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Sugammadex, neostigmine and postoperative pulmonary complications (SNaPP): a feasibility and pilot trial
Expand descriptionDuring general anaesthesia muscle relaxant drugs are administered to make airway management and surgery easier. Muscle relaxants are usually reversed with neostigmine at the end of the operation. A newer drug, sugammadex, reverses muscle relaxants more rapidly than neostigmine, but is not clear whether sugammadex results in fewer postoperative complications than neostigmine. We are planning a large multi-centre randomised controlled trial to investigate whether sugammadex is associated with fewer postoperative lung complications than neostigmine. The current study is a pilot study that will determine if the larger trial is feasible. We will measure feasibility outcomes (e.g. recruitment rates) and pilot the main trial outcomes (e.g. postoperative pulmonary complications)
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Evaluation of two healthy lifestyle and exercise support programs for adults aged 60 and over: a randomised controlled trial (Healthy and Active for life trial)
Expand descriptionNSW Health’s Active Ageing portfolio, managed by the NSW Office of Preventive Health (OPH), provides a suite of evidence-based programs for older adults. These programs aim to increase healthy lifestyle behaviours and decrease the risk of chronic disease and falls in the older population. The Active Ageing portfolio has recently been revised to place more focus on physical activity and healthy eating. As part of this work, OPH has designed a new program Healthy and Active for Life (HAL), which targets adults aged over 60 years. The proposed research will assess the impacts of the HAL face-to-face, with a digital version of the HAL program, as well as a control condition. Participants will be randomly allocated to each arm.
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Palmitoylethanolamide and polydatin effect on pain and dysmenorrhea in women scheduled for laparoscopic treatment of possible endometriosis: a double blind randomised controlled trial.
Expand descriptionEffective medical therapies for the treatment of endometriosis related pelvic pain are limited and are often associated with side-effects. Palmitoylethanolamide (PEA) is a food supplement that has been shown to have anti-inflammatory action. Polydatin (PLD) is also a food supplement that has antioxidant and pain inhibiting activities. There have been some small studies performed to assess if the combination of PEA/PLD is helpful for persistent pain associated with endometriosis. The results suggest it might have benefit, but further studies are required. Multiple studies that assessed PEA/PLD for pain relief in various other pain conditions have not reported any significant side effects. The aim of this study is to determine if treatment with PEA/PLD improves endometriosis associated pain. Women who are booked for surgical treatment of possible endometriosis will be offered participation in this study. Participation will not change their surgeon’s care plan. The participants will be randomised to either receive 8 weeks of PEA/PLD treatment or placebo prior to their surgery. The endometriosis will then be confirmed or excluded during the surgery. Lesions of endometriosis, endometrium, pelvic fluid and blood will be collected where possible to assess inflammatory markers. Participants will also complete a survey including pain and quality of life assessments. This survey will be completed at recruitment, after 8 weeks of treatment (pre surgery) and at 6 months (4 months after surgery). We will assess the change in pain scores and quality of life scores between the 2 groups to see if PEA/PLD is beneficial.
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Investigating resistance training in people living with psychotic disorders.
Expand descriptionPeople with chronic psychotic disorders experience functional disability, poor physical health and incomplete recovery that can be poorly responsive to first line treatments. Research has clearly demonstrated mental and physical health improvements from exercise, however predominantly utilising aerobic protocols. There is scant evidence regarding resistance training in people with psychotic disorders, even though preliminary evidence suggests safety and preference for this type of training. We will recruit participants with chronic psychotic disorders from three mental health rehabilitation units and randomise participants to resistance training, or control (aerobic- moderate intensity interval training), three supervised sessions per week for 8 weeks in a randomised controlled trial in which outcome assessors will be blind to condition allocation. The primary aim of this study will be to investigate the feasibility and acceptability of resistance training (recruitment, retention and participation). Secondary aims will include a comparison of various mental and physical health outcomes between exercise types pre and post the intervention. We hypothesise that resistance training will be feasible and acceptable to people with psychotic disorders.
