ANZCTR search results

What is this study about? The purpose of this study is to investigate how safe and tolerable a single dose (worn for 24 hrs, 3.5 days or 7 days) and repeat doses (worn for 14 days) of ZYN001 transdermal delivery system is in healthy volunteers. The study will look at how the body absorbs, distributes, breaks down and then removes the study drug from your body. This will be done by analysing the levels of ZYN001 in your blood and urine at various times following drug administration. Your skin at the application sites will be checked to see if there is any irritation or reactions present when the ZYN001 patch is removed. The study will also investigate if ZYN001 affects your brain functioning by administering a number of neuropsychological tests. Who is if for? You may be eligible to join this study if you are aged between 18 and 55 years and are in good health. Study details: This study will investigate different formulation of patches containing ZYN001 compared to a placebo patch (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 ZYN001 or a placebo patch. What does study participation involve? Initially, the study will investigate four (4) different patches in each study period. All patches will have the same amount of THC drug within a study period but the ingredients in the patches will be different. You will report to the clinic the day before receiving treatment (Day -1). You will participate in either: • Period 1 - one patch worn for 24 hours • Period 2 - one patch worn for 3.5 days • Period 3 - one patch worn for 7 days OR, you will participate in either: Period 4 - one patch applied and worn for 3.5 days, removed and patch #2 applied and worn for 3.5 days, removed and patch #3 applied and worn for 3.5 days, removed and patch #4 applied and removed 3.5 days later Period 5 - one patch applied and worn for 7 days, removed and patch #2 applied and worn for 7 days You will receive application of ZYN001 or a placebo patch. The patch will be applied to either your left or right upper arm. Throughout the study you will have various medical tests (physical examinations, vital signs measured, ECG measured, neuropsychological tests) and will have several blood and urine samples collected for laboratory analysis.

STX-100/Alhydrogel, the study drug being researched in this project, is an experimental vaccine being developed by Sentinext Therapeutics. This means that it is not an approved treatment in Australia, and is not yet approved anywhere else in the world. STX-100/Alhydrogel is a vaccine that is intended to prevent hand, foot and mouth disease. The primary objective of this study is to determine the safety and tolerability of STX-100/Alhydrogel vaccine compared to placebo controls when administered to healthy adults.

The aim of the project is to measure the physical activity of participants on the rehabilitation ward over their inpatient hospital admission. The research design is a prospective pre-­post study. Data will be collected on 161 participants (control group) over their inpatient rehabilitation admission. Changes to ward practice will be then be implemented. These changes include, but are not be limited to, increased group therapy (balance, community access, gardening), meals in the dining area and education sessions. Data will then be collected on another 161 participants (treatment group) over their inpatient rehabilitation admission. An activity monitor (ActivPAL micro) will be taped and a waterproof dressing applied to one thigh on each participant's mid­thigh. The activity monitor measures sedentary (lying/sitting), standing, stepping and metabolic equivalent time (MET); as well as step and transition (sit to stand) counts and cadence. The activity monitor will removed weekly, data uploaded to computer and into Sydney Local Health District Targeted Activity and Reporting System (STARS) in the late afternoon, charged and reapplied the following morning. Data from the activity monitors will be matched to participant data from STARS. Specifically, Australian National Subacute and Non­acute Patient (AN­-SNAP) classification, change in motor Functional Independence Measure (m-FIM) and length of stay.

This research study will look at the 'real world' effectiveness of a novel approach to treating overweight/obesity with co-morbid binge eating disorder, bulimia nervosa or other specified feeding and eating disorder by way of the HAPIFED program, which combines behavioural weight loss therapy with enhanced cognitive behaviour therapy. It is hypothesised that the HAPIFED Program will result in an average weight loss of greater than or equal to 5% of body weight in the group overall and in at least 50% of participants. In addition, it will result in a global score on the Eating Disorder Examination Questionnaire (EDE-Q) of less than 1 standard deviation above Australian community norms (i.e. below 2.46) in at least 40% of participants, at 52 weeks after commencement of treatment.

