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The Healthy Youngsters, Healthy Dads Program: A healthy lifestyle program for fathers and their preschool-aged children.
HYHD is an evidenced-based 8-week program aiming to improve the healthy lifestyle behaviours of fathers and their pre-school aged children. HYHD provides fathers with the knowledge, motivation and parenting strategies to engage with their children and become role models to improve physical activity levels, dietary behaviours and weight status of both themselves and their children. This program has been successfully tested in a feasibility trial at the University of Newcastle. The aim of this RCT is to test the effectiveness of the HYHD program when delivered by local trained facilitators.
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Preventing Hospital Falls: Optimal Screening
This NHMRC funded partnership grant project is a Falls Risk Assessment Form (FRAT) dis-investment non-inferiority study and investigates the effects of cessation of a traditional hospital FRAT (currently used in many public and private hospitals Australia-wide) and implementation of an evidence-based procedure where clinicians prioritize mitigating falls. It is predicted that dis-investing from rating falls risk using the traditional FRAT and prioritising clinician judgement about falls mitigation will require less resources to implement and will not lead to worse hospital falls outcomes than the usual care FRAT.
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A study of a single oral dose of 4 g of N-Acetyl-D-Mannosamine Monohydrate (ManNAc) in each of fasted and fed conditions to determine the differences in absorption of ManNAc with food intake in healthy participants.
Background: Patients with GNE myopathy have muscle weakness and can have difficulty walking . The disease comes from a gene mutation related to the production of a sugar called sialic acid. Researchers think decreased sialic acid may cause the muscle problems. Researchers are testing the drug ManNAc which is a building block of sialic acid. It is a powder that is dissolved in water. Study Rationale: Because ManNAc is a simple monosaccharide, there is a possibility that its absorption can be impacted by co-ingestion with other foods. There is, therefore, a need to better understand any potential effects of food on the absorption of ManNAc by comparing the administration of 4 g of ManNAc under fed or fasted conditions.
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The Lignocaine infusion on Donor Site Pain in Patients with Burns study
We propose a trial to assess if intravenous (into the bloodstream via a vein) Lignocaine infusion helps to reduce donor site pain in patients undergoing split skin grafting (SSG) following major burns. The pain caused by a burns injury can be difficult to manage and often needs high doses of strong pain killing medications. Patients often report that the pain from the skin graft donor site can be as severe as the pain from the burn itself. The pain from the donor site is often poorly responsive to strong painkillers such as morphine. Lignocaine is commonly used for pain that is generated by damaged nerves (neuropathic pain). There is evidence to support use of Lignocaine to reduce the pain caused by other burns procedures such as dressing changes. There is currently no evidence regarding the use of Lignocaine for pain that is specific to the donor site. This study will help to guide evidence based practice regarding Lignocaine infusions for donor site pain. We will randomly assign all patients admitted under the Burns team at The Alfred who are older than 18 years, who have a burn affecting over 10% of their body surface area and who have the capacity to record pain scores and consent, to one of two groups; Group one will receive standard care plus a bolus and intravenous infusion of Lignocaine Group two will receive standard care plus a bolus and intravenous infusion of Saline (Saline has no effect on pain and acts as a placebo). Neither the patients nor the medical teams will know which patients are in which group. We will record information about the pain the patient is experiencing and also the pain medications they are using before and after the surgery. The infusions will run for 24 hours. We will continue to follow up the patients for 5 days after their surgery. All the patients will be reviewed by the acute pain team who will assess the patient’s pain and make adjustments to the other pain treatments the patients receive. We have a strict protocol for how the medications can be increased. Treating pain is the first priority and no patient will have pain that is uncontrolled as a result of the trial. We will collect two blood samples during the trial to assess the blood level of the trial drug Lignocaine. One will be taken whilst the patient is asleep during their surgery and the second will be taken when the infusion is stopped. The second sample will be taken with the usual post-operative blood tests to minimise extra blood tests. We will follow up the patients 6 months following their burns injury to ask them if they have any ongoing pain that is caused by their burns injury. If they answer yes we will ask them a brief questionnaire asking them about their pain and also collect a list of the medications they are taking for pain. All data collected as part of the trial will be de-identified at all stages and will be submitted for publication in a medical journal. Results of the trial will be available if the patients request it through the burns team, although we will not be able to release any individual data.
