ANZCTR search results

This study is a 6-week, naturalistic open-label evaluation of the efficacy and tolerability of ziprasidone hydrochloride (20mg/day to 80mg/day), in combination with an antidepressant in the treatment of patients with major depressive disorder (MDD), and aims to assess the antidepressant effect of ziprasidone in conjunction with an antidepressant in treating patients who have shown an incomplete or partial response an antidepressant alone.

FAVOURED is a multicentre, randomised controlled trial design. The objectives of this trial are to determine whether the use of the omega-3 fatty acids and to a lesser extent, aspirin, will effectively improve postsurgical outcomes for patients with de novo arterio-venous fistulae (AVF). The study population are patients with stage IV or V chronic kidney disease who require or will require haemodialysis and who are scheduled to undergo creation of an AVF. The primary outcome is AVF Access Failure, which is a composite of Thrombosis, AVF Abandonment, and Cannulation Failure during the Cannulation Assessment Period. Secondary outcomes include AVF access failure according to strata of aspirin use, safety and adverse events of omega-3 fatty acids and aspirin alone or in combination, catheter use, and rescue interventions.

Study Title An open label, phase IV clinical trial examining the efficacy of Prothrombinex alone versus Prothrombinex combined with fresh frozen plasma in patients who require Warfarin reversal Trial Objectives The primary aim of this study is to determine whether Prothrombinex alone is adequate and effective in the reversal of the anticoagulant activity of Warfarin. Number of patients 40 Inclusion Criteria 1. Patients who are on Warfarin therapy with an asymptomatic INR >9 where the treating clinician wishes to reverse the effects of the drug 2. Any clinically significant bleeding where Warfarin induced coagulopathy is considered a contributing factor and an INR of >2.5 where Warfarin reversal is considered important by the clinician 3. Pre surgery if INR >2.5 on the day of surgery and the clinician requires reversal of the effects of Warfarin 4. Patient is = 18 years of age. 5. Patients that are able to understand and apply with study protocol requirements and instructions and intends to complete the study as planned.6. Patient signs and dates written informed consent. Exclusion Criteria 1. Active bleeding requiring blood transfusion. 2. Patients with a known allergy to prothrombin complex concentrates or fresh frozen plasma. 3. Participation in another pharmacotherapeutic study within 30 days. Objective criteria for study entry 1. Asymptomatic INR > 9 where there is a high risk of bleeding 2. Any clinically significant bleeding where Warfarin induced coagulopathy is considered a contributing factor and an INR >2.5 where Warfarin reversal is considered important by the clinician 3. Pre surgery if INR > 2.5 on day of surgery and the clinician requires reversal of the effects of Warfarin Outcomes The primary outcome is the rapid reversal of Warfarin as indicated by the correction of the INR to < 2. Safety outcomes: Allergic reaction to Prothrombinex, the development of a complicating thrombosis (venous or arterial) and the presentation of clinically overt bleeding

This project aims to determine the dose-response effect of low doses of long chain omega-3 polyunsaturated fatty acids on plasma triglyceride levels in pre-menopausal women with mildly elevated triglycerides. The dose-response effect on plasma lipoprotein levels and particle size, as well as omega-3 levels in various blood samples (plasma, erythrocytes, whole blood from fingertip) will also be investigated.

Paracetamol is first-line pain management for osteoarthrits and this study is designed to investigate patient preference for sustained release paracetamol given 3xdaily compared with standard paracetamol tablet given 4xdaily.

All head lice products will be applied on Day 0, Day 7 and Day 14. The combing procedure normally used in combination with KP24 Medicated Foam will not be performed in order to compare the efficacy of the components of each product without confounding the efficacy measurements by physically removing head lice by combing. The louse free rate (see glossary) at Day 21 after 3 applications of all three treatments will be determined by wet combing for the Intention to Treat population (primary outcome measure) and the Per Protocol population (secondary outcome measure). The louse free rate at Day 1 will be determined by dry combing (secondary outcome measure).

This study aims: 1. To implement a tailored exercise program designed to minimise disability and falls among older adults who have recently had a hospital stay. 2.To conduct a randomised controlled trial to determine: - the success of the program in minimising disability and falls; - the effects of the program on risk factors for falls and quality of life

Delirium is prevalent in patients with advanced cancer and in the palliative care setting, and is associated with significant and distressing symptomatology and poor prognosis. Antipsychotics are considered by most clinicians as first line pharmacotherapeutic agents for delirium despite limited randomized double blind controlled evidence for management of delirium in any health care setting, including palliative care. The few studies that exist explore post treatment efficacy in relation to total delirium score reduction, and do not guide management of target symptomatology. There as been no systematic evaluation of toxicity profile in relation to delirium management with typical or atypical antipsychotics, in particular extrapyramidal toxicity and degree of sedation. There is need for randomized control trial evidence of the efficacy of antipsychotics to control targeted delirium symptoms, and also to consider broader implications on caregiver and patient distress.

This study in pregnant women with asthma compares the guiding of asthma therapy by FENO level to asthma therapy guided by clinical guidelines on reducing asthma exacerbations during pregnancy

Children with neurofibromatosis type 1 (NF1) frequently demonstrate impairments in attention and visuospatial learning. Despite the significant negative impact of this disorder on cognitive functioning, no studies have examined the effects of interventions on the cognitive functioning of children with NF1. Mice mutated at the NF1 gene provide a useful experimental model to study the biological basis of cognitive deficits in NF1 as they exhibit cognitive impairments that appear to mimic those displayed in children with NF1. Recent evidence has shown that the pharmacological agent lovastatin can reverse attention and learning deficits in NF1 mice. Lovastatin has a 20 year history as in treating hyperlipidemia and Phase I data in children with NF1 suggests that it is safe and tolerable. We intend to conduct a multi-centre, randomised trial examining the efficacy of lovastatin in children with NF1. There will be two treatment groups: one on lovastatin and the other a placebo control. The primary aim will be to establish whether lovastatin significantly improves visuospatial learning and/or sustained attention in children with NF1. Secondary aims include examining the effect of lovastatin on measures of executive function, behaviour and quality of life, as well as further evaluating the toxicity and tolerability of lovastatin in children with NF1.