ANZCTR search results

Calcific aortic stenosis is a condition in which build-up of calcium on the aortic valve, located at the outflow of the heart, progressively blocks blood flow to the organs and can cause debilitating symptoms and very poor survival. Timely replacement of the valve can be lifesaving but comes with significant risks and at high cost. The incidence is increasing in Australia. Until now there have been no treatments that can prevent the progressive obstruction of the aortic valve. Our pilot study showed that supplementation of Vitamin-K, 10mg per day is safe and can prevent all early types of calcification in the arteries. The double-blind, randomised, placebo-controlled PASSPORT trial will test whether Vitamin-K can slow or prevent the calcium build-up and obstruction of the aortic valve. 108 subjects with mild or moderate aortic stenosis on echocardiography will be randomised to Vitamin K1 10mg per day or matching placebo for a median duration of 16 months (range 12-21 months). All subjects will receive an echocardiogram and non-contrast CT-calcium score at baseline and at the end of the trial. The primary end point will be progression in aortic valve calcium score on CT scans and secondary outcomes will be progression of flow obstruction parameters as assessed by echocardiography.

The objective of the research is to examine the difference in blood glucose control and length of stay in people that manage their own insulin and blood sugar levels in hospital versus people whose insulin and blood glucose cares are performed by a clinician (usual care) in an acute care setting. Blood glucose control will be measured by a continuous glucose monitor that will measure the percentage of time the blood glucose is within range. Participants will be screened for participation in the study and will require informed consent. Eligibility is people over the age of 18 who have been managing their insulin independently at home prior to admission. Participants will be randomly allocated to either the intervention or control group. The intervention group will measure their blood glucose levels via finger prick and inject their own insulin as they do at home. The control group will be managed by the nurses and doctors as is current practice. Continuous Glucose Monitoring will be performed on all participants. Out study will investigate if independent patient diabetes management in the acute setting will lead to improved glucose control, reduced length of stay, improved patient satisfaction, improved clinician satisfaction and reduced readmissions within 30 days.

Buprenorphine and methadone are medications used in the treatment of opioid dependence. Buprenorphine is a partial opioid agonist, meaning it has a ceiling effect, and thus transferring from a full opioid agonist such as methadone can be challenging because of the risk of causing precipitated opioid withdrawal for the patient. Current standard practice is to reduce Methadone doses to lowest dose possible , wait until the patient is in moderate withdrawal, then commence buprenorphine. This can be a time-consuming process, often requiring hospital admission for a week, or even longer in some cases, putting additional strain on public health systems. Micro-dosing is a novel approach to transitioning patients on full-agonist opioids (heroin, methadone, oxycodone, morphine) to buprenorphine using very small doses of buprenorphine concurrently with a full opioid agonist. The aim of this prospective dual arm, clinical trial is to establish a safe micro-dosing regimen for completing transfers from methadone to buprenorphine, and compare outcomes in patients that undergo micro-dose transfers from methadone to buprenorphine to those completing a standard of care transfer. Our hypothesis is that micro-dosing is a safe method for transitioning patients from methadone to buprenorphine in the community.

Following elective total hip or knee replacement surgery (THR/TKR), receiving care at home instead of hospital is recommended for most patients. However, care at home services such as rehabilitation-at-home are underutilised in private hospitals. Research suggests the primary reason patients spend additional time in private hospitals is driven by patient concerns with safety and value of care at home. To address patient concerns, we have designed new patient information aiming to dispel fears about safety and better inform patients about the benefits of rehabilitation-at-home. The primary aim of our trial is to investigate if new patient information helps more patients to receive rehabilitation-at-home instead of hospital. For patients scheduled for a THR or TKR at a private hospital, we will randomly select 299 patients to receive new patient information before surgery, and another 299 patients who will receive the current information only. Then we can compare the two groups to see if the new information help more patients receive rehabilitation-at-home. We will also measure patient outcomes (e.g., quality of life) and costs between the two groups. We also plan to compare outcomes between participants who receive non-inpatient rehabilitation (i.e., rehabilitation-at-home or outpatient rehabilitation) versus inpatient rehabilitation care. Alongside the trial, we will also conduct interviews with a subset of participants who received the new patient information, to explore their perspectives on the intervention based on their experiences.

