ANZCTR search results

This is the 2nd human trial in gerilimzumab testing the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of gerilimzumab. A single dose of 5 mg gerilimzumab or 20 mg gerilimzumab or placebo is administered at three 4-weekly intervals (D1, 28, 56). Participants are followed through to D84. This is a randomized, double-blind, placebo-controlled, multiple dose study.

Low plasma vitamin C and E have been more likely to be found in demented patients than in healthy controls. This is supported by findings from a prospective cohort study from Department of Health/Medical Research Council Nutritional Programme in which participants (n = 921; greater than or equal to 65 years) with the lowest Vitamin C status displayed the poorest cognitive function, a finding which persisted when corrected for age, illness, social class, or other dietary variables. Additionally, a recent an epidemiological prospective cohort study showed that high dietary intake of vitamin C and vitamin E may lower the risk of Alzheimer disease. Higher vitamin C blood levels have been found in association with a better memory performance among subjects older than 65 years. Studies have shown that blood vitamin C concentration falls during acute phase responses such as after surgery, trauma, sepsis, and burns. Researchers at the University of Toronto have shown that anaesthetics following surgery can cause long-term memory loss. In a recent study, blood concentration of vitamin C decreased post-operatively and the reduction was significant 7 days after coronary heart surgery. A study is yet to correlate paper and pen assessments such as the Mini mental State Examination (MMSE), Hopkins Verbal Learning test (HVLT-R) and symbol digit modalities test (SDMT) with a computer based cognitive testing such as the SUCCAB. The SUCCAB assesses accuracy and speed, which have been shown to correlate to cognitive decline through ageing. There is consensus that crystallised abilities (vocabulary and general knowledge) can remain stable until very late in life whereas fluid abilities (attention, executive function and memory) decline from middle adulthood until late age. The cognitive tests incorporated in the present study will primarily examine these fluid abilities. The MMSE assesses cognitive impairments in clinical and research settings. The HVLT-R is a reliable neuropsychological test of many aspects of verbal learning and memory, requiring subjects to recall as many items as possible from a list of common words. The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. Previous research measuring vitamin C has incorporated simple food questionnaires to predict vitamin C levels. The proposed study will measure serum vitamin C levels thoroughly through a means of ELISA testing. The proposed project aims to examine vitamin C serum concentration and cognitive performance measured by SUCCAB, and the pen and paper tests, including the MMSE, SDMT, and HVLT-R.

Participation will involve being randomly assigned to one of two routinely used pain management protocols to provide pain relief in the period immediately after total knee replacement surgery. Participants will be unaware as to which group they are in. A pain specialist doctor and nurse will assess pain control and range of movement of the knee at regular intervals following the surgery. This will assist surgeons and anaesthetists to determine the most effective regimen for future patients.

Background: Young people with type 1 diabetes (T1DM) are life-long health service users. Good control of blood glucose can reduce or slow complications, but require services that support effective self-management. When teenagers must move to adult care, transition is often problematic; up to 40% attrition and poor diabetic control result in crisis use of acute services. Evidence is limited, especially outside urban services, but effective transition provides age-appropriate care and can maintain young people in the health system. Aims: To examine whether a new Systems Navigation model of transition and care for young people with type 1 diabetes in regional/rural NSW will result in the improved outcomes seen for this model in other settings; To examine the effectiveness of service redesign processes to support implementation of this new care model. Design is a single blind cluster randomized controlled trial, randomizing the 8 service clusters of Hunter New England Health to either intervention (new Systems Navigation model) or control (current) service models with patient-level outcomes assessment. Participants are young people with T1DM transitioning from paediatric care in their first two years with HNEH adult services. Sample size calculation is based on the primary outcome of usage of planned, routine preventive services; 152 subjects will convey 80% power to detect a 50% improvement in the intervention compared to control group. Outcomes: We aim to increase follow-up of young people with T1DM moving to adult services, and their retention in contact with services. This should improve indices of diabetes control such as HbA1c levels, reduce use of acute services and costs. Patient service satisfaction should be maintained. Data will be analysed on intention to treat basis, taking account of clustering of patients; appropriate regression models will determine if there is statistically significant difference between intervention versus control group outcomes.

In this project, we will study the clinical efficacy of an 8 week graded isometric home exercise program in patients with tennis elbow, by comparing it to a wait and see approach. Exercise is commonly prescribed to reduce pain and disability from tendinopathy, however the optimal type and dose of exercise is not clear. A recent systematic review identified only two clinical trials investigating the effects of isometric exercise in people with tennis elbow, with inconsistent findings. Neither of these studies quantified the exercise load, limiting conclusions regarding dose response. We will compare the effects of an 8 week home program of isometric exercise with a wait and see approach on global recovery, pain, disability and pain free grip strength. Many patients with tennis elbow exhibit signs of central sensitisation, including widespread sensitivity to mechanical and thermal stimuli. It is not known whether exercise can improve the processes involved in central sensitisation. We will test the effects of 8 weeks of exercise on quantitative sensory tests and conditioned pain modulation. Exercise induced analgesia will be also evaluated at baseline using a submaximal (20% MVC) isometric endurance task.

