ANZCTR search results

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

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31212 results sorted by trial registration date.
  • Omega-3 supplementation on behaviour, mental health and cardiovascular health

    The purpose of this research study is to see if omega-3 fats (the healthy fats) can improve on various health conditions, including depression, anxiety, stress, impulsive behaviour, as well as risk factors for heart disease, which will be measured in a blood sample. Study participants that have volunteered for this study will be provided with the omega-3 supplements which they will take daily for up to 16 weeks. They will attend 2 clinic visits before and after omega-3 supplementation, provide blood samples and answer various questionnaires at both clinic visits, so we (the researchers) can see what potential improvements have been made to the various health conditions.

  • EMPOWERED-GP: Evaluating the Effectiveness of Education through online Media around Pregnancy planning and cOntraception for Women's EmpoweRmEnt in Diabetes in General Practice: a feasibility, acceptability and efficacy study.

    This project aims to improve the engagement of general practitioners (GPs) in discussions with women of reproductive age with pre-existing diabetes mellitus, regarding preconception care (PCC) and effective contraception to address the risks associated with elevated HbA1c levels. The research includes an audit of eMRs from the past 5 years, and a knowledge assessment questionnaire, pre- and post-implementation. The implementation phase involves an eMR alert system to assist GPs in assessing participants' pregnancy intentions within the next 12 months, while educational resources will be provided to participants. The results of this study will inform clinical practice and public health measures at NBMLHD and around Australia on improving PCC and effective contraception among women of reproductive age with pre-existing diabetes in GP setting. A specific Medicare item for these consultations could also facilitate audit and incentivize GP.

  • Short term haemodynamic effects of high flow humidified nasal oxygen in pregnant people with hypertension – a pilot study

    This is a single arm interventional study investigating the effect of short duration high flow nasal oxygen on blood pressure in pregnant people with a hypertensive disorder of pregnancy. Our hypothesis is that this therapy will either lower or not significantly alter systolic and diastolic blood pressure levels in this population. We are also collecting important consumer feedback data around therapy comfort. These findings are key feasibility challenges if larger trials examining high flow nasal oxygen during sleep in pregnant people are to be considered.

  • Safety and Tolerability of CLB-4000 in Subjects with Chronic Hepatitis B: Randomised cohort

    Summary A Phase 1b Study Evaluating the Safety and Tolerability of CLB-4000 with or without Peg-IFNa-2a in Subjects with Chronic Hepatitis B Who is it for? You may be eligible for this study if you are an adult aged between 18 and 60 years old with chronic hepatitis B. Participants in this study will be randomly allocated (by chance) to one of two treatments: - Arm 1: CLB-4000 (250 µg CLB-405 and 250 µg CLB-505 adjuvanted with 400 µg TQL-1055), or - Arm 2: CLB-4000 (250 µg CLB-405 and 250 µg CLB-505 adjuvanted with 200 µg TQL-1055) with 180 µg Peg-IFNa-2a Eligible participants will receive 5 monthly Intramuscular (IM) injections of CLB-4000 on Days 1, 30, 60, 90, and 120. Subjects participating in arm 2 will self-administer or have a caregiver administer a weekly subcutaneous injection of Peg-IFNa-2a 180 mcg for 8 weeks during a run-in period and then for 16 weeks during the CLB-4000 treatment phase following injection training and instructions on proper storage and disposal by a clinician. The end of the study is defined as the last subject last visit at Day 300. The estimated duration of the study is approximately 11 months or, for subjects participating in Peg-IFNa-2a arms, 13 months.

  • Driver Sleepiness Detection Device – Optimising Road Safety by Targeting Sleepiness on Australian Roads

    A laboratory-based study will recruit adults 18-75 years (healthy sleepers, shift workers, and individuals with sleep apnoea). Participants will be exposed to a 29-hour extended wakefulness protocol as part of the intervention. During this time, participants will complete cognitive testing, vestibular and ocular motor (VOM) assessments, and driving simulators. The study will determine whether changes in VOM reflexes, measured objectively by the NeuroFlex device, can identify those who are sleepy and at risk of a motor vehicle accident during an extended wakefulness protocol.

  • An examination into the safety and efficacy of Khapregesic®, a Khaya senegalensis preparation, on vasomotor, physical, and psychological wellbeing in women experiencing perimenopause and menopause

    In this randomised, double-blind, placebo-controlled study, 140 women aged 42 to 62 years experiencing menopausal symptoms will be randomly assigned to receive 2 grams daily of a proprietary preparation of pure Khaya Senegalensis Dry Stem Bark (Khapregesic) or a placebo for 28 days. Changes in menopausal symptoms, sleep, and fatigue will be assessed before, during, and after the intake of the investigational product. It is hypothesised that compared to the placebo, Khaya Senegalensis will be associated with greater improvements in menopausal symptoms, sleep and fatigue.

  • An Open-Label Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)

    The purpose of this protocol is to allow for subjects who have previously been enrolled in and completed an Avalyn Pharma Sponsored study of an inhaled antifibrotic, such as AP01, to continue therapy until drug approval, study termination, or withdrawal of the subject from the study.

  • Novel co-designed service to support health and wellbeing of older carers of older people: A study protocol.

    This study aims to evaluate (1) the effectiveness outcomes for older carers participating in the Carer Health and Wellbeing Service; (2) the implementation outcomes associated with the Carer Health and Wellbeing Service – including feasibility, reach, acceptability (carers, Service staff, referrers), maintenance and fidelity; and (3) the cost-utility of the Carer Health and Wellbeing Service. It is hypothesised that the Carer Health and Wellbeing Service will improve carer preparedness to care and other carer outcomes, be cost effective, and will be acceptable and feasible to implement.

  • Simultaneous Measurement and Responsive Treatment (SMART01): A Feasibility Study of a Combined Insulin-Delivery and Glucose Sensory System and Patch Pump System in Persons with Type 1 Diabetes

    This study will evaluate the accuracy of an experimental CGM measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery via a novel insulin patch pump in people with type 1 diabetes (T1D) on insulin pump therapy. Glucose sensory accuracy will be measured over a 72 hour period, along with device survival over the same period. Accuracy of the device will be tested in both a free living state, as well as over two seperate mixed meal challenges in order to test the device accuracy over a range of glucose levels.

  • Investigation of growth hormone for knee and ankle arthritis.

    The purpose of the study is to investigate the intra-articular injection of growth hormone in combination with a carrier for arthritis in the knee and ankle. The hypothesis of the study is the intra-articular injection of growth hormone will increase healing of arthritic or injured joints when compared to standard treatment. The patients are to be referred by their GP to be recruited to the private surgical clinic. The pain and mobility of the joints will be measured by using the American Orthopaedic Foot and Ankle Society (AOFAS) and American Knee Society (AKS) indexes to test the mobility of the ankle and knee respectively.

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