ANZCTR search results

The overarching primary research question for the QoVAX SET Statewide study is; In the Queensland community statewide, what level of short-term vaccine humoral immunity induced at one to three months post vaccination is associated with i) protection from community acquired SARS-CoV-2 infection with known or emergent variants of concern, and ii) severe health outcomes of community acquired COVID-19. The QoVAX Statewide study will address these specific research questions; 1. What are the host intrinsic (level of antibody response, , HLA type) and extrinsic factors (socio-economic health determinants, environmental exposures e.g. smoking) associated with i) vaccine efficacy, and ii) severe COVID-19? 2. Do members of the community who identify as Aboriginal and/or Torres Strait and/or South Sea Islander, or as being from diverse ethnic backgrounds, show similar vaccine responses, and associations with i) vaccine efficacy, and ii) severe COVID-19, and the general Queensland population? 3. Do certain pre-existing health conditions (autoimmunity, cancer, immunodeficiency), and medication use effect i) vaccine efficacy, and ii) vulnerability to severe COVID-19? A statewide recruitment campaign will be undertaken and participants will self-enrol via the study website. A questionnaire will be completed and blood samples collected at 1 - < 3 months following the last dose of a COVID-19 vaccine or at enrolment for unvaccinated participants. Participants will be followed over the long term via both repeat questionnaires and data linkage with administrative health datasets to ascertain study outcomes.

The purpose of this substudy is to better understand the effects of exercise on a number of the body’s responses to complex cancer surgery, including immune effects and the performance of certain organs, such as the heart and brain. Who is it for? You may be eligible for this study if you are an adult who is undergoing complex surgery for treatment of cancers of the gastro-intestinal tract and has already been enrolled in the PRIORITY trial (as described in registration ACTRN12621000617864). Study details In addition to taking part in the PRIORITY trial, participants in this sub-study will be asked to provide blood samples before and after their operation. They will also be asked to complete additional questionnaires before and after their operation to assess for any changes to brain function. Participants will then be asked to complete those questionnaires again one year after their surgery. It is hoped that this study will help researchers to understand the biological reasons why exercise and fitness influences a person’s ability to recover from major surgery, including whether or not they suffer complications following their operation. The ability to answer this question is an important research target because it will advance an understanding of interventions that can be offered to patients to reduce the risks associated with undergoing complex surgery.

Automated insulin delivery can assist in achieving the metabolic goals of people living with type 1 diabetes while at the same time reducing the heavy intellectual and psychological burden of care. The Medtronic 780G is a second generation closed loop (artificial pancreas) system incorporating several enhancements to the currently commercially available 670G hybrid closed loop (HCL) system. Modifications include an advanced hybrid closed loop (AHCL) algorithm with adjustable glucose targets, automated correction boluses, software modifications allowing greater persistence in closed loop with fewer alarms in conjunction with smartphone connectivity. The initial pivotal trials of the 780G have demonstrated promising clinical and safety outcomes. The success of these automated devices moving forward hinge upon their ease of use and ability to reduce and relieve the burden of living with type 1 diabetes. The Melbourne cohort of twenty-two participants with type 1 diabetes using pumps with the AHCL algorithm include individuals that were involved in early feasibility studies, and some have had over two years of experience with the same AHCL algorithm used in 780G. They are currently enrolled in an extension study (ACTRN12620000687998) with their glucose levels managed by the MiniMed™ AHCL system (Medtronic, Northridge, CA), consisting of a MiniMedTM 600 series insulin pump with the AHCL algorithm in conjunction with a Medtronic GuardianTM Sensor 3. The system utilizes RF connectivity requiring initiation and implementation of data upload by the user. The sensor configuration requires calibration at least twice daily using a capillary blood glucose reading using a blood glucose meter. The 700 series Medtronic pumps utilize blue-tooth connectivity transmitting insulin delivery and glucose data seamlessly to the cloud and there is no requirement for the user to implement download of the pumps data. Also, very recently, further technical advances including a seven-day extended wear infusion set and an improved sensor form factor reducing intrusiveness and the requirement for calibration fingersticks have the potential to improve the experience of those using Closed Loop Technology. Aim: To determine feasibility and acceptance of the Next Generation Medtronic HCL System (780G; Synergy Glucose Sensor; and Extended wear infusion set)

The purpose of this study is to determine the safety and efficacy of the addition of an anti-nausea drug called prochlorperazine to current standard of care treatment for patients with HER2-positive breast cancer. By administering a high dose of prochlorperazine as an infusion directly into your veins over a short period of time (20-30 minutes), the process by which cells absorb molecules may be blocked. When this absorption process is blocked, it is thought that individuals may respond better to one of the drugs used to treat HER2-positive breast cancer. Who is it for? You may be eligible for this study if you are an adult who has metastatic HER2-positive breast cancer and you haven’t chemotherapy treatment yet. Study details All patients in this study will receive a high dose of prochlorperazine 3 weeks after the commencement of their chemotherapy. After this, all patients will receive the prochlorperazine weekly with their usual chemotherapy. There will be different doses of the prochlorperazine given to participants depending on when the participant joins the study, with the doses starting at the highest dose and then decreasing over time dependent upon any safety concerns. It is hoped that this research will help determine if the high dose prochlorperazine is safe in combination with chemotherapy to treat patients with HER2-postive breast cancer, while also testing whether this has an effect on improving health outcomes.

