ANZCTR search results

This is a multicentre, double-blind, phase II study to evaluate the efficacy, safety and tolerability of BP101, administered as two nasal sprays once daily for 28 days, in pre-menopausal women with HSDD. Participants will be randomly assigned to receive one of three different doses of BP101, or placebo. Study assessments include safety checks including vital signs, physical exam and blood tests, and questionnaires to determine whether BP101 can improve sexual function and desire.

COVID-19 response in Australia relies on people getting tested should they experience symptoms; however, national data indicate suboptimal uptake. This study aims to improve the uptake of COVID-19 testing by addressing peoples’ specific reasons for not getting tested. We will test the following research questions: (1) Can we improve understanding of government testing messages, by making the messages simpler? (2) Can we improve peoples’ intention to get tested by tailoring prevention information to their specific testing barriers, and making the messaging more persuasive? (3) Can we increase the number of people getting tested using action plans tailored to their specific testing barriers?

Aims: The aim of this study is to demonstrate clinical proof of concept of tobramycin inhaled dry powder formulation using the Orbital device in a Phase I clinical trial. Tolerability, safety (including pharmacokinetic (PK) assessments) and efficacy will be evaluated and compared to inhaled tobramycin using the standard care capsule-based TOBI Podhaler Pulmosphere therapy. Specifically, the study aims to collect information about the efficacy, tolerability and safety, of the Orbital DPI in comparison to the TOBI Podhaler. The results of this study will be used to inform a larger trial in the future. Hypotheses: It is hypothesised that the use of the Orbital Device with multi-breath inhalation manoeuvres of the same dose will be better tolerated in terms of decreased coughing generally associated with DPIs, and overall convenience in device use when compared to the TOBI Podhaler. The single dose disposable Orbital DPI device is expected to be as effective (comparable FEV1 change and decrease in Pseudomonas density), safe (maximum blood concentration – Cmax not exceeding 2µg/mL) as well as more tolerable for patients (Cough Severity Scale and Tolerability Questionnaire) which will lead to improved adherence.

This feasibility study aims to determine whether a drug screening model can be created using tumour cells from patients with metastatic colorectal cancer that have not been responsive to previous treatments. Who is it for? You may be eligible for this study if you are aged 18 years or older, and have been diagnosed with metastatic colorectal cancer (cancer that has spread to another part of the body) that has so far been unresponsive to or has progressed through other cancer treatments. Study details Participants in this study will undergo a tumour biopsy procedure. For this procedure, a tissue sample will be taken under radiological imaging, by an experienced doctor. The tissue sample will then be used in laboratory tests by the research team to determine how the cells react to different types of drugs. Participants will also have information about their specific disease characteristics, treatments administered and the outcome of each treatment collected by their doctor as is usual practice. This information will also be shared with the research team to further their understanding of disease-drug interactions. It is hoped this research may be used to improve health outcomes for future patients with metastatic colorectal cancer by determining whether it is possible to create a specific tumour cell drug screening model to test the effectiveness of cancer drugs.

We are performing a cross-sectional and longitudinal analysis of airway oscillometry after lung transplantation. We aim to define airway oscillometry indices in patients who are: Stable, have acute lung allograft dysfunction, baseline lung allograft dysfunction and chronic lung allograft dysfunction. We are interested to define early airway closure and elastic recoil properties of the lung allograft.

The purpose of this research is to test if a brief Virtual Reality session reduces anxiety levels in people having elective surgery. Managing anxiety in people having surgery is important because high levels of anxiety can lead to increased pain, surgical infection, poorer wound healing and delayed recovery. Previous research that has used VR has shown that it reduces surgery-related anxiety and leads to better surgical outcomes. This is a randomised controlled trial which means that participants are randomly allocated to either receive the Virtual Reality session or not. Everyone who agrees to participate will be asked to: 1- Have heart rate taken at 3 time-point, two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic. 2- Rate your anxiety level on a 100-points scale (zero means you don’t feel anxious, and 100 means you feel extremely anxious) two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic. 3- Provide a saliva sample at 3 time-points to test your stress levels two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic. The saliva is taken from your mouth using a cotton swab by yourself, and instruction of use will be provided to you. 4- Rate your pain level on a 100-points scale (zero means you don’t have any pain, and 100 means you feel the worst pain) two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic. 5- Complete a 39 item satisfaction questionnaire before you are discharged from the hospital. 6- Allow the researcher to access your medical record to extract the following information: type of surgery, type of anaesthesia, any medications given before surgery and length of hospital stay. Those people randomly allocated to receive the Virtual Reality session will be asked to: 1- Use a Virtual Reality device to watch and listen to a nature scene for 5-10 minutes in the waiting area before surgery. 2- Complete a 13 item questionnaire after the virtual reality session asking about any side effects. Those people randomly allocated to the control group will receive: 1- Routine preoperative care only.

