ANZCTR search results

This study will be a placebo-controlled, double-blind, randomised Phase 2b/3 study in participants with established cardiovascular disease to evaluate the impact of statin therapy on changes in plaque burden and composition in participants with different polygenic risk scores using CT coronary angiogram. The study will take place at ten sites in Australia.

The purpose of this project is to examine the effectiveness of a self-help manual intervention compared to treatment as usual for reducing emotional distress, increasing effective coping and improving quality of life in patients undergoing a stem cell or bone marrow transplant. Previous experience has shown that this type of transplant is an intensive procedure that is physically and emotionally challenging, and many people undergoing a transplant experience significant emotional distress (ie. anxiety or depression). This can make it more difficult to cope with the treatment, and return to normal activities after treatment which may affect work, social and recreational interests. Providing people with education about emotional distress and strategies to better manage it, has been shown to improve the ability to cope with physical and emotional distress. It was hypothesised that a self-help manual intervention in addition to TAU will lead to reduced psychological distress and improved QoL at 2-3 weeks and 3-months post-HSCT compared with TAU alone.

In young people (<40 years), arthritis commonly occurs following knee reconstruction, forcing them to live with old knees and reducing their quality of life. In the SUPER KNEE trial we aim to evaluate whether supervised exercise and education can improve knee symptoms, function and quality of life and prevent joint deterioration compared to usual care in 184 young adults with knee reconstruction. We hypothesis that individuals in the supervised exercise and education intervention will have significantly less pain, greater quality of life and less early arthritis after 4 and 12 months compared to the usual care control group.

This project seeks to improve health and return to work outcomes for injured workers with work-related mental health conditions (MHCs) by improving the care provided by their general practitioner (GP). Workers with MHCs take three times longer to return to work and receive approximately three times more in compensation, compared to workers with musculoskeletal injuries. In Australia, GPs see 97% of injured workers and thus play a pivotal role in directing the recovery and return to work journey for these patients. However, current practice is hampered by clinical uncertainties and system difficulties that GPs encounter in practice. A national evidence-based clinical guideline on diagnosing and managing work-related MHCs in general practice is currently in development anticipating NHMRC approval, RACGP endorsement, and publication in early 2019. However, unless the guideline is actively implemented, it risks being underutilised. Our study aims to improve the health outcomes of people with work-related MHCs by implementing an intervention designed to increase the delivery of evidence-based care by Australian GPs. We will utilise a parallel cluster randomised controlled trial design to trial a complex intervention in general practice. Intervention components will consist of proven methods such as academic detailing, resource provision, and support through a community of practice. Our key objectives are to increase the delivery of evidence-based care for patients with work-related MHCs in general practice and to assess the cost-effectiveness of our intervention. The partnership team has unparalleled expertise with the proposed methods and is uniquely placed to conduct a high quality, pragmatic implementation trial that will be applicable across compensation jurisdictions in Australia. This trial is likely to produce both policy and practice changes that improve health outcomes of patients in the general practice setting.

Continuous Glucose Monitoring (CGM) systems have been commercially available for several years and have been of benefit in patients with Diabetes. A key goal for next generation Continuous Glucose Monitoring products is to have a sensor use life greater than the currently approved 7 days. The purpose of this study is to collect performance data on the Medtronic Extended Life Glucose Sensor System, which aims to provide accurate glucose sensor data for 16 days. The hypothesis is that the Medtronic Extended Life Glucose Sensor will provide glucose sensor data up to 16 days that compares in accuracy to currently commercially available sensors that only provide data for 7 days. The investigational device is similar in form and function to currently commerically available CGM devices, but also includes low doses of the anti-inflammatory drug dexamethasone to help improve device longevity. In this study participants will have 1 or 2 investigational sensors inserted into the arm, abdomen or arm and abdomen, as well as a control sensor without dexamethasone into the arm or abdomen. The investigational sensors will not provide glucose information to participants, and so decisions regarding their diabetes treatment will be made as usual and participants may continue to wear their own glucose sensor if they wish to do so.

Achieving optimal glucose control in type 1 diabetes requires frequent monitoring of glucose which can be burdensome for many patients. The most common methods for self-monitoring glucose involve frequent "finger-pricking" or continuous glucose monitors inserted under the skin which last up to 1-2 weeks and require at least daily calibration with finger-pricks. This study aims to collect glucose information from the implanted sensor to optimise sensor signal processing and improve sensor performance. This investigational device is an implantable long-term glucose sensor that measures an individual's glucose levels continuously and sends data to a receiver outside the body. Following implantation, the sensor requires no user interaction, and the receiver only needs to be kept close by. The only maintenance required of the receiver is battery changes and data downloading.

