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Correlation between Surgical Pleth Index and acute postoperative pain in the recovery room
Surgical Pleth Index (SPI, GE Healthcare) has been suggested to be a potentially useful parameter to assess the depth of analgesia (freedom of pain) in patients under general anaesthesia. SPI is completely risk free and requires no extra monitoring as is simply uses existing data from standard anaesthesia monitoring (from peripheral oxygen saturation sensor) to calculate a 0-100 analgesia score. Though experiments have shown that SPI scores may “respond” (i.e. going up with a painful stimulus), it is unclear whether the score may be useful to predict acute postoperative pain the recovery room. Aim of this purely observational study is to monitor SPI in 70 patients scheduled for elective surgery and to observe and record SPI data during the last approx.15 minutes of surgery until the patient wakes up from anaesthesia. This data will be compared with the first 15 minutes of 3-minutely assessed postoperative pain (0-10 numeric rating scale) in the recovery room (time counting from when patients are capable of pain self-rating). All assessments of interest for this study are standard practice of intraoperative monitoring and no additional monitoring is required for this study. The sole difference to standard practice is that the data from the anaesthesia monitor will be downloaded onto a laptop PC for analysis of the correlation between SPI and postoperative acute pain scores
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Narrow band ultraviolet B (UVB) phototherapy in amyotrophic lateral sclerosis
While the cause of amyotrophic lateral sclerosis (ALS) is unknown, recent evidence points to an important role for immune dysregulation in ALS disease. In particular, a role for the suppressive arm of the immune system, directed primarily by regulatory T cells (Tregs), may slow disease progression. In this project we will conduct the first trial in ALS of a specific immune therapy, narrow band UVB phototherapy, known to increase Treg activity. Narrow band UVB phototherapy is a simple, safe and non-invasive treatment used routinely to suppress damaging immune reactions in other conditions such as psoriasis. We will determine whether UVB phototherapy is safe in ALS and whether it induces regulatory T cells. If effective, this would support a larger trial examining whether UVB phototherapy can slow the progression of disease. Slowing disease progression using phototherapy would be a major advance for this disease. If phototherapy has no effect on disease progression but can increase regulatory T cells it may be useful in combination with other neuron-regenerating treatments that are in development, by reducing immune-mediated neuron damage. The study proposed here will expand our knowledge of the role of the immune system in ALS and highlight the potential to harness its regulatory arm to slow disease progress.
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Delivery of dignity therapy to people with limited life expectancy using e-health: A feasibility study
This study will examine the feasibility, acceptability and potential effectiveness of dignity therapy delivered through e-health methods for people with terminal illnesses. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with a life-limiting condition with a prognosis of six months or less, but are expected to survive 4 weeks or more. Study details All participants in this study will receive dignity therapy. Dignity therapy is an individualised end-of-life psychotherapy that aims to reduce distress and enhance quality of life for people with terminal illnesses and their families. Participants will receive 4 to 6 one hour sessions with a psychotherapist via e-health methods, such as videoconferencing, email or chat (depending on personal preference). Participants will be asked to complete some questionnaires one week post treatment in order to provide feedback and evaluate levels of anxiety and depression, quality of life and hopefulness.
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DIVIT D - A prospective study on predictors and risk factors for acute and recurrent diverticulitis.
The DIVIT study is a prospective, observational study of hospitalised patients that have been diagnosed diverticulitis and diverticular disease. We will plan to identify those admitted to the Gold Coast and Robina Hospitals with the condition, and following them through their admission and discharge. In Liaison with the Acute Surgical and Gastroenterology teams at the Gold Coast Hospital will enable the Research team to identify potential candidates. We will also monitor the computer tomography (CT) scans performed at the Gold Hospital health service for diagnosis of diverticulitis that are related to presentation. We will follow their progress with use of the electronic medical records (eMR). Information about the study as well as a questionnaire looking at particular clinical factors will be given to the patients who have consented for the study. As part of standard clinical care, patients will undergo blood tests, stool tests, imaging and endoscopy. These are what is comprised of standard treatment for acute diverticulitis. There is no alteration in their clinical care. We will then analyse the collected data to determine any predictors for severe disease/ recurrent disease as stated in our aims. The data will be kept for 5 years, and at the end, will be deleted and consent forms will be destroyed. We hope to capture a sample size of around 150-200 patients over the 2 year period The purpose of the research is to identify and better understand the factors that cause diverticulitis, and distinguish between people who are more likely to develop the disease early in life and also get frequent attacks. This could have implications in aggressive approach or more conservative approach to management of acute and recurrent diverticulitis.
