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Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry
Expand descriptionThe INSIGHT ('Insight into Real-world Practice of Management of HCC in Asia-Pacific') registry is designed as a multi-centre longitudinal cohort study of patients diagnosed with HCC between 1st January 2013 and 31st December 2019 in nine countries (i.e., South Korea, Taiwan, Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore). Approximately 30% of the sample size will be identified retrospectively and 70% will be identified prospectively from the start date of the registry (October 2016), with an even distribution of consecutively diagnosed patients within the different years.
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The Severity Of Individual Breathing Cessation Events In Diagnostics Of Obstructive Sleep Apnea
Expand descriptionObstructive sleep apnea (OSA) is a common nocturnal breathing disorder characterized by complete (apnea) and partial (hypopnea) breathing cessations during sleep. Currently, clinical diagnosis of OSA is based on the clinical symptoms, especially excessive daytime sleepiness, and apnea-hypopnea index (AHI) providing a limited overview of the breathing cessation event frequency during the night. Longer obstruction events and deeper desaturations have been suggested to be more harmful than shorter and shallower events and these individual characteristics are completely neglected by conventional and currently used AHI. The investigators have previously introduced novel diagnostic parameters incorporating the number, duration and morphology of individual obstruction events and shown that they improve the severity estimation of OSA compared to traditional measures. Even though, the novel diagnostic parameters have so far tackled some of shortcomings of AHI, they need to be refined to further increase the accuracy of the OSA severity estimation. It has been shown that age, body mass index (BMI) and sleeping position are strongly related to the severity OSA. However, it is not thoroughly studied whether the severity of individual obstruction events progress over time (the aging process) and which factors affect to this progression. It is known that OSA patients with similar AHI values, durations of individual breathing cessation events can differ significantly. Longer and deeper events are connected to increased mortality rate in patients with moderate or severe OSA and thus, could be considered to be more detrimental than shorter and shallower ones. However, it has not been thoroughly investigated whether in severe OSA patients with identical AHI values, sleep efficiency or hypertension is related to the severity of individual breathing cessation events. The investigators planned to explore, whether the individual breathing cessation event severity progress over time and how different confounding factors affect this progression. Furthermore, the correlation of EDS with the individual breathing cessation event severity, sleep structure, and frequency and occurrence of cortical arousals will be investigated. Also, the investigators will explore whether the percentage time of disturbed breathing from total sleep time is related to sleep efficiency or hypertension in severe OSA patients having similar AHI. Moreover, Positional therapy (PT) i.e., the avoidance of the supine posture during sleep is the treatment of choice for Positional Patients (PP) having most of their breathing abnormalities while sleeping supine. Since it is known that apneas/hypopneas are more severe while sleeping supine, this time the investigators will assess the therapeutic value of PT for severe Non Positional patients (NPP).
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Rapid Point-of-care Testing for Hepatitis C in Community Clinics (RAPID-EC) Pilot Study
Expand descriptionThe Rapid-EC pilot study will determine feasibility of providing rapid point-of-care (POC) testing for HCV in community clinics, and whether the availability of POC testing increases uptake of testing, engagement in care and completion of treatment among people who inject drugs. The POC tests being utilised in this study are the OraQuick mouth swab test for the presence of HCV antibodies, and the Xpert HCV RNA viral load test using serum.
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Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)
Expand descriptionThe primary objective is to compare the failure rate due to splenic bleeding between the patients undergoing pre-emptive splenic arterial embolization (SAE) as part of non-operative management (NOM) and the patients not undergoing SAE. We hypothesize that the use of pre-emptive SAE will decrease the delayed bleeding rate and increase the success rate of NOM.
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A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis
Expand descriptionThis is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.
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Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
Expand descriptionMulticenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
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Oxytocin and Non-verbal Communication
Expand descriptionIn this protocol registration, the investigators plan a secondary data analysis of a dataset to explore the effects of intra-nasal oxytocin on the non-verbal expression of affiliation.
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A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
Expand descriptionThis is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).
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A Prospective Natural History Study of Mucopolysaccharidosis Type IIIB (MPS IIIB)
Expand descriptionThis is a natural history study for children up to 18 years of age who have been diagnosed with Mucopolysaccharidosis Type IIIB (MPS IIIB, also known as Sanfilippo Syndrome Type B). Mucopolysaccharidosis type IIIB is a severe neurodegenerative disorder. The information gathered from this trial may help inform the design and interpretation of subsequent interventional studies. No clinical intervention or study drug is provided by Allievex in this study.
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The PREDICT Study- a Registry in Critically Ill Patients to Determine Predictors of Disability Free Survival
Expand descriptionAs mortality from critical illness has reduced, the importance of measuring disabilities (cognitive, functional and psychological) in surviving critically ill patients has become more important. Currently, the causes, long-term effects and frequency of disabilities in patients surviving ICU in Australia are unknown. In the US and UK, studies have been undertaken to assess the effects of specific long-term outcomes, such as functional disability and depression, which found long-term disabilities were much higher than baselines (pre-illness function) and ongoing at five years after ICU discharge. In order to improve quality of life of ICU survivors and ensure that medical specialists apply appropriate interventions to reduce the cost of these surviving patients on the community, the PREDICT management committee proposes the introduction of a patient-reported outcomes registry.