ANZCTR search results

A sequential, multi-stage, open-label, multi-national, multiple-center, multiple-dose study to assess the long-term safety and tolerability of ZYN002 (transdermal CBD gel) in child and adolescent epilepsy patients 3 to <18 years of age with seizures associated with developmental and epileptic encephalopathies (DEE) according to the International League Against Epilepsy (ILEA) classification. In Period A patients will undergo a baseline period of 4-weeks, followed by a 2-week titration period, and a 24-week maintenance period. Patients will be treated for a total of 26 weeks. For Patients not continuing to Period B, following Week 26 or Early Termination, study drug will be tapered over a 1 to 3-week period (depending on dose). After the final dose, patients will be followed weekly for 4 weeks by telephone. After the 4 weeks, the patient will be discharged from the study. Patients progressing to Period B will continue to receive ZYN002 for a further 24 weeks at the same maintenance dose received at Week 26 (e.g. end of Period A). Upon treatment termination, the patient will be required to complete the taper and follow-up period. After the final tapered dose, patients will be followed weekly for 4 weeks by telephone. After the 4 weeks of follow-up, the patient will be discharged from the study.

The Physical Activity in Venous Leg Ulcer Patients pilot observational cohort study is a prospective multicentre observational cohort study to examine the feasibility of recruitment, the feasibility and acceptability of wearing an accelerometer and data output from the accelerometer as a means of assessing physical activity and sleep in venous leg ulcer patients. Between 20-40 participants will be asked to wear the ActiSleep-BT accelerometer (ActiGraph, Pensacola, Florida) over a 7 day period between Baseline and Week 12 and complete a daily log to record wake and sleep times and actigraph removal greater than 15 minutes. A physical activity questionnaire (IPAQ) will be completed at Baseline and an acceptability survey will be completed at the end of the wear period. Participants will also be asked to complete a questionnaire at three time points (Baseline, Week 12 and Week 24) and their medical records will be accessed twice (Baseline and Week 24). The primary objective is to determine if wound healing within 12 weeks from the baseline is associated with physical activity (and sleep) and the secondary objectives are: to examine factors related to ulcer healing and recurrence within 24 weeks and to examine study feasibility and patient accelerometer wear acceptability.

The aim of this study is to examine a memory training program that not only integrates various strengths of previous training programs, but also provides training that is practical, feasible and transferable to real-world tasks. It is hypothesized that (1) The will be a significant improvement on the Name-Face Task from pre-test to post-test for the experimental group (2) The experimental group will perform significantly better than the control group on the Place-Learning Task, Text Learning Task, and the Name-Face Task at post-test and follow-up.

Transcranial direct current stimulation is a cheap, portable device that may have application as a clinical tool for cognitive remediation. In the current study we will assess the effectiveness of high-definition transcranial direct current stimulation (HD-tDCS) to the dorsomedial prefrontal cortex (dmPFC) and right temporoparietal junction (rTPJ) to affect social cognition in patients with first-episode psychosis. We hypothesize that the patient group will show impairments at integrating and distinguishing between self and other processes across perspective taking and episodic memory tasks. They will also be impaired on an affective theory of mind (ToM) task. We hypothesize that dmPFC anodal stimulation will increase the integration of other into self across perspective taking and episodic memory tasks and improve affective ToM performance. Anodal stimulation to the rTPJ will improve the ability to inhibit the self-perspective in a perspective taking task that relies on mental rotation.

One Australian loses a limb every 3 hours as a result of diabetic foot ulcers (DFU) with infection. This common condition accounts for substantial morbidity and mortality for affected individuals and heavy economic costs for WA Health and the community. There is an urgent need to test interventions that improve wound healing time, prevent amputations and recurrent ulceration in patients presenting with DFU whilst improving quality of life and reducing health care costs. A novel intervention towards achieving these goals is the use of spray-on skin for patients with DFU. The application of ‘spray-on’ autologous skin grafting aids epithelial regeneration and wound healing and has been used successfully for the treatment of burns to improve healing. In this research project we will compare spray-on skin with standard care in an open label randomised controlled trial in patients presenting to hospital with DFU. We hypothesise that spray-on skin will shorten the time for the ulcer to heal completely. In doing so, this approach can be expected to prevent amputations and recurrent ulceration whilst improving quality of life. Outpatient costs for dressings, home nursing visits and outpatient appointments are key cost drivers for DFU. If spray-on skin is effective, large cost savings to WA Health will be realised immediately through a shortened time to healing, and through a higher proportion of patients achieving complete healing. Any economic benefits are likely to be amplified across Australia and other similar demographic settings where aging populations with increased diabetes rates are considered major future challenges.

