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Bowel Motility Patterns in Newborns
Expand descriptionThe stethoscope is the standard tool used to assess bowel sounds, however, a regular stethoscope does not allow recording of bowel sounds and therefore can be subject to bias. We aimed to establish normal bowel motility patterns in relation to feeding in newborn infants using the Littmann Electronic Stethoscope 3200. This tool enables transmission of real time bowel sounds to a computer for further analysis and standardisation of frequency and amplitude. We hypothesis there is no difference in peristalsis in relation to feeding.
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Saliva for Assessment of Vitamin A status in preterm Infants
Expand descriptionBackground: Vitamin A is essential for development and growth of lungs in preterm infants. Diseases characterised by abnormal lung development such as bronchopulmonary dysplasia (BPD) may be linked to vitamin A deficiency. BPD is associated with long term breathing and developmental problems. Very preterm infants are at risk of vitamin A deficiency. Timely evaluation of vitamin A status of preterm infants may help to assess the risk of BPD and tailor vitamin A therapy based on the infant’s vitamin A status. Current method of assessment of vitamin A is “Relative Dose Response” (RDR). RDR test involves collection of two blood samples from the infant, one before and one after a dose of vitamin A. Thus, the requirement of repeated blood sampling, which is an invasive procedure and also increases risk of anaemia, is a major disadvantage of current RDR test. Therefore, a minimally invasive method with least harm is required. Aim: 1) To compare salivary vitamin A with blood vitamin A, and RDR using saliva with RDR using blood; 2) Assess safety of the test Participant group: Participants will be preterm infants admitted in King Edward Memorial Hospital, less than 30 weeks gestational age at birth and 21 to 28 days of life, and tolerating milk feeds. Project design and Methods: An informed consent will be obtained from the parents of the eligible infants. RDR test will be performed. The test involves collection of blood samples of 0.5 mL each, before and five hours after a dose of vitamin A (2000 IU/kg body weight). Along with the blood samples, samples of saliva will also be collected using proprietary swab specifically designed for infants. An additional saliva sample will be collected at seven hours, as appearance of vitamin A in saliva may lag behind its appearance in blood. Collection of saliva is a painless procedure with no expected harm to the infant. Vitamin A levels will be measured in blood and saliva samples with high performance liquid chromatography which is a standard method of vitamin A measurement. All the study infants will be monitored for 24 hours for adverse effect of vitamin A. Expected outcomes: A study in adults showed a good correlation between salivary and blood vitamin A in adults. We expect that salivary vitamin A level will correlate with blood vitamin A in preterm infants and will be useful to assess vitamin A status of preterm infant
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A Phase Ib, Randomised, Placebo-Controlled, Double-Blind Study to Evaluate Potential Benefits of Two Concentrations of Betahistine Dihydrochloride Spray Administered as a Single Intranasal Dose in Adult Male and Female Volunteers with Eustachian Tube Dysfunction
Expand descriptionThis study is testing the potential benefits (if any) of betahistine dihydrochloride when administered as an intranasal spray (via the nose) to Eustachian tube function. This study involves a total of up to 24 participants. Betahistine dihydrochloride, the Otifex Therapeutics study drug, is an experimental drug being investigated for its potential as a treatment for middle ear disorders. Betahistine dihydrochloride taken orally (via the mouth) has been approved for marketing by the Therapeutics Goods Administration (TGA) in Australia for the treatment of vertigo (dizziness) related to Meniere's syndrome (inner ear disorder). Healthy participants have previously been dosed intranasally with the study drug in a separate study. In the first group of 8 participants (6 receiving the study drug and 2 receiving a placebo), the study drug was well tolerated intranasally with no clinical signs of any concern. There were two events reported that were related to an effect on the hearing in participants who received the active study drug. A review of the data by an independent audiologist concluded that both participants had pre-existing hearing defects prior to the study. That is why in this study, your ears will be examined prior to study entry, as part of determining your suitability to take part in the study. In subsequent study groups, a further 32 participants (4 groups of 8 participants - 6 receiving the study drug and 2 receiving a placebo) have been dosed at the dose levels of 5, 10, 20 and 40 mg. All dose levels were very well tolerated and there were no significant changes in the hearing assessments noted. This study is being conducted at the The Wesley Research Institute Clinical Trials Centre in conjunction with the Wesley Centre for Hyperbaric Medicine. This study is being sponsored by Otifex Therapeutics Pty Ltd (AUS).
