ANZCTR search results

A prospective, randomised study of seriously injured, shocked adult trauma patients in an urban setting, comparing resuscitation outcomes and serious adverse effects of an intravenous oxygen carrier (HBOC-201) to Normal Saline. In this Victorian study environment it is expected that all patients transported by road to a Major Trauma Centre will have prehospital times of >=20 minutes from the time of first ambulance arrival.

The aim of this project is to evaluate the feasibility and safety of dancing classes for individuals with Parkinson's disease (PD). We will compare mixed genre dancing classes with Argentine tango classes. Mobility, walking performance, quality of life and wellbeing will be assessed up to one week before, up to one week after the program. Our hypothesis is that participants in the mixed dancing group will improve the outcomes analysed more than the ones on the tango group.

This study examines the biochemical effects of two different dialysis modes. Surprisingly, this has not been well covered in the literature, despite both modes having been practiced for 20+ years. As a secondary feature it also compares two different dialysis membranes utilised in these dialysis modes.

This study aims to evaluate the safety, tolerability and preliminary efficacy of 3 different doses of a cancer vaccine, manufactured from a patient's own tumour. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have banked a tumour sample in the Regeneus Tumour Bank (ACTRN12615000476538) and your tumour is inoperable and non-treatable or current treatment is refractory. Study details All patients enrolled in this safety and tolerability study will have their banked tumour samples used to develop a tumour specific vaccine. In brief, the vaccine is manufactured from the tumour, which is homogenised, processed and combined with streptavidin, an immunostimulant. Tumour cells are burst open during this process so that only the tumour proteins remain, i.e. no viable tumour cells remain in the vaccine. At the bedside, the vaccine is mixed with Freund’s Incomplete Adjuvant (FIA), which assists in immune recognition. Patients are given a single, small volume vaccine into the skin on Weeks 1, 4, and 7. Three different dose levels of streptavidin will be assessed (100, 250 or 500 ug) to identify the dose that is biologically active. Safety and tolerability will be assessed over a 24 week period by recording adverse event information, vital signs, physical examinations and various laboratory assessments. CT or MRI scans and blood samples will also be taken over this period for determination of your response to the vaccine. It is hoped that this study will aid in the treatment of solid tumours by harnessing a patient's own immune system to target and destroy cancer proteins.

This project aims to evaluate the efficacy of a 6-session parenting intervention (Fear-less Triple P) in reducing the anxiety symptomatology of anxiety-disordered children aged 7-14 years. Outcomes will be compared with a wait list control group, and will be examined at post-treatment, 3-month, 6-month and 12-month follow-up.

This study is a prospective, randomised clinical study comparing clinical outcomes of Knee Replacement using the Oxford Knee Score (OKS), in patients receiving either Bicompartmental Knee Replacement performed using Stryker’s robotic-arm assisted surgery system Mako, to Total Knee Replacement using the Triathlon Total Knee System performed with either conventional instrumentation or navigation. Functional and radiographic outcomes will be additionally collected as part of this study. The study will be conducted in patients with non-inflammatory degenerative joint disease who are randomised to either the Restoris'Registered TradeMark' MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR), or the Triathlon Total Knee System for Total Knee Replacement (TKR), with a minimum 2 year patient evaluation period.

This study aims to evaluate the efficacy of nutrition therapy with additional high intensity interval training in improving cancer-related fatigue and quality of life in men with prostate cancer on androgen deprivation therapy. Who is it for? Men aged 18 years or over who have prostate cancer and are currently being treated with androgen deprivation therapy (ADT), for longer than 3 months. Study details Research has found that men with prostate cancer treated with ADT have a high prevalence of cancer-related fatigue, which affects quality of life during and after treatment. Whilst the benefits of both dietary modification and exercise prescription have been well described in prostate cancer prevention and progression, little is known about the influence of nutrition therapy and high intensity exercise on cancer-related fatigue in men with prostate cancer during or after ADT treatment. This study aims to evaluate the efficacy of nutrition therapy and high intensity exercise in prostate cancer-related fatigue. All participants in this study are randomly allocated (by chance) to one of the two groups. Participants in one group will be invited to attend fortnightly 45 min long dietetic consults with an Accredited Practicing Dietitian for 20 weeks and to undertake high intensity interval training sessions, 3 times per week, in weeks 12-20. Participants in the second group will receive usual care monitoring followed by moderate or high intensity interval training, 3 times per week, for eight weeks after usual care has finished. The usual care group will continue to be treated with ADT, or adjunctive ADT with chemotherapy/radiotherapy for the study duration. Throughout the study, participants will be asked to answer questionnaires on prostate cancer-related fatigue and quality of life as well as have blood samples taken and perform some physical function tests. It is hoped that this study will help assist in alleviating cancer-related fatigue, and improving quality of life for men with prostate cancer treated with ADT.

This study will assess consecutively the safety, tolerability, and pharmacokinetics of single and multiple doses of CTP-730 in healthy volunteers.

Military personnel returning from overseas deployment often suffer from sleep difficulties. Demanding and altered working hours, challenging environmental conditions, high work tempo, and altered interpersonal and support environments contribute to disturbed sleep during operations. If left untreated, sleep difficulties can lead to poorer mental health outcomes; in fact, sleep complications may become a chronic health issue. The research will evaluate the effectiveness of two treatments. Cognitive Behavioural Therapy for Insomnia (CBT-i) and Bright Light Therapy (BLT) for improving sleep and mental health will be trialed in a sample of 40 ADF personnel.

Dementia is the single greatest cause of disability in older Australians and the third leading cause of disability burden in Australia. Due to our aging population the number of Australians living with dementia is expected to increase rapidly over the next decade placing additional burden on the health system and on the unpaid/family carers of people with dementia. Behavioural changes occur in 90% of people with dementia. These changes are stressful and challenging for carers. The purpose of this study is to examine an online educational training program that teaches carers of people with dementia ways to manage common behaviours. It is expected that the program will reduce carer burden and stress.