Plasma Exchange And Glucocorticoids In ANCA Associated Vasculitis: A Randomised Controlled Trial (PEXIVAS Australia)
Funder
National Health and Medical Research Council
Funding Amount
$635,243.00
Summary
Vasculitis is a life-threatening disease, and the current treatment for this condition is not satisfactory. This clinical trial aims to determine 1) if plasma exchange can lower mortality and the development of severe kidney failure due to this disease, and 2) if the use of lower doses of corticosteroids can lessen the infectious complications of treatment. This trial is part of a major international effort which will involve a total of 500 patients from Australia, UK, Europe, USA and NZ.
A Randomised Controlled Trial Of Alternative Treatments To Intramuscular Penicillin For Impetigo In Aboriginal Children
Funder
National Health and Medical Research Council
Funding Amount
$1,326,182.00
Summary
We will conduct clinical trials to find an effective, simple and cheap oral alternative to injected penicillin for skin sores which could become the universal standard of care whether the patient is in Melbourne or Milingimbi. It would also likely be adopted by the World Health Organization as a standard of care for developing countries. This would lead directly to a reduced burden of skin sores and their complications. It would also open the way for studies to explore even simpler regimens.
A Randomised Controlled Trial Examining Stability Of New Types Of Highly Porous Surfaced Acetabular Components In Total Hip Replacement
Funder
National Health and Medical Research Council
Funding Amount
$216,490.00
Summary
Numbers of total hip replacements are steadily increasing. The most common complication of hip replacement is late implant loosening, which can be predicted by early migration. We will examine early migration of a trabecular metal acetabular cup without screws, compared to a titanium fibre metal acetabular cup fixed with screws. Ideally, an acetabular cup would achieve a level of initial stability by press-fit alone without screws, as screws increase the risk of bone loss around the prosthesis.
Evaluation Of Internet-based, Cognitive Behaviour Therapy For The Treatment Of Anxiety Disorders In Adolescents
Funder
National Health and Medical Research Council
Funding Amount
$570,750.00
Summary
Anxiety disorders affect around 5-10% of adolescents and are associated with a range of adverse consequences if left untreated. The majority of young people with anxiety disorders do not seek nor receive treatment. This may be due partly to the perceived stigma of attending a mental health clinic and logistic problems of attending therapy. A challenge is to identify ways in which treatment can be made more accessible to adolescents in need, particularly those in rural and remote areas. Contrary ....Anxiety disorders affect around 5-10% of adolescents and are associated with a range of adverse consequences if left untreated. The majority of young people with anxiety disorders do not seek nor receive treatment. This may be due partly to the perceived stigma of attending a mental health clinic and logistic problems of attending therapy. A challenge is to identify ways in which treatment can be made more accessible to adolescents in need, particularly those in rural and remote areas. Contrary to original beliefs, evidence shows that the internet can be used to deliver effective psychological therapies for a range of mental health problems, including anxiety disorders. So far this research has focused on adults, but adolescents may be in a particularly strong position to benefit from these forms of therapy, being experienced users of internet resources. This research investigates the effectiveness of internet-based cognitive-behaviour therapy (CBT) in the treatment for anxiety disorders in adolescents. Recently we have piloted CBT for anxious children that combines clinic and internet therapy, with half the therapy sessions in the clinic and half over the internet. Pilot data show that clinic + internet therapy produced significant reductions in anxiety and is almost as effective full clinic-based therapy. The proposed research builds on our pilot work by evaluating the effectiveness of a more extensive internet-based therapy in which all sessions are completed using the internet and with an older age group. The research also examines the factors that predict which young people will respond most positively to the intervention so that the treatment can be matched to those most likely to benefit from it in the future. The aim is to develop an effective internet-based treatment for adolescents with anxiety disorders that is easily accessed and suitable for use in rural and remote populations, requiring minimal face-to-face therapist contact.Read moreRead less
Value Of Androgen Deprivation And Bisphosphonate Therapy In Patients Treated By Radiotherapy For Limited Prostate Cancer
Funder
National Health and Medical Research Council
Funding Amount
$1,757,375.00
Summary
