ANZCTR search results

The purpose of this study is to assess any benefits of adding a drug called ‘zoledronic acid’ (also known as ZometaTM) to the standard treatments for breast cancer. Zoledronic acid is one of a class of drugs that are known as bisphosphonates. In Australia, bisphosphonates are already approved to treat a number of medical conditions including osteoporosis (thinning of the bones), and in cancer patients to prevent pain and problems that occur when there has been spread of cancer to the bones. However, these drugs are not approved by Australian heatlh authorities for use in reducing the risk of breast cancer spreading to the bones. For this reason, ZometaTM is considered an investigational drug in this study. There is evidence from earlier studies that bisphosphonates may prevent cancer spreading to the bones. This may be through their effects on bone, which make it more difficult for cancer cells to damage bone. Additionally, very strong bisphosphonates like zoledronic acid may have effects on the cancer cells themselves or help the drugs you are receiving to treat your cancer better. This study was developed by doctors from the United Kingdom and Australia . The overall coordination of the trial is being done by the Clinical Trials and Research Unit at the University of Leeds, UK. The trial is being coordinated in Victoria by the Cancer Council Victoria who seek approximately 300 women to take part throughout Australia. Approximately 3,300 women will take part in this study internationally, half of the women who take part will have the standard treatment that is normally given to treat breast cancer (this half are known as the “control group”), and the other half will have standard treatment plus zoledronic acid. Women who choose to enter this trial may have treatments for 5 years and progress assessments for 10 years.

Meconium aspiration syndrome (MAS) is a complex disease of the newborn lung that can cause life-threatening respiratory distress very soon after birth. Current management consists mainly of providing supportive care, rather than removing meconium from the lung to hault or slow disease progression. This multicentre randomised controlled trial will test whether therapeutic lung lavage, using a dilute surfactant preparation, improves outcomes in infants with severe MAS. The study will include a total of 66 newborn infants, who are receiving mechanical ventilation because of MAS. The main outcome measure will be duration of respiratory support; secondary outcomes will be duration of oxygen therpay; duration of hospitalisation, and evidence of chronic lung disease.

The main purpose of this study is to investigate whether bosentan (Tracleer®) affects the wall thickness of the pulmonary arteries in patients with idiopathic pulmonary arterial hypertension (iPAH) and PAH related to systemic sclerosis (PAH-SSc)

The purpose of the study is to determine whether the use of heated, humidified carbon dioxide during laparoscopy lasting greater than 90 minutes results in less pain and shorter hospital stay than using cold, dry carbon dioxide (which is currently standardly used). Animal models show that use of cold, dry gas results in drying and damage to the cells in the lining of the abdomen, whereas using heated, humidified gas prevents this from occuring. Some human studies have shown that the heated, humidified gas results in less post-operative pain. Both the patients and the post-operative nursing staff will be blinded to the type of gas used. Patients will blinded to the type of gas used as randomisation occurs once they are under the anaesthetic. The type of gas used will not be recorded in the research notes and as such, the nursing staff will not be aware of the type of gas used.

This study in asthma examines the ability of lycopene-rich supplements to improve neutrophilic inflammation and disease control, and to reduce exacerbation frequency and severity. It uses a blinded comparison of subjects consuming lycopene-rich supplements versus placebo. It also includes a comparison group of subjects with a high dietary intake of antioxidants.

Given the significant incidence of deep venous thromboses (DVT) in critically ill patients and the failure of current prophylactic regimens to fully prevent DVT, additional pharmacokinetic information regarding the efficacy of heparin and fondaparinux in critically ill patients is required. We aim to assess the bioavailability of heparin administered subcutaneously and intravenously and fondaparinux administered subcutaneously in a cohort of critically ill patients with severe sepsis.

Subjects with mild to moderate obstructive sleep apnoea will be invited to participate in a supervised 4-month diet and exercise program. We will measure daytime function, quality of life and severity of sleep-disordered breathing before and after the study, and in addition will followup subjects for 12 months after they complete the active intervention protocol.

Adefovir dipivoxil 10mg tablets were approved for the treatment of chronic hepatitis B by the TGA in 2003 and are now marketed as Hepsera(r) by Gilead Sciences. Patients who are not resistant to another anti-hepatitis B virus drug called lamivudine are not able to access Hepsera at a PBS reimbursed price. Patients who participated in the adefovir dipivoxil clinical trials GS-98-437, GS-98-438, and GS-00-480 and are still taking adefovir dipivoxil have never received lamivudine and thus cannot receive Hepsera at reduced price. This study will allow the patients to continue accessing adefovir free of charge and provide unprecedented data on the long-term safety and efficacy of adefovir dipivoxil without changing the procedures and tests routinely done during normal visits to the clinic.

To determine whether patients with a history of gout are meeting nutritional requirements, are aware of dietary risk factors for their condition and whether they have a need or interest in receiving dietary support for their condition.

In this study we will compare the effects of fish oil (n=165) or placebo (n=165) in early infancy (from 0-6 months of age) on the risk of developing allergic sensitisation or allergic disease in early childhood. Both study groups will include children deemed to be at high risk of allergic disease (based on maternal allergy history).