ANZCTR search results

This project is designed to investigate the impact and efficacy of the new digital method to deliver a mindfulness-based program over a 4-week period using a two-group (immediate vs wait-list) trial design. It is intended that this trial will explore how a social humanoid robot can help people to learn and practice mindfulness and its impact on state and trait well-being, including finding a new and interactive ways to engage people in practice that can be used in conjunction with other services, if effective.

The objective of the proposed investigation is to assess the safety and performance of the Genesis Medtech Vascular Closure Device System used to close arterial access sites on patients undergoing endovascular interventions. The study will be a prospective non-randomized, single-arm trial of up to 12 patients enrolled in two centres. Appropriate patients will be enrolled in the study by the principal investigator (PI) at each site after obtaining informed consent. Patients will have a basic health screening history recorded pre-operatively; with a clinical exam at hospital discharge; and with visual inspection of the closure site from 14-30 days, post-procedure; the timing of this last review is left open to the discretion of the PI and to best coincide with the scheduled follow up for the original endovascular procedure. Other examinations will be performed as deemed necessary by the investigator. Safety will be evaluated by the incidence of adverse/serious adverse events at discharge (in clinic/hospital) and at the stated post-procedure follow-up intervals. Performance will be measured in terms of technical evaluation of the device deployment.

This protocol describes is a method comparison study which aims to determine the reproducibility of on-screen assessment of 3D images featuring colour and fluorescence produced by intraoral scanners for dental disease detection amongst populations of Australian children. Intraoral Scanners (IOS) are devices used for taking digital impressions in dentistry. They have recently been introduced into clinical practice to support caries diagnostics due to the addition of technology such as fluorescence within IOS hardware. However, there is little research into their diagnostic performance in clinical settings. Dental examination data and Intraoral scans will be sourced from participants who underwent dental examination at the 60 months study visit as part of a broader clinical trial (MISBAIR). Consenting participants who meet study inclusion criteria, will have the intra oral scans examined by a qualified dental practitioner for the purpose of detecting and classifying dental caries. 3D images will first be examined based on 3D geometry and colour, followed 4 weeks later by 3D geometry, colour and fluorescence. The diagnostic agreement between each method compared to conventional visual examination will be determined. The findings of these investigations will inform if novel technologies are equivalent to conventional methods used for dental diagnostics in children. If the methods agree 3D images could have broad application in supporting clinical diagnostics, early disease detection and potentially substitute clinical examination for the purpose of teledentistry and epidemiological research.

This study will determine if the combination of abatacept and nasal insulin is more effective than abatacept therapy alone to preserve beta cell function in people who have recently been diagnosed with type 1 diabetes. It will involve 62 children and young adults who will be randomly assigned to receive 48 weeks’ treatment with either abatacept and nasal insulin or abatacept and nasal placebo.

Many patients are admitted to hospital each year for a laparoscopic surgical procedure. At times, the procedure requires general anaesthesia and mechanical ventilation. General anaesthesia means that you will be unaware of the procedure as it is happening and mechanical ventilation involves the placement of a breathing tube into the upper airway to support breathing and oxygenation. Two key components of mechanical ventilation are tidal volume (volume of air breathed and positive-end expiratory pressure (PEEP)(pressure in the lungs after breathing out). Traditionally, for patients having laparoscopic surgery conventional tidal volumes (10 to 15 ml per kilogram of predicted body weight) are used as a means to prevent low-blood oxygen or lung tissue collapse. However, studies involving people suggests that high tidal volumes are injurious to healthy lungs and can cause localised inflammation. Similarly, accumulating data from observational and small randomized controlled human studies have found that high tidal volumes can damage the lungs. Conversely, using low tidal volumes (6 ml per kilogram of predicated body weight) during mechanical ventilation has been shown to be beneficial in patients suffering from acute respiratory distress syndrome. Indeed, low tidal volume ventilation has been adopted for the management of critically ill patients at risk of respiratory distress syndrome. At the present time it is unclear whether a higher tidal volume strategy – conventional ventilation, or a lower tidal volume strategy – known as protective ventilation, during mechanical ventilation for patients having laparoscopic surgery requiring general anaesthesia. We believe that the information obtained from this study will help anaesthetists to better manage the ventilator management for patients who are having a laparoscopic surgical procedure that requires general anaesthesia. This study will involve 1750 patients admitted to hospital to have laparoscopic surgery under general anaesthesia. The research has been initiated by the researchers at the Austin Hospital (Melbourne) and is anticipated it will take two years to complete.

Cardiovascular (CV) disease including coronary artery disease (CAD) is the leading global cause of morbidity and mortality, Early diagnosis of CAD can help to manage the disease. Invasive coronary angiography (ICA) is a common diagnostic test used to detect CAD, but ICA provides no direct assessment of plaque burden, is costly, and also exposes patients to potentially serious complications such as stroke, coronary dissection, and local access site complications. Recently, we showed that polarisation-sensitive optical coherence tomography (PS-OCT) can be used to non-invasively assess the structure of retinal blood vessel wall tissue in-vivo (https://opg.optica.org/boe/viewmedia.cfm?uri=boe-12-7-4340&html=true). Retinal blood vessels share structure and function with the heart, making them an interesting non-invasive proxy for coronary artery disease. The objective of the trial is to develop an accurate low-cost tool based on the assessment of retinal blood vessel wall tissue through PS-OCT measurements that can non-invasively screen for cardiovascular diseases, particularly for CAD.

