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A Single and Multiple Daily Injection Study of DUR-928 in Healthy Volunteers.
This research project is being conducted to look at how safe and well tolerated a new drug called DUR-928 is when given as an intramuscular injection to healthy volunteers. The study will look at the study drug’s effect when given as a single dose at 4 different dose levels, and then once daily for 5 days at 2 different dose levels. The pharmacokinetics of DUR-928 will also be studied; this is done by measuring the amount of DUR-928 in the blood at different times throughout the dosing periods, allowing us to evaluate how DUR-928 is handled by the body (for example how quickly it gets into the blood stream).
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Optimising pertussis vaccination in infants: a new approach. Effects of delaying the third pertussis vaccine to 11 months old.
This study aims to protect infants and young children from whooping cough, also known as pertussis, by finding a more effective timing for immunisations. Possibly the best way to prevent whooping cough in early infancy and also in 3-5 year olds may be by a vaccine schedule consisting of two early doses in infancy (6 and 12 weeks old) and a third dose at 11-12 months old. This study aims to look at whether an alternate pertussis vaccination schedule (given at 6 weeks, 12 weeks and 11-12 months old), gives the same immune protection as the current pertussis vaccination schedule (at 6 weeks, 4 months and 6 months old).
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A prospective validation of a simplified Screening model of questionnaire and oximetry for detecting moderate to severe Obstructive Sleep Apnoea in chronic Tetraplegia. (SOSAT)
Approximately 50% of people with tetraplegia have obstructive sleep apnoea (OSA), which is a direct consequence of their injury. OSA has been linked to poor quality of life and problems with memory, learning and concentration in people with tetraplegia. Current guidelines recommend that all people with tetraplegia and symptoms of sleepiness undergo a full sleep study (polysomnography) to diagnose OSA or not. However, very few spinal units have access to this expensive and highly specialised equipment, a sleep scientist to perform the test and a sleep physician to understand and communicate the results. It is therefore likely that most people with tetraplegia and OSA are undiagnosed and untreated. This project aims to test whether a questionnaire followed by overnight oximetry (a finger probe that measures the oxygen level of the blood) can accurately detect moderate to severe OSA in people with tetraplegia. If successful, this simple screening test could replace the need for a full sleep study. Improving the diagnosis of this condition will enable many people with tetraplegia and OSA to access treatment for their condition with likely improvement in their quality of life.
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The effect of implantation of biventricular pacemaker with or without defibrillator on blood vessels function and electrical changes in the hearts of patients with severe heart failure
The planned studies will evaluate the central-peripheral interactions in cardiac resynchronisation therapy to determine the changes induced by the process and their various roles in modulating overall clinical response in patients with heart failure
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Oral Paclitaxel for the Treatment of Cancer
Oraxol is a combination of an oral tablet, HM30181 methanesulfonate, and capsules that contain paclitaxel. HM30181 is a drug that helps the body absorb paclitaxel, a drug used to treat cancer. The purpose of this study is to measure the levels of paclitaxel in your blood at different times when given by intravenous (IV) drip (through a vein in your arm) compared to the levels of paclitaxel at different times in your blood when given by mouth (as Oraxol).
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A First in Human study assessing the safety, tolerability and pharmacokinetics (blood levels) of gerilimzumab against placebo.
This is a first in human trial testing the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of gerilimzumab. Four doses (1 mg, 5 mg, 15 mg, and 30 mg) will be tested in a sequential manner. After the completion of Day 7 at each dose level, a safety monitoring committee will meet and review blinded data to date. They will decide if the study should continue as planned. Only at that time will the next dose level be enrolled. This is a randomized, double-blind, placebo-controlled, single ascending dose study.
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Gender differences in fat preference and perception in healthy volunteers.
This study aims to investigate fat taste preference in a sweet vs. a savoury food and the differences between men and women. 30 males and 30 females (18-50 y, BMI: 18.5-25 kg/m2) will be included in the study. In addition, individual fat taste sensitivity will be measured by two different methods. The study will aid to the contributions of either salt, sugar, and fat on food pleasantness, and the minimum levels that are required for food pleasantness in order to prevent obesity.
