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Protocol for a prospective cross-sectional, study using Poisson renewal theory to study rotor formation and destruction rates in atrial fibrillation: the RENEWAL-AF study
Introduction Unstable functional re-entrant circuits known as rotors have been consistently observed in atrial fibrillation, and are mechanistically believed critical to the maintenance of the arrhythmia. Recently, using a Poisson renewal theory-based quantitative framework, we have demonstrated that rotor formation (lambda-f) and destruction rates (lambda-d) can be accurately measured using in vivo electrophysiologic data. RENEWAL-AF measures the electrical, structural heart changes associated with differences in lambda-d and lambda-f.
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Investigator Led Study of Intravenous Milrinone in Heart Failure with Preserved Ejection Fraction (HFpEF).
Study Overview: This is a phase 1b, exploratory study to evaluate the effect of IV milrinone on exercise hemodynamics. This is a double blinded, placebo-controlled investigator led trial. The study cohort will comprise of 8 patients (6 active, 2 placebo). Subjects who are successfully screened will be enrolled into trial. After baseline evaluation on day 1, subjects will be randomly allocated. After the baseline rest and exercise haemodynamic evaluation, subjects will be randomised to receive either active (milrinone) or placebo (saline) infusion. At the conclusion of the infusion, rest and exercise measures will be repeated. Exercise will be conducted at individual matched workloads and durations1. The primary objective was to compare the between-group changes in exercise hemodynamics after administration of placebo versus milrinone. Parameters to be evaluated are described in the prior sections.
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An observational study of general surgery models in Australia
To date, a total of sixteen Australian public hospitals have published their uptake of the Acute Surgical Unit (ASU) model, while another two have documented successful persistence with Traditional models. However, for the great majority of public hospitals in Australia, the emergency general surgery (EGS) model in use remains unknown. In 2010, General Surgery Australia’s ‘12 Point Plan for Emergency General Surgery’ recommended separation of emergency and elective activity. However, these were non-binding recommendations and explicitly expected variation in EGS models. Departments remain free to choose their preferred system and no national registry or automated reporting of structure exists. This lack of information regarding EGS models in the large majority of Australian hospitals is problematic. A national survey could be used to guide other hospitals considering commencing an ASU, or by health bodies to inform future policy. We aimed therefore to survey the structure of EGS care of adults in all Australian medium to major public hospitals, with particular regard to the chronological and geographical spread of EGS models, the impact of trauma care and other variables on choice of EGS model, reasons for or against commencing an ASU model, staff satisfaction, registrar operative exposure and safe working hours.
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Impact of post-operative Lidocaine Infusion on GastroIntestinal Tract function in patients undergoing laparoscopic colorectal resections
This trial aims to assess if the addition of a post-operative lidocaine infusion results in an earlier return of bowel function in adult patients undergoing elective laparoscopic colorectal surgery. This will be determined by the time to first passage of wind or the passage of bowel motion and the tolerance of solid diet. Patients will be randomised and allocated to either placebo or lidocaine infusion. The allocation will be blinded and the patient and all researchers involved will be blinded throughout the duration of the study. The differences in the return of gastrointestinal function post-operatively between the two groups will then be assessed to determine if lidocaine has an effect on bowel function. Delay in the return of bowel function after bowel surgery can manifest as nausea, vomiting, abdominal distention and absence of passing wind or bowel motions. These symptoms are important as they are the most frequent cause of delayed recovery and prolonged hospital stay. The only time commitment required for patients involved in this study would be to record when they first pass wind, pass a bowel motion, and tolerted a solid meal. The safety of patients involved in the study would be ensured by following the protocol already in place at Austin Health for post-operative lidocaine infusion.
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Topical Modification of Dental Pain and Movement
Wisdom tooth extraction often causes significant local tissue injury in a highly innervated area. This results in significant pain and loss of function. Reduced ability to open the jaw often also accompanies pain and lasts for several days. Dental nerves can express TRPV1, TRPA1 and TRPM3 and are known in allergy work to cause pain when stimulated by inflammatory mediators. Two products, a spray and cream, have been developed that target these receptors via a topical approach. This study will assess pain and mobility after a reproducible "injury" following wisdom teeth surgery, compared to placebo.