This randomised controlled trial will investigate the effectiveness of a web-based peer support intervention for reducing levels of depression among community-dwelling older Australians. It will also determine whether older adults receiving access to the intervention experience: (a) reduced levels of anxiety, (b) reduced levels of loneliness, and (c) higher levels of quality of life. Eligible participants (aged 65 years or older; English speaking; with access to the internet) will be randomly allocated to one of two groups: (1) usual care, or (2) web-based peer support intervention. The web-based peer support intervention includes a secure study-specific online community dedicated to older people, where participants can meet and engage in asynchronous one-to-one and group-based communication with other study participants allocated to the intervention arm. The primary outcome (mean depression scores) will be collected at 6-months post study recruitment.

People who have been diagnosed with a blood cancer that has a risk of relapse, (e.g. Acute Myeloid Leukemia, Myeloid Dysplastic Syndrome, Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma) may benefit from having a transplant of healthy stem cells into their bone marrow to encourage their body to produce healthy cells. This treatment has a high risk of transplant rejection and so patients often need to take immuno-suppressing drugs for a time before and after the transplant to ensure the transplant is not rejected. This study aims to assess 4 different immuno-suppressing treatment regimes (drugs and body irradiation/radiotherapy) to determine which treatment is best at suppressing the rejection response without compromising the overall health of the patient. Who is it for? You may be eligible for this study if you are aged 16 to 75 years of age, you have been diagnosed with a blood cancer that has a risk of relapse and your doctor has recommended that a stem cell transplant is indicated. You may also need to meet additional criteria (heart, lung and kidney health criteria) in order to be eligible for this study. Study details Participants in this study will take part in one of two separate sub-studies. The decision of which of the two sub-studies a participant will take part in is at the discretion of the study investigator. The two sub-studies are: 1. Reduced Intensity Conditioning (RIC) -Sub-study 1: contains two sequential treatment arms. The first treatment arms.will examine using will use standard of care radiation but at a higher dose with fludarabine. The second treatment arm will use of treosulfan instead of standard of care busulfan with fludarabine. Patients will have scans and blood tests before and after the transplant. Medical review will occur daily whilst in hospital and then once discharged as medically required ( may start weekly then monthly) 2 Myeloablative Conditioning (MAC) - Sub-study 2: contains 2 treatment arms running concurrently. One will use of treosulfan instead of standard of care busulfan with fludarabine and the other will use standard of care radiation but at a higher dose. Patients will have scans and blood tests before and after the transplant. Medical review will occur daily whilst in hospital and then once discharged as medically required ( may start weekly then monthly) It is hoped this research will demonstrate that one (or many) of the treatment regimes tested is safe for cancer patients and effective at keeping the transplant rejection response rate low. The best treatment regime may then be tested in a larger randomised trial that could benefit future patients with blood cancers.

Painful exercise or exercising into pain, is a form of therapeutic exercise that allows temporary aggravation of a person’s pain. In people with chronic pain, painful exercise offers small, short-term benefits in reducing pain compared to non-painful exercise. One potential mechanism for painful exercise is that they typically induce higher loads and dose of exercise and thus likely to evoke a greater analgesic response (reduction of pain following exercise). However, the literature regarding painful versus non-painful exercise is sparse (n=7 trials, n=385 participants) and includes only a small range of chronic pain conditions (e.g. back, shoulder and ankle pain). Moreover, the effect of painful exercise in people with knee osteoarthritis (OA), one of the most prevalent and disabling musculoskeletal conditions in Australia and globally, has not been studied. In addition, there is considerable variability in how painful exercise has been prescribed (e.g. pain allowed versus recommended, measurement of pain during exercise, and the timeframe after exercise for pain to subside), limiting its application in clinical practice. The current project will examine the feasibility of painful exercise compared to non-painful exercise in people with knee OA. This study is significant because, while guidelines recommend different types of exercise (e.g. aerobic and strength exercise for people with knee OA, they do not advise on exercising into pain (or not). Therefore, clinicians must rely on their learnings, prior experiences and patient preferences to prescribe exercise appropriately, but this currently varies considerably in clinical practice with respect to exercising into pain. This may be due to the lack of studies of painful versus non-painful exercise for people with knee OA. This study will provide insight into whether painful exercise under the guidance of AEPs using evidence-based best-practice exercise and education is a feasible intervention for people with knee OA. The outcomes may have implications for how exercise is prescribed in clinical practice in the management of knee OA, including strategies to improve the effectiveness of, and adherence to, exercise in people with knee OA in whom pain and maladaptive beliefs about pain and exercise are often a barrier to treatment engagement.

The aim of the clinical trial is to determine if the novel Moisturising Skin Support is as effective or more effective in managing chronic wounds than standard care (sorbolene cream) when used by wound care nurses within the pharmacy setting over a 3 year period. The hypothesis is that the novel moisturising skin support will be as more effective than standard treatment in managing chronic wounds,