ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32850 results sorted by trial registration date.
  • Administration of clinical doses of neostigmine, commonly used in anaesthesia, and assessment of its effects on muscle strength, using a dynamometer, in healthy awake volunteers.

    Neostigmine is an anticholinesterase agent that is commonly used in anesthesia to reverse non-depolarizing neuromuscular blocking agents (NMBA). It is used to improve the rate of recovery from moderate non-depolarizing neuromuscular blockade and reduce the incidence of residual blockade. Neostigmine increases acetylcholine levels at the neuromuscular junction by inhibiting the breakdown of acetylcholine (Ach), which competitively antagonizes the NMBA. Neostigmine also acts at muscarinic sites leading to unwanted cholinergic side effects. Therefore the anti-muscarinic agents glycopyrrolate or atropine are administered in conjunction with neostigmine to reduce the severity of the effects. Clinical doses of neostigmine have been reported to cause muscle weakness when administered after full recovery from blockade. However, these reports are potentially confounded by the presence of other anesthetic agents also known to influence neuromuscular blockade.Without the use of quantitative neuromuscular function monitoring, patients who have spontaneously recovered from NMBAs may be given neostigmine unnecessarily. The primary aim of this study is to determine if clinical doses of neostigmine administered to healthy, unanesthetized volunteers would cause muscle weakness and impair respiratory function. We sought to define the size of the effect with hand grip strength, electromyography and spirometry. The secondary aim was to record the signs and symptoms experienced by the participants.

  • Tympanometry in the Emergency Management of Children with Acute Otitis Media

    This study seeks to determine if Tympanometry is beneficial in the care of children with suspected AOM when using the Queensland Health management guidelines. Currently, AOM is diagnosed through a combination of case history, body temperature and otoscopic examination to ascertain the presence of acute middle ear infection. Otoscopy can be difficult to perform on a distressed child and is insufficiently precise to diagnose AOM by itself. The objective information provided by Tympanometry can exclude normal from abnormal middle ear function, providing evidence for a differential diagnosis in these situations. It is anticipated this information will support Physicians to consider alternative management strategies to routine antibiotic prescription when faced with these presentations. The primary goal of the research project is to determine if providing Tympanometry reduces the antibiotic prescription rate in children attending the Emergency Department with suspected AOM. This will be determined by comparing the antibiotic prescription rate between two groups of children, those who receive the standard care as per the management guidelines, and those who receive the standard care plus tympanometry testing. Research by Spiro et al., showed 40% of children were over-diagnosed with Acute Otitis Media in the absence of middle ear dysfunction/effusion. Identifying children who do not have a middle ear infection will result in a reduction in the percentage of children presenting with suspected AOM that are diagnosed with AOM and in the amount of antibiotics prescribed. Secondary analysis will determine if there is a difference in the length of stay times between the two groups. The results from this study will provide clinical data to support Queensland Health guidelines in the management of this patient group. It is anticipated the results from this study will support the implementation of Tympanometry in the ED for the management of children with AOM by reducing unnecessary antibiotic prescribing and reducing the length of stay in the ED.

  • Making tonsillectomy surgery safer for children by examining obstructive sleep apnoea

