ANZCTR search results

The main purpose of this study is to see how safe and tolerable OV329 is when compared with placebo in participants who have focal epilepsy when it is added to current antiseizure therapy. OV329 works by lowering the risk of seizures. It does this by blocking a specific protein in the brain called GABA-AT, which slows down how fast the brain breaks down a calming chemical called GABA. With more GABA in the brain, the nervous system becomes more balanced and stable, making seizures less likely. The study consists of an approximate 16 week period including screening, 4-8 weeks of baseline, 8 weeks of treatment, 1 week of tapering and a 2 week follow up period. OV329 is an oral capsule and during the treatment period the dose will be 7mg (1 x 5mg and 2 x 1mg capsules) daily.

Children frequently fall over and fracture their forearm. Most forearm fractures are routinely put into a plaster cast and are sent to fracture clinic for follow-up. Recent studies show that removable wrist splints work well for stable fractures in that they provide rigidity but can be removed for comfort and hygiene purposes. This pilot study will explore the use of wrist splints to manage distal forearm fractures in children. It will primarily test whether we can successfully recruit enough families to participate in a larger trial but will also inform estimates on safety of wrist splints. If wrist splints are a suitable alternative to casts this could also help the health care service, which can better focus on children with more complex fractures. If this pilot study shows we can efficiently recruit participants and that the treatment appears to be safe, this would provide the foundation for a larger clinical trial to evaluate effectiveness of splints compared to casts. Given that upper arm fractures in children are a common reason for presentation, a change in practice to splint use could have global impact.

Children are spending increasing amounts of time with screens. Both International and national guidelines suggest limits for screen time for children 5-12 years old, still many children exceed these limits. However, time is only part of the issue, and other factors also need to be considered. Therefore, it is essential to support their parents to promote healthier habits in their children when interacting with screens. This study aims to evaluate the efficacy of the Healthy Screentime Habits Seminar (HSHS) through a randomised controlled trial (RCT) involving 500 parents of children aged 5 to 12 years old. It is expected that, when compared to waitlist group, parents who participate in HSHS would report improved parent, child, and family outcomes at post-intervention and 3-month follow-up. The initial evidence of the efficacy of the seminar would inform future research and scaling up implementation.

This study is being conducted to evaluate the safety, tolerability, and pharmacokinetic profile of single escalating doses of CLIP-100 administered as an injectable lipolysis agent into the subcutaneous abdominal fat of healthy adult participants. Up to 25 healthy participants with subcutaneous fat in the abdominal region will be enrolled in five escalating dose cohorts.

People receiving peritoneal dialysis (PD) are expected to record considerable clinical and dialysis-related information at home. This study aimed to assess the feasibility and clinical outcomes of a novel smartphone application (App), PD-Buddy, developed to facilitate timely and accurate PD data collection and sharing with the PD healthcare team.

OV4071 is an investigational product being tested for neurological disorders. Part B is a food effect cohort of eight participants being administered a single dose on Day 1, followed by a washout period of at least 7 days and a second single dose administered on Day 8 or later under fasted and fed conditions.

This Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of OV4071 in healthy participants. It is hypothesised that OV4071 will be safe and well tolerated within predefined exposure limits supporting further clinical development.

Intermittent has been shown to be beneficial in several medical conditions. Alzheimer's dementia has no definitive treatments yet. This study investigates the feasibility of intermittent fasting through time-restricted eating in people at risk for Alzheimer's dementia. The study hypothesis is that the feasibility of time-restricted eating in people at risk of Alzheimer's dementia will be comparable to normal diet.

This study is assessing the feasibility of an exercise prehabilitation program for adults with lymphoma planned to receive CAR-T therapy Who is it for? You may be eligible to join this study if you are aged 18 years or above and scheduled to receive CAR-T cell therapy for lymphoma cancer Study details All participants in this study will receive a personalized prehabilitation exercise program with an exercise physiologist involving 3 exercise sessions per week via telehealth for 4 weeks. Each supervised exercise session will go for 30-45 mins and will include aerobic and resistance exercises. Participants will commence exercise sessions up to 4 weeks prior to the planned start of CAR-T therapy and end just before CAR-T therapy commencement. All participants will complete questionnaires and physical assessments at baseline and 2 weeks post-intervention to determine feasibility and efficacy of the program and a questionnaire to assess the acceptability at 2 weeks post-intervention. We hope that the information learned from this study will help to inform larger prehabilitation exercise trials for people with haemotological cancers planned to receive CAR-T therapy.

This study will develop a pharmacokinetic model of isradipine, an oral treatment for acute hypertension in children, to facilitate accurate, age-specific dosing. We aim to clearly understand how isradipine is processed in children experiencing severe high blood pressure. With these data, we expect to prevent ‘under-doses’ that lead to delays, ineffective management, and disease progression requiring intensive care admissions. We also expect to avoid ‘over-doses’, leading to dangerously large blood pressure (BP) reduction and permanent damage to major organs. By identifying and quantifying critical factors that influence pharmacokinetic parameters in these children, we will develop a dosage regimen stratified by age and comorbidity. This approach will provide improved care to children over the current ‘trial-and-error’ approach with dosing regimens extrapolated from adult data in treating this at-risk population.