ANZCTR search results

The aim of this study is to assess the effectiveness and safety of using Eltrombopag in patients with early refractory ITP. Early refractory ITP is when the ITP is not responding to standard therapy within 6 months of diagnosis. Eltrombopag is approved in Australia to treat severe chronic ITP however it is not approved for use in early refractory ITP. Personal experience provided by doctors who have used this medication indicate that as well as being effective in treating patients with chronic severe ITP, it might also be effective when treating patients in the earlier stages of ITP when initial steroid therapy is no longer adequately working. This is an open label study, all patients will receive an oral tablet dose daily of eltrombopag based on their platelet count and ethnicity (patients from Japan have been shown to have an increased eltrombopag serum level by approximately 80% compared to Caucasian patients). All patients will receive the study drug for 12 weeks and assessed for bleeding episodes and platelet count. Patients deemed to have responded will stay on eltrombopag with the opportunity to dose reduce to the lowest possible dose whilst maintaining a response over time. The study will run for 130 weeks (2 1/2 years) for those who continue to respond and there will be availability of the medication to patients beyond that. Overall response will be assessed at week 12 and defined as the achievement of CR, PR and MR. Time to response and duration of response and alternative treatment free survival will also be assessed. Therapeutic response will be assessed at week 26.

Endoscopic management of large colonic polyps is an increasingly utilised and accepted alternative to surgery. Complete polyp removal after a single treatment session is high with a recent prospective study reporting first-time success in 84% of patients presenting for endoscopic management. The success rate of first time complete polypectomy is significantly lower when the lesion cannot be fully excised utilising a standard injection and snare technique. This is more common in large rectal polyps, polyps that have undergone partial or incomplete resection, and polyps that have been marked with SPOT tattoo. All these scenarios result in submucosal fibrosis and therefore failed lift with standard submucosal injection. In this setting the traditional approach has been to resort to ablative techniques such as argon plasma coagulation (APC) and snare tip coagulation (STC), however the use of APC has been identified as a risk factor for residual adenoma at follow-up colonoscopy with a recent study showing an increase in residual adenoma at follow-up from 17.5 to 39.5% (RR 2.25; 1.45-3.50, p=0.002). Recently, the use of hot avulsion (HA) has been shown in a prospective pilot study, to be a safe and highly effective technique for dealing with difficult non-lifting polyps (NLP). Currently there is no published literature to guide effective management of the NLP. The proposed study design is a randomised clinical trial comparing HA to APC (the current standard of care) for the management of polyps that fail removal using a standard snare resection technique. We postulate that HA will result in a significantly higher rate of complete polyp removal of the non-lifting polyp when compared to standard therapy. Patients undergoing colonoscopy for removal of large polyps (>20mm), polyps that have failed previous resection, polyps that have previously been injected with SPOT tattoo or patients presenting for follow-up of previously removed large polyps will be approach for inclusion in the study. Following commencement of polypectomy, if the endoscopist fails to remove the polyp entirely using standard snare techniques, they will be randomised to either HA or standard of care (APC). The primary outcome measure of this study is the rate of macroscopic and histologic eradication of neoplasia at the first follow up colonoscopy which is routinely performed at 4 months. The outcome variable is dichotomous (residual or no residual) and will be expressed as a proportion. If patients fail removal at first follow-up, a second treatment will be attempted. If at the second follow-up there is persistent polyp, this will be considered a treatment failure and the treating physician will then be able to either cross arms or refer the patient for surgical management.

The current study aims to examine the effects of protein and fat ‘preloads’ of RYGB on GE or SI transit, appetite-related and incretin hormones, GI symptoms and haemodynamics. We hypothesized that when given before a mixed meal, (A) a fat ‘preload’ has no effect on GE but slows SI transit, increases the GLP-1 and PYY responses, reduces glycaemic and insulin responses and attenuates the fall in BP and rises in HR/SMA blood flow, as well as symptoms; and (B) a protein ‘preload’ has no effect on GE but slows SI transit, increases GLP-1 and PYY responses, reduces the glycaemic but increases the insulin response and attenuates the fall in BP and rises in HR/SMA flow and symptoms.

