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The aim of the CSI (Climate Schools Interactive) Study is to evaluate the Climate Schools: Ecstasy & Emerging Drugs module, an online, school-based prevention program designed to educate adolescents about the harms associated with illicit drug use. To our knowledge, this will be the first trial of any internet-based program specifically designed to prevent the uptake and use of ecstasy and NPS. It is hypothesized that students receiving the Climate Schools intervention will report reduced ecstasy and NPS use, reduced intentions to use ecstasy and NPS in the future, increased knowledge about these drugs and reduced associated harms.

Participants are invited to take part in this research project if they are undergoing a coronary artery bypass graft surgery (CABG). During the surgery, blood vessels from other parts of the body will be used to ‘bypass’ blocked blood vessels in the heart which will improve the blood flow to the heart muscle. When blood vessels are removed from the body they must be immersed in a solution (salts in water) to keep them healthy before until they are replaced onto the heart. This research project is testing a new solution known as SOMVC001 (also known as GALA), which is intended to improve the preservation of the blood vessels, which are removed during the operation until they are placed on the heart.

Acute exercise increases skeletal muscle insulin sensitivity for hours after exercise by mechanisms that are incompletely understood. The aims of this project is to examine whether the increase in insulin-stimulated skeletal muscle glucose uptake following exercise/ is determined, in part, by undercarboxylated osteocalcin (ucOC), a bone formation marker produced by osteoblasts. Methods: 12 overweight/obese men (age 40-70) will be recruited. Volunteers will perform the following assessments: body composition measurements, fasting blood test, bone scans and a fitness test. Participants will also perform 2 hyperinsulinaemic euglycaemic clamp (Insulin Clamp) sessions once at rest and the other one following high intensity interval exercise session. Blood samples will be taken at rest, during and following exercise (or rest), and throughout the insulin clamp to measure blood glucose, insulin, ucOC and other markers associated with metabolic risk factors. Muscle biopsy samples will be taken at rest, 1h after exercise and at the conclusion of the insulin clamp. Muscle samples will be analysed for activation of exercise and insulin sensitive signalling proteins, muscle gene expression, markers of mitochondria respiration, inflammatory markers and other markers in the muscle. This project will bring new insights into the connection between exercise-bone-glucose control in overweigh/obese men. Understanding the mechanism that is involved in glycaemic control may lead to new interventions, pharmacological and non-pharmacological, for the prevention and management of type 2 diabetes in this population.

Glucose sensor technology for continuous glucose monitoring (CGM) in diabetes has been evolving with an ultimate goal of achieving a level of reliability and accuracy required to replace finger prick glucose measurement. Although CGM technology advances have increased accuracy, reliability and ease of use, further improvements are required. A CGM system based on a novel technology platform has been developed. Early laboratory testing, animal studies and limited testing in humans indicates that further human studies are warranted. This feasibility study of the novel glucose sensor is the first extensive testing of this sensor in humans.

Current methods of retracting the liver during surgery (to allow sight of and access to target surgical organs) can be traumatic or painful, and can require additional surgical assistants. The LiVac Retractor System has been developed to retract and hold the liver by suction, therefore reducing trauma and the need for extra assistance. This proof of concept study will assss how well the devices work during surgery and whether there are any safety issues.

Substitution of an innovator to a generic drug product has been continuously rising. In the US, approximately $8 billion to $10 billion is the average cost saving per year of brand substitution and the generic drug prescription has increased from 19% in 1984 to 60-70% in 2009. The increase in drug brand substitution is a call for scientific attention of the appropriateness of available bioequivalence (BE) study guidelines at present. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. The conclusion of BE studies is based on the assumption that if the test and reference drug products exhibit similar in vitro (i.e. acceptable drug content, similar dissolution/release profile) and in vivo performance (i.e. acceptable bioavailability), these drug products should possess therapeutic equivalence which includes efficacy and safety. However, because bioequivalence studies are conducted in healthy volunteers, these studies may or may not provide definitive evidence to guarantee the therapeutic equivalence in patients. This study aims to compare efficacy and safety of two warfarin products marketed in Australia, namely Coumadin registered trademark or Marevan registered trademark. The study is designed as an openlabel, prospective, observational trial. A total of 300 patients who are prescribed with either brand of warfarin will be recruited in accordance with the inclusion and exclusion criteria. The patients will be followed up opportunistically as their medical appointments for anticoagulant evaluation. The additional 5 mL of the participant blood samples and about 25 mL of urine samples will be collected at each visit. Total and free racemic, R- and S-warfarin enantiomer concentration in plasma, as well as 4',6,7,8, and 10hydroxywarfarin metabolites in urine will be quantified by LC MS/MS. The efficacy of the two warfarin brands will be compared by evaluating International Normalized Ratio (INR) values. The safety profile evaluation will be achieved by recording any adverse drug reactions or adverse events in a questionnaire. The frequency of adverse events reported from two groups of patients will be analyzed and compared.

