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The purpose of this study is to test the safety and efficacy of a new treatment for COPD, HI-164OV, in participants with moderate to severe COPD. COPD (which includes emphysema and chronic bronchitis) causes irreversible damage to the lungs and is the most common respiratory disease in Australia affecting up to 1 in 10 people over the age of 45 years. Exacerbations of symptoms often require hospitalisation and happen most often during the winter months. HI-164OV is an oral vaccine tablet that contains killed non-typeable Haemophilus influenza bacteria, which are commonly found in the sputum of COPD patients. It is hoped that HI-164OV may help reduce the severity, duration and rate of exacerbations in COPD patients. The study is a multi-centre, placebo controlled, randomised, double blind study that will occur over 12 months. It is anticipated that 340 participants, aged 40-85 years, will be randomised in a 1:1 ratio to receive either HI-164OV or placebo. Participants will be asked to take the study medication on three consecutive days each month for the first three months (ie. nine doses in total). Each daily dose of HI-164OV contains 90 mg of HI-164 or placebo. Participants will be asked to attend seven study visits over a nine month period, approximately, for safety and efficacy assessments. Participants will be asked to keep a daily diary during the study to record COPD exacerbation details. Safety will be assessed by collecting data on adverse events, routine clinical laboratory measurements (haematology, biochemistry and sputum), cardio-thoracic physical examination, ECG and vital signs. The efficacy of HI-164OV in reducing the rate and severity of exacerbations in comparison to placebo will be determined by measuring: 1. number of moderate to severe acute COPD exacerbations 2. number of days of antibiotic usage 3. duration of acute exacerbations 4. duration of moderate and severe exacerbations 5. hospitalisations 6. quality of life (using the validated St George’s Respiratory Questionnaire-C)

This study looks at the effectiveness of bevacizumab when combined with a type of chemotherapy called carboplatin in treating recurrent Glioblastoma Multiforme (a type of brain tumour). Who is it for? You can join this study if you are a person with glioblastoma multiforme (GBM) (brain tumour) which has been previously treated with both radiotherapy and the drug temozolomide. Trial details Participants will be divided into two groups. One group (Arm A) will receive bevacizumab intravenously every 2 weeks until disease progression. The other group (Arm B) will receive bevacizumab intravenously every 2 weeks and carboplatin every 4 weeks until disease progression. Following disease progression, people in Arm A will receive carboplatin or best supportive care and either stop bevacizumab (Arm C) or continue bevacizumab (Arm D). People in Arm B will receive temozolomide or etopside or best supportive care and either stop bevacizumab (Arm E) or continue bevacizumab (Arm F). Best supportive care involves treatments to assist with controlling the symptoms of cancer such as antibiotics and pain medication. The study aims to measure the effectiveness of the different treatment regimes in terms of survival and well being.

Newly diagnosed PCNS lymphoma patients will be randomised to either 2 courses of MBVP or 2 courses of MBVP+Rituximab. All patients will undergo an MRI at the end of chemotherapy and be assessed for consolidation treatment with AraC, after which these patients will undergo another MRI to determine their eligibility or need for WBRT or not. The primary objective of the trial is event free survival.

Proclear's Phosphorylcholine (PC Technology TM ) has given Proclear lenses FDA clearance for the claim: “may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms relating to dryness during lens wear.” Such claim was debatable in previous literature. The purpose of this study is to evaluate clinical performance of Proclear 1-day contact lenses in terms of fitting, physiological and subjective responses. Such that comparison with other daily wear lenses especially new silicone hydrogel lenses can be made.

The purpose of this study is to investigate the effect of an acute exercise bout, based on current exercise guidelines for type 2 diabetic patients, on blood glucose levels.

Swinburne's eTherapy Unit will run a research trial to investigate the efficacy of a fully automated self-help online mindfulness intervention, Mindfulness Online, in the promotion of wellbeing amongst people who drink alcohol to harmful levels. Swinburne University of Technology's eTherapy Unit and National eTherapy Centre (NeTC) have developed numerous internet-based prevention and treatment programs that are available to the general public for the treatment of clinical conditions and the promotion of well being. To continue the development of effective online programs, information relating to the appropriateness and efficacy of specific programs for specific user groups is required. The current project seeks to examine the efficacy of the Mindfulness Online program (developed by Dr Jo Mitchell) in its application to adults aged 18 years and over, who scored 8 or higher on the AUDIT. The results of this research will inform future development and recommendation of internet based interventions for specific user groups.

