ANZCTR search results

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

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32873 results sorted by trial registration date.
  • Transthoracic echocardiographic assessment of cardiac output in healthy women at elective caesarean section under spinal anaesthesia with ephedrine hypotension prophylaxis: an observational cohort study

    One of the most common types of anaesthetic used for caesarean section is a spinal anaesthetic. In order for women to be comfortable during the operation a large number of nerves are blocked. In addition to the pain nerves it is very common for other nerves to be affected, including those which are responsible for other types of sensation, movement in the legs and also those which normally help control blood pressure. Significantly low blood pressure in the mother may be associated with side-effects including nausea and vomiting, dizziness and possibly loss of consciousness and in extreme situations the baby may also receive a reduced blood supply from the placenta. For the anaesthetist to provide a safe anaesthetic it is very important to monitor these effects and especially any changes to blood pressure and how the woman’s body responds to it. This is particularly important during the first 5 to 10 minutes after the injection of the spinal anaesthetic. During this period it is usual to closely measure blood pressure, heart rate, the amount of oxygen in the blood and the electrical activity of the heart from an electrocardiogram. Recently, it has also become possible to directly observe the function of the heart relatively quickly and easily via a hand-held ultrasound probe placed on the chest – a transthoracic echocardiogram or TTE. These devices are very similar to those used for obtaining images of the baby during pregnancy. It is known from the use of these devices in other situations, including in pregnant women, that valuable information may be obtained about how the heart is performing. Until now this has not been done in healthy women having a spinal anaesthetic for an elective caesarean section. Hence, the purpose of our study is to document the effects of a standard spinal anaesthetic on the output of the heart by comparing measurements at approximately 10 minutes after the spinal injection with measurements taken immediately before the spinal using TTE. In keeping with usual practice, drugs will be given to help maintain normal blood pressure throughout. Information obtained from this study will be helpful in further understanding the impact of spinal anaesthetics on the cardiovascular system in pregnant women which is likely to help guide anaesthetists to reduce side effects and improve safety.

  • Melatonin vs. placebo for the symptoms of delirium in elderly medical inpatients

    This is a pilot trial testing the feasibility and participants required to test the hypothesis that melatonin 5mg capsule every night will decrease the symptoms of delirium in elderly medical inpatients.

  • The maximum tolerated dose of walking for people with osteoarthritis of the knee: a phase I trial

    Lack of physical activity is a major health issue for people with osteoarthritis of the knee leading to increased risks of cardiovascular disease. Only about 1 in 10 people with knee osteoarthritis meets the current physical activity guidelines of at least 150 minutes of moderate intensity activity in minimum of 10 minute bouts each week. It is not known if it is safe or feasible to encourage these people to increase their physical activity level as recommended in the guidelines. This project will determine how much physical activity in the form of walking can be safely and feasibly prescribed for people with severe knee osteoarthritis in the community. Patients that attend the orthopaedic outpatients department at Eastern Health will be invited to participate. We will apply methods commonly used in drug trials to work out how much of a medication can be safely prescribed, but apply these methods to physical activity to work out the maximum tolerated dose of walking for people with severe knee osteoarthritis. The project will begin with prescribing small doses of walking, and measuring the participants’ responses to determine if the prescribed dose is tolerated safely. For example, the walking dose may cause substantial knee pain for the participant that does not settle quickly with rest. This response is termed an adverse or undesired event. If there are no adverse events, the prescribed dose of walking will be escalated in the next independent group of participants until the maximum tolerated dose is reached. This is a phase I dose response trial to characterise the safety profile of a treatment. The outcome of this study will provide evidence for the level of physical activity that can be safely tolerated by people with knee osteoarthritis, and assist health professionals to prescribe safe amounts of walking.

  • Exercise preference in overweight adults with clinical depression: a pilot study

    The propsed study will investigate the suitablity (particularly enjoyment, motivation to continue) of three formats of exercise intervention (Moderate Intensity Personal Preference; Moderate Intensity Steady State; and High Intensity Interval Training) for overweight or obese individuals with clinical depression. In essence, the proposed research will act as a feasibility/pilot study for a later study, which will be based on the results of the proposed research. In this future study a 12 week exercise program will be implemented (based on the proposed study outcomes) which will be compared to and used alongside a “gold standard” treatment of Cognitive Behaviour Therapy for depression. It is important to understand exercise preferences and motivation to continue exercise in this population prior to designing this treatment protocol. We expect that the format of exercise (high intensity vs moderate intensity; interval vs steady state vs personal preference) will differentially affect motivation and enjoyment as well as markers of inflammation, appetite, symptoms of depression and sleep quality.

