ANZCTR search results

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

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31182 results sorted by trial registration date.
  • Analysis of features of eye gaze useful in the diagnosis of Parkinson's disease for people living in rural and remote communities. A comparative study between people with early to mid-stage Parkinson's disease and age-matched healthy volunteers.

    Eye movement abnormalities including the pupillary light reflex (PLR) and saccades occur in movement disorders including Parkinson’s disease. The purpose of this study is to identify robust features of eye gaze as demonstrated using a commercial eye tracking device that may be used to identify and assess eye movement abnormalities in Parkinson’s disease patients and those at risk of developing Parkinson’s disease. The ultimate aim of this work is to develop an automated diagnostic tool for the diagnosis and assessment of eye gaze abnormalities for people living in rural and remote communities. Patients will be able to record their eye gaze under specified conditions. The recordings will be analysed and eye gaze and analysis sent to a specialist physician. The aim of this study is to ascertain features of the PLR and saccades that are most useful in identifying differences between Parkinson’s disease patients and healthy age-matched controls using a commercially available eye tracker. The hypothesis is that Parkinson’s disease patients will exhibit significantly different eye gaze features compared with healthy age-matched controls.

  • The use of a handwriting app for diagnosis of Parkinson's disease for people living in rural and remote communities. A comparative study between people with early to mid-stage Parkinson's disease and age-matched healthy volunteers.

    Parkinson’s disease is characterised by impaired motor function including stiffness, bradykinesia and tremor. These changes also affect hand writing causing changes in writing kinematics and pen pressure. Changes in hand writing may also be an early marker of Parkinson’s disease. Computerised graphic tablets are capable of analysing the dynamic aspects of writing. The aim of this study is to ascertain features of different hand writing tasks that are most useful in identifying differences in hand writing features between Parkinson’s disease patients and healthy age-matched controls using a computerised graphic tablet. The hypothesis is that Parkinson’s disease patients will exhibit significantly different dynamic features of hand writing compared with healthy age-matched controls.

  • The use of a voice recording app for diagnosis of Parkinson's disease for people living in rural and remote communities. A comparative study between people with early to mid-stage Parkinson's disease and age-matched healthy volunteers.

    Speech impairment is an early sign of Parkinson’s disease. Analysis of features of voice may be used as a diagnostic tool for the detection of Parkinson’s disease and in the assessment of its severity. In addition, people living in rural and remote communities often have difficulties in accessing specialist physicians for both diagnosis and continued assessment of Parkinson’s disease. The ultimate aim of this work is to develop an automated diagnostic tool for the assessment of speech impairments associated with Parkinson’s disease that may be used remotely. Patients will be able to record their voice on their personal device. Voice recordings will be analysed and the recorded voice and analysis sent to the specialist physician. The aim of this study is to ascertain features of the voice that are most useful in identifying differences in voice features between Parkinson’s disease patients and healthy age-matched controls using a mobile device. The hypothesis is that Parkinson’s disease patients will exhibit significantly different voice features compared with healthy age-matched controls.

  • Examining the efficacy and acceptability of an internet-delivered pain management program for endometriosis

    The Endometriosis Pain Course is an internet-delivered psychological treatment that addresses the impacts of endometriosis-associated symptoms and difficulties, such as chronic pain, on women's daily functioning and wellbeing. The course is based on cognitive behaviour therapy principles and consists of 5 lessons released over an 8-week period. Each lesson covers a different topic and introduces 1-2 core CBT skills designed to promote self-management, psychological wellbeing and quality of life. In addition to the core lessons, the program includes extra resources such as redirecting attention from pain and do-it-yourself guides to promote skills practise. Alongside the internet-delivered materials, participants have the option of accessing telephone support from a Clinical Psychologist who is available during the 8 weeks to discuss concepts, answer questions and promote and encourage skills practise. This intervention will be a modified version of the Pain Course, which was developed and validated through 4 randomised controlled trials by the eCentreClinic at Macquarie University and is now widely available through the MindSpot Clinic. The aim of this study is to investigate the efficacy of a psychologically-based pain management program when specifically adapted for women with endometriosis. We hypothesise that, compared to a delayed treatment waitlist group, participants in the Endometriosis Pain Course will report greater symptom improvements (in terms of mood, anxiety and level of pain-related disability). By recruiting a large group of participants, we are also aiming to understand what particular groups of people (or what participant characteristics) may benefit most from the Endometriosis Pain Course.

  • Assessing the Efficacy and Durability of Faricimab in Patients Currently Treated for Neovascular Age-Related Macular Degeneration.

