ANZCTR search results

AF is a very common heart rhythm disturbance. It is caused by irregular electrical activity in the upper chambers (atria) of the heart. Treatments available for AF are medications and a catheter ablation. Sleep apnoea is a condition in which people stop breathing for periods of time during sleep and is also very common and is often undiagnosed. There are some small studies showing that treatment of sleep apnoea improves heart rhythm control such as AF. However, there are no high quality studies that show this. The aim of this project is to investigate the possible association of these two commonly encountered conditions and in particular whether treating sleep apnoea reduces the risk of AF recurrence after ablation therapy. This study may provide very important information about this link that can help us treat patients in the future. We hypothesise that treatment of sleep apnoea will reduce the recurrence of atrial fibrillation.

Optimal nutrition is critical in protecting against frailty in later life. A Mediterranean diet has been shown in international trials to reduce frailty in elderly individuals living independently. This benefit is related in part to the impact of diet on gut microbiology. Our study focuses on extending this highly successful nutritional strategy to those living in residential aged care facilities.

Preterm birth is associated with maternal and neonatal morbidity and mortality. For women who are considered socially disadvantaged, or vulnerable, adverse neonatal outcomes such as preterm birth are substantially poorer than for women who are not from these groups. How perinatal care is provided has the potential to have a major impact on these outcomes. Caseload midwifery, where women receive care from one midwife during pregnancy, labour, birth and postpartum, is associated with improved clinical and psychosocial outcomes among women with low-risk pregnancies. Using a two-arm multi-site randomised controlled trial (RCT) design, this study aims to evaluate the effectiveness of caseload midwifery care for women identified as being socially vulnerable, compared to usual maternity care, on preterm delivery. Secondary aims of the study include low birthweight (< 2,500 grams); admission to the neonatal intensive care unit; caesarean birth; birth experience; maternal satisfaction with perinatal care; breastfeeding initiation and maintenance; maternal psychological wellbeing; health service use; and cost-effectiveness of the model. The views and experiences of care providers and other key stakeholders will also be explored, and a nested sub-study of physiological stress responses will be conducted at one study site to explore the stress response among women in both trial arms.

Non-alcoholic fatty liver disease (NAFLD) is increasing in prevalence worldwide. It can cause advanced fibrosis and lead to complications of cirrhosis and hepatocellular carcinoma (HCC). Current treatments for NAFLD revolve around weight loss and lifestyle modification without any approved drug therapies in Australia. Coffee consumption is thought to be beneficial in patients with NAFLD. It has been associated with reduced prevalence of advanced fibrosis in patients with NAFLD through epidemiological and cross-sectional studies. Our study is a randomized controlled trial aiming to assess the effect of moderate coffee consumption on patients with NAFLD, looking at the percentage change in hepatic steatosis as measured by MRI over 26 weeks. Participants at baseline will need to be non-regular coffee drinkers. Participants will be randomised into 2 groups. The coffee group will be required to consume 2-3 coffees per day. Coffee pods and coffee machines will be supplied for the duration of the trial. All participants will receive standard lifestyle modification advice at commencement. Other parameters will also be assessed during the trial including anthropometric measures, biochemical markers and stool microbiome.

The primary objectives of this 2-Arm trial are to; 1) further ascertain the effects of various levels of acute alcohol (Arm 1) and alcohol-hangover (Arm 2) on simulated driving performance and cognitive functioning; 2) compare the results of simulated driving performance with findings from a battery of cognitive tests (Schuhfried Vienna Test System) to examine the effectiveness of Schuhfried in evaluating driver performance; and 3) validate the use of a semi-naturalistic research design in measuring the effects of alcohol-hangover. A total of 35 healthy participants, aged 18-40 years will complete this within-subjects crossover trial. Arm 1 of the trial is single-blinded and involves three administrations of alcohol 0.0 g/kg, 0.65 g/kg and 0.85 g/kg across separate sessions to achieve BACs of 0.00%, 0.05% and 0.08%. Alcohol will be Vodka mixed with orange juice in the alcohol conditions. Arm 2 is a trial on alcohol hangover in two phases. Arm 2a follows two visits in Arm 1, placebo and 0.85 g/kg conditions. Further alcohol will be administered after the 0.85 g/kg session. Up to 1.3 g/kg alcohol will be administered accounting for alcohol already consumed. Participants will be assessed the morning following alcohol consumption and after the placebo condition where no alcohol is consumed. Arm 2b of the trial is a semi-naturalistic study design. Participants consume alcohol on a 'normal' night out. Participants will be assessed the morning following alcohol consumption and a night of no alcohol. At all test sessions, participants will complete simulated driving, cognitive measures and questionnaires including perceived performance, willingness to drive and sleep

The primary objective of this study is to compare persistence with Prolia to persistence with weekly alendronate in postmenopausal women with osteoporosis at 12 months. The clinical hypothesis is that denosumab 60 mg 6-monthly subcutaneous (Prolia) treatment will result in a higher proportion of patients being persistent at 12 months of treatment compared with 70 mg once weekly alendronate treatment in the 5 Asian-Pacific countries included in this study.

