ANZCTR search results

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

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30794 results sorted by trial registration date.
  • OPTIMISing induction of labour care: oral misoprostol versus balloon dilatation within a stratified inpatient to outpatient setting [The OptiMis-IO study]

    Around 35% of labours are induced, and the rates are rapidly rising. Most induction start with 'cervical ripening', traditionally an invasive procedure with a balloon device or hormonal medication administered vaginally in hospital. Low-dose oral misoprostol is a promising alternative - less invasive, can be administered in an outpatient setting, and associated with fewer caesarean sections and equivalent rates of uterine stimulation compared to balloon methods. However, limited clinical trials have directly compared it to balloon methods, none within an outpatient setting. Therefore, we will compare low-dose, oral misoprostol with balloon methods for induction of labour to determine intervention feasibility and acceptability within two-discrete randomised controlled trials within the Sunshine Coast University Hospital and Royal Brisbane and Womens' Hospital. As the context of the intervention (inpatient or outpatient) is likely to influence outcomes, an initial study will be used to assess feasibility and ensure safety and acceptability in the inpatient setting and if it meets a priori criteria the second study will be conducted to demonstrate the same measure in an outpatient setting.

  • Evaluating Glucose Levels and Risk of Ketoacidosis in People with Type 1 Diabetes Receiving SGLT1/2 inhibitor Therapy Using a Novel Continuous Ketone Sensor; Exercise Sub-Study

    When people with Diabetes exercise it can make their blood sugar drop too low, for this doctors recommend ways to adjust insulin before exercising. SGLT Inhibitors can increase the risk of Diabetic Ketoacidosis. The Abbott Sensor-Based Ketone Monitoring system will be used to assess the effect ketone responses during exercise in people with type 1 diabetes. We believe that ketones will risk in individuals that undertake high intensity interval exercise.

  • SLeep Evaluation and Effectiveness Protocol for Intensive Care Units (SLEEP-ICU)

    Incorporating dexmedetomidine into a comprehensive sleep promotion bundle, which includes minimising night-time disruptions and aligning care activities with the patient’s natural sleep-wake cycles, optimising the sleep environment through monitoring temperature, noise and ambient light could significantly enhance sleep quality in ICU patients. Improved sleep may contribute to better recovery outcomes, reduction in delirium incidence, and overall improved patient well-being. The primary objective of this trial is to provide a comprehensive evaluation of the efficacy and safety of dexmedetomidine in improving sleep in adult ICU patients as part of a sleep promotion bundle as determined by the patient’s subjective sleep assessment.

  • A Study Assessing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-3505 in Healthy Volunteers (PART I).

    K-3505 P001 (PART I) is a study of an intravenously (i.v.) administered drug called K-3505. This study which will be conducted in healthy volunteers is a double-blind, placebo-controlled, single rising dose study with a primary purpose of assessing teh safety and tolerability of single i.v doses of K-3505.

  • Effectiveness of educational interventions to improve the quality use of medicines in Australian general practice for people with gout and older adults prescribed antidepressants

    Improving GP care for people with gout and antidepressant prescription in older adults have been identified as priority areas for Quality Use of Medicine (QUM) programs in the Quality Use of Diagnostics, Therapeutics and Pathology (QUDTP) guidelines. The aim of this trial is to determine the effect of co-designed, tailored and facilitated educational interventions in improving the quality use of medicines in general practice for people with gout and older adults prescribed antidepressant medication. Each group will act as the other’s control. Both groups will have access to educational resources available on demand for both topics via the Medcast online education platform. The study hypothesis is that co-designed, tailored and facilitated educational interventions will be effective in improving general practice care for people with gout and older adults prescribed antidepressant medication.

  • The immediate and short term effects of individualised physiotherapy manual therapy treatment for people with migraine during an acute attack

    This pilot study will explore the immediate and short term effects of individualised physiotherapy manual therapy treatment during the prodromal phase or beginning (up to 4 hours) of a migraine attack episode. Our hypothesis is that delivery of individualised physiotherapy manual therapy treatment in this period will help to reduce symptoms and burden of the single migraine attack in the immediate and short term.

  • Feasibility of a tailored weekly meal box delivery service addressing nutritional intake and quality of life in the Western Australian neurological community

    Nutritional challenges due to motor, cognitive and swallowing issues, arise in Huntington's Disease (HD), leading to malnutrition and reduced quality of life (QoL). We aim to evaluate a co-designed meal-box solution for improving nutrition and QoL in HD. Fifteen HD families will receive the meal-box comprising recipes and ingredients for five meals. Feasibility, acceptability, QoL and nutritional intake will be assessed pre and post, using qualitative and quantitative measures. Positive results could lead to rapid implementation within the HD community through our industry partner, with potential to extend the novel approach to other neurological conditions, thereby addressing a critical need.

  • Retinal red flag screening for headache in the emergency department

    Headache is the fourth most common chief complaint in the ED. Optic disc oedema, characterized by optic nerve swelling from intracranial hypertension, is one of the most important red flags that prompts timely further evaluation of life-threatening headache. However, examination of the optic nerve is infrequently and poorly performed by ED physicians. While artificial intelligence has enabled the automated detection of optic disc oedema from retinal images, these AI systems have not been clinically validated in real-world settings. A group of researchers from the Centre for Eye Research Australia, Monash and Melbourne university have worked with Eyetelligence Ltd to develop the world’s first hardware-software integrated system (i.e. AI-powered Smart Camera) to screen the retinal red flag of headache automatically. We hypothesize that the Smart Camera system will demonstrate reasonably good feasibility, accuracy and end-user acceptance in screening for red flags of life-threatening headache in the Emergency Department.

  • A Phase 1, Randomized Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intermittent Consecutive Day Dosing Regimen of PRTX007 in Healthy Adults

    This is a Phase 1, single-center, prospective, randomized, double-blind study examining an intermittent consecutive day dosing regimen of PRTX007 administered orally to healthy male and female volunteers. Study drug (PRTX007 or placebo) will be given once daily (QD) for 3 consecutive days, followed by 4 days off for 2 cycles plus one additional day of dosing after the 2nd cycle. Over 15 days, subjects will receive 7 doses of study drug.

  • CONNECT: A Support Program for Families Following a Developmental Assessment

    Children with neurodevelopmental delays and/or differences can benefit significantly when they have access to the right supports and services. However, it can be hard for many families to access these supports for a variety of reasons. For example, some services are too expensive or too inconvenient to attend. CONNECT is a new individualised support program for families after their child has completed a developmental assessment and received a neurodevelopmental diagnosis (e.g., autism, ADHD, etc.). Clinician-researchers developed CONNECT as a way to help families connect with the right supports and services for their child. The aim of our research project is to evaluate whether CONNECT helps families access the supports that they need more quickly and easily than their current care pathways.

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