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Parental and Healthcare Professional Concern in the Diagnosis of Paediatric Sepsis
Expand descriptionThe primary purpose of this study is to determine if the level of concern of parents and healthcare workers, within the emergency setting, can help improve diagnostic accuracy for paediatric sepsis.
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REscuing bone marrow function in patients with aplaStic anaEmia and bone marrow faiLure post allogEneiC Transplantation (RESELECT) Phase I/II single arm with historical control study assessing the efficacy and safety of Atorvastatin and N-Acetyl Cysteine in the treatment of Poor Graft Function post allogeneic transplantation and relapsed/refractory aplastic anaemia
Expand descriptionAllogeneic Stem Cell transplant (alloSCT) is a curative procedure for many blood disorders and involves the transplantation of donor blood cells into a compatible recipient. Engraftment is a key milestone of success of alloSCT and is measured by standard blood tests to ensure normal levels of blood cells as well as a specialised blood test to confirm this blood is being produced by donor tissue. Poor graft function (PGF) is a significant complication of alloSCT and results in poor blood cell production by engrafted donor tissue. Aplastic anaemia(AA) is an autoimmune disease that results in the body's own immune cells attacking the bone marrow (the organ that produces blood cells) resulting in decreased production of blood cells. The mechanisms leading to PGF and AA are similar. There is evidence that the bone marrow microenvironment, the ecosystem in which blood cells reside, is abnormal in both PGF and AA. Atorvastatin is an old drug that has been used to treat high cholestrol and N-acetyl-cysteine (NAC) has been used as an antioxidant to treat paracetamol overdose. There is evidence that atorvastatin and NAC may be able to reverse this microenvironment dysfunction in PGF and AA. This study is aimed at testing the efficacy and safety of atorvastatin and NAC in the treatment of PGF and relapsed/refractory Aplastic anaemia.
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A cluster randomised controlled trial of the impact of a multi-strategy behavioural intervention on the nutritional quality of secondary school student food purchases from online canteens.
Expand descriptionThe aim of this study is to assess the effectiveness of integrating consumer behaviour strategies (including menu labelling, item positioning, tailored feedback & prompts) into an online canteen ordering system, to improve the nutritional quality of foods purchased by secondary school students via online canteens. This study will employ a clustered randomised controlled design. Ten NSW secondary schools currently using an online canteen ordering system will be randomised in a 1:1 ratio to receive either the intervention or control (standard online ordering only). Intervention effectiveness will be assessed via between group differences in the proportion of online orders classified as ‘Everyday’, ‘Occasional’ or ‘Should Not Be Sold’ according to the NSW Healthy School Canteen Strategy, using purchase data automatically recorded by the online ordering system at baseline (the 2-month period prior to intervention commencement) and follow up (the 2-month period immediately post-intervention commencement).
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A randomised controlled single blinded multicentre trial of polyethylene glycol sealant to the staple line vs staple line alone in distal pancreatectomy.
Expand descriptionDistal pancreatectomy is a surgical procedure commonly used to remove tumours in the body and tail of the pancreas. Postoperative pancreatic fistula formation, where fluid leaks from the remaining pancreas into the abdomen, is the most common and significant surgical complication after this surgery. This can lead to further complications such as intra-abdominal abscess, bleeding, sepsis, and delayed emptying of the stomach. Different techniques have been tried to reduce the rate of POPF. The most successful to date is the use of staples to close the cut edge of the pancreas but the rate of fistula formation continues to be clinically significant. Polyethylene glycol sealants have been successfully used in lung resection surgery to stop air leaks. This type of sealant has not been tested in pancreatic surgery. This study will examine if a polyethylene glycol sealant reduces the rate of postoperative pancreatic fistula formation when used in conjunction with stapling to seal the pancreas.
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A Telehealth Cancer-Related Fatigue Clinic Model for Cancer Survivors: A Pilot Randomised Controlled Trial (The T-CRF Trial)
Expand descriptionThe purpose of this study is to test the feasibility and impact of a telehealth cancer-related fatigue clinic model of care. Who is it for? You may be eligible for this study if you are aged 18 or older, you have completed your primary cancer treatment (including surgery, radiotherapy or chemotherapy) at least 6 weeks ago, or you have completed at least 3-months of maintenance treatment (ongoing cancer therapy, such as hormone therapy, immunotherapy, chemotherapy) at Princess Alexandra Hospital (PAH) Outpatient Clinics. Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will receive standard follow-up care as determined by their treating cancer specialists as well as a booklet on cancer-related fatigue. The other group will undergo the telehealth fatigue clinic model of care. This involves three telehealth appointments (up to 60 minutes) with a specialist nurse at 2, 14 and 26 weeks after you have been enrolled. Participants in the second group will also be offered follow-up phone calls in between the telehealth appointments to check their progress. As part of the study all participants will answer a series of questionnaires at 3, 6 and 12 months after enrolment. It is hoped this research will demonstrate the feasibility and usefulness of the new telehealth model of care which could influence future cancer-related fatigue care.
