ANZCTR search results

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

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31193 results sorted by trial registration date.
  • Evaluation of Shift, a novel smartphone application to support the mental health and wellbeing of UNSW Senior Medical Students

    The primary objective of this study is to evaluate Shift, a novel smartphone application designed to support the mental health and wellbeing of Junior Medical Officers in a cohort of senior medical students. We anticipate that senior medical students experience reductions in depression and anxiety symptoms after using Shift because the app addresses familiar challenges, for example, through experiences in clinical placement programs. Shift will be the first app of its kind, in that it is specifically designed for emerging doctors who would like to learn about how to improve or maintain their mental health while entering the workforce in the demanding medical profession. The app uses therapeutic elements (cognitive-behavioural, mindfulness, and psycho-educational contents) designed to alleviate or prevent the worsening of mental health symptoms and encourage help-seeking behaviours.

  • The effects of glucagon-like peptide-1 on glycaemia in the critically ill.

    High blood sugar levels are common in patients who are critically ill even if they do not have a history of diabetes. Glucagon-like-peptide-1 (GLP-1) is thought to be an alternative treatment to control high blood sugar levels in intensive care patients as it has the advantage of not causing low blood sugar levels. The purpose of this study is to compare glycaemic control between exogenous intravenous glucagon-like peptide-1 (GLP-1) and insulin for the management of stress-induced hyperglycaemia in critically ill patients. The study is a randomised, double-blind, double-dummy, parallel study comparing GLP-1 and insulin intravenous infusions over 48 hours in critically ill patients. It is hypothesised that there will be no difference in the time outside target glucose range (4.0 – 10.0 mmol/L) between exogenous intravenous GLP-1 and insulin infusions.

  • Antimicrobial Sealants at Lower Uterine Caesarean section on rates of surgical site infection: A Pilot Trial

    The proposed pilot trial will be the first of its kind in the world with an aim to assess the role of using an antimicrobial sealant in reducing the incidence of surgical site infection following elective caesarean section. We believe this study will assist in planning and implementation of methods to minimise post operative complications, maximise recovery after surgery, and increase patient satisfaction. By participating in the study you will be allocated randomly to either a treatment group or a control group on the day of your operation. Participants allocated in the treatment group will have an antimicrobial sealant and antibacterial skin preparation applied to their abdomen before the caesarean section begins. Participants in the control group will receive only antibacterial skin preparation (routine surgical care) prior to their caesarean section. Although at this point you will have an epidural/spinal anaesthetic, the application of the antimicrobial sealant is not painful. Following your procedure, we will care for you as we usually would following a caesarean section. We will record any evidence of surgical site infection whilst you are an inpatient. Once you are discharged from hospital, we will continue to check in with you on Day 7-10 and day 28-30 post operatively to assess for the development of infection. We will contact you through a videoconference call so we can both talk to you and review your wound visually. We will also ask you to take a picture of your caesarean wound at these video conference reviews which we will keep to assess for infection. There will be no identifying features on these photos, so you don’t need to worry about being identified from the photo. All photographs will be deleted following the mandatory period in which they are required to be stored. We will also assess your recovery activity using another visual scoring system, which will be provided to you on you discharge from hospital. We will use the collated information to determine whether using an antimicrobial sealant reduces the likelihood of developing a surgical site infection after a Caesarean section, compared to current standard practice. We will also look at the rate of readmission to hospital with infection following the operation, rate of skin irritation, rate of antibiotic prescription and overall recovery following the Caesarean section between the two groups

  • Milrinone infusion for cerebral vasospasm in aneurysmal sub-arachnoid haemorrhage patients: a pilot randomised controlled study

    Background: Cerebral vasospasm is a relatively common complication following aneurysmal subarachnoid haemorrhage (aSAH), which is associated with significant morbidity and mortality. Current treatment options to treat cerebral vasospasm are limited. Intravenous milrinone infusion is a potentially promising treatment with a relatively low incidence of adverse effects however, has not been explored in a randomized controlled trial. Aim: This will be a pilot study to determine the safety and feasibility of intravenous milrinone infusion as a treatment for cerebral vasospasm following aSAH compared to current standard therapy. Hypothesis: Intravenous milrinone will be a feasible treatment option in the management of cerebral vasospasm following aSAH Methods: The proposed study is a pilot study trialling intravenous milrinone infusion in patients with radiographically confirmed cerebral vasospasm following aSAH. 20 patients will be allocated to receive IV milrinone alongside standard therapy. A control group of 20 patients will receive standard therapy alone. The primary outcome measured will include the dose and duration of milrinone infusion. Secondary outcomes will include the incidence of adverse events, the resolution of cerebral vasospasm on CT or digital-subtraction angiography (DSA) and the vasopressor requirement.

