INTERACT: A Randomised Trial Of Intensive Blood Pressure Lowering In Acute Intracerebral Haemorrhage
Funder
National Health and Medical Research Council
Funding Amount
$2,680,868.00
Summary
Intracerebral haemorrhage (ICH) is a serious type of stroke affecting thousands of Australians and 2-3 million people in the world each year, with most either dying or left disabled. There is no proven treatment for ICH, although surgery is sometimes used and early injection of a special clotting factor may improve outcome. One potential simple therapy is the rapid control of elevated blood pressure (BP) which occurs commonly and predicts a poor outcome in ICH, possibly by increasing bleeding an ....Intracerebral haemorrhage (ICH) is a serious type of stroke affecting thousands of Australians and 2-3 million people in the world each year, with most either dying or left disabled. There is no proven treatment for ICH, although surgery is sometimes used and early injection of a special clotting factor may improve outcome. One potential simple therapy is the rapid control of elevated blood pressure (BP) which occurs commonly and predicts a poor outcome in ICH, possibly by increasing bleeding and swelling in the brain. There is much uncertainty as to the optimal management of elevated BP in ICH. This study, called INTERACT, aims to determine the balance of benefits and risks of a management strategy of early rapid BP lowering in 2000 patients with ICH randomised from 100 clinical sites in Australia-Asia.Read moreRead less
Cognitive-behaviour Therapy For Tinnitus: Dismantling Study To Maximise Treatment Efficacy
Funder
National Health and Medical Research Council
Funding Amount
$230,220.00
Summary
Tinnitus (ringing in the ears) is a problem which affects a large number of people and for which there is no generally successful medical treatment. People are usually told that they will have to learn to live with the problem. Cognitive-behaviour therapy (CBT) has emerged as the principle means of helping people to cope with tinnitus. The proposed study aims to: (a) enhance the efficacy of CBT interventions for tinnitus, (b) identify the active components of CBT that mediate treatment gains, an ....Tinnitus (ringing in the ears) is a problem which affects a large number of people and for which there is no generally successful medical treatment. People are usually told that they will have to learn to live with the problem. Cognitive-behaviour therapy (CBT) has emerged as the principle means of helping people to cope with tinnitus. The proposed study aims to: (a) enhance the efficacy of CBT interventions for tinnitus, (b) identify the active components of CBT that mediate treatment gains, and (c) specify the mechanisms by which change occurs. The study is designed to dismantle the multi-component CBT tinnitus management protocol to investigate the relative efficacy of the individual components of treatment. The need to identify the types of psychological therapies which work best for potentially different kinds of tinnitus patients is important on both practical and theoretical grounds. Identifying and including only those components of treatment that are beneficial, and eliminating those that are not, is crucial to matching specific treatments to specific patients, which represents a major endeavour in contemporary psychotherapy research. Whether there are individual differences in response to the different components of the treatment or whether there is a single most potent component is of considerable theoretical interest. It is expected that subjects who receive the full treatment will display the largest immediate and long-term gains. Treatments which involve cognitive restructuring will produce better effects than those that do not. This project will contribute to enhanced functioning among tinnitus patients and increase the proportion of those who can benefit from empirically supported therapies.Read moreRead less
Supported Treadmill Training To Establish Walking In Non-ambulatory Patients Early After Stroke
Funder
National Health and Medical Research Council
Funding Amount
$341,349.00
Summary
