ANZCTR search results

This study is testing whether cannabidiol (CBD), a non-psychoactive compound from the cannabis plant, can reduce irritability and aggressive behaviour in children, adolescents, and young adults with autism spectrum disorder (ASD). Over the first 12 weeks, participants will be randomly assigned to receive CBD at one of three doses or a placebo (inactive treatment) to compare differences in behaviour, sleep, and anxiety. After this, everyone will receive CBD for another 12 weeks, with some participants also receiving melatonin (to improve sleep) and/or N-acetylcysteine (to support emotional regulation). We believe CBD, alone or in combination with melatonin and N-acetylcysteine, will improve irritability, aggression, sleep, and overall quality of life for people with ASD.

The proposed intervention involves a single subcutaneous injection of ketamine (0.75 mg/kg) or a matched placebo (0.9% saline) administered to participants with difficult-to-treat depression (DTD). The intervention is delivered under double-blind conditions at the Royal Melbourne Hospital Clinical Trials Centre. The ketamine dose is administered once only and is not part of any ongoing therapeutic protocol. The intervention is designed to investigate neural and clinical changes following ketamine administration, with a particular focus on the habenula (Hb) - a subcortical region implicated in reward processing and mood regulation. The intervention is embedded within a case-control, pre-post imaging study framework. Participants undergo ultra-high field 7-Tesla MRI scans before and 24-48 hours after the injection to assess changes in Hb activity and connectivity. Secondary behavioural and clinical assessments (e.g., MADRS, QIDS-C, SHAPS, GAD-7, actigraphy, and mobile sensing) will evaluate treatment response, mood, circadian regulation, and anhedonia. This intervention is not intended as a clinical treatment but rather as a mechanism-focused investigation. Participants are fully informed that the intervention is experimental and not part of routine care. Safety monitoring includes cardiorespiratory assessment, adverse event screening, and psychiatric review before and after the injection, following established ketamine research protocol.

This study will test how accurately a new rapid test, StrepSure™, detects group B streptococcus (GBS) in pregnant women. GBS is a common bacteria that can be passed to babies during birth and sometimes cause serious illness. The current test takes up to two days, while StrepSure™ may give faster results at the point of care. Researchers will compare StrepSure™ to the standard test to see how reliable it is. The study will take place at Northern Hospital in Epping and involve women already receiving care there. The results of the StrepSure™ test will not be revealed to the participant or the clinical team. There will be no allocation to an intervention; therefore, this is not a clinical trial.

This pilot, crossover trial will recruit 12 participants aged 10-25 years with dysarthria. Participants will compete 4 weeks of speech therapy using a voice-assistant device, according to a therapy plan provided by the research team. The aim of this study is to describe the parent/caregiver and patient experience of the tolerability, safety and utility of a four-week period of voice assistant-based speech therapy, using the 'Alexa' system. Pre/post changes in speech intelligibility, and perceptual and acoustic speech quality will also be explored.

Participants will be randomly allocated in a 1:1 ratio to receive the same home strength program prescribed either i) once a week or ii) three times a week. Participants in both exercise groups will receive one videoconferencing consultation with a physiotherapist (within one week post-randomisation, 30 minutes). The physiotherapist will prescribe the same 5 standardised exercises to all participants at a standardised dosage of 3 sets of 12 repetitions per exercise. The physiotherapist will instruct the participants to perform their exercise program unsupervised at home, at their allocated weekly frequency, until the 3-month reassessment. The time point for re-assessment will be 3 months post-randomisation. The primary outcome measure will be the change in average walking pain over the past week on an NRS. Secondary outcome measures will include WOMAC pain and function; quality-of-life; arthritis and exercise self-efficacy; global rating of change; patient specific functional scale; patient acceptance of symptoms; sit to stand test; calf raise test; and willingness for joint replacement. We hypothesise that a strengthening exercise program prescribed once a week is non-inferior to the same home program prescribed three times a week in people with knee OA.

