ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Development of a novel intravaginal device for rehabilitating women with pelvic organ prolapse.

    Pelvic organ prolapse (POP) is a common gynaecological condition which has been observed in up to 50% of women above 50 and has an associated 20% risk of surgery during a woman’s lifetime. Despite impacting the lives of millions of women in our society, there are few options available for preventing or addressing this condition. Defined as the downward displacement of one or more pelvic organs into the vagina, POP can significantly impact the quality-of-life of women with the condition. It has a number of causes including injury from vaginal birth/pregnancy, and is exacerbated by ageing, obesity, genetics, constipation, chronic coughing, heavy lifting, and smoking. Severity is graded using the Pelvic Organ Prolapse Quantification (POP-Q) tool which classifies the degree of descent using the hymen as a reference point. Stages of descent vary from minor descent (Stage 1) to the complete external presentation of the organ (uterus, bladder, bowel) through the vagina (Stage 4). Symptoms include a heavy sensation or dragging feeling in the vagina, a lump in the vagina, a lump which bulges out and can be felt or seen when standing, painful intercourse or loss of sensation, difficulty emptying the bowel or bladder, recurring urinary tract infections, and faecal or urinary incontinence (UI). According to a report by the Australian Institute of Health and Welfare, UI alone accounts for >$200 million each year in healthcare expenditure in Australia, with drastically more women being affected than men for this condition. Current clinical protocols primarily have a passive management focus, which includes lifestyle changes or simple intravaginal pessaries, both of which require long-term (often until surgery or end-of-life) investment and adherence by patients; or a rehabilitation focus where pelvic floor muscle training attempts to strengthen the pelvic floor muscles. On the spectrum of invasive practices, 10-20% of women will undergo surgical intervention. However, surgery carries a number of risks, contraindications, and has the disadvantage that up to a third of women may have a recurrence. Additionally, vaginal mesh procedures introduced to reduce the risk of recurrence caused unacceptable adverse events and are no longer approved. Due to these limitations with current management protocols, there is a demand for novel non-surgical treatments which can improve or cure the condition. IVES could play a role in rehabilitating the pelvic floor muscles of women with POP. It does this by triggering neuromuscular contractions in the pelvic floor which may either increase muscle bulk or tone muscles to improve their ability to support the organs. With research suggesting that IVES may be effective at treating UI and at increasing pelvic floor muscle strength, it is possible that IVES may be an effective treatment for mild-to-moderate POP.

  • The second usability and efficacy trial of a co-designed wellbeing and preventative mental health app with University students enrolled at an Australian University.

    University students and young people are already a known high risk group for experiencing poor mental health and wellbeing. This at-risk group also demonstrates low uptake for early help seeking where the largest barrier often experienced by this group to seek help early is lack of awareness and understanding about the process and often associated bias or stigma. It is critically important to develop the resources and tools to support students in feeling like they understand mental health, can recognise early trends in mood and behaviours that might be early symptoms of poor mental health, and feel supported and empowered to reach out for help when they need it. The Monash THRIVE App is being developed to help students track their own feelings and set, and achieve, their own wellbeing goals through a tailor made resource that is private and secure on their own device. Through using the Monash THRIVE App students will learn more about mental health, and themselves and feel more supported to seek help early when they are struggling. This trial has been designed to measure both efficacy in terms of perceived willingness to seek help and overall wellbeing as well as the user feedback on the design, functionality, and usability of the Monash THRIVE App in a true co-design and co-development process with users. Note that no specific mental health condition or diagnosis is explored in this trial as all participants are pre-clinical. The core outcome of this trial is to explore improved wellbeing and App feedback amongst a healthy population of University students. It is hypothesised that through a 12-week period of using the THRIVE App to actively monitor emotions and engage in feedback from the app students will show an improvement in mental health awareness and psychological literacy outcomes, as well as a potential improvement in overall wellbeing and intention to seek help.

