ANZCTR search results

This integrated, adaptive, single and multiple dose study is designed to determine the maximum tolerated dose as assessed by safety and tolerability and to determine the plasma pharmacokinetics of EMA401 following single and multiple escalating doses, administered orally (up to 2,000 mg/day) in healthy adult male subjects.

The Women's Wellness after Cancer Program (WWACP) will determine the effect of a 12 week, e-health enabled program, on the health-related quality of life (HRQoL) in women who have received treatment for breast, blood, or gynecological cancer. Those who are eligible to join the study are women aged 18 years or above who have completed surgery, chemotherapy, and / or radiotherapy within the past 12 months. Participants in this study are randomly allocated (by chance) to one of two groups. Participants in the intervention group are are given access to an e-health enabled, structured health promotion program which will include an interactive iBook and website containing health information, planning and goal setting, and three personal conferences with a nurse via video-conferencing. Participants in the control group will receive usual care which includes only that information and support that is given as part of usual practice through their usual clinic visits. Participants from both groups will be asked to complete questionnaires before the program begins (0 weeks), at 12 weeks, and again at 24 weeks, in order to determine the effect of the program on HRQoL

This is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation. The study is unmasked with no control group, no randomization and will include approximately 4 sites. The primary objective of the study is to characterize the safety (adverse events) and effectiveness (residual cylinder and visual acuity) of the AcrySof IQ ReSTOR +2.5 D Multifocal Toric IOL in primary eyes of subjects at least 3 months and no more than 14 months after IOL implantation. The primary eye is defined as the eye of a subject that qualifies with the most recent implantation of the study lens (AcrySof IQ ReSTOR +2.5 D Multifocal Toric IOL Models SV25T2-SV25T5)

The majority (60%) of Aboriginal people live in urban Australia. Despite various strategies to “close the gap” in access to care and social services, health inequities and culturally inappropriate care persist. The “Ways of Thinking, Ways of Doing (WoTWoD)” program and toolkit, implemented through partnerships of general practice and Aboriginal Community Controlled Health Services (ACCHs), was developed to guide and effect a whole-of-practice clinical re-design process to embed cultural respect in general practice. Following promising pilot studies, this randomized control trial will test the effectiveness of WoTWoD to improve cultural respect, health checks and cardiovascular risk factors of Aboriginal people in Sydney and Melbourne. The study will be implemented through Medicare Locals in collaboration with local ACCHS. Our hypothesis is that the WoTWoD and care partnerships will improve culturally and clinically appropriate care for Aboriginal people in Australian general practice.

This study aims to investigate the impact of a tailored supervised exercise program on the metabolic, psychosocial and cardiovascular risk factors of adolescent and young adult survivors of childhood cancer. Who is it for? You or your child may be eligible to join this study if you/they are aged between 15-23 years and have had either brain tumours or cranial irradiation. Study details: Participants in this study will be randomly (by chance) allocated to one of two groups. The first group will take part in a 6 month supervised exercise program which is administered by an exercise physiologist (personal trainor)for 3 x 1 hour sessions per week. Participants in the other group will receive no intervention initially, but will take part in the exercise program after a period of 6 months. Proir to and on completion of the program participants will undergo clinical tests and complete some questionnaires in order to evaluate the impact of exercise on metabolic, cardiovascular and psychosocial wellbeing.

Respiratory failure is the major cause of mortality and morbidity in patients with MND. Non-invasive ventilation provides respiratory support via a mask and machine and has become part of standard care for MND patients who develop sleep symptoms or respiratory failure. The current recommendations for NIV are mainly based on one study which reported that NIV prolonged survival and increased quality of life in a sub-group of patients with MND. However this study had only 22 patients in the NIV treatment group and NIV settings were changed based on patient tolerance and daytime blood gas changes, rather than in response to the type of abnormal breathing. In clinical practice, NIV is initially delivered during sleep, but is sometimes extended to the daytime as the disease progresses. The usual mode of NIV requires that the patient generates sufficient inspiratory effort to trigger pressure delivery by the machine. Inspiratory (and expiratory) pressure levels are usually chosen empirically without a sleep study. In a recent preliminary study including more systematic sleep studies, we found that NIV as currently provided to MND patients is suboptimal and in some instances may be dangerous. MND patients showed a variety of breathing abnormalities including obstructive apnea (a clinically silent variant not associated with snoring), central sleep apnea and varying levels of hypoventilation. Consequently, the traditional “one size fits all” approach to NIV treatment using empirically determined pressure settings is clearly sub-optimal. This project aims, for the first time, to characterize the patterns of abnormal breathing in MND patients and to investigate changes in breathing abnormalities as the disease progresses. We will also test the usefulness of a new “smart” ventilator in MND patients. This will help clarify the nature of gradually progressive deteriorations in breathing and how best to tailor treatments to improve breathing, sleep, quality of life and survival in patients with MND.