  • Testing persuasive messages about booster doses of COVID-19 vaccines on intention to vaccinate in Australian adults

    The aim of this study is to test the impact of messages about COVID-19 vaccine booster doses in adults vaccinated against COVID-19 on intention to receive a COVID-19 vaccine booster dose. We will recruit adults vaccinated against COVID-19. Participants will receive 1 of 4 information conditions or a control. The 4 information conditions will focus on: the personal health impacts of vaccinating; family and community health impacts of vaccinating; non-health benefits of vaccinating; and personal choice and control associated with vaccinating. The control will be text about eligibility for a COVID-19 vaccine booster dose. Analysis will compare the primary outcome measure (intention to receive a COVID-19 vaccine booster dose) between intervention groups and the control (4 comparisons) using an ANOVA test. Secondary analyses will compare secondary outcome measures (beliefs about COVID-19 vaccines) between intervention groups and the control using an ANOVA test.

  • Trial investigating the safety and efficacy of an ultra-fast acting insulin in an open source automated insulin delivery system without manual mealtime boluses, in people with type 1 diabetes

    Less than one third of people with type 1 diabetes (T1D) achieve glycaemic targets known to reduce the risk of long-term complications. Automated insulin delivery (AID; also known as closed loop or artificial pancreas) is a new therapy that improves outcomes for people with T1D. AID combines an insulin pump and continuous glucose monitor (a small sensor worn under the skin) with a maths program, which tells the pump how much insulin to give based on the glucose levels. Current AID systems still require users to manually give insulin at mealtimes. We are investigating an open-source AID system developed within the diabetes community, to see if it can safely treat diabetes without any manual input. A key barrier that may prevent AID systems from maintaining good glucose control around meal times is speed. This is because it takes several minutes for the glucose sensor to detect a rise in blood glucose, and then several minutes for the insulin to act once it is delivered. We are investigating an ultra-fast acting preparation of insulin, called Fiasp, to see if this is more effective than a "standard" insulin (NovoRapid) in managing mealtime glucose levels. We will recruit 20 participants into this trial. They will have already completed a six-month trial (CLOSE IT), in which they will have used an automated insulin delivery system without mealtime boluses, using insulin NovoRapid. We will change NovoRapid to Fiasp and look to see if this has any effect on glucose levels over the course of four weeks. During the trial we'll closely monitor every participant to ensure their safety, and issue a report if any issues emerge.

  • Randomised controlled trial investigating the safety and efficacy of an open source automated insulin delivery system without manual mealtime boluses, in people with type 1 diabetes

    Less than one third of people with type 1 diabetes (T1D) achieve glycaemic targets known to reduce the risk of long-term complications. Automated insulin delivery (AID; also known as closed loop or artificial pancreas) is a new therapy that improves outcomes for people with T1D. AID combines an insulin pump and continuous glucose monitor (a small sensor worn under the skin) with a maths program, which tells the pump how much insulin to give based on the glucose levels. Current AID systems still require users to manually give insulin at mealtimes. In this trial we will investigate an open-source AID system developed within the diabetes community, to see if it can safely treat diabetes without any manual input. We will recruit 75 people with diabetes across Australia and New Zealand to one of two study sites: the Baker Institute in Melbourne and the University of Otago in Christchurch. The duration of the study is six months. During the first three months everyone will start on an insulin pump and continuous glucose monitor. Participants will need to manually give a bolus whenever they have a meal, but the system will automate all other aspects of insulin deliver. We'll gradually adjust the settings to achieve the best possible control. During the second three months participants will be randomly divided into two groups. The first group will stop giving manual insulin boluses with meals. The second group will continue to give manual insulin boluses with meals. At the end of the trial we'll compare the glucose recording between the two groups, to see if stopping manual boluses made any difference to diabetes control. During the trial we'll closely monitor every participant to ensure their safety, and issue a report if any issues emerge. We'll also collect data relating to the experiences of participants using the AID system, including standardised questionnaires and an interview with 15 participants.