Pulmonary hypertension (PH) is a disease in which blood pressure in lung circulation is abnormally high. PH remains highly-debilitating and deadly – half of patients may die within 5-years of diagnosis. Therefore, new PH treatments are urgently needed. This project builds on discovery by our group that medications working through "beta3 adrenergic receptors" reduce blood pressure in lung circulation of laboratory animals. This study aims to assess the safety and effect of mirabegron - a medication from this family that is used for overactive bladder in Australia – in adult patients with PH. We will administer mirabegron at the hospital and closely monitor the patients. We will measure the blood pressure in the lung circulation using special catheters that are routinely used for this purpose. If mirabegron is safe and effective, we will prescribe it for 8 days and assess the effects by ultrasound of heart in follow-up.

The overarching aim of this project is to investigate a strategy to help maximise human cognitive performance in an encapsulated shift-work environment through evidence-based LED lighting design interventions optimised to support successful circadian physiology entrainment. We will conduct a randomised counter-balanced crossover experimental study designed to investigate the effectiveness of standard versus optimised LED lighting systems on cognitive performance, circadian entrainment, and objective sleep parameters during an 8 day simulated shift-work schedule in a laboratory environment.

OzHarvest, Australia’s leading food rescue organization has developed a primary school program called FEAST (Food Education and Sustainability Training). OzHarvest will provide resources, support, and training to primary-school teachers so that they can implement the FEAST program in the classroom setting. FEAST is designed to provide Year 5 and 6 students with knowledge about healthy eating, food waste, and the impact food choices make on the environment while teaching students to cook. The program is integrated into the Australian Curriculum and embraces Year 5-6 key learning areas (Science, Technology, English, Mathematics) and cross-curriculum priority of Sustainability. The aim of this study is to explore the impact of the FEAST program on children’s fruit and vegetable intakes, cooking behaviour, self-efficacy and skills, and food waste knowledge and behaviours, as well as student’s satisfaction with the program. It is hypothesized that students that undertake this program will increase their fruit and vegetable intake, learn how to follow recipes and prepare simple meals, reduce their food waste by eating their lunch box contents, eat fruits and vegetables that are not ‘perfect’ looking, and understand the impact of their choices on the environment.

Dry eye disease affects between 5 and 50% of the population. In many cases, dry eye disease is idiopathic, however dry eye disease secondary to systemic disease has been identified as a major risk factor in the 2017 Tear Film and Ocular Surface Dry Eye Workshop II (TFOS DEWSII) report. In a study of 199 patients with type 2 diabetes, 54.3% were found to have dry eye disease, with dry eye frequency correlating with the duration of diabetes, where a 100% frequency was reported in patients who had a history of diabetes of greater than 15 years. The concurrent presence of dry eye disease in diabetes poses an additional risk to a potentially already compromised ocular surface: diabetes is known to increase the risk of corneal erosion formation, neurotrophic ulceration and persistent epithelial defects. Diabetes is currently estimated to affect 1.7 million Australians, with this figure predicted to rise to 3 million by 2025. It is associated with a multitude of microvascular and macrovascular complications due to the widespread effects of hyperglycaemia on the body’s various systems. The most commonly recognized diabetes-related complications are diabetic retinopathy and diabetic peripheral neuropathy. The prevalence of diabetic neuropathy is 26.4%15-70% depending on the method of detection used. The prevalence rises to 50% following 10 years of disease duration in type 2 diabetes. The clinical consequences are neuropathic pain, weakness with an increased risk of falls, and loss of sensation which may progress to foot ulceration and even amputation. The cornea, being one of the most densely innervated tissues, contains myelinated A-d and unmyelinated C fibers and has been advocated as a surrogate measure of peripheral neuropathy. We, and others, have previously reported a reduction in corneal nerve fiber length, fiber density and branch density with increasing neuropathic severity in both type 1 and type 2 diabetes. We hypothesize that the presence of neuropathy will increase the prevalence and severity of dry eye disease among those with diabetes. We further hypothesize that treating those with secondary dry eye disease with Systane Hydration will reduce these signs and symptoms, whether or not there is existing neuropathy. Primary Objective: This study will establish the odds of dry eye disease in diabetes when neuropathy is present, compared to diabetes without neuropathy (phase 1). Secondary objectives: This study will establish whether regular ocular lubrication with Systane Hydration can alleviate the signs and symptoms of secondary dry eye disease, whether it be due to diabetes alone or diabetic neuropathy (phase 2).