Recent studies have suggested that the transition through puberty is marked by an increased risk of behavioural and emotional health problems. These include common emotional problems such as depression and anxiety; substance use; eating disorders; self-harm; antisocial behaviours, and functional somatic disorders such as headaches and irritable bowel syndrome. Previous studies have not adequately answered whether differences in social, lifestyle and biological transitions during puberty may explain the emergence of these difficulties. This is despite the evidence that adolescent mental and behavioural disorders have become more common in recent decades with the reasons likely to lie in changes in the social and lifestyle context of development. The aim of this study is to prospectively examine the factors that may influence the onset and course of pubertal-onset health problems. This study will provide the most comprehensive quantification of the association between puberty development and the major health problems that become prevalent in early adolescence. Participants will be 1239 grade 3 students (age 8-9 years) at public, Catholic and independent schools in metropolitan Melbourne. There will be annual assessments, over a nine-year period. Participants will complete web-based questionnaires covering a range of topics including mental and physical health, pubertal development, social context, activities of daily living and emotional style. Additionally, participants’ height, weight and waist circumference will be measured. A saliva sample will also be collected from each student in order to measure saliva hormone levels (another measure of pubertal stage). Parents and teachers will also be asked to complete a questionnaire. Parents will provide information regarding socio-demographics, family background, child behavioural and emotional adjustment and parental health and lifestyle. Teachers will be asked to complete a very brief questionnaire about the strengths and difficulties and academic attainment for each student.

This pilot study will be a randomised controlled trial of two physical activity (PA) interventions for adults with mental illness: i) PA self-monitoring using technology (wrist-worn Garmin Vivofits, which provide real-time feedback on the face of the device), and ii) supervised exercise intervention at a community gym. As a pilot study, the primary outcomes will be 1) feasibility of the trial, and 2) feasibility and acceptability of the interventions. Secondary outcomes will be the impact on PA behaviour change (assessed using accelerometers and self-report questionnaires), PA motivations, physical health (weight, waist, blood pressure) and psychosocial wellbeing (self-reported sleep quality and psychological distress). The interlinked aims of this pilot study are to: i) Assess the feasibility of the trial ii) Assess the feasibility and acceptability of the PA interventions iii) Compare the change in PA participation in response to interventions that either promote PA motivation, or provide PA opportunity. Additional aims are to assess: i) The utility of the 6-min walk test, wrist-worn accelerometry, and questionnaires on physical activity, sedentary behaviour and sleep. ii) The impact of the intervention on mental and physical health. It is hypothesised that: i) The trial will be feasible to conduct on a larger scale. ii) The PA interventions will be feasible to implement in the mental health service iii) There will be a qualitative difference in the acceptability of the interventions, dependent upon how they influence capability, opportunity and motivation to promote behaviour change. Inclusion criteria: i) Current adult consumer of Metro North Mental Health Services and Metro South Addictions and Mental Health Services (other than acute care teams) ii) Aged 18-65 years iii) Willingness to provide written informed consent. Exclusion criteria: i) Diagnosed with an eating disorder (assessed by referring clinician) ii) Identification of medical risk factors on the Adult Pre-exercise Screening Tool, and NOT cleared to participate by a medical professional iii) Physically active, defined as more than 300 minutes/week of self-reported moderate-to-vigorous PA (assessed using the Active Australia questionnaire)

