ANZCTR search results

This project will investigate how VOMS assessments, measured by the Neuroflex®, can identify sleepiness that affects the performance of driving tasks. Your participation in this project will involve visiting the Flinders Health and Medical Research Institute Sleep Health group laboratory (located in the Mark Oliphant Building, Bedford Park) for a 2-hour introductory laboratory visit. You will then be asked to complete 7-days of monitoring of your sleep and daytime activity at home with an activity monitor worn on your wrist before returning to the laboratory. During your experimental laboratory visit you will first undergo an overnight sleep study followed by the next day and night of performance testing until you finish the protocol at 1pm (i.e., 2 nights and 1.5 days in the laboratory)

Substantial persistent pain after major lung surgery remains a significant problem despite new methods of pain control with up to one third of these patients still experiencing pain severe enough to affect their daily living months after lung surgeries. In addition to its effect on the essential daily tasks of living, long term pain is also known to cause mental health problems and lead to long-term opioid dependency further affecting the quality of life of patients and incurring extra cost to the healthcare system. Optimization of the acute pain control immediately after surgery is the single most important factor affecting the development of long-term pain. One of the more recently developed techniques of pain control is a technique called regional anaesthesia whereby local anaesthetic is injected next to the nerves supplying that area of the body with the surgical incision, thereby effectively ‘numbing’ them to reduce the pain felt by the patients. An alternative pain relief technique involves giving a small dose of local anaesthetic, such as lidocaine, directly into the veins of the patient. This method can offer a much more predictable pain relief than a regional anaesthetic technique because it does not require the specialized technical skills to perform and hence it may have a great potential for general use to reduce pain effectively. Nonetheless, administering local anaesthetic agent, such as lidocaine, directly into the blood can still have some rare side effect including drowsiness and changes in heart rhythm and blood pressure. In this study, we aim to compare these two pain relief methods, not only to assess whether one is better than the other in relieving pain, but also whether one is better to allow the patients to recover from surgery.

This observational study aims to investigate the sociodemographic, medical, and intra- and interpersonal characteristics of men with prostate cancer experiencing cognitive changes following hormone therapy. We also aim to examine in-depth the nature and impact of hormone therapy-associated cognitive changes on these men’s and their partner’s lives and the types of cognitive change. This will be compared to individuals with prostate cancer who are undergoing ‘watchful waiting’ or ‘active surveillance', and individuals without prostate cancer. Who is it for? You may be eligible for this study if you are a male aged 18 years or older, with or without prostate cancer. If you have prostate cancer, you may be eligible if you are currently undergoing hormone therapy, or are undergoing ‘watchful waiting’ or ‘active surveillance’. Study details All enrolled participants will be asked to complete a number of questionnaires regarding quality of life, cognition, physical activity, diet, and mental health. It is expected that the online survey will take approximately 20-30 minutes to complete in total. Participants will be required to complete the survey only once. Participants and their loved ones will also have the choice to sign up for an optional interview with a research team member to explore their experiences in more depth. This interview will take around 20-60 minutes. It can be either conducted over the phone or via videoconferencing. Participants will be reimbursed for the interview. It is hoped that with the findings obtained from this study, this information will help clinicians identify patients who may be at risk of cognitive changes from hormone therapy. Moreover, the findings will aid the development of a neuropsychological intervention to support these patients and their families with managing the cognitive changes they are experiencing.

