ANZCTR search results

This study aims to investigate the safety and patient experience of prescribing by credentialed physiotherapists. Patients attending emergency departments and outpatient clinics with musculoskeletal conditions will be prescribed medications from a limited list to manage pain and support physiotherapy treatment.

Schizophrenia has a lifetime risk of 7.2 per 1000 persons with 25-50% of people with schizophrenia failing to respond to typical and atypical antipsychotics. For these people clozapine is the gold standard treatment, however, clozapine greatly increases the risk of weight gain and type 2 diabetes (T2DM) which contribute to cardiovascular disease and premature mortality. Current interventions against antipsychotic-associated metabolic dysregulation are limited and insufficient. The mechanism of action for metabolic abnormalities associated with clz is not completely understood; however, recent pre-clinical models have shown that clozapine causes acute deficits in glucose metabolism. This occurred via suppression of glucagon-like-peptide-1 (GLP-1) levels and these defects could be overcome by treatment with a GLP-1 agonist. Exenatide, a GLP-1 agonist, is available in a once weekly injectable formulation which is practical for this population with poor adherence. Therefore, in consideration of the promising preclinical data, the use of exenatide, which is already known to improve glycaemic control and reduce body weight in subjects with and without T2DM, may represent an effective therapeutic intervention for clozapine-associated obesity and T2DM. Therefore, the present study is a 24-week investigator-initiated, parallel group, randomised, open-label pilot study designed to evaluate the acceptability of exenatide weekly and determine the preliminary clinical efficacy and tolerability of exenatide for weight loss and glycaemic control in clozapine-associated obesity and T2DM. This study also has exploratory objectives to examine the feasibility of recruitment, retention, assessment methods and implementation of this intervention for subsequent larger scale, multicenter studies.

Arthritis NSW has identified that there is a need for more information and support for women faced with family decisions in the context of their RA. Therefore the aim of this project was to develop a Decision Aid (DA) resource (printed booklet and an online version) for women with Rheumatoid Arthritis (RA) who were contemplating pregnancy. In order to evaluate the effectiveness of the DA, a randomised control trial (n = 200) was conducted with women diagnosed with RA, aged between 20-45 and who may be contemplating pregnancy.

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.