ANZCTR search results

Brief description of the study purpose This study aims to assess the feasibility and accuracy of using core biopsies to diagnose uterine masses at two hospital centres. Who is it for? You are eligible for this study if you are aged 18 years or over, are not pregnant and have a uterine mass at least 5cm or greater with either rapid growth on sequential assessment, suspicious features on MRI or have known or suspected cancer predisposition syndromes including pathogenic mutations in BRCA1 or BRCA2 and mismatch repair genes (Lynch syndrome). Study details All those who are eligible will undergo a one-off percutaneous uterine needle biopsy (PUB) which will be performed by the treating gynecology oncologist at the hospital site where you are being treated. A comparison will be made with the findings from your resected specimen as part of the planned surgery. If surgery is not performed then the comparator will be the clinical course of the uterine mass at 6 and 12 month clinical follow up visits. If you are not eligible for PUB prior to surgery then you may still have the option to participate by consenting to a biopsy of your removed uterine mass. The cases contributed via this alternate pathway will help to improve the determination of the accuracy and reliability of core biopsies. It is hoped that the results from this study will help explore the possibility of using core biopsies for diagnosis of uterine masses, particularly for women who wish to preserve their fertility.

This study will evaluate LipReader, a smartphone-based artificial intelligence communication tool designed to support voiceless intensive care unit and step-down patients. LipReader uses the device camera to analyse silently mouthed phrases and convert them into text and speech output. Participants will complete a single supervised study session using both LipReader and standard bedside communication tools such as alphabet charts and pen-and-paper. The study will assess time to successful message understanding, message success rate, usability and perceived impact on nursing workflow. Findings will inform future refinement of the technology and the design of larger clinical trials.

The primary purpose of this study is to test a new experimental recombinant Poliomyelitis vaccine (rPV) in comparison to the commercially available inactivated poliovirus vaccine. The design of the study is double-blinded, randomised and active controlled. The active controlled product is considered the commercially available vaccine (IPOL).

This study is testing a new experimental antibody treatment called MQ005 for adults with sepsis, a serious infection that can cause organ failure. The main goal is to evaluate whether MQ005 is safe and well-tolerated when given in single ascending doses. Researchers will also explore how the drug affects the immune system and sepsis outcomes. The study aims to determine the best dose for future research while monitoring participants closely for side effects.

The single group assignment, open label, clinical trial will enroll up to 30 participants with the goal of at least 20 participants completing the yearlong study implant duration. Enrolled Participants will have the CBGM system implanted via a 20–30-minute procedure. Post procedure, after the initial 14-day post implant assessment, Participants will undergo In-Clinic visits every few months during their yearlong implant duration that include both safety and performance assessments of the CBGM System. Outside of the clinic, Participants will complete a minimum of 3 fingerpicks per day (with a study provided commercially approved BG meter and supplies, carry a study phone to collect investigational sensor data (data is blinded to the participant) and complete a study diary. Removal of the CBGM System will be similar to the implant procedure. A final 14-Day post removal visit will occur to follow-up with the participant to assess the wound. If there are not outstanding safety events or items for follow-up, this will be considered the participants final visit and they can safely exit the study.

This study will use a combined multiple-baseline with reversal single-case experimental design (SCED) to evaluate the efficacy and feasibility of a virutal reality walking intervention. The study will use an ABABC design. A refers to the non-intervention phases, B will be the intervention phases. C phase will be used as an assessment of feasibility. The duration of each phase will be Baseline(~2-3wks), Intervention1 (4wks), Wash out (~3-4wks), Intervention2 (4wks), Follow-up (2wks). . We will measure changes in pain, and wellbeing as well as feasibility through questionnaires before and after the intervention. The results will help us understand whether this type of intervention is effective and feasiblity in the medium to long term for people with SCI-related NP. We hypothesise that VRWalk will have positive long-term effects on NP intensity. Additionally, we hypothesise that VRWalk will be feasible.

The iROAR registry is a prospective, multicentre observational study designed to evaluate the real-world effectiveness of low-dose radiotherapy (LDRT) in adults with symptomatic osteoarthritis across Australia. Participants receiving standard-of-care LDRT will be followed for up to 24 months to assess changes in pain, physical function, and health-related quality of life using validated patient-reported outcome measures. The primary objective is to determine the proportion of treated joints achieving a clinically meaningful response at 6 months based on OMERACT-OARSI criteria. Secondary outcomes include long-term clinical response, safety, retreatment rates, and healthcare utilisation outcomes associated with LDRT. The registry aims to generate the first prospective Australian dataset to inform clinical practice, treatment standardisation, and future research on LDRT for osteoarthritis.

ISLAND hypothesises that a public health approach to dementia prevention can reduce modifiable risk factors in the Tasmanian community. Our novel approach to dementia prevention involves a combination of education with positive lifestyle change. We have shown that our public health approach has efficacy to reduce modifiable risk factors in the Tasmanian community.

Metformin is the first-line glucose-lowering medicine in most clinical guidelines on the management of type 2 diabetes. Standard advice has been to take metformin with meals. However, recent evidence suggests that taking metformin an interval before each meal may work better for lowering blood glucose after the meal. In this study, we will test whether taking metformin 60 min before meals improves glucose-lowering after each meal, compared to taking it with meals in people with type 2 diabetes.

This study is a prospective, multicentre, first-in-human study to evaluate the safety and effectiveness of the Shockwave Medical Valvular Transcatheter Lithotripsy II (VTL II) System in subjects with symptomatic, severe calcified mitral stenosis. Eligible participants who meet all inclusion and exclusion criteria and provide informed consent will undergo a transcatheter mitral valve lithotripsy (TMVL) procedure using the VTL II System. The procedure is performed via a trans-vascular approach in a catheterisation laboratory or a hybrid suite, where lithotripsy (soundwaves) pulses are delivered to modify calcified mitral valve tissue. Additional balloon mitral valvuloplasty may be performed at the operator's discretion. Participants will receive standard post-procedural care and be followed during hospitalisation and at discharge. Follow-up assessments will occur at discharge, 30 days, 6 months, and 12 months post procedure. Study exit occurs at 12 months following the index procedure.