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A randomised controlled trial to evaluate the effects of marked weight loss combined with exercise training on metabolic, immunological, and imaging biomarkers of systemic and brain inflammation in participants undergoing bariatric surgery.
This randomised controlled trial aims to evaluate the effects of marked weight loss, via bariatric surgery, combined with a personalised exercise intervention on markers of brain inflammation. This study will allow us to explore the link between excessive adiposity-induced systemic chronic inflammation, metabolic abnormalities, and neuroinflammation. We hypothesise that bariatric surgery, i.e., marked weight loss, and exercise will result in attenuated neuroinflammation (as measured by neuroimaging), improvements in cognitive function, improvements in immune-inflammatory markers, and improvements in cardiometabolic biomarkers at 12 months compared to control.
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Safety, tolerability and pharmacokinetics of SSTK-101 in healthy volunteers
SSKI-101 is a novel anti-SARS-CoV-2 IgY antibody spray that has been developed as a Class 3 - Medical Device under the TGA guidelines. It is for use 4 times daily through self-administration in the nose and mouth for prevention of COVID-19 in adults. The IgY neutralizing antibody is obtained from the egg yolk of hens immunised with a purified recombinant SARS-CoV-2 extracellular domain of the spike protein (S-ECD). SSKI-101 has the potential to prevent infection with SARS-CoV-2 by acting as a barrier to the virus entering the body through cells in the nose and mouth. Initial human studies have been undertaken and have been positive thus far. This human healthy volunteer Clinical study is designed to determine the safety and tolerability of SSTK-101 when administered in the nose and mouth and also to investigate whether SSTK-101 is absorbed systemically following administration to the nasal cavity and mouth. It is also being completed to assess further the preventative results.
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The Effect of a Prehabilitation Exercise Program on Peritoneal Dialysis Outcomes: A Feasibility Study
The physical function of people commencing peritoneal dialysis is poor as a result of their kidney disease. The choice of receiving peritoneal dialysis requires people to self-manage their treatment which includes being able to set up their home peritoneal dialysis machine, move large bags of dialysate fluid and connect to and disconnect themselves from the machine. Hence, they must maintain sufficient physical function to continue managing their peritoneal dialysis. In this cohort, poor physical function has adverse effects on the core patient outcomes of life participation, independence and peritoneal dialysis technique survival Pre-operative exercise, also termed prehabilitation, is defined as a process of improving the functional capability of a person prior to a surgical procedure. This study will establish the feasibility/acceptability of a prehabilitation-focused exercise program in people commencing peritoneal dialysis. The hypothesis is that by introducing exercise early into the treatment plan, people receiving peritoneal dialysis will be more able to incorporate, and maintain, a safe exercise program to maintain physical function, live well, and remain on peritoneal dialysis longer.
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FusiOn veRsus bEst coNServatIve Care (the FORENSIC-Australia trial)
FORENSIC-Australia aims to find out: 1) if lumbar fusion surgery (an operation that fixes spinal bones together) for a carefully selected group of patients with on-going, severe low back pain and spine degeneration, and who have already tried non-surgical treatment, is better than best conservative care (personalised spinal care) at improving back-related disability. Best conservative care is a personalised, patient-focused treatment plan with evidence-based options including advice and education, exercise, combined physical and psychological treatment, and other pain control strategies; 2) if the surgery is good value for money.
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Oral Lisdexamfetamine for the treatment of Acute Methamphetamine withdrawal (the OLAM trial): A randomised controlled trial
Untreated methamphetamine withdrawal is a significant barrier to people meeting their treatment goals. Lisdexamfetamine has the potential to help manage withdrawal from methamphetamine. This study is a randomised controlled trial of a tapering dose of lisdexamfetamine for the treatment of acute methamphetamine withdrawal, over a 7 day period in hospital. We will then follow up participants for 84 days.
