ANZCTR search results

This is a single-centre observational study that aims to measure the gas flow delivered by bubble CPAP to preterm infants in neonatal intensive care. The project will aim to recruit 50 stable infants currently receiving bubble CPAP in the Royal Women’s Hospital Neonatal Intensive Care Unit. The data collection process involves: recording of the gas flow and pressure of the bubble CPAP apparatus at baseline; decreasing the gas flow until bubbling ceases whilst maintaining the CPAP pressure to record the gas flow being delivered to the infant; recording the gas flow with the infant’s mouth closed; after which the gas flow will be returned to its initial setting. This information will provide insight into the mechanism of action of bubble CPAP compared to other non-invasive respiratory supports such as Nasal High-flow Therapy (nHFT). We hypothesise that the gas flow produced in bubble CPAP is similar to that used in nHFT.

Bacterial vaginosis (BV) is the most common cause of abnormal vaginal discharge in women of reproductive age affecting between 12-30% of women, suggesting it may currently affect at least 1 million Australian women. We have shown that 1 in 2 women will get BV back again after recommended treatment. BV-associated bacteria are present in male partners of women with BV on the male genitals. We believe that these bacteria may be exchanged during sex and that this may be contributing to the high rates of women getting their BV back again. Currently only women are treated for BV and their male partners are not. Our research study “StepUp RCT” aims to determine whether the combined antibiotic treatment of male partners of women receiving therapy for BV significantly reduces the risk of BV recurrence compared to no male treatment, in the 12 weeks after randomisation. We aim to recruit 342 couples in Melbourne and Sydney and we are using a randomised study design: half of men will receive antibiotic treatment (dual couple treatment) and the other half will not (female treatment only). We will collect genital specimens from all participants before and after treatment and then at weeks 4,8 and 12 to see if the female gets her BV back again or not.

The primary objective of this study is to evaluate the feasibility of a blinded, randomised controlled trial of Club Connect: a group-based cognitive training program comprised of psychoeducation on topics related to healthy brain ageing and computer-based ‘brain training’. Participants will comprise a hospital sample of older adults with clinically significant depressive symptoms or history of a major depressive episode within the last five years, and without dementia.

This study is intended to investigate if wearing an activity tracker during inpatient hospital stay impacts the length of inpatient stay, in days. Who is it for? You may be eligible for this study if you are aged at 18-85 years and are undergoing surgery for stomach, liver or pancreatic cancer with one of the participating surgeons involved in this study at the Royal Prince Alfred Hospital and the Chris O'Brien Lifehouse in Sydney. Study details Participants in this study will be randomised (by chance) into two groups. Both groups will undergo their planed surgery procedure. One group will then wear an activity tracker during their inpatient stay in hospital in addition to receiving the usual post operative care, while the other group will not wear an activity tracker but will also receive the usual post-operative care.. All participants will complete a number of questionnaires at 3 timepoints over the weeks just prior to and following their surgery. It is intended that this study will help to improve post-operative care for stomach, liver and/or pancreatic cancer patients in the future.

This research primarily aims to investigate the feasibility and acceptability of the Australian Joy of Moving program in specialist schools. This research also aims to increase key factors (i.e. preference for physical activity, enjoyment of physical activity, motor proficiency and parental support) that influence physical activity participation in children with special needs in order to get children more active. The current research will do this through the Australian Joy of Moving Program which involves active classroom breaks for children in specialist schools and parent/caregiver information sheets. Specifically, this study will (1) investigate the feasibility of the Australian Joy of Moving intervention in specialist school classrooms, (2) investigate the effectiveness of the Australian Joy of Moving intervention on increasing factors related to physical activity engagement in children with special needs (including preference for being physically active, enjoyment of physical activity, motor proficiency and parental support for facilitation of participation in physical activity) and (3) investigate the effectiveness of the Australian Joy of Moving intervention on improving children with special needs’ classroom behaviour and teachers' sense of efficacy. It is hoped that this intervention will increase children’s physical activity and consequently lead to healthy development and wellbeing. Given the benefits of physical activity on aspects of health, we expect that the pilot of the Australian Joy of Moving program may improve factors that promote engagement in physical activities which may have downstream effects for children’s physical and emotional health.

