ANZCTR search results

This is phase 1 first-in-human trial evaluating KP-104 to assess safety, tolerability, pharmacokinetics and pharmacodynamics. This study will be conducted in 2 parts - SAD and MAD with target of 64 healthy volunteers.

Pain management of the acutely injured patient with rib fractures in the Emergency Department (ED) can be difficult. Severe pain from multiple rib fractures can splint the chest wall, decreasing the ability to clear respiratory secretions and increasing rates of pneumonia. The older person is at increased risk of these complications as well as in-hospital death. At present, pain relief options include simple analgesics (paracetamol, ibuprofen), opiates (including morphine and fentanyl) or ketamine. In the elderly, many of these medications contribute to in-hospital falls, delirium and constipation and are addictive. Thoracic epidurals are utilised by specialist pain teams however these are contraindicated in anticoagulated patients and not typically available in the ED. The serratus anterior block is an ultrasound-guided, regional anaesthesia technique utilising a single-injection method to anaesthetise the chest wall in patients with multiple rib fractures. They are being utilised at increasing rates across emergency departments worldwide. The limited evidence available on these blocks suggests they reduce pain scores and may improve respiratory function. The block has not specifically been investigated in an older population. This study aims to evaluate the effectiveness of an ED-administered, serratus anterior plane block at reducing pain scores in patients with multiple rib fractures following blunt thoracic trauma who are also receiving protocolised rib fracture care (the current standard at participating hospitals).

This study aims to investigate the efficacy of palmitoylethanolamide (PEA) and probiotics for wellbeing and osteoarthritic pain. The primary hypothesis is that oral administration of PEA and probiotics will be associated with a decrease in pain, as measured by a numerical rating scale, in comparison with a placebo. The active interventions include a probiotic (including three different strains) and a form of micronized PEA. Participants will be asked to take one capsule of each intervention in the morning after meals and another capsule of each intervention in the evening after meals.

In 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.

The 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.

Global 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.

The 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.

This 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

This 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.

Compensable 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.