ANZCTR search results

STAR-PAD trial intend to answer the question of: Does the ß3AR agonist Mirabegron (50 mg/day), administered for 12 weeks, improve lower limb perfusion and intermittent claudication in patients with PAD compared with placebo control? The intervention will be oral tablet Mirabegron 50mg/day for 12 weeks vs Placebo, The primary outcome will be improvement in peak walk time (PWT) on a graded treadmill test

We hypothesise that whey protein slows gastric emptying, stimulates “incretin” hormones and insulin secretion, and reduces glycaemia; that age and type 2 diabetes will modify these responses. The study aims to determine the acute effects of drinks containing either (i) whey protein, (ii) glucose, (iii) whey protein plus glucose, or (iv) control on blood gucose, insulin and gut hormones. A total of 20 older and 20 younger people with type 2 diabetesand 40 healthy controls, will be recruited. Blood samples, Gastric emptying, blood pressure, heart rate etc will be measured after taking informed consent. Completion of the study will provide us with useful data on gastric emptying of carbohydrates, protein and a combination of these nutrients, and on the effects of these nutrients on energy intake. This will give us novel and important information which can be translated to the community to improve overall health in older people.

Pharmacokinetics (metabolism) of tenofovir alafenamide (TAF) used in HBV-infected women that are breast feeding. Both analogues of tenofovir, differing only by their side chains, TAF has been demonstrated to be safer than tenofovir disoproxil fumurate (TDF), especially in patients with osteopaenia or osteoporosis, thus TAF is likely to be also superior to TDF for pregnant and breast feeding women. Women in this study may choose to take TAF in pregnancy or only postpartum whilst breast feeding. The study will be a one day pharmacokinetic study. There is no registration data on TAF or TDF in pregnancy, but both are allowable and TAF has superior pharmacology to TDF. TDF has been available for ten years and post-registration safety data for TDF are excellent. This project will determine if TAF is detectable in breast milk, maternal blood and infant urine.

Chronic low level inflammation within the central nervous system (CNS) is increasingly being recognised as a potential contributor to many types of persistent pain. Through the activation of glia, especially microglia and astrocytes, it is thought that alterations in synaptic function lead to changes in the way that pain is processed within the CNS. It is believed that these changes play a significant part in the development of central sensitisation. There is also evidence that this glial activation may also account for many of the neuro-vegetative features common in persistent pain such as anxiety, depression, fatigue, poor sleep and cognitive problems. It is hoped that medicines that are able to suppress CNS inflammation might help relieve pain, improve function and associated psychiatric symptoms in patients with chronic pain. Palmitoylethanolamide (PEA) is a naturally occurring fatty acid involved with known anti-inflammatory properties and has been suggested to be involved in the regulation and termination of inflammatory responses within the CNS. It is currently classed as a nutraceutical and available from compounding chemists without prescription. There is some evidence that administration of PEA has analgesic benefits in a variety of causes of persistent pain, although evidence is limited by significant industry support. It does have anecdotal evidence of positive effects and appears to be very well tolerated, with a low risk of serious adverse effects. Given the limitations in current pharmacologic options in the management of persistent pain, it represents a potential useful addition to the current therapeutic options. The aim of this study is to assess the ability of daily oral administration of PEA to achieve long lasting improvements pain and function in patients being treated in a tertiary hospital pain clinic. Patients will be selected based on evidence of neuro- vegetative features as assessed by the Symptom Severity Score (SSS ) from the 2011 revised ACR Fibromyalgia Criteria regardless of primary pain diagnosis. The study aims to have high external validity. Patients will be randomised to PEA or placebo in addition to their current therapy for a period of 6 months. Outcomes will be assessed via the electronic Persistent Pain Outcomes Collaborative (ePPOC) questionnaires, with a primary outcome of Pain Interference as assessed by the Brief Pain Inventory (BPI) at 6 months.

