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Effect of low dose steroids on blood glucose and risk of heart disease
Glucocorticoids are potent anti inflammatory agents that are used to treat a wide range of inflammatory and rheumatologic conditions. Most patients require a relatively low dose of glucocorticoid for disease control, with one study reporting a mean prednisolone dose of 8mg/day which is approximately 2 to 3 times the physiological glucocorticoid production. The purpose of this study is to investigate : whether typical therapeutic steroid doses increase the risk of a heart attack. whether high blood sugars after a meal are related to risk of heart attack. a novel mechanism by which steroids might increase fat mass through reducing brown fat activity.
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Cerebral Oximetry to Reduce Peri-operative Morbidity: A Pilot Study
Cerebral oximetry is a clinical monitor which is used routinely for heart surgery patients at Austin Health. When the device is used, a sensor is applied to the forehead and safe near-infrared light is shone through the skull. The reflected light gives information about the level of oxygen in the brain. Previous research has shown that using this monitor can reduce the risk of complications after heart surgery. Other clinical research has shown that complications after surgery are more common as people get older. In one large study it was shown that complications occur in one fifth of patients over the age of 70. The complications studied included heart attack, major breathing complications, stroke, infections, kidney failure, being admitted to the intensive care unit, or death. The aim of this study is to find out whether using a cerebral oximeter during other types of surgery can reduce the rate of complications for patients over the age of 70. There is currently no research evidence to show whether this is the case. 40 patients over the age of 70 will be asked to participate in this study. These patients will all be having joint replacement or bowel surgery. All the participants will have a cerebral oximeter monitor applied at the start of the anaesthetic. For half the participants the anaesthetist will no be able to see the numbers on the monitor. In the other half, the anaesthetist will be asked to monitor the levels of oxygen in the brain, and to try to keep them close to (within 25% of) the participant’s starting level. This is done by methods which are part of normal anaesthetic care. For example, the anaesthetist makes small changes to the amount of anaesthetic, or to the blood pressure. There is no other change to the operation, anaesthetic, or hospital care. The number and types of complications which occur in each of these two groups will be compared. This study will determine if using the cerebral oximeter results in fewer complications. The results of this small study may help to design larger research studies in the future.
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One injection in the palm versus two injections on the back of the hand to numb the finger for minor surgery
Patients with finger injuries often require their finger to be numb to allow their injury to be assessed properly and treated. There are several methods available to numb the finger. Our study aims to compare two methods for numbing the patient’s finger to see which one of these methods is least painful for the patient. The first method is a single injection in the palm of the hand and the second method is two injections in the back of the hand or finger. The second method is the most commonly used method in our emergency department. Our hypothesis is that the single injection into the palm is less painful than the double injection in the back of the hand or finger. Patients who present to the emergency department with finger injuries that require their finger to be numb for treatment or assessment of their injury will be given a study information sheet and consent will be obtained for participation in the study. Participants will then be randomly assigned to receive either the single injection in the palm or the double injection in the back of the hand or finger. A medical officer will perform the injection to numb the finger and a separate medical officer will then ask the patients to rate the pain of the injection to numb their finger. Participants will also be asked to rate their pain level before and five and ten minutes after the injection. The patient’s finger injuries will be treated as per standard care for their injury. Patients will be contacted at one week following the injection to ask them if they have any pain or signs of infection such as redness or swelling.
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The effect of non-steroidal anti-inflammatory drugs on hormones and metabolism in overweight men with low testosterone and obstructive sleep apnea (optional partner participation)
This is a parrallel randomised controlled pilot study designed to investigate the effect of non-steroidal therapy on inflammation in obstructive sleep apnea (OSA) with regard to sleep apnea severity, reproductive function, androgen profile, cardio-metabolic health and quality of life. This study will use the drug celecoxib (Celebrex) which is a marketed drug in Australia that is commonly prescribed for arthritic conditions to relieve joint pain. Participants will be asked to attend the clinic for a 3 month period involving 5 short visits and 2 overnight stays with PSG and blood sampling.
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MGMT Gene Therapy and Chemotherapy for the treatment of Childhood Brain Tumours
This trial aims to test the safety and feasibility of infusing gene-modified bone marrow stem cells into paediatric patients with high risk brain tumours. Who is it for? Patients between the ages of 1 and 21 who have a brain tumour which has recurred, or a newly diagnosed brainstem tumour are eligible for this trial. Trial details. Bone marrow stem cells will be harvested from patients, and then modified with a form of a drug resistance gene called MGMT. These cells will be given back to patients after they have received chemotherapy to aid in the engraftment of the cells in the bone marrow and treat the tumour. Further cycles of chemotherapy will then be given at 4 weekly intervals and the survival and/or expansion of the gene-modified cells will be measured. If possible, the dose of chemotherapy given will be increased if the gene-modified cells successfully engraft in the patient and prove to be drug resistant to the chemotherapy.
