ANZCTR search results

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

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31593 results sorted by trial registration date.
  • Hypofractionated image guided radiotherapy ("stereotactic") versus conventional radiotherapy for inoperable early stage I non small cell lung cancer (NSCLC).

    The purpose of this study is to investigate whether radiotherapy given as three large doses over a period of two weeks (hypofractionated radiotherapy) is more effective than standard radiotherapy for patients with non-small cell lung cancer that has not spread beyond the lung. Who is it for? You may be eligible to join this study if you aged 18 years or above and have a confirmed diagnosis of non-small cell lung cancer within 6 weeks of study enrolment. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current standard of care treatment, which consists of chemotherapy and radiotherapy given in a number of small doses over a period of about 6 weeks. Participants in the other group will instead receive hypofractionated radiotherapy (HypoRT) in three large doses over a period of 2 weeks. All participants will be regularly monitored for up to 2 years in order to evaluate treatment response, survival, toxicity and quality of life. This will help us to determine whether hypofractionated radiotherapy is more effective, results in longer life expectancy and if it is just as safe as standard fractionated radiotherapy.

  • The effect of postoperative radiation therapy on time to local relapse in patients with neurotropic melanoma of the head and neck.

    This study is comparing surgery alone with surgery plus post-operative radiation therapy for patients with completely resected primary melanoma showing histological features of neurotropism. Who is it for? You may be eligible to join this study if you aged 18 years or above and have been diagnosed with neurotropic primary melanoma in the head/neck area. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will undergo radiation therapy over 4 weeks, commencing within 3 months of surgery. Participants in the other group will undergo surgery followed by observation only. Participants will be monitored for up to 5 years in order to evaluate treatment effect, survival rates, and quality of life.

  • Acetazolamide in X-linked Retinoschisis

    X-linked retinoschisis is a genetic eye disorder characterised by abnormal splitting of the retina, resulting in a loss of vision. Currently there is no treatment available for X-linked retinoschisis. However, an improvement in sight has been reported following the use of topical and oral acetazolamide in people with X-linked retinoschisis. Hence, the objective of this study is to investigate whether oral acetazolamide improves the sight of people with X-linked retinoschisis.

  • Successful insertion rates of the i-gel supraglottic device compared to the Smiths Soft Seal laryngeal mask airway (LMA) for out-of-hospital cardiac arrest: A randomised controlled trial

    Paramedic use of supraglottic airway devices is increaing and it is also seen as a life-saving skill, necessary for protecting and maintaining a patients airway and providing a channel for direct oxygen administration. The current rate for successful insertions of supraglottic airway devices by Ambulance Service of NSW paramedics below optimal. The i-gel supraglottic airway device is a new airway style with a non-inflatable cuff and is structured differently to the Smiths Soft Seal (the device currently in use by ASNSW). This theoretically makes it easier to use and may result in a higher rate of successful insertion. We hypothesise that the i-gel, when compared to the Smiths Soft Seal LMA will result in a higher rate of airway placement.

  • Efficacy of motivational interviewing prior to cognitive behavioural treatment for social phobia

    Several research groups from around the world, including our own group at the Centre for Emotional Health (Macquarie University), have demonstrated the efficacy of theoretically derived cognitive behavioural treatment (CBT) protocols for Social Phobia (Clark et al, 2003; 2006; Rapee, Gaston, & Abbott, 2009). However, despite the effective treatments available there is evidence that treatment outcomes are still less than optimal due to poor engagement and motivation for treatment. For example, Issakidis & Andrews (2004) found that around 30% of clients presenting for CBT group treatment for social phobia did not commence treatment, and a further 10% discontinued their treatment. Similarly, in a large trial in our own clinic, 18% of clients who commenced treatment for social phobia discontinued after less than 3 sessions (Rapee et al, 2009). This suggests that strategies that promote engagement with and motivation for treatment may further enhance treatment outcomes. One approach that has received attention, particularly in the substance use disorders, is motivational interviewing (MI; Miller & Rollnick, 2002). This approach aims to enhance motivation for change and focuses on ambivalence about embarking upon treatment that might lead to clients not engaging fully in, or dropping out completely from, treatment (Arkowitz & Miller, 2008). While this approach has good evidence for its value in the substance-use field (Arkowitz & Miller, 2008), it is only beginning to be considered in the anxiety-disorders literature (e.g., Westra & Dozois, 2008). The aim of the current project is to determine whether the addition of motivational interviewing to a highly efficacious CBT treatment package for social phobia can provide a significantly greater treatment effect and improved maintenance of effects.

  • Effect of dairy intake and resistance exercise on weight loss in overweight or obese caucasian men and women

    There is evidence to support a beneficial effect of dairy products in weight loss programs. This trial hopes to document whether increasing the number of serves of dairy per day will increase the amount of body fat lost or change its distribution to a more healthy profile. We will also study if there are any benefits for cardiovascular disease and type 2 diabetes, by monitoring the changes in some key risk markers for these conditions.

