You can narrow down the results using the filters
-
ACE: Advanced Cancer & Cachexia Exercise Trial
Cancer cachexia is a complex, multifaceted syndrome that remains both challenging to diagnose and treat. In addition to negatively impacting patients’ quality of life and decreasing physical function, cachexia may worsen cancer treatment side-effects and significantly impact patient prognosis. Exercise has been shown to be an effective strategy to manage the adverse effects of cancer and its treatment. However, whether these benefits extend to individuals with cancer cachexia has been underexplored. This project will therefore aim to evaluate whether an individualised, 12 week supervised exercise training program is safe, feasible and effective as a management strategy for cancer cachexia. Who is this study for? You may be eligible to join this study if you have a diagnosis of locally advanced or metastatic cancer and are experiencing involuntary weight loss. Study details: Participants will be randomly assigned (by chance) to one of two groups: 1) an immediate exercise group; or 2) a delayed exercise group. Both groups will continue to receive standard medical care. The immediate exercise group will commence a 12 week exercise program (36 sessions) plus protein supplementation (three days/week) immediately following enrollment. The delayed exercise group will receive usual care (i.e. no change to their current lifestyle) following enrollment and will be offered participation in an identical exercise intervention 12 weeks after randomisation. In-person testing will be conducted at baseline, 12-weeks and 24 weeks. Testing will involve, strength and aerobic tests, a body scan, questionnaires and a fasted blood sample. Questionnaires will also be administered at 6-weeks but can be completed at home (online or paper copies). In addition, participants will be invited to complete optional assessments, which involve providing a muscle biopsy (sample of muscle tissue) and/or an evaluation of resting metabolic rate. This research is a critical first step in to determine the most feasible and effective ways to utilise exercise as a strategy to counteract the burden of cachexia in individuals with advanced cancer and therefore lay the foundation for future research.
-
Assessment of a new direct wire-guided oral intubation device
An endotracheal tube (ETT) is used to safely and securely manage a patient's airway during anaesthesia. Sometimes these can be difficult to insert, requiring the use of an introducer - something smaller and solid that fits inside the ETT, and is easier to insert into the trachea ('wind pipe') than the tube initially. One of the problems that exists with this technique is that any gap between the ETT and the introducer can lead to the ETT getting caught on structures around the vocal cords as it is railroaded over the introducer. Our study uses a novel ETT/guidewire system that was developed to overcome these problems. The ETT has a channel for the guidewire in its wall, and the rate of deformation of the ETT matches the rate of deformation of the guidewire. This allows the ETT to follow the path of the guidewire easily. We will use an accepted technique of visualising the vocal cords (using a video laryngoscope) to pass the guidewire into the 'wind pipe', and then railroad the ETT over the guidewire under vision. Our hypothesis is that this system will have a very low rate of ETT hold-up or impingement on entering the 'wind pipe', and therefore provide reliable and atraumatic intubation. We will record the incidence of all complications, including trauma to any airway structures, misplacement of the tube, difficulty placing the tube in the 'wind pipe', problems with oxygen levels during the procedure, and the time taken for the procedure. We expect the system to be very effective and reliable, based on preliminary studies on manikins and cadavers, and also based on one human study done overseas using this system.
-
Pilot study to assess biochemical efficacy of 2 dialysis membranes in the setting of nocturnal haemodialysis.
This trial examines the safety and efficacy of a (relatively) new haemodialysis membrane in the setting of extended hours (nocturnal) haemodialysis, compared to an existing, commonly used membrane. The company has no data on the toxin clearance with this membrane in this setting. Extended hours dialysis offers improved clearances of toxins, compared to conventional 4-hour dialysis, hence it is appropriate to assess the performance of these membranes in the setting of nocturnal HD/Extended hours HD. Both dialysis membranes used are commercially available. Outcome measures include clearances for uremic toxins (eg. urea, creatinine, phosphate, and indoxyl sulfate) and safety measures such as haematology indices: - full-blood examination and clotting, and biocompatibility indices (Interleukin-6 - known as IL-6).
-
The STAR-PAD trial is testing a new treatment for Peripheral Arterial Disease (PAD).
STAR-PAD trial intend to answer the question of: Does the ß3AR agonist Mirabegron (50 mg/day), administered for 12 weeks, improve lower limb perfusion and intermittent claudication in patients with PAD compared with placebo control? The intervention will be oral tablet Mirabegron 50mg/day for 12 weeks vs Placebo, The primary outcome will be improvement in peak walk time (PWT) on a graded treadmill test
-
The impact of age on the effects of whey protein intake on blood glucose, insulin and gut mechanisms.
We hypothesise that whey protein slows gastric emptying, stimulates “incretin” hormones and insulin secretion, and reduces glycaemia; that age and type 2 diabetes will modify these responses. The study aims to determine the acute effects of drinks containing either (i) whey protein, (ii) glucose, (iii) whey protein plus glucose, or (iv) control on blood gucose, insulin and gut hormones. A total of 20 older and 20 younger people with type 2 diabetesand 40 healthy controls, will be recruited. Blood samples, Gastric emptying, blood pressure, heart rate etc will be measured after taking informed consent. Completion of the study will provide us with useful data on gastric emptying of carbohydrates, protein and a combination of these nutrients, and on the effects of these nutrients on energy intake. This will give us novel and important information which can be translated to the community to improve overall health in older people.
