ANZCTR search results

The purpose of this research is to compare 2 different formulations of a study drug called asengeprast. The study will compare the safety, side effects, pharmacokinetics (the amount of study drug or any of its breakdown products in your body), of these two different formulations of a single oral dose (taken up to 3 times). This study will allow Certa to determine the doses and the type of formulation to take into future clinical trials in patients with Systemic Sclerosis. You may be eligible for this study if you are a healthy male or female volunteer aged 18 to 65 years of age who has met all inclusion criteria and do not meet any exclusion criteria. Part B involves participants receiving a single dose of the original form of asengeprast and then a single dose of asengeprast new formulation before and after a high fat meal. Therefore, participants in Part B will receive a total of 3 single doses of the study drug. Participants will be screened and if eligible (i.e. they meet all of the inclusion criteria and none of the exclusion criteria) participants will be enrolled into the study. Being enrolled means being admitted into the study centre on three occasions for a 3-night inpatient stay. You will also be required to attend the study centre on three occasions, following your discharge. All participants will have their vital signs (heart rate, blood pressure, oxygen saturation, temperature and respiratory rate) and ECGs checked, and will provide blood and urine samples for testing to ensure asengeprast is safe and well tolerated.

Shortness of breath, known as dyspnoea, is a common and distressing symptom experienced by lung cancer patients that can severely impact physical functioning and quality of life. Yoga is an ancient mind-body practice that may provide relief from dyspnoea in this cohort, however few quality studies have been conducted to test effectiveness. The purpose of this study is to determine if an 8 week yoga therapy is a feasibly treatment in lung cancer patients. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with non-small cell lung cancer and are experiencing shortness of breath. Study details Participants in this study will receive one of the two below treatments: Group 1: Participants in this group will receive an information booklet focussed on optimal care and receive video recordings of all yoga sessions 9 weeks after enrolment. Group 2: Participants in this group will take part in an 8-week yoga exercise intervention, requiring participants to attend one face-to-face session per week and up to two online sessions per week. The group that participants take part in will be determined randomly (by chance). Throughout the study, participants will be asked to complete questionnaires and complete physical exercise testing. It is hoped that this study will help determine whether an 8-week yoga intervention is a feasible treatment to address shortness of breath in lung cancer patients and provide information that will help inform a larger trial.

Japanese Encephalitis (JE) vaccine and Yellow Fever (YF) vaccine we are using in this study are both “attenuated” vaccines. This means the virus they contain is live but has been weakened and doesn’t cause sickness in healthy people. After JE or YF vaccination, the weakened virus can reproduce itself a little bit for around 1-2 weeks, this makes your immune system start fighting the weakened virus and gives you lasting protection against the disease. The JE vaccine virus has part of the YF virus inside it. If someone is having both vaccines, isn’t known if the order you receive the vaccines changes the immune response to the vaccine viruses. The primary study objective is to assess how the adaptive immune response (responses to antigen) to a live-attenuated JE vaccine impacts the replication of YF virus vaccine following YF vaccination. We will randomise participants to the order in which they receive a YF vaccine and a JE vaccine (JE-YF or YF-JE vaccination arms), given 4 months apart. Participants will have blood samples collected to follow their immune responses to the vaccines.

This study aims to determine the efficacy of 1) topical (applied to the nasal mucosa) lidocaine and usual care, 2) intranasal midazolam plus topical lidocaine and usual care and 3) intranasal fentanyl plus topical lidocaine and usual care compared to 4) usual care for reducing the occurrence of severe distress experienced by children aged 6 months to less than 5 years (i.e. 4 years and 364 days) associated with NG tube insertion.

