ANZCTR search results

The HSCT-BIOME study aims to promote gut microbiota health prior to conditioning chemotherapy and promote its stability/recovery after HSCT using encapsuled, lyophilised faecal microbiota transplantation (FMT). Who is it for? You may be eligible for this study if you are a male or female over the age of 18 and have been diagnosed with multiple myeloma, leukaemia, lymphoma or another haematological malignancy to be treated with auto-HSCT. Study details Participants in this study will be randomised to receive either encapsulated faecal microbiota transplantation (FMT) or placebo; each given as 2 courses of 36 capsules. The first course starts before chemotherapy, aiming to boost gut microbiota health. You will be given the second course after HSCT, once your immune system has recovered. Participants' bowel function and symptom burden will be assessed daily for 3 weeks after HSCT. Other clinical data, including how long you stay in hospital and the use of other medications to control side effects, will also be collected. Any adverse event will be constantly monitored during intervention until 30 days post FMT. It is hoped that findings from this study will show FMT is safe and effective at reducing HSCT complications.

Rapid Sequence Intubation (RSI) is a high-risk procedure in the emergency department (ED). Patients are routinely preoxygenated (given supplemental oxygen) prior to RSI to prevent hypoxia during intubation. For many years anaesthetists have used end-tidal oxygen (ETO2) levels to guide the effectiveness of preoxygenation prior to intubation. The ETO2 gives an objective measurement of preoxygenation efficacy, this is not currently available in most EDs. This trial evaluates the use of ETO2 on the rate of hypoxia during intubation for patients in the ED.

Both dietary fibre and unsaturated fats are known for their health benefits on cardiovascular health, however, there are a lack of studies evaluating the effects of dietary fibre from whole foods on endothelial function. The purpose of the study is to assess the impact of a high fibre diet compared to a lower carbohydrate, high unsaturated fat diet on endothelial function, as an early indicator of cardiovascular disease risk. Males over 45 years old and females post menopause with a low dietary fibre intake of less than 15 g/day will be randomised to one of two groups: high fibre diet (40 g/day from whole foods - wholegrains, legumes, fruits, vegetables, nuts and seeds), or high unsaturated fat diet (approx. 40% energy intake from fat from whole foods). Participants will be provided with dietetic counselling to adhere to their allocated diet during the first 3 months of the study, with a follow up at 6 months from commencement. A subset of participants will be assessed in the postprandial phase (as a more sensitive marker or metabolic health), where they will be provided with a high fat, high sugar meal and have their endothelial function tested every 2 hours for up to 6 hours at baseline and 3 months. This study may help with the development of clinical practice guidelines for dietitians to provide dietary advice to patients for vascular health. We hypothesise that both diets will improve endothelial function.

The purpose of this study is to assess the feasibility and safety of an exercise program concurrent with immune checkpoint inhibitor (ICI) immunotherapy for people diagnosed with melanoma. Who is it for? You may be eligible for this study if you are a patient aged 18 years or over with a diagnosis of cutaneous melanoma and are scheduled to receive adjuvant immune checkpoint inhibitor immunotherapy treatment. Study details Participants will be randomly allocated to either an exercise intervention, or standard medical care. Participants randomised to the exercise group receive a structured exercise intervention for the duration of their ICI immunotherapy treatment (approximately 12 months). The intervention will involve 3 exercise sessions per week (45-60min per session) involving both supervised and unsupervised exercise sessions. Participants randomised to the control group will receive usual medical care and general exercise advice as per the current exercise oncology guidelines. Participants will be asked to complete a variety of questionnaires, undergo fitness testing, and provide blood samples. It is hoped that findings from this study will inform researchers of the effects of exercise concurrent to ICI immunotherapy, following surgery, for patients with melanoma.