An Australian Double-Blind Randomised Controlled Trial of Genotype-guided versus Standard Psychotropic Therapy in People with Treatment Resistant Depression. The study intervention consists of a pharmacogenomic (PG) test with resulting recommendations for which antidepressants may work better for that participant. Eligible participants will be randomised to one of two arms. 1. PG-informed treatment arm: The treatment plan for their antidepressants will be informed by participant’s PG results. 2. Standard treatment arm: The treatment plan for their antidepressants will follow current treatment guidelines but will not be informed by participant’s PG results. Both groups will be recommended medications that follows current treatment guidelines for moderate to severe treatment resistant depression. To test the hypothesis that pharmacogenomic-guided treatment compared to standard treatment improves clinical outcomes in treatment-resistant MDD Study Procedures Pharmacogenetic testing PG-informed or standard care antidepressant treatment Clinical outcome assessments and questionnaires at baseline, and week 2, 4, 12

Almost half of patients with heart failure may be frail and previous studies suggest that frail heart failure patients are less likely to receive evidence-based heart failure specific treatment. The prevalence of frailty among heart failure patients who needs hospitalisation in Australia is unknown. This study aims to determine the prevalence of frailty in heart failure patients and will also determine whether clinical outcomes among patients who received heart failure medications were different when compared to those who did not receive treatment.

This prospective study will monitor ANCA levels in patients with ANCA vasculitis. The purpose of this study is to Identify if ANCA rises are associated with relapse of ANCA vasculitis. Study hypothesis: two and four-fold ANCA rises will precede clinical relapses within the prior 6 months

This is a single centre, investigator-led study of venous compliance in patients with heart failure (heart failure with reduced ejection fraction: HFrEF and heart failure with preserved ejection fraction: HFpEF) and the relationship with central haemodynamics.

Burn wound progression can be variable after the initial injury has occurred. Tissue oedema as a result of the injury can compromise microcirculation resulting in this progression. Pressure applied to this area through NPWT is known to squeeze oedema fluid out of the interstitial space. It is plausible that applying NPWT within this initial timeframe may halt or limit burn wound progression. The use of Negative Pressure Wound therapy (NPWT) in the treatment of burns has increased over the past decade. It is common practice at the Pegg Leditschke Children’s Burns Centre, Queensland Children’s Hospital to apply NPWT post-split thickness graft to improve take of the graft and more recently it’s efficacy in acute burns has been tested using the Renasys Go. More recently the Renasys Go has been trialled in the unit for burns less than 5% TBSA within 1 week of injury. This study found improved clinical outcomes, especially when applied within 48 hours. However, parents reported a burden due to the size of the Renasys Go and need for recharging accessories. There is lack of information regarding the use of the smaller, battery operated NPWT device, PICO, as a primary treatment for acute burns. Applying NPWT could greatly improve the final outcome of a burn wound. This could have multiple implications as improved time to re-epithelialisation can impact on overall cost of treatment, requirements for scar management as well as possible reconstructive requirement in the future. This study will address the paucity of knowledge of “ultra portable” negative pressure devices for use in acute burn wound care. This will build on knowledge recently acquired in a randomised controlled with a larger device (Smith and Nephew – Renasys Go). This study aims to establish the feasibility and safety for the use of the ultra-portable PICO negative pressure device in children with burn injuries.

The purpose of this study is to test a drug called GDD3898 Topical Gel on participants with Sebaceous Hyperplasia. Sebaceous hyperplasia is a disorder in which sebaceous glands become enlarged, producing flesh-coloured or yellowish, papules on the face. Lesions of sebaceous hyperplasia do not resolve spontaneously and are resistant to a variety of treatments. They are subject to irritation with shaving and patients frequently complain about their appearance. Sebaceous hyperplasia occurs in 1-2% of the population. Current treatment options include, but are not limited to, the use of topical retinoids, electrocauterisation, photodynamic, laser, or cryotherapy, etc.; however there is currently no approved pharmacological treatments for Sebaceous Hyperplasia. Animal studies have shown that GDD3898 can decrease sebaceous gland size and inhibit cell growth, which may translate into therapeutic benefits in people with Sebaceous Hyperplasia. The main aims of this trial are: • To assess the effect of the study drug on Sebaceous Hyperplasia • To assess the safety and tolerability of the study drug