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.
  • The effect of exercise on peripheral neuropathy in people with diabetes

    Diabetic neuropathy is a common co-morbidity of diabetes that is a risk factor for foot ulceration and lower limb amputation. Exercise interventions may have the potential to reduce the burden of diabetic foot problems as a recent study demonstrated improvement in peripheral neuropathy symptoms after a structured exercise program in laboratory conditions. Exploration of these promising results in a pragmatic environment is required to understand the true effect of exercise in the management of peripheral neuropathy. Therefore, we will attempt to answer the following research question: Does structured exercise training improve neuropathic signs and symptoms in people with diabetes and peripheral neuropathy? To answer this question, a pilot randomised controlled trial will be conducted. People with diabetes and peripheral neuropathy will be recruited. Following preliminary testing and randomisation, participants will attend three supervised exercise sessions per week or a diabetes lifestyle coaching program for 8-weeks. Repeat testing will be completed after the completion of the exercise or education program. The primary outcome will be the validated Michigan Neuropathy Screening Instrument score and secondary outcomes will include three separate physical function tests that explore aerobic fitness, lower limb endurance and balance. Based on neuropathy-related effect found in the previous study, approximately 24 participants in each group are required to identify a medium effect (power = 80%, p = 0.05).

  • Choice of breast reconstruction (immediate, delayed or none) and quality of life for women undergoing mastectomy and radiotherapy for breast cancer.

    This study will assess the quality of life in women with breast cancer, from a surgical oncology practice in North Sydney, Australia, who undergo mastectomy and post-mastectomy radiotherapy (PMRT). Study details All participants in this study will be asked to complete a number of questionnaires over a period of 5 years post-mastectomy in order to assess quality of life, pain, aesthetic outcomes and clinical outcomes. If immediate breast reconstruction (IBR) is found to improve the quality of life of patients who are undergoing mastectomy and subsequent adjuvant treatments, then IBR could be offered as an option to breast cancer patients who are reasonable candidates for this procedure. This will be the first prospective cohort study in Australia to assess the quality of life of women undergoing mastectomy and PMRT, and allows for comparison of outcomes according to breast reconstruction choices - immediate, delayed or none.

  • A person-centred model of residential respite care transition support: The Transition Support-Person Centred Care (TS-PCC) Program for family caregivers and care recipients with dementia

    The research design to be employed is a cluster randomized controlled trial of a multi-component intervention designed to improve the experience of Residential Respite Care (RRC) for people with dementia and their carers. Clustering will occur at the facility level with randomisation by necessity occurring at this level in order to prevent contamination of results due to changed processes during RRC admission required by the intervention. Thus, two facilities will be allocated as the intervention facilities and two as control facilities. Random allocation will occur via a random number generator. The program will provide support and communication before, during and after residential respite admission in order to facilitate the transition to respite care. Participants with dementia (PWD) and their carers will be interviewed face – to –face and also complete self –report instruments 2 weeks prior to moving into RRC. Allocation of residents will occur to either intervention or control group and all will be assessed during RRC admission. PWD and their carers will be interviewed face to face and asked to complete self report measures when transiting back to home care. PWD and their carers will be interviewed via telephone and asked to complete self report measures three months following return to home care.

  • PROTECT-ICD Trial: Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias following Acute Myocardial Infarction

    The PROTECT-ICD study is a multi-centre randomised controlled trial targeting prevention of sudden cardiac death in patients who have reduced cardiac function following a myocardial infarct. The primary objective of the trial is to assess whether electrophysiologic study to guide prophylactic implantation of an implantable cardioverter-defibrillator early following MI (first 40 days) will lead to a significant reduction in sudden cardiac death. The secondary objective is to assess the utility of cardiac magnetic resonance imaging in assessing early myocardial viability, and its predictive value for both inducible and spontaneous ventricular tachyarrhythmias post-myocardial infarction.

  • Patient Satisfaction Following Breast Reduction

    Breast reduction surgery improves the quality of life of women with large breasts, with regard to both physical and psychosocial symptoms. At present two very different techniques predominate, with no consensus on whether the choice of operative technique affects patient satisfaction/quality of life (QOL). We aim to perform a prospective randomised cohort study to compare patient satisfaction/QOL following breast reduction using either the inferior pedicle Wise pattern or superomedial pedicle Hall-Findlay technique.

  • Prostaglandin Inpatient iNduction of labour Compared with BALLOon Outpatient iNduction of labour: a randomised controlled trial

