ANZCTR search results

KER-050 is a muscle anabolic agent proposed to increase muscle mass and strength and is in development for the treatment of Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Duchenne muscular dystrophy is the most common form of muscular dystrophy and is estimated to affect 1 in every 3500 males globally. FSHD is one of the most prevalent adult forms of muscular dystrophy and can also affect children. The study hypothesis is that Ker-050 is safe to administer to participants and provides an indication that has an effect on the growth of adipose tissue and bone.

This is a clinical trial of the accuracy of “Gazefinder” eye-tracking technology to support the identification and diagnosis of autism in young children aged 2- to 4-years, funded by JVCKENWOOD Corporation, Japan (developers and manufacturers of “Gazefinder”) and run by researchers at two Australian sites (Melbourne, Perth). Children in two groups – those with a diagnosis of autism and those with no developmental difficulties or close family members with autism – will view the 2½-minute animation, with preferential attention to more vs. less ‘social’ Regions of Interest (ROIs) automatically determined by Gazefinder software. The hypothesis is that “Gazefinder” will accurately differentiate children with and without autism on the basis of gaze patterns whilst watching the animation sequence.

Female chronic pelvic pain is a debilitating condition that significantly impacts women’s’ health and quality of life. WCH Physiotherapy referrals for chronic pelvic pain are rising in an unsustainable way for the current individualised care approach. A revised, coordinated approach to care is required, in response to growing demand. This project plans to determine if outcomes are improved when women with chronic pelvic pain have group education sessions included in care pathways. There will be 3 treatment arms: treatment arm 1 – individualised care; treatment arm 2 - an introductory group education session followed by individual care; treatment arm 3 – group education, individual care and an 8 week group therapy program. Group sessions will provide information about chronic pain, introduce relevant therapeutic concepts, promote treatment adherence and maintain motivation through regular contact and message reinforcement. Pelvic pain scores and pain impact are the primary outcomes assessed. Other secondary outcomes include patient satisfaction surveys, time off work/school, use of medications to manage pain, physical activity engagement, and time to discharge from physiotherapy.

This retrospective observational study will be conducted by the Department of anaesthesia. Total hip arthroplasty (THA) can result in a significant surgical stress, which in turn can trigger a hypercoagulable state. These patients are at significant risk for the development of thromboembolic complications. Despite venous thromboembolism (VTE) chemoprophylaxis being administered to all patients who undergo THA at Austin Health, VTE remains a common cause of preventable death and a well recognised complication after total THA. Despite combining extended VTE chemoprophylaxis with early mobilization, compression stockings and intermittent pneumatic compression devices, many patients at Austin Health who undergo THA remain at high risk for VTE because of advanced age, extensive surgical procedures, and greater medical comorbidities. Furthermore, a large multicenter study showed that most VTE’s occur due to prophylaxis failure rather than failure to provide prophylaxis. Although several agents have been shown to reduce the risk of thromboembolic disease, there is no clear preference for thromboembolic chemoprophylaxis for patients undergoing elective total hip arthroplasty. Thromboelastography (TEG) measures whole blood coagulation and fibrinolysis providing a global view of the interaction between all components of clot formation, retraction and lysis. TEG is one of the most sensitive methods currently available for the assessment of a perioperative hypercoagulable state with numerous reports in surgical patients demonstrating an association between TEG measured variables, anaesthetic techniques, and postoperative thrombotic events. Studies have demonstrated that major joint arthroplasty is associated with activation of coagulation (hypercoagulable state) as measured by TEG, however there have been few comparisons of the effects of general and regional anaesthesia techniques on coagulation. Therefore, we propose to perform a retrospective audit of patients who underwent THA at Austin Health, who received a TEG as part of routine care. The primary aims of this retrospective review are to determine if VTE chemoprophylaxis with low molecular weight heparin prevents hypercoagulability after THA (as assessed by TEG) and if general or spinal anaesthesia had similar effects on perioperative coagulability as measured by TEG. Notably, there will be NO CLINICAL or patient contact at any point. All data collected has already been collected as part of routine clinical care according to standard anaesthesia and surgical processes. No new data will be collected.

