ANZCTR search results

This study seeks to assess the effectiveness of an 18-month digital health intervention (Tiny Bites) targeting infant feeding practices, delivered to ECEC educators and primary caregivers of children aged between 4-12 months (inclusive) relative to a usual care control group. We hypothesise that children in the intervention group will have a 0.26 lower BMI zscore compared to those in the control group. We will recruit 60 early childhood education and care services and 540 carer/child dyads. Services will be randomly assigned to intervention or control in a 1:1 ratio. To improve infant feeding practices, services allocated to the intervention group will receive access to an online portal (which includes a self-assessment and webinars around infant nutrition) and support from health service staff. Parents in the intervention group will receive text messages tailored to their child's age around infant feeding. After delivering the intervention for 18 months, we will compare the BMI zscores of children in the intervention group to the control.

This study aims to assess the safety and efficacy of an Advanced closed-loop Android Artificial Pancreas System over an extended period of 12 months. All participants will continue with the equipment provided for the original study i.e. AAPS using a Ypsomed pump, Dexcom G6 CGM and an Android phone with an installed AAPS algorithm on the Lotus app. The advanced features and enhancements of the algorithm will be activated for all participants at the beginning of this extension trial. Those assigned to Advanced AAPS with announced meals in CLOSE IT will commence using the fully closed loop with no meal announcements. During this study, participants will have the choice of using either NovoRapid® or Fiasp® insulins. Participants will receive support from your usual clinical team in addition to our clinical research team as required. Assessments of HBA1C, weight and questionnaires will be completed at the start and after each 3-month period of the study.This trial is an extension of the original Close It trial ( ACTRN12622001401741).

This study is an audit of usual care physiotherapy for intensive care patients who have experienced mechanical ventilation of 5 days or longer duration. This audit will be conducted for a two-month period following appropriate ethics and governance approvals, or until a minimum of 100 participants have been recruited, to accurately capture the usual care in several hospitals around Australia. This audit is an essential first step prior to launching a multicentre study of a physiotherapy intervention (inspiratory muscle training) later in 2024. Due to the negligible risk to patients, and the need to capture usual care for patients who are unconscious, this observational study has obtained a waiver of consent. This multicentre study will be led by Canberra Hospital intensive care unit (ICU) researchers, but is overseen by a well-established group of expert researchers in ICU rehabilitation. The audit tool has been co-designed and tested by physiotherapists from various sites, with input from a consumer representative. This study will pave the way for high-quality Canberra-led multicentre research in 2024 and beyond.

Next day discharge after transcatheter aortic valve implantation (TAVI) has been shown to be safe and is now commonly implemented in clinical practice. A small number of studies have investigated same day discharge (SDD) after TAVI, but more studies are needed, particularly in self-expanding valves. This study will prospectively apply a locally derived discharge protocol to all consecutive patients undergoing elective, transfemoral TAVI procedures at our centres. The study aims to determine if the NORTH SHORE DAY-STAY TAVI clinical pathway effectively identifies patients who are at low risk of post-procedural complications and to evaluate if they can be safely discharged on the same day following transfemoral transcatheter aortic valve implantation (tf-TAVI). The project will measure endpoints including all-cause mortality, stroke, major bleeding, major vascular complication, new renal replacement therapy and high-grade AV block during index hospitalization and at 30-day follow up.

The study will determine the effects of 12 weeks treatment with the 'long-acting' glucagon-like peptide-1 (GLP-1) agonist, semaglutide once weekly (QW), on the rate of stomach emptying, glycaemia, blood pressure (BP) and heart rate (HR) following a standardised mashed potato meal, in type 2 diabetes (T2DM). The study will also assess the effect of cessation of semaglutide on gastric emptying at 1 and 4 weeks post-cessation. This is a randomised parallel designed study. Subjects recruited into the study who pass screening criteria will be randomised to receive semaglutide QW or matching placebo. They will have a gastric emptying study performed using the gold standard technique (scintigraphy) at baseline, at 12 weeks, and 1 and 4 weeks post cessation of semaglutide QW. Immediately following the first gastric emptying study they will commence treatment with semaglutide QW or Placebo, administered subcutaneously at weekly intervals. Glucose absorption, blood pressure, blood glucose and plasma insulin will be assessed during each of the gastric emptying measurements.

