ANZCTR search results

The research is to check the improved safety features of a modified airway device called a laryngeal mask airway. The modification to the device is suction enhancement to allow for suction of secretions and blood that usually collect to the upper (supraglottic) surface of the airway device during oral and nose surgery. Suction of the blood and secretions is anticipated to result in improved patient safety.

This study compares the effectiveness of using virtual reality during outpatient colposcopy in decreasing anxiety in pain compared to colposcopy without it. Willing patients will be randomly allocated to either arm and asked to complete a pre and post procedure questionnaire on the day of colposcopy to assess their pain and anxiety scores. Our hypothesis is that virtual reality by creating an immersive experience can distract patients during colposcopy and decrease their pain and anxiety. 200 patients are required to show such a difference, 100 patients in each arm.

The WoundView pilot study responds to the urgent need to develop a digital solution bringing together wound analysis within video telehealth and increase access to wound care in Residential Aged Care Homes (RACHs). A set of digital tools that use simple and affordable technology to collect, analyse, and track wound images will be tested, and included in an existing secure video telehealth platform (Coviu). The tool, WoundView, will allow for timely access and improved wound care. The aim of this study is to determine the feasibility of WoundView to improve chronic wound management for people living in RACHs. The results of the pilot will inform a future research to further assess the utility of WoundView.

This is a Phase 1, open-label, placebo-controlled, randomized crossover study evaluating the pharmacokinetics (PK), safety, tolerability, and adhesion performance of multiple formulations of the TRX-248 transdermal system (TS) in healthy female volunteers. The study consists of two parts: Part A: Subjects receive single doses of three different TRX-248 formulations in a crossover design, with PK and safety assessments after each 24-hour application. Part B: Based on Part A results, one optimized formulation is selected for further evaluation, where subjects receive either three patches of the selected formulation from Part A or a newly optimized Formulation D. The TRX-248 Transdermal System is expected to provide the convenience of a once-daily needle-free delivery system, steady and continuous delivery of treprostinil, which provides optimal efficacy and safety.

ENABLE is a two-phase study involving implementation of a Digital Wound Model of Care (digital wound platform and specialist wound care service). Phase one involves co-development of implementation strategies and understanding current care with seven partner sites guided by the Consolidated Framework for Implementation Research. Baseline data will also be collected in Phase One. Phase Two will involve a stepped-wedge, cluster randomised trial, followed by a post-implementation data collection period evaluating clinical efficacy, cost-effectiveness, and implementation. There will be a staggered entry for each site. Patients greater than or equal to 18 years with a chronic or complex wound (wound that has not healed within 30 days as defined by NSW Health Value-Based Health Care Wound Tranche 2 and Value-Based Health Care High Risk Foot Service Tranche 1) will be included. Clinician (doctors, nurses, podiatrists, occupational therapists) from our partners sites will be included. This current clinical trials registration covers Phase 1 and Phase 2.

This is a dose-ranging study to evaluate the safety and preliminary efficacy of LMN-0801 for weight loss. 126 adults with obesity (BMI > 30 and BMI < 40) will participate in the study. LMN-0801 will be assessed across dose levels, frequency of dosing, and different formulations of LMN-0801. After enrollment and randomization into one of ten cohorts, participants will take the study drug for 24 weeks and then be followed for an additional 4 weeks. During this time participants will come into the clinic for scheduled study visits to monitor safety, undergo study evaluations and measurements, assess study drug adherence and replenish study drug supplies. Each participant will be in the study for a duration of 29 weeks from enrollment.

We propose a novel hypothesis that short-chain fatty acids (SCFAs) influence BP through the ‘gut-brain axis’. The two key systems involved in this process are the 'fight or flight' (sympathetic nervous system, SNS) and the 'rest and digest' (parasympathetic nervous system, PNS), both part of the autonomic nervous system (ANS). Our primary aim is to quantify if SCFAs modulate SNS and PNS activity associated with BP regulation. Understanding the influence of SCFAs on the gut-brain axis could pave the way for new treatments for hypertension and other conditions linked to this axis, such as irritable bowel syndrome and neuropsychiatric disorders like depression and anxiety. This research could lead to advances in managing these debilitating conditions.

This pilot randomised controlled clinical trial will explore the feasibility of delivering a new, in-home intervention to individuals with an alcohol use disorder and acquired brain injury. It aims to generate exploratory data on treatment engagement, change in alcohol use, community participation, and healthcare utilisation/costs that could inform hypotheses for a larger clinical trial.

This is a Phase 2b, randomized, double-blind, placebo-controlled, multicentre trial evaluating two dose levels of BRP-185 against placebo in adult patients diagnosed with idiopathic hypersomnia. Participants will be randomly assigned in a 1:1:1 ratio to one of the following arms: 1. High-dose BRP-185 group (225 mg) – orally once daily in the morning 2. Low-dose BRP-185 group (150 mg) – orally once daily in the morning 3. Placebo group – orally once daily in the morning This trial aims to provide critical data on BRP-185's ability to improve wakefulness and reduce hypersomnolence symptoms, addressing an unmet need in the treatment of idiopathic hypersomnia.

This is a multicentre trial that will evaluate the diagnostic and clinical accuracy (utility) of home-based L3 sleep studies compared to the current standard of laboratory-based polysomnography (L1 PSG). The clinical utility will be determined by including participants who reflect all of the clinical subgroups that comprise a typical clinical load in Australian paediatric sleep laboratories.