  • Immunogenicity and safety of the Japanese encephalitis vaccine given intradermally in children and adults

    Australia is on the cusp of a potential outbreak of Japanese encephalitis (JE) viral infections as we move into spring and summer and having back-to-back La Niña seasons. There are effective JE vaccines which are licensed for children over 9 months old and given by subcutaneous (SC) injection. Intradermal (ID) vaccine administration only uses 1/5 of the subcutaneous dose and is therefore “dose sparing” enabling more people to be vaccinated from each vaccine vial. ID JE vaccination has found to be safe and immunogenic in adults, however has not yet been tested in children and adolescents. One recent study suggests that as much as 3% of the Australian population may be at risk of JE virus (JEV) exposure. In a naïve population, the risk of severe disease is likely to be equally distributed between age-groups. Of the 6 JEV deaths recorded in 2022, one was an infant. The aim of this project is to study immunogenicity and safety of JE viral vaccine (Imojev®) given ID using traditional needle and syringe in children and adults and to compare safety and immunogenicity with Imojev® given via the current recommended SC route. The results will be useful to inform vaccination programs if there is a significant JEV outbreak and especially if we have insufficient supplies of JE vaccines in Australia to vaccinate our most at risk populations, including children.

  • Exploring the efficacy of remote stepped care treatment for obsessive-compulsive disorder: A feasibility study.

    The purpose of this project is to assess the acceptability and feasibility of a remote stepped care treatment for individuals with obsessive-compulsive disorder. After assessment all participants will commence clinician-guided cognitive-behavioural bibliotherapy (BCBT) for 8 weeks. Participants who do not meet the predefined response criteria (YBOCS reduction of greater than or equal to 25% and a CGI-I score of less than or equal to 3) will then complete 8 sessions of internet-videoconferencing cognitive-behavioural therapy (VCBT) with a psychologist.

  • A novel knot-free proximal skin closure technique for transverse caesarean section skin incisions

    This pilot study will investigate the use of a new knot-free skin closure technique for caesarean section skin wounds. By using this new method to close the skin wound, the researchers aim to reduce the risk of post-operative wound infections and improve patient comfort, whilst also providing surgeons with an easy and reproducible skin closure technique. Currently, a surgical knot named an ‘Aberdeen knot’ is placed beneath the skin at the end of a running stitch during the skin closure at caesarean section. Unfortunately, patients have reported discomfort from the bulky nature of this knot and the bulky knot also increases the risk of wound infection and wound breakdown. Participants will have the proposed skin closure technique performed at the time of their caesarean section and will then be monitored post-operatively by the midwifery and medical staff at Frankston Hospital. Participants will also be required to submit serial photographs and short questionnaires as means of follow-up. This will allow for appropriate monitoring for any wound complications, such as wound infection or wound breakdown. The researchers hope to prove that this knot-free skin closure technique is safe for use in closing the skin wound during caesarean section. Should this small initial study prove to be safe and of good design, a larger randomised trial will be commenced.

  • A Biomarker-Driven Approach to Identify Pathogenic Mechanisms and Novel Therapeutic Targets in Chronic Wounds (Pyoderma Gangrenosum) using Tildrakizumab

    This study aims to look at measures of disease activity in ulcers (Pyoderma Gangrenosum) and the potential of response to a new therapy, Tildrakizumab, an injection which is administered under the skin every 4 weeks, for a total of 12 weeks. We intend to perform an exploratory analysis for potential biomarkers of disease activity in Pyoderma Gangrenosum (PG). Our proposal would include an open-label study with 12 weeks of treatment with Tildrakizumab in line with the published dosing frequency for Hidradenitis Suppurativa (200mg Week 0,4 and 8). Outcome measures are obtained from a recent systematic review of outcome measures used in clinical trials of PG.

  • The Baby Gut Health Study

    The early life microbiome plays a crucial role in immune system development and is associated with various health outcomes later in life. A healthy gut microbiome established in early life can reduce the risk of microbiome-related diseases and promote long-term health benefits. Weaning, the transition to solid foods during early life, particularly complex carbohydrates, is considered a “window of opportunity” for shaping the gut microbiome with its optimal configuration. Introducing prebiotic complementary foods can be an effective strategy for establishing a healthy microbiome during this time. However, the infant gut microbiota at the early weaning stage has limited capability to ferment complex carbohydrates and prebiotic substrates. It remains unclear how and when important carbohydrate fermenting microbes and butyrate producers colonize the infant's gut. To develop an effective and practical strategy for shaping healthy infant gut microbiota, a deeper understanding of the developmental trajectory of gut microbiota and its fermentation ability along with the introduction of solid foods is required.

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