ANZCTR search results

The aim of this study is to investigate whether addition of a new therapy using the NanoKnife system improves survival in patients with unresectable stage 3 pancreatic cancer. The Nanoknife system is a type of irreversible electroporation (IRE) device. “Electroporation” is a cellular destruction technology that can be used to treat cancer. It uses electrical pulses to make small holes in cells that cause cell death. This destroys the targeted tissue in the body and the treated tissue is then removed by the body’s natural processes in a matter of weeks, mimicking natural cell death. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a diagnosis of unresectable stage 3 pancreatic ductal adenocarcinoma, and have received (or will receive) at least 3 months of a single line of chemotherapy prior to enrolment. Study details Within 1 to 3 weeks after completing their 3 months of chemotherapy, all participants will undergo the IRE procedure. The IRE procedure will only be performed by a surgeon qualified in the use of the NanoKnife System. The procedure will require a general anaesthetic and will take approximately 2-3 hours to complete. As part of the procedure, a diagnostic laparoscopy (a procedure where a camera is inserted into the abdomen through small incisions) will be used to rule out the presence of metastases. Following this, the abdomen will be opened to perform IRE. A tissue biopsy will be taken during the procedure if safe to do so. After recovery from anaesthesia, participants will stay in hospital for up to 7 days before being discharged home when they are well. Participants will be asked to complete a number of questionnaires at 3, 6, 12, 18, and 24 months following the procedure, and will also be asked to report any side-effects that they experience for the duration of follow-up. Following treatment with the NanoKnife, you may continue to receive other standard of care treatment such as further chemotherapy or radiotherapy. This will be decided by your treating oncologist. It is hoped that this study may demonstrate that use of the NanoKnife system in patients with unresectable stage 3 pancreatic cancer who have already received chemotherapy is safe to use, improves survival, reduces pain, and increases quality of life compared to patients receiving chemotherapy alone.

We aim to examine the clinical effectiveness and economic benefit of a whole of class self-regulation program in mainstream schools. We aim to: 1) improve the self-regulation skills of school-aged children experiencing social disadvantage and 2) determine the cost of an occupational therapy service delivering the intervention. Participants: Eligible Stage 2 students from two separate schools, one as the control group and the other an intervention group. Participants will be children aged 8-10 years, and their classroom teacher. Methods: a control group and treatment group will be utilised to establish a cause and effect relationship between a whole class occupational therapy led self-regulation program, and the selfregulation skills of participants. Hypotheses: we expect that the self-regulation skills of children in the treatment group will show more improvement over time than the control group. A reduction in behavioural incidents, suspensions and absenteeism is also expected.

This study aims to investigate the impact of a body appreciation-based writing intervention on a female cancer survivor population. Who is it for? You may be eligible for this study if you are a female aged 18+ years who has completed active anticancer treatments (i.e. not currently receiving chemotherapy, radiotherapy, surgery), for any cancer type. Study details Participants will be randomly allocated by chance (similar to flipping a coin) to a single-session 15-minute writing intervention which will either be writing about your day, or writing about appreciating your body. Measures will be taken directly before the writing session, after the writing session, and one week later. It is hoped that information from this study will help develop a program aimed at improving wellbeing for female cancer survivors.

This project will be part of a larger international effort that is examining the best way to transfuse patients who are 65 years old or younger and undergoing cardiac surgery, We will determine if there is an association between baseline hepcidin values and patient outcomes 28 days after cardiac surgery, after taking into account iron storage, haemoglobin values, transfusion strategy and other factors known to influence cardiac surgical outcomes, which has not been examined previously. We will also explore the association between hepcidin and the recovery of haemoglobin levels back to normal 30 days post-surgery after accounting for other factors that may cause haemoglobin to recover slowly.

