You can narrow down the results using the filters
-
Surgical Reconstruction of Gluteal Tendon Tears
Expand descriptionThis is a non-randomized study that seeks to comprehensively evaluate the clinical and functional outcome of a consecutive series of patients undergoing gluteal tendon repair surgery augmented with a synthetic ligament. We hypothesize that symptomatic patients failing prior conservative treatment and with evidence of gluteal tendon tearing diagnosed via magnetic resonance imaging (MRI), will demonstrate significant clinical improvement up until 24 months post-surgery.
-
A non-inferiority trial of cytisine versus varenicline for smoking cessation
Expand descriptionThis study will evaluate the cost-effectiveness of cytisine in comparison with varenicline. A total of 1450 smokers will be recruited from state Quitline services. Participants will have an equal chance of being randomly allocated to either the intervention or control arm (1:1 ratio). Participants in the intervention arm will receive a 25-day supply of cytisine capsules (1.5 mg cytisine). Participants in the varenicline arm will receive a 12-week supply of varenicline tablet (0.5 mg/1.0 mg varenicline). All participants will also receive standard Quitline behavioural support. All participants will be followed-up for six months and the follow-up interviews will be held at one, three and six months after the quit date. The main outcome measures are abstinence from smoking at one, three and six months follow-ups.
-
A study investigating alternative ways to plan radiotherapy treatment using MRI alone for prostate cancer.
Expand descriptionThe primary purpose of this trial is to evaluate whether treatment planning for prostate cancer radiotherapy can be completed using only MRI scans, in place of the standard care which involves both MRI and CT scans. Who is it for? You may be eligible to participate in this study if you are aged over 18 years and have been diagnosed with prostate cancer for which you are scheduled to undergo radiotherapy treatment. Study details All participants enrolled in this trial will have the standard care CT scan and MRI scan performed as part of their radiotherapy treatment planning, with an extra type of MRI scan added on to the existing MRI. This will add approximately six minutes to the duration of the MRI scan. A team of doctors, physicists and radiation therapists will work together to generate two treatment plans (CT plan and MRI plan). If the treatment plans are similar then the new MRI only treatment plan will be used for treatment. If the two treatment plans differ then the standard care CT and MRI plan will be used for treatment. Researchers will keep track of the number of times that the new MRI only treatment plan is used, the doses calculated and the locations of any gold markers used. It is hoped that the findings of this trial will provide information on whether radiotherapy treatment planning for prostate cancer can be completed using only MRI scans, without the need for CT scans. This would reduce the time and cost required for radiotherapy treatment planning in these patients.
-
Protein absorption in critical illness
Expand descriptionSingle centre exploratory unblinded observational study. Using a unique method that has been developed to label intact proteins rather than amino acids by infusing cows with large quantities of D5-phenylalanine and then collecting their labelled milk. This labelled cow milk can then be administered to humans for research purposes and the metabolic fate of the protein determined. This technique allows the fate of intact protein to be followed from ingestion, through digestion and absorption to muscle deposition. The biological value of the protein can thus be determined i.e. the proportion that becomes incorporated into body tissues, particularly muscle. This is relevant in the critically ill as the protein content of enteral feed formulae is usually presented as a protein such as casein or whey protein. Reduced amino acid absorption has been reported in rats following haemorrhagic shock, in patients with pancreatitis, and in critically ill patients following trauma. However the mechanisms underlying protein malabsorption are not well understood. A more comprehensive understanding of protein absorption during critical illness, and the effect of feeding intolerance on protein uptake will allow the rational development of feeding strategies to improve nutritional outcomes in these patients.
-
Does the addition of intravenous lignocaine to midazolam and fentanyl sedation for gastrointestinal endoscopy improve the quality and safety of sedation?
Expand descriptionSedation and analgesia during GI endoscopy under proceduralist guided sedation is limited by the dose dependent adverse effect profile of midazolam and fentanyl. Quality of sedation and patient comfort must be balanced against adverse effects such as respiratory depression, airway obstruction, and loss of verbal response. Intravenous lignocaine possesses a different side effect profile, with less sedative and respiratory effects. The airway reflex suppressive and analgesic properties of intravenous lignocaine may allow a reduction in the required dose of fentanyl and/or midazolam, limiting the incidence of clinically relevant adverse events (multimodal sedation) and allowing an improved quality of sedation. Intravenous lignocaine has shown to provide significant postoperative analgesia in open and laparoscopic abdominal surgery, with improved pain, reduced opioid requirements and improved quality of recovery. It has also been shown to improve tolerability of instrumentation of the upper airway, with improved haemodynamic following laryngoscopy and intubation, as well as decreased rates of coughing, gagging and laryngospasm with LMA insertion. The objective of this trial is to assess whether the addition of intravenous lignocaine as to standard sedation protocol reduces midazolam/fentanyl requirements, improves the quality of sedation and decreases adverse events in patients undergoing GI endoscopy. The trial will be a randomised, double-blind, placebo controlled trial. Patients will be stratified into those undergoing upper GI endoscopy, colonoscopy or both. Patients will be randomised to a loading bolus of 2mg/kg lignocaine or saline, at commencement of sedation, with further 0.5mg/kg lignocaine or saline boluses ever 15 mins for the duration of the procedure. Primary outcome will be midazolam/fentanyl dose. Secondary outcomes will be proceduralist rated quality of sedation, patient satisfaction with sedation, incidence of bradycardia, hypotension, desaturations, airway support and sedation failure.
