There are about 10460 clinical studies being (or have been) conducted in Australia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients through Month 36 posttransplant. Patients will continue their study medications that were previously assigned.
To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients
The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.
A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis.
Adequate administration of drugs via dry powder inhalers is dependent on adequate inspiratory flow rates and volumes. These vary according to the device being used and its resistance. The dry powder inhaler device under investigation is a device approved by the Therapeutic Goods Administration (ARTG no. 196255) for use with dry powder mannitol. Dry powder mannitol is currently being investigated as a treatment for bronchiectasis. We wish to measure the inspiratory flow characteristics of both the low and high resistance devices amongst a group of subjects with bronchiectasis. We propose that the majority of subjects investigated with varying lung function will achieve adequate flow during a controlled inspiration.
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
Urotensin II (U-II) is newly discovered protein that may play an important role in human health and disease. U-II has been found to be a potent vasoconstrictor (narrower of blood vessels) which therefore may be involved in important diseases such as chronic heart failure - CHF (weak heart muscle disease). Many vasoconstrictors have been found to have effects on key organs such as the heart. Preliminary data by our group have demonstrated this is true of U-II. Recent evidence shows that in CHF, U-II levels in the blood are increased. The proposed study seek to determine the effect of blocking a possible downstream mediator of U-II on blood vessels by administration of soluble epoxide hydrolase inhibitor (sEHI). There will be 2 study groups 1) Healthy volunteers and, 2) CHF patients. Each arm of the study will run independently and will require 16 participants each (16 normal subjects and 16 CHF subjects). Participants will be screened to ensure that they are eligible. CHF patients will be required to withdraw from their CHF medication 24 hours prior to the study day (except for diuretics). On the study day, sEHI will be administered on the skin of participants in 3 asceding dosages. The technique to be used is iontophoresis. This is a non invasive technique in which a small amount of the compound is placed on the skin of the forearm. The drug is delivered across the skin by passing a small electric current over the area. The change in blood flow is then measured and analysed. We will also administer U-II agonist, noradrenaline, and distilled water (all via iontophoresis). Noradrenaline will be used a positive constrictor control. Change in blood flow will be assessed by Laser Doppler Velocimetry. If it is found that the sEHI is able to prevent blood vessel constriction in CHF patients, then it may represent a major therapeutic advance in the management of CHF.
This phase III trial studies the side effects of combination chemotherapy, 3-dimensional conformal radiation therapy, and an autologous peripheral blood stem cell transplant, and to see how well they work in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy or radiation therapy.
This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered for 6 (±1) days.