ANZCTR search results

The main aim of the study is to evaluate the safety and tolerability of single doses of APG808 in healthy participants, and multiple doses of APG808 in patients with mild-to-moderate asthma.

Anxiety disorders are one of the most common mental health conditions in young people, affecting around 7% of adolescents in Australia. Yet, the rate of inadequate treatment response and corresponding functional impairment in anxiety is high. Cannabidiol (CBD), a main component of Cannabis, can effectively reduce anxiety in adults with social anxiety disorder and has found to be safe and well tolerated in children and adolescents with epilepsy. The current study team have previously tested CBD (up to 800 mg/day for 12 weeks) in a pilot study involving in 31 individuals (mean 21 yrs) with treatment resistant anxiety disorders (ACTRN12617000825358). Two-thirds of participants had a >33% reduction in anxiety severity and 40% of participants had >50% reduction at 12 weeks. CBD was well tolerated with no severe, or unexpected adverse events; 94% of participants completed the intervention, indicating high acceptability. Thus, CBD may be a suitable candidate intervention for youth with inadequate response to anxiety treatments. This is a two-armed randomised control trial in 180 young people with a treatment-resistant anxiety disorder aged 12-25 years, randomised to receive CBD (600mg -800mg/d) or placebo equivalent at a 1:1 ratio, for 12 weeks. Ethics approval was received on 24/10/2023.

This project will test the impact of a nurse-led care co-ordination intervention for people living with dementia and their carers. People with dementia and their carers will be randomly allocated as a pair to either the intervention or usual care condition. For those in the intervention condition, will receive a nurse-delivered care co-ordination intervention over 7 months. It is expected that people with dementia who receive the intervention will have more days in the community at 12 months' post enrollment, reflecting fewer unplanned hospital transitions.

To test the efficacy of a second version of a new virtual reality intervention that was designed to support the social and cognitive recovery of young people with psychosis. This second version was designed alongside young people with lived experience of psychosis and social challenges, and the purpose of this study is to compare version 1 to version 2 of this intervention, to determine the differences in efficacy. The study team hypothesize that version 2 of the intervention will be more effective at improving social functioning compared to the first version at a follow up interview six months after the delivery of the intervention.

This is a non interventional extension study to assess immunogenicity of Tdap-1018 3000 mcg and Boostrix approximately 2.5 to 3 years after study injection in Study DV2-TDAP-01. Adult individuals who participated in Dynavax-sponsored study DV2-TDAP-01 and received either Tdap-1018 3000 mcg or Boostrix will be invited to return 2.5 to 3 years (± 60 days) after the DV2-TDAP-01 study injection for a follow-up blood draw. This is an extension study to ACTRN12620001177943.

This research project aims to investigate the feasibility and acceptability of a multicomponent lifestyle intervention program in community dwelling adults aged 65 and over who are at risk of functional decline. It will also explore the potential effectiveness of the program on ageing related functions. The project aims to recruit 30 participants. The 12-week multicomponent intervention is an established outpatient program at a rehabilitation facility. The program includes individualised physical exercises, facilitated cognitive training and a collection of other lifestyle components including nutritional intervention, mindfulness practice, social interaction, yoga, and healthy ageing strategy education. A comprehensive geriatric assessment is also part of the program. A purpose-designed questionnaire and a semi-structured focus group discussion will be completed at the end of intervention to evaluate the feasibility and acceptability of the program. Assessments on ageing-related outcome measures will be completed at baseline and end-of-intervention.

The primary objective of this study is to determine if the addition of running retraining, by reducing step length, to best standard care is beneficial in the management of medial tibial stress syndrome in runners. A double-blinded, randomised controlled trial will recruit participants with MTSS. Participants will receive standard care (control) or standard care with running retraining (intervention) over eight weeks. Standard care involves load management and strengthening exercises, while running retraining includes step length reduction cues. The primary outcome measure will be the University of Wisconsin Running Injury and Recovery Index at week 4.

Rapid Syllable Transition Treatment (ReST) is a speech pathology treatment which is effective for treatment of apraxia of speech in children and young people. We know it is being used clinically with adults however this has not been reported in the literature. Six adults will be provided with ReST treatment twice per week for six weeks. The research is a single-case experimental design using within participant control. Treatment will be provided by speech pathologists or supervised speech pathology students either online (zoom) or on-campus at the University of Sydney speech pathology clinic in the Susan Wakil Health Building in Camperdown NSW Australia. We hypothesise that participants speech will improve as a result of the treatment.

Cardiac implantable electronic devices consisting of pacemakers and defibrillators are complex pieces of technology. Historically these devices have required schedule in-office checks, but in the past decade improvements in technology have now facilitated completely remote follow-up. In this trial, we aim to evaluate if exception-based care will be a clinically safe and cost-effective strategy with the potential to deliver safe and convenient CIED care for patients, clinicians, and the wider community.

The current study aims to test the feasibility and efficacy of Mother-Infant Dialectical Behaviour Therapy (MI-DBT) mothers with borderline personality disorder (BPD). MI-DBT involves weekly 3-hour group therapy sessions across 24 weeks within community mental health settings. Outcome measures will be assessed at pre- and post-treatment and at a 12- and 36-month follow-up. Primary outcomes are BPD symptom severity and mother-infant interaction. Important secondary outcomes include parental competence, reflection of mental experience, DBT skill use, parental stress, and child social-emotional functioning. It is hypothesised that MI-DBT will be feasible (measured via mother’s reports in a semi-structured interview), and we predict that most clients will achieve significant improvement from pre- to post-treatment in terms of BPD symptom severity and mother-child interaction scores.