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.
  • Changing practice in the assessment and treatment of somatosensory loss in stroke survivors: An Implementation study

    Stroke continues to be the leading cause of adult disability in Australia. Research reveals half of all stroke survivors present with sensory deficits, resulting in difficulty feeling everyday objects through touch and knowing where one’s limbs are in space. Rehabilitation of sensory deficits has historically been neglected, with an evidence-practice gap existing between research knowledge and clinical practice. The primary aim of this implementation study is to improve the health outcomes and reduce the burden of sensory loss in stroke survivors. Implementation will be achieved through the use of evidence-based research-transfer methods and outcomes will include functional outcomes for stroke survivors and effective transfer of knowledge to occupational therapists and physiotherapists.

  • A randomised controlled trial of online versus telephone-based information and support: Can electronic platforms deliver effective care for lung cancer patients?

    The primary purpose of this study is to evaluate whether proactive telephone or online support for lung cancer patients can improve patient wellbeing. Who is it for? You may be eligible to join this study if you are aged 18 years or over, have been diagnosed with any form of lung cancer in the past 4 months and have internet access on any device. Study details Lung cancer patients often experience poorer prognosis, more severe physical effects and more pronounced psychosocial distress than patients with other major cancers. A highly accessible and sustainable source of personalised support for cancer patients is the Cancer Council Helpline in each state. Participants in this study will be randomly allocated (by chance) to receive either telephone support including at least 1 telephone call from the Helpline, Online support by email or live web chat including at least 1 email from the Helpline, or to receive a booklet 'Understanding lung cancer' in the mail. Helpline support provided to the telephone and email support groups includes information, linking callers with services in their local area, and providing emotional support. When patient distress is high or medical advice is required, referral to relevant services within or outside the Cancer Council will be offered. All participants will be asked to fill out a mailed questionnaire at 3 and 6 months after their enrolment in the study. It is hoped that this study will provide evidence of whether a proactive approach can recruit a high proportion of lung cancer patients to Helpline, whether the Helpline model of information and support is effective in improving wellbeing, and whether an electronic approach can provide equivalent outcomes to a telephone-based approach. These results will have national and international relevance for decisions about community-based information and support.

  • The springboarD trial: Trial of a self-help intervention to improve functioning and emotional well-being for people with type 2 diabetes

    This project will test the hypothesis that functioning and mental wellbeing will be improved in people with type 2 diabetes and comorbid depression following the use of a fully-automated mobile phone and web-based mental health intervention (‘myCompass’) for 12 weeks, compared with those who receive a placebo intervention.

  • Chronic effects of isoflavones on cognition and aggression in a female population across the menstrual cycle.

    Cognition and aggression were assessed during four phases of the menstrual cycle across one baseline cycle with no treatment, followed by two cycles with either 200 mg isoflavones daily or placebo. A comparison group of long term oral contraceptive users were also included and received only placebo during the treatment cycles. Brain activity was measured using electroencephalography (EEG) during the baseline and second treatment cycles.

  • Efficacy of cognitive behavioural therapy for social anxiety disorder, and the use of stress and sex hormones for predicting response to treatment

    The main aims of the current study are to: (a) investigate the efficacy of intensive individual cognitive behavioural therapy (CBT) for social anxiety disorder (SAD) and (b) examine the capacity of the stress hormone cortisol to predict treatment response to intensive CBT in individuals with SAD. This project will test these aims in a preliminary, single group open trial design. Treatment will consist of three 60-minute sessions of CBT each week over four weeks, (12 hours in total). Saliva samples will be collected at 3 of these 12 sessions in order to measure cortisol levels in response to exposure therapy.

  • Nurse-led atrial fibrillation management- the NEAT study.

    The study is a single blind randomised controlled trial to determine whether a nurse-led clinic which uses a mobile enable web app (a computer program that also works on a smartphone or tablet) to guide discussion between the nurse and patient, can improve lifestyle risk factors and health related quality of life (HR-QoL) in participants with AF. The study aims to provide evidence of feasibility with the intention to seek funding for a larger study.

