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Agouti-related peptide (AgRP) in well trained wrestlers
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Single Patient Multiple Cross-Over Trials To Determine The Efficacy Of Pilocarpine In Relieving Dry Mouth In Patients With Cancer
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A Phase 1, single dose, dose-ascending study of VRS-859, to observe the safety, tolerability and effect in Patients with Type 2 Diabetes Mellitus
This will be the first time VRS-859 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data from type 2 diabetic patients administered a subcutaneous dose of VRS-859. The study will also provide data on the single dose pharmacokinetics. Assessment of the activity of VRS-859 will be measured by testing fasting plasma glucose (FPG) and response to oral GTTs at selected times post-dose. This combined data will help establish the best dose and optimum dosage regimen for administration to patients. The study design provides an opportunity to evaluate the potential of VRS-859 to be administered monthly to patients that are already on a diet and exercise program with a well established standard of care, metformin. Interim safety assessments of each treatment group (cohort dose) will be made prior to escalating to the next higher dose thus providing additional opportunity to evaluate the overall safety of each dose and to define the safest monthly dose.
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Concord Falls and Bone Service Study: An evaluation of the effectiveness of a specialist service on reducing falls in community dwelling older people who have fallen.
Falls are a common occurrence in older people and can have adverse affects on health and independence. It is unclear how best to provide interventions to prevent falls. The primary aim of this study is to evaluate the effectiveness of a hospital based specialist led falls and bone service at reducing the number of falls and number of fallers in a group of community living older people. Our hypothesis is that a hospital based specialist service is more effective at assessing fall and osteoporosis risk and coordinating interventions to prevent falls and treat osteoporosis than enhanced General Practice care.
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Metformin for the management of insulin resistance in overweight women at midlife.
Brief summary* Abdominal weight gain and insulin resistance (IR) significantly increase the risk of some age related conditions in midlife women, namely cardiovascular disease, dementia and breast cancer. The aim of early intervention in individuals with abdominal obesity and IR when they are still euglycaemic is to prevent progression to type 2 diabetes mellitus and the development of other co-morbidities. We hypothesise that treatment of obese midlife euglycemic women with metformin will result in improved insulin sensitivity (assessed by homeostasis model of assessment (HOMA-IR) and increase in sex hormone binding globulin (SHBG)), weight loss, improved lipid parameters and an increase in adiponectin levels.
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Bioequivalence study comparing AndroForte 5 (Registered Trademark (R)) and Testogel (R) 1%
The study will determine if AndroForte (R) 5 (testosterone cream) is bioequivalent to Testogel (R) 1% (testosterone gel) for the treatment of men with low testosterone levels. Participants will apply the cream or gel to their torso for 30 days during each treatment period and at the start and finish of each of the treatment periods, participants will provide blood samples at pre-determined time points for the measurement of blood testosterone levels. This study aims to establish that AndroForte (R) 5 is equally effective as Testogel (R) 1% (considered to be the standard comparator for transdermal testosterone worldwide), in increasing the testosterone levels in men with low testosterone to within the normal circulating range.
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A randomised controlled trial of a fully automated online mindfulness program focussing on 18-25 Australian Tertiary Education students
Swinburne's eTherapy Unit will run a research trial to investigate the efficacy of a fully automated self-help online mindfulness intervention, Mindfulness Online, in the promotion of wellbeing amongst 18 to 25 year old TAFE and Further Education students. Swinburne University of Technology's eTherapy Unit and National eTherapy Centre (NeTC) have developed numerous internet-based prevention and treatment programs that are available to the general public for the treatment of clinical conditions and the promotion of well being. To continue the development of effective online programs information relating to the appropriateness and efficacy of specific programs for specific user groups is required. The current project seeks to examine the efficacy of the Mindfulness Online program (developed by Dr Jo Mitchell) in its application to a group of 18 - 25 year old Australian Tertiary education students. The results of this research will inform future development and recommendation of internet based interventions for specific user groups.
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Continuous Local Anaesthetic Wound Infiltration in Hepatobiliary Surgery - A Comparison with Placebo
The aim of this project is to see whether continuous local anaesthetic wound infiltration for 48 hours post-operatively is useful in hepatobiliary surgical procedures in terms of: 1. Better pain relief 2. Reduced opiate consumption via patient-controlled analgesia (PCA) regime 3. Reduced opiate side effects (eg. nausea and vomiting, sedation, itch) All patients enrolled would have a continuous wound infiltration catheter with a local anaesthetic pump device attached, as well as an opioid-continaing PCA machine. The contents of this pump device would be randomised to contain either local anaesthetic agent or normal saline (placebo). The wound infiltration catheter and infusion pump would remain for 48 hours post-operatively, and the PCA would remain available to each patient as long as clinically required. Each patient would be reviewed post-operatively as per our normal Acute Pain Service (APS) practice, and each patient would have regular observations performed and recorded as per normal protocol. The data collected from each patient would include total opioid requirement via PCA, visual analogue scale (VAS) pain scores both at rest and with movement, and any side effects possibly related to local anaesthetic agents or infusion pump catheters.
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The aim of the study is to determine if the development of thyroid disease during treatment with Ribavirin and Interferon-alpha for chronic hepatitis C delivers a better chance of achieving a viral cure.
Hepatitis C is one of the major global causes of chronic hepatic infections, particularly in third world countries, and is associated with a significant rate of cirrhosis and hepatoma. In Australia and the United States of America, the burden of disease is significant. Unfortunately, the incidence and associated sequelae have been predicted to increase in the coming decades. Consequently, a large and growing number of patients will undergo treatment for hepatitis C. Of those receiving combination treatment with interferon (IFN)-a and ribavirin (RBV), approximately 5-10% will develop thyroid-related complications. Whilst there are a number of favourable factors in the prediction of favourable hepatic outcome such as genotype, ethnicity, and early viral load reduction, there are few published reports that assess the development of thyroid disease (TD) in relation to sustained virological response (SVR). Our previous meta-analysis did not find any difference, although this may be due to inherent differences in the published reports. The aim of this report is to investigate the hypothesis that the development of thyroid disease in patients treated for HCV is associated with a significantly increased likelihood of attaining SVR.
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A pilot randomised controlled trial to evaluate the benefits of Exposure Therapy and Cognitive Therapy for problem gamblers
The nul hypothesis for the study is that there will be no significant difference in the clinical outcomes of cognitive and behavioural therapy approaches to the treatment of pathological gambling (gambling addiction). Some cost or time efficienciies may emerge from this detailed study fo the outcomes of these two approaches to therapy.