ANZCTR search results

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).

This is a multicentre, prospective observational cohort study across three centres in Melbourne, Victoria, Australia examining differences in the microbiota of people with leukaemia, people with liver disease, people with other types of cancer who are receiving immunotherapy and healthy volunteers. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older and you are either: a) a healthy volunteer who has not been diagnosed with cancer or liver disease, or b) someone who has been diagnosed with acute leukaemia who has or has not received an allogeneic stem cell transplant, or c) someone who has end stage liver disease and has received a liver transplant, or d) someone who has another type of cancer who is receiving an immunotherapy treatment. Study details Participants who fall into one of the health conditions described above who choose to enrol in this study will be asked to provide a series of blood, stool (faeces) and saliva samples weekly for initial hospital duration then 3 monthly for up to 2 years after enrolment. Participants who are healthy volunteers will be asked to provide a once off blood, stool and saliva sample at the time of enrolment. It is hoped this research will determine whether there are any differences in the diversity of microbiota in people who are immunocompromised compared to healthy volunteers, and whether the type of microbiota that a person hosts has an impact on their susceptability to infection.

The purpose of this research is to evaluate the effectiveness of training in a brief mindfulness meditation vs clinical hypnosis intervention for addressing symptoms of burnout and optimising wellbeing in uninjured competitive athletes. Additionally, the study aims to investigate potential psychological factors underlying the effects of these mind-body therapies. It is hypothesised that mindfulness meditation and clinical hypnosis will be effective via changes in unique mechanisms.

The Northern Sydney Frailty Group lead by Professor Susan Kurrle is presently conducting a frailty intervention trial (FORTRESS) which uses past experience and knowledge gained, to address frailty in the acute hospital setting and extend this intervention into the community. Interventions are based on the Asia- Pacific Clinical Practice Guidelines for the Management of Frailty adopted as best practice at Hornsby Ku-ring-gai hospital in NSW. The FORTRESS Plus study will use a similar cohort, frailty measurement tool and eligibility criteria to the FORTRESS study but provide added community facilitation in the form of weekly supervised progressive exercise sessions at home after discharge from hospital. The 2020 – 2024 FORTRESS Study intervention group will be used as a comparison group.

Previous research shows that 12 months post pelvic fracture, women commonly experience issues with their bladder, bowel and sexual function, collectively known as pelvic floor dysfunction (PFD). This preliminary study also highlighted that men experienced significant sexual dysfunction post-pelvic fracture, but not bladder or bowel dysfunction. In the current study, eligible patients will be asked a series of questions pertaining to their normal bladder, bowel and sexual function during their acute hospital admission. Three months after their discharge from hospital, we will contact them via email or phone and these questions will be re-administered in order to detect any symptoms of PFD (such as pain or incontinence). This will enable patients with PFD to be randomly assigned to either receive usual care or usual care plus onward referral to a sub-acute outpatient continence or urology service. At 12 months post injury, all patients will again be asked the same series of questions to determine whether their symptoms have changed.