ANZCTR search results

The purpose of this pilot trial is to provide preliminary evidence for any effect of Oral Appliance Therapy (OAT) for Obstructive Sleep Apnoea (OSA) on a range of intermediary cardiovascular risk markers (vs. control group) in sleep clinic patients with OSA identified to be at high cardiovascular risk (Framingham risk assessment) but without established cardiovascular disease. Intermediary cardiovascular risk markers (peripheral and central blood pressure, arterial stiffness, endothelial function, autonomic function, carotid intima-media thickness, and blood biomarkers) will be assessed at 3 and 6 months post OAT implementation. Efficacy of OAT in controlling OSA at the end of study and adherence to OAT over the study period will also be assessed. The recruitment target is 105 participants, aiming for 35 in the control arm and 70 in the OAT arm. The OAT arm recruitment has been inflated due to known variations in OAT efficacy to aim to achieve 35 participants who show high efficacy to OAT. Data from this pilot trial will be used to inform future trials of OAT for cardiovascular disease prevention.

This study is a randomized, double-blind, multi-centre, single dose, parallel group, 3-Arm, PK study in healthy subjects. The primary objective is to assess the pharmacokinetic similarity of JHL1266 compared with reference Prolia sourced from the European Union (Prolia-EU) and the United States (Prolia-US) after a single subcutaneous injection in healthy human subjects. The secondary objective is to assess the safety, tolerability, and immunogenicity and PD of JHL1266 as compared to Prolia. Healthy subjects aged between 25 to 55 (males) or 25 to 45 (females) years old who met the inclusion/exclusion criteria during the screening who met the inclusion/exclusion criteria during the screening period will be enrolled into this study. The enrolled subjects will be randomized into 3 cohorts, JHL1266, Prolia-EU, or Prolia-US. A single 60 mg dose of JHL1266, Prolia-EU or Prolia-US will be administered subcutaneously on Day 1, and subjects will be observed for safety and tolerability and pharmacokinetic and pharmacodynamic blood samples will be collected for 20 weeks.

Following baseline assessment, participants (adults with knee osteoarthritis who meet eligibility criteria) will be randomly allocated to one of two groups i) intervention - online yoga program plus online education, or ii) control - online education only. The intervention group will have access to an online 12-week progressive yoga program guided by an instructor delivering the program in a pre-recorded video format. The study hypothesis is that the yoga-plus-education group will have greater benefits in improving pain and function compared to the education-only group for people with knee osteoarthritis..

The consumption of red meat and processed red meat is associated with cardiovascular disease and mortality risk. There is strong evidence that plant-based sources of protein are associated with beneficial outcomes, particularly when replacing red meat in the diet. This project will be looking at the effect of a plant-based meat-alternative burger versus a traditional meat burger on post-meal biomarkers including TMAO, triglycerides, as well as endothelial function in 20 healthy human adults, aged 18-45 years. Participants will be given one of the two types of burger on each visit, after an overnight fast. A blood sample and an ultrasound will be taken at before consuming the meal, and 2 hours and 4 hours post-meal. An additional blood sample will be taken at 24 hours post-meal. Cardiovascular risk factors including LDL-cholesterol, triglycerides, IL-6, glucose, blood pressure and body weight will also be assessed at each visit.

This project will evaluate a multifaceted educational intervention for Australian general practitioners (GPs). The educational intervention will be conducted by Medcast Pty Ltd on behalf of the funding body, the Australian Digital Health Agency (ADHA), and is designed to support best-practice clinical behavior and practice for prescribing, pathology and diagnostic imaging ordering utilising My Health Record (MHR - the Australian national patient-controlled electronic health record). The project is an extension of an earlier pilot study (HE 2018/047) which reported promising outcomes from the educational intervention. The research will evaluate the effectiveness of the educational intervention for GPs, regarding use of MHR and rational use of medicines, pathology and imaging, in achieving the following objectives set by the ADHA: 1. improve practitioner knowledge 2. change practitioner behaviour 3. facilitate incorporation of clinical changes and technology usage into routine care 4. make meaningful improvements in clinical care and, 5. result in tangible economic benefits While the mixed-methods study will address the objectives using a combination of quantitative and qualitative methods, we will use resource utilisation as a composite primary quantitative outcome measure for hypothesis testing: • The study will test the composite primary hypothesis that the education intervention will result in a difference between intervention and control groups in changes in the cost per 100 consultations of selected prescriptions, pathology and radiology test ordering in the six months following the intervention compared with six months prior to the intervention.

