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Research Topic : randomised controlled trials
Scheme : NHMRC Project Grants
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  • Funded Activity

    Randomised Controlled Trials Of Laparoscopic Techniques For Antireflux Surgery

    Funder
    National Health and Medical Research Council
    Funding Amount
    $275,923.00
    Summary
    Gastro-oesophageal reflux is common, and over the last decade there has been an exponential rise in the usage of acid suppressing medication. Current trends suggest that the national cost of medical treatment of reflux will become unaffordable unless new management or preventative strategies can be developed. Presently, surgery is the only treatment which can cure reflux. Laparoscopic fundoplication has recently become an acceptable, low morbidity keyhole surgical treatment for this problem. How .... Gastro-oesophageal reflux is common, and over the last decade there has been an exponential rise in the usage of acid suppressing medication. Current trends suggest that the national cost of medical treatment of reflux will become unaffordable unless new management or preventative strategies can be developed. Presently, surgery is the only treatment which can cure reflux. Laparoscopic fundoplication has recently become an acceptable, low morbidity keyhole surgical treatment for this problem. However, research is essential to develop a procedure which optimizes the outcome for patients undergoing surgical management of reflux, and minimizes the risk of complications. This may provide a better alternative to long term management with acid suppressing medication, and could eventually achieve long term savings to the nation's health budget. Since 1994 research conducted at the Royal Adelaide Hospital has evaluated a range of different key hole operations aimed at improving the outcome for patients undergoing surgery for gastro-oesophageal reflux. Over 100 patients have been entered into each of the following clinical trials: total fundoplication with or without division of the short gastric vessels, total versus anterior partial fundoplication and posterior or anterior hiatal repair. Further trials will compare a lesser degree of anterior partial fundoplication with total fundoplication. A common research protocol has been developed and applied to all of these trials. This involves the use of double blind randomised methodology, with independent follow-up obtained by an independent investigator. These trials will determine the best surgical technique for the surgical correction of reflux, and this should lead to a more widely accepted surgical alternative to existing non-operative strategies for pathological reflux.
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    Funded Activity

    Effects Of Laterally Wedged Insoles On Symptoms And Disease Progression In Knee Osteoarthritis

    Funder
    National Health and Medical Research Council
    Funding Amount
    $480,850.00
    Summary
    Knee arthritis is a painful, disabling, costly condition particularly affecting the elderly. As there is presently no cure for knee arthritis, strategies that slow progression of the disease will reduce the personal and societal burden of arthritis. Most research has focussed on drug therapies, which are effective in reducing pain and disability but have side effects and are expensive. Insoles worn inside the shoes are a simple, cheap, self-administered intervention with the potential to slow di .... Knee arthritis is a painful, disabling, costly condition particularly affecting the elderly. As there is presently no cure for knee arthritis, strategies that slow progression of the disease will reduce the personal and societal burden of arthritis. Most research has focussed on drug therapies, which are effective in reducing pain and disability but have side effects and are expensive. Insoles worn inside the shoes are a simple, cheap, self-administered intervention with the potential to slow disease progression in certain patients, in addition to managing symptoms. However, to date there has been little quality research investigating the effectiveness of insoles in knee arthritis. This study aims to see whether 12 months of wearing insoles can lead to improvements in knee pain and function and slow disease progression in 200 people with knee arthritis. It will use state-of-the-art technology, magnetic resonance imaging, to measure changes in the amount of knee cartilage. This research is timely and the findings will be of major significance as there is increasing world-wide attention on slowing progression of knee arthritis. Insoles are one of the few non-drug therapies with the potential to influence both symptoms and disease progression. If the results show that insoles are beneficial, then this research will: 1. Better inform clinical guidelines to firmly recommend insoles to manage knee arthritis 2. Provide the basis for developing education strategies for health care practitioners and patients about the benefits of insoles 3. Provide the impetus to make insoles more readily available directly to patients 4. Ultimately lead to better patient outcomes
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    Funded Activity

    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.
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    Funded Activity

