ANZCTR search results

This trial will evaluate the efficacy of an ultra-brief online psychological treatment for women with perinatal depression or anxiety. The treatment involves online materials and optional support from a psychologist. We will evaluate efficacy against a waitlist control group 2-months after starting (i.e., 9-weeks later). Questionnaires will be administered Week 1, Week 5, Week 9, Week 13, and Week 17. We expect that the treatment will be more effective in reducing depression and anxiety symptoms.

This is a Phase 2, randomised, double-blind, placebo-controlled study assessing the safety, tolerability, and efficacy of KNX100 in both out-patients and care facility participants with clinically significant agitation/aggression associated with dementia. The primary objective is to evaluate the effect of twice daily oral dosing of KNX100 for 4 weeks, compared to placebo, on symptoms of agitation in subjects with dementia as measured by Cohen-Mansfield Agitation Inventory. The secondary objectives of the study include evaluation of the effects of KNX100 on NPI-12/NPI-NH and CGI(S/I) as well as evaluation of caregiver burden by CSI for community dwelling subjects. Safety and tolerability of KNX100 will be also assessed. Upon meeting eligibility criteria participants will receive blinded treatment twice daily for 4 weeks followed up by 2 weeks of follow up.

This phase 2 study is a randomized, placebo-controlled, double-blind trial of an oral drug called AT-5214 vs placebo in participants with moderate to severe facial acne vulgaris. The study will assess the efficacy and safety of AT-5214.

This study aims to develop, implement, and evaluate an allied health led mHealth assisted opioid tapering intervention for people with chronic pain on long-term opioid therapy. A pilot Randomised Controlled Trial (RCT) will be used to investigate the acceptability, feasibility and potential efficacy of this novel approach to supportive opioid tapering. Potential efficacy will be established by comparing the mHealth assisted intervention to usual care (i.e. GP correspondence) to determine potential clinically meaningful differences in health outcomes at 6 months follow up pertaining to opioid use, pain severity and pain interference (i.e. the impact of pain on one’s life). Our progression criteria for a more robust and full scale RCT for this trial are: i) adequate recruitment (equal to or greater than 6 participants/month), ii) retention (equal to or less than 25% drop out) and iii) intervention acceptability (equal to or greater than 80% of mHealth intervention participants recording a positive response on the 7-point Likert scale (i.e. score equal to or greater than 5)).

(O-acyl)-hydroxy fatty acids (OAHFA) and Wax esters (WE) are part of the natural lipid layer of the tear film, which helps to stabilize tears, and is believed to maintain comfort. During contact lens wear, the tear film rapidly breaks up, and this may be a reason for people complaining of discomfort during lens wear. The aim of this study is to investigate changes in the ocular surface (corneal and conjunctival staining, non-invasive tear break-up time, and tear lipid layer thickness) of experience contact lens wearers wearing OAHFAs-loaded contact lens, Wax esters (WE) loaded contact lens and commercially available contact lens. The findings from this study will explore the use of OAHFAs and WE to improve the comfort of daily disposable contact lenses. We hypothesize that wearing contact lenses containing OAHFAs or WEs will result in a more stable tear film and increase wearer comfort.

Given the burden of chronic pain to society and individuals and the potential to improve outcomes through adjunctive treatment, a randomised controlled trial comparing the effectiveness of multi-disciplinary pain management (PM) on its own versus multi-disciplinary pain management plus an additional treatment is planned for people with nociceptive or neuropathic dominant low back pain. We hypothesise that the additional treatment added to a pain management program will lead to some additional benefits for people with low back pain compared to a pain management program alone.

The research study is looking at what are the effects of orthodontic treatment of a small lower jaw in children. The treatment being investigated in this study is composed of an appliance (known as invisible functional appliance) that will help the lower jaw posture forward. The invisible functional appliance will be used for 9-12 months and will be compared with two other commonly used appliances to correct the small lower jaw.

This study aims to investigate whether using alternative diagnosis labels for melanoma in situ has any impact on worry/anxiety and treatment preferences for adults. Who is it for? You may be eligible for this study if you are aged 40 years or older and are in good general health without a clinically significant medical history. People who have been diagnosed with melanoma will not be eligible for this study. Study details This trial will be conducted online and no in-person visits are required. Participants who choose to enrol in this study will be asked to access an online survey via a link provided to them by email. Participants will then be presented with one of three different diagnosis scenarios where one of three labels for low-risk melanoma may be used. After reviewing this information, participants will then be asked to respond to a series of questions about their preferred choice of management for that diagnosis, their level of anxiety about that diagnosis, and their level of anxiety about that management choice. Completion of the survey is anticipated to take up to 15 minutes during a single session, no further participation is required. It is hoped this research will determine whether different diagnosis labels influence management choices and anxiety after a low-risk melanoma diagnosis.

This is a Phase 1, first-in-human (FIH), randomised, double-blind, placebo controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of SION-719 administered as an oral suspension in healthy participants.

This study will evaluate the safety and efficacy of Combining Oral Azacitidine and Dendritic Cell Vaccination Vididencel in maintenance for Acute Myeloid Leukemia. Who is it for? You may be eligible to join this study if you are aged 16 and above and have Acute Myeloid Leukemia in first complete remission following intensive chemotherapy, not planned for allogeneic stem cell transplant Study details: This study is part of the International AML Platform Consortium. Participants in this study will be randomly allocated (by chance) to one of two treatment groups. Participants in one group will receive the oral drug Azacitidine daily on Days 1-14 of each 28 day cycle and a course of vididencel will be administered intradermally on cycle 1 (Day 1, Day 15), Cycle 2 (Day 1, Day 15), Cycle 4 day 1, Cycle 5 day 1, and Cycle 6 day 1. Oral-Aza 300mg will continued until progression to >15% blasts or unacceptable adverse events. Participants in the other group will receive the oral drug Azacitidine daily on Days 1-14 of each 28 day cycle, continued until progression to >15% blasts or unacceptable adverse events. Patient with low blast count (5-15%) can have oral Aza dosing regimen increased to 21 days per cycle, if Investigators finds that beneficial for the patient. As part of the study, participants will have blood tests at the start of each cycle (every 28 days) and measurable residual disease testing on bone marrow samples at the end of each second cycle until cycle 6 and then end of every 3 cycles. We hope that the results from this trial will be used to help these new treatments which may be better for people with AML than what is currently available become accessible to the general population at faster than the normal process.