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The effects of Lutein/Zeaxanthin supplementation on cognitive function in adults with self-reported mild cognitive complaints
Expand descriptionIn this randomised, double-blind, placebo-controlled study, 90 adults with self-reported cognitive complaints will be randomly assigned to receive capsules containing either a Lutein/Zeaxanthin combination (10mg Lutein and 2mg Zeaxanthin, once daily) or a placebo for 180 days. A computer-based assessment and several validated clinician-administered and self-report measures (to be completed at various time points throughout the study) will be administered to assess change in cognitive performance, mood, and quality of life.
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The Plate or Screw in Proximal Phalangeal Fractures [POSI-P1]
Expand descriptionThe proximal phalanges are the first bone in each finger. When people break their proximal phalanges, the break may need to be fixed surgically. The break may be fixed with a plate on the back of the bone [where the overlying tendon is cut and later repaired]; a plate on the side of the bone; or a screw through the middle of the bone. We want to find out which option gives the best result, in terms of finger movement and overall. The main finding of this study will tell us which surgical option gives the most finger movement, which may allow better use of that finger and hand. The other findings will look at which surgical option gives the best overall result from a patient’s point of view; which option allows the patient to regain better pinching and gripping power; and which option has more frequent risks. This knowledge, and identification of the balance of risks and benefits for each option, will help more patients receive the treatment that will give them the best chance of obtaining good function in that finger and hand, as well as help surgeons guide patients in making informed health decisions. Regaining function will be important not only for the patient [who will be able to return to work or their daily activities more rapidly], but also the health system and community as a whole. Although a plate on the back of the bone has been commonly used to fix breaks, there are concerns that cutting the tendon and putting a plate underneath will cause scarring, diminishing finger motion and patient satisfaction. This study will compare a plate on the back of the proximal phalanx to two other options: a plate on the side of the bone and a screw through the middle of the bone. There are no studies that have previously performed such a comparison. The objective of this study is to determine which of the three options provides the best balance of risk and benefit for the patient. The main finding assessed will be finger movement, which may allow better use of that finger and hand. Other findings will look at the overall result for the patient; pinching and gripping power; and the risks of each operation.
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Comparing albumin and saline for treatment of patients with severe infection in the Emergency Department: A randomised trial
Expand descriptionGlobal estimates suggest that approximately 5 million people die from infection each year. Research into improved management and treatment for patients with infection is essential for reducing such mortality. Individuals who present to the Emergency Department with severe infections are treated with fluids in the vein to maintain optimal blood volume, keep the heart working properly, and keep tissues well oxygenated. There are a number of fluids that Emergency Physicians can provide to patients, including crystalloids (water-based fluids that include salts and other water-soluble molecules), and albumin (a fluid manufactured from human plasma). Any of these fluids can be used by Emergency physicians, but crystalloids are most commonly used in standard care. There is some initial evidence that albumin may result in better outcomes for patients with severe infections, but further quality trials are required to validate these initial studies. Within this study, we will randomise patients with severe infection to receive either albumin or crystalloids while they are in the Emergency Department. The aim is to determine whether albumin improves the patient’s blood pressure, reduces the amount of fluid they need to receive, reduces organ failure, and reduces the need for intensive care admission.. The results of the study will provide emergency doctors with important information about how to best treat patients with infections and potentially reduce the number of deaths. The primary hypothesis is that In patients presenting to the Emergency Department with presumed infection, usual care plus intervention with 400mL 20% albumin IV over 4 hours compared to usual treatment without albumin results in higher systolic blood pressure at 24 hours.
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The effectiveness of an integrated approach of transcranial direct current stimulation and exposure and response prevention for treatment refractory obsessive-compulsive disorder: A case series
Expand descriptionThe overall aim of this research is to examine the effectiveness of an integrated approach of transcranial direct current stimulation (tDCS) with cognitive behaviour therapy with exposure and response prevention, in the treatment of treatment refractory OCD. A case series will be conducted involving tDCS over the brain regions that have been implicated in OCD in a group of treatment resistant OCD patients. We hypothesise that the participants will show clinically and statistically significant improvement in their OCD symptoms, their depression and anxiety symptoms, a reduction in obsessive beliefs and an increase in their quality of life. We also anticipate that there will be an improvement in inhibitory control and cognitive flexibility, which are central to extinction and inhibitory learning associated with exposure and response prevention.
