ANZCTR search results

A multi-centre Australian trial with four arms aims to evaluate several different immune modulating drugs for prevention and treatment of COVID-19 specifically in the cancer population. This study arm (arm 3) is evaluating the effect of Selinexor on the incidence of COVID-19 infection in cancer patients with moderate COVID-19 infection. Who is it for? You may be eligible to join this study arm if you are aged 18 and above, have any haematological or solid tumour, currently receiving cancer-related treatment, and are hospitalised with a moderate COVID-19 infection Study details Participants in this study arm are randomly allocated (by chance) to one of two groups. One group will receive oral Selinexor 3 times a week for 2 weeks while the other group will receive oral placebo 3 times a week for 2 weeks Participants will be followed for 60 days to assess effectiveness and safety. This study is one arm of a four arm, sequential multiple assignment randomisation trial where participants may become eligible and transition to different arms and treatments if they become exposed to COVID-19 or are hospitalised with an active moderate/severe COVID-19 infection. It is hoped this research will provide insight into the best practice for prevention and treatment COVID-19 in cancer patients as emerging standard of care measures are not always suitable to this especially vulnerable population.

The cytokine storm, resulting from the extreme immune response to COVID-19 virus, has been identified as the key event that leads to the acute respiratory distress and multiple organ damage, eventually leading to death in COVID-19 infection. The cell therapy, mesenchymal stromal cells (MSC), secrete anti-inflammatory factors that can prevent the cytokine storm. The first published report of 7 patients with severe COVID-19 pneumonia showed that MSC therapy was able to change the inflammatory status of severely ill patients and significantly improve pulmonary function. The small study demonstrated that MSC therapy was safe and effective in severe COVID-19 pneumonia. Our centre manufactures an allogeneic MSC product, under licence from Isopogen Pty Ltd, that is cryopreserved for off-the-shelf use. No donor matching is required and the MSC have natural immunity to COVID-19. The objective of this study is to identify and treat deteriorating COVID-19 patients with MSC therapy to attenuate the cytokine storm response to the COVID-19 virus and thus prevent acute respiratory distress and multi organ damage, improving chance of survival. This is an open label trial, planned to recruit and consent 10 high risk patients on admission. Patients will receive MSC infusions if they are COVID-19 positive and have increasing oxygen requirements to maintain O2 sat of >92%. The primary study endpoint is safety, with secondary endpoints of clinical parameter assessment, including oxygen requirements, ventilatory support, ICU admission, length of stay, survival and the effect of treatment on inflammatory markers.

The present study seeks to evaluate a brief online intervention, Managing Emotion, which has been developed by the present investigators for the purpose of supporting the psychological and emotional well-being of university students. Participants will be randomly assigned to either the Managing Emotion intervention or a wait-list control. The intervention content seeks to increase understanding of the relationship between thoughts, emotions, and behaviour, and discusses a number of evidence-based strategies for managing one’s emotions, particularly during times of stress. The intervention content is divided into five self-paced modules, to be completed over the course of one week. Each module includes a number of brief engaging videos, light reading material, and take-home activities. A set of questionnaire measures will be administered immediately before and after completion of the Managing Emotion program to provide an evaluation of the efficacy, acceptability and feasibility of this intervention. We predict that completion of the Managing Emotion program will be associated with an increase in participants' ability to regulate their own emotions, an increase in participants' perceived self-efficacy and resilience, and reductions in reported depressed mood, anxiety and stress.

Cough commonly occurs after upper respiratory tract infection. The aim of the study is to determine whether early intervention for acute cough following upper respiratory tract infection (common cold) reduces the proportion of patients who develop chronic cough. The study involves a randomised control trial of intervention for acute cough involving 101 participants. Participants will undergo a baseline assessment and brief intervention. Follow-up visits to determine whether cough has persisted, reduced resolved will occur at 8, 12 and 26 weeks post-onset of cough.

Glaucoma is a chronic, progressive degeneration of the optic nerve which results in visual loss from the peripheral visual field, creeping towards complete blindness. It is the leading cause of irreversible blindness worldwide and in Australia. There are many sight-saving treatments available, but identifying who is likely to worsen is a critical step to intervening for the right patients. Problems with the blood flow to the back of the eye have been identified as a significant contributing factor in glaucoma, and may occur early in the pathophysiology of diabetic retinopathy. A new imaging technique called optical coherence tomography angiography (OCT-A) allows rapid, non-invasive imaging of the blood flow of the optic nerve. The blood flow at the back of the eye changes in response to the blood pressure and the pressure inside the eye (IOP). Isometric exercise (a simple handgrip test) is a simple, yet reliable method to increase blood pressure temporarily. This study will help determine if we can detect the changes in blood flow using OCT-A, and whether the changes are different between healthy people and people with glaucoma or diabetes. In future, this research may help to generate clinical tests to detect glaucoma or diabetes earlier, or pick who will get worse and therefore would benefit from more treatment to prevent vision loss.

