ANZCTR search results

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

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33646 results sorted by trial registration date.
  • A trial of computerised brain training to improve cognitive function in adults with cochlear implants

    Cochlear implant surgery is used to treat moderately-severe to profound hearing loss, but there are currently no treatments for cognitive impairment associated with hearing loss. The current clinical trial will examine and compare different types of computer-based brain training activities to determine which type of training will improve memory and thinking skills, hearing abilities, mood, and quality of life in adults with cochlear implants. We hypothesise that cochlear implant recipients will experience significant improvement in memory and thinking skills, hearing abilities, mood, and quality of life in response to auditory training combined with cognitive training. Considering that dementia is now the second leading cause of death in Australia and mid-life hearing loss may predict the development of dementia in later-life, findings from this study have the potential to inform the broader community of steps they can take to potentially limit and prevent the onset of dementia associated with their hearing loss.

  • Combined endurance and resistance exercise training for physical and mental health in the academic workplace; significance for both employer and employee.

    Full-time desk-based workers may be at greater risk of mental (e.g. depression and anxiety) and physical (e.g. diabetes and cardiovascular disease) disease due to low levels of physical activity and/or chronic stress. There is preliminary evidence that increasing physical activity through a combined resistance and endurance exercise training intervention (CT) could provide significant mental and physical health benefits to employees within this workplace. The academic workplace is unique in that academics have higher psychological strain and lower job satisfaction compared to other university staff, who already present with greater symptoms of anxiety and depression than the general population. Considering the paucity of health research within academia, this high-risk cohort lends itself to an investigation of the impact of CT on mental and physical health within the workplace. In turn, this study will determine the effects of a 14-week CT intervention on the mental and physical health of inactive full-time academics.

  • Should we CHECK it? Assessing interrogation of cardiac implantable electronic devices in the Emergency Department

    The purpose of this study is to investigate the outcomes of Cardiac Implantable Electronic Device (CIED) interrogations performed in the Emergency Department (ED). Patients who present to the Royal Adelaide Hospital’s (RAH) ED whom have an Implanted Cardiac Electronic Device (CIED) currently have their device interrogated upon request by the attending ED physician. These device interrogations are performed by Cardiac Physiologists, often requiring call-backs at the expense of the hospital, who use specialised computer systems which can interact with the device by telemetry. The performance of the CIED can be assessed during these interrogations to exclude device malfunction as a contributing factor to the patient’s clinical presentation. Furthermore, clinical data trends stored in the device can assist in diagnostics for the ED physician. It is not known how frequently significant issues are detected from these device checks. We hypothesize that there is a low yield of significant issues identified by CIED checks performed in the ED. The outcomes of this study can be used to develop evidence-based triaging methods to reduce the number of unnecessary checks and call-backs being performed.

  • Assessing the effect of changing a women's diet during breastfeeding on the levels of nutrients and hormones in their breast milk.

    Breast milk is the optimal form of infant feeding, and it is recommended that all infants should be exclusively breastfeed for the first 6 months after birth. Breast milk contains the essential nutrients, immune factors and hormones to support infant growth and development. However, it is becoming increasingly clear that the levels of these factors vary considerably between mothers, and that these differences may affect the short and longer-term health of the child. Maternal diet is thought to be an important determinant of the breast milk composition, however there is very little known about how changes to the maternal diet while breastfeeding can impact on breast milk composition. Many women in Australia currently consume poor quality Western diets that contain excess amounts of fat and added sugars, and there are suggestions that this might be having a negative effect on the quality of the mother’s milk. However, no studies have determined whether and to what extent improving dietary quality during breastfeeding can affect the composition of human milk. The aim of this research study is to determine the effect of improving dietary quality during breastfeeding on the concentrations of macronutrients (fat, sugar, lactose) and metabolic hormones (leptin, adiponectin, insulin, ghrelin) in breast milk.

