ANZCTR search results

It has been estimated that 1 in every 750 individuals worldwide likely to have keratoconus, a condition that affects the front transparent structure of the eye called cornea. Whereas normal healthy corneas are generally spherical in shape, eyes with keratoconus assume conic shape thereby affecting vision of the individual. The onset of this condition is generally during adolescence and the progresses until the age of 40. Early detection of this condition is important to apply appropriate clinical management strategies. Currently keratoconus is detected early by the use of a diagnostic instrument called corneal topographer that assesses shape of the front surface of the eye and provide certain corneal indices to differentiate keratoconus from normal eyes. Unfortunately, corneal topographers are expensive and are rarely available in rural optometric practices making it difficult to detect keratoconus in the rural areas. The primary purpose of this research study is develop a smart phone based photography technique that indirectly captures the shape of the cornea, the shape indices thus determined from the reconstructed corneal shape will help differentiate keratoconus from normals, eliminating the dependency on the expensive corneal topographers that are rarely available in rural optometric practices. Individuals aged between 18 and 40 years who are diagnosed to have keratoconus from various optometry and ophthalmology practices in Sydney are enrolled in this study. Individuals with healthy corneas falling in the same age range will also be enrolled into this study but will be classified as controls. Participants who are currently rigid contact lens wearers, have intolerance to rigid contact lens wear and have astigmatism more than 2 dioptre are not eligible to participate in this study. Standard optometric tests including vision test, determination of spectacle power, assessment of corneal shape (topography) and a anterior eye health assessment using a slit lamp will be performed. Rigid contact trial lenses will be applied to one or both eyes. A standard orange dye (Sodium fluorescein) will then be applied to aid the visibility of tears under the contact lens. Anaesthetic eye drops will be used to avoid any discomfort that may arise from the applied rigid contact lenses. Anterior eye photograph, while the contact lens is in place, will be captured using a smart phone. A custom software program will analyse the dyed tear layer behind the contact lens to reconstruct underlying corneal shape providing corneal shape indices. These corneal shape indices will be used to detect keratoconus from normal eyes.

Breathing events are common in premature babies cared for in the neonatal unit. This study aims to evaluate the impact of position changes and feeding changes on breathing events in preterm babies managed in a neonatal unit. Babies recruited through this study underwent three care conditions: 1. Care as usual (baby nursed flat on back, with normal tube feeds) 2. Positional intervention (baby nursed on stomach with the cot propped, with normal tube feeds) 3. Feed rate intervention (baby nursed flat on back, with tube feed given over 45min). We predict that position or feed rate changes may reduce breathing events in preterm infants.

Metabolic syndrome and cardiovascular diseases (CVDs) represent the major cause of morbidity and mortality globally. According to the World Health Organisation, more people die annually from CVDs than from any other cause. Hormones underpin the pathophysiological changes surrounding the disease progression. Steroids such as prednisolone are one of the most widely prescribed and effective therapeutics for a variety of inflammatory and autoimmune conditions including inflammatory arthritis, arteritis, asthma, sarcoidosis and nephritis due to their powerful anti-inflammatory effects, but benefits are limited by serious cardiometabolic adverse effects. To date, there is no established specific means to counteract the cardiometabolic complications. There is strong evidence in animals that the adverse cardiometabolic effects of steroids are mediated by closely-related hormone receptors called mineralocorticoid receptors (MRs) which are present on fat cells, heart and immune cells, and that blockade of MRs (MR antagonism) protects against steroid-induced cardiometabolic complications while maintaining the anti-inflammatory benefit. This body of work will define, for the first time in humans, the therapeutic potential of MR antagonism to counteract steroid-induced adverse metabolic and cardiac complications, and provide novel evidence for paradigm shifts in the management of patients exposed to excess steroids.

Mental health (e.g., anxiety, depression) and functional difficulties (e.g., cognitive problems) are highly comorbid in people with Multiple Sclerosis (MS). However, access to effective psychological treatments are limited. People with MS face many barriers (e.g., costs, limited trained clinicians, mobility issues) accessing effective psychological care. Moreover, limited resourcing has meant that specialist mental health and other supportive care has yet to be integrated into neurology settings as has occurred in other areas, such as cancer care. The purpose of this project is to assess the acceptability, feasibility and effectiveness of an established internet-delivered psychological treatment, the Wellbeing Neuro Course, in reducing symptoms of depression, anxiety and disability in patients with Multiple Sclerosis attending the MS Clinic at the Royal North Shore Hospital (MSC-RNSH). The secondary aim is to gather information about the implementation of the Wellbeing Neuro Course into routine care at the MSC-RNSH. It is hypothesised that: (1) the program will be highly acceptable and that high levels of engagement will be observed; (2) the program will require relatively little clinician time to administer; and (3) preliminary evidence of improvements in disability, anxiety, and depression will be observed at post-treatment and maintained at 3-month follow-up in patients with MS.

