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IBCSG 13-93 - Adjuvant therapy for premenopausal patients with node positive breast cancer who are not suitable for endocrine therapy alone
Expand descriptionThis clinical trial is for premenopausal women who after their breast cancer surgery are found to have breast cancer which is not suitable for hormonal treatment alone, and who also have cancer cells in the glands of the arm pit ('positive axillary lymph nodes’). It is known that these women will benefit substantially by having chemotherapy after surgery for breast cancer. The optimal chemotherapy program involves two short courses of different chemotherapy programmes (AC [doxorubicin or epirubicin + cyclophosphamide] & CMF [cyclophosphamide, methotrexate, 5-fluorouracil). It is not known whether the second chemotherapy course (CMF) should begin immediately after the first course (AC) or whether it should be delayed with a break in between. Whether or not a patient will have a gap between her chemotherapy programmes, as well as whether she will have Tamoxifen or not will be allocated by a process called randomisation which is similar to tossing a coin. This trial will test whether the delay between the chemotherapy courses is needed as well as if there is an extra benefit of adding a hormonal treatment to the chemotherapy.
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IBCSG 14-93 - Adjuvant therapy for post/peri menopausal patients with node positive breast cancer who are not suitable for endocrine therapy alone
Expand descriptionThis clinical trial is for post and perimenopausal women who after their breast cancer surgery are found to have breast cancer which does not contain hormone receptors (is not stimulated by hormones), and who also have cancer cells in the glands of the arm pit (‘positive axillary lymph nodes’). It is known that these women will benefit substantially by having chemotherapy after surgery as well as long term hormonal treatment for their breast cancer. The optimal chemotherapy program involves two short courses of different chemotherapy programmes (AC & CMF). It is not known whether the second chemotherapy course (CMF) should begin immediately after the first course (AC) or whether it should be delayed (with a break in between). Whether or not a patient will have a gap between her chemotherapy programmes will be allocated by a process called randomisation which is similar to tossing a coin. This clinical trial will assess which method of giving chemotherapy is optimal for decreasing the chance of breast cancer recurrence and increasing patient survival.
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Intergroup Exemestane Study (IES)
Expand descriptionAt present, it is standard for women with early breast cancer to receive five years of treatment with tamoxifen, following surgery. For many women, tamoxifen reduces the risk of breast cancer returning. However, some information suggests that tamoxifen may be of most benefit in the two to three years after surgery, after which it becomes less effective. The Adjuvant Exemestane trial will test whether it is better to take five years of tamoxifen, or to begin a new treatment (exemestane) after two to three years of tamoxifen, for the remainder of the five years. Exemestane is effective in patients with advanced cancer who have already been treated with tamoxifen and had their cancer return. Internationally, 4400 postmenopausal women who have had early breast cancer and taken two to three years of tamoxifen treatment will take part in the trial, and be given either exemestane or more tamoxifen to finish five years of treatment. It is hoped that switching treatments will be more effective at lowering the risk of breast cancer returning than continuing tamoxifen, and it may also lower the risk of developing long-term side effects from tamoxifen.
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BCIRG 007 / ANZBCTG 0102 A phase III trial to evaluate Taxotere® and Herceptin® Vs Taxotere®, Carboplatin and Herceptin® as First Line Chemotherapy in Metastatic Breast Cancer patients containing the Her2 Gene Amplification.
Expand descriptionApproximately 20-30% of women with advanced breast cancer have a genetic alteration in the HER2 gene (human epidermal growth factor receptor-2), causing an over-expression of the HER2 protein in the tumour, which is associated with a more aggressive disease and a worse prognosis. Patients with this type of breast cancer benefit from treatment with Herceptin when the patient has not previously received chemotherapy for their advanced disease. This randomised clinical trial evaluates the use of Herceptin in combination with currently available chemotherapy treatments in providing a better outcome for these patients by delaying progression of the cancer and death with as little toxicity as possible. The trial will compare two treatments: (1) a combination of the drugs Taxotereâ, platinum salt and Herceptinâ and (2) a standard treatment of Taxotereâ and Herceptinâ in combination without platinum salt.
