ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32707 results sorted by trial registration date.
  • The impact of sex hormones on one-session cognitive therapy for women with spider phobia. .

    Women are 2-3 times more likely to have an anxiety disorders compared to men. One proposed biological reason for this difference is that changes in sex hormones, particularly, estrogen impact treatment efficacy. The aim of this study is to assess whether sex hormones, particularly estrogen, impact a single-session cognitive intervention for women with spider phobia. Naturally cycling women with spider phobia will receive a one-session cognitive intervention for spider phobia. Outcome measures (scores on the BAT and SPQ, conviction ratings and diagnostic criteria) will be compared for women with high estradiol levels (the main estrogen derivative) versus low estradiol levels as determined by blood serum levels. It is hypothesised that women with high estradaiol levels will have better treatment outcomes compared to women with low estradiol levels.

  • EWING 2008 Clinical trial for the treatment of Localized and Disseminated Ewing sarcoma

    What is this project about? EWING 2008 is a joint protocol of European and North American Ewing sarcoma study groups. The protocol is aimed at optimising treatment and treatment results of patients with Ewing sarcomas. Who is it for? The EWING 2008 protocol is open to all patients aged 4-49 years, diagnosed with Ewing sarcomas of bone or soft tissue, localised or metastatic, who are considered eligible for neoadjuvant chemotherapy. Study details All patients registered will receive induction chemotherapy consisting of six cycles of vincristine, ifosfamide, doxorubicin and etoposide (VIDE). The decision regarding local therapy must be made following the fifth cycle of induction treatment, with a preference for surgical intervention with or without additional radiotherapy. Standard Risk R1 Good responders (R1) (< 10% viable tumour cells) with localised disease are allocated to the standard risk arm and will receive a further eight cycles of chemotherapy composed of vincristine, actinomycin D, and cyclophosphamide (VAC) (females) or ifosfamide instead of cyclophosphamide (VAI) (males). They will be randomised to receive add-on treatment with zoledronic acid, or no add-on treatment. Very High Risk R3 Patients with disseminated disease, i.e. dissemination to bone and/or other sites and possibly additional pulmonary dissemination (R3), receive six cycles of VIDE induction chemotherapy. Patients are then randomised to either continue with eight cycles of vincristine, actinomycin D and cyclophosphamide (VAC) chemotherapy or high dose treosulfan-melphalan (TreoMel) chemotherapy followed by autologous stem cell reinfusion followed thereafter by eight cycles of VAC chemotherapy. Local therapy in R3 patients is following VIDE induction, whenever feasible prior to high dose therapy (HDT). It is hoped that the findings from this trial will provide information of the efficacy and toxicity of each of the chemotherapy treatment protocols for patients newly diagnosed with Ewing sarcoma.

  • The effect of re-positioning fruit and vegetable items within an online menu on the purchasing patterns of users of an online lunch ordering systems for primary school students.

  • Evaluating the effectiveness of a healthy lifestyle clinician in addressing the chronic disease risk behaviours of community mental health clients

    People with a mental illness have significantly poorer physical health and shorter life expectancy than the general population, primarily due to chronic diseases. A higher prevalence of modifiable health risk behaviours such as poor nutrition, inadequate physical activity, harmful alcohol consumption and smoking contribute substantially to this disparity. Evidence based guidelines recommend that mental health services routinely provide care to address these risk behaviours, however, the provision of such care is consistently reported to be low in Australia and internationally. A randomised controlled trial will be conducted to determine the effectiveness, acceptability and feasibility of allocating a designated clinician within a community mental health service to the specific role of providing assessment, advice and referral for clients' chronic disease risk behaviours. Clients of one community mental health service in NSW, Australia will be randomly allocated to receive either usual care for chronic disease risk behaviours, or usual care plus an additional face-to-face consultation and follow-up telephone call with a ‘healthy lifestyle clinician’. The role of the clinician will be to assess clients’ chronic disease risk behaviours, provide advice to change behaviours, and refer at-risk clients with free government telephone coaching services (NSW Quitline and NSW Get Healthy Information and Coaching Service) for ongoing care. The primary outcomes, referral to and uptake of the NSW Quitline and NSW Get Healthy Information and Coaching Service, will be obtained from the respective services. Telephone interviews of clients will be conducted at baseline and one and six month post baseline follow-up to assess secondary outcomes: self-reported chronic disease risk behaviour status, self-reported receipt of any assessment, advice and referral from the mental health service, satisfaction with the receipt of such care, and interest, confidence and perceived importance of changing risk behaviours.