    Many babies arrive naturally in a timely manner, however, sometimes we need to assist (or ‘induce’) a pregnancy if there are any complications, or if the pregnancy goes well beyond the due date. It is estimated that one in four women have an induced labour. The induction of labour is commonly commenced by placing some hormone gel (called Prostaglandin) in the vagina to make the cervix (the opening of the womb into the vagina) softer and allow it to open. Induction of labour can also be commenced using a small tube with a balloon on the end, inserted through the cervix and then inflated to mechanically stretch the cervix. In Australia, both methods are commonly used to prepare the cervix for labour. Following either method, when the cervix is more open, contractions are brought on by breaking the waters around the baby (called artificial rupture of membranes or ARM) and administering a hormone fluid (called Syntocinon) intravenously (IV; or into a vein). Sometimes, the induction process may be prolonged and it can take many hours, even days, before the cervix is more open. Prostaglandin hormone gel, in particular, can induce contractions. It is common practice that women undergoing induction remain an inpatient over this time. Balloon catheter induction is however very unlikely to induce contractions and there is even some published studies suggesting balloon catheter inductions may be associated with less chance of distress to babies. As such, for some women undergoing induction of labour with a low-risk, uncomplicated pregnancy, it would seem reasonable to go home after placement of the balloon catheter. The primary aim of the study is to demonstrate that going home after commencing an induction of labour using a balloon catheter is just as safe as having prostaglandin gel induction and remaining as an inpatient. We are additionally interested in the duration of labour, mode of birth, length of hospital stay, overall healthcare costs for women undergoing both induction policies, and which method is perceived by women to be more satisfactory.

  • Does disinfection of Intensive Care Unit rooms with Hydrogen Peroxide Vapour, in adults, compared to standard disinfection practices, is equivalent to, or reduce the transmission to patients of Clostridium difficile and multi-resistant organisms?

    The transmission and acquisition of health care associated microorganisms by hospitalised patients is associated with serious morbidity. Critically ill patients are particularly susceptible to serious infections with these organisms due to the nature of their illness and the numerous vascular and intra-cavity devices they have. It is known that persistence of these organisms within the healthcare environment is a major source of these transmissions. Environmental cleaning is important in the control of these organisms and traditionally relies on wet cleaning methods of the patient environment with detergents and disinfectants. This process of cleaning is time consuming, requiring significant resources and personnel. In addition, much of the environment is not easily amenable to these cleaning methods (e.g under surfaces, monitoring devices). Increasing bed occupancy and bed turnover creates added pressure to the effectiveness of these traditional cleaning methods. Hydrogen peroxide vapour (HPV) is an attractive alternative to these traditional cleaning strategies. This is due to being less personnel dependent, the vapour will effectively reach more difficult areas, simplifies complex cleaning process for numerous types of surfaces and recent evidence suggests that it is more effective in eliminating environmental organisms than traditional disinfection treatments. This study aims at assessing the effectiveness and practicality of using HPV compared to traditional cleaning methods in the routine ICU patient discharge cleaning process. Specifically we are looking at the control of the acquisition of hospital acquired organisms by patients in a busy general intensive care unit. Null Hypothesis: “ That Hydrogen Peroxide Vapour is no better than standard double cleaning (viraclean and detergent, no bleach) procedures in regards to acquisition of hospital acquired Clostridium difficile and multiresistant organisms during the course of an ICU admission. “ The Multi Resistant Organism (MROs) acquisitions to be measured include: - Multi Resistant Gram Negative bacteria (MRGN), - Methicillin Resistant Staphylococcus aureus (MRSA), - Vancomycin Resistant enterococci (VRE) and Clostridium Difficile cultures will only be collected if they are clinically indicated. Clostridium Difficile will not be included on routine admission and discharge swabs to Intensive Care. There will be a planned interim analysis at 4 months to re-calculate the sample size required.

  • Is reading therapy effective for people who have reading difficulties related to impaired cognition and language after stroke?

  • Evaluation of short term support for emergency department attendees who present with moderate and high levels of stress: a pilot study

    Mental health (MH) problems are a major public health concern. Because the prevalence of MH issues is higher in the Emergency Department (ED) than the general population norm, the ED is a potentially effective (but neglected) setting to target these issues. Detection of mental health problems before they become severe will enable intervention and support to be provided at an early stage, which may improve health and prevent further deterioration. The proposed study focuses primarily on participants with mild and moderate levels of psychological distress as identified by the Kessler Psychological Distress Scales and will exclude those with severe levels of psychological distress as this may indicate an existing mental disorder. The primary hypothesis to be tested is that, compared to patients who receive standard care i.e. no BI, patients who receive early BI (MI and MI follow-up) will report: 1) reduced levels of depression, anxiety and stress; 2) higher levels of motivation to self-manage health needs; 3) increased (appropriate) healthcare-seeking behaviours; and 4) improved quality of life.

  • Identification of biomarkers in patients with malignant pleural mesothelioma undergoing chemotherapy

    The study will investigate how to improve identification of patients with malignant pleural mesothelioma who will derive benefit from treatment with chemotherapy and/or investigational agents, and also identify any potential factors that may predict overall outcome of the patients including survival (prognostic factors) so that individualised therapy is possible for patients with malignant pleural mesotheliom. Who is it for? You may be eligible to join this study if you are aged over 18 years, have a pathological diagnosis of malignant pleural mesothelioma, and about to commence on chemotherapy of choice by the treating physician including first line, second line or experimental regimens. Trial details: Participants with malignant pleural mesothelioma in all stages of disease will be recruited. Participants will be treated with the current chemotherapy of choice by the treating physician, including first line, second line or experimental regimens. There is no study specific intervention. participants will be consented for collection of their tumour tissue, blood samples and answering some questionnaires at baseline and subsequent follow ups.

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