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A Phase 2A, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ES-481 in Adult Patients with Drug Resistant Epilepsy.
Expand descriptionThis is a Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study with cross-over to Evaluate the Efficacy, Safety, and Pharmacokinetics of ES-481 in Adult Patients with Drug Resistant Epilepsy
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Home-based virtual rehabililtation for people with persistent symptoms after COVID-19 disease (Long COVID-19)
Expand descriptionThis study is investigating the effect of an exercise program (pulmonary rehabilitation) delivered through videoconferencing for people who have been diagnosed with Long COVID-19 (ongoing symptoms 4 months or more after original COVID-19 infection.) People will be recruited to this study only if they are already enrolled in the ADAPT COVID-19 study running through St Vincent's Hospital Sydney (ACTRN12620000554965) Of those in the ADAPT study, people that have ongoing symptoms such as fatigue or breathlessness after four months will be offered the study. Study details Eligible participants will complete an initial assessment of one hours duration consisting of walking tests and questionnaires. After this appointment they will be randomly allocated to participate in either the exercise group or control group. The exercise group will complete two exercise sessions/week for eight weeks over Zoom supervised by a physiotherapist. Both groups will then complete the walking tests and questionnaires again after eight weeks. It is hoped that this study will provide further information about the role of pulmonary rehabilitation after COVID-19 in those with persistent symptoms.
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INTEGRATE - A feasibility trial of stratified Cognitive Functional Therapy for high risk neck and back injuries following road traffic crash
Expand descriptionCompensable traffic injury claims in Western Australia present a $2.8 billion liability for the government insurer, with spine and neck injuries being the most frequent and costly complaint. Of these, Whiplash-Associated Disorders (WAD) are the most prevalent, placing a large burden on individuals, families and health systems because around half those with acute WAD develop persistent pain and disability. The proposed research aims to improve the outcomes of those at high risk of unresolved WAD and/or back pain by piloting an innovative integrated physiotherapy and psychology intervention – stratified Cognitive Functional Therapy (CFT). This is a patient-centred, individualised treatment led by physiotherapists and integrated with collaborative care from psychologists using a common clinical reasoning framework in cases where psychological risk factors predict poor prognosis. This time-limited non-interventional treatment uses an evidence-based self-management approach that targets modifiable risk factors. Trials in back pain show that CFT produces large, sustained improvements in functional recovery. This feasibility randomised controlled trial will test the potential for an integrated multidisciplinary version of CFT to be applied to crash-related spinal pain, including quantifying expected cost savings, compared to usual care, for the Insurance Commission of Western Australia.
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Effect of Probiotic supplementation on gut bacteria in children with autism - a pilot randomized controlled trial
Expand descriptionAutism is a condition with early-onset difficulties in social communication and unusually restricted, repetitive behaviors. It is being increasingly diagnosed in the last 10 years and is currently diagnosed in 1 in 59 children. Children with Autism need lifelong support for their symptoms and associated conditions. Current options for improving their behavioral issues are limited or only partially effective. Beneficial bacteria that commonly live in the gut promote health by suppressing the growth of harmful bacteria, and improving immune function of the gut. Humans have been consuming probiotics (beneficial bacteria) for hundreds of years in the form of various foods. . Research suggests that the proportion of beneficial bacteria in the gut is reduced (called as ‘dysbiosis’) in children with autism, and may explain their symptoms. We plan to study whether probiotic supplementation will improve the proportion of beneficial bacteria in the gut of children with autism. Such an effect may improve their behavioral symptoms
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Clinical Validation of a Smart Wearable Device to Monitor Cardiac and Respiratory Vital Signs using Morphic Band Sensors “ASPEN Trial”
Expand descriptionThe purpose of the study is to validate the cardiac and respiratory vital signs form the Saiiv Medical vital signs monitoring kit against gold standard vital signs monitoring devices which have been approved by the Therapeutic Goods Administration (TGA).
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Wellbeing outcomes in Prince of Wales Hospital staff
Expand descriptionThis is a 12-week trial involving a 7-week wellbeing program. The trial will recruit staff from Prince of Wales Hospital in Sydney (primarily nurses, but anyone employed at the hospital will be eligible to join), and the aim will be to measure the participants' levels of wellbeing over time and to determine whether the 7-week program is effective at increasing their wellbeing, compared to an alternative program.