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The acute effects of Yohimbine on fear conditioning and the neural processing of emotional images, and on delayed extinction learning and memory for the images.
Expand descriptionThis study aims to examine sex differences in the effects of Yohimbine on the neural processing of, and delayed memory for, emotional images. Sex differences will also be explored in the effects of Yohimbine on fear conditioning, and whether this impacts the rate of extinction learning after a delay. Participants will be randomly assigned to recieve either Yohimbine or Placebo. Participants will first undergo a fear conditioning procedure in which they will be presented with coloured circles and a particular colour will be paired with a mild electrical stimulus. Rate of conditioning (or associative fear learning) will be measured via skin conductance responses across trials. Subsequently, in an fMRI scanning machine, all participants will view a series of emotional and neutral images. Two days later, participants will return and undergo a surprise memory test for the images. Following the memory tests, participants will undergo an extinction learning procedure in which skin conductance will be recorded across trials in which the same circles will be presented without any reinforcement (electrical stimulus). The hypothesis is that Yohimbine will enhance amydgala activation during the processing of emotional images, and be associated with superior memory for the emotional images. It is predicted that Yohimbine will enhance the rate of fear conditioning, particularly in women. It is also predicted that the administration of Yohimbine will result in strong amygdala activation during the processing of emotional images as well as the deactivation of prefrontal regions of the brain in participants with higher levels of endogenous cortisol. Finally, it is believed that participants in the Yohimbine group will experience a slower rate of extinction learning after the delay (and particularly in women). All participants and research staff will be blind to the drug contition of the subject until after the study is completed.
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MITCHEx-11: An extension trial to assess long-term serum metal ions in patients recruited in the MITCH Metal Ions Study.
Expand descriptionThe aim of the study is to analyse the serum metal ions for the MITCH system throughout the steady state phase after surgery. This study extends the current MITCH Metal Ions Study from an endpoint of 2 years to a longer post-operative time point of 5 years. The results will be used as a direct comparison to other research completed for hip resurfacing components on the Australian Market. This study also forms part of the post-market surveillance activities of the Sponsor.
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A controlled trial of Acamprosate to reduce the severity of neurocognitive impairment during alcohol with
Expand descriptionThis study seeks to compare the prevalence of cognitive impairment in a population of alcohol dependent patients randomly allocated to have either Acamprosate or a Placebo during inpatient alcohol withdrawal. Acamprosate is thought to stabilise Glutamate mediated NMDA receptors and reduce hyper excitatory neurotoxicity in the neurons on which they occur. These neurons are thought to play an important part in neuroplasticity and working memory. Sensitive computerised psychological testing which has been shown to detect neurocognitive impairment in patients during medicated alcohol withdrawal will be used to compare the response in the test and placebo groups. A standard measure of ataxia will also be used to compare the two groups.
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A randomised, open-label study to evaluate the efficacy and safety of maraviroc (MVC) as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected individuals with stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART): MARCH study
Expand descriptionMARCH is an international, multicentre trial planning to enroll 560 HIV-1 infected patients who are currently on 2N(t)RTI + PI/r regimen and virologically suppressed. Participants will be randomized (1:2:2) to one of three treatment groups: to continue their current treatment regimen, maraviroc dose at 150 mg twice daily with PI/r, or maraviroc at 300 mg twice daily with 2N(t)RTI. As the participants population have HIV RNA <200 copies/mL, the phenotypic assessment of tropism cannot be used to determine tropism, instead we will employ the genotypic assessment of tropism by sequencing the V3 loop of the HIV envelope. The main aim of this study is to investigate whether switching to maraviroc, in combination with either RTI or PI/r, is as good at keeping the HIV viral load undetectable as the combination of RTI with PI/r. The other aim is to see if switching to these combinations with maraviroc will improve some of the side effects that can be seen when people take combination therapy including RTI and PI/r. The study hypothesis is that in stable, virologically suppressed (plasma HIV-RNA <200 copies/mL) patients with no history of prior virological failure, a switch to either MVC dosed at 300mg twice daily (bid) combined with the same 2N(t)RTI backbone regimen or MVC dosed at 150mg twice daily (bid) with the current PI/r (or 300mg bid at the discretion of the investigator if the PI/r is fosamprenavir/r) provides similar (non-inferior) antiretroviral efficacy compared to continuation of the current 2N(t)RTI + PI/r regimen.
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Using a biodegradable polyurethane foam in comparison with Granufoam (black, non-biodegradable foam) with Vacuum-Assisted Closure in the management of decubitus ulcers (pressure sores)
Expand descriptionComparison of new biodegradable foam against commercially available non-biodegradable foam under topical negative pressure dressings for safety and efficacy in transmitting the vacuum to the wound bed.
