ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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30938 results sorted by trial registration date.
  • 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

  • A controlled evaluation of social prescribing programs for adults in Queensland, Australia

    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).

  • Protocol of a mixed-method feasibility, acceptability, and appropriateness trial of the Bright Tomorrows Parenting app in engaging parents of young children aged 0-5 years, in brain-building activities

    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.

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