ANZCTR search results

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

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31198 results sorted by trial registration date.
  • An open-label, parallel-group Phase I study to assess safety, tolerability, and pharmacokinetics of single doses of EU-C-001 administered with an apomorphine challenge, or when 90 mg EU-C-001 are administered alone twice (two times) a day (BID) for 7 doses in 12-hour intervals

    This is a phase 1 study in healthy subjects. It is planned to develop the drug for reducing pressure in the brain of patients with a traumatic brain injury (TBI). Increased pressure following TBI can lead to death or can cause permanent disability. There are currently no medications that are approved for improving outcomes after TBI. The drug will also be tested for improving clinical outcome in patients that suffered a concussion. The study drug being evaluated is called EU-C-001 and is being developed by an Australian company called PresSura Neuro. Studies in animals have shown that EU-C-001 may reduce pressure in the brain. Therefore, it is thought that EU-C-001 may improve outcomes in patients with TBI by increasing the amount of oxygen available to brain tissue. In other studies it was shown that the EU-C-001 may also have potential to improve outcomes in patients with concussion. This is the first in-man study planned to assess the pharmacodynamic potency as well as safety and tolerability and pharmacokinetics in man after a single intravenous administration when given together with apomorphine. The ability of EU-C-001 to penetrate the human brain is an important prerequisite for efficacy in its core indications. The inhibition of apomorphine-induced emesis will be used in this study as proof of receptor occupancy and EU-C-001 brain penetrance.

  • VegEze: A mobile phone app to increase vegetable consumption.

    Australians are not eating enough vegetables. The CSIRO Healthy Diet Score survey has found that reported to ‘always’ consume 3 different types of vegetables at their evening meal were twice as likely to meet their daily requirements. An explosion of health promoting mobile apps has occurred in recent years including healthy eating ones. However, most mobile apps are not scientifically developed and have yet to undergo rigorous evaluation. Therefore, this research aims to develop and test the useability and effectiveness of a mobile App to increase the variety and amount of vegetables participants consume. Aims / Objectives: The overarching aim is to develop a highly engaging mobile App which motivates adults to increase the variety of vegetables they consume at their main/evening meal to at least 3 different types, as impetus to increase their total variety and the total amount of vegetables they usually consume.

  • Nocturnal blood glucose responses to potato-based mixed evening meals

    The purpose of the present study is to investigate the impact of potato consumption on postprandial and nocturnal glycemic response and postprandial insulin response when consumed as balanced mixed meal in a real-word setting in individuals with T2DM. Additionally, different cooking methods of potatoes will be explored (baked, boiled and boiled then cooled) and compared to brown rice of equal carbohydrate content (control). We hypothesize ingestion of potato as part of a mixed evening meal will not result in any greater postprandial or nocturnal glycemic response or postprandial insulin response to an isoenergetic, macronutrient-matched control test meal due to the diurnal fluctuations in glucose regulation. Additionally, we hypothesize pre-cooking then cooling potato before consumption will lower the postprandial glycemic response of potato as part of a mixed evening meal.

  • Improving Engagement in Patients with Young Adult Onset Type 2 Diabetes (Text2U)

    Young adult onset type 2 diabetes (YT2DM) is an aggressive condition with a rapid progression to diabetes complications. Expert bodies have recommended that YT2DM patients be reviewed every three to six months for assessment of blood glucose control and cardiovascular risk factors. Significant barriers have been identified in the delivery of care for YT2DM patients. The Australian Centre for Behavioural Research in Diabetes has recommended increased support from health care providers and greater engagement in self-care which does not place a significant extra burden on YT2DM patients. A previous survey of our clinic population revealed a high level of mobile phone ownership. Consequently, implementation of an SMS-based intervention to facilitate engagement in the YT2DM cohort would appear to be an ideal strategy to trial. It is hypothesized that by improving engagement in the YT2DM cohort (through a personalised and supportive SMS program), attendance at clinical follow up appointments will improve. This will facilitate an improved approach to diabetes management and the development of a therapeutic relationship between patients and their health care team.

  • Evaluating the feasibility of an exercise program for people with severe mental illness living within a rehabilitation unit.