  • Observing activity levels within an Acute Stroke and Sub-Acute Inpatient Rehabilitation Unit pre and post transition to a new hospital

    Rehabilitation is required for functional recovery from many acute illnesses such as stroke, orthopedic fractures and de-conditioning seen during extended hospitalization. Unfortunately, research into physical, social and cognitive activity of patients undergoing rehabilitation has shown that patients spend almost all of their time alone, inactive and disengaged. There is increasing interest in how changing the physical environment may improve activity levels, and therefore recovery, but it is currently unknown what impact changing design features such as single vs. multi- bedrooms and proximity to outdoor areas and communal spaces has on physical activity levels. The move to the new Kawana Hospital provides a unique opportuntity to examine this, and consequently this study will determine how changes in hospital design influences physical, social and cognitive activity levels of patients in Acute Stroke and Rehabilitation Units. This prospective observational study will examine the effects of the change in physical environment with transition to a new hospital by observing total activity levels using behavioral mapping and accelerometers in patients recovering in acute stroke and sub-acute rehabilitation units before and after transition. By embedding the use of advanced technologies such as Actigraph and Stepwatch accelerometers, and the building of collaborative networks with the University of the Sunshine Coast, our hospital and health service is set to lead the development of interventions that may guide national and international treatment guidelines.

  • Early PARacetamol (EPAR) to promote early closure of the ductus arteriosus in preterm infants

    The optimal management of PDA is highly controversial with a lack of consensus regarding the need to treat, timing of intervention, the most appropriate pharmacological agents (including dose, dose intervals, duration, repeat courses, routes of administration) and the role of surgical intervention. Traditionally, the medications we use to treat PDA are non-steroidal anti-inflammatory drugs (NSAIDs), which decrease prostaglandin production by inhibiting cyclooxygenases (COX). The most commonly used medications, indomethacin and ibuprofen, have a success rate of approximately 70% - 85%. Unfortunately these medications are associated a number of unwanted adverse effects due to decreased blood flow to the brain, gastrointestinal tract and kidneys. Exposure to these medications puts vulnerable preterm infants at risk of significant complications such as intestinal perforation and necrotising enterocolitis. The alternative to medications is surgical intervention, which also carries significant risks, particularly for extreme preterm infants. Paracetamol is a medication with an excellent safety profile in infants when used to treat mild to moderate pain and fever. Although the mechanism of action of paracetamol is not completely understood, part of its spectrum of activity resembles that of a COX-2 selective inhibitor. Similar to traditional NSAIDs, this results in decreased prostaglandin production. It is therefore intuitive that this may also be effective in promoting ductal closure without the adverse effects associated with NSAIDs. Early experiences with the use of paracetamol for ductal closure have been encouraging. Paracetamol appears to have similar efficacy to NSAIDs, without the gastrointestinal complications associated with NSAIDs, and is well tolerated in the preterm infant population. It has been suggested as a safe alternative medication in situations where other medications have failed or are contraindicated. The aims of this study are to study the effect of early treatment of patent ductus arteriosus with paracetamol and to examine the safety and efficacy profile of paracetamol during the early postnatal period. We hypothesise that early treatment with paracetamol will reduce the number of infants requiring intervention for PDA and that the use of paracetamol in preterm infants with a patent ductus arteriosus will result in a higher rate of ductal closure compared with placebo. We also am to show that paracetamol can be used safely in preterm infants during the early postnatal period.

  • Nasal High-Frequency Oscillation to Improve Respiratory Stability of Preterm Infants: A Randomized Crossover Study

    Intermittent hypoxia (pulse oximetry saturation <80%) and bradycardia (pulse rate <80 beats per minute) frequently occur in preterm infants, often associated with apnoea of prematurity. Such episodes of hypoxia and re-oxygenation have the potential to trigger a pro-inflammatory cascade leading to multisystem morbidity including retinopathy of prematurity, impaired growth, longer-term cardiorespiratory instability, and poor neurodevelopmental outcome. Widely used treatments such as methylxanthines and continuous positive airway pressure (CPAP) are sometimes insufficient and endotracheal intubation and mechanical ventilation are required. Nasal CPAP is the most widely used from of 'non-invasive' ventilation (NIV) in very preterm infants. NIV refers to respiratory support without the need for an endotracheal tube, usually delivered via nasal prongs. Nasal CPAP is an alternative to mechanical ventilation in preterm infants soon after birth. A meta-analysis comparing early CPAP with intubation and mechanical ventilation showed that CPAP reduce the risk of the combined outcome of death or bronchopulmonary dysplasia (BPD). CPAP failure primarily occurs due to AOP, oxygen requirements pre-specified thresholds, and hypercapnia related to hypoventilation. Ventilation failure in infants treated with CPAP may be due to inadequate alveolar ventilation and carbon dioxide elimination. High-frequency oscillatory ventilation (HFOV) delivered via an endotracheal tube leads to excellent carbon dioxide removal using a tidal volume less than the volume of the dead space. HFOV, which has until recently only been delivered via endotracheal tube, uses oscillations of low amplitude and high frequencies quite different from those of normal respiration. It may cause less lung injury than conventional mechanical ventilation. The combination of HFOV and NIV could provide lung-protection, improved oxygenation, better gas exchange, and reduced rates of AOP compared to NIV alone. Therefore, we aim to assess the effect of nHFO versus CPAP therapy in very preterm infants born <30 weeks’ gestation on the cumulative event rate of all bradycardias (< 80 bpm) and desaturations (< 80%) during a 120-minute recording period for each therapy. We hypothesize that in very preterm infants, nHFO is associated with a significant decrease in the number of bradycardias and desaturations compared with CPAP.

