ANZCTR search results

This study evaluates the safety and tolerability of the Suono 1 System, a low frequency ultrasound device intended to enhance mesalazine drug concentrations in colon tissue without increasing systemic (bloodstream) concentrations. Mesalazine is an approved therapeutic used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD) that causes inflammation and ulcers on the inner lining of the large intestine. Patients with a UC flare are prescribed mesalazine enemas for daily use until condition improves. This preliminary study will assess safety and tolerability of ultrasound mediated mesalazine enemas in healthy participants. It is expected that ultrasound mediated mesalazine enemas will be tolerable and exhibit gross and cellular tissue appearance with no clinical significance.

“Approach bias modification” (ApBM) is a cognitive training task designed to reduce impulses to seek and consume alcohol. ApBM has been shown to reduce risk of relapse when delivered by computer during residential treatment for alcohol use disorder (AUD), but no previous studies have tested whether giving people access to ApBM via smartphone app that they can use after leaving rehabilitation treatment is also an effective way to prevent relapse. We have designed “AAT-App”, a smartphone app that incorporates ApBM training. We aim to conduct a randomised trial comparing the “active” version of AAT-App (which includes ApBM training) to a “control” version which also contains a cognitive task that is similar to ApBM but which (unlike ApBM) is not designed to change the mental processes that are believed to contribute to urges to seek and consume alcohol. We will provide AAT-App to participants when they discharge from residential rehabilitation. The app will send notifications prompting participants to complete the cognitive task and provide weekly reports of their alcohol use over a 4-week intervention period. We predict that participants who receive ApBM training will be more likely than those who receive the control version to abstain from alcohol during the intervention, and at 1-month, 3-month, and 6-month follow-ups after the end of the intervention. We also predict that they will have lower average alcohol consumption, less severe dependence on alcohol, less craving, reduced impulses to approach images of alcohol, and will be less likely to require readmission to hospital or residential treatment for AUD, as well as reduced depression, anxiety, and stress and improved quality of life and enjoyment of life.

This study will test the use of JettProof sensory singlets among children with a diagnosis of Autism Spectrum Disorder. The primary objective of this trial is to evaluate the effects of JettProof sensory singlets – applied for at least 6 hours/day for a three-week period – on the self-regulatory and motor functioning of autistic children. We hypothesise that application of the JettProof sensory singlet will lead to a reduction in autonomic and behavioural markers of affective and motor dysregulation and the subsequent attainment of individualized goals, relative to standard care. A second objective is to evaluate the effects of JettProof sensory singlets on additional outcomes related to sensory and motor functioning difficulties for autistic children and their caregivers. We hypothesize that, for children, the application of the JettProof sensory singlet will lead to a reduction in anxiety, less negative and more positive daily affect, and improvements in sleep quality for children and, for caregivers, a reduction in the levels of stress and perceived effort required to assist their children. A third objective is to assess the feasibility and acceptability of implementing JettProof sensory singlets with autistic children. We anticipate that most children will wear the singlet for 6 hours/day or more during the full-scale intervention phase, and report that it is at least tolerable. A fourth, exploratory objective is to determine whether there may be sensory characteristics of autistic children that predict differential response to JettProof sensory garments. We hypothesize that JettProof sensory singlets will evidence greater efficacy among children with a dysfunction in proprioceptive and/or vestibular sensory systems.

Myalgic encephalomyelitis, or chronic fatigue syndrome (ME/CFS) is a severe, chronic disease with an estimated prevalence of 0.76% in the Australian population. Post-exertional malaise (PEM) is the key symptom of ME/CFS which can last for several weeks or months, where patients have an exacerbation of symptoms (chronic fatigue, headaches, sleep disturbance, brain fog etc) following exertion, that cannot be relieved by sleep or rest. Simple everyday activities (such as walking and showers) can trigger PEM. Patients may face years of persistent symptoms including fatigue, PEM, sleep disturbance, impaired cognition, mood disturbance and muscle and/or joint pain. Despite the debilitating nature of its symptoms and high personal and socio-economic burden, there is no clear understanding of the underlying pathophysiology of the disease and no effective treatments . ME/CFS is a complex multisystem disease with potential involvement of the immune system, nervous system, and the musculoskeletal system in addition to nociception, mitochondria metabolism, and oxidative defence mechanisms. To be efficacious, potential treatments will need to target multiple systems and multiple processes to meaningfully impact quality of life. We believe that krill oil is a potential treatment option. Krill oil is a sustainable source of the long chain omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). It is also high in the antioxidant astaxanthin and the essential nutrient choline. EPA and DHA play critical roles in brain and metabolic function, in addition to being potent anti-inflammatory agents with analgesic properties. It is also known to improve cognitive and sleep quality. Choline plays an important role in the nervous system and energy metabolism while astaxanthin is a potent antioxidant proven to improve oxidative stress in humans. These compounds have systemic biological actions, and they have the potential to alleviate some of the systemic disruptions associated with ME/CFS such as brain fog, chronic pain and sleep disturbance resulting in reduced fatigue. Therefore, we propose that krill oil may be a viable treatment option for ME/CFS.

This is a prospective observational cohort study of 110 participants who are presenting to Royal Prince Alfred Hospital for delivery of a baby. The primary objective of this study is to determine feasibility data on collecting and testing cord blood. Secondary objectives include determining normal ranges for blood biomarkers, assessing brain biomarkers against antenatal, perinatal and postnatal complications and outcomes and assessing additional risk factors on the brain biomarker values. Three millilitres of cord blood will be collected in addition to the standard cord blood collection following clamping and cutting of the umbilical cord by the midwives. The cord blood will be spun into plasma aliquots and sent to an external laboratory for analysis of inflammatory brain biomarkers- Neurofilament light and tau (a phosphoprotein). Research staff will collect health information from the antenatal record, labour record and postnatal progress notes. Analysis of the brain biomarkers and health data will take place once samples are sent for analysis.

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.