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Evaluation of the efficacy and safety of LDE225 in the treatment of patients with advanced or metastatic sarcomas
The purpose of this study is to evaluate the efficacy and safety of LDE225 as a treatment for patients with metastatic sarcoma who can not be treated by surgery. Who is it for? You may be eligible for this study if you are aged 18 years or above, have a histologically confirmed diagnosis of metastatic or unresectable sarcoma with no known curative treatment options, and give your consent to take part. The full inclusion criteria details can be found in the relevant section of this form. Trial details: In this study, you will receive the drug LDE225 in the form of 4x200mg capsules daily, taken orally until your disease progresses. You will be required to attend regular clinic visits for routine tests and assessments.
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An experienced physiotherapist prescribing and administering corticosteroid and local anaesthetic injections to the shoulder in an Australian orthopaedic service: a non-inferiority RCT.
Corticosteroid and local anaesthetic injections (often called cortisone) are commonly used to treat shoulder pain. For over 10 years in the UK, physiotherapists with additional training in medicines and injecting, have been able to independently give these injections. UK services involving physiotherapist injecting have been found to be effective and help patients get appropriate care sooner. In Australia physiotherapists are not normally permitted to prescribe or inject. We want to see whether allowing an appropriately trained physiotherapist to give shoulder injections, would be feasible or beneficial for Gold Coast patients. We will use an experienced Australian physiotherapist who has completed the necessary prescribing and injecting training in the UK, has 5 years experience of giving these injections to patients in the UK and has undertaken a further period of supervised injection practice in Australia. Our research will compare this physiotherapist with a Specialist Orthopaedic Surgeon in relation to decisions about who should be offered an injection and responses to the injection.
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Fish Oil, Exercise, and Mediterranean Diet on Metabolic Markers of Inactive Premenopausal Women
The focus of this study was to investigate the effect of the combination of chronic high intensity interval exercise, a Mediterranean diet, and regular fish oil ingestion on improvements in body composition (body fat) and metabolic syndrome markers in overweight women.
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eRiCC trial: Early rehabilitation in Critical Care
Intensive care acquired weakness is a common problem following an ICU admission and leads to significant impairment in physical function and strength which is most prevalent in individuals affected with sepsis. Muscle mass reductions occur rapidly with up to 20% lost within the first week alone, this is accelerated in sepsis with greater muscle protein degradation. Whilst early rehabilitation commonly involving mobilisation has been shown to be both feasible and safe, it often is delayed in commencement as it relies on the individual being alert and able to participate in therapy. This trial involves the use of an intervention which can commence early in the ICU admission to try to minimise the muscle changes that occur without the direct need for patient participation and engagement. This trial will examine the effectiveness of functional electrical stimulation assisted cycling using a supine cycling machine and cycling alone compared to standard care in individuals with sepsis within the intensive care unit. Within a subgroup of 20 individuals biomarker analyses will be performed to try to understand the cellular and molecular mechanisms responsible for the changes observed.
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A continence promotion intervention involving a pelvic floor muscle rehabilitation exercise program to reduce lower urinary tract, lower bowel symptoms and erectile dysfunction in men receiving radiation therapy with or without androgen deprivation therapy (ADT): A Pilot Study
This pilot study aims to define the variation in endpoint measures in men who are prescribed radiation therapy (RT) with or without androgen deprivation therapy (ADT). This will allow the determination of a sample size sufficiently powered to detect such a difference so that a formal randomised controlled trial might be designed. Who is it for? This study is open to men aged 40-90 years with early stage prostate cancer, without any neurological conditions and absent from any other bladder conditions or secondary malignancies. You will not be eligible to participate if you have had any type of abdominal surgery in the past 2 years. You may also be allowed entry to this study if you are currently receiving radiation therapy with 6 months non-adjuvant androgen deprivation therapy, or NOT receiving (ADT) prior to beginning scheduled radiation therapy. Trial details: In this study, you will be randomised to one of two treatment arms. For Arm 1, if you are currently receiving radiation therapy with 6 months non-adjuvant androgen deprivation therapy (ADT) or NOT receiving ADT prior to beginning scheduled radiation therapy, you will receive a specifically designed continence promotion intervention including a tailored pelvic floor muscle rehabilitation exercise program to reduce lower urinary tract , lower bowel symptoms and erectile dysfunction. This intervention will be tailored to you and delivered one on one by a physiotherapist. All men in Arm 1 of the study will receive a copy of a pelvic floor exercise DVD which they will be encouraged to use. If you are receiving radiation therapy alone WITHOUT androgen deprivation therapy, you will meet with a physiotherapist for review immediately after your radiation therapy, and then at 1 and 3 months after it. If you ARE receiving ADT, you will need to exercise for 6 months prior to your scheduled radiotherapy, and these exercises will be tailored to you. For Arm 2, you will receive the current, usual care with no additional instructions when you undergo your radiation therapy, except in relation to having empty bladder and bowels at each radiation therapy session. All men in the study who are receiving Androgen Deprivation Therapy will be given the option to take part in “The Man Plan", an individually tailored general exercise and fitness regimen, which includes support, education and exercise options but with no attention paid to continence promotion or pelvic floor muscle function. The program will be supervised by local exercise physiologists and delivered in a format that suits you best.