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Potential of natural dietary antioxidants in improving heart health in obesity
This project aims to evaluate the effect of anthocyanins, an antioxidant derived from fruits and vegetables, as an anti-thrombotic prophylaxis in normal healthy individuals versus obese pro-thrombotic individuals (predisposed to heart attacks and stroke). Increased platelet activity is an important contributor to thrombosis in vascular diseases. Antioxidants have been shown to act on several platelet activation pathways, reducing inflammatory responses thereby mimicking antiplatelet and anti-inflammatory drugs. We have previously shown that antioxidants in the form of a plum juice have potential to alleviate thrombotic risk in normal healthy population by reducing platelet aggregation, platelet activation and improving coagulation profile. Furthermore it has been demonstrated that anthocyanins target similar platelet activation pathways as aspirin (cyclooxygenase-1 pathway) and clopidogrel (ADP P2Y12 pathway), the commonly used antithrombotic drugs. In spite of the effectiveness of these drugs, prolonged usage has been associated with a number of side effects. We believe that anthocyanins have the potential to be used in the pro-thrombotic, drug resistant/non-responsive patient population either as a replacement or complementary therapy in prevention of cardiovascular diseases (CVD). The outcome of this project will significantly support a therapeutic alternative to currently used therapeutics, leading to effective prevention and treatment of oxidative stress induced metabolic syndrome conditions, providing fiscal and health benefit to society.
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Evaluation of anatomical head center, gait and bone re-modelling after Total hip replacement – Randomized controlled trial of neck preserving versus conventional hip prosthesis
This clinical study is a single centre, prospective, randomized, participant-blinded trial enrolling 40 patients to receive either a Cementless Neck Preserving stem or a Conventional Hip stem Prosthesis. Neck preserving prostheses to offer a more physiological load transmission across the femur, the nature of achieving a stable press-fit means that the stem must adapt to the geometry of the bone. As patient anatomy is highly variable, there is limited ability to adjust the femoral offset, centre of rotation, femoral anteversion and leg length. It is unclear whether anatomical restoration, offered by neck preserving prostheses is comparable to conventional prostheses. The success of the neck preserving systems relies on the precise positioning and sizing of the implant and the excellent long-term durability of the ceramic bearings. Hence, we propose a randomized comparative study to assess and compare the anatomical head centre, gait analysis and bone remodelling of two parallel groups receiving either a Neck preserving or a Conventional hip stem prosthesis by the direct anterior approach. Antero-posterior and modified Budin x-rays will be analysed at preoperatively, 3 months, 12 months, 2 years and 5 years to assess femoral head offset, stem orientation and leg length. DEXA (bone density) scans will be assessed pre-operatively and 12 months to measure femoral bone density, with the aim of assessing bone remodelling after total hip replacement. Spatial-Temporal gait analysis will be used to quantify measurement of standard gait (6 minute walking test – 6MWT) and sit-to-stand preoperatively, 3 months and 12 months. Standard, functional parameters will be assessed pre-operatively, 3 months, 12 months, 2 years and 5 years.
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Contact&Connect: A randomised trial of a multimedia-based mental health wellbeing program for unemployed construction workers.
Recent unemployment represents a significant risk factor for the development of mental health problems, such as depression, and suicidal behaviour. This relationship may be affected by age and gender with working age males at particular risk. Interventions which target recently unemployed working age males to reduce mental health stigma and improve mental health literacy skills may be effective in this population to reduce depression symptomatology and suicidal ideation. The Contact&Connect intervention will be a series of digital ‘brief contact interventions’ (BCIs) with male unemployed construction workers aged 30-64 years. BCIs are defined a structured contacts using a variety of modalities that seek to provide support, education and maintain long-term contact with individuals. The BCIs will be delivered to workers’ smartphones via SMS rich text messages. These messages will include embedded hyperlinks to other digital resources the project will make available on the internet, including microsites, videos, and digital wallet cards. In terms of stigma reduction, the intervention will largely be educational. Content will flow across three main themes: de-bunking myths and stereotypes, normalisation, and empowerment.