This project will improve the health and well being of people affected by stroke. Stroke is the most common disabling neurological condition in adults and consumes up to 5% of health care expenditure in developed countries, estimated by the National Stroke Foundation at $1-2 billion per year in Australia. Some 48,000 people suffer a stroke each year in Australia, with approximately one third of these people requiring inpatient rehabilitation and 70% of them are unable to walk on admission to reh ....This project will improve the health and well being of people affected by stroke. Stroke is the most common disabling neurological condition in adults and consumes up to 5% of health care expenditure in developed countries, estimated by the National Stroke Foundation at $1-2 billion per year in Australia. Some 48,000 people suffer a stroke each year in Australia, with approximately one third of these people requiring inpatient rehabilitation and 70% of them are unable to walk on admission to rehabilitation. This randomised controlled trial will investigate whether treadmill walking with partial weight support via an overhead harness is effective at establishing independent walking (i) more often, (ii) earlier and (iii) with a better quality of walking, than current treatment for stroke patients who cannot walk. We will measure (i) whether patients achieve independent walking and (ii) the time taken to achieve independent walking. We will also measure parameters of walking such as speed, step length and step width to evaluate the effect of treadmill training on the quality of walking. Furthermore, by measuring participation in the community at 6 months, we will evaluate the long-term effect of this innovative treatment. Given that independence in walking is a major factor in the decision to discharge patients from inpatient care, earlier independent walking should result in a reduction in length of hospital stay which will save about $800 per patient per day in a teaching hospital setting. Identifying rehabilitation strategies which enhance walking outcome will not only improve quality of life of both stroke patients and their carers by reducing disability and handicap but also reduce the cost of rehabilitation.Read moreRead less
Hyperbaric Oxygen In Lower Limb Trauma: A Randomised Controlled Clinical Trial
Funder
National Health and Medical Research Council
Funding Amount
$729,288.00
Summary
HOLLT is an international multi-centre randomised clinical trial aimed at assessing the impact of hyperbaric oxygen therapy (HBO) on acute complication rates and long term outcomes following severe musculoskeletal trauma. The study will enrol 250 patients with severe, open tibial fractures over a 2-3 year period. Enrolled subjects will be followed up for 2 years with radiological, clinical and quality of life measures.
A Randomised Controlled Trial Of Outpatient Cervical Priming For Induction Of Labour
Funder
National Health and Medical Research Council
Funding Amount
$611,611.00
Summary
This study aims to compare two approaches that prepare pregnant women before they are induced to give birth. Eligible women who agree to be in the study will be allocated to receive (a) the usual, standard care already used in SA hospitals or, (b) a new method. In the new approach, women will have their labour primed by a midwife and will be discharged and further monitored by the midwife from hospital. This approach might give women a more satisfying experience with less medical intervention.
SNAC1:A Randomised Trial Of Sentinel Node Based Management Versus Axillary Clearance For Women With Small Breast Cancers
Funder
National Health and Medical Research Council
Funding Amount
$1,338,436.00
Summary
SNAC1 compares two operations for assessing cancer spread to the lymph nodes in women with early breast cancer: 1) axillary clearance and 2)sentinel node biopsy. Axillary clearance involves removal of most lymph nodes in the armpit. In sentinel node biopsy only a few lymph nodes most closely related to the breast cancer are removed. The trial will determine if sentinel node biopsy reduces lymphoedema and gives equivalent cure rates. If it does, then it should become standard practice.
Vaginal Progesterone For The Prevention Of Neonatal Respiratory Distress Syndrome - A Randomised Controlled Trial
Funder
National Health and Medical Research Council
Funding Amount
$935,107.00
Summary
Respiratory distress syndrome is a significant problem for babies born preterm. For these babies, a significant number will require support for their breathing. These babies are also at increased risk of dying, and in survivors, there is a risk of long-term disability. It is uncertain if giving vaginal progesterone therapy during pregnancy to women who have had a previous preterm birth can reduce these risks.
