ANZCTR search results

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

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33673 results sorted by trial registration date.
  • Effect of ongoing feedback on compliance with physical activity following an exercise intervention in chronic disease

    The project aims to determine the effect of different types of ongoing feedback regarding maintenance of physical activity levels post completion of the 12-week strength2strength exercise treatment program. It is hypothesised that activity trackers will be as effective as telephone counselling for assisting participants to maintain their activity, however will be a more cost effective method.

  • The effect of probiotic supplementation on symptoms and quality of life of individuals suffering Allergic rhinitis

    The symptoms of Allergic rhinitis, such as nasal congestion and itching, are a burden for an estimated 3.2 million Australians and its prevalence is increasing. There is growing evidence to suggest that probiotic supplementation elicits beneficial health effects on the host through modulation of the immune system and thereby can improve symptoms associated with Allergic rhinitis. The aim of this research is to examine the effect of probiotic supplementation on symptoms and quality of life in individuals suffering from Allergic rhinitis

  • Can intervention for perfectionism reduce the onset of postnatal depression?

    This study aims to investigate the potential impact of a perfectionism self-help intervention on maternal mental health outcomes. In particular, the potential benefits of a brief self-help intervention for new mothers with high levels of perfectionism. The study is designed to investigate if mothers who make use of a perfectionism self-help booklet during their third trimester score differently than waitlist controls on measures of perfectionism, rumination and symptoms of anxiety and depression. It is hypothesized that perfectionism and rumination will be positively correlated with postnatal depression and anxiety, and that rumination will mediate the relationship between perfectionism and symptoms of postnatal depression and anxiety. It is also hypothesized that scores on measures of perfectionism, rumination, and symptoms of anxiety and postnatal depression will change significantly more from pre to post intervention for new mothers in the self-help group than for the waitlist control group, and this will be maintained at 3 month follow-up.

  • Haemodynamic Effect of Intravenous Paracetamol during and after Cardiac Surgery

    There are currently no double-blinded, randomised controlled trials that assess the haemodynamic effects of paracetamol in patients undergoing cardiac surgery. The effects of cardiopulmonary bypass (CPB) on paracetamol pharmacokinetic are also poorly understood. This study will add to a growing body of evidence evaluating the safety and efficacy of paracetamol use in patients undergoing cardiac surgery. Hypothesis: Paracetamol (1g IV) has adverse effects on blood pressure in patients undergoing cardiac surgery. No of patients: 50 No of recruiting hospitals: 1 Randomisation: Patients will be randomised in a 1:1 fashion via a computer generated randomisation program to either paracetamol IV formulation (N=25) or control treatment (normal saline 0.9%) (N=25). Blinding: This is a double-blinded clinical trial. Surgical teams, intraoperative and postoperative nursing staff, and patients will be blinded to assignment of treatment.

  • 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.

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