ANZCTR search results

This is a randomised, double-blind, placebo-controlled, parallel group study evaluating the safety, tolerability and PK of multiple doses of KAI-7531 in a non-Asian (Cohort 1) and Asian (Cohort 2) participants. The study will also evaluate the effect of food on safety, tolerability, and PK. Who is it for? You may be eligible for this study if you are aged 18 to 55 years with body mass index of 25.0 to 40.0 kg/m2 (inclusive), medically healthy and without clinically significant (CS) abnormalities. Study details All participants who choose to enrol in this study will be assigned by chance to receive multiple doses of KAI-7531 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. It is hoped this research will determine the maximum dose tolerated of KAI-7531 that can be administered safely without causing severe reactions. KAI-7531 is intended to be used for the treatment of metabolic diseases such as type 2 diabetes mellitus and obesity or overweight with comorbidities. The data collected will also support dose administration for future clinical studies.

This study is investigating whether a ketone product improves exercise capacity in children with IEMEM, and if the ketone product is acceptable and tolerated by participants. Secondly, to assess quality of life in children with IEMEM, and glean feedback on an IEM-specific quality of life questionnaire for future adaptation in LC-FAOD. We hypothesise that an exogenous ketone product will improve exercise capacity compared to standard therapy, in children with an IEMEM (LC-FAOD or HMG-CoA-lyase deficiency.) Also that quality of life in children with an IEMEM will be negatively impacted, compared to healthy children.

This is a prospective safety and feasibility study of a new device designed to deliver a low electrical pulse to the intestine from inside the body. Candidates for this study will be participants with Type 2 diabetes. This study intends to assess and prove that the device is safe for use for the delivery of energy within the intestine and may be an effective treatment. Participants will be followed up by the study team for up to 1-year post-procedure. This is a powered study, so there is no formal hypothesis. This research will determine whether use of this new system is safe and feasible

This research project is testing an experimental treatment for people with glioblastoma that has returned after treatment with first- or second-line therapy. The experimental treatment that will be tested in this research project is called EGFR-targeted EDV-Dox. The EDV is a delivery vehicle (manufactured from a non-disease-causing salmonella bacteria) that is carrying a drug called Doxorubicin or E-EDV-Dox directly to the tumour via the blood stream. The E-EDV-Dox are mixed with another EDV investigational product, thought to boost the body's own immune system to fight the cancer, consisting of non-targeted EDVs carrying a-galactosyl ceramide or EDV-GC. The combination of these 2 products is known as E-EDV-Dox/GC. Who is it for? You may be eligible to join this study if you are aged 18 years and older, with a Karnofsky performance score of greater than 70. A life expectancy greater than 3 months, measurable disease per RANO 2.0 criteria, adequate haematological, renal, hepatic and cardiac function. Study details In Phase I of the study a safety assessment will be performed on 6 participants. In Phase II the recommended dosing regimen from Phase I will be open to a maximum of 40 participants. The first treatment cycle will involve bi-weekly visits for 4 weeks where a single dose will be administered at each visit (8 doses), after which 2 doses of the Investigational Product will be administered 90 minutes apart during each visit occurring once/week for a further 3 weeks (6 doses). Doses of E-EDV-Dox/GC in 3mL of 0.9% sodium chloride will be administered intravenously over 10 seconds. In week 8, tumour burden will be radiologically re-evaluated in accordance with RANO 2.0 to determine treatment response. Subsequent cycles will consist of weekly visits for 7 weeks where two doses will be administered at each visit 90 minutes apart. Following each 7-week treatment period is a treatment free week in which tumour burden is radiologically re-assessed (Week 8). Treatment may continue until the participant or investigator deems it suitable to stop treatment, for example if serious side effects occur or if the participants disease continues to grow. It is hoped the findings from this study will help determine the safety and efficacy of E-EDV-Dox/GC treatment for recurrent glioblastoma.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia worldwide. Surgical ablation for the treatment of AF during concomitant cardiac surgery is a class I recommendation per Society of Thoracic Surgeons (STS) and Heart Rhythm Society (HRS) guidelines. The AtriCure Isolator Synergy EnCompass-S ARFA PFA Dual Energy Ablation System will be used to treat AF as part of planned cardiac surgery. The objective of this study is to evaluate the safety and feasibility of the Isolator Synergy EnCompass-S2 AFRA PFA Dual Energy System in participants with atrial fibrillation (AF) undergoing cardiac ablation concomitant to cardiac surgery.

