ANZCTR search results

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.

The study aims to collection information on the performance of the robot system intra-operatively. Enrolment is eligible candidates undergoing primary Total Knee Arthroplasty using a Persona total knee implant system or Vanguard total knee implant system or NexGen total knee implant system. There will be three research centres. One surgeon at each centre. Ten participants will be recruited at each centre.

The aim of this study is to investigate the utility of Compassionate Mind Training (CMT) for ex-service personnel with PTSD and their partners, and determine if the training has an impact on compassion, psychological symptom severity, quality of life as well as relationship satisfaction. Four CMT programs will be run between August and December 2018. Group sizes will be limited to 10 participants (5 dyads) in total. Following consent, participants will undertake a 2-hour CMT session, twice weekly for 6 weeks (12 sessions in total) within a group setting. Couples will attend these sessions together. These sessions will be facilitated by two clinical psychologists who are trained and experienced in the delivery of CMT interventions, as well as experienced in delivering group interventions with ex-service personnel. Evidence from prior CMT interventions demonstrates that on completion of a CMT intervention, participants see an increase in compassion and a reduction in psychological symptoms. As such, it is expected that ex-service personnel and their partners may experience an increase in compassion towards themselves and towards others as well as a potential reduction of psychological symptom severity including PTSD, depression and anxiety. Findings of this study will also inform the feasibility of conducting a larger controlled trial of CMT for ex-service personnel and their partners, as well as the application of compassion focussed interventions more broadly to the veteran population.

A rise in systolic blood pressure at the end of dialysis treatment compared to the beginning is associated with increased mortality during follow-up. This observational study aimed to see whether adjusting the dialysate sodium such that it matched the patient sodium helped to prevent significant rises in blood pressure during treatment, without causing undesirable falls in blood pressure. Matching of patient and dialysate sodium will be accomplished by adjusting the dialysate sodium so that the blood sodium concentration leaving the patient to go through the dialyser is the same as that re-entering the patient after its passage through the dialyser. Our hypothesis is that individualising the dialysate sodium in this way will reduce blood pressure problems during the dialysis treatment and may improve thirst.