This study aims to find the safest and most effective dose of a new investigational drug called Sapu003 (Everolimus) when given together with exemestane in women with advanced or metastatic breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2–). Who is it for? You may be eligible for this study if you are an adult woman aged 18 years or older, you are post-menopausal (no periods for more than 12 months), and you have been diagnosed with Stage 4/metastatic or locally advanced breast cancer that is HR+ and HER2-. You may also be asked to complete additional health checks with a study doctor to determine if you are able to enrol in this study. Study details All participants who choose to enrol in this study will be allocated to a treatment group to receive a dose of Sapu003 (Everolimus) that will be given intravenously (via a vein) once a week for a 4-week cycle. Participants who don't experience any dangerous side effects will be asked to continue receiving Sapu003 each month for up to 6 months. All participants will be asked to take a single oral dose of exemestane daily throughout their time in the study so that any drug interactions between exemestane and Sapu003 can be studied. Higher doses of Sapu003 may be studied if the initial participant group reports no dangerous side effects. Participants will also be asked to provide additional blood samples throughout the study and to report any side effects they experience while taking the study drugs. It is hoped this research will determine a safe dose of Sapu003 for future trials and to see whether the combination of Sapu003 and exemestane shows promise in controlling cancer spread in patients with HR+/HER- breast cancer who are also post-menopausal.

The HI-TIDE Research Project involves the evaluation of the implementation of an advanced videoconferencing and emergency telehealth service at selected remote Western Australian health services. The project will consist of two phases - an initial community consultancy phase to co-design and finalise the evaluation process, followed by implementation of evaluation tools and framework. The evaluation will evaluate the experiences of patients, carers and staff in healthcare, and changes in health system outcomes resulting from the implementation of the technology. The results will inform how best any further implementation should proceed.

The aim of this study is to compare the positioning of the Hydrus Microstent and iStent Infinite devices after insertion into the eye for patients undergoing routine glaucoma surgery. It is predicted that by using a specialized camera to take high resolution images of the eye, the positioning of the devices will be able to be more precisely compared. The positioning of the devices will be examined at 3 months post insertion using a specialized camera which takes high resolution pictures of the eye.

This study is testing whether an advanced type of MRI scan (called diffusion weighted MRI) can be used to guide and safely increase radiation doses to “high-risk” areas of head and neck cancers, with the aim of improving tumour control while still protecting surrounding healthy tissue. Who is it for? Adults aged 18 years and older with squamous cell carcinoma of the head and neck, or with large nodal metastases suspected to be from the head and neck region, who are not eligible for curative treatment. Participants must be able to give informed consent. Study details Before radiotherapy planning, participants will attend an MRI scan at Sunshine Coast University Hospital, lying in the treatment position with a fitted mask. This scan takes up to one hour. Radiation therapy will then be delivered using the palliative schedule (four treatments per cycle, 3 cycles in total with 1 month gap in between). An extra “boost” dose of radiation will be targeted at the high-risk tumour area identified on the MRI. Each treatment lasts about 15 minutes. Participants will also complete short quality-of-life questionnaires before, during and after treatment (about 10 minutes each). The study will closely monitor side effects during and after radiation treatment. It is hoped that this approach will improve control of head and neck cancers and patient quality of life without adding significant treatment burden.

Adolescents living with type 1 diabetes (T1D) are 2-3 times more likely to develop disordered eating behaviours (DEB) than their peers without T1D. T1D guidelines recommend routine screening for DEB from 10-12 years, yet an early intervention model for treating DEB in adolescents is lacking. The Diabetes Body Project (DBP) is a virtual care early intervention model for treating DEB. The DBP has been developed and piloted internationally in a cohort of adolescent and young adult females with T1D, showing promising patient experience and clinical outcomes such as reduced DEBs. This project seeks to be the first to adapt the DBP for implementation in an Australian paediatric clinic and evaluate its’ acceptability, feasibility, and preliminary efficacy in an exclusively adolescent population. Additionally in line with model of care we seek to evaluate a parent/carer group to support the adolescent intervention.