ANZCTR search results

This study will investigate whether in subjects (people with idiopathic pulmonary fibrosis (IPF) and aged matched controls without lung or gastroesophageal disease) who are found to have pepsin (an enzyme normally found in the stomach and not in the lungs) in the exhaled breath (EBC), simple postural measures and common acid suppression medication can reduce the level of pepsin in the EBC

Patients with glioblastoma have particular needs that distinguish them from other patients with cancer, as they also have neurological issues that can affect them physically, cognitively and psychologically. This in turn produces significant burdens on their carers. The aim of this study is to assess the effect of having brain tumour nurses visit patients at home. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with a glioblastoma, and you are well enough to undergo combined radiotherapy and chemotherapy treatment. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants who are allocated to the first group will have brain tumour nurses visit them at home every 2-4 weeks. This may increase over time as the needs of participants and their carers change. During the at home visits, nurses will assess the participant and carers needs and act as a point of contact to address any issues that may arise. Occupational therapists will assist in assessing the needs of these patients and providing the necessary equipment to enable them to remain safely at home. Participants who are allocated to the second group will continue to receive their usual care from their oncologist but will not receive at home visits from a brain tumour nurse or occupational therapist. These participants will be able to request additional assistance and equipment from the hospital if needed, but they will not have any at home visits as part of their involvement in the study. Participants in both groups will be asked to fill in forms to assess their symptoms. Participants who have the nurses visit them at home will be asked to attend one-on-one interviews with a member of the research team to provide their feedback on the care they have received. It is hoped this research will show whether providing at home care options to patients with glioblastoma has a positive impact upon their quality of life and reduces the need for hospital admission compared to usual care practices. If this study does show a positive impact of the at home visits, a larger trial involving a greater number of glioblastoma patients may be undertaken to further investigate this method of care.

Background: The benefits of cycling are increasingly recognised and promoted while safety is declining for cyclists in proportion to other road users and measures to protect cyclists are often ineffective. Falls (non-collision crashes) also cause severe injuries and crashes between bicycles in bicycle lanes can cause a high percentage of injuries. Unique data is therefore needed to inform the establishment of an safe system approach that takes into account and reconciles the needs of all road users, based on evidence based modifications, design values and passive safety measures in order to be a feasible method of giving cyclists equity in the transport system and balances the benefits of cycling with acceptable levels of safety. Outcomes: 1) This study aims to identify and quantify differences in circumstances contributing to crash and injury amongst cyclists and identify the major contributing factors to injury severity. 2) Assessment of the 3 month recovery outcomes of injuries including the rate of recovery, impact of injuries on daily living activities and attitudes to more protective gear. Participants: Injured pedal bikes riders over the age of 18 years presenting at the Emergency Department, Royal North Shore Hospital Methods: Data will be collected from consenting patient records relating to the circumstances of the accident, injuries and treatment. Patients who consent to participate in the follow up interview survey will be contacted three-months following their discharge from the hospital. The survey is in the form of a short 10-minute telephone semi-structured interview to review their recovery from injuries and the long term impact of their injuries.

In this randomised, double-blind, placebo-controlled study, 70 high electronic screen users aged 18 to 65 years will be randomly assigned to receive capsules containing either Lute-gen (Lutein 10 mg & Zeaxanthin-isomers 2mg) daily or a placebo for 6 months. Changes in eye strain, eye fatigue, dry eye symptoms and general visual health will be assessed over time by administering several validated self-report questionnaires and objective eye assessments. Moreover, changes in sleep quality and attention will be evaluated over time.

Safe vascular access is essential for treatment of critically ill newborns. The NeoNav ECHO Study investigates electrocardiographic (ECG) signals measured through catheters placed as part of clinical care and checks if these signals can reliably determine where the tip is located as checked on ultrasound. This knowledge will contribute to develop a new device that doctors and nurses can use while placing these catheters to increase success rates of the procedures and make them faster and less stressful for babies. The research team will approach potential participants to offer study participation and obtain consent. When consent is given, the Neonav device (provided by Navi Medical Technologies Pty Ltd and used under TGA Clinical Trials Notification) will be used to record intravascular ECG traces through the catheter during the catheter insertion, daily spot checks post-insertion and at removal of the catheter. Echocardiography will be done to determine where the catheter tip is located. Analyses will determine if and how ECG waveform characteristics compare to the position of the catheter tip as determined by ultrasound.