  • The INTErGenerational intervention taRgeting fraIlTY trial (INTEGRITY)

    Frailty has been described as the ‘public health crisis for an ageing society’. As many as 24% of older Australians are frail, with heightened vulnerability and susceptibility to stressors, and growing economic and societal costs. The recent ABC TV show ‘Old People’s Home for Four Year Olds’ has shown on-screen benefits from a non-familial intergenerational practice – by bringing together community-dwelling older adults and pre-schoolers to reduce the older adults frailty. The shows popularity has lead communities around Australia to instigate similar intergenerational programs. However, our recent systematic review finds only small-scale, largely qualitative evidence for such intergenerational practice. Given the potential benefit at low interventional cost, we now urgently need to establish whether (and to what degree) intergenerational practice effectively reduces frailty in our aging population. To do this, the INTErGenerational Intervention to taRget fraIlTY (INTEGRITY) trial extends our pilot trials to rigorously test an intergenerational practice program using a cluster randomised, blinded endpoints clinical trial bringing older adults and preschool children together in 44 clusters. Frailty measures collected from clusters randomised to receive an intergenerational practice intervention or wait list control will be compared. Secondary outcomes include self-reported older adult health and quality of life, child language and empathy measures. We hypothesised that participating in a 20-week intergernerational program will prevent frailty, improve older adults' health and quality of life, and improve the children's developmental skills. The community-based INTEGRITY trial has been co-conceived and co-designed with a community and stakeholder team and will establish the first robust evidence for community based intergenerational practice. These results will help improve and inform both current and future practice programs. We will also use our learning from the trial to build an accessible online guide for communities wishing to run intergenerational activities.

  • The effect of coconut oil on healing of childhood burns

    This pilot study aims to demonstrate the effects of using coconut oil compared to standard therapy (sorbelene cream) for the treatment of burns scars. Burn injuries in children are common and result in painful wounds with a varying capacity to heal. Time to healing is key in driving long-term scar outcomes. Deeper wounds will be treated surgically with a combination of traditional skin grafts and cell-based therapies. Standard of care (SOC) is to commence skin moisturizing the newly sealed wounds with massage of topical ointments to prevent surface drying and secondary disruption of the surface and associated infections, which usually occur between 7 to 14 days post operation. Coconut oil is rich in fatty acids, which have natural activity against common skin microbes and inflammation. Coconut oil for skin care has been shown to improve skin condition. Laboratory studies have shown that Monolaurin (the primary fatty acid in coconut oil), at the concentrations present in the coconut oil used for skin care, has substantial antimicrobial activity. In this pilot randomised controlled trial we aim to assess the healing properties of virgin coconut oil in the treatment of burns injuries. We will randomise 100 paediatric burns patients to either receive coconut oil or standard care (sorbelene cream) for burns care. In the intervention group coconut oil will be applied twice per day to surgically managed burn wound sites, skin graft donor sites and conservatively managed burn wound sites for a period of 12 weeks. In the control group, patients will receive routine care (sorbelene cream) forburn wound sites, skin graft donor sites and conservatively managed burn wound sites for the same time period. This study will provide valuable pilot data for the potential role of coconut oil in children with burns, which will be used to design future large multi-centre studies and potentially change the standard of care.

  • ExTRA - Exercise Therapy to Reduce Anxiety Pilot Study

    ExTRA will develop and pilot an 8-week self-directed web-based exercise intervention to reduce anxiety. Participants will undertake the program independently and receive strategies/prompts/encouragement/reminders to their email/smart phone tailored to activity level measured by a device, and rating scale responses – this process will be pre-determined so that it can become an automated or semi-automated process in future research. It will aim to be cost-effective and scalable to increase access. Feasibility and acceptability will be investigated with 20-30 participants. It will target mid-life onwards to maximise impact given the higher risk of chronic disease in this age group. The findings will provide crucial data for larger effectiveness and implementation trials.

