ANZCTR search results

Gout is a chronic inflammatory arthritis. This study aims to see if krill oil ( a natural anti-inflammatory therapy) can reduce inflammation in people with gout, as well as the current standard of care, colchicine. People with gout, and evidence of inflammation on ultrasound will be randomized to either krill oil or colchicine for 12 weeks, and then return for a follow-up ultrasound to see if the ultrasound detected inflammation has decreased, increased or unchanged. WE will also look to see what effects krill oil has on pain, quality of life, global health, blood test of inflammation and the number of flares of gout.

The objective of this study is to collect data on current general practitioner preferences for management of low back pain. This includes both preferences for imaging of low back pain and preferences for prescription of medication for low back pain.

The study is being done to compare to 2 methods of incision ( a surgical cut to the skin and tissue) in patients undergoing surgical removal of part or all of the thyroid gland.: 1. Using a scalpel (cutting skin and tissue with a metal blade) or 2. Electrocautery (also known as diathermy, a method of cutting skin and tissue using heat). The researchers want to find out which of these procedures can make the quickest incision, the best cosmetic outcome (the best looking scar), is least painful for the participant and heals the best.

This randomised controlled trial will assess a pharmacist led intervention to reduce medicine induced deterioration and adverse reactions. Medicine induced deterioration encompasses the spectrum of side effects that are frequently not recognised as medication related but are misattributed as geriatric syndromes, frailty or “changes due to aging”. The aim of the service is to enable early identification of signs and symptoms of medicine-induced deterioration so that worsening frailty and subsequent adverse events, such as injurious falls, fractures and delirium are prevented. In implementing the service, the pharmacist will use a suite of validated tools to assist in the detection of signs and symptoms of medicine-induced deterioration. The validated tools will encompass assessments to monitor changes in cognition, change in 24-hour movement behavior, including sleep, as well as grip strength. In addition, pharmacists will assess the potential for adverse medicine events via review of the resident care assessment record and through patient or carer reported changes in health since the medicine regimen was changed. The pharmacist service will be compared with usual care. The trial, involving 354 patients will take place in aged-care facilities in South Australia and Tasmania. The expected clinical outcome is a reduction in medication-induced deterioration, as measured by change in frailty score.

Patients with Chronic Obstructive Pulmonary Disease (COPD) have damage to their airways which makes it difficult to fully exhale, causing air to become trapped in the lung. This leads patients to breathe at abnormally high lung volumes. Increased lung volume squashes the small blood vessels surrounding the lung and may reduce the flow of blood back to the heart. A reduction in the volume of blood into the heart may reduce the ability of the heart to function properly. Gentle compression of the abdomen and chest surrounding the lung has been shown to reduce the lung volume at which patients with COPD breathe. We predict lowering lung volume with gentle lung compression will relieve the pressure on small blood vessels and have beneficial effects on heart function. The purpose of the research study is to determine whether breathing at lower lung volumes is advantageous in patients with COPD. In this research study you will perform various lung function tests and undergo cardiac magnetic resonance imaging to assess heart function. We will then place an elastic corset around your abdomen/chest to provide gentle lung compression which will slightly decrease the lung volume at which you breathe. We will then ask you to repeat the lung function tests and cardiac imaging.

Purpose and Hypothesis: The purpose of this project is to examine whether Autologous Conditioned Plasma (ACP) therapy can enhance semitendinosus healing after Anterior Cruciate Ligament (ACL) reconstruction. Knee function and muscle-tendon regeneration will be compared 1-year post-surgery between a group receiving ACL reconstruction and a group receiving ACL reconstruction combined with Arthrex’ ACP application to the donor site. Previous studies have found donor hamstring muscles experience substantial wasting (e.g., reduce in size and strength) following ACL reconstruction. Specifically, semitendinosus and gracilis muscles and muscle-tendons experience little regeneration, retraction of the muscle belly, atrophy, strength deficits, and impairments of function. We hypothesize ACL reconstruction combined with ACP application, referred to as “ACLR+”, will result in better muscle and tendon regeneration and improved knee function at 1 year following surgery. Specifically, we hypothesize individuals receiving ACLR+ will have knee flexion strength more similar to their contralateral leg than those receiving standard ACLR. Further, we hypothesize individuals receiving ACLR+ will have muscle-tendon morphology (i.e., muscle-tendon volumes, lengths, and cross-sectional areas) similar to the muscles and tendons in the untreated contralateral leg. Conversely, those receiving standard ACL reconstruction will have a significantly smaller and lower quality donor muscle and tendons compared to the contralateral leg.

