ANZCTR search results

The aim of the proposed study is to test the efficacy of a herbal and nutritional supplement (BioCeuticals Pty Ltd Cognition Support Formula) in a sample of older adults who report Subjective Cognitive Impairment (SCI). The proposed study is a 6 month randomised double blind placebo controlled trial which will test the effects of cognition support formula on cognition (CogState), mood, fatigue, electrophysiology and autonomic function in older adults with SCI. Participants will undergo telephone and face to face screening in order to determine if they meet the criteria for participation. During the telephone screening, participants will respond to questions from a cognitive status questionnaire (TICS-M). General health and depression questionnaires will be administered during the face to face screening. At baseline (0 months), midpoint (3 months) and endpoint (6 months) participants will complete a series of mood, fatigue and cognitive tests (both computerised and pen and paper tests).Opportunities will be made available for participants to additionally take part in Electroencephalography (EEG) testing at baseline and endpoint. These measures will enable a greater capacity to determine the efficacy of cognition support formula on cognitive health in older adults with SCI.

Invasive coronary angiography is the benchmark investigation for Coronary Artery Disease (CAD) with approximately 6,000 performed in South Australian public hospitals each year. The ACCESS Program (The Assessment of Coronary artery disease using Computed tomography Effectively for Stable Symptoms) is a large project involving the development and application of a simple clinical tool to identify which patients are likely to have a normal angiogram amongst those scheduled for elective invasive coronary angiography. These patients can then be alternatively referred for coronary computed tomography angiography, a noninvasive technique that is safer and less expensive than invasive angiography yet has shown to be as reliable as the benchmark test in confirming the presence of normal coronary arteries. The ACCESS Tool has been retrospectively developed from a local cardiac procedures registry (CADOSA – Coronary Angiogram Database of South Australia) using statistical modeling techniques to pre-procedurally identify patients with a high probability of normal coronary angiography. To asses the effectiveness of this Tool in clinical practice, it is important to ‘field test’ the ACCESS Tool prospectively as its utility may change when being by applied by hospital staff in a real-world setting. This current protocol refers to the Field Testing of the ACCESS Tool, whereby for a 3-month period, hospital staff will apply the ACCESS Tool to patients booked for elective angiography via a short phonecall. The outcome of the ACCESS Tool will be recorded and compared to the angiography findings. The sensitivity, specificity and receiver operator characteristics of the ACCESS Tool in practice will then be evaluated in preparation for a clinical trial.

This phase 1b study will determine the safety and efficacy of combined treatment of Abraxane and phenelzine sulfate (Nardil) for metastatic or locally advanced breast cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with metastatic breast cancer or inoperable locally advanced breast cancer. Study details All participants will receive a combination of intravenous Abraxane and an oral dose of phenelzine sulfate. Abraxane will be administered weekly for the first 3 weeks of a 4-week cycle for 3 consecutive cycles. Phenelzine sulfate will be taken daily for the duration of the 3 cycles. Five patient cohort groups will receive a progressively increasing dose of phenelzine sulfate. Safety and efficacy will be assessed weekly over the 3 cycles of treatment. Although both drugs have been used in clinical care for more than a decade, they have not been intentionally combined together in a cancer therapy setting. This means that the combined effect of these two drugs has not been documented. This is being addressed in this study.

Carers of young people with first episode psychosis endure high levels of stress and depression, and eroded social networks. Family cognitive behaviour therapy (CBT) leads to significantly improved perceived stress, but there are well-known barriers to dissemination. To address this, we have developed a novel online intervention (‘Altitudes’) that integrates social networking, expert and peer moderation, and evidence-based psychoeducation. The aim of this cluster randomised controlled trial is to evaluate the effectiveness of Altitudes relative to Treatment as Usual (TAU) in real-world clinical services in Perth and Melbourne. We will recruit family members of 12-40 year-olds with first episode psychosis. The primary hypothesis is that carers accessing Altitudes + TAU will report significantly less perceived stress at 6 months compared with those receiving TAU only. We also predict that the Altitudes group will experience reduced objective stress, improved positive coping, self-efficacy, depression and perceived social support at follow-up.

The proposed clinical trial aims to investigate the performance of the SPOT UV Indicating Stickers in pool water and on dry land. SPOT stickers are applied to a user’s skin before they apply their sunscreen, and their intended function is to change colour to warn users when their sunscreen is no longer protecting them. Participants in the study will be randomly assigned to one of the two activity groups (pool or dry) and will be wearing both sunscreen and SPOT stickers. Periodically, participants will have their SPOT stickers and skin swabbed, and the colour of the SPOT stickers measured. The aim of the study is to see that the amount of the sunscreen protecting the skin and the amount of sunscreen on the SPOT stickers are correlated. The study also will note that if a sufficient amount of sunscreen has worn off of a user’s skin that the SPOTs are changing colour to warn the user of overexposure to UV light. The study will be run over 3 weekend days, for 5 hours per participant session. The intended outcome is that SPOT stickers are seen to change colour should the amount of sunscreen protecting the users skin goes below a concentration of 0.5mg/cm3.