Substitution of an innovator to a generic drug product has been continuously rising. In the US, approximately $8 billion to $10 billion is the average cost saving per year of brand substitution and the generic drug prescription has increased from 19% in 1984 to 60-70% in 2009. The increase in drug brand substitution is a call for scientific attention of the appropriateness of available bioequivalence (BE) study guidelines at present. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. The conclusion of BE studies is based on the assumption that if the test and reference drug products exhibit similar in vitro (i.e. acceptable drug content, similar dissolution/release profile) and in vivo performance (i.e. acceptable bioavailability), these drug products should possess therapeutic equivalence which includes efficacy and safety. However, because bioequivalence studies are conducted in healthy volunteers, these studies may or may not provide definitive evidence to guarantee the therapeutic equivalence in patients. This study aims to compare efficacy and safety of two warfarin products marketed in Australia, namely Coumadin or Marevan. The study design is a randomized, open-label, two-way, two-period, crossover study. A total of 50 patients who are prescribed with either brand of warfarin and clinically stable will be recruited in accordance with the inclusion and exclusion criteria. The patients will be allocated as the assigned randomized treatment sequence into 2 groups. For the first 4 weeks, Group I will start with Coumadin and Group II will start with Marevan. Then the participants will be crossed over to the other brand for another 4 weeks. Participant blood samples will be collected at baseline and weekly until the end of the study. Total and free racemic, R- and S-warfarin enantiomer concentration in plasma, as well as 4',6,7,8, and 10hydroxywarfarin metabolites in urine will be quantified by LC MS/MS. The efficacy of the two warfarin brands will be compared by evaluating International Normalized Ratio (INR) values, warfarin dose variation, mean warfarin dose to achieve target INR, area under the plasma concentrationtime curve, and warfarin metabolites to drug ratio. The safety profile evaluation will be achieved by recording any adverse drug.

Obesity is a major health issue that is currently affecting millions of Australians, in addition to having a high economic cost both in this country and around the world. Some individuals are more susceptible to obesity that others; one factor may be variance in taste system due to genetic and environmental factors such as diet. The present study aims to identify and investigate the associations between individual differences in sweet and carbohydrate taste sensitivity with diet and BMI. Proposal research design and methods: The study will involve 100 subjects. These participants will be over 18 years of age and within a BMI range of 18-35kg/m2. Participation in this study involves attending at least 16 laboratory sessions. The first three sessions will involve taste function assessment of the five basic taste qualities (Sweet, sour, bitter, salty and umami). The remaining sessions will involve taste function assessment for different kinds of sugars, natural sweeteners and artificial sweeteners. Participants will be given a copy of the Cancer Council Food Frequency Questionnaire and a 7-day diet diary at baseline, and will be asked to complete them within one month of the sensory testing period. Subject's height, hip and waist circumference, and tongue swab for cell collection will be collected at baseline. Subject's weight will be measured twice, at baseline and at the final visit. The study will use a range of methods and will take place in Deakin University sensory laboratories. Sensory evaluations, including ascending detection and recognition thresholds (sample a series of eight solutions arranged in ascending order to determine taste thresholds) and ascending forced-choice test (correctly choosing a sample that has added sugars/sweeteners/starch at specific concentration) will be used to determine sweet and carbohydrate taste function.

Adolescents are at particular risk of vitamin D deficiency and are also a group who may not take medications regularly. The optimal dosage regimen for adolescents to help them take vitamin D regularly enough to correct deficiency is not known. Therefore the main aim of this study is to test two different vitamin D dosage regimens to see if they can both correct vitamin D deficiency in adolescents. The study will also show whether vitamin D deficient adolescents can be successfully identified through general practice and provide preliminary pilot data on whether correcting vitamin D deficiency results in significant improvements in bone density.

This is a single-center, randomized controlled, study using induced blood stage malaria (IBSM) infection to characterize the activity of griseofulvin as a potential treatment of early Plasmodium falciparum blood stage infection in healthy volunteers.