You can narrow down the results using the filters
-
Pre-surgical embolisation with a novel embolic agent, the Distal Penetrating Embolic System (DPE), for participants with hypervascular extra-axial brain tumours
The EMBO-01 study is a first-in-human study of a new investigational device, the Distal Penetrating Embolic System (DPE), for pre-operative embolisation of a type of brain tumour that is hypervascular (has a lot of blood vessels) and extra-axial (not part of normal brain tissue). The purpose of this study is to assess the safety and feasibility of using DPE in patients with these types of brain tumours, and to assess whether embolisation can reduce blood loss during surgery and make the tumour easier to remove. Who is it for? You may be eligible for this study if you are aged between 18 and 80 years (inclusive), have been diagnosed with a hypervascular extra-axial brain tumour, and are planned for pre-operative embolisation and subsequent surgical removal of the tumour within the next 7 days. Study details All participants will undergo the embolisation procedure within 7 days of their surgery. Embolisation is a separate procedure in which a material known as an “embolic agent” is injected into the blood vessel(s) to form a plug within the vessels to stop blood flow to the tumour. The procedure will be done by a specialised doctor called a neurointerventional radiologist, and will take approximately 2 hours to complete. An x-ray will be performed before and after the embolisation process to document successful injection of the DPE into the target vessels supplying the tumour and the effects of this on blood supply to the tumour. During the surgical procedure to remove the tumour, data will also be collected such as blood loss, surgical time, and time taken to remove the tumour. The removed tumour may then be analysed by a pathologist. Additionally, participants will be asked to complete a number questionnaires for up to 90 days post-embolisation to assess for any complications of the procedure. It is hoped that this study may show that pre-operative embolisation using the DPE is safe and feasible in patients with hypervascular extra-axial brain tumours. It is also hoped that the procedure is able to reduce blood loss during surgery and reduce the time taken to remove the tumour, which may lead the way for a larger trial.
-
The effects of ankle and proximal tibiofibular manipulations on ankle range of motion (ROM) and squat strength and biomechanics
This project is a cross-over trial that will compare the effect of two approaches to lower limb manipulation on maximum strength and movement strategies during a weighted squat, using healthy participants with experience in strength training and with limited ankle mobility. Each participant will attend three sessions. The first session will involve familiarisation with the procedures and baseline tests. The second and third sessions will involve a series of different manipulations to the ankle and knee. After each treatment, participants will perform a weighted squat and strength and movement strategies will be recorded using video motion capture. We hypothesise that the ankle and knee manipulations will improve maximum squat weight, lower limb movement strategies, and ankle range of motion, with possible differences between the two approaches.
-
The impact of addressing binge eating on weight management in people with obesity: A pilot service-evaluation of group-based guided self-help (GSH) for binge eating disorder in a specialist hospital-based obesity service
Binge eating is the defining feature of binge eating disorder (BED). What distinguishes BED from bulimia nervosa is the absence of purging after the binge (by self-induced vomiting, starving or extreme exercise). Binges are recurrent episodes of uncontrolled overeating, they involve eating rapidly, leaving the individual feeling uncomfortably full, embarrassed, disgusted and guilty. They are distressing and debilitating experiences. Specialist eating disorder services are less likely to recognise or prioritise BED. In the Sydney Local Health District, there is no formal treatment program available. It affects more men than the other eating disorders, those who are older and those with overweight or obesity. Consequently, health professionals, including eating disorder staff, are less familiar with BED and may lack confidence in how to treat it. Compounding this, there is a reluctance of those with BED to seek treatment. Some also have obesity and a past history of failing to manage their overweight (and their binge eating) can act as a barrier to engaging with treatment. In the newly revised NICE guidance for eating disorders, the recommended first line of treatment for adults with BED is a guided self-help program. The guide in guided self-help is what distinguishes ‘guided’ self-help from ‘pure’ self-help. The guide is central to engagement and adherence. Guides help a participant work around a self-help resource, facilitate engagement, motivate and help review participants’ progress. Guides are supportive, faciliatory and provide continuity through the program. Guides are typically qualified health/well-being professionals (such as dietitians and nurses) with an interest in working psychologically. They need no specialist expertise in eating disorders. As yet, there has been no evaluation of whether offering a group based program to reduce binge eating before participants start a weight management program at the Metabolism & Obesity Service will better help them to lose weight. This study aims to investigate this.