This study will investigate the feasibility of performing stereotactic radiosurgery prior to operative management to remove brain lesions in patients with metastatic breast or non-small cell lung cancer. Who is it for? You may be eligible for this study if you are aged 18 or older and have confirmed metastatic breast cancer or non-small cell lung cancer with between 1-4 identified brain lesions that require surgical removal. Study details Participants enrolled in this study will attend a radiotherapy planning appointment where they will undergo a brain CT scan and a MRI brain. At the time of the CT scan a stereotactic radiotherapy mask will be made for immobilisation during radiotherapy treatment. Radiation treatment will take place after an appropriate treatment plan has been formulated. Within 48 hours of the stereotactic radiotherapy a neurosurgeon will then operate to remove the cancer tissue from the brain. Participants will then be asked to attend follow-up visits with their doctor and have regular follow up MRI scans, as normal, and information regarding their disease progress after the procedure will be shared with the research team. Participants will also be asked to complete a short study questionnaire about their satisfaction with the radiosurgery intervention at 6 and 12 months after the procedures were completed. It is hoped this research will demonstrate that the combination of radiotherapy prior to surgical intervention for the treatment of brain lesions is feasible, and that a larger trial to investigate the efficacy of these treatments for cancer patients can be conducted in the future.

Heart failure is one of the most common causes of hospital admissions globally. Typical signs and symptoms of acute heart failure (HF) are mostly related to congestion, driven by sodium retention and subsequent fluid retention. Removal of excess sodium and water (decongestive therapy) by diuretics is the cornerstone of treatment. Assessing the efficacy of treatment by current methods, such as weight loss and net fluid balance is very challenging. Diuretics act by diminishing sodium reabsorption at different sites in the kidney, thereby increasing urinary sodium and water loss. Hence, a limited number of small prospective observational studies have suggested the role of urinary sodium content (UNa) as a tool to rapidly assess the response to decongestive therapy and to estimate future outcomes. Aims and Objectives: 1. To assess the feasibility and efficacy of adjusting diuretic therapy using UNa in patients presenting with AHF in an Australian metropolitan hospital 2. To evaluate the safety of this method 3. To determine if UNa guided diuretic therapy improves clinical outcomes Design: A prospective, randomized controlled trial. Study population 60 patients >18 years old admitted under cardiology team with the primary diagnosis of AHF, requiring intravenous diuretics. Recruitment period: 6month. Expected number: 60 patients.

We aim to establish the usability and effectiveness of a new insufflation device, as a way to open the Eustachain Tube and drain the middle ear fluid in children with chronic otitis media with effusion (OME).

Gynecology trainees continue to face difficulty in obtaining adequate procedural experience due to increased trainee numbers, restrictions on working hours and advances in medical management. A prospective cohort study was conducted assessing the efficacy of a virtual reality stimulation (VRS) -integrated curriculum for gynecology trainees The primary outcome of interest was the impact of the virtual reality training program on live operating performance at 6 months, hypothesising that involvement in a VRS-integrated curriculum should improve live-operating performance for novice and experienced trainees.

The study aims to evaluate feasibility, safety and acceptability of an integrated community-based model-of-care for low risk patients with AF and to gather data that will allow this new model-of-care to be implemented system-wide. The research hypothesis is that it is feasible for Ambulance Victoria and specialist AF clinics to deliver an integrated safe and timely community-based model-of-care for AF patients with low risk acute presentations. By implementing a novel clinical pathway supported by cardiology consultation, paramedics can accurately and safely treat AF in the homes, avoiding the need for transport to ED.

A pressure injury, sometimes known as a bedsore, is an injury to the skin and/or underlying tissue. They usually occur on bony areas of the body like the sacrum (tail bone) and heels. Pressure injuries, are caused by pressure, from not being able to move easily, lying or sitting in the same position for too long, or sliding down the bed or chair. Patients are at risk of developing pressure injuries in hospital. Pressure injuries are largely preventable, and are painful, may become infected, can take a long time to heal, and can mean a longer time spent in hospital. Better strategies are needed to prevent pressure injuries in hospital patients. The Subepidermal Moisture (SEM) Scanner is a tool that can be used to detect early changes in tissue that may develop into a pressure injury. The SEM Scanner does this by measuring changes in the tissue moisture and inflammation just below the skin. The differences in the tissue moisture and inflammation are caused by tissue damage early in the development of a pressure injury, and before the pressure injury can be seen. The SEM scanner can detect tissue changes 3-5 days before a pressure injury can be seen. The main aims of this study are to test whether using a SEM scanner in addition to routine care, compared to routine care only, in hospital patients, is acceptable and feasible, and to compare the number and severity of pressure injuries that develop in both groups.