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AMLM22/D2-The International Acute myeloid leukaemia (AML) Platform Consortium (IAPC) trial is a randomised, multi-arm study platform to compare the efficacy of experimental therapies versus standard of care in subjects with acute myeloid leukaemia in first complete remission. Domain 2 is investigating the safety and efficacy of Venetoclax as a maintenance therapy alone or in combination with low dose cytarabine (LDAC).
Expand descriptionThis study will evaluate the safety and efficacy of venetoclax alone or in combination with low-dose cytarabine (LDAC) for Acute Myeloid Leukemia Who is it for? You may be eligible to join this study if you are aged 16 and above and have Acute Myeloid Leukemia in first complete remission. Study details This study is part of the International AML Platform Consortium. Participants in this study will be randomly allocated (by chance) to one of three treatment groups. Participants in one group will receive standard care which is generally observation. Participants in the other groups will receive the drug Venetoclax daily for a total of 24 months or Venetoclax in combination with low-dose cytarabine (LDAC) for a total of 24 months. As part of the study, participants will have blood tests at the start of each cycle (every 28 days) as well as additional blood tests depending on the treatment arm you have been randomised to. These additional blood tests are to monitor the level of neutrophils (type of white blood cell that is important in fighting infection) and platelets (platelets help your blood clot) We hope that the results from this trial will be used to help these new treatments which may be better for people with AML than what is currently available become accessible to the general population at faster than the normal process.
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THE KNEE STRESS TEST: a proposed test for assessing patient outcomes following knee replacement using a bicycle power meter
Expand descriptionThis study will look at a new method for testing muscle function and outcome following knee surgery. The new method uses a bicycle power meter to test muscle power before and after surgery. Ninety patients who are having knee surgery will be tested before and after surgery to look for improvements in muscle power and whether this corresponds with self-reported function. We hypothesise that the bike power meter is a reliable and easy test to look at patient outcome following knee surgery. Results will help surgeons in identifying patients with poor recovery so that more rehabilitation can be provided to improve their surgery outcome.
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The HERALD study. A pragmatic pre-post implementation study on the effects of a HEalth liteRAcy sensitive modeL of Dietetic care on diet quality in nephrology outpatient clinics.
Expand descriptionThe Illawarra Shoalhaven Local Health District has twice the national prevalence of chronic kidney disease. Dietary modification plays a key part in preventing progression of kidney disease and managing the complications of end stage kidney disease. Recent research has indicated that inadequate health literacy is common in patients with kidney disease and they have particular problems understanding health information. Local research using a health literacy sensitive question prompt sheet has also found a significant improvement in clinic participation and patient centredness of the consultation. However little is known if this translates into improved patient reported and clinical outcomes. Thus the objectives of this project are to: 1. Evaluate the impact on clinical outcomes of a redesigned health literacy sensitive model of care in the renal dietetic clinics 2. Evaluate the impact of the new model of care on patient reported outcomes 3. Evaluate patient and dietitian satisfaction with the new model of care 4. Make recommendations for ongoing practice
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Resuscitating newborn infants with the umbilical cord intact to improve oxygen delivery to the brain- a substudy of a randomised trial
Expand descriptionThe study aims to evaluate whether, in infants greater than or equal to 32 weeks gestation who require resuscitation at birth, the initiation of breathing either prior to or after umbilical cord clamping affects cerebral blood pressure, blood flow and oxygenation. Large changes in these parameters are potentially injurious and have been seen in animal models following immediate cord clamping. This is a sub-study nested within the Baby-DUCC Physiology Randomised Trial (ACTRN12618000621213). All infants will follow the protocol for the Baby-DUCC Physiology RCT for enrolment, randomisation and follow-up. We present the CHOP study as a sub-study because (a) it addresses a separate, distinct hypothesis using physiological measurements not performed within the BabyDUCC trial, and (b) it has additional inclusion criteria, meaning only a subgroup of infants in the BabyDUCC trial will be eligible. If the infant requires resuscitation after birth, the infant will be randomised to Baby-DUCC (resuscitation prior to umbilical cord clamping) or the control arm (immediate cord clamping and the infant will be moved to the warming bed for resuscitation measures). If the infant is vigorous and does not need resuscitation, the infant will not be randomised and umbilical cord clamping will occur at least 2 minutes after birth, oxytocin administration will occur after umbilical cord clamping. In these vigorous infants, we aim to collect blood pressure, cerebral blood flow and cerebral oxygenation after birth.
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Positioning the preterm Infant for Neuroprotection (PIN study)
Expand descriptionThe purpose of the study is to investigate whether specific positioning of the preterm baby’s head in the first 72 hours of life will reduce brain bleeds and lead to improved developmental outcomes. The first stage is to determine whether this study is acceptable to parents and whether it is possible to recruit preterm babies in the first four hours of life when the delivery is often an emergency situation. We hypothesize that the study will be acceptable to parents and that it will be possible to recruit babies within the four hour time frame. Babies born less than 29 weeks gestation will receive either usual positioning practice for the first 72 hours or the optimal positioning group. For the usual positioning group, there is currently no standard way to position the preterm baby for the first 72 hours. Babies in the optimal positioning group will be placed on a slightly tilted surface, on their back and with their head in the centre, for 72 hours. The head will be placed on a special pillow designed to mould to the baby’s head and keep the position stable during this time. Brain oxygen levels and presence of brain bleeds will be measured.
