ANZCTR search results

This trial aims to determine the safety, feasibility, and efficacy of a combination of chemotherapy, immunotherapy, and chest radiation therapy in extensive stage small cell lung cancer. Who is it for? You may be eligible for this study if you are 18 or above and have untreated extensive stage small cell lung cancer. Study details Participants will be given durvalumab (an immunotherapy drug) concurrently with 4 cycles of cisplatin/carboplatin and etoposide chemotherapy, which is given as in injection every three weeks over approx. 12 weeks. Maintenance treatment with durvalumab alone will continue every 4 weeks after the completion of the chemotherapy cycles until there is evidence of disease progression. Participants will also receive 10 chest radiotherapy sessions, which will take approx. 2 weeks to complete (given either concurrently with cycle 3 or 4 of chemotherapy (called concurrent radiotherapy) or within 6 weeks of finishing chemotherapy (called consolidation radiotherapy). Fractions are expected to be delivered daily. When RT is to start depends on the location and size of the area to be treated). Throughout the study, participants will be monitored regularly for any adverse effects, and for progression of disease using a number of imaging techniques. It is hoped that this study may demonstrate that chest radiation is safe and beneficial when given in combination with chemotherapy and immunotherapy for the treatment of extensive stage small cell lung cancer.

This study aims to assess the efficacy of Restorabite, a trismus treatment device, as an early intervention for trismus and its impact on quality of life for patients with head and neck cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have a diagnosis of head and neck cancer, and you are experiencing trouble opening your jaw wider than 35mm. Study details Participants will attend 10 x 1 hour weekly sessions with a speech pathologist, where they will be taken through passive and active jaw range of motion exercises. They will also be instructed to complete 20 minutes of home practice daily over the 10 week study period. Data on changes in jaw opening distance and quality of life will be collected over a 12 month period. It is hoped that this study will demonstrate that the Restorabite device is effective in treating trismus in patients with head and neck cancer, which could lead to an improvement in quality of life for these patients.

Our study hypothesis is that 20mL of bupivacaine 0.5% infiltrated via paracervical block after induction of general anaesthesia and prior to the initial surgical incision will improve patients’ quality of recovery at 24-36 hours following total laparoscopic hysterectomy.

This project aims to improve GP use of CVD prevention guidelines. This will involve implementing and evaluating a new online format for the guidelines (www.auscvdrisk.com.au), using a national stepped wedge cluster randomised trial. The intervention comprises three evidence-based behaviour change strategies that improve guidelines use and doctor-patient communication: 1) an interactive CVD risk calculator that automatically applies assessment and management algorithms to the patient; 2) self-directed audit and feedback exercise with example cases for GPs; and 3) personalised decision aid for patients. We hypothesise this will increase: 1) complete absolute CVD risk assessment data for patients in the target age range; 2) lifestyle referral for high risk patients; and 3) risk-appropriate prescribing of blood pressure and cholesterol-lowering medication to high risk and not low risk patients.

Although verbal education has been found to be ineffective in preventing inpatient falls for patients with cognitive impairment, educational videos seem promising. Literature suggests that visual stimuli is better retained than words in patients with cognitive impairment. Quasi-experimental (pre- and post-intervention) studies inclusive of patients with cognitive impairment have shown reductions in falls rate following the addition of an educational video to existing falls prevention programmes. However, randomized controlled trials evaluating educational videos have excluded cognitively impaired individuals. We conducted a randomized trial to test if our falls prevention educational video is better retained by individuals with cognitive impairment when compared with the standard practice of verbal falls education. We hypothesize that the educational video will be better remembered.

Depression is a mental illness which is the leading cause of disease burden in middle-income and high-income countries. It is characterised by low mood (i.e., feeling sad or down), loss of interest in or pleasure from things that were previously enjoyable, changes in appetite or weight, fatigue and sleep disturbance, difficulties with different thinking skills, and suicidal thoughts or behaviours. Most people with depression (up to 90%) experience sleep problems, which often precede the onset of mood symptoms. Problems with the circadian system, or ‘body clock,’ can contribute to sleep problems, and may play a role in the development of depression. We have previously found that a single dose of citalopram (an antidepressant) increases the effect of light on the body clock in health persons. This may contribute to variability in treatment outcomes in patient with depression. For example, increased light sensitivity may be beneficial for patients who were previously insensitive to light, or for those who exhibit healthy light exposure patterns (as the positive effects would be enhanced). However, for patients with unhealthy light patterns, or who are already hypersensitive, increased sensitivity due to antidepressant treatment may lead to the exacerbation of symptoms. Here, we aim to investigate the effect of chronic citalopram use on the response of the circadian system to light. Our main outcomes are the suppression of melatonin (a sleep-related hormone) and pupillary markers of light responses.

This is a multi-center, prospective, open-label, post-market registry of the safety and efficacy following implantation of iStent inject W stents (G2W), with or without phacoemulsification, in eyes with OAG in a real-world clinical setting. All patients will be evaluated at a preoperative visit the post-operative visita on Day 1, Week 1, and Month 1, 3, 6, 12, 18 and 24 after treatment. Slit lamp and fundus/optic nerve assessments, Gonioscopy, Pachymetry, Visual Field (VF) and Optical Coherence Tomography (OCT) assessment f Retinal nerve fiber layer (RNFL) will be performed at pretreatment baseline and at appropriate times after treatment. it is expected the intervention will demonstrate clinically significant IOP-lowering with a good safety profile.

Functional Neurological Disorder is a common neuropsychiatric condition which is often chronic and results in debilitating symptoms such as weakness or sensory impairment. The symptoms of Functional Neurological Disorder are not caused by structural abnormalities within the brain or nervous system, and unfortunately no effective therapy currently exists. It is thought that drugs belonging to a class known as psychedelics, when administered in conjunction with a physiotherapy regime, may be particularly effective in the treatment of Functional Neurological Disorder but this therapeutic intervention has not previously been investigated in a clinical trial. Therefore, this study will assess the safety and obtain preliminary evidence for efficacy of psilocybin-assisted physiotherapy for patients with refractory motor Functional Neurological Disorder.

The focus of this study is on translating a guideline (to prescribe oxygen therapy for all patients who require oxygen therapy) into clinical practice based on best evidence for acute oxygen use in adults. Our objective is to improve the accurate and appropriate prescription and administration of oxygen therapy to all patients, particularly those with Chronic Obstructive Pulmonary Disease and those at risk of hypercapnoea (obese, neuromuscular disease). We hypothesise that Implementation of a multi-component intervention will be associated with improved rates of accurate prescription and administration of oxygen therapy when compared to a single component intervention.

This study is a prospective, randomized, double-blind, placebo controlled, two-part, Phase 1 clinical study to evaluate the safety, tolerability, PK and PD of oral single-ascending doses (SAD) and oral multiple-ascending doses (MAD) of AZ-3102 in healthy female and male subjects (between 18 and 55 years of age, inclusive), with body mass index between 18 and 30 kg/m^2. The study consists of 2 parts: SAD and MAD. A total of 88 healthy subjects are planned for the study: Part 1 (SAD): 52 subjects (6 cohorts); Part 2 (MAD): 36 subjects (3 cohorts). In the MAD part all subjects will receive once daily dosing of AZ-3102 over 14 days.