ANZCTR search results

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

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31382 results sorted by trial registration date.
  • Treatment of sleep disturbances in individuals with insomnia and depression.

    Insomnia and Depression share many common features such as low energy, fatigue, poor concentration and sleep difficulties. Insomnia is not just a symptom of depression however, and this is why insomnia symptoms remain nearly 50% of the time through antidepressant treatment. The objective of the current research is therefore to treat the sleep disturbances in individuals with depression and insomnia (whose symptoms have not remitted through at least 6-weeks of antidepressant treatment) with 4 sessions of CBT-I. The aims are to improve the participant's quality of sleep and reduce both their insomnia and depression severity. Our primary hypotheses are that participants receiving CBT-I will have significantly improved sleep quality and significantly reduced insomnia and depression severity compared to an information only control (IOC) group after the 8 weeks of treatment and at the 3-month follow-up session.

  • ROLLIS: Radioguided Occult Lesion Localisation using Iodine Seeds to localise impalpable breast lesions: The Pilot Extension Study

    This study aims to allow us to gain more experience in the use of a technique called "ROLLIS" (Radiooccult lesion localisation using Iodine 125 Seeds), which was developed as an alternative to the use of hook wires to guide the operative removal of small abnormal areas in the breast that can't be felt, and has been in routine clinical use at the Mayo Clinic for ten years. Who is it for? This study expands on the inclusion criteria used for prior pilot study ACTRN12611000667910 (http://www.anzctr.org.au/trial_view.aspx?ID=342989) with addition of use of lower dose radioactive seeds (to assess whether technique is still effective) and the inclusion of lesions (a) with benign or indeterminate pathology on core biopsy and (b) use of more than one seed per participant where there are bilateral lesions and to bracket the edges of larger lesions. Trial Details The aim of the current study is to allow us to gain more experience in the use of this technique. Study participants will have both an I 1 25 seed, as well a hookwire inserted by a radiologist, to localise the abnormal area in their breast. The insertion of the seed will add approximately 5 minutes to the time usually needed by the radiologist to mark the abnormality. No extra discomfort will be experienced as local anaesthetic is routinely given for the standard procedure and no extra mammograms will be needed in most cases. The seed usually makes it quicker and easier for the surgeon to find and remove the abnormality. The seed is removed together with the abnormal area in the breast and pathology processing of the specimen occurs as per routine. The seed is removed from the specimen by the pathologist and given to the physicist for return to Medical Physics for disposal. Participants will be asked to complete two questionnaires, one at the first post op visit designed to assess their experience with the procedures, and the other will be posted to them, to evaluate how participants feel about the appearance o f their breast after the surgery. Completion of these will be voluntary. The literature suggests that cosmetic results may be improved with ROLLIS. We wish to assess participants experiences (positive or negative) with the technique and validate the use of these questionnaires for a future Randomised Controlled Trial to assess whether ROLLIS produces better patient outcomes compared with Wire Localised Surgery.

  • The Usefulness of On-site Physiotherapy Triage Services for Professional Orchestral Musicians - A National Study

    The term triage is used to refer to health services that provide a preliminary assessment of patients reporting an injury to then determine an appropriate course of management. This approach has been shown to be successful in many other elite performance domains within the athletic and dance populations. The purpose of this study is to evaluate the effectiveness of on-site physiotherapy triage clinics in a national cohort of professional orchestral musicians. Outcomes will include recording the numbers of musicians using the service, analysing the consultation information from the physiotherapists, and evaluating the 3 month follow up feedback from the musicians on their perceived helpfulness of this service.

  • Drug assisted psychotherapy to treat posttraumatic stress disorder in war veterans, using 3,4-methylenedioxymethamphetamine (commonly known as MDMA).

    This is a Phase 2 randomised, multi dose, double-blind study to assess the safety and efficacy of MDMA-assisted manualised psychotherapy in Australian military war veterans with chronic, treatment-resistant PTSD.

  • Investigating Fatigue, Balance, Falls and Mobility in people with Multiple Sclerosis

    The purpose of this study is to examine the effects of fatigue on mobility, balance and falls risk in people with Multiple Sclerosis. We also would like to investigate the effect of a simple Dynamic Dorsiflexion Ankle Orthosis (DDAO) on mobility and balance.

  • Can Transcranial Electrical Stimulation enhance working memory in schizophrenia and healthy controls?

