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Effects of Galvus (Vildagliptin) on Markers of Inflammation in Diabetic Foot Ulcer: A prospective, randomized, double-blind, placebo-controlled pilot study
Diabetic patients are at a particularly high risk for poor wound healing in general and foot ulcer in particular. The lifetime risk for developing chronic foot ulcer has been estimated to reach about 15-20% (1). Despite considerable advances in diabetic care, foot ulcers continue to be responsible for a high number of lower limb amputations that are associated with decrease in quality of life and increased risk of mortality (2). The major risk factors for diabetic foot ulcer (DFU) are polyneuropathy and peripheral vascular disease. Diabetes induces complex vascular changes, promoting accelerated atherosclerosis and hypercoagulability complicating foot ulcer which can be assessed indirectly by a number of inflammatory markers. Animal studies have suggested numerous beneficial anti-inflammatory effects of dipeptidyl peptidase-4 inhibitors (DPP4i), well beyond the effects on blood glucose alone (3). Interestingly, investigation on anti-inflammatory property of DPP4i-vildagliptin in human setting is scanty (4). Treatment with a DPP4i may offer an attractive blood glucose reduction with synergistic mechanism of action while exerting additional wound healing properties. Reduction of inflammatory marker levels is of great clinical importance and may correlate with improvement of diabetic wound healing. Therefore, in the present study we plan to focus on possible anti inflammatory properties of DPP4i in subjects with DFU. Primary objective: To demonstrate that Vildagliptin therapy is associated with clinically significant reduction in biological markers of inflammation compared to placebo in patients with DFU. Our Primary aim is demonstration of a significant (= 20%) reduction in the serum levels of interleukin 6 (IL-6). Secondary objectives: Partial or complete closure of foot ulcer or improvement in other biological markers of inflammation including: hs-CRP, platelet reactivity testing, TNF-alpha, interleukin 1 beta (IL-1 beta), adiponectin and tissue TGF- beta-1 levels. References 1. Lavery LA, et al. Diabetes Care. 2006:1288. 2. Singh N, et al. JAMA 2005: 293:217. 3. Shah Z, et al. Circulation. 2011: 124:2338. 4. Rizzo MR, et al. Diabetes Care. 2012: 35:2076.
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Short-term effects on blood pressure of reducing nitrate metabolism using antibacterial mouthwash in treated hypertensive individuals
There is now consistent and convincing evidence that dietary inorganic nitrate plays an important role in the physiological control of blood pressure. Clinical trials have established that an increase in nitrate intake, either from supplements or vegetables, results in a dose-related decrease in blood pressure in healthy normotensive individuals. This trial will address the importance of nitrate reduction by bacteria in the mouth for the control of level of blood pressure in treated hypertensive individuals.
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Wrist acupressure for post-operative nausea and vomiting: A feasibility study
Post-operative nausea and vomiting (PONV) are unwanted complications following anaesthesia and surgery. The occurrence of PONV ranges from 20% to 80%, despite optimal pharmacologic interventions. The burden of caring for patients post cardiac surgery in healthcare system world-wide is immense. In 2009-2010, In Australia alone, over 230,000 cardiac procedures were performed, and the number and rate of cardiac procedures are increasing. Similar to many countries world-wide, cardiovascular disease (CVD) remains the most expensive disease group in Australia, costing about $5.9 billion in 2004–05 with just over half of this money spent on patients admitted to hospital. As part of their illness treatment and recovery, cardiac surgery patients experience varying rates of PONV; studies across various populations have reported rates ranging from 22% to 50%.
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The Green Card Pilot: a randomised controlled trial of an education/reward intervention to aid diabetes self-management.
