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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.

SDC-1801 is a small molecule tyrosine kinase 2 (TYK2)/janus kinase 1 (JAK1) inhibitor entering clinical development for the treatment of participants with inflammatory diseases such as psoriasis. The nonclinical good laboratory practice (GLP) toxicology and safety pharmacology studies indicate that it is appropriate to cautiously assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SDC-1801 in the context of a well-designed, first-in-human (FIH) study. It is reasonable to say that the risk of adverse events (AEs) for JAK inhibitors are broadly similar to those for other biological disease modifying antirheumatic drug (bDMARD) classes. However, concealed within this, there are also important differences between JAK inhibitors and bDMARDs. Tofacitinib and baricitinib have AE profile characteristics that distinguish them from the other bDMARD classes, with signals including an increased risk of herpes zoster reactivation, elevation in lipids, and decreases in haemoglobin and lymphocytes (including natural killer cells). Based on available nonclinical data, SDC-1801 is a potent and selective small molecule TYK2/JAK1 inhibitor currently in development for inflammatory and autoimmune indications, and it has the potential to have an improved safety profile and similar efficacy profile compared with other JAK inhibitors and specific TYK2 inhibitors. A randomised, placebo controlled, dose-escalation, sequential group design is regarded as an appropriate standard design to initiate the cautious assessment of safety, tolerability, and PK of a new investigational product in healthy volunteers. The chosen sample sizes will provide sufficient data to make an initial assessment of the safety, tolerability, and PK of SDC-1801. In addition, the effect of food on SDC-1801 PK will be evaluated to characterise the PK of SDC-1801 in fasted and fed conditions and to guide the selection of a dosing regimen for use in further studies.

Our First trial (ACTRN12609000905268) examined if giving babies the pertussis vaccine (Pa vaccine) earlier than 6 weeks old means that they are better protected. Children on this original trial are now being followed up to compare the pertussis immune responses and safety of a booster dose of either DTPa or low dose dTpa vaccine when given between 18-36 months old. we are hoping to find out if a lower dose diphtheria, tetanus and pertussis booster vaccine (dTpa) may provide comparable immune responses to the currently recommended DTPa vaccine however with a more favourable safety profile.