ANZCTR search results

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

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31593 results sorted by trial registration date.
  • Queensland COVID-19 Vaccination (QoVAX) Safety and Efficacy Trial Program: Mixed Dose 1 and 2 Study

    The overarching primary research question for the QoVax SET Mixed Dose 1 and 2 study is; In the Queensland community, do heterologous COVID-19 vaccine doses 1 and 2 compared with homologous doses 1 and 2, offer higher recall levels of spike IgG, spike IgA, neutralizing IgG, and cell mediated immunity at 4 months post dose 2. The QoVAX Mixed Dose 1 and 2 study will address these specific research questions; 1. What are the host intrinsic (HLA type, genetic traits, immunological T and B cell receptor repertoires) and extrinsic factors (socio-economic health determinants, environmental exposures e.g. smoking) associated with variation in immune outcomes following vaccination? 2. Do members of the community who identify as Aboriginal and/or Torres Strait and/or South Sea Islander, or as being from diverse ethnic backgrounds, show similar vaccine responses? 3. Do certain pre-existing health conditions (autoimmunity, cancer, immunodeficiency), and medication use effect response variation of primary immune outcome measures? Further research objectives are to investigate medium-term health outcomes of vaccinated research participants at 12 months following recruitment, to identify factors associated with i) safety outcomes, and ii) vaccine efficacy outcomes in the study cohort.

  • Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnoea (OSA) and Outcomes in Pregnancy

    Our study's primary aim is to inform the feasibility and recruitability of a larger scale RCT to investigate maternal and foetal outcomes after diagnosis and treatment of moderate-severe OSA in pregnancy. We aim to test women with body mass index greater than or equal to 35 for sleep apnoea, and determine if treating moderate to severe disease will in pregnancy will impact maternal or neonatal outcomes. Additionally we will investigate if the intervention is acceptable to women, and if it has any impact on their quality of life, or any impact on placental histology after the birth of their baby. Additionally we will assess the predictive utility of questionnaires, BMI, neck circumference in OSA in pregnancy.

  • The effect on Signal Quality using the Isometric Hand-Grip Test to maximize Vascular Flow in patients with macular disease

    This pilot project aims to investigate whether the quality of optical coherence tomography angiography (OCTA) scans, performed on patients with macular disease, can be improved using an in-office Isometric Hand Grip Test. The primary research question this study seeks to address is: *Does the signal quality of OCTA scans improve after performing the isometric hand grip test in individuals with macular disease? The secondary research question is: *Do parameters of OCTA images such as vessel density, vessel perfusion and foveal avascular zone area alter after performing the isometric hand grip test in individuals with macular disease?

  • Diagnosis of vocal cord dysfunction / inducible laryngeal obstruction – a Delphi study

    Introduction Currently there is no consistent and widely accepted approach to the diagnosis of vocal cord dysfunction/inducible laryngeal obstruction (VCD/ILO). Harmonised diagnostic methods are vital to enable facilitate optimal diagnosis, advance management and enable research. Aim To obtain consensus on how expert clinicians diagnose VCD/ILO. Methods and analysis Two-round modified Delphi. Ethics and dissemination Ethics will be obtained from the Monash Health Human Research Ethics Committee. The dissemination plan is for presentation and publication.

  • POST-operative Variations in anaemia treatmenT and Transfusions (POSTVenTT)

    Anaemia affects nearly a quarter of the world and is common in surgical patients. A third of patients present with preoperative anaemia and three quarters of patients are discharged from hospital with anaemia. The World Health Organisation defines anaemia as an insufficient circulating red cell mass, with a haemoglobin (Hb) concentration of < 130 g/L for men and < 120 g/L for women. Perioperative anaemia is associated with delayed patient recovery and increased postoperative complications, leading to increased post-operative morbidity and mortality. In recent years, there has been a significant increase in the in the use of intravenous iron therapy for preoperative anaemia in line with major international guidelines. This is common practice in Australia and New Zealand. However, the recent PREVENTT study has questioned the value of preoperative iron transfusion in anaemic patients. Management of anaemia in the perioperative setting is variable and compliance to recommended practices such as measurement of haemoglobin levels, use of tranexamic acid, and avoidance of oral iron remains unknown. The POSTVenTT (POST-operative Variations in anaemia treatmenT and Transfusions) audit aims to determine the variability in adherence to anaemia management guidelines in the perioperative setting and to assess its impact on clinical outcomes following major abdominal surgery.