Hypothesis Although it is widely accepted that lifestyle interventions In type 2 diabetes have a beneficial effect in delaying the negative health impact of the disease, achieving and maintaining long term gains remains problematic. Can gains in this area be made by combining an intervention program with a mechanism (the green card) for providing structured visual feedback, along with positive incentives, to induce people to persist with lifestyle change? Aims: The project aims to improve management of type 2 diabetics by: * providing a visual record through which a person with type 2 diabetes and their clinician can track their progress on core predictors of long term health * providing positive feedback into personal health trends * acting as a reminder that encourages adherence to diabetes control, including regular health checks * offering small retail incentives at participating stores which act as a positive re-enforcement to lifestyle changes. * Including educational material relevant to type 2 diabetics in a brochure mailed out to participants with their health summary. Research Plan The green card project is a mixed method cohort study intended to assist type 2 diabetics in their own management of the disease. It codifies three predictive areas of long term diabetic health: HbA1c, Blood Pressure (BP) and lipid profile, into a simple visual colour card. Each of the areas will be graded against a clinical value, with the highest values (furthest from the normal range) in the red zone at the top, moving down to the lowest (normal range) in the green zone at the bottom. Points will be accrued in each area in the following ways: * 100 points for attending a regular health check * 100 points for moving away from the red, and towards the green zone * 200 points for being in the green zone. Participants (minimum sample size 130) will be recruited via their GPs, Key area GPs who would be involved in the project have been consulted. They view this project to be appropriate for a clinical setting and have expressed willingness to participate. Qualitative data will be obtained through a participants’ survey at baseline and in 12 months. Questions incorporated the Health Belief Model and Social Cognitive Theory to assess participants’ individual understanding of their type 2 diabetes, the perceived importance of lifestyle changes, and the perceived ability to make and sustain lifestyle changes. One potential concern in a project such as The Green Card is that a failure to accrue points under the positive incentives provided may have a negative effect, discouraging the kinds of changes desired. People with co morbidities or lower educational backgrounds in particular may be at risk of failure to adhere and thus fail to gain rewards To prevent this, the card has been designed so that one area of points acquisition relies solely on the regular use of lipid lowering medication. This will ensure that participants who have enrolled in the project, but who are not able at a given point to commence active lifestyle changes, should still see an improvement in their points score profile. Likewise, HbA1C is a component of the card. Since HbA1C is extremely responsive to even small amounts of exercise, which may not have an effect on waist measurement within the three month assessment period, this measure will more easily show up as a positive change and a sensitive predictor of improvement in this area. Scientific basis of the study Large scale trials such as the Danish Steno-2 trial (Gaede, P et al 2003, and 2008) have established the benefits of lifestyle modification as an adjunct to pharmacological treatment of Type 2 Diabetes. In the Steno-2 trial, which has now been followed up for more than 13 years, health outcomes of participants vs. controls (receiving standard care) showed an absolute risk reduction of 20%, and a relative risk reduction of 50%. A meta-analysis into the long term effectiveness of lifestyle and behavioural intervention in adults with type 2 diabetes (Norris 2004) concluded: “weight loss and control in the long term appear to be difficult to achieve in adults with type 2 diabetes employing currently used lifestyle and behavioural strategies…Perhaps other strategies in conjunction with lifestyle interventions should be considered.” A search of the literature revealed no exactly comparable prototype for the present study. However, two central defining ideas correlate with findings in related studies. These are: 1.) The promising results of supported self-efficacy in diabetes management (Rieger 2009). Efficacy has been demonstrated across a wide spectrum of socio-economic and ethnic groups (Sarkar 2006). 2.) support mechanisms for maintaining lifestyle change in diabetes management should be open ended and ongoing.(Funnell 2007) Positive incentives have been shown to be of significant benefit in the treatment of a number of chronic conditions and habits. A recent RCT enrolling 878 US employees in a trial comparing positive financial incentives in smoking cessation vs. education only showed significantly higher rates of cessation in the incentives group compared to the education only group (Vollp NEJM 2009). A comprehensive review of Pay-for -Performance programs in the US (Vollp Health Affairs 2009) found that positive incentives were a cost effective strategy to improve a range of destructive behaviours including diet, smoking and asthma control. The most effective models used ‘frequent small rewards’, providing ‘tangible and visible’ incentives for good behaviour. Potential Significance The potential significance of this study is its potential to demonstrate that provision of positive incentives, through motivation and educational tools, accompanied by appropriate clinical support, can maximize the benefit of existing and future interventions to control type 2 diabetes. Given the large cost of diabetes to the community and the health care system, any initiative which enhances the effect of intervention strategies into this disease would represent a considerable health benefit. References: Gaede P, Vedel P, Larsen N. et al; Multifactorial Intervention and Cardiovacular Disease in Patients with Type 2 Diabetes. The New England Journal of Medicine 2003;348(5):383-393 Gaede P, Lund-Andersen H, Parving H, Pedersen O; Effect of a Multifactorial Intervention on Mortality in Type 2 Diabetes.. The New England Journal of Medicine 2008;358:580-591 Norris S, Zhang X, Avenell A, et al; Long-term effectiveness of lifestyle and behavioral weight loss interventions in adults with type 2 diabetes: a meta-analysis. American Journal of Medicine 2004;117(10):762-764 Rieger E; The use of motivational enhancement strategies for the maintenamce of weight loss among obese individuals: a preliminary investigation. Diabetes Obesity and Metabolism 2009;11:637-640 Funnell M, Tang T, Anderson R; From DSME to DSMS: Developing Empoerment-Based Diabetes Self-Management Support. Diabetes Spectrum 2007;20(4):221-226 Sarkar U, Fisher L, Schillinger D; Is self-efficacy associated with diabetes self-management across race/ethnicity and health literacy?.Diabetes Care 2006;29(4):823-829 Vollp K, Paully M, Glick H, et al; A Randomized, Controlled trial of financial Incentives in Smoking Cessation. The New England Journal of Medicine 2009;360(7):699 Vollp K, Pauly M, Loewenstein G, Bangsberg D; P4P4P: An Agenda for Research on Pay-For-Performance for Patients, Health Affairs 2009;28(1):206-215
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Education – Does it alter representations for Medical Care post Ureteric Stent Insertion?