Induction of labour (IOL) is one of the most frequently performed obstetric interventions. In high-income countries nearly one-third of all pregnant women undergo IOL. The process of IOL commonly involves cervical ripening, using mechanical or pharmacological methods; however, the optimum protocol of IOL remains undetermined. For almost 50 years, balloon catheters have been used to mechanically ripen the cervix. Balloon catheters apply direct pressure on the internal os of the cervix, stretching the lower uterine segment and indirectly increasing release of endogenous prostaglandins. In recent years, there has been a shift in clinical practice favouring mechanical methods in response to growing evidence of both efficacy and safety. In randomised controlled trials and meta-analyses mechanical methods appear comparable to pharmacological methods for successful IOL without the complication of uterine hyper-stimulation. Trends toward a reduction in instrumental births, fetal acidaemia and post-partum haemorrhage have also been observed with balloon IOL. IOL using a single or double balloon catheter typically involves removal of the catheter approximately 12 hours after insertion, followed by an artificial rupture of membranes (ARM) and commencement of an oxytocin infusion. Whilst there is good data supporting its efficacy in ripening the cervix, there is limited information to guide exactly how long a balloon catheter should remain in situ. The product recommendation states “up to 12 hours”. There are just two abstracts reporting on small clinical trials comparing a 6-hour versus 12-hour insertion. The methods do not describe how the IOL was managed following removal of the balloon. These data are under-powered but nevertheless reassuring that an earlier removal of the balloon catheter is likely associated with a shorter duration of labour and is unlikely to be associated with a difference in mode of birth. There is evidence to support that a longer duration of induced labour is associated with both a poorer healthcare experience and increased costs. Hence earlier removal of the balloon catheter shows promise as a method to reduce cost, and improve the healthcare experience for women without altering clinical outcomes. This study therefore aims to explore the clinical effectiveness and healthcare experience of women undergoing an IOL using a balloon catheter where the balloon is left in-situ for a shorter versus longer duration of time.

Atropine eye drops are known to affect pupil reactions and the ability of the eyes to focus on near objects. This study will quantify the effects of different concentrations of atropine eye drops on these ocular structures.

Poor bowel preparation is common in inflammatory bowel disease (IBD) and non-IBD patients and can lead to incomplete colonoscopic assessments and missed pathology. As such the patients are required to undergo either a second colonoscopy or earlier surveillance colonoscopies. This creates cumulative risks of colonoscopies (double the anesthetic and procedural risks), increased burden to the health care system (extra resources and colonoscopy spots used that could be used by other patients) and the patient (more inconvenience of further bowel prep and missed work for the procedure) as well as financial costs both to the health care system as well as the patient in multiple ways. Other research has found patient reported bowel preparation quality (no bowel motion pictures) is often not accurate, Being able to assess the patient's bowel preparation before giving them anaesthetic and more importantly, being able to know their prep is poor and given them extra bowel prep and have their procedure delayed by a few hours (put at the end of the endoscopy list) would be of huge benefit for both the patient and the health care system. Our aim is to create a rapid ultrasound assessment (no radiation and no risks to the patient) that focuses on a few specific areas of the bowel to create a bowel prep scoring system which matches current validated colonoscopy bowel preparation scoring systems. Furthermore to show that by using the ultrasound scoring system that the detrimental effects of poor bowel preparation (discussed above) can be avoided and to create a cost-benefit analysis as well.

This study aims to demonstrate a drug called cyclophosphamide is better than the current standard of care at preventing graft versus host disease in patients who have just had a bone marrow transplant. Who is it for? You may be eligible for this study if you are aged 18-70 and have AML or ALL which is in remission, or MDS with <20% myeloblasts; and have a 6/6 matched sibling bone marrow donor. Study details Participants in this study will be randomly assigned (by chance) to one of two treatments. One group will take the study medication cyclophosphamide for 5 days, followed by 90 days of cyclosporin. The other group will take an existing medication regimen of cyclosporine and methotrexate, which is the current standard of care for preventing GVHD. Participants will be followed-up for 2 years post-transplant. The study will look at the number of patients in each treatment arm who develop GVHD, and how each treatment affects the patient quality of life.

Tuning in to Kids Together is a modified version of Tuning in to Kids (TIK). TIK is an evidence-based program which that aims to improve parents’ emotional communication, and consequently improve children’s emotional functioning. Randomised control trials demonstrated that TIK leads to significant changes to parental emotion socialisation practices, improvements to child emotional regulation, and reduction in child behavioural problems (Havighurst et al., 2013; Wilson, Havighurst, Harley, 2012). Although TIK is effective, researchers (e.g. Fienberg, 2002) emphasise the importance of incorporating co-parenting content into parenting programs. The co-parenting relationship is strongly and proximally related to parenting (Abidin & Brunner, 1995), therefore it is a modifiable factor that could improve emotional parenting. In light of the aforementioned research, this study is exploring the feasibility and effectiveness of TIK when it is modified to be delivered to co-parents. The aim of this research is to provide preliminary evidence on the feasibility and effectiveness of Tuning in to Kids Together, a modified version of TIK. This study will address the following research questions: • What factors will impede and facilitate parent engagement and the program delivery? • Will the Tuning in to Kids Together program lead to improvements in: a) parent emotion socialisation practices measured via parent self-report, b) co-parent functioning on parent-self reports, c) parent emotion regulation on parent self-report, d) improved child emotional measured via parent and teacher reports, and e) child behavioural functioning measured via parent and teacher reports B) Research Design The study will use an experimental, longitudinal design. Parents will complete three online surveys: immediately before, immediately after, and 6 months after completing the parenting program. Additionally, parents in the will complete phone interviews after participating in the program. Teachers will complete measures on the child immediately before and at a 6-month follow-up. Facilitators will complete an experience check-list before delivering the program, various measures (fidelity check-list, class attendance, parent participation) at the end of each session, and participate in a phone interview after delivering the program. C) Analyses and Outcomes Analyses will be conducted to determine whether TIK improved parent and child outcomes. Thematic analysis will be performed to analyse information about program engagement and delivery. Findings will be reported in peer review journals and at conferences.