  • Feasibility Trial to Evaluate the Eclipse 3 Continuous Glucose Monitoring System - Australia (FREE - AU Trial)

    This study is to assess the Eclipse 3 Continuous Glucose Monitoring System device (CGM). The Eclipse 3 system is comprised of an implantable CGM (sensor) paired with a mobile App that is designed to capture blood glucose readings in real time. The purpose of this research project is to test the safety and performance of the Eclipse 3 CGM System over a 4 to 8 month period. Six to eight participants who have had type 1 diabetes for at least 5 years, and are using insulin will be enrolled. This sensor will be implanted below the skin into the lower abdominal area and remain there for a minimum 4.5 up to a maximum of 8.5 months . Participants will come in monthly for visits. After 4 months of participation, data from the implanted sensor will be evaluated to determine whether or not participants will continue for the next 2 months. Should the participants continue to have the sensor implanted for an additional 2 months, they will continue to come in for monthly visits. At the 6month mark they will again have their data evaluated to determine if they will continue to have the sensor implanted for an additional 2 months up to a maximum of 8 months. After the 8 month visit (unless determined to be after Month 4 or Month 6) the sensor will be explanted and a biopsy of the tissue will be retrieved for evaluation.

  • Screening for high risk pregnancies with an app

    Its really hard for a woman when she falls pregnant to jump through all the hoops needed to book in to a hospital for her antenatal care. Both with the current lock down issues as well as in the past, the delays have meant that women are booking in to the hospital well after the first trimester. Thus women are missing out on potential therapies that may be able to prevent complications in their pregnancy. A large proportion of women who at risk of complications will be able to be identified based on their personal and family history. We have developed an app that can ask questions to figure out which women are at high risk. This study aims to compare the accuracy of the risk assessment of the app with the current practice of booking in to the hospital. This trial will be undertaken with the app available in three languages with an assessment of user acceptability.

  • Investigating how an exercise intervention influences sleep, and memory and thinking skills, in healthy older adults with poor sleep.

    The aim of the current study is to evaluate relationships between sleep, exercise and memory and thinking skills in older adults who are 'poor sleepers'. The results from this study will allow us to determine how sleep may influence the relationship between exercise and memory, allowing the development of effective lifestyle interventions to delay the onset of memory decline, and ultimately dementia. The intervention for this study involves cycling on a stationary exercise bicycle, and subsequently completing memory testing and sleep measurement. It is hypothesised that immediately after a single session exercise, and 24-hrs post exercise, participants will show improved memory performance, and improved sleep that night, compared to a control session (no exercise).

  • Free Jab (COVID-19) Control group in Australia Health and risk outcomes for Australians who not intending to receive the COVID-19 vaccination.

    This is a one-year independent study designed to provide a database for the unvaccinated population for comparative analysis with the vaccinated population in order to evaluate the success of the Covid19 mass vaccination programme and support future research projects. This study is not, and will never be, linked to any pharmaceutical company.

  • A Single Centre Observational Study to Assess whether a Topically Applied Cannabidiol Gel can Reduce Symptoms of Painful Osteoarthritis of the Hand

    This study will assess whether topical application of a CBD gel can provide analgesia for patients suffering from osteoarthritis of the hand. A growing body of evidence suggests that inflamed tissue caused by osteoarthritis may be susceptible to treatment using CBD. Despite oral ingestion of cannabinoid products being the preferred route of administration, its poor aqueous solubility and extensive first-pass metabolism lead to poor bioavailability, which limits see its potential efficacy. The ability to deliver CBD directly to local, inflamed tissue using topical application may provide superior analgesia than oral dosage forms, whilst minimising any concerns related to systemic exposure. This study will assess whether topical application of a CBD gel can provide analgesia for patients suffering from osteoarthritis of the hand. In addition to analgesia, the study will investigate whether topical CBD can provide benefits for other symptoms of osteoarthritis of the hand; poor grip strength and hand functionality. Results from this study will support further clinical development of the CBD gel, as well as future prescribing to patients.

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