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The role of middle meningeal artery embolisation as post-operative adjunct treatment for chronic subdural haematoma in adult patients
Chronic subdural haematoma (cSDH) is one of the most common neurosurgical conditions and its frequency continues to rise as a result of the aging population and the increasing use of anticoagulation and antiplatelet medications. While there are no established guidelines for its management, symptomatic cSDHs are usually treated with surgical evacuation. The reported recurrence rates following surgical evacuation in the literature vary widely from 2% to 37%, with most estimates ranging between 20% and 30%. Recent studies have suggested middle meningeal artery (MMA) embolisation to be a potential alternative treatment for cSDH. Numerous case reports and series have demonstrated MMA embolisation as a safe primary treatment for cSDHs or as an adjunct treatment following surgical evacuation. We aim to conduct the first randomised controlled trial to further confirm the efficacy of MMA embolisation. -Unstable cSDH patients who require urgent surgical evacuation on admission will be randomly allocated to receive post-operative MMA embolisation or observation (current standard treatment) during the same admission -We aim to demonstrate that post-operative MMA embolisation can reduce the rate of recurrent cSDH requiring repeat surgical evacuation
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Comparison of stiff sole shoes vs flexible sole shoes (sneakers) on foot and ankle function in patients undergoing forefoot surgery
With novel surgical techniques and hardware design, plaster casts are not necessary to immobilise feet after 1st metatarsal surgery. Most surgeons support the use of a stiff sole post-operative shoe in either partial or full weight bearing to protect the surgical site and prevent complications over the course of 6 weeks post-surgery. We have previously demonstrated the use of rigid flat shoes improves satisfaction over the use of reverse camber shoe. The purpose of this study is to assess whether the use of comfortable shoes vs stiff sole shoes affects patient reported outcomes. Differences in long-term surgical outcomes of non-union and recurrence will also be investigated.
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A Pilot Study Exploring the potential benefits of Nursing Case Management In the Management of older Patients with Myeloma
This study is investigating the perceived benefit of implementing a nurse led model of care for older myeloma patients undergoing oral cancer treatment. Who is it for? You may be eligible for this study if you are aged 65 years or older, you are newly diagnosed with Myeloma or first relapse and are being treated at one of the participating hospitals in South Australia. Study details All enrolled participants will be provided with additional education about the disease and treatment by a specialist nurse. The specialist nurse will also act as a first point of contact during chemotherapy to answer questions and provide additional support to participants as required. Participants will have their medical records reviewed by the specialist nurse and may be asked to complete questionnaires at various timepoints over a 12 month period. It is hoped this research will demonstrate that a nurse led model of care for older patients with myeloma has a positive impact on their treatment completion rates and quality of life during cancer treatment.
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Developing a sleep program for caregivers of people living with dementia
Sleep is a physiological requirement which impacts the function of every cell, tissue and organ. Sleep is also pivotal in maintaining psychological wellbeing. Poor sleep quality and reduced sleep quantity have tangible effects on mental and physical wellbeing. Sleep complaints are prevalent amongst caregivers of people living with dementia and have been associated with increased risk of institutionalisation of the person they are caring for, an increased sense of burden and poorer psychological health. This study will be an acceptability and feasibility project which will support the development and implementation of a sleep program for caregivers of people living with dementia. The project aims to develop an intervention which will help equip caregivers with the knowledge and skills to improve their sleep. The sleep intervention will be delivered once a week for four weeks, with sleep and psychological wellbeing being assessed before and after the intervention. We hypothesize that the sleep intervention will improve carers sleep, reduce stress, anxiety and burden, and improve their overall psychological wellbeing. Sleep interventions are an easily implementable, cost-effective means of maintaining and improving caregivers physical and mental wellbeing. By ensuring we optimise the health of the caregiver, we allow them to thrive in their caregiving capacity which has a positive impact on both the caregiver and the person living with dementia.
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Feasibility and acceptability of a digital educational physical activity program for childhood cancer survivors
This trial aims to determine the feasibility and acceptability of a digital educational physical activity program in children who have survived cancer, and to evaluate its impact on physical activity levels, cardiovascular fitness, quality of life, and sugar-sweetened beverage intake in these children. Who is it for? You may be eligible for this study if you are aged 8-13 years, and have completed cancer treatment at least 12 months ago or are in the maintenance phase of leukaemia chemotherapy. Study details Participants will be given a tablet with an installed app that delivers a physical activity education program over 12 weeks through ten 60-minute interactive modules. Participants will also be provided with an activity tracker to wear for the duration of the study. A number of questionnaires will be given before and after the study to assess feasibility and acceptability of the program, and the level of fitness will be assessed at baseline, after the 12 weeks and at 3-month follow-up using the 6-minute walk test, where the participant walks as fast as they can in a 6-minute period. It is hoped that this study may help to foster healthy behaviours and improve physical fitness in childhood cancer survivors.
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A multi-centre, prospective, safety and efficacy evaluation study of automated external defibrillation (CellAED) in patients with cardiac arrythmias.
The CellAED device is a novel automated external defibrillator (AED) or commonly referred to as a defibrillator. The purpose of this study is to test this new AED and demonstrate its ability to deliver an appropriate shock to help restore a patient in cardiac arrest to a normal heart rhythm. The hypothesis is that the CellAED will be able to terminate arrhythmias (VT or VF) in a patient to allow the heart to restore a Normal Sinus Rhythm. Once consented, patients will be scheduled for the cardiac procedure. Patients will have the CellAED applied to their chest prior to the procedure starting. In addition, as a safety precaution, patients will have a traditional defibrillator applied to their chest as a rescue therapy device should the first shock delivered by the CellAED fail to revert the patient to normal sinus rhythm. During the procedure, if patient experiences a shockable rhythm (VT/VF) the cardiologist will activate the CellAED (in accordance with instructions in the Instructions for Use). This will be performed up to a maximum of one (1) time. The rhythm will be immediately assessed and if required, back up defibrillation will be delivered utilizing the standard defibrillator available on site.