  • Brain Oxygenation changes during Heart Surgery

    The aim of this pilot study is to evaluate the relationship between intraoperative blood pressure and brain metabolism during heart surgery using an advanced non-invasive optical imaging technique . We hypothesise that drops in perfusion pressure (below the limit of cerebral autoregulation) which are frequently encountered in heart surgery, not only impair cerebral haemodynamics, but also affect brain metabolism. This research will extend this extensive programme of research for the first time to the cardiac surgical population. This pilot study will inform the feasibility of future studies comparing [oxCCO] with clinical outcomes following cardiac surgery.

  • Makeway Lab, a mobile makerspace for hospitals making a change for hemodialysis patients

    This research is motivated by the notion that we feel alive and valued when we can make and share things. It looks at the benefits of a purposefully designed makerspace and arts in health intervention for long-term patients in assisting them to deal with the change and challenges they face. It examines the experience of a group of adult hemodialysis patients and their interaction with a mobile makerspace, created for this project, the ‘Makeway Lab’. The project will consider the participatory act of ‘making’ and the impact of the Makeway Lab in a hospital setting and deliver a series of digital maker activities with a group of people on the Sunshine Coast, Queensland. For the participants the project provides them interesting and engaging activities, to stimulate them socially, cognitively and physically. For the hospital the project accounts for the social and mental health of the participants and provide an innovative arts in health intervention. At a time of growing international acceptance of the notion that participation in the creative arts can be beneficial for wellbeing and health (Clift, 2012), this study will provide a unique hospital inquiry and patient testimonies for the value of a makerspace for human health.

  • A feasibility and efficacy cross over clinical trial of reinforcing subconscious re framing of past and present programs to reduce symptoms of Post Traumatic Stress Disorder (PTSD)

    PTSD can be characterised by reactivation of memories of past events, which were viewed as being severe and possibly life threatening at the time. The study looks to evaluate if reframing the original memory, creating a vision of a happy and ptsd free future and then reinforcing this with listening to a meditation twice a day for 8 weeks will result in short term and then long term improvements of the symptoms of PTSD.

  • A Pilot Study to Assess the Safety, Hemodynamic and Electrophysiologic Effect of Left Atrial Decompression by an InterAtrial Shunt Device (IASD) in Patients Undergoing Pulmonary Vein Isolation.

    The underpinning pathophysiologic basis for the study is that elevated left atrial pressure is often observed in patients with AF. The hypothesis for the current study is that left atrial decompression using an IASD may improve hemodynamic and electrophysiologic outcomes in patients undergoing repeat pulmonary vein isolation for AF treatment. This study is a pilot study to assess safety and feasibility, together with exploratory hemodynamic and electrophysiologic end-points.

  • The effect of resisted exercise on pain and function in people with de Quervain's syndrome

    The purpose of this study is to investigate the feasibility and safety of a randomised controlled trial (RCT) to examine the effectiveness of isometric exercises in the management of de Quervain's syndrome, and compare low load to high load exercises. All participants will receive a thermoplastic orthosis and education regarding the condition. Participants will then be randomised into low load (25% of max) or high load (70% of max) thumb extension exercises.

  • A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Effects and Exploratory Efficacy of FPP003 Vaccine in Subjects with Psoriasis.

    Psoriasis is an immune-mediated disease that causes raised, red, scaly patches to appear on the skin as a result of a sped-up skin production process. The typical life cycle of a skin cell is 1 month (www.healthline.com/health/psoriasis). Typically, skin cells grow deep in the skin and slowly rise to the surface and eventually fall off. In people with psoriasis, this production process may occur in just a few days resulting in rapid overproduction and build-up of skin cells. This study is investigating a new vaccine called FPP003 which is being developed to treat patients with moderate - severe psoriasis. This study will investigate the safety and tolerability of FPP003. It will also look at the pharmacokinetics (how much of the drug remains in the blood at certain timepoints) of the drug and how effective it is with escalating dose levels. These investigations will be compared with placebo under the same conditions. This study will be conducted in 4 successive, dose escalated, cohorts. In each cohort, participants will receive a subcutaneous dose of the study drug (FPP003 or placebo) on Day 1, Day 15 and Day 29. The study will be divided into a screening phase lasting up to 28 days. The total duration of the study for participants completing the study is about 5 months, with a total of 8 visits to the study unit.

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