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A Phase II randomized study of perioperative beta-blocker vs placebo on gene expression in newly diagnosed breast cancer
This study will investigate whether, in patients receiving breast cancer surgery, pre-operative Propranolol compared with placebo, changes the cancer's gene expression. Who is it for? You may be eligible to join this study if you are a female aged 18-70 years old, have histologically-confirmed breast cancer and will undergo breast cancer surgery at Peter MacCallum Cancer Centre. Study details Participants will be randomly allocated (by chance) to one of two treatment groups. Patients in one group will receive Propranolol for 7 days prior to their scheduled breast cancer surgery while patients in the other group will receive a placebo tablet over the same period. Tablets will be taken two times a day. To determine the results of the study, the researchers will compare blood tests and tumour samples (biopsy and excision samples) obtained before and after administration of the study medication (at the time of surgery). In the samples, the investigators will be looking for the behaviour of specific ‘anti-cancer’ immune cells in the blood and in the tissue surrounding and controlling the tumour. The investigators will also be analysing the immune cells to understand the biological effects of the ‘stress’ that a patient may be experiencing. The information from this study will be presented to clinicians and researchers and will provide very useful information to guide a larger study examining the role of propranolol in all patients receiving breast surgery or in those patients where breast cancer has spread.
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A conversation with patients about medications after a stroke
Medications recommended to reduce the risk of a subsequent stroke are prescribed after a stroke or Transient Ischemic event (TIA). To gain most benefit, patients need to be able to self-manage these medications. That is; to organize continued supply of these medications with their general practitioner and community pharmacy, to take them as agreed with the prescriber and to be able to communicate any unwanted effects they may experience. The primary aim of this study is to determine if a “patient centred educational exchange” added to usual care improves adherence to prescribed medications for secondary prevention for stroke patients compared with usual care. We have a number of secondary aims to investigate the further impact of this relationship based model of information exchange on sustaining adherence, self-reported medication taking behaviour, clinical outcomes, quality of life, changes in knowledge, beliefs towards medicines and illness and to determine the cost of the model. Patients who have been admitted to the Stroke Unit, Princess Alexandra Hospital, with a diagnosis of stroke or TIA and who are being discharged back to their own home will be approached to participate in this study. Participation in this project will involve completing a questionnaire on three or four occasions. The first will be before the participant is discharged from hospital, the second will take place over the telephone about 3 months after discharge and the third over telephone at 12 months after discharge. The questionnaire will take about fifteen minutes to complete. The questionnaire contains questions related to the participant’s quality of life, the participant’s views of stroke, the participant’s view and opinion of their medicines prescribed to reduce the risk of stroke and questions on the way the participant takes their stroke prevention medications. The telephone interviews will also ask questions about GP and Hospital visits, perceived medication related problems, Blood Pressure and Cholesterol results if known. About half of the participants in this study will be chosen (by randomisation) to have a longer interview with the researcher before discharge from hospital. This will be a conversation about the participants’ stroke medications. These participants will also be contacted by telephone approximately ten days after discharge from hospital. The telephone call will involve the same questionnaire, a conversation about their stroke medications and an opportunity to follow-up on any questions the participants’ may have about their medicines.
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A randomised controlled trial evaluating an internet-based cognitive behavioural therapy (iCBT) program for health anxiety
The project aims to evaluate the acceptability and clinical efficacy of the online Health Anxiety Program; and to examine the moderators and mediators of change during the Health Anxiety Program. Up to 60 people with Health Anxiety will be randomly assigned to either the active treatment group or a control group which receives psychoeducation about anxiety in the form of 6 brief fact sheets. The treatment group will commence the Health Anxiety program immediately, whereas the control group will commence once the treatment group has completed. The efficacy of the Health Anxiety program will be determined by comparing the health anxiety severity levels of the two groups at the time the treatment group completes treatment. Mediation analyses will be used to explore the role of variables that may influence positive change (such as changes in behaviours, catastrophic thinking, hypervigilance and intolerance of uncertainty)