    Obstructive sleep apnoea (OSA) is a condition involving repeated episodes of partial or complete blockage of the airway during sleep. Children diagnosed with OSA usually undergo surgical removal of the tonsils and adenoids. However, there is a high rate of complications with approximately 50% of the children suffering from minor or major breathing problems during and/or after surgery requiring specialised care. Additionally, the younger the children are, the higher the risk of breathing problems. The impact on the healthcare system is significant; the number of unplanned admissions necessitating specialised treatment with prolonged hospital stays increases causing delays on theatre lists. This leads to potential cancellations of other children due to the lack of theatre time and consequently increases the waitlist time. The ‘gold standard’ test for diagnosis and classification of OSA is the complex and expensive technique called polysomnography (PSG) (overnight sleep study). The associated high cost and lengthy waiting list means that it is rarely used in clinical practice in this population. Currently, surgeons and anaesthetists assess the children’s risk of respiratory complications through clinical history and questionnaires. However, relying on parental observations alone can make assessment of the presence and severity of OSA challenging. As a result, this screening technique is not sufficient. Children at an increased risk of respiratory problems can be missed through this process & their airway management strategies may not be conservative enough to minimise the risk of respiratory complications during and after their procedure. Since OSA involves a highly collapsible upper airway during sleep and also anaesthesia, we have adopted a method to measure the likelihood of collapse of the upper airway (throat) under anaesthesia to predict OSA severity. This safe, simple and quick technique, that can be implemented in routine practice will provide anaesthetists with a new screening method and allow evidence-based risk stratification of this high risk population and will allow anaesthetists to tailor their management for the individual patient to avoid breathing problems. Alternatively, children with no/mild obstructive sleep apnoea requiring less close observation following surgery will be able to be discharged earlier reducing the overall emotional impact on families by allowing patients to recover in the comfort and familiarity of their own home. This may also reduce overall unnecessary admissions to ICU alleviating some of the economic impact of this problem on the hospitals. This study will also look at other emerging techniques that may estimate OSA severity to examine if they correlate with PSG data and are predictive for respiratory problems. Ultimately, we aim to develop a clinical guideline from some or all of these parameters that will allow improved stratification of preoperative OSA patients without the reliance on PSG.

  • Apheresis of healthy subjects with induced blood stage Plasmodium vivax

    This study will investigate the safety of carrying out an apheresis procedure on healthy participants infected with Plasmodium vivax malaria parasites. Apheresis is the name of a process, which involves the removal of all or, as is the case in this study, part of one of the components that makes up a person’s blood. We want to see whether apheresis can be used as a way of collecting all the stages of the P. vivax parasite found in the blood. We hypothesise that the apheresis procedure is safe in healthy participants infected with P. vivax and that apheresis can be used to extract and concentrate all stages of P. vivax parasites at numbers greater than can be attained by simple blood draws. It is hoped that information gained from this study may lead to the development of interventions that effectively treat and prevent malaria and its spread in areas of the world where this parasite continues to cause significant sickness and death.

  • A Study of Pirfenidone Solution for Inhalation in Healthy Volunteers, Smokers or Former Smokers with Decreased Lung function, and Patients with Idiopathic Pulmonary Fibrosis (IPF) to determine pharmacokinetics, as well as the safety and tolerability in volunteers with a history of smoking with decreased lung function and IPF patients.

    A Phase 1, Randomized, Double-Blinded Study of AP01 (Aerodone, Pirfenidone Solution for Inhalation) Delivered via the PARI eFlow Nebulizer System in Healthy Volunteers, Smokers or Former Smokers with Decreased Lung function, and Patients with Idiopathic Pulmonary Fibrosis to determine the Pharmacokinetics and Maximum Tolerated Dose, as well as the Safety and Tolerability in IPF patients

  • Effectiveness of monitoring levels of Circulating Tumour Cells (CTCs) in blood for early detection and treatment monitoring in cancer patients.

    The aim of this project is (1) to determine effectiveness of monitoring a cancer patient’s response to his/her treatment by detecting and counting the Circulating Tumour Cells (CTCs) in the bloodstream, and (2) to establish the relationship of the number of CTCs in patients before and after cancer diagnosis. Who is it for? You may be eligible to join this study if you are aged 18 years or over and are about to start treatment for cancer (Part 1) or if you a healthy individual not previously diagnosed with cancer (Part 2). Study details For both groups, blood samples will be collected at various timepoints to assess CTCs number. In participants commencing cancer treatment this will be over a 12 month period while healthy individuals will be assessed once a year for 10 years. Upon the completion of this study, we will be able to evaluate the feasibility of using CTCs number as an indicator or marker for early cancer detection and for cancer treatment monitoring for cancer patients.

