ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31339 results sorted by trial registration date.
  • 10-session Cognitive Behavioural Therapy (CBT-T): Pilot study of a newer, shorter psychotherapy for the treatment of eating disorders

    The aim of this research is to investigate a new treatment for eating disorders, a 10-session Cognitive Behavioural Therapy (CBT-T), formulated by Professor Glenn Waller in the United Kingdom, which is a shorter version of the current best psychological treatment targeting all eating disorders. Because CBT-T is new we hope to learn more about how well it works, how it works and who it works best for.

  • Proof of principle study of transabdominal gastrointestinal stimulation (TAGS) for adult constipation.

    A pilot study to assess the effectiveness of a medical device to treat chronic constipation in adults

  • Effect on Hospitalisation and Cost Effectiveness of a Respiratory Coordinated Care Program for patients with Chronic Obstructive Pulmonary Disease.

    COPD patients were enrolled into an RCCP coordinated multidisciplinary program aimed at improving health outcomes and decreasing hospitalisation. Data from 2007-2012 was prospectively collected in a database, and retrospectively reviewed. Patients were analysed as to rates of hospitalisation in the 12 months prior to and after joining the program. The cost of the program was analysed against savings from decreased hospitalisation.

  • The combination treatment of laser bypass (chorioretinal venous anastomosis) and Lucentis for the treatment of macula oedema (swelling at the back of the eye) that has occurred as a result of a central retinal vein occlusion, compared to the published results of Lucentis treatment only.

    This is a monitoring study (phase IV) for participants with swelling in the back of the eye (macula oedema) that has been caused by a blockage to the main vein (retinal vein) draining the back of the eye (central retinal vein occlusion). The current treatment for this condition is a series of injections at monthly intervals of anti-VEGF antibodies (e.g. Lucentis or Avastin) into the back of the eye. Whilst this treatment works well, there is often an ongoing need for the eye injections. A laser treatment developed at the Lions Eye Institute, creates a channel from the retina (back of the eye) to the choroid (layer above the retina) for the blood to drain (laser bypass treatment). In the L-CVBS study participants who received the eye injections and laser bypass treatment require fewer eye injections longer term than participants who only receive the eye injections. Because the laser bypass and injection treatments work differently to address the swelling caused by the blockage, the combination of using both treatments tends to give patients a better visual outcome with fewer injections required. Recruitment for the L-CVBS study has closed, and this new study is a follow on study, where all participants will receive eye injections and the laser bypass treatment. Participants with a macula oedema that is caused by a central retinal vein occlusion will be asked if they would like to participate in this study (consent obtained first). If eligible, all participants will receive the laser bypass treatment followed by the Lucentis injections. The standard loading dose of a monthly Lucentis injection for the first three months will be followed. Participants will be monitored monthly until Month 6. If there is evidence of macula oedema and/or vision loss, further monthly injections will be given until the participants condition stabilises. If after Month 6 visual and macula oedema stability is achieved, the visits can be extended to once every two months until Month 12. If stability is maintained from Month 12, then the visits can be extended to once every three months in the second year. But if visual acuity drops and/or if macular oedema is present, then the eye injections will resume and the visits will be monthly until stability is achieved. We hope to show that fewer injections are required to achieve visual and anatomic stability compared to studies where only Lucentis injections are used.

  • Timely intervention: Efficacy of a depression symptom monitoring smartphone app to deliver psychological intervention at time of greatest need

    The purpose of this project is to conduct a randomised controlled trial (RCT) to compare self-guided use of an online intervention resource against BlueWatch-enhanced use of the same content. BlueWatch monitors depressive symptoms throughout the duration of intervention, and uses this information to obtain a risk profile for each participant, which can be used to predict periods of greater risk of depressed mood. In instances where greater risk is identified, participants are recommended to use the intervention resources immediately. It is hypothesized that this guided use will lead to stronger and quicker improvement in depressive symptoms, and due to the tailored nature of the intervention, will have lower dropout rates than self-guided use of the same intervention resources.

  • Reducing and interrupting prolonged sitting time in adults with pre-diabetes: A pilot study of feasibility and acceptability of a real-life intervention

