ANZCTR search results

In anaesthesia, traditional agents used for the reversal of paralytic agents are designed around the use of an anticholinesterase inhibitor (commonly neostigmine) to increase motor end plate acetylcholine. This is usually combined with an anti-muscarinic agent (atropine or glycopyrullate) to offset the autonomic effects of excess acetylcholine. Sugammadex is a newer agent that works via encapsulation of aminosteroid neuromuscular blocking agents. Whether or not sugammadex is superior to neostigmine based techniques in terms of prevention of the morbidity associated with residual paralysis have never been shown in a prospective randomised trial. P-PERSoN is a prospective multi-centre, double blinded, randomised controlled trial to compare neostigmine/glycopyrullate and sugammadex reversal. The primary outcome is all in-hospital respiratory events. Secondary outcomes will be, recovery room airway and desaturation events, hospital stay, quality of recovery scores, all-cause 30-day mortality and respiratory morbidity.

The communication difficulties associated with aphasia can create a significant barrier to the involvement of people with stroke in healthcare decisions. Our research team has previously demonstrated that people with aphasia can train health professionals to effectively communicate with individuals with aphasia. The current project will extend this research by investigating the effectiveness of delivering the training over the internet to cater for rural clinicians. The project will be a pre-post intervention study with random allocation of health professionals to groups (internet vs. face-to-face). During the study, 60 health professionals will attend a training session where they learn and implement strategies for communicating with people with aphasia (via a 1 hour lecture on communication techniques and then a 15 minute conversation with a person with aphasia). The health professionals will be randomly allocated to either training using the traditional face-to-face format, or training over the internet. The proposed project will provide valuable evidence about whether communication partner training programs for health professionals involving people with aphasia can be delivered over the internet, and will be used as pilot data for a multisite RCT. It is anticipated that the program has the potential to increase the participation of people with aphasia in healthcare decisions.

The purpose of the study is to compare two different chemotherapy regimens for the treatment of inoperable, locally recurrent, or metastatic anal cancer to demonstrate which is more effective and less toxic for patients with this disease. 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 inoperable, locally recurrent or metastatic anal cancer. Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive chemotherapy treatment with cisplatin and 5-FU for 8 x 3 week cycles (about 24 weeks in total) – this is the most frequently prescribed chemotherapy for this condition. Participants in the other group will receive chemotherapy with carboplatin and paclitaxel in 6 x 4 week cycles (24 weeks in total). Both groups will receive their chemotherapy intravenously, i.e. given into a vein through a drip. All participants will be followed for up to 3 years post treatment in order to evaluate treatment response, toxicity and quality of life. This is the first time that a formal comparison of these chemotherapies has been performed.

The research team aims to investigate the use of venous phase coronary angiography to visualise the coronary sinus and tributary vessels in patients who are having a standard coronary angiogram and that are not having CRT implantation. We hypothesise that this imaging will enhance knowledge of CS anatomy and pathology; and that this knowledge will assist both this specific patient population (if needing CRT in the future), and other general populations from a greater understanding and better planning of CRT lead placements. We seek to prove that venous phase coronary angiography CS imaging is able to successfully provide satisfactory imaging of the coronary sinus and its tributaries for cardiac interventions such as left ventricular lead placement in cardiac resynchronisation therapy/biventricular pacing. We also seek to determine relationships between factors (ie. age, gender etc.) and the anatomy/visualisation of coronary sinus and its tributaries.

Dementia is the leading cause of mental and physical disability in the elderly. Vascular dementia (VaD) that accounts for 15-20% of all dementia cases is a syndrome of acquired cognitive functional impairment with a complex pathophysiological basis. Viable pharmaceutical options are currently lacking. Herbal medicine has been used for the treatment of ageing-related disorders for more than 2000 years ago in ancient China. Combination therapies are complex mixtures are believed to be able to enhance therapeutic efficacy through synergistic and multi-target mechanisms and are ideal and may be relevant for disorders such as VaD that has multifactorial / multisystem pathophysiology components. Conventional pharmaceutical techniques have been used to develop a novel, standardised herbal formulation, Sailuotong (SLT) targeting VaD. Data from pre-clinical studies have shown significant improvements in memory functions and in pathogenic biochemical parameters in various animal models. Appropriate safety of SLT has also been shown in acute and chronic toxicity and herb-drug interactions studies. We propose to undertake a rigorous phase III clinical trial of SLT in 250 patients with mild to moderate probable VaD or Alzheimer’s disease with cerebrovascular disease (AD+CVD). The aim of this 52-week randomised, multicentre, double-blind, placebo controlled trial is to: 1. Determine the efficacy of SLT on cognitive function and activities of daily living, and 2. Monitor the safety of SLT as a treatment for VaD or AD+CVD during a 52-week treatment period. The primary outcome measures include Vascular Dementia Assessment Scale cognitive subscale (VaDAS-cog) and Alzheimer’s Disease Co-operative Study Activities of Daily Living Inventory (ADCS-ADL). In addition, there are six secondary outcome measures including: The Clinician’s Interview Based Impression of Change-plus (CIBIC-plus), CLOX, EXIT-25, Quality of life, Neuropsychiatric Inventory-Clinician rating scale (NPI-C), and Functional MRI Assessment in a subset group. Liver and renal function and routine haematological tests will be conducted regularly during the trial. All adverse events will be recorded at each visit, including those suspected to be related to the treatment and any worsening of symptoms will be closely monitored.

