ANZCTR search results

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.

Hyperbaric oxygen therapy may reduce injury related complications and improve outcomes following serious musculo-skeletal injury. The Hyperbaric Oxygen in Lower Limb Trauma (HOLLT) Study will investigate this by conducting a randomised controlled trial aiming to enrol 120 patients with severe tibial fractures within 48 hours of their injury. The study is being conducted by an international network of trauma centres with hyperbaric treatment facilities.

Aim: The aim of this study is to assess the short and long-term efficacy of a behavioural change activity program and motivational interviewing to increase physical activity in older adults. Hypothesis 1: Participants who receive a tailored behavioural change program will have higher physical activity levels compared to those who receive a ‘usual care’ education program. Hypothesis 2: Participants who undergo telephone counselling using motivational interviewing (MI) techniques will have higher physical activity levels compared to those who receive the same number of standard telephone contacts. Hypothesis 3: Participants who receive a tailored behavioural change program and telephone counselling with MI will have higher physical activity levels compared to those who received the other programs. Hypothesis 4: Increased levels of physical activity will be associated with greater health benefits such as increased fitness, reduced blood pressure, body weight, depression, stress, anxiety and improved psychological well-being. Hypothesis 5: Self efficacy will mediate the change in physical activity behaviour. METHODS Healthy, non smoking, sedentary, 50-80 year old men and women will be recruited from the community. Participants will be assessed on physical activity, fitness, body weight, blood pressure and psycho-social aspects of mental health such as stress, depression anxiety and well being at baseline, 6 and 12 months. They will be randomly assigned to a ‘usual care’ education program or a ‘behavioural change’ education program. Within each of these programs they will be further allocated to have standard telephone contacts or motivational interviewing (MI) telephone contacts. All participants will be asked to do 150 minutes/week of moderate physical activity for an initial 6 month intervention and a further 6 months of non contact.