ANZCTR search results

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

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32712 results sorted by trial registration date.
  • 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.

  • Nutriceuticals in Duchenne muscular dystrophy

    This project seeks to explore the efficacy of a standard nutritional supplement in comparison to a standard nutritional supplement enhanced with creatine monohydrate, glutamine and beta-hydroxy-beta-methylbutyrate in maintaining or improving functional ability in boys with Duchenne muscular dystrophy. It combines the expertise of nutrition and dietetics with neurologists to enhance the outcomes of this population group where little is known of their nutritional needs since the standard introduction of steroid therapy. The primary outcome measures functional ability using the StepWatch Activity Monitor. Secondary outcome measures include 6 minute walk test, DXA to measure body composition, functional questionnaires and quality of life questionnaires. Our dietary supplement that we propose to use in this study is contained within a high protein shake, and includes a multivitamin, vitamin D and essential fatty acids given alone or in conjunction with creatine monohydrate (CrM), glutamine, beta-hydroxy-beta-methylbutyrate (HMB). This will be a 12 month, randomized control cross over trial using 24 age matched pairs with a 2 month lead in period and 2 week washout.

  • How does local anesthetic airway topicalisation, for awake fiberbreoptic intubation (AFOI), affect patient reaction time?

    Awake fibreoptic intubation (AFOI) is the method of choice for intubation and securing of a potentially difficult airway. Routine practice worldwide involves ‘topicalisation’ (numbing) of the airway with Local Anaesthetic (LA) to enable a fiber optic camera to be advanced through the airway and into the trachea, usually with the patient awake and under no sedative influence. Currently there are no data on the effects of the LA used this way on cognitive or motor function, and patients are allowed to return home shortly after such a procedure. There is no advice given with regards to driving or operating heavy machinery despite anesthetists who have had this procedure describing ‘funny feelings’ following administration of topical LA and multiple studies that report subjective feeelings of dizzines, tingling, euphoria and dysphoria We wish to assess the impact of LA on reaction time (and hence both neural and motor function) following volunteer participation in an AFOI Course that we run half yearly for anesthetists

  • A comparison of the accuracy of two bowel cancer test kits in healthy people.

    A study comparing two different faecal occult blood testing kits (FOBT). These are tests for detecting early signs of bowel cancer. Patients will be invited who have had a diagnosis of a normal bowel after colonoscopy within the last eighteen months The aim of this study is to determine the accuracy of a new FOBT kit (QuickVue(R) FIT(R)) compared to a proven FOBT kit (Hemoccult II(R) Sensa(R) for detecting the presence of hidden blood in the stool (occult blood). Occult blood in stool is an indication of a number of relatively mild bowel diseases as well a symptom of bowel cancer and bowel polyps. We need to be sure that the QuickVue test does not detect extremely low levels of blood loss which occurs in normal healthy people, to ensure that the test does not give false positive results.

  • Randomised Controlled Trial of Cognitive Behavioural Therapy for the Treatment of Anxiety and Depression in Parkinson’s Disease

    This study examines the effectiveness of a group Cognitive Behavioural Therapy (CBT) treatment designed to help people with Parkinson's Disease manage anxiety and depression problems.

  • The relationship between the numeric rating scale, as a subjective measure of postoperative pain, and the plasma levels of catecholamines

    It is commonly believed that acute postoperative pain can lead to an impaired outcome by means of stress hormone provoked physiological changes (e.g. hyperglycaemia, altered immune response, increased myocardial oxygen consumption). However, it has not yet been investigated whether or not pain that is often measured by means of subjective pain scales (e.g. numeric rating scale, NRS) actually correlates with changes in the plasma level of stress hormones. Aim of this study is to investigate the relationship between the subjective NRS score (0-10; 0= no pain, 10 = worst pain) and the plasma levels of adrenaline and noradrenaline. Furthermore, the correlation between these parameters and other non-invasive measures of pain (heart rate [HR], blood pressure [BP], respiration rate [RR], heart rate variability [HRV]) will be investigated. For this purpose, 85 patients scheduled for non-emergency plastic surgery will be included in the trial. On arrival in the recovery room, 4 ml blood will be taken from a cannula sited during the anaesthetic into the cubital fossa to measure plasma levels of catecholamines. Simultaneously, HR, BP and RR will be recorded as part of the recovery room protocol and the patient will be asked to rate their pain on the NRS. In addition, data from the connected electrocardiogram will be downloaded onto a laptop PC to calculate parameters of HRV by means of the MEMCALC method: total power, low frequency, high frequency, the low: high frequency ratio and a non-linear approach, ultra-short entropy. These HRV parameters are purely mathematical calculations (hence “no touch” technique) and have previously shown correlations with the sympatho-vagal balance. At the time of discharge from the recovery unit, above mentioned procedure will be repeated. In between these 2 time points, the procedure may be repeated up to 3 times if a patient “moves” from one pain category into another (4 categories defined: no [NRS 0], mild [NRS 1-3], moderate [NRS 4-5] and severe [NRS 6-10] pain). To identify changes in pain perception, patients are frequently (approx. 5 minutely) asked to rate their pain on the NRS. This is a standard procedure in the Royal Perth Hospital recovery room. Hence, a minimum of 2 and a maximum of 5 blood samples (=20ml) may be taken of a subject. The study period ends with discharge of a patient from the recovery room.

  • Pilot study of a new less invasive technique of local anaesthesia for the eye in cataract surgery

    Ophthalmic regional blocks are some of the most commonly used in Australia. yet most of them require blind insertions to the posterior of the eye. This study aims to study a new technique which injects under vision to the anterior of the eye. In theory this should be a simpler and safer technique. it's efficacy and safety will be the subject of this study.

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