ANZCTR search results

This study monitored safety and measured specific and non-specific immunological parameters in smokers, who are a group at risk of recurrent bronchitis. This group was chosen rather than healthy non-smoking volunteers for this safety/pharmacokinetic study as it was thought possible that the immune parameters may differ in smokers to that in healthy non-smokers. This safety and immunogenicity study has been completed. It was not registered prior to initiation due to our unawareness of the registration system at that time. As it is a Phase I study and is not required to be registered it is being registered for the purpose of public information as we are now aware that post-initiation registration is possible

This study will evaluate the safety of a new antimicrobial (NEO101) applied to the inside of the nose twice-daily for 7 days. The reduction or eradication by the antimicrobial of nasal Staphylcoccus aureus will also be evaluated.

Traditionally, non-displaced or minimally displaced clavicle fractures in the mid third of the clavicle have been treated non-operatively. The consensus has been that they all heal. Many displaced mid-shaft clavicle fractures are treated non-operatively as well, but these fractures tend to heal with varying degrees of cosmetic deformity, because the fracture ends over-ride, typically causing a bump under the skin at the fracture site. Until now, the surgical scar from operative repair has been equally if not more displeasing cosmetically for the patient. Hill et al found non-unions in 15% of his patients with non-surgical treatment. He reported a clear correlation with shortenings of more than 2cm. At follow up of 157 patients, Matis et al found appreciable deterioration of shoulder function in half of the cases, showing clavicular shortening of 1cm; in cases in which clavicular shortening was 2cm or more deterioration was considerable. While most patients with a middle-third clavicle fracture will heal in a nonanatomic position, it is conceivable that elite competitive or professional athletes who engage in overhead or throwing activities, may not do well with a malunited clavicle. Consequently, treatment recommendations must be individualized. Neurovascular complications associated with non-union, including subclavian artery and vein compression, thoracic outlet syndrome, and brachial plexus palsy, have also been reported. A variable degree of malunion is present in displaced fractures of the middle clavicle, resulting in a permanent visible prominence over the fracture site, with related shortening of the clavicle and concurrent biomechanical disadvantage. Many authors suggest that such malunion results in acceptable function. This is of particular concern cosmetically and emotionally to people who cannot carry shoulder bags or who find it uncomfortable to carry a backpack over the affected area. As a result of the shortening and dropping of the shoulder, the thin straps of clothing can slip off, and low cut attire reveals a prominent cosmetic lump defect. Discomfort can also be experienced when car seat belts are worn. Economic losses whilst waiting for fracture healing, are due to restrictions on employment or non-training/competing time for athletes. There is also discomfort during daily activities with uncomfortable and painful sleeping postures, causing loss of sleep. Rowe reported that midclavicular fractures in adults were often underrated with regard to pain and disability during the first three weeks. In a review of 118 patients with clavicle fractures followed for 2 years, Eskola et al found that 27 (23%) had pain or limited motion with exercise, and 4 (3%) had major functional problems.

RATIONALE: Steroid therapy, such as dexamethasone, may reduce swelling, pain, and other symptoms of inflammation and may be effective in treating some of the problems caused by cancer and cancer treatment. Supportive care improves the quality of life of patients with a serious or life-threatening disease, and prevents or treats symptoms of cancer, side effects of treatment, and other problems related to cancer or its treatment. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether dexamethasone given together with supportive care is more effective with or without whole-brain radiation therapy in treating patients with brain metastases. PURPOSE: This randomized phase III trial is studying dexamethasone and supportive care to see how well it works with or without whole-brain radiation therapy in improving the quality of life of patients with non-small cell lung cancer that has spread to the brain and cannot be removed by surgery.

The use of androgen deprivation therapy (ADT) to reduce testosterone levels in men with prostate carcinoma is accompanied by a number of adverse side effects. This study will investigate the effects of aerobic and resistance exercise on reversing musculoskeletal and cardiorespiratory related side effects in prostate cancer patients undertaking ADT.

This is a phase II randomised, single, dose, masked, multicentre trial to determine the efficacy of 0.5mg Ranibizumab intravitreal injections in the treatment of macular oedema secondary to BRVO over one year compared with standard laser grid. Patients eligible for the study will be randomised to receive an intravitreal injection of 0.5mg Ranibizumab or placebo for 6 months. Patients will be monitored for a further 6 months to see whether further treatment is required. Patients are evaluated by a masked investigator at 3 and 6 months to determine whether they require laser grid, the current standard treatment for this condition. The primary outcome will be the proportion of eyes showing an improvement of visual acuity by 10 letters on the LogMar chart for the treatment group versus the sham group at 52 weeks compared with baseline. The secondary outcome will be the change in baseline OCT central macular thickness between the treatment and the sham groups at 52 weeks. The tertiary objective will be the change in the mean capillary non-perfusion between the sham/laser and treatment groups at 52 weeks and the number of patients requiring grid macular laser.

The purpose of this study is to determine if there is a difference between the number and severity of phototoxic reactions that occurr in patients with Erythropoietic Protoporphyria (EPP) treated with CUV1647 and placebo.

This study will evaluate the safety, including blood sampling for pharmacokinetic monitoring, of a new topical anti-infective (NEO101) applied to each nostril. A single dose will be applied on Day 1 and Day 7 of the study, and three-times-daily doses will be applied on Days 4, 5 and 6.

Trial will involve 80 obese subjects with BMI above 30. It will be randomised placebo controlled trial. Subjects will take Chinese herbal capsules for 12 weeks. The endpoints will be evaluated every 2 weeks.

Main purpose of this study is to identify if there is a need to offer of a large print label, on eye medications, to glaucoma patients that display certain visual function and disease characteristics. In turn, this may assist these patients in adhering to their prescribed treatment.