ANZCTR search results

Stroke is the third leading cause of death in Australia. Ischaemic stroke accounts for ~80% of all stroke cases and is caused by a narrowing or obstruction of the blood vessels resulting in oxygen and nutrient deprivation. Conventional post-stroke management involves combining pharmacotherapy and rehabilitative therapies. Nao Xin Qing (NXQ) is a TGA-approved product (AUSTL196297) in Australia. NXQ is a novel herbal formula made from the standardised extract of persimmon leaves. NXQ has been used clinically in China for numerous years in the treatment of apoplexy, coronary heart disease and enhance recovery from ischemic stroke. The aim of this randomised double-blind controlled study is to assess the clinical effectiveness of NXQ for ischaemic stroke patients during rehabilitation phase. This will provide preliminary data whether NXQ can be used as an effective treatment of ischaemic stroke recovery, to prevent recurrence of stroke and improve quality of life of stroke survivors.

To date, nutrition research in critical illness has focused on the acute early period of illness, when metabolic changes and catabolism occurs. However, despite much research, no large-scale randomised controlled trial (RCT) has demonstrated a clear benefit for nutrition interventions delivered early and for a short duration in the Intensive Care Unit (ICU). Limited work investigating nutrition in the post-ICU phase of illness has been conducted to date, but what is known consistently shows (across many different populations) that intake in this period is below clinician estimates. These shortfalls in nutrition adequacy across acute hospitalisation (and if these shortfalls continue to the sub-acute setting also), may have the potential to impact long-term recovery following critical illness although investigation in this area is lacking. The aim of this study is to describe the nutrition process of care in critically ill adult patients from ICU admission until discharge from inpatient rehabilitation. This study is a single-centre retrospective observational study conducted at an acute care hospital and subacute inpatient facility within Alfred Health, including adult patients aged 18 years and above, who had an ICU admission at The Alfred Hospital for more than 48 hours with discharge to Caulfield Hospital inpatient rehabilitation within 28 days during index hospitalisation admission.

The patients from which this data will be drawn were referred to the clinic by their general practitioner with symptomatic joint osteoarthritis for whom injection of hyaluronic acid (Durolane) was found to be the most appropriate treatment. This data is collected on all patients undergoing such injections as a routine pre and post injection measures of their pain and function. For those who had more than one injection, the time in days between injections will be analysed. Patient data will be included in the analyses if they were >18 years old with painful hip osteoarthritis and mild to moderate radiological changes on their imaging. There was no maximum age limit applied to the inclusion criteria. There were no specific inclusion or exclusion criteria in regards to race and gender. The current data set of the patient cohort intended for analysis was collected over 4 years.The data from these patients who have recieved Durolane injections in normal clinical practice will be analysed retrospectively.

The purpose of this research is to assess the effectiveness of a 16-week web-based low carbohydrate diet program for adults with type 2 diabetes, toward facilitating improvements in glycaemic control, assessed on primary outcome HbA1c. In addition, dietary intake data and self-efficacy will be assessed, along with changes in weight, anti-diabetes medication and diabetes-related comorbidities. Study recruitment will occur online across Australia, with the aim of recruiting 100 adults with non-insulin dependent type 2 diabetes aged between 40-89 years. Participants will be randomised to standard care plus web-based intervention or standard care only. Participants will be provided with login details to the intervention website to access weekly structured behaviour change modules and on demand resources that assist participants to practically implement a low carbohydrate diet. An assessment of participants' experience of and engagement with the intervention will also be explored after the intervention.

This pilot study will assess if blocking the blood supply to part of the stomach (known as a left gastric artery embolisation procedure) is feasible and can be performed safely in a small group of obese patients who are awaiting elective surgery. Blocking up the blood supply to a portion of the stomach reduces the production of the hormone that stimulates appetite (called ghrelin). Lower ghrelin levels in the blood stream have been shown to reduce the "hunger drive" and consequently reduce calories consumed, making dieting more effective and speeding up weight-loss. It is common for elective surgery in obese people to be delayed until they lose weight, and this procedure may help these patients to reach their weight-loss goals earlier. This study may provide information necessary to complete larger studies assessing the effectiveness of left gastric artery embolisaton as a complimentary weight loss technique.

