Clinical trials: Validation Study
Healthy, Arrhythmia
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).
- Trial name
- NCT05640323
- Testing
- Norbert Device
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Norbert Health
Allergic Asthma, Allergy to House Dust
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Mite Allergic Subjects With Asthma
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne house dust mite allergen inducing bronchial response in asthmatic subjects allergic to mite, during allergen exposures in…
- Conditions
- Allergic Asthma, Allergy to House Dust, Allergy
- Trial name
- NCT04663880
- Testing
- Exposure to three concentrations of HDM allergen in EEC, Exposure to a single concentration of HDM allergen in EEC
- Where
- France
- Volunteers
- 27 people
- Sponsor
- Alyatec
Influenza A, Influenza B
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase…
- Trial name
- NCT02487173
- Testing
- Respirio Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Sofia® Influenza A+B Fluorescent Immunoassay (FIA)
- Where
- 4 sites in Australia
- Volunteers
- 83 people
- Sponsor
- Ellume Pty Ltd
Hypoxia
Polso SpO2 Accuracy Validation Study
The purpose of this study is to validate the oxygen saturation (SpO2) accuracy of the Polso Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by…
- Trial name
- NCT03735329
- Testing
- Diagnostic test of SPO2
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- ChroniSense Medical Ltd.
Gout
Validation Study of Physical Measurement of Tophi
The purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout.
- Trial name
- NCT00175006
- Testing
- Measurement of Tophi to validate procedure
- Volunteers
- 13 people
- Sponsor
- Takeda
Atrial Fibrillation, Hypertension
Validation Study of an Advanced Blood Pressure Monitor
The proposed clinical study aims to validate the effectiveness of the WPM04 blood pressure monitor developed by Withings as a diagnostic tool for cardiovascular disorders.
- Conditions
- Atrial Fibrillation, Hypertension, Valvular Heart Disease
- Trial name
- TALISMAN (NCT04030494)
- Testing
- BP measurement, AF detection, VHD detection
- Where
- France
- Volunteers
- 218 people
- Sponsor
- Withings
Streptococcus Agalactiae Infection
Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains
The primary purpose of this clinical investigation is to verify the performance of the GenePOC GBS Assay on the GenePOC Instrument.
- Trial name
- NCT02718157
- Testing
- Comparison between GenePOC PCR and Reference Method
- Where
- 4 sites in United States, Canada
- Volunteers
- 771 people
- Sponsor
- Meridian Bioscience, Inc.
Dementia, Mild Cognitive Impairment
HOme-based Brain Monitoring With a GARment-EEG to Study Cognitive Decline in the Aging Population
This study will investigate the validity of the HOGAR EEG/PSG monitoring kit designed by Bitbrain as a tool for characterizing and assessing cognitive function in older adults, as well as for detecting and predicting cognitive…
- Conditions
- Dementia, Mild Cognitive Impairment, Dementia Alzheimers, Dementia, Mixed
- Trial name
- Hogar (NCT06993207)
- Testing
- Home Lab
- Where
- Spain
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Bitbrain
Bipolar Disorder I or II
Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine
A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.
- Trial name
- NCT00259272
- Testing
- olanzapine
- Where
- 16 sites in France
- Volunteers
- 141 people
- Sponsor
- Eli Lilly and Company
Sepsis, Septic Shock
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic…
- Trial name
- SYMON II (NCT06654895)
- Where
- 5 sites in United States
- Volunteers
- 700 people
- Sponsor
- Bluejay Diagnostics, Inc.
Lifestyle-related Condition, Nutrient; Excess
Dietary Quality Photo Navigation (DQPN) Preliminary Validation Study
The purpose of this research project is to conduct a preliminary validation study of the Diet Quality Photo Navigation (DQPN) method of dietary intake assessment.
