ANZCTR search results

Antimicrobial resistance- AMR (in particular antibiotic resistance) has been identified as one of the biggest threats to global health by the World Health Organization. If no sustained action is taken now, >10 million people could die each year by 2050 directly due to antimicrobial resistance (O'Neil, 2016). Nutritional interventions have been identified through literature review to have potential to combat against AMR. The most promising strategy is the popular use of probiotics (“live microorganisms which when administered in adequate amounts confer a health benefit on the host”) to restore and boost the beneficial microbes in our bodies. Another nutritional strategy for modulating the microbiota is consumption of dietary fibre and prebiotics that can be metabolized by microbes in the gastrointestinal tract. The functional food group of fermented foods, defined as foods or beverages produced through controlled microbial growth, and the conversion of food components through enzymatic action is another potential candidate nutrition strategy for combating AMR. Another food group that shows promise includes the polyphenol-rich food, polyphenols are a group of plant metabolites with potent antioxidant properties, which protect against various chronic diseases induced by oxidative stress. Lastly, interest in the use of trace metals as antimicrobial agents such as zinc, selenium, copper, iron, manganese, and other trace metals are increasing. Trace metals are naturally occurring essential microelements recommended for daily intake. These minerals are present in a wide range of foods in addition to their presence in nutritional supplements. The aim of the proposed project is to conduct a small pilot proof-of-concept human study to investigate the use of combination nutritional interventions to reduce AMR. In this pilot study, we will assess whether the natural nutritional interventions enhance gut microbial diversity and profiles, reducing resistant bacteria in the gut as well as enhancing immune functions in humans. The results of this study will provide proof-of-concept evidence to support the potential role of these nutritional interventions in combatting against AMR, and therefore whether it could be implemented as an adjunct nutritional therapy for AMR.

The aim of this study is to collect information treatment and patient choice in early-stage breast cancer patients. Who is it for? You may be eligible to join this study if you are male or female, aged older than 18 years, and have early-stage breast cancer. Study details At the start of the study, all participants will be asked a series of questionnaires on demographics, perceptions about cancer treatment, and beliefs about medicine; this will be conducted by phone, online, or face-to- face. Afterwards, patient records will be reviewed for breast cancer events, and all participants will be followed up with a brief survey on treatment compliance every 3 months for the first 2 years, then every 6 months up to 5 years. It is hoped that this study will reveal how patient beliefs influence their choice of treatment, and hence allow better psychosocial understanding of breast cancer patients.

The aim of this feasibility study is to compare the effects of dance therapy in addition to usual care with conventional group-based physiotherapy in addition to usual care, on physical function in recently hospitalised adults with acquired brain injuries. Specifically the researchers of this study will examine the effect of dance compared with conventional physiotherapy therapy on physical function, mobility, self-efficacy, quality of life and satisfaction; understand patients’ preferences for dance therapy; and assess the acceptability, adherence and adverse events associated with a dance therapy program. A steering committee of consumers, dancers and the health service will co-design the dance therapy program and will meet bimonthly either face to face or online platform (given general health recommendations during the global pandemic) to discuss about the program. Adding dance to rehabilitation may have the potential to reduce hospital lengths of stay and return people to their homes earlier by enhancing motivation, providing additional opportunities for movement.

This study will investigate whether personalised ear health discharge planning by an Aboriginal Ear Health Professional (either Aboriginal Health Practitioner, Aboriginal Health Worker or Aboriginal Registered Nurse) for in-patient Aboriginal children at Royal Darwin Hospital will improve the ear health problems of those children over the next 4 to 8 months. The Aboriginal Ear Health Professional will also spend time with the children's families whilst they are in hospital, providing them with ear and other more general health education and supporting them through the hospital experience.

Data from small studies indicates high-intensity exercise provides significant benefit to the ageing brain; however, previous intervention studies have rarely delivered exercise above moderate-intensity. In addition, although supervised exercise studies in older adults usually report good attendance, they have not reported long-term changes to exercise levels. The current project will determine the feasibility of a study that will compare 12-months of high-intensity and moderate-intensity group-based exercise in older adults, which will include an exercise program coupled with education and behavioural change techniques, in order to try to get people to change their long-term exercise habits. Participants will be allocated to one of three study groups: high-intensity exercise, moderate-intensity exercise, or a stretching control group. All participants will take part in a 12-month intervention, which is split into two blocks: 1) a supervised exercise intervention coupled with group education that will take place at Murdoch University for 3 months, and 2) followed by a 9-month Maintenance period, where participants in the active exercise groups will be provided with gym memberships and booster education sessions every 2 months. Before, during, and after the intervention, participants will undertake a battery of cognitive tests and questionnaires, DXA scans, and assessment of physical function.

