ANZCTR search results

Hereditary Angiodema (HAE) is a rare disease caused by low levels of C1 serine protease inhibitor in the body. Deficiencies in this protein leads to increased activation of inflammatory pathways which can cause swelling, severe abdominal pain and airway obstruction that can be life threatening. ATN-249 is a potential once a day oral treatment for HAE. The purpose of this research study is to test the safety and tolerability of ATN-249 as well as the pharmacokinetics and pharmacodynamics of the study drug. The study is open to healthy male volunteers and the research goals are: - Does the drug have any side-effects and is it well tolerated when given as a multiple dose over several days? - How much of the drug gets into the blood stream, and how long does the body take to get rid of it? This study will look at how the human body uses ATN-249 at different dose levels and under different dosing regimens (once a day or twice a day).

The aim of this research is to obtain high quality data on the impact of the early application of film forming silicones on burn injuries and donor sites. Objectives include time to healing, patients perceived pain and scar outcomes.

Despite awareness of the advantages of breastfeeding, the rates often fall short of expected practice. In the Whittlesea area alone, the initial rate of breastfeeding is very high at >94% of newborn infants. However, rates drop by 30% at 8 weeks (2 months) post-birth. At The Northern Hospital, there are 2 support systems in place. This is in line with UNICEF and the World Health Organization (WHO) breastfeeding practices. First, all expecting mothers are invited to attend breastfeeding seminars prior to the delivery of their newborns. Secondly, TNH also has a breastfeeding clinic that runs daily and mothers can refer themselves to this clinic when and if they feel the need. However, there is a perception that once the mothers leave hospital, there is lack of breastfeeding support, so we feel that we need to do more to help promote breastfeeding. Our hypothesis was that breastfeeding rates can be improved with additional support and education from a lactation consultant. The study aims to determine if additional support for breastfeeding mothers after they leave hospital improves rates of breastfeeding. In this randomized controlled trial, participants will be randomized to either an intervention or a control group. In the intervention group, a LACTATION CONSULTANT will provide active communication and assistance via telephone to breastfeeding mothers, especially during the first 4 weeks after discharge and then again after 3 months and 6 months. In the control group, a LACTATION CONSULTANT will contact breastfeeding mothers via telephone after 1 month, 3 months, and 6 months to ask about breastfeeding activity/practices. At the end of the study, we will compare the rates of breastfeeding in mothers who received the intervention compared to the control group and determine whether additional assistance from lactation consultants is associated with longer breastfeeding duration.

The aim of this research is to determine whether the inclusion of a physical health nurse will improve the physical health of young people with a first episode of psychosis. The rationale behind this study is that numerous studies have demonstrated that young people who develop a first episode of psychosis have poorer physical health compared to their peers who do not have psychotic disorders, specifically, they are more likely to be overweight or obese, to be inactive, to have a poor diet and to smoke. In addition, some of the medications that are prescribed for psychosis can lead to weight gain, therefore it is important that we address or prevent these physical health problems. We also know that young people with a first episode of psychosis are more likely to have poorer sexual health than their peers, in that they are more likely to engage in high risk sexual behaviours, such as not using contraception. Furthermore, there is evidence emerging that sleep is a very important component of physical and mental well being, so we would like to learn more about the characteristics of sleep in young people with a first episode of psychosis.

Front-of-pack labels (FoPLs) are used in many countries as a tool to increase consumers’ awareness of the nutritional quality of food products and encourage consumption of healthier food. Many different types of FoPLs exist and the design of each influences its effectiveness (e.g., how favourably it is perceived, how easy it is to understand, how likely it is to be incorporated into food decisions). The aim of this study is to compare the effectiveness of and people’s perceptions of 5 different FoPLs used around the world: Health Star Rating system, Multiple Traffic Light system, Nutri-Score, References Intakes label and Warning symbol. Attitudes, understanding and influence on food choice will be assessed for each of these labels via an online survey in 12 countries: Argentina, Australia, Bulgaria, Canada, Denmark, France, Germany, Mexico, Singapore, Spain, the United Kingdom, and the United States of America.

The purpose of this study is to assess whether cannabidoil (CBD) can be used to reduce total symptoms in patients with advanced cancer in palliative care. Who is it for? You may be eligible for this study if you are over 25 years of age and have been diagnosed with advanced cancer. Study details Participants will be randomly assigned to one of two treatment groups; either CBD or a placebo medication. Participants will be asked to take increasing doses of the study medication for 14 days, with the dose increasing until participants are satisfied with the symptom improvement and are experiencing no unacceptable side effects. After these 14 days, participants will be asked to take a steady dose of the medication for another set of 14 days. During the 28 days of the study you will be required to have a routine blood and urine test taken to determine if you are eligible. A further blood test will be taken at day 14 post trial analysis. It is hoped that this research will show a positive effect of CBD on symptoms for patients suffering with advanced cancer and thus provide an option in helping manage symptoms.

