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The immediate and short term effects of individualised physiotherapy manual therapy treatment for people with migraine during an acute attack
This pilot study will explore the immediate and short term effects of individualised physiotherapy manual therapy treatment during the prodromal phase or beginning (up to 4 hours) of a migraine attack episode. Our hypothesis is that delivery of individualised physiotherapy manual therapy treatment in this period will help to reduce symptoms and burden of the single migraine attack in the immediate and short term.
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Feasibility of a tailored weekly meal box delivery service addressing nutritional intake and quality of life in the Western Australian neurological community
Nutritional challenges due to motor, cognitive and swallowing issues, arise in Huntington's Disease (HD), leading to malnutrition and reduced quality of life (QoL). We aim to evaluate a co-designed meal-box solution for improving nutrition and QoL in HD. Fifteen HD families will receive the meal-box comprising recipes and ingredients for five meals. Feasibility, acceptability, QoL and nutritional intake will be assessed pre and post, using qualitative and quantitative measures. Positive results could lead to rapid implementation within the HD community through our industry partner, with potential to extend the novel approach to other neurological conditions, thereby addressing a critical need.
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Retinal red flag screening for headache in the emergency department
Headache is the fourth most common chief complaint in the ED. Optic disc oedema, characterized by optic nerve swelling from intracranial hypertension, is one of the most important red flags that prompts timely further evaluation of life-threatening headache. However, examination of the optic nerve is infrequently and poorly performed by ED physicians. While artificial intelligence has enabled the automated detection of optic disc oedema from retinal images, these AI systems have not been clinically validated in real-world settings. A group of researchers from the Centre for Eye Research Australia, Monash and Melbourne university have worked with Eyetelligence Ltd to develop the world’s first hardware-software integrated system (i.e. AI-powered Smart Camera) to screen the retinal red flag of headache automatically. We hypothesize that the Smart Camera system will demonstrate reasonably good feasibility, accuracy and end-user acceptance in screening for red flags of life-threatening headache in the Emergency Department.
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A Phase 1, Randomized Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intermittent Consecutive Day Dosing Regimen of PRTX007 in Healthy Adults
This is a Phase 1, single-center, prospective, randomized, double-blind study examining an intermittent consecutive day dosing regimen of PRTX007 administered orally to healthy male and female volunteers. Study drug (PRTX007 or placebo) will be given once daily (QD) for 3 consecutive days, followed by 4 days off for 2 cycles plus one additional day of dosing after the 2nd cycle. Over 15 days, subjects will receive 7 doses of study drug.
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CONNECT: A Support Program for Families Following a Developmental Assessment
Children with neurodevelopmental delays and/or differences can benefit significantly when they have access to the right supports and services. However, it can be hard for many families to access these supports for a variety of reasons. For example, some services are too expensive or too inconvenient to attend. CONNECT is a new individualised support program for families after their child has completed a developmental assessment and received a neurodevelopmental diagnosis (e.g., autism, ADHD, etc.). Clinician-researchers developed CONNECT as a way to help families connect with the right supports and services for their child. The aim of our research project is to evaluate whether CONNECT helps families access the supports that they need more quickly and easily than their current care pathways.
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Safety and useability of a novel robot-assisted echocardiographic examination
This pilot study aims to investigate the safety and useability of robotically assisted echocardiographic examinations (echo). The technology is aimed to be deployed in any location (including regional and remote) and may be controlled remotely. Should this study be successful it will allow access of essential standard of care to cardiac patients in remote and rural areas.
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Measuring lung aeration change with lung ultrasound in response to physiotherapy breathing techniques
The main aim of this study is to assess the ability of lung ultrasound to detect an immediate change in lung aeration in patients performing physiotherapist- prescribed lung expansion techniques after upper abdominal surgery. This study will also explore if there are differences between three different lung expansion techniques in improving lung aeration score as assessed using lung ultrasound and will assess the agreement between lung ultrasound and postoperative pulmonary complications as diagnosed using the Melbourne Group Score (MGS) in postoperative upper abdominal surgery patients. A multicentre study will be conducted. Participants will have their lung aeration assessed and scored on postoperative day 1 using bedside lung ultrasound. Those for whom loss of lung aeration is identified will then immediately receive a single physiotherapy treatment session of protocolised coached lung expansion techniques commonly used in clinical practice. The participant will receive either positive expiratory pressure bubble therapy, incentive spirometry or deep breathing exercises dependent on the site the participant is being cared at. Immediately following the lung expansion therapy session, a repeat lung ultrasound will be performed. All lung ultrasound scans, both pre and post- therapy, will be scored for lung aeration by an independent skilled assessor who is unaware of the timing of lung ultrasound (either pre or post) and the specific therapy provided. Participants who don't have reduced lung aeration on their first lung ultrasound will receive standard physiotherapy care at the discretion of the ward physiotherapist. All participants will have another lung ultrasound on postoperative day 2, and screened daily for the presence of a postoperative pulmonary complication using the Melbourne Group Score on postoperative days 1, 2 and 3.
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A multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after multiple dose administration in participants with celiac disease.
This is a first-in-human, multi-centre, randomised, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and immunogenicity of FB102-101 after multiple dose administration in participants with celiac disease. Who is it for? You may be eligible for this study if you are aged 18 to 65 years with a documented diagnosis of celiac disease confirmed by intestinal biopsy and positive celiac serology at least 12 months prior to Screening. Study details: The study will be conducted in a single cohort of participants with biopsy-confirmed, asymptomatic celiac disease who are adhering to a strict gluten free diet, All participants who choose to enrol in this study will receive multiple doses of FB102 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing of celiac disease biomarkers during and following a 16 day gluten challenge. Participants will also have an endoscopy and biopsies done at screening and Day 32. The data generated in this study may inform the design of future clinical studies in patients with autoimmune and inflammatory diseases such as celiac disease.
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RECCE®327 Topical Gel Study for the clinical indication of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
The study is to evaluate the safety and tolerability, plasma pharmacokinetics, and efficacy of RECCE®327 topical gel when applied to Acute Bacterial Skin and Skin Structure Infections. The study will consist of sequential enrolment of up to approximately 30 participants who present with an ABSSSI, and who meet all inclusion criteria and do not meet any exclusion criteria. Participants may be treated in either the outpatient or inpatient setting. RECCE®327 topical gel will be applied once daily for seven (7) days to an ABSSSI, followed by safety and efficacy evaluations, then a possible additional seven (7) day treatment period, with repeat safety and efficacy evaluations at the end of the treatment period.
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A Phase II, Multicentre, 2-part, Study of the Safety, Tolerability, and Efficacy of Intravitreal Fludrocortisone Acetate in Subjects with Geographic Atrophy Secondary to Age-related Macular Degeneration
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