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A Phase 2, Open-label, Single-arm Study to Evaluate the Tolerability, Safety, and Pharmacodynamic Effects of KER-012 in Participants with Chronic Heart Failure.
This study is designed to evaluate the tolerability, safety, and pharmacodynamics of KER-012 in combination with current background therapy at a stable dose in participants with heart failure. Background therapy will be defined by the investigator as appropriate. HF background therapy treatments will be provided by the treating physician based on local treatment guidelines and must remain stable throughout the study. If a participant is observed to show disease progression requiring additional therapy, the participant should receive standard HF treatment following locally relevant guidelines. This study will enroll a total of 12-16 heart failure patients with either preserved or reduced ejection fractions for subcutaneous injections with KER-012 every 4 weeks. Heart Failure is associated with increased activin receptor type II signalling. KER-012 is designed to bind to activins and thereby, potentially reduce activin receptor type II signalling. Therefore, it is anticipated that KER-012 could potentially improve the underlying pathology of heart failure.
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Determining the feasibility of the use of the Crohn’s Disease Exclusion Diet (CDED) in adults with Crohn’s disease: A Pilot Study
The purpose of this study is to investigate the feasibility and effectiveness of the CDED in adult patients with Crohn’s disease on outcomes including compliance of the diet, changes in nutrition impact symptoms and quality of life; in comparison to their baseline diet. It is hypothesized that if patients are compliant with the CDED and the CDED is completed appropriately and in its entirety, it will be a feasible treatment strategy and effective in inducing remission for adult patients with Crohn’s Disease.
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Use of hearing protective devices in the clinical dental setting
The effect of noise in the dental clinical setting has been shown to exceed safe levels, and the potential effects of this on the hearing of dental practitioners well-established. Occupational noise-induced hearing loss (ONIHL) is an irreversible condition that can affect dental practitioners as they are subjected to long-term, frequent exposure to high-frequency noise from equipment and instruments. Prolonged exposure may reduce hearing sensitivity and acuity and is associated with various comorbidities such as tinnitus; it may affect quality of life. Within the last decade ONIHL in dentistry has been well-researched, yet there remains limited discussion regarding use of hearing protection devices e.g., custom-made earplugs, in the clinical setting. Although such devices are a well-established means of preventing ONIHL in noise-prone professions there is little evidence regarding their use in dentistry. This study aims to investigate dental practitioners’ perceptions of the use of hearing protective devices and create a tool for future larger scale investigations. By raising awareness and implementing appropriate hearing protection measures, it may be possible to safeguard the hearing health and overall well-being of dental professionals.
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Befriending with GENIE: Social intervention to address loneliness and social support for people with dementia and caregivers from Culturally and Linguistically Diverse (CaLD) communities.
The BEFRIENDING with GENIE project aims to improve the quality of life of people living with dementia and their caregivers from CaLD backgrounds by reducing loneliness, increasing social support networks and improving access to and knowledge about appropriate services. BEFRIENDING is a program in which trained facilitators provide 8 regular (e.g. weekly) visits interacting with the participants to share informal conversations. GENIE is an online tool that supports participants to expand their social support networks and engagement with existing services based on their interests and intrinsic motivations. GENIE comprises a database of existing services and activities tailored to participants' interests/needs and a network mapping tool that measures their social supports over time. We have successfully implemented BEFRIENDING and GENIE interventions in our previous research, but this is the first project where we bring them together. We will deliver the BEFRIENDING with GENIE program to 100 participants and caregivers from four main language groups of older Australians: Italian, Chinese, Vietnamese and South Asian. The program will use trained facilitators with appropriate language and cultural knowledge. We will work with Partner Organisations (with whom we have a track record of successful research collaboration) who support community-dwelling people living with dementia and their caregivers in four states, WA, SA, Victoria and NSW, thereby providing a strong test of the generalisability of the intervention across Australia. The project methodology utilises a hybrid effectiveness-implementation design including a randomized clinical effectiveness trial combined with a mixed method multi-stakeholder process evaluation. The research is led by a multi-disciplinary team comprising anthropology, sociology, geriatric medicine, public health, social work, nursing, occupational therapy, and implementation science with expertise in CaLD populations and dementia.
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Ultrasound measurement of stable and unstable shoulders
This is the first component of a masters project that is investigating humeral head position and translation in unstable shoulders. In this observational study, we aim to measure the differences in humeral head position and/or translation between unstable and stable shoulders. We hypothesise that there will be detectable differences between stable and unstable shoulders as measured by ultrasound. This may then inform treatment strategies that aim to address the pathological humeral head position / translation.
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Ultrasound measurement of unstable shoulders before and after taping and rehabilitation treatment
This is the second component of a masters project that is investigating humeral head position and translation in unstable shoulders. In this pre- and post-intervention study, we aim to investigate the effect of taping and rehabilitation on humeral head position and/or translation in unstable shoulders. We hypothesise that humeral head inferior position/translation will reduce and that these findings will correlate with other measured improvements of shoulder position, strength, pain, and function.
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RED Penumbra System Registry
This will be a prospective, single-arm, multiple center observational registry which will include patients in whom the Penumbra RED System is used as part of a mechanical thrombectomy procedure to treat intracranial large vessel occlusion presenting with acute stroke. Baseline patient information, relevant co-morbidities, stroke clinical data, procedural data, imaging (CT, DSA, MRI) data, periprocedural complication data, and clinical follow-up information at 90 days will be collected. There is no alteration to the standard of care at the participating site. The purpose of the registry is to collect and analyse data regarding the efficacy and safety of the TGA approved range of Penumbra RED thrombectomy catheters used with the Penumbra Aspiration Tubing and the Penumbra Machine suction pump (referred to together as the Penumbra RED System) that are already in clinical use at the participating sites.
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A comparison of disease activity, quality of life and costs following implementation of a digital monitoring strategy in rural patient with inflammatory bowel disease
This study will compare the impact and acceptability of a digital strategy utilising IBD specific smart phone apps, to standard IBD practice, in the delivery of care to patients from a regional area in Queensland, Australia. We aim to determine the impact of a digital monitoring strategy on quality of life, disease symptoms and costs of care. Participants will be recruited from a regional IBD clinic in Queensland Australia. The trial will run for approximately 15 months. We anticipate that the Implementation of the digital strategy will be non-inferior to standard of care in terms of both patient symptoms and quality of life, whilst reducing health care associated costs.
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Effects of combined arm and leg high-intensity interval training on motor and non-motor symptoms in people with mild to moderate Parkinson's disease: A randomised controlled feasibility trial
An 8-week randomized feasibility trial will be conducted to investigate motor and non-motor responses to high-intensity interval training utilizing a combined arm and leg ergometer in individuals with mild to moderate Parkinson's disease (PD). control group will receive usual care. Primary hypothesis High-intensity combined arm and leg ergometry added to usual care will lead to increases in habitual gait speed in people with PD compared to usual care.
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Knee Injection Study at St George Hospital (KISS) for the Treatment of Knee Osteoarthritis
There is currently no disease-modifying agents available for knee osteoarthritis and treatment focuses on relief of symptoms such as pain and stiffness. There is limited placebo controlled randomised clinical trial data for a number of procedures to improve symptoms of knee osteoarthritis to improve function. These include steroid injections into the joint and blocking the nerves that supply the joint. These interventions have not been adequately studied against placebo. This study will look at comparing the effectiveness and safety profile of these two technqiues agents against a shared placebo group to see if they are effective. A further exploratory outcome is how well these interventions compare against each other if they prove effective against placebo.