ANZCTR search results

The purpose of this study is to evaluate the safety and clinical effectiveness of the Intralink medical device when treating low back pain due to Degenerative Disc Disease in adults. Degenerative disc disease in the lower back refers to a syndrome in which a compromised or damaged disc causes low back pain with or without pain radiating to the leg. Intralink is an injectable soluble polymeric material that is considered as a medical device. Intralink covalently bonds with the collagen in the spinal disc tissue to structurally strengthen the degraded disc and stabilize the spinal joint. These tissue strengthening and joint stabilizing effects, if they occur to the extent intended, may reduce the amount of back pain that the study participant experiences. Intralink contains a substance called Genipin that forms a mesh of load-sharing polymers that bond to the collagen matrix in load supporting tissues. Genipin is made from purified plant sources (Gardenia fruit) and is dissolved in a special buffer liquid prior to being injected into the spinal disc using image-guided injection techniques. A special dye called a contrast agent that is not part of Intralink is also added to Intralink before it is injected so that what is being injected can be seen by the physician doing the injection. There are two primary hypotheses being tested in this study. The first hypothesis involves the safety of the device and its image-guided delivery to the study participant. It is hypothesized that Intralink can be safely applied to degenerated intervertebral discs as evidenced by a clinically acceptable prevalence of Serious Adverse Events reported at 1 month post-procedure. The second primary hypothesis involves the clinical effectiveness of the device. It is hypothesized that the clinical success rate at 3 months after the Intralink implantation procedure will be greater than or equal to 50%. Clinical success is defined as successful injection delivery of Intralink to the targeted disc without the occurrence of serious adverse events with a significant reduction of pain and disability using standard assessment metrics. Objective imaging data will also be used to validate reduction of pain post-treatment. A maximum of 50 participants will be enrolled in this clinical study at 2-5 clinical centers. Safety and clinical effectiveness assessments will be carried out through 12 months post-implantation procedure.

An Open-label Study of Probiotic and Hen’s Egg or Cow’s Milk Oral Immunotherapy. This study is looking at the tolerability of the RUSH (rapid updosing schedule) and build up schedules.

Hormones released from the intestines help minimise the rise in blood glucose after meals. The role of one of these hormones, glucose-dependent insulinotropic polypeptide (GIP), has not been fully understood for lack of suitable tools to investigate its actions in humans. People with type 2 diabetes (T2DM) appear to be unresponsive to GIP, but recent evidence suggests this can be reversed when blood glucose is well controlled. We have now developed a tool – the GIP receptor antagonist, GIP(3-30)NH2 – which is suitable for use in humans, to examine the physiological actions of GIP. We will use this compound to understand how the contribution of GIP to blood glucose control improves in patients who achieve excellent blood glucose control (i.e. HbA1c within the therapeutic target of 7%).

The number of children who are overweight or obese continues to grow in Australia. These children risk getting heart disease and diabetes in their teens or as adults. The main ways for preventing these health problems in children are by modifying diet and exercise. Most individuals working in the healthcare system are for this reason focussed on increasing children’s physical activity levels. While physical activity and fitness are related, they are distinct, wherein physical activity focuses on increasing steps and movement while an increase in fitness also includes a purposeful improvement in the number of steps and movements taken. This program is specifically interested in learning about the importance of improving fitness, not just increasing activity, for preventing heart disease and diabetes in children who are overweight or obese.

The CHEER 3 Trial is a treatment strategy aimed at providing hope for patients who are otherwise very likely to die. In patients who suffer cardiac arrest, a range of interventions such as CPR, defibrillation and injection of drugs are provided at the scene by paramedics to attempt to restart the heart. If paramedics are unsuccessful, there is very little hope of recovery and the patient is usually declared deceased at scene. Transport to hospital with CPR may be attempted but previous research indicates this is usually unsuccessful due to the time taken to arrive at hospital for further treatments. This trial will evaluate an alternative approach involving doctors from The Alfred Hospital being transported to the scene and placing the patient on a heart-lung machine called ECMO. Once stabilised on ECMO, the patient will then be taken to the Alfred Hospital for further investigations and treatment.

Purpose of study. To determine if a simple blood sample can be used to accurately test for colorectal cancer Who is it for? You may be eligible for this study if you are an adult over 40 years of age who has either been very recently diagnosed with colorectal cancer and is progressing to surgery or is scheduled to undergo a colonoscopy in the next 90 days. Study details: All participants in this study will be required to attend a short visit with researchers in order to provide a sample of blood and answer a few questions. Participants will also be asked to provide a faecal sample and give access to their colonoscopy reports. Researchers will then contact participants by phone within a month of the visit for a short check-up. It is hoped that this research will help determine if a simple blood test is effective in detecting colorectal cancer.

