ANZCTR search results

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

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32847 results sorted by trial registration date.
  • Sofosbuvir/Velpatasvir and Mental Health Impact in people with Lived Experience and Hepatitis C infection - SMILE-C Trial

    Hepatitis C virus (HCV) infection has itself been associated with impaired neuropsychological performance. Up to 50% of people diagnosed with HCV have reported neuropsychiatric disorders and neurocognitive dysfunction. People with schizophrenia, schizoaffective disorder and bipolar disorder suffer disproportionately high rates of HCV-infection. We hypothesis, that successful HCV treatment with DAA-based therapy is associated with improved neurocognitive function in people with severe mental illness. This may be particularly important for patients’ overall functioning and for quality of life in this marginalised and understudied population.

  • Objectively Testing Visual Performance in Young Children

    The study will test whether a device can detect OKN in children. The purpose of this study is that it is important in the development of a device that can detect vision problems in children.

  • Extended and Maintenance Oral Ketamine Trial on Suicidality

    This longitudinal study is an extension of the Oral Ketamine Trial on Suicidality. This study is an open-label, dose-ranging clinical trial of oral ketamine. Treatment will involve administration of oral ketamine over a 12-week period for Phase 1 (OKTOS-E) and over 26 weeks for Phase 2 (OKTOS-M). The pathology and neurobiology of suicidality will be examined via MRI and EEG as neurological measures. The primary outcome of change in suicidality will be assessed using the Beck Scale for Suicide Ideation (BSS) and the Suicidal Ideation Attributes Scales (SIDAS) as a composite outcome

  • Bacille-Calmette-Guerin (BCG) vaccine for multifocal motor neuropathy (MMN) and multifocal acquired demyelinating sensory and motor neuropathy (MADSAM).

    The only treatment (intravenous immunoglobulin) shown to be effective in MMN and some patients with MADSAM is expensive and may not slow the long-term decline in physical ability (function). Bacille Calmette Guerin (BCG) vaccine is an intradermal (injected just beneath the skin) vaccine used to prevent tuberculosis; BCG has many effects on the immune system and may have a beneficial effect on the underlying mechanisms of MMN and MADSAM. The purpose of this trial is to study the safety and potential effectiveness of BCG in MMN and MADSAM. We hypothesise that BCG will be a therapeutic option that is safe and will improve outcomes (symptoms and physical ability) in MMN and MADSAM.

  • Promoting mental health in children with dyslexia: Piloting the Clever Kids program

    Reading impairment (dyslexia) is the most common specific learning difficulty in Australia. Approximately 10% of Australian children have substantial difficulties in reading and spelling, and these children are at elevated risk of developing mental health problems: both internalising disorders (e.g. anxiety, depression) and externalising disorders (e.g. attention and conduct problems, delinquency). The transition from primary to secondary school is a particularly stressful period for children with dyslexia, due to the increased educational demands and expectations placed on children regarding quantity and quality of reading and writing. We will conduct a pilot randomised controlled trial to test the efficacy of a mental health promotion program (Clever Kids) in improving coping, emotion regulation, resilience, self-esteem, as well as both internalising and externalising symptoms for children with dyslexia in their final two years of primary school. Acceptability and feasibility of the program will be assessed using in depth qualitative interviews with program attendees. The research will be conducted in partnership with the Dyslexia-SPELD Foundation (DSF).

  • A study to evaluate the safety,tolerability and pharmacokinetics of ACT001 in children with advanced brain and solid tumors

    The purpose of this study is to figure out the ideal dosing schedule for a new chemotherapy medication called ACT001. Who is it for? You may be eligible for this study if you are aged between 1 and 21 years and have brain cancer or another solid tumour. Study details Participants will take capsules of the study medication, either dissolved in apple juice or as tablets, twice per day for 28 days. The amount of medication taken will depend on the results of participants before you. All participants will provide blood samples and have CT and MRI scans. It is hoped this research will find better treatment option for children with advanced brain and solid tumours.

  • Do frozen embryos generated under the influence of growth hormone implant at a higher rate?

    To determine the clinical pregnancy and live births arising from frozen embryos transferred (FET) which had been generated under the influence of IVF adjuvants given to women categorised as poor prognosis. Our hypothesis is that growth hormone, but not other adjuvants, administered in stimulation cycles may improve oocytes with resultant benefits to embryo quality which in turn may result in improved Clinical Pregnancy and Live Birth rates in subsequent FET cycles.

  • Pentoxyfilline for Reduction of Delayed Cerebral Ischaemia after Aneurysmal Subarachnoid Haemorrhage: a pilot study

    Pentoxifylline is a medication that decreases the viscosity of blood and helps red blood cells travel better through narrow blood vessels. Aneurysmal subarachnoid haemorrhage is a type of stroke that can be complicated by a second type of stroke called delayed cerebral ischaemia. This is a pilot, randomized controlled study to determine if pentoxifylline when used in aneurysmal subarachnoid haemorrhage decreases the rate of delayed cerebral ischaemia.

  • A human trial to evaluate the performance and safety of a new formulation containing a cholesterol-lowering drug to healthy male volunteers.

    The purpose of this study is to evaluate the safety and performance of LipoCeramic simvastatin when administered as an oral capsule. Simvastatin is a commonly prescribed lipid-regulating drug which is used to treat hypercholesterolemia, where there is high levels of cholesterol present in the blood. LipoCeramic technology combines simvastatin with numerous approved ingredients to improve the absorption of the drug in the body. A total of twelve healthy male volunteers aged 18 or over, who meet all entry criteria will be accepted into the study. Participants will be randomly allocated to two groups which dictates which formulation they receive. The trial will be “double- blinded” which means neither the participants, nor the study staff, will know which formulations are being administered. Volunteers will undergo a screening process to determine their eligibility for the study. Successfully recruited volunteers will be required to attend the Clinical Trial Facility on three occasions for a full-day (8:00 am to 5:30 pm) visit, where they will receive one oral dose of a commercial simvastatin tablet and two doses of simvastatin in a LipoCeramic Formulation. There will be a 7-day wash-out period between doses, meaning volunteers will return to the Clinical Trial Facility 7 days and 14 days after administration of their first dose to receive subsequent treatments. Each dosing day will require blood sample collection prior to dosing and at 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours post dose administration. Numerous safety assessments will also be performed throughout the day. The study will be held at the University of South Australia Clinical Trial Facility, located at the City East Campus, Bonython Jubilee Building, Frome Road. Volunteers will be financially reimbursed $600 for their time and inconvenience after completion of the study.

  • Arm rehabilitation after stroke using a multimodal device

    Innovative technologies for sensorimotor rehabilitation after acquired brain injury have dramatically increased over the past 20 years and their development, as well as the demand for access to these devices, is expected to continue to increase exponentially. Many of the developments have been technology-driven which may limit their application and acceptance in clinical settings. Emerging research shows promise, and collaborative research with engineers, therapists and end-users is critical for the successful translation of these devices into standard practice. Based on this premise, we aim to examine the potential benefits of using a novel device, which incorporates virtual reality, triggered-electrical stimulation and haptic feedback, as an adjunct therapy for the rehabilitation of people with stroke.

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