This will be a placebo-controlled, randomized, double-blind, parallel-arm trial. The study will consist of two screening visits, one baseline visit (day 0), and two treatment visits (day +28, and +112;). At the baseline visit, subjects will be randomly assigned to one of three treatment groups. The primary aim of this proposed study is to determine the effects of daily Ergothioneine consumption in older adults (59-79 years of age) on a range of outcomes. Older adults who self-report memory complaints (i.e. subjectively experience impairments in their cognitive function) will be recruited from the general population. Participants will be assigned to receive either 25 mg of Ergothioneine per day, 10 mg of Ergothioneine per day, or a placebo control. The impact of the intervention will be assessed at 0 days, 28 days and 112 days of taking Ergothioneine daily for 112 days. Participants attend all study visits in a fasted state where they will consume a low-GI breakfast after providing blood samples, and prior to their cognitive assessment; the same breakfast meal is then adhered to over subsequent visits. At the screening visits, subjects will provide informed consent and undergo screening procedures to determine eligibility. Study procedures will be completed including vital signs and resting blood pressure, heart rate, respiration rate and temperature check. The height, weight, and BMI will also be assessed, as will CNS-VS test battery, the Prospective-Retrospective Memory Questionnaire, the Leeds Sleep Evaluation Questionnaire (LSEQ), and the Profile of Mood States (POMS) Questionnaire will also be administered. A non-fasting venous blood draw will be completed to collect samples for a chemistry profile, hematology profile, hs-CRP, ergothioneine, telomere length, and inflammatory markers. Concomitant medications/supplements, inclusion/exclusion criteria and any adverse events will be reviewed at each visit .

Tonsillectomy is one of the most common childhood surgical procedures, however the postoperative recovery is often long and challenging for children and their families.. This study aims to investigate if seven days of oral clonidine is able to improve pain management in children post-tonsillectomy, without increasing the risk of postoperative complications when compared to placebo. Hypothesis: clonidine will significantly decrease postoperative parental reported pain scores following tonsillectomy.

Lifestyle factors are known to affect the progression of multiple sclerosis (MS). The Multiple Sclerosis Online Course (MSOC)has been developed to deliver a widely accessible and user-friendly educational tool regarding modification of lifestyle related risk factors for people with MS. The intervention consists of arms: 1. an MS Online intervention course based delivering evidence-based information regarding modifiable lifestyle related risk factors implicated in disease progression; and 2. an MS Online standard-care course, similar in format and presentation, but containing general information sourced from standard MS websites. Both courses have seven modules delivered over six weeks. Having conducted a feasibility study, (ACTRN12621000245897. ) the purpose of this study is to test the effectiveness of the intervention course compared with the standard-care arm in a larger randomised controlled trial. The study hypothesis is that undertaking an MS Online Course delivering evidence based information regarding the modification of lifestyle related risk factors will lead to changed behaviours and improved health outcomes for people with MS.

Background Carotid endarterectomy (CEA) and carotid stenting (CAS) are often performed for subgroups of patients for whom procedural benefit has not been established in randomised trials and despite evidence of serious procedural risk. Furthermore, there is no current evidence of procedural benefit compared to optimal medical intervention alone (lifestyle coaching and medication) for any individuals. In some places, the COVID-19 pandemic has made it difficult or impossible to perform CEA and CAS. Aim/Objectives 1. To measure the rate of ipsilateral (same-sided) stroke, and other arterial disease complications, in patients with advanced (50-99%) carotid stenosis who, for any reason, are managed using current best medical intervention alone. Reasons for a nonprocedural approach may include insufficient resources caused by the coronavirus pandemic, unproven procedural benefit, anticipated procedural futility and/or net harm, or patient refusal. We will study patients for whom carotid procedures are not possible or considered unethical and, therefore, where a randomised trial approach involving carotid procedures is inappropriate. 2. To compare the CASCOM Study rate of ipsilateral stroke for symptomatic patients with that reported in the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the European Carotid Surgery Trial (ECST), and the CASCOM Study rate of ipsilateral stroke associated with asymptomatic carotid stenosis with that reported in the Asymptomatic Carotid Atherosclerosis Study (ACAS). Methods CASCOM is a prospective cohort study of current best medical intervention alone for stroke prevention in people who become patients by way of their referral for carotid imaging by a medical practitioner. It is also a multi-national, multi-specialty, collaborative, quality assurance and evaluation project. We will separate patients into those who would, and would not, have been eligible for past randomised CEA trials. We plan to study >367 symptomatic patients and >576 asymptomatic patients in the former, ‘eligible’, category and use them for hypothesis testing. We expect at least a 50% lowering of stroke rates with medical intervention alone in the CASCOM Study compared to that seen in past randomised trials. In addition, we plan to study 600 patients in the latter randomised trial ‘ineligible’ category and report their ipsilateral stroke rate over 5 years of follow-up. We will use ‘REDCap’ (Research Electronic Data Capture) for case reporting. Findings and Significance In CASCOM we expect at least 50% lowering of the ipsilateral stroke rate compared to that seen with medical intervention alone in past randomised trials. If correct, CASCOM will provide new evidence that past randomised trials of CEA and CAS are outdated and elucidate new, improved standards for preventing stroke and other arterial disease complications.

