Clinical trials: VALİDİTY
High-Risk Multidisciplinary Care, Clinical Decision Support
ANCHOR Validation Trial in High-Risk Multidisciplinary Care
This pre-registered, pragmatic, three-arm (1:1:1) patient-level randomized controlled trial with mixed-effects analysis at the encounter level tests two questions in real high-risk multidisciplinary clinical encounters at the…
- Conditions
- High-Risk Multidisciplinary Care, Clinical Decision Support, Artificial Intelligence-Assisted Care, Telemedicine
- Trial name
- NCT07597499
- Testing
- Gemini 3.1 Pro with Safety Prompt, ANCHOR Clinical AI Verification Layer (with Gemini 3.1 Pro)
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Waymark
Pulmonary Disease, Chronic Obstructive
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
The prevalence, low cost, and low burden of wearable devices that provide quantitative and qualitative feedback on a subject's activity level present an opportunity for the use of these devices in clinical and observational…
- Trial name
- NCT02619357
- Testing
- SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- GlaxoSmithKline
Cosmetic Appearance
Evaluation of the Cosmetic Performance of AIR OPTIX® COLORS
The purpose of this study was to evaluate the cosmetic performance of AIR OPTIX® COLORS contact lenses compared to FRESHLOOK® COLORBLENDS contact lenses in habitual FRESHLOOK® COLORBLENDS contact lens wearers.
- Trial name
- NCT01398787
- Testing
- Lotrafilcon B contact lens with color, Phemfilcon A contact lens with color
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- CIBA VISION
Bladder Disease, Bladder Retention Volume
ECHO-012 Kosmos Bladder Clinical Validation Study
The goal of this clinical trial is to compare the Kosmos Automatic Bladder Volume to the manual annotated bladder volume in participants across gender (male and female), age (children ages 7-17 and adults 18-89), and BMI strata…
- Conditions
- Bladder Disease, Bladder Retention Volume, Bladder Dysfunction, Bladder Function
- Trial name
- NCT06792851
- Testing
- Kosmos Bladder Volume Algorithm
- Where
- United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- EchoNous Inc.
Healthy, Hypoxia
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Saturation
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2…
- Trial name
- NCT05685654
- Testing
- Norbert Device
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Norbert Health
Endometriosis
Validation Study for Endometriosis PRO
Assess the psychometric properties of the Endometriosis Symptom Diary (ESD) and the Endometriosis Impact Scale (EIS) and provide evidence whether the PRO measures are reliable, valid and able to detect changes over time in…
- Trial name
- VALEPRO (NCT01643122)
- Testing
- No drug
- Where
- 21 sites in United States, Germany
- Volunteers
- 275 people
- Sponsor
- Bayer
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.
Sleep Apnea Syndromes
Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome
Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders.
- Trial name
- VPASS (NCT04234828)
- Where
- 2 sites in Belgium, France
- Volunteers
- 200 people
- Sponsor
- Withings
Oximetry
EmbracePlus SpO2 Accuracy Validation
The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from…
- Trial name
- NCT04964609
- Testing
- EmbracePlus
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Empatica, Inc.
Ultrasound Imaging of Anatomical Structures
Validity of Experts and ScanNav Anatomy PNB When Identifying Sono-anatomical Structures for Ultrasound-Guided Regional Anaesthesia
This is a multi-centre, prospective, observational study, conducted under the auspices of the University of Oxford to evaluate ultrasound image analysis by human experts and an artificial intelligence device in the context of…
- Trial name
- NCT04983771
- Testing
- Annotate ultrasound scans
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- IntelligentUltrasound Limited
Prenatal Diagnosis, Genetics
Identifai Genetics Analytic Validity Study - Compound Heterozygosity and Samples Collection
The purpose of this study is to validate a noninvasive prenatal diagnosis procedure for genetic conditions in the developing fetus by analyzing fetal genetic material present in the pregnant mother's blood.
- Trial name
- NCT06239077
- Testing
- Non Invasive Prenatal Test via blood sample
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Identifai Genetics
Infant Behavior
Validation of Active-Insights Device to Measure Crying Time
To assess the ability of a machine learning algorithm to accurately detect fussing and crying time in infants using accelerometery data collected from a wearable device, compared to the Barr's parent-/caregiver-completed…
- Trial name
- NCT05165589
- Testing
- ActiveInsights accelerometer device
- Where
- Ireland
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- BioGaia AB
Sleep-Disordered Breathing
Polysomnography Validation of the Sansa Device
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
- Trial name
- NCT06070389
- Testing
- Sansa device
- Where
- 2 sites in United States
- Volunteers
- 533 people, healthy volunteers welcome
- Sponsor
- Huxley Medical, Inc.
Quality of Life, Epilepsy (treatment Refractory)
Evaluation of the Epilepsy-related Quality of Life, Seizure-related Accidents and Validation of the Mjn-SERAS Solution in the Normalised Patient Environment with Real-World Data
The study will be prospective, multicentre, postmarketing clinical study, with a controlled and randomized design, to perform the analysis of 130 subjects with a clinical diagnosis of epilepsy, patients whose clinical semiology…
- Trial name
- SERAS_Home_RWD (NCT05845255)
- Testing
- mjn-SERAS
- Where
- 6 sites in Germany, Spain and 1 more
- Volunteers
- 130 people
- Sponsor
- MJN Neuroserveis, S.L
HIV Infections
Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
The primary purpose of the study is to investigate the safety and efficacy of KP-1461 given every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral regimens.
- Trial name
- NCT00504452
- Testing
- KP-1461
- Where
- 31 sites in United States, Puerto Rico
- Volunteers
- 27 people
- Sponsor
- Koronis Pharmaceuticals.
Healthy Female Volunteers
Validation Study in Healthy Female Volunteers: A Comparison of Two Neurotech Vital Devices Set up to Provide Different Types of Electrical Stimulation
This research is being carried out in order to compare two alternative versions of the Neurotech Vital Devices which have been set up to provide two different types of stimulation.
- Trial name
- NCT01632748
- Testing
- Neurotech Vital Device, Modified Neurotech Vital Device
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bio-Medical Research, Ltd.
Sleep Apnea
Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device
Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders.
- Trial name
- VPASH (NCT04496843)
- Testing
- HWA09 Measurement
- Where
- 2 sites in Belgium, France
- Volunteers
- 220 people
- Sponsor
- Withings
Anoxia
Accuracy Validation of the Cadwell Pulse Oximetry System
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Cadwell Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by…
- Trial name
- NCT02842476
- Testing
- Disposable Sensor, Reusable Sensor, Control Pulse Oximetry
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Cadwell Industries, Inc.
Dry AMD, Geographic Atrophy
Validation of Virtual Reality Tests for the Assessment of Patients With Age-related Macular Degeneration as Clinical Endpoints
Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrialized countries and affects tens of millions of people worldwide, with a rapidly increasing prevalence.
- Conditions
- Dry AMD, Geographic Atrophy, Healhty
- Trial name
- VIRETTA (NCT07433088)
- Testing
- Object recognition and selection task
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Streetlab
Blood Sampling Procedure, Healthy
Clinical Validation of the Fluispotter System for Serial Sampling of Venous Dried Blood Spots
This is a prospective, single-centre, non-comparative, non-randomized, open label, clinical investigation of the clinical performance and safety of Fluispotter.
- Trial name
- NCT04594577
- Testing
- Fluispotter
- Where
- Denmark
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Fluisense ApS