ANZCTR search results

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

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32103 results sorted by trial registration date.
  • A pilot randomised controlled trial examining the feasibility, acceptability and preliminary efficacy of an internet-delivered cognitive bias modification to reduce co-occurring social anxiety and alcohol use in young Australians

    Anxiety and alcohol use disorders are among the leading causes of burden of disease worldwide, and they often co-occur. In recent years, innovative brain training procedures, known as Cognitive Bias Modification, have been developed to target implicit (i.e. subconscious) mental habits that contribute to the development and maintenance of anxiety and alcohol use disorders. Two of the most common types of Cognitive Bias Modification programs are i) Approach Bias Modification (ApBM) programs, which aim to re-train the implicit tendency to approach (rather than avoid) alcohol, and ii) Interpretation Bias Modification (IBM) programs, which aim to re-train the automatic tendency to analyse ambiguous information in a negative or catastrophic way. Given the interconnections between anxiety and alcohol use problems, a promising avenue that has not been explored is the potential of combining these effective cognitive re-training protocols to optimize standard treatments among younger comorbid samples. This project aims to pilot trial the feasibility, acceptability and preliminary efficacy of a 10-session ApBM+IBM intervention (‘Re-Train Your Brain’, delivered via the internet in one of two formats), when added as an add-on to treatment as usual, compared to treatment as usual only. The sample will be comprised of 90 young people aged 18-30 years with social anxiety and alcohol use problems. Outcomes will be assessed at baseline, 6-weeks post-baseline and 3-months post-baseline. It is hypothesised that the program will be deemed feasible, acceptable and show signs of preliminary efficacy.

  • Does sleep medication affect next day performance in athletes

  • A multi-centre, single-arm, prospective, pre-market, pivotal study on robotic instrumentation (ROSA® Partial Knee System) in patients undergoing medial unicompartmental knee arthroplasty

    Robot assisted knee arthroplasty is a relatively recent development intended to assist the surgeons in achieving accurate bone cuts and predictable implant positioning. This study is investigating the accuracy of robotic surgery in partial knee arthroplasty. This will include the assessment of the intraoperative planned vs. actual component positioning. Also investigated will be the evaluation of safety and efficacy of this system including the assessment of common adverse events, physical exam findings, radiologic results and patient reported outcome measures.

  • An online behavioural intervention targeting dietary habits in adults who are overweight

    A growing body of literature emphasises the potential benefits of self-compassion as a new approach to improve the outcomes of nutrition programs by addressing psychological factors such as emotional eating. Online technologies that comprise goal-setting and self-monitoring have also shown promise in increasing healthy dietary behaviours. Therefore, this randomised controlled trial aims to examine the efficacy of an online 12-week intervention that combined self-compassion with goal-setting and self-monitoring to improve dietary habits in people with overweight or obesity compared to the control group.

  • The Loddon Mallee Healthcare Worker COVID-19 Study

    This research will explore the immediate, medium and long-term impacts of COVID-19 on rural and regional health care workers and the communities in which they live. A cohort of Loddon Mallee healthcare workers (COVID-19+/COVID-19-) will be recruited and followed over three years to examine the effects of the COVID-19 pandemic on the health and wellbeing of these workers. The main aims of the study are to: • Use a longitudinal study design to explore and describe the health and wellbeing impacts of the COVID-19 pandemic among the rural/regional healthcare worker cohort and sub-cohorts. • Identify protective/resilience factors, at the individual, organisation and community level that predict better physical and mental health outcomes for health workers. Evidence-based resilience interventions may then be implemented in the future to improve the workforce response to major disruptions such as the COVID-19 pandemic. • Inform policy options to support our rural/regional health care workers in responding to major disruptions such as the COVID-19 pandemic.

  • A comparison of the rate of rise of transcutaneous carbon dioxide during apnoeic oxygenation in microlaryngoscopy using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) versus low flow tracheal insufflation: a randomised control trial

    Trans-nasal humidified rapid insufflation ventilatory exchange (THRIVE) has been widely taken up by anaesthetic and ear, nose and throat (ENT) departments worldwide for airway management. THRIVE is a technique that uses rapidly insufflated, heated and humidified oxygen administered via nasal cannula to maintain oxygenation during periods of apnoea. It is regularly used for ENT procedures, in particular microlaryngoscopy. It allows for maintenance of oxygenation and unobscured surgical field by anaesthetic endotracheal tubes. The mechanism by which THRIVE and other apnoeic techniques (such as low flow intra-tracheal oxygen insufflation) maintain oxygenation is well understood, i.e. bulk flow of oxygen from the upper airway to replace the volume of oxygen taken up from the alveoli. However, a concern with all apnoeic techniques is the rise of blood and tissue carbon dioxide (CO2) levels in the absence of ventilation. Much of the support for THRIVE has centred on claims that unlike other apnoeic techniques, it is effective at eliminating CO2.. Recently, however, a study (1) of THRIVE in ENT microlaryngoscopy patients has suggested that when arterial CO2 levels are measured, the rate of rise of CO2 is actually as much as would be expected with other apnoeic techniques. In our anaesthetic department, we have considerable experience of apneoic oxygenation by low flow intra-tracheal oxygen insufflation (Lo-Flo). An oxygen catheter is directly passed under vision using a laryngoscope through the glottic opening to sit at mid tracheal level. This is then attached to oxygen supply at 0.5-1L/min. Transcutaenous carbon dioxide (TcCO2) can be easily measured with a transcutaneous probe that attaches to the patient’s skin in a non painful, non invasive manner. It is applied a few minutes prior to the start of the procedure. This study would build on the previous departmental experience with apnoeic oxygenation research. We plan to compare the two techniques of apnoeic oxygenation for ENT microlaryngoscopy, focusing particularly on the rate of rise of TcCO2. We believe it is likely that we will disprove the now widely held belief that CO2 rises less quickly with THRIVE than with other apnoeic techniques. (1) Gustafsson IM, Lodenius A, Tunelli J, Ullman J, Jonsson-Fagerlund M. Apnoeic oxygenation in adults under general anaesthesia using transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) – a physiological study. British Journal of Anaesthesia 2017; 118: 610–7

