Clinical trials: Validation Study, open to volunteers
Psychological Well Being
Test-Retest Reliability of the WB6Dim Digital Well-Being Tool: A 3-Day Interval Study
This study aims to establish the test-retest reliability of the WB6Dim digital self-assessment tool across its eight well-being dimensions, using a 3-day interval protocol designed to minimize the probability of genuine…
- Trial name
- WB6Dim-TRT (NCT07433764)
- Where
- France
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Clover Link
Cognitive Intervention to Promote Healthy Development of Executive Function (EF) Skills in Young Children
Parent-Child EF Intervention
Koronis Biomedical Technologies Corporation (KBT) is developing a cognitive intervention to promote healthy development of Executive Function (EF) skills in young children by leveraging a smartphone-based training regime designed…
- Trial name
- NCT06924307
- Testing
- Executive Function Intervention
- Where
- 2 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Koronis Biomedical Technologies
Kidney Transplant Rejection, Cell-free DNA
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.
- Trial name
- NCT07060716
- Testing
- donor-derived cell-free DNA test
- Where
- 10 sites in United States, Germany
- Volunteers
- 125 people
- Sponsor
- Insight Molecular Diagnostics
Atrial Fibrillation (AF), Atrial Fibrillation New Onset
Clinical Validation of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours Using Single-Lead ECG Data
The purpose of this retrospective study is to evaluate the clinical performance of SMD-AFECG, an artificial intelligence-based medical device software that predicts the risk of atrial fibrillation occurring within 2 hours using…
- Trial name
- NCT07722078
- Volunteers
- 797 people
- Sponsor
- HUINNO Co., Ltd
Diagnostic Techniques and Procedures, Clinical Laboratory Techniques
Clinical Validation of an Artificial Intelligence System for the Interpretation of Laboratory Test Results Combined With a Structured Medical History
This study evaluates a certified artificial intelligence (AI) based software system that automatically interprets laboratory test results in combination with a structured, dynamically generated medical history questionnaire.
- Conditions
- Diagnostic Techniques and Procedures, Clinical Laboratory Techniques, Triage
- Trial name
- LTC-VALID (NCT07810491)
- Testing
- AI-based laboratory result interpretation software
- Where
- 2 sites in Poland
- Volunteers
- 899 people
- Sponsor
- Labplus Sp. z o.o.
Alzheimer Disease, Mild Cognitive Impairment
Software Validation Study-Cognitive Status Indicator
The SPARK Cognitive Status Indicator software uses an algorithm to assess a resting state EEG recording as being consistent with a cognitive status of unimpaired, mild cognitive impairment (MCI; MCI AD- or MCI AD+), or dementia…
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Trial name
- REMIND-V (NCT06809725)
- Testing
- SPARK Cognitive Status Indicator (software support data collected via EEG)
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Spark Neuro Inc.
Obstructive Sleep Apnea
Validation and Usability Study of the SleepView+ Home Sleep Testing System for the Evaluation of Moderate to Severe Obstructive Sleep Apnea.
The goal of this observational study is to characterize the performance of the SleepView+ home sleep test system for the evaluation of moderate to severe obstructuve sleep apnea (OSA) in adult and pediatric patients (ages 12 and…
- Trial name
- NCT07476313
- Testing
- SleepView+
- Where
- 4 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Beacon Biosignals
Pneumococcal Disease, Invasive, Pneumococcal Disease
Serum Collection Study for Assay Development
The study will collect serum from 12 participants vaccinated with Gamma-PN to assist with assay development and validation
- Trial name
- NCT07205289
- Testing
- Gamma-PN
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GPN Vaccines
Burns, Burn Injury
Deepview HHF Training and Validation Study
The purpose of this Study is to help expand the use of the DeepView AI System so that it can assess burn injuries on the hands, head/face, and feet. To do this, the Study will collect new images of burns in these areas.