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Effect of a digital intervention on pain and reliance on opioids after total knee replacement surgery
The efficacy and safety of digitally delivered pain self-management interventions for reducing pain after surgeries, including total knee replacement (TKR), have been demonstrated in several randomised controlled trials. However, little is known about the feasibility and effectiveness of these interventions in Australian hospital settings. The current project evaluates the implementation and effectiveness of an mHealth intervention designed to support patients’ engagement with pain self-management after TKR surgery. Consenting patients (N = 130) who are scheduled to undergo TKR surgery will be randomised to receive either a psychoeducational video prior to surgery, and one SMS text message per day for 3 weeks after surgery, or the pre-surgery psychoeducational video only. Both groups will continue to receive usual care. Outcome measures including pain intensity (primary), opioid dose, pain-related distress, and perceived social isolation will be recorded at baseline, 3 days, 3 weeks, 6 weeks, 3 months, and 6 months after surgery using self-reported surveys. Pain self-efficacy will be measured at 6 week, 3 months and 6 months post-surgery. Implementation outcomes will be evaluated using mixed (quantitative-qualitative) methods. This trial represents a first step towards the translation of digitally delivered non-pharmacological acute pain management in the Australian healthcare system.
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The Enhanced Dementia Diagnosis (EDD study) study-Evaluating new diagnostics for Alzheimer's Disease against usual care for people attending memory clinics within Australia.
It is difficult for skilled clinicians to diagnose Alzheimer’s disease in the early stages. A diagnosis of Alzheimer’s disease also requires evidence of a particular type of brain pathology by using a specialized brain scan. The EDD study has been devised as a comprehensive solution to address current diagnostic challenges. The EDD study is integrated into existing clinical services, with the aim of providing clinicians with data on pathology, brain damage, and brain function through advanced blood diagnostics, advanced brain-imaging techniques, and in-depth digital cognitive assessments that can be performed via telehealth. This study will assess the accuracy and usefulness of each element of the EDD program using surveys of physicians and patients, and with reference to gold standards.
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Pilot trial to Evaluate the effect of early multi-disciplinary care on chronicity of transport accident injuries
Objective 1 - Evaluate the potential effectiveness of the stratified care rehabilitation program by assessing the impact on health outcomes pre- to post-intervention,. Objective 2 – To evaluate the acceptability and feasibility of the stratified care rehabilitation program through focus group interviews with trial clients and physiotherapist-participants.
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A pilot study of a lung health check for middle-aged adults.
This research through Floreat surgery will trial a new lung health calculator to help detect a common and serious lung condition called Chronic Obstructive Pulmonary Disease (COPD). This calculator called “PRECURSOR” has been designed to be used by adults aged between 40 and 49 years who smoke or have smoked. It forecasts a person’s chance of having COPD in 10-years’ time. Doctors can use this calculator to help people stop smoking and decide on having a breathing test. The findings from this pilot trial will help the researchers understand: 1) whether completing "PRECURSOR" is motivating for patients aged 40-49 who smoke to stop smoking, and 2) how GPs may wish to adopt this COPD calculator in their clinical practice.
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Stopping Haemorrhage by Application of Randomised Compression or Tourniquet (SHARC-TWO)
Effective haemorrhage control is crucial in cases of limb trauma involving arterial injury, such as shark attacks. International first aid guidelines recommend the use of arterial tourniquets as a primary treatment for life-threatening external bleeding. Manual pressure applied directly over a major artery proximal to the injury (Inguinal Fist Compression, IFC) is more accessible in a first-aid situation than commercial windlass tourniquets (CWTs). Stopping Haemorrhage by Application of Randomised Compression or Tourniquet (SHARC-Two) is a trial designed to examine which of these interventions is superior at reducing arterial blood loss when applied by a member of the general public. Based on a recent pilot study, we anticipate that IFC will achieve a greater reduction in femoral blood flow than a CWT when applied by untrained bystanders after brief infographic exposure.