SNAC1:A Randomised Trial Of Sentinel Node Based Management Versus Axillary Clearance For Women With Small Breast Cancers
Funder
National Health and Medical Research Council
Funding Amount
$240,187.00
Summary
Over 13,000 ANZ women are diagnosed with breast cancer each year. Most need surgery to remove the cancer and determine if it has spead to glands in the armpit (axillary lymph nodes). Knowing whether the cancer has spread to the axillary lymph nodes helps determine prognosis and plan treatment. Surgical removal is the most reliable way to assess the axillary lymph nodes. SNAC1 compares two operations for assessing cancer spread to the lymph nodes in women with early breast cancer: 1) axillary cle ....Over 13,000 ANZ women are diagnosed with breast cancer each year. Most need surgery to remove the cancer and determine if it has spead to glands in the armpit (axillary lymph nodes). Knowing whether the cancer has spread to the axillary lymph nodes helps determine prognosis and plan treatment. Surgical removal is the most reliable way to assess the axillary lymph nodes. SNAC1 compares two operations for assessing cancer spread to the lymph nodes in women with early breast cancer: 1) axillary clearance and 2) sentinel node biopsy. Axillary clearance involves removal of most lymph nodes in the armpit. In sentinel node biopsy only a few lymph nodes most closely related to the breast cancer are removed. Axillary clearance is the current standard operation. However, it is associated with risks including infection, pain, stiffness, numbness and lymphoedema (arm swelling). Lymphoedema may occur in 5-50% of women treated for breast cancer and can cause major suffering and disability. In many women their breast cancer has not spread to the lymph nodes, and axillary clearance is unnecessary. Recent studies suggest sentinel node biopsy may provide as much information as axillary clearance. Scans and dye are used to help locate the sentinel nodes. Minimising the amount of surgery to the armpit should reduce the side effects. However, the long term safety and effectiveness of removing only a few nodes is unknown. The trial will determine if sentinel node biopsy reduces lymohoedema and gives equivalent cure rates. If it does, then it should become standard practice. The study complements comparable studies being done in US, UK and Europe by providing unique information about arm symptoms and quality of life. SNAC1 recruited 1,088 women in 4 years. This application is for the work needed to report on outcomes after all women have been followed for 5 years.Read moreRead less
Treatment Of Bacterial Vaginosis: A Randomised Controlled Trial
Funder
National Health and Medical Research Council
Funding Amount
$265,757.00
Summary
The objective of this research project is to determine if the treatment of Bacterial Vaginosis (BV) can be improved. Bacterial vaginosis is one of the most common causes of vaginal discharge in women. It can also have serious consequences, such as premature labour and can also increase the risk of HIV transmission. These complication cost communities many millions of dollars; for example in the US it is estimated that premature labour caused by BV alone costs about 1 billion dollars a year. The ....The objective of this research project is to determine if the treatment of Bacterial Vaginosis (BV) can be improved. Bacterial vaginosis is one of the most common causes of vaginal discharge in women. It can also have serious consequences, such as premature labour and can also increase the risk of HIV transmission. These complication cost communities many millions of dollars; for example in the US it is estimated that premature labour caused by BV alone costs about 1 billion dollars a year. The currently recommended treatment for BV works well initially (first month about 80% respond) but by 12 months most (60%) have relapsed. This randomised clinical study is investigating new ways to treat BV. The currently recommended arm of treatment (antibiotic metronidazole) is being compared to two other treatments. The second arm of the study involves the use of two antibiotics at once (metronidazole and clindamycin) and the third arm involves the use of a bacterial (lactobacilli) and oestrogen. Lactobacilli are bacteria that may help maintain the normal bacterial (and there by prevent relapse of BV) and oestrogen may have a similar effect. If either of these treatments improved the longer term treatment of BV, very significant benefits would flow to affected women and the community as a whole.Read moreRead less
Vaginal Progesterone For The Prevention Of Neonatal Respiratory Distress Syndrome - A Randomised Controlled Trial
Funder
National Health and Medical Research Council
Funding Amount
$1,243,111.00
Summary
Respiratory Distress Syndrome is a significant problem for babies born very preterm (at less than 34 weeks of pregnancy). For these babies, over 90% will require support for their breathing. These babies are also at increased risk of dying, and in survivors, there is a risk of long-term disability. It is uncertain if giving vaginal progesterone therapy during pregnancy to women who have had a previous preterm birth can reduce these risks. This randomised controlled trial will assess the use of v ....Respiratory Distress Syndrome is a significant problem for babies born very preterm (at less than 34 weeks of pregnancy). For these babies, over 90% will require support for their breathing. These babies are also at increased risk of dying, and in survivors, there is a risk of long-term disability. It is uncertain if giving vaginal progesterone therapy during pregnancy to women who have had a previous preterm birth can reduce these risks. This randomised controlled trial will assess the use of vaginal progesterone therapy for women at risk of preterm birth as a means of reducing the risk of neonatal Respiratory Distress Syndrome and improving the outcomes of their babies.Read moreRead less