ANZCTR search results

The purpose of the proposed study is to evaluate effectiveness and cost effectiveness of heat therapy and/or massage in addition to standard care in people with chemotherapy induced peripheral neuropathy. Who is it for? You may be eligible to join this study if you aged 18 years or over and meet study definition of chemotherapy induced peripheral neuropathy. Study details Patients will be assigned on a 'chance' basis, (like flipping a coin) to receive standard care or an intervention of standard care and heat therapy treatment for four weeks. If after four weeks the intervention decreases CIN nervous system symptoms then the intervention will continue for another 4 weeks. If symptoms do not improve, then the patient will be assigned on a chance basis to receive an alternative intervention of standard care and heat therapy, standard care and massage or standard care, heat therapy and massage. The second intervention will then be received for four weeks. Chemotherapy induced peripheral neuropathy has become a significant health issue which can cause treatment delays and affect functional abilities and quality of life. There are currently no pharmacological interventions that effectively prevent or manage CIN.

The link between carotid artery disease and stroke is well defined in severe carotid artery stenosis. The link between carotid artery disease, cerebral perfusion, and cognitive function, is less well characterised, particularly in the absence of clinical stroke. Characterising the relationship between carotid stenosis, cerebral perfusion, and cognitive function is relevant to 1). understanding the role of carotid intervention in improving cerebral perfusion and cognitive function and, thereby, dementia prevention; 2). reconsidering the threshold for intervention in those patients who are judged ‘asymptomatic’ by current criteria (whereby indications for intervention are based on stroke risk reduction); and 3). examining whether the two distinct forms of intervention for carotid stenosis (carotid endarterectomy and carotid artery stenting) have different impacts on cognitive function. Alongside our study of the impact of intervention for carotid stenosis and cognition, we will also examine relationships between changes in cognition and quality of life. If improvement in cerebral perfusion and cognitive function in patients treated for asymptomatic carotid artery stenosis can be demonstrated, this would impact significantly on decision making and treatment for these patients with respect to the prevention of cognitive decline. The overarching aim of this research is to determine whether changes in cognitive function occur in older adults following intervention for carotid artery stenosis. The primary objectives are to investigate whether: 1) carotid endarterectomy (CEA) improves cognitive function in patients with symptomatic and asymptomatic carotid artery stenosis, 2) changes in cognitive function following CEA are related to changes in cerebral blood flow and cerebrovascular reserve (CVR) in patients with symptomatic and asymptomatic carotid artery stenosis, 4) changes in cognitive function following CEA are related to findings on MRI, and specifically, on arterial spin-labelled cerebral perfusion imaging, 5) changes in cognitive function following CEA are independent of changes in mood scores, 6) changes in cognitive function following CEA are related to changes in quality of life.

This study will examine the emotional responses to a series of emotional film clips before and after the administration of a single dose of oxytocin. The emotional film clips presented will including positive (i.e., happy) and negative (i.e., fearful or painful) scenarios, and the study offers insight into the role of oxytocin in emotional responding behaviour for both positive and negative emotions.

Background: An enhanced recovery strategy involves various pre, intra, and postoperative steps to reduce the normal stress response and organ dysfunction associated with surgical insult, with the ultimate aim of reducing time to full recovery. Preoperative carbohydrate administration is one of the components of an enhanced recovery strategy. However, preoperative carbohydrate treatment for pregnant women undergoing elective caesarean section has the potential to cause rebound hypoglycaemia in the newborn infant. The glycaemic control of newborn infants born to mothers receiving preoperative carbohydrate loading, as a part of an enhanced recovery strategy has not previously been studied. Methods: We propose a pilot randomized controlled clinical trial to investigate the effect of preoperative carbohydrate loading in pregnant women undergoing elective caesarean section, on the glycaemic control of newborn infants. One hundred pregnant women scheduled for an elective caesarean section will be recruited after informed consent. They will be randomised to either intervention or control arm, and receive preoperative carbohydrate loading or no carbohydrate loading respectively. The remainder of their peri-operative management will be as per King Edward Memorial Hospital (KEMH) protocol for enhanced recovery. Newborn infants will be monitored for the risk of hypoglycaemia using KEMH neonatal unit guidelines for “infants at risk of hypoglycaemia”. Outcomes: The primary outcomes will be blood glucose concentration in newborn infant at four and ten hours of life, and the requirement for admission to newborn nursery for the management of hypoglycaemia. Secondary outcomes will include maternal blood glucose concentration during caesarean section, maternal medication requirement for postoperative nausea, and length of hospital stay. Significance: If the study shows that should this pilot study show that pre caesarean section carbohydrate does not increase risk of hypoglycaemia in newborn infants, we can safely introduce this component to our enhanced recovery protocol. Pre caesarean section carbohydrate loading has the potential to enhance maternal recovery and decrease length of hospital stay resulting in financial saving.

