ANZCTR search results

This is a study on the safety and effectiveness of accelerated treatment with three chemotherapy drugs (bleomycin, etoposide and cisplatin with pegylated G-CSF) known as ‘accelerated BEP’, in treating people with advanced germ cell tumours. Who is it for? You can join this study if you have germ cell cancer that has spread to distant sites and is widespread. Trial details All participants will receive accelerated BEP chemotherapy intravenously over two week cycles. The number of cycles will be determined by the person’s risk of disease and their response to treatment. Accelerated BEP is a more intense treatment than the standard treatment, and may cause more side effects. This clinical trial will investigate the safety and efficacy of the new regimen as well as its impact on lung function, and neurotoxicity as rated by the participants.

Comparison of Argon plasma Coagulation with surveillance for the reversal of Barrett's oesophagus and the prevention of cancer in the oesophagus, in patients who are taking conventional medications for gastroesophageal reflux

Comparison of Argon plasma Coagulation with surveillance for the reversal of Barrett's oesophagus and the prevention of cancer in the oesophagus

Respiratory dysfunction is a major cause of morbidity and mortality in spinal cord injury (SCI). Therapeutic singing exercises have been demonstrated to develop muscle control, expand lung capacity and increase vocal intensity with other clinical populations. This study will be the first to systematically document the physiological effect of singing instruction on respiratory function and voice projection in a quadriplegia population. All subjects will participate in physiological and acoustic assessments whilst vocalising, singing, and speaking. Forty subjects with chronic cervical SCI will be randomised into control and experimental groups. Subjects in the treatment group will participate in twice weekly singing instruction in small groups (n=5), with an additional weekly homepractise session, for a period of 20 weeks. All subjects will repeat the initial assessments after 10 and 20 weeks. Control subjects will participate in the vocal training after 20 weeks. The relevance of this project is indicated by research that shows that respiratory disorders and subsequent diminished vocal projection are common and disabling in the quadriplegia population. Singing training has been shown to improve respiratory capacity and voice projection in other clinical populations. In a health care setting where evidence-based practise is highly valued, the examination of the effect of this innovative therapy on ventilatory function is strongly indicated.

The aim of this project is to look at how feasible it is to (1) conduct a functional exercise program in addition to a usual rehabilitation program, and (2) to explore how effective an outcome measure (Physical Performance Test) is at measuring the physical function of people being admitted and discharged from an in-patient rehabilitation program.

The broad aim of the project is to compare MAS and CPAP treatment in patients with Obstructive Sleep Apnoea to test the hypothesis that these treatments have equivalent health effects in terms of important clinical outcomes as a result of the superior efficacy of CPAP being offset by lower treatment compliance than MAS.

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