ANZCTR search results

This study is looking to assess whether alternative treatment to prevent variceal bleeding (variceal banding involving multiple endoscopic procedures) is required if you are on a suboptimal dose of a beta-blocker (Propranolol or Carvedilol); a medication that reduces your heart rate and blood pressure, with the aim of reducing the pressure gradient in the liver. Suboptimal dose suggests this is not the highest dose possible reaching the target of a heart rate less than 60. Reasons for being unable to increase the dose may include side effects such as low blood pressure. The aim of the medication is to reduce portal hypertension (portal vein pressure gradient in the liver, causing higher risk of varices and bleeding). If your portal pressure gradient measurement is adequate (<12mmHg) then you would not require alternative prophylaxis with variceal banding. The aim of this study is to assess the effectiveness of suboptimal doses of beta-blockers in patients unable to tolerate higher doses. Liver inflammation and pressure can be assessed through blood tests, ultrasound and liver elastography (fibroscan) as well as splenic elastography, all of which are non-invasive however these investigations do not measure portal pressure gradient. We are doing this study in the hope that we can optimise treatment management of patients with cirrhosis. Our overall hypothesis is that directly measuring portal pressure gradient via endoscopic ultrasound (EUS-PPG) can identify patients on suboptimal doses of beta-blockers who do or do not require variceal band ligation for primary prophylaxis.

1 in 5 patients after total knee arthroplasty (TKA) are left feeling unsatisfied. Therefore, patient selection prior to TKA is critical. We have developed a prognostic tool that can predict outcomes after TKA before the patient undergoes surgery. Our tool (PROTO-KNEE) uses machine learning algorithms to predict TKA outcome before patients undergo surgery. Patients can use the tool by inputting their age, gender, and pre-operative quality of life (using a validated questionnaire) and the tool will predict their likelihood for improvement or no improvement after TKA. The study will evaluate this tool on patients decision making. In particular, we are interested to understand how this predictive tool influences a patient's willingness for surgery. Our hypothesis is that use of this tool will better inform patient decision making through individualised outcome prediction early in the TKA journey.

This study aims to conduct a first in human, single arm, multicenter trial of the BD(TM) Sirolimus Drug Coated Balloon Catheter for the treatment of femoropopliteal arterial disease to assess the need for future clinical research to evaluate performance and safety.

This pilot trial seeks to evaluate the outcomes of CBT-I delivered via videoconferencing with young adult university students. Self reported sleep quality is the primary outcome in this study. Outcomes will be compared pre to post treatment. This pilot will identify any aspects of the program that need to be adjusted before a larger scale RCT is conducted.

Currently, there are no published trials examining the effect of non-surgical weight loss interventions on CKD progression in those with obesity and CKD. Clinical trials, utilising an effective non-surgical method of low energy meal replacements or prep-prepared meals plus specialised support over the longer term, are needed to determine whether weight loss can reduce cardiovascular risk factors, improve quality of life and delay progression of kidney disease. Before undertaking a definitive trial, the safety, feasibility and acceptability of low energy diets should be tested in patients with kidney disease. Our study has the potential to benefit patients if we can offer an acceptable and effective non-surgical weight loss intervention to potentially modify the course of CKD associated with obesity.

This RCT seeks to evaluate the outcomes of CBT-I delivered via videoconferencing with young adult university students. Self reported sleep quality is the primary outcome in this study.. Outcomes will be compared pre to post treatment with a one month follow up.

This is a pivotal Phase 3, multicenter, randomized, double-blind, placebo controlled study to investigate the efficacy and safety of DMX-200 120 mg twice daily (BID) compared with placebo over a treatment period of 104 weeks in adult patients with FSGS who are being treated with an ARB. With a potential 2-year extension study, after completion of double-blind period.

We propose a world-first dietary intervention clinical trial to investigate whether anthocyanins can sustainably delay or prevent memory loss progression in people at high risk for dementia. Anthocyanins (which provide deep-red and purple-blue pigmentation in plants and fruits) show promise for their pro-cognitive effects and therapeutic potential for diseases that manifest cognitive impairment. Our clinical trials have already demonstrated that consumption of anthocyanin-rich fruit significantly improves both short- and long-term memory, and verbal fluency in older adults with mild to moderate Alzheimer’s dementia (AD) and mixed dementia. However, it is unknown whether anthocyanins can prevent the progression of cognitive decline in persons with mild cognitive impairment. The findings of this study will be critical to underpin dietary advice that better informs prevention of dementia in Australia and allow translation to dietary advice on plant-based foods for better brain health

We are looking for 108 people with multiple sclerosis (MS) in Australia to measure the effects of transcranial magnetic stimulation (TMS for short) on MS. TMS can non-invasively and painlessly activate nerve cells in the human brain and can be used to change nerve cell activity. MBS is currently used to treat depression but has only been used for MS in the research setting. What’s involved: A total of 23 visits over the study duration of 4 to 5 months. 1. A full medical history, physical examination, and extended disability status score (EDSS). This will take about 30 minutes. 2. You will be randomly assigned to a treatment group, and will have a 67% chance of being in the MBS group and 33% chance of being in the placebo group. The placebo is a fake MBS, it looks and feels like the real thing, with no brain stimulation. You will not know which group you are in until the study is completed. 3. Daily MBS or placebo sessions (Mon-Fri) for 4 to 5 weeks, at a time convenient to you. A total of 20 sessions, each one takes about 15 minutes. We will monitor side effects, new symptoms and changes in your medications. You can continue taking your current medications whilst in this study but must tell us about any changes, any GP, hospital or emergency visits, any COVID-19 symptoms or tests. 4. Magnetic Resonance Imaging (MRI) before and after your 20 MBS or placebo sessions. Each MRI takes about an hour. 5. A series of questionnaires before and after your 20 MBS or placebo sessions. You will repeat these again online after 3 months. Questionnaires take about 30 minutes to complete and include. a. hospital anxiety and depression score (HADS), 14 questions b. quality of life assessment (AQoL-8D), 35 questions c. fatigue severity scale (FSS), 9 questions d. sleep quality assessment (PQSI & NRS), 7 questions 6. MS Functional tests: Timed 25-foot walking test (T25-FW), Symbol Digit Modality Test (SDMT) and 9 Hole Peg Test (9HPT) before, during and after your MBS or placebo sessions. You will complete 3 practice sessions before starting the trial. These tests will assess arm and leg mobility as well as brain function and processing speed. The three tests take about 30 minutes to complete. You can use a walking stick or aid during the walking test. The aims of the study are; 1. To determine whether magnetic brain stimulation improves the MS functional composite score for people living with MS. 2. To determine if magnetic brain stimulation; - is safe & tolerable in people with MS. - improves quality of life in people with MS. - reduces anxiety and depression in people with MS. - reduces fatigue in people with MS. - improves sleep quality in people with MS 3. To determine if magnetic brain stimulation can effectively promote remyelination in people with MS, and if remyelination correlates with improvements in functional or patient reported outcomes.

This study is a single-group pilot intervention that aims to evaluates the feasibility, satisfaction, and effectiveness of an 8-week, one-on-one telehealth-supervised exercise program for people with Systemic Lupus Erythematosus (SLE). It is hypothesised that fatigue, quality of life, and muscular strength will improve following the program, however, it is unknown whether participants will be satisfied with the telehealth-supervised exercise program and willing to continue with this type of program.