Transcutaneous electrical nerve stimulation (TENS) is an effective treatment method for overactive bladder and urge incontinence in children (de Gennaro et al., 2011; Barroso et al., 2011). The aim of the study is to analyse the effects of TENS on psychosocial outcomes,quality of life and lower urinary tract symptoms (LUTS) for treating overactive bladder in children by comparing changes in the strengths and difficulties questionnaire (SDQ) scores, the PinQ (paediatric incontinence quality of life) scores and lower urinary tract symptom scores (ICIQ-CLUTS – International Consultation on Incontinence Questionnaire – Pediatric Lower Urinary Tract Symptoms) before and after treatment with TENS for 3 months. The following hypotheses shall be examined: 1. Is there an improvement in psychological symptoms after three months of treatment with TENS? 2. Is there an improvement in quality of life scores after three months of treatment with TENS? 3. Is there a reduction in lower urinary tract symptoms after three months of treatment with TENS?

Charcot foot affects patients with decreased nerve function in their feet, most often due to diabetes, and leads to significant bone deformity. The resulting deformity increases the risk of ulcers, infection and amputation. However, if detected early, this process may be prevented. Standard treatment currently involves using a cast or boot to minimise movement in the foot until inflammation resolves. We will investigate whether the addition of denosumab, a medication currently used for treating osteoporosis, reduces inflammation and bone loss in the foot. Bone loss will be monitored during treatment using a heel ultrasound machine. The potential clinical benefits may include a reduction in the length of time that a cast or boot is required, and reduction in the severity of bone deformity.

Research Question Can measurements of lactate clearance with a point of care lactate measuring device (StatStripAccutrend) assist in the management and early identification of patients at higher risk of deterioration in the emergency department? Rationale for Current Study In the emergency department, the undifferentiated patient presents a diagnostic and time management challenge. Lactate is used as a surrogate marker for global hypoperfusion in sepsis, trauma and patients with surgical abdomens, but there are also other areas of developing interest where lactate measurements could be used to assist in fast tracking decisions and risk stratifying patients to decide their disposition. Primary Objective 1. To measure serial lactate measurements in the ED within the first hour of presentation and at 3 hours of stay to monitor and predict deterioration in the department or the hospital in the first 72 hours? STUDY DESIGN This study is a prospective longitudinal study where data will be collected over a year. The data will be collected with written or and verbal consent, and fact sheet given to the participant about the study. Verbal and written consent will be obtained at the first reading and second readings taken to make sure that participants are happy to continue with the study. Patients can withdraw at any time in the study. Exclusion criteria of patients will include those that are <18 years old, severe hepatic failure, presentation of known seizure disorders and those triaged to other areas apart from the adult acute area or self discharged from the department before completion of treatment, if they don’t have a serial measurement of their lactate at 3 hours. The lactate measurements will be recorded at a time within one hour of presentation and the second reading at 3 hours of presentation electronically on their medical records. The data will then be extracted and de-identified for this research project and determined if the participant is to be excluded or included in the study. . This study to reach the sample size of 1000 participants would approximately go over the course of 6 months to a year.

In March 2016, several new, all oral treatments became available in Australia for chronic hepatitis C virus (HCV) infection, bringing the “interferon era” to a close. These new treatments are much easier to take and more effective than the previous standard treatment, which was based on an injected medicine called interferon. Although we know these new treatments are very safe with side effect rates in clinical trials similar to placebo (sugar pills), we don’t know exactly how much monitoring is needed during a course of treatment. A “standard” monitoring plan has recently been developed by Australian experts, but this is based on what we know of the new treatments, and it has never been directly compared with less intensive monitoring. For the old interferon-based treatments, patients had some blood tests and a clinic appointment every 2 to 4 weeks for at least 24 weeks. For the new all-oral treatments, we know that much less intense monitoring is needed, but different monitoring strategies have not been tested in clinical trials. The purpose of SIMPLICITY is to compare “standard monitoring” with “minimal monitoring”, to determine if minimal monitoring results in similar cure rates but with lower cost and better patient satisfaction. The SIMPLICITY trial is being co-ordinated by Associate Professor Joshua Davis, who is based at John Hunter Hospital in Newcastle, and at the Menzies School of Health Research in Darwin. It aims to enrol a total of 100 participants at two sites in Australia (Darwin and Newcastle). There are no medications being given specifically as part of this study. You will receive the same medications whether or not you choose to take part in this study. The only difference between the two study arms is the number of blood tests and clinic visits during your course of treatment.

Transcranial Magnetic Stimulation is capable of inducing action potentials in cortical neurones, and provides the capacity to measure cortical neuronal excitability and interneuronal function. Preliminary data in previous studies shows this may be a method for measuring neuronal function in Progressive Supranuclear Palsy, which may enable its use as a biomarker. The intention of this study is to determine if these measurements are able to distinguish PSP from other parkinsonian syndromes with similar clinical features, ie. Multiple System Atrophy and Parkinson's Disease, and if these measurements correlate with markers of disease activity including cognitive changes. Results will also be compared with a group of healthy control participants to determine the reliability of these measurements.