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Exercise-therapy following anterior cruciate ligament reconstruction: a pilot randomised clinical trial
Expand descriptionKnee osteoarthritis is a national health priority, and commonly occurs in young adults following anterior cruciate ligament reconstruction (ACLR) – creating a scenario of ‘young people with old knees’. Having an ACL injury combined with a meniscectomy and/or chondral lesion is associated with more pain and worse quality of life after ACLR, and best identifies those at risk of future knee osteoarthritis, low physical activity participation, and worse symptoms and quality of life in the long term. Considering the profound impact of a combined injury after ACLR on young adults, effective interventions targeting functional restoration are urgently needed. Our prior data indicates <30% of people received or completed physiotherapy beyond 6 months post ACLR, which may assist in restoring normal physical function after ACLR. Appropriately supervised and progressed exercise-therapy and patient education that targets individual needs has potential to reduce the burden of impaired function post-ACLR (i.e. young people with old knees). This study aims to investigate the efficacy and feasibility of a randomised controlled trial to improve function, symptoms and quality of life in people with an ACL injury combined with a meniscectomy and/or chondral lesion 6-15 months after ACLR. The study will compare the effects of a Supervised Patient Education Rehabilitation program, targeted to individual needs, (SUPER), to a minimal intervention CONTROL program, where a best practice guide booklet and one face-to-face physiotherapy appointment is provided.
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Understanding your Newborn and Adapting to parenthood (UNA): A randomised clinical effectiveness trial of the Newborn Behavioural Observations (NBO) for new families.
Expand descriptionPostnatal depression (PND) is common and can have a devastating impacts on the parent, the child, the couple and the wider family. There is particularly compelling evidence that mothers with PND are at risk of attachment and interactional difficulties with their infant and adverse consequences for their child’s development. It is important to identify families at risk of postnatal depression and to elucidate preventive interventions that are feasible, acceptable and that promote successful adaptation to parenthood. There is a unique opportunity in the perinatal period to provide effective interventions and potentially make a difference to the developmental trajectory of new families, as it is a time of great motivation and help-seeking, even by individuals and couples who may be otherwise hard to reach. Attachment based, relationship-focussed interventions have been shown to help vulnerable new parents successfully adapt to the role of parenthood and even brief perinatal interventions can be helpful. The Newborn Behavioural Observations (NBO) is a relatively new, brief attachment based intervention that aims to promote adaptation to parenthood by helping new parents get to know, and adapt to caring for, their newborn baby, and by reducing parents’ distress in the transition to parenthood. This reproducible, affordable intervention holds appeal and has generated widespread interest internationally. Pilot studies and clinician reports suggest the NBO is effective in various family contexts and settings and there is preliminary evidence the NBO is associated with reduced post-natal depressive symptoms among new mothers. However, it has not yet been shown that the NBO is an effective intervention in the context of maternal depression. This study therefore aims to determine whether, in an Australian population of new families with antenatal risk factors of PND, the NBO supports the adaptation to parenthood, by reducing symptoms and diagnosis of PND, reducing parenting stress and enhancing the quality of relationship they are able to form with their baby.
