ANZCTR search results

Currently functional endoscopic sinus surgery is a treatment offered to patients with chronic sinus disease. This involved opening channels in the sinuses to allow better ventilation and drainage. This can be achieved by either opening channels between all sinuses or only a select few. There is limited evidence to suggest if once is superior to the other and current standard of practice varies between specialists. There is limited evidence to suggest that opening all channels is better than opening a select few. A randomised controlled trial offers the same standard of care to patients with sinus disease but compare outcomes in two techniques - opening all channels versus opening a select few. This study will compare outcomes between the two methods by measuring patient satisfaction, evaluation with imaging and specialised endoscopy and rates of revision surgery.

This project establishes a proof of concept for an intervention that uses prescribed physical activity intervention, ACTIVE-TBI, to stop the progression of postconcussion symptoms. In patients slow-to-recover from mTBI, persistent postconcussion symptoms adversely impact on patients’ productivity, relationships, and quality of life. We predict a reduction in postconcussion symptoms after the physical activity intervention, ACTIVE-TBI. Other expected outcomes include: decrease of return-to-work or study times; decreased health service utilisation, and improved recovery outlook.

Owing to advances in neonatal care, survival of preterm infants, particularly those born at less than or equal to 28 weeks, is increasing. Survival brings with it the risk of morbidity. Bronchopulmonary dysplasia (BPD), lung disease unique to preterm infants, is an important morbidity associated with long term impairments of lung function and neurodevelopment. Despite advances in the care of preterm infants, rates of BPD in survivors have not changed over recent decades. In fact, pulmonary outcomes in recent cohorts of preterm infants appear worse. With developments in neonatal medicine over the last few decades the phenotype of BPD has changed. Today, infants at greatest risk of BPD are born in the canalicular phase of lung development, a time when alveolar and distal capillary development commences. Preterm delivery and the interventions compromising neonatal intensive care create a proinflammatory environment disrupting the architecture of vulnerable developing lungs. Targeting inflammation with new generation therapies may provide new therapeutic options for BPD. Preclinical models have demonstrated human amnion epithelial cells (hAECs) can prevent and repair lung injury by modifying the inflammatory response, helping to restore normal lung architecture. hAECs have potential to reduce the incidence and/or severity of BPD. A small phase 1 study completed at Monash Health in Melbourne, Australia gave 1 million hAECs/kg to infants with established BPD. This was a first-in-human study and appropriately gave a conservative dose of hAECs to assess safety. Prior to larger trials to study the efficacy of hAECs as a preventive therapy for BPD, tolerance to higher doses of hAECs, which are more likely to be efficacious based on preclinical studies, must be established in a younger, less mature population of preterm infants. Accordingly, we propose a multicentre dose escalation trial to assess the safety of intravenously administered hAECs in preterm infants at high risk of developing BPD. Infants will be assessed as being at high risk of BPD if delivered at less than 29 weeks gestational age and on Day 14 of life require either mechanical ventilation with an FiO2 greater than or equal to 0.25 or non-invasive respiratory support with an FiO2 greater than or equal to 0.35. 24 infants will be recruited and given intravenous hAECs during the third and fourth week of life at doses increasing from 2 million hAECs/kg to 30 million hAECs/kg. The first 12 infants will receive a single infusion to a maximum dose of 10 million hAECs/kg. Larger total doses will be achieved in the final 12 patients by repeat infusions at 5 day intervals. Safety is the primary outcome and will be defined by the occurrence of adverse events during the 2 year follow-up period. Secondary outcomes include cytokine profiling and neonatal morbidities, in particular the incidence and severity of BPD.

This study aims to see if a group therapeutic songwriting intervention is able to support community-dwelling people with dementia and their family carers. Based on previous research, it is anticipated that group songwriting will have a positive effect on participants living with dementia and their family caregivers' relationship quality, social connection, health and wellbeing. For this study, participants with dementia and their family carers will participate together. Participants in this single group pre-post design will be asked to complete health/wellbeing questionnaires at weeks 0 and 13. All participants will attend 6 x weekly 1hr group songwriting sessions and participate in an interview regarding their experience of the intervention.

