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A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel plus or minus Sorafenib (BAY 43-9006) in chemonaive patients with Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC) Bay 43-9006 / 11961
Expand descriptionThis study is designed to compare the efficacy of sorafenib in combination with paclitaxel and carboplatin versus placebo in combination with paclitaxel and carboplatin for patients with NSCLC Stage IV or Stage IIIB with pleural or pericardial effusion. Treatments will be blinded to both the investigator and the patient. Double-blinding will be assured by having identical packaging of the sorafenib treatment and the placebo. An interactive voice response system will be used to accomplish allocation of treatment group.
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The Quality of Life Outcomes and the Pharmacokinetic and Pharmacodynamic Sequelae of Testosterone Undecanoate Injections compared with Testosterone Implants for Androgen Replacement Therapy in men with Classical Male Hypogonadism
Expand descriptionThis study is designed to determine whether men with androgen deficiency prefer a long acting injection that requires administration each three months or whether they prefer subcutaneously implanted testosterone pellets administered approximately each 6 months.
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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung Cancer or Esophageal Cancer
Expand descriptionThis trial is a randomized, double-blind (investigator and patient), multi-center, 2 arm, parallel design study of aprotinin (Trasylol) versus placebo in subjects undergoing selected surgeries on the lung consisting of planned complete primary pneumonectomy or other pulmonary resection with high likelihood of blood transfusion, completion pneumonectomy or decortication for lung cancer, or undergoing esophagectomy (by transthoracic or transhiatal approach) for esophageal cancer. The aprotinin or placebo will be given by intravenous infusion until the end of the surgery.
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Improving intra-family support during paediatric bone marrow transplantation: a randomised controlled exploratory study of videotelephony
Expand descriptionTo determine whether videotelephony is an effective means of improving support during paediatric bone marrow transplantation at a metropolitan hospital
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Improving paediatric palliative care for rural and remote families: a randomised controlled exploratory study of videotelephony
Expand descriptionTo determine whether videotelephony is an effective means of improving the support provided to regional and remote families receiving paediatric oncology palliative care from a metropolitan hospital
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A randomised double blind placebo controlled clinical trial of the efficacy of an Australian naltrexone implant compared to oral naltrexone for the long-term management of heroin-dependent persons
Expand descriptionGoMedical Industries has developed a formulation of sustained release naltrexone, suitable for subcutaneous depot administration. Currently, implants are inserted by minor surgery under local anaesthetic in high risk patients under the Therapeutic Goods Administration (TGA) Special Access Category A scheme (SAS) through the Australian Medical Procedures Research Foundation (AMPRF), Western Australia. Although there is a preliminary basis for believing that this naltrexone implant treatment may offer significant benefits over oral and other naltrexone depot preparations thus far reported for managing the heroin dependent patient, this needs to be verified through a clinical trial. Hence, the main objective of this study is to provide rigorous clinical data using a double blind, double placebo controlled study, on the effectiveness of this naltrexone implant compared to oral naltrexone in the management of heroin dependent persons by primarily monitoring: maintenance of blood naltrexone and 6-b-naltrexol concentrations above therapeutic levels; prevention of accidental opiate overdose; reduced opiate use; reduced opiate related morbidity and mortality; reduced craving for heroin and other health related outcomes.
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Fetal intrapartum pulse oximetry to reduce operative delivery rates in the presence of a non-reassuring fetal heart rate: a multicentre randomised controlled trial (the FOREMOST trial).
Expand descriptionCurrent methods of monitoring the well-being of the unborn baby during labour often result in concern about the unborn baby's health. This leads to delivery by caesarean section, forceps, or vacuum. These babies are usually found to be healthy once born, meaning that the operation was unnecessary. In this study, when an unborn baby appears to be distressed, half of the study participants will be allocated to continue with the current monitoring of the baby's heartbeat. The other half will have a new form of monitoring, fetal oxygen saturation monitoring, added. We will then determine whether the new form of monitoring makes a difference int he number of times women need to have a caesarian section, forceps or vacuum delivery.
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Monotherapy Phase II Dose Ranging Study of DAC HYP in Relapsing Remitting Multiple Sclerosis
Expand descriptionThe purpose of the study is to determine whether or not 3 different doses of DAC HYP are effective in decreasing the number of abnormal spots (lesions) on brain magnetic resonance imaging (MRI) scans and in delaying the progression of MS, and to test the safety of DAC HYP in patients with relapsing-remitting MS. This is a double blind, parallel group study where subjects will receive either placebo, or Dac HYP 25mg, 100 mg or 200 mg every 4 weeks by subcutaneous injection for 52 weeks.
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A clinical trial of neoadjuvant taxane chemotherapy for women with locally advanced breast cancer
Expand descriptionPreliminary studies indicated that docetaxel and doxorubicin work well in patients with incurable breast cancer. The doses used in this study were based on earlier phase I studies. Phase II studies had been done to assess the effect of the combination of docetaxel and doxorubicin. This combination was found to work well in patients with metastatic or incurable breast cancer. This study will allowed us to use both drugs in a different way - that is, before surgery and in patients with locally advanced breast cancer (where the cancer has not spread anywhere else). By doing the study, we hoped to provide better local treatment and better cure rates. This had not yet been proven in earlier studies.
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Trial of nurse and GP partnership for care of COPD
Expand descriptionThis cluster randomised controlled trial (RCT) tests a new approach to improving the care of patients with Chronic Obstructive Pulmonary Disease (COPD) managed in general practice. The intervention involves a registered nurse with specific training and the general practitioner (GP) working in partnership with the patient and other health professionals to provide evidence-based care according to the Australian COPDX guidelines. The research aims to determine the impact of this partnership on the quality of care and health outcomes for patients with COPD at six and 12 months follow-up. The hypotheses to be tested are: 1. The intervention improves disease-related quality of life and overall health of patients with COPD measured by patient health status, lung function and health service use 2. The intervention improves the quality of care provided to patients with COPD with impacts on knowledge, immunisation compliance, smoking cessation and satisfaction with care. Since this trial is Single Blind, the data collection staff will be blinded to group allocation.