ANZCTR search results

Haemodialysis cleans the blood and replaces some of the function of the kidneys when they are no longer working. Patients undergoing haemodialysis have traditionally been prescribed diets low in fruits and vegetables and high in animal protein, sugar and fat to prevent malnutrition and limit dietary potassium and phosphate. Research has shown that healthy diet patterns high in fruits, vegetables, nuts and legumes, and lower in meat and processed food are associated with lower risk of death in those with early stages of kidney disease, however studies examining these outcomes for haemodialysis patients are sparse. The aim of the study is to examine the extent to which healthy diet patterns and meeting core food requirements occur in our patients requiring haemodialysis and follow up participants for up to 5 years for heart disease related events. The study will use a questionnaire to collect information on dietary intake from patients undergoing haemodialysis. Data will be examined for diet quality by food groups and assessed against healthy diet criteria.

Strive to Thrive was created by people with a lived experience of stroke, clinicians and researchers. It is designed to help people who have had a stroke identify what helps and hinders them at their work and create a personalised action plan to manage the impact of the stroke on their day-to-day work life. We want to see if Strive to Thrive is acceptable to a broader group of people who have had a stroke, and make further adjustments and improvements based on their feedback. If Strive to Thrive is acceptable and seen as useful, we can then do a larger study to find out if it has a positive effect on the person who has had a stroke.

This is a pilot feasibility study to evaluate mobile rapid point-of-care hepatitis C antibody and RNA testing and treatment initiation for individuals completing community correction orders, who are at high risk of viral hepatitis but currently cannot access prison-based hepatitis screening and treatment programs. This study will evaluate the feasibility, acceptability and efficacy of point-of-care fingerstick testing for hepatitis C antibodies and hepatitis C viral load, as well as rates of direct-acting antiviral (DAA) initiation (including same day hepatitis C testing and initiation of treatment) and treatment outcomes. A mobile clinic van fitted with medical equipment and staffed by a hepatitis clinical nurse consultants and peer mentor will attend community corrections facilities to recruit individuals attending these sites. Following recruitment, study personnel will conduct hepatitis C point-of-care testing, clinical assessments from the van, and initiate DAA therapy and discuss harm reduction strategies where appropriate. The study is a prospective cohort design recruiting consecutive participants at designated community correction sites over an 18 month period. Participants will be tested for hepatitis C exposure using a point of care antibody test. For participants who test positive for hepatitis C antibodies, current hepatitis C infection will be tested using rapid POC HCV VL fingerstick testing through the mobile van service. All participants who have current hepatitis C infection will be offered DAA treatment in line with the Australian consensus statement on the management of hepatitis C. Following completion of DAA therapy, participants will be monitored for an additional 4-12 weeks and offered hepatitis C point-of-care RNA PCR testing to confirm cure. The primary outcomes of the study are the feasibility of POC hepatitis C testing amongst the study population, DAA treatment initiation, uptake of same day hepatitis C testing and treatment initiation and likelihood of hepatitis C cure.

Naltrexone (NTX) is an opioid receptor antagonist commonly used to treat opioid withdrawal at a dose of 50.0-100.0 mg daily. Low dose NTX (LDN), within a specific dosage window of 1-5 mg/day as been used off-label since the mid-1980s due to improvements in chronic pain, stamina, cognition, fatigue, and inflammation for many autoimmune disorders, chronic pain syndromes, malignancies, and mental health disorders to target symptoms overlapping with long COVID. There is evidence to suggest the use of LDN will be beneficial to treat patient outcomes for those with Long COVID. A randomised dose ranging double blind placebo controlled 12-week clinical trial is proposed to determine the efficacy of LDN based on clinical symptoms and quality of life. Primary and secondary outcomes will be assessed through a series of online questionnaires to determine changes in symptom presentation (primary outcome) and through a series of validated patient reported outcome measures for quality of life.

Models of health care have traditionally been episodic and diagnosis centred. In an era of increased chronic illness, multi-morbidity and disability, there is a clear need for health care to transition towards integrated, person-centred and goal-oriented care. However, aligning care planning and delivery with healthcare consumers’ needs and preferences is operationally challenging, particularly across settings and clinical specialties. The aim of this study is to assess the feasibility of (i) healthcare consumers using a recently codesigned consumer digital health intervention, the MyNeeds intervention, to capture needs and preferences directly from healthcare consumers, and (ii) healthcare staff accessing and using this consumer data to inform person-centred care planning. This study is a non-randomised feasibility study that will be conducted sequentially across two inpatient wards: an acute medical ward; and an inpatient general subacute ward at an Australian metropolitan public health network. Primary outcome will be feasibility assessed using Bowen’s framework across the following focus areas: acceptability; demand; practicality; implementation; adaption; and integration. All consumers admitted to wards one and two during a six-week feasibility testing period will be screened for eligibility and all eligible consumers invited to participate. Consumers will be eligible unless they are: admitted and discharged after hours or on weekends; predicted to be discharged within 24 hours of admission; or currently participating in another unrelated trial where the fidelity of either trial could be impacted. All clinical and clinical support staff working on the test wards during the feasibility testing period will be eligible and invited to participate.