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A RCT of OA self-management programs comparing health professionals to lay leaders
Expand descriptionA greater proportion of people with osteoarthritis of the knee who complete the OAK Program will report minimal clinically important improvements in pain, knee function and quality of life, at 8 and 12 weeks, compared with those completing the generic ASMP course.
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Identification of Susceptibility to Abacavir Hypersensitivity Reaction (HSR) in HIV-1 Infected Patients in Sydney, Australia and Development of Mechanisms for Risk Reduction
Expand descriptionThis study is being conducted in order to determine the proportion of HIV-1 patients attending Holdsworth House Medical Practice that may be susceptible to abacavir hypersensitivity reaction (HSR), which is associated with a genetic marker HLA-B*5701. Abacavir is a drug used in combination with other antiviral drugs, which is helpful in treating HIV infection. Abacavir is generally well tolerated, but 5-8% of patients develop an allergic reaction to the drug and the allergic reaction is much more common in those patients who have the genetic marker HLA-B*5701. Abacavir HSR is an allergic reaction characterised by respiratory and gastrointestinal symptoms that may be life threatening if abacavir dosing continues. Thus avoiding the use of abacavir in patients carrying this genetic marker will reduce the likelihood of developing a potentially serious allergic reaction. The study also aims to set up a model for a Registry where patient HLA-B*5701 results can be entered and made available to doctors who are licensed to prescribe HIV therapies in Australia via a secure password protected system. Ideally the Registry will be web-based, but if this is not feasible, it will be paper-based and managed by a recognised independent body already involved in the HIV field.
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IBCSG IX - Adjuvant therapy in postmenopausal patients with node negative breast cancer
Expand descriptionThis randomised clinical trial will compare the combination of three cycles of chemotherapy (CMF) followed by tamoxifen versus tamoxifen alone in postmenopausal patients with node negative, oestrogen receptor positive breast cancer to determine which therapeutic strategy is better in terms of disease-free survival, overall survival and quality of life.
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Statins in Sepsis Study
Expand descriptionBackground: 15,000 people are admitted to an Intensive Care Unit in Australia with severe sepsis every year. One third of these patients will die. Severe sepsis occurs when an infection causes dysfunction of one or more of the major organs (such as the heart or kidneys). A significant factor in this illness is that the body's normal response to infection or'inflammatory response' becomes abnormal. The statins are a class of medications commonly used in Australia to lower cholesterol. Previous research suggests that they may also have a beneficial effect on inflammation and that it may be harmful for people who are already taking statins to stop taking them if they develop severe sepsis. There is a lack of current information on the effects of these drugs in acute illness and the risks and benefits of continuing or starting treatment with them in patients with severe sepsis in the ICU. The aims of this project are: To assess the safety profile of atorvastatin in patients with severe sepsis To assess the effect of atorvastatin on inflammation and the outcome of patients with severe sepsis Research Design: A randomised controlled trial of atorvastatin 20mg versus placebo. Methods: Patients in the ICU with severe sepsis who meet the entry criteria will be given 20 mg of atorvastatin (a commerically available medication) or a placebo ("dummy drug"). The study drug will be given as a capsule by mouth or the contents will be given mixed with water via a feeding tube. Drug will be given once per day while the patient is in the ICU to a maximum of 28 days. Safety blood tests to look for signs of liver or muscle damage will be taken every day. Additional blood tests to assess inflammation will be taken 6 times during the study. All other care will be given as standard care.
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Investigation into the treatment of Female Pattern Hair Loss
Expand descriptionPilot studies show that spironolactone is effective in the arrest of female pattern hair loss and may result in some hair gain. However to date there have been no placebo controlled trials to verify this. As well minoxidil has been shown to be efficacious in the treatment of female pattern hair loss and there are recent case reports that it may have a synergistic effect when used with spironolactone. This project aims to study the effectiveness of these treatments as well as determining underlying tissue and genetic factors that may effect response.
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Evaluation of a couple-based program for promoting a positive transition to parenthood
Expand descriptionThe aim of the study is to test the effects of a couple based education program (Couple CARE for Parents) with couples having their first baby. We will assign couples to receive Couple CARE for Parents or usual woman focused education and support. We predict that Couple CARE for Parents will enhance couple relationship satisfaction, individual adjustment and parenting.