ANZCTR search results

We are investigating how a high diary diet (compared to a low dairy diet) will affect insulin sensitivity in normal weight, and overweight/obese people with normal/impaired glucose tolerance. There is evidence that dairy may affect insulin sensitivity, but currently the studies that perform dairy interventions in a diet are conflicted. There is therefore a need to design and perform dairy study that may help argue the case for our population eating more dairy in order to prevent developing type II diabetes. Hypothesis: eating higher amounts of dairy each day for four weeks will improve insulin sensitivity.

Nalu Medical (the sponsor) is developing an implantable medical device that is designed as an adjunctive therapy to medical management of patients with chronic pain in the trunk and/or limbs. To support the design and development of this implantable device, Nalu Medical has developed an External Trial Stimulator (ETS) for use during a trial of Spinal Cord Stimulation (SCS) prior to implanting the permanent device. All commercial devices are trialed in a similar manner, through the use of a proprietary ETS, prior to permanent implant. This study is intended to evaluate the Nalu ETS.

The ageing population and the success of treating previously fatal acute cardiac disease has led to an ongoing epidemic of heart failure. Given the status of this diagnosis as a component of overall health costs, controlling HF readmission represents a significant component of controlling hospital expenditure in the coming years. Furthermore, the lessons learned from a successful partnership approach to integration of hospital and community services will inform similar approaches to other chronic diseases including chronic lung disease and diabetes. In the current context, success of this program will have wide reaching implications for service delivery nationally and internationally. This randomized trial will provide the information with which to make evidence-based decisions about improved transfer of HF to community care and improved systems of community maintenance. This Partnership seeks to provide the necessary steps in system re-design to overcome identified problems. Specifically, the research-specific outcomes from this project will be to define where best to invest community resources for the management of heart failure, how to improve hospital and primary care integration in the management of this condition, how to identify early deteriorations and keep patients at home, reduce hospitalisations and save money.

One of the most effective treatments for PTSD is prolonged exposure (PE). In this treatment, the person is helped to gradually address the difficult memories and avoided situations in a supportive and controlled fashion. PE is delivered by qualified therapists in sessions that are held once a week for 10 weeks. For some people, this can pose a barrier – it may be difficult to get time off work or to make other arrangements for family commitments. Allocating 10 weeks for treatment can also be difficult for serving members. There is now some early evidence that we may be able to get equivalent results by providing the same number of sessions on a daily basis in just two weeks. In this study we seek to test whether the intensive approach is as effective as the 10-week model. If so, it has the potential to increase how accessible and acceptable this evidence based treatment is to veterans, serving members, civilians and their families. Using a randomised controlled trial design, we will therefore compare the effectiveness of the standard and intensive versions of PE in the treatment of PTSD in veterans and serving members. Eligible veterans and currently serving Defence members who meet criteria for PTSD will be randomly allocated to either standard PE (SPE; 10 weekly 90-minute sessions or intensive PE (IPE; 10 daily 90-minute sessions). Participants will be assess pre-treatment and at 4 weeks, 12 weeks and 12 months post-treatment commencement. We hypothesise that IPE will be as effective as SPE in reducing the severity of PTSD symptoms at post-treatment and 12 month follow-up.

This project aims to test whether enhanced fluid intake on the morning of a colonoscopy can avoid some of the deleterious effects associated with bowel preparation and prolonged fasting. It will examine whether increased fluid intake of up to 1,200 mls of Gatorade during the morning, up to 2.5 hours before the start of the afternoon list will alter the incidence of fluid depletion and dehydration, and the associated symptoms and clinical signs such as headache, dry moth, thirst, dizziness, postural hypotension and concentrated urine. This will be compared to a control group fasting from 0600 on the day of the procedure.

This study aims to test a primary care intervention that is designed to improve uptake of bowel cancer screening among primary care patients. Who is it for? You may be eligible to join this study if you are aged 50 to 74 years, are presenting for a general practice appointment, and have been identified via a brief baseline assessment as being at average or slightly increased risk of bowel cancer. You will not be eligible if you have been screened for bowel cancer using a faecal occult blood test (FOBT) in the past two years or colonoscopy in the past five years. Study details Clinics will be randomly allocated by day to intervention or usual care, therefore participants will receive the intervention based on the day of the week they attend the practice. Participants in the intervention group will receive: 1) A faecal occult blood test kit 2) A feedback sheet containing screening recommendations for those at average risk of bowel cancer 3) General practitioner endorsement of the importance of faecal occult blood test screening. Participants in the usual care group will receive standard care, and then the feedback sheet once the study is completed. All participants will be asked to complete a telephone interview 6 weeks after their initial appointment. During the interview, participants will be asked whether they have completed a faecal occult blood test within the past 6 weeks and will be asked questions to assess their bowel cancer screening knowledge. It is hoped that this primary care intervention will be an effective way to increase the uptake of bowel cancer screening