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The effects of creatine supplementation and weight training on muscle mass in individuals with prostate cancer undergoing androgen deprivation therapy.
The purpose of this study is to examine the effects of creatine supplementation in conjunction exercise on muscle mass, muscle strength and physical function in prostate cancer patients. Who is it for? You may be eligible for this study if you are aged 18 or over and have localised or locally advanced prostate cancer. Participants must be currently on androgen deprivation therapy and be remaining so for the next three months. Participants will be randomised by chance into two groups. Both groups will partake in a 12 week exercise program targeting the major muscle groups. Sessions will be three times a week and go for approximately an hour. Both groups will also drink a dissolved powder every day for the 12 weeks. One group will drink creatine powder, and the other group will drink dextrose powder (sugar). Participants and researchers will not know which powder each participant is consuming until the end of the study. As part of the study, participants will answer questionnaires, provide a blood sample and do some fitness tests. It is hoped that this research will answer the question if creatine supplementation with weight training can result in greater improvements in muscle mass and strength in men with prostate cancer undergoing androgen deprivation therapy. These results will be important in allowing us to design future studies to further study these questions and ultimately translate these findings into clinical practice.
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Comparison of two different recovery strategies on post-exercise blood flow and recovery.
This research aims to investigate the effects of SCG on markers of venous return and muscle blood flow post-exercise, and the influence this has on aspects of muscle recovery. Participants will complete a lower-body resistance training session followed by an assigned recovery intervention of either SCG tights, placebo (artificial sweetener) or control. A number of performance, physiological and psychological measures will be taken to assess the effectiveness of SCG on recovery post-exercise. It is hypothesized, wearing SCG post-exercise will enhance markers of venous return, muscle blood flow and muscle recovery.
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Combined radiotherapy and immunotherapy for men with early metastatic prostate cancer not on hormone therapy
The purpose of this study is to test the effectiveness of a medication called Durvalumab in combination with radiotherapy for prostate cancer. Who is it for? You may be eligible for this study if you are aged 18 or over and have prostate cancer and are not currently taking treatments that block male hormones. Study details All participants in this study will take Durvalumab every 4 weeks for a year. The medication is given through a needle in the arm. Additionally, participants will undergo radiotherapy one month after starting the Durvalumab. As part of this study, participants will undergo blood tests and answer questionnaires. It is hoped this research will contribute to the care of prostate cancer patients by treating the disease without the use of hormone blocking drugs.
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Rectal stump management after subtotal colectomy for severe colitis
The primary purpose of this study was to evaluate the current practice at a single inflammatory bowel (IBD) tertiary referral center, in order to identify the optimal surgical and medical management of the rectal stump after an subtotal colectomy for severe colitis. We hypothesize that an extra-fascial management of the rectal stump will have lower complication rates compared to an in-situ management of the rectal stump.
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Epidemiology of adult patients with headache presenting to emergency departments (The HEAD study)
Headache is a common reason for presentation to emergency departments (ED). Headache presentations have been shown to comprise 1.35% (95%CI 1.34-1.36%) of total public hospital ED presentations across Queensland. There are a wide range of possible causes including primary headache (benign headache), migraine, trigeminal neuralgia, tumours, ntracranial haemorrhage, meningitis/ encephalitis/ cerebral abscess, toxicities and cerebrovascular events. This study will provide aninter-regional and international perspective on the epidemiology of non-trauma-related headache, its investigation, treatment and outcome.
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A comparison of two commonly used devices during surgical removal of the uterus in women
The colpotomiser is a key instrument utilised at laparoscopic hysterectomy. In the Western Sydney Local Health District (WSLHD), the Rumi II® [Cooper Surgical] and the Biswas [Storz] are two commonly used uterine manipulators during laparoscopic hysterectomy. Both of these devices are FDA approved and already in general use. Currently, there are multiple published articles evaluating the effectiveness of individual colpotomisers at hysterectomy, however there are few randomised controlled trials comparing devices, and none comparing Rumi II and Biswas. The study aims to recruit 96 patients over a 12 month period. The primary outcome is operative time. Secondary outcomes include standard peri-operative measures including blood loss, blood transfusion, complications, readmission, return to theatre, and conversion to an alternative colpotomiser device. A subjective surgeon assessment using a Likert scale will assess the ease of insertion, manipulation, surgical access and maintenance of pneumoperitoneum.