ANZCTR search results

5-azacitidine, a demethylating agent, has been approved for use in USA for treatment of Myelodysplastic Syndromes (MDS), with overall response rates of approximately 48%, a delay to progression to acute leukaemia or death and an improvement in quality of life. Thalidomide has also shown some activity as a single agent in MDS though with poor tolerance at doses above 100mg/day. Neither of these agents is currently routinely available in Australia for MDS. This trial aims to show the safety and tolerability of the combination of these two agents in MDS, with responses at least as good as single agent 5-azacitidine, and to investigate further the mechanisms by which these drugs work and whether we can predict which patients may be more likely to respond.

Phase 1 This trial investigates the safety and feasibility of escalating doses of mesenchymal stem cells (multipotent stem cells that can differentiate into a variety of cell types) in people with life-threatening disease requiring umbilical cord blood transfusion. Who is it for? You can join this study if you have a life threatening disease – either leukaemia, lymphoma or myeloma – requiring umbilical cord blood transfusion. There are only nine participants in this trial. Trial details Participants will receive an infusion of mesenchymal stem cells. There will be three groups of three people only, given different doses of mesenchymal stem cells. Infusion toxicity will be measured up to 4 hours after transfusion. Adverse events including infection and recurrence of cancer up to 2 years after transfusion will also be measured. This trial aims to test the safety and feasibility of treatment with mesenchymal stem cells. The study will test the safety and feasibility of manufacturing mesenchymal stem cells from the placentas of women undergoing elective Caesarean section and transplanting the cells into people with life threatening blood cancers. The placentas would otherwise be discarded.

Study design: a parallel 18-month randomised, double-blind, placebo-controlled intervention trial with repeated measures every 6 months, totalling 4 measurement points. Participants: 400 men & women, aged 65-90 years. Intervention: Half the participants will receive fish-oil capsules and the other half will receive placebo capsules for 18 months. Outcome measures: cognitive performance and cognitive change, well-being, blood pressure, oxidative stress, and inflammation. Demographic and nutritional data will be collected as covariates.

1. To identify the prevalence of smoking and the potential impact upon patients entering into a non-smoking mental health environment. 2. To identify possible changes in patient refusal for admission / discharge due to smoking restrictions, and on the potential for a change in the ratio of voluntary / involuntary admissions. 3. To identify the relationship between the impact of staff implementing the smoking cessation policy and possible violence against staff & behavioural patient management 4. Establish baseline status of prescribed medications whose actions are known to be modified by smoking

Subjects presenting to the general practitioner (GP) with suspected or possible sleep apnea will be asked to participate, and undergo the components of the index test (questionnaire instruments, anthropometric testing and the home based portable monitor) and the reference standard in-laboratory polysomnogram in random order. All tests will be performed within a 4 week period. The results will not be communicated to the participant or the treating physicians until all components have been performed. The participants will then be referred to a sleep specialist to have the results of the polysomnogram discussed, and appropriate management instituted outside of the study, as dictated by usual clinical practice.

This study aims to compare a new intervention for alcohol craving with two other evidence-based treatments for alcohol use; 12 hours of CBT and a 2 hour brief motivational intervention. It is hypothesised that the new craving intervention will produce reductions in alcohol consumption and cravings greater than those achieved by the other two treatments.

The aim of this study is to determine the effect of regular maternal weighing in pregnancy to acheive optimal weight gains during pregnancy

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.