  • The Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI) Project Cluster Randomised Controlled Trial

    The Enhanced Advance care planning and life Review Longitudinal Intervention (EARLI) aims to enable older adults to effectively engage with Advance Care Planning (ACP), in the home care setting. Advance care planning is the process by which older adults, or people who are experiencing chronic disease, terminal illness (including cancer) and/or are at risk of dementia and similar conditions can provide instructions to their carer/s about their main preferences and goals for future care, should they reach a stage where they may not be able to make these decisions on a day-to-day basis. Who is it for? You may be eligible for this study if you are aged 65 years or older (50 years or older for Aboriginal or Torres Strait Islander people), you have had a previous aged care assessment team (ACAT) assessment, you are living in a private residence (own or rented dwelling, including retirement village or other co-operative housing, but NOT a residential aged care facility) and you are receiving home care services from one of the participating aged care provider study sites (Home Care Package Level 1-4, or commensurate self-funded service). Participants who meet these criteria and have been diagnosed with cancer will also be eligible. Study details Participants who choose to enrol in this study will be allocated to one of two groups. The first group will receive the EARLI program which involves meeting with a member of the research team every fortnight for up to 10 weeks. Each meeting is expected to last up to 1 hour and these participants will be guided through the ACP process and given an opportunity to discuss their goals and preferences with members of their aged care and primary care (GP or other specialist) teams. The second group will be given one 30 minute session which provides a brief introduction to ACP and directs participants to available resources. The allocation into the first or second group is randomised (like flipping a coin) - each aged care provider study site will be randomly allocated to recruit for the first or second group for a defined period of time, before swapping over. Each participant will be invited to participate in just one of the groups, with the allocation depending on which stage of the process the aged care organisation is in at the time the participant is recruited to the study. The overall duration of participation in this study will be 3 months from the date of enrolment. It is hoped that this study will determine whether this program is effective in helping older adults in the home care setting to be clearer about their values, preferences and plans for the future, while strengthening relationships and improving wellbeing.

  • Evaluating the Efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) in Young People with Autism Spectrum Disorder, a Double-Blind, Randomised and Controlled-to-Open-Label Study.

    This is an 18 to 54 week study assessing the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of autism spectrum disorder in young people. The purpose of this study is to determine the effectiveness of NTI164 in patients with ASD when treated with 20mg/kg/day for 8 - 54 weeks. The study comprises of an 8-week double-blinded randomised controlled treatment period followed by an 8-week open-label maintenance period followed by a 2-week wash-out period. Participants who wish to continue receiving the study treatment beyond the 16 week period may do so for up to fifty-two weeks (Extension phase) Efficacy will be measured and monitored by performing participant- and psychologist- led questionnaires specific to measuring changes in the behaviour of patients with ASD. Safety will be measured and monitored by performing full blood examinations and liver and renal function tests throughout the study. Additional assessments include microbiome and inflammatory marker assessments.

  • Testing the impact of the #chatsafe social media intervention on young people’s ability to communicate safely online about suicide: a randomised-controlled trial

    Our previous work has established that social media presents a unique opportunity for suicide prevention initiatives, particularly with young people. However, only recently have we started exploring the impact of using social media for the purpose of delivering suicide prevention interventions. Further, while it is known that young people often turn to social media to discuss and share information about suicide, little is known about the types of social media content that young people find most helpful and informative when it comes to educating them about safe online communication about suicide, and what impact such information has on their communication behaviours. To extend this body of work and to develop a social media campaign that is safe, acceptable and helpful for young people, Orygen has received funding to conduct a randomised controlled trial (RCT) with young people across Australia. This project will not only further test the impact of the #chatsafe suicide prevention social media campaign in a controlled study, it will add to the body of knowledge relating to youth-friendly and effective suicide prevention initiatives that can be delivered to young people directly through social media.

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