ANZCTR search results

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

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31134 results sorted by trial registration date.
  • The effect of aerobic exercise on pain in people with diabetic neuropathy

    The beneficial effects of physical activity and exercise on pain, function and quality of life in people with chronic musculoskeletal pain are well-described. In rodents, exercise can reduce neuropathic pain and improve nerve function and structure, but whether physical activity and exercise improve these same outcomes in people with neuropathic pain is poorly understood. Improving understanding of the relationship between physical activity with pain and nerve structure/function in people with diabetic peripheral neuropathy, as well as the effect of a single bout of exercise on these outcomes, could help improve exercise programming to prevent or slow progression of diabetic neuropathy. We hypothesise that an acute bout of exercise will briefly reduce pain in people with diabetic neuropathy. We also hypothesise that people with diabetic neuropathy who are more physically active will report less pain and have less impaired nerve structure and function.

  • A new clinical tool to assess fitness-to-drive in obstructive sleep apnea

    Obstructive sleep apnea (OSA) is a common sleep disorder linked with impaired driving performance. The problem is that the current standard tests to evaluate driving ability is very labour intensive and expensive, limiting its utility to only a small portion of OSA patients. The aim is to validate biomarkers of alertness failure and driving impairment in patients with OSA towards developing a clinically deployable, simplified and cost effect fitness to drive assessment. We expect that, on the basis of biomarkers that can be easily obtained in clinical sleep services, we can identify OSA patients at high risk of driving impairment and accidents, and distinguish them from patients who are at negligible risk.

  • Efficacy of Regional Anaesthesia in a Dedicated Service: A Retrospective Comparison of Supervised Trainees and Consultant Anaesthetists

    Training junior clinicians requires appropriate case selection and supervision. Thus, randomising patients to be exposed to trainees is problematic. We designed a retrospective observational study examining prospectively collected data. Data will be retrieved from an ongoing audit database of every regional anaesthesia procedure performed by the dedicated regional anaesthesia service of our hospital. This service performs regional anaesthesia using a block room or block team model. The principal proceduralist was recorded immediately after performance of the block as either a consultant or registrar. The study group includes all patients who received care from supervised trainees. The comparator group included patients who received regional anaesthesia care from consultant anaesthestists. Null hypothesis: There is no difference in the effectiveness of regional anaesthesia (defined as inadequate analgesia [NRS >5] in PACU) when supervised trainees are the principal proceduralist, when compared with consultants.

  • The effect of caloric vestibular stimulation on pain levels in phantom limb sensations

    Phantom limb sensations are well-known phenomena, occurring in up to 55-80% of amputees. A subset of these individuals experience a neuropathic pain syndrome known as phantom limb pain (PLP), which can occur from days to years after amputation. This can be both psychological and physically draining for amputees. The vestibular (balance) system is widely integrated within the somatosensory system and is thought to modulate the perception of neuropathic pain. The aim of this study is to investigate the use of caloric vestibular stimulation (CVS) for alleviating PLP. Activation of the vestibular system by CVS may represent a novel, safe and alternative therapy for patients suffering from PLP.

  • A study to evaluate the biosimilarity of SBS6002 to Neulasta when administered to healthy participants

    This research project is being conducted to evaluate the bioequivalence and biosimilarity of SBS6002 to Neulasta when administered to healthy participants by comparing PK, PD, safety and tolerability.

  • Does the introduction of rotational thromboelastometry (ROTEM)-guided transfusion management for patients undergoing surgical intervention for post-partum haemorrhage (PPH) affect blood product use and patient outcomes?

    Post-partum haemorrhage (PPH) is a common obstetric complication and a major cause of maternal mortality and morbidity in Australia. Treatment of PPH often involves significant healthcare resources, including blood products, operating theatre time, prolonged hospital length of stay, and in severe cases, admission to intensive care. PPH is often associated with, and is exacerbated by, abnormalities of haemostasis. Traditional coagulation tests are insensitive at predicting severity of PPH and guiding its management, with a paucity of evidence supporting their use for transfusion management in the peri-operative setting. Rotational thromboelastometry (ROTEM) is a point-of-care test of whole blood coagulation that provides rapid information about time to clot formation, strength of clot and presence of fibrinolysis. ROTEM can be used to help guide replacement coagulation treatments in peri-operative settings. ROTEM was introduced in June 2016 in the operating suite at Sunshine Hospital, alongside a transfusion algorithm. This study aims to examine the effect that the introduction of ROTEM-guided transfusion management has had on the utilisation of blood products and on clinical outcomes in patients with PPH requiring surgical management. This will help us to better understand the role and benefits of ROTEM in the peri-operative setting, which will in turn benefit patient care by better informing future management of PPH and related clinical conditions.