The project aims to investigate the longitudinal trajectory of ventilation-perfusion mismatch measured using the Lockwood method in preterm infants less than 32 weeks of age at the end of first week, first month and 36 weeks postmenstrual age. This will be novel non-invasive data which may help to identify those infants at risk of developing bronchopulmonary dysplasia.

We aim to utilise a novel method for non-invasively estimating the ventilation-perfusion mismatch, a measure of the severity of lung disease of preterm babies with respiratory distress syndrome. The Lockwood algorithm uses routinely measure oxygen saturation levels paired with the amount of oxygen needed in order to calculate how much the oxygen dissociation curve has been "shifted" to provide a measure of the right-left shunt. This study aims to use measures of oxygen levels before and after surfactant treatment and the corresponding ventilation-perfusion levels in order to gauge response of the infant's lungs to surfactant treatment. The hypothesis is that the Lockwood measure will provide robust measure of ventilation-perfusion status in preterm infants with respiratory distress,

Vagal nerve stimulation is a noninvasive tool to improve mental health. vagal nerve stimulation uses a device that is attached either to the ear or held at the neck that emits a very low electrical pulse, which stimulates the nerve. Participants use this in the clinic for up to 30 minutes to improve physical and mental health.The study aims to compare a four week trial using VNS to treatment as usual using traditional biofeedback. The hypothesis is that vagal stimulation has a similar outcome to treatment as usual but requires less active participation by the patient

Exercise training is recommended for people with interstitial lung disease (ILD), to improve their exercise capacity, symptoms and quality of life. However, our group recently found that people who have ILD that is related to their underlying connective tissue disease showed less improvement in physical function and fatigue compared to other types of ILD. People with connective tissue disease often experience muscle and joint pain and weakness and this may make the standard gym-based approach difficult and painful. Water-based exercise uses warm water to relieve pain and the water's buoyancy reduces the impact on joints. It has been shown to be effective in people with other chronic lung conditions such as chronic obstructive pulmonary disease and in patients with rheumatoid arthritis. No previous studies have examined the benefits of water-based exercise in people with CTD-ILD. This study will establish whether water-based exercise is viable and beneficial in CTD-ILD and whether it can improve their breathing symptoms and physical function.

The purpose of this study is to evaluate the safety and clinical effectiveness of the Intralink medical device when treating low back pain due to Degenerative Disc Disease in adults. Degenerative disc disease in the lower back refers to a syndrome in which a compromised or damaged disc causes low back pain with or without pain radiating to the leg. Intralink is an injectable soluble polymeric material that is considered as a medical device. Intralink covalently bonds with the collagen in the spinal disc tissue to structurally strengthen the degraded disc and stabilize the spinal joint. These tissue strengthening and joint stabilizing effects, if they occur to the extent intended, may reduce the amount of back pain that the study participant experiences. Intralink contains a substance called Genipin that forms a mesh of load-sharing polymers that bond to the collagen matrix in load supporting tissues. Genipin is made from purified plant sources (Gardenia fruit) and is dissolved in a special buffer liquid prior to being injected into the spinal disc using image-guided injection techniques. A special dye called a contrast agent that is not part of Intralink is also added to Intralink before it is injected so that what is being injected can be seen by the physician doing the injection. There are two primary hypotheses being tested in this study. The first hypothesis involves the safety of the device and its image-guided delivery to the study participant. It is hypothesized that Intralink can be safely applied to degenerated intervertebral discs as evidenced by a clinically acceptable prevalence of Serious Adverse Events reported at 1 month post-procedure. The second primary hypothesis involves the clinical effectiveness of the device. It is hypothesized that the clinical success rate at 3 months after the Intralink implantation procedure will be greater than or equal to 50%. Clinical success is defined as successful injection delivery of Intralink to the targeted disc without the occurrence of serious adverse events with a significant reduction of pain and disability using standard assessment metrics. Objective imaging data will also be used to validate reduction of pain post-treatment. A maximum of 50 participants will be enrolled in this clinical study at 2-5 clinical centers. Safety and clinical effectiveness assessments will be carried out through 12 months post-implantation procedure.

An Open-label Study of Probiotic and Hen’s Egg or Cow’s Milk Oral Immunotherapy. This study is looking at the tolerability of the RUSH (rapid updosing schedule) and build up schedules.