This first in human (FIH) Phase 1 study is a prospective, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability and PK, including the effect on PK of fed vs. fasting, of single oral ascending doses of BioE-1115 in healthy adult subjects followed by the safety, tolerability, PK and PD effects assessed as FS-DNL and RMR of multiple oral doses of BioE-1115 in healthy adult subjects. A total of up to approximately 121 subjects from both parts is expected to be enrolled in this study. Subjects will be recruited to participate in either a SAD cohort or MAD cohort but not both. Safety data for each cohort will be reviewed by a Safety Review Committee. The study will be conducted in 2 parts of 5 SAD and 4 MAD dose cohorts: Part A (SAD): Part A of the study will include a double-blind assessment of the safety, tolerability and PK, including the effect on PK of fed vs. fasting, of SAD of BioE-1115. Each SAD cohort will consist of 8 subjects, including 2 receiving placebo and 6 receiving BioE-1115, in fasting state. One of the cohorts may be called back to be redosed in a fed state. Part B (MAD): Part B of the study will include a double-blind assessment of the safety, tolerability, PK and PD assessed as FS-DNL and RMR of MAD of BioE-1115/placebo. Each MAD cohort consists of 15 subjects, including 3 receiving placebo and 12 receiving BioE-1115. MAD subjects will be dosed in a fasted state

Hemodialysis is life saving for patients with kidney failure. The contact of blood with an artificial environment may cause clots. Heparin is a substance that slows the formation of clots. However, this cannot be given to some patients who have high risk of bleeding. The aim of this research is to compare 5 different ways of providing heparin-free dialysis. These include intermittent saline flushes, artificial circuit coated with heparin, artificial circuit coated with heparin & intermittent saline flush, online predilution and predilution with coating of heparin. We aim to look at successful completion of dialysis without bleeding or clotting problems.

As Parkinson's Disease (PD) progresses, people develop significant mobility limitations and falls despite optimal medical care. The objective of the research is to help people with advancing PD and their families to live better by maintaining safe mobility for longer. Many of the impairments commonly associated with PD contribute to mobility limitations, including impaired balance , freezing of gait and cognitive impairment. The proposed project aims to to determine if a 6 month home based environmental, behavioral and exercise multi factorial intervention for people with PD improves mobility and safe mobility behaviors. Secondary aims are to determine the effect of the program on walking quantity and quality, leg muscle strength, FOG, concern about falling, activities of daily living and care partner burden.

This study will evaluate the effectiveness of electrical stimulation in improving swallowing function and quality of life among adults with MS with swallowing problems. Research around electrical stimulation suggests that there is considerable potential for participants of this project to improve their functional swallowing abilities and hence improving quality of life and emotional wellbeing.

This study will investigate the effects of intragastric administration of specific L-amino acids on gastric emptying, gut hormone release, glycaemic control and appetite perceptions in normal weight, overweight or obese type 2 diabetic patients. We hypothesize that the gastric emptying, gastrointestinal hormone, glycemic and appetite repsonses will be affected by specific L-amino acids in type 2 diabetic patients.

This project seeks to understand the effects of various forms of teacher professional development on teachers' practice and student outcomes. This research involves a 4-arm Randomised Controlled Trial to test the efficacy of Quality Teaching Rounds (trained in two modes), alongside an alternative (Peer Observation) professional development approach and a usual professional development practice control condition. Data will be collected from participating teachers via surveys, lesson observations and interviews. Data will be collected from participating students in the form of Progressive Achievement Tests (PATs) and surveys. We hypothesise that students taught by a teacher who has undertaken QTR will display greater positive achievement growth in mathematics, reading and science, and hold more positive perceptions of their own academic performance, their relationships with teachers, and the relevance of their schooling, compared with students whose teachers undertook alternate methods of professional development. We also hypothesise that teachers undertaking QTR will display gains in teaching quality, and improvements in morale, engagement, individual efficacy, and collective efficacy above that of teachers undertaking alternate methods of professional development.