  • Effects of acute and sub-acute treatment with metformin on cardiovascular responses to a glucose challenge in type 2 diabetes

    Patients with type 2 diabetes are at high risk of cardiovascular disease. Treatments targeted at lowering glucose may reduce the risk of cardiovascular disease, however other approaches are needed as patients remain at an elevated residual risk of cardiovascular events. There is evidence that fluctuation in blood pressure (blood pressure variability) is an important risk factor for cardiovascular disease, such that substantial changes over time are detrimental and lead to an increased risk of cardiovascular disease. Metformin is a drug that has been used for diabetes for many years, though the mechanism of action remains incompletely understood. Early studies with this drug suggested that this particular agent was effective at reducing cardiovascular events and there is some evidence that metformin can modify both blood pressure, and gut responses following a meal. We are interested in looking to see whether metformin could reduce blood pressure fluctuations induced throughout the day, and in particular following meals. Information from this study will help guide further research into mechanisms behind and potential novel approaches to cardiovascular disease and blood pressure in diabetes. Given recent interest in the bacteria in the gut and how this influences health and blood sugar control, we will also look at the effect of metformin on bugs in the gut (microbiome).

  • RETHINK: a Cohort study to REconsider the Factors that INfluence StroKe Recovery.

    RETHINK is a cohort study to REconsider THe Factors that INfluence stroKe recovery. The hypothesis is that there are domain specific biological biomarkers and psychosocial determinants that predict clinically relevant recovery after stroke. The primary aim of this study is to investigate and characterise biomarker and psychosocial determinants for upper limb motor deficits that associate with favourable and unfavourable recovery at multiple time-points following ischaemic stroke. These common deficits affect upwards 70% of those with a stroke making it a particularly pertinent focus of study. In addition to upper motor deficits, RETHINK will investigate stroke recovery across specific domains (lower limb, cognitive-aphasia, neglect, sensory) using a global approach. Participants will be asked to provide blood and microbiome samples at study enrolment and at primary and secondary time-points. Participants will also be asked to complete one Patient Reported Outcome Measure (PROMS) online survey about quality of life and for a small subgroup, will be invited to participate in one face to face interview about their experiences in the study and with the outcome metrics.

  • Aboriginal and non-Aboriginal women perpetrators of violence: a trial of a prison-based intervention (Beyond Violence)

    While women comprise a small (8%), but rapidly growing segment of the prisoner population, 57% of incarcerated Aboriginal women were incarcerated for a violent offence, much higher than for non-Aboriginal women (33%). Violent women offenders pose a significant challenge to custodial authorities as they have more complex physical and mental health needs than men. The study aims to determine the effectiveness of a targeted substance, mental health and violence intervention (Beyond Violence) in reducing re-offending at 24 months among Aboriginal and non-Aboriginal women with convictions for a violent offence.

  • An evaluation of contrast sensitivity function with optical filters, myopia control spectacles and contact lenses in myopes

    This is a prospective, cross-over clinical trial to determine the effect of filters, myopia control spectacles and soft contact lenses on the contrast sensitivity function. Up to 30 prototype designs may be assessed during the study. Up to 20 participants (minimum of 10) will be included in the evaluation of each prototype design. The contrast sensitivity function (plotting of contrast thresholds at various spatial frequencies) obtained with filters, myopia control spectacles and soft contact lenses will be compared to the contrast sensitivity function obtained with single vision spectacles and soft contact lenses. Healthy adults aged at least 18 years old will be recruited. Habitual spectacle wearers, experienced and inexperienced contact lens wearers will be recruited.

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