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Outback Quit Pack: A cancer risk reduction trial for Rural, Regional, and Remote Smokers in New South Wales
Expand descriptionThe purpose of this study is to determine if the Outback Quit Pack, an information and pharmacological support pack, for those who are trying to quit smoking, is feasible, effective and acceptable to participants. Who is it for? You may be eligible for this study if you are an adult residing in rural, regional and remote areas of New South Wales who is trying to quit smoking. Study details Participants will be randomly allocated to either: Arm A: the Outback Quit Pack intervention, and receive nicotine patches, nicotine gum, nicotine lozenge counselling and self-help materials; or, Arm B: a minimal support group which receives an information sheet about support for quitting smoking. Participants will complete a survey after the 12-week program to assess their tobacco smoking. If feasible, the Outback Quit Pack may become a model for cancer risk reduction intervention for other health risk behaviours.
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Effect of topical coconut oil on infection rates in extremely premature infants
Expand descriptionLate-onset sepsis (bloodstream infection) remains one of the most common complications of extremely early birth (more than 3 months before the due date). Skin condition in preterm infants deteriorates quickly after birth and the majority of bloodstream infections are caused by bacteria that reside on the skin. At present there is no available skin care product with proven benefit on skin condition and rates of infection. In this new trial, Neonatal Intensive Care Units of the Australia and New Zealand Neonatal Network will be randomly allocated to either using topical coconut oil or their current standard of skin care for all infants born extremely early to determine if coconut oil may reduce the rate of bloodstream infections. The findings of this trial could be readily translated into clinical practice.
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Effects of a herbal supplement on cognition and social behaviour in healthy adults.
Expand descriptionEvidence from scientifc studies demonstrate positive effects of ingredients Ginseng (Cereboost), Bacopa and Coffee fruit extract as isolated components, on various mechanisms that impact cognitive performance and mood. For example, Ginseng and Gingko have been shown to enhance cognitive performance after acute dosing whilst Bacopa has been shown to have effects primarily with chronic dosing. To date however, the effect of these combined ingredients on cognition, behaviour and brain functioning as a result of chronic dosing has not been evaluated. The study involves a four-week supplementation period followed by a two-week washout period. Measures of cognitive performance, behaviour, and BDNF levels are undertaken at baseline (presupplementation), postsupplementation (week 4) and at the end of the washout period (week 6) to assess potential supplementation effects on cognitive performance and functioning. This research seeks to understand any changes in cognitive performance and brain activation patterns using standardized cognitive tasks and a non-invasive functional near infrared spectroscopy (fNIRS), measured both before and after taking the active or placebo supplement.
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Breathless Clinic - working together to defeat breathlessness in chronic obstructive pulmonary disease (COPD)
Expand descriptionBreathlessness is a distressing and incapacitating symptom, responsible for a high proportion of healthcare separations and costs with far-reaching consequences in terms of affected individuals’ quality of life, independence, community interactions and workforce participation. Patients suffering refractory breathlessness and their caregivers feel that awareness of the symptom burden amongst healthcare providers and provision to address this burden within healthcare services is lacking. Breathless Clinic (BC), is a 9 week, predominantly home-based, multidisciplinary “clinic” for COPD patients with refractory dyspnoea. Through BC an individualised treatment plan is developed, comprising a variety of non-pharmacologic interventions to help patients manage their breathlessness in the community. Hypothesis: Participation in BC will result in an improvement in patients' ability to cope with breathlessness, as evidenced by improvements in measures of breathlessness impact (breathlessness severity and intensity, symptoms burden, depression and anxiety, health status status and health-related quality of life). Participation in BC will also reduce healthcare outcomes such as healthcare usage and respiratory exacerbations (flares of COPD).
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Comparison of two different suction rectal biopsy forceps for the diagnosis of Hirschsprung disease in children: A randomised controlled trial
Expand descriptionA randomised controlled trial (RCT) will be conducted at Monash Children’s Hospital on infants less than 6 months of age with suspected Hirschsprung disease, requiring a suction rectal biopsy. The study will be an open-label (unblinded) randomised controlled trial: due to the nature of the intervention (i.e. different appearance of the rbi2® and SBT200®) biopsy forceps blinding is not possible. The hypothesis to be tested is that the SBT200® SRB forceps will have lower rates of inadequate specimen sampling, lower re-biopsy rates and lower or comparable complication rates. The proposed sample size for this trial is 40 children in total with 20 in each arm. Since the SBT200® is a brand-new device, no data is available regarding the rate of insufficient biopsy. The sample size has been chosen on feasibility based on the number of patients investigated for Hirschsprung disease each year at Monash Children’s Hospital (20-30) with the aim of completing the trial within 18-24 months. Primary endpoints for the trial will be the effectiveness and the complications with each SRB forceps - Number of biopsies attempted at each episode - Number of inadequate specimens obtained - Number of biopsy episodes performed - Complications: o Bleeding requiring admission/blood transfusion o Rectal perforation o Pelvic abscess/sepsis