ANZCTR search results

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

You can narrow down the results using the filters

31103 results sorted by trial registration date.
  • A Facebook delivered physical activity focused group lifestyle intervention for older adults during the COVID-19 pandemic

    As countries are affect by coronavirus disease 2019 (COVID-19), the impact of social isolation and the uncertainty of an epidemic on individuals mental health is concerning. Self-isolation will disproportionately affect older people, particularly those who are living alone with limited opportunities for social contact. Social isolation and loneliness are strongly associated with poor psychological wellbeing and physical health. Promoting physical activity and social connectedness during this time is an evidence-based strategy that can potentially help alleviate symptoms of psychological distress and improve quality of life in older adults. Online technologies provide a novel method of reaching people. This study will recruit 20 older adults (60 years and over) to a 6 week group based physical activity intervention delivered online through a private Facebook group. The group will allow members to receive information and contribute to weekly conversations on pre-specified topics related to physical activity, including goal setting, balance and strength straining. The purpose of the group is to facilitate social support and provide participants with a platform to exchange personal experiences including barriers and facilitators to commencing a physical activity program at home.

  • The Carer's Way Ahead: Helping Families Manage with Challenging Behaviour following Traumatic Brain Injury

    Managing challenging behaviour in the home is very difficult for families dealing with an adult relative with a brain injury. It is often difficult to access specialist support, and assistance from a psychologist can be costly and represent a barrier to accessing useful treatment, particularly for those with geographical limitations. In light of this, we recently developed ‘The Carers' Way Ahead’, an internet based program specifically tailored for Australian carers managing adult family members with traumatic brain injury. It is a step by step program, training carers how to implement an treatment approaches to behaviour management. We aim to determine if the program is effective in: 1. Reducing the frequency and intensity of challenging behaviours in the family member with brain injury 2. Improving the well-being of carers compared to families who are not receiving clinical input, including greater social problem solving, decreased strain, increased mood, improved satisfaction with life and improved family relations 3. Yielding health benefits in terms of quality of life and economic benefit Participants will complete a baseline assessment where they will be asked to fill out various questionnaires. They will then be randomly allocated to receive ‘immediate treatment’ or ‘deferred treatment’ (i.e., waitlist control group). Treatment will involve the family member completing 'The Carer's Way Ahead' program. These include two psychoeducational modules, four modules addressing specific challenging behaviours (i.e., apathy, disinhibition, social difficulties, and aggression) and a self-care module to assist carers manage stress, low mood and other emotional states. Participants will complete these modules over a six to eight week period with support by a clinical psychologist (accessed remotely). They will then complete a post-assessment In the waitlist/deferred condition, participants will be asked to wait 10 weeks before gaining access to the online platform. They will attend a second assessment prior to commencement.

  • A phase I/II single arm study of combination Belantamab Mafodotin, Carfilzomib, Dexamethasone in patients with early relapsed multiple myeloma

    The study aims to determine the efficacy of combination therapy with Carfilzomib and Dexamethasone and Belantamab mafodotin (BelaMaf-Kd) for patients with relapsed refractory multiple myeloma. Belantamab mafodotin is a new drug which has not been approved for use by the Therapeutic Goods Administration and so this combination is considered an experimental treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or over, and have received between 1 to 3 prior lines of therapy for multiple myeloma but have not undergone allogeneic stem cell transplantation. Study Details Eligible participants will receive 6 cycles of combination BelaMafKd with treatment given over a 28 day cycle as tolerated. Belantamab mafodotin and Carfilzomib will be delivered by IV infusion on days 1 and 8 and days 1, 8 and 15 respectively. Dexamethasone will be given orally weekly. Participants will be required to have blood samples taken and medical reviews (including ophthalmic examination) at the beginning of each cycle. An ultrasound test of cardiac function will be performed at screening and within 2 weeks of completion of cycle 6. A bone marrow biopsy will be performed at screening, at cycle 6 and to confirm a complete response or disease progression. These assessments will enable researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. Study treatments will be halted if participants show disease progression, unacceptable toxicity, or upon withdrawal of consent. A final medical assessment and ophthalmic exam will be performed at end of treatment, with follow up to continue every 12 weeks until one year after the final cycle of treatment. Follow up assessments will continue every 12 weeks until one year after the final cycle of treatment. It is hoped that the findings of this trial will establish the benefits of Belantamab mafodotin in combination with Carfilzomib and Dexamethasone for the treatment of patients with early relapsed multiple myeloma.

  • Black Dog Institute (BDI) Gatekeeper program non-inferiority trial

    The aim of the present study is to examine the short and long term impacts of an online gatekeeper training program on measures of confidence in identifying and supporting someone having thoughts of suicide, attitudes towards suicide prevention, and knowledge of appropriate responses to signs of suicide. This training program comprises interactive learning modules with presentations, videos depicting interactions between a person experiencing thoughts of suicide and a helper, and a quiz to test the learner’s knowledge. The BDI program will be tested against the program QPR online in a non-inferiority trial. It is hypothesised that participants who complete the BDI online gatekeeper program will show an equivalent improvement from baseline to post-training and 3-month follow up on confidence in gatekeeper skills, attitudes towards suicide prevention, and knowledge of appropriate responses to signs of suicide.

  • Study evaluating Coronavirus (COVID-19) nasal/oral swab results compared to blood antibody results in COVID-19 clinic patients.

    This study will compare standard of care nasopharyngeal swab NAT results to the presence of SARS-CoV-2 IgG, IgA and IgM antibodies approximately 14 days after initial onset of symptoms in intermediate/high risk participants presenting to the Albury Wodonga Health Coronavirus Clinic.

