ANZCTR search results

The aim of this project is to extend our recent work and examine the feasibility, acceptability, and potential efficacy of modifying the physical environmental and policy factors, and to assesses the potential psycho-social variables that might influence change in school playground physical activity levels among primary school children. A secondary outcome is to assess the association between bullying and its effect on playground physical activity levels.

The RCT compares three treatments: (i) Delayed Program Access – undertakes usual diabetes care for 3 months Post-Baseline, followed by access to the full OnTrack Diabetes program, (ii) Immediate Program – receives full access to the self-guided program from Baseline onwards, and (iii) Immediate Program plus Therapist Support. Measures are administered at Baseline, and at 3, 6, and 12 months Post-Baseline. Outcomes are glycosylated haemoglobin A1c (HbA1c) level and diabetes-specific distress, depression, anxiety, diabetes self-care, self-efficacy and adherence, and quality of life. Exposure data in terms of program uptake, use, time on each page, and program completion as well as implementation feasibility, will be conducted. It is predicted that OnTrack Diabetes will improve adherenec to diabetes self-care behaviours and FIT will enhance this effect. This is the first known trial of an automated, self-guided, web-based support program that uses a holistic approach in targeting both Type 2 diabetes self-management and dysphoria. Findings will inform the feasibility of implementing such a program on an ongoing basis, including in rural and regional locations.

There are increasing concerns regarding the treatment efficacy of azithromycin 1g single dose for the treatment of rectal chlamydia infections with treatment failure rates up to 21% being reported. There is no evidence available from randomised controlled trials directly comparing doxycycline with azithromycin for the treatment of rectal chlamydia with a recent meta-analysis reporting an efficacy of approximately 85% for azithromycin compared with 99% for doxycycline - however, these efficacy estimates are based on poor quality evidence. The purpose of this study is to provide the world first evidence on the treatment efficacy of the two recommended treatments for rectal chlamydia - azithromycin 1g single dose versus 7 days of doxycycline (100mg twice a day)

It remains unclear whether obesity itself or its accompanying co-morbidities are causative in the development of the favourable substrate for atrial fibrillation. The exact mechanisms remain the subject of current research. There is preliminary data suggesting a reversal of this substrate following interventional weight loss strategies. Intensive weight reduction strategies may play a role in reversing the adverse electromechanical substrate and thus complementing concurrent therapies, pharmacotherapy or catheter-based. In this observational clinical study, we propose to evaluate the effects of weight loss on the substrate predisposing to AF (clinically collected maps) and arrhythmia burden (during routine follow up).

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.

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.

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.

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.

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.

To assess the perioperative analgesic requirements of single dose intraoperative, intravenous methadone versus single dose, intraoperative, intravenous morphine during shoulder arthroscopy.