Cardiovascular disease remains a leading cause of death. The burden of arterial calcifications remains an important predictor of cardiovascular disease events and deaths, however, predicting those who will eventually develop a large arterial calcification burden is difficult. Recently, lab studies have suggested that a low level of oxygen within the arterial wall, and plaque, may predispose to increasing calcification in the same region. 18F-Fluoromisonidazole (18F-FMISO) Positron Emission Tomography (PET) is a novel molecular imaging modality that can detect areas of low oxygen in the arterial wall and plaque and may be a suitable imaging tool to predict where calcification develops. In a prospective arm, we aim to determine if regions of low oxygen in the vessel wall, detected with 18F-FMISO PET, in patients undergoing lower limb amputation, is associated with other markers of hypoxia (in-vitro hypoxia inducible factor 1-alpha) and calcification (ex-vivo 18F-Sodium Flouride PET) in the same anatomical region.

This prospective cohort study will recruit consecutive clients attending the withdrawal unit and offer them rapid point-of-care testing for hepatitis C viral load by fingerstick. This will be compared to current standard-of-care hepatitis C testing through a retrospective analysis of testing and treatment over the preceding 12 month period. The study will aim to evaluate the uptake and acceptability of point-of-care testing of hepatitis C amongst individuals with substance dependence presenting to a residential withdrawal unit along with the rates of direct acting antiviral treatment initiation and adherence for individuals with confirmed hepatitis C. The study will be undertaken at Depaul House, a residential withdrawal unit attached to St Vincent's Hospital Melbourne.

Osteoarthritis is the most common form of arthritis and is a leading cause of global disability. This study will evaluate the effects of two different nutrition programs in individuals with knee OA delivered over 12 weeks. We hypothesise that the anti-inflammatory dietary intervention will result in greater improvements in pain, function, quality of life, inflammatory biomarkers and body composition after 12 and 26 weeks compared to a standard care control group.

The aim of the study is to prove that the Felix™ System is just as good as either or both the Density Gradient Centrifugation (DGC) and Swim-up (SU) methods of spermatozoa separation when using Intracytoplasmic Spermatozoa Injection (ICSI) fertilisation. This will be measured based on how many embryos could be immediately transferred, 5 or 6 days post fertilisation or retained and frozen for later transfer.

Autism spectrum disorder (ASD) is a highly prevalent neurodevelopmental disorder with no validated biomedical treatments for the core social and behavioural symptoms. The current study is a randomised crossover trial to assess whether cannabidiol (CBD) can promote behavioural and neurophysiological improvements in 5- to 12-year-old children. Several recent studies have investigated acute CBD administration on neurophysiological processes in the adult autistic brain (Pretzsch, Freyberg, Voinescu, et al., 2019a; Pretzsch, Voinescu, Lythgoe, et al., 2019a, 2019b; Pretzsch et al., 2021a). Others have documented behavioural outcomes following chronic (long-term) administration of the compound (Aran et al., 2019, 2021; Bar-Lev Schleider et al., 2019). To date, no investigation has explored effects of long-term CBD administration on glutamate and GABA concentrations alongside social communication outcomes. With a specific focus on the Research Domain Criteria (RDoC) ‘social processes’ domain (Cuthbert & Insel, 2013), which is heavily implicated in ASD, this study will utilise electroencephalography (EEG) to measure neurophysiological changes after chronic administration of CBD over a 12-week period. EEG will be used to acquire resting-state, social task-related processing, and mismatch negativity (MMN) data. MMN is a recognised measure of glutamatergic NMDA receptor function, and thus, neuronal excitation (Kompus et al., 2015). The study is designed to address the following aims: Behavioural: to measure the effect of CBD on the RDoC social processes domain in children with autism. More specifically, to observe a change in Social Responsiveness Scale (SRS) scores from baseline to Week 12. Neurophysiological: to observe whether CBD ‘shifts’ cortical excitation/inhibition during a social task, measured using EEG.

To assess whether incorporation of a polygenic risk score (PRS) into cardiovascular disease examinations (e.g., Heart Health Check), through the PPP-CAD clinical pathway, identifies subclinical CAD in participants considered to be at low or moderate 5-year absolute cardiovascular disease (CVD) risk (Absolute CVD Risk).