This study aims to explore the effect of pain-related attentional bias modification on the interpretation and experience of acute pain, and on psychological variables. Participants will complete the the questionnaires, then a computer based interpretation bias task, followed by the attentional bias modification. They will then then complete the interpretation bias task again, and finally the experimental pain tasks.

Prior to transplantation, patients with end stage liver failure experience marked declines in cardiorespiratory fitness and muscular strength compared to age matched healthy controls. This affects the patient’s ability to perform activities of daily living, which severely impacts upon health related quality of life. Emerging evidence suggests that a higher cardiorespiratory fitness prior to transplant surgery can result in higher post-operative survival rate. It has also been demonstrated that there is a decreased time in critical care following transplantation. Exercise training has demonstrated to be a safe and effective therapy for improving these physiological parameters, however evidence as to whether it is safe, feasible and efficacious in end stage liver disease patients requiring a liver transplantation is minimal and requires further investigation. Therefore, the aim of this study is to investigate the safety, adherence and efficacy of a 12-week exercise training program and exercise maintenance in patients awaiting a liver transplantation.

There is no good evidence to guide the choice of breath size (tidal volume) delivered by the breathing machine during anaesthesia. In a recent multi-centre study, we found that anaesthetists deliver a variable tidal volumes with some patients receiving low-tidal volumes (6-7 ml/kg) and others receiving high-tidal volumes (9-10 ml/Kg) according to clinician preference. We also found that they typically positive end expiratory pressure (PEEP) (pressure to keep lung when breathing out has been completed) at an average modest value of 5.0 cmH2O. Thus, in Victoria and the Austin hospital in patients under general anaesthesia administered tidal volume can be variably high or low and PEEP is often applied at modest levels. Because of such variability and the possibility that one approach or another may be better at avoiding lung complications after anaesthesia, we wish to perform prospective randomised trial to evaluate the impact and outcome of two different tidal volume strategies during anaesthesia. Specifically, we wish to conduct a pilot single-centre prospective randomised trial comparing a low tidal volume (6 ml/kg) to a higher tidal volume (10 ml/kg) tidal volume strategy in combination with PEEP at 5 cm H2O for patients undergoing major surgery. The anticipated sample size is 900 participants over a 18 month period. Patients will be randomly allocated to either low or control tidal volume ventilation for the period of their surgical procedure to test the hypothesis that one of these two approaches in superior at decreasing post-surgical lung complications.

This study will evaluate the effects of a drug, AUY922 which inhibits heat shock protein 90 and may disrupt cancer cell growth in men with high-risk, localised protate cancer. You may be eligible to join this study if you are male, aged 18 years or over and have been diagnosed with prostate cancer and scheduled for a prostectomy surgery. The majority of men diagnosed with prostate cancer have disease confined to their prostate and surgery and/or radiotherapy offers a potential cure. However many men can have the cancer return within 5 - 7 years. Treatments for these men with recurrent prostate cancer are limited. The purpose of this study is to answer the question if treatment with a new drug called AUY922 (a 60 minute intravenous infusion at 70 mg/m2 on days 1, 8, 15 and 22 over a 28 day cycle) can stop the growth of prostate cancer cells. Prostate cancer cell growth can be measured by a protein called Ki67. Prostate tissue from biopsies from men with prostate cancer will be collected before treatment with AUY922. All men approached will be having a prostatectomy. After patients have received treatment, their prostate tissue will be collected at surgery evaluated for expression of Ki67. It is hypothesised that Ki67 expression will be 50% lower compared with before treatment. If there is sufficient activity in the first 25 men who receive treatment, the study will continue to a full experimental cohort of 41 patients. Fourteen (14) patients will be recruited to be a control group with no treatment prior to prostatectomy.