The purpose of this study is to assess the effect of the 'Optimise' decision aid on choices regarding taking low dose aspirin for the prevention of cardiovascular disease and colorectal cancer. Who is it for? You may be eligible for this study if you are an adult aged 50-70 years who has not been diagnosed with a serious illness. Study details Participants will be recruited through their GP and randomised to one of two groups. All participants will complete a baseline questionnaire which involves individual risk calculations for cardiovascular disease and colorectal cancer. In one group patients will be taken through the 'Optimise' decision aid to consider the use of regular low-dose aspirin, weighing up the health benefits and the risk of side effects of aspirin, including gastrointestinal bleeding, along with personal preferences regarding taking aspirin. The other group (the control group) will receive general information about prevention of colorectal cancer. Participants will then be followed up after three months by telephone survey, including a measurement of informed choice regarding taking low - dose aspirin, and adherence to aspirin. They will also be followed up by SMS every 3 months for one year to assess adherence to aspirin. Patient data regarding health outcomes will be collected from health data sets for up to 10 years after enrolment. Outcomes It is hoped that the use of the Optimise decision aid will increase the proportion of participants making an informed choice about the use of aspirin to prevent cardiovascular disease and colorectal cancer.

This is a single-site, double-blind, randomised, clinical trial for 6 months treatment duration and utilising active and placebo arms with baseline data collection. 150 overweight male and female participants aged between 20 and 65 years will be recruited from databases and public media outlets. Following preliminary screening via telephone, potential participants will attend the clinic for an information session and will be required to provide their consent for inclusion in the trial. Consenting participants will undergo a health assessment including lifestyle, current medications and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study. Once enrolled in the trial, participants will be randomly allocated to either the placebo comparator group (n=75) or the active intervention group (n=75 per group). Dietary intake and body measurements (weight, height, hip circumference, waist circumference, blood pressure and heart rate) will be assessed at enrolment. Within the week pre-treatment, participant’s blood will be collected for analysis of pre-treatment blood markers. Participants will also be required to have a DXA scan. All participants will receive the same standard advice regarding physical activity. Specifically, participants will be asked to undertake 30 minutes of walking 3 times per week and record all physical activity in their diaries. In terms of dietary advice, participants will be asked to follow a kilojoule controlled diet. The amount of kilojoules to be consumed daily by each participant will be calculated using the basal metabolic rate score from their DEXA scan. Participants will be asked to record their daily food intake in a kilojoule counter app and submit a 24hr food recall every two months during the study. Guidance in the form of example meal plans will be provided. Participants will be asked to take the allocated product according to the dose prescribed. In addition, participants will be asked to attend the study site at months 1, 2, 3, 4 and 5 for a body measures, dietary intake and tolerance assessment. At the completion of the study (month 6), an assessment identical to that undertaken at baseline will be carried out. Participants will be monitored for compliance with the protocol by a combination of telephone and email communications in addition to during each scheduled site visit.

The VERILY project aims to trial and evaluate a set of strategies for increasing online support for rural carers of people living with dementia. Participants will include carers, volunteers, and staff, who will be asked to use a website or mobile app and participate in videoconference support groups and then provide feedback about their experiences by completing surveys, a focus group, or an interview, and by responding to follow-up telephone calls from researchers.

The current project will evaluate the effectiveness of a theory-based intervention utilising implementation imagery to reduce Australian drivers’ intentions to attempt to drive through floodwaters–a behaviour that carries significant risk of drowning. The aim is to develop an effective intervention that can be used as content by stakeholders with interests in drowning prevention to minimise risky driving behaviours and drowning risk. Hypotheses Hypothesis 1: We hypothesise that drivers assigned to the intervention condition will report significantly lower intentions to drive through floodwater, relative to the control condition immediately post-intervention at T2 (primary outcome). Hypothesis 2: With regard to the secondary outcomes, we hypothesise that drivers assigned to the intervention condition will report significantly less favourable attitudes and reduced perceived social pressure to drive through floodwater, as well as greater perceptions of behavioural control, risk perception, perceived susceptibility, perceived severity, and anticipated regret toward driving through floodwater, relative to the control condition immediately post-intervention at T2. Hypothesis 3: We further hypothesise that that drivers assigned to the intervention condition will report significantly greater barrier self-efficacy and action planning regarding avoiding driving through floodwater, relative to the control condition immediately post-intervention at T2. Hypothesis 4: We also expect that the effects of the intervention will be maintained four-weeks later at T3. Given our previous research has identified sex differences in changing beliefs (Hamilton, et al., 2018), we will also test for gender differences in the effects of the intervention on study outcomes. Timepoints: Baseline (T1), immediately post-intervention (T2), 1-month follow-up post-intervention (T3).