ANZCTR search results

International guidelines provide conflicting recommendations regarding the discontinuation of DOACs prior to polypectomy. We are undertaking a multicentre prospective cohort study with patients who are using DOAC therapy while undergoing colonoscopy. Many centres have adopted the strategy to withhold DOAC only on the morning of colonoscopy which has retrospective data showing no increased delayed post-cold snare polypectomy bleeding, but potential reduced thromboembolic events and less changes to patients' procedure timing. This study will only include prospectively collected data.

This study is an early-stage clinical trial to check whether a new medicine called PTC612 is safe for healthy adults to take. Blood samples will be collected to measure the amount of medicine in the body and to look at substances related to inflammation. The study is based on the idea that PTC612 can be taken safely and may help reduce inflammation, supporting its future use in inflammatory diseases.

RECCE®327 topical gel has been developed through a stepwise clinical program from early evaluation of safety, pharmacokinetics (PK), and preliminary efficacy to later-stage development in diabetic-related foot infection (DFI). Early clinical studies demonstrated minimal systemic absorption following topical administration, with systemic exposures substantially below those shown to be well tolerated following intravenous administration, supporting continued clinical development of RECCE®327 as a topical antibacterial therapy. DFI has been selected as the primary target indication because of its significant unmet medical need and the potential advantages of achieving high local antimicrobial concentrations while minimizing systemic exposure. Part A of this study (ACTRN12624000973516) provided the safety, PK, and preliminary efficacy data that informed the design of Part B, a randomized, active-controlled study intended to generate comparative efficacy and safety data. Although conducted under a common protocol and governance framework, Parts A and B have separate objectives, study designs, and statistical analysis plans, and data from each part will be analysed and reported separately.

This Phase 1/2 study is evaluating safety, tolerability, pharmacokinetics and preliminary antitumour activity of different doses of Lutetium-177 in people with fibroblast activation protein (FAP)-expressing pancreatic ductal adenocarcinoma, biliary tract carcinoma and other FAP-expressing solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with locally advanced and/or metastatic cancer expressing FAP, including pancreatic ductal adenocarcinoma, biliary tract carcinoma and other solid tumours. Study details There are 4 parts to this study. Participants will be allocated to different parts based on their tumour type and timing of allocation. Part 1A will assess 4 different doses of Lutetium-177 administered intravenously on Day 1 of each cycle for at least 4 cycles. Safety, tolerability and recommended dose for Part 2 will be assessed in Part 1A using vital signs, laboratory values, electrocardiogram and adverse event monitoring from the time of administration until the end of each cycle. Pharmacokinetics will also be assessed for Part 1A using serum samples at specific time intervals. Part 1B will administer a single low-dose Lutetium-177 administered intravenously on Day 1 of cycle 1. Imaging and dosimetry will be assessed using Dosimetry SPECT scan at specific times within the first 8 days of treatment. Part 2A will administer two recommended dose-for-expansion levels, based on dosages determined from Part 1A, for 4 cycles (6 weeks each) plus 2 optional additional cycles. Safety, tolerability and preliminary antitumour activity will be assessed using vital signs laboratory values, electrocardiogram, adverse event monitoring from the time of administration until the end of each cycle. Quality of life will also be assessed using a questionnaire. Part 2B will administer one recommended Phase 2 dose, based on dosages determined from Part 2A, for 4 cycles (plus additional 2 optional cycles). Safety, tolerability and preliminary antitumour activity using vital signs, laboratory values, electrocardiogram, adverse event monitoring and RECIST v1.1 from the time of administration until the end of each cycle.

