ANZCTR search results

To determine the safety and tolerability of ALD403 via injection and infusion in healthy participants. To determine the pharmacokinetics, pharmacodynamics, and immunogenicity of ALD403 via injection and infusion in healthy participants.

This project aims to develop and test a nurse-led model of survivorship care for lymphoma survivors. You may be eligible to join this study if you are over 18 years, have completed first line chemotherapy treatment for new Hodgkin or non-Hodgkin lymphoma or second line curative intent autologous transplant and have no evidence of lymphoma on PET scan. Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will continue to receive usual follow-up care with their haematologist. Participants in the other group will take part in an evidenced-based survivorship clinic that will provide tailored care to meet the informational and practical needs of lymphoma cancer patients who have completed active treatment. The nurse-led lymphoma survivorship clinic intervention will involve three 1 hour face-to-face structured interviews that will occur over a 6 month period. These will involve discussion and delivery of a survivorship care plan, treatment summary and resource pack. Participants in both groups will be asked to complete a number of questionnaires at baseline, 3 months and 6 months in order to evaluate unmet informational and practical needs, depression, anxiety, stress, coping and self-empowerment. The findings from this study will add to a limited body of knowledge in this cancer survivor group and make a significant contribution to the planning and delivery of survivorship care.

The older population often presented with changes in mood, such as depression. Biological changes in the body can contribute to depression. These changes can be altered by strategic management of light exposure. It is believed that exposing older people to light in the early morning will lead to biological shifts, which will reduce depressive symptoms. The purpose of the study is to see whether exposing older people to artificial light and natural sunlight can improve their symptoms of depression, with the aim of improving treatment opportunities for the older population.

We aim to measure the adequacy of preoxygenation by NRB and BVM in the abscence and presence of a simulated mask leak, and whether the addition of oxygen via NP significantly improves preoxygenation in these conditions, as measured by ETO2. We propose to perform a four-period crossover study (repeated measures design) with two arms, using healthy volunteers. There will be a NRB arm and BVM arm. After informed consent participants with be randomised to NRB and BVM. They will then be randomised to a sequence of 3minutes preoxygenation using the NRB, NRB+NP, NRB and simulated leak, NRB+NP and simulated leak in the NRB arm; or BVM, BVM+NP, BVM and simulated leak, BVM+NP and simulated leak in the BVM arm. ETO2 and endtidal carbon dioxide (ETCO2) will be measured using the gas sample analyser on an anaesthetic machine. Participants will also be asked to rate their comfort with each preoxygenation method.

This pilot trial aims to evaluate if a structured exercise intervention improves fitness, lowers fatigue and improves quality of life in adolescents and young adults after the completion of cancer treatment. Who is it for? You may be eligible to join this study if you are aged between 15 and 25 years of age, are diagnosed with a haematological malignancy or solid tumour and have completed a systemic cancer treatment (ie chemotherapy and/or radiotherapy). Study details: Participants in this study will be assigned to either an intervention group or the control group by chance. Participants in the intervention group will receive 10 weeks of structured, individually tailored exercise intervention performed twice a week for 60 min per session. The control group will not receive exercise physiology input and will not be offered an exercise intervention during the study period; however no restrictions will be imposed on their activities. (Once the study is over, control patients will be offered participation in an exercise intervention if they want, but this will not be part of the study). Participants in both groups will have a blinded assessment of physical fitness, fatigue, and quality of life at baseline, 10 weeks, and 6 months. These measures will be compared between the group undertaking the programme and the control arm to determine whether the programme is associated with initial improvements, and whether these improvements are sustained at 6 months. It is hoped that this study will help determine whether a structured exercise programme speeds up recovery of physical fitness, reduces fatigue, and improves quality of life in adolescent and young adult patients who have been treated for cancer.

This study aims to investigate the safety and patient experience of prescribing by credentialed physiotherapists. Patients attending emergency departments and outpatient clinics with musculoskeletal conditions will be prescribed medications from a limited list to manage pain and support physiotherapy treatment.

Schizophrenia has a lifetime risk of 7.2 per 1000 persons with 25-50% of people with schizophrenia failing to respond to typical and atypical antipsychotics. For these people clozapine is the gold standard treatment, however, clozapine greatly increases the risk of weight gain and type 2 diabetes (T2DM) which contribute to cardiovascular disease and premature mortality. Current interventions against antipsychotic-associated metabolic dysregulation are limited and insufficient. The mechanism of action for metabolic abnormalities associated with clz is not completely understood; however, recent pre-clinical models have shown that clozapine causes acute deficits in glucose metabolism. This occurred via suppression of glucagon-like-peptide-1 (GLP-1) levels and these defects could be overcome by treatment with a GLP-1 agonist. Exenatide, a GLP-1 agonist, is available in a once weekly injectable formulation which is practical for this population with poor adherence. Therefore, in consideration of the promising preclinical data, the use of exenatide, which is already known to improve glycaemic control and reduce body weight in subjects with and without T2DM, may represent an effective therapeutic intervention for clozapine-associated obesity and T2DM. Therefore, the present study is a 24-week investigator-initiated, parallel group, randomised, open-label pilot study designed to evaluate the acceptability of exenatide weekly and determine the preliminary clinical efficacy and tolerability of exenatide for weight loss and glycaemic control in clozapine-associated obesity and T2DM. This study also has exploratory objectives to examine the feasibility of recruitment, retention, assessment methods and implementation of this intervention for subsequent larger scale, multicenter studies.

Arthritis NSW has identified that there is a need for more information and support for women faced with family decisions in the context of their RA. Therefore the aim of this project was to develop a Decision Aid (DA) resource (printed booklet and an online version) for women with Rheumatoid Arthritis (RA) who were contemplating pregnancy. In order to evaluate the effectiveness of the DA, a randomised control trial (n = 200) was conducted with women diagnosed with RA, aged between 20-45 and who may be contemplating pregnancy.

A prospective, randomised study of seriously injured, shocked adult trauma patients in an urban setting, comparing resuscitation outcomes and serious adverse effects of an intravenous oxygen carrier (HBOC-201) to Normal Saline. In this Victorian study environment it is expected that all patients transported by road to a Major Trauma Centre will have prehospital times of >=20 minutes from the time of first ambulance arrival.

The aim of this project is to evaluate the feasibility and safety of dancing classes for individuals with Parkinson's disease (PD). We will compare mixed genre dancing classes with Argentine tango classes. Mobility, walking performance, quality of life and wellbeing will be assessed up to one week before, up to one week after the program. Our hypothesis is that participants in the mixed dancing group will improve the outcomes analysed more than the ones on the tango group.