Despite favourable trends in survival, heart failure (HF) remains a leading cause of mortality and morbidity across the developed world. Consequently, emphasis has been placed upon identifying solutions for the treatable co-morbidities associated with this chronic, incurable disease. Sleep disorders are one of the most commonly reported features of HF. Sleep disorders are a group of syndromes which are characterised by disturbance in the amount, quality, timing or architecture of sleep. The most frequent and troubling of these in HF includes Obstructive Sleep Apnoea (OSA) syndrome, Central Sleep Apnoea syndrome (CSA), periodic limb movement disorder and insomnia. These disorders impair quality of life (QOL) and are linked with repeat health care visits. Exercise is an important component of the multidisciplinary management of HF and has recently been established in the ACTION:HF study as an effective means of improving the QOL of HF patients. Exercise is also thought to improve sleep in this population however this theory remains controversial in light of small number of studies conducted in the area to date. The hypothesis that exercise improves sleep in HF patients has been developed in reflection of the positive effect of exercise on sleep seen in elderly populations and patients with other chronic diseases. These studies are valuable sources of information as the typical HF patient shares many of the co-morbidities seen in patients studied. The common theme established in these publications is that physically active patients have improved sleep duration and quality when compared to their sedentary counterparts. Physical activity has been identified to relieve problems associated with frailty and disease co-morbidities and lacks many of the negative side-affects related to sleep medications such as confusion and falls. It is linked with improvements in vitality, symptom severity, daytime sleepiness, depression, QOL, pain and strength. Physically active patients also exhibit improved ventilatory capacity, reduced vascular resistance and improvements in endothelial dysfunction. Polysomnography (PSG) is the current gold standard device for the examination of sleep disorders but is expensive, labour intensive and limited in its availability. Reliance on quantitative measures to identify sleep disturbance may not be practical in this population given the limited availability of PSG combined with the fact that HF is an increasingly common disease with correspondingly high rates of sleep disorders. In addition, as it is often the individual’s perception of their sleep state which motivates them to seek treatment, examination of sleep quality may be cost-effective, convenient alternative to ensure the prompt identification of sleep disturbance. Appropriate medical management of HF is thought to alleviate sleep disturbance however studies suggest that treatments produce only minor improvements in sleep in this population. The most common non-pharmacological form of treatment for diagnosed sleep apnoeas is continuous positive airway pressure (CPAP). Several studies have found that although CPAP may decrease the number of apnoeas and hypopneas and improve sympathetic activity it fails to improve cardiovascular variables or overall survival in HF. CPAP machines are also difficult to use and cause significant patient discomfort. Given issues associated with current screening and treatment methods of sleep disorders and in light of increasing demand on the health care resources in this population there is a need to identify alternative solutions for sleep problems in HF patients. Exercise presents a potential therapeutic alternative given poor CPAP compliance and limited alternative treatment options. The examination of the effect of exercise on sleep quality in contrast to sleep architecture is important as an outcome of improved sleep is one which carries a real meaning for patients and is likely to improve compliance with exercise regimes. In addition, the improvement of sleep through exercise is expected to have direct physiological benefits for HF patients and may improve cardiovascular variables and overall survival.

Dental caries (tooth decay) is the second most costly diet-related disease in Australia. Its economic impact is comparable with that of heart disease and diabetes with an increasing total expenditure for dental services from $4.4 billion per annum (6.1 % of total health expenditure) in 2001 to more than $5.3 billion per annum (10% of total health expenditure across Australia) in 2007. Research has demonstrated that placing dental fillings does nothing to manage the dental caries disease process. Minimal Intervention Dentistry (MID) is a multi-pronged approach which focuses on the management of dental caries as a diet related, transmissible, infectious disease. It comprises measures that range from prevention, early intervention, and treatment. The proposed research will be undertaken with a group of adolescent public dental patients (concession-card holders). The current direct-service delivery model does not place specific emphasis on the management of dental caries through caries risk assessment, prevention or early intervention. The overall goal of this project is to undertake a pilot study to test the impact on caries-risk status of implementing a MID clinical protocol to a group of adolescent public dental patients (aged 13-18 years) who are at high risk to dental caries.

This study aims to compare the efficacy of ultrasound guided intralesional injection of autologous platelet rich plasma (PRP) with corticosteroid injection for plantar fasciitis present for more than six weeks that has failed to settle symptomatically with conservative management.

Observational pharmacology/pharmacogenomic/imaging study in patients receiving standard FOLFIRI ± Avastin for advanced incurable colorectal cancer. Patients will undergo baseline nuclear hepatic functional imaging with IDA scans and bloods will be taken for metabolic/pharmacodynamic pharmacogenomics. Bloods will be taken for Irinotecan PK in course 1. Toxicities will be documented in the first 4 cycles and patients will be restaged at the end of cycle 4 (i.e. 8 weeks). No trial involvement beyond 4 cycles is required and treatment beyond this point will be at the discretion of the treating clinician.