ANZCTR search results

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.

Influenza infection is a frequent and important problem in chronic obstructive pulmonary disease (COPD). Influenza can have severe consequences in these patients, leading to acute exacerbations of COPD, pneumonia and respiratory failure. COPD patients are thus recognised as a group at particular risk of influenza, and current guidelines recommend yearly influenza vaccination. These recommendations are largely based on expert opinion and observational studies, with very few randomised controlled trials having been conducted in COPD. It has been suggested that people with COPD may have an aberrant immune response to influenza viruses, and as such, they may be less able to effectively mount an immune response to influenza vaccination. This study will examine influenza vaccination in people with COPD, and healthy age-matched controls, focussing on the factors that predict an effective antibody response to the vaccine (seroprotection), especially aspects of dendritic cell and T-cell function. We will conduct an open-label observational study of seasonal influenza vaccine in 108 COPD patients and 108 healthy, age-matched control subjects. Subjects will receive a single dose of inactivated and purified split influenza vaccine in the autumn of 2015, 2016 and 2017. Primary outcomes of this study will be the proportion of vaccine recipients who achieve seroprotection or seroconversion.

Paradigm Biopharmaceuticals Ltd (Paradigm) is focusing on Pentosan Polysulfate Sodium (PPS) for the treatment of conditions that are associated with inflammation and progress chronically with tissue degeneration, including the treatment of Osteoarthritis Knee pain. Previous studies demonstrate that PPS is tolerated at the proposed dose (2 mg/kg) and duration (once or twice weekly for 6 weeks). While most of the clinical data obtained were acquired using a twice weekly regimen, a once weekly SC injection program, if effective and safe, would be ideal for feasibility. This study is will assess safety, tolerability, and pharmacokinetic responses of multiple sub-cutaneous doses of PPS in a healthy western population to support the development program. The clinical and nonclinical evidence demonstrate that PPS is tolerated at the proposed dose (2 mg/kg) and duration (once or twice weekly for 6 weeks). In two studies evaluating dose limiting toxicity, maximum tolerated doses were determined to be 3 mg/kg/day continuous infusion (Pluda et al., 1993) and 22.5 mg/m2 SC injection every 6 hours (Swain et al., 1995). Assuming an average male of 60 kg and 1.9 m, these doses are roughly equivalent to 180 mg/day and 171 mg/day, respectively. These levels are greater than the Sponsor’s current proposed dosing regimen of 2 mg/kg (approximately 120 mg) SC once or twice per week. The PK sampling design in this study will allow comparison with an earlier PK study which evaluated 50 mg to 300 mg PPS administered by SC injection once weekly for 4 weeks. While most of the clinical data obtained were acquired using a twice weekly regimen, a once weekly SC injection program, if effective and safe, would be ideal for feasibility. Therefore, PK data obtained from once and twice weekly dosing regimens will support the development program.

The T-POT study will assess a brain pulse oximeter designed to non-invasively monitor brain oxygen and brain blood flow in patients requiring acute neurological monitoring in the hospital or intensive care unit (ICU) with acute brain injury or at high risk of acute neurological deterioration. It is known that patients with an acute brain injury are at risk of neurological deterioration, typically as a result of low blood flow in the minutes, hours or days after the initial injury. Available brain monitoring is highly invasive and therefore only used in the most severe cases. An accurate non-invasive method to monitor brain oxygen levels and brain blood flow would facilitate monitoring in more patients and earlier detection and treatment of acute neurological deterioration. This could improve healthcare outcomes, reducing both long-term disability and death. The T-POT pulse oximetry technology can monitor oxygen levels and blood volume changes in organs of the body, including the brain. The sensor and algorithms of the Brain Pulse Oximeter were developed to overcome limitations of conventional pulse oximeters that only provide oxygen and a photoplethysmogram (PPG) signal from blood flow in the skin. The PPG detects blood volume changes in the microvascular bed of a tissue. The major aim of the study is to assess the correlation of the brain pulse oximeter oxygen levels with invasively measured cerebral perfusion pressure (CPP).

This study is designed to assess the rate of response to treatment (subcutaneous golimumab 50mg given four weekly) on MRI and other clinical RA measures in 12 participants diagnosed with active rheumatoid arthritis with inadequate response to Methotrexate. Study duration is 12 weeks. The aim is to assess at what timepoints specific MRI changes are seen with golimumab use; which aspects of rheumatoid involvement respond earliest; and if this precedes the timepoints when other clinical RA outcome measures change. Clinical response to treatment will involve assessing response to treatment on MRI of the participant’s most affected hand/wrist (as determined by Investigator assessment by examination at screening), as well as clinical outcome measures such as CRP, ESR and joint count assessments. In addition, participant reported outcomes (PROs) will be completed to assess the overall disease activity levels as reported by the participant. The PROs chosen include the conventional PROs EQ-5D, SF-36, FACIT-F and PtGA as these are well-established PROs that have demonstrated validity and reliability in assessing disease state, as well as a specific upper limb function PRO, the DASH. Visit timepoints are baseline, week 2, week 6 and week 12. At the end of the study, the participant will return to their normal treating rheumatologist for ongoing care.

This case-control study aims to identify whether correcting serum parathyroid hormone (PTH) after parathyroidectomy would have an effect on the clinical criteria for frailty, which are highly prevalent in older persons suffering from primary hyperparathyroidism (pPTH). Women (60 and older) undergoing neck exploration for pHPT will be assessed for general functional parameters (gait, balance, and muscle power and strength) and clinical criteria for frailty (Fried’s criteria) before and after (3 months) surgery. Women of the same age undergoing neck exploration for benign nontoxic goiter will serve as controls. This study will provide a new understanding of the role of PTH in the pathophysiology of frailty. We will also identify novel potential interventions to prevent frailty, falls and fractures in high-risk older persons with alterations in their calciotropic hormones.