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A Pilot, Randomised, Blinded, Feasibility, Safety and Biochemical and Physiological Efficacy Study of Terlipressin vs. Placebo in Cardiac Surgery Patients with the Post-operative High Cardiac Output and Hypotension syndrome
Expand descriptionThe management of patients who have a high cardiac output (the amount of blood pumped by the heart every minute) and a low blood pressure after open heart surgery is complex because the best way to deliver best post-operative treatment of the circulation is uncertain. However, treatment typically includes the use of fluids given though a vein and drugs to help increase blood pressure to safer levels. Such blood pressure drugs can be useful but can have adverse effects on heart function or cause disturbances of the heart rhythm. Thus, they are often avoided and used very late in the management of these patients when blood pressure is really low. As a consequence, blood pressure may remain undesirably low for a long time and patients may be given large amounts of fluids instead, which can also be undesirable. More recently, however, a medication called terlipressin has been developed to help liver patients who have a high cardiac output with low blood pressure and worsening kidney function. Terlipressin can be given as a single shot through any hand or arm vein and can increase blood pressure for up to 6 hours. Terlipressin offers the opportunity to improve blood pressure management in patients with a high cardiac output and a low blood pressure after heart surgery without the risk of causing heart injury and rhythm disturbances. However, because terlipressin has only been used to support blood pressure in this way in liver patients, we do not know how effective it would be in such selected cardiac surgery patients. In this study we wish to test whether, in open heart surgery patients with a high cardiac output but a low blood pressure, terlipressin is more effective than placebo (dummy injection) at restoring blood pressure and whether such treatment is safe and changes the amount of fluid given and kidney function for the better.
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Attitudes and beliefs of dietary intake and health risks in people with type 1 & type 2 diabetes
Expand descriptionTo investigate in a cohort of people with type 1 and type 2 diabetes: - The knowledge of the health risks associated with dietary intake - Ability to interpret the nutrition information on Australian food labels - The frequency of use of nutrition labelling on food products - The influence nutrition panels has on shopping behaviour - Urinary electrolyte excretion and the association this has with dietary intake - Usual dietary intake - Body mass index and HbA1c in association with the above information
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A Pilot, Randomised, Blinded, Feasibility, Safety and Biochemical and Physiological Efficacy Study of Terlipressin versus Placebo in Hypotensive Sepsis
Expand descriptionThe management of patients who have serious infection and a low blood pressure is complex and includes making sure that the circulation is stable, safe and optimal in terms of blood flow to vital organs. This is called resuscitation. The best way to deliver resuscitation is uncertain. However, it typically includes the use of fluids given though a vein and drugs to help increase blood pressure. Drugs to increase blood pressure can be useful but those available either have a short duration of action (minutes) or can only be given though a large vein. As the need for drugs to increase blood pressure can last for hours or even days, this means that a special catheter needs to be inserted for such treatment into a large central vein like the jugular (neck) vein. This carries risks, requires special expertise and takes time. Thus, potentially helpful treatment is often delayed. As a consequence, blood pressure may remain undesirably low for more than an hour and/or the patient may be given large amounts of fluids instead, which can be undesirable. More recently, however, a medication called terlipressin has been developed to help liver patients with low blood pressure and worsening kidney function. Terlipressin can be given as a single dose injection through any hand or arm vein and can increase blood pressure for up to 6 hours. Terlipressin offers the opportunity to improve blood pressure management in patients with serious infection. However, because terlipressin has only been used to support blood pressure in this way in liver patients, we do not know how effective it would be in patients with infection. In this study we aim to test whether, in patients with infection and low blood pressure, terlipressin is more effective than placebo (dummy injection) at restoring blood pressure and whether such treatment changes the amount of fluid given and kidney function.
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A comparison of different endoscopic modalities for the detection of dysplasia and early cancer in patients with Barrett's Oesophagus undergoing surveillance endoscopy.
Expand descriptionThis project will examine the utility of a novel endoscopic imaging device (Narrow Band Imaging – NBI) and compare this technology against the present standard of care in patients with a chronic premalignant condition known as Barrett's Oesophagus. Who is it for? You may be eligible to join this study if you are aged between 18-85 years and are scheduled to undergo surveillance endoscopy for Barrett’s Oesophagus (BE), or have been referred for further assessment of dysplasia/early cancer in BE. Study details: Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive standard care, which consists of white light endoscopy (WLE) and random biopsies followed by examination with NBI and NBI and dual focus magnification (NBI-DF). Participants in the other group, will receive an examination with NBI and with NBI-DF in addition to standard care. NBI and NBI-DF are endoscopic imaging technologies which can be utilized with a switch of a button on the endoscope. Images can then be obtained which may enable better visualization of the Barrett’s segment. These are non invasive technologies where the light at the end of the endoscope changes to a more ‘narrow wave length light’ which could improve visualization of vasculature which can be more pronounced in early neoplasia. Targeted and random biopsies will then be taken. Endoscopy results will be compared to histology to determine whether NBI and NBI-DF can improve the detection of precursors of cancer or early cancer which may enable earlier and less invasive interventions for these patients. All patients will receive the same treatments,but in a random order.
