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 oral sensory exposure on pork sensory specific satiety: a functional magnetic resonance imaging study

    The aim of this project is to study whether the flavor of pork meat, together with a standard meal, could exert higher satiating effect. The satiety will not only be studied using subjective sensation of appetite, but also by looking at the brain response to food-related visual cues and food-related odour cues using Magnetic Resonance Imaging technique. The purpose of this project is to improve the understanding of the correlation between sensory specific satiety and brain activity.

  • Topical Imiquimod or Diphenylcyclopropenone for the Management of Cutaneous In-transit Melanoma Metastases – A Phase II Single Centre Prospective Randomised Pilot Study

    Study Details This study aims to compare two different non-invasive topical immunotherapies in patients with multiple, in-transit, cutaneous melanoma metastases. The hypothesis is that these treatments are at least as clinically effective as current therapies for patients with selective in-transit melanoma metastases and can be used to enhance patients’ quality of life and decrease health-related costs. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have been diagnosed with histologically or cytologically proven in-transit melanoma metastases, which are considered unsuitable for surgery. Intervention Description Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will be given imiquimod cream and asked to apply it to their lesions five times weekly for up to 12 months. Participants in the other group will be given diphenylcyclopropenone (DPCP) cream instead, and asked to apply it to their lesions once weekly for up to 12 months. All participants will undergo regular clinical review with measurement of the treated lesions and assessment of their lymph nodes, routine blood tests and CT/PET scans, in order to evaluate the response to treatment. Patients will also be asked to complete a questionnaire evaluating quality of life at 3, 6, 12, and 18 months. Study Outcomes The results of this study may lead to improved patient rated outcomes compared to current strategies through a reduction in the burden of local disease, fewer serious treatment-related complications, more convenient application, streamlined review and ultimately decreased healthcare-associated expenditure.

  • The effect of supplemental nasal prong oxygen during standard pre-oxygenation techniques in healthy volunteers.

    The 2 most common breathing methods of pre-oxygenation involve 8 deep breaths over 60 seconds or 3 minutes of tidal volume breathing (normal breathing) using high flow oxygen. In the operating theatre this involves an anaesthesia machine that can deliver 100% oxygen at 15L/minute. In the emergency department, an anaesthesia machine is not present so a simple non rebreather mask or a bag valve /mask kit is used. Typically both of these devices can only deliver 60 -70% oxygen, so pre-oxygenation is often inadequate in these settings. In the recent KEMH anaesthesia preoxygenation trial we found that nasal prongs improved preoxygenation effectiveness when used with the anaesthesia machine. We are examining if nasal prong oxygen also improves preoxygenation when non rebreather mask and bag valve / masks are used.

  • A Prospective Phase 1 Study of a Novel Bi-Directional Arterial Cannula in Patients requiring Peripheral Veno-Arterial Extra Corporeal Membrane Oxygenation (VA-ECMO) Support.

    The aim of this study is to test a novel cannula that permits blood flow up and down the leg (called bi-directional) when placed in the femoral artery for the purposes of connecting the patient to Veno-Arterial Extracorporeal Membrane Oxygenation (V-A ECMO) support. As the cannula needs to be large to allow for a large volume of blood that must pass through the ECMO machine, the diameter of the cannula is almost the same as the diameter of the femoral artery so there is little room around the cannula for the blood to flow down the leg. Complications can arise due to poor blood flow down the leg which may result in irreversible damage to structures in the leg. To overcome this problem, a second cannula or downstream cannula is inserted to provide blood flow down the leg and less frequently a sidegraft to the femoral artery is performed. These techniques are time consuming and cumbersome and can delay the return of blood flow to the leg as the patient is placed on ECMO. The novel bi-directional flow cannula is designed to provide blood flow up and down the leg so that a second downstream cannula is not needed. Blood flow in the leg will be measured while the cannula is in place, using non-invasive ultrasound and non-invasive near infra-red spectroscopy (NIRS) which is a simple, painless, non-invasive way of measuring oxygen in the blood in the leg. Prior testing of the cannula in animal models proved safe and effective.

  • A pilot study in humans for purified Plasmodium falciparum 7G8 malaria parasites attenuated with Tafuramycin-A.

    This study is examining the safety, tolerability, persistence and immunogenicity of Tafuramycin-A (TF-A) attenuated purified P. falciparum 7G8 blood stage parasites. Participants will receive a single inoculum of purified malaria parasites attenuated with either 200nM or 400nM of Tafuramycin-A. Following administration of the inoculum, we will measure the level of malaria parasites in the blood-stream and then administer anti-malarial treatment (Riamet) at D28. We will also be assessing the safety of the inoculum and the way the immune system responds to it. Determining the safety, persistence and immunogenicity of the Tafuramycin-A attenuated purified malaria parasites is important as they form the basis of a novel malaria vaccine approach.

