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Beverage Choice Decisions (BCD) study
Consumption of sugar sweetened beverages (SSBs) such as softdrinks, cordials, flavoured milks and sports drinks is linked to increased risk of becoming overweight or obese and developing Type 2 Diabetes and dental decay. Increasing sugar sweetened beverage prices by taxing them and discouraging people from buying them using educational messages have both been proposed as strategies to discourage consumption. This study aims to explore the characteristics of beverages that people consider when deciding which beverage to buy. It will also examine preferences for different educational messages and pricing changes designed to reduce purchasing of sugar sweetened beverages. In this Discrete Choice Experiment (DCE) participants will be asked to choose between different beverage options with variable prices, volumes and under different conditions including after seeing an educational message. We hypothesise that increasing the price of sugary drinks and showing participants an educational poster about the negative health effects of sugary drinks will both decrease the likelihood participants will select a sugary drink. The results will be relevant to government and policy makers, by helping them to understand which types and size of pricing strategies are useful in reducing sugar sweetened beverage consumption in different groups of consumers, for example those with low and high incomes.
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Identifying Neuroimaging Markers of Neuroinflammation in Neurodegenerative Diseases
Immune-responsive cells of the brain – namely microglia and astrocytes – activate in response to brain injury or pathogens. This activation leads to a local neuroinflammatory response that serves to isolate and protect the tissue, remove the noxious agent, and promote recovery. However, while beneficial in the short term, the chronic release of pro-inflammatory chemicals (cytokines and chemokines) becomes increasingly toxic, and actually begins to contribute to neuropathology in its own right. Chronic neuroinflammation is thought to play a central role in the progressive neural morbidity that underlies neurodegenerative disorders such as Huntington’s Disease (HD), Alzheimer’s Disease (AD), and Parkinson’s Disease (PD). However, there is little current understanding of the link between in vivo neuroinflammation and in vivo brain atrophy in humans, particularly as it relates to how the disease spreads to regions beyond primary sites of pathology. In this study, we will use a novel multi-modal neuroimaging approach that combines positron emission tomography (PET), magnetic resonance spectroscopy (MRS), and magnetic resonance imaging (MRI) to investigate the contribution of neuroinflammation to brain atrophy in individuals with neurodegenerative disorders. This work has direct implications for (i) developing more complete models of the pathological processes underpinning disease expression, (ii) assessing the sensitivity of neuroinflammatory measures as disease biomarkers, and (iii) providing support for (or against) the value of pursing novel disease monitoring and intervention approaches that respectively involve measuring or mitigating chronic neuroinflammatory processes.
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Phase 2 trial of alternating osimertinib with gefitinib in patients with EGFR-T790M mutation positive advanced non-small cell lung cancer
The primary purpose of this trial is to evaluate the efficacy, safety and feasibility of osimertinib and gefitinib for the treatment of EGFR-T790M mutation positive advanced non-small cell lung cancer. Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over and have been diagnosed with EGFR-T790M mutation positive advanced non-small cell lung cancer which has acquired resistance to EGFR tyrosine kinase inhibitors (TKIs). Study details All participants enrolled in this trial will begin with induction therapy which involves taking an osimertinib tablet once per day for eight weeks. Participants will then move onto the alternating phase, which involves alternating four-weekly cycles of treatment with gefitinib and osimertinib (i.e. four weeks gefitinib then four weeks osimertinib) until disease progression or unacceptable side effects. Following progression, some participants may be eligible to continue with alternating treatment or switch to continuous osimertinib treatment until further progression, depending on whether your doctor believes that this would be of benefit to you. All patients will be reviewed up to every four weeks by blood samples, CT scans and side effect assessments. It is hoped that the findings from this trial will provide information on whether alternating treatment with osimertinib and gefitinib is feasible, safe and effective for the treatment of EGFR-T790M mutation positive advanced non-small cell lung cancer.
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Effects of small intestinal quinine (bitter agonist) on gut function and blood glucose in healthy, lean volunteers.
