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Radiation-Emitting SIR-Spheres in Non-resectable (RESIN) Liver Tumor Patient Registry. Australia
The purpose of the study is to provide a real world view of clinical practice, patient outcomes, safety, and the comparative effectiveness of SIR-Spheres treatment in patients with liver cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or over and Y90 therapy for the first time as treatment for either primary or secondary liver cancer. Study details The treatment is for primary and secondary liver cancer. The Radiation-Emitting SIR-Spheres In Non-resectable (RESIN) Liver Tumor involves patients with primary and secondary liver cancer receiving (Y90 resin microspheres) treatment as part of their overall oncologic management. The microsphere are injected into the liver through a blood vessel. This allows a large dose of radiation to be delivered to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue. All visits and procedures related to SIR-Spheres treatment are performed on an outpatient basis per standard of care. Prior to treatment, patients are assessed by physical examination, radiographic evaluation, and blood tests to determine the health of the patient and liver. Standard of care tests done before this procedure may include: • physical exam and medical history • blood tests requiring about 2 tablespoons of blood • a chest x-ray, CT or MRI scan • an imaging scan (CT or MRI scan) of the liver Patients undergo an initial mapping arteriogram, to determine the distribution of blood vessels to the tumor(s), identify possible vessels which are to be avoided due to supply to the stomach/small bowel, and evaluate the amount of shunting through the tumor(s) to the lungs. This procedure is performed under sterile conditions with patients having a small tube (catheter) inserted through the skin. It is usually inserted into the thigh, into a blood vessel going to the liver. Depending on the size and location of tumors, there may be more than one treatment with SIR-Spheres planned. Repeat treatment is done between 4-8 weeks after the first treatment if there is more disease to treat.
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Prospective characterisation of a novel circulating tumour-derived DNA methylation assay to monitor tumour burden and response to therapy in metastatic colorectal cancer (CATCHER-1)
The purpose of the CATCHER-1 study is to assess the usefulness of a blood test called Colvera in patients with bowel cancer over time. Colvera may provide information about the progress of bowel cancer and help to determine if a cancer treatment is working. When bowel cancer has spread to other organs or parts of the body (for example, liver, lung and the lining of the abdomen), this is known as advanced or metastatic bowel caner. Patients with advanced bowel cancer are generally treated with different types of drug therapy (systemic therapy) with the aim to control the cancer, slow its growth and manage symptoms. To monitor if systemic therapies are effective or not, patients undergo regular CT scans and often a blood test called CEA. However, sometimes, it can time for changes to become noticeable on CT, such that the images may not reflect a patient’s true clinical state. CEA, used alone, can have variable results. Who is it for? You may be eligible for this study if you are an adult who is commencing a new cancer treatment. Study details Colvera is designed to identify small amounts of altered DNA which may leak from a tumor into the bloodstream, called circulating tumor DNA or ctDNA. Colvera detects the presence or absence of two genes in ctDNA, (BCAT1 and IKZF1), that are often associated with colorectal cancer growth. While Colvera detects changes found in most advanced bowel cancers , Colvera may not be detectable in all patients. In this study, patients who are starting a new drug treatment for advanced bowel cancer, will undergo additional blood sampling for Colvera and CEA in addition to planned treatment. Your doctor remains in control of your care and this study will not impact on the standard of care you receive. The study is designed to monitor your care to evaluate if the level of Colvera in the blood is an effective marker in advanced bowel cancer, including in comparison with standard measures (CT scan and CEA). It is hoped that this research will determine whether Colvera is an effective way of determining whether treatment is effective, and if it is, will provide a more accurate way of guiding treatment in those with colorectal cancer
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Metabolic responses to night-time eating: a randomised control trial in men with high fasting lipids
People who work out of synchronisation with their body clock e.g shift workers face higher rates of chronic diseases such as type 2 diabetes and cardiovascular disease. Eating at night time may contribute to this increased risk by forcing the body to break down and process food at a time usually associated with sleeping. Consuming the same meal at night time compared to the morning is associated with glucose intolerance, insulin resistance and changes in the expression of circadian genes. We hypothesise that altering the type of food consumed at night time may help modify these metabolic risks. In this study we aim to investigate the impact of two isocaloric meals differing in macronutrient composition on glucose and lipid homeostasis and expression of circadian genes in men with high fasting lipids kept awake overnight.
