ANZCTR search results

The purpose of this study is to investigate the safety, tolerability and efficacy of pharmaceutical grade cannabis-based medicines (MC-1019 and/or MC-1022), prescribed by eligible doctors to patients who meet the clinical criteria for the administration of MC- 1019 and/or MC-1022 for chronic conditions with a focus on chronic pain in clinical practice (i.e. general practices and/or specialty medical practices). Who is it for? You may be eligible for this study if you are an adult who has been prescribed MC-1019 and/or MC-1022™ for chronic conditions with a focus on chronic pain in clinical practice (ie. general practices and/or specialty medical practices). Study details All participants will be followed up on a monthly basis for up to 24 months. These follow ups will involve completion of surveys and provision of information regarding the administration of MC-1019 and/or MC-1022. Participants will not be asked to undergo any procedures or tests as part of this study. It is hoped that this study will help determine whether pharmaceutical grade cannabis is an options for pain management.

The aim of this study is to determine if Mediterranean diet can be followed by diagnosed cancer patients about to commence immunotherapy. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are about to commence immunotherapy (with or without chemotherapy). Study details All participants will attend a 1-2 hour session with a dietitian to develop a diet plan, where the participant’s existing diet will be modified to meet the requirements of a Mediterranean diet through addition of extra virgin olive oil and nuts to the diet as well as setting goals to meet vegetables, fruits, fish, legumes, meat and dairy requirements. This diet plan will be followed from the time of commencement of immunotherapy treatment until 12 weeks from commencement. Throughout the 12-week study period, participants will be monitored for immune related adverse events through through data collection from medical records. Before and after commencing the dietary intervention, participants will also complete questionnaires regarding their dietary intake, and will have blood samples taken for the assessment of inflammatory markers. These outcomes will be compared to a cohort of 53 cancer patients from a similar setting who received no dietary intervention in the past. It is hoped that this study may show that a Mediterranean diet can be successfully followed by the participants and reduces the degree of immune related adverse events and markers of inflammation in patients undergoing immunotherapy for cancer.

The purpose of this study is to determine how well the Cxbladder urine test detects bladder cancer in patients who have blood in their urine. Who is it for? You may be eligible to join this study if you are aged 18 years or older, and have recently been confirmed to have blood in your urine. Study details All participants will be asked to provide a urine sample, to be used for standard urine testing and the Cxbladder test. Cxbladder results will not be shared, and will not affect the treatment or further diagnostic procedures provided to participants. Instead, participants will be diagnosed and treated as per current standard of care. Medical records will be reviewed for up to 24 month in order to compare the standard-of-care diagnosis with the Cxbladder diagnosis. It is hoped that this study will show how well the Cxbladder test is able to diagnose bladder cancer compared to current standard practices, and lead to improved bladder cancer testing services available for people who have blood in their urine.

A mixed method, waitlist-randomised controlled trial with 200 older adults in rural and remote areas in Australia will be conducted. The aim of the program is to implement an intervention to improve dementia risk, dementia awareness and cognition. Participants will be assigned to either the multidomain behaviour change group or a waiting-list control group and assessed when they initially register for the program, 3 and 9 months after the intervention. The waiting-list control group will receive the intervention after 12 weeks. The primary outcome is dementia risk score, measured by the LIBRA index. Secondary outcomes include dementia awareness and cognitive performance. An impact/outcome evaluation, which will involve semi-structured interviews, will be conducted at the end of the trial including participants from both multidomain behaviour change group and control groups to examine the feasibility and acceptability of the intervention. The aim of this intervention is to increase awareness of dementia, decrease risk of dementia through reducing lifestyle factors and improve brain health in the long-term.

