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.
  • A double-blinded randomised control human clinical trial evaluating the safety and effectiveness of colloidal silver sinonasal rinse versus standard of care on post-operative symptomatic outcomes in the treatment of Chronic Rhinosinusitis in adults.

    Chronic sinusitis is a debilitating and costly disease. Consistent inflammation and infection of the sinuses causes headaches, facial pain, blockage of the nose and discharge from the nose. The cause of this condition is not fully understood, and it is difficult to treat with surgery being the recommended treatment for some patients. But even after surgery, many patient’s symptoms return, and they may need repeat surgeries in the future. We currently recommend sinus rinses after surgery as a way of keeping sinuses clean and clear and to assist with healing and reducing inflammation and infection. We have previously found that proper care post-operatively can reduce the chances of requiring further surgeries and part of our research has been assessing the different rinses. Our laboratory studies have shown that colloidal silver reduces infection load significantly. In the laboratory, we have improved this product’s manufacturing process by using extracts from gum tree fresh leaves which are abundant in Australia. The safety of colloidal silver was tested in the lab and according to the results it is safe to the sinuses. This clinical trial is aimed at assessing 1. The safety of colloidal silver administration by sino-nasal rinse by documenting any adverse effects and 2. The effect of sinonasal rinse of colloidal silver combined with topical antibiotics on infection load in chronic sinusitis, compared to standard-of-care oral antibiotic tablets. This will be assessed by endoscopic assessment of the sino-nasal tract by a doctor, measuring bacterial load in the laboratory and completion of symptom questionnaires by participants.

  • Integrating Palliative Care in Liver Cancer Care Pathways

    This study aims to evaluate the effectiveness of a symptom assessment supported by a clinical care pathway for adult patients with liver cancer who are attending ambulatory liver cancer clinics. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with an active liver cancer and you are attending one of the participating liver cancer and palliative care centres as an outpatient (Royal Prince Alfred Hospital, Westmead Hospital, Liverpool Hospital and St George Hospital). Unpaid carers for eligible patients will also be invited to participate. Study details Depending upon the hospital/clinical care centre that participants would normally attend they will either continue to be treated per the current care guidelines or they will be invited to participate in the intervention model of care. Participants who attend either of the usual care or intervention centres will be asked to complete two questionnaires about their symptoms and quality of life at each of their scheduled visits, and will be provided with instructions that they can raise any symptom concerns with their treating clinician at their appointment. Completion of the questionnaires is anticipated to take 10-15 minutes. Carers of participants who attend one of the intervention centres will also be asked to complete a questionnaire about their support needs. For participants and carers who attend one of the intervention centres, the questionnaire responses will be assessed against a set of criteria. If the participant is experiencing a decrease in their quality of life, an increase in their symptoms and/or severity of symptoms, or the carer has identified that their support needs are not being met this will trigger a referral to be sent to palliative care services. Participants who receive this referral will also be reviewed by a Palliative Medicine Specialist for further clinical review so that they may be provided with personalised symptom management, other supportive management and interdisciplinary referral as required. It is hoped this research will determine whether implementation of a symptom and needs-based assessment framework for additional palliative care services is feasible and whether this framework has a positive impact on the quality of care of patients with liver cancer. If the assessment framework model of care is seen to have a positive impact, it may be expanded to include a greater number of clinic care centres which would allow further patients with liver cancer to receive more personalised care.

  • Australian Epilepsy Project

    The Australian Epilepsy Project (AEP) is a large scale project with a planned 4000 participants using a package of both established and experimental testing in epilepsy to improve our ability to both provide accurate prognosis and diagnose surgically-curable disease. The package will include advanced MRI, neuropsychological assessment and genetic testing.

  • Efficacy of a digital pain management intervention on pain and reliance on opioids in patients with rib fractures

    Patients who engage with behavioural pain management strategies (e.g., relaxation, thought management) have better pain relief and use less opioids. However, delivering these strategies in hospital settings can be costly and often is not feasible during acute pain service rounds. Emerging research indicates that behavioural pain management education can effectively be delivered using low-cost digital technology. The aim of this study is to test the hypothesis that patients who receive an mHealth intervention (educational video + supportive daily text messages) will utilise lower doses of opioids across the first week of hospitalisation and one week after discharge compared to those who receive the education video only.

  • Acceptability, feasibility, and effectiveness of a choir for enhancing quality of life in people diagnosed with dementia and their caregivers

    People with dementia and their caregivers often experience loneliness and depression, which can impact their quality of life and caregiver burden. One promising social intervention is choir singing - an accessible and enjoyable activity that benefits memory and thinking, social connectedness, and mental wellbeing of older adults. Previous studies have reported varying results about the extent to which choirs improve quality of life, mood, and wellbeing for people with dementia and their carers. We are partnering with Bulimba community centre to evaluate the Sing Sing Sing choir program for people with dementia and their caregivers living in the community. We will survey people in the early days of joining the choir (0-3 months post starting intervention) and follow them up once 6-8 months after their first survey to determine whether choir participation improves the quality of life, wellbeing, mood and loneliness of people with dementia and their carers; and whether it reduces burden for carers of people with dementia. We will also interview the participants to ask them about what they have experienced as the most significant change for them since taking part in the choir. By building on the growing body of research into choirs for people living with dementia, we will develop an evidence base to understand how to make these interventions most effective.

