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A Prospective Double Blinded, Randomised, Placebo-Controlled Study to Evaluate Safety and Efficacy of Two (2) Herbal Formulations in Reducing Menopausal Symptoms in Otherwise Healthy Women.
Expand descriptionThe aim of this study is to evaluate the safety and efficacy of two herbal formulations in reducing menopausal symptoms in otherwise healthy women. Participants will be enrolled in the study between September 2014 and October 2015 and provided treatment for 3 months. All participants are provided with the treatment pack – which includes the product (active intervention 1, active intervention 2 or placebo), a daily symptom diary and a pre-prepared QML pathology form for safety profiling and hormone assessment. Participants take the medication daily and complete the symptom diary daily for 1 week/month. At month 1 and month 2, a telephone interview is conducted to confirm compliance and complete the QOL questionnaires. At month 3, participants repeat the blood test at a QML collection centre and they return to the clinic for final assessment. There will be regular communication with all participants during the study. There will be supervision of the trial by a qualified Medical Practitioner / Endocrinologist, A/Prof Warrick Inder who will monitor any adverse events associated with the trial.
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Comparative plasma and cerebrospinal fluid pharmacokinetics of paracetamol following intravenous and oral administration
Expand descriptionThe primary purpose of this study was to determine the concentrations of the drug paracetamol in the plasma and cerebrospinal fluid after intravenous and oral administration to adult patients having surgery under spinal anaesthesia.
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Does sildenafil reduce the risk of fetal distress in labour?
Expand descriptionLabour is perhaps the most hazardous time in pregnancy for the fetus. Uterine contractions can contribute to more than a halving of blood flow to the uterus and placenta and this in turn may lead to fetal distress. In most pregnancies, the placental blood supply and function is adequate but it may not be sufficient to tolerate the extra demands of labour. Up to 63% of babies who become distressed and suffer oxygen deprivation in labour have no prior risk factors. Furthermore, events in labour account for as many as 20% of cases of cerebral palsy in term infants. Recent research demonstrates that the changes in blood flow to the fetus can be detected by ultrasound and that these changes are highly predictive of identifying fetuses at risk of becoming distressed in labour, as well as reliably excluding those that were not at risk. With this in mind, investigating ways to preserve and promote the blood supply and in turn, the oxygenation to the fetus has the potential to significantly change intrapartum care. Sildenafil is a vasodilator (opens blood vessels) and based on previous research may play a role in enhancing blood flow to the fetus. This clinical trial will investigate if having sildenafil in labour improves the blood flow to the fetus and reduces the need for emergency operative delivery (either caesarean section or operative vaginal birth) for fetal distress.
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ICEAGE trial - Incidence of Complications following Emergency Abdominal surgery: Get Exercising.
Expand descriptionBackground: Postoperative complications and delayed physical recovery are significant problems following emergency abdominal surgery. Physiotherapy aims to aid recovery and prevent complications in the acute phase after surgery and is commonplace in most first-world hospitals. Despite ubiquitous service provision, no well-designed, adequately-powered, parallel-group, randomised controlled trial has investigated the effect of physiotherapy on the incidence of respiratory complications, paralytic ileus, rate of physical recovery, ongoing need for formal sub-acute rehabilitation, hospital length of stay, health-related quality of life, and mortality following emergency abdominal surgery. We hypothesise that an enhanced physiotherapy care package of additional education, breathing exercises, and early rehabilitation prevents postoperative complications and improves physical recovery following emergency abdominal surgery compared to standard-care alone. Methods: The Incidence of Complications following Emergency Abdominal surgery: Get Exercising (ICEAGE) trial is a pragmatic, investigator-initiated, multicentre, patient and assessor-blinded, parallel-group, active-placebo controlled randomised trial, powered for superiority. ICEAGE will compare standard-care physiotherapy to an enhanced physiotherapy care package in 288 participants admitted for emergency abdominal surgery at three Australian hospitals. Participants will be randomised using concealed allocation to receive either standard-care physiotherapy (education, single session of coached breathing exercises, and daily early ambulation for 15-minutes), or an enhanced physiotherapy care package (education, twice daily coached breathing exercises for a minimum two days, and at least 30-minutes of daily supervised early rehabilitation for at least five postoperative days). The primary outcome is respiratory complications during the first seven postoperative hospital days assessed daily with standardised diagnostic criteria. Secondary outcomes include referral for sub-acute rehabilitation services, discharge destination, paralytic ileus, hospital length of stay and costs, intensive care unit utilisation, 90-day patient-reported complications and health-related quality of life and physical capacity, and mortality at 30-days and at one year following surgery. Discussion: The morbidity, mortality, and fiscal burdens following emergency abdominal surgery are some of the worst within surgery. Physiotherapy may be an effective, low-cost, low-harm intervention to improve outcomes and reduce hospital utilisation following this surgery type. ICEAGE will test the benefits of this commonly provided intervention within a methodologically robust, multicentre, double-blinded, active-placebo controlled randomised trial.