The interstitial lung diseases (ILDs) are a debilitating group of over 200 chronic lung conditions characterised by scarring of the lungs, progressive decline in lung function and few treatment options. Exercise-induced hypoxaemia and dyspnoea on exertion are key features of the ILDs. Pulmonary rehabilitation is a recommended treatment for the ILDs, providing short-term improvements in exercised capacity, symptoms and quality of life following pulmonary rehabilitation. Despite this robust evidence for pulmonary rehabilitation at a group level, only one third of individuals with ILD who undertake PR appear to experience a clinically significant benefit. In our RCT of PR in ILD, thirty-three percent of participants with ILD achieved improvement in 6MWD that exceeded the minimal important difference at the end of PR. The proportion of participants who achieved a clinically significant benefit was slightly greater for those with IPF (42%) and more so for those with asbestosis (55%). Therefore, it appears traditional exercise prescription in PR is inadequate in at least 50% people with ILD. Alternative training strategies may prove more effective in both minimising symptoms and improving exercise tolerance in people with ILD. Interval training (IT) consists of periods of relative high intensity exercise interspersed with periods of low intensity exercise and/or rest. In healthy, interval training induces similar or even superior physiological changes to traditional endurance training. In COPD, interval training delivers equivalent improvements in exercise capacity and quality of life with less dyspnoea and leg discomfort. Whether interval training is tolerable and feasible in patients with ILD is not known. The ideal length of the interval is also unknown. This is a prospective, randomised, crossover trial will investigate the acute physiological effects of high intensity interval cycle training compared to lower intensity interval training and standard continuous training in people with ILD participating in pulmonary rehabilitation.

Metformin is the first-line oral glucose-lowering medicine in almost all clinical guidelines on the management of type 2 diabetes (T2DM). It was long thought that metformin’s main action was to suppress glucose output from the liver. However, newer evidence suggests that the gastrointestinal tract is a key site of metformin action. In this study, we want to define the role of bile acids in the anti-diabetic action of metformin in type 2 diabetes. We wish to investigate whether the addition of exogenous bile will induce substantially more glucagon-like peptide-1 (GLP-1) secretion when compared to the removal of endogenous bile.

A major contributor to postoperative pulmonary complications after major surgery is collapse (atelectasis) in poorly ventilated lung segments during and after general anaesthesia (GA). Atelectasis arises from the reduced muscle tone caused by nearly all anaesthetics,and the non-physiological pattern of distribution of ventilation that characterizes controlled mechanical positive pressure ventilation (CMV), and occurs early in the course of anaesthesia. Strategies to reduce lung atelectasis and postoperative pulmonary complications include the use of positive end-expiratory pressure (PEEP) and lung recruitment manoeuvres. Recently, Maquet Critical Care AB (Sweden) have released a new functionality on their Flow-i anaesthesia machine which allows targeted lung recruitment using a stepped increase in PEEP and lung inflation pressures. The system simultaneously monitors airway pressures and dynamic lung compliance, The latter is used to identify the optimal level of PEEP to minimize lung atelectasis, where measured dynamic lung compliance (Cdyn) is maximal. We wish to measure the effectiveness of this new technology on improving lung function and gas exchange in patients under GA for elective surgery.

Stroke affects millions of people worldwide. Endovascular treatment is an effective treatment for stroke patients with a blockage in a large brain artery. By collecting information about the brain scan changes from acute stroke patients, MOSES study aims to improve the way doctors use brain imaging in the future to guide endovascular treatment for stroke, leading to improved patient outcomes . Research questions: - Is there a certain volume of ischemic core (dead brain) (for example >100ml) beyond which benefits from thrombectomy are negated. -As age increases, does pre-treatment volume of dead brain for which a favorable outcome can be achieved decline? - Is the benefit of thrombectomy the same for distal (small) blocked arteries comparable to large blocked arteries? - How can we more accurately predict the outcome from thrombectomy in patients who will have long transfer times to a comprehensive stroke centre? - What is an ‘acceptable’ outcome, particularly in patients with a large volume of pre-treatment dead brain and/or premorbid disability. - For which groups of stroke patients does thrombectomy confer good ‘value for money’?