The purpose of this study is to assess the safety of a genetically modified virus, called T3011 in advanced cancer Who is it for? You may be eligible for this study if you are aged 18 or over and have advanced cancer presenting with a skin or subcutaneous (under the skin) malignancy. Study details All participants in this study will have injections into their tumour(s). These injections will contain the genetically modified virus T3011, which is oncolytic – this means it bursts open cancer cells. The dose administered will increase for each new cohort until the maximum tolerated dose is identified. Participants will have the injection every 2 weeks for up to 2 years, depending on how well the treatment is tolerated. As part of the study, participants will provide saliva, blood and urine samples. It is hoped this research will provide some safety data for T3011 and identify the appropriate dose of T3011 for bigger clinical trials.

The purpose of this study is to determine whether a smartphone-based cardiovascular risk reduction program can improve exercise capacity and heart health in patients who are undergoing treatment for breast cancer. Who is it for? You may be eligible for this study if you are an adult female who has been diagnosed with breast cancer and own a smartphone. Study details This study is a randomized controlled study recruiting consecutive patients with newly diagnosed breast cancer. This type of study is designed to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusion. Patients over the age of 18 with a new diagnosis of breast cancer will be eligible for inclusion. The other major inclusion criteria will be personal ownership of a smartphone. Exclusion criteria includes patients with a prognosis of less than 6 months as determined by their treating oncologist. Half of the people recruited for the trial will download the SmartPhone app. This app will then be used by participants to monitor heart health, exercise and dietary habits for 12 months. Participants will also have access to feedback from researchers in regards to their heart health as well as support from researchers. The other half will have the stand treatment for their breast cancer which doesn't include any cardiovascular input. They will have access to the treatment centre's health and wellness program which has an exercise program available. It is hoped that this research will help determine if this smartphone application is beneficial in monitoring heart health for those with breast cancer.

Patients admitted to ICU often suffer from muscle wasting and ICU acquired weakness associated with complications such as reduced mobilisation, respiratory weakness requiring prolonged ventilatory support, and prolonged ICU and hospital length of stay (LOS). There is renewed interest in provision of more protein, as this may increase muscle synthesis and thus improve functional recovery. While international recommendations encourage providing more protein, this is not yet supported by high quality evidence. Previous data from a randomised controlled trial conducted > 10 years ago, as well as survey data from our region, suggests that usual practice is to deliver much less than that recommended by international guidelines. Our group has planned a trial to answer the question whether greater protein doses can improve survival and patient recovery compared to current practice. However, to ensure the standard care arm constitutes true current practice, we need to first quantify how much protein patients in Australia and New Zealand actually receive. We plan to conduct an observational study evaluating current practice. One hundred and twenty patients will be included consecutively across 6 sites and protein delivery evaluated.

A safe and common surgical procedure; hip and knee arthroplasty (THA, TKA) is not immune to the occurrence of postoperative complications such as surgical site infection (SSI) or surgical wound dehiscence (SWD). While published rates of SSI following hip or knee arthroplasty are low, 1-2% in some cases, it is the resulting wound complication and its clinical management and the catastrophic impact to the patient’s wound healing and wellbeing and return to daily life that is of considerable concern. Complications such as surgical site infection and/or dehiscence following TKA and THA, often result in extended lengths of stay, readmission for further surgery, primary and community nursing visits, and are a costly burden to healthcare settings. To address the evidence gap for the early identification and prevention of postoperative wound complications in obese patients following hip or knee arthroplasty, a non randomized pragmatic trial is proposed which will utilize an advanced hydropolymer wound dressing coupled with smartphone technology for the early identification of complication and prevention. The advanced wound hydropolymer dressing is transparent and allows for complete visibility of the incision line. This allows the patient to send digital images of their incision line to the clinician who is able determine the healing progress of the participants surgical wound. The use of digital images of the wound sent to the clinician for assessment remotely and without removal of the dressing potentially removes the need for hospital readmission due the ability to diagnose a complication early and intervene. Furthermore, use of this patient engaged model empowers the patient in their wound healing. This study will determine the feasibility of such a model in the post discharge setting to assist in reducing the number of hospital readmission due to surgical wound breakdowns, often diagnosed and treated too late to prevent the escalation to a catastrophic wound breakdown.

Obesity and high blood sugars are common in patients who require hip or knee replacement and are associated with poor outcomes such as infection. The study seeks to clarify if 6 weeks of dietary change in the form of the CSIRO's Low Carb Diet book can improve weight and blood sugar management around the time of surgery. Blood sugar will be monitored by a small wearable device known as a continuous glucose monitor. The hypothesis of the study is that 6 weeks of dietary change will improve patients blood sugars around the time of joint replacement.