Faecal incontinence (FI) is a chronic, debilitating condition with enormous consequences for patients and the community. Numerous studies have documented the tremendous negative impact of FI on quality of life. FI has also been shown to be associated with substantial economic costs for the local health system. Since FI is believed to be a heterogeneous disorder, initial management is symptom based. Addressing the underlying abnormal bowel habits, if present, is the first step. Additional conservative therapies include dietary, medical and psychological modifications, and are estimated to benefit a quarter of patients. When a conservative approach fails, treatment with biofeedback (BF) is often recommended. A multitude of perspective and randomized trials have persistently shown short and long-term improvement in around 60% to 70% of patients treated with BF. Neuromodulation is an established therapeutic modality in the treatment of patients suffering from different pelvic floor disorders. For patients with FI failing BF, the only well-established option at present is neuromodulation by an implantable sacral nerve stimulator. This treatment is invasive and costly, has potential significant complications and is associated with significant financial burden for the local health system. Therefore, there is a need for a less invasive and costly method of performing neuromodulation. Percutaneous tibial nerve stimulation (PTNS) has the potential to address these disadvantages. With this method, neuromodulation is delivered through the posterior tibial nerve using a disposable needle electrode. Although PTNS is a well-proven and recognized treatment for urge urinary incontinence, in the last decade its role in treating patients with FI is slowly being elucidated. A recent systemic review included 6 prospective studies of PTNS for treating FI, and showed that PTNS results in significant improvements in some outcome measures of these patients. In all of these studies, patients were required to fail conservative management, but not specifically biofeedback, and in none of the studies was PTNS evaluated in combination with BF. We thus hypothesize that the combination of PTNS and BF for treating patients with FI, especially patients with urge incontinence, who are at high risk for BF failure, will be more effective than the current standard of care of BF treatment only. The impact of this combined efficacy will translate into improving the care of our patients, reducing the negative impact on the patients and their families’ quality of life, and reducing the costs for our local health system. Our main study objective is to determine the feasibility of combining PTNS with BF for the treatment of patients with faecal incontinence. Our secondary objectives are (1) To determine the physiological effect of combination therapy of PTNS and BF on anorectal dysfunction and (2) To assess the efficacy of combination therapy of PTNS and BF for FI.