-
Tenofovir Alafenamide (TAF) Breast Milk Pharmacokinetics (PK) study
Pharmacokinetics (metabolism) of tenofovir alafenamide (TAF) used in HBV-infected women that are breast feeding. Both analogues of tenofovir, differing only by their side chains, TAF has been demonstrated to be safer than tenofovir disoproxil fumurate (TDF), especially in patients with osteopaenia or osteoporosis, thus TAF is likely to be also superior to TDF for pregnant and breast feeding women. Women in this study may choose to take TAF in pregnancy or only postpartum whilst breast feeding. The study will be a one day pharmacokinetic study. There is no registration data on TAF or TDF in pregnancy, but both are allowable and TAF has superior pharmacology to TDF. TDF has been available for ten years and post-registration safety data for TDF are excellent. This project will determine if TAF is detectable in breast milk, maternal blood and infant urine.
-
Palmitoylethanolamide for the treatment of centralised chronic pain
Chronic low level inflammation within the central nervous system (CNS) is increasingly being recognised as a potential contributor to many types of persistent pain. Through the activation of glia, especially microglia and astrocytes, it is thought that alterations in synaptic function lead to changes in the way that pain is processed within the CNS. It is believed that these changes play a significant part in the development of central sensitisation. There is also evidence that this glial activation may also account for many of the neuro-vegetative features common in persistent pain such as anxiety, depression, fatigue, poor sleep and cognitive problems. It is hoped that medicines that are able to suppress CNS inflammation might help relieve pain, improve function and associated psychiatric symptoms in patients with chronic pain. Palmitoylethanolamide (PEA) is a naturally occurring fatty acid involved with known anti-inflammatory properties and has been suggested to be involved in the regulation and termination of inflammatory responses within the CNS. It is currently classed as a nutraceutical and available from compounding chemists without prescription. There is some evidence that administration of PEA has analgesic benefits in a variety of causes of persistent pain, although evidence is limited by significant industry support. It does have anecdotal evidence of positive effects and appears to be very well tolerated, with a low risk of serious adverse effects. Given the limitations in current pharmacologic options in the management of persistent pain, it represents a potential useful addition to the current therapeutic options. The aim of this study is to assess the ability of daily oral administration of PEA to achieve long lasting improvements pain and function in patients being treated in a tertiary hospital pain clinic. Patients will be selected based on evidence of neuro- vegetative features as assessed by the Symptom Severity Score (SSS ) from the 2011 revised ACR Fibromyalgia Criteria regardless of primary pain diagnosis. The study aims to have high external validity. Patients will be randomised to PEA or placebo in addition to their current therapy for a period of 6 months. Outcomes will be assessed via the electronic Persistent Pain Outcomes Collaborative (ePPOC) questionnaires, with a primary outcome of Pain Interference as assessed by the Brief Pain Inventory (BPI) at 6 months.
-
A Phase I Study to assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Ascending Doses of BioE-1115 in Healthy Adult Volunteers
This first in human (FIH) Phase 1 study is a prospective, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability and PK, including the effect on PK of fed vs. fasting, of single oral ascending doses of BioE-1115 in healthy adult subjects followed by the safety, tolerability, PK and PD effects assessed as FS-DNL and RMR of multiple oral doses of BioE-1115 in healthy adult subjects. A total of up to approximately 121 subjects from both parts is expected to be enrolled in this study. Subjects will be recruited to participate in either a SAD cohort or MAD cohort but not both. Safety data for each cohort will be reviewed by a Safety Review Committee. The study will be conducted in 2 parts of 5 SAD and 4 MAD dose cohorts: Part A (SAD): Part A of the study will include a double-blind assessment of the safety, tolerability and PK, including the effect on PK of fed vs. fasting, of SAD of BioE-1115. Each SAD cohort will consist of 8 subjects, including 2 receiving placebo and 6 receiving BioE-1115, in fasting state. One of the cohorts may be called back to be redosed in a fed state. Part B (MAD): Part B of the study will include a double-blind assessment of the safety, tolerability, PK and PD assessed as FS-DNL and RMR of MAD of BioE-1115/placebo. Each MAD cohort consists of 15 subjects, including 3 receiving placebo and 12 receiving BioE-1115. MAD subjects will be dosed in a fasted state
-
HepFree Trial: a Study to Compare Five Different Ways of Providing Heparin-free Hemodialysis in Patients With High Risk of Bleeding
Hemodialysis is life saving for patients with kidney failure. The contact of blood with an artificial environment may cause clots. Heparin is a substance that slows the formation of clots. However, this cannot be given to some patients who have high risk of bleeding. The aim of this research is to compare 5 different ways of providing heparin-free dialysis. These include intermittent saline flushes, artificial circuit coated with heparin, artificial circuit coated with heparin & intermittent saline flush, online predilution and predilution with coating of heparin. We aim to look at successful completion of dialysis without bleeding or clotting problems.
-
The Integrate program for safe mobility in Parkinson's Disease.
As Parkinson's Disease (PD) progresses, people develop significant mobility limitations and falls despite optimal medical care. The objective of the research is to help people with advancing PD and their families to live better by maintaining safe mobility for longer. Many of the impairments commonly associated with PD contribute to mobility limitations, including impaired balance , freezing of gait and cognitive impairment. The proposed project aims to to determine if a 6 month home based environmental, behavioral and exercise multi factorial intervention for people with PD improves mobility and safe mobility behaviors. Secondary aims are to determine the effect of the program on walking quantity and quality, leg muscle strength, FOG, concern about falling, activities of daily living and care partner burden.