ANZCTR search results

The main aim is to find out if targeted strength training for the lower limbs can improve walking ability of adolescents and young adults with cerebral palsy (CP). CP is the most common cause of childhood disability in Australia. Difficulty with walking is the major issue affecting the independence of many young people with CP. Preliminary data suggests that strengthening weak muscles of young people with CP can improve functional activities like walking. In addition, pilot data indicates that strength training works best for adolescents and young adults with CP after other managements like surgery and rehabilitation have been completed.A randomised controlled trial will compare strength training against a control group receiving usual care.This will be the first fully powered randomised controlled trial to find out if strength training can help the walking ability of young people with CP, the major issue affecting their independence. If successful strength training could be an important treatment option for young people with CP as they make the transition to adulthood and sustained independence.

The goal of this Phase 1 vaccine trial is to demonstrate safety and immunogenicity of MSP2-C1/ISA720 malaria vaccine in healthy adult human volunteers. The World Health Organisation reported in 2005 that malaria kills more than 1 million people annually and that approximately 3.2 million people living in 107 countries or territories are at risk of infection [1]. Most of the malaria mortality occurs in sub Saharan Africa and in children under 5 years of age. Of the four species of malaria parasite that infect humans, Plasmodium falciparum is responsible for the majority of these deaths. Mounting drug resistance of the malaria parasite, as well as widespread resistance of mosquitoes to insecticides, make these control strategies increasingly unrealistic. A vaccine that would reduce both mortality and morbidity secondary to P. falciparum infection would be a valuable resource in the fight against this disease.

Preeclampsia, spontaneous preterm birth and birth of a small for gestational age (growth restricted) baby are the three major complications of late pregnancy, affecting approximately 19% of first pregnancies. They are a leading cause of maternal morbidity, perinatal morbidity and mortality, neuro-developmental handicap and lifelong health consequences. There are a number of clinical risk factors and biomarkers for these diseases, but currently there are no predictive tests for these conditions. Although no single clinical risk factor or biomarker is a useful predictor, novel combinations of clinical risk factors and/or biomarkers are likely to perform as reliable screening tests for these conditions. The primary aim of SCOPE is to produce clinically useful screening tests based on 1) clinical risk factors, 2) biomarkers and 3) a combination of clinical risk factors and biomarkers to detect first time mothers at high risk of preeclampsia, spontaneous preterm birth and/or small for gestational age babies. If successful, this will allow individualised tailoring of antenatal care for future first time mothers and where appropriate, intervention to prevent these conditions. This will empower women and their clinicians to make informed decisions about their care in pregnancy, thereby optimizing the health of mothers and babies. The first generation of predictive tests based on clinical risk factors and biomarkers alone or in combination with clinical risk factors will be developed in the first 2500 women recruited into SCOPE. The total sample size for further testing and validation is estimated at 10,000.

Procedural sedation is frequently used in Emergency Departments (ED) for orthopaedic reductions, cardioversions and other painful but brief procedures. Various pharmacologic agents have been used, including nitrous oxide, ketamine, propofol and combinations of benzodiazepine and opioid. Propofol, a potent, short-acting sedative agent, has gained widespread popularity and has been shown to be safe for procedural sedation in the ED. The advantages of propofol include rapid onset, short duration of action, antiemetic effect and high degree of patient satisfaction. Potential disadvantages include deep sedation, apnoea and hypotension. Patient controlled sedation (PCS) has been investigated for more than 20 years, primarily for minor procedures in the operating theatre, such as colonoscopy and dental extractions. The potential advantage of the PCS technique is that the patient is able to match their sedation requirement with the noxious stimuli and titrate themselves to an appropriate level of sedation without the risk of over-sedation. A second potential advantage of PCS is the psychological benefit it confers on its user with a sense of control over a stressful and painful procedure. Little data has been published on the use of PCS in the ED setting. The objective of this study is to investigate the efficacy of using propofol in a standard patient-controlled infusion pump for procedural sedation in the ED.

