ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Dose response measurements of low dose atropine eye drops over time

    Atropine eye drops are known to affect pupil reactions and the ability of the eyes to focus on near objects. This study will quantify the effects of different concentrations of atropine eye drops on these ocular structures.

  • Bowel Preparation Assessment Using Ultrasound Examination

    Poor bowel preparation is common in inflammatory bowel disease (IBD) and non-IBD patients and can lead to incomplete colonoscopic assessments and missed pathology. As such the patients are required to undergo either a second colonoscopy or earlier surveillance colonoscopies. This creates cumulative risks of colonoscopies (double the anesthetic and procedural risks), increased burden to the health care system (extra resources and colonoscopy spots used that could be used by other patients) and the patient (more inconvenience of further bowel prep and missed work for the procedure) as well as financial costs both to the health care system as well as the patient in multiple ways. Other research has found patient reported bowel preparation quality (no bowel motion pictures) is often not accurate, Being able to assess the patient's bowel preparation before giving them anaesthetic and more importantly, being able to know their prep is poor and given them extra bowel prep and have their procedure delayed by a few hours (put at the end of the endoscopy list) would be of huge benefit for both the patient and the health care system. Our aim is to create a rapid ultrasound assessment (no radiation and no risks to the patient) that focuses on a few specific areas of the bowel to create a bowel prep scoring system which matches current validated colonoscopy bowel preparation scoring systems. Furthermore to show that by using the ultrasound scoring system that the detrimental effects of poor bowel preparation (discussed above) can be avoided and to create a cost-benefit analysis as well.

  • Study of using Cyclophosphamide After Sibling-donor allogeneic stem-cell Transplantation (CAST) in patients with acute leukaemia and myelodysplasia

    This study aims to demonstrate a drug called cyclophosphamide is better than the current standard of care at preventing graft versus host disease in patients who have just had a bone marrow transplant. Who is it for? You may be eligible for this study if you are aged 18-70 and have AML or ALL which is in remission, or MDS with <20% myeloblasts; and have a 6/6 matched sibling bone marrow donor. Study details Participants in this study will be randomly assigned (by chance) to one of two treatments. One group will take the study medication cyclophosphamide for 5 days, followed by 90 days of cyclosporin. The other group will take an existing medication regimen of cyclosporine and methotrexate, which is the current standard of care for preventing GVHD. Participants will be followed-up for 2 years post-transplant. The study will look at the number of patients in each treatment arm who develop GVHD, and how each treatment affects the patient quality of life.

  • Tuning in to Kids Together: Exploring a parenting program designed for parents raising children together with the focus of improving children's emotions and behaviours.

    Tuning in to Kids Together is a modified version of Tuning in to Kids (TIK). TIK is an evidence-based program which that aims to improve parents’ emotional communication, and consequently improve children’s emotional functioning. Randomised control trials demonstrated that TIK leads to significant changes to parental emotion socialisation practices, improvements to child emotional regulation, and reduction in child behavioural problems (Havighurst et al., 2013; Wilson, Havighurst, Harley, 2012). Although TIK is effective, researchers (e.g. Fienberg, 2002) emphasise the importance of incorporating co-parenting content into parenting programs. The co-parenting relationship is strongly and proximally related to parenting (Abidin & Brunner, 1995), therefore it is a modifiable factor that could improve emotional parenting. In light of the aforementioned research, this study is exploring the feasibility and effectiveness of TIK when it is modified to be delivered to co-parents. The aim of this research is to provide preliminary evidence on the feasibility and effectiveness of Tuning in to Kids Together, a modified version of TIK. This study will address the following research questions: • What factors will impede and facilitate parent engagement and the program delivery? • Will the Tuning in to Kids Together program lead to improvements in: a) parent emotion socialisation practices measured via parent self-report, b) co-parent functioning on parent-self reports, c) parent emotion regulation on parent self-report, d) improved child emotional measured via parent and teacher reports, and e) child behavioural functioning measured via parent and teacher reports B) Research Design The study will use an experimental, longitudinal design. Parents will complete three online surveys: immediately before, immediately after, and 6 months after completing the parenting program. Additionally, parents in the will complete phone interviews after participating in the program. Teachers will complete measures on the child immediately before and at a 6-month follow-up. Facilitators will complete an experience check-list before delivering the program, various measures (fidelity check-list, class attendance, parent participation) at the end of each session, and participate in a phone interview after delivering the program. C) Analyses and Outcomes Analyses will be conducted to determine whether TIK improved parent and child outcomes. Thematic analysis will be performed to analyse information about program engagement and delivery. Findings will be reported in peer review journals and at conferences.

