ANZCTR search results

The purpose of this study is to test a new version of mental health and wellbeing program, the Be Well Plan, in university students. This program aims to build the mental health and wellbeing of participants through 5 weekly, online or in-person, group-based sessions which are designed to assist participants in in developing their own wellbeing plan to better cope with the challenges of university life. In addition, the project aims to understand if the program is beneficial for students with body image or eating concerns and whether any adaptions need to be considered.

This clinical trial will evaluate the effectiveness, safety and cost-effectiveness of NVPs compared to the pharmacotherapy, varenicline, for smoking cessation among people experiencing social disadvantage. The trial is a two-group superiority randomised controlled trial (RCT) that compares smoking rates between two groups of 436 low-socioeconomic status smokers (N = 872), randomly allocated to either: 1) standard varenicline treatment; or 2) NVPs treatment. Both groups will be provided text message behavioural support. This work is of national and international significance as it will provide much-needed data on the effectiveness, safety and cost-effectiveness of latest generation vaping products at achieving smoking cessation amongst a priority population. This will directly address peak health bodies’ calls for high quality large-scale RCT evidence and contribute significantly to existing knowledge in this research area. Furthermore, the outcomes of this study will help guide government and policy decision-making in the future.

The goal of COSMOS is to conduct an open label feasibility study of hypertonic sodium ascorbate for the management of intracranial hypertension in traumatic brain injury

Rates of single-occasion heavy drinking are higher among young university students (17-25 years old; 50%), particularly residential college students (67%), compared to their same-age, non-student peers. There have been calls for more effective alcohol and other drug (AOD) interventions in colleges, particularly during the first week of semester one (Orientation-week or O’week) when risky drinking and related-harm is highest. We developed the QuikFix Good Night Out (GNO) College harm reduction program with college students and staff to address this need. The program is comprised of two parts: (i) an AOD trivia harm workshop delivered by student peer leaders during O’week; and (ii) the delivery of a brief telehealth intervention to socially influential heavy drinking students in the college network. We have demonstrated the feasibility of the QuikFix GNO College Program for reducing alcohol use and related problems in young university students in two pilot trials. Our 2021 feasibility trial (497 students from four colleges) found that students in co-educational colleges which received the QuikFix GNO College Program (AOD trivia workshop + QuikFix brief telehealth intervention) reported significantly less alcohol use than those in colleges which received only the AOD trivia Workshop. Our 2022 cluster RCT (716 students from six colleges) replicated these findings with students who received the full QuikFix GNO College Program reporting less alcohol use and related problems at 24 and 52 weeks compared to those in the AOD trivia workshop-only group. While the results of these pilot studies are promising, both of these trials were conducted at one university. We are now seeking to evaluate the scalability, efficacy, and cost effectiveness of the QuikFix GNO College Program for reducing AOD use and related harms in first-year college students across three Australian states. A two-arm randomised controlled design will be conducted comparing the impact of the QuikFix GNO College Program to an AOD-education only control on alcohol use and related problems. The inclusion of a control group (usual AOD-education) will evaluate the effects of the QuikFix GNO College Program compared to the typical college AOD messaging that first-year students receive within the residential college environment.

This is a Phase 2 study to evaluate the safety and tolerability, PK/PD, and antiviral activity/efficacy of cavrotolimod and cavrotolimod-containing combinations in CHB infected subjects who are on nucleos(t)ide therapy. Cavrotolimod +Nivolumab+ BJT-778 is being developed to address the high unmet medical need with possible benefits for participants with Chronic Hepatis B virus infection (CHB). This study will enroll non-cirrhotic, chronic hepatitis B (CHB) infected adults aged 18-65 years of age, inclusive, on nucleos(t)ide therapy. The study consists of four parts (Part A, Part B, Part C and Part D). Part D will enroll up to 90 participants. 15 to 30 participants per cohort across 3 possible cohorts.

The aim of this project is to demonstrate that for patients with a UTI in whom intravenous antibiotic therapy is clinically indicated, there is a subset of these patients who can be safely managed at home by Hospital in the Home (HITH). The hypothesis is that HITH treatment for appropriately chosen patients with UTI has comparable (or even better) clinical outcomes when compared to available data on UTI treatment in a hospital ward setting in terms of length of stay, morbidity and mortality. It also aims to determine what patient factors may be associated with prolonged length of stay and poorer clinical outcomes. How well antibiotic prescription concurs with recommended antibiotic prescribing practices will also be assessed

Study Title: The NIKI-PT Study - A study of plasma pharmacokinetics of nebulized ketamine in post-operative and trauma patients in intensive care unit: A phase 2, single site, prospective, interventional, open-label pharmacokinetic study. A minimum of 20 patients will be consented and enrolled to receive a single dose of nebulized ketamine 0.75mg/kg (ideal body weight). Over a 2 hour sampling period 8 blood and 2 urine samples will be collected. Assessments will be conducted to report on feasibility, pain, tolerance, concomitant sedatives and analgesia as well as monitoring for study specific adverse events. The hypothesis of the study are that 1. Plasma blood levels of nebulized ketamine in ICU post-operative or trauma patients is adequate to provide analgesia 2. Nebulized ketamine is not associated with any serious adverse events in ICU post-operative or trauma patients

Temporal lobe epilepsy is the most common form of focal epilepsy, and is commonly resistant to treatment with anti-seizure medications (ASMs). Successful epilepsy surgery is dependent on accurate delineation (and resection) of the epileptogenic zone (EZ). Astrocytes are a type of immune cell within the brain which are activated in response to acute injury or insult. Studies have demonstrated that activated astrocytes are present in surgically resected tissue of people with epilepsy, with other studies suggesting dysfunctional astrocytes contribute to seizure generation and propagation in drug resistant epilepsy. 18F-FDED, binds to the mono-amine oxidase B enzyme which is expressed on the surface of activated astrocytes, thus the present study will evaluate 18F-FDED PET as a technique for localising the EZ in patients with focal epilepsy.

The Eating Well with MS study aims to evaluate the effectiveness of an online nutrition education program designed to improve diet quality and food literacy in people living with multiple sclerosis (MS). We hypothesize that participants who complete the program will demonstrate significant improvements in their diet quality, food literacy, and overall quality of life, symptoms, and disease progression, compared to those receiving standard care. The study seeks to provide accessible and practical tools to support healthier eating habits in individuals with MS.

This study aims to assess whether it is safe and possible to insert a hyaluronic acid gel spacer within the area between the vagina and rectum for patients who are undergoing brachytherapy for gynaecological cancers. Who is it for? You may be eligible for this study if you are female, aged 18 years or older, you have been diagnosed with cervical, uterine, and/or vaginal cancer and you will be undergoing MRI-guided high dose rate brachytherapy to treat your cancer. Study details Participants who choose to enrol in this study will undergo insertion of a gel spacer (Barrigel). Participants will have the spacer inserted under anaesthetic by the radiation oncologist prior to their second brachytherapy session. It is anticipated that the spacer will break down and be excreted by the body over 3-6 months. The researchers will also take additional MRI scans to determine the location and size of the spacer over a period of 12 months after insertion. It is hoped this research will determine that use of a gel spacer is safe and does not cause any unacceptable side effects for cancer patients who are undergoing MRI-guided brachytherapy. If this study finds that the spacer is safe and able to protect other organs that are not receiving therapy, a larger study enrolling a greater number of cancer patients may be undertaken.