ANZCTR search results

This study will investigate the effectiveness of two interventions to prevent surgical site infection after below-knee surgery for skin cancer in adults. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with a skin cancer below the knee which requires a complex surgical technique (flap or graft repair), and you are a patient at one of the participating centres in Queensland. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups. Participants allocated to the first group will be asked to take an oral tablet pre- and post-surgery, and use an antibacterial body wash prior to their surgery. Participants allocated to the second group will also be asked to take a pre- and post-surgery antibiotic dose and use a provided body wash prior to their surgery. Participants allocated to the third group will be asked to take an oral tablet pre- and post-surgery and use a provided body wash prior to their surgery. It is hoped this research will determine whether use of oral antibiotics with or without antibacterial body wash has any impact on the incidence of post-surgical skin infections in patients undergoing surgical removal of below the knee skin cancers. If one or both of these measures is found to be effective, a larger trial enrolling a greater number of participants may be undertaken.

This study is designed to evaluate the safety and tolerability of arginine undecylenate (15% w/w undecylenic acid) and to explore its effectiveness in mitigating the pain associated with the lesions that present as a result of VZV infection (shingles). Up to a total of 30 eligible participants will be randomly assigned in a ratio of 2:1 to apply either arginine undecylenate (n=20) or placebo (n=10) to their shingles lesions twice daily for 10 consecutive days. The Zoster Brief Pain Inventory (ZPBI) will be completed by the participant throughout the study. Participants will return to the clinic on Day 5, Day 11, and Day 30 for safety review and preliminary efficacy assessments.

The study aims to investigate the impact of legume consumption on mood. It is a 4 week randomized controlled trial where three meals per week are provided to the participants. The meals will be matched for macronutrient content between the control and intervention groups. The primary endpoint is understanding change in mood due to legume consumption. Secondary measures will consider impact of legume consumption on gastrointestinal symptoms, diet and sleep quality and physical activity. All study visits will be conducted at the nutrition teaching laboratory at the University of Canberra.

To assess current management, including adherence to national guidelines, and outcomes in patients with intracranial haemorrhage. To also improve adherence to guidelines through the use of an integrated continuous Quality Improvement program assessing key performance indicators of blood pressure control and reversal of anticoagulant medications.

This study aims to assess the effect of positive and negative expectations that develop in response to our daily experience. It is believed that positive expectations increase the benefit from pain program and negative expectations reduce the benefit from the same pain program. Study participants will be asked to fill out a daily questionnaire containing the same seven questions for 28 days when they attend the weekly CALM group program. This will then be assessed against changes in their pain psychometrics before and after the pain program.

Some patients when receiving such mechanical ventilation develop hypercapnia and associated hypercapnic acidosis. Such patients have an increased risk of mortality. While the exact reasons of such increase in mortality is not known, it is recommended to minimise hypercapnia and hypercapnic acidosis during lung protective ventilation. Minimally invasive extracorporeal carbon dioxide removal (ECCO2R) devices are shown to reduce hypercapnia and hypercapnic acidosis. There are several devices that are currently available in the current clinical practice. However the effect of these devices on reduction in ventilator induced lung injury is not clearly demonstrated. This study aims to assess the reduction in ventilator induced lung injury with the use of ECCO2R device called Prismalung that is currently used in our intensive care unit. This assessment is done by measuring of pulmonary interleukins and blood interleukin levels as well as clinical assessment including the reduction of driving pressure.

This study aims to evaluate the efficacy of Savi Scout® a radar localisation (RL) device in localising non-palpable breast lesion and axillary marking Who is it for? You may be eligible to join this study if you are aged 18 years and older, and have non-palpable breast cancer/breast lesions Study details Participants will be allocated to the intervention group if they consent for participation. Otherwise, they will be allocated to the control group. Participants in the intervention group will undergo RL using the Savi Scout® device to determine tissue margins prior to surgery while the control group will undergo standard of care wire localisation (WL) using Kopans hookwire to determine tissue margins prior to surgery. Participants will be followed-up postoperatively within one month following surgery to assess accuracy of margins, the outcome of a Multidisciplinary Meeting to determine the next step in cancer management. It is hoped that this research project will provide useful information about whether RL is a cost-effective intervention compared to traditional WL.

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.