ANZCTR search results

What is this study about? The purpose of this study is to investigate how safe and tolerable a single dose of ZYN002 transdermal gel is in healthy participants and patients with epilepsy. 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 ZYN002 in your blood and urine at various times following drug administration. Your skin at the application site will be checked to see if there is any irritation or reactions present after ZYN002 application. The study will also investigate the effect that ZYN002 has on your visual attention and ability to complete a simple task. The task requires you to ‘connect-the-dots’ of 25 consecutive dots as fast as possible. Who is if for? You may be eligible to join this study if you are aged between 18 and 55 years and are either in general good health or have epilepsy with partial onset seizures that is stable. 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; One confinement period starting on the evening before dosing and lasting until 48 hours after the study treatment i.e. a total of about 62 hours (2.5 days). This will require three (3) nights in the clinic. There are also two out-patient clinic visits following the confinement period on Days 4 and 5. These visits will be at 72 and 96 hours after the application of the study treatment. Additional out-patient visits may be required if there is any skin irritation present at the study treatment application site. 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.

This study aims to compare Skype-based intervention with in-person intervention involving a conversation skills training program for people with traumatic brain injury and their family, friends or carers. We will determine whether there is any difference in outcomes between Skype-based and in-person conversation skills training.

Winter is a surprisingly dangerous time in Australia with greatly increased rates of death and hospitalisation. Winter death rates are 47% higher for heart failure and 32% higher for hypertensive disease compared with summer. Warm countries like Australia have a far greater winter increase in morbidity and mortality than cold countries like Sweden. This is because many Australian homes are inadequately insulated or heated, with indoor temperatures in winter often below 18 degrees C. This cold exposure increases blood pressure and inflammatory factors, which increases the risk of an acute cardiovascular event. Home insulation and heating have both been proven to improve cardiovascular health and wellbeing during winter. This study will test if personal insulation also improves cardiovascular health. Heart failure patients will be randomised to receive no intervention or a pack containing thermal tops, hats and socks, indoor temperature monitors, and advice on when to wear the thermals. Our primary hypothesis is that winter hospital admissions will be reduced, and we will also examine improvements in blood pressure, inflammatory factors, quality of life, sleep and personal insulation. This will be the world’s largest study of the health benefits of personal insulation, and will build on our work with heart failure patients at The Prince Charles Hospital. Thermal clothes are a cheap and simple intervention that could greatly reduce winter morbidity and mortality across Australia.

To determine if: Patients who obtain and participate in a home exercise program received via 2 home visits, in addition to group exercise will experience greater improvements in balance than participants who participate in the group program and are given a home exercise program at the hospital (normal care).

The purpose of the proposed project is to conduct a pilot study of the acceptability, efficacy and feasibility of a low-intensity internet-delivered CBT (iCBT) self-management program, the Chronic Conditions Course, in reducing symptoms of anxiety and depression adults with functional gastrointestinal disorders. The proposed trial employs a single-group open-trial design (n = 30) and participants will be given access to an internet-delivered CBT Course; a 5-lesson 8 week self-management program. Participants will have brief weekly contact with a Clinical Psychologist as they work through the Course.

The purpose of this study is to assess if melanoma prevention behaviours can be improved by providing individuals with personalised melanoma risk information and prevention recommendations based on their level of risk. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have the capacity to give informed consent in English. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in both groups will receive general prevention information on melanoma. One group will then additionally receive personalised melanoma risk information and prevention recommendations based on their risk levels. Risk levels will be based on self-assessed melanoma information. Participants will be assessed on melanoma risk perceptions, melanoma risk reduction intentions and melanoma prevention behaviours 6 and 12 weeks after the intervention by follow up questionnaire. This research will help determine if providing individual melanoma risk information improves melanoma prevention behaviours in healthy adults.

Few studies have compared sitting on a standard ergonomic chair with working on a sit-stand desk in terms of health benefits. In terms of broader cardio-metabolic benefits of alternative office working modes, research on standing is particularly scarce and the very few studies that examined how cardiometabolic blood biomarkers respond to replacements of sitting were done in laboratory conditions that are not necessarily translatable in real-life office environments. Very little evidence exists on how changes in work time sitting influences fatigue, and mood, or after work hours physical activity and sedentary behavior. The objectives of this pilot intervention are to examine: The acceptability of and adherence to different sitting-standing protocols to participants b) The impact of the different sitting-standing protocols on participants’ outcome measures (see below) c) The acceptability of and adherence to data collection procedures such as taking blood samples and wearing an inclinometer for 7days (24hrs a day), and a kinematic sensor for 2 days. This pilot study will provide valuable information on planning for a larger randomised controlled trial which will examine the effects of different sitting-standing modes on the health of office workers.

