ANZCTR search results

Effective haemorrhage control is crucial in cases of limb trauma involving arterial injury, such as shark attacks. International first aid guidelines recommend the use of arterial tourniquets as a primary treatment for life-threatening external bleeding. Manual pressure applied directly over a major artery proximal to the injury (Inguinal Fist Compression, IFC) is more accessible in a first-aid situation than commercial windlass tourniquets (CWTs). Stopping Haemorrhage by Application of Randomised Compression or Tourniquet (SHARC-Two) is a trial designed to examine which of these interventions is superior at reducing arterial blood loss when applied by a member of the general public. Based on a recent pilot study, we anticipate that IFC will achieve a greater reduction in femoral blood flow than a CWT when applied by untrained bystanders after brief infographic exposure.

The primary objective of this study is to undertake a small scale preliminary study (cluster randomised control trial) to identify the effect of DDDAA on depressive symptoms among elderly persons in residential care. Facilities are randomised not individuals. This will be achieved through measuring changes in response to thirty (30) specific items on the Geriatric Depression Scale, GDS score from baseline to follow up. We will additionally compare scores between the three (3) groups (face to face delivery, digital delivery, and control) to identify the strength of DDDAA vs face to face DAA.

The purposes of this study is to 1. Determine if integrated health mobile text messages (unidirectional), including medical, diet, exercises, and psychological support follow-up people with Type 2 diabetes for 12 months, can improve their glycaemic control at 6 and 12 months. 2. Determine if participants’ lipid profiles, blood pressure, and weight status (BMI) can also be improved at 6 and 12 months We hypothesize that there will be improved HbA1c, lipid profiles, blood pressure, and weight status (BMI) in 6 months and a further improvement in 12 months; there will be a high acceptance rate or high satisfaction levels about this research from participants.

Alcoholic hepatitis is an acute deterioration in liver function in the context of excessive alcohol consumption. Those with severe Alcoholic Hepatitis (sAH) have a high short-term mortality. Prednisolone has a modest efficacy in reducing short-term mortality in sAH, but it cannot used in many patients because of contraindications, and if used, it is associated with increased risk of infections. The gut-liver axis modulation through healthy donor faecal microbiota transplantation (FMT) has been proposed as a therapeutic alternative in managing patients with sAH. FMT has been shown to alleviate gut dysbiosis and restore gut microbial diversity. The role of orally delivered FMT capsules in sAH is yet to be explored. We hypothesize that orally delivered FMT capsules is a safe and efficacious therapy in patients with sAH. Aims of this study are: (i) to assess the gut microbial signatures in those with sAH, followed by (ii) A pilot randomised controlled trial to assess the safety and efficacy (primary outcome: 28- day mortality) of FMT compared to prednisolone in patients with sAH.

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.