ANZCTR search results

The primary purpose of the study is to investigate the feasibility of using the Handbook Emergency Protocols during simulated medical emergencies. It is expected that use of the handbook of emergency protocols will be at least be as effective as current models of care. It is anticipated that use of these protocols may lead to more accurate adherence to current resuscitation guidelines. In the TEMPIST study we will evaluate the standard list of emergency guidelines in current use in Australia. All of these guidelines have been reformatted into a step by step, easy to follow format, presented as a Handbook of Emergency Protocols. It is the presentation of this information that has been modified in order to produce a simple cognitive aid for medical staff. Experts from the aircraft industry and graphic designers have been consulted in an attempt to produce a handbook that is free of excessive information and visual distraction. Attention has been given to the colour and size of the text used and diagrams have been designed to be clear and well presented. Instructions are delivered in an easy to follow, step by step format designed to be read out loud during a resuscitation event. The TEMPIST trial will investigate the feasibility of using the Handbook Emergency Protocols during simulated medical emergencies. Objective: The aim of this study is to determine whether the use of the Handbook of Emergency Protocols leads to, or detracts from, the provision of correct care, in accordance with current Australian and New Zealand Resuscitation Committee guidelines. Method : A prospective block randomized controlled trial will be conducted. The research will be conducted in a high fidelity simulation laboratory. Groups of medical staff will be asked to manage four simulated emergency medicine scenarios.Groups will receive either the Checklist scenario or usual care. Each group will manage two scenarios with the emergency protocol handbook and two scenarios using only the wall charts and drug administration handbooks that are found in every Australian Emergency Department. Each group will perform each scenario only once, either with or without the emergency protocol handbook. The four scenarios are: 1. Paediatric seizure 2. Adult pulseless ventricular tachycardia 3. Newborn resuscitation. 4. Tricyclic antidepressant overdose. Each scenario will be recorded on video and the primary outcome measures will be a list of 15 tasks per scenario that are expected to be completed within the 15 minute time frame. At the end of all 4 clinical scenarios, participants will be asked to fill out a brief questionnaire to evaluate their subjective experience of using the emergency protocol handbook and to try and identify potential hurdles to its adoption. The patient will be a simulation manikin (Sim man 3G). The trial groups will be made up from doctors and nurses with a mixed level of emergency medical training.

This study is an open-label extension study to Protocol ZYN2-CL-03 (STAR1). The study aims to evaluate the long term effectiveness, safety, tolerability and blood levels of twice daily ZYN002 in addition to regular seizure medication for 24 months in up to 180 adults with partial onset seizures (POS) who have participated in study ZYN2-CL-03. This will be done by analysing a daily seizure and skin irritation diary, drug levels in the blood at various times following drug administration, and side effects. Skin at the application sites will be checked to see if there is any irritation or reactions present after applications. Who is if for? You may be eligible to join this study if have completed the 12 weeks of study treatment on protocol ZYN2-CL-03. Study details: All participants will administer ZYN002 transdermal gel twice daily for 24 months. What does study participation involve? Eligible patients can immediately transition after completing day 84 (at Week 12) of the double-blind study, ZYN2-CL-03, to the open label study, ZYN2-CL-004. All participants in this extension study will receive active ZYN002. This could be the first time a participant receives ZYN002, depending on which treatment they received in the previous study (ZYN2-CL-03). After pre-dosing procedures are completed, patients will start study medication (Day 1). The first dose of study drug will be applied by the patient at this visit. Patients will be required to visit the clinic at Week 2 and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, Adhoc and End of Study to have study procedures completed. Participants will continue to record their seizure frequency and type in their daily diary. At the clinic visits the following procedures will occur: blood sampling; review of daily diary, medications, adverse events and skin irritation; measurement of blood pressure, heart rate, breathing rate and temperature ; suicide risk; and possibly, a brief physical and neurological exam, pregnancy tests (females only, if applicable) and an ECG. Participants withhold their morning application until after blood sample collection at these visits. Additional out-patient visits may be required if there is skin irritation present at the application site.

