ANZCTR search results

This study will test the efficacy of a teacher professional development intervention (Thinking While Moving in English) for enhancing teachers’ understanding and competency to plan, deliver and evaluate movement-based learning in primary school English lessons. Thinking While Moving in English will be designed to positively enhance a range of key educational and health-related outcomes: increased moderate to vigorous physical activity within the intervention session and the school day, reduce sitting time, improve classroom behavior

The purpose of this study is to explore the clinical impart of providing telehealth for palliative care patients in rural and metropolitan Victoria. Who is it for? You may be eligible for this study if you are an adult with a diagnosis of a life-limiting illness. Study details If you participate in this research you will be randomly allocated either to the telehealth consultation group or the "usual" care group in which we will simply ask you to complete questionnaires which will greatly assist us to assess and compare telehealth to usual care. The random choice is done using a dedicated computer program to ensure it is completely random. If you are in the telehealth group then your GP/palliative care community nurse will make an appointment with the specialist palliative care doctor based at the Monash Medical Centre in Clayton for a video conference. Our team will provide all the equipment needed for this to take place in your home. Before you begin, the specialists will already have your information, from your GP and nurse. It is hoped that this research will provide the basis for more extensive research. The system used for the video conference is a special dedicated system is completely confidential and nothing from the consultation is stored

Aim: To evaluate the anti-inflammatory, antioxidant and bioavailability of polyphenols in obese populations post-coloured rice consumption. Design/Participants: The anti-inflammatory, antioxidant properties and polyphenol bioavailability will be tested by collecting fasting and post rice consumption blood samples from healthy but sedentary obese (perform < 3 hours of exercise weekly, BMI > 30) participants. Methodology: Visit 1: Health screening and questionnaires (recruitment). Visit 2: Fasting volunteers will be cannulated and baseline blood samples (25 mL) will be obtained. Volunteers will then be fed a serving of cooked coloured rice 1 (200 g or one cup). Post consumption, blood samples will be collected at different time points (30 min, 1h, 2h, 4h)a second blood sample (25 mL) will be taken and analysed. Visit 3 & 4: Crossover for coloured rice 2 and coloured rice 3 respectively. All blood samples will be analysed for Aanti-inflammatory properties will be evaluated for( pro-inflammatory cytokines and lipid peroxidation); antioxidant properties will be evaluated using( total antioxidant assays) and bioavailability of polyphenols will be determined by( HPLC). Expected outcomes: Consumption of coloured rice rich in polyphenols might potentially alleviate biomarkers of inflammation and oxidative stress in obese population.

During shoulder surgery patients are positioned into an upright sitting position for optimal access to the shoulder joint. In some patients blood pressure may become low during surgery and a concern of the anaesthetist is whether sufficient blood reaches vital organs, including the brain. Chronic disease such as hypertension can alter the size and shape of a patient’s heart, placing them more at risk of low blood pressure during surgery. This study aims to assess the heart with ultrasound before surgery and to further examine the heart during surgery. This examination will enable the anaesthetist to anticipate a major change in blood pressure and treat it effectively. Such information can be used to better protect the patient.

Introduction: External cephalic version (ECV) is a procedure whereby a fetus is manually rotated, by applying pressure to the maternal abdomen, from a bottom/feet first position to the preferred head first position to enable safer vaginal delivery. Whilst safe and low-risk, it has been associated with moderate pain, in part, due to the lack of administered analgesia. To address this, research groups around the world have experimented with various modalities of relief, including regional anaesthesia, hypnosis, and systemic opioids; but have not produced any conclusive demonstration of benefit to date. As such, there is a clinical gap in addressing pain during the procedure. Virtual reality (VR) is a technological medium that is used to create simulated scenarios in which users are immersed and able to interact with through stimulation of the senses. In recent years, there has been a growing interest in medicine for its potential to provide pain relief. To date, positive results have been observed in patients requiring port access, venepuncture, chronic wound/burn dressing changes, and episiotomy. The mechanism responsible for this phenomenon is not yet fully understood, but is attributed to its ability to distract users from perceiving pain and also due to neurophysiological changes that result from long-term use. Given the potential of VR to facilitate analgesia and the lack of effective pain relief during ECV, this study will function as a proof-of-concept to determine if VR technology can be used to reduce pain perception during this procedure. Aims: 1) Investigate the effect of VR on: * Pain scores during ECV. * Physiological parameters during and after ECV. 2) Elicit patient opinion about using VR during the ECV procedure (ie. what do patients think?) and investigate potential side effects and their acceptability. Participants: In this study, 50 pregnant women will be recruited from the Breech Clinic at Monash Medical Centre. To be considered as an eligible participant, the women must fulfill the criteria outlined previously. Methods: Participants will be screened for inclusion into the study. They will then be randomly allocated to either, the control (no VR) group or the intervention (VR) group. Immediately prior to the procedure, routine monitoring and tocolysis will be performed. The ECV will commence after and patients will receive either, routine care or routine care with VR intervention. Post-procedure, vital signs will be evaluated. Questionnaires about pain perceived and device experience will also be provided. Expected Outcomes: A demonstrated potential for VR as an analgesic will be demonstrated by: * Reduced pain scores in the intervention (VR) group. * Minimal side effects. * Positive feedback about the device and content.

