ANZCTR search results

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

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31380 results sorted by trial registration date.
  • Breaking up prolonged sitting with intermittent standing: acute effects in overweight inactive adults.

    It is well known that being physically active is important for maintaining good health. However, new evidence has emerged showing that being sedentary (sitting for prolonged periods) is adversely associated with indicators of poor health, such as elevated blood glucose and blood fats. Recent experimental evidence suggests that breaking up sitting time throughout the day with light-intensity activity (ie. walking) results in lower blood glucose and blood fat levels than sitting for prolonged periods without activity breaks. However, it is not known whether short-duration bouts of standing, of comparable frequency, can elicit similar metabolic benefits to those observed with treadmill walking. Consequently, this study aims to test the acute (7-hour) effect of prolonged sitting on glucose metabolism and vascular function with and without intermittent breaks of standing.

  • Heart function in women with preeclampsia after treatment

    The purpose of this study is to determine heart function in pregnant women after they are treated for the disease of preeclampsia. The reason to do this is that the drug treatments that are used to control the high blood pressure in this disease have not been examined with respect to how they alter heart function in these sick pregnant women.

  • Metformin in overweight adults with type 1 diabetes mellitus

    Metformin is a first line drug treatment in overweight patients with type 2 diabetes mellitus and has been used for decades in the treatment of these patients. People with type 2 diabetes mellitus can produce some insulin (which is different from patients with type 1 diabetes who need insulin to survive), but the body tissues are resistant to insulin leading to high blood glucose (sugar) because glucose in the blood is not absorbed. Many people with type 1 diabetes mellitus also have insulin resistance and in addition the insulin therapy that they need to survive often leads to weight gain. Metformin works by decreasing blood glucose (sugar) levels by increasing insulin sensitivity in muscle cells, decreasing glucose production in the liver and delaying glucose uptake from the guts. Metformin also have beneficial effects on weight management and risk of stroke and heart attacks in people type 2 diabetes mellitus. Some studies have found evidence that metformin added to insulin therapy in type 1 diabetes mellitus leads to weight loss and reduced requirement for insulin, but the results are not conclusive. We are conducting this trial to investigate if metformin is useful as an addition to insulin therapy to lose weight, improve glucose control, reduce insulin dose requirement and improve blood lipids in people with type 1 diabetes mellitus.

  • The effect of foot massage on long-term care staff stress levels, anxiety, mood state, somatic symptoms and experiences of working with people with dementia

    This study has the primary aim of comparing the effect of foot massage versus a control activity of silent resting on perceived stress levels of care staff caring for people with dementia in long-term care. A secondary aim is to explore the effects on participants’: physiological indicators of stress, including blood pressure (BP), heart rate (HR) and temperature (T); anxiety levels; mood state; somatic symptoms; and experiences of working with people with dementia.

  • The effect of foot massage on agitation in people with dementia living in residential care.

    Behavioural changes including agitation occur to a significant degree in up to 90% of people with dementia. This experimental, within-subjects, crossover design study with nursing home residents aims to compare the effects of foot massage and quiet presence on agitated behaviours in people living with moderate to severe dementia in residental care settings.

  • An absolute bioavailability, safety and tolerability study of BMS-936557 following subcutaneous administration compared to intravenous administration in healthy subjects.

    The purpose of this study is to assess the bioavailability, safety and tolerability of study drug BMS-929075 using blood samples and safety assessments following either a SC injection compared to IV administration of BMS- in healthy subjects.

  • Is amitriptyline cream effective in the management of vestibulodynia - a condition which refers to pain at the opening of the vagina?

    The aim of this project is to evaluate whether amitriptyline 5% cream is an effective treatment for a condition known as “vestibulodynia”, which refers to pain at the opening of the vagina. Pain is felt when any pressure is applied to this area.

  • Dietary Fats and Biomarkers of Human Health: Excess Saturated Fat or Lack of Omega 3 Fatty Acids

    Consumption of foods rich in saturated fats have been associated with elevated blood lipid levels and adverse health effects. However studies using animal models have demonstrated that dietary saturated fats raise blood lipid (cholesterol and triglyceride) levels only when the diet is low/deficient in omega-3 fatty acids. If the same is true for humans, this research will have important implications for the prevention of cardiovascular and other chronic diseases. Therefore we hypothesise that saturated fat consumption does not raise blood lipid levels if the diet is sufficient in omega-3 polyunsaturated fatty acids. We also hypothesise that the benefits of n-3 PUFA can be optimised when consumed in combination with saturated fats. This is a randomized controlled trial in cross-over design. It involves intervention with a single dose of dietary regimen, after an overnight fast, followed by collection of 5 blood samples at 0, 3, 4, 5 and 6 hours following meal consumption. Participants will be randomised to one of two diets, high saturated fat or high omega-6 polyunsaturated fatty acids. They will be given a portion of mashed potatoes containing either butter (saturated fat) or vegetable oil (omega-6) and 3 capsules of fish oil. After a week period the participants will come back and repeat the procedure receiving the alternative diets. They will also be asked to fill a medical and physical activity questionnaire and a 24 hour food diary in each visit.

  • Safety of RAPid INJECTion of Undiluted Ferric Carboxymaltose to Patients with Iron Deficiency Anaemia (RAPINJECT)

    Iron deficiency anaemia remains an important clinical problem. Although oral iron is usually an adequate treatment, intravenous iron is often indicated. However, currently available agents available for total dose intravenous iron replacement require prolonged administration with admission to day wards or hospital beds, consuming considerable staff and patient time and health care resources. Ferric carboxymaltose, a novel iron-carbohydrate, has been extensively trialed and has been approved by the TGA for administration of up to 1000mg of iron (diluted in saline) intravenously over 15 minutes. This promises to greatly accelerate the treatment of iron deficiency anaemia. However, preliminary data suggest that high doses of undiluted ferric carboxymaltose may be safely administered even more quickly, by rapid bolus injection. Such an approach could revolutionize the treatment of iron deficiency as patients could receive total dose iron replacement in the clinic, without requiring a hospital bed or pharmacy. We propose a three stage, single arm study two determine the safety of rapid infusion of ferric carboxymaltose at doses of up to 1000mg. We plan to recruit patients with iron deficiency anaemia presenting to Southern Health into this three stage study. In Stage 1, 30 patients will be administered iron carboxymaltose as per the TGA approved approach (up to 1000mg diluted in saline and administered over 15 minutes). Subsequently, in Stage 2, 12 patients will be assigned to a dose escalation study to identify any dose limiting toxicities associated with rapid infusion. Finally, in Stage 3, 100 subjects will be administered a total dose (based on calculated iron deficit up to 1000mg, maximum dose of 20mg/kg) of ferric carboxymaltose. The primary outcome of the study is the incidence of adverse events related to rapid infusion.

  • Study of the Drug BTD-001 in Young Adults and Adolescents with Down Syndrome

    BTD-001, has been used for several decades around the world as a treatment for dementia, a respiratory stimulant and as an ingredient of a cough medication. Studies in a mouse model of Down syndrome (DS) (Ts65Dn transgenic mouse) have demonstrated that chronic administration of the product improved cognition on a number of behavioural assessments. These improvements were sustained months after discontinuation of drug administration, indicating that BTD-001 may cause long-lasting synaptic changes supporting improved cognition. These data indicate that BTD-001, may improve function and cognition in persons with DS and has the potential to improve educational and quality of life outcomes for this population.

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