  • Metacognition and Mindfulness: A Group Intervention for Reducing Distress in Early Episode Psychosis

    To the author’s knowledge, this is the first intervention within Australia with any psychotic population which combines metacognitive and mindfulness interventions. It is also to the author’s knowledge, the first intervention which has used metacognitive or mindfulness interventions for individuals with First Episode Psychosis. All previous evaluations of metacognitive (see Moritz and Woodward, 2010; Moritz et al, 2007) or mindfulness interventions have focused on individuals with chronic psychosis (see Chadwick et al 2009; Taylor and Chadwick et al 2009; Clarke, 2001). However, delivering psychological interventions at an earlier stage of psychosis (such as in Early Episode Psychosis program) has been demonstrated to have a better prognosis, decrease longer-term negative impact of psychosis on the individuals functioning, and to offer potential in decreasing relapse and hospitalization rates (McGorry, 2009; Birchwood, 2008; Boonstra et al 2009). The intervention, being implemented by Peel and Rockingham Kwinana Mental Health Service (PaRK), therefore offers the potential to decrease distress and dysfunction associated with psychosis in the short and longer-term by combining the two previously evidenced based psychological interventions.

  • Continuous Monitoring of Patients with Severe Sepsis or Septic Shock using SeptiCyte (registered trademark) Lab and Procalcitonin Comparator to Determine the Relationship Between Inflammatory Index and Clinical Progression and Outcome Measures

    Sepsis is a specific systemic inflammatory response to either a gram positive or gram negative bacterial or fungal infection. The cornerstone of sepsis diagnosis and prognosis for many decades has been identifying the causative circulating pathogen and quantitating single blood analytes to assess the patient’s physiological response to the pathogen. However, it is an individual’s immune system, which determines clinical escalation to septic shock and not the causative pathogen. Given that the immune response is complex and multifactorial there is a necessity for an assay that can expedite the early diagnosis of sepsis, as well as evaluate the individual’s response to therapy/management. Recent developments in biomolecular technologies using quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) enable gene expression patterns to be translated into diagnostic pathology profiles and have the capacity to improve acute clinical management. “Athlomics” development has characterised a panel of 42 inflammatory gene expression biomarkers that significantly correlate with incidence of sepsis using both equine and human models. Athlomics preliminary outcomes, using data sets from local clinical trials, suggest that this investigational diagnostic has a better than 95% accuracy of detecting sepsis in patients admitted to a tertiary clinical setting with an acute non-specific immunoinflammatory response, based on area under the curve calculations using receiver operator characteristics (ROC) analyses. This is an important finding, and indicates that the specificity of the Athlomics sepsis signature is well within the performance band required for clinical use. To improve the strength of this signal Gene Expression Omnibus (GEO) samples were compared with gene expression profiles from the sepsis cohort, demonstrating a specificity of greater than 99% based on ROC curves. The Athlomics sepsis signature was applied to all currently available GEO Genechip data for human whole blood studies and a subset of 168 control samples, including both healthy controls and controls with known conditions not expected to produce inflammatory signals. These outcomes, suggest that this assay is robust and has the capacity to be used in future clinical practice for the definitive diagnosis of sepsis. Moreover, it has the potential to be used in the practice of ‘personalised’ medicine, where an individual’s gene expression signature can be used to structure a specific clinical management plan, determine response to therapy and provide prognostic updates

  • Efficacy of sertraline for palliative management of refractory breathlessness

    Breathlessness continues to be a major clinical problem for many people with advanced progressive illnesses such as cancer, end-stage cardiac failure or chronic obstructive pulmonary disease even when they are receiving the best treatment for the underlying disease. Although there are some interventions that may offer benefit (oxygen therapy, sustained release low dose morphine), there is still a need for a wider range of interventions to meet the needs of people with refractory breathlessness. Sertraline, an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class, is primarily used to treat major depression as well as obsessive–compulsive, panic, and social anxiety disorders. Previous research has suggested that treatment of concomitant mood or anxiety symptoms can improve dyspnoea however studies are needed to further clarify its potential benefits for the treatment of breathlessness. The research team has conducted a Phase II double blind, titrated dose, multi-site placebo controlled pilot study of sertraline (ACTRN12608000253303) using the proposed inclusion and exclusion criteria and the measures proposed in this study design. The pilot study has demonstrated acceptability and feasibility of this study, however further Phase III data is needed in order to ensure that this is a well tolerated and effective intervention suitable for a broad range of people with refractory breathlessness. This study will evaluate critically a new but theoretically useful therapy whose role needs to be carefully defined. Although sertraline has been used in small uncontrolled studies, the evidence for a net clinical benefit is inadequate. Aim: The primary aim is to test the efficacy of sertraline compared with placebo in relieving the sensation of intractable breathlessness. Secondary aims focus on the impact of the sertraline on improving quality of life (QOL), dyspnoea-related anxiety and depression, adverse effects, function and clinical predictors of benefit.

  • Identifying user and usage characteristics of Mindfulness Online from the general public

    Swinburne University of Technology is currently running a research trial to indentify which people use Mindfulness Online, an internet-based program designed to teach you skills to improve mental and physical wellbeing. We are interested in how often they use and for what reasons do they stop using the program. Swinburne University of Technology’s eTherapy Unit and National eTherapy Centre (NeTC) have developed internet-based treatment programs that are available for the general public. These programs can be used to treat clinical conditions (Anxiety Online) and to promote health and well being (Living Well Feeling Well). As part of developing effective programs, information on users and their usage of such programs is needed. The current project seeks to predict which user characteristics influence adherence and attrition in Mindfulness Online, an online intervention targeting well being. The results of this research will be used to improve the way internet-based interventions are developed and offered to the public.

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