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Live versus heat-inactivated probiotic strains in preterm infants: The Pro-Para study
Expand descriptionBackground Probiotics significantly reduce the risk of death, and serious complications (e.g. necrotising enterocolitis- an inflammatory bowel condition with high risk of death and disability, and hospital acquired infections), and improve nutrition in premature babies. However, despite the overwhelming evidence, acceptance of probiotics as a standard of care for premature babies has been slow considering the associated risks including infection due to probiotic bacteria, development of antibiotic resistance, and altered immune responses. Emerging evidence indicates that heat inactivated/killed probiotic bacteria (‘Paraprobiotics’) may provide a safe and effective alternative to probiotics (live bacteria) by overcoming their risks while retaining their benefits. Objectives The objectives of our novel pilot study comparing paraprobiotic vs. probiotic focus on finding a safe and effective alternative to probiotics. Results of our study have the potential to guide research on paraprobiotics for reducing death and disability in a wide range of population across the world (e.g. mature infants with surgical conditions of the intestine, children with inflammatory bowel disease, and immunocompromised adults) where probiotics are not used or evaluated due to their risks. Trial plan This pilot double blinded randomized controlled trial will be conducted over a period of 12-18 months (May 2018- November 2019) at King Edward Memorial Hospital. Very preterm infants < 32 weeks with specified inclusion and exclusion criteria will be recruited. Approval will be obtained from the KEMHW ethics committee. Therapeutic Goods Administration (TGA) and Clinical Trial Notification (CTN) approval will be obtained for importing the live and heat inactivated/killed probiotics from Japan. The trial protocol will be registered with the Australia New Zealand Clinical Trial Registry. Specified primary and secondary outcomes (clinical and laboratory based) will be measured.
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Active Games and Cognitive Development in Preschool Children
Expand descriptionThe proposed pilot group randomised controlled trial will test the effects of cognitively engaging physical activities on executive functions, frontal lobe EEG activity and habitual physical activity in 4-5 year-old preschool children (n = 30 in intervention group; n = 30 in control group). It is hypothesised that cognitively engaging physical activities will improve executive functions and increase frontal lobe EEG activity in preschool children.
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The CANBACK trial, to determine the efficacy of oral cannabidiol, when compared to placebo, as an adjunct for the treatment of acute non-traumatic low back pain.
Expand descriptionAcute, non-traumatic, low back pain is one of the most common musculoskeletal complaints worldwide and affects people of all ages. Although the majority of these individuals present to a primary care provider for assessment and management of their pain, a large proportion present to the emergency department (ED), especially when conventional analgesia is not working. Research suggests that low back pain is one of the leading causes of ED visits worldwide. While simple analgesics, opioids and muscle relaxants are commonly used to provide relief, there is little evidence to support the efficacy of these treatments. Accordingly, the management of acute low back pain in the ED represents a real challenge to clinicians. Cannabidiol (CBD), a major non-psychotropic constituent of Cannabis, has pharmacological actions as an anxiolytic, antipsychotic, antiemetic and anti-inflammatory. There are data indicating that CBD and its analogues may be beneficial for pain resulting from inflammation. In addition, CBD has considerable efficacy in managing the pain and spasm of patients with multiple sclerosis. Despite these data, no randomized, placebo-controlled trials have been undertaken to assess the utility of CBD for the treatment of acute back pain. In this study, patients presenting to the Austin ED with a diagnosis of acute (or acute-on-chronic), non-traumatic, low back pain will be randomized to either a single dose of CBD or placebo. This will be as an adjunct to the standard ED medication regimen for this condition. A verbal numerical pain scale (range 0-10) will be used to record pain scores at triage and at 0, 30, 60 and 120 minutes post study drug administration and at ED discharge. Patients may be admitted to the short stay unit during their stay. We hypothesize that, among patients presenting to the ED with acute, non-traumatic, low back pain, a single dose of oral CBD will result in lower pain scores on the VAS at 2 hours, with minimal adverse effects, as compared to placebo.
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Glue in Skin Grafts for Skin Cancer
Expand descriptionThe purpose of this study is to compare the use of fibrin glue with sutures or staples for affixing skin grafts in skin cancer patients. Who is it for? You may be eligible for the trial if you are over the age of 18 and have been diagnosed with any type of skin cancer. If your skin cancer requires a skin graft to close the wound then you may be able to enrol in this trial. If you agree to enrol you would answer some basic questions and be randomised to have either glue or sutures/staples to affix your skin graft. Your surgery and appointments will be the same as if you weren’t enrolled in the trial. After the surgery you would have an appointment at one week and one month where your wound will be reviewed, your pain noted and photographs taken. We hope this research will be able to decrease skin graft failure in patients who have skin grafts for skin cancer.