This study is an open-label trial investigating the safety, feasibility, and tolerability of photo-biomodulation Therapy (PBMT) on healthy participants aged 50 to 70 years. Photo-biomodulation (PBMT) employs red or near-infrared (NIR) light (600-1100nm) to stimulate healing, protect tissue from dying, increase mitochondrial function, improve blood flow, and tissue oxygenation (Dompe et al., 2020; Hamblin, 2018). PBMT can also act to reduce swelling, increase antioxidant defence, decrease inflammation, protect against apoptosis, and modulate microglial activation states (de Freitas & Hamblin, 2016; Hamblin, 2017). All these mechanisms of action strongly suggest that PBMT delivered to the head could be beneficial in cases of mild cognitive impairment and dementia (Hamblin, 2016; Hennessy & Hamblin, 2016). The study will also determine the relevant parameters of PBMT that will be used to design a larger randomised blinded trial. We hypothesize that the (1) PBMT intervention will be safe and tolerable for an older adult population and (2) the treatment will result in discernible changes in MRI measures and these will be correlated to improvements on neuropsychological assessment outcomes on the CANTAB that reflect decision making and working memory constructs, as well as EEG measures of attention and working memory. The 12-week intervention will include participants undergoing pre-treatment assessments (week 0), 12 weeks of PBMT (week 1-12), and post-treatment assessments (week 12). The PBMT trial will be evaluated against baseline verse follow up cognitive, psychological, and neuroanatomical changes, along with participant safety and tolerability (number and severity of adverse events) and program completion (actual treatment completed).

Craniosynostosis is a condition where the bones in a baby’s skull fuse too early causing an unusual head shape. Most children with this condition undergo cranial vault remodeling surgery within the first 2 years of life. This operation is generally effective in normalising the overall shape of the skull, however, a common issue after surgery is hollowing of the temples just in front of the hairline (temporal hollowing). The current way that temporal hollowing is corrected involves using artificial materials (for example, a bone substitute putty or plastic-like implant) but they have some limitations and can only been used when the child is in their teenage years and their skull has stopped growing. A new approach to fix this problem uses a specially made, degradable tissue scaffold. This scaffold is designed to fit in the affected area and can be placed through a smaller incision. The benefits of using this scaffold include the potential for further growth, which is not possible with current materials used for correction. The scaffold is made of a material called Polycarprolactone (PCL) which is the same material that some dissolving sutures are made of and is known to support tissue growth. The scaffold will also have a compound called Tricalcium Phosphate added which encourages bone to form. Eventually the scaffold will be replaced by the patient’s own bone as the scaffold slowly degrades. These scaffolds have been studied extensively and are currently being used in Australia in trials for other types of reconstruction (eg skull defects, leg bone defects, and jaw bone defects). Aims of the study: The main aim of the study is see how effective a tissue scaffold is at improving the appearance of the temporal region and forehead in children with temporal hollowing. The study will also investigate how much new bone forms within the scaffold. Importance of the findings: Tissue scaffolds have been used in other parts of the face, but this will be the first time they have been used in the temporal region, laid on top of the bone. This study will therefore tell us how effective scaffolds are at augmenting bone. This is relevant for many children with congenital conditions that affect the face, where the facial bones do not grow normally and may need to be augmented.

A trial in healthy adults to evaluate how AR882 may interact with common drugs such as fluconazole, carbamazepine, celecoxib, and sulfasalazine.

We aim to determine if maternal oxygen supplementation 5-10 min prior to birth of term and near-term infants (32 weeks gestation or above at birth) utilising heated humidified high flow nasal cannula with 100% oxygen at 30-70L/min is feasible at both caesarean section and vaginal births. The information gained from this feasibility study will inform the planned randomised controlled trial of maternal oxygen in very preterm infants.

Four in five (80%) older Australians report having one or more long-term health condition. Older frail patients who undergo cardiac surgery have poorer postoperative outcomes. There is some evidence that multidisciplinary prehabilitation may reduce the number of postoperative complications in older patients undergoing abdominal cancer surgery. There is a need for the current pilot study to demonstrate the feasibility of the multidisciplinary prehabilitation program in frail older persons and to investigate any potential risk, adverse events, compliance to exercise program and satisfaction in this patient population who has higher likelihood of unwanted postoperative outcome after cardiac surgery.