ANZCTR search results

Cigarette smoking is one of the leading causes of preventable deaths worldwide. In Australia, in the year 2016 alone, 14,900 Australians died from smoking related illnesses. Various pharmaceutical agents are currently available to assist those trying to quit. Nicotine replacement therapies (NRTs) and varenicline are two such agents. To date, several studies have evaluated the efficacy and safety of NRTs and varenicline for smoking cessation. Evidence surrounding their use in combination is limited to the use of NRT patches with varenicline. The efficacy and safety of varenicline in combination with short-acting forms of NRT (such as lozenges) is yet to be known. This research project, therefore, aims to evaluate the efficacy and safety of this combination treatment.

The Baby EATS Study aims to evaluate the rate of inclusion of allergens (specifically peanut, egg and wheat) in infant’s diets at 1 year of age by families who receive an evidence-based, education package outlining the infant guidelines for infant feeding and allergy prevention and reminder SMS messages compared with families of young babies who do not receive the SMS reminders.

The purpose of this study is to compare the accommodative and binocular function (defined by refractive measurements and binocular vision assessments) between dual focus, centre-distance multifocal, three different Extended Depth-of-Focus (EDOF) prototypes and single vision contact lenses. To achieve this, participants will wear the 6 lens designs separately during six short assessment visits. Outcomes will be accommodative responses in the form of accommodative lag/lead (measured in dioptres) and phoria measurements (measured in prism dioptres). Our hypotheses is that there will be no difference between lens designs for either outcomes.

Brief description of the study purpose You may be eligible for this study if you attend either the Royal Brisbane & Womens Hospital in Queensland or the Sir Charles Gairdner Hospital in Western Australia and have a nodule on the lung suspicious for cancer. Who is it for? Your doctor has sent you to have tests to investigate a spot (nodule) on your lung. Taking samples of the nodule may require by a bronchoscopy ( a camera into the lung) or samples taken with a thin needle passed directly into the nodule through the chest wall (directed by a CAT scanner). Study details PET/CT scans are approved in Australia when patients have lung nodules PET/CT scans are a way to take pictures of the lung and the rest of the body to show up “hot spots”and whether there are any other hot spots in the body that need to sampled. This study is seeing how putting PET/CT first (ie before any other tests) might improve the way all nodules are tested. If other spots in the lung or in lymph nodes or in other parts of the body are shown on PET/CT scan before any biopsies are done, it may be that doctors decide to biopsy those other spots first, rather than the nodule, to give the best information to allow treatment of your condition with one test, not two or three. All study participants will have a PET/CT first. They will also have detailed CT scan of the chest up front as well to possibly improve detection of the nodule. They will aslo all have a blood test, to study the use of new technology to confirm whether a nodule may be cancerous by just doing a blood test. There is no randomisation and all patients will have these tests before their other investigations. The purpose of this study is to determine whether using a test first (a PET/CT scan) when diagnosing cancer, changes the way a cancer is tested- which sampling test should come first. We hope it improves health outcomes by reducing the total number of tests a patient needs.

Rib fractures are painful and affect the ability to cough and deep breathe, resulting in a high risk of complications, such as pneumonias, lung collapse and the need for mechanical ventilation (life support). Numbing the nerves to the fractured ribs by injecting local anaesthetic (LA) improves breathing and reduces the risk of complications. Two techniques are commonly used at the RBWH; erector spinae plane blocks (ESPB) and paravertebral blocks (PVB). The techniques are similar, however the LA is injected near nerves at two different locations. The PVB is immediately adjacent to the vertebrae, whereas the ESPB is slightly further away from the midline. Both techniques use ultrasound to ensure the LA is directed to the intended place. Adult patients with > 3 rib fractures will be consented, then randomised to receive either a ESPB or a PVB. The anaesthetist will know which procedure the patient has been randomised to, however once the ultrasound is gone, the locations are so close that patient and staff can be blinded. It is expected that both groups will significantly improve in terms of pain score, opioids needed, and breathing ability (spirometry) however it is unclear which technique will provide better 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.