ANZCTR search results

The trial is a trial comparing two modes of mechanical weaning in patients in ICU who are eligible for weaning from mechanical ventilation

This is a pilot study of safety and infectivity in 2 healthy volunteers of a new Plasmodium vivax Malaria bank obtained from a malaria infected patient under HREC approval from both Royal Brisbane and Women’s Hospital and Queensland Institute of Medical Research. The Malaria bank was prepared under highly controlled conditions using protocols developed in conjunction with the Red Cross the US FDA and QGen. The clinical protocol is based on prior studies using the 3D7 Plasmodium falciparum isolate. The malaria bank has had full serological and PCR evaluations over 6 months meeting the criteria of ARCBS blood donation requirements. The antimalarial agent used to treat the malaria is the TGA approved Riamet, which was also used to eradicated the malaria infection in the patient donor.

Pregnancy is associated with major physiological changes that affect coagulation and fibrinolytic system. An imbalance to this system leads to a hypercoaguable state and pregnant women are therefore at an increased risk of venous thromboembolic disease (VTE), especially if they are affected by an associated acquired or inherited thrombophilia. There are two factors that may exaggerate this risk; the high-risk nature of the thrombophilia and a history of a previous unprovoked VTE. High-risk hereditary thrombophilia include antithrombin deficiency, prothrombin gene mutation (PGM), and factor V leiden (FVL), while the presence of lupus anticoagulant or anticardiolipin antibodies are considered as acquired risk factors. Furthermore, homozygosity or presence of a combination of thrombophilia factors will aggravate the VTE-risk by certain fold increase. Apart from the occurrence of VTE, maternal thrombophilia has also been variably associated with an increased risk of early miscarriages, intrauterine growth restriction (IUGR), and pregnancy loss. Although it may seem intuitive to treat pregnant women with high-risk thrombophilia with anticoagulant prophylactically, there is a paucity of randomised trials in this area, and the balance of intervention versus conservative management should be carefully evaluated from both fetal and maternal point of view. Evidence-based guidelines have been published in an attempt to provide a more uniform clinical approach; however there appears to be a lack of consistency among different guidelines. The decision to recommend anticoagulant prophylaxis to women with thrombophilia is based on the risk-assessment or balance of bleeding versus VTE-risk as well as the potential effects of VTE and anticoagulant can have on pregnancy. However, the use of anticoagulant in pregnancy is challenging because of the potential for maternal and fetal complications. Despite this and the lack of controlled trials, there has been increased use of anticoagulants to prevent VTE and adverse pregnancy outcomes. In this retrospective/prospective study, the management strategies of women with high risk for thrombophilia who received antenatal care at a single institution during the period between Jan 2007 and December 2010 were reviewed and analysed.

The study is a double-blind trial to evaluate the safety and efficacy of RT001 compared to placebo in subjects with allergic rhinitis who test positive to rye grass. Previously reported studies conducted with a similar compound have shown reduction of the typical symptoms of seasonal allergy.

NAFLD is a common liver disease associated with obesity and insulin resistance. There is no drug therapy and while there is general consensus that lifestyle intervention is effective at reducing steatosis our understanding of the distinct roles of diet and exercise on liver injury remains unclear. This study assesses the histological and metabolic effects of 6 months circuit exercise training compared with diet-induced weight loss in overweight patients with NAFLD.

The proposed project will investigate whether a methionine restricted diet is a feasible nutritional regimen for healthy ageing in a healthy population. This project will consist of 2 diets: a methionine restricted diet and a standard western diet. As methionine content tends to be higher in flesh foods, the methionine restricted diet will be predominantly plant based. The proposed project will utilise a randomised cross-over design so that each volunteer consumes both diets. Healthy volunteers (n=20) with no history of cancer will be recruited. The proposed project will measure the effect of a methionine restricted diet on biomarkers of health and ageing. Blood will be collected from the volunteers at specific time points and analysed for biomarkers of ageing; lymphocytes will be isolated to measure genome integrity and serum will be utilised in vitro to determine rate of growth of established cancer cell lines.

Postnatal growth restriction, or faltering growth, is almost universal in extremely low birthweight (ELBW) babies. This is largely due to inadequate nutrition, as it is very difficult to maintain nutritional intake in the smallest babies, particularly in the first week after birth. ELBW babies are also at risk of adverse neurodevelopmental outcomes, likely also due, in part, to inadequate nutrition. We have shown that increasing protein intakes in early life prevents faltering growth. We now propose to determine whether increased protein intake in early life in ELBW babies improves neurodevelopmental outcomes through a multicentre, double-blind randomised placebo-controlled trial. The findings of this trial will be of relevance to the management of all preterm babies because the intervention is simple and cheap.

Mindfulness has been shown to be effective in treating fatigue and mood problems in people with MS. At the same time, there is evidence that training in mindfulness meditation can improve brain function - specifically increasing the volume of the hippocampus - in healthy people. MS is characterised by hippocampal loss early in the progression of the disease. This research project asks whether mindfulness could potentially protect against hippocampal loss in people with multiple sclerosis.

Participants: 110 HIV positive patients who are currently taking anti-HIV medications, have well controlled HIV and are at moderate risk for heart disease (and thus do not currently qualify for statin therapy) will be recruited from the Infectious Diseases Clinic of the Alfred Hospital. Methods: Participants will be randomised to receive either the active agent (Rosuvastatin) or a placebo once daily for 96 weeks. Rosuvastatin is a statin licensed for use in Australia to control high cholesterol levels and prevent heart disease in patients at high risk. Participants will undergo blood tests and ultrasounds of the arteries of the neck prior to starting Rosuvastatin and then after 1 and 2 years on the drug to determine what effect it has on markers of inflammation, cholesterol levels and thickness of blood vessels (which relates to damage of blood vessels supplying the heart and thus the risk of heart attacks) Analysis: The main outcome will be to compare the rate at which blood vessels thicken in the participants receiving rosuvastatin compared with those receiving placebo. We will also compare the amount of inflammation (based on blood tests) in each group and the presence of any side effects. Significance By showing that there are advantages to starting statin therapy earlier then currently recommended in people with HIV infection it may be possible to reverse some of the increased risks of heart attacks and strokes seen in these patients.

A Single Exposure Trial to Evaluate the Dose Duration Response of Mometasone Furoate Cream and Vasoconstrictive Activity of MK0887G Topically applied to the skin of Healthy Subjects MK0887G (fixed dose cream) is being developed for the treatment of infected dermatoses. However, this study is in healthy volunteers only.