Standard treatment of gestational diabetes mellitus (GDM) involves a moderately reduced carbohydrate intake spread evenly across the day to reduce glucose spikes, regular moderate physical activity, finger prick glucose monitoring four times daily and where necessary insulin to control maternal glucose levels. Although improving lifestyle is the first-line treatment for GDM, there is no agreement for the best diet. This 21-day pilot randomised control crossover study will see if a low glycaemic load breakfast can improve daily glucose control, reduce the need for insulin and is safe and acceptable in women with GDM. The primary outcomes include measures of glycaemic variability including time in range, time below the range and time above the range, Secondary outcomes include maternal metabolic parameters (fasting lipids and beta-hydroxybutyrate).

Approximately 5 million people are affected by bone marrow failure syndromes (BMFS) worldwide each year, but individually many of the BMFS are rare. In Australia there are 160 new diagnoses each year, of which 50% do not survive. The rarity of these conditions and the absence of coordinated data and sample collection present barriers to research into biology and optimal treatment of BMFS. In Australia, Maddie Riewoldt's Vision (MRV) has supported a national comprehensive clinical data set on newly diagnosed patients with BMFS through strategic funding of the Aplastic Anaemia Registry and Other Bone Marrow Failure Syndromes Registry (AAR). MRV seeks to build on this initiative by establishing a matched research sample set that will allow new research questions to be asked, provide a feasible and ready-to-go sample set that will support BMFS research. The purpose of the AMFB is to establish a national repository of samples from patients with BMFS to serve as a community resource for clinicians and researchers. Promote nationally consistent, comprehensive diagnostic (including molecular) testing for patients with BMFS. It is hoped that the research from this biobank will provide valuable information to improve the diagnosis, treatment, or care of people with BMFS.

Lucid-201 is a psychedelic compound that is expected to impact mood, thinking, and behaviour. The growing evidence of psychedelic compounds for a variety of mental health conditions inspired the investigation of Lucid-201 in humans. This study aims to determine the safety, tolerability, and pharmacokinetics (amount of drug in your body) of Lucid-201 in healthy volunteers and patients with symptoms of depression on certain antidepressant medications. This study also aims to determine the intensity, duration, and types of effects of Lucid-201. The maximum study duration for participants in this study would be approximately 9 weeks. This includes a 6-week screening period, a 3-day and 2-night dosing period, and a follow-up appointment two-weeks later.

Peripheral artery disease (PAD) involves blockages in the leg arteries, leading to exertional lower-limb pain and reduced physical capacity and quality of life. Supervised exercise therapy is an effective treatment for impaired walking due to peripheral artery disease. However, availability and uptake of supervised exercise therapy is limited, perhaps due to the requirement to attend a central facility. The SHAPE trial is a multi-centre, prospective, parallel-group, randomized controlled and assessor-blinded trial. 130 eligible participants with peripheral artery disease will be recruited and consented to the study. In this randomised controlled trial (RCT) the effectiveness and acceptability of SHAPE is compared to current standard of care (centre-based supervised exercise). Participants will be randomly allocated to one of these programs. SHAPE is evidence-based and was designed in partnership with patients, GPs, vascular surgeons and AEPs. This exercise program is done entirely within the participants’ home, supervised by AEPs using telehealth and uses behavioural monitoring via a worn accelerometer. The tertiary facility centre-based supervised exercise program is a exercise program run at a tertiary facility in line with current guidelines. Both programs provide supervised exercise three times per week for 12 weeks. The primary outcome is to test the non-inferiority of SHAPE compared to the centre-based exercise program through a difference of less than 20m during a six minute walk test. Secondary outcomes include health-related quality of life (HRQOL), cardiovascular risk factors, engagement with the program, and participant satisfaction assessed by a survey and, in a sub-set of participants, through interviews.

Loading doses of methotrexate (where high dose methotrexate injection is given once weekly for three weeks at the start to control the disease activity of rheumatoid arthritis, followed by lower dose of oral methotrexate as maintenance) have been used sporadically by rheumatologists in practice, but the research evidence for the loading dose of methotrexate is limited. This study is aimed to investigate how the concentration of methotrexate and its active metabolites differ compared to the standard dose regimen. Also, this study is also aimed to assess the feasibility to implement this loading dose regimen in real life, and the patient's attitude towards this new dosing regimen.