FETs using HRT stimulation occur with no corpus luteum. This means endometrial growth, maturation and maintenance is entirely dependent on the effect of HRT for at least the first 2-5 weeks post-transfer. By 10 weeks post-transfer the placenta is producing adequate hormone to support the endometrium. Although intramuscular progesterone treatment is popular in North America, in Australia and Europe vaginal preparations are preferred. Natural and HRT FET cycles have been compared and show equivalent live birth rates on meta-analysis. The local experience at Monash IVF is different, with a significantly lower live birth rate for HRT compared to natural FETs (14.5% vs 22.4% - OR 0.59 (0.55-0.62)) for all comers. This difference is maintained when 20 potential confounding factors are allowed for using logistic regression (patient age; number of embryos transferred, embryo maturity etc) with an adjusted odds ratio of 0.55 (0.48-0.64). A recent publication from Yovich (2015) showed a significantly higher live birth rate in women undergoing HRT FETs, where the mid-luteal phase serum progesterone was >50 nmol/L. Review of the Monash IVF dataset investigating serum progesterone concentrations after 14-18 days of treatment in HRT FETs confirmed a significantly higher live birth rate (26.4% vs 11.3%). A shortcoming of measuring progesterone both at mid-luteal and Day 14-18, is that the opportunity to change management and improve outcome has potentially already passed. A further retrospective review of Monash IVF HRT FET cycles investigating progesterone dosage, Day 14-18 serum progesterone and live birth rates, suggested that dose frequency may be as important of actual dosage. This study aims to investigate “at risk” women with low serum progesterone (<50 nmol/L), but measure this after 2 days of treatment and then assess the effect of adding an extra dose of progesterone each day upon the live birth rate.

The aim of this study was to assess trends in sodium intake from food sources among Australian children and adolescents from 2007 to 2011-12. To do this we have completed secondary data analysis of two existing data sets, the 2007 CNPAS and the 2011/12 NNPAS.

Knee osteoarthritis (OA) is a major public health problem with significant personal, social and economic burden. Being overweight is a known risk factor for the development and progression of symptomatic knee OA. One potential reason may be due to the increased forces placed on the knee joint during weight bearing activities in people that are overweight. The development of targeted treatments for people at high risk of disease progression, such as those who are overweight, is a research priority. Our primary aim will therefore be to evaluate whether people with knee OA and obesity respond differently to two different types of exercise; 1) weight bearing functional exercise and ii) non-weight bearing quadriceps strengthening exercise. Participants will be randomly allocated to one of the two exercise groups. Over 12 weeks participants will attend 5 in clinic physiotherapist appointments. The physiotherapist will prescribe a home based exercise program following the exercise protocol assigned to the participant. The home based exercise program will be completed 4 times a week, in addition to the physiotherapy sessions. Primary outcomes are overall knee pain and physical function measured at 12 weeks. As body mass index is easily measured our findings will potentially provide clinicians with a simple and effective means to tailor their exercise prescription and optimise outcomes for their patients with knee osteoarthritis.

There is an increasing number of people developing end-stage kidney disease in Australia every year. Peritoneal dialysis (PD) is the most cost-effective and user friendly form of dialysis, yet the rate of PD utilisation in Australia has been steadily falling since 2003. A major contributor to low referral rates by physicians to PD and relatively high rates of PD technique failure is PD related peritonitis. Studies in a number of countries have shown that peritonitis rates vary greatly between PD units (between 5 to 20 fold variation). With PD critically dependent on patient self-management, research is required into potentially modifiable peritonitis risk factors, including patient training. The primary objective of the TEACH-PD (Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes) pilot study is to refine the TEACH-PD training modules for PD patients and trainers. TEACH-PD pilot study is an investigator-initiated, single-armed, non-randomised, pilot trial assessing the use of training modules for both PD nurse trainers and incident PD patients undertaking PD training. A total of 10 PD trainers will be enrolled and at least 1 PD patient per trainer and at least 10 English speaking patients (between 10 and 20 patients in total) from PD units at John Hunter Hospital, New South Wales and Logan Hospital in Queensland. PD trainers will complete “train the trainer” modules during the study which have a focus on adult learning principals and be provided with Patient Training Manuals. Once the PD trainers are assessed for competency with the modules, the trainers will then instruct the incident PD patient using the Patient Training Manuals and practical demonstrations. The primary objective of this pilot study is to further refine the TEACH-PD training modules designed for PD trainers and patients. The TEACH-PD training modules were developed by the Home Network, a group of health professionals focused on identifying and addressing barriers to home dialysis. The study is being coordinated by the Australasian Kidney Trial Network (AKTN).