Resveratrol, which is a nutritional supplement derived from certain plant foods including red grapes, has the potential to improve blood sugar levels in patients with type 2 diabetes by uncertain mechanisms. In this study, we aim to identify the effects of resveratrol on the rate of gastric emptying, blood sugar levels and blood levels of hormones produced by the intestines

Less than half of all people at highest risk of a cardiovascular disease (CVD) event are receiving and adhering to best practice recommendations to lower their risk. In this project we examine the role of an e-health assisted consumer strategy as a means of overcoming such health system inefficiencies. With the implementation of the Personally Controlled E-Health Record (PCEHR) for all Australians in 2012, consumer focussed e-health is set to become a key component of the health system. Despite the scale of this initiative, few people even know of its existence and there is little research on the factors that will support its uptake. Innovative strategies that are practical to implement and support negotiation of care between consumers and care providers are therefore urgently needed.

The main aim is to investigate the efficacy and safety of methoxyflurane as a patient controlled analgesia in colonoscopic procedures, as compared to the traditional endoscopist provided analgesia/sedation. Hypothesis Methoxyflurane is as effective and safe in providing adequate analgesia for patients undergoing colonoscopic procedures as conventional intravenous sedative/analgesia with midazolam and fentanyl. Patients prefer patient controlled analgesia, compared with endoscopist administered analgesia.

The aim of the CSI (Climate Schools Interactive) Study is to evaluate the Climate Schools: Ecstasy & Emerging Drugs module, an online, school-based prevention program designed to educate adolescents about the harms associated with illicit drug use. To our knowledge, this will be the first trial of any internet-based program specifically designed to prevent the uptake and use of ecstasy and NPS. It is hypothesized that students receiving the Climate Schools intervention will report reduced ecstasy and NPS use, reduced intentions to use ecstasy and NPS in the future, increased knowledge about these drugs and reduced associated harms.

Participants are invited to take part in this research project if they are undergoing a coronary artery bypass graft surgery (CABG). During the surgery, blood vessels from other parts of the body will be used to ‘bypass’ blocked blood vessels in the heart which will improve the blood flow to the heart muscle. When blood vessels are removed from the body they must be immersed in a solution (salts in water) to keep them healthy before until they are replaced onto the heart. This research project is testing a new solution known as SOMVC001 (also known as GALA), which is intended to improve the preservation of the blood vessels, which are removed during the operation until they are placed on the heart.

Acute exercise increases skeletal muscle insulin sensitivity for hours after exercise by mechanisms that are incompletely understood. The aims of this project is to examine whether the increase in insulin-stimulated skeletal muscle glucose uptake following exercise/ is determined, in part, by undercarboxylated osteocalcin (ucOC), a bone formation marker produced by osteoblasts. Methods: 12 overweight/obese men (age 40-70) will be recruited. Volunteers will perform the following assessments: body composition measurements, fasting blood test, bone scans and a fitness test. Participants will also perform 2 hyperinsulinaemic euglycaemic clamp (Insulin Clamp) sessions once at rest and the other one following high intensity interval exercise session. Blood samples will be taken at rest, during and following exercise (or rest), and throughout the insulin clamp to measure blood glucose, insulin, ucOC and other markers associated with metabolic risk factors. Muscle biopsy samples will be taken at rest, 1h after exercise and at the conclusion of the insulin clamp. Muscle samples will be analysed for activation of exercise and insulin sensitive signalling proteins, muscle gene expression, markers of mitochondria respiration, inflammatory markers and other markers in the muscle. This project will bring new insights into the connection between exercise-bone-glucose control in overweigh/obese men. Understanding the mechanism that is involved in glycaemic control may lead to new interventions, pharmacological and non-pharmacological, for the prevention and management of type 2 diabetes in this population.

Glucose sensor technology for continuous glucose monitoring (CGM) in diabetes has been evolving with an ultimate goal of achieving a level of reliability and accuracy required to replace finger prick glucose measurement. Although CGM technology advances have increased accuracy, reliability and ease of use, further improvements are required. A CGM system based on a novel technology platform has been developed. Early laboratory testing, animal studies and limited testing in humans indicates that further human studies are warranted. This feasibility study of the novel glucose sensor is the first extensive testing of this sensor in humans.