-
A multicentre randomised controlled trial of the modified Kono S anastomosis versus the stapled side to side anastomosis after ileocolic resection for Crohn’s disease
Crohn’s disease (CD) is a chronic inflammatory bowel disease that occurs in a genetically susceptible individual in response to an unknown environmental stimulus. The incidence in Western populations is estimated to be between 5 to 7 per 100 000. 1 It is estimated that 80% of patients require surgery at some point in their life and of these, 70% require a further operation. After surgery, symptomatic recurrence is common and estimated at 28% and 36% at five and ten years post-operative (Bernell et al, Risk factors for surgery and recurrence in 907 patients with primary ileocaecal Crohn's disease. British J Surgery. 2000; 87:169). Endoscopic recurrence (ER) is even more common with up to 90% of patients found to have ER at 12 months. (Rutgeerts P, Get al. Natural history of recurrent Crohn's disease at the ileocolonic anastomosis after curative surgery. Gut. 1984). Emerging evidence suggests that the anastomotic configuration has a role in the recurrence rate. In 2003, a new approach to anastomosis was described, the Kono-S anastomosis, showing better surgery free rates compared to end-to-end anastomosis (preferred approach). Since the early observations, many other studies have presented outcomes in favour of the Kono-S anastomosis in the management of CD. Data suggest further research is needed to determine the optimal anastomotic configuration that can return the lowest recurrence rate and lowest complications for patients with CD requiring surgical management.
-
Dexamethasone in Orbital Cellulitis (DOC) Trial
Orbital cellulitis is a serious infection that can lead to permanent vision loss and death. Pre-septal cellulitis refers to infection that remains in front of the orbital septum, which can be clinically indistinguishable from orbital cellulitis when severe. Current treatment options for these conditions include intravenous antibiotics and surgical drainage. Although these methods are effective, inflammation can often persist for weeks to months. The use of steroids in orbital cellulitis is controversial and practices vary widely. The literature around this remains minimal and there are currently no studies to determine the role of corticosteroids in severe pre-septal cellulitis. We aim to conduct the first comprehensive randomised controlled trial to evaluate the role of corticosteroids in the management of orbital cellulitis and severe preseptal cellulitis. This study will be significant in informing future clinical practice by providing a standardised corticosteroid treatment protocol. Each enrolled participant will be randomised to receive either steroid or placebo and will be required to be followed up for 12 weeks after their initial admission to hospital.?
-
Interaction between learning bias and stress as modulator of cognitive flexibility and fear extinction.
We are testing whether having a bias for positive reinforcement versus one for avoiding punishment can modulate one's response to a stressor (cold water) and in turn predict how flexible our behaviour is in addition to how fast we can extinguish a physiological response to a fearful stimulus.
-
Factors influencing community participation outcomes for adults who have sustained an acquired brain injury: A scoping review
The primary purpose of this research project is to investigate community participation outcomes for adults with acquired brain injury (ABI) after discharge from post-acute rehabilitation. Community participation refers to the meaningful participation and engagement of an individual in life roles, occupations and activities conducted outside the home environment as well as actively being involved with society. The Brightwater 'Oats Street' Facility is a community-based residential acquired brain injury rehabilitation facility where clients live on-site to receive rehabilitation and support from a multidisciplinary team of health professionals. Rehabilitation at this facility is considered 'post-acute' rehabilitation. This research project is made up of three sequential Parts. Part 1 will include a scoping review of research literature to identify factors influencing community participation for adults with ABI. After this has been completed, Part 2 will involve interviews that will then be conducted with adults with ABI who were previous clients at Oats Street, their family member/s or carers, and staff members who have worked at Oats Street. Part 3 will involve the development of a protocol for a future study that will be conducted after this current study has been completed.
-
Stroke in patients with large Ischaemic Core: Assessment of Reperfusion therapy Impact on Outcome (SICARIO-LC)
SICARIO-LC is designed to test the effect of endovascular thrombectomy (with or without thrombolysis) on three-month functional outcomes in the population defined by the size of baseline perfusion core lesion volume between 70 and 100mL. Primary outcome will be the proportion of patients with modified Rankin Scale (mRS) 0-2 (no significant disability) at 3 months.
-
The effect of technology-assisted dietetic counselling on diet quality of adults living with obesity
There are very few publicly available weight management services led by dietitians the experts in dietary advice; leaving 30 % of Australians living with obesity limited treatment options. To address this gap, General Practitioners (GPs) will be able to offer their patients referral to a digital weight management trial led by clinical dietitians who will deliver cutting edge, high quality, cost-effective dietetic care for weight management. The randomised controlled trial will compare a 1-year digital tailored feedback dietary intervention with control (standard care). If successful, this model of care will build capacity for GPs and dietitians to deliver effective evidence-based weight management advice using new technologies, increasing reach and improving patient outcomes.
-
Addressing unmet social needs using a health navigator for cancer patients at a major metropolitan hospital: a mixed-methods feasibility and acceptability study
Expand description