The aim of this research study is to assess whether patient education alters the frequency of representations to a doctor, following insertion of a ureteric stent for calculus (stone) disease. Patients who have ureteric stents placed for stone disease will be approached for this study. They will be consented to: 1. Placement of their name on a register 2. Being contacted within 3 months by telephone where they will be asked whether they presented to their General Practitioner (GP) or Emergency Department (ED) for stent symptoms and if so, what the symptoms were. 3. GP may be called to clarify further information Patients involved in the study will be randomised (through time of presentation) to either standard care, education leaflet or education leaflet as well as educational video. Participants in the study will then be contacted by telephone within 3 months of stent insertion and questioned regarding presentations to their GP or ED. If they did, they will be asked regarding what symptoms they presented for and the health provider may be contacted to clarify further information. The data will be evaluated to review if different levels of education may affect the representation rate following stent insertion.
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Deep Brain Stimulation in the Treatment of Depression
Major depressive disorder is a common psychiatric illness that in a small subset of patients fails to respond to multiple trials of standard treatments including medication, psychotherapy and electroconvulsive therapy. In recent years, deep brain stimulation (DBS) has begun to be investigated as a novel intervention for patients with this kind of severe treatment resistant depression. In the proposed study, we will investigate the therapeutic efficacy of DBS applied to the bed nucleus of the stria terminalis. This brain region is an important junction point in depression relevant brain circuitry. We have obtained highly promising results in our pilot study of DBS applied to this brain region. In the proposed study, 16 patients will undergo the DBS operative procedure. Stimulation will be commenced in a randomised, controlled manner, including periods of active and sham stimulation and antidepressant responses will be evaluated in a blinded manner.
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Healthy Thinking Project: A randomised controlled trial of a web-based self-help program to reduce suicide ideation
This project aims to test whether a web-based self-help program is effective in reducing suicidal thoughts when compared with an attention matched control condition.
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A trial examining the bioavailability of 4 doses of 3 different formulations of Afuresertib - a Gelatin Formulation and Two Prototype Formulations of Afuresertib, in Normal Healthy Volunteers in both the fasted and non-fasted states .
This study is comparing the extent to which the drug Afuresertib can be used by the body when administered to healthy volunteers in 3 different formulations under fasted and non-fasted states. Who is it for? You may be eligible to join this study if you are a healthy male or female aged between 18-40 years, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. Trial details: This is a trial examining the bioavailability of a total of 4 doses of 3 different formulations of the same drug (Afuresertib), in both fasted and non-fasted states. The 3 formulations are a Gelatin Capsule and two prototype formulations of Afuresertib, which are another capsule and the other, a tablet. This means that throughout the study you will be asked to take a tablet or a capsule on 4 different occasions and on each of these occasions, you will be asked to either eat (non-fasted state) or not eat (fasted state). Whether you will receive a tablet formulation or one of the 2 capsule formulations will depend on what treatment sequence you are randomly allocated to. Likewise, whether you will be receiving your dose in the non-fasted state or fasted state will again depend on what treatment sequence you are randomised to ('randomisation' is like flipping a coin, where the outcome cannot definitely be determined). Throughout the trial, apart from other assessments, blood samples will be taken from you to measure the absorption and elimination of the drug in your body. This is measuring the 'bioavailability' of the drug. You will also be assessed for Adverse Events to be able to evaluate the safety of the drug. You will be on-study for a total duration of 9 weeks (3 weeks for screening, 5 weeks for the treatment phase and 1 week for a Follow-up Visit). You participation maybe be less should the screening phase of your participation take less than the maximum of 21 days. It is hoped that eventually, the data obtained from this study will help us to determine the best formulation of the drug Afuresertib to administer to cancer patients diagnosed with, for example, multiple myeloma or other haematological malignancies].
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The MindSpot Clinic: Telephone and internet-delivered psychological assessment and treatment for Australians with symptoms of anxiety and depression
This study evaluates the short and medium term efficacy of assessment and treatment at the MindSpot Clinic in Australians aged 18+ with symptoms of anxiety or low mood.
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Study of hemodialysis patients where Calcium Flux into the dialysate is measured during anticoagulation with sodium citrate
A convenience sample of patients receiving regional citrate hemodialyis by means of the Canberra Hospital Protocol are assessed for calcium and citrate flux during dialysis by means of a complete dialysate collection.