ANZCTR search results

There is a 25% failure rate for peripheral intravenous catheters (PIVC) inserted for infants and children requiring treatment within the emergency department and during hospitalisation. Our trial aims to test if new advances in catheter securement, medical grade superglue and an integrated dressing securement product are effective at preventing cannula failure and complications in paediatric patients. The outcome we are measuring is the decrease in failure rate between standard treatment and our new securement devices.

This randomised study compared how tibial fixation affected component migration, bone remodelling and clinical outcomes in Posterior Stabilised Total Knee Replacements. 100 patients were randomised to receive TKRs with cemented or cementless tibial components. The hypothesis was that tibial fixation method would impact implant stability.

The primary aims of this first-in-human study are to investigate the safety and immunogenicity of ACT-1239, a Vaccine for Plasmodium falciparum Malaria. Up to 50 participants will be recruited to five Cohorts of 10 participants each in this open-label, dose escalation, first in human (FIH) study. Participants will receive an intramuscular (IM) injection of ACT-1239 at the specified dose level per their allocated treatment group. Two sentinel participants of each Cohort will be dosed initially. If dosing of these sentinel participants proceeds without clinically-significant adverse events (AEs) over a 24 hour period, the remaining 8 participants of that Cohort will be dosed. Participants will receive a total of 3 IM vaccinations, administered 28 days apart. The dose level will be established following assessment of safety data of the preceding cohorts but is planned to increase from 1µg (Cohort 1) to 3µg (Cohort 2), 10µg (Cohort 3), 30µg (Cohort 4) and 100µg (Cohort 5). Participants will be followed up post-vaccinations via phone call and clinic visits up until Day 85 following vaccination number 3 ( the last administered vaccination) for safety and other assessments. Participants will then be required to return to the site at 6 and 12 months for safety follow up.

Atherosclerotic plaques are a major contributor to ischaemic strokes. While magnetic resonance imaging (MRI), duplex ultrasonography, computer tomography (CT) and angiographic investigations can detect atherosclerosis, there is currently no method to accurately determine which plaques are most likely to cause clinical events, or alternatively, which plaques are stable. Identifying “vulnerable” plaques, irrespective of the degree of stenosis, is therefore a key aim of vascular researchers. It is suggested that vulnerable plaques have a higher degree of hypoxia than asymptomatic plaques. FMISO is a tracer known to accumulated in hypoxic regions. The proposed project is a pilot study that aims to utilize FMISO for carotid artery imaging to determine whether it can distinguish between vulnerable and stable plaques This study will recruit patients at Royal North Shore Hospital who have had previous stroke and undertake FMISO PET scans of their carotid arteries. It will compare them to PET images from patients who have plaque but who have not had ischaemic events in order to ascertain whether positive PET scans correlate with symptomatic plaques compared to negative controls who have no history of TIA.

This study will review the intervention of administration of oral propranolol tablets to patients with HHT (Hereditary Haemorrhagic Telangiectasia) . Patients will be monitored to see if Propranolol helps reduce epistaxis (nosebleeds) . The most common symptom of HHT is having recurrent, spontaneous nosebleeds. Propranolol has been used for a similar purpose in another group of patients with good effect. If it should work it would be a very simple and cost effective way to reduce patient symptoms and approve quality of life for these patients..

Childhood obesity is a serious public health problem which tracks into adulthood. While some community-based prevention efforts have been shown to be successful, this is not the case for disadvantaged culturally diverse populations. Family dysfunction contributes to unhealthy eating and physical activity (PA) patterns among children and is common in disadvantaged populations. Family-focused programs that include positive support are effective in improving family dynamics and may be important in preventing childhood obesity in these populations. We will test whether a 6-week behavioural parenting and lifestyle (BPL) intervention (+2 boosters) for parents and carers of 5-11 year-old children is effective, sustainable and cost-effective in improving children’s anthropometric outcomes and family functioning. Measurements at baseline, end of intervention and 12 months post-intervention will assess changes in children’s weight, PA, and eating behaviours, as well as in family functioning and parent knowledge and behaviour. This family-centred intervention has the potential to reduce obesity through improved family functioning in relation to eating and physical activity patterns in children in disadvantaged and multi-ethnic populations. Cost-effective programs are urgently needed to reduce childhood obesity and its inequalities among ‘at-risk’ populations.

We propose a prospective cohort study of 210 adult liver transplant recipients followed up for 12-months, to determine the utility of combining two novel blood tests - quantiferon monitor and donor-specific cell free DNA (QFMdscfDNA) - in monitoring and managing immunosuppression post liver transplantation. Our primary hypothesis is that the QFM-dscfDNA tests can be used to accurately diagnose the occurrence of rejection or infective complications after liver transplantation. The secondary hypotheses are that the QFM-dscfDNA tests can be used to predict acute rejection or infective complications, monitor treatment responses and improve healthcare resource utilisation.

There is controversy both in lay and scientific circles regarding the best dietary approach to promote maximum performance gains during training for endurance sports. The current study will utilise the recognised research skills of AIS Sports Nutrition and the AIS Canberra Campus environment to implement careful dietary control to compare the results of the three different dietary approaches to the same intensive and periodised training program in elite distance athletes: 1. High carbohydrate (CHO) availability for all training sessions 2. High-fat low CHO (LCHF) 3. Periodised diet involving a careful integration of sessions with high and low CHO availability We will examine the effect of a 3 week training block with these different approaches to dietary support on indices of health, adaptation of the metabolic response to exercise and performance in a cohort of highly competitive race walkers, undertaken within 2 training/research camps.

ImPaCt is a study to trial the PCI within the community nursing service to enhance detection of the patient complexity in our service. The primary objective is to explore whether adding the PCI to usual assessment process could enhance detection of complexity of patients. The secondary objective is to explore whether using the PCI derived patient complexity could facilitate appropriate resource allocation; this resource being the time allocated to providing clinical care to the complex patient. The study will also explore issues around feasibility and acceptability of the PCI in the community nursing service.It is anticipated that the study will explore if the PCI is a suitable tool to enhance the detection of complexity and support resource and time allocation for patient. This study has the potential to provide recommendations to the developer for modifications for Australian use and inform a larger multi-site trial.

There is some evidence that cannabinoids may enable patients to reduce their opioid medication whilst maintaining adequate analgesia - known as opioid sparing. If so, cannabinoids could prove effective in reducing drop-out rates in opioid dose taper regimen, assisting patients with poorly managed pain. This protocol is a preliminary dose escalation pharmacokinetic study which will evaluate the safety and tolerability of a cannabinoid (THC:CBD) oil formulation following a single dose and following repeated dosing in patients with chronic non-cancer pain. The data from this pharmacokinetic study will inform a subsequent trial which will assess the impact of oral CBD/THC combination oil on patient ability to tolerate a stepped opioid tapering protocol at a rate of 10% per week over 10 weeks.