    Working memory difficulties are commonly experienced by individuals with schizophrenia and schizoaffective disorder. These difficulties have been shown to negatively influence patients’ psychosocial functioning. Any technique that may enhance working memory would therefore be very useful. Recent research has suggested that brain stimulation, and in particular transcranial Electrical Stimulation (TES) techniques such as transcranial Direct Current Stimulation (tDCS) and transcranial Alternating Current Stimulation (tACS), may have a role to play in improving cognition. TES techniques have been shown to be a safe and non-invasive way of modulating brain activity, by applying a very weak electrical current (1-2mA) to the cortex via electrodes that are placed on the scalp. While tDCS has been shown to improve working memory in a number of conditions, to date there have been no tDCS or tACS studies looking at the enhancement of working memory in schizophrenia. The current study will investigate whether working memory can be improved using tDCS and tACS in healthy participants and patients with schizophrenia or schizoaffective disorder. Further, the study aims to establish the most effective stimulation parameters for optimal working memory enhancement. Twenty healthy controls and 20 individuals with schizophrenia or schizoaffective disorder will attend 3 sessions at The Alfred hospital, each session involving a different type of TES (1mA tACS, 2ma tDCS, or sham stimulation). Participants' performance on a working memory task will be assessed following application of the stimulation, and brain activity will be monitored throughout the tasks using electroencephalography (EEG).

  • Botulinum Toxin A (BTXA) versus Hydrodistension for Refractory Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)- a Multicentre, Prospective, Randomized, Double Blind Study

    Background IC/PBS requires effective treatment options. Objective Is BTXA effective for the treatment of IC/PBS? Design, Setting and Participants: 2003-2009, 55 severe, refractory female subjects from 3 referral centres invited. UTI, malignancy, steroid use excluded. Intervention Double blind design, random allocation to treatment with hydrodistension and bladder wall injection of normal saline, or else hydrodistension with injection of BTXA. Outcome measures and statistical Analysis O’Leary Sant (OLS) problem (PI) and Symptom (SI), UIIQ, compared between BTXA and controls. Repeated measures ANOVA tested whether BTXA subjects performed better than control subjects (group effect) for changes from baseline to 3 months (time effect) by assessing significance of group by time interaction. Multivariate modelling analyzed effect over time of other possible confounders. Measurements made beyond 3 months, but no further randomized comparisons possible, as majority subjects then chose active BTXA injection. Withdrawal; 4 subjects completed questionnaires too poorly, 1 withdrawn pre treatment with bladder cancer, leaving 50. Results and limitations: In both groups, the OLS, bladder diary, UIIQ scores showed improvement over 3 months. But no difference detected during initial analysis between the BTXA and control subjects for any outcome measure except OLS PI, where improvement noted at 3 months (P=0.04). 12 had UTI treated during the study. This significantly confounded, with greater improvement seen in the control group treated for UTI. Multivariate modelling accounted for effect of UTI showing improvement in the total OLS score (P=0.02), the OLS SI for the BTXA (P=0.008) group, pain (Q4 of OLS PI) (P=0.015) for the BTXA group at 3 months. 24% request continuing periodic BTXA treatment. Conclusions BTXA treatment improves OLS score at 3 months when compared to hydrodistension and saline injection alone, for a minority women. Consideration of the significant confounding effect of UTI, strengthened this improvement.

  • Visually Induced Postural Sway in Elderly Fallers

    The purpose of this study is to determine whether certain visual conditions affect elderly fallers ability to balance when standing. We will see if changes to balance have any relationship to symptons of dizziness, anxiety and/or fear of falling.

  • A randomised controlled trial (RCT) of brief internet-delivered education about managing symptoms of anxiety and depression in tertiary Chinese students

    The purpose of this project is to explore the efficacy of a clinician-guided education course for symptoms of anxiety and depression in International Chinese-speaking tertiary students (aged 18+), administered over the internet in a randomised controlled trial. A secondary purpose is to determine the acceptability of the education protocol and materials to International Chinese-speaking tertiary students with symptoms of anxiety and depression. A tertiary purpose of this project is to explore the efficacy of a self-guided version of the course, with participants from the Waitlist Control Group.

  • Internet Self Help Therapy for Problem Drinking: Retention and Effectiveness

    The current study aims to conduct a randomised controlled trial over 3 months (with the possibility of a 6 month follow up) that compares the impact of the following two internet-delivered interventions on alcohol consumption: 1. Online alcohol intervention: includes open access to the OnTrack alcohol intervention 2. Online alcohol intervention with text messaging: includes open access to the OnTrack alcohol intervention plus the addition of text messages reminding participants to log on to the program and stay on track The study has three major research aims: Aim I: to investigate the impact of text messaging as a supplementary support for online treatments. * determine to what extent the addition of text messaging impacts participants’ engagement in the program * does the addition of text-messaging impact the effectiveness of the program * are drop-out rates lower in the text messaging condition than in the control condition Aim II: to determine the average dose of treatment required for improvement * investigate the effectiveness of the intervention in relation to the amount of time spent utilising it Aim III: to learn more about people who prematurely discontinue online treatments * gain a better understanding of why individuals drop-out through follow-up interviews * identify to what extent these individuals are still utilising the skills and techniques they acquired within the intervention after drop-out It is predicted that the web-based alcohol intervention with text messaging will result in lower attrition rates, greater engagement with the program and greater utility of skills than the treatment alone condition. Further, it is predicted that the addition of text messages will improve the effectiveness of the program by reducing self-reported alcohol intake. We also hope to determine whether the intervention improves quality of life; and general well-being and if it is considered useful, relevant, satisfying and easy to use.

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