Introduction: Medication errors are the most frequent cause of preventable harm in hospitals. Medication management in paediatric patients is particularly complex and consequently potential for harms are greater than in adults. Electronic medication management (eMM) systems are heralded as a highly effective intervention to reduce adverse drug events (ADEs), yet internationally evidence of their effectiveness in paediatric populations is limited. This study will assess the effectiveness of an eMM system to reduce medication errors, ADEs, and length of stay (LOS). The study will also investigate system impact on clinical work processes. Methods and Analysis: A stepped-wedge cluster randomised control trial (SWCRCT) will measure changes pre and post eMM system implementation in prescribing and medication administration error (MAE) rates, potential and actual ADEs, and average ward LOS. In stage 1, 8 wards within the first paediatric hospital will be randomised to receive the eMM system one week apart. In stage 2, the second paediatric hospital will randomise implementation of a modified eMM and outcomes will be assessed. Prescribing errors will be identified through record reviews, and MAEs through direct observation of nurses and record reviews. Actual and potential severity will be assigned. Outcomes will be assessed at the patient-level using mixed models, taking into account correlation of admissions within wards and multiple admissions for the same patient, with adjustment for potential confounders. Interviews and direct observation of clinicians will investigate the effects of the system on workflow. Data from site 1 will be used to develop improvements in the eMM and implemented at site 2, where the SWCRCT will be repeated (stage 2). Ethics and Dissemination: The research has been approved by the Human Research Ethics Committee of the Sydney Children’s Hospitals Network and Macquarie University. Results will be reported through academic journals and seminar and conference presentations.

The gastrointestinal tract is host to a vast number of bacterial species outnumbering the cells of the organism by around 100 fold. The importance of the gut flora (or microbiota) is increasingly being recognised. There is now compelling evidence that the composition of the microbiota in the human gastrointestinal tract (the microbiome) plays an integral role in human health and disease and that altering its composition can have a profound impact on an individual’s metabolic and immune profile. The first few weeks and months of life are known to be critical for the establishment of the gut microbiome, however there is currently limited knowledge of the factors which regulate this development. The omega-3 LCPUFA, DHA, has been shown to promote the colonisation of the gut by beneficial bacteria, and promote gut development, in adult humans, older infants and in animal studies. While breast milk contains some DHA, the amount it contains is directly related to the amount consumed by the mother, and most breastfeeding women in Australia have a low dietary DHA intakes. Therefore, this study aims to determine whether increasing the amount of DHA in breast milk, by providing DHA supplements to breastfeeding women, will promote the colonisation of the infant gut with beneficial bacterial species over the first 3 months of life. The results have the potential to identify a safe and effective approach for promoting the establishment of the healthiest possible gut microbiome in breast-fed infants, something which is known to have both short- and long-term health benefits.

This is an initial study to apply speech intervention using the principles of motor learning to cleft type speech errors. Cleft palate is known to impact on speech and language development and at least 50% of children with repaired cleft palate will require speech therapy. It is an alternating treatment single subject design with multiple baselines across participants and behaviours over two treatment phases. Two treatment phases, phase I and phase II, will be conducted twice weekly for eight weeks. A 4 week maintenance phase will follow each treatment phase. A final assessment will be administered 4 weeks after the final treatment session in phase II. The total study duration will be 28 weeks. The speech pathology intervention will be conducted through a series of age appropriate play based activities and educational games that have been carefully selected and/or designed as they directly relate to the participants' targets and/or to facilitate many productions of the target word. The participant will be presented with picture cards (that represent a word) and be asked to produce the words. Words will be elicited in an age appropriate manner, such as through games, activities and educational play. The principles of motor learning (practice amount, practice delivery and feedback) will be used to structure and guide the therapy. 8 participants will be required for the study. Participants will be aged between the ages of 3-6 years of age, have a non-syndromic cleft palate, and have evidence of at least two cleft type speech errors (1 active and 1 passive) on assessment by a speech pathologist.

