ANZCTR search results

This is a parallel arm, 1:1 allocated randomised controlled trial comparing anterior cruciate ligament (ACL) reconstruction with suture tape augmentation of the graft to standard ACL reconstructive technique. Whilst many ACL reconstruction patients return to sport, a significant minority suffer complications of graft rupture, particularly during the early return to sport and rehabilitative period. Inherent weakness of the graft in withstanding the loads applied during these periods has been attributed to graft failure risk, as well as residual laxity (looseness) of the knee. Recently, the use of suture-tape to run alongside the graft (or augment) has emerged to increase the strength of the new ACL, however, there is little comparative evidence available regarding this technique, particularly in its capacity to reduce residual knee laxity, or improve patient outcomes after ACLR. We aim to investigate the use of this technique by randomly allocating ACL reconstructive patient to receive it, or standard technique (the same surgery without the additional suture). We will compare the outcomes following this by testing the looseness of the knee at standard time points (3 months, 12 months and 2 years) compared with the patients other 'normal' knee. We will also compare patient reported outcomes (via patient delivered surveys), findings on examination of the knee, return to sport times and rates and complications such as the need for return to surgery, and failure of the ACL reconstruction. We will perform this study with an aim to improve our understandings about the potential benefit or harms associated with tape augmentation, with the hope that it will inform the use of this technique in future patients needing to undergo ACL reconstruction to return to sport. We hypothesise that patients whose knees are reconstructed with suture-tape augmented grafts will have a smaller difference between operative and non operative sides at two years after surgery, compared with patients who undergo standard ACL reconstruction. Secondly, we hypothesise that patients with tape augmented ACL grafts will return to sport sooner, and have improved patient reported outcome measures during the follow up period (2 years).

Systemic lupus erythematosus (SLE) is an autoimmune disease with multiple organ involvement characterized by chronic immune activation, severe inflammation and organ damage. Although multiple genetic and environmental factors act synergistically to promote immunopathology and tissue damage in SLE patients, dysregulation of cytokines plays an important role in SLE patients. Interleukin 2 (IL-2) deficiency has been implicated in SLE progression and immunopathology in SLE patients. RS2102 is PEG-modified, N88R-mutated IL-2. N88R mutation reduces the affinity of RS2102 for Interleukin-2 Receptor beta and gamma chains and further improves the selectivity of RS2102 binding to Interleukin-2 Receptor alpha, beta and gamma chains, allowing it specifically activate Treg cells. Meanwhile, PEG modification can prolong the half-life of RS2102 in vivo and maintain the efficacy duration. Therefore, RS2102 can be used for the treatment of autoimmune diseases such as SLE by specifically binding Interleukin-2 Receptor alpha, beta and gamma chains and activating Treg cells, which are expected to be administered once every 2 weeks in clinical settings.

This is the initial Phase I/IIa, first-in-human study of EDV nanocells packaged with SARS-CoV-2 spike protein and alpha galacosylceramide adjuvant (EDV-plasmid-spike-GC) as a COVID-19 vaccine. The study follows an open label, non-randomised dose escalation study design across three dose levels, whereby the EDV-plasmid-spike-GC is administered intramuscularly (IM) at a dosage dependent on the cohort in order to assess the safety and tolerability of the vaccine in healthy volunteers 18 years and older. Up to a total of 200 participants will be recruited to the study, at 6 per cohort during dose escalation. Each cohort follows the same timepoints of dosing on Days 1 and 21, followed by subsequent visits at 28 days, 2 months, 3 months and 6 months. Adverse events and DLT evaluation will occur between Day 1 and 28 in order to assess the safety and tolerability of each dose level before continuing to the next cohort. Once a recommended dose level has been identified from one of the cohorts, recruitment will continue until a maximum of 200 participants.

Work4Dementia is a novel evidence-based intervention that aims to improve the capacity and resilience of the aged and dementia care workforce. The intervention will include an organisational component addressing change readiness with workplace leaders. This will be followed by a shared practice group for employees involved in direct care. The employee component of the intervention will cover topics including capacity and resilience in care work, understanding dementia and communication, the power of social connections and strengths to cope with emotionally demanding jobs. This study will use a waitlist controlled trial design to pilot test the intervention in two aged care organisations in Australia focusing on the acceptability and feasibility of implementing the intervention. Qualitative interviews and focus groups, and quantitative audits of participation data will be undertaken to assess this and explore perceived enablers and barriers to the intervention. This study will also include a preliminary assessment of the efficacy of this intervention to reduce job stress, enhance work engagement, reduce turnover and improve quality care. Study participants will include managers and direct care workers of the participating organisations, care recipients and those who support them. Pre- and post-intervention questionnaires will be used to assess the impact of the intervention and interviews and focus groups will explore perceptions of whether any care changes occurred.

