ANZCTR search results

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

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32856 results sorted by trial registration date.
  • Effect of speed of processing training on older driver screening measures

    Computerised training for cognitive enhancement is of great public interest, however, there is as yet insufficient data on whether, and how, such training leads to changes in everyday activity that relies on the trained cognitive function. Speed of processing training is a commercial software that has been examined in a number of large trials, particularly in the context of ageing and driving safety. This pilot study aims to examine whether online speed of processing training in healthy older drivers will lead to improvement in other measures known to be associated with driving safety.

  • A feasibility study of hair sparing whole brain radiotherapy with volumetric modulated arc therapy for patients who have brain metastases from any malignancy. (The Hair Spare Study)

    The primary purpose of this trial is to evaluate the feasibility of conducting volumetric modulated arc therapy hair sparing whole brain radiotherapy (VMAT HSWBRT) in cancer patients with brain metastases. Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over and have a solid tumour or melanoma with brain metastases, for which you require whole brain radiotherapy (WBRT). The trial will enrol thirteen (13) patients with stable scalp hair of at least 2.5cm in length and two patients who are bald. Study details Standard WBRT involves the scalp receiving the full dose of radiation, damaging hair follicles and often leading to alopecia, which decreases quality of life. VMAT HSWBRT may allow for the radiation to be delivered to the metastases whilst minimising the radiation received by the scalp. For all participants, the treatment will involve attending radiotherapy planning/simulation sessions. Patients are treated with VMAT HSWBRT 30Gy in 15 fractions, one fraction delivered at each daily session. Participants will also undergo follow up visits at 4 weeks and 3 months after treatment. It is hoped that if found to be feasible and effective, the use of VMAT HSWBRT could reduce symptoms of alopecia following WBRT for brain metastases and increase quality of life.

  • Helping farmers to better cope with things beyond their control

    We will test whether a low cost, self-help intervention based on Acceptance and Commitment Therapy (ACT), developed in consultation with consumers, is perceived as acceptable and helpful by Australian farmers, improves their well-being, and leads to effective coping when faced with future challenges such as drought. The website contains five short, interactive modules designed to teach users new tools to equip them to take charge and reduce the negative impact that stressful situations can have as well as better cope with things beyond their control. The website features text message reminders and support messages, audio and video, interactive exercises, farming-related humour, and functionality for use on laptops, desktops, tablets and mobile devices. Interested participants (farmers in Australia over 18, with internet and mobile phone access) will be asked to register online, where they will be asked to complete a short series of questions. Participants will then complete the five modules over several weeks, and at the end, complete the same questions, and repeat them once more six months later. Participants will also be asked to express interest in providing feedback on the intervention in an interview at a later time, or in being re-contacted at a later date (e.g. a period of drought) to complete the questions again. Farming is known to be one of the most physically and psychologically hazardous occupations. For generations Australian farmers have been independent, stoic and skilled at solving practical problems. However, a characteristic of farming that makes it psychologically hazardous, is the fact that farmers' levels of personal and economic success is largely dependent upon factors beyond their control (e.g. weather, disease outbreaks, commodity prices). Periods of drought are expected to become more frequent and prolonged in the future, therefore it is important to conduct research like this to find effective ways for farmers who are interested, to learn how to better cope with things beyond their control.

  • Comparing models of physiotherapy service delivery in Parkinson's disease: A feasibility study

    There is growing evidence that physiotherapy and exercise can improve mobility and balance in people with Parkinson's disease (PD). However, there is limited research on the method of service delivery to provide optimally effective and efficient physiotherapy to people with PD. The primary aim of this pilot randomised controlled trial is to investigate the feasibility of a predominantly home-based physiotherapy program compared to a predominantly group-based program. The secondary aim is to determine the effect of the programs on balance and mobility in people with PD. In addition participants will also provide feedback on their satisfaction of exercising in group environment and at home.