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An open-label, parallel-group Phase I study to assess safety, tolerability, and pharmacokinetics of single doses of EU-C-001 administered with an apomorphine challenge, or when 90 mg EU-C-001 are administered alone twice (two times) a day (BID) for 7 doses in 12-hour intervals
Expand descriptionThis is a phase 1 study in healthy subjects. It is planned to develop the drug for reducing pressure in the brain of patients with a traumatic brain injury (TBI). Increased pressure following TBI can lead to death or can cause permanent disability. There are currently no medications that are approved for improving outcomes after TBI. The drug will also be tested for improving clinical outcome in patients that suffered a concussion. The study drug being evaluated is called EU-C-001 and is being developed by an Australian company called PresSura Neuro. Studies in animals have shown that EU-C-001 may reduce pressure in the brain. Therefore, it is thought that EU-C-001 may improve outcomes in patients with TBI by increasing the amount of oxygen available to brain tissue. In other studies it was shown that the EU-C-001 may also have potential to improve outcomes in patients with concussion. This is the first in-man study planned to assess the pharmacodynamic potency as well as safety and tolerability and pharmacokinetics in man after a single intravenous administration when given together with apomorphine. The ability of EU-C-001 to penetrate the human brain is an important prerequisite for efficacy in its core indications. The inhibition of apomorphine-induced emesis will be used in this study as proof of receptor occupancy and EU-C-001 brain penetrance.
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VegEze: A mobile phone app to increase vegetable consumption.
Expand descriptionAustralians are not eating enough vegetables. The CSIRO Healthy Diet Score survey has found that reported to ‘always’ consume 3 different types of vegetables at their evening meal were twice as likely to meet their daily requirements. An explosion of health promoting mobile apps has occurred in recent years including healthy eating ones. However, most mobile apps are not scientifically developed and have yet to undergo rigorous evaluation. Therefore, this research aims to develop and test the useability and effectiveness of a mobile App to increase the variety and amount of vegetables participants consume. Aims / Objectives: The overarching aim is to develop a highly engaging mobile App which motivates adults to increase the variety of vegetables they consume at their main/evening meal to at least 3 different types, as impetus to increase their total variety and the total amount of vegetables they usually consume.
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Nocturnal blood glucose responses to potato-based mixed evening meals
Expand descriptionThe purpose of the present study is to investigate the impact of potato consumption on postprandial and nocturnal glycemic response and postprandial insulin response when consumed as balanced mixed meal in a real-word setting in individuals with T2DM. Additionally, different cooking methods of potatoes will be explored (baked, boiled and boiled then cooled) and compared to brown rice of equal carbohydrate content (control). We hypothesize ingestion of potato as part of a mixed evening meal will not result in any greater postprandial or nocturnal glycemic response or postprandial insulin response to an isoenergetic, macronutrient-matched control test meal due to the diurnal fluctuations in glucose regulation. Additionally, we hypothesize pre-cooking then cooling potato before consumption will lower the postprandial glycemic response of potato as part of a mixed evening meal.
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Improving Engagement in Patients with Young Adult Onset Type 2 Diabetes (Text2U)
Expand descriptionYoung adult onset type 2 diabetes (YT2DM) is an aggressive condition with a rapid progression to diabetes complications. Expert bodies have recommended that YT2DM patients be reviewed every three to six months for assessment of blood glucose control and cardiovascular risk factors. Significant barriers have been identified in the delivery of care for YT2DM patients. The Australian Centre for Behavioural Research in Diabetes has recommended increased support from health care providers and greater engagement in self-care which does not place a significant extra burden on YT2DM patients. A previous survey of our clinic population revealed a high level of mobile phone ownership. Consequently, implementation of an SMS-based intervention to facilitate engagement in the YT2DM cohort would appear to be an ideal strategy to trial. It is hypothesized that by improving engagement in the YT2DM cohort (through a personalised and supportive SMS program), attendance at clinical follow up appointments will improve. This will facilitate an improved approach to diabetes management and the development of a therapeutic relationship between patients and their health care team.