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An Open-Label Ascending Dose Pharmacokinetic, Safety and Tolerability Study of Treatment with TKAine System (Bupivacaine HCl Monohydrate) After Total Knee Arthroplasty (TKA)
The primary objective of the study is to determine the amount of bupivacaine in the blood for adult subjects undergoing a total knee arthroplasty.
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Influences of Viscosity of Lubricating Eye Drops on Orthokeratology Treatment Outcomes
The aim of this study is to determine whether the thickness of lubricating eye drops for the front surface of the eye influences orthokeratology (OK) contact lens treatment outcomes. The primary outcomes to be measured are anterior eye health and comfort; the secondary outcomes of vision (eye prescription and how well an OK wearer sees) will also be explored with non-contact instruments. The participant, who is an existing OK lenses wearer, will be required to use their own lenses along with two lubricating eye drops that will be given to them by the researchers. These drops will be used once before inserting their lenses at night and once again before removing them. The participants will be required to visit the research clinic and researchers (UNSW Optometry Clinic, Kensington, NSW, Australia 2052) once a week for a total of 4 visits throughout the study. After the 2nd visit, the participants will undergo a wash-out period where they will be instructed to not use the provided lubricating eye drops. In this period, the participants have the opportunity to schedule their 3rd and 4th visit to their earliest convenience. Therefore, the participants can finish the study as quick as 1 month after applying.
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Does Moffett’s solution cause greater post-operative throat pain compared to Co-phenylcaine in sinonasal surgery?
The purpose of the study is to determine whether there is increased post-operative throat pain associated with Moffett's solution nasal preparation when compared with Co-phenylcaine. We hypothesize that there will be an increased in post-operative throat pain in the Moffett's solution group.
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A clinical registry to monitor outcomes of upper limb pathology (PRULO)
This is an implementation study, aiming to design and implement a clinical outcomes orthopaedic registry for patients presenting to a single centre practice with upper limb pathologies. The purpose of this registry is to report patient outcomes after treatment through a prospective, consecutive observational cohort study design. This clinical registry will collate and store patient outcomes collected routinely as part of the standard clinical pathway for upper limb pathology treatments. Outcomes will include objective joint function, patient reported outcomes (pain, satisfaction, quality of life), radiological findings and rates of revision surgery or complications. Recruitment will include all patients presenting with upper limb pathology to the principal or associate investigators at a single clinical practice (Geelong Orthopaedics). Patients will undergo standard of care consultation for diagnosis and treatment, including the collection of demographic data, patient medical history, radiological findings, pathology, and functional analysis. Patient evaluation will be completed routinely as part of the standard clinical pathway performed by the principal and associate investigators via the consulting rooms at Geelong Orthopaedics or hospital clinics. Patients will in addition be requested to complete a set of questionnaires (EQ-5D, Oxford shoulder scores (Pain and Instability scores), Quick DASH (upper limb function score), American Shoulder and Elbow Society (ASES) Score, Western Ontario Rotator Cuff (WORC) Score) and return to activity questions to enable evaluation of patient reported outcomes and complete physical assessments as part of the post- treatment follow up. The clinical outcomes of individual patients will be monitored for up to 5 years.
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A pilot study to evaluate the safety and efficacy of a personalised cancer vaccine in patients with completely resected early stage lung cancer
This is a pilot study to evaluate the safety of a personalized tumour neo-antigen peptide vaccine strategy in non-small cell lung cancer (NSCLC). Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with early stage non-small cell lung cancer and is planned for surgery. Study details All participants in this study will be required to attend the Sir Charles Gardner Hospital to receive a vaccine fortnightly for the first 4 doses (8 weeks), and then 4 weekly for another 4 doses (16 weeks). You will monitored with blood tests before each dose. This research project hopes to discover a new and effective treatment for patients with non-small cell lung cancer.
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Study comparing antibiotics versus placebo at time of catheter removal post robotic prostate removal
The purpose of this study is to determine if the use of an antibiotic (Ceftriaxone) post-radical prostatectomy will help prevent urinary tract infections in patients with a indwelling catheter inserted at time of trial of void. You may be eligible for this study if you have prostate cancer and are undergoing a robot assisted laparoscopic radical prostatectomy at the Wesley Hospital. Study details Participants will be randomly allocated to one of two groups, the intervention group (standard care) or the placebo group. The procedure in the intervention group will involve: a) Injecting 1g of antibiotic (Ceftriaxone) via an injection in the arm at time of catheter removal (one week post-surgery). b) Collection of urine samples and blood The placebo group will receive: a) Injecting 10ml of saline via an injection in the arm at time of catheter removal (one week post-surgery). b) Collection of urine samples and blood It is hoped that this study will determine if antibiotics reduce the incidence of symptomatic urinary tract infections after catheter removal as currently they are being given to every person, which may lead to increased antibiotic resistance if they are not actually required.
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Utility of fundus photography versus ophthalmoscopy in Australian emergency department settings
Funduscopy is not widely performed, to the detriment of patients whose vision-threatening and life-threatening disorders may not be detected. The decline of fundoscopy has been ascribed to technical challenges of the examination, and difficulties interpreting the findings. Non-mydriatic fundus photography (NMFP) has been demonstrated to improve detection of fundus abnormalities in patients presenting to the emergency department (ED). We aim to determine the prevalence of fundus abnormalities amongst selected patients presenting to Australian EDs, and the clinical impact of NMFP for these patients.
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Kick-Smart: Promoting academic achievement, fitness and well-being in primary school-aged children
This study aims to test the feasibility of a six week intervention on a class of stage 3 students. The intervention will involve two one-hour sessions per week. Each session will include a combination of martial arts inspired activities, mathematics games, and well-being discussions. The content aims to improve childen's cognition, on-task behaviour, academic performance, social and emotional well-being, and physical fitness. Based on previous studies of (somewhat) similar natures, The research team hypothesises that the intervention will be successful in making positive impacts on these outcomes.
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The effect of functional foods intervention on common symptoms such as fatigue and depression in patients with multiple sclerosis
Multiple sclerosis (MS) is rare but increasing in incidence. Our Australian work shows that five years of a first demyelinating event, 41% of people will have clinical fatigue with depression frequently comorbid. Single nutrient therapy with antioxidants directed to mitochondrial support have shown some benefit for fatigue and depression, oxidant damage prevention and improved clinical course in multiple sclerosis. This double-blind randomised controlled trial will run a 20-week therapy of combined mitochondrial support agents against placebo. The therapy will include coenzyme Q10, alpha-lipoic acid, N acetyl cysteine, biotin and other agents. Trial participants will be people with relapsing remitting multiple sclerosis with fatigue. The trial will assess the extent that these therapies reduce fatigue, depression, and metabolomic abnormalities in MS.
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A phase III study of the safety and efficacy of povidone-iodine nasal spray (“Nasodine”) in the treatment of subjects with the common cold in the natural setting.
This is a phase 3 randomised, double blind, placebo controlled efficacy study in 255 participants exhibiting the common cold. Subjects will dose 20 times over 5-6 days, max 4 doses a day. Subjects will also complete the WURSS 21 questionnaire from day 1 to Day 6, and complete item 1 from the questionnaire from day 7 to 14.