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.
  • A prospective cohort study evaluating the incidence of and outcomes associated with dose reductions of diabetic medications in a population of older inpatients discharged to a nursing home

    Modern medical care can provide many medications for problems, whether simply short-term medications like antibiotics or longer-term medications like those used to treat high blood pressure. But we do not know enough about when medication can and should be ceased, especially in older patients with diabetes. We know that often medications are ceased while a patient is in hospital; sometimes medications are not ceased. We want to collect data about those patients who had medications for diabetes stopped and those who did not, and compare the two groups later to look for any differences. Many older people complain about being on too many medications. People on lots of medications might wonder what would happen if one or more of their regular medications was ceased. Our purpose is to understand better any benefits for older people to be on fewer regular medications, and understand any unforeseen risks of stopping regular medications in older people. Hospital doctors often cease a regular medication. We will not influence when and how that happens for you, only observe whether or not it does happen for you and call you after discharge to find out how you are feeling. Nothing about your hospital care will be different. Sometimes a patient is hospitalised as a result of a side effect of a medication which is then stopped; sometimes a patient is admitted to hospital for a different reason but a medicine needs to be stopped in hospital; sometimes a medicine is stopped because it is no longer beneficial. And sometimes no medications need to be stopped. These measures are all part of routine hospital care. We simply want to check on you after your hospital stay to see how you are feeling. We will also ask your nursing home for information about falls and General Practitioner (GP) call-outs to see you and any changes to your medication since discharge. With your permission we will also contact your GP and ask them to perform a routine diabetes blood test 3 months after you are discharged. This is called a “HbA1c” and it is a blood test that looks at your diabetes control in the last 3 months. Your GP would probably be doing this blood test anyway and we will ask him or her for the result. We will document your age and information such as your list of medications at the time of admission as well as discharge, the reason for your hospitalisation, what over medical conditions you have, whether or not you required another presentation or admission to hospital in the 6 months prior to and after this admission; your glucose (sugar) control before and after the first hospitalisation; the reason for admission if you do require readmission; which medications you are taking at 30 days and 3 months after discharge, to determine if any medications have been restarted that were ceased while you were in hospital the first time and the reason why a medication was restarted; and lastly, how you rate your quality of life.

  • Investigating the effectiveness of the Active Team mobile phone application in increasing physical activity

    Physical inactivity is a leading cause of disease and premature death worldwide. To address this, a growing area of interest is web-based physical activity interventions, which have the potential to reach large numbers of users at relatively low costs, and to effectively change behaviour. At the forefront are interventions capitalising on online social networks and gamification. The current study aims to test the efficacy of 'Active Team', a purpose-built, gamified physical activity intervention that connects users to each other via their Facebook profiles and is delivered via mobile phone application.

  • Influence of the Disease Label 'Polycystic Ovary Syndrome' on Intention to have an Ultrasound and Psychosocial Outcomes: A Randomised Online Study in Young Women

    Widening diagnostic criteria and improved imaging sensitivity have increased the number of reproductive-aged women diagnosed with PCOS from 4-8% to up to 21%. Given the increase in prevalence, the uncertain clinical benefit of knowing this diagnosis needs to be weighed against the potential for poor psychological outcomes in women labelled with PCOS. The purpose of this experimental study was to investigate the impact of the disease label PCOS on interest in medical interventions and on psychosocial outcomes. 181 young women were randomised online to receive one of four hypothetical scenarios of a doctor’s visit in a 2 (PCOS disease label vs. no disease label) x 2 (information about unreliability of ultrasounds in clarifying diagnosis vs. no information) design. Participants were university students (mean age: 19.4). After presenting the scenario, intention to have an ultrasound, negative affect, self-esteem, perceived severity of condition, credibility of the doctor, interest in a second opinion and response efficacy and costs of having the ultrasound were measured. Participants were then presented with a second scenario, where the possibility of PCOS overdiagnosis was mentioned. Change in intention and perceived severity were then assessed.