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Infectivity of the Plasmodium falciparum 7G8 malaria cell bank, MCB-004, in humans.
Expand descriptionThis study is examining the infectivity of a Plasmodium falciparum 7G8 malaria cell bank in humans. Participants will receive a single inoculum of the malaria cell bank, which consists of human red blood cells containing P. falciparum 7G8 malaria parasites. Followng administration of the inoculum, we will measure the growth of the malaria parasites in the blood-stream and then administer anti-malarial treatment (Riamet) according to specific criteria (based on the number of parasites in the blood as well as clinical signs/symptoms of malaria). We will also be assessing the safety of the inoculum and also the way the immune system responds to it. Determining the infectivity and safety of the malaria cell bank is important as it will form a critical part of future clinical trials investigating the effectiveness of a new malaria vaccine that is currently being developed.
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Go Nuts! - Including non-allergic nuts in the diet of children with nut allergy
Expand descriptionChildren who have nut allergies must avoid that nut in their diet, but this can be difficult to achieve. Young children may be unable to tell different nuts apart due to similarities in appearance. Nuts can also be present in baked goods, dips, muesli bars and other foods, requiring reading of the label. Some children are also allergic to more than one nut adding complexity to this process. Having a child who is allergic to nuts can also cause anxiety around social events such as parties and school camps and can have a significant impact on quality of life of both the parents and child. Due to the difficult nature of avoiding one type of nut, in the past it has been common for parents to avoid all nuts, either on advice of their doctor, or for their own peace of mind. More recently however, it appears that there may be benefits from having ongoing exposure to non-allergic nuts in our diets. Totally avoiding nuts we are not allergic to may increase the risk of developing an allergy to this nut later on. Parents of children with nut allergy are now being advised to include non-allergic nuts in their child’s diet on an ongoing basis. To ingest the suggested amount of nut as often as required can be difficult. In this study, we will provide to the intervention group, a resource which aims to help parents achieve this. It contains a series of recipes and suggestions for including nuts in every day foods to provide an alternative to eating whole nuts. This group will also receive monthly text messages reminding them to include non-allergic nuts in the diet. We also hope that this will increase knowledge surrounding the intake of nuts, reduce anxiety and help to improve quality of life for these families.
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Investigating the efficacy of repetitive transcranial magnetic stimulation for people with Mal de Debarquement Syndrome
Expand descriptionMal de Debarquement Syndrome is a rare condition whereby the person has continued perception of rocking and imbalance, usually occurring after a cruise, aircraft flight, or other sustained motion event. In many cases this continued perception of motion recedes after several hours or days. However in some cases persistent Mal de Debarquement Syndrome will last for years and decades. It has only recently received attention and very little scientific research has been conducted. However, the limited research to date has suggested that this condition is due to changes in excitability within the brain. The aim of this study is to investigate the efficacy of repetitive brain stimulation on people with Mal de Debarquement Syndrome. Individuals with this condition will receive eight sessions of repetitive brain stimulation, an established and safe technique, versus sham. Tests of brain excitability, balance testing, and self-reported perception of balance in daily activities will be undertaken prior to and at the end of the brain stimulation intervention, with self-reported perception of balance in daily activities followed up at six and eight weeks post intervention. It is hypothesised that those who received the real brain stimulation treatment will reduce symptoms in imbalance compared to those receiving sham. It is also hypothesised that brain excitability will reduce in those receiving the real treatment compared to sham treatment.
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The effect of the Mathys Affinis Short Stem Total Shoulder Replacement on medium to long term pain and functional outcomes in patients with shoulder arthritis
Expand descriptionShoulder arthritis can be extremely painful and debilitating and impact on a person's work and life. A solution in appropriate patients is the replace the ball and socket joint of the shoulder and so reduce pain and improve mobility. Historically these replacements have had a long stem in the humerus (long bone of the upper arm) and a new socket in the shoulder where the glenoid bone is. The developments in hip surgery with the replacement of the hip ball and socket, includes a stem which is now much shorter. It is postulated this results in less pain in the femur and may decrease the possibility of mid shaft fracture around the base of the stem. The development in shoulder prostheses has adopted the same concept. Short stem prostheses have been used for several years and this study is not experimental. This study will evaluate whether in this Australian population the short stem ceramic head has greater efficacy than the published studies of the long stem metal head prosthesis in total shoulder replacement. The five year prosthesis outcomes have been submitted for publication and a manuscript on the differences in outcomes between anatomic and reverse prostheses is in final draft. A second analysis will evaluate the efficacy of the Vitamin E enhanced crosslinked polyethylene glenoid component . A study of outcomes in patients 70 and above and below 70 in this cohort is in preparation.. The five year outcomes and the outcomes comparing the Anatomic shoulder replacement and reverse shoulder replacements of younger and older than 75 years have been published.
