ANZCTR search results

The purpose of the study is to evaluate the impact of a structured weight managment program as part of the management of atrial fibrillation. It is also intended to assess the effect of weight reduction on the efficacy of atrial fibrillation following catheter ablation and the effect of weight and risk factor management on autonomic tone/pro-arrhythmic substrate.

Lay Summary: Support of the blood circulation during heart surgery using the heart-lung bypass machine is inevitably associated with organ damage and associated reduced function. This is due to reduced blood flow (ischemia), the effects of restoration of flow (reperfusion injury) and the subsequent inflammation that is caused. The body has its own way of protecting itself against reduced blood flow and oxygen by a mechanism known as preconditioning. In essence, brief periods of mild ischemia are protective against a subsequent more severe episode of ischemia. These periods of mild ischemia can be of the organ itself or of another organ in the body. For example ischemia of the leg can protect the heart against ischemia, so called “remote preconditioning”. We have shown in animal and human models that remote preconditioning using a tourniquet (or blood pressure cuff) placed around a thigh for brief periods (similar in duration to when taking blood samples from children) reduces the amount of injury to heart muscle by 50% and also leads to improved heart and lung function. We have shown that remote preconditioning in a similar way protects the organs of a heterogeneous group of children undergoing cardiac surgery, resulting in better function of the heart and lungs and also a reduction of the inflammatory response to the heart-lung machine. This could potentially reduce the problems in looking after children after surgery and also reduce the amount of time spent in the intensive care unit. We will study paediatric patients undergoing heart surgery inorder to identify key protein and metabolic changes that occur within this 'heart-protection' protocol. All interventions will be performed during the period of routine general anaesthesia at the time of surgical repair. We will study the degree of organ injury induced by heart-lung bypass using standard intensive care parameters and equipment for measuring lung function. The degree of plasma and blood cell metabolic function will be assessed by laboratory tests. Blood samples will be taken from indwelling catheters routinely placed at the time of surgery and not require additional venepuncture. Measurements will be made prior to surgery and also at set time intervals in the first 24 hours postoperatively to determine the evolution of effects. Primary Objective: Does remote ischemic preconditioning (RIPC) modify the global plasma proteomic and mitochondrial response in patients undergoing congenital heart surgery? Hypothesis: RIPC induces significant changes to global proteomic response in plasma and the metabolic function in heart muscle and lymphocyte mitochondria of patients undergoing congenital heart surgery. Aims: To assess in blood plasma and lymphocyte/myocardial mitochondria the impact of RIPC on the global proteomic and mitochondrial metabolic function response to heart surgery with cardiopulmonary bypass support. Secondary Objectives: Does RIPC modify clinical markers of injury and cardiopulmonary function post-Cardiopulmonary bypass in patients undergoing congenital heart surgery? Hypothesis: Remote IPC reduces post-cardiopulmonary bypass release of markers of cellular injury and permits recovery of cardiac pump function with less complication including inotrope requirement in patients undergoing congenital heart surgery. Aims: To assess the impact of remote IPC on lactate release, inotrope requirement, and standard clinical cardiopulmonary assessments in response to heart surgery with cardiopulmonary bypass support. This small randomised, blinded, surgical trial of preoperative therapy with highly regulated, brief, non-invasively-induced, localised leg ischaemia and reperfusion, will test for the capacity to invoke remote ischemic preconditioning-related molecular signalling (proteomic and metabolic) changes. The study will recruit 40 paediatric tetralogy of patients to RIPC treatment or SHAM RIPC (Placebo control) treatment groups and is expected to be completed by the end of March 2012.

Observational evidence suggests that vitamin D deficiency may have a role in the causes of osteoarthritis (OA) and there are biologically plausible mechanisms to explain this. There is, however, no evidence which shows that intervening with vitamin D supplementation can slow the progression of OA. This study will compare knee OA structural changes in patients receiving vitamin D supplementation with those receiving a placebo. Use of MRI will provide sensitive measures of knee OA changes.

Visual loss following stroke impacts significantly on activities of daily living and is an independent risk factor for becoming dependent. Routinely, allied health clinicians provide training for visual field loss, mainly with eye movement based therapy. The effectiveness of the compensatory approach to rehabilitation remains inconclusive largely due to difficulty in validating functional outcome with the varied type and dosage of therapy received by an individual patient. This study aims to determine which treatment is more effective, a standardized dosage approach or individualized therapy in patients with homonymous hemianopia post stroke.

Computer assisted surgery has been developed to assist in obtaining ideal alignment of knee replacement prosthesis in patients with advanced knee osteoarthritis. Obtaining the precise positioning during sugery can be difficult. Using intraoperative dynamic movement of the knee a computer can take into account three dimensions and obtain a true "functional flexion axis" (FFA) of the knee which may more closely represent the true anatomical axis of the knee. This study will assess whether measurement of the "functional flexion axis" of the knee during surgery using specialised computer software is closely related to the Trans-Epicondylar Axis (TEA) obtained from an Computed tomography (CT) scan.

Study 105 (VX08-770-105) is an open-label, VX-770 treatment extension of Study VX08-770-102 (Study 102) and Study VX08-770-103 (Study 103). This rollover study evaluates the long-term safety and efficacy of treatment with the experimental drug, VX-770, for a duration of up to 96 weeks. Male and female subjects 6 years and older with cystic fibrosis who have completed Study 102 or 103 without major protocol violations are eligible to enrol. This project is an international, multi-centre trial, with subjects from 70 sites worldwide including Australia, Europe and North America. [Study 102: NCT00909532] [Study 103: NCT00909727]

The aim of this trial is to examine whether 50mg of DCS can augment a single session of graded exposure therapy in children suffering from spider or dog phobia. The researchers are particularly interested in whether treatment gains can be maintained one week later both within and outside of the treatment context, as measured by Behavioral Approach Tests. The researchers hypothesize that children who receive the DCS in addition to exposure therapy will be less fearful of spiders or dogs one week later both within and outside of the treatment context.

Intense exercise can lead to muscle damage, pain, swelling and loss of strength, which can take up to 7 days to recover. This recovery can impact negatively on athletic training and competition and predispose to injury. Cycloidal vibration therapy has been shown in recent studies to reduce limb swelling in patients who have undergone surgery and may be an effective treatment for reducing muscle swelling after exercise and promote recovery from intense exercise. The aim of the project is to evaluate the potential for the use of cycloidal vibration therapy to promote muscle recovery following exercise by examining effects on the return of muscle strength and the reduction in swelling, muscle damage and inflammation following intense exercise. This will provide evidence to support the use of cycloidal vibration therapy by athletes to promote recovery after exercise.

Continous postitive airway pressure (CPAP) is a proven therapy when administered in the emergency department. The evidence supporting it's use in the preshospital setting is not definitive and consisits of surrogate outcome measures hence this trial, powered to detect a difference in the true outcome of mortality, should provide important evidence. Our hypothesis is that adding continous positive airway pressure to standard care in the prehospial setting will decrease hospital mortality comparted to standard care alone.

Learning difficulties are common and can cause school failure and poor self-esteem. They are associated with specific problems with temporarily remembering and using information (‘working memory’). Research suggests that improving working memory might improve academic achievement. We will study this intervention in a large group of primary school children who have poor working memory. If successful, the intervention will provide a way to improve the learning skills of these high-risk children.