-
Are the broad cognitive improvements seen with tDCS in healthy controls a result of general or specific effects?
Expand descriptionThe aim of the research project is to investigate whether the broad improvements seen across cognitive domains following tDCS in the healthy population are a result of general effects (i.e. improving speed of information processing) or specific effects (i.e. improving working memory capacity or social decision making ability).
-
A pilot trial of the iCanADAPT Advanced Program, an internet Cognitive Behaviour Therapy (iCBT) program for the treatment of depression and anxiety in ambulatory advanced-stage cancer patients.
Expand descriptionThe primary purpose of this trial is to explore the outcomes of the clinician-guided iCBT program for people experiencing anxiety and/or depression symptoms who have been diagnosed with advanced-stage cancer. Who is it for? You may be eligible to participate in this study if you are aged 18 years or over, suffer from anxiety or depression and have been diagnosed with advanced-stage cancer. Study details The iCanADAPT Advanced Program is a 12 week online program which involves learning about tackling depression and anxiety with a form of therapy called Cognitive Behavioural Therapy (CBT). CBT looks at improving how we manage our thoughts, actions and feelings. There are 6 lessons, each one taking up to an hour to complete, with the recommendation to do a new lesson every 1-2 weeks. There will also then be additional activities to do for around 3 hours per week. The program is tailored to unique aspects of the cancer context, such as fear of cancer progression, adapting to illness and end-of-life concerns. Participants will complete a number of important questionnaires to assess their depression and anxiety levels among other psychological factors, at the beginning of the program, mid-way through, then again at the end of the program and the last time is 3 months after finishing the program. Participants will also be asked to complete a short questionnaire before every lesson. It is hoped that the findings of this trial will provide information regarding the efficacy of the iCanADAPT Advanced Program in reducing depression and anxiety in advanced cancer patients.
-
Non-invasive medical device for the treatment of chronic constipation: 1. Proof of Principle study in children.
Expand descriptionThis study aims to determine proof-of-principle if a new medical device (rhythm.IC, GI Therapies) is able to improve symptoms of chronic constipation in children. the device delivers painless electrical stimulation across the skin. The new device has been designed using existing devices with additional safety features and better ease of use. The device has not yet been tested on patients. The study does not aim to measure overall effectiveness, but to determine if the new device is able to improve symptoms of chronic constipation in some patients. The primary objective is to determine if stimulation with rhythm.IC can improve constipation symptoms measured with a global measure (Wexner constipation scoring system) after 2 months stimulation.
-
The Milky Way Study: Comparing effects of regular fat vs reduced fat dairy products on heart and gut health in young children
Expand descriptionThis project is a randomised controlled double-blind trial. It will involve recruiting 55 children aged 4-6 years, who normally consume dairy products on a regular basis. The three month intervention will involve fortnightly delivery of plain packaged dairy products, either reduced fat or regular fat, tailored to suit the child’s normal intake. Assessments conducted at the start and end of the intervention period will include body composition assessment using a BOD POD; blood analysis of lipids, insulin resistance, inflammation and fatty acid biomarkers; blood pressure; strength testing; diet assessment, and gut health using faecal samples. The project will also include a follow up collection point three months after the completion of the intervention. At this time point only a 3-day food record and set of faecal samples will be collected. This project will provide proof of concept for a similar project on a large scale. The study procedures have been informed by preceding focus group research in a convenience sample of parents of young children (manuscript in preparation).
-
Tobacco Harm Reduction with Vaporised Nicotine (THRiVe): Feasibility Study
Expand descriptionThere is mounting evidence of widespread use of vaporised nicotine products (VNPs) among the general population of smokers. There is also evidence of their effectiveness at achieving short-term cessation with few reported side effects, although limited long term efficacy and safety data is available. VNPs may offer a harm reduction approach to tobacco in populations such as people living with HIV who have high rates of smoking and experience significant associated health consequences. This study will examine whether such products that deliver liquid nicotine are acceptable to people living with HIV who smoke and whether a larger, randomised controlled trial to assess long-term cessation outcomes and relapse prevention would be feasible.