The primary purpose of this study is to determine whether ASN-002 alone or in combination with 5-FUis safe and effective in the treatment of nodular basal cell carcinoma (nBCC). Who is it for? You may be eligible to join this study if you are aged 18 or over, have been diagnosed with nBCC. Study details ASN-002 is a vaccine-like product that is injected into the BCC spot to be treated. It is made from modified adenovirus serotype 5 (also called Ad5). Adenoviruses are common in nature worldwide and can cause mild colds and respiratory infections from which people usually recover without treatment. The Ad5 used in this study has been modified so that it cannot grow in the body or cause an infection. The modified Ad5 in this study will deliver artificially made genetic material into the cancerous and surrounding cells. This genetic material will produce human interferon which is normally produced by the body to stimulate the immune system. It is hoped that injected ASN-002 will cause the body’s own cells to produce interferon and stimulate the immune system to attack the cancerous cells and reduce the size of or eliminate the nBCC. 5-FU is a chemotherapeutic agent approved to treat many types of cancer. Participants will attend the study centre weekly for an injection of ASN-002 alone or in combination with 5-FU into the nBCC. The participants recruited will have 3 injections over 3 weeks, and then undergo surgical excision of the tumour. Patient outcomes will then be assessed using a tumour sample collected during surgery and by the incidence of adverse events which occur throughout the study. It is hoped that the findings of this trial will provide information on the safety and efficacy of using ASN-002 alone and in combination with 5-FU for nBCC, particularly for patients in whom the standard treatment of surgery is not possible or not recommended.

This study aims to find out if this evidence-based alternative to the traditional use of triaged waiting lists reduces waiting time for a variety of community health and sub-acute ambulatory care services. It is hypothesised that this will be achieved without detrimental effects on service quality, patient outcomes, patient satisfaction or service cost.

A randomised controlled trial will be used to investigate the effectiveness of the iChooseWell program. The iChooseWell program will be placed within the Federation eHealth Platform. People visiting the website, in response to advertisements or through self interest, will be informed of the availability of the iChooseWell program and invited to participate in the study. People who consent to take part in the study will be randomly allocated to either an immediate access to the program condition or a delayed access condition (8 week delay). The iChooseWell eHealth program consists of forty biological, psychological, social, and wellness strategies, all designed to increase mind and body health (e.g., brain & gut nutrition, emotional regulation strategies, problem solving, sleep hygiene, social connectedness, practising gratitude). Participants will be able to choose from the array of biopsychosocial strategies available within iChooseWell. Background information is also provided on health and wellbeing (e.g., the stress response, brain/neural plasticity) and useful resources are provided (e.g., self monitoring, ‘On the Go’ mobile tools). Each individual wellness strategy is 2-6 web pages in length (taking between 5-20 minutes to read) and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (10 minutes per day on average) to complete offline to practise the principles of the chosen wellness strategies. Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked several questions during the study period to monitor their progress. The iChooseWell program includes text, graphics, audio, video, quizzes, and downloads. iChooseWell can be accessible via web, mobile or tablet devices. Participants randomised to the iChooseWell eHealth immediate access group will complete a pre-intervention assessment (Week 0), during intervention (Week 3) assessment, post-intervention assessment (Week 5) and a 1 and 3 month follow-up assessment (Week 9 and Week 17). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to the iChooseWell eHealth program following the 1 month follow-up assessment (Week 9). However the delayed access group will be asked to complete the post intervention assessment after they have completed the iChooseWell program (Week 13) and a 1 month follow-up (post program) (Week 17). Access to iChooseWell will be provided for the entire trial period. Adherence will be measured by the number of strategies visited by post assessment (measured via passive analytics) as well as questions regarding engagement levels. It is expected that people who undertake iChooseWell will show increases in mental health and wellbeing and optimism and reductions in negative affect at post and the 1 month follow-up time points.