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Pilot Study: Evaluation of a silicone gel adhesive hydrocellular foam dressing for the prevention of sacral pressure injuries in hospitalised elderly patients
Expand descriptionThe aim of this study is to gather information about the effectiveness of a foam dressing to prevent the development of sacral pressure injuries (PI). Currently, preventative dressings are not used routinely. In this study,of adult patients who are at high risk of developing a PI, half of the sample of 126 patients will be randomly allocated to receive the sacral foam dressing and half will receive standard care i.e. no sacral dressing. The dressing will remain in place for the duration of each participant's hospital stay. It will be replaced routinely after 7 days, or before if needed. In all patients, the sacral skin will be inspected on a daily basis to observe for the presence of PI, for a maximum period of 4 weeks. The main outcome measure will be the occurrence of sacral PI. Dressing comfort will be evaluated from the patient's perspective, and its utility will be evaluated by nurses. A cost analysis will also be undertaken. It is anticipated that patients treated with the foam dressing will have a lower incidence of pressure injuries than those receiving standard care.
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Identification of clinical data useful to predict the development of prolonged symptoms after a concussion, at the time of initial assessment in the Emergency Department.
Expand descriptionThe Predictors of Post Concussive Syndrome Protocol that we are developing concerns a study on the derivation and validation of a clinical prediction rule for PCS in children aged 5 to 18 years, who present to the ED for concussion. In order to assist clinicians in identifying patients at high risk of PCS, who will benefit from a closer follow up and early referral to a dedicated concussion clinic, we set out to derive and validate a clinical prediction rule based on pre-injury and injury-related data to be used in the ED.
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Factor concentrates versus Allogeneic blood in CardioThoracic Surgery trial
Expand descriptionThe aims of our study are to determine whether the use of algorithms with point of care testing to guide the use of factor concentrates can target bleeding more quickly and precisely and lead to a reduction in red cell transfusion rates compared to the use of allogeneic blood products. We will also examine its impact on other secondary outcomes, such as morbidity and mortality, bleeding and thrombotic complications.
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kContact: Keeping Contact between parents and children in care. A trial of an enhanced model of contact with parents to reduce child distress and improve children's emotional safety.
Expand descriptionkContact is a three-year study to develop and trial an enhanced model of managing and supporting contact between children in care and their birth parents. The aim is to reduce current and future distress related to contact, improve children's relationships with their parents.
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Examining the effect of Tranexamic Acid (TXA) on the functional fibrinolysis assay in patients with hereditary bleeding disorder (HBD) compared with healthy controls.
Expand descriptionIt is routine practice at the Haemophilia Treatment Centre at The Alfred that patients who undergo dental extraction or low risk endoscopic procedures receive tranexamic acid (TXA) with or without factor concentrate replacement (depending on proceduralist determined bleeding risk). Despite clinical reports of no increased rate of bleeding utilising this strategy, the underlying biological mechanism has not been extensively explored. We aim to evaluate the impact of TXA on functional fibrionolysis by enrolling such patients and healthy controls into the proposed study. Enrolled patients will ingest one gram of oral tranexamic acid on the day of procedure and blood will be collected immediately before and 4 hours post ingestion. Plasma samples will be prepared and stored for evaluation of fibrinolysis utilising contemporary clot lysis assay. Correlation of the results will be made with clinical bleeding as reported by the proceduralist who are blinded to the results. Healthy volunteer subjects will also take a dose of one gram of tranexamic acid and have plasma samples collected at 2,4, and 8 hours post ingestion. Fibrinolysis will be measured using a light transmission based assay where thrombin and tissue plasminogen activator are added to the plasma. The expected effect of tranexamic acid is a delay in fibrinolysis in the control samples. In the patient samples, it is expected that clot formation will be impaired by the bleeding disorder but the tranexamic acid may similarly delay fibrinolysis when compared with controls.
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Preoperative Immunonutrition in Patients Undergoing Pelvic Exenteration Surgery for Cancer
Expand descriptionThe purpose of this study is to determine if immunonutrition prior to pelvic exenteration surgery for people with cancer decreases complications, length of hospital stay and immune markers after their surgery. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are scheduled to undergo pelvic exenteration surgery for cancer. Study details - Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will consume 3 immunonutrition supplements (known as Impact Advanced Recovery) each day for 5 days prior to their surgery. Participants in the other group will instead consume 3 nutrition supplements with equivalent protein and energy as the immunonutrition supplements (3 x Resource Protein) each day for 5 days prior to their operation. All participants will be monitored for up to 3 months post hospital discharge for any post-operative complications, such as infectious or non-infectious complications and immune markers.