  • Pilot testing of a decision aid for nutrition support in paediatric oncology.

    The primary purpose of this study is to investigate the acceptability, usability and comprehensibility of a decision aid which aims to help parents make a decision about nutrition support to treat malnutrition during their child's cancer treatment. Who is it for? You may be eligible to participate in this study if you are the parent, carer or clinician of a child who has been diagnosed with cancer or a haematological condition at the Kids Cancer Centre at Sydney Children's Hospital, and have had to consider nutrition support in the past five years. Study details: All participants recruited in this study will be asked to read the decision aid and then complete a questionnaire regarding its acceptability, usability and comprehensibility. It is hoped that the findings of this pilot study may be used to support the implementation of the decision aid to inform parents and carers facing choices regarding their children's nutrition support during cancer treatment.

  • The Effects of Probiotics on Depression: Can a Daily Drink of Good Bacteria Improve Mental Wellbeing?

    Whilst CBT has been validated as an effective psychological treatment for depression, efficacy rates of treatment still indicate the need for improvement. Emerging evidence indicates that the relationship between the gut and the brain can be harnessed, so that changes in gastrointestinal health can have positive or negative effects on mental health, and vice versa. This trial investigates whether administration of a probiotic is effective in reducing levels of depression in a population of depressed adults. Participants will consume the probiotic daily, and provide measures of mood throughout the study period. We will measure baseline and post-intervention levels of depressive symptoms, and compare changes in levels of depression between a group provided with the probiotic, and a control group given a placebo.

  • Are early somatosensory abnormalities after back pain a biomarker for chronic pain?

    Low back pain (LBP) is a highly prevalent health condition affecting up to 80% of individuals at some point in life. It is acknowledged that abnormal clinical findings, such as structural alterations of the spine found from imaging, poorly correlate with clinical status. Further, current prediction models that take into account psychological, demographical and physical factors explain only a small proportion of the variance in clinical outcomes. In recent years, evidence has accumulated that abnormal somatosensory processing occurs in people with chronic LBP. Psychophysical studies have commonly found pain hypersensitivity to various sensory stimuli in people with chronic LBP compared with healthy controls, not only at the back, but also at non-painful remote sites (e.g. at the hand). These changes in pain sensitivity in areas remote from the low back implicate abnormal central mechanisms. At present, it is not yet established to what extent these sensory alterations contribute to the generation and maintenance of LBP. Also, the temporal aspects of these changes are unknown. However, recent research has shown that somatosensory abnormalities can be detected early (i.e. within 4 weeks) after the onset of LBP. These include augmented spinal cord excitability as well as pressure pain hypersensitivity. Further, longitudinal studies in acute whiplash injury cohorts have shown that widespread pain hypersensitivity persisted only in subjects who did not recover at 6 months. Cold pain threshold was found the sensory parameter that most significantly predicted non-recovery at 6 months. The primary aim of this study is to investigate whether psychophysical measures of pain sensitivity contribute to predicting non-recovery in low back pain and to evaluate the time course of somatosensory changes from the onset of low back pain to 4 months.

  • Patient preferences for receiving an early intervention after critical illness to improve psychological recovery

    Survivors of critical illness experience significant physical, psychological and cognitive compromise during recovery. ICU diaries have been proposed as one intervention that may be effective in helping survivors recover psychological function. Despite support by some members of the intensive care community, there is a lack of empirical work investigating diaries and subsequent concern regarding the potential harm of such an intervention exists. This study is designed to determine feasibility of two proposed psychological interventions for survivors of critical illness: (1) the use of ICU diaries and (2) the provision of an individualised summary of the ICU experience prepared by ICU staff and based on the User Centred Critical Care Discharge Information. The effect size of each psychological intervention to reduce psychological compromise (anxiety, depression, posttraumatic stress symptomatology) will also be determined to inform sample size calculations for a larger efficacy randomised control trial. Other aims of this pilot study are to determine the feasibility of early screening for psychological health for survivors of critical illness, and to validate the Intensive Care Psychological Assessment Tool (IPAT) against recognised depression and anxiety screening instruments in an Australian ICU population.

  • ‘Mindfulness Acceptance Commitment (MAC) for Performance Enhancement’ with a Motivational Interviewing Framework: A RCT for Para Athletes, their Well-being and Performance

    This randomised controlled trial will compare the effect of an 8-week well-being and performance enhancement program with a wait-list control group for Australian Para athletes with a physical impairments who are competing at a national level or above and aged 18 years and over. Athletes will be asked to complete electronic questionnaires and semi-structured interviews in addition to completing the well-being program.

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