ANZCTR search results

This study is examining a combination of hormone treatments that may be useful as pre-surgery treatment for breast cancer. Who is it for? You may be eligible for this study if you are female, post-menopausal and have histologically confirmed newly diagnosed hormone receptor positive breast cancer. Study details Participants in this study will be randomised (by chance) to one of three groups. One group will receive the medications letrozole and promethium, another group will receive the medications tamoxifen and promethium, and the other group will receive the medication letrozole alone. The assigned treatments will be taken daily for two weeks prior to surgery. Participants will provide blood samples and consent to their cancer tissue being used for analysis, in addition to medical examination. It is hoped this research will provide fundamental evidence of the efficacy and safety of these medications in patients with early stage breast cancer

The purpose of this study is to test the safety and tolerability of the MultiBiotic probiotic formulation before starting chemotherapy and until the end of treatment. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with cancer and have not yet commenced chemotherapy. Study details Patients who decide to take part in this trial will be given probiotic (friendly gut bacteria) capsules to be taken daily before and during the duration of the chemotherapy. The probiotic has been developed to support gastrointestinal health. It contains three species of Lactobacilli, three species of Bifidobacterium and one species of Streptococcus bacteria. Participants will be asked about their general wellbeing at the beginning and at the end of the study. They will also be asked to keep a record of intestinal symptoms. A stool and a blood test will be required at beginning and at the end of the study. Chemotherapy is associated with mucositis manifesting as pain, inflammation, diarrhoea, weight loss, and infection. It is hoped that this research will help improve the general wellbeing of patients during chemotherapy.

The aim of this study to assess the effectiveness of an online cognitive behavioural program (myCompass) versus a health education program for 6 weeks at reducing concerns about falling in community-dwelling older people. The primary outcome (concern about consequences of falling) and secondary outcomes (concerns about falls, balance confidence, activity avoidance, depression, anxiety, health literacy and physical activity) will be measured in the form of a randomised controlled trial.

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.