ANZCTR search results

The hypothesis to be tested is that wearing thicker wet suits (7mm or double 7mm on torso) impairs the ventilatory mechanics of healthy divers. This has never been studied for colder water wetsuits that are often used in Tasmania. Divers wearing thinner wetsuits (median 3mm), have been studied in the past. The aim is to measure the effect that wearing thicker (7mm or greater thickness) wetsuits has on the respiratory function of healthy divers measured by lung function testing.. A series of volunteer healthy divers will be enrolled. Spirometry (lung function) measurements will be be undertaken firstly without a wetsuit, and when wearing 7mm one- piece Summer suit and/or 7mm dual layer Winter suits, These wetsuits are standard for Tasmania’s climate. Based on previous studies of divers in thinner wetsuits, we expect that there will be significant impairment in lung function when wearing a 7mm or greater thickness wetsuit. The information gained from the study could guide medical advice to older divers and also divers with pre-existing medical conditions. In addition it may provide some physiological information that helps to unlock why some older divers in colder water are prone to breathing problems associated with immersion.

Lipiodol, an oil soluble contrast medium (OSCM) has a clear fertility enhancing effect, but its mechanism of action is uncertain. This trial seeks to determine the feasibility, from both the clinical perspective and the laboratory perspective, of changes brought about by lipiodol within the endometrium, the fallopian tubes and the peritoneal lining. Establishing the variables within these tissues that demonstrate the trends of effect of largest magnitude when women who have had a lipiodol hysterosalpingogram (HSG) are compared to women who have had an HSG with a water soluble contrast medium (WSCM), and when women who have had a lipiodol HSG are compared to women who have had no intervention, is likely to point towards candidate mechanisms. This pilot randomised controlled trial (RCT) will then inform the feasibility of testing such variables in a definitive RCT of women with infertility that could, in the future, assess whether such changes are associated with a successful fertility outcome. Future RCTs examining the fertility efficacy of lipiodol could then endeavour to link fertility efficacy to the candidate mechanism as part of the entire RCT or within a cohort of women who form part of the overall RCT group, but in whom the mechanisms of lipiodol are also sought.

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.