ANZCTR search results

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.

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.

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.

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.

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.

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.

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.

The purpose of this study is to test the effectiveness and safety of the investigational medication in the threatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) in at risk adults. This is a randomized, double-blind, placebo controlled and parallel group study of GL0034 (Utreglutide) for the treatment of (MASH). Approximately 60 participants will be randomly assigned to receive GL0034/Placebo in a ratio of 2:1. GL0034/Placebo is administered weekly as a subcutaneous injection for a period of 24 weeks, The dose will be increased gradually for a period of 20 weeks (called the Dose Titration Period) and then will remain at a fixed dose for 4 weeks (called the Final Dose Period)

Paramedics worldwide have a higher prevalence of PTSD, anxiety, and depression than the general population. Paramedicine students predominately enter the profession without preventative techniques to manage stress, depression and fatigue. The objective of this study was to examine the effect of Transcendental Meditation Technique (TM) on the well-being and resilience of paramedicine students.

A 2-arm randomised clinically controlled trial to determine if there is a difference in palatal volume and surface area between conventional expander appliance and appliances fabricated by a clear aligner company. The study intervention includes the placement of rapid palatal expander appliances or clear aligner expander appliances. The rapid maxillary expanders are adjusted at home by the participant using a key which expands the device; the clear aligner expanders are removed and replaced at home with sequentially expanded appliances. The palate is then scanned and the palatal volume measured digitally. The palatal volume is used to determine if there are any significant differences in expansion of the palatal between the appliances..