  • SurgiSeal (Registered Trademark) (medical adhesive) to prevent ooze and early dressing failure for Peripherally Inserted Central Catheters (PICCs) (The STICC randomised controlled trial)

    The primary aim of this study is to identify clinical, cost-effective methods to promote haemostasis and prevent PICC dressing failure and associated workloads. The randomised controlled trial also aims to compare current PICC dressing techniques with tissue adhesive (TA) in terms of haemostasis, dressing duration, workload and healthcare costs; and evaluate the acceptability of this product to paediatric and adult patients and health professionals. You may be eligible to participate in this trial if you are receiving treatment in a tertiary health-care setting and a receiving a Peripherally Inserted Central Catheter (PICC) as part of your prescribed care (no age limits). All participants enrolled in this trial will be randomly allocated (by chance) to receive (1) standard care with tissue adhesive (TA) at the PICC insertion site or (2) standard care (with no tissue adhesive). If you are allocated to the Tissue Adhesive (TA) group, the medical-grade glue will be applied at the time of PICC insertion only (one-time application). All participants: standard care dressing and securement will continue to be applied (routinely or as clinically indicated) from device insertion until the time of device removal. Participants will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine dressing changes, side effects, device failures and infections. It is hoped that the findings of this trial will provide information of the efficacy and acceptability of medical-grade tissue adhesive to promote haemostatis at the PICC insertion site (to prevent early dressing failure).

  • Does using an automated bladder diary improve compliance and data accuracy in patient completing a bladder diary?

    Voiding diaries are essential in the effective evaluation of males and females with lower urinary tract symptoms (LUTS). Since their initial use more than 50 years ago, voiding diaries have helped to contribute to the diagnosis and appropriate management of many patients suffering from functional urological issues. The evolution of the bladder diary over time has led to multiple formats and alterations tailored to suit differing clinical need. Although there is no accepted scoring system for urgency, incontinence and patient validation, the bladder diary is still currently the recommended and most accurate method of collecting voiding data. Despite this, these dairies are frequently tedious and time-consuming and are fraught with erroneous results due to a lack of patient compliance and accuracy of data collected. With the recent utilization of e-health devices and technology in both society and clinical practice, electronic voiding diaries have been introduced. These electronic diaries offer advantages over traditional paper diaries that result in improved data quality and increased patient compliance. However, current electronic diaries still depend on patient handling and measurement of urine and manual input of voiding data into devices. This remains burdensome and is a potential additive factor to inaccurately recorded volumes, incomplete data collection and potential misdiagnosis. The use of a fully automated voiding diary has definite potential advantages. By eliminating urine handling and automating measurement, it reduces the burden to patients, adds to accuracy of measured volumes and facilitates immediate and precise data entry. This may benefit clinicians by providing more detailed, easy to interpret results and ultimately improve clinical outcomes for the patient. The iUFlow (Kesem Health, Melbourne, Australia) device is one such example of an automated voiding diary.

  • MoOVi-therapy: Using illusory virtual reality exercises to treat neck pain

    Illusory movement as therapy: Background and plausible mechanisms. To date, persistent pain treatments targeting suspected tissue pathology have shown to have very limited or no ongoing benefit (see e.g. van Tulder et al., 2006a; van Tulder et al., 2006b). The quest for better treatments has seen attention shifted to include central mechanisms (Wand et al. 2011; Moseley & Flor 2012). While cognitive and behavioural approaches targeting thoughts, beliefs and behaviors undoubtedly have potential to alter neural processes associated with pain, considering brain-based approaches from a perceptual and brain science perspective will likely lead to a range of different treatment avenues. Recent perspectives highlight several pathways by which perception-altering associative learning processes might lead to chronic pain (Moseley & Vlaeyen 2015; Tabor et al. in publication; Zaman et al. 2015). Further, recent reviews have highlighted a potential role for multisensory illusions in developing future treatment opportunities (Senkowski and Heinz 2016; Moseley & Flor 2014; Boesch et al. 2016). It follows that similar mechanisms applied differently might reverse some of these processes. The view of chronic pain employed here, is one where pain persists because the affected body part(s) in someway continue to be represented in the brain as being under threat and requiring certain protections—perhaps because the injurious event-related encoding persists (Moseley & Vlaeyen 2015). One way to consider altering this bodily threat-related neural encoding is to disconfirm implicit expectations of pain, such as those during associated with movements. This requires an experience that is normally painful to be experienced without pain. Such violations of expectation are known to be powerful drivers of learning (Rescorla & Wagner, 1972), and are thought to alter prior implicit expectancies that may drive the resulting pain responses (Tabor et al. in press). Under normal clinical conditions, creating pain-free or non-threatening movement experiences, through which to extinguish implicit expectations of pain, can be difficult. The MoOVi illusion presents an opportunity for users to experience ranges of pain-free movement that exceed the expected range of pain-free movement. Doing so may assist to reinstate a less threatened bodily representation. This is conceptually similar, not only to mirror therapy, but to Graded Motor Imagery (GMI) — which targets progressive activation of motor processes without triggering unwanted protective responses (Moseley 2004; Moseley 2006). Indeed the final phase of three in graded motor imagery is illusory movement with mirror therapy, which has preliminary evidence of benefit for arm pain (Bowering et al. 2013). The purpose of this study is to determine whether pain-free illusory movement can reduce pain. We hypothesise that illusory movement exercises will reduce pain greater than movement alone.