    Rationale Based on evidence from the AusDiab study, it is estimated that at least 2 million Australians have prediabetes, a condition that carries a 10–20 fold increased risk of developing T2D. In people with prediabetes, too much sitting – accumulated throughout the day and across multiple settings – is now understood to be related to increased risk of T2D, microvascular and macrovascular complications, and premature mortality. This is distinct from the known adverse consequences of too little exercise. Descriptive epidemiological evidence shows that a high proportion of adults aged in their 50s and 60s can spend more than 9 hours each day sitting. Significant health benefits can be gained through innovative and feasible lifestyle-change strategies that take a ‘whole-of-day’ approach to reducing and interrupting the multiple consecutive hours spent sitting. Those at risk of diabetes are a high priority group for preventive initiatives. Given the escalating healthcare system, societal and economic burden associated with diabetes and cardiovascular disease, this will be an important and timely study and a vital step in developing affordable and effective evidence-based interventions to reduce and interrupt prolonged sitting, which will ultimately contribute to Australia’s national strategy for the prevention of major non-communicable diseases. Aim We aim to undertake pilot work to examine the short-term feasibility and acceptance of a proposed future randomised controlled trial (RCT) investigating the long-term efficacy of an intervention to reduce and interrupt prolonged sitting time in overweight or obese adults with prediabetes. Over a 4-week period we will examine the acceptability of participants to take part in the trial, and scrutinise the feasibility of interventions and assessment procedures proposed in the future trial. Conducting this study allow us to refine the design and/or methodology for the proposed future trial. Hypothesis We hypothesise that the intervention and assessment procedures used over the 4-week trial period will prove feasible to be included in the proposed future trial. Furthermore, participants will adapt and maintain compliance with the intervention and, on reflection, will express good acceptability of the intervention. We also hypothesise that the 4-week intervention will show small improvements from baseline in postprandial insulin and glucose, sitting time and bouts of prolonged sitting, endothelial function, body composition, blood pressure, and cardiometabolic markers.

  • Effect of oral sensory exposure on pork sensory specific satiety: a functional magnetic resonance imaging study

    The aim of this project is to study whether the flavor of pork meat, together with a standard meal, could exert higher satiating effect. The satiety will not only be studied using subjective sensation of appetite, but also by looking at the brain response to food-related visual cues and food-related odour cues using Magnetic Resonance Imaging technique. The purpose of this project is to improve the understanding of the correlation between sensory specific satiety and brain activity.

  • Topical Imiquimod or Diphenylcyclopropenone for the Management of Cutaneous In-transit Melanoma Metastases – A Phase II Single Centre Prospective Randomised Pilot Study

    Study Details This study aims to compare two different non-invasive topical immunotherapies in patients with multiple, in-transit, cutaneous melanoma metastases. The hypothesis is that these treatments are at least as clinically effective as current therapies for patients with selective in-transit melanoma metastases and can be used to enhance patients’ quality of life and decrease health-related costs. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have been diagnosed with histologically or cytologically proven in-transit melanoma metastases, which are considered unsuitable for surgery. Intervention Description Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will be given imiquimod cream and asked to apply it to their lesions five times weekly for up to 12 months. Participants in the other group will be given diphenylcyclopropenone (DPCP) cream instead, and asked to apply it to their lesions once weekly for up to 12 months. All participants will undergo regular clinical review with measurement of the treated lesions and assessment of their lymph nodes, routine blood tests and CT/PET scans, in order to evaluate the response to treatment. Patients will also be asked to complete a questionnaire evaluating quality of life at 3, 6, 12, and 18 months. Study Outcomes The results of this study may lead to improved patient rated outcomes compared to current strategies through a reduction in the burden of local disease, fewer serious treatment-related complications, more convenient application, streamlined review and ultimately decreased healthcare-associated expenditure.

  • The effect of supplemental nasal prong oxygen during standard pre-oxygenation techniques in healthy volunteers.

    The 2 most common breathing methods of pre-oxygenation involve 8 deep breaths over 60 seconds or 3 minutes of tidal volume breathing (normal breathing) using high flow oxygen. In the operating theatre this involves an anaesthesia machine that can deliver 100% oxygen at 15L/minute. In the emergency department, an anaesthesia machine is not present so a simple non rebreather mask or a bag valve /mask kit is used. Typically both of these devices can only deliver 60 -70% oxygen, so pre-oxygenation is often inadequate in these settings. In the recent KEMH anaesthesia preoxygenation trial we found that nasal prongs improved preoxygenation effectiveness when used with the anaesthesia machine. We are examining if nasal prong oxygen also improves preoxygenation when non rebreather mask and bag valve / masks are used.

  • A Prospective Phase 1 Study of a Novel Bi-Directional Arterial Cannula in Patients requiring Peripheral Veno-Arterial Extra Corporeal Membrane Oxygenation (VA-ECMO) Support.

    The aim of this study is to test a novel cannula that permits blood flow up and down the leg (called bi-directional) when placed in the femoral artery for the purposes of connecting the patient to Veno-Arterial Extracorporeal Membrane Oxygenation (V-A ECMO) support. As the cannula needs to be large to allow for a large volume of blood that must pass through the ECMO machine, the diameter of the cannula is almost the same as the diameter of the femoral artery so there is little room around the cannula for the blood to flow down the leg. Complications can arise due to poor blood flow down the leg which may result in irreversible damage to structures in the leg. To overcome this problem, a second cannula or downstream cannula is inserted to provide blood flow down the leg and less frequently a sidegraft to the femoral artery is performed. These techniques are time consuming and cumbersome and can delay the return of blood flow to the leg as the patient is placed on ECMO. The novel bi-directional flow cannula is designed to provide blood flow up and down the leg so that a second downstream cannula is not needed. Blood flow in the leg will be measured while the cannula is in place, using non-invasive ultrasound and non-invasive near infra-red spectroscopy (NIRS) which is a simple, painless, non-invasive way of measuring oxygen in the blood in the leg. Prior testing of the cannula in animal models proved safe and effective.

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