In this study we propose to identify a cohort of 200 men who have a higher-than-normal amyloid in the brain, who are experiencing Subjective Memory Complaints but are not symptomatic for Alzheimer's disease. These men will be treated with testosterone (intramuscular injection), with and without DHA (oral administration) over 56 weeks. The study will evaluate the ability of testosterone & DHA to reduce the levels of LH, beta amyloid levels and subsequent impact on amyloid PIB-like load in the brain. This study will look at the effects of study treatment on brain images (MRI, PET scans), participants’ scores on psychometric tasks, neuropsychological questionnaires (measurement of memory loss and thinking ability) tests and the effect of treatment on different blood biomarkers. This study will look at the effects of study treatment on brain images (MRI, PET scans), participants’ scores on psychometric tasks, neuropsychological questionnaires (measurement of memory loss and thinking ability) tests and the effect of treatment on different blood biomarkers.

The diagnosis of sleep-disordered breathing (SDB) is associated with increased incidence and prevalence of atrial fibrillation (AF). However, nightly SDB-severity rather than the categorical diagnosis of SDB may directly influence AF-risk during the respective day thereby creating a dynamic substrate for AF. While chronic structural alterations induced by SDB have been already described in AF patients with SDB, the role of night-to-night variability in SDB severity is unclear and clinical evidence for a dynamic AF substrate in patients related to nightly SDB severity is lacking. By simultaneous long-term night-by-night SDB and AF monitoring, we examine the dynamic intra-individual relationship between daily SDB-severity and risk of incident AF during the respective day.

The primary aims of this first-in-human study are to investigate the safety and tolerability of CBP-201. The secondary aim is to investigate the pharmacokinetics and pharmacodynamics of CBP-201 related to contact pathway activation. Up to 40 participants will be recruited to five Cohorts of 8 participants each in this double-blind study. Participants in Cohort 1 will be randomized to receive an subcutaneous injection of 75 mg of CBP-201 (6 participants) or placebo (2 participants). Two sentinel participants (one allocated to placebo and one allocated to CBP-201) will be dosed initially. If dosing of these sentinel participant proceeds without clinically-significant adverse events (AEs) over a defined period (as adjudicated by a Safety Monitoring Committee), the remaining participants will be dosed. Cohorts 2-4 will be analogous to Cohort 1 in terms of study procedures. The dose level will be established following assessment of safety and PK data of the preceding cohorts but is planned to increase to 150mg (cohort 2), 300mg (cohort 3) or 600mg (cohort 4). An additional cohort (5) will receive 300mg of CBP-201 or placebo via IV injection instead of subcutaneous injection but all other study procedures will be the same of previous cohorts.

Inclusion body myositis (IBM) is the most commonly acquired skeletal muscle disease associated with aging. The cause is not known, and it affects men more often than women. The condition is progressive, resulting in muscle weakness and wasting including the muscles used for breathing and swallowing. There is no known cure and the impact on health-related quality of life is considerable. Exercise helps to prevent loss of muscle mass and maintain strength; and in healthy men the combination of testosterone and exercise has been shown to further increase muscle strength, performance and physical activity overall. In this study we propose to examine whether testosterone treatment, used in combination with exercise improves muscle strength and rates of physical activity in men affected by IBM. The study will be done in the context of a double-blind, randomised, clinical trial. The study investigators have expertise in neurology, endocrinology, immunology and physical sciences. In March 2019, a 12 month Open Label Extension study was approved.