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Investigating whether blocking intestinal sweet taste sensing alters blood glucose control in adults with type 2 diabetes
Intestinal sweet taste receptors (STRs) sense all sweet stimuli to coordinate the absorption and metabolism of glucose. We have shown that a defect in intestinal STRs in patients with type 2 diabetes (T2D), as well as supplementation of low-calorie sweeteners in non-diabetic subjects, both accelerate glucose absorption and worsen glycaemic control. We now propose to block intestinal STRs in patients with T2D to evaluate the potential glycaemic benefits of this potential 'next generation' diabetes therapy.
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Creation of a Statistical Shape Model (SSM) of the head and airway to improve CPAP delivery in OSA using prospectively collected CT head scans
Otopure Pty Ltd in collaboration with ResMed is undertaking this study to generate a uniquely valuable data set that includes a statistically significant number of volunteers providing informed consent for prospective CT scanning that will allow for the generation of a Statistical Shape Model (SSM) of the head that incorporates the face and the upper aerodigestive tract. These SSM models will be able to generate usable, realistic geometry in any of these forms in a matter of minutes. The primary objective of this study is to generate a statistical shape model (SSM) of the head and airway in order to improve treatment for patients with OSA.
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MyCOACH (COnnected Advice for Cognitive Health) - Evaluation of an e-learning and active lifestyle program for cognitive decline and risk of dementia in adults with mild cognitive impairment or subjective cognitive decline.
The MyCoach (COnnected Advice for Cognitive Health) clinical trial aims to test the effectiveness of an e-learning course designed to support healthy brain ageing and reduce risk of dementia, tailored for people living with mild cognitive impairment or subjective cognitive decline. The e-learning course provides information on memory impairments and dementia, memory strategies, and the association of different lifestyle factors (diet, physical activity, social and cognitive activity, and stress) with brain ageing. The course is complemented with additional practical support for healthy lifestyle change, and the components combined run for 12 weeks. The MyCoach intervention will be evaluated against a control group receiving general education. We will be evaluating the effectiveness of MyCoach at improving dementia risk scores, cognition, as well as healthy ageing outcomes.
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Tissue and Blood-based Biomarker in Colorectal Cancer
This study is investigating whether known (already identified) or new potential biomarkers found in blood or tissue can be used to detect colorectal cancer, or to predict the outcomes of patients who have been diagnosed with colorectal cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have confirmed colorectal cancer or benign (non-cancerous) bowel disease or you are healthy without any history of bowel disease (cancerous or benign) Study details All participants who choose to enroll in this study will be asked to provide up to 6 blood samples over a 5 year period. Participants who have confirmed colorectal cancer will be asked to allow research on tissue collected at surgery or colonoscopy for 5 years post consent. Participants who have confirmed cancer will also be asked to share their medical history and any new test results with the research team to determine how the disease is responding to treatments provided. It is hoped this research will identify new biomarkers that may be used to improve health outcomes for colorectal cancer patients, either by allowing earlier detection of cancer, or by allowing detection of people who have a genetic risk of cancer so that they might take steps to reduce their future risk of developing cancer.
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Optimal patient selection for physiotherapy pathways after total knee arthroplasty: the KAPPA trial
Total knee arthroplasty (TKA) surgery is considered the gold standard procedure for symptomatic knee osteoarthritis, and in line with increasing osteoarthritis rates, TKA surgery is also projected to rise. Traditionally, TKA was associated with a long and extensive physical recovery, and supervised physiotherapy was considered routine. Recent peri-operative advancements and rapid recovery protocols have meant that TKA patients regain functional independence much sooner and are less reliant on formal rehabilitation. However, despite this progress, some patients still have suboptimal functional outcomes or self-reported dissatisfaction when their rehabilitation is self-directed, and are then subsequently referred by their orthopaedic specialist, or self-seek, supervised physiotherapy. The aim of the Knee Arthroplasty Physiotherapy Pathways (KAPPA) trial is to determine which patient variables are associated with poor physical or self-reported outcomes after undergoing self-directed physiotherapy. If patients at higher risk of suboptimal outcomes can be identified, then early referral to supervised physiotherapy can be implemented.
