ANZCTR search results

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 5 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.

The purpose of this Part A study is to assess the pharmacokinetic and safety profile of asengeprast MEA salt. 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 A involves participants receiving a total of two single doses, one low and one high dose of the asengeprast new formulation over two treatment periods. Therefore, participants in Part A will receive a total of 2 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 two occasions for a 3-night inpatient stay. You will also be required to attend the study centre on two 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.

The primary purpose of this study is to evaluate the efficacy and safety of combining a T-cell engager epcoritamab with venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This combination therapy aims to address the unmet clinical need for novel treatment strategies in these patients. Who is it for? This study is for patients with documented relapsed or refractory CLL or SLL patients that have received at least one initial treatment that works throughout the entire body. Study details Venetoclax is taken by mouth once a day. After gradually increasing the venetoclax dose up to 35 days, all patients will receive 26 cycles of venetoclax. Each cycle has a duration of 28 days. All patients will then begin treatment with epcoritamab. Epcoritamab is given as an injection under the skin. All patients will receive weekly injections for the first 3 cycles. For patients receiving 6 cycles, it will be given every two weeks during cycles 4-6. For patients receiving 12 cycles, it will be given every two weeks during cycles 4-9 and every four weeks during cycles 10-12. It is hoped this research will identify the most effective and safest dosage for patients, improving overall survival and molecular response rates, while reducing treatment-related complications and deaths for those with CLL and SLL.

This study aims to better understand eating disorders by examining the biological, psychological, social, and neurological factors that contribute to their development, maintenance, and recovery. People aged 14 and over with a current or past eating disorder will be invited to take part in a series of assessments, including surveys, interviews, cognitive tasks, brain imaging, and biological sample collection. By collecting this information, the study hopes to identify patterns and individual differences that could help improve early identification and develop more personalised and effective treatments in the future. We hypothesise that eating disorders are influenced by a combination of genetic, brain-based, behavioural, and environmental factors, and that understanding these in greater detail will lead to better outcomes for individuals affected by these conditions.