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An evaluation of the efficacy of curcumin and saffron for the treatment of depression
This is a double-blind, placebo controlled study assessing the antidepressant effects of curcumin or curcumin/saffron in 160 adults suffering from depression (mild to moderate severity). Participants will be randomly allocated into one of four groups (1) curcumin (BCM-95 'Registered Trademark' - 250mg twice daily); (2) curcumin/ saffron (BCM-95 'Registered Trademark' - 250mg + 15mg saffron twice daily); (3) curcumin (BCM-95 'Registered Trademark' - 500mg twice daily); (4) placebo. Changes in depression and anxiety will be measured over a 12-week period. The aim of this study is also to investigate potential mechanisms of action of curcumin so urine and blood samples will be collected at the beginning and completion of the study. Levels of markers associated with inflammation and oxidative stress will be assessed over time.
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Curcumin for the treatment of attention deficit hyperactivity disorder (ADHD) - a randomised, double-blind, placebo-controlled study
This is a double-blind, placebo controlled study assessing the therapuetic effects of curcumin in 60 youth suffering from ADHD or significant attentional problem. Participants will be randomly allocated into either a curcumin (BCM-95 'Registered Trademark' - 250-500mg twice daily) or placebo group and changes in ADHD symptoms and general behaviour will be measured over a 12-week period.
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A randomized and controlled study comparing efficacy of intra-operative patient controlled sedation versus radiologist controlled sedation using midazolam and fentanyl, for patients undergoing insertion of a central venous line.
Diagnostic and therapeutic procedures performed in interventional radiology can provoke anxiety and may be painful. Mild sedation with analgesia is administered by the interventional radiologist to calm patient anxiety, reduce unwanted movements and alleviate patient discomfort. Central line placements are common, (including Hickman line placement, tunnelled dialysis catheter placement, injectable port implantation) and intravenous sedation would typically be used for these procedures. The most commonly used drug for sedation in radiology is midazolam, a benzodiazepine. Midazolam has a short half-life of 2-6 hrs, but very powerful anxiolytic (anti-anxiety), amnestic, hypnotic, anticonvulsant, skeletal muscle relaxant, and sedative actions. It is administered at 1 milligram per dose to the desired response, has a 2 minute onset time and duration of 45 to 60 minutes. The most common analgesic used is fentanyl, a short acting opioid that is administered at an incremental dose of 25 micrograms and repeated every 5 minutes to a maximum dose of 100 micrograms. Its onset time is 2-3 minutes and it has a duration time of 30-60 minutes. Midazolam and fentanyl are usually administered concurrently, with 1 milligram midazolam and 25 micrograms fentanyl being the standard single dose. Multiple doses are titrated carefully to achieve and maintain adequate sedation and alleviation of anxiety, while preserving cardio-respiratory function, protective reflexes and the ability to respond appropriately to verbal and/or tactile stimulation. Doses are given incrementally, often starting with a double dose with at least 5 minutes interval before the next dose to allow evaluation of drug effect. Oxygen saturation, blood pressure, heart rate, and respiratory rate are monitored continuously and documented every 10 minutes. Neurological response is also monitored continuously by observing the patients response to command or conversation. Reversal "antidote" agents for these medications are flumazenil and naloxone respectively. The current practice is that the radiologist takes a history from the patient, looking for patient factors that may affect the safety and practice of sedation. These would include patient size, age, prior cardiac and respiratory disease, diabetes, renal failure, obesity, allergies, drug interactions, previous anaesthetic history, and airway issues. There will be assessment of the patient’s level of anxiety and expectation of procedural discomfort. The radiologist will then decide on the appropriateness of midazolam/fentanyl sedation, and choose an initial dose. As the procedure starts, the level of sedation is assessed, and if needed, further aliquots of midazolam/fentanyl are administered at the radiologists’ discretion. Our hypothesis is that this practice has problems in that there is a fear of the effects of oversedation (eg low blood pressure or slower respiratory rate), and this results in many patients being undersedated. The patient may be apprehensive to ask for more sedation and thus their overall experience of the procedure is suboptimal. Based on prior evidence in the literature in other medical settings, we believe that by giving the control of sedation to the patient (within a safe dose and lockout period), that the patient is more likely to seek sedation when required and hence will be at less risk of undersedation. We expect that this will lead to an overall greater experience for the patient. The medical procedure being performed (ie insertion of a tunnelled central line) will not be affected by this study.