  • NEST4E: A pilot study into the clinical effectiveness of Non-invasive Preimplantation Genetic Screening (PGS) method for Embryo ploidy status among patients undergoing IVF treatment

    The primary objective of this pilot study is to evaluate the clinical effectiveness of our NEST4E non-invasive method for screening embryo ploidy by determining the number of embryos that can that be successfully screened for aneuploidy using the NEST4E rather than invasive biopsy. Aim 1: For euploid embryos the percentage concordance of media sample screening will be confirmed using non-invasive NIPT based first trimester screening as early as 10 week pregnancy. For aneuploid embryos, we will determine the percentage of embryos with concordance by confirmatory trophectoderm biopsy and PGS screening. Aim 2: To determine clinical pregnancy rates and live birth outcomes of embryos that are transferred once screened as euploid. Fifteen patients will be recruited by informed consent to participate in this pilot study to assess the clinical efficacy of our NEST4E non-invasive PGS test to screen their embryos for aneuploidy. Participants will be made aware that their participation in the study is entirely voluntary and that they can withdraw at any point in time. As per standard protocol, patient confidentially will be strictly maintained and their identity will not be revealed in any reviews and reports of this study which may be published. Patients treatment will not be altered in any way and will proceed as per standard IVF cycle, including medications, oocyte retrieval, insemination and fertilization and embryo culture. Patient embryos will be cultured as per standard protocols; G1/G2 Plus media (Vitrolife) overlayed with oil (Ovoil, Vitrolife) in 6% CO2, 5% O2, 37 degrees. A 4 micro litre drop of the spent culture medium will be sampled using PCR grade filtered tips, under laminar flow, and placed into PCR grade 0.6 ml tubes and assessed for aneuploidy as described below. DNA from the culture media sample will be amplified. If this amplification should fail, the embryo will be removed from the trial and will revert to standard care which involves a biopsy followed by vitrification and sample screening. If the amplification is successful, the embryo will be vitrified and the DNA amplified from the media sample used for screening by NEST4E. If conclusive sequence data is obtained, euploid embryos will be made available for transfer.

  • Non drug interventions to reduce breathlessness in patients with Chronic Obstructive Pulmonary Disease (Emphysema)

    The aim of this project is examine non drug methods of relieving breathlessness. We will also examine the effects of the non drug interventions on anxiety, depression and quality of life in this patient population with severe chronic obstructive lung disease. We will ask all patients attending the breathlessness clinic to participate. They will be randomly assigned to either start the interventions for breathlessness immediately or delayed start in 8 weeks. All patients will receive current standard of care. They will be asked to complete questionnaires, wear a pedometer (step counter), and to undergo breathing and walking tests. We hope that we can prove non drug management of breathlessness is possible in this patient population.

  • A Single-Centre Open-label Pharmacology Study of Topically Applied MTC896 Gel in Healthy Volunteers.

    This study is designed to investigate the pharmacology of MTC896 Gel in otherwise healthy female participants with oily skin. In this study, MTC896 Gel will be applied at 1 concentration, twice daily (bid) for 4 weeks to the postauricular region (behind the ear) a region known to be rich in sebaceous glands. Participants will be required to administer study drug at home, other than when applications coincide with study outpatient visits. All participants will be required to attend a screening visit, at which skin oilyness will be measured with a Sebumeter (a non-invasive skin probe), If participants are deemed eligible for the study, a small biopsy will be collected from the post auricular region. Study participants will be shown how to administer study drug, and will be discharged with study medication for home dosing. Participants will be asked to record their doses and any symptoms in a diary during the 28 day follow up period. Participants will be asked to return for an outpatient visit after 14 days, then a final follow up visit at 28 days. At the final follow up visit a second biopsy sample will be collected from the post-auricular region, and sebum (oil) levels will be evaluated with a sebumeter. It is hoped that the results of this study will provide evidence that MCL16001 is able to reduce skin oiliness, and may therefore be useful in the prevention and treatment of acne.

  • A study to evaluate the viability and efficacy of integrating the BeyondNow suicide prevention smartphone app into a telephone support service for callers who are experiencing suicidal thoughts.