    Antiplatelets For Prevention Of Pre-eclampsia: An Individual Patient Data Review

    Funder
    National Health and Medical Research Council
    Funding Amount
    $274,000.00
    Summary
    High blood pressure is a common complication of pregnancy affecting ~20,000 Australian women each year. Although most women and their babies do well, pre-eclampsia, defined as high blood pressure together with protein in the urine is a more serious problem. Severe pre-eclampsia is associated with 10-15% of maternal deaths. Fetal and newborn baby deaths are also increased. Mother and baby morbidity is high principally due to the associated complications in pregnancy, increased obstetric intervent .... High blood pressure is a common complication of pregnancy affecting ~20,000 Australian women each year. Although most women and their babies do well, pre-eclampsia, defined as high blood pressure together with protein in the urine is a more serious problem. Severe pre-eclampsia is associated with 10-15% of maternal deaths. Fetal and newborn baby deaths are also increased. Mother and baby morbidity is high principally due to the associated complications in pregnancy, increased obstetric interventions, fetal growth restriction and preterm birth. As yet we have no safe and effective way of preventing this life threatening condition. Aggregation of platelets (involved in blood clotting) is known to be part of the disease and could lead to the disturbances in the circulation of the mother and the placenta. Antiplatelet agents, low dose aspirin in particular, might prevent or delay the development of pre-eclampsia. Some trials and a Cochrane systematic review of all trials (involving over 30,000 women) suggest that pre-eclampsia, preterm birth and perinatal death could be reduced. However, it is still not clear which women will benefit, when in pregnancy the treatment should start and what dose of aspirin is both effective and safe. This proposed individual patient data review in which data on all women who have been entered in trials is gathered from the original investigators, including missing information on potential harms. This proposal represents a good investment of resources to obtain the information needed by women and health professional to make decisions about the use of aspirin. International investigators from all the primary trials have already formed a collaboration to oversee the project: the Perinatal Antiplatelet Review of International Studies (PARIS) Collaboration Furthermore, working through an international collaboration will ensure the highest quality in data availability, as well endorsement and implementation of the results in practice.
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    Funded Activity

    A Randomised Trial Of Adjuvant Chemotherapies In Resectable Pancreatic Cancer: ESPAC-3

    Funder
    National Health and Medical Research Council
    Funding Amount
    $430,500.00
    Summary
    Over 1,650 Australians are diagnosed with pancreatic cancer each year. In most cases, surgery will remove the tumour but it is possible that the cancer will return as a result of undetectable disease (micrometastases). The cancer will return and be incurable in the majority of patients. More than 1600 Australians die of the disease every year. This study compares the impact of adding chemotherapy to surgery alone (the current standard of care). The study will also compare the effectiveness of tw .... Over 1,650 Australians are diagnosed with pancreatic cancer each year. In most cases, surgery will remove the tumour but it is possible that the cancer will return as a result of undetectable disease (micrometastases). The cancer will return and be incurable in the majority of patients. More than 1600 Australians die of the disease every year. This study compares the impact of adding chemotherapy to surgery alone (the current standard of care). The study will also compare the effectiveness of two different types of chemotherapy. Surgical resection of a pancreas tumour is the current standard of care for this disease. It is possible that people treated with chemotherapy after their tumour has been surgically removed may live longer before their disease returns and may liver longer overall. This has been shown to be true in other in cancers; eg. breast and bowel. The side effects of chemotherapy are important and can be severe in some people. Recent studies in advanced pancreatic cancer have suggested that the new drug gemcitabine may be more effective than other drugs. For this reason, the trial compares the outcomes in people treated with gemcitabine to those treated with an older drug 5FU, which has been shown to improve survival in an earlier study by a European group. This trial will determine if chemotherapy in addition to surgery increases the length of time before the disease comes back and survival. If it does, it should become standard practice. This study is an important international initiative that will provide unique information about effectiveness of these treatments and their impact on quality of life from the patient's perspective. This study and the previous European study are the largest of their type ever done. 900 people will take part. This study is being conducted in Australia by the Australasian Gastro-Intestinal Trials in collaboration with the Australian Hepatobilary Association and the NHMRC Clinical Trials Centre.
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    Funded Activity

    WHO-ISH Blood Pressure Lowering Treatment Trialists' Collaboration

    Funder
    National Health and Medical Research Council
    Funding Amount
    $82,551.00
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    Funded Activity

