ANZCTR search results

Ambroxol is a simple cough medicine that is predicted to slow ALS disease progression. This study is the open label extension (OLE) of the parent study, which aims to investigate if ambroxol in high doses is effective in treating ALS. This OLE study will be carried out across 5 research sites in Australia (2 NSW, 1 VIC, 1 SA and 1 TAS), where ALS patients whole have successfully completed the randomised phase of the parent study, will be asked to participate in the OLE phase. Participation will be over a 52-week period, where they will come in for a an OLE baseline, followed by 48-week treatment, and 4-week end of study safety follow-up period. All participants will active drug that they will take three times a day, Throughout the study their disease progression will be assessed using tests, questionnaires, and blood biomarkers.

The purpose of the study is to evaluate the effect that hydration and fluid restriction might have on postural stability, aiming and shooting targets during and after a simulated march in the heat. The expected outcomes are that participants will show greater signs of fatigue by measure of postural stability and target accuracy when dehydrated in the heat.

The Sydney COAST study will create a clinician-defined, meaningful dataset containing both prehospital and in-hospital data. The study will examine this for the identification of physiological, mechanistic, or biochemical risk factors that influence in-hospital mortality for major trauma patients with shock, across the greater Sydney area.

Nephrotic syndrome (NS) affects around 1 in 50,000 children. Nephrotic syndrome causes the kidneys to leak too much protein into the urine leading to a drop in protein levels in the blood. This causes swelling in the body, especially in the face, legs and feet. The treatment of NS is steroid therapy. Most children with NS get better with steroid therapy but for many children, the disease comes back (relapses). NS often continues to relapse for many years. Steroids can help in treating relapses but they come with many side effects like changes in behaviour and sleep, appetite, weight and growth.

Who is it for? You may be eligible for this study if you are a male or female over the age of 18, and test positive in a NATA-accredited molecular laboratory for a germline likely pathogenic (Class 4) or pathogenic (class 5) variant in either BRCA1, BRCA2 or PALB2 genes during the period of the trial, and have no current cancer diagnosis of any type, or previous diagnosis of breast, ovary or prostate cancer. Study details In this Hybrid two effectiveness and Implementation trial, participants will be randomly allocated to 1) access to the Website - ActionPlan, 2) access to ActionPlan with telephone conversation one month after access to improve uptake of the website or 3) standard care. In the Website ActionPlan arm, participants will receive personalised interactive risk graphics, and information modules -breast cancer risk reduction /screening, ovarian cancer risk reduction, lifestyle factors, psychological support, grief support, reproductive options, family communication and cascade tool, rarer cancers and research opportunities. The website can be accessed at the participant discretion. In the ActionPlan and telephone conversation arm, participants will receive access to the website ActionPlan and a follow up telephone call one month after access to ActionPlan using behaviour change theory aimed at addressing any digital or health literacy issues. Participants will be followed up at baseline, 2 , 5 and 8 months post intervention commencement to assess for patient empowerment, coping with a genetic diagnosis, and decisional conflict. It is hoped that this study will contribute to our understanding of digital interventions in healthcare, and improve person-centred care by empowering participants to be more actively engaged in in their health and values- based decision making.

The aim of this study is to test a telehealth-delivered, stoma-specific exercise and physical activity program, establishing whether the delivery of physical activity via telehealth is feasible, acceptable and safe for this group. Who is it for? You may be eligible for this study if you are a male or female age 18 or older, who have received a stoma as a result of cancer in the five years prior to enrolment. Stoma is either permanent or long-term. Have access to the internet and own, or have access to a computer or tablet device. Study details Participants will receive a stoma-specific exercise intervention delivered via telehealth. Intervention material will include an exercise manual, web-based exercise videos and guides, and a one-hour individual telehealth exercise and coaching session each week with a stoma-trained exercise professional for 12-weeks. Participants will also be encouraged to undertake self-managed sessions twice weekly, to accumulate three organised exercise sessions and progress towards a minimum physical activity target of equal to or greater than 150 minutes per week. Each exercise session will constitute three primary components: Soma-specific strengthening, aerobic exercise, and resistance exercise. After commencement of the intervention, participants will be asked to respond to questionnaires regarding acceptability and quality of life, safety data and feasibility data will be collected during the intervention. It is hoped that findings from this study will enhance physical activity and quality of life in people with a stoma following cancer.

This study aims to investigate the impact of Personalised Exercise Rehabilitation for people with Multimorbidity (PERFORM-Aus Trial) on hospitalisation compared with usual care. Who is it for? You may be eligible for this study if you are a male or female age 18 or older independently ambulant, diagnosis of two or more long-term health conditions, at least one of which has evidence of benefit from an exercise-based intervention. Study details Participants will be randomised to receive either PREFORM intervention or usual care. The PERFORM intervention involves an 8-week in-person supervised program at a rehabilitation centre, with sessions held twice weekly. Each session will last 2 hours and consist of one hour of exercise training (Move and Improve) and another hour focusing on patient self-care support and education (Health and Wellbeing sessions). After completion of the intervention, participants will be assessed for hospital admission, quality of life, exercise capacity, mental health, physical activity, treatment burden, fatigue, pain, breathlessness, adverse events and adherence. It is hoped that findings from this study will help manage these patients effectively with a multidisciplinary approach to address complex disease interactions.

This study will evaluate a wellbeing workshop designed for GPs and GP trainees. The workshop is based on research with GPs and will provide them with education about wellbeing and burnout, and include several activities for them to develop a wellbeing plan. Those attending the workshops will be invited to complete a baseline survey, another survey 1 week after the workshop (for feedback on the workshop), and a final survey 3 months after completing the workshop. These surveys will measure GPs' reported burnout levels, sense of value fulfilment, satisfaction with work/life balance, and self-care behaviours.

Insomnia is a prevalent and debilitating disorder in Australia. Cognitive behavioural therapy for insomnia (CBTi) is the recommended 'first line' treatment for insomnia (Qaseem et al., 2016, Ann Intern Med). However, there are very few clinicians in Australia with training in CBTi. Consequently, most patients with insomnia never access CBTi (Miller et al., 2017, JCSM). This project aims to test the effectiveness of a dCBTi intervention in the Australian general practice context. Self-guided and clinician-guided digital CBTi programs are an effective and potentially scalable intervention to manage insomnia. There are very few evidence-based digital CBTi programs available in Australia, and currently no publicly-available digital CBTi programs that provide personalised weekly behavioural therapy recommendations. This cluster randomised controlled implementation trial aims to investigate the effectiveness of three digital treatment options for insomnia in Australian general practice. Following recruitment of eligible patients with insomnia symptoms, general practice clinics will be cluster-randomised 1:1:1 to; 1. Digital sleep hygiene education (treatment as usual control) 2. Self-guided digital cognitive behavioural therapy for insomnia program 3. Clinician-guided digital cognitive behavioural therapy for insomnia program (digital program plus three sessions with general practitioner to provide guidance and motivational support). It is hyopthesised that the groups that receive the digital CBTi program will report a greater reduction in insomnia and depressive symptoms and lower rates of medicine use for insomnia, compared to the group that receive sleep education (control). Furthermore, it is hypothesised that the group that receive clinician-guided digital CBTi will experience greater reduction of insomnia and depressive symptoms, and lower rates of medicine use for insomnia compared to the group that receive self-guided digital CBTi.

Explore the effects of using a mini-bike on levels of physical activity and loads in the body. Our hypothesis is that mini-bikes will elicit low intensity levels of physical activity.