The aim of the current study is to investigate whether adding nivolumab and ipilimumab after chemoradiotherapy helps to stop small cell lung cancer coming back. You may be eligible for this study if you are an adult with confirmed small cell lung carcinoma. If the study is suitable for you, you will commence treatment with chemotherapy and thoracic (chest) radiotherapy and prophylactic cranial irradiation (PCI/ brain) radiotherapy which are the standard of care treatment for SCLC. Following completion of the chemotherapy and radiotherapy part of your treatment you will have a CT scan to see if your cancer is shrinking or growing. If your cancer has grown your consulting doctor will discuss the most suitable treatment for you at that time. If your cancer has not grown, you will go on to the next part of the study, and you will be randomised into one of two study groups: Group 1: Nivolumab plus ipilimumab (experimental treatment) Group 2: Observation (no further treatment) If you take part in STIMULI, you will have a number of tests at the first study visit to confirm that the study is suitable for you. At each study visit, you will have various assessments, such as blood testing, urine testing. Computerised Tomography (CT) scans to assess your cancer will be performed every 2-3 months for the first 2 years and then less frequently. This study will help researchers understand how well this treatment works and how severe the side effects are of the standard treatment (chemotherapy and radiotherapy) alone, compared with the standard treatment (chemotherapy and radiotherapy) followed by immunotherapy (nivolumab and ipilimumab) in patients with limited SCLC.

This study aims to evaluate whether intravenous iron is superior to oral iron in correcting preoperative iron deficiency in children undergoing posterior spinal fusion surgery. As there is often a limited time window between patients being booked for surgery (and undergoing preoperative screening) and their surgical date it is important to determine what is the more effective treatment method. The null hypothesis states that there is no difference between oral and IV iron therapy in the incidence of severe anaemia at the time of discharge following elective spinal fusion surgery. The primary outcome measure is the incidence of severe anaemia (haemoglobin <100g/L) at the time of discharge from hospital.

In this research project we will be comparing anaesthesia with xenon to anaesthesia with our usual anaesthetic agent, sevoflurane. Xenon has been used as an anaesthetic agent for many years but it’s use is limited because it is so expensive. In order to justify its use there needs to be good evidence that it has a significant benefit. One area in which xenon appears to have benefit is in protecting the brain during anaesthesia and surgery. There is growing evidence that having an anaesthetic and surgery can cause some problems with how the brain functions. This is of particular concern in infants and older people. This study is considering if there is evidence that xenon may be more protective of the brain than the usual anaesthetic. For the study, patients having a minor surgical procedure will have anaesthetic with either xenon or sevoflurane. We will take blood tests from both sets of patients. The blood tests will look for evidence of any harm to the brain cells of the patients to identify if one anaesthetic is better than the other.

Osteoporosis is a major cause of morbidity in patients with spinal cord injury (SCI) and is under-recognised in this population. Osteoporosis is universal in SCI sufferers and typically results in pelvic and lower limb fractures which heighten the risk of limb contracture, pressure sores, local bone complications including infection and non-union and thus, increases complication and death rates in this population. The primary aim and objective of this prospective study is to try and prevent the occurrence of osteoporosis in acute SCI. This aim involves early assessment of musculoskeletal parameters in SCI patients within 8-12 weeks following an acute traumatic spinal cord injury, and the use of a preventative treatment with an already approved osteoporosis drug to prevent the rapid bone loss which occurs in the acute phase of the spinal cord injury.

The purpose of this study is to determine whether certain biomarkers have an impact on the effectiveness of treatment of bladder cancer. Who is it for? You may be eligible for this study if you are over the age of 18 and have been diagnosed with bladder cancer or urinary tract cancer. Study details All participants will be required to give blood and urine samples at predetermined time points while completing their own cancer treatment. Where possible, blood collection will be at the same time as routine blood tests to reduce the number of times blood is taken. If there is left over tissue after planned medical procedures then a sample of this tissue will be kept. The blood, urine and tissue samples will then be tested to determine how the cells, genes and immune system interact with the cancer and whether these relate to treatment results. It is hoped that this research will help us to better understand why some bladder and urinary tract cancers are more aggressive than other and also why some treatments work better in some patients than others.

Eligible patients will randomly assigned (50/50 chance) to receive both the propagermanium and placebo in different orders as follows, either: 1. Treatment Period 1: Propagermanium capsule twice a day for 16 weeks Treatment Period 2: Placebo capsule twice a day for 16 weeks. OR 2. Treatment Period 1: Placebo capsule twice a day for 16 weeks Treatment Period 2: Propagermanium capsule twice a day for 16 weeks. This study will determine how safe and effective propagermanium is in the treatment of paients with FSGS by: • monitoring symptoms that patients may experience while on the study • measuring levels of protein in patients urine and kidney function during the course of the study. • measuring the levels of propagermanium and irbesartan that enters into patients blood • comparing the propagermanium result to patients' pre-study and placebo results