  • Attitudes of anaesthetists attending the funeral of patients they care for: a cross-sectional survey amongst Australian and New Zealand Anaesthetists

    The role of holistic approach to patient-centred care and empathic anaesthesia practice has been growing over the last decade. The concept of a bio-psycho-social model of care, which readily integrates modern medicine together with treating the patient and their family, is widely accepted by anaesthetists. This can include the attendance at the patient’s funeral to share the grieving process with the family for the loss of their beloved one. Anaesthetists, however, have been traditionally considered as having short-term doctor-patient relationship, which makes the application of bio-psycho-social model of care more challenging. Although research with bereaved families has shown that they appreciate contact with clinicians after a patient’s death, this realm of clinical practice remains empirically uncharted. We aim to discover the attitudes of, and perceived benefits and barriers to Australian anaesthetists in attending the funeral of a patient that they cared for. A cross-sectional survey of Australian and New Zealand anaesthetists is employed using commercial, Web-based survey (Survey Monkey®). The survey contains 17 questions that aim to solicit information about the attitudes of anaesthetists attending the funeral of a patient that they cared for. Participants will also be asked to self-report geographic region, age, gender, public vs. private hospital, type of hospital (rural, secondary, tertiary level) and their area of practice (anaesthesia, intensive care, pain medicine or other). An invitation letter which includes objectives of the study, a brief summary of the study, information about consent and a link to the online survey (https://www.surveymonkey.com/r/JPZJC7R) will be distributed to consultant anaesthetists via an invitation letter to directors of anesthesia departments asking them to forward an email link to their fellows of ANZCA in their department. The email link will have an invitation letter that clearly informs the participants to complete the survey. The survey is voluntary and anonymous, and no email or website IP (internet protocol) address will be collected. The survey will be open for approximately one month. Objectives of the study are to discover Australian and New Zealand anaesthetists' attitudes of, and perceived benefits and barriers to attending the funeral of patients whom they cared for.

  • Improving the response to high intensity interval training through the ingestion of a daily prebiotic fibre.

    Cardiorespiratory fitness (CRF) is the biggest predictor for chronic disease morbidity and mortality; however, one in five adults report little to no improvement in CRF (VO2max) following exercise training. Variability can be attributed to a myriad of factors, such as age, sex, gender and baseline VO2max. One of the biggest predictors is genetic make-up; which contributes to approximately 50% of VO2max trainability. From our systematic review, we identified nearly 100 genetic variants associated with VO2max trainability. Individuals can be given a gene predictor score (GPS) based on how many genetic variants they have that contribute to a high or low VO2max training response. Typically, there are fewer low responders with high intensity interval training (HIIT) compared to other forms of training. Individuals with a low GPS ideally should be prescribed a HIIT intervention over other forms of training for greater adaptations. Despite this, variability will still exist. There has been minimal, if any, research to identify the association between the gut microbiome (the bacteria that lives within our large intestines) and its effect on VO2peak trainability (our improvement in cardiorespiratory fitness). More specifically, is our GPS related to the bacteria within our gut; and can this gut bacteria be positively influenced to improve our cardiorespiratory training response? The overall objective of IMPROVE HIIT is to contribute to evidence-based personalised medicine. Understanding the factors that influence training variability that could be used to improve individualised exercise prescription, thereby contributing to health maintenance and treatment/prevention of disease. Aims: The aims of IMPROVE-HIIT include: 1) determining the association between our genetic make-up and the bacteria within our gut 2) investigating whether improving our gut bacteria via diet can influence our cardiorespiratory training response

  • Study Evaluating the Efficacy of Maintenance Olaparib and Cediranib or Olaparib Alone in Ovarian Cancer Patients.

    Study purpose The purpose of the study is to investigate whether we can increase the effectiveness of treatment in ovarian cancer by adding one or two new anti-cancer drugs: cediranib and olaparib. Who is it for? You may be eligible for this study if you are a female aged over 18 years and have a histologically proven diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, which responded to platinum-based chemotherapy. Study details Participants will be randomly assigned (by chance) to one of two treatment groups. One group will receive two medications, called cediranib and olaparib taken once daily and twice daily respectively. The other group will receive olaparib twice daily. Participants will attend a number of hospital visits to give blood and answer questionnaires about their quality of life. It is hoped that this research may help people in the future who have the same kind of cancer as you have.

  • Is dysfunction of brain blood vessels associated with cognitive impairment in type-1 diabetes?