    PREOPERATIVE RISK FACTORS, ADVERSE OUTCOMES AND EFFECTS OF EPIDURAL AND SPINAL ANAESTHESIA

    Funder
    National Health and Medical Research Council
    Funding Amount
    $66,110.00
    Summary
    Anaesthesia and major surgery in patients with coexisting important medical problems present a major challenge to health professionals to avoid and minimise life threatening complications of such surgery. Accurate prediction of which patients are likely to fare badly, and therefore need more intensive peri-operative care and supervision, and knowing definitively whether epidural techniques really do improve the outcome of surgery are issues of central importance in the practice of anaesthesia. P .... Anaesthesia and major surgery in patients with coexisting important medical problems present a major challenge to health professionals to avoid and minimise life threatening complications of such surgery. Accurate prediction of which patients are likely to fare badly, and therefore need more intensive peri-operative care and supervision, and knowing definitively whether epidural techniques really do improve the outcome of surgery are issues of central importance in the practice of anaesthesia. Providing clear answers to both questions requires careful analysis of large amounts of data in which systematic and random errors have been minimised. Databases from well-designed and supervised clinical trials represent an invaluable resource in this regard because they have been compiled through the rigorous application of unambiguous definitions and protocols during the process of recording, coding and entering the information. By bringing together the resources and expertise of the MASTER Trial group and the Collaborative Overview of Randomised of Trials of Regional Anaesthesia (CORTRA), both of which are major international projects led from the Australasian region, we have a unique opportunity to provide exceptionally robust answers to some of the most challenging issues in anaesthesia. The combined study of two large international databases will provide a more precise quantitative analysis of the components of preoperative risk and their relationship to life threatening post operative complications, and the possible role of epidural and spinal anaesthesia in minimising risk by reducing the frequency of these complications.
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    Funded Activity

    Transdiagnostic Internet Therapy For Internalizing Disorders

    Funder
    National Health and Medical Research Council
    Funding Amount
    $687,348.00
    Summary
    Anxiety and depressive disorders account for 58% of the burden of mental disorders, or 7.5% of the burden of human disease. Internet treatments for the individual disorders are effective but require careful diagnosis. We intend to develop and prove the effectiveness of a transdiagnostic Internet treatment program that will be easily used by primary care clinicians. We will disseminate and evaluate the developed and proven program to general practitioners and psychologists.
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    Funded Activity

    Gabapentin In The Treatment Of Idiopathic Chronic Cough: A Randomised Double-blind Placebo-controlled Trial

    Funder
    National Health and Medical Research Council
    Funding Amount
    $331,229.00
    Summary
    Better treatment approaches are needed to address the significant quality of life impairment associated with chronic cough. We propose to conduct a double-blind, placebo controlled study comparing the efficacy (and safety) of oral gabapentin therapy on cough reflex severity and cough-specific quality of life in people with idiopathic cough. The advantages are a strong design, use of objective assessment techniques, and investigation of a new treatment modality for cough.
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    Funded Activity

    A Randomised Trial Of The Effects Of Cholesterol Lowering Therapy Among Patients With Chronic Renal Impairment

    Funder
    National Health and Medical Research Council
    Funding Amount
    $333,250.00
    Summary
    People with kidney disease are well known to be at high risk of developing major health problems earlier in life than people without kidney problems. In particular, people with kidney disease are more likely to suffer from heart attacks and strokes. For a number of other high-risk patient groups (such as people with heart disease), studies have clearly shown that cholesterol-lowering treatment can significantly reduce the risks of serious complications. However, until now, patients with kidney d .... People with kidney disease are well known to be at high risk of developing major health problems earlier in life than people without kidney problems. In particular, people with kidney disease are more likely to suffer from heart attacks and strokes. For a number of other high-risk patient groups (such as people with heart disease), studies have clearly shown that cholesterol-lowering treatment can significantly reduce the risks of serious complications. However, until now, patients with kidney disease have generally been excluded from such studies because of concerns about drug side effects. New, better-tolerated cholesterol lowering drugs now offer an opportunity to see if this highly effective treatment is also protective among people with kidney disease. The HARP (Heart And Renal Protection) trial is a large new study that will be done as a collaboration between Australian researchers and researchers from the University of Oxford in the UK. The aim of the study is to see if low doses of two cholesterol-lowering drugs can reduce the risks of stroke and heart attack. The study will include about 9,000 people with chronic kidney disease followed for an average of 4 years. It is hoped that by using low doses of two treatments, rather than a high dose of one, it will be possible to get substantial benefits without side effects. There are presently many tens of thousands of individual in Australia with chronic kidney disease and many millions of such individuals worldwide. The results of the HARP study will therefore influence the care of a very large number of people. If the results were positive, implementation of this new treatment would be expected to prevent many tens of thousands of premature strokes and heart attacks around the world each year.
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