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A Phase 1/2 randomized, placebo-controlled, multi-centre study to evaluate the safety and immunogenicity of a novel Receptor Binding Domain (RBD) COVID-19 Vaccine in Healthy Adults
Expand descriptionThe receptor-binding domain (RBD) in SARS-CoV-2 S protein has been identified as the component required for coronaviruses to enter the human cells using the human receptor angiotensin converting enzyme 2 (ACE2). The investigational vaccine, RBD SARS-CoV-2 HBsAg VLP vaccine, is a subunit vaccine where the RBD antigen is conjugated to the hepatitis B surface antigen to allow the stimulation of the immune system to produce anti-RBD (CoV2 Receptor binding domain) antibodies. The study will be conducted in two stages: phase I and phase II. Phase I will include healthy adults aged 18 - 45 years and evaluate the safety and immunogenicity outcomes following administration of different formulations of the vaccine when compared with placebo. Phase II will include a separate group of healthy adults participants aged 18 - 79 years and evaluate the safety and immunogenicity outcomes following dosing of different formulations of vaccine and different dose strengths 28 days apart when compared with placebo.
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A Prospective Photographic Analysis Of Psoriasis Severity Following Treatment With Tildrakizumab
Expand descriptionPlaque psoriasis is a multifaceted immunological condition primarily resulting from a dysfunctional immune response with T-cells at the center of immunogenesis. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with moderate to severe plaque psoriasis and your treating physician has prescribed you Tildrakizumab. Your treating physician will have prescribed two loading doses of Tildrakizumab 4 weeks apart. Study details: This is an observational study that uses high quality photography and investigator assessments to determine changes to plaque psoriasis over a period of 64 weeks (Study visits will be conducted at week 0,4,8,16,28,40,52 and 64.). The aim of the study is to evaluate the efficacy of Tildrakizumab in the resolution/treatment of psoriasis.
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Depression Screening and Care in Coronary Heart Disease Patients
Expand descriptionCollaborative depression care in chronic disease populations is established in the USA and UK, however this model of care is not widely implemented in Australia, and the effectiveness and cost-effectiveness is unknown within our healthcare system. This quality improvement initiative, embedded within an implementation-science trial, aims to evaluate whether standardised depression screening performed by site-specific nurse coordinators, improves the uptake of collaborative depression care in Australian coronary heart disease populations, with concomitant reductions in depressive symptoms and major adverse cardiac events, with cost-utility.
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ß-Hydroxy-ß-Methylbutrate (HMB) supplementation and functiOnal OutcomeS in multi-Trauma patients (BOOST TRIAL)
Expand descriptionPatients who survive ICU stay often develop important muscle weakness and rapid reduction in muscle mass. Furthermore, they often have notable deficits in nutritional intake. These changes in body composition and nutritional shortfalls may negatively impact long term outcomes and recovery. Therefore, ward based interventions or therapeutic agents which may slow muscle loss or aid in recovery from critical illness associated muscle loss have the potential to deliver clinical benefits. This study aims to determine the feasibility of providing a nutrition intervention to critically ill multi-trauma populations throughout hospital admission at the Royal Melbourne Hospital. Secondly, we aim to describe nutrition related patient outcomes (including anthropometric changes, nutritional intake, muscle strength and physical function) in this group.
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Specialist Treatment of Inpatients: Caring for Diabetes (STOIC-D) - A single centre, randomised, controlled trial assessing the impact of a proactive specialist inpatient diabetes service on outcomes in inpatients with diabetes or hyperglycaemia.
Expand descriptionThis study aims to answer the question: Does proactive (early intervention) specialist care for hospital inpatients with diabetes or new hyperglycaemia improve glucometric and clinical outcomes? All patients admitted to The Royal Melbourne Hospital during the trial period who have diabetes or hyperglycaemia will be randomised to usual care or proactive specialist care. Proactive specialist care involves the inpatient diabetes service (IDS) identifying patients with diabetes or hyperglycaemia proactively without the team looking after the patient necessarily referring to the IDS for their input. The IDS will then make management suggestions with the effect of these suggestions on outcomes such as glucose levels, in-hospital complications, and length of stay assessed.
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A randomised, double-blind, placebo-controlled study evaluating Palmitoylethanolamide for diabetic-related peripheral neuropathic pain, inflammation and quality of life
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