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A randomised, assessor blind, comparative trial of MOOV (reg. trade mark) Lotion, MOOV (reg. trade mark) Shampoo and KP24 Medicated Foam in the treatment of head lice in children
Expand descriptionAll 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).
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Minimising disability and falls in older people through a post-hospital individualised exercise program.
Expand descriptionThis 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
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Oral risperidone, oral haloperidol, and oral placebo in the management of delirium in palliative care.
Expand descriptionDelirium 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.
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Managing Asthma in Pregnancy (MAP) Study
Expand descriptionThis 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
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A randomised placebo-controlled study of lovastatin in children with neurofibromatosis type 1
Expand descriptionChildren 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.
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Hyperbaric Oxygen in Lower Limb Trauma
Expand descriptionHyperbaric 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.
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Home-based Physical Activity Program for Seniors
Expand descriptionAim: 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.
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Cooling for perineal pain relief after childbirth: randomised trial
Expand descriptionPerineal tears or cuts are common with childbirth and are often painful. Women are often advised to use ice packs to help relieve the pain, although there is very little evidence that this is effective. This trial will compare pain relief using two regimes of applying ice to the perineum. One group of women will have an ice pack applied to the perineum after giving birth, then replace it occasionally. The other group will have ice packs held firmly in place and be advised to rest and elevate the region. The results will enable a more evidence-based approach to care than is currently available.
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Contraceptive trial in healthy young women in which the use of a radiopaque etonogestrel implant inserted with a next generation applicator is evaluated.
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Safety and pharmacodynamics of KB002, an anti granulocyte monocyte colony stimulating factor (GM-CSF) monoclonal antibody, in patients with persistent symptomatic asthma
Expand descriptionThe purpose of this study is to look at the safety and effectiveness of a drug called KB002. KB002 is a monoclonal antibody which specifically target parts of the immune system that lead to inflammation, which can contribute to asthma. This study will help decide if KB002 may be safe at reducing the symptoms of asthma.