ANZCTR search results

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.

The study aims to find out if giving local anaesthetic (a medication that numbs an area of the body) into the bloodstream and via small plastic tube placed during surgery into the abdomen will improve part of the immune system in patients undergoing surgery for colorectal cancer. Who is it for? You may be eligible to join this study if you aged 18 years or more and are scheduled to undergo a keyhole operation (laparoscopic surgery) for colorectal cancer to remove a section of the bowel (also known as colon). Study details Participants in this study will be randomly allocated (by chance) into one of two groups. Participants in one group will receive a local anaesthetic drug called Lignocaine infused directly into the bloodstream and also into the abdomen using a small plastic tube placed during surgery. Lignocaine is very commonly used to numb areas of skin or muscle before or during an operation. Importantly it has also been shown to help the natural killer cells (NKC) to destroy cancer cells. NKCs are a special type of white blood cell which recognises and destroys cancer cells. Participants in the other group will instead be given a placebo (salty water). Participants will not know which group they are in. All participants will be monitored for up to 30 days post-surgery in order to evaluate safety and also to see if the natural killer cells in the blood work better after lignocaine is used.

Study Aims This study aims to assess the impact of a telehealth-delivered cognitive and exercise training (CET) program versus lifestyle guidance on cognition in breast cancer patients. Who is it for? You may be eligible to participate in this study if you are aged 21 years or older, have been diagnosed with Stage I-III breast cancer and have received chemotherapy treatment. Study details Participants will be randomly assigned (by chance) to receive either the cognitive & exercise training (CET) program or lifestyle guidance program. Those in the CET group will be asked to undertake cognitive and exercise training four times per week (4 hours in total). The lifestyle guidance group will be provided with evidence-based recommendations regarding cognitive and exercise training. All participants will undergo a series of diagnostic and clinical tests, including blood tests, fitness and cognitive tests, sleep tests and questionnaires. Potential study outcomes It is hoped this research will inform the treatment of breast cancer patients presenting with detrimental cognitive changes as a result of chemotherapy, and this research may lead to better quality of life for patients.

This controlled trial aims to determine the feasibility of virtual reality as a non-pharmacological approach to improve mood states within Residential Aged Care. Specifically, we aim to determine the effects of virtual reality on: • Mood as measured through the use of observer and participant ratings of emotional response, apathy, and group engagement • Agitation, anxiety, and depression levels • Psychotropic prescribing and the administration of pro re nata (PRN) medications We hypothesize that group based VR sessions will increase resident engagement and social interactions, reduce agitation, anxiety and apathy, and improve mental wellbeing. Based on the finding of the pilot study we have conducted we anticipate results that have the potential to change the landscape of leisure and lifestyle activities conducted in RAC homes, and to supplement our current knowledge of non-pharmacological approaches for RAC resident mental wellbeing.

In this randomised, double-blind, placebo-controlled study, 160 adults who are currently taking an antidepressant medication but continue to suffer from depressive symptoms (mild-to-moderate severity) will be randomly assigned to receive tablets containing either a saffron extract (28mg a day) or placebo for 8 weeks. Participants recruited for this study will be on a stable medication dose for at least 8-weeks and will have no plan to change the dosage or medication type during the study. We will assess change in depressive symptoms via a validated clinician-rated instrument and a self-report measure (to be completed every 4 weeks). We will also assess whether saffron is able to reduce some of the side effects associated with antidepressant drug use (in 2 studies it has previously shown to reduce sexually-related side effects).