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.
The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and coagulation variables, vital signs and adverse events. Further objectives to evaluate are the influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red blood cells and serum.
SJW has the greatest evidence of herbal medicine efficacy in treating MDD. In treating anxiety, kava has the greatest evidence of efficacy. As comorbidity of MDD and anxiety commonly occurs, it is conceivable that a combination of an established antidepressant agent such as SJW and an established anxiolytic agent such as kava may effectively treat MDD presenting with comorbid anxiety. It is possible that a beneficial synergistic effect may also occur between SJW and kava, improving the treatment outcomes in MDD with comorbid anxiety, than by the individual substances alone. Determination of this is not addressed in this study due to limitations of time and resources. The determination of the strength of the SJW-kava combination will be ascertained by comparing similar trials using SJW and kava mono-therapy in addressing MDD and GAD. The hypothesis is that a combination of SJW and kava will reduce MDD occurring with comorbid anxiety more than placebo.
The purpose of this study is determine the minimal effective dose and the impact on: 1. treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode 2. the final maintenance doses 3. the use of other medications 4. the amount of changes to other antipsychotic medication 5. the number of hospitalization days
This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Dementing syndromes are, for the most part, incurable. People with dementia become highly dependent and frequently have to move from their homes into residential aged care facilities. Medications aimed at reducing the severity of a number of symptoms associated with the different types of dementia have had only modest success. Increasingly, people with dementia, their families and carers are turning to supplementary or alternative approaches to the management of their symptoms. There are many published reports describing the successful use of music therapy in reducing the severity of many symptoms of dementia. These include reports of improved memory, improved language skills, reduced anxiety and depression, reductions in agitation and disruptive behaviours and better social relationships with family, peers and carers. However, the quality of evidence they provide for the most part fails meet the standards of evidence required by health care providers. This clinical trial will examine the effects of a music therapy intervention. The study will recruit 180 patients in sub-acute hospital wards. Participants will be randomly placed in groups that receive either occupational therapy or music therapy. Before the therapy programs begin, we will use questionnaires to measure memory function, language ability, orientation and mood. We will also record brain activity from the surface of the scalp, blood pressure and pulse to examine physiological responses. The same measures will be repeated after the 3 weeks of therapy to determine whether there has been any improvement in the symptoms of the participants and whether the group that had music therapy showed greater improvement than the group that had occupational therapy. We will make a video recording during one therapy session to allow us to observe levels of engagement and to assess changes in facial expressions. This will provide information about the immediate effects of music on mood and social interaction. The information we collect about brain activity and blood pressure will help us to understand how music therapy might bring about changes in the symptoms of dementia. This understanding will be useful in developing better applications of music therapy. It will also add to our current knowledge about how the various diseases cause the problems they do. In summary, the primary aim of the project is to determine whether the reported effects of music therapy are supported by objective evidence.
To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population
To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)
The purpose of this study was to compare the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required.
The purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have demonstrated an improvement in lung function related to small airways obstruction and a significant improvement in respiratory symptoms and quality of life after a 2 week treatment with mannitol. This current study seeks to support these early findings and to extend the evidence to support its use as a mucoactive therapy in cystic fibrosis. In particular, the hypothesis that enhanced mucus clearance will improve the lung function and clinical presentation in this population, will be investigated. We also hypothesize that enhanced mucociliary clearance will result in a sustained reduction in mucus load, thus providing less opportunity for bacteria to proliferate, affording a reduction in antibiotic use and hospitalizations. The initial 6 month blinded phase will be followed with an additional 6 months of open label treatment.
COPD is a major cause of ill health and death in Australia with 40,000 hospital admissions, and a national cost of $898,000,000 annually. The gold standard treatment of COPD is steroids for inflammation, antibiotics for infection and bronchodilators and oxygen for respiratory failure. However, associated mucus hypersecretion is responsible for much of the inflammation and infection. The use of pharmaceutical agents to assist in the early clearance of the retained mucus has been limited, primarily because of lack of demonstrated effect. There has been a recent development of interest in pursuing new therapies for improving mucociliary clearance and several studies have demonstrated that clinical outcomes can be improved when osmotic agents such as mannitol are added to standard treatments. The purpose of this study is to conduct a pilot safety study in patients with an acute exacerbation of COPD to determine if it is safe to administer inhaled mannitol for facilitating mucus clearance.