ANZCTR search results

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.

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.

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.

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.

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.

For many years health professionals have recommended ‘slow and steady’ weight loss. Recently however an increasing number of health professionals have begun prescribing very low energy diets (VLEDs) for the management of excess body weight. VLEDs can induce fast weight losses of approximately 0.5 to 2 kilos per week, which some people find motivating. Moreover, some people report not feeling hungry while on a VLED. While VLEDs are known to be safe and effective in the short-term, the long-term consequences are unknown. There is some concern that compared to slower weight loss, VLEDs may increase the likelihood of weight regain, particularly in the abdominal region, and this could increase the risk of cardiovascular disease. Additionally, VLEDs may cause greater losses of muscle mass, muscle strength and bone density compared to slower ‘conventional diets’, but this has never been tested. This study will demonstrate whether or not there are any differences between VLED and conventional diet with respect to effects on body fat content and distribution, muscle mass, muscle strength or bone density for up to 3 years after commencement of either diet.

This is a study of the effects of a corticosteroid (dexamethasone) on sleep quality in patients with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of cancer. You should be on a stable dose of corticosteroid for the previous 48 hours for any indication, and likely to remain on a stable dose of corticosteroids for the next 10 days. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take their usual dose of dexamethasone in the morning and a placebo (sham tablet) at night for five days, and then switch the order for the next five days (i.e. placebo in the morning and dexamethasone at night). Participants in the other group will complete this treatment in reverse order. Only the pharmacist will know which drugs are being taken when. Participants will be asked to complete a sleep questionnaire each morning in order to assess the effect of the timing of dexamethasone on sleep quality.

To evaluate in a free-living setting the digestive health of 8 to 12 year old children and the impact a high fibre breakfast cereal has on their digestive health.

This study aims to provide patients receiving enteral nutrition with a lower or higher FODMAP formula and monitor the proportion of patients that develop diarrhoea. We hypothesise that the lower FODMAP formula will prevent the development of diarrhoea.

Consumption of foods and beverages rich in nitrate can increase circulating nitrite and nitric oxide, improve endothelial function and lower blood pressure acutely. Effects of dietary nitrate on arterial stiffness have yet to be explored. We aim to assess the acute effects of a single meal containing nitrate-rich spinach on arterial stiffness in healthy men and women. Effects on blood pressure will also be assessed.