  • A Phase II pilot study to determine protocol feasibility, and potential efficacy for disease modification of combined Doxycycline and Ambroxol in Dementia with Lewy Bodies

    The purpose of this study is to determine the feasibility of the research protocol, as well as assess the potential effectiveness of the study medication (combination of doxycyline and ambroxol) in slowing the progression of Dementia with Lewy Bodies. Treatment effectiveness will be evaluated by means of clinical disease rating scales and questionnaires that evaluate participants’ DLB-related symptoms, quality of life and general health. The results of this study may help identify future disease modifying strategies for DLB, as well as provide the clinical trial framework with which to further investigate their effects on the disease. Participants will be assigned to either the active treatment group, or a placebo group. To try to ensure the groups are allocated fairly, each participant is put into a group by chance (randomisation).

  • Phase II trial to evaluate the safety, feasibility and efficacy of using therapeutic weighted blankets for agitation in patients with dementia in acute care settings.

    The rate of hospitalisations for persons living with dementia has increased in recent years, and the average length of stay is 13 days (five times the average hospitalisation) (AIHW, 2021). Persons with dementia can often experience behavioural and psychological symptoms of dementia (BPSD) including agitation while in hospital. Agitation experienced by patients with dementia is associated with poor health outcomes, long-term hospitalisation, overuse of medication, and increased health care costs (Cerejeira et al, 2012). Medical-grade therapeutic weighted blankets may be safe, and feasible to reduce agitation experienced by patients with dementia during hospitalisation. This research aims to evaluate the feasibility, safety and efficacy of using therapeutic weighted blankets to reduce agitation in patients with dementia in acute care settings. Objectives: To report the safety of using weighted blankets for patients who have a dementia diagnosis in acute healthcare settings. To report the feasibility of using weighted blankets for patients who have a dementia diagnosis in acute healthcare settings. To report the efficacy of using weighted blankets for patients who have a dementia diagnosis in acute healthcare settings.

  • Screening participant and health service impact of population-based breast density notification in Australia: a randomised controlled trial in BreastScreen Queensland

    This study aims to assess the effect of notifying women participating in population-based breast cancer screening of their breast density on their psychosocial outcomes and health services use; and to determine whether using different modes of communication (hard-copy vs online) alters these effects. Study details: You may be eligible for this study if you are a woman attending BreastScreen Queensland Sunshine Coast Service for a mammogram and are found to have dense breasts (BI-RADS category C or D - heterogeneously dense or extremely dense). Please note that this study is not enrolling women who have been diagnosed with breast cancer or ductal carcinoma in-situ. Participants will be randomly allocated to one of three arms: 1) standard care in BreastScreen Australia (no notification of breast density) vs. 2) notification of breast density plus a hard-copy written health literacy sensitive information vs. 3) notification of breast density plus online written and video-based health literacy sensitive information. Participants will then be followed up for over 2 years and be asked to complete questionnaires assessing their anxiety, health service usage and changes in knowledge and breast screening habits. It is hoped that findings from this study will help determine the utility and effects of providing breast density information to women as part of population-based breast screening.

  • The ROSEND Trial - A Randomised trial for the treatment of recalcitrant symptomatic rosacea using definitive volumetric modulated arc radiotherapy or standard dermatological treatment

    The ROSEND clinical trial aims to compare standard of care dermatological treatment with a specialised type of radiotherapy called volumetric modulated arc radiotherapy (VMAT) in patients who suffer from chronic, recurrent rosacea. The study hypothesis is that VMAT will lead to a significantly lower rate of return of rosacea in the treatment area within 12 months of randomisation. Who is it for? You may be eligible for this study if you are an adult over the age of 60 who has been diagnosed with chronic, recurrent, moderate to severe rosacea for at least 10 years and have relapsed following treatment with at least one systemic therapy and one topical therapy. Study details Participants will be randomly assigned to either standard of care dermatological treatment or VMAT as part of this study. In Arm A, called the current standard of care, treatment will be one or a combination of the standard dermatological treatments which will involve; topical therapy applied for a minimum of 16 weeks (Metronidazole (0.75%) gel or cream, applied once or twice daily or Ivermectin (1%) cream applied once daily), and/or Vascular laser or Intense pulse light treatment – limited to three episodes of treatment, with a maximum of four weeks between each episode, and/or Oral antibiotic therapy (Doxycycline 50-100 mg per day or Minocycline 50-200 mg per day) taken for a minimum of eight weeks. All patients will complete quality of life and a medication diary. In Arm B, called Volumetric Modulated Arc Therapy (VMAT), participants will be given 20 treatments in once daily fractions delivered within a period of eight (8) weeks in total inclusive of a mid-treatment break of a minimum of two (2) weeks. Each treatment will take around 15 to 20 minutes. A medication diary (for arm A patients only) and questionnaires will be completed at the initial assessment, last day of treatment, 4 weeks after radiotherapy and at 3, 6, 9, 12, 18 and 24 months following the date of randomisation.

  • Pilot testing the clinical audit and implementation of neonatal brain MRI for North-Queensland infants at high-risk for adverse neurodevelopmental outcomes

    This project will test the implementation and clinical utility of neonatal brain MRI at Townsville University Hospital and Cairns Hospital for infants at high-risk for adverse neurodevelopmental outcomes. Infants born preterm, with low birth weight, who have a hypoxic event at birth and/or a brain injury are at high risk for adverse neurodevelopmental outcomes. An MRI can provide detailed and accurate information about brain injury and growth impairments to assist with risk stratification, however, currently, the timing of MRI is variable, with the MRI often performed at an age when general anaesthesia is required (>4 months), posing additional risks and costs. Neonatal MRI performed at term-age (without sedation) diminishes the risks and costs associated with later MRI under general anaesthesia and provides the opportunity to identify infants’ risk status early, enabling earlier and personalized treatment plans. This project aims to test the feasibility and use of neonatal MRI (at term-age) for 42 infants identified as high risk based on the cranial ultrasound or clinical grounds, making use of the learnings from the successful implementation of neonatal MRI protocols at Royal Brisbane Women’s Hospital.

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