Recent evidence suggests that obstructive sleep apnoea (OSA) is a multifactorial disorder and is not only the result of a small, collapsible upper airway anatomy. Several non-anatomical physiological traits have been identified that can also play an important role in causing OSA. These include: (1) an oversensitive ventilatory control system (i.e. ventilatory control instability or high loop gain), (2) poor pharyngeal muscle responsiveness, and (3) a low respiratory arousal threshold. Importantly, the relative contribution of each of these traits varies between patients. Thus patients often have OSA for different reasons. An oversensitive ventilatory control system also referred to as having “high loop gain” has been shown to contribute to OSA severity in at least one third of patients. Loop gain characterises the sensitivity of the control of breathing during sleep. Patients with high loop gain have an overly large compensatory respiratory response to any given disturbance in breathing. In such patients, even a mild disturbance to breathing (i.e. hypopnoea) during sleep can produce a self-sustaining unstable breathing pattern, leading to repetitive airway collapse. While singular therapies targeted towards lowering loop gain have shown promise—including oxygen therapy and respiratory stimulants such as the drug acetazolamide (ACZ),— their effect size on reducing loop gain has not been large enough to resolve OSA in the majority of patients studied. Importantly, physiological studies have shown that oxygen and ACZ manipulate different sub-components of the respiratory control system; oxygen reduces ‘controller gain’ whereas ACZ reduces ‘plant gain’. That is, according to respiratory control theory, both of these treatments should have an independent and additive effect on lowering loop gain. As yet no study has assessed the therapeutic effect of manipulating loop gain with a combination of both agents. Importantly, in a sub-group of OSA patients where loop gain is abnormally high (36%), a large reduction in loop gain, is likely to be sufficient to resolve their OSA. The primary purpose of this clinical trial is to assess, for the first time, the ability of the combination of oxygen therapy and ACZ to reduce loop gain and thereby reduce OSA severity. We expect that this combination of therapeutic agents to have a greater effect on lowering loop gain than either alone. As a secondary objective of this trial, we intend to measure, at baseline, each of the four known traits known to cause OSA (upper airway collapsibility, loop gain, pharyngeal muscle responsiveness and respiratory arousal threshold) so that we can determine the characteristics of individuals that demonstrate that greatest therapeutic benefit from this combination therapy.

Primary purpose of this study is to evaluate the efficacy of manual-based ATT for individuals with BN and BED compared to a waitlist control condition. Brief statement intended for the lay public: Researchers at the University of Sydney and the University of Western Sydney are conducting a study examining the effect of attention training on binge eating. We hope to learn whether Attention Training Therapy (ATT) is helpful in reducing symptoms of binge eating, characteristic of individuals with Bulimia Nervosa and Binge Eating Disorder.

BACKGROUND Stroke is a leading cause of disability and death. Four out of five strokes are due to blockage of blood supply to a part of the brain. Atrial fibrillation (AF) is a common heart rhythm irregularity associated with blood clot formation in the heart that can migrate to the brain and cause strokes. There are proven treatments that can greatly reduce the occurrence of stroke in people with AF. AF can be present intermittently and without any symptoms, therefore can be hard to detect. However, strokes occur just as frequently in people with intermittent AF as in those with continuous AF. Currently stroke sufferers frequently undergo 24 to 48 hours of continuous heart rhythm monitoring using either a non-portable (telemetry) or a portable (Holter) external monitor. However, the cause cannot be determined in a quarter of all strokes despite these tests. The AliveCor Mobile ECG is a novel device that comprises a smart phone case containing 2 electrocardiogram (ECG) electrodes and a smart phone application that generates 30 seconds of ECG (equivalent to lead I of 12-lead ECG) and automatically diagnose the presence of AF with 97% accuracy. We hypothesize the use of AliveCor Mobile ECG by nurses in the stroke unit will be an effective and inexpensive way to increase in-hospital AF detection following stroke. AIMS We aim to compare the number of stroke sufferers with previously undiagnosed intermittent AF that are detected by the AliveCor Mobile ECG to that detected using current standard testing with 12-lead ECG and 24 to 48 hours of Holter monitoring or cardiac telemetry. PROPOSED RESEARCH DESIGN Up to 300 consecutive stroke sufferers without known AF admitted to the participating stroke centers will be included in the study. All nurses working in the participating stroke centers will be trained to use the AliveCor Mobile ECG. All participating stroke sufferers will receive checks with the AliveCor Mobile ECG at the same frequency as all their other regular nursing checks from the time they arrive in the participating stroke centers to the time they are well enough to go home or are transferred to another ward or facility. All participating stroke sufferers will also receive all standard heart monitoring available at each participating stroke center.

Chronic venous leg ulcers are an extremely common and costly problem across the globe. The burden is expected to rise with an ageing population and the growing epidemic of diabetes and obesity. This will increase the therapeutic challenge for treating clinicians. Standard best practice treatment is compression of the lower leg by bandaging to reduce hydrostatic pressure in the leg. Healing rates vary widely and even after two years of compression therapy up to 50% of all chronic VLUs remain unhealed as patient adherence to compression therapy is a continuing challenge, as is best practice management of people with VLUs in the community. Autologous Platelet Gel (APG) together with compression appears to be a promising new intervention for VLU healing. While there is encouraging data from in vitro, animal and clinical studies, strong evidence for its effectiveness from high quality randomised controlled trials is currently lacking. We propose a pilot clinical trial to determine the efficacy, safety and cost-effectiveness of APG gel as an adjunct to compression therapy in healing venous ulcers. We will also assess ulcer recurrence rate of venous ulcers within 3 months of healing.