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Development of Risk Models for Cognitive Decline and Delirium in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
This study aims to identify risk factors for a deterioration in thinking and memory skills after a type of heart procedure known as transcatheter aortic valve implantation (TAVI). These changes may be short-term (such as delirium) or long-term cognitive decline. There will be 100 participants undergoing TAVI and 100 age-matched controls. Another part of this study will compare the 100 participants undergoing TAVI and the 100 control participants before the TAVI procedure i.e. the baseline data. This analysis will identify if participants with aortic stenosis compared with participants without aortic stenosis have different motor symptoms (walking, eye movement, voice, swallowing), mood, behaviour, brain activity (measured non-invasively using electroencephalogram or EEG), and their genotype taken from a saliva sample (with consent from participants).
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A long term follow up study of ATX-101 given by intravenous infusion once every week in patients with advanced solid tumours.
This is a Phase I, open-label, single arm, long term follow up study to assess safety of ATX-101 in subjects with advanced solid tumours over a maximum period of 12 months. Who is it for? You may be eligible to join this study if you have completed participation in the preceding study AM ATX101-01. Study details The study is designed to systematically assess safety and tolerability of an additional 12 months of treatment with ATX-101, and to further investigate the exploratory pharmacodynamics (PD; biomarker analyses) and preliminary efficacy of ATX-101 (anti-tumour activity and maintenance of non-progressive disease status). Willing subjects must provide voluntary written informed consent prior to undergoing any further procedures to determine study eligibility. Screening evaluations will ensure that potential study subjects fulfil all requirements for entry into the long term follow up study. Up to 36 study subjects who have been exposed to ATX-101 in AM ATX101-01 will be enrolled. ATX-101 treatment will be administered weekly in cycles of 21-day duration, with a single IV infusion of ATX-101 on Day 1, 8 and 15 (± 3 days) of each cycle for up to 12 months, unless criteria for early termination is met. Prior to each infusion subjects will receive mandated premedication with corticosteroid and H1 and H2 inhibitors.
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The prevalence of visual defects during early stages of stroke
Impaired motor function and cognitive confusion are the most common diagnostic symptoms associated with "stroke". Few acute clinical investigations of visual function are conducted even though far greater volumes of cortical and subcortical regions of the brain are directly involved with visual functions than with motor function. Van Essen et al (1984) first highlighted the vast number of visual areas and volume of cortex attributed to visual sensory processing, visual attention, visuo-motor functions and visually driven emotional processing. Furthermore the eye and the brain share similar embryonically derived vascular tissues and blood flow making vision defect a likely companion to a brain blood disorder (stroke). Over the last decade Rowe et al (2009), Spotfforth et al (2017) and Quinn et al (2018) have described significant persistent visual deficits following stroke. Of those affected common visual deficits up to a year later include visual field loss (hemianopia, quadrantanopia) ,perceptual disorders (visual inattention/neglect) and eye movement disorders. Rowe et al (2009) also noted the large proportion of ocular alignment deficits co-morbid with visual field defects. Most recently Quinn et al (2018) highlighted the incidence of visual field deficits with coexisting visual neglect in post stroke survivors. Hemifield neglect has long been known as a perceptual deficit sometimes associated with stroke although when tested it is most often tested manually by line bisection or star cancellation even though stroke itself is usually defined by motor impairments. Application of sophisticated visual field analyzers such as the Humphrey have seldom been utilized in hospitalized stroke patients given that most cases involve elderly patients limited in mobility and who suffer motor impairment for at least 24 hours. Thus the purpose of this study was to consider whether visual field losses can be identified and quantified in the acute stages of stroke using an ipad based bed side perimetry app, The Melbourne Rapid Fields (MRF), developed to measure visual acuity and visual field integrity. The neuroanatomical site of lesion was also considered in relation to field deficits to evalute the clinical and radiographic imaging patterns with the patient’s visual acuity and visual field intergrity.
