that this study seeks to address are: 1. In persons with T2D and OA, both multidisciplinary exercise, nutrition and self-management group programs, and individual telehealth counselling will improve cardiometabolic risk profiles when compared with usual medical care over 10 weeks 2. The Meta-Health Clinic program will: • Improve muscular strength, fitness and physical function • Improve glycaemic control • Improve condition self-management and quality of life (e.g. T2D and pain management)

This project aims to obtain the views of people about what they think about the Geldom and how it performs (e.g. did it break or slip) compared with a latex condom during intercourse. It is not testing the condom’s performance as a barrier contraceptive or at how it prevents STI transmission. The information will be used to support the development of additional studies that will look at confirming the views and performance of the Geldom during intercourse, these studies are called pivotal studies. The study requires that you are sexually active and in a stable current relationship of equal or greater than 3 months. You will be required to have penile-vaginal intercourse with your partner a total of 6 times over a 4 week period while using the condom provided by the study; either the Geldom condom or a latex condom.

This platform trial will initially enroll patients to the Australasian Leukaemia and Lymphoma Group (ALLG) National Blood Cancer Registry (NBCR) which acts as the initial gateway to data collection and Acute Myeloid Leukaemia (AML) trials for the ALLG. Patients unfit for intensive chemotherapy and planned to receive Venetoclax and Azacitidine (VEN-AZA) as standard of care will be invited to sign the AMLM28 ADAPT master consent form. This trial will utilise serial Minimal Residual Disease (MRD) monitoring, performed centrally, to guide adaptive changes in therapy aimed at improving patient outcomes and quality of life. This platform trial aims to provide an overarching research framework that will enable research questions to be addressed prospectively and systematically for AML patients receiving VEN-AZA. Who is it for? You may be eligible for this study if you are aged 18 and above and have been diagnosed with AML. Study details Participants who choose to participate in this trial are required to consent to both the NBCR and the AMLM28 ADAPT platform prior to commencement of VEN-AZA. This is to enable a baseline and monitoring centralised MRD assessment to be performed. Patients will be enrolled into the master protocol and commence on VEN-AZA. Subsequent adaptive interventions will be based on the patient’s response to treatment after starting VEN-AZA. Domain 2 (ADAPT-STOP) aims to address the question of whether it is safe to stop therapy in patients responding well to venetoclax and azacitidine (VEN-AZA) therapy. Approximately 50 “opt-in” patients will be initially randomised 1-to-1 to the treatment cessation arms. An interim analysis will be performed upon recruitment of 50 “opt-in” patients. A further expansion of recruitment up to 100 “opt-in” patients may be allowed, and will be determined by the Trial Management Committee and sponsor. Up to 50 “opt-out” patients will be followed for VEN-AZA treatment duration, PROs, disease status including relapse and survival. If the patient experiences MRD relapse or morphologic relapse at any stage of the study, the patient may be considered for eligibility for the ALLG AMLM26 INTERCEPT study. It is hoped this research will deliver adaptive interventions to improve clinical outcomes in patients receiving frontline VEN-AZA for newly diagnosed AML.

This is a first in human testing of novel HIV-1 protein nanoparticles vaccine candidates, UVAX-1107 and UVAX-1197 mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants. After meeting all eligibility criteria, approximately 34 participants will receive a 4 dose vaccination regimen of either 2 priming vaccinations of UVAX-1107 followed by 2 boosting vaccinations of UVAX-1197, or 4 doses of UVAX-1107, or placebo. Subject participation is expected to last up to 374 days, including up to a 30-day screening period and a 337-day study period during which subjects will be followed for safety and immunogenicity outcomes.