This is a single-arm pilot study, involving 28 individuals with diabetes; aged between 14 and 26 years old, wearing up to four blinded DS5 sensors for a period of 15 days. The DS5 device is a new disposable sensor platform utilising the Enlite 3 sensor technology which provides a longer sensor wear and improved ease of device insertion. The product incorporates an insertion device, a sensor recorder, and sensor flex into a single disposable device. The primary aims of this pilot study will be to assess the feasibility and acceptability of the study protocol, familiarise the team with the study procedures, identify potential logistical difficulties that may arise in the main study, and collect estimates of parameters to inform power calculations for the larger study. Sensor performance will be assessed against the gold standard venous glucose readings generated by the bedside Yellow Springs Instrument (YSI) glucose lactate analyser. Patient visits will be scheduled to ensure observations are equally spread over 10 days for both the hypo- and hyper-glycaemic conditions.

The project aims to continue from a previous exploration. We will implement a feasibility clinical trial/teletrial to 1) determine the impact of having a co-facilitator with lived experience of voice-hearing sharing their experiences as part of the delivery method, on participants’ levels of empathy and 2) explore whether this translates to a change in practice. Workshops will be delivered in regional and remote South Australia and available to health and social care staff and undergraduate health sciences students.

This study aims to investigate if pre-exercise ingestion of whey protein isolate can prevent hypoglycaemia in adults with T1D using automated insulin delivery (AID) during moderate intensity exercise. We will explore this under both 'optimal' conditions (session A) and modified 'sub-optimal' conditions when pre-exercise and exercise conditions are modified (session B and C). We will also investigate in a sub-cohort of individuals the effect whey protein ingestion has on blood glucagon levels during the 'optimal' exercise session and a 'rest' session (session D). We hypothesise that the used of whey protein ingestion will mitigate the risk of hypoglycaemia during moderate intensity exercise in people with T1D.

This research aims to evaluate the real-world feasibility, acceptability and effectiveness of the Stress Autism Mate app for autistic adults in Australia and New Zealand. Participants will include approximately 45 autistic adults who are experiencing stress, can read and type English, have a smartphone and are residents of Australia/New Zealand. Using a single group repeated measures design, participants will complete a baseline survey, use the Stress Autism Mate app for four weeks, complete a post-trial survey, then complete a follow-up survey four weeks after completing the app trial. Expected outcomes are reduced perceived stress, increased coping self-efficacy and improved subjective wellbeing.

Loss of visual clarity during laparoscopic surgery remains a major challenge for surgeons as this can contribute to the safety and outcomes of patients. Typically, a suboptimal display of surgical field can occur due to fogging on the front of the laparoscope lens, smoke generated during tissue cutting, and/or splatter of blood, bodily fluids, fat droplets or tissue etc. When the visual clarity is suboptimal, the surgical procedure will be disrupted or prolonged. Currently there are a number of products for restoring laparoscopic visual clarity. Multiple products are often needed in a surgery to tackle the visual clarity challenge. The frequent practice is still to remove the laparoscope from the abdomen for lens cleaning outside of the body. The F&P Laparoscopic Vision System is designed to remove smoke from the field of view of surgeons, enabling surgeons to continue with their work with better visual clarity and less interruption. Better visual clarity has been demonstrated in bench model and uses in patients. The aim of this prospective randomized study is to evaluate whether laparoscopic visual clarity can be improved by using the F&P Vision System compared to other available visual clarity products. Participants will be recruited and randomized to the intervention (where surgeons will use the F&P Laparoscopic Vision System during the surgery) or control group (where surgeons will use the off-the-shelf smoke filter plus other available visual clarity products during the surgery). All other aspects of the surgery are to be carried out as per standard of care and hospital practice. Study participation ends at the end of surgery.

The aim of this randomised controlled trial is to compare the safety and efficacy of the MAXM Skate Rehabilitation Device and associated digital rehab program to standard rehabilitative care for elective Knee Arthroplasty Patients in a Public Health Setting. Comparisons will be made between several functional, self-reported and performance-based outcomes measures until the completion of their rehab program 3 months post total knee arthroplasty. It is hypothesised that a TKA patient, in a public health care setting, uses MAXM Skate Device and digital rehab program then they will experience equal or greater return of function, clinical performance, and satisfaction in comparison to those receiving standard rehabilitative care.