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The effect of Systane Complete versus saline on tear film properties in a symptomatic dry eye population
Expand descriptionThis study aims to compare tear film properties including lipid layer thickness, tear osmolarity, tear evaporation rate and noninvasive tear breakup time up to 2 hours after instillation of Systane Complete (test eye drop) versus unpreserved unit dose saline (control), and after 4 weeks of daily use. Participants will be randomly assigned to receive either the test or control eye drop at the first visit. Tear film measurements including the thickness of the oily layer (lipid), stability (noninvasive tear break-up time and tear evaporation rate) and osmolarity (saltiness), and tear collection will be conducted at 1 hour and 2 hours post-eye drop instillation. Participants will be dispensed with this eye drop to be used four times a day until the 4 week follow-up visit. At the 4 week follow-up visit, measurements will be conducted again and the eye drops will be collected. Participants will undergo a 4 week washout period and then be crossed over to receive the alternate eye drop where the same procedures will be repeated as for the first eye drop. Participants will be dispensed with this second eye drop to be used four times a day until the 4 week follow-up visit. At the 4 week follow-up visit, measurements will be conducted again and the eye drops will be collected.
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The effect of Systane Complete and Systane Hydration on comfort, vision and satisfaction with mini-scleral contact lens wear
Expand descriptionThe purpose of this study is to compare subjective comfort, vision and satisfaction ratings, after insertion of mini-scleral (small diameter rigid gas permeable) contact lenses, when a drop of either ocular (eye) lubricant (i) Systane Complete containing HP-Guar and mineral oil (test eye drop #1) or (ii) Systane Hydration containing HP-Guar and sodium hyaluronate (test eye drop #2) is instilled prior to filling with unpreserved saline before inserting the lenses on eye, compared to filling with unpreserved saline alone (control eye drop), up to 6 hours after lens insertion. The hypothesis is that subjective ratings will be superior at any timepoint (2, 4 or 6 hours) post-lens insertion, when a drop of Systane Complete (test eye drop #1) and/or Systane Hydration (test eye drop #2) is instilled in mini-scleral contact lenses prior to filling with unpreserved saline, compared to filling with unpreserved saline (control) alone.
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Ultrarapid iron polymaltose infusion for treatment of iron deficiency anaemia in a general hospital population at a single centre safety study
Expand descriptionIron deficiency anaemia is a common condition that frequently requires intravenous treatment in patients with chronic conditions. Two formulations of intravenous iron are available in Australia that are used for total body iron replacement. However, the newer ferric carboxymaltose is limited by high cost and a maximum dose of 1000 mg per week over 15 minutes. Iron polymaltose has the advantage of being cost-effective with the ability to provide total body iron replacement in one administration of up to 1500 mg over 1 hour or greater amounts over 4 hours. A pilot study in 2017-2018 demonstrated safety of delivering iron polymaltose at doses up to and including 1500 mg over 30 and 15 minutes. This will be an open-label, single centre study aiming to confirm the safety of iron polymaltose administered as an ultrarapid (15-minute) infusion in a general hospital population. Patients diagnosed with iron deficiency anaemia of any cause requiring replacement with iron polymaltose doses up to 1500 mg will be enrolled into the study after obtaining consent. Rates and severity of adverse events will be compared to those previously published for iron polymaltose administered over 1 hour and 4 hours, as well as to previously published safety outcomes for ferric carboxymaltose infusions.
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Minimising Immunisation Pain of Childhood vaccines: The MIPY Study
Expand descriptionThe aim of the proposed study, 'Minimising Immunisatin Pain in Younger Children (MIPY) is to evaluate the efficacy of two novel devices, Coolsense® (cools and numbs the skin) and Buzzy® (vibration) with cooling pads (wings) versus standard care, and to minimise pain during immunisations in younger (aged 3.5 - 9 years inclusive) children (MIPY). Outcome measures will include 1. Child/adolescent self report of pain using the Wong Baker Faces pain rating scale, 2. Parent assessment of their child's fear/anxiety using the Child Fear Scale (CFS) (Pre and post procedure), 3. Nurse assessment of child's fear/anxiety using the CFS scale (Pre and post procedure) 4. Nurse report of observed pain using the VAS Scale, 5. Parent perception of usefulness of Intervention and Nurse observed compliance with intervention. We estimate it will take up to 6 months to recruit the required number of children for these studies based on 75% uptake of those that meet the inclusion criteria. The study groups will be assigned randomly by a computer. It is hoped 492 children will participate in this study, with 164 participants in each group. Before each child has their vaccine, we will either apply Buzzy® (with the cooling pad) or the Coolsense®device, or use the standard distraction method (blowing bubbles). Possible outcomes will be reduced pain and fear/anxiety scores and improved patient and family experience of vaccination.
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Evaluation of the effects of the Good Cholesterol on Wound Healing
Expand descriptionThis study will test the efficacy of topically applied rHDL to acute wounds of patients that have just had a ray amputation (removal of toe(s)) due to diabetes-related necrosis. They will receive rHDL three times a week for 6 weeks. Follow up will be for a total of 12 months.