The purpose of this trial is to investigate the dose-related effects of small intestinal administration of the bitter agonist, quinine, a non-nutritive (calorie-free) compound, on the motor and hormone functions of the upper gastrointestinal tract, appetite, energy intake and blood glucose. The relationship between outcomes and the ability to detect bitter in the oral cavity will also be investigated. We have found previously that specific dietary nutrients, when given into the small intestine in small amounts (and so not contributing significantly to overall energy intake) have the unique ability to substantially stimulate gastrointestinal functions leading to marked energy intake suppression and improvements in postprandial blood glucose. There has been a recent interest in the effects of bitter compounds, some of which also occur in the diet, including thio-urea compounds in certain vegetables or fruit, or quinine in tonic water, with reported effects on gut functions and energy intake suppression. This study aims to characterise the dose-related effects of quinine, when delivered to the small intestine, in an effort to identify an optimal dose for beneficial effect on the outcomes mentioned herein. This may then guide future research to evaluate hypotheses that observed effects may be further enhanced by combining nutrients with quinine.
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Effects of small intestinal L-valine on gut function, gut hormone release and blood glucose control in healthy, lean volunteers.
The primary purpose of this study is to investigate the effects of varying doses of L-valine (a branched chain amino acid (BCAA)) on gastrointestinal motility, gut hormone release, glycaemic control, and appetite and energy intake in healthy lean individuals. The other BCAA’s are isoleucine and leucine, and there is some evidence that valine and isoleucine, when added in combination with leucine to the diet, may be associated with decreased energy intake, improved postprandial blood glucose and weight loss. Valine is widely used in BCAA mixtures, however evidence for its effects on blood glucose metabolism and gastric function is limited. Thus, it is of special interest, in terms of potential therapeutic approaches for obesity and type 2 diabetes, to characterise the dose-related effects of L-valine when administered in isolation, in a healthy sample. The exploratory nature of this trial bears no formal hypothesis, as its purpose lies in finding the effects of L-valine on the outcomes listed, which may then guide specific hypotheses for future research.
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A randomised trial of nonselective versus selective adjuvant therapy in high risk apparent stage 1 endometrial cancer.
This study is testing the use of a surgical procedure called lymphadenectomy (or lymph gland removal) to help guide further treatment in women with endometrial (womb) cancer. Who is it for? You may be eligible to join this study if you are a woman aged 16 years or above, have histologically confirmed high risk apparent International Federation of Gynecology and Obstetrics (FIGO) stage I endometrial cancer. Study details Patients will be randomly allocated to one of two groups, Group 1 or Group 2. Patients in Group 1 will have surgery with lymph glands removed. The results of the lymph glands will be used to decide on the further treatment. Women with cancer in their lymph nodes (‘node positive’) will receive chemotherapy with or without radiotherapy. Women with no cancer in their lymph nodes (‘node negative’) will only receive an internal form of radiotherapy called brachytherapy and will not be given chemotherapy or external radiotherapy. Patients in Group 2 will have surgery with no lymph glands removed. After surgery, all women in this group will then receive chemotherapy with or without external radiotherapy. Specifics of the chemotherapy and radiotherapy will vary depending on the specific institution and individual doctor conducting the study. The purpose of this study is to find out whether there is any difference in clinical response between patients in Group 1 and those in Group 2 and to determine whether lymph gland removal improves quality of life in some patients.