This project aims to assess the feasibility of a student-led, semi-individualised Falls Prevention and Education Program (FALLS-EDU) for community-dwelling older adults in a university health clinic setting. Participants aged 55 years and older will complete a structured assessment, falls risk stratification and receive tailored falls prevention education and exercise strategies delivered by supervised student osteopaths. The study will evaluate recruitment, attendance, acceptability, logistical considerations, and resource needs over an 18-week total study period. Mixed-methods will be used, including pre-post outcome measures and focus groups with participants, students, and staff to explore experiences and perceptions. Findings will inform future integration of student-led falls prevention models into broader community and aged care settings.

The SMART-AF trial is a single-centre, randomized controlled study evaluating an AI-powered educational platform for patients newly diagnosed with atrial fibrillation. Participants are randomized 1:1 to receive either standard care or access to a structured online curriculum and chatbot designed to improve AF-related knowledge. The primary outcome is the improvement in patients’ AF knowledge, assessed through validated questionnaires before and after the intervention. Secondary outcomes include changes in quality of life, symptoms, lifestyle measures, and anxiety and depression. The study aims to recruit 158 participants over 9 months, with follow-up assessments completed within 12 weeks.

Medications used for male lower urinary tract symptoms are known to cause retrograde ejaculation, however the extent of this is unknown. Quantification of ejaculatory dysfunction and impact on semen quality of medications used for male lower urinary tract symptoms (Silodosin and Alfuzosin) will provide urologists with more accurate and tangible statistics on their impact on ejaculation. Comparisons to placebo will further contextualise results to increase validity and utility of study findings. This will assist in counselling men starting Silodosin or Alfuzosin for lower urinary tract symptoms, to improve patient expectations and understanding, avoid unexpected side effects, and allow patients to make informed decisions in their choice to commence medical therapy for their symptoms. It is hypothesised that both Silodosin and Alfuzosin will result in retrograde ejaculation, demonstrated by a significant deterioration in semen analysis parameters and evidence of semen in urine on urine analysis, to the degree of subfertility, relative to placebo.

This study aims to evaluate the efficacy of two promising treatments for reducing neuropathic pain in individuals with spinal cord injury - electroencephalography neurofeedback (EEG-NF) and transcranial direct current stimulation (tDCS) - delivered individually and in combination in 20 sessions over 6 weeks. EEG-NF trains individuals to self-regulate brainwave activity, with the goal of regulating neural patterns associated with neuropathic pain. tDCS involves the application of an electrical current via two electrodes (anode and cathode) to modulate cortical excitability in a safe and non-invasive manner. The primary hypotheses for 6 weeks post-randomisation are: (1) Participants receiving EEG-NF will report significantly lower pain severity compared to those not receiving EEG-NF. (2) Participants receiving active tDCS will report significantly lower pain severity compared to those receiving sham tDCS. (3) Participants receiving the combination of EEG-NF and active tDCS will report significantly lower pain severity compared to those receiving either EEG-NF or active tDCS.

This study is a world-first pilot trial of a recently developed technique (transcranial magnetic stimulation) to treat patients with Lennox-Gastaut syndrome (LGS). Our recent brain imaging studies have shown that a key area of the brain (“prefrontal cortex”) may play an important role in driving seizures in LGS ans this has led us to hypothesise that changing the activity in this area may reduce a patient’s seizures and help with their learning. Transcranial magnetic stimulation (TMS) is a powerful and non-invasive way of altering brain activity, involving placing a coil over a small area of the patient’s scalp and delivering rapid magnetic bursts that can either increase or decrease activity in the brain area below the scalp. In this pilot study, we will deliver TMS to 10 patients with LGS, measuring safety, tolerability and whether it reduces seizures.

The EngAGE program aims to provide senior Australians an avenue for fun, safe, and socially engaging exercise to combat the social, psychological and physical burdens of ageing. A secondary aim of EngAGE is to provide students of sports and exercise science and exercise physiology an opportunity for authentic work integrated learning opportunities. It is hypothesized that older adult participants will experience improvements in social, psychological and physical wellbeing and that students will see increases in their work readiness and confidence in their ability to work.