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ANZ 0301 / BCIRG 103 (1839 IL / 0219) : Presurgical Study Evaluating IRESSA
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Adjuvant Therapy for Postmenopausal Patients with Operable Breast Cancer who have Estrogen Receptor or Progesterone Receptor Positive Tumors. Tamoxifen vs. Letrozole vs. Tamoxifen followed by Letrozole vs. Letrozole followed by Tamoxifen
Expand descriptionTamoxifen is a hormone tablet that improves cure rates in women with early breast cancer. Letrozole is a new hormone tablet that has recently been shown to work in advanced breast cancer. This international trial will determine if in women with early breast cancer, Letrozole is as good or better than tamoxifen, and whether taking both together is better still.
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HERA (HERceptin Adjuvant) Trial
Expand descriptionThe best treatment for some women with early breast cancer includes a few months of chemotherapy after their surgery. However, even with the best treatment, the cancer sometimes re-occurs. Trastuzumab, also known as Herceptin, is a new drug that targets breast cancer cellls that have a special receptor (HER2) on them. Trastuzumab is benefical for women with advanced breast cancers that have HER2. This large, international trial will determine if adding Trastuzumab to best standard treatment improves cure rates for women with early breast cancers with HER2. It will also determine whether it is better to continue treatment with Trastuzumab for 1 or 2 years.
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MOSAIC (Mothers’ Advocates In the Community)
Expand descriptionMOSAIC is a community randomised trial which examines whether mentor mothers can reduce partner abuse and depression, and strengthen health, wellbeing and mother-child bonds in women who are pregnant or have children under 5, attending upskilled and supported Maternal and Child Health (MCH) nurses or GPs. Mentor mothers (MMs) are para-professional trusted community women with additional training in domestic violence and parenting skills, who provide home-visiting, empowerment, advocacy and support to women pregnant or with children under 5, identified as abused or symptomatic of abuse by their GP or nurse. AIMS: The study’s primary aims are: • to reduce partner abuse or depression by 16% among women pregnant or with children under 5 whom GPs or MCH nurses identify as abused or at risk Its secondary aims are: • to strengthen infrastructure support for GP and nurse management of partner abuse, by enhancing effective inter-sectoral collaboration between general practice, MCH nurse teams and community-based family violence networks • to enhance health professional case management of family members living with partner abuse
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The Impact of Inpatient Weight Restoration in Adoelscent Anorexia Nervosa
Expand descriptionSimple Description of the Project This study examines the effect of length of hospital admission for refeeding, prior to manualised outpatient family therapy on outcomes for patients with AN. Subjects will include 72 children and adolescents aged 10 to 18 years admitted for medical management of AN of less than 3 years duration. This study aims to randomly allocate and compare outcomes between individuals with AN admitted for medical stabilisation, approximately 2 to 3 weeks, followed by 20 one hour sessions of outpatient family therapy over a 12 month period versus those admitted for full weight restoration, approximately 9 to 12 weeks also followed by 20 one hour sessions of outpatient family therapy. Physical and psychological outcomes will be measured at admission, at discharge from hospital, completion of outpatient treatment and at 6 and 12 months following outpatient treatment. Interpretation of Results If hospitalisation to a minimum healthy weight produces equivalent outcomes this has the potential to reduce the standard length of current hospital treatment for AN in adolescents from approximately 9 to 12 weeks to 2 to 3 weeks, resulting in benefits including savings of hospital based resources and reductions in the disruptions to schooling, peer and family relationships, adolescent development and family life. Should this not be the case this would support this would support the need for increased periods of hospitalisation with the possible benefits including reduced hospital readmission rates, decreased length of illness, decreased medical complications from malnutrition and lower levels of family and patient distress.
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A Phase I, single dose, open, two-way crossover blood level study of vardenafil blood levels administered as LEVITRA 10mg oral tablets verses a single dose of vardenafil aqueous solution administered to healthy volunteers by inhalation using the IMT nebuliser
Expand descriptionThe study aims to compare the blood levels of vardenafil produced by a single Levitra Tablet vs a nebulised (inhaled) dose of vardenafil.
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The Rabeprazole and Esomeprazole Reflux Assessment Trial
Expand descriptionThe primary purpose of the TREAT study is to compare the number of subjects in which heartburn and regurgitation symptoms resolve after being treated with either PARIET 20mg, NEXIUM 20mg or NEXIUM 40mg. All 3 medications are commonly prescribed for Gastro-oesophageal Reflux Disease (GORD). It is hypothesised that PARIET 20mg will be non-inferior to NEXIUM 40mg in resolving GORD symptoms.
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The effect of remote ischaemic preconditioning on lowering postoperative myocardial troponin I release in children with congenital heart disease undergoing cardiopulmonary bypass.
Expand descriptionSupport 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.
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A Phase 3 Study of Abatacept in Patients With Active Ulcerative Colitis
Expand descriptionThe 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
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A Phase 3 Study of Abatacept in Patients With Active Crohn's Disease
Expand descriptionThe 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.