The primary aim of the trial is to examine, using a randomised controlled trial, the effectiveness of an online healthy recovery intervention program (“Prevent 2nd Stroke”[P2S]) in improving health-related quality of life amongst stroke survivors at 6 months follow-up. Stroke survivors will be recruited from the The Australian Stroke Clinical Registry (AuSCR) or the Hunter Stroke Research Volunteer Register (HSRVR) databases which contain the contact information of individuals who have had a stoke or TIA (indexed stroke event). Individuals assigned to the intervention group will receive 12 weeks access to the P2S program which they are able to to use to help improve their health behaviours and health outcomes. P2S is an online health behaviour change program containing six modules: 1) Blood Pressure, 2) Smoking, 3) Alcohol, 4) Activity, 5) Nutrition, and 6) Feelings and Mood. The program is interactive and tailored to accommodate stroke-related symptoms. Goals and progress will be monitored and graphed and will be available to the user in a ‘My Progress’ section of the program. at 6 months follow-up, Health-related quality of life will be determined, as too will be: a) depression and anxiety levels; b) self-reported physical functioning and independent living; c) four health risk behaviours (smoking cessation, reduction in alcohol use, diet quality, and increase in moderate physical activity), and; d) hospital admission for recurrent stroke, myocardial infarction and all causes Cost-effectiveness of the intervention will also be determined at 6 months.

Background: The majority of extremely premature infants receive mechanical ventilation despite current strategies for prevention. They remain at high risk of mortality, bronchopulmonary dysplasia (BPD) and other morbidities, and developmental disabilities. In an era of high use of antenatal corticosteroids for lung maturation and postnatal nCPAP, the optimal respiratory support strategy for extremely premature infants is currently unclear. Substantial practice variation exists including prophylactic intubation and surfactant either with immediate extubation or brief mechanical ventilation (goal <1 hour) and extubation to nCPAP, or nCPAP and rescue surfactant using various techniques. Primary clinical hypothesis: To determine if early surfactant administration via a thin catheter to spontaneously breathing preterm infants on nCPAP will reduce need for mechanical ventilation without an increase in neonatal morbidity or mortality compared to prophylactic surfactant with brief mechanical ventilation. Study objectives In extremely premature infants, the pilot study aims to determine the following to inform a larger definitive trial: 1. The feasibility and tolerance of delivery room thin catheter instillation of surfactant. 2. Effectiveness of prophylactic thin catheter surfactant in preventing intubation and mechanical ventilation. 3. Optimal enrolment and randomisation procedures. Study design This is a pilot parallel open label randomised controlled pilot study trial to one of 2 strategies of respiratory support and surfactant delivery. Study population All infants born at 24 weeks and 0 days to 27 weeks and 6 days completed gestation. Study interventions Infants born at <28 weeks: all infants with parental consent will be enrolled at birth and randomised to either: 1. Intubation, surfactant and brief mechanical ventilation 2. Nasal continuous positive airway pressure (nCPAP) with thin catheter surfactant Primary outcome [pilot study] 1. Intubation and mechanical ventilation 2. Incidence of events requiring resuscitation during surfactant administration (events requiring IPPV and/or intubation) Secondary outcomes Secondary outcomes include all major neonatal morbidities during hospital admission and neurodevelopmental outcomes at 3 years of age. Power and Sample Size 62 infants (31 each group) will be required to detect a 30% absolute reduction in the rate of intubation and ventilation in the first week after birth from 90% in the prophylactic / rescue surfactant group to 60% in the nCPAP with thin catheter surfactant group with a power of 80% at the p=0.05 level. For a 20% absolute risk reduction with 80% power at the p=0.05 level, 124 infants (62 each group) are required.

This study aims to determine if acute ingestion of EMIQ, a dietary flavonoid, can improve blood vessel function and blood pressure stress response in human volunteers. We will investigate the biochemical mechanism of any beneficial effects via the measurement of plasma levels of nitrate, nitrite and biomarkers of vascular function and oxidative stress. We hypothesize that EMIQ will improve vascular function and moderate the BP response to stress.