  • Comparison of visual outcomes and patient satisfaction after implantation of non-diffractive extended depth of focus and aspheric monofocal intraocular lenses with monovision: a randomised trial

    Implantation of an intraocular lens (IOL) is a standard method of visual rehabilitation in pseudophakic eyes following cataract removal. Although modern IOLs can offer high quality vision at a selected distance, correction over a continuous range of viewing distance is challenging. Plethora of IOL designs, such as accommodating, multifocal and extended depth-of-focus (EDoF) IOLs, have been introduced in attempts to address the issue. To date, commercially available IOL designs are limited in their ability to provide clear vision over a range of focal distances without causing undesirable disturbances in vision– Some fail to offer adequate near vision and others have inherent design-related visual disturbances and dysphotopsia. RayOne EMV IOL is a non-diffractive Extended Depth of Field (EDoF) presbyopia correcting IOL using a non difractive technique based on enhancing and utilising the normal positive spherical aberration of the human optical system. The IOL is specifically designed to avoid the photopic symptoms associated with the diffractive and split refractive designs currently available. This study aims to investigate visual outcome and patient satisfaction after implantation of RayOne EMV EDoF IOL employing a monovision (-0.75 to -1.0D) strategy and compare the results from those using a standard RayOne aspheric IOL with the same Monovision approach. This will be a single centre randomised clinical trial. A total of 110 subjects with bilateral senile cataract will be recruited and randomised equally into two treatment arms. Four to six weeks and 12 to 16 weeks post-operative monocular and binocular visual acuities at distance, intermediate and near will be investigated as the primary outcome variables and compared between the two groups. Other outcome variables will include stereoacuity, contrast sensitivity, patient satisfaction and spectacle independence.

  • Benefits of education and exercise for knee osteoarthritis

    This pilot feasibility randomised controlled trial will recruit 24 people with knee osteoarthritis. Consenting participants will be randomised to either a self-directed exercise-therapy (n=16) or supervised exercise-therapy (n=8). Both groups will receive a digitally support patient education through the ‘My Knee’ tool kit. The primary aim of this study is to determine the feasibility of conducting a fully powered randomised controlled trial to compare self-directed to supervised exercise-therapy for people with knee osteoarthritis. Secondary aims include: • To compare outcomes between groups, 12 weeks following treatment commencement, related to average pain, physical function, joint- and health-quality of life, exercise and physical activity participation, self-efficacy with exercise and osteoarthritis management, outcome expectations for exercise, people’s beliefs about management treatment, determinants of exercise behaviour, global rating of change and treatment satisfaction; • To explore barriers and enablers to intervention effectiveness, potential intervention and study design improvements, and other factors that might influence the participant’s adherence.

  • Coconut oil for eczema in young children

    The aim of this study is to investigate whether topical coconut oil is effective and safe as a maintenance treatment of eczema in young children. We hypothesize that topical coconut oil in children with eczema will be beneficial in reducing disease severity and frequency of eczema flares through its combined effect of anti-microbial and anti-inflammatory properties Eczema is a common chronic inflammatory skin disorder characterised by dry itchy skin, and is one of the most common skin conditions affecting young children. Cracked and dry skin caused by eczema leads to loss of moisture, a dysregulated immune system causing inflammation and changes the composition of bacterial that naturally occur on children’s skin which that may cause infection and disease flares. In addition, eczema often is the start of the allergic reactions with a significant proportion of these children going on to develop other allergies, including food allergies, hayfever and allergic asthma. Regular liberal application of creams or emollients is an integral part of eczema management which improves and maintains the skin barrier, in combination with prescribed medications (i.e. corticosteroid creams) when there is active eczema flares. Trying to avoid eczema recurring with emollient use alone does not appear to prevent reoccurring eczema flares, leading to ongoing cycles requiring the use of medications, patient suffering and frustrated caregivers. Coconut oil is rich in fatty acids, which have natural activity against microbes and inflammation. Coconut oil for skin care has been shown to improve skin condition. Our laboratory studies have shown that Monolaurin (the primary fatty acid in coconut oil), at the concentrations present in the coconut oil used for skin care, has substantial antimicrobial activity, particularly against bacteria that commonly cause eczema flares. We propose to conduct a practical, pilot, randomised controlled trial (RCT), to investigate the effects of daily topical coconut oil in 60 children under 6 years of age with doctor diagnosed eczema. Participants will be randomised to either apply daily topical 100% certified organic, virgin coconut oil, or to standard care (topical coconut oil avoidance) for a period of 12 weeks. This study will provide valuable pilot data for the potential role of coconut oil in children with eczema, which will be used to design future large multi-centre studies.