Failure of the upper oesophageal sphincter (UOS) relaxation is frequently observed in Parkinson's Disease. It contributes to swallowing dysfunction which has enormous impact on quality of life and is an important risk factor for life-threatening aspiration pneumonia. The randomized controlled trial aims to determine the efficacy of a novel, minimally invasive endoscopic myotomy of the cricopharyngeus muscle (C-POEM) as a treatment for swallowing dysfunction attributable to failed upper oesophageal sphincter relaxation. Participants will undergo baseline assessments including pharyngeal high-resolution impedance-manometry (P-HRM-I) to confirm a diagnosis of UOS dysfunction. Participants with P-HRM-I features of failed UOS relaxation will be randomised to receive either: 1) C-POEM (treatment group) or 2) swallow therapy guided by a speech pathologist (control group). At 12 weeks following randomisation and completion of assigned treatment, participants from both arms will undergo repeat evaluation, including: patient-reported outcome questionnaires, P-HRM-I, videofluoroscopic swallow study and clinical outcomes. Participants in the control group who do not respond to dysphagia therapy will be offered a cross-over to undergo C-POEM.

Kidney transplantation improves the survival and quality of life of people with end-stage kidney disease (ESKD) compared to remaining on dialysis. One of the major barriers preventing some people with ESKD from receiving a transplant is the presence of antibodies against a broad range of HLA antigens found in the community. Transplantation in the presence of antibodies directed against the HLA type of the donor (donor specific antibody, DSA) is associated with an increased risk of antibody-mediated rejection, development of transplant glomerulopathy and graft loss. To minimise this risk, many deceased donor kidney transplant allocation systems allow potential recipients to avoid donors with HLA antigens to which the recipient has detectable antibodies. There is therefore an unmet need for a strategy to reduce the number of HLA-specific antibodies in these highly sensitised patients. This study will specifically investigate whether Clazakizumab is effective at reducing HLA antibody levels, whether this allows some HLA types to be removed from the list deemed unacceptable and whether this increases the chance of transplantation. It will also study the safety of this intervention and the outcomes of the transplants performed.

We have highly effective psychological therapies for post-traumatic stress disorder (PTSD), however, individuals face multiple barriers to receiving gold-standard treatments. Most prolific of these is long waiting times, due to the limited number of professionals trained in specialist PTSD treatments. Here, we aim to evaluate a simple, digital, memory-based program MemFlex, which has been demonstrated to improve PTSD symptoms, and ameliorate cognitive difficulties that predict prognosis and impede the efficacy of psychological therapy. It is expected that offering MemFlex to individuals on the waitlist for psychological therapies will improve both a) cognitive predictors of PTSD, and b) post-treatment symptoms, relative to waitlist as usual.

A first time in human study to evaluate safety, tolerability, and pharmacokinetics of SIR2501 tablets compared with placebo in normal healthy adult participants. A single and multiple-ascending dose study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SIR2501 n healthy adult participants. Results of this study will inform dose selection and design of studies to assess the efficacy and safety of SIR2501 in neuropathies and neural degenerative disorders.

We are yet to fully understand which women are more likely to suffer pelvic floor (PF) trauma and dysfunction. The aim of this study will be to determine if there are pre-existing conditions that predispose women to prolonged second stage or instrumental births which ultimately leads to PF trauma and dysfunction. We would like to create an evidence-based screening questionnaire to identify women and track their birth outcomes. The screening questionnaire would be completed at their initial midwifery appointment. North Canberra Hospital are collaborating with experienced academic staff at the University of Canberra in the design of these projects to ensure high-quality research can be achieved and published in reputable journals to influence international practice. This information will be relevant to women’s health services around the world.