ANZCTR search results

What is this study about The purpose of this study is to investigate how safe and tolerable repeat doses (applied twice daily for 13 days and once on the 14th day) of ZYN002 transdermal gel is in healthy volunteers. The study will look at how the body absorbs the study drug. This will be done by analysing the levels of ZYN002 in your blood at various times following drug administration. Your skin at the application sites and your hands will be checked to see if there is any irritation or reactions present after ZYN002 application. In the study you will be provided with moisturizer to apply to assist with potential dryness of the skin caused by the study treatment. Who is if for? You may be eligible to join this study if you are aged between 18 and 55 years and are in general good health. Study details: This study will investigate various doses of ZYN002 compared to a placebo gel (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means you and your study doctor, together with the study staff administering the study treatment will not know whether you are receiving ZYN002 or placebo gel. What does study participation involve? Your participation in the study includes A screening visit, which could be up to 28 days before your study treatment..Throughout the study you will have various medical tests (physical examinations, vital signs measured, ECG measured, C-SSRS assessment and will have several blood and urine samples collected for laboratory analysis. You will report to the clinic your first day of treatment (Day 1). The study treatment will be applied twice daily for 13 days with one treatment on day 14. Days 1-13, each morning while at the research facility, you will apply your AM treatment of ZYN002 or placebo gel. You will apply the study treatment to the treatment site assigned to you (either your left and right shoulder and/or upper arms, or your left and right upper thighs). You will apply your AM dose of all the study drug to clean, dry, intact skin, thoroughly massaging it into the application sites assigned. You will continue to massage study drug into the application site until the application site feels dry to the touch. This will take approximately 2-4 minutes but everyone’s skin is different so it could take less or more time for you. You will repeat this procedure at your home for the afternoon application on Days 1 to 13. You will return to the research facility every morning on Days 1-13 for the AM dose. On Day 14 you will stay at the research facility until the evening of Day 15, 36 hours after the last study treatment. You will return to the research facility on Days 17, 19, 21, 23, 27, 31 and Day 35 for study assessments.

Most options for HIV and hepatitis C testing currently involve people attending clinics or community testing sites. The purpose of the Dried Blood Spot (DBS) HIV/hep C testing pilot is to increase access to testing by providing people with ways to collect their own blood samples in the comfort of their own home. It offers significant advantages to conventional blood testing such as providing added convenience, privacy and confidentiality. This study also aims to assess whether DBS is an effective and manageable option for increasing access to HIV and hepatitis C testing among priority populations in NSW. It will also assess who is likely to use the program as well as ascertaining participants’ perspectives on the testing process. Addition of a sub-study for validation of hepatitis C testing Participants will be recruited from selected sites participating in the HIV and HCV Dried Blood Spot Testing Pilot with a focus on sites with high testing volumes. Clinic staff will identify participants and offer participation in the sub-study. After providing consent, participants complete a capillary blood finger-stick DBS sample and a venous blood sample. The paired identically labelled samples will be sent to the Serology & Virology Division, NSW Health Pathology, Randwick (SAViD NSWHP) for testing. Results delivery will be as per standard of care by NSW Health Pathology to the service ordering the tests. Participants will not receive HCV treatment as part of this study. Participants that are RNA positive will be linked to standard of care to assess for HCV treatment eligibility.

This study is assessing the efficacy of Theta Burst Stimulation (TBS), a form of Transcranial Magnetic Stimulation (TMS), in treating Obsessive Compulsive Disorder (OCD). It is a randomised control trial where participants will receive bilateral TBS to one of two different brain cortical regions. Each treatment course will involve TBS twice daily for 2 weeks (10 treatment days). Each treatment session will involve the application of 2 TBS trains, 15 minutes apart (a total of 4 trains per day and 40 trains per treatment course). Patients who do not respond to treatment will be crossed over and provided the alternate treatment. During treatment patients will be reclined in a comfortable chair and will be alert and awake. The sensation associated with treatment is usually well tolerated with most people describing it as a tapping sensation.

Our novel clinical approach could place innovative non-drug treatment solutions in the hands of children with Juvenile Idiopathic Arthritis (JIA). This multi centre randomised control-trial aims to integrate the Smart Watch to monitor pain levels, customised physical activity progression, and drug-therapy adherence in children with JIA.

People with dementia often have complex health and social needs that do not always receive appropriate attention. This can result in the person exhibiting symptoms such as anxiety, agitation and aggression. These are referred to as behavioural and psychological symptoms of dementia (BPSD) and are often related to the person having a need that has not been fulfilled. Pharmacological treatments have been the preferred treatment to alleviate such symptoms. As a result of a greater understanding about the adverse side effects of pharmacological treatments, a number of psychosocial interventions have been trialled. One psychosocial intervention that is increasingly being used to comfort, occupy and care for people with dementia is Lifelike Baby Dolls even though there is limited evidence for their use. It is imperative that we understand if these dolls are beneficial, harmful or indeed worthless in helping to comfort people with dementia. This parallel-randomised controlled trial will compare a Lifelike Baby Doll intervention with Usual Care in reducing anxiety, agitation and aggression symptoms in people with dementia. Participants will be assessed pre-and post- intervention for BPSD using the Neuropsychiatric Inventory and video recordings. Post intervention interviews with staff and family will evaluate the impact and perceptions of the doll.