Dexamethasone has been shown to effectively reduce the incidence of death in hospitalised patients with COVID-19 who require oxygen supplementation and invasive ventilation. Prednisolone is the same class of drug ( steroid) however it does not cross the placenta. therefore we wonder if we can use prednisolone instead of dexamethasone to create women with covid-19 in pregnancy and reduce risks to the baby. The TGA advise that dexamethasone is a category C drug in pregnancy, prednisolone is category A. There are no trials (published or in progress) comparing efficacy of dexamethasone versus prednisolone in the treatment of COVID-19 in pregnancy. A non-inferiority study may prove similar maternal mortality reductions with minimal fetal effects. It is expected that prednisolone will prevent deteriorating illness as well as dexamethasone without exposing the fetus to the effects of the steroids treatment.

The purpose of this open-label, single-centre pilot randomised controlled trial (RCT) is to investigate the use of supervised moderate-to-high intensity exercise in patients with un-resectable stage III non-small cell lung cancer (NSCLC) undergoing chemo-radiotherapy. Who is this study for? You may be eligible to join this study if you are aged 18 years or above, and have previously untreated stage IIIA, IIIB, or IIIC NSCLC that is amenable to be treated with radical-intent chemo-radiotherapy, as decided through a multidisciplinary meeting. What are the specific details? Participants will be randomised (i.e. allocated by chance) to receive either an exercise program for the duration of chemo-radiotherapy treatment, or chemo-radiotherapy treatment alone. The exercise program will involve 20 minutes of moderate-to-high intensity aerobic exercise 3 times per week, which will be supervised by a qualified exercise physiologist. Prior to commencing treatment and 8 weeks after commencing the study, all participants will undergo a number of tests of lung function and physical fitness, as well as completion of questionnaires regarding quality of life, depression, anxiety, and investigation of any exercise- or treatment-related side effects. What are you hoping to find? It is hoped that this study may show that moderate-to-high intensity exercise therapy is a feasible, safe, and efficacious method for improving quality of life and cardio-respiratory health in patients undergoing chemo-radiotherapy for the treatment of stage III non-small cell lung cancer (NSCLC).

Following Roux-en-Y gastric bypass, a type of surgery to induce weight loss in individuals who are obese, the size of the stomach is considerably reduced and food passes through to the small intestines faster. When food passes through the small intestines, various ‘hormones’ that are thought to assist with weight loss are released and enter the bloodstream. While this seems to be a useful effect, a proportion of patients can experience complications such as having an abnormally low blood sugar level (hypoglycaemia) or low blood pressure after eating. We think this may happen due to these patients producing more of these ‘hormones’ than others. This study will evaluate the movement of solid and liquid food that have been eaten and how it affects the amount of ‘hormones’ produced. Given the smaller size of the stomach, liquids could ‘wash down’ the solid food and increase the amount of ‘hormones’ produced. Learning about how the passage of solid and liquid food through the small intestine changes the amount of ‘hormones’ produced will lead to a better understanding these complications and help us develop new and more effective treatment. This information may also help us improve the dietary advice provided to patients who have had this surgery.