  • A randomised controlled trial comparing internet-delivered Cognitive Behavioural Therapy (iCBT), internet-delivered Mindfulness-Enhanced Cognitive Behavioural Therapy, internet-delivered Mindfulness Skills Training versus usual care for adults with depression and/or anxiety.

    This project aims to compare the efficacy, acceptability and feasibility of three internet-delivered programs for adults with depression and/or anxiety symptoms: an internet-delivered cognitive behavioural therapy program versus an internet-delivered mindfulness-enhanced cognitive behavioural therapy program versus mindfulness skills training program, compared to usual care. Up to 200 people with elevated symptoms of depression and/or anxiety will be randomly assigned to one of the three treatment groups or the treatment as usual control group (TAU). All groups will commence their intervention immediately, except for the TAU group who will receive the mindfulness-enhanced iCBT program after the 14 week waiting period. The efficacy of the three programs will be compared at post-treatment (immediately after the treatment period finishes) and 3-month follow-up by comparing their symptoms of depression, anxiety and distress.

  • Understanding the Falls Experience in People with Intellectual Disability in Western Australia

    Falls have also been identified as a serious health issue which can cause serious physical injuries and fear of falling. People living with intellectual disability (ID) in residential settings have been reported to have a higher incidence of falls and experience falls at a younger age than the general older population. There are existing comprehensive multi-targeted interventions and services for the older mainstream populations, however, its been reported that there are no suitable falls prevention guidelines or specific services targeting people with ID and their care providers. The purpose of this study is to gain an understanding of the nature of falls in people with ID and to identify gaps in recommended falls prevention service pathways that people with ID may face. The study will also investigate the barriers that people with intellectual disability may face in engaging in evidence based falls prevention guidelines. This will allow the development of preliminary recommendations for falls prevention that are specifically targeted for people with ID.

  • Evaluation of Donepezil Transdermal Delivery System (TDS) formulations versus oral Donezepil (Aricept) in healthy volunteers

    This is a Phase 1, open-label, cross-over, randomized, study in healthy subjects conducted in two parts. Part A of the study is a three-way cross-over, partially randomized (for the first two treatment periods) design to evaluate the PK, safety, tolerability and PD of donepezil administered from two different formulations of a TDS (Donepezil TDS LF 50 cm2 and Donepezil TDS HF 50 cm2) compared to oral donepezil (Aricept). Part B of the study is a two-way cross-over, randomized design to evaluate the adhesive properties, safety, tolerability and PK of a larger donepezil TDS (either Donepezil TDS LF 150cm2 or Donepezil TDS HF 100cm2) with two different backing laminate compositions.

  • Simple solutions to gastro-intestinal symptoms in chemotherapy patients

    The primary purpose of this study is to determine whether simple mouthwashes can decrease symptoms of poor appetite, taste changes, nausea and vomiting due to chemotherapy. The study also aims to predict which patients will develop the most symptoms based on genetic and taste bud counting tests. Who is it for? You may be eligible to join this study if you are aged 18-85 years and due to receive intravenous chemotherapy of cyclophosphamide or 5-FU. Study details Prior to the first cycle of chemotherapy, genetic characteristics of each participant's taste will be tested using saliva samples, and the number of taste buds on the tongue will be counted. After 2 cycles of chemotherapy, participants will be asked to rate their symptoms of appetite, taste changes, nausea and vomiting. Patients with these symptoms will then test 6 different simple mouthwashes, including salt, sodium bicarbonate, sugar, ginger and peppermint oil, in a random order for 1 day per mouthwash. Patients will be asked to rate the effectiveness of each of the mouthwashes in reducing symptoms via questionnaire. It is hoped that these simple mouthwashes may be able to minimise symptoms, thus improving chemotherapy patient well-being, potentially increasing oral intake and thereby improving nutritional status.

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