ANZCTR search results

This is a dose-ranging study to evaluate the safety and preliminary efficacy of LMN-0801 for weight loss. 126 adults with obesity (BMI > 30 and BMI < 40) will participate in the study. LMN-0801 will be assessed across dose levels, frequency of dosing, and different formulations of LMN-0801. After enrollment and randomization into one of ten cohorts, participants will take the study drug for 24 weeks and then be followed for an additional 4 weeks. During this time participants will come into the clinic for scheduled study visits to monitor safety, undergo study evaluations and measurements, assess study drug adherence and replenish study drug supplies. Each participant will be in the study for a duration of 29 weeks from enrollment.

We propose a novel hypothesis that short-chain fatty acids (SCFAs) influence BP through the ‘gut-brain axis’. The two key systems involved in this process are the 'fight or flight' (sympathetic nervous system, SNS) and the 'rest and digest' (parasympathetic nervous system, PNS), both part of the autonomic nervous system (ANS). Our primary aim is to quantify if SCFAs modulate SNS and PNS activity associated with BP regulation. Understanding the influence of SCFAs on the gut-brain axis could pave the way for new treatments for hypertension and other conditions linked to this axis, such as irritable bowel syndrome and neuropsychiatric disorders like depression and anxiety. This research could lead to advances in managing these debilitating conditions.

This pilot randomised controlled clinical trial will explore the feasibility of delivering a new, in-home intervention to individuals with an alcohol use disorder and acquired brain injury. It aims to generate exploratory data on treatment engagement, change in alcohol use, community participation, and healthcare utilisation/costs that could inform hypotheses for a larger clinical trial.

This is a Phase 2b, randomized, double-blind, placebo-controlled, multicentre trial evaluating two dose levels of BRP-185 against placebo in adult patients diagnosed with idiopathic hypersomnia. Participants will be randomly assigned in a 1:1:1 ratio to one of the following arms: 1. High-dose BRP-185 group (225 mg) – orally once daily in the morning 2. Low-dose BRP-185 group (150 mg) – orally once daily in the morning 3. Placebo group – orally once daily in the morning This trial aims to provide critical data on BRP-185's ability to improve wakefulness and reduce hypersomnolence symptoms, addressing an unmet need in the treatment of idiopathic hypersomnia.

This is a multicentre trial that will evaluate the diagnostic and clinical accuracy (utility) of home-based L3 sleep studies compared to the current standard of laboratory-based polysomnography (L1 PSG). The clinical utility will be determined by including participants who reflect all of the clinical subgroups that comprise a typical clinical load in Australian paediatric sleep laboratories.

This single group pilot trial will evaluate the outcomes, feasibility and acceptability of a brief, 4-module online, CBT treatment targeting rumination and worry in adults tailored to individuals with Premenstrual Dysphoric Disorder (PMDD) or heightened premenstrual distress. Outcomes will be measured from pre-to post-treatment and up to 5 weeks follow-up.

The primary aim of this study is to test the feasibility of a clinical trial comparing TENS alone to TENS combined with self-selected music, in patients with persistent spinal pain. The results of this feasibility study will be used to inform a larger trial of these interventions in patients with persistent spinal pain. A secondary aim is to study the analgesic effects of each intervention over the course of the TENS treatment, impact of participant's function and mood and adverse outcomes.We hypothesise that administration of TENS combined with music will be equally feasible compared to TENS alone, and will be well tolerated by participants. Secondly, we hypothesise that participants will have superior analgesia when TENS is combined with music treatment will have improved analgesia compared to TENS alone.

Unfortunately, many people will experience knee osteoarthritis at some point in their life. This can be diagnosed by a health professional. People often have beliefs about treatments for, and the prognosis of, their knee osteoarthritis. Currently, we do not know whether the advice someone receives makes any difference to their beliefs about osteoarthritis treatment or prognosis. This study is interested in learning more about this, and whether different ways of providing advice about knee osteoarthritis impacts people’s beliefs about the condition.

This study aims to assess whether a remotely supervised home-based minimal equipment exercise training program is a feasible and acceptable model of pulmonary rehabilitation for people with chronic respiratory disease. Participants assigned to the intervention group will complete home-based minimal equipment exercise training delivered using remote supervision (video-conferencing, Zoom). This involves 8 weeks of twice-weekly remotely supervised (via video-conferencing) exercise training sessions in groups of 2-4 participants. Participants will be able to interact via video-conferencing technology with other group participants and the supervising clinician. Each session, participants will undertake circuit-based training incorporating 7 exercises. The total training session duration will be 45minutes; each exercise circuit will be between 15-16minutes in duration (including interval rests) and repeated 3 times, accounting for a total exercise time of 31.5minutes. A 5minute rest period will be undertaken between each circuit. Additional to this, the intervention group will complete a short questionnaire and a qualitative interview with a clinician following their engagement in the program to understand participant experiences.

Gestational diabetes (GDM) is one of the most common medical complications of pregnancy and its incidence is rising. Due to the large population that continually requires this service, the current model of care is inconvenient, inefficient, unsustainable, and expensive for both patients and health care providers. This trial is an unblinded single centre randomized control trial comparing remote blood sugar monitoring solution via a web-based dashboard to conventional clinic based consultations in gestational diabetes. It will compare pregnancy, foetal, neonatal, patient satisfaction and cost outcomes.