  • An assessment of the impact of midodrine on early mobilisation after hip replacement surgery

    Total hip replacement is a common operation performed in Australia. A proportion of patients will transiently feel unable to get out of bed following this surgery due to dizziness, lightheadedness, blurred vision, nausea or low blood pressure. The medical term for this is orthostatic intolerance or orthostatic hypotension. The aim of this study is to administer a medication to investigate its effect on mobilisation after this operation.

  • A synthetic haemostatic agent (PuraStat) for endonasal surgery

    Bleeding is among the most common complications following endoscopic sinus and turbinate surgery and has historically been managed through the use of nasal packing. Haemostatic gels are seeing as use as an alternative method that is more comfortable for patients and reduces complications due to excessive tamponade by packs. This study evaluates the effect of RADA16, a nanopeptide based haemostatic hydrogel with a proposed role in reducing post-operative bleeding as well as reducing the incidence of other common complications including crusting/adhesion formation and chronic nasal infection, in the setting of endoscopic nasal surgery.

  • Novel Delivery of Chemotherapy for Treatment of Patients with Mesothelioma: A Feasibility Study

    Malignant pleural mesothelioma (MPM) is a rare cancer of the lung lining caused by exposure to asbestos. MPM is regarded as one of the most aggressive solid tumours, with limited treatment options and poor prognosis. Emerging MPM treatment options are of particular interest in Australia where the incidence of MPM is among the highest in the world. One such emerging treatment involves the injection of chemotherapeutic agents into the aorta, where they perfuse directly into the vessels which supply the pleural lining. This approach, termed transarterial chemoperfusion, allows a high concentration of chemotherapy to be delivered directly to the cancer. This study is investigating the safety and effectiveness of transarterial chemoperfusion for the treatment of patients with MPM. We will evaluate tumour response, symptoms, quality of life, progression free survival and overall survival. Who is it for? You may be eligible to participate in this study if you are aged 18 years or older, have been diagnosed with malignant pleural mesothelioma that is not being treated with surgery and you have not had recent chemotherapy (within the last 4 weeks). Study details Participants enrolled in this study will undergo an angiogram (imaging of the heart and blood vessels), which involves having a catheter inserted into a vein. The chemotherapy agents will then be directly infused into the aorta and surrounding blood vessels over a period of 60 minutes. All participants will be receive this treatment for at least 2 sessions scheduled every 3-6 weeks, before undergoing a CT scan to assess treatment response. Participants who show a reduction in their tumour burden will continue to receive therapy every 3-6 weeks until they no longer respond to treatment. Participants who do not show a response to treatment after the first 2 procedures will not undergo further infusion therapy. It is hoped this research will determine whether this specific method of chemotherapy infusion is a safe and effective treatment for patients with malignant pleural mesothelioma, and can improve outcomes for future patients.

  • The effect of maintenance macrolide antibiotic de-escalation during the Australian summer season on exacerbations of respiratory diseases such as asthma, COPD and bronchiectasis

    This study is a new initiative to promote appropriate use of long-term macrolide antibiotics such as azithromycin, clarithromycin, roxithromycin and erythromycin in the management of respiratory diseases such as asthma, COPD and non-cystic fibrosis bronchiectasis. Although these drugs are effective, it is not clear for how long the treatment should be continued. Guidelines recommend a treatment duration of 6-12 months. They also recommend a drug break each year. In this study, we are investigating whether it is possible to stop these drugs permanently or at least temporarily after undergoing a certain period of treatment. We are looking for participants who are currently taking azithromycin, clarithromycin, roxithromycin or erythromycin for the treatment of asthma, COPD or bronchiectasis for at least 6 months. Participants will be randomised to one of the two study groups. Participants in both groups will stop the current macrolide during the Australian summer season as we anticipate that the summer season would be the best time to try medication withdrawal in respiratory diseases. After stopping the current macrolide, group 1 will start an equivalent macrolide which will be azithromycin, and group 2 will start an identical placebo. Participants will continue the study medication for a period of nine months with scheduled follow-ups at 3-, 6- and 9-months.

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