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A phase I single ascending dose (SAD) study to investigate the safety, tolerability and pharmacokinetics of oral Capromorelin in spinal cord injury (SCI) and able-bodied volunteers
Capromorelin (CP424391) is a ghrelin receptor agonist which shows evidence of promoting defecation and may be of use in spinal cord injury (SCI) patients to promote bowel movements. The purpose of the study was to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics following single oral doses of 20, 50 and 100 mg of Capromorelin in SCI and in able-bodied participants.
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Post operative analgesic effect of intra-articular ropivacaine at the start and end of hip arthroscopy
Hip arthroscopy is a surgical procedure that gives doctors a clear view of the inside of a hip joint. Little attention has been paid to the pain management of patients undergoing hip arthroscopy. The aim of this study is to demonstrate the difference in quality of analgesia between dosage and timing of IALA (intra-articular local anaesthetic) administration in the hip joint. 150 patients undergoing hip arthroscopy by the study surgeon in a private hospital setting will be recruited in the study. Group 1 (Group R100E) will be the control group and will be administered 100mg IA Ropivacaine at the end of the procedure, as per standard practice. Group 2 (Group R200E) will be administered 200mg IA Ropivacaine at the end of the procedure. Group 3 (Group R100BE) will be administered 100mg IA Ropivacaine immediately after access is gained to the joint space, and 100mg IA Ropivacaine IA at the end of the procedure. Post-operative pain will be recorded 1) using NRS-11 score in the recovery room and (2)using a VAS scale after 0.5, 1, 2, 4, 8, 12, and 24 hours post-operatively. Patients will receive a standardised general anaesthesia and intraoperative mulitimodal analgesia regimen. Total perioperative intravenous morphine equivalent analgesic requirements, antiemetic requiremeents, will be compared in the 24 hour postoperative period. Requirement for rescue fascia iliaca block will be recorded however the study is not powered to detect a difference in this requirement.
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Feasibility of Text message based intervention for ongoing support and education of whiplash associated disorder among people with injury in a land transport crash
Whiplash-associated disorder (WAD) represents a significant public health problem, resulting in substantial social and economic costs throughout the industrialized world. Chronic WAD is a bio-psycho-social condition. And though education is an effective intervention for people with WAD, providing access to such interventions is a major challenge. The randomised control trial aims to investigate whether simple reminders about self-management sent via mobile phone text message improves health outcomes in people with chronic WAD. This is pilot for a randomised controlled trial with three months follow-up to evaluate the feasibility, acceptability and effect on health outcomes of repeated reminders sent via mobile phone text messages compared to usual care. A total of 50 patients, with chronic WAD will be randomised to either standard care or the TEXT WAD intervention. The participants will be identified through Personal Injury Registry, Motor Accident Authority, NSW. The intervention group will receive two weekly text messages that provide information, reassurance, support, and recommendations for “act usual” and physical activity. The primary endpoint is change in score of Neck Disability Index. Process outcomes related to acceptability and feasibility of TEXT WAD will also be collected. Text messaging has potential as a cheap, safe and simple method to support and educate people with chronic WAD. However, its effectiveness and feasibility in practice must be proven in a well-designed and rigorously conducted trial.
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The role of glucagon-like peptide-1 (GLP-1) in glycaemic, triglyceride and energy expenditure responses to fat in type 2 diabetes.
When we ingest a meal a number of hormones, including glucagon-like peptide-1 (GLP-1), are released from the small intestine. These hormones play an important role in regulating the motor function of the gut, blood pressure, the levels of sugar and fat in the blood, and the rate at which the body uses energy. The effect of these hormones is, however, limited by the fact that they undergo rapid degradation by an enzyme in the blood. There is a new class of type 2 diabetic drugs that act by inhibiting this enzyme, and as a result, these drugs improve blood glucose levels. We have recently shown that these drugs (e.g. vildagliptin) also enhance metabolic rate (an effect that may prevent weight gain) and decrease levels of triglycerides in the blood in healthy volunteers. This study aims to determine if these drugs have the same effects during fat infusion in patients with type 2 diabetes, and to determine the specific role of the gut hormone, glucagon-like peptide-1 (GLP-1) in mediating these responses.