  • A Systems aPproach to community-based medIcation REview for people at risk of medication harm after a hospital stay: ASPIRE trial

    Medication-related problems are common after hospital admissions. Medication reviews are an established service, funded by the Australian Government for over 20 years, to help people to get the most benefit from their medicines and reduce their chance of experiencing harm from them. Currently, there is no system in place to ensure that this service is routinely offered to people at risk of medication harm when they leave hospital. The aim of the trial is to investigate whether an implementation model for improving access to a timely post-discharge medication review reduces 90-day readmissions. The trial will use a stepped-wedge cluster randomised design involving four centres (one per cluster), each consisting of a hospital and associated Primary Health Network (PHN). Three centres are in New South Wales and one is in Queensland. Patient participants will be recruited over a 24-month period from February 2023 to January 2025. The model will be co-adapted to suit local circumstances with the involvement of local hospital and primary care healthcare practitioners and consumers. Core features of the model will include: (1) a hospital-based pharmacist or nurse responsible for identifying patients likely to benefit from a medication review; (2) implementation of a PHN-based Medication Safety Hub with a dedicated Medication Safety Pharmacist to coordinate the medication review and other medication safety initiatives in the PHN; (3) Communication channels for medication safety oversight between hospitals and primary care; (4) PHN-led multi-disciplinary continuing professional development events on medication safety for local hospital and primary care healthcare practitioners (5) A communication strategy to raise awareness of the new role of the PHN and importance of medication review after a hospital stay (6) Indicator development to support GPs identify patients who would benefit from a medication review, and to monitor uptake and effectiveness. Data collected from participants in the trial will be linked with hospitalisations and Medicare data to measure outcomes, including readmissions, emergency presentations and healthcare utilisation.

  • The Anti-Anginal effect of Zinc in Angina with Non-Obstructive Coronary Arteries (ANOCA) Patients

    In 30% of patients with angina, angiography does not reveal obstructive coronary artery disease and the myocardial ischaemia may arise from large vessel coronary artery spasm (vasospastic angina) or coronary microvascular dysfunction (microvascular angina). Collectively, these patients are labelled as ANOCA (Angina with Non Obstructive Coronary Arteries) with 1,800 patients/year being afflicted within South Australia. These patients are significantly disabled with an impaired quality of life and have limited available effective therapies, except for calcium channel blockers in vasospastic angina. There is a need to develop novel therapies that effectively target coronary vasomotor dysfunction. Zinc (Zn), an essential micronutrient, is critical to the functioning of many metalloenzymes and transcription factors. Deficiency of Zn can exacerbate or complicate disease in multiple organ systems. We have demonstrated the importance of Zn homeostasis for the vasculature, including potentiating vasodilator responses via the nitric oxide production and inhibiting endothelin-1-induced constriction. We have recently conducted the first systematic study in Australian cardiac patients, showing a high prevalence of Zn deficiency (29%, n = 400), associated with worse disease. This study is a randomised, double-blind, placebo-controlled crossover study assessing the anti-anginal benefits and impact on health status of Zn 30mg once daily in ANOCA patients experiencing angina at least 3 times/week.

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