ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33021 results sorted by trial registration date.
  • A study in participants with glioblastoma that has progressed after standard of care therapy, looking at the safety and effect of treatment with the experimental drug E-EDV-Dox/GC or EnGeneIC Dream Vectors (EDVs) packaged with the chemotherapy (Doxorubicin) given simultaneously with non-targeted EDVs carrying an immune enhancer called EDV-GC. (EDV-GBM Trial)

    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.

  • First-In-Human Study to evaluate the safety and feasibility of EnCompass-S2 ARFA PFA (Advanced Radiofrequency Ablation Pulsed Field Ablation) Dual Energy Clamp in patients undergoing cardiac ablation during a concomitant cardiac surgical procedure. (EnCompass-S2 FIH)

    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.

  • Evaluating the utility of continuous thermodilution to detect Coronary Microvascular Dysfunction among patients with Acute Coronary Syndrome

    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.

  • Evaluating the utility of continuous thermodilution to detect Coronary Microvascular Dysfunction among patients with angina and non-obstructive coronary arteries.

    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.

  • Validating Intensive Care Risk Scoring Tests in the Oldest Patients admitted to Intensive Care

    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.

  • Comparison of an online and centre-based group exercise program to improve balance for people with Parkinson's Disease

    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.

  • Exercise Interventions for Mood, Physical health And Cognition, Tailored for Young Onset Dementia (The Exercise IMPACT for YOD study) - A feasibility case series

    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.

  • Strengthening Memory and Anxiety Reduction Trial (SMART)

    Outcomes for child anxiety treatment are suboptimal. Exposure therapy is the key technique to reduce anxiety, and involves facing the feared situation to learn that it is safe (i.e., safety learning). However safety learning can be forgotten, and fears come back. This clinical trial will assess whether adjunctive memory rehearsal after exposure therapy enhances outcomes and prevents relapse. Results will advance understanding of treatment mechanisms and optimise child anxiety treatment.

  • Piloting a Co-Designed Digital Body Image Intervention for Young Australian Women

    The aim of this study is to test the feasibility, efficacy, and acceptability of a co-designed digital body image intervention, a website, intended to provide non-clinical adult women with cognitive behavioural, psychoeducational, and media and health literacy activities. We hypothesise that relative to pre-intervention, participants in the treatment group would report decreased body dissatisfaction and ideal internalisations, and higher body acceptance and health confidence at post-intervention. We hypothesise sustained effects at one -month follow-up, compared to a wait list control group. We also aimed to learn more about how treatment group participants would rate the website in acceptability, and how the website could be improved. By evaluating the efficacy of the present co-designed website, there is potential to address the gap in scalable, user-centred body image interventions that are suitable for preventative and early care.

  • Early delirium detection and prediction in hospitalised patients through analysis of clinical signs and behaviours.

    Delirium is a clinical condition characterized by an acute disturbance in a person's attention, cognition, and awareness. It can occur in any age group but is more common in older adults. It can be caused by the combined effect of hospital admissions, certain medications, and underlying medical conditions. Delirium is associated with poor outcomes for patients, with increased postoperative complications, delayed functional recovery, and prolonged hospital stays, and increased risk of death. Healthcare providers face difficulties in identifying or diagnosing delirium and providing high standard care for patients experiencing delirium. In this project, we will evaluate a comprehensive approach involving data from wearable devices and clinical records of patients to develop a predictive model to detect the onset of delirium and to classify the hypoactive and hyperactive states of delirium. The wearable device, which is a smartwatch designed for clinical trials, can monitor physical activity and physiological parameters in older adults, and the clinical records can provide valuable patient health information. This project aims to develop Artificial Intelligence (AI)-based predictive and diagnostic applications using the data collected from the wearable device worn by inpatients along with their clinical records to predict and classify delirium. This will help in timely identification and management of the underlying causes and risk factors, which are crucial in preventing the development of delirium and understanding its symptoms. The developed predictive and diagnostic applications could assist healthcare providers in enhancing health outcomes for older adults admitted to hospitals.

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