ANZCTR search results

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.

The aim of this research is to establish how good current x-ray methods are at identifying artery wall dissections that are severe enough to require further treatment. Dissections are tears of the inner layer of the artery wall caused by angioplasty (the deliberate stretching open of a blocked or narrowed artery using a balloon placed inside the artery). Dissection is a common complication of treatment with most being minor and requiring no further action, however some dissections are severe enough that they need further treatment. Currently very little is known about the accuracy of the current x-ray-based methods of identifying severe dissection. We also don’t know how much variation in diagnosis of dissection there is between doctors or whether there is a difference in the results of treatment at one year between mild and severe dissections. In this research project we will be obtaining several other measurements in addition to x-rays (including conventional ultrasound imaging, intravascular ultrasound (a miniaturised form of ultrasound mounted on a catheter that is placed within the artery), and pressure measurments within the artery) to assess the severity of dissections seen after initial treatment. We will also follow up participants for one year after the treatment to check on the success of the treatment. If current x-ray methods are found to perform poorly, it may be possible to develop better methods using some of these other measurement methods. We hope that this research will improve the diagnosis of dissection in the future and ensure that patients in the future will have better outcomes from their angioplasty treatment.

People with haematological malignancies are at increased risk of severe disease and death from COVID-19. New vaccines from Pfizer and AstraZeneca are reporting high immunogenicity and efficacy in clinical trials, but there is lack of data regarding how well people with haematological cancers respond to vaccines, to what extent and how durable responses may be. It seems reasonable that responses will differ in patients with haematological malignancy, based on both disease factors and factors related to specific anti-cancer treatments. Follicular lymphoma (FL) and Waldenstrom Macroglobulinaemia (WM) are two low grade non-Hodgkin lymphomas that offer potential models to study the impact of immunocompromisation on the immunogenicity of the COVID-19 vaccines. This study, combined with our evolving understanding of which types of vaccine responses are most important in conferring long-term protection against COVID-19, will allow people with FL and WM to make better informed decisions about treatment induction and maintenance options when indicated. It will also provide patients who have already completed treatment a better idea of how much protection to expect and what additional precautions might be required (e.g. preventative pharmacological agents in development, ongoing isolation if necessary, or additional vaccination if evidence emerges to support that).

Venous thromboembolism (VTE) is a condition whereby a blood clot forms inappropriately in the veins. This clot may dislodge from its point of origin and be carried to the lung vasculature, which may be a fatal event. It has been estimated that the Australian annual incidence of VTE is 0.83 per 1000 individuals and is associated with significant morbidity and health related economic costs. In 2008, the estimated cost to the Australian economy was $1.7 billion dollars. Venous thromboembolism may be provoked by major surgery. The risk of surgically provoked VTE may be mitigated by the combined use of mechanical thromboprophylaxis, as recommended by the 2012 American College of Chest Physicians (ACCP) clinical practice guidelines and more recently, the 2019 American Society of Hematology (ASH) clinical practice guidelines. Despite this, there is no clear recommendation as to the type of mechanical thromboprophylaxis that should be used, with either or both graduated compression stockings (GCSs) or sequential calf compression devices (SCCDs) used. We wish to perform a cohort study of all laparoscopic cholecystectomies (elective and emergency) with a standardized mechanical prophylaxis protocol, to determine if we can maintain a low rate of VTE on SCCDs alone compared with the historical cohort of patients managed with combined SCCDs and GCSs, whilst maintaining safety including the risk of bleeding. The hypothesis of this study is that there is no difference between combined SCCDs and GCSs when compared with SCCDs alone. If this is true, GCSs could be removed from normal care, reducing GCS related complications and producing substantial cost savings for hospitals.

The DELTA study is a double blinded parallel arm randomised controlled trial designed to test the hypothesis that a two-day course of oral dexamethasone in mild to moderate COVID-19 patients results in fewer COVID-19 related hospitalisations, intensive care unit admissions and death; and reduced time to self-reported symptom resolution. Once patients have consented to participate in the study, they will be randomised to receive either 6mg oral dexamethasone or 150mg thiamine (placebo). Study information will be collected from electronic Medical Records (eMR). Only routinely collected data will be used for this study, and will include disposition, intensive care admission, ventilation days and total hospital length of stay. Data managers and/or clinical nurse consultants will assist with data extraction. Data will be collected and entered into SLHD RedCap. Data analysis will follow.