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A comparison between two differing ways of commencing labour and their effect on duration of labour in women giving birth for the first time.
Expand descriptionWe are determining, as a pilot study, if we are able to reduce the duration of labour associated with induction of labour, when oxytocin is provided in a pulsatile (intermittent) fashion as opposed to the existing continuous infusion. Furthermore, by the use of paired blood samples, we are determining if restriction, as opposed to a liberal fluid strategy, changes baseline serum osmolality and serum copeptin levels, which may be impacting upon the birth outcomes.
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Personalised add-on Acupuncture service at Northern emergency Department for Acute pain (PANDA)
Expand descriptionThe PANDA (Personalised Add-on Acupuncture Service at Northern Emergency Department for Acute Pain) project is a feasibility study aimed at integrating acupuncture into the emergency department (ED) to manage acute pain and improve patient outcomes. This interdisciplinary research investigates the effectiveness of acupuncture in reducing pain intensity, minimizing opioid use, improve the key performence index of hospital and enhancing overall patient satisfaction. The study involves non-randomized allocation of patients to either receive standard care or additional acupuncture treatment, with key outcomes measured through various clinical and patient-reported metrics. Ethical approval for the project has been granted by the St Vincent’s Hospital (Melbourne) Human Research Ethics Committee (HREC).
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efficacy of LOw dose antihypertensive and lipid lowering pill combinations To improve stroke oUtcomeS (LOTUS)
Expand descriptionLOTUS is an investigator-initiated and nurse-led trial with a two-arm, open-label, randomised, multicentre design. Low dose combination therapies for treatment of hypertension and (optional factorial arm) hypercholesterolaemia will be compared to usual care in stroke survivors over 26 weeks. The primary aim of LOTUS is to assess whether an innovative model of care involving low dose antihypertensive (and optionally) lipid lowering treatment underpinned by team-based, telehealth-supported care will reduce BP over 26 weeks when compared to usual care in survivors of ischaemic stroke/transient ischaemic attack (TIA). Secondary aims include if this new model (when compared to usual care): reduces cholesterol, is acceptable to patients and clinicians, is cost-effective, improves medication adherence and patient acceptability, and is safe.
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Effect of tirzepatide on asthma control in obese asthmatics
Expand descriptionThis study is seeking to investigate the commercially available and TGA approved drug Tirzepatide in obese asthmatics with uncontrolled symptoms. The trial will be a pilot phase 3 placebo controlled randomised trial. The trial is seeking to determine if this drug improves asthma symptoms over a 36 week period in the setting of weight loss. Furthermore, secondary and exploratory outcome measures are seeking to determine how these benefits, if they are observed, can be explained. For example it might not just be about weight loss that improves asthma symptoms. Maybe other changes in the bodies inflammatory pathways can explain any improved symptoms observed in asthmatics. It's very important for doctors to understand how drugs work as this allows improved prescribing practices and improves the ability to identify patients who are most likely to benefit from any drug intervention.
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An Open-Label Study to Evaluate the Systemic Pharmacokinetics and Bioavailability of Single and Multiple Doses of RECCE®327 Topical Gel Applied to Normal Intact Skin in Healthy Male and Female Participants
Expand descriptionThis is an open-label study to evaluate the safety/tolerability and pharmacokinetics of RECCE327 topical gel in the systemic circulation when applied to intact human skin. The study will also evaluate the safety and tolerability of RECCE327 topical gel when applied to intact human skin. All participants must meet all inclusion criteria and not meet any exclusion criteria. Study medication will be applied once daily for seven (7) days to normal intact skin. The location of the gel administration will be on the ventral mid-section of the forearm. Participants will be treated in an inpatient setting at the clinical site for 8 days, and return to the clinic for a follow-up visit on Day 14 (+/- 3 days).
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OsteoVelocity - Effects of different Velocities in Resistance Training on Bone Mineral Density in Women: A Randomized Controlled Trial
Expand descriptionBone loss is a common health problem in older people, particularly women, and can significantly affect their quality of life. Progressive resistance training has been shown to be effective in preventing bone loss. However, several questions remain regarding the optimal design of such interventions. One such aspect is movement velocity. The aim of this project is to investigate whether faster movement velocities are more effective in improving bone mineral density.
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A Phase 1 Open-label Skin Safety, Tolerability and Pharmacokinetic Study of MRX-7MLL (Memantine Transdermal Delivery System) in Healthy Adults
Expand descriptionThis Phase 1, first-in-human, open-label, fixed-sequence, 3-period, 3-treatment study is designed to assess the skin safety, tolerability and PK of MRX-7MLL compared to the oral reference product, Namenda® (Memantine HCl oral tablet) or generic equivalent. This pilot study will also assess TDS adhesion, validate analytical methodology, assess inter- and intra-participant variability, and/or optimize PK sample collection timepoints for MRX-7MLL and oral memantine HCl tablets. The results of this study will support dose selection in future bioequivalence studies with MRX-7MLL and oral reference product or may be used to identify candidate formulation(s) for the pivotal study.
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Clinical Evaluation of Amyloid Positron Emission Tomography (PET) for Alzheimer’s Disease Assessment
Expand descriptionThis study aims to evaluate whether a new type of brain imaging called an Amyloid PET/CT scan can improve the diagnosis of Alzheimer’s disease in patients where previous tests have been inconclusive. The hypothesis is that this scan will provide additional diagnostic information, helping doctors make a clearer diagnosis or exclude Alzheimer’s disease. Fifty patients with unclear results from an earlier scan (FDG PET/CT) will undergo the Amyloid PET/CT scan. The results will be reviewed by a team of specialists to determine if the new imaging adds value to the diagnosis.
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Cellular Pathophysiology of Trigeminal Neuropathic Pain
Expand descriptionChronic trigeminal neuropathic pain resulting from a nerve lesion/disease and affecting the mouth/face, is a highly prevalent condition having severe effects on an individual's quality of life. Although functional brain imaging studies have established brain regions involved in chronic pain processing, the altered engagement of neuroglia astrocytes and microglia remain under-investigated. To develop personalised pain treatments, a better understanding of these non-neuronal cells which encompass and support ascending and descending pain pathways needs to be established. The aim of this proposal is to use a multimodal approach to investigate underlying neurobiology of trigeminal neuropathic pain.
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Effect of Lifestyle Modification Program and Supplementation with Dietary Fibre on Metabolic Health in overweight adults.
Expand descriptionIt was hypothesised that combining lifestyle modification with dietary fibre supplementation will be more effective for weight loss than either strategy alone. The aim was to examine the effect of a specific lifestyle modification program (LSMA, AstonRx Program) combining time-restricted eating (TRE) and dietary fibre supplementation on body weight, body composition and biomarkers of metabolic health in healthy overweight adults. Using a randomized, double-blind, placebo-controlled trial, the study aimed to examine the effect of a specific lifestyle modification program (LSMA, AstonRx Program) combining time-restricted eating (TRE) and dietary fibre supplementation on body weight, body composition and biomarkers of metabolic health, and safety and tolerability of a new dietary fibre BioPB-01 in healthy overweight adults. The primary outcomes included – changes in body weight and composition and safety and tolerability of BioPB-01 dietary fibre. The secondary outcomes included - changes in lipid profiles, fasting blood glucose and insulin levels, gut microbiota structure and function and inflammatory markers.