Poor adherence to medication is a global concern, especially in chronic diseases, such as cardiovascular disease. In Australia, it is estimated that between 14 to 43% of patients with cardiovascular disease do not adhere to medications. The use of smartphone apps has been proposed as a potential solution for this problem. In recent years, the increasing popularity of apps is evident as there has been exponential growth in numbers of apps available in online stores. Despite the plethora of health apps, there is a lack of information on the quality of apps, how they differ, which are more effective and why, making it difficult for health professionals to recommend a useful app to patients. In our systematic search of app stores, we have identified around 300 medication adherence apps. About half of these apps identified had basic features involving simple reminders for patients to take medication at appropriate times. The other half included additional customisable and interactive features that could increase engagement with the app and motivate sustained usage. Through a quality assessment, we selected two high-quality apps to be tested in this study. In this trial, we aim to determine whether smartphone apps to remind patients to take their medication can improve medication adherence, blood pressure and cholesterol levels. We also aim to compare and contrast the features of the smartphone apps through a detailed qualitative evaluation that will provide evidence on which features consumers perceive to be most useful, enhance engagement and optimise effects.. Our results will inform future research about the role of apps in improving medication adherence.

Obesity is at epidemic proportions and current weight loss programs offer little respite. While many current interventions help individuals to reduce 5-10% of their body weight, most individuals regain the weight as soon as professional contact ends (Perri & Corsica, 2002). Treatment strategies that will aid with weight loss maintenance are urgently needed. Recently weight loss failure has been linked to cognitive difficulties, specifically problems with executive functioning. Executive functioning encompasses a range of processes that facilitate initiation, inhibition, planning, regulation, sequencing and achievement of complex goal-oriented behaviour. It is evident that executive functioning underlies many behaviours associated with successful weight management (Riggs, Spruitt-Metz, Chou & Pentz, 2012). Our review (Smith et al., 2011) found 22 out of 24 studies showed a negative association between obesity and executive function. Despite this, current treatments do not target executive function deficits. Manualised cognitive remediation therapy (CRT) is a face-to-face treatment approach with a focus on improving cognitive functioning. CRT consists of mental exercises aimed at improving cognitive strategies, thinking skills and information processing through practice (Tchanturia, 2014). There is evidence that CRT improves executive function and helps individuals regulate their eating. It has been shown to be effective at improving executive function in those with anorexia nervosa (Dingemans et al., 2014). Our recent pilot RCT on manualised CRT for obesity provides promising evidence for its efficacy (Raman, Hay & Smith, 2014). The results showed that those in the CRT group experienced a significant increase in executive function and a significant decrease in weight compared to controls and that changes in executive function predicted changes in weight. This study aims to determine the efficacy of CRT in reducing weight and improving executive function in obese patients. The following conditions will be compared; CRT plus behavioural weight loss (BWL) compared to BWL (standard care) alone. It is hypothesized that individuals who receive CRT will show greater weight-loss and improved executive functioning than those in the BWL alone, both at post-treatment and at 1-year follow-up (post-treatment). Treatment will continue for 5 months and be provided by two psychologists and a dietician. Participants aged 18 to 55, with a BMI of 30 or above will be randomly allocated to one of two conditions: 1) CRT group: Eight 50 minute weekly sessions of individual CRT plus twelve, 2hour, weekly sessions of group Behavioural Weight Loss (BWL) 2) BWL group: Eight 50 minute weekly sessions of individual BWL plus twelve, 2 hour, weekly sessions of group Behavioural Weight Loss (BWL)

The hypothesis of this research project is that LED (Light emitting diode) light (photobiomodulation) will minimise orthodontic root resorption while allowing an accelerated rate of orthodontic tooth movement (acceleration of tooth movement is claimed by the manufacturer).

There is now substantial evidence that mindfulness training improves wellbeing. Smartphones have become an integral part of young peoples’ daily life. Smartphone applications (apps) can potentially serve as an intervention medium to improve youth’s mental health. While there are many mobile phone apps on mindfulness, there is little evidence on the efficacy of these apps. The present study aims to evaluate the efficacy of a high qualtiy mindfulness app through a 6-week delayed treatment randomized controlled trial. A sample of 150 young people who experience at least mild level of distress (scoring between 17 and 50 in Kessler 10) will be recruited for the trial. The primary outcome variable is wellbeing, measured by the Mental Health Continuum – Short Form (MHC-SF) and the secondary outcome variables are distress, measured by Kessler-10 (K10), mindfulness, measured by Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) and happiness, measured by Oxford Happiness Questionnaire - Short form (OHQ-SF). Outcomes will be assessed at baseline, 6, 12 and 18 weeks follow up.

The Prevention Across the Spectrum (PAS) project builds on previous school-based eating disorder prevention research by Dr Simon Wilksch and Prof Tracey Wade as well as a considerable body of prevention work by Prof Susan Paxton (LaTrobe University) and work in the area of obesity by Dr Sue Byrne (University of Western Australia). In brief, the PAS project will compare the effect of three prevention programs on risk factors for both eating disorders and obesity, in a controlled trial with Grade 7 male and female students across South Australia, Victoria and Western Australia. Two of the interventions, Media Smart (MS: Wilksch & Wade, 2009) and Happy Being Me (HBM: Richardson & Paxton, in press), have been found to be promising eating disorder risk reduction programs. However, their effect on risk factors for obesity has not yet been evaluated and this is the key aim of the current project - to see if it is possible for individual programs to reduce the risk of both eating disorders and obesity developing. Happy Being Me is a 3-lesson program that was adapted into an 8-lesson program titled Helping, Encouraging, Listening and Protecting Peers (HELPP) for the current study (so that all 3 programs were of the same length to rule out dose-response as a reason for differences across the groups). These two interventions will be compared to a control group and a program developed for the purpose of this study, Life Smart (LS). While MS and HBM were originally developed to directly target eating disorder risk factors, LS is designed to focus more on obesity risk factors and is informed by aspects of previous successful school-based obesity prevention programs (e.g., Gortmaker et al., 1999).