ANZCTR search results

This study aims to evaluate the use of smaller-calibre endoscopic equipment during routine ureteroscopy and laser treatment for kidney and ureteric stones. Smaller instruments may allow the procedure to be completed more easily and with higher rates of success. The main aim is to assess whether these procedures can be completed successfully without use of pre-operative ureteric stents, and potentially also post-operatively, while monitoring procedural safety and short-term complication outcomes.

The closure of corneal wounds during cataract surgery remains reliant upon sutures, self-sealing corneal incisions, or tissue adhesives. Each of these methods have disadvantages, including time-consuming procedures, distortion of the eye’s shape, increased risk of endophthalmitis, wound leaks, lack of mechanical strength and toxicity to the ocular surface. We have developed a thin, laser-activated chitosan adhesive film that can be rapidly applied to the eye for sutureless sealing of corneal wounds. In this study, we propose to demonstrate the safety and efficacy of our adhesive film-based technology, termed ‘Kleer-i’, in sealing corneal wounds for the treatment of corneal wound incisions created during cataract surgery. The film may allow for quicker surgery, rapid healing and prevent the risk of complications such as scarring, infection and wound leakage.

This is a double-blind, placebo-controlled, First-In-Human Study of the safety, tolerability, pharmacokinetics of LW-1017 in Healthy Volunteers. Who is it for? You may be eligible for this study if you are aged between 18 to 80 years old and are in good general health without a clinically significant medical history. Study details Healthy volunteers will be randomly assigned to receive single or multiple oral doses of LW-1017 or placebo. Participants will undergo regular safety assessments, including vital signs, blood and urine tests, and other clinical evaluations. The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics of LW-1017 and to identify dose levels suitable for future clinical studies. If results are acceptable, subsequent studies may evaluate LW-1017 in patients with Alzheimer’s disease or Parkinson’s disease.

This trial aims to assess the feasibility of delivering a once-off co-designed online learning module to promote and support healthy sleep practices among graduate nurses and midwives.

Amino acid sweat loss during high-intensity exercise in hot conditions may contribute to muscle fatigue and slower recovery after strenuous activity. The purpose of this project is to examine differences in post-exercise recovery, as measured by maximum voluntary isometric contraction (MVIC) of knee extensors and subjective fatigue rating, between intra-session HDAA supplementation and placebo. The aim is to examine the effect of HDAA supplementation against placebo in recreationally trained male and female cyclists. This study is a randomised, double-blind, crossover design involving two conditions: high-demand amino acid (HDAA) supplementation and a BCAA placebo control. Participants will be healthy recreationally trained cyclists 18-45 years of age. Objective and subjective measures of fatigue will be used to assess the effectiveness of the HDAA supplement compared to placebo in mitigating fatigue following strenuous exercise in the heat. Sweat will be collected and analysed for electrolyte concentrations during each exercise bout to examine relationships with electrolyte loss. Finally, muscle oxygenation will be used to examine the change in oxygenation patterns with supplementation.

The aim of the study is to evaluate the safety, tolerability, PK and preliminary efficacy of intravenous (IV) administered RC220 in combination with oral osimertinib in patients diagnosed with non-small cell lung cancer (NSCLC) with an activating Epidermal Growth Factor Receptor mutation (EGFRm) known to confer sensitivity to EGFR tyrosine kinase inhibitors (TKIs). Who is it for? You may be eligible to join this study if you are aged 18 to 80 years of age, with life expectancy greater than 6 months, ECOG performance status 0 or 1, a diagnosis of confirmed Non–Small Cell Lung Cancer (NSCLC) with an activating EGFR mutation (EGFRm). In addition, you must have been receiving a stable maintenance dose of osimertinib (a medication approved under the brand name Tagrisso®) for at least 6 months prior to enrolment and either measurable or evaluable disease or a positive activating EGFRm ctDNA result. Study details There are 2 parts to this study Part 1. ctDNA (molecular) pre-screening. Participants will have blood tests to assess for ctDNA levels of the activating EGFRm identified at diagnosis as an indicator of disease status. If there are signs your cancer is progressing during this part, you will be invited to participate in the treatment part (Part 2) of the study. Part 2 (dose escalation) will investigate effects of escalating doses of RC220 to determine the maximum tolerated dose (MTD) when administered in combination with osimertinib. There will be up to 7 different doses of RC220 used to determine the MTD dose. Each RC220 dose is administered into the vein (IV) on day 1 of a 21-day treatment cycle with daily oral doses of osimertinib (80 mg). If participants don't experience any specific side effects, they will continue to receive study treatment in 21-day cycles. A new group of participants will receive treatment at a RC220 higher dose if deemed appropriate following a review of safety from the first cycle of treatment in the prior group of participants. All participants in Part 2 will be monitored with clinical visits, blood tests, electrocardiogram, echocardiogram (heart tests) and radiology images. This research will hopefully help further the development of RC220 when given with osimertinib to improve and or extend treatment for NSCLC patients with activating EGFR mutations.

