ANZCTR search results

Automated insulin delivery via an advanced hybrid closed loop (AHCL) system is accepted as the most effective management strategy, proven in clinical trials and real-world studies, wherein a continuous glucose monitor (CGM) provides glucose information to an insulin pump which can then adjust insulin delivery via an algorithm (housed in an application or in the pump). Due to the established glycaemic benefits, access to AHCL therapy is recommended for all children with T1D according to the latest international guidelines. However, despite national subsidy for CGM, AHCL access in Australia is limited as insulin pumps are primarily self-funded or accessed via health insurance funds or philanthropic programs. This has led to significant inequity in accessing AHCL. The Department of Endocrinology and Diabetes at Perth Children’s Hospital is implementing a new clinical model of care that will provide early access to AHCL to all children with a new diagnosis of T1D. This study aims to evaluate the impact of the new model of care through a combination of routinely collected clinical information and prospectively collected survey data. The overall objective is to comprehensively evaluate a model of care providing early access to AHCL following diagnosis of T1D.

Study purpose: The aim of this study is to evaluate tumour cell death and its potential to predict patient outcomes, to assess efficacy of neoadjuvant chemotherapy and radiotherapy, and as a potential novel theranostic treatment modality in pancreatic ductal adenocarcinoma (PDAC) patients. Who is it for? Newly diagnosed, histologically or cytologically confirmed PDAC patients (male or female) 18 years or older will be recruited to this study after an initial referral from participating oncology centres. Study details: Participants will be administered CDI-DX001 as a bolus by intravenous (IV) infusion. Study participants will be scanned using PET/CT 60 mins post CDI-DX001 administration. There will be 3 scans in total for participants in Phase 1, and 2 scans for participants in Phase 2, over a period of 4-6 weeks. No dose modifications of CDI-DX001 are permitted. Patients' uptake of CDI-DX001, progress of treatment, physical function, vital signs, and laboratory values will be assessed. It is hoped that findings from this study will provide an efficient, accurate, and minimally invasive method to characterise and monitor PDAC, and inform new methods of treatment.

This study will investigate the effect of Expiratory Muscle Strength Training (EMST) on Maximum Expiratory Pressure (MEP) as well as swallowing safety and voice function in head and neck cancer (HNC) survivors with dysphagia Who is it for? You may be eligible to join this study if you are aged 18 years or above, have survived head and neck cancer, completed treatment (surgery and or chemoradiotherapy) more than 3 months ago and are experiencing associated dysphagia (difficulty swallowing). Study details: All participants in this study will receive an Expiratory Muscle Strength Training device (EMST150) to use 5 days a week over 5 weeks at home, Participants will be required to attend a 1-hour in-person speech pathology appointment week 1 and 5 of the study, with weekly 15-minute telehealth consultations week 2, 3 and 4. Participants will undergo some testing procedures pre and post the 5-week EMST therapy period to determine maximum expiratory pressure, swallowing safety, voice function and quality of life.

The aim of this study is to evaluate the safety and feasibility of Endobronchial thermal liquid ablation (ETLA-LC) for the Treatment of Pulmonary Cancer Lesions. Who is this for? You may be eligible for this study if you are a male or female age 18 or older with non small cell lung cancer that is scheduled for lobectomy. Study details: Participants will receive a bronchoscopic procedure which delivers heated normal saline to targeted region(s) where the lung tumour resides. The heated saline causes coagulative necrosis of the tumour and surrounding vasculature that feeds the tumour, and the heated saline takes a margin around the tumour as well. Participants will undergo surgical lobectomy as their standard of care 5 - 14 days after undergoing the bronchoscopy with heated saline. Pathology on the removed lung tissue (and area treated with heated normal saline) will be performed to confirm complete tumour kill. It is hoped that findings from this study will show that the heated saline completely kills the tumour and therefore, provides an option for a procedure to kill a cancerous tumour in patients that cannot tolerate lung surgery.

This Phase 1 clinical trial will test the hypothesis that co-delivery of calcitriol with PI33-63 self-antigen in a liposome is safe and promotes antigen-specific immune regulation in adult patients with Stage 3 type one diabetes. The study is in two parts, where after dose finding in Part A, Part B will commence. Part A is a randomised double blind, placebo-controlled, single centre, single-dose escalation study. Up to 18 eligible participants will be randomised into Part A of the study and three dose levels will be assessed in a single dose escalation. Part B is a randomised double blind, placebo-controlled, multi centre, multiple-dose escalation study. Up to 18 eligible participants will be randomised into Part B and the dose levels to be tested will be based upon review of aggregated data for safety by the Safety Monitoring Committee and immunomodulatory effects by the statistician for all dose levels tested in Part A.

The Body and Brain in IBS Study is a randomised double-blind crossover trial designed to assess the effects of dietary challenge in irritable bowel syndrome. Twenty adults with IBS will undertake five test phases in random order over a 5-week period. During four of the phases, test drinks will be consumed on the first three days of the test phase. Some drinks will contain fructans and some not, During one of the five test phases, no test drinks will be consumed. Each test phase will be separated by a 4-d washout period.

Clonal haematopoiesis of indeterminant potential (CHIP) is defined a genetic variation that leads to expansion of certain blood cells, particularly those with an immune function. CHIP is increasingly common beyond the age of 65 and associated with an increased risk of heart attack. The purpose of this study is to find out more about inflammatory processes after heart attack for CHIP positive patients compared to CHIP negative patients. We will screen for inflammatory markers and other molecular information in blood samples from people with and without CHIP who have had a recent heart attack.

We have developed a non-Invasive Intracranial Pressure Measurement via a Modified Photoplethysmography Technique. We have published several papers, demonstrating the accuracy of the system, which was large and unwieldy. We have shrunk the system down so that it can now be held by an examiners hand and used in patients who were bedbound, or have other medical problems. We wish to measure the accuracy and utility of such a portable photoplethysmographic system in assessing intracranial pressure. If the system is accurate, then it could save many patients from requiring invasive lumbar puncture or external ventricular drain when they have conditions where elevated intracranial pressure is thought to be a factor.

Eating ultra-processed foods high in saturated fats and refined carbohydrates, and low in essential nutrients, can disrupt the body’s natural metabolic balance over time, leading to increased metabolic stress. This stress arises because energy-dense foods challenge the body’s ability to process fats and sugars. Previous studies have shown that consuming such meals can trigger a postprandial response, as indicated by a negative correlation between postprandial glucose area under the curve (AUC) and superoxide dismutase (SOD) levels both before and after eating. Incorporating more whole foods, such as fruits, into the daily diet may help mitigate the effects of less nutritious meals. Fruits are rich in essential nutrients that can alleviate oxidative stress and promote better metabolic health. Specifically, incorporating freeze-dried blueberries into a high-fat, high-carbohydrate meal may play a protective role against oxidative stress.. This study will assess whether incorporating fruits (blueberries) into a high-fat, high-carbohydrate meal could play a protective role against postprandial oxidative stress markers induced by the meal.

Survivors of critical illness are burdened by persistent disability, termed post intensive care syndrome (PICS), encompassing cognitive, physical and psychological impairments that lead to loss of independence and increased healthcare utilisation. To address this post-ICU disability, critical care follow-up clinics have been implemented and tested internationally although are limited in availability and efficacy. Most of these clinics are medical or nurse-led. Allied health professionals may be another workforce capable of leading post-ICU interventions. We propose AH-led interventions targeting PICS recovery and delivered via a centralised and integrated approach early after hospital discharge, may improve patient and health-system outcomes.