ANZCTR search results

This is open label, cross over study to evaluate the safety, tolerability, pharmacokinetics (PK) food effects of AC-101 following oral single/multiple ascending dose administration in healthy male and female participants. The impact of food (high-fat breakfast) on the rate and extent of absorption will be evaluated. Food Effect (FE) study enrolling 1 cohort of subjects (Part 2) to receive AC-101 under both fasted and fed conditions for investigating the effect of food. In this part of the study the dose given in Fed Period will be administered 30 minutes after starting a high-fat breakfast. A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal will provide to the subject 30 min prior to dosing. This test meal should derive approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively.

Individuals with Cerebral Palsy who are reliant on wheelchairs for mobility have significantly reduced options for participating in physical activity and movement. For those with significant disabilities encompassing not only the musculoskeletal system but also cognition, behaviour and communication face a unique set of challenges requiring new and novel treatment options. In addition to the barriers of access and transport consideration also needs to be given to the timing of medications and feeds. The MOTOmed is a motorised movement (cycling) device, accessed from a person’s wheelchair that provides an option to move for non-ambulant adults with CP. The passive rhythmical cycling motion provides movement at the hip, knee and ankle joints that is otherwise not possible for those with a lack of independent and functional active movement. This movement opportunity may be beneficial given that adults with CP are otherwise in static postures for the majority of their day and night. This study will explore the frequency of use of the MOTOmed within the home, analyse data retrieved from the MOTOmed regarding usage and gain perspectives on the experience and perceived benefits of a home-based motorised cycling intervention. Those involved in the study will use the MOTOmed a minimum of four times per week over a 4 week period. A questionnaire at the completion of the study will enable participants to provide feedback on how the use of the MOTOmed impacted areas such as muscle tone / spasticity, sleep, mood, level of alertness and interactions with others alongside information on if it is an appropriate method of increasing physical activity and movement, where they would ideally like to access the device and if they would like to continue using it given the opportunity to do so. Additional information is downloaded from the MOTOmed such as number of spasms, duration and distance covered with each use.

We aim to develop a population pharmacokinetic model for lidocaine administration by intravenous infusion and identify clinically important covariates by conducting a prospective, single-centre, exploratory interventional study. It is anticipated that this project will provide data to inform a model which will facilitate accurate and potentially safer dosing of intravenous lidocaine. We plan to recruit 40 female adult patients undergoing breast reconstruction surgery. Patients will receive a bolus dose of lidocaine followed by an intravenous infusion. Dosing will be calculated using lean body weight and based on the dosing protocol approved and used in the LOLIPOP Pilot Trial (1) which has proven it to be safe and feasible. As an additional safety feature, we will be using half the dose of that used in LOLIPOP. This is because, unlike the LOLIPOP Trial, pain is not one of our outcome measures. Our primary aim of examining serial serum lidocaine concentrations and the potential formulation of a pharmacokinetic model is achievable at these lower doses. Lidocaine samples will be taken at hourly intervals throughout the duration of the infusion, and twice postoperatively between 8 and 26 hours of ceasing the infusion Current research (including the LOLIPOP Trial) is focussed on the analgesic properties of intravenous lidocaine. Several studies have already demonstrated a reduction in pain scores and a decrease in peri-operative opioid consumption. The goal of intravenous infusion is to establish and maintain therapeutic plasma concentrations of 0.5-5 mcg/mL, whilst avoiding higher doses that may result in toxicity. Lidocaine has complex pharmacokinetics and demonstrates non-linear (time-dependent) pharmacokinetics with prolonged infusion, including increasing plasma concentrations and prolonging elimination half-life. Establishing a population-based pharmacokinetic model will facilitate a dosing regimen that maintains plasma lidocaine concentrations within a safe therapeutic window. This will improve the safety of intravenous lidocaine infusion by decreasing the risks of systemic toxicity, and potentially improve its efficacy by maintaining effective therapeutic plasma levels. [1] Toner A.J. BMA, Schug S.A., Corcoran T.B. A pilot multicentre randomised controlled trial of lidocaine infusion in women undergoing breast cancer surgery. Anaesthesia. 2021. ClinicalTrials.gov registration ID: NCT05072314

At The Northern Hospital, on average, 1 in 4 women will require their labour to be induced with oxytocin. Currently, this medication is given as a continuous infusion intravenously, with the amount of oxytocin given increased every 30 minutes until 4 uterine contractions within 10 minutes are regularly observed. However, the body normally releases this hormone in a 'pulsatile' or intermittent fashion every 3-5 minutes during labour, rather then releasing it continuously. The hypothesis being tested is whether giving oxytocin intravenously in a pulsatile fashion, which mimicks the physiological process, leads to better obstetric outcomes, in particular, a shorter duration of labour, more successful vaginal deliveries, less postpartum haemorrhage and less requirement for epidural analgesia, when compared to the current process of providing oxytocin in a continuous fashion. This hypothesis will be tested by a randomised controlled trial of 412 participants, Half of the participants will be randomised to continous infusion of oxytocin, whereas the other half will be randomised to pulsatile oxytocin. The primary outcome of interest will be the duration of labour as defined by the commencement of oxytocin, until the birth of the neonate.

