ANZCTR search results

Cancer patients often experience inflammation, which is thought to be associated with cancer development and progression, as well as being linked to side effects experienced during and after treatment. As exercise is known to have an effect on systemic inflammation, the aim of this project is to investigate the effect of exercise intensity on markers of inflammation in patients with cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with any cancer type, and are 3-12 months post-completion of primary cancer treatment with curative intent. Study details Participants who enrol in this study will be randomly allocated by chance (similar to flipping a coin) to begin with 2 weeks of either low- or high-intensity exercise involving stationary cycling. Participants will complete 3, 25 minute (total time required per visit: 1 hour) exercise sessions per week (i.e. 6 sessions in total) supervised by an accredited exercise physiologist. After completing the 2-week program, participants will take a 6-week break before switching over to the other intensity for a further two weeks. Blood samples and tests of muscle pain will be performed before each 2-week exercise period, after the first session of each exercise period, and at the end of each 2-week exercise period. It is hoped this research will help us to determine the intensity of exercise that best reduces markers of inflammation in cancer patients, with improvements in cancer pain.

Rationale: Transradial access for coronary angiogram is now standard for coronary angiography. It requires a guidewire to be directed up the radial artery to the aortic root to allow safe mobilization of catheters over it into the aorta to complete the procedure. The traditional guidewire made for femoral angiograms and predating transradial angiography is the peripheral 0.035” fixed core PTFE J-tipped wire (FC0.035) with a 3mm J tip curve radius. Radial arteries are smaller than femoral arteries and typically range from 2.2mm in diameter in women, to 2.7mm in men, both smaller than the J tip curve radius of 3mm in the FC0.035 wire which may predispose to radial spasm or vessel trauma. The hydrophilic J tip ‘baby J’ guidewire with a 1.5mm J tip radius has been designed to traverse areas of radial tortuosity and stenosis easier aiming for less spasm to improve success of passing catheters to the aortic root and is commonly used in coronary angiographic suites second line. However, the FC0.035 wire is still the traditional wire used in transradial coronary angiography, and direct comparison of their procedural success has not been studies to date. If indeed the baby J wire was demonstrated to have a higher success rate in gaining access to the aortic root compared to the FC0.035 wire, it would lead to less wire changes, and less need for alternate arterial punctures and subsequent predisposition to further vascular complications. If this were the case it would suggest it the baby J wire should be considered for use first line in transradial coronary angiography. The objective of this study is to determine if use of the baby J guidewire in transradial coronary angiogram has any difference in technical success compared to the traditionally used FC0.035” wire. The study design is a prospective randomised controlled trial with intention to treat analysis. The study population consists of Participants undergoing best practice coronary angiography or percutaneous intervention at Gosford District Hospital who consent to become enrolled in the trial. At least three hundred and ten Participants are aimed to be enrolled over 12 months. The main study endpoints include the primary outcome of technical success rates between guidewires. Secondary outcomes include crossover to alternative peripheral wire, crossover to alternative access site, bleeding rates (BARC criteria), vascular complications (VARC 2 criteria), radial spasm, haematoma formation (EASY criteria) time to wire entry of subclavian, aorta, and selective coronary intubation.

Medial meniscal root tears are a specific injury to the meniscus which have significant biomechanical implications. There are multiple options for treating these injuries. Some providers treat these injuries without surgery, including physical therapy, reducing the amount of weight you put on the injury leg using either crutches or a brace, and medications that help relieve pain and reduce inflammation. The other option is to treat this injury with surgery, in which the orthopaedic surgeon uses a camera (arthroscope), small tools, and surgical drills to repair the meniscus. The purpose of this study is to compare the results from these two treatment approaches to see if there are any difference in pain, function, and indicators of arthritis and the function of the meniscus that we are able to see on x-rays and magnetic resonance imaging (MRI). Our hypothesis is that medial meniscal root repair will lead to improved outcomes when compared to non-operative treatment.

The project will investigate the efficacy of intratympanic injections of dexamethasone in combatting Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL). This is a prospective, cross-over, double blinded randomised controlled trial. Patients presenting to the Emergency Department with ISSNHL and who meet the eligibility criteria will receive two intratympanic (IT) injections to the effected ear - one within the first 14 days of hearing loss onset, and the other 14 to 21 days later. The first injection will contain either 24mg/ml of dexamethasone or a placebo, and the second injection will be the opposite of the first injection. It is hoped that the IT dexamethasone injection will improve the patient's hearing in the effected ear. All patients involved will be prescribed a course of the oral corticosteroid prednisolone as part of standard care in addition to the IT injections. The primary aim is to determine if 24mg/ml IT dexamethasone in the treatment of ISSNHL will improve hearing. Hearing tests and questionnaires will be administered prior to each IT injection to assess the patient's hearing and to evaluate if the timing of the dexamethasone injection has an impact on hearing recovery.

The aim of this study is to test the impact of different messages about COVID-19 vaccines in parents of children aged 5-11 years on intention to take their child for a COVID-19 vaccine. The hypothesis is if persuasive messaging affects intention to vaccinate, then mean intention to vaccinate will be higher in persuasive messaging conditions than the control. Participants will receive 1 of 4 information conditions or a control. The 4 information conditions will focus on: the personal health impacts of vaccinating; family and community health impacts of vaccinating; non-health benefits of vaccinating; and personal choice and control associated with vaccinating. The control will be text about eligibility for paediatric COVID-19 vaccines. Analysis will compare the primary outcome measure (intention to vaccinate child aged 5-11 years for COVID-19) between intervention groups and the control (4 comparisons) using an ANOVA test. Secondary analyses will compare secondary outcome measures (beliefs about COVID-19 vaccines) between intervention groups and the control using an ANOVA test.

The Syncope Stopper trial is a randomised controlled trial which will enroll patients hospitalised with unexplained syncope who have additional high risk features for recurrent syncope. Participants will be randomised 1:1 to either insertion of a permanent pacemaker or to standard care. Participants will be followed up for 12 months and will be assessed for the frequency of a composite primary endpoint comprising cardiovascular death, recurrent syncope, bradycardia resulting in pacemaker insertion or device-related complications. Our overall study hypothesis is that early pacemaker implantation (a ‘Syncope-Stopper’) is the safest and most cost-effective strategy for managing high-risk patients with unexplained syncope, with the novel DROP score able to identify patients at highest risk of bradycardia.

Children with developmental language disorder (DLD) struggle with the learning, use and/or understanding of grammar. This project examines the efficacy of a theory driven empirically based grammar intervention approach, graduated input type variation (GITV), for young English-speaking children with DLD. The aim is to compare participating children’s performance on both the trained grammar target, and the control grammar item which they will not receive treatment, before and after intervention. During intervention, children will receive input of 30 exemplars provided using two evidence-based procedures, recast and focused stimulation, in which the speech-language pathology student uses a special way of commenting on what is going on and responding to the child’s communication attempts of the target in meaningful contexts during fun activities. Both procedures are typically included in the standard-of-care of children with DLD during language intervention. The relative frequency of the verbs in the input exemplars is manipulated such that in the skewed input stage, one verb appears in a disproportionally higher number of the exemplars, whereas in the balanced input stage, all the verbs appear in similar frequencies. Children will participate in 16 sessions of intervention, twice a week for eight weeks. It is predicted that children will make significant gains in the production of the trained grammar target but show no change in the control grammar item. Children will also demonstrate learning of another grammar item that is structurally similar to the trained grammar target, and maintenance of learning of the target 3 weeks after intervention ends.

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.