- Conditions
- Burns, Burn Injury, Diagnostic
- Trial name
- UK HHF (NCT07677657)
- Testing
- DeepView AI System
- Volunteers
- 280 people
- Sponsor
- SpectralMD
Endometriosis
Multicenter Study for Diagnostic Validation of a Laboratory Test for the Diagnosis of Endometriosis
Endometriosis affects at least 1 in 10 women worldwide and is associated with a diagnostic delay of 5-10 years. Currently, definitive diagnosis requires invasive laparoscopy, which is costly and burdensome for patients.
- Trial name
- NCT07553676
- Where
- 8 sites in Austria, Germany
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Diamens FlexCo
Pathological Processes
This Study is the Clinical Validation Study for Validation for the Digital Pathology System 'SGi 1.0 + EPW 1.0 + Compatible Clinical Displays'
The primary objective of this study is to show safety and effectiveness of the investigational device for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical…
- Trial name
- NCT07881874
- Testing
- Digital pathology system
- Where
- 2 sites in United States
- Volunteers
- 470 people
- Sponsor
- Philips Digital & Computational Pathology
Cardiopulmonary
Observational, Non-Interventional Study Supporting Validation of eVO2peak Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
In this study, the hypothesis being explored is that peak VO2 and potentially other CPET parameters can be accurately estimated from biosignals (namely, motion from accelerometers and cardiopulmonary variables from EKG) collected…
- Trial name
- NCT05678530
- Where
- 16 sites in United States, Canada
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Prolaio
Contraception
Validation of Effectiveness on NaturalCycles Users
The goal of this observational study is to measure the effectiveness of the Natural Cycles digital birth control application at preventing pregnancy in sexually active women aged 18 to 35 with no known history of infertility.
- Trial name
- VENUS (NCT07566793)
- Testing
- Log daily intercourse information, Natural Cycles application
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Natural Cycles
Atrial Fibrillation (AF), Atrial Fibrillation With Rapid Ventricular Response
Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
The purpose of this retrospective study is to evaluate the clinical performance of SMD-RVECG, an artificial intelligence-based medical device software that analyzes single-lead electrocardiogram data to predict the risk of atrial…
- Trial name
- AFRVR (NCT07722039)
- Testing
- SMD-RVECG
- Volunteers
- 348 people
- Sponsor
- HUINNO Co., Ltd
To Assess Cardiovascular Function
QuantaFlo HD Clinical Validation Study
The primary aim of this validation protocol is to assess cardiovascular function through transthoracic echocardiography ("Echo") measurements and the QuantaFlo HD test measuring blood flow at the finger during a forced expiration…
- Trial name
- NCT07219693
- Testing
- QuantaFlo HD
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Semler Scientific
Aortic Stenosis
Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study
AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study. This study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients…
- Trial name
- AoS-SEDAI (NCT07479992)
- Testing
- Willem AI ECG assessment
- Where
- 2 sites in Germany
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Blood Pressure, Hypertension
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
This study aims to evaluate the accuracy of the CART BP, a medically approved ring-type blood pressure monitor, in comparison to the traditional auscultatory method using a dual-head stethoscope.
- Conditions
- Blood Pressure, Hypertension, Blood Pressure, High, Blood Pressure, Low
- Trial name
- NCT06513975
- Testing
- CART BP, sphygmomanometer
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sky Labs
Dengue
Dengue - Sample Collection Study Pakistan
The objective of this study is to collect well-characterized serum and plasma specimens from confirmed dengue positive and dengue negative subjects to support dengue diagnostic products development.
- Trial name
- NCT07203183
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Abbott Rapid Dx
Cardiac Arrythmias, Valve Heart Disease
FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study
The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients.
- Conditions
- Cardiac Arrythmias, Valve Heart Disease, Cardiac Ischemia
- Trial name
- FRAILTY-CW2 (NCT06930833)
- Testing
- Corsano CardioWatch 287-2
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Corsano Health B.V.
Acute Respiratory Infections (ARIs)
FebriDx® Pediatric Validation Study
The primary objective of this study is to determine performance characteristics of the FebriDx® test in differentiating bacterial from non-bacterial etiology among febrile pediatric patients (2-11 years) presenting to the…
- Trial name
- NCT07211997
- Testing
- FebriDx
- Where
- 10 sites in United States
- Volunteers
- 800 people
- Sponsor
- Lumos Diagnostics