We aim to investigate new techniques in magnetic resonance imaging (MRI) pre and post airway clearance techniques (ACT). Adults with CF will be invited to participate, and to perform their usual ACT (i.e. breathing exercises to clear mucus from their airways) within the MRI under the guidance of an experienced physiotherapist. This will allow for innovative cutting edge imaging to be performed before and after the ACT are performed, to provide information on airway structure and function; specifically in regard to the movement of mucous (sputum) and trapped air, and well as dynamic function of the larger airways. This is important, as ACT are one of the cornerstone daily treatments undertaken in CF, yet to date no modern ACT has been shown to be superior, largely due to limited outcome measures. While lung imaging is appealing, until recently only computed tomography (CT) has been available to provide the necessary imaging. Unfortunately, CT exposes the patient to ionising radiation exposure which limits its use for especially functional imaging. Using MRI provides avoids radiation risk, therefore is an excellent option for structure and function imaging in relation to ACT. This is the first study of its kind, utilising novel MRI techniques. The experienced and capable research team will investigate the use of novel MRI techniques to objectively quantify lung structure and ventilation during ACT in adults with CF, providing new data in this area to assist in the understanding of ACT in the future. The MRI techniques used have the potential to also be used in other lung diseases such as bronchiectasis, COPD and asthma, and therefore this study is the beginning of a much larger research focus in this field. Aims In adults with CF: 1) Establish a protocol for the use of MRI to detect changes in lung structure and ventilation in relation to mucus movement during ACT; 2) Conduct a series of three MRI in adults with CF (n = 12) of varying disease severities before and after different ACT to explore the obtainable information including mucus movement and static and dynamic airway ventilation. Hypothesis MRI is a novel and suitable tool for the assessment of lung structure and ventilation during ACT in adults with CF, which will provide a new outcome measure for use in future larger clinical trials in this area. Each participant will complete three separate MRI scans, lasting approximately 20 minutes each, interspersed throughout the visit. They will also complete a 25 minute control period of resting breathing, and a 25 minute intervention period consisting of performing their usual ACT. The order of the intervention and control periods will be determined by randomisation. The ACT performed at each visit will be supervised by Jamie Wood and ACT will be performed according to International Physiotherapy Group for CF guidelines.

We documented in a previous study in patients with sciatica that reduced touch sensitivity in their leg prior to back surgery was associated with pain persistency 12 months after surgery. However, it is unclear if this reduced sensitivity/loss of sensory nerve function does imply structural nerve damage. The purpose of the current study is to investigate if structural nerve fibre damage exists in patients with sciatica pre-surgery; if structural nerve fibre damage is associated with loss of sensory nerve function and if the extent of nerve fibre damage may predict poor postoperative outcome. We do hypothesise that structural nerve fibre damage is associated with altered sensory nerve function In this pilot study 10 patients with sciatica and 10 healthy people will undergo laboratory sensory testing to assess their nerve function in their back and leg. In addition, tissue samples will be taken from their back and leg to determine the structural integrity of nerve fibres. Patients will be followed up at 3 and 12 months to monitor their progress.

This is a prospective randomized controlled trial to evaluate two approaches to reducing EEG electrode induced skin injury among ambulatory EEG patients. The trial is to compare skin injury related to EEG electrode application using Ten-20 paste with Tensive adhesive gel versus mixed EEG electrodes with hydrogel electrodes Research Questions are: i) Is a mixed approach to EEG electrode application (one which uses hydrogel electrodes in hairless scalp locations), a superior approach to reducing electrode-related skin injury than the standard approach across all scalp locations, among patients undergoing ambulatory EEG monitoring? ii) Does the use of the novel mixed EEG electrode approach yield equivocal quality EEG recording data and self-reported patient satisfaction when compared with the standard approach? We hope that our research will continue contributing to the development of an evidence base on the prevention and minimization of electrode-induced skin injury in the patients undergoing AEEG monitoring.

The purpose of this study is to assess the safety and tolerability of inclacumab, as well as the pharmacokinetics (PK – how your body uses the study drug) and pharmacodynamics (PD – how the study drug carries out its actions on the body). Inclacumab will be tested in 15 healthy participants aged 18 to 65 years. Participants will be administered a single doses of inclacumab as an intravenous infusion over 1 hour. Participants will then be followed up for 203 days for safety and PK/PD assessments