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Can a new intensive model of aphasia rehabilitation achieve better outcomes than usual care with chronic aphasia resulting from stroke?
Expand descriptionStroke is one of the leading causes of death and chronic disability in Australia. Chronic aphasia associated with stroke affects access to services, creates social isolation, depression and decreases quality of life. People with aphasia following a stroke experience a sudden loss of language ability but their intelligence is not affected. As a consequence of their communication disability, the person’s access to services is limited, adversely affecting rehabilitation outcomes and often resulting in increased rates of depression and social isolation, and decreased quality of life. Current rehabilitation for aphasia consists of long-term, infrequent and predominantly one-to-one therapy, the cost of which is taxing on an already-stretched health system. The proposed study will determine if the outcomes of an intensive, comprehensive and time-limited rehabilitation are better than current speech pathology intervention and evaluate the cost effectiveness of this model. Access to aphasia rehabilitation and meaningful outcomes for this under-served population will therefore be improved. UQ’s CCRE Aphasia Rehabilitation researchers have taken evidence from the bench to bedside by using principles of neuroplasticity from animal models to stroke recovery, and built an evidence base for the new intervention. Using implementation science we will determine the best methods to help translate new evidence into public policy and improve clinical practice. The overarching aim of this research is to determine the effectiveness of a new model of care for aphasia rehabilitation compared to usual care. There is a critical gap between the treatment that people with aphasia require to live successfully, and the limited services that are provided in most cases. Speech pathologists from our major Partner Organisation, Queensland Health (QH), have been seeking a new model of care to meet the National Clinical Guidelines of Stroke Management recommendation that aphasia therapy be delivered intensively (NSF, 2010; Wenke, 2012). At the same time, The University of Queensland (UQ) research team have developed and piloted an intensive, comprehensive, aphasia program, the Language Impairment and Functioning Therapy (LIFT) program. This program is the translation of decades of aphasia research into an intensive, comprehensive, time limited package and is the first of its kind in Australia. Intensive programs ensure that experience-dependent neuroplasticity occurs; comprehensive programs ensure that all clinical guidelines are adhered to and patients and their family have their needs met; and time-limited programs ensure costs are contained. This project seeks to develop a partnership whereby we work with our Partner Organisations (POs) to trial the LIFT program as a cost effective solution to closing the main evidence-practice gap in aphasia rehabilitation. Our partnership also recognises the nee d to translate the research into everyday health care. The pioneering research of implementation science brings potential solutions to overcoming the barriers to implementing intensive and comprehensive aphasia rehabilitation such that patients and health systems benefit from clinically effective and cost effective programs. Primary aim: 1) Assess the clinical effectiveness of LIFT compared to usual care; Secondary aims: 2) Assess the cost-effectiveness of LIFT compared to usual care; 3) Describe the barriers and enablers to uptake of LIFT by POs; 4) Develop a strategy for implementing LIFT into routine clinical practice. Hypothesis: Clinical and cost effectiveness outcomes for LIFT will be significantly better than usual care.
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The INDIGO Study - A randomised controlled trial of physical activity with individual goal-setting and volunteer mentors to increase physical activity in insufficiently active older adults at risk of cognitive decline.
Expand descriptionAIM: The aim of this project is to determine whether a home-based six-month physical activity program with individual goal-setting and volunteer peer mentors can significantly increase physical activity levels in physically inactive older adults at risk of developing Alzheimer's Disease. HYPOTHESIS: that insufficiently active participants with subjective memory complaints or mild cognitive impairment who are randomised to the goal setting intervention with a mentor compared to participants randomised to a control group receiving standard education and peer contact will show a significantly greater increase in their PA at the end of the intervention. RESEARCH DESIGN: This study is a randomised, single-blind controlled trial. METHODS: Participants are individuals with subjective memory complaints or mild cognitive impairment and do not regularly engage in 60 minutes or more of moderate intensity leisure time physical activity. The primary outcome of interest is increase in physical activity as measured by a pedometer (steps/day). We are also collecting cognitive, personality, physical and clinical parameters. Participants are asked to provide a DNA sample via a saliva sample. Participants in both groups are asked to attend three workshops in six months. At the first workshop, they will meet a peer-age volunteer. These individuals are recruited and randomly assigned to provide either telephone mentoring or telephone contact. Volunteers are trained for each role and their self-confidence and level of physical activity are measured.