ANZCTR search results

The study will investigate the effectiveness of six months of self-paced aquatic exercise for individuals with CFS/ME, compared to usual care (control group). Outcome measures will include physical capacity (resting heart rate, resting blood pressure, oxygen saturation, perceived exertion (RPE), 6 minute walk test, hand grip strength, sit to stand test, sit and reach test, and the Apley's shoulder test); health and symptoms (full blood test with white cell differential, assessment of orthostatic blood pressure, FACIT fatigue and tiredness scale, and a VAS Pain scale); and quality of life (SF-36 Quality of Life; Hospital Anxiety and Depression Scale [HADS], surveys, and open-ended questions in interviews). Participants will be allocated to an exercise or control group, and supervised, self-paced exercise sessions will be held twice a week in a heated pool. The results will be applicable to all age groups who suffer CFS/ME, with or without FM. This is a proof-of-concept study with a view to conducting a larger, longitudinal trial to provide further evidence for clinical practice. It is hypothesized that (1) the aquatic exercise group will improve their exercise tolerance, physiological responses and quality of life, and reduce symptoms of fatigue, pain and anxiety compared to the control group; (2) the number of immune cells (leukocytes) will increase in the exercise group compared to the control group.

The purpose of this research project is to determine the effects and safety of Cera-Q on memory, cognitive function and mood. With Australia's increasingly ageing population, interventions capable of ameliorating age-related neurocognitive change are becoming vital areas of research. In addition to pharmacological interventions, nutritional supplements such as silk fibroin proteins provide an alternative way for maintaining optimal health, including brain health. This study will be the first study in Australia to assess the effectiveness and safety of Cera-Q on cognitive function and mood. Cera-Q is an extract of fibroin protein from silkworm (Bombyx mori) cocoon, and is available commercially in the Republic of Korea and the United States of America. It is a bioactive peptide (protein fragment formed by amino acids) suggested to support brain/cognitive function. Whilst the exact composition of this product may be slightly different to others used in animal and human studies, several studies of the effects of fibroin proteins from silkworm cocoon have shown positive effects on cognitive function. We will be measuring the effects and safety of Cera-Q compared to a placebo using assessments of mental performance and mood, along with the collection of blood samples. Seventy-five participants will be enrolled into this trial, in order to obtain a sample of 60 participants who will complete the trial. Bio and Gene Pty Ltd. are covering all of the costs of this study and providing the products to Swinburne University for the purpose of this research project.

The eustachian tube constitutes a natural conduit between the middle ear (ME) and the nasopharynx and is essential for normal ME function. Eustachian tube dilatory dysfunction (ETDD) causes inadequate ventilation of the ME and is associated with significant morbidity. Several treatments have been proposed to treat ETDD, including breathing manoeuvres, pharmacological agents, mechanical devices and nasal surgery, though these methods have had limited success and can be ineffective at treating the underlying tubal dysfunction. Recently, catheter assisted balloon dilatation of the eustachian tube (BDET) has been undertaken as a means of improving ME ventilation and eustachian tube compliance with safety and success for the treatment of persistent ETDD. The proposed study aims to assess the effectiveness of the Spiggle and Theis Medizentechnik balloon catheter system for the treatment of ETDD in conjunction with medical management (MM) of ETDD compared with MM alone. Participants with a diagnosis of ETTD who consent, will be randomised to BDET + MM or MM alone and followed up at 2,6,12 and 24 weeks. They will undergo repeat examination and tympanometry to examine for resolution of ETDD. The primary outcome measure for the study will be normalisation of tympanometry at 6 weeks post intervention. For patients in the control group that elect to do so, they will be permitted to undergo the intervention intervention. The proposed study is a prospective multicenter, non­-significant risk, randomised control trial that has been designed to demonstrate the superiority of balloon dilatation of the eustachian tube using a eustachian tube balloon catheter plus medical management when compared to medical management alone for the treatment of ETDD.

Cardiovascular disease remains a leading cause of morbidity and mortality in the developed world. Patients who have heart attacks remain the highest risk group, with up to 30% dying or having a further event in 3 years and improved methods of risk stratification are urgently needed. Intra-coronary optical coherence tomography (OCT) is a modality based on near infrared spectrum light with a superior resolution of the high risk components of coronary plaque. We hypothesise that coronary OCT imaging at the time of routine coronary revascularisation when combined with computational methods will be superior to conventional risk scores in predicting future major adverse cardiovascular events. Patients admitted with a Non ST elevation Myocardial Infarction (NSTEMI) and who proceed to inpatient angiography or a ST Elevation Myocardial Infarction (STEMI) and who proceed to non-emergency in-patient angiography or stable/unstable angina may be eligible to participate in the study. The study aims to 1) to determine the predictive value of high risk plaque on OCT for patient oriented clinical events (POCE: recurrent myocardial infarction, coronary revascularisation or death). 2) to determine the predictive value of OCT derived low endothelial shear stress for recurrent POCE. 3) To determine the predictive value of OCT derived high endothelial shear stress for recurrent myocardial infarction and death 4) To develop a multivariate model for predicting residual risk based on multiple imaging parameters and determine its incremental predictive power when added to clinical risk factors and existing risk scores (eg. GRACE-score, Syntax score, Clinical Syntax score).

Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial or ‘TRIDENT’, is investigating the effectiveness of more intensive blood pressure-lowering treatment to prevent recurrent stroke. As part of the TRIDENT study, we are inviting participants to the TRIDENT Cognitive Sub-study to assess the effectiveness of the TRIDENT blood pressure-lowering study treatment on cognition as assessed by neuropsychological tests. ‘Cognition’ is a term referring to memory and other thinking skills. These processes include speed of thinking, finding words, visual skills and problem-solving. Neuropsychological tests, also referred to as ‘cognitive assessments’ assess these mental processes. Cerebral small vessel disease (CSVD) is a disease process in the brain involving small blood vessels. CSVD is common in people who have had a stroke caused by intracerebral haemorrhage (ICH) (large bleed in the brain). CSVD has been shown to be associated with dementia, memory problems, balance disturbances and other neurological conditions such as Parkinson’s disease. CSVD is also known to be more common in people with high blood pressure or hypertension. There is uncertainty, however, if lowering blood pressure slows the progression of cognitive decline associated with CSVD. The purpose of this study is to investigate the effect of intensive blood pressure-lowering treatment on cognitive decline measured by specific neuropsychological tests.

The Synergy Online System collects data via multiple sources including online self-report, health professional and service surveys as well as third-party integrations (e.g. Fitbit) as a means to offer individual user’s personalised assessment and intervention options as well as continuous monitoring. This research employs a naturalistic prospective clinical trial design wherein all individuals presenting for care to a traditional face-to-face or online mental health service (participating in Project Synergy research studies) will be informed of the trial via a tiered consenting process including 'opt-out'. Upon consent, Synergy collects, stores and analyses personal and health information (data) in its database. By taking part in this clinical trial, participants give researchers permission to access their non-identified data, which will be used to scientifically, clinically and analytically validate "stage-based stepped-care" recommendations generated by the System.

Septic shock is a state of low blood pressure resulting from a physiological response to an infection. The low blood pressure commonly presents along with an elevated heart rate, which is in turn associated with poor outcomes in patients. Beta blockers have had favourable effects in the past, but its use in this clinical context may potentially lead to an exacerbation of the low blood pressure. Ivabradine causes selective heart rate reduction via an alternative pathway and is not known to have any other effects on the heart. It has previously been shown to have benefit in the treatment of chronic heart failure and stable cardiac disease, and previous studies have documented safety and tolerability. Furthermore, it has been used in acute medicine for the treat-ment of patients with low blood pressure due to acute heart failure and is currently being tested in critically ill patients with multi-organ failure. We propose to conduct a feasibility study to test whether Ivabradine can be used safely to reduce the heart rate in patients who are in septic shock with an elevated heart rate.

PTSD is the most common psychological disorder in veterans, and while evidence-based treatments exist, much can be done to improve outcomes. The study is a pilot randomised-controlled-trial comparing two interventions in veterans with a diagnosis of PTSD before and after they receive standard hospital treatment. This study will test the efficacy of two types of attention training to augment standard treatment for veterans with a diagnosis of PTSD. Attention training is delivered via computer and involves participants viewing words on a screen and then pressing a corresponding button on the keyboard. The first task, ‘Attention Control Training’ (ACT) works by re-balancing attention, whilst 'Attention Bias Modification; (ABM) aims to decrease over-responding to threat stimuli. We want to investigate whether receiving either one of these attention training programs significantly improves mental health outcomes after receiving standard treatment.

Traditionally, latent tuberculosis infection (LTBI) in Australia are treated with either six to nine months of daily isoniazid (6-9H). These regimens are hepatotoxic and long. Recent randomized trials have shown that two shorter regimens are equally effective, but substantially less toxic. Four months of daily rifampicin (4RIF) and three months of once weekly rifapentine and isoniazid (3HP). This study will address the following primary research question: What is the treatment completion rate for patients with LTBI treated with home-based 3HP plus SMS monitoring, compared to daily self-administered 4RIF?

The purpose of this study is to examine the feasibility of body-mind exercises (called ‘Qigong’) for cancer survivors. Who is it for? You may be eligible for this study if you are aged 18 or over, completed anticancer treatment at least 3 months ago and meet a criteria for insomnia. Study details All participants will partake in a three week group program, involving two face-to-face sessions and three online sessions. The program will involve slow-moving gentle exercise in a standing or sitting position. Participants will complete a diary and answer some questionnaires throughout the three week program and for a week after the program It is hoped this research will provide some evidence of the feasibility and potential benefits of Qigong for insomnia in this patient group.