ANZCTR search results

The overall goal of the study is to evaluate whether Enbrel® and its biosimilar Brenzys® are interchangeable in the treatment of patients with rheumatoid arthritis. That is, different sequences of Enbrel® and Brenzys® use are not associated with increased immunogenicity as evident by treatment related loss of clinical efficacy and development of treatment related clinical toxicity. The specific aim of the study is to test whether multiple switching between the etanercept biosimilar Brenzys® and the etanercept reference product Enbrel® (the intervention group) is non-inferior with regard to disease control and clinical immunogenicity compared to no switching, that is, continuing on Enbrel® (the control group), in participants with stable rheumatoid arthritis on Enbrel® who are in clinical remission or a low disease activity state by the DAS28-CRP.

Orthokeratology contact lenses are specialised rigid contact lenses are worn overnight and are removed in the morning. During overnight wear, orthokeratology lenses temporarily change the shape of the front surface of the eye, or cornea, which acts to correct mild to moderate degrees of myopia, providing wearers clear unaided vision throughout the day. The renewal and regeneration of corneal cells are important for maintaining transparency of the cornea which is crucial for clear vision. Surrounding the clear cornea is the limbus or limbal region which contains the stem cells that are responsible for maintaining renewal and regeneration of corneal cells and thus it's clarity. Previous studies have demonstrated changes to the limbal stem cells associated with soft contact lens wear. A deficiency in limbal cells can lead to decreased vision. Although orthokeratology lenses have a smaller overall diameter than soft contact lenses, its proximity to the limbus and rigid nature of the lens raises the question of whether there are any mechanical impacts on the limbal region associated with lens movement which may lead to changes in limbal stem cells. This study aims to investigate if there are any associated limbal changes with orthokeratology lens wear.

This feasibility study is aiming to test the SunVisor app and messages to determine its effectiveness before it can be applied to a randomised controlled trial setting. The app aims to improve sun protection strategies and reduce sunburn incidence. We plan to recruit up to 115 participants to test the feasibility and satisfaction with the app. Participants will be asked to use the app for a two week period and receive a daily sun protection message. Participants will be asked to complete a evaluation survey after the 2 week intervention period to assess satisfaction with the app and messages.

A comparative randomised double blind study to evaluate the effect of Lutein supplementation on Macular Pigment Optical Density (MPOD) and blood Lutein levels in healthy adults over 16 weeks.

A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed Almega PL on cardio-metabolic parameters and inflammatory markers in men and women.

Body dysmorphic disorder is a characterised by perceived defects or flaws in appearance which are associated with distressing thoughts, repetitive or obsessive behaviours, and significant impairment in social and occupational functioning. A core feature of BDD involves abnormalities of visual processing, although this is predominantly ignored within psychological and psychiatric treatments. While current treatments such as cognitive behavioural therapy or antidepressant medications generally show moderate effectiveness in the short-term, those with BDD can have high relapse rates, perhaps as they can see ‘see’ their flaws or defects. The current research is a single group pilot study to trial a visual training program designed to remediate visual abnormalities and reduce symptom severity of BDD. This pilot trial will be conducted at Swinburne University of Technology, Melbourne Australia, and will involve up to 20 participants diagnosed with BDD. These participants will complete pre- and post-assessments, and a 10-week visual training program encompassing three phases of: basic visual processing, face and emotion recognition, and self-perception. These training activities will include a combination of computer and therapist-administered tasks. Outcomes include a variety of clinical interview, self-report questionnaires, and a full eye tracking battery to assess overall clinical and visual performance across time. Analyses will compare participant’s overall symptom severity and eye movements across five timepoints using repeated measures ANOVAS. Qualitative data will also be collected to assess the feasibility and efficacy of the program using thematic analysis methods. This pilot trial will be the first of its kind to translate the empirical findings of abnormalities in visual processing among those diagnosed with BDD, to an innovative treatment method across a range of visual processing levels. This trial will additionally assess the efficacy and feasibility of such a visual training program, paving the way for additional research including future randomised control trials.

The objective of the study is to determine if a predefined quotient of supplementary language exposure improves short, intermediate and long-term neurodevelopmental outcomes in preterm infants (<30 weeks) cared for in the neonatal unit. Participants <30 weeks gestational age, admitted to the Neonatal Intensive Care Unit, will be randomised to receive either one of two levels of supplemental language exposure in the form of recorded maternal voice, delivered via micro speaker. The intervention group will receive a treatment level of exposure of 6000 words/hour and the control group will receive a placebo of 600 words/hour within a developmental appropriate decibel range. The exposure will occur for one hour, three times daily, commencing on day 7 of life until 37 weeks gestational age or discharge. The level of 6000 words was chosen as the rate of slow speech is approximately 100 words/minute. Mothers of participants included in the trial will be directed to speak in 'motherese' style language at this rate for ten minutes. The recording will then be repeated six times. Control group infants will receive 10% of the language exposure level of the intervention group.

Airway or respiratory complication is one of leading causes of morbidity and mortality in anaesthesia. There are different techniques and intubating equipment (laryngoscope) available for anaesthetists to deal withdifficult airways. Anaesthetists use their knowledge and previous experience to decide which type of laryngoscope to use in these cases. In this study, we are evaluating, for the first time, this newly available videolaryngoscope. We are comparing it with the widely used Glidescope® video laryngoscope. The reason for comparing these two devices is because the blade design of both devices is similar. We hypothesise that In simulated difficult airways, the novel videolaryngoscope allows a faster tracheal intubation time as compared to the Glidescope® video laryngoscope. We will prospectively recruit 30 voluntary anaesthetic residents, registrars or consultants for this study. All participants will be tested on using each of the two intubation devices on a manikin with a simulated difficult airway. Participants will be assigned to one of the two groups – Group 1: novel videolaryngoscope followed by Glidescope® videolaryngoscope, or Group 2: Glidescope® videolaryngoscope followed by novel videolaryngoscope. The primary outcome is the time taken for successful tracheal intubation. Secondary outcomes include: the number of failed intubation, the number of intubation attempts, the number and type of intubating adjuncts used, the best laryngoscopy view achieved and the ease of intubation.

The current study is a prospective cohort study that will test the feasibility and acceptability of heat wrap therapy as well as our ability to collect the key outcomes planned for the RCT, which are use of analgesic medications, clinical outcomes (such as pain, function), and adverse events.

The primary aim of this study is to determine if short-term regular apple intake (4 weeks) results in a sustained benefit on measures of vascular health in individuals with at least one risk factor for cardiovascular disease.