ANZCTR search results

Parkinson’s disease is a neurological condition that results in degeneration of nerve cells in a particular part of the brain that produce the chemical dopamine. The exact cause of Parkinson’s disease is not yet known, however there is some evidence that the gut may be involved. Faecal Microbiota Transplant (FMT) involves delivering a stool sample from a healthy individual (“donor”), to the bowel of the person taking part in the study (“recipient”). The aim of this study is to determine whether FMT is tolerated in individuals with Parkinson's disease and to evaluate for side effects, if any. This treatment is already TGA approved and used in many other conditions. We also aim to evaluate if FMT can improve motor function in patients with Parkinson’s disease, for example tremor, walking, stiffness and slowness. We also aim to determine whether FMT improves constipation or quality of life in Parkinson’s disease. We will also examine the stool of participants over the course of the study to see how the stool make-up changes after receiving the transplant. Participants will receive infusions of placebo or FMT via a gastrointestinal tube and then swap over after the first two infusions. Participants will not know what infusion they are receiving. This is a pilot study, which means it is a small study to test whether FMT might work but it is not yet an established treatment for Parkinson’s disease.

In this study (called a randomised, sham-controlled clinical trial) we want to find out if the application of an innovative new adhesive light patch can reduce pain and improve recovery of movement after knee replacement surgery. In this study, we will compare the effect of the active device with the inactive (sham) device. Half of the participants will receive the active treatment, and half will receive the sham treatment. Today, the usual approach to pain relief and movement recovery after knee replacement surgery is a combination of pain-relief drugs (analgesics) and exercise rehabilitation. They work well, but some people continue to have pain after knee replacement for up to 6 or even 12 months; and they may require continued need for pain medications. We have previously carried out a small feasibility study to work out the protocol details for this new research study. In the feasibility study, we found that patients accepted and tolerated the device, that it was easy for patients to apply at home, and the device provided good pain relief both before and after knee replacement surgery and good recovery of physical movement after the surgery. Based on our previous research, we expect that using a low dose of light therapy daily before knee replacement surgery, and daily after the surgery for one week after surgery, may help people to have less pain in the days following surgery. We also think that further treatment in the second week after surgery will aid recovery of movement and reduce pain in the weeks and months following the operation. The device we are testing is called CareWear. CareWear is a novel, 3-D printed self-adhesive patch with hundreds of micro-diodes (light emitting diodes are found in many home appliances) that emit specific light frequencies that have been found in other research to reduce inflammation and pain. The CareWear patch is registered in the USA and with the Australian Therapeutic Goods Administration (TGA) for applying light to areas of pain and inflammation.

Congenital heart disease (CHD) is the most common congenital disorder in newborns, with an estimated 2400 Australian babies born with CHD each year. Despite improved survival due to advances in surgical techniques and medical care, premature morbidity and mortality are common. In this multi-centre randomised controlled trial, eligible participants with CHD will be allocated to either a 4-month face-to-face or telehealth moderate-to-vigorous physical activity and exercise training program or a usual care (control) group. Participants allocated in the intervention groups will also engage in an 8-month maintenance phase. Detailed assessment of exercise capacity, body composition, vascular function, physical activity levels, liver stiffness, cardiac function, quality of life, cognitive function, lung function, dietary and nutritional status, peripheral venous pressure, and musculoskeletal fitness will be performed. Testing and assessments will be performed at baseline, 4-months, and 12-months.

The purpose of this study is to examine the effect of the Braun Enteroenterostomy (BE) surgical method during surgery to remove cancer in the pancreas or small intestine. Who is it for? You may be eligible for this study if you are over 18 years of age and will be undergoing surgery to remove cancer in the pancreas or small intestines. Study details All patients will undergo pancreaticoduodenectomy surgery with antecolic Billroth II style reconstruction, as per usual treatment. Patients will be randomly allocated to either have the BE procedure added to their surgery or to not have BE. The BE procedure is by joining the small bowel to the large bowel (also known as Braun Enteroenterostomy). This takes which takes an additional 15 minutes. Hospital data will be collected to assess surgery recovery daily and questionnaires will be given days 30 and 90 after surgery. It is hoped that this research will reveal if adding the BE surgical technique during surgery will improve patient safety and recovery after surgery, and results in better surgical treatment for digestive system cancer.