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Evaluating the impact of the Students As LifeStyle Activists (SALSA) project on dietary and physical activity of high school students
The SALSA (Students As LifeStyle Activists) program is a school-based, peer-led initiative to improve nutritional intake and increase physical activity amongst high school students. Since 2004, the SALSA program has been provided to high schools in Western Sydney with the support of various organisations including Rooty Hill High School, Mt Druitt and Blacktown Medical Practitioner’s Associations, Primary Health Care Education and Research Unit, the University of Sydney and Western Sydney Medicare Local. The Commonwealth Department of Health has provided funding to support the implementation and evaluation of the SALSA program in high schools in 2014/15. The SALSA program is incorporated into each school’s curriculum to complement lessons taught by teachers. The program is simply described in this brief video: https://youtu.be/jiudp1few9Q This research aims to determine the extent in which the SALSA program influences positive changes in key dietary and physical activity behaviours, and intentions regarding these behvaiours, associated with a healthy lifestyle in Year 8 participants and Year 10 peer leaders. Key outcomes were: * Frequency of breakfast intake, and intention to eat breakfast daily. * Usual daily intake of fruit; and intention to eat more fruit. * Usual daily intake of vegetables; and intention to eat more vegetables. * Usual daily consumption of fruit juice and other sugary drinks (e.g. soft drinks, cordials, sports drinks and energy drinks). * Frequency of being sufficiently physically active (i.e. 60 minutes or more daily); and intention to be physically active more often. * Usual daily recreational screen use; and intention to devote less recreational time to screen activities. We hypothesised that the SALSA program would influence positive changes in the frequency of breakfast eating and other health related behaviours in Year 8 students and Year 10 Peer Leaders. In Year 8 students and Year 10 peer leaders, behaviours and behavioural intentions were measured before the SALSA program, 2 weeks after completing the program, and 3-5 months after completing the program. Ethical approval was granted in 2014 from the University of Sydney and the Department of Education (the University of Sydney no: 2014/203; SERAP no: 2014096). In late 2014, we also received approval from the Catholic Education Office to approach and recruit Catholic Schools in western Sydney to participate in the SALSA program evaluation. All high schools that implemented the SALSA program agreed to participate in the evaluation. As partners, they were responsible for distributing a letter to parents/caregivers of Peer Leaders and Year 8 students informing them of the school’s and their child’s invitation to participate in SALSA program. If parents did not wish for their child to participate in the program evaluation, a tear off slip was to be signed and returned to the school.
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Clinical trial investigating if anti-malaria treatment DSM265 causes an allergic reaction.
This is a clinical research study investigating the allergic potential of the experimental anti-malarial drug DSM265. Following the occurrence of cutaneous rash in one healthy subject (hereafter, subject R107) involved in a clinical investigation of the antimalarial potential of DSM265 (QP15C11/P2142), the study sponsor intends to perform cutaneous testing with DSM265. This new study has 3 parts. In Part 1, skin prick testing with various concentrations of DSM265 will be carried out in 10 healthy volunteers, to determine a non-irritant concentration for subsequent testing. In Part 2, subject R107 will be skin prick tested for DSM265 allergy, as well as for allergy to polysorbate 80, an excipient used in the preparation and in many commercially available drugs. Part 3 of the study will proceed if subject R107 skin prick testing in Part 2 is negative or inconclusive: subject R107 will be administered DSM265 p.o. and assessed for allergic symptoms.
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Mental health and wellbeing in community sport: The Ahead of the Game program
The overall goal of this project is to reduce the risk of mental health problems among adolescent males who participate in sports by delivering a series of mental health programs through their organised sporting club. To do this, we will embed and then test a multi-level, multi-component intervention in community sporting clubs with the primary aim of preventing the onset of mental health problems. Specifically, we aim to: (1) increase mental health literacy among adolescents and their parents; (2) increase intentions to seek and provide help for mental health problems; and (3) increase resilience. The secondary aims of this project are to prevent dropout form organised sports and to reduce the stigma associated with mental health problems among males aged 12-17 years who are associated with organised sports clubs in Australia. In combination, the programs aim to improve mental health by preventing the onset of mental health problems and encouraging early help-seeking behaviours..
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CLinical Evaluation of the FluidVision Mongoose X Accommodating Intraocular Lens for Accommodation Restoration
The objective of this study is to evaluate the safety and effectiveness of the investigational FluidVision (registered trademark) MX Accommodating Intraocular Lens (AIOL) in providing distance, intermediate, and near vision as compared to a trifocal IOL (Alcon PanOptix IQ), in patients undergoing bilateral cataract extraction and bilateral intraocular lens implantation.