    People with severe mental illness are sedentary, have high cardio-metabolic risks and reduced life expectancy. Despite evidence regarding positive physical and mental health outcomes following exercise interventions, evaluation of real-world programs is lacking. The aim was to evaluate the feasibility of an exercise intervention implemented by exercise physiology students within a residential rehabilitation unit for people with severe mental illness. Exercise physiology students implemented a supervised group exercise program for people with severe mental illness. It occurred three times per week, for 10 weeks, on site, at a mental health residential rehabilitation unit, Outcomes were measured pre and post the intervention. Participants in the study were residents of the rehabilitation unit, with a primary diagnosis of schizophrenia. Primary outcomes were the feasibility of the exercise program (recruitment, completion, participation and adverse events). Secondary outcomes included a range of other physical and mental health outcomes assessed pre and post the 10 week exercise intervention.

  • Assessing the efficacy of a stepped care treatment program for Borderline Personality Disorder

    People meeting the criteria for Borderline Personality Disorder have a variety of mental health and psychosocial difficulties. The disorder can have a significant burden on the person's partner and family and can lead to high costs to health services if left untreated.. Approximately 10% of clients with Borderline Personality Disorder die by suicide. Costs to the health service include a high number of emergency department presentations and hospital beds occupied by people with this condition. Psychological therapy is the mainstay of treatment of borderline personality disorder; However, the demand for psychological treatment has resulted in excessive waitlists for a high risk cohort. This study aims to investigate the effectiveness of a stepped care group program compared to tailored individual care.

  • Acceptability and safety of a fact sheet for cognition in young people with depression.

    Peak onset for depression occurs during adolescence and young adulthood, with one in five young people experiencing a clinical depressive episode by the age of 18. Both objective and subjective cognitive difficulties such as poor concentration and memory are features of depression in young people. Cognitive difficulties in depression contribute to everyday functioning difficulties. Managing cognitive issues is therefore an important part of treatment. One potentially useful method of providing information on, and strategies for management of cognitive difficulties, is through fact sheet provision during routine clinical care. Nevertheless, it is currently unclear whether fact sheets are an acceptable and safe method of providing information about cognition to young people with depression, or whether this has the potential to be useful for increasing awareness and self-management strategies. The aim of this study is to investigate the acceptability, safety and potential effectiveness of a cognition fact sheet for young people receiving treatment for depression. If found to be acceptable, safe and potentially useful, the utility of a fact sheet could be further explored in a larger trial with a controlled comparison group.

  • Assessing motor and cognitive function pre and post propofol only anaesthesia for endoscopic procedures.

    There has been an increase in the number of discharges against medical advice for endoscopic procedures in recent times and given this, patients could be at significant risk when discharging unsupervised from the clinical environment. As many patients now receive propofol as the sole agent for sedational anaesthesia for endoscopic procedures, we decided to conduct a study that assesses the cognitive and motor function of patients before and after propofol only anaesthesia in this clinical setting. We did this by using two computer tests called the SART and SOPT, which are validated to a BAL of 0.05 and were completed by patients prior to and again one hour after their procedure. We also conduced the same battery of tests on volunteers not receiving propofol to assess for any learning bias obtained by participants completing the test at one hour intervals. From this study, we aim to determine the level of cognitive impairment 1 hour post propofol only anaesthesia for endoscopic procedures, if any, which may help with discharge planning for patients in the future.

  • MATCH - Myocardial de-Airing and Tissue preservation using carbon dioxide (CO2) with Humidification in patients undergoing open-chamber cardiac surgery

    During open-heart surgery, gaseous micro-emboli (small gas bubbles) are commonly seen in the heart and bloodstream. This is thought to be associated with post-operative cognitive decline. To minimize this, it is common practice to insufflate the heart cavity with dry carbon dioxide (CO2) via a small tube. It is believed that CO2 causes less gaseous micro-emboli because it is denser and more soluble than air. However, dry and cold CO2 insufflation can cause tissue damage. A more sophisticated device, called the HumiGardTM system, is currently available in the market. It allows a continuous flow of warm and humidified CO2 to be insufflated via a gas diffuser into the heart cavity. In this study, we would like to test if warm and humidified CO2 will reduce the amount of tissue damage and also the number of micro-emboli travelling within the heart and to the brain, when compared to dry and cold CO2 insufflation.

  • Microbiome Understanding in Maternity Study. A comprehensive assessment of its composition and relationship to health and disease throughout pregnancy and infancy.

    The human microbiome is known to have a major impact on human health. Pregnancy is a unique state where enormous hormonal, metabolic, immune and cardiovascular changes occur. We will assess the changes occurring in the microbiome in association to dietary changes at stages throughout this critical period of a mother and child’s life in response to these changes. Samples of the microbiome during pregnancy (faecal, oral, and vaginal) and after birth (placental, breastmilk, meconium) will be assessed to determine a link between pregnancy outcome and disease. We will study each participant during her pregnancy and for 1 year post partum.

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