The study aims to evaluate the factors that contribute to the success of a Cognitive Bias Modification of Interpretations (CBM-I) program. Specifically, the study will look at whether the content (or topic) of the training scenarios in the program needs to match participants’ anxiety concerns (e.g., social concerns) to be effective in modifying the ways that individuals interpret information. Adults with elevated symptoms of social anxiety will be randomly allocated to CBM-I training that matches their anxiety type (using social scenarios), or CBM-I training that does not match their anxiety type (using fear of heights scenarios). All participants will complete a single session of CBM-I, with 60 training scenarios. Interpretation bias, social anxiety symptoms, and state anxiety will be assessed immediately before and after the CBM-I training. We expect that that the group that receives training scenarios that matches their anxiety type (social) will demonstrated greater reductions in negative interpretation bias, social anxiety, and state anxiety from pre-training to post-training, compared to the group that is assigned scenarios that do not match their anxiety type (heights).

To validate a brief cognitive screening tool for young people with FEP using established classification accuracy methodology and to explore the acceptability, feasibility and implementation barriers and facilitators of screening as part of an implementation evaluation.

This is a single center, randomized, double-blind, placebo-controlled, dose-escalation study to evaluatethe safety, tolerability, pharmacokinetics (PK) f AC-101 following oral single/multiple ascending doseadministration in healthy male and female participants. The study will consist of 3 parts: a SAD phase (Part1) enrolling a total of 5 cohorts of healthy participants; and a MAD phase (Part 3) enrolling 3 cohorts ofhealthy participants. All doses of study drug will be administered orally with approximately 240mL of room temperature water. In Part 1 to Part 3, all doses will be administered after an overnight fast of at least 10 hours,

An unintended but common outcome of bariatric surgeries is reduced preference for sweet and fatty foods. It is not known why this occurs. This study will examine whether changes in food preferences after bariatric surgery are related to changes in taste receptors in the gut. In volunteers undergoing sleeve gastrectomy or gastric bypass, food preferences and gut taste receptors will be examined and compared before and 12 months after surgery. Relationships between food preferences, gut taste receptors, weight loss, blood glucose and lipid profile will be examined. This will indicate whether changes in gut taste receptors are related to the effects of bariatric surgery.

This study will explore whether intraoperative pain measured with the NIPE monitor correlates to the level of postoperative pain and the amount of analgesia required after elective laparoscopic and open inguinal hernia repair. This could clarify if laparoscopic inguinal hernia repair is associated with reduced intraoperative and postoperative pain leading to a reduction of postoperative analgesia and length of hospital stay. This has not yet been explored and this may ultimately result in less pain and distress to children and their carers, and also reduce healthcare costs.

The overall project is a mixed-method implementation study conducted over four phases. This record focusses on phase one, a context analysis that includes understanding Aboriginal patients experience of communication (objective 1 – mixed method design using a patient survey and qualitative data collection), developing a system to collate existing health care information known to be associated with patient-practitioner communication (objective 2 – system development and retrospective audit of data from patient health care databases), and investigating barriers and enablers to implementing Clinical Yarning in Western Australia Midwest (objective 3 – qualitative interviews with health care staff). Study hypotheses are that: • taking an evidence-informed, systematic approach will result in effective implementation of Clinical Yarning in WA Country Health Service (WACHS) - Midwest region • implementation of Clinical Yarning will result in improved patient-practitioner communication and health service outcomes Objectives: Context • to ascertain barriers and enablers to implementing Clinical Yarning training across the Midwest region at the individual, health service, and system-level • using this information, to develop a systematic, evidence-informed implementation strategy, including a system for ongoing evaluation and monitoring of communication outcomes • to implement Clinical Yarning training across the Midwest • to investigate changes in communication, patient, and health service outcomes following Clinical Yarning implementation strategies • to embed findings in a subsequent Clinical Yarning implementation strategy for sustainable use in other regions