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The Study for Mother-Infant Sleep (The SMILE Project): Reducing postpartum insomnia in first-time mothers.
Symptoms of insomnia are common for women in the perinatal period. A primary precipitating factor for postpartum insomnia is infant nocturnal awakenings. As women cope with these significant sleep disruptions, they may also develop unhelpful sleep-related cognitions/behaviours, which can perpetuate sleep problems well into the postpartum period. Therefore, (a) infant sleep as a precipitator, and (b) maternal sleep-related cognitions and behaviours as perpetuators are sound therapeutic targets for reducing and preventing insomnia in perinatal women. The primary aim (Aim 1) is to examine whether reducing exposure to a major precipitator of postpartum insomnia by increasing infant sleep continuity and duration from 0-6 months, lowers symptoms of postpartum insomnia in first-time mothers who are at risk for insomnia. It is predicted that compared to controls, women receiving the infant sleep intervention will report better sleep and wellbeing. The secondary aim (Aim 2) is exploratory. It examines how two interventions, one addressing infant sleep, the other targeting maternal sleep-related cognition/behaviours, might ameliorate the development of postpartum insomnia. Participants, 114 mother-and-infant dyads recruited during pregnancy (N = 228), will be randomised into 1 of 3 conditions: (a) an infant sleep intervention, (b) a maternal sleep intervention, and (c) a control condition. Infant sleep intervention participants will receive a bassinet that uses noise and ‘rocking’ motions to boost infant sleep. The maternal sleep intervention is based on Cognitive Behavioural Therapy for Insomnia (CBT-I), and is delivered at 6 stages: 30 and 35 weeks pregnancy, then 2 weeks, 2 months, 3 months, and 6 months postpartum. The control group will receive sleep information at 26-32 weeks pregnancy. Outcome measures of sleep and wellbeing will be collected at 30 and 35 weeks pregnancy, and 2, 6, and 12 months postpartum.
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The use of padded headgear in Australian youth football players: Video footage analysis of player behaviour and impact severity
This project will address the complex issue of the use of headgear for the prevention of sports concussion in junior Australian Rules football. Specifically, we will explore injury rates and on-field player behaviour in a repeated-measures study design. Players will be asked to wear headgear for half the match (and not wear headgear for the other half) for five matches during their regular season to facilitate comparison of injury rates and on-field behaviour with and without headgear.
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Early vocational intervention for people after stroke: A randomised pilot trial
This study will explore the feasibility and potential benefit of providing early vocational rehabilitation following a stroke. Participants will be n=54 males and females, all aged over 18 who have been admitted to inpatient rehabilitation with new stroke (all severities) and who were working (including self-employed, paid or unpaid) prior to their stroke. Participants will be recruited from all rehabilitation services across Alfred Health, including in-hospital, home-based and community rehabilitation. Researchers will liaise with clinicians to identify eligible participants for the study, and the research assistant will undertake the informed consent process. Following participant consent, participants will be randomised to either the usual care (control) or intervention group. Participants in the intervention group will receive 'Early Vocational Rehabilitation' for 12 weeks, delivered by a stroke specialist occupational therapist (in addition to usual clinical rehabilitation). The experimental intervention will be tailored to the needs of the individual participant. The control group will receive usual clinical rehabilitation only.
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Investigation to assess whether Mi-Gel applied to the vulvar vestibule results in a reduction in pain with intercourse compared to a placebo
A randomised, double-blinded study to determine if the application of Mi-Gel to the vulvar vestibule results in reduced impact of pain compared to placebo in patients with entry dyspareunia.
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A study to assess the long-term safety and performance of patients previously treated with NovoSorb® Biodegradable Temporising Matrix (BTM) for the repair of skin injuries.
PolyNovo Biomaterials Pty Ltd has developed a new medical device, NovoSorb® Biodegradable Temporising Matrix (BTM), BTM is a skin substitute used to treat patients who need their wounds to be covered after an injury such as a deep burn, an accident where the skin has been damaged, or a severe skin infection. This study will assess the long-term safety and performance in patients where BTM was applied to at least 5% of their body at least 18 months ago. Patients will be asked to return to their hospital where a surgeon will examine them to assess their current health. Areas of the body where BTM was applied will also be examined by the surgeon. Patients will also assess the areas treated with BTM.