ANZCTR search results

WalkingTall is a novel neuro-rehabilitation program delivered through a tablet/smart phone and smart socks for people with Parkinson’s that aims to improve mobility and reduce falls. It consists of smart socks, which deliver haptic stepping stimulus via small vibrators, balance and walking exercises, visual and auditory cues delivered via a tablet and mobile phone. Training may be done with the assistance of a trainer, independently or a combination of both. The purpose of this study is to investigate how WalkingTall may improve gait stability and mobility in people living with Parkinson's. It comprises a 2-week neuro-rehabilitation program including a combination of supervised and unsupervised sessions. Our key aims are to collect preliminary evidence for improved step-time variability, determine training dose tolerance and participant safety, identify the characteristics of people most likely to benefit from WalkingTall and engage end-users in the ongoing design process.

This study will investigate the effect of self-directed physical activity and motivational interviewing on quality of life, psychological health and immune outcomes in female breast cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with breast cancer or ductal carcinoma in situ within 3 years and are at least 6 months post-active treatment. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in both groups will be administered 2 components of the intervention: a self-directed physical activity component (supplied with a step count tracker) and a motivational interviewing component. The self-directed physical activity component involves one supervised session by an exercise physiologist at the first week and independent physical activity at home or community using a step tracker throughout 24 weeks. The supervised session will be last 30 minutes for the application of step tracker and jogging or walking at moderate intensity exertion (at their perception of taking some effort but can talk during physical activity). The motivational interviewing components involve a combination of face-to-face and phone calls during self-directed physical activity. The timing of the motivational interviewing component will be randomly allocated to the first 12 weeks or the last 12 weeks. Quality of life, psychological health and immune function will be assessed using questionnaires and blood tests before, during and after the intervention. The study hopes to see the benefits of self-directed physical activity combined with motivational interviewing on the improvement of psychological well-being, quality of life and immune outcomes in female breast cancer survivors. So this program implementation could be rolled out more widely at a low cost in the future in female breast cancer survivors.

Osteoarthritis is a debilitating condition affecting 9% of Australians, and this is likely to increase as our population ages. There are currently no drug treatments for prevention or cure of osteoarthritis, only temporary solutions to treat pain and symptoms. Osteoarthritis can have a huge impact on quality of life and can lead to other complications, like cardiovascular disease. Looking for prevention and treatment options is therefore very important, and dietary oils might provide one potential treatment option. Some research has investigated dietary oils and osteoarthritis. There is some evidence that certain types of oil might have some benefit, but we need to conduct more trials to find out. One of the problems with dietary oils studies is that they are difficult to blind. Blinding means that the participants in the study don’t know which treatment they are receiving, and neither do the researchers. Blinded studies are very useful, because when the treatment is kept secret, any results that are found are more likely to be because of the treatment, and not because of researcher bias or participant belief (placebo effect). We are not sure whether it is possible to blind a dietary oils trial, how participants will handle taking different types of oils, and what impact this might have on their diets, symptoms of arthritis and other health markers like weight and cholesterol. We’d like to answer these questions, to help design a large, blinded, dietary oils study in the future. This study has a couple of main purposes. We want to know: • if people will be able to identify dietary oils, without being told what they are • how people go about consuming the dietary oils (for example, alone, or with food) • whether dietary intake of other foods and oils will be affected • whether consuming different types of dietary oils will impact on symptoms of arthritis, such as pain, and other health markers such as weight and cholesterol levels We will give patients with osteoarthritis three different types of dietary oils for 3 months, and assess how they take the oils, whether they can tell what the type of oil is, whether their diets change, and measure some health markers like lipids and weight. We will also look at pain scores from their arthritis to see if the dietary oils have any therapeutic effect on pain.

The purpose of this trial is to determine, and compare, the effects of intraduodenal versus intragastric administration of quinine on blood glucose, gastric emptying, gut and gluco-regulatory hormones, and gastrointestinal symptoms in comparison to intraduodenal and intragastric water controls respectively.

Description of the intervention and Aim: In Sweden, the TRANSITION program reported promising evidence in facilitating adult transition for individuals with autism, including improved goal achievement in adult domains and overall well-being. This program runs for 24 weeks and consists of a combination of group-based workshops covering important adult life domains and a mentor program. Given the success of the TRANSITION program, this research project aims to adapt and evaluate the TRANSITION Program for adolescents and young adults within the Australian context. The objectives are: o To evaluate the feasibility and preliminary effectiveness of TRANSITION Australia in supporting transition outcomes for young adults with autism o To determine to efficacy of the TRANSITION Australian in improving adult transition outcomes for individuals with autism Hypothesis: It is hypothesised that participants receiving TRANSITION program will demonstrate better goal attainment and self-efficacy in adult transition domains, e.g. outcomes in employment, education, quality of life and community participation.

