ANZCTR search results

Support of the circulation during heart surgery using the heart-lung bypass machine is inevitably associated with organ damage and associated reduced function. This is due to reduced blood flow (ischaemia), the effects of restoration of flow (reperfusion injury) and the subsequent inflammation that is caused. The body has its own way of protecting itself against reduced blood flow and oxygen by a mechanism known as preconditioning. In essence, brief periods of mild ischaemia are protective against a subsequent more severe episode of ischaemia. These periods of mild ischaemia can be of the organ itself or of another organ in the body. For example ischaemia of the leg can protect the heart against ischaemia, so called “remote preconditioning”. We have shown in animal and human models that remote preconditioning using a tourniquet placed around the leg for brief periods (similar in duration to when taking blood samples from children) reduces the amount of injury to heart muscle by 50% and also leads to improved heart and lung function. We have shown that remote preconditioning in a similar way protects the organs of a heterogeneous group of children undergoing cardiac surgery, resulting in better function of the heart and lungs and also a reduction of the inflammatory response to the heart-lung machine. This could potentially reduce the problems in looking after children after surgery and also reduce the amount of time spent on the intensive care unit. We intend to study a more uniform group of patients undergoing cardiac surgery in the neonatal period. All interventions will be performed during the period of routine general anaesthesia at the time of surgical repair. We will study the degree of organ injury induced by heart-lung bypass using standard intensive care parameters and equipment for measuring lung function. In addition, the degree heart muscle death and inflammation will be assessed by blood tests. Samples will be taken from indwelling catheters routinely placed at the time of surgery and not require additional venepuncture. Measurements will be made prior to surgery and also at set time intervals in the first 24 hours postoperatively to determine the evolution of effects.

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.

In people with medial knee osteoarthritis, a 12-week program of strengthening the hip abductor and adductor muscles will reduce knee loading during walking gait, as measured by a reduction in the knee adduction moment.

This trial involves premenopausal women who after surgery for their breast cancer are found to have tumours which are hormone receptor positive (stimulated by hormones) and who also have positive axillary lymph nodes (‘glands under the arm pit’ containing cancer). For these women it is not known whether hormonal treatment alone is sufficient, or whether the addition of chemotherapy may be beneficial in reducing the incidence of disease recurrence and improving survival. Women who take part in this trial will all have their ovarian function suppressed and receive Tamoxifen. In addition, patients may or may not receive chemotherapy.

Trials of adjuvant tamoxifen in women with early breast cancer have demonstrated a highly significant improvement in 10-year survival. However it is not yet known how long women with early breast cancer should continue to take adjuvant tamoxifen. The ATLAS trial will determine if it is better to stop taking tamoxifen after 5 years, or continue taking it for another 5 years (10 years in total).

This clinical trial is for post and perimenopausal women who after having surgery for their breast cancer are found to have tumours which are stimulated by oestrogens (‘oestrogen receptor positive’) and who have cancer present in the glands of the arm pits (‘positive axillary lymph nodes’). For this group of women it is not known whether the addition of chemotherapy to hormonal treatment is beneficial in reducing disease recurrence and improving survival. Patients on this trial will all receive a hormonal therapy for their breast cancer. Some patients will also receive chemotherapy either at the same time, or before their hormonal treatment. This will be determined by a process called randomisation which is similar to the toss of a coin. This trial assesses the optimal way of combining these treatments for this type of breast cancer.

This study investigates if: (i) high-protein diets are superior to standard low-protein diet, and (ii) animal protein is superior to plant protein in weight management of overweight and obese individuals.

This project is investigating the optimal use of docetaxel and doxorubicin in the treatment of women with breast cancer and involved lymph nodes (N+). The efficacy of adjuvant chemotherapy in early breast cancer is well established by the international overview conducted by the Early Breast Cancer Trialist's Collaborative Group (EBCTCG). They have demonstrated the efficacy of adjuvant chemotherapy on reducing mortality and recurrence rates, but current regimens are far from optimal. Docetaxel (Taxotere), a new agent, has effectiveness and manageable side effects in the treatment of advanced breast cancer patients, and can plausibly improve outcomes for patients with early N+ breast cancer by optimal integration into current adjuvant chemotherapy regimens. This clinical trial is designed to compare whether it is advantageous to use docetaxel and/or doxorubicin in combination or sequentially with other currently available chemotherapy drugs

The ATAC trial is testing an alternative, new agent, to tamoxifen for women with early breast cancer. The new agent, Arimidex, is an aromatase inhibitor which acts to reduce the level of circulating oestrogen in post menopausal women. This drug seems to be well tolerated and also effective against breast cancer. The ATAC trial is a double blind study comparing 5 years of tamoxifen, with 5 years of Arimidex, and with 5 years of tamoxifen plus Arimidex. In addition, there are three very important sub studies which investigate the effects of the treatments on bone, the endometrium and quality of life (QOL). Australia had a high rate of recruitment to the QOL sub study and is also one of the few countries contributing to the endometrial sub study. The ATAC trial is one of the largest (over 9000 women internationally) and most rapidly completed breast cancer studies in the world. Active accrual to the main study and sub-studies was completed internationally in May 2000, and patient follow-up continues.