Prostate artery embolisation (PAE) is an emerging, minimally invasive treatment for lower urinary tract symptoms caused by benign prostate enlargement. The first prospective trial of PAE in Australia was performed at The Wesley Hospital, and this project builds on those successful results. Whilst PAE was shown to be very effective at shrinking the prostate and relieving urinary tract symptoms during short-term follow-up, its impact on urodynamics, and the complex interplay between prostate obstruction and bladder function, is yet to be studied. This project aims to be the first study to comprehensively assess the impact of PAE on bladder function (urodynamics), as well as improvements in urinary symptoms and quality of life. The study will also compare the responses of patients with differing severity of prostate enlargement, and those with recurrent symptoms after a surgical resection. This information will be used to hopefully predict which patients are likely to best respond to a PAE, and can therefore be considered as an alternative to medical therapy or as an effective medium term precursor to more invasive surgical resection.

Prostate artery embolisation (PAE) is a minimally invasive technique that has proven effective in decreasing lower urinary tract symptoms (LUTS) in men with medically refractive benign prostatic hyperplasia (BPH). BPH, or an enlarging prostate, affects more than 50% of males older than 60 years. LUTS include multiple night-time urination, urgency, hesitancy initiating urination, weak or interrupted urinary stream and post-urination dribble. The primary goals of BPH therapy are to decrease LUTS, improve quality of life (QoL) and prevent disease progression. For men with mild-to-moderate symptoms, sequential step-up therapy starting with watchful waiting and escalating to single or multiple medical therapies and, in some cases surgery, constitutes common clinical practice. A common combined medical therapy is Duodart, a fixed-dose combination of 0.5 mg Dutasteride and 0.4 mg Tamsulosin, that is usually prescribed for men with more severe prostate enlargement. The benefits of combined therapy can be explained by the synergistic mechanisms of action of the component drugs. Tamsulosin, an a-blocker, relaxes the smooth muscle tissue in the prostate and bladder neck, allowing urine to flow more freely. Treatment with Tamsulosin provides improvement of LUTS but has no effect on prostate growth. Dutasteride, a 5-alpha reductase inhibitor, blocks the production of dihydrotestosterone, the metabolic driver of prostate growth. Thus Dutasteride treatment reduces prostate size and impedes disease progression related to prostatic overgrowth. Adverse side effects associated with these medication include retrograde ejaculation, urinary incontinence and impotence. Overall, medications are generally ineffective for long-term control of LUTS, and medical therapies are often abandoned because of poor tolerance and inefficacy. PAE is emerging as a viable alternative to medication and invasive surgery for patients with LUTS. PAE has already shown promise as a short to medium-term treatment in patients who are not willing, or not able to undergo surgery. Medium-term follow-up in patients who have undergone PAE demonstrates that: • Improved symptoms and increased quality of life persist for at least 5 years in a majority of patients, • PAE is more efficacious than medical therapy alone, • PAE causes fewer side-effects than surgical resection, • PAE can be repeated if required, and does not preclude future surgical options. To date, a direct comparison between PAE and medical therapy in a randomised controlled trial has not been performed. The study proposed here will extend knowledge in this area by investigating whether PAE is a suitable intervention in treatment-naive men who would otherwise be prescribed medications as a first-line treatment.

The purpose of this study is to test whether a video designed to trigger the Autonomous Sensory Meridian Response (ASMR) will have an effect on preoperative anxiety. Preoperative anxiety is a significant phenomenon that negatively impacts patients that are preparing to undergo a procedure. In this study, we showed preoperative patients an informational video that told them about the anesthetic procedure that they were going to undergo. This video was either one specially designed to trigger an ASMR, or a normal video with the same information. ASMR is an alternative approach to relaxation and is currently very popular. You-Tube channels dedicated to producing ASMR videos have large followings and achieves significant viewership. Despite its rising popularity in society, only a few studies have been conducted to scientifically evaluate the effects of ASMR. We measured preoperative anxiety using standardized questionnaires that have been proven to be effective in many other studies. The questionnaires that we chose are the Visual Analogue Scale (VAS), the State-Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). We compared the results from the patients that watched the ASMR video with the results from patients that watched a normal video. Our aim is to assess the effects of ASMR on preoperative anxiety and determine if it yielded any clinically significant effects.