E5555 is a small molecule that inhibits activation of protease-activated receptor 1 (PAR-1), the main thrombin receptor on platelets, preventing platelet aggregation (which is essential to clot formation); preventing platelet activation and release of inflammatory substances locally and into the bloodstream; reducing generation of more thrombin. These actions suggest that it may be a useful adjunct to current therapy for Acute Coronary Syndrome (ACS) and not a replacement for any currently established forms of treatment for Acute Coronary Syndrome (ACS). This study will look at the safety and efficacy of E5555 in patients admitted to hospital with symptoms, and objective evidence, of acute coronary syndrome, for a period of 12 weeks. There will also be a further visit 4 weeks after the last intake of study drug. The entire study participation will be 16 weeks. The patients would be seen initially on a daily basis during the hospitalisaiton period, and once discharged, asked to attend clinic for a total of 5 visits over the outpatient phase of the study. Visits will be between 2 and 4 weeks apart. The type of assessments at each visit are what would be typically undergone by cardiac patients - physical examinations; blood pressure, pulse, temperature, electrocardiongrams (up to 11 in total); blood draws (8 in total) and regular intake of study medication (three tables taken once a day with breakfast). Continuous electrocardiogram (ECG) monitoring (Holter monitoring) will also be done for the first 48 hours following randomisation. Any adverse events will be recorded, as will details of concurrent medication. There is a sub-study being undertaken by selected sites, and participation in this will be optional for the patients. This sub-study would entail additional blood samples being taken for pharmacokinetics (PK) and platelet aggregation purposes

The primary objective of this trial is to assess whether long term consumption of black tea results in increased endothelium-dependent flow-mediated dilatation of the brachial artery and a decreased 24-hour ambulatory blood pressure. Efeects on other cardiovascular disease-related measurements will also be assessed.

Phase 3 This study looks at cognitive (mental) function among premenopausal women with hormone-responsive breast cancer participating in SOFT (ACTRN12605000416695). Who is it for? You can join this study if you are participating in the SOFT trial and you have not yet started (or previously received) hormone treatment. Trial details Testing will measure and compare cognitive function among women in different treatment groups in the SOFT trial. Cognitive function will be measured using a set of computerised card memory games.

E5555 is a small molecule that inhibits activation of PAR-1, the main thrombin receptor on platelets, preventing platelet aggregation (which is essential to clot formation); preventing platelet activation and release of inflammatory substances locally and into the bloodstream; reducing generation of more thrombin. These actions suggest that it may be a useful adjunct to current therapy for CAD and not a replacement for any currently established forms of treatment for CAD. This study will look at the safety and tolerability of E5555 in CAD patients for a period of 24 weeks. There will also be a further visit 4 weeks after the last intake of study drug. The entire study participation will be up to 31 weeks, to allow for a maximum 3 weeks screening period. The patient would be asked to attend clinic for a total of 11 visits over the course of the study, with visits being between 1 and 4 weeks apart. The type of assessments at each visit are what would be typically undergone by cardiac patients - physical examinations; blood pressure, pulse, temperature, ECGs (up to 11 in total); blood tests (up to 11 in total) and regular intake of study medication (three tablets taken once a day with breakfast). Any adverse events will be recorded, as will details of concurrent medication. There is a sub-study being undertaken by selected sites, and participation in this will be optional for the patients. This sub-study would entail 3 additional visits and several additional blood samples being taken for pharmacokinetic and pharmacodynamic purposes.

The primary purpose of this study is to determine the prevalence of diabetes in subjects on long-term glucocorticoid (steroid) therapy and the best way to diagnose diabetes in this patient group.

This study will measure the activity of the unborn baby during pregnancy, looking at the number of times s/he moves and how simple or complex the movements are. We expect that the unborn baby who is not getting enough nutrition during pregnancy will have fewer movements than other unborn babies. Once we have this information, we will be able to use it in the future to possibly prevent poor outcomes in those babies who do need help.