Older people are more likely to lose than gain weight and weight loss is a strong predictor of poor outcomes in older people. Weight lost in older people predominantly comprises muscle and insufficient protein intake is likely to exacerbate muscle loss by limiting muscle anabolism. When severe, muscle loss leads to sarcopenia or cachexia, which are strongly associated with adverse outcomes. Protein-enriched supplements are often used to preserve and restore skeletal muscle mass in the elderly population. The rationale for using protein supplements in older people is strengthened by evidence that ageing has a minimal effect on the capacity to synthesize muscle protein acutely after protein ingestion. Accordingly if older people can ingest enough protein it is likely to have beneficial effects on muscle mass. Muscle protein deposition and anabolic effects are greater when amino acid concentrations are higher, however, there are limits to the amount of protein that can be chronically ingested, particularly by older people, due to factors such as cost, palatability and suppression of energy intake at subsequent meals. Furthermore, in young adults, the onset of satiety after ingestion of more rapidly digested and absorbed proteins is earlier, and its duration shorter than with ‘slower’ proteins. Administration of more rapidly absorbed proteins to under-nourished older people may, therefore, have the advantages of not only enhancing muscle protein synthesis, but also of minimising the duration of any potentially appetite suppressant effects. An effective way to increase muscle protein deposition, by accelerating the absorption of proteins, may be to hydrolyse them, ie digest proteins in their component amino acids. In healthy older people, for example, administration of partially hydrolysed casein resulted in earlier and higher peak amino acids (particularly essential amino acids, e.g. ~3-fold increase in peak plasma leucine concentration) than administration of the same amounts of un-hydrolysed casein (~2-fold increase). Insights into the digestion and absorption kinetics of dietary protein-derived amino acids after protein ingestion can successfully be obtained by using cow milk protein with intrinsically labelled amino acids (L-[1-13C]-phenylalanine and L-[1-13C]-leucine), which are measured in muscle biopsies after administration to calculate fractional synthetic rates of the muscle. Aim: To determine the acute effects of hydrolysis of protein on protein absorption and digestion kinetics of milk protein, administered directly into the small intestine. Hypothesis: In older subjects the plasma amino acid concentrations will peak more rapidly and the muscle protein deposition will be higher after ingestion of the completely digested protein (free amino acids) when compared with the intact intrinsically-labelled milk protein.

Background: Intravenous paracetamol is ubiquitously used in hospitals as an antipyretic and analgesic worldwide. It is administered to a wide array of patients including those undergoing major surgeries due to its minimal side effect profile. Previous studies have suggested that 4g/day paracetamol is safe in patients undergoing liver resection surgery, however other authorities recommend that administration be kept at a maximum of 2g/day in patients with hepatic impairment. There is now a growing body of evidence that supports the safety of paracetamol use even in patients with liver disease. However, there are no studies to date that have investigated the haemodynamic effects of paracetamol in patients with chronic liver disease. Recent studies have provided evidence that paracetamol may cause hypotension in critically ill patients, which may have important clinical implications for patients undergoing major surgery. The mechanism for this hypotension is unknown but may be attributable to one the stabilizing compounds found in the formulation, mannitol. Mannitol is a known diuretic and even in small quantities can cause episodes of transient hypotension. There is insufficient evidence evaluating the use of paracetamol in the setting of liver transplantation, and importantly there are no pharmacokinetic studies that evaluate safety and efficacy in this setting. Hypothesis: A single dose of paracetamol (1g IV) has adverse effects on blood pressure in patients with chronic liver disease undergoing liver transplantation surgery. Study aims: To determine whether paracetamol has any adverse haemodynamic effects in patients with chronic liver disease who are undegoing liver transplantation.

The aim of this project is to study whether the oral sensitivity to basic tastes (umami taste, Monosodium glutamate MSG and sweet taste; sucrose) would influence on human eating behavior which include total energy intake, sensitivity to satiety, appetite hormone profiles and salivary flow rate and hormone profiles. The purpose of this project is to improve the understanding of the correlation between taste perception and food eating behaviors.

The General practitioners Antimicrobial Stewardship Survey (GAPS) is a research project funded by the Department of Health which aims to decrease antibiotic resistance in Australia by reducing the antibiotic prescribing rates for Acute Respiratory Infections in primary care. Utilising the considerable expertise from several institutions in Queensland (The University of Queensland, Bond University and Queensland University of Technology) we propose to investigate innovative and cost effective interventions which will lead to a reduction in antibiotic prescribing in primary care. This is a diverse group of experts from clinical and academic fields who work together on research that will translate into a reduction of antibiotic resistance and improved strategies for the appropriate use of antibiotics at clinical and policy level.

Clinical experience and reports from families of children with type 1 diabetes has long suggested that meals high in protein and/or fat cause an increase in blood glucose levels after eating. Increased blood glucose levels, including after consumption of food, is well-known to add to long term health complications in type 1 diabetes. Current type 1 diabetes management guidelines recommend adjusting insulin doses for food based on the amount of carbohydrate to be eaten at each meal. However, there has been an increase in evidence, including that from a recent study by our study group, to suggest that other nutrients such as fat and protein should be considered when calculating pre meal insulin. High levels of protein and/or fat in a meal cause a larger than expected rise in blood glucose levels after eating and these high blood glucose levels persist, suggesting the need for extra insulin. This research project will compare the insulin required to maintain blood glucose levels at a constant level when consuming two meals, one high in protein and the other low in protein. This will be determined by looking at the difference in intra venous insulin requirements after both meals. IV insulin will be given to participants to maintain blood glucose levels at a constant level whilst they are eating the meal and in the 5 hours following. Fifteen participants will consume both a high protein and a low protein meal, at least one week apart. The different insulin amounts needed to maintain blood glucose levels after each test meal will provide accurate calculation of the expected increase in insulin requirements on consumption of a high protein meal. This study will provide important information in the management of type 1 diabetes in both adults and children. This information will be used immediately in our day to day management of patients and will guide the development of clinical guidelines to minimize the rise in blood glucose levels after eating.