Cardiac Implantable Electronic Device (CIED) therapy is a safe and effective therapy, but is not without complications. Bleeding complications, which can potentially be preventable, are of concern as they significantly increase the risk of infection with subsequently increased morbidity and mortality. Arista™AH Absorbable Hemostat (Arista) is a novel powder, that has been shown in surgical settings to be safe, effective and result in significantly reduced haemostasis time and requirement for blood transfusion. The aim of this study is to investigate the potential benefits of routine use of Arista in CIED implantation procedures. Participants will receive either standard of care, or standard of care in addition to the administration of Arista to the CIED pocket prior to skin closure. It is expected that participants who receive Arista will have a lower incidence of device haematomas post-implant. Participants will be followed up for 6 months post device implant.

This study, PRIME005, aims to investigate if treatment with oral Azacitidine and Carboplatin enhances the immune response to immunotherapy rechallenge with Ipilimumab and Nivolumab in patients previously unresponsive to treatment. Who is it for? You may be eligible for this study if you are aged 18 years or over and have unresectable or metastatic melanoma, with failed previous CPI immunotherapy with a combination of anti-PD1 and anti CTLA4 antibodies. Study details Participants will receive injection of Azacitidine and injection of Carboplatin for 2 cycles of treatment and addition of injection of Ipilimumab and Nivolumab over cycles 3 and 4 of treatment. Ipilimumab and Nivolumab will continue for 24 months or until disease progression, unless the treating clinician believes there is benefit with continuing treatment. Tissue samples, disease progression rates and adverse events will be collected from participants. It is hoped that data from this trial will help investigators understand the tumour microenvironment of treatment-resistant metastatic melanoma

Currently about 50% of patients living with diabetic retinopathy remain unaware they have the disease. Similarly, large amount of glaucoma and age-related macular degeneration cases remain undetected. To improve the detection rate. a novel system of automated fundus photography coupled with artificial intelligence (AI) will be evaluated in real world clinics to provide opportunistic screening for diabetic retinopathy, glaucoma, and age-related macular degeneration. The device is fully automated for image acquisition, analysis and report, which negates the need for clinical staffs. No prior training is required of the users. Within 2 to 3 minutes, participants can complete their own retinal photography and obtain a grading report based on the retinal photos for the risk of the above diseases. Referral recommendations are also included. This may benefit the patients in clinical settings where eye clinicians are in short supply. This study aims to test the performance of the AI screening kiosk in real world clinical settings. The AI screening results will be compared with the gold standard assessment by three eye clinicians. We hypothesize that this AI screening system is accurate, user friendly and can help improve the detection rate of some common eye diseases.

This pilot study will trial a personalised 12-week home-based physical activity intervention, using ICT, to help middle aged and older people who experience memory concerns and troubles with low mood, anxiety or stress to meet Australian physical activity guidelines.

Obstructive sleep apnoea (OSA) affects 1 billion people worldwide. It is characterised by breathing pauses during sleep when the air passage in the throat narrows or blocks. The severity of OSA is based on the number of these breathing pauses per hour of sleep. Recent studies suggest that OSA may be an important cause of depression. OSA and depression have common symptoms such as disrupted sleep, poor concentration, fatigue and low mood. Also, the risk factors for each condition overlap. It is difficult to know whether OSA causes depression (or vice-versa), or if these two conditions simply have overlapping features, but it is clear that 1 in every 4 adults with OSA have significant symptoms of depression. The Depression in Sleep Apnoea study aims to determine if CPAP is more efficacious than placebo, and at least as efficacious as standard antidepressant medication (escitalopram), for the treatment of a major depressive episode in adults with OSA. CPAP is an approved intervention for the treatment of OSA, but its efficacy for the treatment of major depressive episodes has not been established. Escitalopram is a selective serotonin reuptake inhibitor (SSRI) approved for the treatment of depression and anxiety, but it has not been tested for the treatment of a major depressive episode among adults with OSA nor as a treatment for OSA. Our objective is to identify if CPAP is more efficacious than placebo, and at least as efficacious as standard antidepressant medication, to treat a major depressive episode in adults with OSA. We hypothesise that among adults with moderate-severe OSA and a major depressive episode will experience clinically significant improvement of depressive symptoms compared with participants randomly assigned to treatment that with placebo for 12 weeks.

Reducing repetition of deliberate self-poisoning is an important suicide prevention objective. The Way Back Support Service is a non-clinical care coordination service for people who have attempted suicide that is designed to link people with the services and supports they need after discharge from hospital. The aim of this study is to investigate the effectiveness of the Way Back Support Service as delivered in the Hunter region (Australia) for a population of hospital-treated deliberate self-poisoning patients. Primary outcomes include any, and number of, deliberate self-poisoning readmissions within 12 months of the index admission. Outcomes will be compared for the intervention cohort with two historical control cohorts using intention-to-treat analyses. Findings from this study are relevant to the design and dissemination of aftercare models and other Way Back Support Service sites.