This study will explore the hypothesis that the advanced HCL (AHCL) system will reduce the glycaemic variability and thereby improve the glycaemic outcomes of children and improve the wellbeing of parents/caregivers. This proposed study is a 3-month multicentre randomised controlled study in children aged 2 to 7 years with Type 1 Diabetes (T1D) on insulin pump therapy. The participants will be randomly assigned to two groups: control group on standard therapy and the intervention group on AHCL system in the Medtronic 780G pumps. The primary objective is to compare the proportion of time in target range (sensor glucose 3.9-10mmol/l) in young children with T1D while using AHCL or standard insulin pump therapy. The secondary aims are to determine the effect of AHCL on hypoglycaemia and hyperglycaemia and to determine the psychological and social well-being of caregivers compared to standard care. The age of the participants means that this is placed in a category more than low risk although the level of parental supervision at this age and the use of a system that allows 24/7 glucose monitoring in reality more than mitigates this theoretical consideration. There are no potential ethical issues in the proposed study.

Infants and children with a symptom or abnormality involving the upper gastro-intestinal system often require a gastroscopy procedure. During anaesthesia for this procedure both the proceduralist and the anaesthetist share the child’s upper airway for delivery of oxygen and for the placement of a small flexible pipe with a fibre-optic camera (endoscope) to directly view the anatomy within the oesophagus, stomach, and upper small intestine. The choice of airway for this procedure is usually at the discretion of the anaesthetist of which various options are currently available. We aim to compare the newer technique of Nasal High Flow (NHF) with conventional ventilation using a laryngeal mask airway (LMA), through a randomised controlled trial in infants and children during upper gastro-intestinal endoscopy. If we can determine that NHF is not inferior to the use of an LMA, this has the potential to both reduce the number of interruptions, improve the access of the scope, and limit the anaesthetic exposure required to successfully complete these procedures in children.

In this trial, we will investigate the effectiveness of a campaign about low back pain compared to no intervention at improving an essential domain of pain-related self-efficacy. We will also conduct qualitative testing, including evaluating engagement to maximise the impact of delivering a reassuring message about low back pain using social media.

Pleural effusions (excess fluid accumulation between the lung and chest wall) affect 60,000 Australians every year and can arise from a wide range of causes including cancer, heart and liver failure. Pleural effusions often cause disabling breathlessness. Drainage of the fluid (usually requires inserting tubes between the ribs) can relieve symptoms, but the benefits vary among patients. The mechanism by which pleural effusion causes breathlessness remains unclear. A reliable method of identifying the patients likely to respond to drainage may help reduce unnecessary, painful procedures and their associated complications and healthcare costs. The PLeural Effusion And Symptom Evaluation project aims address this knowledge gap. Bendopnoea (breathlessness on bending forward) is a common clinical complaint in patients with pleural effusion but has not been previously studied. Our pilot data found that bendopnoea was significantly associated with the presence of pleural effusion. The PLEASE-3 study will aim to evaluate the value of bendopnoea as a screening test for effusion-related breathlessness, its predictive value of symptomatic benefits from fluid drainage and explore the physiological mechanisms underlying bendopnoea. Participation on this study involves completing questionnaires, performing a bendopnoea test, breathing test via spirometry and a 6-Minute walk test. If there is fluid needed to be drained first, the tests will be performed once before and once after the fluid is drained (within 36 hours of removal of the fluid). The results of these 2 sets will be compared to each other to find out the difference, if any, of removing the fluid.

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of CBD capsules in adults with sleep disturbance. Adults will be screened for study eligibility by attending the clinic between Day -28 and Day -4. Study eligibility will be confirmed at the clinic on Day -3 and baseline measures will be conducted at home between Days -3 to Day 1 with Day 1 being the first day of study drug administration. Participants will be required to attend the study clinic at screening, on Day 31, and Day 37 (EOS) or ETV. There will be no clinical confinement period in this study and all clinical assessments will be performed as outpatient visits or telehealth consultations. The study will evaluate 3 dose levels of the investigational product, Satipharm CBD capsules or placebo in 4 parallel treatment arms of 53 participants per arm. Participants will be enrolled across 4 parallel treatment arms to receive daily doses of Satipharm CBD or placebo for a period of 30 days. Treatment Arm 1 : 0mg (placebo), Treatment Arm 2: 25 mg, treatment arm 3: 50 mg, treatment arm 4:100 mg. A single daily dose of Satipharm CBD capsules or placebo (2 capsules/dose) will be administered from Day 1 to Day 30 whereby each participant will receive a total of 30 doses with an evening meal. Study drug will be self-administered on a daily basis from Day 1 through to Day 30. Outpatient clinic visits are scheduled for Days 31 (the day following the last dose of study drug), and again on Day 37 which is the end of study (EOS) visit.