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Research Topic : randomized controlled trial
Country : Australia
Australian State/Territory : VIC
Australian State/Territory : NSW
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  • Funded Activity

    Early Intervention For Anxiety And Phobic Disorders In Young Children With Intellectual Disability

    Funder
    National Health and Medical Research Council
    Funding Amount
    $305,674.00
    Summary
    Children with intellectual disability (ID) are 2-3 times more likely to have behavioural and emotional disturbance, including anxiety and fears, than children of normal intellectual ability. Anxiety problems are a source of distress for the child, impair their ability to learn and are a cause of family burden and community cost. Therefore, effective interventions are urgently required. Research with non-disabled children has demonstrated the effectiveness of teaching parents to manage their chil .... Children with intellectual disability (ID) are 2-3 times more likely to have behavioural and emotional disturbance, including anxiety and fears, than children of normal intellectual ability. Anxiety problems are a source of distress for the child, impair their ability to learn and are a cause of family burden and community cost. Therefore, effective interventions are urgently required. Research with non-disabled children has demonstrated the effectiveness of teaching parents to manage their child's anxiety, however the effectiveness of this approach in children with ID has not yet been established. This project aims to compare the relative effectiveness of two intervention conditions compared to a waiting list group, for highly anxious children aged 4-7 years with ID. One intervention will teach parents to help their child deal with anxiety problems, and develop skills to overcome their own associated emotional upset and family and social problems. The other intervention will provide non-directive counselling and support to help the parents understand the nature and causes of ID, associated anxiety problems in the child, and parent and family stress. The long term outcome of these two interventions will be assessed by following the children and their families for two years. A manual of each treatment is produced. This project aims to provide evidence for a relatively inexpensive, feasible and effective early intervention program for young children with ID at risk for developing anxiety problems that can be easily taught to professionals and is acceptable to parents. Widespread use of this intervention has the potential to reduce the added burden and cost to families and the community of persistent severe anxiety in young people with ID.
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    Funded Activity

    Ketamine Therapy Among Patients With Treatment-resistant Depression: A Randomised, Double-blind, Placebo-controlled Trial

    Funder
    National Health and Medical Research Council
    Funding Amount
    $2,069,382.00
    Summary
    In the last decade, there have been reports of powerful antidepressant effects after a single injection of anaesthetic ketamine, with dramatic (though shortlasting) effects within 24 hours. This will be the first controlled study to test whether a course of repeated ketamine treatments, given over 4 weeks, is effective and safe in treating depression.
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    Funded Activity

    Improving Access To Psychological Services For People With Cancer: A Randomised Control Trial Of An Interactive Web-Based Intervention

    Funder
    National Health and Medical Research Council
    Funding Amount
    $612,715.00
    Summary
    Approximately 35% of people diagnosed with cancer will experience persistent significant distress, and unmet psychological supportive care needs in Australian cancer patients are highly prevalent. The web presents a unique method of delivery of supportive care. However, to our knowledge this type of intervention has not been examined. This two-phased study will develop and test a novel web-based intervention to improve psychological outcomes in cancer patients experiencing distress.
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    Funded Activity

    Re-EValuating The Inhibition Of Stress Erosions (REVISE): Gastrointestinal Bleeding Prophylaxis In ICU

    Funder
    National Health and Medical Research Council
    Funding Amount
    $2,955,164.00
    Summary
    Around 50,000 patients in Australian Intensive Care Units receive a drug called pantoprazole each year with the aim of preventing bleeding from the gut. Recent research suggests this practice is ineffective and may harm patients by increasing their risk of serious infections. We will perform a definitive study to determine whether the widespread use of pantoprazole is beneficial or harmful.
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    Funded Activity

    Modifying The Trajectory Of Insidious Late Life Cognitive Decline Using Computerised Cognitive Training

    Funder
    National Health and Medical Research Council
    Funding Amount
    $743,152.00
    Summary
    Supervised, group-based computerised cognitive training (CCT) is a safe and effective intervention to maintain cognition in healthy older adults. This project will examine the extent to which CCT can attenuate or even reverse the rate of decline in older people with previously documented cognitive decline, as well as strategies to maintain CCT effects in the long term.
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    Funded Activity

    A Phase III Trial Comparing Adjuvant Versus Salvage Radiotherapy For High Risk Patients Post Radical Prostatectomy

    Funder
    National Health and Medical Research Council
    Funding Amount
    $819,138.00
    Summary
    About half of all patients Treated with an operation to remove their prostate cancer have a high chance of the cancer coming back. Giving immediate radiotherapy to all patients will improve cure rates but does not benefit all men and can cause significant side effects. This study explores whether it is safe to wait and only give radiotherapy when there is a rising PSA after surgery indicating active cancer. A total of 470 men from Australasia will enter this study comparing the two approaches.
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    Funded Activity

    A Randomised Placebo-controlled Trial Of Antibiotics To Prevent Urinary Tract Infection In Children