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A Multicentre trial for the treatment of adolescents aged 15 years and above, and young adults aged up to 40 years, with newly diagnosed Acute Lymphoblastic Leukaemia (ALL)
Expand descriptionThis study will be a national clinical trial that will evaluate the safety and efficacy of a chemotherapy treatment, administered to adolescents and young adults with a newly diagnosed bone marrow cancer, called acute lymphoblastic leukaemia (ALL). Who is it for? You may be able to join this study if you are aged between 15 to 40 years and have been recently diagnosed with acute lymphoblastic leukaemia (ALL), for which you have not yet undergone any treatment. Trial details: ALL is the most common form of childhood cancer, but in over 80% of children it can be cured with chemotherapy. Adults with ALL do much worse and this trial will examine whether exactly the same treatment given to children can also be given to adults, and if so, are the results as good. In order to determine this, all patients in this trial will be administered the same chemotherapy treatment given to children. Patients' response to this chemotherapy will determine subsequent treatment. Participants in this trial will be regularly assessed throughout this trial to determine remission rates, survival, toxicity and quality of life.
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Exercise-based videogames for stroke rehabilitation at home: a single subject randomised trial
Expand descriptionThe primary aims of the study include 1)to determine whether 8 weeks of exercise-based videogame exercise performed at home independently by a chronic stroke survivor is feasible; and 2) to determine whether exercise-based videogames used at home independently by a chronic stroke survivor improve upper and lower limb motor coordination. A single-subject randomised controlled trial design will be used. The participant is an independently-living 51 year old long-term male stroke survivor with ongoing lower limb and upper limb motor coordination problems on his affected side. The participant will practise upper limb and lower limb exercise-based videogames independently at home over an 8-week period (2 x 2 weeks of upper limb exercise-based videogames, and 2 x 2 weeks of lower limb exercise-based videogames). The order of the upper limb and lower limb exercise periods will be randomised. The participant will practise the games as much as possible during his normal daily routine. The primary outcomes include choice stepping time (lower limb) and arm reach reaction time (upper limb). Secondary outcomes include the High-level Mobility Assessment Tool, tandem walk, step test, 6-minute walk, upper limb items of the Motor Assessment Scale, Box-and-Block Test, Action Research Arm Test, System Usability Scale, and subjective gait video assessment. This study will provide valuable information on the feasibility and efficacy of using exercise-based videogame exercises in the home after stroke
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An evaluation of the drug interaction potential of extended-release felodipine in healthy volunteers, using a cocktail approach
Expand descriptionTo determine whether a commonly used medication for blood pressure (felodipine) could be a cause of interactions with other medication that can lead to adverse effects.
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The effect of Tai Ji Quan on stress
Expand descriptionTai Ji or Tai Chi (TC) is an ancient Chinese mind body exercise that is practised worldwide by millions of people daily with the belief that it has the potent healing effects upon the practitioner and a fundamental path for longevity. Whilst the mechanisms behind TC are not fully understood it is a general consensus among the general population that TC calms the mind and benefits health. There has been growing interest in the scientific community to evaluate the efficacy of TC in various physiological and psychological conditions; in particular the therapeutic effects of TC in psychological conditions. This study will hope to evaluate whether TC can improve stress level as measured by the State/trait anxiety scale and several objective physiological measures such as blood pressure, heart rate variability and galvanic skin response in a clinical trial with thirty participants. The participants will be randomly allocated by computer to three equal sized groups (n=10 per group), the TC intervention group, Gym group and Waiting list. The TC intervention group will complete five hours of TC exercise per week (minimum 2 contact hours with the instructor) over a period of 6sixweeks and followed by six weeks of self practise. The gym group will receive 12 weeks of free gym membership at the UTS Fitness centre, whilst the waiting list forms the non-active control group. The waiting list group will however be given six weeks of TC class after the experimental period as thanks for participation in the trial. The primary aim of this study is to evaluate if six weeks of TC practise can significantly reduce levels of stress in healthy but stressed individuals compared to a waiting list and if TC practise is equivalent to standard exercise in controlling stress levels. The trial will also evaluate if the effects of TC practise on stress can also be sustained when individuals are asked to practise without guidance and the comparative results of this compared to both waiting list and standard exercise groups. The primary measure will be the State/trait anxiety inventory and secondary measures will be blood pressure, SF36 (Short Form 36 questions to assess general health status), heart rate variability and a Visual Analogue Scale (VAS) on their perceived level of stress.
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Synbiotic supplementation: effects on faecal microbiota and immunity in physically active individuals.
Expand descriptionThe aim of this study is to compare a synbiotic supplement containing pre- and probiotics, bovine lactoferrin and bovine immunoglobulines with acacia gum on gut bacteria and indices of immunity. The study will provide consumers with evidence based advice on the use of a synbiotic supplement.