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Effect of spironolactone on human brown fat in patients with primary aldosteronism
Brown Fat, unlike ordinary 'white fat', functions like generators, burning fat to produce heat and dissipate energy. Brown fat protects animals against cold and from developing obesity. In humans, it was previously believed that brown fat disappears after infancy. However, research including our own has shown that brown fat is present in most if not all adult humans and is located mainly around the neck. Brown fat activity in humans is detected by a PET scan based on uptake of glucose that is tagged with a small amount of radioactivity. This is a widely used diagnostic method in medicine. Brown fat is more abundant in lean than in obese individuals. Stimulating its activity may be a simple way of controlling body weight in humans. Apart from the cold exposure, very little is known about what regulates brown fat in humans. Our research aims to identify factors that regulate brown fat in humans. Aldosterone is a mineralocorticoid hormone produced from the adrenal glands. In animals, it was found that aldosterone suppresses the activity of brown fat and blocking aldosterone action by a medication called spironolactone increases brown fat activity. In this study, we will study in humans whether spironolactone reactivates brown fat activity in subjects with primary aldosteronism and whether the changes in brown fat activity is associated with changes in energy expenditures.
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A double-blinded, randomised control trial to compare intraoperative morphine and methadone on the post-operative pain scores and analgesic requirements after shoulder arthroscopic surgery
To assess the perioperative analgesic requirements of single dose intraoperative, intravenous methadone versus single dose, intraoperative, intravenous morphine during shoulder arthroscopy.
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Determining prognosis and treatment response: novel imaging modalities for Glioblastoma
This study is investigating the effectiveness of new imaging techniques in determining prognosis and treatment response in patients with glioblastoma. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been newly diagnosed with glioblastoma grade IV, for which your are planned to undergo radiotherapy or combined chemoradiotherapy. Study details All participants in this study will undergo either 2 (group B) or 3 (group A) PET scans, scheduled around their routine radiotherapy, these scans would not normally be part of their routine care. The scans are known as O-(2-[18F]-fluoroethyl)-L-tyrosine Positron Emission Tomography (FET-PET), and involve injection of a radioactive tracer to perform a PET scan. You will need to fast for a minimum of 4 hours before the scan. You will also need to provide a small blood sample when attending for your first PET scan. We will also ask for permission to access tumour tissue samples that were collected during your previous surgery. Participants will be followed up after treatment in order to determine overall survival and disease progression. This information will be used to evaluate the usefulness of the FET-PET scans in predicting prognosis and in identifying treatment-resistant tumours. There are no additional appointments to attend outside your normal treatment visits except for the PET scan visits, which should take approximately one hour. All followup data will be collected from your medical notes when you attend your routine treatment appointments.
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Evaluating the Effect of a Shared Care Pathway Intervention on Unplanned Presentations to Hospital by Chemotherapy Outpatients
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Effect of spironolactone on brown fat activity in adult humans
Brown fat, unlike ordinary 'white' fat , functions like generators, burning fat to produce heat and dissipate energy. Brown fat protects animals against cold and from developing obesity. In humans it was previously believed that brown fat disappears after infancy. However, research including our own has shown that brown fat is present in most if not all adult humans and is located mainly around the neck. Brown fat activity in humans is detected by a PET scan based on uptake of glucose that is tagged with a small amount of radioactivity. This is a widely used diagnostic method in medicine. Brown fat is more abundant in lean than in obese individuals. Stimulating its activity may be a simple way of controlling body weight in humans. Apart from the cold exposure, very little is known about what can activate brown fat in humans. Our research aims to identify agents that can activate brown fat in humans. Aldosterone is a mineralocorticoid hormone produced from the adrenal glands. In animals, it was found that aldosterone suppresses the activity of brown fat and blocking aldosterone action by a medication called spironolactone increases brown fat activity. In this study, we will study the regulation of brown fat activity by spironolactone in humans and its metabolic significance
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Sight word and phonics training in children with poor reading
This study tested potential treatments for Australian children who have severe problems learning to read. Some of poor readers find it hard to read via the letter-sound rules (phonics), some find it hard to read whole words by sight (sight-word reading), and many have both of these problems. In this study, one group of poor readers (N = 41) did 8 weeks of specific phonics training (i.e., reading via phonological decoding) and then 8 weeks of specific sight word training (i.e., reading via recognition of irregular words from memory). A second group of poor readers (N = 44) did the reverse order of training. The results showed that both specific sight word training and specific phonics training had large and significant valid treatment effects on trained irregular words, untrained irregular words, and word reading fluency; and that specific phonics training had an additional large and significant valid treatment effect on reading comprehension. These findings demonstrate the reliability of both phonics and sight word training in treating poor readers. This will aid Australia’s efforts to counteract the effects of poor reading in children by revealing how different treatments should be tailored to children with different types of reading impairment.