Polycystic Ovary Syndrome (PCOS) is the most common endocrine condition, with no studies in PCOS in young women. Adolescent PCOS is characterised by irregular menstrual cycles, acne, excess hair, obesity and psychological distress. Adolescents with PCOS have impaired quality of life (QOL) and increased stress. There are recent data suggesting that self-management strategies (mindfulness) have a role in improving QOL in women with PCOS however there are no studies in adolescents. Transcendental Meditation (TM) is a well-established and easy technique that is delivered in a standardised manner ensuring follow up. Meditation trials have shown beneficial effects on stress and blood pressure in adults. This project aims to evaluate the effect of TM on QOL and stress in adolescents with PCOS in a randomized trial over 8 weeks with assessments at 0 and 8 weeks. We expect the adolescents practicing TM will have a significant improvement in QOL and stress in comparison to adolescents not practicing TM.

Nevakar Inc. is developing NVK016 which is a ready to use formulation for IV administration that contains 1 mg of fosaprepitant free acid per 1 mL of solution. This study will be conducted in upto 56 normal healthy subjects who meet all of the inclusion criteria and none of the exclusion criteria. This study aims to demonstrate bioequivalence of a test formulation of NVK016 (150 mg Fosaprepitant, Nevakar, Inc.) with EMEND® (fosaprepitant) for injection, 150 mg (Merck) as the reference formulation. This is a two part open-label pharmacokinetic (PK) study designed to assess bioequivalence between a test (T) and reference (R) formulation of 150 mg Fosaprepitant.

The study hypothesizes it's feasible and effective to use intensive BP-lowering to reduce AF burden. In this pilot study of 60 patients with non-permanent AF who have a baseline BP >130/80, we aim to examine whether patients randomized to intensive BP-lowering in addition to usual care will have reduced AF burden as measured by continuous cardiac monitoring using an implanted device. Intensive BP-lowering will be achieved by randomizing patients to the quadpill (single pill with irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg) or to placebo on top of usual care.

The purpose of this study is to assess whether early unclamping during robot assisted partial nephrectomy surgery for kidney cancer is superior to regular clamping in maintaining renal function 6 months after surgery Who is it for? You may be eligible for this study if you are aged at least 18 years and are undergoing a partial nephrectomy for kidney cancer with one of the participating surgeons involved in this study. Study details Participants in this study will be randomised (by chance) into two groups. Both groups will have urine and blood tests, a CT-scan and a DTPA renal scan before surgery. Both groups will then undergo their planed partial nephrectomy procedure. One group will have their renal blood vessels unclamped at the regular (standard) time during the procedure, and the other group will have their renal blood vessels unclamped slightly earlier during the procedure. All participants will have repeat blood and urine tests at 6 timepoints over the 2 years following their surgery, and a repeat CT-scan and DTPA-scan at 6 months after their surgery. It is intended that this study will help to find out which clamping technique (regular or early unclamping) is better for maintaining kidney function after partial nephrectomy surgery.

We are investigating how Atrial Fibrillation (AF), a common heart rhythm disorder, disrupts normal cardiovascular reflexes by affecting nerves from the heart. Whilst it is known that nerves leading to the heart can cause AF, we aim to study whether nerves arising from the heart are equally implicated, in order to provide information that can be used to offer targeted treatment using these nerves. Hypotheses: 1. Patients with Atrial Fibrillation (AF) have abnormal cardiovascular reflexes; likely arising from dysfunction of sensory nerves arising from the heart (cardiopulmonary receptors). 2. These abnormal reflexes are more severe in patients with Permanent AF compared to paroxysmal AF and treatment of AF results in improvement of cardiac reflexes. 3. Autonomic dysfunction parallels disease progression; therefore the nerves of the heart may represent a therapeutic target in the management of AF. We aim to characterise cardiovascular reflex function in detail of patients with AF with a minimally- invasive protocol designed to evaluate the normal function of the heart to maintain blood pressure in response to changes in blood volume (simulated by gently creating a vacuum seal around the legs; negative pressure and raising the legs passively; returning blood to the heart). We shall measure blood pressure, heart rate and do a blood test to measure hormones involved in blood pressure control. We shall also use a painless stimulator of the nerve leading from the heart (using a clip that attaches to the tragus of the ear), thereby bypassing the heart nerves on the way to the brain in order to confirm that any abnormality seen is due to the nerves within the heart rather than elsewhere). In a subset of patients, we shall insert a small needle (similar to acupuncture) to directly measure nerve activity in the forearm during reflex testing.