ANZCTR search results

Aneurysmal subarachnoid haemorrhage (aSAH) is a devastating form of haemorrhagic stroke, that results from bleeding from an intracranial aneurysm. A common complication of aSAH is hyponatremia with a reported prevalence of between 35% to 77%.Our group has recently demonstrated that patients in whom the sodium concentration decreases over the ICU stay have a higher likelihood of a worse outcome at 6-months compared to those patients in whom the sodium concentration remains steady. Fludrocortisone is a synthetic adrenocortical steroid possessing activity which produces significant sodium and fluid retention. Previous studies of fludrocortisone have demonstrated a reduction in hyponatraemia and fluid loss, but these studies were underpowered to show a clinical outcome benefit. Fludrocortisone therefore has the potential to prevent the onset of hyponatraemia in aSAH and lead to improved outcomes; however, this has never been tested in an adequately designed trial. This proposal is for a Phase 2 trial to examine the effect of fludrocortisone administration on serum sodium concentrations, fluid balance and clinical outcomes measures in patients with aSAH.

This is a randomized, double-blind, placebo-controlled, phase 1 first-in-human study to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of ABBV-CLS-628 in healthy adult volunteers

Concussion is a significant public health concern among Australian children and adolescents. A large population of children who experience a concussion (approximately 30%) will go on to experience persistence post-concussion symptoms for more than 4 weeks following their injury. These symptoms can limit their ability to attend and engage in school, extra-curricular activities and can lead to reduced quality of life. International consensus on Concussion recommends a brief period of physical rest immediately after concussion (24-48 hours) followed by a graduated return to physical activity at a level that does not provoke significant symptom exacerbation . Active rehabilitation involving sub-symptom threshold aerobic activity is a growing area of research with evidence showing reduced symptoms and improvements in recovery following concussion. The primary aim of the study is to evaluate whether a telehealth-supervised sub-symptom, graded return to aerobic exercise program improves recovery for children and adolescents who have sustained a concussion when compared to standard care. This study will be commenced once the Phase 1 - Validation of Modified Shuttle Test has been completed. We aim to see children by 3 months post-injury in the Complex Concussion Clinic: our current wait time is 3 months. While the child is waiting to be seen, PPCS limits physical activity and quality of life limiting their ability to participate in school and recreational activities. The longer symptoms persist the more difficult it is to treat these persistent symptoms and more health-related interventions are often needed to aid the child to return to normal school and sport activities. If the trial is successful, children will be able to return to these activities quicker, with a resultant decrease in the burden of the injury, and improvement in quality of life. A later cost-effectiveness of the intervention will be performed. The projected outcome of the project is to have a fully completed study protocol, with ethics approval, and a completed RCT within the specified timeline (24 months). This project is significant because not only will it impact QPRS, but the results of the study will have a far reach, Queensland wide with a more equitable service able to be provided to patients across the state. Information gained from the study could potentially lead to a change in current practice within QPRS and lead to future studies looking a how to translate this knowledge across QLD and Australia.

This study is investigating cancer-related cognitive impairment, and the impact of a cognitive training intervention. Who is it for? You may be eligible for this study if you are aged 18 years or over, living in or near the Perth/Peel regions of Western Australia, are currently undergoing any treatment for a confirmed diagnosis of cancer, AND are experiencing possible associated cognitive decline. Completion of baseline of this study will determine said eligibility. Study details The intervention of the study requires participants to complete brain training sessions involving puzzles, games, and word problems for 12 hours across 6 weeks. Follow-up tests (1 week and 3 month) investigating memory, attention, executive function, and processing speed will be performed, as well as other psychological factors such as quality of life, sleep, anxiety, and pain. Biological markers implicated in neurogenesis will also be assessed through blood tests, direct questions, and with reference to medical history. It is hoped that findings from this study will assist researchers with optimising daily oncology care.

Paramedics experience high levels of mental ill-health and family and friends are a main source of care and support. However, this caring role can result in significant difficulties. Interventions targeting these challenges among family and friends are therefore important for preventing psychological distress among this group and to strengthen the support they provide to others. Everymind has developed a prevention and early-intervention program for carers of individuals experiencing depression and anxiety, and has adapted it to target carers of paramedics. We are proposing to evaluate the effectiveness and implementation potential of the adapted Minds Together program. We will carry out a two-arm randomised controlled trial in which carers will be randomly allocated to either a wait-list control group or to Minds Together. Follow-up online assessments will occur at two- and six-months post randomisation. Mixed methods analyses will be used to examine the reach, adoption, implementation and maintenance of the program. Aim 1: To determine the effectiveness of the Minds Together program . Hypothesis 1: Compared with the wait-list controls, Minds Together participants will achieve a: -greater mean increase in coping self-efficacy -greater mean reduction in caregiver burden at two months. Hypothesis 2: Mean coping self-efficacy and caregiver burden scores will remain improved at six months. Aim 2: Assess the potential for reach, adoption, implementation and maintenance of Minds Together for family and friends supporting a paramedic impacted by mental ill-health or suicidal distress. It is hypothesised that Minds Together participants who complete the program will experience increased coping skills and reduced strain from their caregiving role. We expect these benefits to continue over time (at least 4 months).