Prostate cancer depends for its growth on the male hormone, testosterone, which circulates in the blood. As a result treatment which reduces testosterone level ('androgen deprivation'[AD] therapy) can produce clinically important shrinkage of prostate cancer. Each year approximately 4000 men in Australia and New Zealand develop prostate cancer which has not spread widely and which is amenable to attempted cure by surgery or radiation. Results from recent trials, including a large trial run in Au ....Prostate cancer depends for its growth on the male hormone, testosterone, which circulates in the blood. As a result treatment which reduces testosterone level ('androgen deprivation'[AD] therapy) can produce clinically important shrinkage of prostate cancer. Each year approximately 4000 men in Australia and New Zealand develop prostate cancer which has not spread widely and which is amenable to attempted cure by surgery or radiation. Results from recent trials, including a large trial run in Australia and New Zealand by the Trans-Tasman Radiation Oncology Group (TROG) between 1996 and 2000, suggest that 6 months AD will benefit many of these men if administered in conjunction with radiotherapy.The aim of this project is to run a further trial to find out whether 12 months of AD, after radiotherapy will prevent the need for further treatment and prolong more lives than only 6 months AD. Bisphosphonate treatment also offers important benefits to prostate cancer patients because it can increase bony stregth by increasing its density and can also arrest cancerous growth in bones. A further aim of the trial therefore is to determine whether 18 months of bisphosphonate therapy (BP) will prevent bone loss (osteoporosis) caused by AD, and also further reduce the risk of secondary bone cancer developing. This trial will involve recruitment of 1000 men across Australia and New Zealand over a 5 year period. When complete the trial will determine whether further treatment can be delayed and life prolonged in up to half of all men in whom treatment presently fails. This grant will support collection of patient data and the necessary quality checks to ensure that reliable conclusions can be drawn.Read moreRead less
Systematic Expansion Of The Clinical Evidence Base In Opioid Prescribing For Refractory Dyspnoea At The End Of Life
Funder
National Health and Medical Research Council
Funding Amount
$414,535.00
Summary
Morphine can relieve breathlessness in the palliative setting. But many important questions remain. What is the best dose, should the dose change over time, do different medications provide the same relief, and how common is dyspnoea in the general population? This three part project will extend our knowledge to answer these questions. Population data will provide critical background to plan best care for future palliative patients distressed by breathlessness.
Improved Support For Regional And Remote Paediatric Oncology Families: A Randomised Controlled Trial Of Videotelephony
Funder
National Health and Medical Research Council
Funding Amount
$304,843.00
Summary
Childhood cancer presents a major life stressor for the entire family. Significant changes to the everyday lives of families, practically, socially and emotionally cause major disruption. There is evidence that this disruption results in isolation and poor communication between family members, anxiety, low self-esteem and school problems for siblings and anxiety, post-traumatic stress symptoms and risk of depression for parents. Providing ongoing support to these families is an essential part of ....Childhood cancer presents a major life stressor for the entire family. Significant changes to the everyday lives of families, practically, socially and emotionally cause major disruption. There is evidence that this disruption results in isolation and poor communication between family members, anxiety, low self-esteem and school problems for siblings and anxiety, post-traumatic stress symptoms and risk of depression for parents. Providing ongoing support to these families is an essential part of care. The Royal Children's Hospital (RCH) Paediatric Oncology Service in Brisbane is the major tertiary paediatric referral centre for Queensland, northern New South Wales and the southwest Pacific. A multidisciplinary team of medical, nursing, and allied health professionals provides care and support to children with cancer, as well as their families. Each year around 100 newly diagnosed patients are cared for. Around 60% of the families cared for by the service live in regional and remote areas. There are a number of challenges which inhibit the equitable provision of specialist health services to these areas including availability of health care professionals and accessibility due to distance, time, cost and transport. For paediatric oncology families, opportunities to receive support are limited. One possible solution is the use of online support mechanisms, such as videotelephony, to facilitate the provision of much needed support to patients, parents, siblings and the family as a whole. The objective of this research is to see if videotelephony can be used to support regional and remote families of the Royal Children's Hospital Paediatric Oncology Service providing indizidualised communication, education, counselling and monitoring. This will present a new and innovative use of videophone technology as well as a new method for supporting regional and remote oncology patients and their families.Read moreRead less