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Graft Patency and Clinical Outcomes Following Coronary Artery Bypass Grafting with Instrumented Radial Arteries
Our study is designed to evalute the patency rates and clinical outcomes in patients using an instrumented radial artery for coronary artery bypass grafting. An instrumented radial artery is one where an invasive coronary angiogram has been performed by inserting wires and catheters through the radial artery in to the heart. It is possible that this procedure may injure the radial artery and make it less useful as a bypass graft. In recent years, there has been an increasing preference for using arteries as bypass grafts in coronary artery bypass grafting, and invasive coronary angiograms are now routinely performed via the radial artery. Therefore, there is an increasingly common scenario of deciding whether the instrumented radial artery should be used as a bypass graft, and there is very little evidence to guide this decision. Our study will retrospectively identify patients who underwent CABG with instrumented radial arteries. We will then compare their outcomes to patients who did not have an instrumented radial artery used as a graft. Additionally, a subset of patients will undergo CT coronary angiograms. CT coronary angiograms look for narrowings in the blood vessels that supply the heart, without the need for catheters to be inserted. We will compare the narrowings / blockages in the instrumented radial artery with non-instrumented radial arteries, internal mammary arteries and saphenous vein grafts to determine whether instrumented radial arteries become blocked more quickly. Our hypothesis is that instrumented radial arteries have lower patency rates, and therefore higher rates of graft failure, then non-instrumented radial arteries, when used for coronary artery bypass grafting
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Inflammation and the Microbiome: the effect of Physical Activity in cancer Survivors (IMPACT Trial)
This study aims to determine whether a personalised exercise program has any protective effects on the gut microbiota in breast cancer survivors, which may have follow-on effects for overall health and immune response in these patients. Who is it for? You may be eligible for this study if you are aged between 18-80, you are a Stage I-III breast cancer survivor who is 3-12 months post completion of your adjuvant treatment (hormone therapy and Herceptin may be continuing), you have undergone curative surgery and/or chemotherapy and/or radiotherapy and you are currently completing less than the recommended physical activity guidelines (150 minutes of moderate intensity structured activity per week). Study details Participants who enroll in this study will be randomly allocated by chance (similar to flipping a coin) to either the intervention or the control treatment. Participants allocated to the intervention treatment will be prescribed an individualised exercise program to be completed for 12 weeks. The exercise program will involve a combination of aerobic exercise (such as jogging/swimming/cycling) and upper and lower limb resistance exercises using a thera-band. Each week, participants in the intervention group will also receive a 10–20-minute telephone call with a member of the research team to discuss their progress and any concerns they may have about the exercise program. Participants allocated to the control treatment will be asked to maintain their current physical activity levels throughout the 12-week intervention. No telephone support will be provided to the control participants throughout the intervention. At the completion of the intervention, after follow-up testing, the control participants will be offered an opportunity to receive an individualised exercise program. All participants in this study will undergo a baseline (pre-intervention) and follow-up assessment to determine their fitness levels, and will be asked to provide stool and blood samples to determine their levels of inflammation and the characteristics of their gut microbiome. All participants will be asked to wear an activity tracker to monitor their physical activity daily for the 12 weeks of the study. It is hoped this research will demonstrate that moderate physical exercise has a positive effect on the gut microbiota of cancer survivors and this may also reduce systemic inflammation in these patients.
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A Double-Blind, Randomised, Vehicle-Controlled Phase 1b Study to Evaluate the Safety and Pharmacokinetics of a Topical Gel in Healthy Volunteers
This is a single centre, double-blind, randomised, vehicle-controlled study designed to assess the safety, tolerability, and pharmacokinetics of GDD3898 Topical Gel following twice daily application for 14 days in healthy volunteers. 16 subjects will be enrolled in 2 cohorts. Cohort 1 will comprise of 8 subjects randomised in a 3: to 1 ratio to be treated with either GDD3898 Topical Gel (1.75%) BID or vehicle gel BID on the anterior and posterior sections one forearm (540 cm2) for 14 days.. Cohort 2 will comprise of 8 subjects randomised in a 3 to :1 ratio to be treated with either GDD3898 Topical Gel (1.75%) BID or vehicle gel BID on the anterior and posterior sections of one arm, both forearm and upper arm (1260 cm2), for 14 days. Serial blood pharmacokinetic samples will be collected. After discharge from the CRU on Day 16, all subjects will have a follow-up telephone contact 7 days after last application of study drug.
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Efficacy of oral pyridostigmine for the treatment of acute colonic pseudo-obstruction - a prospective, randomized, placebo-controlled trial.
This trial aims to investigate the efficacy of oral pyridostigmine, a medication currently used to treat Myasthenia Gravis, in the treatment of acute colonic pseudo-obstruction (ACPO). Acute colonic pseudo-obstruction occurs when the large intestine becomes dilated in the absence of downstream mechanical obstruction, and often occurs in the setting of hospitalized patients who are non-mobile, and/or are on significant amounts of opioid medications. Current treatment options for ACPO include the use of medications such as intravenous neostigmine, which is effective but requires cardiac monitoring due to the risk of cardiac arrhythmias, endoscopic decompression, or surgery. A recently published case series has suggested that oral pyridostigmine is effective in treating patients with ACPO, without the need for cardiac monitoring, unlike neostigmine. However, strong evidence in this field is still lacking, which this study aims to help address.