  • The effect of upper airway surgery on obstructive sleep apnoea

    Obstructive sleep apnoea (OSA) affects 1.5 million Australians and results in significant morbidity and mortality. However, half of patients cannot tolerate the leading treatment, continuous positive airways pressure (CPAP). For those intolerant of CPAP, a common treatment alternative involves upper airway surgery (UAS). Unfortunately, a significant number of patients referred for this treatment do not respond and suffer from residual OSA with its inherent cardiovascular and neurocognitive consequences. Furthermore, current clinical predictive tools are poor at identifying responders to UAS and there are no proven additional therapies to offer those patients failing UAS treatment. The key to providing better predictors of OSA resolution with UAS is to understand how these interventions affect the physiology responsible for OSA. It is clear that UAS improves upper airway anatomy/collapsibility. However, poor upper airway anatomy is not the only factor contributing to OSA. Recent evidence suggests that several additional, non­anatomical, physiological traits contribute to the pathogenesis of OSA including: 1) an oversensitive ventilatory control system (i.e. high loop gain), 2) a low respiratory arousal threshold, and 3) poor pharyngeal dilator muscle effectiveness characterised by an inability of the pharyngeal muscles to hold open or stiffen the airway during sleep. However, it is not known how UAS alter these non­anatomical traits and whether abnormalities in these traits are the reason for the variability in the success of UAS treatments. Furthermore, it is also not known if targeting non­ anatomical traits with additional treatments (i.e. combination therapy) will improve outcomes for those patients who have had only a partial response to UAS. Our goal is to be able to accurately identify which OSA patients are good candidates for UAS therapy by identifying robust predictors of OSA resolution with these interventions. Furthermore, we aim to offer additional treatments to ‘salvage’ those patients who have failed to respond completely to UAS.

  • A smartphone intervention to improve health in truck drivers

    Truck drivers are highly susceptible to cardiovascular disease (CVD), type 2 diabetes, obesity, high blood pressure and stress. Employees within this industry are typically older men and therefore more likely to develop CVD related conditions, compared to other occupational groups. Furthermore, inflexible and unhealthy work conditions often mean truck drivers are particularly inactive, engage in long periods of sedentary behaviour (or sitting), and have poor diets consisting of high fat convenience food, and drinks with high fat or sugar content. Effective strategies need to be developed to counter these poor lifestyle choices, but to date, no intervention study has targeted inactivity, sedentary time and diet in truck drivers; consequently, evidence is lacking on how best to empower drivers towards active living and healthy eating/drinking approaches. This study will test the feasibility of a new intervention (termed 'Shifting Gears'), designed to promote healthy lifestyle choices, and reduce cardiovascular risk, in Australian truck drivers. The study aims to develop and implement active living and healthy eating/drinking strategies in driver breaks, and evaluate the efficacy of these strategies over a six month intervention period, using measured changes in physical activity, sedentary behaviour and healthy food/drink options, as the main study outcomes.

  • Short-term exercise training and its effect on glucose tolerance and immune function

    Current evidence suggests exercise plays an important role in the management of blood glucose levels for individuals with T2DM.The comparison on mode of exercise on glucose regulation is not well understood and limited. Previous research have investigated treadmill or cycling exercise on glucose tolerance separately, however the comparison between the two modes of exercise on glucose regulation is limited. We seek to determine which mode of exercise would be more effective in managing glucose tolerance since walking/running is freely accessible without having the need to sign up to a gym or to invest in a bicycle. It is now understood that type 2 diabetes is associated with a chronic state of inflammation. Recent evidence have shown that exercise is beneficial in improving inflammation along with reducing insulin resistance. We aim to identify whether the mode of exercise influences the level of inflammation and glucose tolerance following a two-week training period. Findings of this study may help inform future exercise prescription to improving health status in this population.

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