ANZCTR search results

This study will use EIT to define the patterns of tidal ventilation within the chest in infants undergoing inguinal hernia surgery with four different anaesthetic types, two where they are spontaneously breathing, and two where they are having a general anaesthetic with either spontaneous ventilation with laryngeal mask airway or mechanical ventilation. This study will determine whether mechanical ventilation during general anaesthesia increases the risk of lung inhomogeneity in neonates and small infants. We also hope to determine if there is a correlation between the degree of lung inhomogeneity and the four types of anaesthetic techniques.

This study will determine if there are any changes in sleep difficulties in relation to menopause, and other symptoms of menopause as well as looking at the rate of adverse events after using medicinal cannabis. This study will provide data for future clinical trials if potential benefits are found. We hypothesise that medicinal cannabis can improve sleep quality in relation to menopause, alongside other symptoms.

The aim of this project is to identify the most promising approach of improving diabetes risk factors for Indigenous Australians with type 2 diabetes using LibrePro continuous glucose monitoring and a 10-week intensive lifestyle program. Up to 90 participants who identify as Aboriginal and/or Torres Strait Islander, have been diagnosed with type 2 diabetes and have recently recorded a HbA1c >7.5% will be recruited from multiple locations. This study follows a basket trial methodology with 2 groups assessed at each stage: participants taking insulin &/- sulfonylureas and other diabetes medications; and participants on other diabetes medication (NOT taking insulin &/or sulfonylureas). Fifteen participants will be recruited for each group at each stage. It is expected that LibrePro continuous glucose monitoring and a 10-week intensive lifestyle program will be of sufficient promise to be taken forward to a Phase IIb-III trial and subsequent translation into clinical care. This will be based on the combination of efficacy, safety and feasibility with type 2 diabetes treated with insulin AND/OR sulfonylureas & other diabetes medications or treated with other diabetes medication (excluding Insulin AND/OR sulfonylureas) respectively.

This study investigates ongoing symptoms following COVID-19 and influenza infections in children and teenagers. Parents of children who have had COVID-19 or influenza will be invited to participate. Initially, cases will be identified through presentations at the Women's and Children's Hospital and will then expand to include statewide notifications. After providing consent, participants (or their parents) will complete surveys at the start of the study and then again at 3, 6, and 12 months after the viral infection. These surveys will help researchers monitor any persistent health issues over time. The primary goal of the study is to understand how common these ongoing health problems are in young people and how they impact their daily lives.

This study aims to evaluate whether local vibration therapy self-applied to the lower limbs can improve balance in older adults. Participants will use a handheld vibration device on their lower limbs daily for six weeks. Their balance will be measured using the Four-Square Step Test and what they feel their 'balance confidence' in would be when performing various activities will be measured with the Activities-specific Balance Confidence Scale. We hypothesise that this therapy will improve balance and increase confidence. The results could provide a simple, cost-effective method to help older adults improve their balance.

PReventing chronic pain after whiplash Road Traffic Injury (PRioRTI) is a randomised, double-blinded, placebo-controlled, multi-centre Phase III trial to evaluate the effectiveness of early (within 96 hours of injury) treatment with pregabalin vs placebo in development of chronic pain after whiplash injury. 258 male and female participants, aged between 18 and 70 years old will be recruited in Emergency Departments (EDs) across several sites in Australia (Qld, NSW). Follow-up assessments will be completed at 6 weeks, 3-, 6- and 12-months using Participant Reported Outcome Measures completed by participants online in REDCap. It is hypothesised that participants who receive the pregabalin treatment will report lower levels of neck pain at the follow up time points than participants who receive the inactive placebo treatment.

The main aim of the study is to test the safety, tolerability, pharmacokinetics, and immunogenicity of a single dose of APG333. The results of this study will help inform the dosing and frequency of dosing in patients with inflammatory diseases such as asthma and chronic obstructive pulmonary disease, which is the anticipated main therapeutic use for APG333.

The objective of this study is to assess the tendon healing rates and clinical outcomes of arthroscopic rotator cuff repair (aRCR). This randomised control trial (RCT) will compare the standard aRCR (Control group) with two treatment groups, aRCR augmented with either intra-operative administration of concentrated bone marrow aspirate (cBMA) or leukocyte-poor platelet rich plasma (LP-PRP). We hypothesise that augmented rotator cuff repair will result in statistically significant benefits for rotator cuff healing on ultrasound and MRI as well as clinical shoulder scores.

This study will investigate the acceptability and impact of a hybrid paper- and web-based Australian Decision Aid on shared decision making for low-risk Papillary Thyroid Cancer Who is it for? You may be eligible to join this study if you are aged 18 years or above with a clinical suspicion of low-risk thyroid cancer Study details Participants in this study will be allocated to one of two groups based on the time point of clinical review: one group will receive standard care, where a decision on thyroid treatment is made in consultation with the patient's clinician. The other group will be provided with a hybrid (paper and web-based) decision aid for initial management of low-risk thyroid cancer. These decision aids will assist in providing the patient with relevant information and awareness, therefore creating choices for patients and their individual preferences. Information is tailored to patients and their treatment options, to enable shared decision making with their specialist. Clinicians’ and patients’ acceptability of the support aids in clinical practice will be assessed. Patients will answer questionnaires to determine decisional conflict, regret, satisfaction and health related quality of life. Total thyroidectomy remains the predominant procedure, despite recent guidelines advocating a de-escalation approach to thyroid cancer surgery. Treatment decision making in low-risk thyroid cancer is complex. This research will address the information gap in low-risk thyroid cancer management and examine the effect of a patient decision aid on the clinical encounter.

This early phase study is to assess the pharmacokinetics (how the body processes a drug), safety, and tolerability of ILYX-002 administered as an eye drop. ILYX-002 is being developed as a potential treatment for Dry Eye Disease. In this study, approximately 16 generally healthy male and female adults will be enrolled. Fourteen will receive ILYX-002 and two will receive vehicle, which is an eye drop of similar makeup except no active drug substance. Participants will stay at the study center for a total of 9 days. While residing at the study center, participants will receive their assigned study treatment approximately twice per day, be monitored closely for safety and tolerability, and have multiple, repeat blood draws. After discharge, participants will return for a final safety follow-up visit on Day 15. The total study duration will be up to 6 weeks, including a 4-week window for screening and determination of eligibility.