ECHONOF III is a parallel group, pragmatic randomised controlled multi-centre trial, in which patients presenting with hip fracture are randomised to receive or not receive preoperative focused transthoracic echocardiography (TTE) before surgery. The trial aims to assess whether adding a focused TTE will lead to a reduced composite outcome of at least one of: all-cause mortality, cardiac failure, myocardial injury in noncardiac surgery, acute kidney injury or hospital readmission at 30 days post-surgery compared to patients who do not receive preoperative focused TTE (the current standard of care). A sample size of 2,000 patients has been estimated (1,000 per group). Secondary outcomes include in-hospital medical complications, quality of recovery, independent living and health cost analysis.

The Sonomat is a non-invasive sleep mat which has recently been validated in children. The primary aim of this study is to evaluate the potential clinical application of the Sonomat, in children with Neurodisability. Participants will undergo sonomat monitoring at the same time as having their in lab sleep study (polysonomgraphy - PSG) and then use the mat at home for three nights. We hypothesise that the sonomat will be comparable to an in lan sleep study for the diagnosis of sleep disordered breathing in children with neurodisability.

Contact lens discomfort or dryness is the primary reason to discontinue using soft contact lenses. Contact lens users with decreased tear volume are more intolerant to lenses (but not tested with daily disposable lenses). Contact lens materials, replacement schedules and care regimens may affect corneal structure and tear physiology . There is an increase in ocular discomfort at end of the day (but there is a paucity of information for daily disposable lens wearers). We have found that Dailies Total 1 has greater comfort than Acuvue TruEye (unpublished data). Also, transferring people to Dailies Total 1 was associated subjects being reclassified as asymptomatic. However, the reason for this change has not been identified. Meibomian glands are oil-producing glands in the eyelids. Their dysfunction is a primary cause of dry eye. Changes in the quality and composition of their oily secretions (meibum) cause tear film instability which might lead to discomfort and dryness during lens wear. Sphingolipids are components of the meibum that play an important role in inflammation. In tears, sphingolipid composition is correlated with tear production and dry eye symptoms in non-contact lens wearers..There are no studies on this relationship during contact lens wear. Somatosensory dysfunction (such as stress and anxiety) may cause dry eyes in the absence of any clinical changes to the ocular structure or tear film.. We have anecdotally noted a relationship between cornea thickness and comfort. This study will determine whether this anecdotal observation can be reproduced by scientific evaluation. The primary outcome is change in physicochemical changes in the tear film To correlate changes in tear film and meibomian gland structure and composition to comfort during contact lens wear. Secondary Outcomes To investigate the relationship between discomfort during lens wear with sleep disturbance.

The main purpose of this study is to test the safety of a new cancer therapy targeting the tumour marker Lewis Y (‘Lewis Y Chimeric Antigen Receptor T-cell Therapy’) in combination with the commonly used cancer drug nivolumab for the treatment of patients with Lewis Y-expressing solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or older, you have an advanced incurable or metastatic cancer and your cancer expresses the marker Lewis Y on tumour biopsy. Study details All participants will receive treatment with Lewis Y Chimeric Antigen Receptor T-cell Therapy and nivolumab. Prior to treatment, participants will have blood collected to generate the T-cells required for treatment. Participants will then follow a chemotherapy regimen designed to reduce the number of the body’s T cells so that the newly generated T-cells can be administered. This will involve intravenous infusions of the drugs fludarabine and cyclophosphamide once per day for 3 consecutive days in the week prior to T-cell therapy. Patients enrolled in this study will be part of one of two groups of patients: -Dose escalation for LeY CAR T cells with nivolumab -Dose expansion for LeY CAR T cells with nivolumab The dose escalation phase is when different doses (total number of cells infused) of the cell therapy will be tested. Each participant will receive one dose only by intravenous infusion. The doses tested will be increased or decreased for additional participants enrolled until a safe dose is determined. This safe dose will then be used for the dose expansion phase, where participants may receive up to two doses of cells infused one hour apart by intravenous infusion. Nivolumab will be administered to all participants by intravenous infusion on the day prior to T-cell therapy, and on days 14, 28, and 42 after T-cell therapy. During the follow-up phase, beyond the first 8 weeks (day 56) post-infusion, imaging and blood tests will occur once a month up to one year post-infusion then every 3 months thereafter for long-term follow-up to the full study period of 5 years. It is hoped that Lewis Y Chimeric Antigen Receptor T-cell therapy in combination with nivolumab is safe, tolerable, and effective for the treatment of advanced solid cancers expressing the Lewis Y marker. This study will also help to define the dose of T-cell therapy that may be used for treatment of similar individuals in future.

The aim of this research program is to determine whether prescribed medicinal cannabis products impacts driving and cognitive/psychomotor performance and whether this can be effectively indexed and monitored through objective markers of performance. Secondly, using our high-fidelity driving simulator with simultaneous eye-monitoring technologies, we will use examine the relationship between gaze vector and driver behaviour to better understand the impact of medicinal cannabis use on driving performance in healthy adults under a variety of common formulations, preparations, and doses of medicinal cannabis products available to patients.