ANZCTR search results

Have received feedback which we are actively addressing to obtain HREC approval ERM Reference Number: 116499 Monash Health Reference: RES-25-0000-173A This study, called SLUMBER, is investigating whether melatonin—a natural hormone known to help regulate sleep—can improve sleep quality in women with endometriosis, a condition often linked to both pain and sleep disturbance. Participants will take either a placebo, 10 mg, or 20 mg of slow-release melatonin nightly for eight weeks. Researchers will assess changes in sleep, pain, and overall well-being through surveys completed before and after the trial. The study hypothesis is that melatonin use will lead to improved sleep quality, compared to placebo, in women with endometriosis.

This is a first-in-human, multi-center, randomized, double blind, two-part single and multiple ascending dose study to assess the safety of SNT9465, and how this drug acts in the body in healthy volunteers. SNT9465 may be indicated for use in patients with Hypertrophic Scars, but a trial of the drug in healthy volunteers is needed before trials in patients with Hypertrophic Scars can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. Study details: All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single or multiple doses of SNT9465 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with Hypertrophic Scars.

This is a prospective, multi-center, single-arm phased study assessing the efficacy and safety of the ETLA system for the treatment of severe emphysema with hyperinflation. The ETLA System is a minimally invasive bronchoscopic treatment designed to deliver heated normal saline to targeted emphysematous lung regions with hyperinflation to cause tissue ablation and subsequent volume reduction as a means for treating emphysema. The ETLA therapy will be delivered sequentially over two (2) procedures. The magnitude of clinical benefit associated with ETLA is anticipated to correlate with the relative volume of diseased tissue removed/reduced, therefore it is anticipated that a higher relative saline dose may result in greater improvement.

This study intervention proposes EMDR Therapy may facilitate more rapid and effective improvement in mood (anxiety and depression), cognition (attention/concentration, memory) and quality of life for individuals who have experienced a recent concussion when compared to care as usual (CAU). Further aim of the current study intervention is to examine functional connectivity within the Default Mode Network (DMN) and associated neurological changes following EMDR relative to control groups.

Menaquinone in Children (MIC) is a world-first study, being conducted in Western Australia, assessing the bioavailability of a Vitamin K- K2-Mk7 liquid supplement, assessing Vitamin K status using three functional markers as Vitamin K dependent proteins, and determining dietary Vitamin K1 and K2 intake using a new Australian foods Vitamin K database. It is a double-blind randomised control trial for 1 month of Vitamin K versus placebo in 50 healthy children and adolescents aged 4 to 17 years old. The intervention dosing is at 1.5 micrograms per kilogram of bodyweight.

The primary purpose of this study is to identify and treat patients with Ultra-High Risk Large B-Cell Lymphoma (UHR-LBCL) using an early intervention strategy with Axicabtagene Ciloleucel (Axi-cel), a type of CAR-T cell therapy. Who is it for? Patients enrolled onto the NHL34 CLARIFY-Prognostic Platform (ACTR12619001656123) and identified with Ultra-High Risk Large B-Cell Lymphoma (UHR-LBCL), eligible for Car-T cell therapy. Study details All participants in this study will undergo the following treatment. First, participants will have their immune cells collected through a process called leukapheresis. While waiting for their CAR-T cells to be prepared, they may receive optional “bridging” treatment to keep the cancer under control. This treatment can vary from steroids, rituximab monotherapy, localized radiation therapy, to more intensive chemotherapy, depending on the participant. Before the CAR-T infusion, all participants get a short course of chemotherapy. Finally, the modified CAR-T cells (Axi-cel) are infused, and patients are closely monitored for side effects and followed up for up to two years. It is hoped this study will help determine if Axi-cel is a feasible and safe treatment, with the goal of improving progression-free survival and overall survival rates in this high-risk patient population.

A number of neurological disorders such as Parkinson’s disease (PD) are characterised by abnormal brain activity (e.g., unusually large numbers of brain cells (neurons) simultaneously active). A pattern of stimulation which has shown therapeutic benefit is called coordinated reset stimulation (CRS). CRS involves the administration of brief, electrical pulses to the body through multiple electrode contacts, with parameters designed specifically to “reset” the abnormal brain activity associated with disorders such as PD. However, CRS stimulation has mainly been applied to fingers. To address walking impairments in PD, stimulation to the feet would target more appropriate receptors. Our work on people without PD has shown that vibration applied to the feet generates a brain response as measured using electroencephalography (EEG, or brain electrical activity). The aim of this study is to investigate the effect of non-invasive peripheral stimulation to the feet, on gait impairments in PD. Stimulation will be in the form of vibration or mild electrical pulses applied to the feet.

Many individuals with a history of electroconvulsive therapy (ECT) report ongoing difficulties with memory. The current study aims to trial 2-weeks of self-guided online memory strategy training for adults with a history of ECT and memory concerns (N=50). The control group will receive a hand-out with written memory strategies. Tests of memory and self-report questionnaires of mood and memory functioning will be given online before and after the 2-week intervention period. It is anticipated that individuals who access the online memory strategy training will show more improvement in memory and better satisfaction with memory, than the individuals in the control group.

There are different surgical options for people with an ACL injury. The most common is reconstruction, which uses tissue from other parts of the body, such as the hamstrings, to act as a replacement. This is a successful operation but does involve damage to bones from drilling holes, removal of tissue from elsewhere in the body, and does not keep any of the torn ligament which has potentially useful nerve endings. Modern ACL repair (stitching) is relatively new and, despite clear potential, has not been fully evaluated. It remains unknown whether it confers any of the theoretical benefits. We aim to conduct a comparative study to find out which is the best technique, reconstructing the ligament or repairing it. The research question is: For patients with recent proximal ACL ruptures (where the ligament has pulled directly off the bone), is ACL repair superior to ACL reconstruction at 24 months post-surgery? This will be measured by a questionnaire relating to the knee called KOOS-4.

This study is a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of FSD202 in adult participants with musculoskeletal nociplastic pain associated with MCAS. The study will be conducted as a decentralized clinical trial. Participants who meet the eligibility criteria will be randomized remotely, via the IVRS system, to receive 300 mg FSD202 or a placebo orally twice daily for 56 days in a ratio of 2:1. The study design consists of up to 17 days screening period, up to 4 days for randomization and initial delivery of IP to participant’s home, a 56-day treatment period, and a 7-day follow-up period. Each participant will participate in the trial for up to 84 days. 1. The study aimes to evaluate the analgesic efficacy of FSD202 compared to placebo in participants with chronic widespread musculoskeletal nociplastic pain associated with Idiopathic Mast Cell Activation Syndrome/ Disorder (MCAS/MCAD).