Aims: To investigate the role of the rotator cuff muscles in limiting glenohumeral joint translation. This study will compare the electromyographic (EMG) activity of rotator cuff muscles in response to an external translation force in a healthy and pathological population. Participants: There will be a total of 40 participants in this trial - 20 each in the comparison and experimental groups. The participants will be more than 18 years old. The experimental group participants will have diagnosed rotator cuff pathology – typically a tear. The comparison group participants will be gender- and age-matched (within 5 years) and have normal healthy shoulders with no present history of pain or shoulder dysfunction. Brief Description: The rotator cuff is a musculotendinous unit consisting of four muscles (supraspinatus, subscapularis, infraspinatus and teres minor) whose tendons blend into and reinforce the glenohumeral joint capsule (Moore & Dalley, 2006). The close proximity of the rotator cuff muscles to the shoulder joint means they are ideally located to act concurrently, providing dynamic stability that could potentially limit the amount of unwanted translation and increase stability at the shoulder joint (Hess, 2000; Magarey & Jones, 2003). The high prevalence of rotator cuff pathology in shoulder injuries (Murrell & Walton, 2001) and the poor diagnostic accuracy of the clinical tests currently used to diagnose rotator cuff disease (Hughes, Taylor, & Green, 2008) emphasizes the importance of gaining a more thorough understanding of the rotator cuff’s function in dynamic control of shoulder motion. The ability of all rotator cuff muscles in limiting glenohumeral translation in young healthy shoulders has been measured in our previous study (Rathi et al, 2015). This method of measurement will now be replicated in patients with rotator cuff pathology in the present study. This comparative study will determine whether pathology of rotator cuff muscles affects the shoulder movements, specifically glenohumeral joint translations. Intramuscular bipolar fine wire electrodes will be inserted in the rotator cuff muscles to measure muscle activity. Participants will be seated upright in a chair with their affected upper limb fully supported through the use of straps. Elbow, hand and wrist orthoses will be used to allow the limb to maintain position without the use of muscle activity. A vertical board will be strapped across the chest to stabilize the trunk to the chair, particularly during translation procedures. Participants will be tested in two shoulder positions: in neutral and with the shoulder abducted 90º and externally rotated. A standardised procedure will be used for the setting up of the equipment, for instructions to the participants and for the placement of electrodes. These procedures and electrode placements have been established in previous studies in our laboratory. Methods of Data Analysis: To assess whether significant differences exist between the translation of humeral head with and without rotator cuff muscles’ activation will be analysed using independent ANOVAs for each shoulder position (neutral, abduction+ external rotation). Each ANOVA will have three factors: translation force (none, anterior, posterior), activity (none, isometric internal rotation force, and isometric external rotation) and group (patient vs control) with level of significance set at p<0.05.

Osteoarthritis (OA) is the leading cause of pain and disability in Australia and the knee is commonly affected. OA is the 11th highest contributor to global disability and in 2008-9 was the eighth most-managed problem by Australian GPs. Exercise is a core component of best-practice management, yet access by Australians to appropriately-qualified health care providers for exercise prescription and advice is very limited. Furthermore, uptake of exercise by people with knee OA in Australia is grossly inadequate, and long-term adherence is poor. This randomised controlled trial (RCT) will evaluate the effectiveness of telephone-delivered exercise advice and behaviour change support by physiotherapists for improving knee pain and function in people with knee OA. The service will be embedded into the Musculoskeletal Help Line that is provided by Arthritis & Osteoporosis Victoria.

Low birth weight is an important risk factor for adult ischemic heart disease. Those born small-for-gestational-age (<10th percentile for gestational age and gender) are at the highest risk for adult cardiovascular disease. Children and adults born small for gestational age have increased arterial intima-media thickness – a noninvasive marker of subclinical atherosclerosis, the underlying disease process responsible for the majority of cardiovascular events. Birth weight is inversely associated with blood pressure – a major cardiovascular risk factor, in both children and adults. Published data from populations of children and young adults suggest that omega-3 fatty acid supplementation will have beneficial effects in reducing arterial intima-medial thickness and systolic blood pressure in children who were born small for gestational age. This hypothesis has not been tested in a randomized controlled trial. This study is designed to test the effectiveness of omega-3 fatty acid supplementation from 6 to 18 months of age in reducing aortic intima-media thickness and systolic blood pressure in children born small-for-gestational-age. The study will be conducted as an open label randomized controlled trial over a 1 year intervention (when the infant is 6-18 months old) where aortic intima media thickness and systolic blood pressure will be measured at recruitment, 6, 12 and 18 months of age.

Current stroke guidelines recommend as much physical practice as possible in the first 6 months after stroke. A number of recent reviews concluded that therapy should include intensive repetitive task training to improve functional outcomes (such as the ability to transfer and walk). However, a number of factors can lead to patients remaining inactive, particularly once home. 1) Limitations of outpatient therapy: Frequency of appointments is low and programs are time limited in duration. 2) Motivation and confidence: Low motivation and lack of a therapist monitoring practice can contribute to poor adherence to exercise. Providing accurate feedback, goal setting and rewards can enhance compliance and self efficacy. 3) Geographical location: Patients may live in remote or rural areas resulting in less access to specialist rehabilitation services or have limited access to transport to attend therapy. Novel, cost-effective and enjoyable ways are needed to increase the intensity of practice outside of centre-based therapy. Therefore, the purpose of this study is to investigate whether for people who have had a stroke: 1. a smart device application and activity monitor (AM) can be used to increase repetitions of a functional exercise outside of centre-based therapy 2. the activity monitor and smart device application package is enjoyable, acceptable and easy to use. 3. progression of intensity of practice can be delivered remotely by a therapist via the internet.