The purpose of this study is to compare the effect of 4 (four) Eicosapentaenoic acid (EPA)/Docosahexaenoic acid (DHA) formulations at different doses on increasing omega-3 fatty acid concentrations in healthy participants over an 8-week period. The first formulation is standard EPA/DHA oil from Fish and the second formulation is EPA/DHA from Krill. The change in cellular EPA/DHA concentrations, omega 3:6 ratio, speed of response over 8 weeks will be assessed.

This project aims to study the incidence of vocal cord paresis and evaluate implementation of a multi-modal education program and structured multidisciplinary pathway in patients after congenital heart surgery.

CytoAgents Inc is developing GP1681, an effective immunomodulary agent whose parent compound (Beraprost Sodium, i.e., BPS) has the advantage of an excellent safety record over many years of clinical use. This study will determine the safety, tolerability, pharmacokinetics and pharmacodynamics of GP1681 in healthy adults, with the aim of developing GP1681 to treat patients admitted to the hospital with COVID-19 disease. This study will be conducted in up to 24 healthy volunteers who meet all of the inclusion criteria and none of the exclusion criteria. The study is a double-blinded, randomized, placebo-controlled, multiple ascending dose (MAD) study of GP1681 as compared with placebo to be conducted in three sequential cohorts of healthy volunteers. Participants will receive study drug (GP1681 or placebo) every 8 hours (q8h) within 30 minutes of eating a meal or snack, for a total of 7 consecutive days (Day 1 to Day 7, inclusive) while domiciled at the clinical research unit (CRU). The first cohort will receive the predefined dose of 5 mcg q8h (15 mcg/day). Subsequent dose levels will be determined by the Dose Escalation Committee until either an MTD or a maximum dose of 90 µg/day is reached or until 3 cohorts have been enrolled.

Antenatal care traditionally involves a schedule of one-to-one visits with a care provider, however an emerging way of providing antenatal care involves the use of a group model, which already shows promise in optimising birth outcomes such as preterm birth and low birth weight. Current maternity models such as shared-care or midwife-led care attempt to provide a women-centred philosophy, incorporating continuity of care. Despite best efforts there are shortcomings in antenatal service delivery, including a lack of timely information and professional and emotional support. The evidence largely indicates that women feel unprepared for the psychological, social, and physical challenges, creating risk for mental health problems during a time of unparalleled change. Acquisition of knowledge is important in influencing maternal behaviour and birth outcomes. While the etiology of birth outcomes is complex, psychosocial factors including stress, anxiety, depression, and social support are critical factors that can increase the risk of medical complications and further increases the risk of children having a wide range of adverse outcomes. While antenatal care has traditionally involved a schedule of one-to-one visits, group models of care are emerging as a way of delivering clinical health services to pregnant women, integrating the usual pregnancy health assessment with tailored group education and peer support, thus incorporating broader psychosocial aspects. In promoting health and wellbeing during a time where reconfiguration of service delivery is required. The primary purpose of the current research is to examine a group model of multidisciplinary care. It is hypothesized that a group model comprising care and education provided in-part via telehealth digital technologies for pregnant women that extends into the postpartum period, will provide greater access to care and education, improving perinatal physical and psychosocial health outcomes for mother and infant, in comparison to women receiving standard maternity care.

The objective of this research program is to investigate new magnetic technology to determine the feasibility of detecting microscopic spread of Oral Squamous Cell Carcinoma (OSCC) to the neck. Who is it for? This study will enrol adults aged 18 years or over who have a biopsy proven T1-T2 oral SCC (tongue, RMT, buccal mucosa, FOM, hard palate). Study details Study participants will be injected with a single dose of MagTrace or FerroTrace magnetic tracer. One of these two tracers will be delivered around the tumour in 5 injections. The tracer will be used to identify sentinel lymph nodes (nodes that are likely to contain cancer) which will then be surgically removed. It is hoped this research will provide a new method able to detect cancer metastasis (spread to other body parts), and will also reduce complications associated with oral cancer surgery.