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Effect of Paracervical Block on Post-operative Pain Following Benign Laparoscopic Hysterectomy: Objective Evaluation Of Parameters By Utilising A Single Centre Double Blind Randomized Controlled Trial
We propose a study which is first of its kind in Australia/New Zealand with an aim to objectively assess the role of performing a paracervical block in reducing postoperative pain and enhancing post-operative recovery following benign indicated laparoscopic hysterectomy. Paracervical block with 0.5% Bupivacaine (with adrenaline) has been previously tested as a potential strategy to optimise post-operative pain management following total laparoscopic hysterectomies (TLH). However, data in this regards remains scarce. Our proposed study aims to conduct objective evaluation of pain by measuring opioid intake post-operatively as well as by determining the impact of paracervical block in patient reported pain beyond the first 24 hours postextubation. In addition, we also attempt to determine subsequent impact on return to normal activity. The proposed study is a two-arm single centre double blinded randomized placebo-controlled trial. We believe this study will not only add to the current body of limited evidence but will also assist in planning and implementation of methods to improve perioperative pain management, maximise enhance recovery after surgery, and increase patient satisfaction. The potential overall impact in cost efficacy and economic gain is also worth consideration. Drug used in trial: The medication that we will examine and use in ‘treatment’ group is 0.5% Bupivacaine with Adrenaline. This is a TGA approved drug, with a well-established safety profile, frequently used in a number of gynecological procedures, and readily available in the institution where the trial will be carried out.
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KIDS AID Treatment Trial: Transdiagnostic therapy for children who have experienced trauma and/or major stress
Present trauma interventions are limited in that they tend to be designed for children diagnosed with PTSD. This study aims to test an intervention that is suitable for children who have experienced trauma but are experiencing a wide range of symptoms. We want to see whether this treatment is acceptable to children and their parents, whether it is effective at reducing mental health symptoms, and whether it prevents future difficulties associated with trauma such as suicide and psychosis symptoms. We are also interested in what mechanisms the treatment may work through (e.g., emotion regulation).
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Effectiveness of exercise in Systemic Lupus Erythematosus.
The aim of this project is to compare the effectiveness and individual experience of supervised and structured aerobic exercise to resistance exercise on key clinical outcomes in people with Systemic Lupus Erythematosus.
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PROM implementation for elective surgery patients in Australia: national implementation of the “AusPROM Recommendations” (Phase III)
Incorporating patient reported outcome measures (PROMs) into usual care in hospitals can improve safety, quality and patient satisfaction. The aims of this clinical trial are to: (i) test the feasibility of national implementation of the QoR-15 PROM for elective surgery; (ii) test the patient acceptability of the QoR-15 PROM for elective surgery day and overnight patients, (iii) establish if the QoR-15 PROM has concurrent validity with the EQ-5D-5L, and (iv) report the percentage of patients who return to pre-surgery status (as measured on the QoR-15) in the week following surgery and at four weeks following surgery. The trial protocol has adopted the Guidelines for Inclusion of Patient Reported Outcomes in Clinical Trials Protocols (SPIRIT-PRO). The findings will highlight value of patient (acceptability domains) feedback to inform the AusPROM recommendations for the implementation of patient focused outcome measures. The trial will also illuminate the feasibility and value of using the QoR-15 to understand patient views about elective surgery outcomes.
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Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) : Amoxicillin Duration
Acute respiratory infection (ARI) is a common cause of childhood morbidity and the most common reason for paediatric emergency department presentation and hospitalisation. Despite numerous professional bodies describing the limited trial data available to inform management guidelines, there has been little progress towards evidence-based ARI care in developed nations in the past decade. Antimicrobial use (or misuse) is a major driver for antimicrobial resistance (AMR) and identified by the WHO as an urgent threat to the prevention and treatment of an ever-increasing range of infections. AMR is a serious threat to global public health, requiring urgent action across all government sectors and society. Most antibiotics in children are prescribed for common paediatric conditions, particularly ARI. Our group has demonstrated that >50% of ARI-episodes are confirmed to be secondary to viral infections, yet >50% of children with fever and cough are prescribed antibiotics. Therefore, most antibiotics prescribed to children with ARI are likely to be unhelpful and given the impact on AMR, potentially harmful. The primary objective of this trial is to generate the evidence for optimal duration of antibiotic treatment for pneumonia and ARIs in children. This trial will compare different treatment arms of amoxicillin for 2, 3, 4 or 5 days for physician-diagnosed pneumonia in children aged greater than or equal to 6 months to 15 years.