This study will evaluate the safety and tolerability of ACT001 in combination with standard of care whole brain radiation therapy for patients with metastatic brain cancer (cancer that has spread to the brain from another body part). Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with secondary brain metastases (cancer lesions that have spread to the brain) from solid tumours including non-small cell lung cancer, breast, urogenital, head and neck, hepatocellular, melanoma and colorectal cancers, and you are eligible to undergo whole brain radiation therapy. Study details Participants will be asked to take 4 oral capsules of the study drug-ACT001 twice a day for up to 18 weeks. Standard care whole brain radiation therapy sessions will be scheduled to start 2 weeks after the first dose of ACT001, participants will continue to self-administer the daily doses of ACT001 until the end of the 18 week study period. During the study participants will be asked to attend a study clinic to report any unexpected side effects they experience during the study, and to complete quality of life questionnaires. Additional doses of ACT001 will be given to participants during these visits so that they can continue to self-administer the drug at home. All participants who are enrolled in this study will be asked to undergo a pre-treatment MRI, followed by two post-treatment MRIs at week 10 and week 18. It is hoped this research will demonstrate that ACT001 is safe and effective in treating patients with metastatic brain cancer, and is able to protect healthy cells during whole brain radiation therapy.

The SCRIPT Trial: A study of DNA testing to tailor bowel cancer screening in primary care. What is the purpose of this research? In Australia anyone aged 50-74 should have some sort of bowel cancer screening. People at increased rick of bowel cancer should start screening earlier. Screening is a highly effective way to diagnose bowel cancer earlier and save your life. There are two main ways you can be screened for bowel cancer, by FOBT (or poo test) or colonoscopy. Depending on your risk of getting bowel cancer, the age when you start and the type of bowel cancer screening will vary. Who is this for? People with a GP appointment at participating General Practices, aged 45 to 70 years who have not previously been diagnosed with bowel cancer. Study Details: Once agreed and consented to take part, the researcher will ask some health questions then provide a DNA test to inform of bowel cancer risk. The researcher will discuss this test with the participant beforehand and the DNA sample is by a self collected mouth swab. After this the participant is placed at random into one of two groups. Randomisation means that you are put into a group by chance, like the toss of a coin. Neither the participant or their doctors can chose which group. If in the intervention group, after 2-3 weeks the participant will meet with the researcher at the GP practice or by phone to discuss the DNA test results. They will be given a report summarising their bowel cancer risk and screening recommendations to be discussed with their GP. For the control group, they will have a consultation with the researcher to discuss cancer risk, lifestyle factors and bowel cancer screening options. They will be given the option to receive their bowel cancer risk results after 12 months from recruitment. Follow up questionnaires will be sent to all participants at 1, 6 and 12 months after recruitment.

A multi-centre pragmatic randomised controlled trial will be undertaken to compare 10 weeks of early and intensive motor training with usual care for people with recent SCI. The primary endpoint will be Total Motor Score (/100 points) at 10 weeks to reflect neurological recovery. Secondary endpoints will be other measures of neurological status, the Spinal Cord Independence Measure (SCIM), ability to walk, psychological status, time to discharge, improvement on self-selected goals and participants' impressions of therapeutic benefit/change at 10 weeks and 6 months.

Team leading the resuscitation of a seriously injured or critical unwell patient can be stressful and this stress may affect the clinician’s ability to perform optimally, potentially adversely affecting patient care. Our recent systematic review of the literature revealed a paucity of studies looking at strategies for mitigating the effects of stress on clinician performance and this randomised controlled study will look at whether the deleterious effects of stress on clinician performance can be mitigated by a novel stress mitigation method. Our plain language research question: During a simulated stressful resuscitation can a novel stress mitigation method ameliorate the effects of stress on: 1. Objective physiological stress measures 2. Subjective stress assessment 3. Decision-making performance The primary outcome will be the ability of the intervention to ameliorate the change in physiological stress measures (based on real-time assessment of participants heart rate variability (HRV) during the simulated scenario as compared to their baseline). Secondary outcomes will be subjective measures of stress as well as an assessment of the effect of the intervention on the decision-making performance related to the scenario.

The study investigates the efficacy and cost-effectiveness of remote monitoring in patients with Implantable Loop Recorders, It is an observational study that collects data on time to detection of abnormal heart rhythms and clinical decision making in patients with and without remote monitoring attached to their devices. The utilization of health care resources (in-office visits) and cost-effectiveness of remote monitoring will be assessed.