    To date, almost all large neurocognitive studies of type 1 diabetes (T1D) have focused on paediatric groups, as compared to most type 2 diabetes (T2D) studies which focus on old age. Early onset diabetes has severe impacts on the neurocognitive development of children and adolescents with T1D, particularly in learning and memory skills. This deficit is accompanied by atrophic changes in the medial prefrontal regions that are known to be rapidly developing in children. While there is a plethora of literature linking T2D with greater risk of dementia, little is known about the role of metabolic and vascular factors on the ageing brain in adults with T1D. One retrospective study has shown that elderly adults with T1D are 83% more likely to get dementia compared to a 50% greater risk in T2D than in non-diabetic adults. However, the frequent presence of comorbidities in older diabetic adults further complicates the underlying mechanism of accelerated brain ageing in T1D. A postulated underlying mechanism of T1D-related cognitive decline is endothelial dysfunction in the cerebral microvasculature caused by pro-inflammatory cytokines associated with the disease and advanced glycation end-products (AGE) due to hyperglycaemia. We have shown significant cerebral arterial stiffness (20%) in elderly T2D adults compared to non-diabetics, which is linked to poorer perfusion and performance during cognitive testing. Structural and functional changes of the cerebral vasculature is already evident in young T1D adults (mean age of 32 years) where a significant 20% reduction in cerebral vasodilator responsiveness to a hypercapnic challenge was seen compared to non-diabetic controls. The authors also reported significant stiffening of the carotid arteries that is independent of the presence of hyperlipidaemia. It seems that despite the arduous therapy of multiple insulin injections daily, this does not prevent the occurrence of serious late-arising complications including kidney failure, blindness and widespread cardiovascular disease in T1D. Given that diabetes is a systemic disease, it is plausible that multiple organs including the auditory system are also affected; yet little attention has been given to preserving auditory function in diabetes. Age-related neurodegeneration of different cortical areas and/or cognitive impairment may also affect central auditory function. Central auditory dysfunction is hypothesised to occur before objective cognitive tests become abnormal. There is no study evaluating the link between cerebrovascular dysfunction and cognitive impairment and central auditory dysfunction in T1D. We hypothesise that T1D adults have cerebrovascular dysfunction and elevated inflammation, mediated by glycation of the endothelium, which will negatively impact their cognitive and auditory function.

  • Exercise-therapy following anterior cruciate ligament reconstruction: a pilot randomised clinical trial

    Knee osteoarthritis is a national health priority, and commonly occurs in young adults following anterior cruciate ligament reconstruction (ACLR) – creating a scenario of ‘young people with old knees’. Having an ACL injury combined with a meniscectomy and/or chondral lesion is associated with more pain and worse quality of life after ACLR, and best identifies those at risk of future knee osteoarthritis, low physical activity participation, and worse symptoms and quality of life in the long term. Considering the profound impact of a combined injury after ACLR on young adults, effective interventions targeting functional restoration are urgently needed. Our prior data indicates <30% of people received or completed physiotherapy beyond 6 months post ACLR, which may assist in restoring normal physical function after ACLR. Appropriately supervised and progressed exercise-therapy and patient education that targets individual needs has potential to reduce the burden of impaired function post-ACLR (i.e. young people with old knees). This study aims to investigate the efficacy and feasibility of a randomised controlled trial to improve function, symptoms and quality of life in people with an ACL injury combined with a meniscectomy and/or chondral lesion 6-15 months after ACLR. The study will compare the effects of a Supervised Patient Education Rehabilitation program, targeted to individual needs, (SUPER), to a minimal intervention CONTROL program, where a best practice guide booklet and one face-to-face physiotherapy appointment is provided.

  • Understanding your Newborn and Adapting to parenthood (UNA): A randomised clinical effectiveness trial of the Newborn Behavioural Observations (NBO) for new families.

    Postnatal depression (PND) is common and can have a devastating impacts on the parent, the child, the couple and the wider family. There is particularly compelling evidence that mothers with PND are at risk of attachment and interactional difficulties with their infant and adverse consequences for their child’s development. It is important to identify families at risk of postnatal depression and to elucidate preventive interventions that are feasible, acceptable and that promote successful adaptation to parenthood. There is a unique opportunity in the perinatal period to provide effective interventions and potentially make a difference to the developmental trajectory of new families, as it is a time of great motivation and help-seeking, even by individuals and couples who may be otherwise hard to reach. Attachment based, relationship-focussed interventions have been shown to help vulnerable new parents successfully adapt to the role of parenthood and even brief perinatal interventions can be helpful. The Newborn Behavioural Observations (NBO) is a relatively new, brief attachment based intervention that aims to promote adaptation to parenthood by helping new parents get to know, and adapt to caring for, their newborn baby, and by reducing parents’ distress in the transition to parenthood. This reproducible, affordable intervention holds appeal and has generated widespread interest internationally. Pilot studies and clinician reports suggest the NBO is effective in various family contexts and settings and there is preliminary evidence the NBO is associated with reduced post-natal depressive symptoms among new mothers. However, it has not yet been shown that the NBO is an effective intervention in the context of maternal depression. This study therefore aims to determine whether, in an Australian population of new families with antenatal risk factors of PND, the NBO supports the adaptation to parenthood, by reducing symptoms and diagnosis of PND, reducing parenting stress and enhancing the quality of relationship they are able to form with their baby.

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