  • iStoppFalls - Information and communication technologies (ICT) based system to predict and prevent falls

    This project addresses the urgent health care problem of falls in old age that affects a rapidly increasing number of people in Australia and is geared towards self-management of fall-related risk factors in old age. Technology-based solutions have potential to increase accuracy of fall prediction tools and develop standardized tailored intervention strategies. The emphasis of the project is not on laboratory research, but on active implementation of existing technologies and evidence-based fall prevention strategies for older people living in the community. The primary aim of the project is to develop and evaluate innovative home-based technologies for continuous monitoring and prevention of falls risk in older people.

  • Can exercise change core stability in recreational athletes?

    This project investigates whether lumbopelvic or "core" stability in recreational athletes is improved by 12 weeks of stability or stretching exercises. Participants' movement control of the back, pelvis and thigh will be assessed at baseline, 12 weeks and 12 months after baseline to determine the influence of exercise training on stability. The hypothesis is that the stability training program will achieve measurable and superior results in lumbopelvic control compared to the stretching program

  • "The LoDoCo2 Trial":Low Dose Colchicine for secondary prevention of cardiovascular disease.

    The primary objective of this study is to evaluate clinical efficacy of treatment with colchicine 0.5mg once daily as compared to placebo in patients with stable coronary artery disease on the incidence of first occurrence of the composite of cardiovascular death, myocardial infarction, ischemic stroke or ischemia-driven coronary revascularisation.

  • A randomised double-blind controlled trial of lignocaine/phenylephrine nasal spray vs placebo for pain and distress of nasogastric tube insertion in children

    Nasogastric tube insertion is consistently rated as one of the most painful and distressing procedures undertaken in the emergency department. Multiple adult studies have demonstrated that use of local anaesthetic prior to insertion markedly reduces this pain and distress, however, the only study undertaken in children did not show any benefit. We plan to undertake a randomised trial in children aged 6 months to 5 years of age. The trial will compare the effects of a spray of salty water (saline) to a spray of local anaesthetic (lignocaine and phenylephrine) into the nose prior to insertion of the nasogastric tube. An observer will measure pain and distress experienced by the child before, during and after the procedure. The child's carer will also be asked to rate the child's pain and distress. Insertion of a nasogastric tube usually takes approximately 5-10 minutes. The anticipated duration of the study is 20-30 minutes, including time for explanation and consent. Approximately 100 children will need to be recruited to complete the study We hypothesise that lignocaine / phenylephrine spray and intranasal placebo spray will be equally effective in the prevention of pain and distress associated with nasogastric tube insertion in children

  • Targeting pain mechanisms from the 'top-down' and the 'bottom-up' in chronic tension-type headache

    Tension-type headache (TTH) is the most common and costly primary headache disorder. Up to 2-5% of individuals with TTH experience severe, persistent and disabling headaches (chronic tension-type headache; CTTH). CTTH is a major health problem and currently, there are few effective therapies available for CTTH, which only target generic symptoms. Recent work has revealed a role for biological mechanisms in affecting pain in CTTH. Therefore, novel therapies that aim to target the biological mechanisms are needed to reduce the social and economic burden on sufferers and the wider community. Here we aim to conduct a 'proof of concept' study to investigate the use of an innovative 'top-down' and 'bottom-up' approach to therapy through the combined application of transcranial (tDCS) and transspinal direct stimulation (tsDCS). This study will provide the initial test of the feasibility, safety and potential benefit on pain outcomes. We anticipate that the combination of tDCS and tsDCS will have an affect on improving CCTH intensity, frequency and duration by targeting the biological mechanisms that contribute to pain.

  • Spironolactone in myocardial dysfunction with reduced exercise capacity

    The main aim of this study is to use aldosterone blockade for the treatment of exercise intolerance in the presence of diastolic dysfunction (DD) and preserved LV systolic function. The responses will be sought by measurement of: 1) exercise capacity, 2) techniques to quantify myocardial structure and function. Our primary hypotheses are that spironolactone therapy is associated with improved; 1. Exercise capacity by reduction of myocardial fibrosis and improvement in LV compliance with aldosterone blockade, 2. Post-exercise LV filling pressure. Our secondary hypotheses are that spironolactone therapy is associated with; 3. Avoidance of a hypertensive response to exercise, 4. Improvements in myocardial deformation properties.

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