ANZCTR search results

There is relatively little information available regarding how to tailor remotely delivered lifestyle behaviour change interventions to the unique needs of shift-workers. The primary aims of the proposed project is to assess the feasibility of the study protocol of the proposed shift-worker tailored intervention utilising an app-based intervention to target multiple health behaviours by conducting a parallel 2-arm pilot-RCT, and evaluate the implementation outcomes. The intervention is a modified version of an existing intervention that targets physical activity, dietary and sleep behaviours.

Post Traumatic Stress Disorder (PTSD) is hard to treat effectively, as most patients who take the standard treatments still have PTSD symptoms afterwards. We have found that a drug called n-acetylcysteine (NAC), which supports the body’s anti-oxidants, can help to treat PTSD, as well as the depression and addictions that many people with PTSD also have. We would like to investigate this by doing a trial comparing NAC with placebo, in patients with PTSD who have already had the standard treatments, to see if NAC helps reduce PTSD symptoms. We will ask 192 individuals with PTSD from the general community, the Heidelberg Repatriation Hospital, and the Melbourne Clinic to join the study. These individuals would have tried standard treatments, but still be experience PTSD symptoms.. We will randomly divide them into two groups – one group which is given the NAC for 12 weeks, and one group which is given a placebo pill – though neither the researchers, nor the patients, will know which is which until the trial ends. They will keep taking their other treatments as usual. Every four weeks we will measure their PTSD symptoms, as well as their mood, their drug and alcohol use, somatic symptoms and their quality of life, until four weeks after the trial is over, when we will open the list that tells us who was taking the NAC, and who was taking the placebo, and compare the two groups. We expect that those who took the NAC will have fewer PTSD symptoms, better mood, less drug and alcohol use, fewer somatic symptoms and a better quality of life, and, most importantly, that more patients who took the NAC will no longer have PTSD.

SAR441121 is an experimental treatment. This means that it is not an approved treatment for Malaria in Australia by the Regulatory Authority (Therapeutic Goods Administration - TGA) or any other international Regulatory Authority. The purpose of this study is to establish the safety, tolerability (how easily it is to tolerate) and pharmacokinetics (what the body does to the study drug, such as absorption, distribution and excretion) of SAR441121 in healthy male volunteers, This study also aims to investigate the effect that food may have in the safety, tolerability and pharmacokinetics of the study drug.

The aim of this study is to determine the effectiveness of supported referral to healthy lifestyle interventions in reducing number of modifiable risk factors among primary care patients. Patients identified at baseline who have one or more modifiable risk factors (smoking, overweight/obesity, drinking alcohol above recommended levels) will be randomised to receive standard care. or the intervention. Those allocated to the intervention group will be offered feedback on their risk factors and a session with the practice nurse to review the feedback and identify referrals as needed. Participants will completed follow-up surveys at 3 and 6 months. We hypothesise that patients offered feedback and a session with the practice nurse, as well as telephone follow-up with a freely available service (Quitline or Get Healthy) will have less risk factors at follow-up than those receiving standard care.

Early detection of acute kidney injury in high-risk patients will enable clinicans to apply interventions to mitigate or prevent it early. Ten healthy adult volunteers will participate in this randomised crossover study. This study is evaluating the impact of hydration on urinary levels of two naturally occuring biomarkers with acute kidney injury. Participants will drink an additional 1000ml of water above their daily intake or fast from midnight for 12 hours. Urine samples will be tested at baseline, 12-hours and 24-hours to assess for changes in the urinary levels of these two biomarkers.

Deoxycholic acid is a treatment for excess adiposity an an ARTG registered medicine. There are limitations to the total amount that can be administered. In this case, we will treat one side of the body first, then the other side to minimise the total amount of deoxycholic acid administered.

The purpose of this study is to evaluate the feasibility of a new laser therapy system (called ProFocal­-Rx Laser Therapy System) for the treatment of certain prostate cancers. Who is it for? You may be eligible for this study if you are aged 50 or older and have a diagnosis of prostate cancer. Study details All participants in this study will undergo a general anaesthetic and targeted treatment (called ‘ablation’) of their prostate cancer in an outpatient setting. Immediate following the procedure, an MRI scan will be performed to determine the extent of the laser ablation. Six weeks after the procedure participants will have a targeted biopsy of the prostate to assess the outcome of the laser therapy. It is hoped this research will demonstrate the feasibility of this technology to treat prostate tumours, reduce discomfort and improve patients quality of life.

The purpose of this observational study (no treatment) is to determine the amount of postoperative astigmatism compared to the preoperative astigmatism for participants implanted with TECNIS toric ZCT100 IOL. For eyes implanted with the TECNIS toric ZCT100, the amount of postoperative astigmatism should be lower than the amount of preoperative astigmatism. For eyes implanted with the TECNIS ZCB00, the amount of postoperative astigmatism may be unchanged compared to the amount of preoperative astigmatism. This trial will collect preoperative, operative, and postoperative data from the participant’s clinical records for the visits already occurred, and data for the single visit to be collected for the prospective visit.

This study will specifically investigate whether functional electrical stimulation (FES) reverses myelin abnormalities in peripheral nerves of people with spinal cord injury. Participants who are scheduled to undergo nerve transfer surgery will be asked to undertake a program of FES using the ReGrasp device (Rehabtronics Inc, Edmonton Canada) for at least one hour dail, 5 days per week for 6 weeks prior to the surgery. This device enables a person to close and open the hand and can be operated independently by simple head motions detected by an earpiece. Biopsies of the relevant nerves and muscles will be obtained during the surgery, and these will be processed, analysed and compared with those obtained from previous nerve transfer surgery participants (historical controls). The primary outcome measure is the axon/nerve fibre ratio. Secondary outcomes include clinical assessments of hand function, independence, pain, well-being and quality of life, with participants being followed up for 24 months post-surgery. A cost-utility analysis will also be conducted.

This is a single centre, randomized, double-blind, placebo-controlled, sequential, single dose-escalation study of AK-119 administered to healthy adults and multiple dose-escalation study of AK-119 administered to healthy adults. The study comprises three parts A,B & C. Part A of the study is a single dose escalation arm. The safety data will be reviewed after each Cohort prior to dose escalation. The selected dose cohort will participate in a two-way crossover design and return to the clinical unit to receive AK-119/placebo administration of the same for evaluation of the food effect after a washout of at least 7 days. In Part B All subjects will be admitted to the Phase 1 unit on Day -1 for pre-treatment assessments then given a single dose of AK-119 or placebo once or twice daily from Day 1 to Day 7. They will remain inpatients until Day 10, returning as outpatients for follow-up assessments on Day 14. Part C will start after completing the multiple dose, dose escalation components in healthy volunteers in Part B, one cohort with healthy volunteers will be enrolled to receive 1 dose level of AK-119/placebo, as determined from the Part B in healthy volunteers. The dosing period will be upto 28 days as once or twice daily, commencing on Day 1 (dosing regimen to be determined from Part B).