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IBCSG 24-02 / BIG 2-02: Suppression of Ovarian Function Trial
Expand descriptionPhase 3 This trial evaluates the role of suppressing ovarian function, and also the role of the drug exemestane as preventative therapies for premenopausal women with breast cancer that responds to hormones. Who is it for? You can join this study if you are a woman with early breast cancer that responds to hormones and you are still premenopausal even after treatment (with surgery or chemotherapy). Trial details Chemotherapy, hormone tablets, and turning off the ovaries all reduce the risk of breast cancer coming back in young women with early breast cancer that responds to hormone therapy. However it is unclear whether all 3 are necessary or what the best way to combine them is. This study will determine if turning off the ovaries for 5 years helps young women with early breast cancer Participants will be randomly assigned to receive Tamoxifen alone (standard treatment for this group of patients), ovarian function suppression with Tamoxifen, or ovarian function suppression with Exemestane (a drug designed to reduce the amount of oestrogen in the body, so as to reduce cancer growth). Patients assigned to ovarian function suppression as part of their treatment will be able to choose the method of treatment (either by tablet, radiotherapy or surgery).
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The effect of inspiratory duration and chinstrap during non-invasive ventilation
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A novel weight-bearing resistance training program for inpatient aged care rehabilitation: comparison with a non-weight-bearing program in a randomised controlled trial.
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A preliminary safety study comparing the concentration of a local anaesthetic absorbed into the blood (when trickling near the surgical site for 96hours after surgery) to published threshold for toxicity
Expand descriptionThis is a pilot study to consider whether post-operative pain management (following right hemicolectomy surgery using a lateral transverse incision) with continuous ropivacaine infusion using an elastomeric infusion pump (ON-Q Painbusterÿ¿??ÿ¿?ÿ¿ÿ®) for 96hr (rather than epidural) is safe, based on the margin between steady-state plasma ropivacaine concentrations attained (in particular, the unbound concentrations) and the systemic toxicity threshold(s). Whilst this device and local anaesthetic approach are currently used for post-op pain management, common usage in Australia is currently limited to 48-hr post-op.
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Chlamydia screening in general practice - a randomised controlled trial
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Resting energy expenditure and hip fracture
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SNAC2: A randomised phase III study to determine in women with early breast cancer whether sentinel node based management increases the risk of loco-regional recurrence and in particular, axillary clearance, compared with axillary clearance with any subgroup of women
Expand descriptionThe Sentinel Node versus Axillary Clearance (SNAC) trial was the first, large, Australasian prospective assessment of the risk of lymphoedema after surgery for early breast cancer. The trial compared sentinel node biopsy of selected lymph nodes with clearance of axillary nodes in women with tumours smaller than 3 cm. Short-term results showed that arm swelling was less in the group having only sentinel node biopsy. Both treatment groups had moderate limitations in arm movement over the first 6 months, which then recovered to near normal levels. The results showed that for women with small tumours, sentinel node biopsy was a viable alternative to axillary clearance. The patients are being followed up so that long-term effects can be measured. Outcomes at 3 years will shortly be published. In SNAC 2, the investigators are recruiting women with large or multiple tumours in a more extensive trial with similar questions, which will allow any differences in subgroups of women to be analysed.
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Safety and pharmacokinetic study of ACV1, a potential neuropathic pain treatment.
Expand descriptionThe primary purpose of this study is to assess the safety and tolerability of subcutaneous doses of ACV1 in healthy adult males.
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ESPRIT TOXIL-2 UNSW PSO 6361
Expand descriptionThis substudy is an open-label, randomised study comparing the uptake of rIL-2 in HIV-1 infected individuals receiving different combinations of antiemetics and analgesic agents during rIL-2 dosing in ESPRIT. The design is a factorial one with 4 arms, all patients will receive regular ibuprofen and paracetamol from days 1-6 of the rIL-2 dosing cycle in addition, patients will be randomised to receive one of two antiemetic combinations i.e. ondansetron or metoclopramide with or without low dose codeine phosphate as an additional analgesic agent.
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The effects of a nutritional supplementation on premenstrual syndrome
Expand descriptionA randomised, double blind, placebo controlled trial was conducted over 42 weeks using parallel groups of individuals with prospectively confirmed mild to moderate premenstrual tension. The primary outcome measure was the Premenstrual Symptom Score (PMSS) assessed by questionnaire. Women were initially enrolled based on the Menstrual Health Questionnaire results taken at baseline. They then completed the assessment instrument each day for 2-3 menstrual cycles. Subjects were then excluded if they did not demonstrate a 30% increase in premenstrual symptoms between the follicular and luteal phases of 2 consecutive cycles. Only subjects meeting these criteria were randomised for the intervention phase. The treatment arms were 1) Swisse Ultivite for Women and 2) placebo. Minimal side effects were reported during the treatment period. Initial consideration of the data pertaining to liver, renal and hemopoietic function showed no clinically significant changes. There were significant reductions in premenstrual syndrome symptoms between the pre-treatment and post treatment stages of the study for both the placebo and active treatments.