In addition to medical therapy, current guidelines recommend early invasive management for patients with acute coronary syndrome (ACS) due to data supporting myocardial revascularisation (PCI or bypass surgery) for obstructive large (conduit) artery disease in this setting. Despite advances in medical therapy and the adoption of emergency pathways that facilitate the delivery of timely invasive assessment and revascularisation, patients with ACS remain at significant risk of future adverse cardiovascular (CV) events. The coronary microcirculation plays a pivotal role in the autoregulation of myocardial blood flow and ability of the myocardium to recover following ACS. Indeed, following ACS, the presence of CMD predicts an increased risk of repeat myocardial infarction and heart failure hospitalisation. Therefore, in this study we aim to investigate the health and reactivity of the coronary microcirculation at the time of ACS (during index admission and staged invasive re-assessment). Furthermore, we aim to measure cOCT at baseline (time of ACS) and at follow up (3-months) to assess for longitudinal change and an association between central (coronary) and peripheral (cutaneous) microvascular reactivity.

Among patients undergoing invasive coronary angiography for the investigation of anginal chest pain, the absence of angiographically obstructive coronary artery disease that may account for symptoms remains common, occurring up to 60% of the time. In this situation it is possible that symptoms may be due to conditions of the coronary microcirculation (coronary microvascular dysfunction, CMD) or vasomotor disorders (vasospastic angina) with these conditions being referred to collectively as angina with non-obstructive coronary arteries (ANOCA). Following the exclusion of secondary causes of CMD, such as cardiomyopathy or valvular heart disease, patients with ANOCA represent a cohort of primary CMD within which we may study the relationship between central (coronary) and peripheral (Cutaneous OCT) microvascular reactivity. This may provide novel insights into the physiological interplay between vascular beds so that we may be able to advance the development of urgently needed less or non-invasive tests helpful in the detection of patients with CMD.

This retrospective, observational cohort study will include nonagenarians admitted to the intensive care unit (ICU) between 2010 and 2023 across Australia and New Zealand. The study will utilise data from the Australian and New Zealand Intensive Care Society (ANZICS) Adult Patient Database. Who is it for? You are eligible if you are greater than 90 years old and admitted to ICU. Patients will be categorised into those with a normal body mass index and thiose with either a high or low body mass index. Study details This study will evaluate and compare the prognostic performance of common ICU risk stratification scores including the APACHE III, SOFA, and ANZROD scores in a large binational cohort of ICU-admitted nonagenarians and centenarians. Discriminative ability, risk stratification, and predictive utility for both short- and long-term mortality will be assessed. We hope these findings will emphasise the importance of shared decision-making that respects patient autonomy and considers clinical, cultural, and systemic factors.

Exercise improves wellbeing of people living with Parkinson’s disease (PD). However, travelling to and participating in exercise classes at a community centre may be difficult. This study will investigate whether an online PD targeted exercise program is acceptable and feasible for people living with PD. We will recruit up to 20 people with PD and allocate them randomly into two groups. Both groups will participate in a 1-hour exercise class twice a week for 8 weeks. Group 1 will participate in the online class and Group 2 in the face-to-face class. We will also investigate how this program can improve mobility and balance in people with PD.

This project will aim to examine the feasibility of an 8-week, tailored, multimodality exercise intervention tailored for people living with young onset dementia, as well as the potential benefit to physical health, mood and cognition. We hypothesize that tailored physical activity interventions will be both feasible and acceptable for people with young onset dementia, in particular with the removal of transportation barriers.