ANZCTR search results

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.

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.?

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.

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.

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.

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.

The primary purpose of the study is to assess whether it is feasible and acceptable to implement a system of screening for unmet health-related social needs and service navigation using a Health Navigator (HN), a type of community worker, in those receiving cancer treatment. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are receiving cancer treatment at the Northern Cancer Centre. Study details Upon enrolment to the study, all participants will be screened for unmet health-related social needs (food and housing instability, financial insecurity, social isolation etc.) using a number of questionnaires. Those determined to have unmet needs will be referred, with their consent, to a HN to help connect them with community resources that may be able to help with their unmet needs. Participants will meet with their HN once every month for about one hour, or more as requested to plan and prioritise any unmet needs. HNs will work with participants to set up referral pathways and follow-ups with community services designed to meet their needs, over a maximum period of 6 months. Such community services could include Anglicare, Uniting Communities, Baptist Care, the Legal Services Commission and local community centres. Participants with no unmet needs on screening will not be referred to the HN service. After the 6-month intervention period, all participants will repeat the screening questionnaires, and will be asked to rate their acceptability of the intervention. Feasibility of the intervention will be determined as the number of referrals to the HN pathway, the number of community services to which participants in the HN pathway were referred and the number of participants who chose to stay in the study for the 6 months of intervention, or how many chose to leave the study and their reasons for withdrawal. Acceptability will be determined through focus groups with participants, stakeholders and healthcare workers to understand what they thought worked, did not work and how the intervention could be improved. It is hoped that this study may show that a screening for unmet health-related social needs is feasible, acceptable, and effective for reducing the burden of unmet needs in patients receiving treatment for cancer.

Loneliness is a distressing emotional state resulting from having less social interaction than desired. Social prescribing offers a community-based approach to managing loneliness, but there have been few controlled trials of social prescribing to date and a lack of theoretical framework to explain how social prescribing works. This project draws on social identity theorising to address these questions. This controlled trial will recruit 90 community dwelling adults in two conditions: Social Prescribing v GP treatment as usual (TAU), and survey them at two timepoints: first engagement with a social program (T1) and 8 weeks later (T2). Primary outcomes include loneliness, mental wellbeing, and health service use (past 2 months).

This research project is a 8-week evaluation of an innovative science-informed support app called the Bright Tomorrows Parenting app, designed for use by caregivers of children aged 0-5 years. The Bright Tomorrows app provides parents information about their children’s learning, health and development, and support services they may wish to contact. The app aims to assist parents in building their child’s essential life skills (including social and emotional wellbeing) and improve their knowledge and awareness of how the developing brain supports these capacities in the early years. By providing parents with a better understanding of ways to improve their child’s development, the app will also enhance their parent/child relationship and assist the growth of their child’s health and learning. The proposed study aims to test the feasibility, usability, and appropriateness of the Bright Tomorrows Parenting app in engaging parents of children aged 0-5 years over a 8-week trial. It is anticipated that repeated engagement with the Bright Tomorrows Parenting app for 8-weeks will improve parent responsiveness to their child, beliefs about their own parenting, and sense of empowerment. These, in turn, will lead to overall improvements in social-emotional wellbeing in the parent-child dyad. *In this document, the term’ parent’ refers to any adult, biologically related to the child or not, who fulfils a primary caregiver role.

The purpose of this research is to assess the safety, tolerability and effectiveness of bitopertin in patients with EPP and XLP. This will be the first time it has been given to individuals with EPP/XLP. In this study, up to 22 patients will be enrolled in Australia only. Erythropoietic protoporphyria and XLP are rare diseases which cause severe light sensitivity. Both are caused by mutations in the genes that produce enzymes of the heme production pathway. These defects lead to abnormally high levels of protoporphyrin IX (PPIX) in red blood cells, which leads to painful reactions when exposed to light. Additionally, PPIX accumulates in the liver and gall bladder and can cause gallstones and liver impairment. Current therapies for EPP/XLP are aimed at managing symptoms. At present, none act to reduce the high levels of PPIX in the blood. Increased PPIX is thought to be the underlying cause of the severe and potentially life-threatening effects of EPP/XLP. Thus, there remains a significant unmet medical need for new therapies which address the underlying causes of the disease. Disc Medicine Inc is developing bitopertin, an inhibitor of glycine transporter-1 (GlyT1) as a new treatment for EPP/XLP.