The efficacy, safety, and tolerability of daily intranasal insulin as a potential treatment for neurocognitive deficits in bipolar disorder (BD) will be investigated in a randomised controlled trial (RCT) across 12 weeks. Neurocognitive deficits are common in BD and can cause significant impairment in everyday functioning. Currently, there are no recommended treatments for neurocognitive deficits in BD, antipsychotics might aggravate cognition and the first line treatment for BD (lithium) has uncertain pro-cognitive effects. Thus, advances in the treatment of neurocognitive deficits in BD are urgently needed. The current study will investigate the efficacy of insulin in improving global neurocognition and psychosocial functioning in people with BD. The safety and adherence of the treatment will also be assessed. This novel clinical trial has the potential to be transformational for people with BD given the critical need to improve neurocognition and psychosocial functioning in those who experience it.

The purpose of this project is to investigate the effect of a 6-month personalised lifestyle protocol that incorporates recommendations from the ph360/Shae platform and phone app (nutrition, exercise, sleep, mindset, relationships, environment) and group coaching on the change in markers of diabetes and pre-diabetes. It is hypothesised that the personalised intervention using Shae will result in greater overall improvement in markers relating to Type 2 Diabetes. If the results are confirmatory, this study will contribute to an evidence-based rationale for personalising lifestyle medicine interventions for the care of type 2 diabetes.

This is a phase I, open-label, dose-escalation, multiple-dose study to investigate pharmacokinetics and safety of JT001 in Caucasian healthy subjects. The study consists of three dose level (200, 400, 600 mg). and the participant will be sequentially assigned from low-dose group to high-dose group to receive the JT001 at one of the three doses according to the dose escalation scheme. The total duration of participants in the study will be of 14 to 26 days. The study includes a screening phase (up to 14 days), a 6-day multiple-dose phase (D1-D6), a 3-day safety observation phase (end of administration) and 4-day safety follow up period. Total approximately 27 participants will be enrolled in the study. Each group of dose level will enroll approximately 9 participants. Oversight of the study will be provided by a committee (the Safety Review Committee) comprising a representative of the Sponsor or Sponsor’s designee, the investigator, and the medical monitor.

The study aims to evaluate the effectiveness of Gaming Habit Hacker, which is an internet-delivered intervention for people who want to reduce time spent gaming. Gaming Habit Hacker offers an innovative 28-day program to develop new habits that can support gaming reduction. Gaming Habit Hacker is informed by the Health Action Process Approach and implementation intentions literature and delivered in accordance with Self-determination Theory. Eligible participants will be randomised to the intervention group or comparison group. The intervention group will receive Gaming Habit Hacker, which delivers feedback on assessment, goal setting, action and coping planning, and feedback on outcomes of behaviour. The comparison group will receive assessment only. Participants will complete the baseline, 4-week post intervention, and 26-week follow-up evaluation surveys.

Aims • To quantitatively describe details of normal lumbar interspinous ligament and interlaminar foramen anatomy. • To define features that may influence needle access to the neuraxis. Hypotheses • The anterior lumbar interspinous ligament may be bilaminar with a gap corresponding to a midline gap between the opposing leaves of the ligamentum flavum. • An anterior midline gap in the lumbar interspinous ligament contains fat. • The lumbar interspinous ligament may have structural gaps not related to the ligamentum flavum. • The gaps may have a size equivalent to an epidural needle orifice. Objectives • Derive morphometric data of posterior lumbar structures of normal adult volunteers using high-definition magnetic resonance and ultrasound imaging. • Present quantitative description of normal posterior lumbar structures in a manner directly applicable to the midline passage of a needle into the neuraxis. Methods Recruit normal adult volunteers. Record demographic data then generate and record measurements pertaining to their lumbar spine using clinical examination, ultrasound scanning and high-definition magnetic resonance imaging. Generate descriptive statistical results, compare equivalent measurements derived from the different modalities, and describe in detail anatomical midline and adjacent features that may be sensed during needle passage to the neuraxis.

We propose that i) collection of sufficient cord blood will be feasible in infants with antenatally diagnosed fetal stroke, and ii) (multiple) autologous intravenous administration of processed umbilical cord blood derived cells in these infants in the newborn period will be safe. This phase I trial will be the first study in the translational pipeline for this neurological condition, and will test the feasibility of cord blood collection, sufficient cell availability and safety of cell administration in this vulnerable group. Following successful completion of this study, an efficacy trial will be planned to determine the efficacy of autologous UCB cell administration in fetal stroke.