ANZCTR search results

Light exposure influences a range of processes involved in the development of PTSD, including hormone release, stress, mood, cognition and sleep. The impact of light varies by wavelength (colour). This study will investigate whether regulating evening light exposure using coloured glasses can reduce symptom severity and the risk of developing PTSD after traumatic injury. Adults admitted to The Alfred Hospital Trauma Service will be asked to complete a two-step screening process that includes a light-sensitivity assessment. Eligible individuals will then complete a baseline assessment, including clinical interviews and questionnaires on mental health and sleep and may provide an optional saliva sample for genetic analysis. Participants will then be randomly assigned to wear one of two types of coloured glasses that selectively filter different wavelengths of light. Participants will wear the glasses for two weeks during the three hours before bedtime, complete brief daily sleep and mood assessments, and wear devices to track light exposure, sleep, activity, heart rate, and skin temperature. Follow-up assessments, including clinical interviews and self-report questionnaires, will be conducted at 6 and 12 weeks post-baseline. We hypothesise that individuals allocated to receive the intervention glasses will have reduced severity and risk of developing PTSD at 6 and 12 weeks post-baseline.

This study is testing whether a telehealth-delivered digital rehabilitation programme, called BIBO, is a practical and acceptable way to help people recover after knee replacement surgery. Thirty adults aged 55 and over who are having a knee replacement will take part in this single-group feasibility study, using the BIBO programme alongside their usual care instead of traditional face-to-face physiotherapy visits. The study team expects that most participants will be able to use the programme regularly and will find it acceptable, and that recovery outcomes will be broadly similar to those seen with standard rehabilitation care. Participants will complete short questionnaires and physical assessments at several points before and after their surgery to track their knee function, pain, range of motion and satisfaction with the programme. The findings will help determine whether a larger study of telehealth rehabilitation after knee replacement is worthwhile.

Around 3.6 million Australians live with chronic pain, which can have a major impact on health, wellbeing and daily life, particularly in rural and regional communities where access to evidence-based pain care may be limited. EQUiPP aims to find out whether a community-based approach involving local communities and primary healthcare services can improve understanding of chronic pain, reduce stigma and misconceptions, and support evidence-based pain care. The study will implement a co-designed public awareness campaign, education for healthcare professionals, and Community Champions working across seven rural and regional communities. We expect this approach will help people make more informed decisions about managing chronic pain, increase use of recommended evidence-based care, and reduce unnecessary use of opioid and pregabalin medicines. The findings will help determine whether this approach can improve chronic pain care and be successfully expanded to other rural and regional communities across Australia.

Competency in a range of movement skills (e.g. kicking, running, throwing) provides the foundation for an active lifestyle, however, very few children leave primary school having mastered foundational movement skills to support participation in a variety of physical activities. Our project will evaluate the effectiveness of a time-efficient foundational movement skill program in primary schools.

In this study, the safety and tolerability of the study treatment, CBT-248, will be evaluated in healthy volunteers when it is taken orally as single dose. CBT-248 is a potential new treatment for chronic pancreatitis which has not been given to humans before. This study aims to test how the body responds to the study drug, and whether it has any undesirable side effects.

In this study, the safety and tolerability of the study treatment, CBT-248, will be evaluated in healthy volunteers when it is taken orally as two single doses, one when fasted and one when fed a high calorie meal. CBT-248 is a potential new treatment for chronic pancreatitis which has not been given to humans before. This study aims to test how the body responds to the study drug, and whether it has any undesirable side effects.

Deep Vein Thrombosis ( DVT) is a serious, preventable and treatable medical condition. Without timely treatment, there is significant morbidity and mortality. Optimal patient outcomes require judicious prevention strategy with pressure stocking and prophylactic anticoagulants as well as early recognition of venous thromboembolism and prompt treatment with therapeutic anticoagulants. There is a reasonable amount of literature guiding the management of inpatient thromboembolism prevention. However, there is a paucity of evidence-based recommendations to guide the management for Emergency department patients discharged with lower limb immobilization. We are proposing to target these patients in a randomized Control Trial to determine whether oral aspirin is an effective alternative to subcutaneous (SC) Enoxaparin (Clexane) to prevent DVT on low to medium risk group of these patients. This pilot study can help to design a larger scale trial in this population.

Title: An ALLG phase II, multicenter, open-label trial evaluating the efficacy and safety of ELVN-001 in patients With Chronic Myeloid Leukemia (CML). Purpose of this trial: The purpose of this study is to determine if the drug ELVN-001 is safe and can help patients with chronic myeloid leukaemia (CML) live longer without the disease returning or worsening. ELVN-001 is designed to specifically block the activity of the abnormal BCR::ABL1 protein that causes CML. Who is this trial for: You may be eligible to join this study if you are aged 18 years or above, have a new diagnosis of CML, and have specific changes in the BCR::ABL1 gene. Your treating hospital will assess whether you meet all the requirements. This multi-centre study will recruit a total of up to 100 participants across Australia and New Zealand. Trial details: This is a phase 2 study. Participants will receive an oral tablet of ELVN-001 given once a day with a large glass of water at the same time each day. The total treatment time is about 4-5 years. Participants will be eligible for treatment-free remission (TFR) after taking ELVN-001 for at least 4 years, with no signs of the cancer returning for at least 2 years. Participants will be checked at the hospital after taking the drug for 1 week, then at each month until 3 months, then every 3 months until 5 years. Data will be collected about the participant through the National Blood Cancer Registry (NBCR) for 5 years. Researchers hope that treatment with ELVN-001 will help more patients achieve a deep response to treatment, improve long-term outcomes, and reduce the risk of complications and side effects related to CML and its treatment.

Many people with pancreatic cancer experience severe abdominal pain caused by involvement of the celiac plexus, a group of nerves in the upper abdomen. The INCEPTION study is evaluating a new radiotherapy approach called three-fraction celiac plexus radioablation, which aims to reduce pain while minimising side effects. Who is it for? You may be eligible for this study if you are an adult with pancreatic cancer and cancer-related abdominal pain caused by involvement of the celiac plexus. Participants must have either biopsy-confirmed pancreatic cancer or imaging evidence of a tumour involving the celiac axis. Study details All participants will undergo a planning CT scan, followed by three 15-30 minute radiotherapy treatments each separated by at least 48 hours, over the course of about one week. Follow-up assessments will occur approximately 48 hours, 2 weeks, 4 weeks and 3 months after treatment and will include pain assessments, quality of life questionnaires, opioid medication use and safety monitoring It is hoped that findings from this study will help clinicians and researchers evaluate whether this treatment can be delivered efficiently within routine clinical practice.

This project aims to conduct a controlled trial to investigate the effectiveness of MindWise Leadership, an evidence-based mental health training program for people-leaders in nursing and midwifery. This trial will be used to measure whether this training program will improve managers' and leaders' responsive behaviours, preventative behaviours, confidence, knowledge and stigma regarding employee mental health. It also aims to investigate whether any changes are sustained over a 6-month period. The research aims that this research seeks to address are: Primary objective: Evaluate the effectiveness of MindWise Leadership in improving managers’ behaviour regarding employee mental health matters in the workplace Secondary objectives: Evaluate the effectiveness of MindWise Leadership in improving managers’ confidence, attitude, and knowledge regarding employee mental health. Evaluate the effectiveness of MindWise Leadership on reducing employees’ sick leave and medical errors.