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A Lifestyle Intervention Program to treat Mild to Moderate Obstructive Sleep apnoea
Expand descriptionSubjects with mild to moderate obstructive sleep apnoea will be invited to participate in a supervised 4-month diet and exercise program. We will measure daytime function, quality of life and severity of sleep-disordered breathing before and after the study, and in addition will followup subjects for 12 months after they complete the active intervention protocol.
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The Extension Study
Expand descriptionAdefovir dipivoxil 10mg tablets were approved for the treatment of chronic hepatitis B by the TGA in 2003 and are now marketed as Hepsera(r) by Gilead Sciences. Patients who are not resistant to another anti-hepatitis B virus drug called lamivudine are not able to access Hepsera at a PBS reimbursed price. Patients who participated in the adefovir dipivoxil clinical trials GS-98-437, GS-98-438, and GS-00-480 and are still taking adefovir dipivoxil have never received lamivudine and thus cannot receive Hepsera at reduced price. This study will allow the patients to continue accessing adefovir free of charge and provide unprecedented data on the long-term safety and efficacy of adefovir dipivoxil without changing the procedures and tests routinely done during normal visits to the clinic.
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Dietary advice and management of gout
Expand descriptionTo determine whether patients with a history of gout are meeting nutritional requirements, are aware of dietary risk factors for their condition and whether they have a need or interest in receiving dietary support for their condition.
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Infant fish oil study
Expand descriptionIn this study we will compare the effects of fish oil (n=165) or placebo (n=165) in early infancy (from 0-6 months of age) on the risk of developing allergic sensitisation or allergic disease in early childhood. Both study groups will include children deemed to be at high risk of allergic disease (based on maternal allergy history).
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Probiotic Allergy Prevention Study
Expand descriptionTo aim of this study is to investigate the effects of probiotic supplementation for the first 6 months of life in infants at high risk of allergic disease. The study has been designed to determine if this intervention reduces the risk of developing allergic sensitisation (determined by allergy skin testing) and allergic disease (such as food allergy, atopic dermatitis and asthma) in early childhood. The participants and investigators remained blind to the intervention throughout the follow up period.
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Dreaming and EEG changes during anaesthesia maintained with propofol or desflurane
Expand descriptionDreaming is commonly reported after anaesthesia. There is some evidence that dreaming is more likely to be reported after anaesthesia maintained with propofol than anaesthesia maintained with desflurane. In this study, we will randomise patients having non-cardiac surgery to anaesthesia with propofol or desflurane and will measure the incidence of dreaming. Post-operative observers will be blind to group allocation (propofol or desflurane)
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Economic and Social Benefits of Treating and Preventing Influenza in Aged Care Facilities
Expand descriptionInfluenza (the ‘flu’) may cause mild to severe illness, and some people, including older people, are at a higher risk for death and serious complications. Flu is easier to catch where people live in communities like aged-care facilities (ACFs). This trial aims primarily to assess the value of two different policies for control of influenza outbreaks (when several people get infected at the same time) in ACFs using the antiviral drug oseltamivir (Tamiflu). It is licensed for treating and preventing flu. This research will help to find out the benefits of starting the drug treatment early for people who have flu, compared with starting the drug treatment early for people who have flu, and also giving the drug to well people in the aged care facility who have been exposed to the sick people. The study will be carried out for three years (three influenza seasons) commencing in 2006.
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The Postcard Study
Expand descriptionThe aims of this study are to reduce suicidal behaviour and improve self-esteem amongst a cohort of adolescents identified as being at high-risk of suicidal behaviour, who are referred to ORYGEN Youth Health. We aim to do this by replicating previous intervention studies which have shown that sending a regular postcard to adults at high risk of suicide enquiring about their well being has reduced subsequent suicidal behaviour. We further intend to add individually tailored information regarding sources of help to each postcard, as well as some basic information about self-help strategies aimed at reducing depression and anxiety.The overall hypothesis is that receipt of a regular postcard enquiring about well being and informing the young person about appropriate, previously identified sources of help will reduce suicidal behaviour, over the study period. Specific hypotheses to be examined are that the receipt of a regular postcard will result in: 1) Decreased suicidal behaviour and ideation 2) A reduction in factors associated with suicide such as hopelessness and depression 3) Improved self-esteem and 4) An increase in perceived social support. We further hypothesise that: 5) There will be a positive association between reductions in suicidal behaviour and improved self-esteem and perceived support and 6) There will be a positive association between reduced suicidal behaviour and a reduction in hopelessness and depression.
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International neonatal immunotherapy study
Expand descriptionThis trial will test if intravenous immunoglobulin (IVIG) reduces death and disability in up to 5000 babies with suspected serious infection in the UK, Europe, Argentina, Australia and New Zealand. Newborn babies are deficient in immunoglobulins (physiological deficiency), especially if they are premature. Babies with severe infection after birth carry a high risk of death or life-long disability, even with appropriate antibiotics. IVIG is concentrated from plasma carefully screened blood donors and is one of the safest blood products available. Earlier trials suggest IVIG may reduce death rates in newborn infants, but did not report disability rates in survivors. Participants, Trialists at the coordinating centre, and clinical professionals involved in the care of the child are blinded to the study treatment. Only the pharmacist and lead statistician are aware of the treatment allocation.
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A double-blinded, placebo-controlled trial of modafinil for amphetamine withdrawal
Expand descriptionThe project aims to develop a greater understanding of amphetamine withdrawal and whether medication, such as modafinil, is effective in the management of amphetamine withdrawal in an inpatient setting. Participants will be randomised to a single morning dose of modafinil or matching placebo. Participants will receive medication for seven days (tapering doses from 200mg to 100mg). The two treatment groups will be compared for their symptoms of amphetamine withdrawal, including symptoms of depression and sleep disturbance, neuro-cognitive function, as well as any potential side effects from the medication. Other outcome measures will include retention in treatment and monitoring the rate of relapse to amphetamine use post withdrawal. This information will then inform guidelines for withdrawal management, including psychosocial and medical aspects. The protocol will be distilled for a clinical audience and include principles and practice, practice guidelines and recommendations for implementation