ANZCTR search results

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.

We will recruit 120 women with singleton pregnancies without cardiac abnormalities from 28 weeks gestation to term. Each participant will undergo a NI-FECG recording session with concurrently recorded CTG and tocodynamometer to ascertain a gold standard for the fetal heart activity and uterine activity.

D-mannose is a carbohydrate and important in the metabolism of some proteins within the human body. It has been shown to prevent the adherence of E-coli bacteria to the uroepithelial lining found in the bladder. This is important because E coli is the most common pathogen responsible for urinary tract infections. D-mannose has also been shown to be useful in reducing the bacteriuria (bacteria in the urine) in animal studies and is used in equine veterinarian practices for this purpose. Previous studies using D-mannose as a preventative measure against UTI have been promising. However, none have examined the effect in patients with diabetes mellitus or the elderly patient, who frequently have recurrent and resistant strains of E-coli in their urine. Therefore the aim of this study is to measure the effectiveness of D-Mannose in reducing the development of full urinary tract infection in those high risk patients who experience recurrent urinary tract infection. The study will be a double blind randomised trial with the primary outcome examining the percentage of patients developing a UTI during the study period. It will be conducted over a 24 week period.

There are many factors which are thought to contribute to the ability to maintain good brain health, including genetics, psychosocial and environmental factors. In addition, recent research has indicated that it may be possible to induce, or promote, brain health using non-invasive brain stimulation - namely transcranial Alternating Current Stimulation (tACS). Therefore, the purpose of this project is to investigate brain activity that is related to cognitive performance (i.e. thinking skills) in people with mild cognitive impairment. We will conduct these investigations a number of times over a three-year period to allow us to look at any changes that may occur in brain activity and cognitive performance. We will also be looking at any psychosocial and environmental factors that might contribute to changes in brain activity and cognitive performance. Finally, we will also investigate the effects of tACS on brain activity and cognition over the same period of time. Overall, this project aims to help provide a better understanding of the reasons why some people with MCI go on to develop Alzheimer’s, whilst others do not, and ultimately help in the development of early intervention treatments for Alzheimer’s disease. It is hypothesised that participants receiving active treatment will improve cognitive function, enhance brain activity, and strengthen functional brain connectivity after each yearly treatment course compared to those who undergo sham treatment. It is also hypothesised that there will be a lower conversion from MCI to Alzheimer’s disease in individuals receiving the active treatment over the three-year period, compared to those receiving the sham treatment. Finally, it is hypothesised that biopsychosocial factors will influence pathophysiological changes in people with MCI over time.