ANZCTR search results

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.

The Enhanced Advance care planning and life Review Longitudinal Intervention Community Outreach (EARLI-comm) Project aims to enable older adults to effectively engage with Advance Care Planning (ACP), in the home care setting. Advance care planning is the process by which older adults, or people who are experiencing chronic disease, terminal illness (including cancer) and/or are at risk of dementia and similar conditions can provide instructions to their carer/s about their main preferences and goals for future care, should they reach a stage where they may not be able to make these decisions on a day-to-day basis. The EARLI-comm project focuses on enabling diverse adults with diagnosed life-limiting conditions and/or emerging frailty to express their values, goals and preferences regarding future care and treatment. Who is it for? You may be eligible for this study if you are aged 45 years or older, you have been diagnosed with a life-limiting neurological condition (dementia, Parkinson's disease, Huntington's disease, Motor Neurone disease, mitochondrial disease) or Human Immunodeficiency Virus (HIV). Adults (aged 18 years or older) who also provide support/care to participants who meet these criteria will also be eligible to participate and provide their feedback on the EARLI-comm program. Participants who meet these criteria and have been diagnosed with cancer will also be eligible. Study details Participants who choose to enrol in this study will be allocated by chance (similar to flipping a coin) to one of two groups. The first group will receive the EARLI-comm program which involves meeting with a member of the research team every fortnight for up to 12 weeks. Each meeting is expected to last up to 1 hour and these participants will be guided through the ACP process and given an opportunity to discuss their goals and preferences with members of their aged care and primary care (GP or other specialist) teams. The second group will continue with their usual care for 12 weeks. After the 12 weeks of follow-up has been completed for both groups, participants who were allocated to the second group will be able to commence the EARLI-comm program if they wish. The overall duration of participation in this study will be 12 weeks from the date of enrolment. It is hoped that this study will determine whether this program is effective in helping older adults in the home care setting to be clearer about their values, preferences and plans for the future, while strengthening relationships and improving wellbeing.

We aim to collect data on pain and functional benefits following 6 sessions of caloric vestibular stimulation (CVS) in up to 100 patients with persistent pain (PP). We will gather open label case series data of CVS pain modulation in these PP patients to justify and inform design of a future double blind randomised controlled trial (DB-RCT). We hypothesise that 6 sessions of CVS will induce pain reduction of at least 20% magnitude, for at least 6 weeks duration, in at least 20% of enrolled PP patients. We further hypothesise, based on previous data, that allodynia (pain in response to a non-painful stimulus) will be particularly susceptible to improvement following CVS.

Comparing the complication rate between 2 different types of ureteric stent (Magnetic stent vs stent on extraction strings) which are used during the surgical treatment of kidney stones. We believe that magnetic stent may have less complication and side effects than the stent on extraction string.