The purpose of this study is to determine whether adding tailored ablation of atrial regions showing reduced spatiotemporal intermittency to standard pulmonary vein isolation produces measurable improvements in the organisation of electrical activity in patients undergoing pulsed-field ablation for persistent atrial fibrillation. Patients may be eligible for this study if you are aged 18 years or older, have persistent atrial fibrillation, have a left atrial diameter greater than 40mm, and are scheduled to undergo a first-time pulmonary vein isolation procedure using pulsed-field ablation. Study details: participants in this pilot study will be randomly allocated by chance (1:1) to either standard pulmonary vein isolation alone, or to standard pulmonary vein isolation plus additional mapping and ablation of up to five sites identified in real time by the research team's analysis software,. All participants will have electrical mapping of the left atrium performed before and after ablation, and will be followed with clinical/telehealth review andmonitoring at baseline, 6 months and 12 months to assess symptoms and any recurrence of arrhythmia. It is hoped that this research will show whether targeting these regions improves the organisation of atrial fibrillation wavefronts and slows the atrial fibrillation cycle length, providing mechanistic evidence to inform the design of a larger, adequately powered randomised trial of clinical outcomes.

Tracheomalacia is an early-life health condition of weak or abnormally shaped airway cartilage, causing the windpipe to collapse during breathing out or coughing. The collapse traps mucus and leads to repeated infections, and can cause dangerously low oxygen levels and long-term lung damage. Current diagnosis relies on symptoms, CT scans, and bronchoscopy - none of which can actually see the cartilage responsible. We are using a laser-based imaging method called PS-OCT to visualise and measure the cartilage in the windpipe. We expect this will allow direct assessment of cartilage abnormalities that current methods cannot detect, and that these abnormalities will be associated with a tracheomalacia diagnosis and to the degree of airway collapse. PS-OCT images will be used for correlation with standard clinical diagnosis only, and PS-OCT will not be used to diagnose participants. We will also track the children's health over the following year (after PS-OCT imaging), including symptoms, hospital visits, and medication use, to study the relationship between PS-OCT findings and the overall health trajectory.

This study will evaluate a new model of of care for people with musculoskeletal pain (e.g., back, neck or joint pain) in primary care. It will compare usual GP-led care with a model that also allows patients direct access to publicly funded physiotherapy. The study will involve 16 general practices and their associated physiotherapy clinics across Australia. Adult patients attending these clinics for musculoskeletal pain may be invited to participate by completing online questionnaires about their health, healthcare use, and experiences over 12 months. The study will also collect de-identified information from clinical records about healthcare use, such as healthcare visits, diagnostic imaging referrals, and medication prescriptions related to musculoskeletal pain. The study aims to determine whether direct access to publicly funded physiotherapy provides physical health outcomes that are no worse than usual GP-led care, while improving healthcare use and value for money. Findings will help inform future healthcare policy in Australia.

This study aims to examine possible changes in brain activity in people with alcohol use disorder after receiving focused ultrasound stimulation guided by brain imaging. Stimulation will be applied to the anterior insula, a brain region involved in craving. We will assess changes in brain activation, connections and chemistry, self-reported craving, and cognition and behaviour. We will also assess emotional awareness to better understand how the intervention works. We hypothesise that applying focused ultrasound stimulation to the left anterior insula will facilitate insula connections with the prefrontal cortex, which is a brain region involved in craving regulation.

BMB-105 is a novel, potent, and selective 5-HT2C receptor agonist being developed for the treatment of hyperphagia and associated neurobehavioral symptoms in PWS. Preclinical pharmacokinetic data indicate good oral bioavailability. Part 1 SAD: will be 4 single dose cohorts, consisting of 8 participants each. Dosing will be initiated at 0.8mg/kg (or matching placebo) once. Part 2 Food Effect: 12 participants will have a single dose of BMB-105 with and without a meal 7 days apart (crossover). The dose will be determined following the SRC of Part 1 data. Part 3 MAD: will be 4 cohorts of 8 participants each, using different doses. Dosing will be initiated at 0.8mg/kg (or matching placebo) daily for 7 days.

Intracytoplasmic Sperm Injection (ICSI) was first described in 1992 and has since been routinely used to treat patients with severe male factor infertility with much success. An alternative method of injecting sperm into the oocyte has been described: PIEZO-ICSI. This utilises an actuator in piercing the zona pellucida of oocytes, which allows for microinjections with less physical stress being applied during the procedure. The hypothesis of this study is that using the PIEZO-ICSI technique to inject sperm will result in a higher fertilisation rate compared to conventional ICSI. This will be a sibling oocyte study in patients aged 38 and over.