Search results for "Proof of Concept Study"
showing 10 items of 12 documents
Mediterranean diet and sars-cov-2 infection: Is there any association? a proof-of-concept study
2021
The aim of this observational study was investigating the possible correlation between adherence to the Mediterranean diet (MeD) and SARS-COV-2 infection rates and severity among healthcare professionals (HCPs). An online self-administrated questionnaire (evaluating both MeD adherence and dietary habits) was filled out by HCPs working in Piedmont (Northern Italy) from 15 January to 28 February 2021. Out of the 1206 questionnaires collected, 900 were considered reliable and analyzed. Individuals who reported the SARS-COV-2 infection (n = 148) showed a significantly lower MeD score, with a lower adherence in fruit, vegetables, cereals, and olive oil consumption. In a logistic regression model…
Molecular similarities and differences from human pulmonary fibrosis and corresponding mouse model: MALDI imaging mass spectrometry in comparative me…
2017
Animal models can reproduce some model-specific aspects of human diseases, but some animal models translate poorly or fail to translate to the corresponding human disease. Here, we develop a strategy to systematically compare human and mouse tissues, and conduct a proof-of-concept experiment to identify molecular similarities and differences using patients with idiopathic pulmonary fibrosis and a bleomycin-induced fibrosis mouse model. Our novel approach employs high-throughput tissue microarrays (TMAs) of humans and mice, high-resolution matrix-assisted laser desorption/ionization-Fourier transform-ion cyclotron resonance-mass spectrometry imaging (MALDI-FT-ICR-MSI) to spatially resolve ma…
A Novel Anti-CD40 Monoclonal Antibody, Iscalimab, for Control of Graves Hyperthyroidism—A Proof-of-Concept Trial
2019
Abstract Context The CD40-CD154 co-stimulatory pathway plays an important role in the pathogenesis of Graves disease (GD) by promoting autoreactive B-cell activation. Objective Evaluate efficacy and safety of a human, blocking, nondepleting anti-CD40 monoclonal antibody, iscalimab, in hyperthyroid patients with GD. Design Open-label, phase II proof-of-concept study. Setting Multicenter. Patients Fifteen with GD. Intervention Patients received 5 doses of iscalimab at 10 mg/kg intravenously over 12 weeks. Main outcome measures Thyroid-related hormones and autoantibodies, plasma soluble CD40, free CD40 on B cells, soluble CXCL13, pharmacokinetics, and safety were assessed. Results The iscalima…
Multimodal Device for Real-Time Monitoring of Skin Oxygen Saturation and Microcirculation Function
2019
The present study introduces a recently developed compact hybrid device for real-time monitoring of skin oxygen saturation and temperature distribution. The prototype involves a snapshot hyperspectral camera, multi-wavelength illuminator, thermal camera, and built-in computer with custom-developed software. To validate this device in-vivo we performed upper arm vascular occlusion on eight healthy volunteers. Palm skin oxygen saturation maps were analyzed in real-time using k-means segmentation algorithm and two-layer optical diffuse model. The prototype system demonstrated a satisfying performance of skin hyperspectral measurements in the spectral range of 507&ndash
Fractal-structured multifocal intraocular lens
2017
[EN] In this work, we present a new concept of IOL design inspired by the demonstrated properties of reduced chromatic aberration and extended depth of focus of Fractal zone plates. A detailed description of a proof of concept IOL is provided. The result was numerically characterized, and fabricated by lathe turning. The prototype was tested in vitro using dedicated optical system and software. The theoretical Point Spread Function along the optical axis, computed for several wavelengths, showed that for each wavelength, the IOL produces two main foci surrounded by numerous secondary foci that partially overlap each other for different wavelengths. The result is that both, the near focus an…
HL7 FHIR with SNOMED-CT to Achieve Semantic and Structural Interoperability in Personal Health Data: A Proof-of-Concept Study
2022
Heterogeneity is a problem in storing and exchanging data in a digital health information system (HIS) following semantic and structural integrity. The existing literature shows different methods to overcome this problem. Fast healthcare interoperable resources (FHIR) as a structural standard may explain other information models, (e.g., personal, physiological, and behavioral data from heterogeneous sources, such as activity sensors, questionnaires, and interviews) with semantic vocabularies, (e.g., Systematized Nomenclature of Medicine—Clinical Terms (SNOMED-CT)) to connect personal health data to an electronic health record (EHR). We design and develop an intuitive health coaching (eCoach…
Association Between Serum Levels of Neurofilament Light Chains and Minimal Hepatic Encephalopathy in Patients With Liver Cirrhosis.
2021
INTRODUCTION: Serum biomarkers for the diagnosis of minimal hepatic encephalopathy (MHE) in patients with liver cirrhosis would be desirable. In this proof-of-concept study, we investigated the association between MHE and serum levels of neurofilament light chains (sNfL) in patients with liver cirrhosis. METHODS: sNfL were studied in patients with liver cirrhosis (with or without MHE) and controls (patients with ischemic stroke, transitory ischemic attack, and healthy individuals). MHE was diagnosed using the Psychometric Hepatic Encephalopathy Score. RESULTS: Patients with MHE showed higher sNfL than patients without MHE and controls. In multivariable analyses, higher sNfL were independent…
A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjögren’s syndrome
2020
Abstract Objectives This phase 2 proof-of-concept study (NCT02610543) assessed efficacy, safety and effects on salivary gland inflammation of seletalisib, a potent and selective PI3Kδ inhibitor, in patients with moderate-to-severe primary Sjögren’s syndrome (PSS). Methods Adults with PSS were randomized 1:1 to seletalisib 45 mg/day or placebo, in addition to current PSS therapy. Primary end points were safety and tolerability and change from baseline in EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score at week 12. Secondary end points included change from baseline at week 12 in EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score and histological features in salivary …
A Nomogram to Characterize the Severity of Detrusor Overactivity during the Ice Water Test: Description of the Method and Proof of Concept
2017
<b><i>Aims:</i></b> To develop a nomogram with severity categories for detrusor overactivity (DO). <b><i>Methods:</i></b> By conducting ice water tests (IWT) in 55 patients with Parkinson’s disease, we identified criteria to describe characteristics of the detrusor pressure curves: (1) a gradient of Δ<i>pdet</i> over Δt at the maximum detrusor pressure and (2) the area under the curve. In a nomogram, 10 severity categories of DO were established: 1 and 2 were assigned to group A (mild), 3 and 4 to group B (moderate) and 5–10 to group C (severe). <b><i>Results:</i></b> In the nomogram, negative IWT (20) appea…
Infrared based saliva screening test for COVID‐19
2021
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in an unprecedented need for diagnostic testing that is critical in controlling the spread of COVID-19. We propose a portable infrared spectrometer with purpose-built transflection accessory for rapid point-of-care detection of COVID-19 markers in saliva. Initially, purified virion particles were characterized with Raman spectroscopy, synchrotron infrared (IR) and AFM-IR. A data set comprising 171 transflection infrared spectra from 29 subjects testing positive for SARS-CoV-2 by RT-qPCR and 28 testing negative, was modeled using Monte Carlo Double Cross Validation with 50 randomized test and model sets. The testing se…