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An Australia and New Zealand-wide survey of extracorporeal membrane oxygen (ECMO)-related infection and dressing and securement practices.
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Is water-based exercise as effective as land-based exercise in improving walking speed and leg muscle strength in stroke survivors?
Stroke survivors often have difficulty walking quickly and this can limit their ability to walk at home and in the community. Exercises to train power in the leg muscles, plyometric exercises, have been shown to improve the speed of walking in younger and healthy older people. These exercises can be undertaken on land or in the pool, but stroke survivors may find the exercises easier in the pool. This pilot trial will therefore investigate whether aquatic plyometric exercises are as effective as land-based plyometric exercises to improving walking speed, endurance and leg power in stroke survivors. Hypotheses: • It is hypothesised that aquatic plyometric exercise will be equally effective as land-based plyometric exercise in improving gait speed, endurance and plantar flexor power in people with chronic stroke. • It is hypothesised that land-based plyometric exercise will result in greater heart rate and blood pressure changes than aquatic plyometric exercise The trial will aim to recruit twenty stroke survivors who have suffered a stroke more than three months ago, are living at home and can walk at least 10m independently or only need a walking stick. The trial will be a cross-over design, with participants randomly assigned into one of two groups. One group will start with twice a week aquatic exercise for two weeks, while the other group will start with twice a week land-based exercises. After two weeks, the groups will swap over with the aquatic group completing the land exercises and the second group completing the exercises in the pool. A range of functional assessments will be completed. Walking speed will be measured on a ten metre walking track. Endurance will be measured by the distance participants can walk in six minutes. Lower leg power and strength will be recorded using a small, hand-held device which measures how much force is used to push into the device's force plate. Leg power will also be measured by seeing how high participants can reach when jumping from a standing position. In addition, measures of heart rate, blood pressure and muscle soreness will be recorded before and after each of the exercise sessions. Functional assessments will be completed before starting the exercise programs, after two weeks before swapping to the other exercise modality, after finishing the final exercise program and four weeks after completing the exercise protocols. Statistical analysis will be used to compare differences between the two exercise programs and groups of participants to see whether the exercise programs increased walking speed, endurance and leg power in stroke survivors.
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Keep it Real: A web-based program for psychotic-like experiences and cannabis use
Young cannabis users (16-25 years) will be recruited from the general community and substance use services to complete an online survey exploring the relationship between cannabis use and psychosis. They will be asked to repeat the online survey at 6 and 12-month follow ups. Eligible participants (past month cannabis use + at least 3 Psychotic Experiences (PLEs) ‘sometimes’ or 1 PLE ‘nearly always’ in the past 3 months; who express interest in trialling a website for PLEs during the baseline survey will then be invited to participate in a randomised controlled trial (RCT) comparing the efficacy and usability of the Keep it Real website versus a minimal web-based Information Control Website (ICW). Four followup online surveys will be completed at 3, 6, 9 and 12 months post baseline.
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Enhanced intervention to improve medication adherence in a community pharmacy setting
Patients are reported to be largely non-adherent to their medication, with medication non-adherence rates ranging from 30-70% among patients with chronic conditions. The Medication Adherence Service aims to develop, implement and evaluate a professional pharmacy service that is focused on increasing patient adherence whilst simultaneously examining the corresponding economic, clinical and humanistic implications the intervention poses. The research project proposes that a brief complex intervention tailored to the patient’s requirements performed on a regular basis during the dispensing process will improve patients’ adherence. The research project will be conducted in conjunction with GuildLink Pty. Ltd. a wholly owned subsidiary of the Pharmacy Guild of Australia, through use of their GuildCare software. A cluster randomised control trial will be conducted utilising a mixed method approach combining quantitative and qualitative data. The study aims to assess the impact that an enhanced intervention has on medication adherence when compared with usual care and the current adherence intervention provided through utilisation of GuildCare software.