The aim of this study is to assess feasibility, including the acceptability and fidelity, of a preschool dance participation intervention for extremely preterm (EP) children with motor impairment. Children born EP (<28 weeks gestation) are at increased risk of motor difficulty compared to children born at term. Motor skills developed during the preschool years provide the foundation for the development of more complex motor skills, and facilitate participation in lifelong physical activity (PA). Current evidence suggests that motor impairment in EP children persists throughout childhood and adolescence, with relevance for lifelong PA participation and associated health outcomes. A feasibility case series trial will recruit EP preschool age children with motor impairment from the Victorian Infant Collaborative Study 2016 cohort at the Royal Women’s Hospital (n=10). Melbourne based dance teachers will be recruited and provided with physiotherapy-led training and support to facilitate the participation of EP children in community dance classes. A mixed-methods approach (quantitative and qualitative) will be used to analyse the acceptability and feasibility of the intervention from the perspectives of families and dance teachers.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of trastuzumab emtansine (T-DM1) in patients with advanced tumours with HER2 amplification or mutations. Who is it for? You may be eligible to join the study if you are aged 18 years and older with either; a. advanced and/or metastatic solid tumour of any cell type that is no longer responding to treatment or unsuitable for standard therapies for that cancer type, or b. metastatic, non-squamous, non-small cell lung cancer (NSCLC) Participants will have tumours with HER2 alterations Study details Participants will continue to receive T-DM1 intravenously at a dose of 3.6 mg/kg every 21 days continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 9 weekly intervals or as clinically indicated in order to evaluate tumour response. Safety and tolerability of treatment and health related quality of life during treatment will be assessed at 3 weekly intervals. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that T-DM1 will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

The purpose of this study is to determine the clinical utility of therapy based on the result of a PET-scan for patients with follicular lymphoma. Who is it for? You may be eligible for this study if you are aged over 18 and have a documented diagnosis of follicular lymphoma What it involves Participants in this study will be divided into groups (PET-ve and PET +ve) based on their PET-scan. PET +ve patients will be randomised (by chance) into two groups. One group (called Arm A) will have the drug Rituximab through a needle in the arm every 8 weeks for up to 22 months. The other PET +ve group (called Arm B) will also have Rituximab, but will also receive a drug called Lenalidomide by orally every month for up to 24 months. PET –ve patients will also be randomised (by chance) into two groups. One group (called Arm A) will have the drug Rituximab through a needle in the arm every 8 weeks for up to 22 months. The other PET –ve group (called Arm B) will receive no treatment. All participants in all groups and arms will be monitored for disease progression by physical examination and PET scans throughout their time in the study. It is hoped this study will demonstrate effectiveness of Lenalidomide in converting PET positive patients to PET negative patients. It is also hoped this research will show no treatment to be as effective as the current maintenance treatment (Rituximab) in PET negative patients.

Functional dyspepsia affects 1 in 6 Australians with currently no cure for this condition. This study aims to test the effects of antibiotic therapy on gastrointestinal symptoms, meal related quality of life (QoL), anxiety and depression and the symptom response to a standardised nutrient challenge (active therapy is superior to placebo) in up to 100 patients with functional dyspepsia with and without non constipation irritable bowel syndrome (IBS) attending the Department of Gastroenterology at the Princess Alexandra Hospital. By defining the effects of interventions targeting the gastrointestinal microbiota with regard to symptoms and gut function, we will pave the path for a paradigm shift regarding both treatment and overall understanding of the pathophysiology of functional dyspepsia. This will change how patients with functional dyspepsia are treated, enabling for the first time, targeting of the underlying causes of functional dyspepsia, which may ultimately cure this condition.

Following acute blunt cervical injury, there is ongoing debate regarding the reliability of Computed Tomography (CT) and plain radiographs versus the need for Magnetic Resonance Imaging (MRI). The objectives of this study was to determine the incidence of new findings found on MRI following normal CT or plain radiographs in patients with persistent cervical tenderness, focal neurology or in patients who are clinically unevaluable; and to assess if the management was altered following MRI results.