ANZCTR search results

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.

The current study aims to test the feasibility and efficacy of combining Mother-Infant Dialectical Behaviour Therapy (MI-DBT) with Attachment and Biobehavioral Catch-up (ABC) for mothers with borderline personality disorder (BPD). The study uses a non-randomised crossover design, where participants start with either MI-DBT or ABC dependent on their position on the waitlist for the MI-DBT group. MI-DBT involves weekly 3-hour group therapy sessions across 24 weeks within community mental health settings, whereas ABC involves weekly 1-hour therapy sessions that occur over 10 weeks within the mother’s homes. 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 depression, anxiety, parental competence, reflection of mental experience, DBT skill use, parental stress, and child social-emotional functioning. It is hypothesised that this approach 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.

The primary objective is to evaluate the safety (pulmonary, cardiovascular [CV], and overall safety) and tolerability of FlecIH-103 (75 mg/mL flecainide acetate inhalation solution) delivered via oral inhalation using an investigational, single use, vibrating mesh nebulizer (VMN) delivery system. Up to three doses of FlecIH-103 inhalation solution will be tested. • Dose 1: 1.4 mL (75 mg/mL) = 105 mg dispensed; 58 mg emitted from the nebulizer mouthpiece • Dose 2: 1.7 mL (75 mg/mL) = 127.5 mg dispensed; 70 mg emitted from the nebulizer mouthpiece • Dose 3: 2.0 mL (75 mg/mL) = 150 mg dispensed; 83 mg emitted from the nebulizer mouthpiece After Cohort 1 is completed, all data will be reviewed by the SMG and a decision to move forward to Cohort 2 will be based on the analyses of these data. The dose and inhalation duration will be based on the safety and PK results from Cohort 1.

Low cardiac output (CO) is common post cardiac surgery and associated with increased morbidity and mortality, ICU length of stay and healthcare costs. Optimising heart rate with atrial pacing may result in improved cardiac output. We hypothesise that increasing heart rate via atrial pacing in post-operative cardiac surgery patients will increase cardiac output until an optimal heart rate is reached at which point further increases will not increase cardiac output. This study will aim to provide information regarding the optimal heart rate, through the use of existing atrial pacing wires and measure cardiac index via pulmonary artery catheters.

The Clareon Monofocal Toric intraocular lens (IOL) is a relatively recently released device from Alcon. It is an IOL based on the successful AcrySof IQ Aspheric Monofocal Toric format with modifications made to the material and edge design aimed at improving optical clarity, rotational stability, and optical side effects. The purpose of this study was to comprehensively assess the safety and effectiveness of the Clareon Monofocal Toric IOLs from those who received the Clareon Monofocal Toric IOLs implantation following cataract surgery.

This is a double-blind, placebo-controlled, First-in-Human Study study to assess the safety of 83-0060, and how this drug acts in the body in healthy volunteers. 83-0060 may be indicated for use in patients with SARS-CoV-2, but a trial of the drug in healthy volunteers is needed before trials in SARS-CoV-2 patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single or multiple doses of 83-0060 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. It is hoped this research will determine the maximum dose of 83-0060 that can be administered safely without causing severe reactions. Once the dose of 83-0060 has been determined in healthy volunteers, a trial investigating the efficacy of 83-0060 as a treatment for patients with SARS-CoV-2 may proceed.