ANZCTR search results

Multiple system atrophy (MSA) is a rare, severe and life-threatening adult-onset neurodegenerative disease, characterized by a combination of parkinsonism, cerebellar ataxia, and autonomic dysfunction. At present, only symptomatic therapy is available for the treatment of MSA, and most of the prescribed medications are being used in an off-label manner. YA-101 is being developed for the treatment of subjects with MSA, a serious and life-threatening condition with a high, unmet clinical need. The safety, tolerability, PK, and food effect of YA-101 will be evaluated in HV in Parts 1 and 2 of this study. The study will be conducted in healthy volunters aged between 18-65 years . Besides the one food effect (FE) cohort, each cohort in Part 1~Part 2 is randomized, placebo-controlled, double-blinded to establish safety and tolerability in healthy volunteers (HV) following single ascending dose (SAD) and multiple ascending dose (MAD). A total of 60 participants will be enrolled in Australia. Duration of the study Part 1 HV SAD: Total duration of study is up to 8 days with 1-day treatment Part 2 HV MAD: Total duration of study is up to 21 days, 14-day treatment Part 2 HV FE: Total duration of study is up to 11 days with 1-day treatment

This is a characterisation research study investigating the different features of the Nutromics Sensor Device platform.Characterisation studies to help guide development of the Nutromics Sensor Device platform will provide invaluable information to Research and Development (R&D) teams. Since this is a minimally invasive patch based platform, with minimally invasive needle, characterisation of adhesive, ergonomics and human factors will be crucial.

Traditionally, many dancers and instructors use light aerobic activity combined with static stretching as a warm-up. There is limited research investigating how a warm-up affects dance performance, particularly for range of motion, jump height, force production and muscle activation for unilateral jumps and dance specific skills. The aim of this research is to compare a dynamic warm-up to a traditional dance warm-up and determine how this affects dance performance. Participants will each complete 3 separate days of testing, each one beginning with warm-up that includes either static stretching, dynamic stretching and no stretching (control). It is hypothesised that dancers will demonstrate superior performance when a dynamic warm-up is used compared to a traditional dance warm-up. The outcomes will be valuable as it will allows dancer and dance instructors to implement more evidence-based training to produce optimal results.

The study aims to investigate whether the use of mindfulness applications that incorporate peer support improves perinatal mental health outcomes. An exploratory sequential mixed method design consisting of two phases will be used in the study. The first phase involves qualitative study conducted through a focus group to explore women's knowledge and experiences of support groups and mindfulness. Phase one findings will inform the design and structure of the intervention in phase two. In the second phase, a pilot study using a quasi-experimental one-group pre-post test design will be used to assess peer support combined with a mindfulness app on anxiety, depression, mindfulness practices, perceived social support, and salivary cortisol levels. Peer support groups intervention aim to bring women together for mutual support and use of the mindfulness-based app (Headspace) activity together.

The HEPATA Trial is designed to deliver comprehensive evidence for TP-IAT inclusion on the Australian Medicare Benefits Schedule. This will provide activity based funding enabling equitable access to this therapeutic intervention to all Australians and dramatically improve outcomes and prognosis for all HP patients. It will also inform the generation of clinical guidelines for treatment of hereditary pancreatitis with TP-IAT. This study is designed to deliver comprehensive evidence for Total Pancreatectomy and Islet-Auto Transplantation (TP-IAT) inclusion on the Australian Medicare Benefits Schedule for patients with hereditary pancreatitis Who is it for? You may be eligible to join this study if you are less than 75 years old and have molecular genotype-confirmed hereditary pancreatitis (PRSS-1, SPINK-1, CFTR, CTRC) and symptoms of pancreatitis Study details All participants in this study will undergo a total pancreatectomy procedure performed by a hepatobiliary surgeon. The pancreas will then be prepared for transport to the islet cell isolation facility by a renal surgeon. Islet cells are isolated for transplantation the same day. A radiologist transplants the isolated islet cells back (via infusion) into the patient. Participants will then be followed-up and assessed regularly at 3, 6, 12, 24 and 36 months post-procedure to determine impact of TP-IAT on glycemic control, pain and quality of life. It is hoped that this research project will provide evidence to support an application for activity based funding for the TP-IAT procedure through the Australian Medicare Benefits Schedule. This would ensure all Australians have access to this treatment in the future

Diabetes-related foot ulceration (DFU) affects 56,000 Australians yearly, with one person every hour undergoing a foot/leg amputation. DFU healing is complex and multi-factorial. Our research is focused on diets in DFU healing, which is currently under-researched and highly topical. The research team have added to the literature significantly, demonstrating Australian Adults with DFU have poor quality and variety of dietary intake, have micronutrient deficiencies, and individuals with DFU taking supplementation have significantly increased likelihood of healing. However, we do not currently understand best nutrition intervention to support wound healing in those with diabetes. Therefore, this trail was co-designed with people with DFU and wound clinicians to increase acceptability and feasibility. We propose a a 6-week superiority pilot multicentre, double blinded, parallel-group randomised controlled trial that will determine if a personalised dietary intervention in combination with a food box improves wound healing in those living with a DFU.

The primary purpose of this single dose study is to assess the safety and preliminary efficacy of ARG-007 in participants with AIS undergoing endovascular revascularization.

Pneumothorax (collapsed lung) occurs when air leaks from the lung and accumulates between the chest wall and lung. The mechanism of breathlessness in pneumothorax is unclear, and symptoms vary between patients. Sometimes tubes need to be inserted between the ribs to drain the collected air and help the lung reinflate, and occasionally surgery is required. Currently, the effect of accumulated air in the pleural space and its association with diaphragmatic function and symptoms of breathlessness is not understood. Bendopnoea (breathlessness when bending forward) is an evolving clinical symptom that has been demonstrated as clinically useful in some heart and lung conditions. Whether bendopnoea is present in patients with pneumothorax, and its potential clinical usefulness has not yet been investigated. The PASE study is a pilot study to explore the incidence and clinical relevance of bendopnoea in patients with pneumothorax and may provide better understanding of breathlessness in pneumothorax.

This project aims to evaluate the effectiveness of a school-based program (The Let’sTALK Program) in improving communication skills and promoting psychological safety in teachers and students. We hope to learn whether the program leads to increased help-seeking and well-being in students.

A pragmatic before and after study across NSW spinal services (RNSH, POWH, RR) to identify key evidence to practice gaps and evaluate adherence to one guideline recommendation. The study has 4 distinct phases; 1. Retrospective notes audit of current clinical practice to confirm evidence to practice gap and determine adherence to key recommendations from the ‘Clinical practice guidelines for the physiotherapy management of people with SCI’ (Audit Phase). 2. Interview physiotherapists to identify barriers and facilitators of practice for key guideline recommendations from the ‘Clinical practice guidelines for the physiotherapy management of people with SCI’ (Development of Implementation Intervention Phase). 3. Implementation of tailored intervention(s) using the COM-B model for behaviour change (Implementation Phase). 4. Evaluation of change in adherence to key recommendations from the Guidelines for the physiotherapy management of people with SCI (Evaluation Phase).