Clinical trials: VALİDİTY
Coronary Artery Disease, Angina Pectoris
Personalized Risk Evaluation and Diagnosis (Using Corus CAD or ASGES) in the Coronary Tree
The PREDICT study is to develop and validate a diagnostic blood ASGES (age, sex, gene expression score) or Corus CAD for atherosclerotic coronary artery disease (CAD).
- Conditions
- Coronary Artery Disease, Angina Pectoris, Chest Pain, Cardiovascular Diseases
- Trial name
- PREDICT (NCT00500617)
- Testing
- Corus CAD (ASGES)
- Where
- 10 sites in United States
- Volunteers
- 4,350 people
- Sponsor
- CardioDx
Healthy, Atrial Fibrillation
Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057
The objective of this study is to validate the performance of the electrocardiogram (ECG) function of the Masimo INVSENSOR00057 against contemporaneous measurements
- Trial name
- NCT06071754
- Testing
- Masimo INVSENSOR00057
- Where
- 4 sites in United States
- Volunteers
- 365 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Atrial Fibrillation, Arrythmia, Cardiac
Validation Study of the Watch HWA09 and Its Softwares ECG-SW1 and PPG-SW1 for the Detection of Atrial Fibrillation
The proposed clinical study aims to validate the diagnostic performance, compared to a reference ECG, of the ECG-SW1 software and the PPG-SW1 software integrated into the HWA09 watch developed by Withings for the automatic…
- Trial name
- WEFA (NCT04351386)
- Testing
- AF Detection
- Where
- 3 sites in France
- Volunteers
- 283 people
- Sponsor
- Withings
Pulmonary Disease, Chronic Obstructive, Infections, Bacterial
Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD)
The aim of the study is to develop a new patient-reported outcome (PRO) questionnaire measuring the impact of an acute exacerbation on daily lives of patients with chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT00259909
- Testing
- GSK questionnaire, St. George's Respiratory Questionnaire, Acute Short Form 12 version 2
- Where
- 123 sites in United States, Germany and 1 more
- Volunteers
- 259 people
- Sponsor
- GlaxoSmithKline
Chest Pain
Low Dose One-Day Tc99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera For Detection of Coronary Disease
A prospective single clinical trial to validate the use of a low-dose (~5mSv) Tc-99m protocol with a high-efficiency cardiac dedicated camera (Dynamic Single Photon Emission Computed Tomography; D-SPECT) to detect myocardial…
- Trial name
- NCT01135095
- Testing
- low-dose imaging
- Where
- 2 sites in United States
- Volunteers
- 101 people
- Sponsor
- Spectrum Dynamics
Varicose Veins
Validity of Electronic Diary for Monitoring Varicose Veins Symptoms
The purpose of this study is to contribute to the validation of an electronic daily diary to assess symptoms in patients with varicose veins.
- Trial name
- NCT01200199
- Where
- United Kingdom
- Volunteers
- 45 people
- Sponsor
- Boston Scientific Corporation
Chronic Cough
Cough Count Validation
People with respiratory infection, asthmatic patients and cystic fibrosis (CF) patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.
- Trial name
- NCT01413698
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- KarmelSonix Ltd.
Acute Kidney Injury
Clinical Validation of NAVOY® Acute Kidney Injury in Swedish ICU Patients
The study aims to evaluate the performance of the prediction algorithm NAVOY® AKI in a Swedish adult ICU patient population versus fulfilment of KDIGO diagnostic criteria.
- Trial name
- ExTRACT (NCT05424874)
- Where
- Sweden
- Volunteers
- 304 people
- Sponsor
- AlgoDx
Sleep Apnea
AirSense 10 AHI Validation Study
The AirSense 10 platform is able to detect respiratory events at night and report these data via telemonitoring. The accuracy of the AirSense 10 will be compared with scoring with polysomnography (PSG).
- Trial name
- NCT03043703
- Testing
- AirSense 10 AutoSet for Her
- Where
- 2 sites in Germany
- Sponsor
- ResMed
Breast Cancer, Early Breast Cancer
Independent, External, Blinded Retrospective Validation of an AI-based Prognostic Assay in ER-Positive/HER2-Negative Early Breast Cancer
This retrospective observational study evaluates the prognostic performance of a locked Artificial Intelligence (AI)-based assay in patients with Estrogen Receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2…
- Conditions
- Breast Cancer, Early Breast Cancer, ER-Positive HER2-Negative Breast Cancer
- Trial name
- NCT07541703
- Testing
- Locked AI-based prognostic assay
- Where
- Austria
- Volunteers
- 2,200 people
- Sponsor
- Spotlight Medical
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
Chronic Pain
Validating and Evaluating the Pain Medicine Digital Workflow Algorithm (PGS 1.0)
This is a prospective, non-randomized, double blind, single center, single arm, validation study, to evaluate the performance of PGS 1.0 algorithm in analyzing pain specific symptoms and medical history data of pain patients…
- Trial name
- NCT07195162
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- PG Medical Systems Ltd.
Oxygen Saturation Measurement
Controlled Desaturation Study for Perin Health Patch Validation
This study aims to test the accuracy of the Perin Health Patch (PHP), a non-invasive, chest-worn device that measures blood oxygen levels, by comparing its readings to a standard pulse oximeter device.
- Trial name
- NCT06680700
- Testing
- Perin Health Patch
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Perin Health Devices
Atrial Fibrillation
Clinical Data Validation of Novel Wireless Cortrium C3 Monitor for Continuous Electrocardiogram Measurements
The purpose of this study is to validate the quality of the ECG-signal acquired with the Cortrium C3 monitor. The intention is to evaluate whether the diagnosis of atrial fibrillation based on the ECG signal from the C3 monitor…
- Trial name
- NCT02714907
- Testing
- Cortrium C3 device, Holter device
- Where
- 2 sites in Denmark
- Volunteers
- 158 people
- Sponsor
- Cortrium
Keratoconjunctivitis Sicca
TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease
This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective…
- Trial name
- CVS (NCT00848198)
- Where
- 10 sites in United States, France and 3 more
- Volunteers
- 314 people, healthy volunteers welcome
- Sponsor
- TearLab Corporation
Obstructive Sleep Apnea
Validation of an Integrated Digital Solution (SUNrise®) Versus Polysomnography for Obstructive Sleep Apnea Diagnosis
Validation of an integrated digital solution (SUNrise®) of mandibular movement automatic analysis by artificial intelligence versus polysomnography for obstructive sleep apnea diagnosis: a prospective, randomized, parallel-arm…
- Trial name
- SUNSAS (NCT05057975)
- Testing
- Sunrise, polysomnography
- Where
- 19 sites in France
- Volunteers
- 848 people, healthy volunteers welcome
- Sponsor
- Sunrise
Heart Failure, High Blood Pressure
BVA-200 vs BVA-100 Validation Study
The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device.
- Conditions
- Heart Failure, High Blood Pressure, High Cholesterol, Anemia
- Trial name
- NCT06227819
- Testing
- BVA-200
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Daxor Corporation
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.
Opioid-Related Disorders, Opiate Addiction
Validation of PRISM-5-Op, Measure Of Addiction To Prescription Opioid Medication
The purpose is to validate the PRISM-5-Op as a measurement of prescription opioid substance use disorder.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02660619
- Testing
- Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)
- Volunteers
- 606 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Epilepsy
Formative Validation of the MoveChecker System
obtain motion sequences of at least 60 epileptic seizures
- Trial name
- NCT05824611
- Testing
- collect movement data from epileptic seizures
- Where
- 4 sites in Germany
- Volunteers
- 53 people
- Sponsor
- Gaia AG