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Evaluation of a new biomarker for tear film health
As the most common indication for seeking medical eye care in developed countries, tear dysfunction is a major public health issue. The most common form of tear dysfunction is dry eye disease. At present, major barriers to optimal dry eye medical care are difficulties in reliably diagnosing and assessing the severity of the condition. There is therefore a need for new, rapid, cost-effective methods for detecting and staging dry eye, and tear dysfunction more generally, in clinical practice. This study seeks to evaluate a new method for analysing tear health, based upon quantifying biophysical attributes related to tear viscoelasticity, using a novel acoustically-driven microfluidic extensional rheometry platform. This study seeks to assess the therapeutic responsivity of the new method by examining correlations between the changes to dry eye clinical signs and ADMiER-derived tear rheology attributes, in response to established interventions for dry eye. We hypothesise that the viscoelastic properties of the tears will correlate to changes in the clinical signs and symptoms of dry eye disease.
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Inspire Beyond ICU: Inspiratory muscle training for Intensive Care patients requiring prolonged mechanical ventilation
The sickest patients in the intensive care unit (ICU) receive prolonged, invasive mechanical support for their breathing, which may be lifesaving. But after this, it is common for the breathing muscles to be weak, which makes it difficult to get back to normal breathing, with an increased risk of death or poor recovery. We have found that 2 weeks of breathing muscle training, started in the ICU, is safe, improves breathing muscle strength, and may improve quality of life after ICU. This study tests whether 6 weeks of training improves quality of life after ICU in a larger group of up to 300 patients. We do not know whether the longer period of training will result in significantly better outcomes for patients, and the results of this study will help physiotherapists know whether this is a useful approach for future ICU survivors.
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Monitoring glucose levels in Australian children with early stage type 1 diabetes (T1D)
In this study, we want to learn about how and when glucose levels measured using continuous glucose monitoring (CGM) in Australian children change over time so that we can better understand how T1D develops. By monitoring changes in glucose levels and patterns with CGM, this study will also provide useful additional information on whether these children are progressing towards a clinical diagnosis of T1D, and treatment with insulin. The CGM will be worn “blinded” meaning no glucose readings will be visible to participants whilst wearing the CGM. Participants will be asked to wear at least 2 sensors, each lasting up-to 10 days to obtain at least 14 days of glucose data. These CGM sensors will be worn at a minimum every 6 months until either the participant no longer wishes to participate, turns 18 years old, develops clinical T1D or the study finishes. This study hypothesises that CGM can be used as a tool in children with islet autoantibodies to identify those who are more likely to progress or closer to clinical diagnosis and prevent the likelihood to DKA at diagnosis.
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Comparison of computer automated design and computer automated manufactured (CAD/CAM)-based fixed retainers versus conventional fixed retainers: A randomised clinical trial
Hypothesis: There is no difference between computer automated designed and computer automated manufactured (CAD-CAM) based fixed bonded metal orthodontic retainers used to hold tooth positions after active orthodontic treatment and conventional, non-customised bonded fixed retainers. At the completion of orthodontic treatment, patients are provided with orthodontic retainers to keep their teeth and bite stable, and to prevent relapse of teeth back into their pre-treatment positions. Fixed retainers are advantageous due to their lack of reliance on patient compliance; however they do suffer a high rate of failure. The popularity of chairside CAD/CAM wire bending robot machines is increasing due to their ease of use and fast turnaround time. The aim of the study is to compare computer-aided design and computer-aided manufacturing (CAD/CAM) custom robot bent fixed orthodontic retainers to conventional Ortho FlexTech direct bonded fixed retainers in terms of orthodontic treatment stability by means of a prospective, randomised clinical trial. Additionally, secondary objectives are to assess and compare patient satisfaction, survivability, cleansibility and periodontal health with each type of bonded retainer.
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Effect of photobiomodulation 808 nm and 660 nm by assessing S100 A8/A9 protein level in pulp blood and gingival crevicular fluid in patients with symptomatic irreversible pulpitis
This study aims to evaluate the efficacy of a non-invasive photobiomodulation diode laser in symptomatic irreversible pulpitis by assessing Inflammatory biomarkers S100 A8/A9 protein in pulp blood (PB) and gingival cervical fluids (GCF) before and after intervention
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The effects of supplementation with a phyto-blend (Osteosine) on makers of bone health and general wellbeing in post-menopausal women
In this randomised, double-blind, placebo-controlled study, 60 generally healthy post-menopausal women aged 50 to 80 years will be randomly assigned to receive a phyto-blend comprising Cuscuta chinensis and Cnidium monnieri (Osteosine), or a placebo for 180 days (6 months). Changes in blood markers of bone turnover comprising Procollagen type 1 N-terminal Propeptide (PINP) and ß-isomerized C-terminal telopeptide (ß-CTX) will be measured at the beginning and end of supplementation to examine the effects of supplementation on bone turnover. A self-report questionnaire will also be regularly administered to examine changes in quality of life.
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Study to Examine the Safety, Tolerability and Pharmacokinetics of ascending doses of KNX100 in healthy volunteers.
This is Phase 1, single treatment, two-period (Part A and B), two-group (Group 1 and 2), open-label study of ascending doses of KNX100 administered to healthy volunteers once or twice daily. Up to 5 dose cohorts, ranging from 30mg twice daily (60mg) to 80 mg twice daily (160 mg) of KNX100 will be evaluated. Approximately 6 male and female adult healthy volunteers will be enrolled in Group 1, and approximately 6 elderly, male and female healthy volunteers, 65 years of age and over, will be enrolled in Group 2. The same set of participants will be involved in both parts A and B. The participants will attend in the clinic and stay inpatient during the dosing. In part A inpatient period for Group 1 is 4 nights and for Group 2 it is 2 nights. There will be approximately 3 weeks rest period between Part A and Part B. In Part B inpatient period for Group 1 is 3 nights and for Group 2 it is 2 nights.
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Comparison of StrataMGT and Estrogen Cream for Treating Genitourinary syndrome of menopause in Women: A Non-Inferiority Study
The main goal of the study is to determine the safety and efficacy of StrataMGT in the management of genitourinary syndrome of menopause. The primary objective of this study is to assess the improvement on patient quality of life for patients treating genitourinary syndrome of menopause with 940 compared to standard of care.
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Is the Sway App a valid and sensitive tool to measure balance in healthy adults?
The unilateral stance test (UST), where a person is asked to stand on one leg with eyes open and with eyes closed, is commonly used in the clinics. However, it is a crude measure of balance. The Sway App (a smartphone application), has been developed as a tool that claims to be accurate and is readily available. Investigating the validity of the Sway App against the gold standard is important to accurately measure balance in clinics. The primary purpose of the study was to determine validity and sensitivity to change of the smartphone application the Sway App in measuring balance before and after foot mobilisation when compared with the gold standard SMART EquiTest System. It is expected that the foot mobilisation will immediately improve participants’ balance and that the Sway App will prove to be a valid measure of balance sensitive to change in the clinical settings.
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Effect of water soluble defoamer on colonoscopic bubble score in adult patients undergoing colonoscopy
This is study aimed at determining whether propylene glycol (a water soluble food additive) is effective in reducing the number of bubbles at colonoscopy, thereby improving visualisation. The Propylene glycol will be administered into the colon via the colonoscope.