  • Evaluating an online intervention for General Practitioners (GPs) to use delayed prescribing for acute respiratory infections in general practice

    Antibiotics treat infections by killing bacteria. Antibiotic resistance occurs when an antibiotic has lost its ability to kill the bacteria; the bacteria has become resistant to the antibiotic and continues to multiply. One of the main reasons antibiotics lose their effectiveness is we take antibiotics when we don’t need them. Most antibiotics are prescribed for respiratory tract infections, in the community, that often get better without the need for medical intervention. There are many strategies to help doctors and patients to reduce antibiotic use in the community. One of these strategies is called ‘delayed prescribing’. Delayed prescribing, also called ‘wait-and-see prescribing’, is the process whereby a general practitioner (GP) makes available an antibiotic prescription during the consultation, but asks the patient to delay its use to see if symptoms will resolve first. This has been used in other countries very successfully but has never been trialed in Australia. The GP4DP trial wants to test if delayed prescribing can help reduce antibiotic use in community for people who present to their GP with respiratory tract infections. This trial will ask GPs not to prescribe antibiotics unnecessarily and if they do think it might be necessary, to ask the patient to wait and see if the illness will get better on its own before taking the antibiotic. Other studies have shown that most people do wait before taking the antibiotics, complications are extremely rare and the amount of people who present to the Emergency Department does not increase.

  • The buccal administration of a NanoCelle™ Cannabidiol formulation to healthy volunteers: a pharmacokinetic, safety and tolerability exploratory pilot study.

    This is a single blinded randomised placebo-controlled study. This study will be performed in healthy subjects to determine the pharmacokinetic, safety and tolerability characteristics of a novel Cannabidiol formulation in the form of an oro-buccal spray. The drug contains 6 mg CBD and <0.3 mg other cannabinoids (including THC)/0.3 mL in 2 actuations of the pump (equals 1 dose).

  • A pilot randomised open-label taste-testing study to evaluate the acceptability of chocolate-based tramadol in children

    There is a limited number of strong pain relieving medications available for children. All have their own advantages and dis-advantages. For example, anti-inflammatories, like ibuprofen, are unsuitable for those with a bleeding risk and can cause kidney damage. Morphine like drugs come with the risk of slowing breathing and a fear of diversion for illegal use. Tramadol is a medicine that has been used safely for many years in both adults and children. Its advantage is that is has similar pain relieving power to morphine like drugs in the typical dose range, but because it works in a different way, it has much less ability to impair breathing. Its main disadvantage in children is that the drug itself tastes very bitter. In adults, this is overcome by presenting the medication in capsules, so the drug is not released until it reaches the stomach. While there are some 82 registered products in Australia containing tramadol, none of them are licenced for use in children. To provide a suitable dose to small child, the standard adult dose capsule must be broken open, the drug dissolved in water, and the correct proportion given. This is cumbersome for parents, risks error in dosing and produces a horrible tasting solution that most children dislike. There is one preparation available (although not licensed for use in children) of very concentrated oral drops, 1ml containing 100mg of drug, equal to 2 standard capsules. This is unsuitable for young children because the risk of overdose with such a concentrated solution is great, and has occurred with this formulation. To make drugs more palatable to young children they are often dissolved in syrup, but this only masks the bitter taste to a degree and often involves adding artificial flavours and sweeteners. The pharmacy department at Princess Margaret hospital (PMH) in partnership with the Anaesthesiology, Pharmacology and Pharmacy Unit at the University of Western Australia has developed a novel chocolate sweet which can be used to mask the taste of bitter drugs. It has already been used successfully for other medications and found to be very acceptable to children. Using this delivery system has also given the ability to deliver a smaller defined dose, not previously available in Australia, which will allow easier and more reliable dosing in smaller children. This study plans to test the chocolate tramadol tablet against the current broken-open capsule method of delivering tramadol in patients following minor to moderate operations at Princess Margaret Hospital. We will compare how the new “tablet” is tolerated, absorbed and if it is an effective pain reliever. Ultimately we hope to develop a new method to deliver tramadol so it can be more easily and safely be given to children.

  • Fit4Two: Feasibility, acceptability and efficacy of a tailored eHealth physical activity intervention for pregnant women integrated into clinical practice – a randomised controlled trial

    Inactivity during pregnancy is associated with adverse health and pregnancy related outcomes for the mother and her unborn child. This innovative randomised controlled trial aims to increase physical activity in pregnant women by integrating an already examined eHealth intervention (Fit4Two) into clinical practice. This intervention will provide participants with highly personalised and automated physical activity feedback, endorsed by their practitioner. As such, participants will receive high quality care in a convenient, credible and time efficient manner, whilst placing very little additional burden on practitioners.

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