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Phase I trial of autologous cytomegalovirus (CMV)-specific T cells as adjuvant therapy for primary glioblastoma multiforme
Expand descriptionThis study is assessing the safety and tolerability of using T cell therapy targeting human cytomegalovirus (CMV) in treating brain cancer (glioblastoma multiforme). Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with primary glioblastoma multiforme, and have human cytomegalovirus (CMV)-positive serology or positive staining for CMV in tumour tissue. Study details A blood sample will be taken from patients in order to grow the cells for the experimental therapy. These cells, known as T cells (a type of white blood cell) will be grown in the laboratory from each patient’s blood sample. Following generation of the T cell therapy, the participants will commence T cell infusions. The specific timing of each infusion will be dependent on the participants’ chemotherapy regimen. Treatment consists of 2 to 6 infusions (each taking 5-15 min) of T cells, and patients are monitored for 12 months afterwards to see if the treatment is safe. It is hoped that the development of an immunotherapy as an adjuvant to standard chemotherapy and radiotherapy will reduce the rate of tumour recurrence in patients with glioblastoma multiforme.
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The efficacy of the Royal Melbourne Hospital Obesity Clinic in the treatment of obesity in the Victorian adult population.
Expand descriptionThis project aims to determine: 1. Weight loss profiles for patients attend the Royal Melbourne Hospital Obesity clinic. 2. The impact of this weight loss of metabolic parameters such as lipid profile and liver function tests. 3. To determine the impact of this weight loss on Quality of Life Survey results 4. To find factors that predict the occurrence of weight loss in people with obesity who attended the Obesity Clinic. Hypothesis: Weight loss will be comparable to published data on lifestyle interventions at an average of 5% body weight loss. This weight loss will be variable depending on baseline characteristics such as family history, concurrent mental health issues and low starting motivation being negative predictors for weight loss. Patients who lose weight will show improvement in the metabolic profiles and Quality of Life survey results when compared to those who do not lose weight.
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Rates and cost of falls after total hip and total knee replacement surgery - an observational cohort study
Expand descriptionOlder people in Australia are increasingly undergoing hip and knee joint replacement , and with aging of the population this figure will increase. Although outcomes are positive after this surgery there are limited data that have investigated the incidence of falls after this surgery. Falls are associated with injury and loss of function as well as psychological consequences which could lead to reduced health related quality of life. This study will prospectively sample over 500 older people to measure the incidence of falls in the 12 months after discharge. The aim of the study is to identify the number of falls and risk factors for falling as well as patient health related quality of life among older people in the 12 months after they have hip or knee joint replacements.
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Dispensing study to assess the visual performance of optimised prototype contact lenses
Expand descriptionTo assess visual performance of multiple optimised prototype soft contact lens designs compared to commercially available contact lenses
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Children with Unilateral Hearing Loss (CUHL) study: Does early hearing device fitting improve language and psychosocial outcomes?
Expand descriptionDespite early detection of congenital unilateral hearing loss (UHL) via universal newborn hearing screening (UNHS), there is a lack of evidence on the efficacy of early intervention (in the form of device fitting) for improving outcomes, and the benefit vs harms of early detection and treatment is uncertain. Consequently, there is clinical equipoise concerning whether children should receive amplification (as well as surveillance). The overall goal of this project is to determine the efficacy of device intervention for improving outcomes of children diagnosed with permanent unilateral hearing loss at or shortly after birth. The aims are to: 1) investigate the impact of early detection and treatment of UHL on the child and family; 2) determine factors affecting outcomes at 3 years of age for children with congenital UHL; and 3) assess the efficacy of device fitting on improving outcomes. The results of this research will provide the much-needed evidence-based guidance for clinical practice.
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Evaluating the effect of increased allied health services in two medical units: comparison with an historical cohort.
Expand descriptionThe primary aim of this study is to evaluate the effectiveness of implementing increased allied health services to the Acute Medical Unit and General Medicine services across Central Adelaide Local Health Network, by comparing outcome data post-implementation of the increased allied health staffing levels to historical and Australia-wide data. In order to be able to compare data between the prospective and historical cohorts, the main outcomes that will be used to assess the effectiveness of the increased allied health services will comprise data that have been collected and are available for comparison from current databases (i.e. Central Adelaide Clinical Casemix and Costing databases, Health Round Table reports, Client Management Engine).
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The comparison of surgical outcomes of using LigaSure and Gyrus PK in total laparoscopic hysterectomy
Expand descriptionThis is a randomised controlled trial. All components used in this study are TGA approved. Women, who undergo a laparoscopic hysterectomy for benign indications will be randomised to the use of LigaSure or Gyrus PK blood vessel sealing devices. The aim is to compare operative time and blood loss with the use of LigaSure (LF 1737 5mm laparoscopic 37cm sealer /divider) versus Gyrus PK (5mm LYONS™ 33cm dissecting forceps) blood vessel sealing device during laparoscopic hysterectomy. A minimum of 64 patients will be enrolled into the study. Operating time (from initial skin incision until detachment of the uterus with secured haemostasis), total operating time (from initial skin incision until final skin closure), intra-operative blood loss, major complications, post-operative analgesia usage, conversion rate, ergonomics and costs will be evaluated.