    Smartphone apps are an effective way to provide health services to the community. The current study will investigate the viability and efficacy of integrating the BeyondNow suicide prevention smartphone app into a telephone support service for callers who are experiencing suicidal thoughts. Participants will install and set up their safety plan using the BeyondNow app with a telephone support service counsellor. The app will remain installed on participants' phones for the subsequent 6-weeks. Opinions on the integration of the BeyondNow app into the telephone support service will be collected. How the participants use their apps, as well as measures related to suicide (suicide coping, hopelessness, perceived burdensomeness, and emotional and physical pain) will also be collected over the 6-week trial.

  • Behavioural and psychological symptoms of dementia in residential care: efficacy of an education and non-pharmacological intervention program

    In Australia, between 60-80% of all residents in aged care facilities (RACF) have dementia. Rates of behavioural and psychological symptoms of dementia (BPSD) amongst people living in RACF are high with over 90% of Australian RACF residents exhibiting clinically significant BPSD. Physical aggression, agitation, wandering and disinhibition, especially when severe, are difficult to manage and can put residents, carers and other residents at risk. Likewise apathy and depression cause considerable discomfort to residents and require a skilled approach to manage effectively. Management of BPSD has recently become a focus of attention for the Australian Government, especially in relation to inappropriate overprescribing of antipsychotics. International good practice guidelines recommend the use of non-pharmacological interventions as the first-line of treatment for BPSD, while pharmacological interventions are considered second-line treatments. Despite little evidence of effectiveness and high rates of adverse effects, including increased morbidity and mortality, pharmacological methods are still commonly used to manage BPSD. The discrepancy between international and national recommendations and the continued over-prescription of medication to manage BPSD must be addressed. This project will evaluate the efficacy of BPSDplus, a person-centred intervention program developed to reduce the prevalence of BPSD and medication use in Australian RACF. This program will equip Australian staff working within RACF with the specialised training and skills needed to provide care proactively for all residents with BPSD and improve quality of life for residents, carers and relatives. The BPSDplus program offers a proactive, rather than, as at present, reactive response to BPSD. The unique contribution of this research is the evaluation of the impact of the BPSDplus program on RACF staff, their attitudes towards dementia care and quality of interactions with residents.

  • A Case Series Evaluation of a Pilot Brief Behavioural Activation Intervention for Pathological Grief

    As Prolonged grief disorder (PGD) is known to persist without appropriate treatment, it is imperative to identify those at risk of PGD and to develop effective treatments. Treatments for PGD thus far are largely based on the cognitive behavioural model and there is a mounting research demonstrating its effectiveness; however, these CBT-based interventions have several components and little is known about which components are essential to alleviate PGD symptomatology (Jordan and Litz, 2014). There is a need to clarify which bereaved individuals are likely to benefit from which types of interventions. Furthermore, given that rumination, avoidance, and disengagement are key maintaining mechanisms of PGD, studying the effects of BA will provide a clearer understanding about the possible underlying maintaining mechanisms underlying post-loss psychopathology. Additionally, many CBT-based grief treatments have required long treatment protocols and while longer protocols of BA have demonstrated preliminary evidence of reducing PGD symptomatology, few studies have investigated whether the same benefits are possible with a briefer BA protocol. As such, the current study seeks to examine the feasibility of a 6-week intervention of BATD-R among two bereaved individuals with PGD and explore patterns of symptomatic and functional change based upon weekly measures to monitor symptoms and track the hypothesised mechanisms of change. It was hypothesised that: (a) BATD-R will result in pre-post decreases in post-loss psychopathology including PGD, Post-traumatic stress disorder (PTSD), and Major Depressive Disorder (MDD) symptomatology, and (b) activation will be the mechanism of change underlying reductions in rumination, disengagement, and avoidance. If the current 6-week intervention is effective in reducing PGD symptomatology, this may provide a platform for advancing the development and implementation of brief behavioural activation interventions for PGD.

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