ANZCTR search results

This project aims to determine how many patients that receive sedation for endoscopy procedures (in this study referred to as 'procedural sedation') experience heat loss. The project also aims to investigate the pattern of heat loss. No guidance exists for prevention of hypothermia (heat loss to below 36 degrees Celsius related to a surgical procedure) for patients receiving procedural sedation during endoscopy. This means that patients remain exposed toside effects related to heat loss: for example, discomfort related to feeling cold, and prolonged recovery. Whilst temperature measurement during procedural sedation is often neglected entirely, in this project we will use a temperature monitoring device that is non-invasive and provides continuous monitoring of temperature. New knowledge to guide future interventions to prevent heat loss for patients receiving sedation for endoscopy procedures will be generated.

HMI-115 re-established the growth phase for hair follicles to stimulate hair regrowth through blocking the function of prolactin on hair follicles. it is expected that HMI-115 will resolve current clinical unmet needs, not only provide excellent and durable efficacy of hair growth for man and women, but also provide a favorable safety profile. This study aims to explore the preliminary efficacy and safety of HMI-115 in male and female AGA patients aged 18 to 65 years (inclusive) at 240 mg every 2 weeks (Q2W).

Young people with mental ill-health continue to be at a higher risk for poorer sexual health compared to their peers in the general population. However, there is yet to be an intervention introduced that promotes sexual health and wellbeing within this at-risk group. Ensuring that young people have good sexual/reproductive health is a public health concern, yet is commonly overlooked by healthcare professionals. Learnings from a large systematic review have shown that future interventions should address sexual health as more than the absence of negative outcomes in at risk populations. The PROSPEct project has developed a sexual health promotion intervention, which was co-designed with key stakeholders, in order to address this issue. The purpose of this feasibility trial will be to determine if it is feasible and acceptable to run a trial of this co-designed sexual health promotion intervention with young people with mental ill-health. With the knowledge gained from this feasibility trial, we hope to be able to answer this research question and establish the parameters for a fully powered trial. We hope that findings from the PROSPECT project can inform clinical practice, and that this intervention can eventually translate to routine clinical practice whereby a multidisciplinary approach is taken to ensure positive sexual health for young people with mental illness.

This mixed methods study aims to improve tertiary care hospital experiences of, and service delivery to, children with medically complex cerebral palsy and their caregivers. We will use an integrated knowledge translation approach to: 1) describe and compare service use and outcomes between children who receive support from a state-wide multidisciplinary Complex Care Hub (CCH) situated within the Royal Children’s Hospital (RCH) and those who do not and 2) gain stakeholder perspectives between the 2 groups through focus groups and/or interviews with parents and (where possible) young people with cerebral palsy as well as multi-disciplinary clinicians working with this population.

The ReMoTe Ward Study is an observational study assessing the reliability and usability of a pulse oximetry device and thermometer used by patients in remote monitoring. In-patients at RPAH (n=50) will be asked to use the devices themselves (after receiving some training) while they are in hospital, and provide their feedback on using it. The patient will be given a pulse oximeter, a thermometer and a mobile phone. The measurements taken with the pulse oximeter and thermometer will transmit measurement data via the mobile phone into the patient's electronic medical record. The reliability and usability of patients using the devices (with connection to eMR) compared to the nurse-administered usual care pulse oximetry device and thermometer will be evaluated.

The aim of this study is to assess the toxicity, efficacy, and optimum dosing of autologous GD2-specific chimeric antigen receptor-expressing T cells (GD2-iCAR-PBT, a cell product infusion derived from the patient’s own T cells) in paediatric patients with Diffuse Midline Glioma. Who is it for? You may be eligible for this study if you are aged 21 years or younger, and have diffuse intrinsic pontine glioma diagnosed by MRI and/or a histological diagnosis of diffuse midline glioma with an H3K27M mutation or loss of H3K27 trimethylation. Study details All participants will undergo collection of peripheral T cells by apheresis (i.e. removing whole blood from a vein and separating out T cells) to manufacture the study therapy GD2-iCAR-PBT. The therapy will take approximately 3 weeks to manufacture, during which time participants may receive radiotherapy as part of standard care. If manufacture of the therapy is successful, the participant will receive a single treatment of GD2-iCAR-PBT intravenously at an starting dose of 1 x 10^7 cells/m^2. Participants will also receive up to three doses of bevacizumab intravenously at a dose of 10mg/kg in the period surrounding the injection of GD2-iCAR-PBT. The first dose will be given one week prior to the GD2-iCAR-PBT injection, with subsequent doses every two weeks, with the third dose being optional. For 6 weeks following the GD2-iCAR-PBT injection, participants will be assessed for any toxicities from the treatment, and at 6 weeks post-injection their tumour response will be assessed using brain MRI. If responding to the treatment and experiencing minimal toxicities, participants will be eligible to receive additional treatments of GD2-iCAR-PBT at least 6 weeks apart. The additional doses will be given intravenously at the same dose level or intracerebroventricularly at a fixed dose of 30 x 10^6 cells. Subsequent participants enrolled into the study may receive a higher starting dose of GD2-iCAR-PBT, to determine the maximum safe dose of administration. All participants will be monitored for up to 5 years post-infusion for efficacy of the treatment using brain MRI. It is hoped that this study may help us find the dose of administration of GD2-iCAR-PBT that produces the greatest tumour response with the least toxicities, for the treatment of Diffuse Midline Glioma. This may help to direct treatment of other paediatric patients with this tumour in future.

POSNOC was designed to assess the need for additional local axillary treatment in those with limited disease in the sentinel node who will be treated with adjuvant systemic therapy. The original plan was for 5 years of follow-up, based on data suggesting that the large majority of regional recurrences occurred within the first 2 years. Recent data suggests that with modern systemic therapy, regional recurrences may be delayed, and therefore extended follow up is important to address the POSNOC hypothesis. It is expected that the addition of complete mortality and cancer incidence data from the Australian and New Zealand participants in addition to that collected in the UK will increase the power of the POSNOC study to determine whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment. The objectives of the POSNOC Extended Follow Up and Data Registry substudy are the same as those of the main POSNOC study. The objective of this substudy is to increase the power of the study to address the questions. Who Is It For? Patients who are randomized to the ANZ 1501 POSNOC study in Australia and New Zealand (ISRCTN54765244, NCT02401685). Substudy details: Data collection in this project will be obtained by: 1. One additional contact in 2026 (when the final patient recruited to POSNOC has reached 5 years of follow up). Data linkage will be used where a patient cannot be contacted; and 2. Subsequent follow up by data linkage. The data will be requested from the respective national and jurisdictional data registries for Australia and New Zealand such as the Australian Institute of Health and Welfare (AIHW) and New Zealand’s Breast Cancer Foundation National Register (BCFNR). Data will be cleaned and securely stored on servers within the Breast Cancer Trials, Trials Department, Newcastle, NSW Australia.

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.