To perform a prospective non-inferiority study of a rapid cardiac MRI acquisition protocol using 4D-flow compared to the current gold standard cardiac MRI examination to measure cardiac function and detect pathology

The purpose of this study is to test whether metformin treatment is associated with greater improvement of cognitive function and brain growth compared to placebo group for children/adolescents with medulloblastoma. Who is it for? You may be eligible to participate in this study if you are between 7 years and 17 years and 11 months old and have been treated for medulloblastoma. Study Details Participants will be required to take oral medication in tablet form daily for 16 weeks. 'Participants will be randomly allocated to receive either metformin as an oral tablet taken daily or a placebo tablet. Participation in this trial will require an overall time commitment of 40 weeks as participants must undergo screening and pre-treatment assessments and as well as a 6 month post-treatment follow-up. Assessments will include MRI scans and cognitive testing to measure memory, attention and processing speed. It is hoped that this research will help to determine if metformin has a positive effect on cognitive and brain recovery from medulloblastoma in this population

Paediatric Hand and Feet burns are a challenging injury for burns clinicians. They have a high prevalence and rate of ongoing morbidity. This is due to a combination of factors including children being curious about their environment and exploring with their hands, having slow withdrawal reflexes and hands and feet having multiple joints within a small body surface area. We believe the management of these burns could be further improved to try and reduce the ongoing morbidity. Currently, standard dressings (mepitel, acticoat and hypafix) are used to dress these burns but there is evidence to suggest that including Negative Pressure Wound Therapy as well may reduce the time to healing and therefore the ongoing morbidity. To include negative pressure as a standard practice of treatment, it must first be shown that it is both feasible and safe. Hypothesis: That the use of NPWT is both feasible and safe in paediatric hand and feet burns.

A transradial arterial approach is being used more frequently for coronary angiography due to the lower vascular complications and lower bleeding rates reported in recent large trials. Radial artery spasm, subclavian tortuosity and the increased technical difficulty of puncturing a smaller and more mobile artery are causes for access failure. This prospective randomised placebo controlled trial aims to look at the role of subcutaneous glyceryl trinitrate, as a vasodilatory agent, injected prior to arterial puncture to improve the technique. Radial artery diameter change will be assessed using ultrasound at the site of injection as well as the contralateral side to review for a systemic effect. Time to successful arterial access will be recorded and patient satisfaction in the form of pain scores will also be recorded.

This study aims to evaluate a 12-week Tai Chi training program as an intervention to add evidence on the therapeutic effect of a non-pharmacological approach in chronic disease management. We hypothesize that QoL, physical function, and mental wellbeing in Tai Chi group is better than the waiting list control group. We hope that the results of our research can be used to inform our knowledge about how to better manage chronic diseases. There are no foreseeable risks associated with this research project.

Dry mouth and the sensation of thirst are common and significant symptoms experienced by people with advanced illness. Dry mouth can be a distressing symptom, and it can interfere with talking and eating. The cause of dry mouth is often multi-factorial and includes the administration of medications which dry out oral secretions. The current management strategies for alleviating the symptom of dry mouth are limited and lack a strong evidence base, particularly in the palliative care setting. The use of mini mint ice cubes for the relief of thirst was established as effective in significantly reducing thirst intensity and distress in critical care patients in two French intensive care units (Lemyze, Lavoisier, Temime, Granier, & Mallat, 2020). However, the mint ice cubes were not evaluated against a control group and the authors noted that further trials may be needed to confirm their findings. This intervention was identified as appropriate for the inpatient palliative care population as the ice cubes are cost-effective and easy to produce. It is also similar to the usual care already provided at the Laurel hospice (plain ice), so is likely to be acceptable to the staff implementing the care. Therefore, there is the potential for significant clinical benefit with little cost and minimal impact to current practice patterns. Demonstrating the efficacy of this intervention for palliative care patients and comparing against a control intervention will comprise a meaningful and novel contribution to the evidence base. Lemyze, Lavoisier, Temime, Granier, & Mallat. (2020). To relieve the patient’s thirst, refresh the mouth first: a pilot study using mini mint ice cubes in severely dehydrated patients. Journal of Pain and Symptom Management, 60(1), e82-e88