The project will evaluate the multidisciplinary team care delivered for patients with complex chronic conditions aged 18 + years, in terms of reach, effectiveness, adoption, implementation, maintenance and translation. Education and facilitation to build the capacity of general practices to identify and appropriately treat patients with chronic conditions, build capacity of allied health providers to appropriately treat patients with chronic conditions, and support coordinated multidisciplinary team care to support patients in primary care settings to live well. Primary care has an important role to play to support healthy ageing for early intervention of chronic disease. However, implementation of healthy ageing interventions into routine primary care has been limited, The program involves early identification, and provision of evidence-based support to improve quality of life and improve patient experience, confidence and capability in self-managing their chronic condition/s. This project will include a mixed methods approach, guided by the application of the Consolidated Framework for Implementation Research (CFIR) and RE-AIM frameworks.

This study aims to investigate whether a 5-week text message program to support pain self-management works at least as well as a 5-week personally tailored cognitive behavioural therapy (CBT)-based pain self-management program run by a hospital pain clinic. Who is it for? You may be eligible for this study if you are an adult who has finished treatment for early-stage breast cancer and continue to experience ongoing pain that affects daily life. Study details About 80 participants will take part in this study. Participants will be randomly allocated (like flipping a coin) to one of two groups: - a mobile phone program that sends two supportive text messages per day for 5 weeks, or - a personally tailored cognitive behavioural therapy (CBT)-based pain self-management program delivered through the hospital pain clinic (format may be group-based, individual sessions, or self-guided materials based on an initial assessment). Both groups will also receive a self-help pain management book and workbook, and will continue to receive all their usual care from their doctors. Participants will complete short online questionnaires about pain, daily activities, mood, fatigue, work, and satisfaction at the start of the study, at 5 weeks, 9 weeks, and 3 months after starting the program. Some participants may also be invited to take part in a one-off telephone interview about their experience. It is hoped that the results of this study will show whether the text message program can be a convenient and acceptable alternative to group pain self-management programs for people living with pain after breast cancer.

This randomised controlled trial aims to evaluate a self-paced online training program called ‘Agile Mind’, designed to support the wellbeing of Emergency Service Workers and protect against common symptoms of depression, anxiety, and PTSD. The program was developed based on the principles of Acceptance and Commitment Therapy, an evidence-based psychotherapy intervention that is used to increase psychological flexibility. Psychological flexibility is the ability to accept uncomfortable situations and respond in ways that align with personal values, and was chosen to be the focus of Agile Mind due to previous research suggesting that it is protective against the development of mental health conditions (especially PTSD). The research questions that the trial seeks to address are whether Agile Mind is relevant and suitable for an emergency service worker population, and whether it leads to changes in this population's reported wellbeing, mental health symptoms, resilience, psychological flexibility, and work performance. To assess the scientific effects of Agile Mind, it will be compared against another a self-paced online training program called 'Wellbeing' (designed for the general working population), as well as a Waitlist control group that will not receive access to a program until later in the study.

This Phase 1 study evaluates the effect of esomeprazole (proton pump inhibitor), on the PK and safety of ATH434 in healthy volunteers. The primary hypothesis is that co-administration of esomeprazole will not significantly change the systemic exposure of a single 75 mg dose of ATH434. The study also aims to confirm the safety and tolerability of combining these treatments, using a fixed-sequence crossover design to compare ATH434 levels with and without esomeprazole.