Rationale: The biological mechanisms leading to psychological disorders and morbidity after MVC remain unclear. There is now solid evidence that aberrant heartbeats are a sign of poor adaptability to stressful events, and this relates to an unbalanced state of the autonomic nervous system (ANS). However, the significance of heart activity to identify who is more likely to develop a psychological distress and to fail to recover from traumatic injury is not yet well understood. The proposed study will address this important gap in research by using heart activity as a promising biomarker in early recognition of psychological sequelae and stress-related morbidity after a MVC. The use of a biopsychosocial model will shed light on possible links to autonomic responses and risks factors identified in the literature as key contributors to recovery following a MVC. Aims: (1) To determine whether heart activity predicts vulnerability to psychopathological conditions (e.g. depression, PTSD, etc) and associated morbidity (eg pain, fatigue, etc) following a MVC. (2) To compare psychophysiological status and morbidity to a group of non-MVC controls. (3) To determine the strength of relationship between ANS activation (heart activity) and key risk factors implicated in recovery after MVC, with an emphasis on emotional and cognitive responses to the crash. Method: The study will utilise a prospective, case-control cohort design. Participants will be adults, who have experienced a minor to moderate injury after a MVC and subsequently admitted to an ED of major hospitals in NSW. Proposed recruitment is approximately 70 to 100 MVC survivors. Comparisons to a healthy control group (who have not experienced a MVC in the past 5 years), age-sex matched to MVC survivors, will also occur. The design will involve longitudinal assessment, with follow-up measures at 3, 6 and 12 months post-injury, after the baseline (within 6 weeks of the MVC). MVC survivors and controls will be similarly assessed. (a) Autonomic assessment: The assessment of ANS will consist of collection of early post-crash vital signs (at the scene and Emergency Department admission), as well as prospective ECG-based HRV recordings, performed at baseline and 3 months post-injury. (b) Biopsychosocial assessment: The autonomic response to the MVC will be investigated over time in relation to personal and environmental factors, known as influencing health outcome and recovery after an injury. This data, together with health and social outcomes, will be collected using online interviewing assessment at baseline, 3, 6 and 12 months post-injury. Significance: Key outcomes are psychological distress, stress-related physical conditions and recovery indicators over a 12 month period after a MVC. Findings will clarify whether biomarkers of psychological distress exist and can aid in identifying the most vulnerable people, avoiding delay in recovery and return to work, decreasing costs, and preventing chronicity.

The skeletal response to exercise is highly dependent on the nature of the activity. The most osteogenic loads are those that induce high magnitude bone strains at high loading rates. However, debate exists as to the predominant source of the adaptive stimulus – muscle forces or gravity-derived impact loads. The determination of the most effective source of loading would provide grounds for optimal exercise prescription for bone health. The aim of this work is to compare the bone response to two known osteogenic loading methods, impact loading exercise versus muscle loading exercise in young women with lower than average bone mass.

This study aims to test a primary care intervention that is designed to improve self-management of risk factors related to bowel, cervical and breast cancer among primary care patients. Who is it for? Patients may be eligible to join this study if they are aged at least 18 years, are presenting for a general practice appointment, and have been identified via a brief baseline assessment as being a smoker, consuming alcohol at risky levels, or have not been screened as per Australian recommended guidelines for bowel, cervical or breast cancer. Study details The study will take place in the waiting rooms of general practices, with participants randomly allocated to one of two groups based on the specific day they attend the practice. All consenting patients will complete a touchscreen survey focussing on the patient's previous participation in cancer screening activities (bowel, cervical, breast), smoking status, alcohol consumption, and depression. While depression is not a cancer risk factor; it may co-occur with other risk factors and impede self-management efforts to reduce modifiable risk factors. Patients from one group will receive printed feedback about their identified health risk factors, along with information about self-management actions for addressing these risks. Participants in the other group will not receive information about their identified health risks or self-management strategies. Eligible patients who complete the baseline survey will undergo a follow-up telephone survey after 1 month to assess how many self-management actions they may have undertaken in relation to any health risk factors identified at baseline. It is hoped that this primary care intervention will be an effective way to increase the proportion of patients who undertake self management actions related to their identified health risks.

LTI-01, the study drug being researched in this project, is an experimental treatment being developed by Lung Therapeutics, Inc. This means that it is not an approved treatment in Australia, and is not yet approved anywhere else in the world. LTI-01 is a treatment that is intended to either prevent or remove the build-up in the pleural space around the lungs (called ‘loculation’) and so promoting drainage of the fluid with the goal of avoiding the need for surgery. Study participants will be given 1 dose of LTI-01 a day for up to 3 days in a row. LTI-01 will be administered directly into the pleural or lung cavity through a chest tube. During and after treatment, participants will be assessed for the following: * how safe and well tolerated the LTI-01 is at the dose they are given * how much of the LTI-01 drug is in your blood at specific times to measure the way the body is processes it * the effect of the LTI-01 drug has on your body

A multi-centre international diagnostic biomarker development and validation study using a secondary analysis of data prospectively collected from multiple cohorts. The overall project objective: To develop and validate an assessment algorithm that allows: 1. The early rule in of AMI for as many patients was possible with a low false positive rate. 2. The early rule out of acute myocardial infarction (AMI) for a large proportion of patients with a very low false negative rate The overall aims are: 1. To derive and validate the Myocardial Ischaemic Injury Index (MI3) for identification of patients with acute myocardial infarction amongst patients being investigated for possible acute coronary syndrome. 2. To derive and validate Index Value thresholds for optimal (i) rule-out and (ii) rule-in of acute myocardial infarction with the MI3 algorithm for rapid assessment of patients being investigated for possible acute coronary syndrome.