Patients with multidirectional instability (MDI) of the shoulder experience pain, reduced quality of life and exhibit altered neuromuscular patterning of shoulder musculature(Illyés, Kiss, & Kiss, 2009). Previous functional MRI (fMRI) work investigating motor sequence learning in shoulder instability, showed increased activation in the fronto-parietal and motor control network compared to matched controls(Howard et al., 2019). This study will (1) investigate brain structure and function in patients with MDI compared to normal controls, and (2). investigate whether brain structure and function of MDI patients is modified by implementation of a rehabilitation program that is known to exhibit clinical therapeutic benefit. MDI participants and age and gender matched controls will have a baseline fMRI prior to rehabilitation. Structural shoulder MRI will be performed to exclude participants with underlying labral pathology accounting for their instability. Participants with MDI will then complete a 6-month (24 weeks) rehabilitation program aimed at restoring neuromuscular control around the shoulder. The fMRI scan will be repeated 6-months post baseline for MDI participants. The primary outcome will be the fMRI results at baseline and 6-months (24 weeks). Secondary outcomes will include patients reported outcomes, strength and scapula position. Analysis will focus on detecting between-group differences at baseline and within-group differences of MDI participants pre- and post-rehabilitation.

This trial aims to determine the clinical effectiveness of erector spinae catheters in pain management for patients undergoing open nephrectomy. Participants will be randomised to two arms: • Intervention (ESP block group): In the ESP (Erector spinae plane) block group, an ultrasound guided ESP block will be performed in the operating theatre while the patient is under general anesthesia followed by the insertion of an erector spinae catheter (ESC). The ESP block group will receive a bolus of 30mL of ropivacaine 0.2% every 4 hours for 24 hours. Our proposed randomised controlled study aims to determine if there is an analgesic benefit of ESP catheter block up to 24 hours in patients undergoing open nephrectomy. Specifically: - procedures and drugs administered: intermittent boluses via Catheter of ropivacaine 0.2%, 30ml bolus every 4 hours Both arms will also be started on an intravenous patient controlled analgesia - who will deliver the intervention: anaesthetists - when the catheter will be placed relative to the nephrectomy procedure: following induction of general anaesthesia. At the beginning of surgery • Control group (Sham ESC group): In the control group, a sham ESC will be used and taped onto the skin on the back. Patients in this group will have their sham catheter connected to a pump to replicate an ESC. Specifically: - what this involves for participants:. a catheter is inserted without administration of anaesthetic, however patients will receive standard patient-controlled analgesia - when the sham procedure will occur relative to the nephrectomy procedure: sham procedure done after induction as well at the start of the operation

The introduction of legal medical cannabis in Australia presents a unique challenge for the current roadside drug testing (RDT) approach which was designed to deter driving after illicit drug use and mitigate associated road safety risks. Having a legal prescription for a THC-containing medical cannabinoid product is not at present a valid legal defence against the charge of driving with a detectable concentration of a prescribed illicit drug, which means that medical cannabis patients are effectively prohibited from driving. Understanding the detectability of medical cannabis products using the Securetec DrugWipe® TWIN and investigating the driving-related effects of medical cannabis use, are important research priorities that can help to inform effective road safety policy and law enforcement strategy in this area. This project will examine whether THC in medicinal cannabis products is detectable (present/absent) with commonly used single-use oral fluid drug detection devices among people who routinely use this medication, and for how long it might be present after consumption. We will assess this in a group of patients who are currently using medicinal cannabis products at different concentrations and in different preparations (e.g., oil and spray, THC dominant and THC/CBD-equivalent). We will also be assessing whether there are any changes to driving or cognitive ability due to using medicinal cannabis products that contain varying concentrations of THC and CBD.

The purpose of our study is to improve the identification of the lesion responsible in patients presenting with NSTEMI (a form of heart attack), as these patients often can have multiple lesions and our ability to identify the culprit is still limited. All patients participating in this study will undergo a heart MRI before their scheduled invasive coronary angiogram to identify the area damaged by the heart attack. They will then proceed to scheduled coronary angiogram as planned. After the angiographic images are obtained, further anatomical and functional information of the heart vessels will be obtained with advanced intracoronary imaging (using OCT) and coronary physiology measurements (FFR, CFR, IMR). We will then see if the interrogation of this further information can help operators in identifying the correct artery responsible for the heart attack.