- Trial name
- NCT03661931
- Testing
- DQPN Validation
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Boston Heart Diagnostics
Rheumatoid Arthritis
Validation Study of RA-INF-Dx, a Multigene Molecular Test Used to Predict Non-Response to INfliximab Therapy
Study Design \& Objectives: Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with a clinical follow-up between 12 and 14 weeks.
- Trial name
- PRINT (NCT01299545)
- Where
- 37 sites in Canada, France and 6 more
- Volunteers
- 123 people
- Sponsor
- TcLand Expression S.A.
Bipolar Disorder, Major Depressive Disorder
Clinical Validation Study for EDIT-B Test: an Aid for Differential Diagnosis of Bipolar Disorder, Based on RNA Editing Blood Biomarkers
Differentiation between major depressive disorder (MDD) and bipolar disorder (BD) as soon as possible in the patient journey represents a major clinical issue.
- Trial name
- EDIT-B (NCT05603819)
- Testing
- EDIT-B
- Where
- 4 sites in Denmark, France and 1 more
- Volunteers
- 418 people
- Sponsor
- Alcediag
Chronic Cough
Validation Study With a Non-CE Marked Medical Device (MD)
This interventional study aims to validate the cough detection device by automatically and continuously measuring the cough frequency with SIVA-MVP among chronic cough patients and in a real-world environment.
- Trial name
- NCT05689307
- Testing
- SIVA-MVP
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Siva Health AG
Hepatic Cancer
Seravue Validation Study for Hepatocellular Carcinoma (HCC) Diagnosis
Currently, ultrasound with or without AFP is the standard of care when it comes to surveillance for HCC in high-risk populations.
- Trial name
- Seravue (NCT06994130)
- Testing
- Seravue
- Where
- United States
- Volunteers
- 1,392 people
- Sponsor
- ImCare Biotech
Pulmonary Arterial Hypertension
Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH
Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in patients with PAH. To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment…
- Trial name
- NCT02112487
- Testing
- Macitentan
- Where
- 32 sites in France, Italy and 1 more
- Volunteers
- 88 people
- Sponsor
- Actelion
Major Depressive Disorder, Bipolar I and Bipolar II
Bipolar Proteomic Assay Validation Study
The purpose of this study is to validate a set of signatures, based on a panel of proteomic markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive episode.
- Trial name
- NCT02746367
- Testing
- Diagnostic test (LDT)
- Where
- 5 sites in United States
- Volunteers
- 261 people
- Sponsor
- Myriad Genetic Laboratories, Inc.
Validation Study
Gait Metric Validation of the Cionic Neural Sleeve
The purpose of this study is to determine the validity of the Neural Sleeve gait metrics compared to gait parameters assessed with a Protokinetics Zeno pressure sensitive walkway.
- Trial name
- NCT06503354
- Testing
- Neural Sleeve and Zeno walkway
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Cionic, Inc.
Proximal Junctional Kyphosis, Spino-pelvic Alignment
MSK Validation Study
Spinal posture and imbalance are known to be related to increased muscle expenditure, with narrow "cone of economy" of muscle effort defining the most comfortable postures.
- Conditions
- Proximal Junctional Kyphosis, Spino-pelvic Alignment, Thoracolumbar Spinal Fusion
- Trial name
- MSK (NCT04422288)
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- NuVasive
Myelodysplastic Syndromes, Leukemia Myeloid Acute
A Study to Determine Final Geriatric Assessment in Haematology (GAH) Score as a Tool for Predicting Tolerance to Treatment in Elderly Patients (≥ 65 Years) With Haematologic Neoplasms
This is a post-authorization, retrospective multicentre observational nationwide study (PAS-OD). It will be conducted by reviewing medical records and database of patients who participated in the validation of the psychometric…
- Conditions
- Myelodysplastic Syndromes, Leukemia Myeloid Acute, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell
- Trial name
- NCT02842229
- Where
- 15 sites in Spain
- Volunteers
- 117 people
- Sponsor
- Celgene