    Funder
    National Health and Medical Research Council
    Funding Amount
    $735,000.00
    Summary
    This study is needed to determine whether a common clinical practice long-term antibiotic treatment for children following urinary tract infection (UTI) - is safe and effective in preventing further UTI and if so, whether all appropriate children are being treated. UTI will affect about 10% of Australian children by high school age (88,000 children per year). Because UTI may damage the kidneys, the management priority for children with UTI has been prevention of further infection. Currently this .... This study is needed to determine whether a common clinical practice long-term antibiotic treatment for children following urinary tract infection (UTI) - is safe and effective in preventing further UTI and if so, whether all appropriate children are being treated. UTI will affect about 10% of Australian children by high school age (88,000 children per year). Because UTI may damage the kidneys, the management priority for children with UTI has been prevention of further infection. Currently this means the identification of children thought to be most at risk of recurrent UTI by renal tract imaging. Those found to have reflux of urine from the bladder to the kidney (present in about 30% of those with UTI) are then placed on antibiotics fro 2-5 years. Unfortunately there has never been a properly designed trial to test whether antibiotics do really prevent UTI and if so, whether children with reflux are the appropriate and only group requiring treatment. Long term antibiotics may in fact do more harm than good because of side effects like skin, bowel and blood problems and because resistant bacteria may develop. The design of this study involves the random allocation of placebo or antibiotic (cotrimoxazole, the usual antibiotic given in this case) to about 800 children after their first symptomatic UTI. These children are treated and followed for one year to determine the rate of futher UTI in both groups. Any difference in outcome between the two groups of children will be because of the antibiotic treatment. This study may prove long-term antibiotics are ineffective and therefore should not be routinely used. In this case investigation of children to detect vesicoureteric reflux would serve little purpose and should be abandoned. Alternatively antibiotic treatment may be shown as effective treatment for preventing further UTI and in this case the study will clearly identify those children who will benefit.
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    Funded Activity

    A Trial Of A Multidisciplinary, Group Based Intervention To Meet The Needs Of Men With Prostate Cancer

    Funder
    National Health and Medical Research Council
    Funding Amount
    $524,285.00
    Summary
    This study will test an innovative approach to meeting the physical and psychosocial needs of men with early stage prostate cancer using a randomised controlled trial. This novel approach involves a combination of individual and group-based consultations which encourages peer-to-peer support, promotes self-care and enhances appropriate multidisciplinary referrals and communication. It provides a new model of care for patients with chronic diseases that can be translated into clinical practice.
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    Funded Activity

    Reducing The Greatest Uncertainty In Radiotherapy.

    Funder
    National Health and Medical Research Council
    Funding Amount
    $594,197.00
    Summary
    The weakest link in radiotherapy is defining treatment volumes (contouring). Lack of accuracy and consistency in clinical trial contouring has been shown to result in reduced patient outcomes. Manual review of contouring is resource intensive, expensive and for advanced treatments unachievable in a timely fashion. We will assess an automated approach to contouring assessment using 4 clinical trial datasets, changing practice for future studies and enabling consistent assessment in the clinic.
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    Funded Activity

    Immunising Aboriginal Mothers With Pneumococcal Polysaccharide Vaccine To Prevent Infant Ear Disease And Carriage

    Funder
    National Health and Medical Research Council
    Funding Amount
    $1,131,530.00
    Summary
    Aboriginal children experience the highest rates of acute and chronic ear infections in the world, with resultant permanent ear damage, hearing loss and educational disadvantage. These infections are mainly bacterial, and Streptococcus pneumoniae (pneumococcus) is the predominant pathogen. Pneumococcal colonisation and infection begins within days of birth, many months before any potential immunological protection from infant pneumococcal conjugate vaccine may be expected. New strategies are nee .... Aboriginal children experience the highest rates of acute and chronic ear infections in the world, with resultant permanent ear damage, hearing loss and educational disadvantage. These infections are mainly bacterial, and Streptococcus pneumoniae (pneumococcus) is the predominant pathogen. Pneumococcal colonisation and infection begins within days of birth, many months before any potential immunological protection from infant pneumococcal conjugate vaccine may be expected. New strategies are needed to eliminate, or at least delay, this early-onset pneumococcal colonisation. One such strategy is the administration to the mother of pneumococcal vaccine, which may protect the newborn infant by leading to higher titres of transplacental or breast milk pneumococcal antibodies and-or by reducing carriage (and transmission to the infant) of maternal pneumococci. Previous small studies using this strategy have been encouraging, but there have been no studies properly evaluating carriage or disease endpoints in infants. The polysaccharide pneumococcal vaccine is currently recommended for all Aboriginal and Torres Islander persons aged 15 years or more in the Northern Territory but uptake of the vaccine has been poor. We propose to conduct a pilot study to determine if maternal immunisation with this vaccine, either in the third trimester of pregancy of immediately following delivery, can reduce pneumococcal carriage and the prevalence of middle ear disease among Aboriginal infants at seven months of age. We aim to recruit 210 Aboriginal women who have uncomplicated pregnancies from Darwin and remote communities in the Top End of the Northern Territory. Each subject and their infant offspring will be followed-up after vaccination and at birth, one , two and seven months after birth.
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