Vocal cord dysfunction/inducible laryngeal obstruction (VCD/ILO) is common but seldom recognised at first since patients experience intermittent breathlessness leading in most cases to a diagnosis of asthma and treatment with inhaled corticosteroids (CS). Diagnosis of VCD/ILO is further complicated by coexistence of asthma and VCD/ILO in 20-40% of asthmatics and VCD/ILO can make asthma seem more severe leading to over-treatment with high-dose inhaled or oral CS. To date a swift diagnosis is seldom achieved. The current gold-standard for diagnosis of VCD/ILO is laryngoscopy and the quintessential abnormality is inspiratory closure of the vocal cords and formation of a diamond-shaped small opening or ‘chink’ posteriorly. Laryngoscopy requires expertise that may not be available within a reasonable time-frame and the procedure can be technically challenging or fail if a patient is breathless and distressed. Consequently, laryngoscopy may be delayed or not performed. Laryngoscopy in expert hands remains the definitive diagnostic modality but innovations in diagnostic imaging have created alternative options. Present-day imaging technologies with superior spatial and temporal resolution have made it possible to visualise not only anatomical features, but also movement and function of a particular organ. We have developed dynamic CT larynx to detect and quantify laryngeal movement, a technology that can be applied wherever cardiac CT is performed. We hypothesised that dynamic CT larynx would have comparable diagnostic accuracy to laryngoscopy in VCD/ILO, when performed contemporaneously and when utilised in a real-world clinical context.

This project is testing the safety, tolerability and brain delivery of INB-01, an intranasal formulation of a currently marketed MRI contrast agent. You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old. Participants will be randomised (assigned randomly, like flipping a coin) to one of two stages. In Stage 1 you will receive a single intranasal dose of placebo. In Stage 2 you will receive a single intranasal dose of INB-01, the active experimental contrast agent. It is hoped that this research will help determine the safety of INB-01 when given to healthy men or women and to see if it gets to the brain tissues

The objective of this Phase 1B, multicentre, longitudinal, prospective, PK, open label study is to assess any changes in LCM plasma concentrations that may result from physiological changes that occur during pregnancy in women with epilepsy. A change of PK during pregnancy will be assessed relative to postpartum LCM concentrations. In addition, if subjects give additional consent, this study will also measure LCM concentrations in mature breast-milk to estimate newborn LCM exposure. This collaborative study will be conducted as a sub-study of The Raoul Wallenberg Australian Pregnancy Register (RWAPR), which is an observational, prospective, longitudinal study of pregnancies in women taking ASMs, and also women with epilepsy not taking ASMs. The study is interventional due to the additional collection of blood samples and breast milk from women which are exceeding medical practice. However, all other study assessments are part of routine clinical practice, and any decision to continue/discontinue or change LCM therapy during pregnancy and breastfeeding will be made between the participant and her treating physician, taking into account potential risks and benefits, and according to the local label.

This study aims to assess whether the technique of snare tip soft coagulation (STSC) during polypectomy (removal of colon polyps) improves safety and reduces polyp recurrence. Who is it for? You may be eligible for this study if you are aged 18 years or above, and will undergo elective colonoscopy. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. One group will be treated with STSC therapy following removal of their colonic polyp. The other group will be treated with standard of care during their removal of colonic polyps removed, without any additional procedures. After treatment, there will be 30-day monitoring of adverse events via a questionnaire. Polyp recurrence will be assessed at 6 months with a follow up colonoscopy. It is hoped that this research will reveal if the STSC technique is safe and effective in reducing polyp rates, thus improving patient outcomes and reducing risk of colon cancer.

There is an acknowledged lack of available specialist vocational rehabilitation services for adults with stroke. This trial-within-a-cohort will investigate the effectiveness of two models shown to be effective outside of Australia: (1) a resource facilitation approach which will support existing clinical rehabilitation teams to address return-to-work goals, and (2) a more intensive specialist rehabilitation model where a central team of expert clinicians will provide the rehabilitation. The aim is to determine whether a model of vocational rehabilitation will support returning to work after stroke more than clinical rehabilitation.

Rates of cross-reactivity to rocuronium and vecuronium can be used to estimate population exposure and therefore correct individual rates to exposure to give a risk per dose.