ANZCTR search results

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

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31214 results sorted by trial registration date.
  • Mobile phone Intervention for Drinking in Young people (MIDY)

    Our proposal is to take brief interventions, proven to have a significant impact on young people's drinking, and apply them via mobile phone during actual drinking occasions. The intervention will consist of hourly mobile assessment and feedback. While on a night out, participants will receive hourly reminders to complete a very brief questionnaire through an online survey accessed via the SMS message. The questionnaire will involve hourly reports of their alcohol consumption and spending, where they are, and their mood. They will then receive an individually tailored feedback message via SMS in response to these data, which aims to stop or slow down their drinking, or avoid harmful consequences of drinking. The intervention will be delivered on drinking occasions on Friday and Saturday nights over a 6-week period. This study aims to determine the impact of a tailored brief intervention delivered by mobile phone on young people's high-risk alcohol consumption. We will use a randomised controlled trial design to generate high quality evidence of the impact of this intervention on single occasion risky drinking among young people.

  • Health eLiteracy for Prevention in General Practice

    Being overweight or obese increases the chance of a person developing chronic conditions such as diabetes and heart disease. This study aims to help these people find and use relevant health information to improve their diet, increase the amount of physical activity they do, and generally improve their health, thereby preventing the development of chronic disease. We are conducting this study in general practice because most Australians routinely visit their general practitioner (GP). We will be supporting GPs and practice nurses (PNs) to provide a smart phone/tablett app (SNAPP) that will allow each person to monitor aspects of their health like their weight, blood pressure and cholesterol and to track changes in these over time. Each person will receive individualised information, advice and support that will help them to set some achievable goals around lifestyle change. Each person will also be offered ten sessions of confidential telephone based counseling over a three month period. Nurses will guide this process and make assisted referrals for patients so they can access the help they want. Our research has shown a need for this type of program and previous results suggest that these programs can create lasting health benefits. This study aims to provide a non- judgemental approach and provide the assistance and advice needed to improve motivation, to stay on track and achieve individual goals. The aim of this study is to evaluate the implementation and effectiveness of a primary care based preventive care intervention. The intervention is tailored to the needs of, and develops the knowledge and skills of overweight or obese patients with low health literacy. The overarching research question is: Can an eHealth intervention tailored to low health literacy and targeted at overweight and obese individuals from general practice change: a) Patients general health literacy and eHealth literacy? b) Physiological risk factors? c) Lifestyle behaviours – smoking diet, alcohol and physical activity? d) The preventive care they receive in general practice from GPs and PNs and their adherence to planned care? PRIMARY HYPOTHESES: 1. Compared to those attending control general practices, overweight or obese patients who attend intervention practices will, at 6 and 12 months: a) Increase health literacy related to preventive care by 10% at 6 and 12 months b) Increased self-reported physical activity and daily fruit and vegetable intake by 10% at 6 and 12 months c) Decrease physiological risk factors by 7%: weight, blood pressure, at 12 months These changes will be greater for intervention group patients with lower than those with higher health literacy.

  • #MindinBody: Impacts of two types of exercise (Bikram yoga versus Adrenaline HIT) on persistent pain in women with a history of trauma.

    To investigate a psychobiological model of persistent pain in a mixed methods intervention study for women with persistent pain and a history of trauma, specifically: To investigate the potential of Bikram yoga as a mind-body integrative persistent pain therapy. That is, to quantitatively assess the efficacy of an 8 week intervention (3 classes per week) of instructor lead Bikram yoga classes, as compared to coached Adrenaline HIT group gym class, on pain levels and the associated underlying psychobiological mechanisms (dysregulated stress response outcomes). It is hypothesized that participants in the Bikram yoga group will show greater improvements in pain and stress dysregulation than the participants in the comparison Adrenaline HIT gym class group To quantitatively assess a psychobiological model of persistent pain, that is, the relationship between trauma history, dysregulated stress response outcomes and persistent pain levels where it is hypothesized that greater stress dysregulation will be associated with increased levels of persistent pain

  • Residential care pharmacists: a pilot trial into a novel clinical pharmacy role for improving quality use of medicines in aged care

    Approval to pilot the new pharmacist role, collect baseline, post-intervention and demographic data from residents at control and intervention site. Staff and residents will be invited to participate in surveys or interviews to describe their experience with the new pharmacy practice role.

  • 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.

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