Randomised Double-blind Controlled Trial Of Oxygen Versus Air To Palliate Intractable End-of-life Dyspnoea When Pa02 >55
Funder
National Health and Medical Research Council
Funding Amount
$463,318.00
Summary
Shortness of breath at the end-of-life is one of the most feared symptoms. Unlike most other symptoms, it worsens as death approaches. Despite the fact that more than 50,000 Australian will die an expected death in the next year, of whom the majority will have breathlessness toward the end-of-life, we know little about how best to treat this symptom. Oxygen is frequently introduced but we have not identified whether it is more effective than medical air, and, if it is more effective, which patie ....Shortness of breath at the end-of-life is one of the most feared symptoms. Unlike most other symptoms, it worsens as death approaches. Despite the fact that more than 50,000 Australian will die an expected death in the next year, of whom the majority will have breathlessness toward the end-of-life, we know little about how best to treat this symptom. Oxygen is frequently introduced but we have not identified whether it is more effective than medical air, and, if it is more effective, which patients would most benefit from it. Because of this lack of evidence, oxygen is only funded in Australia in community settings for people who have severely low oxygen levels in their blood. Palliative oxygen is provided on a compassionate basis at times but this is on an ad hoc basis and does not ensure equitable access for people at the end of life who experience shortness of breath. This multi-centre study will compare oxygen and air, with neither the participant nor caring clinicians knowing which treatment they will receive. After careful explanation, volunteers who agree to participate will be asked to use the oxygen machine for at least 15 hours each day for 7 days and fill out a diary twice each day. Five centres across Australia are planning to enroll 240 participants in this study. Outcomes will include whether the sensation of breathlessness has improved, the overall quality of life while being treated, the ability to perform activities of daily living and any side effects experienced. This study is eagerly awaited by clinicians and health planners not only in Australia but in North America and Europe. This study will provide data in a long-standing international debate about the role of oxygen in people with relatively normal levels of oxygen in their blood who suffer from shortness of breath at the end-of-life.Read moreRead less
A Clinical Trial To Determine The Optimal Timing Of Androgen Deprivation In Relapsed Or Non-curable Prostate Cancer
Funder
National Health and Medical Research Council
Funding Amount
$627,600.00
Summary
The aim of the study is to clarify when is the optimal time to start hormone treatment for men with certain stages of prostate cancer. It has long been known that testosterone removal impedes prostate cancer growth, although not permanently. The removal of testosterone, however, has side effects , including loss of libido, hot flushes, weight gain, and in the longer term osteoporosis, loss of muscle bulk and mental changes such as loss of memory. Any benefit to be gained for a patient must there ....The aim of the study is to clarify when is the optimal time to start hormone treatment for men with certain stages of prostate cancer. It has long been known that testosterone removal impedes prostate cancer growth, although not permanently. The removal of testosterone, however, has side effects , including loss of libido, hot flushes, weight gain, and in the longer term osteoporosis, loss of muscle bulk and mental changes such as loss of memory. Any benefit to be gained for a patient must therefore be weighed against these side effects. This is particularly relevant in situations in which cure is not possible, when the aim of treatment should be to manage symptoms (either by preventing or delaying them or treating them as they arise). There are two situations in which a man may be diagnosed as having active prostate cancer but be without symptoms requiring immediate treatment. The first is after the failure of curative treatment, shown by the presence of prostate specific antigen (PSA) in the blood, but without any other evidence of prostate cancer. The second is a man newly diagnosed with asymptomatic prostate cancer, but with other reasons (such as heart disease) which make an attempt at cure inappropriate. We do not know in either case whether or not men live longer if treatment is started immediately, or whether it is reasonable to wait until symptoms develop, thus potentially postponing the side effects of treatment. The trial will therefore include these two groups of men. Half the men will be randomised to receive immediate treatment, and half to treatment starting when symptoms develop, or when there is evidence of progressive disease. The main endpoint is overall survival, balanced against quality of life and side effects from the disease and treatment. The hypothesis is that early treatment will improve survival with acceptable effects on quality of life.Read moreRead less
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.Read moreRead less