  • A Phase II trial of durvalumab (Medi 4736) in advanced endometrial cancer

    The primary purpose of this trial is to evaluate the safety and efficacy of durvalumab for the treatment of advanced endometrial cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with advanced endometrial carcinoma which is suitable for chemotherapy. Study details All participants enrolled in this trial will receive an intravenous dose of durvalumab once every 28 days until the cancer is seen to have progressed, or until treatment side effects become intolerable. Participants will undergo continuous monitoring for side effects throughout treatment, as well as completing questionnaires and blood tests every four weeks, and CT scans every 8 to 12 weeks for the duration of treatment. It is hoped that this trial will provide information on whether durvalumab is safe and effective for the treatment of advanced endometrial cancer.

  • Comparing Goals-of-Care (GOC) with Not-for-Resuscitation (NFR) Orders in Medical and Oncology Patients. A quasi-experimental comparative pre-and-post study.

    SUMMARY This study aims to compare the current standard-of-treatment Not-for-Resuscitation (NFR) form with the soon to be introduced Goals-of-Care (GOC) form. The purpose of these two forms is to help guide the clinical staff in defining the overarching treatment goals for hospitalised patients, especially potential limitations-in-therapy, but with some fundamental and important differences. The overall design is a quasi-experimental pre and post study over two 6-month periods that will be conducted on the predominately medical and oncological wards of 71, 72 and 35 at St John of God Subiaco Hospital. These wards where specifically chosen because they incorporate healthcare disciplines with a higher burden of advanced disease states (e.g. cancer) and frailty (e.g. old age) requiring a greater awareness of end-of-life issues. The first six-month period will be considered the control period and will investigate the current standard-of-practice NFR form. The second 6-month period will be considered the intervention and investigate the new GOC form. Within each research period the investigators will collect both qualitative (patient and clinical staff surveys and interviews) and quantitative (categorical and continuous variables) data. Before the introduction of the intervention GOC period an education programme about the new form will be undertaken with the relevant clinical staff. The hypothesis of this study is that the new GOC form will lead to an earlier, greater and more controlled delineation of appropriate patient treatment plans by primary care teams at the expense of an increased clinical staff workload. IMPORTANT PLANNED DIFFERENCES BETWEEN THE USE OF GOALS-OF-CARE & NOT-FOR-RESUSCITATION FORMS a) The GOC care form has four clinical pathways compared to the two clinical pathways on the NFR form. b) The GOC form has to be completed for all patients, where the NFR form is completed in an ad-hoc manner. Where patients are clearly for full resuscitation (GOC category A), then any doctor can complete the GOC form without prior patient discussion buy “ticking” Category A and signing and dating the form. All other categories require consultant input. c) The investigators are designating that the GOC form must be completed within 48 hours of admission. There is not designation of timing for the NFR form

  • Probiotics for rupture of the membranes to delay preterm birth (the Pro-PPROM trial)

    Preterm birth is a leading cause of death and long-term neurological disability for infants, with PPROM accounting for over one-third of preterm births. Apart from perinatal morbidity, there is also maternal morbidity from PPROM related to infection, such as chorioamnionitis. This trial aims to provide evidence demonstrating that probiotic therapy in women with PPROM prolongs pregnancy duration, thereby delaying preterm birth and improving neonatal outcomes. Delaying preterm birth will have a major impact on clinical practice and benefit the health of infants locally, nationally and internationally. New molecular techniques using DNA sequencing methods are increasing knowledge and understanding of the organisms and microbiome of women with PPROM and preterm birth. Biospecimens collected in the pilot trial aim to demonstrate the change in the intrauterine and neonatal microbiome to provide more information on the beneficial effects of probiotics for women at risk of preterm birth. This will build on the emerging medical literature on the changes in the intrauterine and vaginal biomes of the pregnant woman and the gastrointestinal biome of the baby associated with preterm birth, antibiotics and probiotics. The changes in the maternal and neonatal biome for women with PPROM may assist in understanding the causation of PPROM and preterm birth.

  • Use of an online stress-reduction program in a workplace environment

    In this study we aim to measure the effectiveness of a series of interactive stress-reduction modules developed into an online platform by the funder Medibio. The Medibio ‘Unwind’ Stress Reduction Tool version 1.0 is a newly developed program of seven (approximately) 20 - 30 minute modules which provides information and strategies to alleviate the mental, physical and emotional effects of stress using the latest resources and treatment strategies from the field of psychology.

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