  • AUSTRALIAN CARDIOVASCULAR COVID-19 REGISTRY (AUS-COVID)

    Patients with pre-existing cardiovascular disease (CVD) have been shown to have a higher mortality from COVID-19 than the general population. Early data from small case series suggests that cardiac complications such as acute cardiac injury, myocarditis and cardiomyopathy are common in patients with COVID-19. Given COVID-19 has become a pandemic, urgent data is required to better understand the cardiovascular sequelae of the infection as well as the effects of pre-existing CVD. The AUS-COVID registry will provide this time critical data needed by clinicians and health services to be better prepared to manage these patients.

  • Effect of ambient temperature on quality of bowel preparation for colonoscopy

    Colonoscopy offers both a diagnostic and therapeutic tool in the early detection of colorectal cancer. The quality of bowel preparation significantly impacts the success of colonoscopy. Optimal bowel preparation leads to decreased procedure time and increased polyp detection rate. A suboptimal bowel preparation can result in small or flat lesions being missed, shortened surveillance times and need for multiple procedures. In addition, it results in increased technical difficulty and likelihood of complications. Factors shown to affect quality of bowel preparation include the type of solution chosen, administration or timing and the patient’s hydration status and diet. The ambient temperature can impact daily activities and as such we propose that this will also have an effect on the quality of bowel preparation. This trial performed secondary analysis of existing data collected as part of a previous prospective trial investigating the tolerability of bowel preparation in inflammatory bowel disease patients compared to the general population. Ambient temperature was recorded as the minimum and maximum temperature as documented by the local Bureau of Meteorology weather observation station on the day prior to the scheduled colonoscopy.

  • Ileal Pouch Microbiome Study: defining a pre-operative microbiological signature that predisposes to anastomotic leak

    Anastomotic leakage (AL) is amongst the most significant complications of intestinal surgery and results in increased morbidity and mortality. Recent research has shown that certain species of E. coli and Pseudomonas have been associated with AL in colorectal anastomoses. These organisms produce collagenases and metalloproteinases that can break down a newly constructed and healing anastomosis. Much research has also gone into defining bacterial populations that are associated with pouchitis. Our project aims to describe the microbiological communities in the terminal ileum and rectum that will contribute to the ultimate ileal pouch microbiome. The future application of this information is to allow intervention for manipulation of the microbiome to more favourable microbial profiles prior to surgery, and thus reduce the leak rate and perhaps, in the long term, protect against the development of pouchitis and perianal disease.

  • COPING: COgnitive impairment in People with glioma and distress in the INformal care-Givers

    The study aims to assess the feasibility and acceptability of a cognitive assessment tool for brain cancer patients. The study will examine if the tool is acceptable to patients and health professionals and could be included in routine health care practices. The study will also look at the relationship between cognitive decline in patients, hospital use, and the impact on caregivers. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have been diagnosed with Brain cancer (Glioma/Glioblastoma) Study details This study will involve a questionnaire about cognitive function. Participants will write down their responses to the verbal questions. The questionnaire will be administered two or three times during the study at regular clinic visits. Carers can also answer questions about their experiences caring for someone with brain cancer. It is hoped this study can provide greater insight to the cognitive challenges of people with brain cancer and the experiences of their carers. The information gathered in this study will help inform future studies regarding the acceptability of the screening tools. Hypotheses: Hypothesis 1: Patients will report the ARCS tool is acceptable (i.e. over 75% of patients will report willingness to complete a similar test in the future), and will record assessment completion rates over 90% at both time-points. Hypothesis 2: A high proportion of participants (>60%) will show cognitive decline over time as measured by changes in ARCS scores between at least two measurement time points. Hypothesis 3: An ARCS score of or below 78 (-1.5 standard deviations below normative value) and subsequent decline between two measurement time points will be significantly associated with decreased survival at 6-months. Hypothesis 4: An ARCS score of or below 78 (-1.5 standard deviations below normative value) and subsequent decline between two measurement time points will be significantly associated with increased logistic odds of hospitalisation at 6-months. Hypothesis 5: An ARCS score of or below 78 (-1.5 standard deviations below normative value) and subsequent decline between two measurement time points will be significantly associated with survival at 6-months. Hypothesis 6: ARCS score of or below 78 at either time point will significantly correspond with caregiver burden as measured by the Zarit Burden Interview Short Version. This will be mediated by caregiver competency as measured by Caregiver Mastery Scale. Hypothesis 6: ARCS score of or below 78 at either time point will significantly correspond with caregiver burden as measured by using the Caregiver Reaction Assessment. This will be mediated by caregiver competency as measured by Caregiver Mastery Scale.

  • Mental health and wellbeing on general population during the COVID-19 outbreak

    Since the first case reported in Wuhan city, China in December, 2019, COVID-19 has now become a pandemic issue and affected more than 1.5 million of people globally. On 23rd January, 2020, Chinese government implemented strict social isolation policy by locking down Wuhan city. Since then, COVID-19 outbreak has gradually been under control in China. However, a significant increase in incidence of COVID-19 occurred outside of China has made it a pandemic issue. More and more countries and cities adopted social isolation policy to ask their residents to stay at home for self-isolation and to maintain social distance in order to minimise disease transmission. On the other hand, this social isolation can also have psychological impacts such as anxiety and depression on the involved residents. The IMSOMNIA study will provide initial unique insights into the impact of social isolation on mental health and to identify the group of people requiring intervention.

Tags:
  • Finding clinical trials