ANZCTR search results

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.

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.

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.

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.

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.

Introduction Individuals with co-morbid chronic pain (CP) and PTSD report greater symptom severity, anxiety, depression, disability, and opioid use than those with only one of these conditions. Deficits in emotion regulation (ER) and autonomic disturbance, represented through Heart Rate Variability (HRV), are both evidenced to interact with and perpetuate the symptoms of CP and PTSD. Furthermore, theoretic models suggest that autonomic dysfunction leads to psychophysiological inflexibility, reducing capacity for regulated emotional responding. This predisposes an individual to respond to potential threat with anxiety. Focusing on these trans-diagnostic factors, which may account for aspects of the comorbidity of symptoms between CP and PTSD, presents valuable treatment targets to interrupt the perpetuating cycle of both. While HRV biofeedback has been reported to improve autonomic flexibility and the symptoms of CP and PTSD separately, it is unclear whether these positive results would be replicated in people with both conditions. Furthermore, while the association with HRV and ER is well documented, it remains unclear whether change in self-reported ER mediates improvement in CP and PTSD symptoms through HRV biofeedback. Consequently, the study aims to answer the following research questions: a) does modifying HRV through biofeedback change symptoms of co-occurring CP and PTSD, b) do changes in ER mediate change in symptoms of CP and PTSD, and c) does change in HRV precede change in ER. Methods A six-week randomised wait-list control HRV biofeedback intervention will be conducted with 50 participants who have both a chronic pain diagnosis and PTSD symptoms. Participants will be instructed to practice at home daily for 40-minutes, as well as attending three, fortnightly training sessions. ECG and psychometric data will be collected at baseline, two mid-points during the intervention (week 2 and 4), as well as end of intervention and three month follow-up. Short daily portable ECG recordings and adherence to biofeedback training will also be collected.

Long-COVID is characterized by symptoms including sleep dysfunction, fatigue, depression, anxiety, anosmia, memory problems, confusional states and others. There is substantial evidence that impaired circadian function contributes to the development of these symptoms. On this basis, a novel approach to treating these symptoms may well be implemented by presenting intense light at a critical time during the light/dark cycle as is achieved with disorders such as season affective disorder (SAD) and Parkinson’s disease. It is hypothesized that this would realign circadian phase and thereby mediating remission in many symptoms of Long-COVID. In view of the breadth of symptoms shared by Long-COVID and prodromal PD alike, we predict that that LT has the potential of providing valuable therapeutic intervention for Long-COVID. While any preliminary results obtained from this case series study will need verification in a controlled trial with a larger sample, this work may provide prima facia evidence that both Long-COVID and PD share a common neuropathological element. This work sets the stage for the expedient development of minimally invasive, effective strategy for treating Long-COVID.

This is a randomised, double-blind, placebo-controlled, single ascending dose treatment, multi-cohort study. The study will evaluate 5 dose levels of the investigational product, OLX72021, in 5 cohorts. Dose levels will be evaluated in a sequential manner starting at the lowest dose level. Healthy male volunteers with mild to severe androgenetic alopecia (AGA), aged 18 to 75 years of age (inclusive) at the time of screening are eligible for recruitment. The total maximum study duration for participants in this study is 87 days (approx. 12 weeks). This includes a screening period (Day -28 to Day -14) and 56 days (± 3 days) post-treatment follow-up. Androgenetic alopecia has been linked to an imbalance of androgen hormones. OLX72021 is designed to target the androgen receptor (AR) gene, leading to reduced AR protein expression in the body. Because androgenetic alopecia could be caused by an imbalance of androgens, blocking the AR gene helps to reduce these harmful responses and allow hair growth to return to normal. The information learned from this study may help future participants with androgenetic alopecia.

The goal of our study is to assess the effects of translingual GTN on exercise capacity as assessed by cardiopulmonary exercise testing (CPET) and 6-minute walk tests (6MWT), in LVAD recipients. GTN is a medication that relaxes the vessels and makes the work of the LVAD and the native heart easier. Additionally, this medication is cheap and readily available. Patients will perform 2 tests each (both CPET and 6MWT), one with a pre exercise dose of GTN and one with a dose of placebo. Patients and investigators will be blind to the treatment assigned to avoid biases. Our main hypothesis is that exercise capacity will be better with a pre exercise dose of GTN as compared to placebo. If this hypothesis is confirmed, GTN could potentially be used in rehabilitation programs for LVAD recipients.

This study aims to identify one or more liver cancer specific microbial based biomarkers using a range of blood, stool (faecal) and oral samples from people who have a confirmed diagnosis of primary liver cancer and people who are at high risk of developing liver cancer due to chronic liver disease. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older who has been diagnosed with chronic liver disease and/or primary liver cancer. Study details All participants who choose to enrol in this study will be asked to provide blood, stool and oral samples at 6 month intervals for up to five years post-enrolment. The study investigators will aim to collect these samples during a routine scheduled clinic visit so that participants do not need to attend additional study visits. It is hoped this research will identify and validate a liver cancer specific biomarker model for early diagnosis of liver cancer. If successful, tests for identified biomarkers may then be used to diagnose liver cancer earlier in at-risk patients, which may lead to better outcomes for future liver cancer patients.