Hand osteoarthritis (OA) is a disabling condition impeding activity of daily living leading to pain, functional impairment, and reduced quality of life. The age-standardised prevalence of hand OA in the general population is 44·2% in women and 37·7% in men. Despite the high prevalence and significant disease burden, there is no effective therapy for hand OA. Hand OA is a heterogeneous condition. The inflammatory phenotype is a commonly encountered clinical phenotype, characterized by joint swelling (synovitis). The presence of synovitis being associated with joint pain and structural progression. Therefore, synovitis has the potential to be a target for treatment in hand OA. Methotrexate is a well-established, low-cost, and effective treatment for inflammatory arthritis with a well-described safety profile. In our previous METHODS study (a randomized, double-blind, placebo-controlled trial to determine the effect of 20 mg methotrexate once weekly on reducing pain and improving function in patients with symptomatic hand OA and synovitis over 6 months, ACTRN12617000877381), we showed that methotrexate would reduce pain and stiffness over 6 months compared to placebo in patients with hand OA and synovitis. But there are still a number of unknown questions regarding the use of methotrexate, including how long we need to treat those with hand OA with methotrexate; is there a group that are more likely to respond; and does response to treatment predict less joint damage. Thus, we conducted this METHODS-Extend open label study to address those queries.

Therapeutic devices are essential to support the clinical care of critically ill patients, yet such devices are recognised as a potential source of harm to the skin and mucous membranes in the form of therapeutic device-related pressure injuries. The neonatal, paediatric and adult populations have distinctive anatomical, physiological and developmental factors that influence their risk for device-related pressure injury development. The project aim is to co-develop implementation strategies, and then test, evaluate and disseminate a bundle of evidence-based, cost-effective scalable practices to prevent medical device-related pressure injury in critically ill patients of all ages. Phase 1 will recruit clinical staff for surveys and workshops to develop the site-specific SAFET bundle. Phase 2 will evaluate the effectiveness of the bundle using a multi-centre, stepped-wedge, cluster randomised trial design comparing device-related pressure injury incidence in patients (proportion) in the control period with the intervention period. The cost-effectiveness of the SAFET bundle will be analysed. The hypothesis of this project will be to detect a significant reduction in device-related pressure injury across the lifespan in ICU leading to the elimination of DRPI among babies, children and adults after using the SAFET care bundle.

The purpose of this research study is to investigate the impact of carbohydrate loading with high and low FODMAP diets on markers of gastrointestinal integrity, function, symptoms and performance implications in response to endurance exercise. FODMAPs are short chain fermentable carbohydrates (e.g., lactose, fructose, fructans, galactans and polyalcohols), which are transported slowly in the small intestine and are rapidly fermentable by the colonic microbiota. This fermentation can lead to bloating, visceral hypersensitivity and/or a change in gut motility. To determine any gastrointestinal changes, this will be achieved through the consumption of a high carbohydrate diet with high or low FODMAPs 48-hours before two hours of continuous running, following by a one-hour performance test.

To study the if cleaning the surgical wound immediately after wound closure causes increase in bacterial growth on the skin. This study includes patients undergoing elective total hip and total knee arthroplasty. Cleaning surgical site after wound closure is a common practice seen in operating theatres. In an attempt to remove dried body fluids from the skin, vigorous rubbing using surgical sponges is often required. Such a technique can introduce skin flora into the wash fluid and may risk a wound infection.

The failing heart has been found to shift to ketone bodies as a significant fuel source with resultant improvements in cardiac function. There is a strong theoretical rationale for ketosis in improving heart failure, yet clinical research of this therapeutic strategy in heart failure with reduced ejection fraction (HFrEF) is lacking. In fact, there are very few dietary trials in patients with heart failure, despite diet being a cornerstone of cardiovascular disease prevention and treatment. This is an investigator-initiated, open-label, prospective randomised controlled pilot study, with two groups: control (no dietary intervention, n=30) and intervention: a normocaloric KD (N=30). This study has the pre-specified goal of exploring the cardiovascular effects of a KD in patients with heart failure to guide a larger clinical trial.

This study aims to establish the feasibility, acceptability and fidelity of a high- and low-intensity self-efficacy-based dietary intervention for adults with CKD for a future large-scale clinical trial.