This study has its objectives: To evaluate the safety and tolerability of multiple oral doses of NPI-001 Tablets in healthy adult subjects; To evaluate the effect of food on the pharmacokinetics (PK) of NPI-001 following single doses, 1500 mg and 750 mg, in the fed versus fasted state; To characterize the pharmacokinetics of NPI-001 following multiple doses over 5 days, fed; To evaluate the effect of NPI-001 on potential biomarkers of the pharmacodynamic effect (protein carbonyls, GSH/GSSG, cysteine/cystine (Cys/Cys-Cys)). Study design: This randomized, double-blinded, cross-over study will include an evaluation of PK of NPI-001 in fed versus fasted healthy volunteers followed by a 5-day dosing period to ascertain if multiple doses of NPI-001 can alter GSH and CYS levels in plasma. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to first dose administration. Subjects will be resident in the clinical facility from the evening prior to first dose (Day -1) until discharge on Day 10. A post-dose follow up visit will occur at Day 15. On Day 1 and Day 3, each subject will receive a single oral dose of NPI-001 or Placebo. The dose levels of NPI-001 will be 1500 mg for Cohort 1 (6 tablets), and 750 mg for Cohort 2 (3 tablets). Dosing on Days 1 and 3 will be a placebo-controlled, balanced, two-treatment two-sequence randomized fasted/fed crossover design, as follows: • 8 subjects in each cohort (6 NPI-001, 2 placebo) will be dosed on Day 1 following a 10 hour overnight fast and on Day 3 following a high fat breakfast [Fasted-Fed]. • 8 subjects in each cohort (6 NPI-001, 2 placebo) will be dosed on Day 1 following a high fat breakfast and on Day 3 following a 10 hour overnight fast [Fed-Fasted]. On Days 5-9, all subjects will receive NPI-001 or placebo three times per day, at approximately 8am (following a standard breakfast), 2pm and 8pm, with the last dose on the morning of Day 9. The dose levels of NPI-001 will be 500 mg per dose for Cohort 1 (2 tablets), and 250 mg per dose for Cohort 2 (1 tablet). Safety measures monitored throughout the study will include adverse events and use of concomitant medication, vital signs, and clinical laboratory tests. Blood samples for assessment of PK will be collected on Days 1, 3 and 9, at pre-dose, then at 0.25, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12 hours post-dose, and on Days 2, 4 and 10 at 24 hours post-dose. Blood samples for assessment of PD will be collected on Days 1 and 3 at pre-dose and 1 hour post-dose, on Day 9 at 1 hour post-dose, and at the follow-up visit.

Community/Citizens’ Juries (CJs) are a form of deliberative democracy which endeavour to elicit informed perspectives and recommendations from community members, on topics often viewed as controversial or with a level of expert uncertainty around the balance of benefits and harms to the community (Carson et al, 2003; Solomon & Abelson, 2012). CJs typically include: several days of expert information provision, opportunities to question the experts, and deliberation with a facilitator and again in private to arrive at an informed decision/recommendation for a stakeholder group. CJs have been used by various levels of government (Australian Institute of Health Policy Studies, 2006; Health Canada Policy Toolkit, 2000) to inform policy decisions and in research to explore community preferences to health related controversies. CJs do not intend to change an individual’s thought or behaviours but rather, to elicit perspectives once individuals are objectively informed of the controversies or difficulties surrounding the issue. However, exposure to expert information and presentations and the act of deliberative exposure to the considered views of others, has the potential to influence participants’ decision making beyond the CJ experience. Exposure to CJs may increase specific knowledge about focussed topics. In our previous CJs we have demonstrated an increased knowledge in information about PSA testing for prostate cancer (Thomas et al, 2014) and dementia (Thomas et al, 2018). However, dissemination of knowledge, is not synonymous with knowledge utilisation. Utilisation requires application of learnt information, and dissemination alone is often insufficient to produce change (Farkas et al., 2003). The information and knowledge gained whilst participating in a CJ has the potential to impact juror’s views and behaviours after the jury concludes, e.g. jurors sharing the information learned during the CJ with others (family members and friends), impacting how jurors view scientific information and medical uncertainty, and affecting how they interact with their healthcare providers. This project aims to identify whether any impacts of participating in a CJ occurred for previous participants and if so, what is the nature of those changes/effects.

