ANZCTR search results

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.

Foot ulceration (open sore) is a worldwide health concern that leads to serious problems such as infection, amputation and even death. There is also the associated economic burden, costing health organisations AUD$22,150 to heal one infected foot ulcer. Research has identified that people with kidney failure, particularly those on dialysis, experience high rates (14.4%) of foot ulcers. Dialysis is a treatment for kidney failure that removes waste products and excess fluid from the body. There is a large amount of information available regarding treatments for diabetes-related foot ulcers, yet little is known about treatments for kidney-related foot ulcers. Preliminary studies that have investigated foot ulcer prevention programs in people with kidney failure have shown promising results, such as a reduction in the amputation rate by up to 17%. However, the research in this area is generally of poor quality so we are not confident about the accuracy of these findings. Given the serious clinical problems associated with kidney-related foot ulcers and the negative impact it has on physical, emotional and social wellbeing, high-quality studies are needed to investigate this important issue. The proposed project aims to evaluate podiatry treatment that is designed to improve foot health in people with kidney failure. The findings of this study may assist in management and even prevention of foot problems in the dialysis population, which should have an impact on reducing costs associated with managing this condition and improving quality of life in these individuals.

This is an observational study looking at well newborn babies’ essential observations such heart rate, breathing (respiratory) rate, blood pressure, temperature and oxygen levels (saturations) to determine the ranges for each of these essential (vital) signs. Very few studies have measured these essential observations for any length of time and many of the ranges have been adapted from paediatric studies or intermittent observations. At the present time, it is unknown whether there are differences in ranges between those babies born late preterm (greater than 34 weeks) compared to those born at term (greater than 37 weeks) or how behaviours such as sleeping, feeding or crying influence these observations as these may contribute to the early signs of deterioration. Understanding if there are differences in these essential observations is important to inform early warning observation tools and the subsequent care that babies may need. This study will be conducted in the postnatal ward and special care nursery at the Royal Brisbane and Women’s Hospital. This study will monitor a baby’s essential observations during normal activities such as cuddling, feeding and sleeping for periods of up to 6 hours each day during hospital stay, in addition to the routine monitoring of essential observations currently undertaken. Findings will potentially inform newborn care practices in Australia and overseas and reduce unnecessary separation of babies from their mothers as a result of the baby being transferred to a nursery for closer monitoring.

To assess how long modified release prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI). To evaluate the safety of several modified release capsule formulations and a placebo capsule.