Research has demonstrated that people with Parkinson’s (PD) and mild cognitive impairment (PD- MCI) can improve their cognitive functioning using both cognitive training and transcranial direct current stimulation (tDCS) independently (e.g., Hindle et al., 2013). Pilot research by Lawrence and colleagues (2018), in this laboratory, suggests that the most effective improvement of PD-MCI occurs following cognitive training coupled with tDCS (compared to either intervention alone), where cognitive training was performed for 2 days per week and tDCS was delivered once per week (on a separate day to the training). The current study will extend these findings by adopting a randomised control trial approach to examine the impact of concurrent tDCS delivery and cognitive training on PD-MCI (that is, both interventions delivered at the same time). This study will examine the impact of standard cognitive training coupled with anodal tDCS over the left dorso-lateral prefrontal cortex (DLPFC) on cognition and quality of life (QOL), after controlling for self-reported sleep, hearing loss, motor symptoms, and mood in PD. A baseline assessment of motor and cognitive symptoms of PD, QOL, sleep, hearing loss, and mood will be completed 1 week prior to the intervention. Participants will be randomly assigned to 1 of 4 groups; (1) anodal (active) tDCS and cognitive training, (2) sham (control) tDCS and cognitive training, (3) anodal (active) tDCS and placebo (control) cognitive training, or (4) sham (control) tDCS and placebo (control) cognitive training. Participants in group 1 will receive 30 minutes of constant 1.5 mA stimulation over the left dorso-lateral prefrontal cortex (DLPFC) whilst simultaneously completing the cognitive training. Participants in group 2 will receive 30 minutes of sham (control) tDCS over left DLPFC whilst simultaneously completing the cognitive training. Participants in group 3 will receive 30 minutes of constant 1.5 mA stimulation over left DLPFC whilst simultaneously completing placebo cognitive training. Group 4 will receive 30 minutes of sham (control) tDCS over left DLPFC whilst simultaneously completing placebo cognitive training. Participants will complete two intervention sessions a week for 4 weeks, resulting in 8 sessions in total. Participants will complete post-intervention measures as at baseline, 1 and 12 weeks post-intervention. Participants will then complete a follow-up assessment at 12 weeks post-cessation. It is hypothesised that the participants receiving both active treatments concurrently will perform better on the cognitive measures and will report higher quality of life than participants receiving just one active treatment. In addition, participants receiving no active treatments will perform more poorly on the cognitive measures and report lower quality of life that participants receiving one or both active treatments.

Study Design: Single centre, open-label, single arm exploratory study Study drugs: A combination of three bacterial strains (SVT9, SVT23 and SVT26) at a concentration of 2.5 billion CFU/mL per bacterial strain in a carrier of sterile saline solution. Dose and duration: The study medication is topically applied (sprayed) to a specified active dermatitis lesion at a dose of 2 x 0.2 mL (0.4 mL per dose; 3 billion CFU/0.4 mL) twice per day (morning and evening) after showering, leaving at least 6 hours between applications. The moistened skin is to dry naturally and not rubbed. The spray cap provides a precise 0.2 mL dose per spray. The duration of administration is for 21 days. Objectives of the Study: Feasibility of methods and procedures, recruitment potential, increase clinical experience of study medication; evaluate surrogate marker data in a small patient cohort to assess if it will be therapeutically effective and safe for further larger studies. Study Endpoints: Primary outcome measures will include assessment of treatment efficacy using 1. Target lesion local objective SCORing Atopic Dermatitis (SCORAD) that will assess the clinical signs and symptoms of the target lesion and control lesion and to monitor changes in disease severity; 2. Sampling and quantification of S. aureus colonisation on the target and contralateral lesion. Secondary outcome measures: 1. Cutaneous tolerability of treatment based on signs of redness, dryness, crusting, weeping, peeling, thickening and itching of the target lesion. All signs classified according to intensity (0 = none, 1 = mild, 2 = moderate and 3 = severe).

Cyclo-Z treatment significantly improved insulin sensitivity in animal models of type 2 diabetes, further clinical trials of Cyclo-Z in diabetic subjects are warranted to determine if Cyclo-Z treatment results in clinical improvements. Since the completion of the pilot Phase 1 clinical trial and the Phase 2 obese Type 2 diabetes trial, the formulation of Cyclo-Z was changed from a capsule to a tablet form. The current study is intended to obtain the additional safety data and pharmacokinetics of escalating doses of the revised formulation of Cyclo-Z when dosed once and when dosed daily for 10 days in healthy volunteers.