Clinical trials: Validation Studies
Alcohol Drinking, Alcohol Intoxication
Breathalyzer Validation Study
The proposed project will test three commercial cellphone breathalyzers against a police grade breathalyzer device.The study will test the accuracy of these smartphone breathalyzers at assessing Breath Alcohol Content (BrAC)…
- Trial name
- BVS (NCT04086576)
- Testing
- Alcohoot, BACtrack Mobile Pro, DRIVESAFE Evoc
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Heart Failure
Withings HFRN Retrospective Study
This is a fully decentralized retrospective, non-interventional study evaluating the diagnostic performance of the Withings Heart Function Risk Notification (HFRN), a software-only medical device (SaMD)
- Trial name
- NCT07654491
- Testing
- Withings Heart Function Risk Notification (HFRN), Claims-based heart-failure adjudication (reference standard)
- Where
- France
- Volunteers
- 9,000 people, healthy volunteers welcome
- Sponsor
- Withings
Delirium, Postoperative Delirium
Stanford PIPRA Validation Study in an Elderly Orthopedic Population
The purpose of this study is to determine the accuracy of an AI-based tool in the prediction of postoperative delirium (POD), in a population at moderately high risk of developing this syndrome (i.e., elderly orthopedic…
- Conditions
- Delirium, Postoperative Delirium, Cognitive Impairment
- Trial name
- PIPRA-ORTHO (NCT06567574)
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Stanford University
Healthy, SIRS
A Prospective Validation Study of Albumin Kinetics With Tracer 123 I-HSA
This is a prospective, validation study of a extempore made tracer compared with a commercial. Studies with tracer have no medical effects but are used for studying human physiology, in this case pharmacokinetic variables of…
- Trial name
- NCT01686776
- Testing
- 123 I-HSA + 125 I HSA
- Where
- Sweden
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Ake Norberg
Health Volunteer Validation Study
Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
This study has the following objective: To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.
- Trial name
- ViVUS (NCT02975050)
- Testing
- Location
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zoll Medical Corporation
Parkinson's Disease, Parkinsonian Syndrome
A Study of Neurophysiologic Changes in Individuals With Parkinson's Disease
The goal of this study is to investigate neurophysiologic tests that have the potential of serving as screening tools for Parkinson's disease.
- Trial name
- NCT00117195
- Testing
- Automated Neuropsychological Assessment Matrix
- Where
- United States
- Volunteers
- 620 people, healthy volunteers welcome
- Sponsor
- Institute for Neurodegenerative Disorders
Diagnostic Imaging, Common Systemic Diseases
Prospective User Study and Clinical Validation of Multimodal Medical Imaging Large Models
Following model development and locking, the fixed model is evaluated in prospectively collected CT cohorts from a single center. The study is observational and does not affect clinical care.
- Conditions
- Diagnostic Imaging, Common Systemic Diseases, Artificial Intelligence (AI)
- Trial name
- NCT07555002
- Testing
- Standalone Radiologist Interpretation, AI-assisted Radiologist Interpretation
- Where
- China
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- The Third Affiliated Hospital of Southern Medical University
Atrial Fibrillation
Electrocardiogram Clinical Validation Study
The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device.
- Trial name
- NCT03492554
- Testing
- 1-Lead ECG, 12-Lead ECG
- Where
- 5 sites in United States
- Volunteers
- 602 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Blood Pressure Monitoring, Blood Pressure
Noninvasive Blood Pressure Validation Study
The purpose of this study is to test how accurately the Perin Health Patch, a small wearable sensor worn on the chest, measures blood pressure without using an arm cuff.
- Trial name
- NCT07774169
- Testing
- Chest Worn Blood Pressure Monitor
- Where
- United States
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Perin Health Devices
Blood Pressure
Comparison of Non-Invasive Blood Pressure Methods
The primary objective of the study is to demonstrate the accuracy in healthy adults with Vital USA Device by comparison to a non-invasive (auscultatory) reference sphygmomanometer.
- Trial name
- NIBP (NCT04296227)
- Testing
- The Vital Detect blood pressure monitor
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Vital USA, Inc.
Multiple Sclerosis
Validation of the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory Target
In multiple sclerosis (MS) cells of the immune system attack the brain causing tissue damage. In secondary progressive MS (SPMS) these repeated immune attacks have stopped but despite this new damage continues to appear.
- Trial name
- TSPO (NCT03850301)
- Testing
- XBD173, Etifoxine
- Where
- United Kingdom
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Loss of Facial Adipose Tissue
Facial Asymmetrical Clinical Evaluation Study
The primary objective of this study is to create digital 3D images of subjects using a Canfield VECTRA H1 digital imaging system and compile a medical, skin/sun exposure and sunscreen use, and skin care product history for a…
- Trial name
- FACE (NCT03347747)
- Testing
- Study Photography + Personal & Medical History Collection
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- McDaniel Institute of Anti-Aging Research
Substance Use Disorder
The Tobacco, Alcohol, Prescription Medication and Other Substances Tool
The purpose of the study is to develop and validate a questionnaire to screen and assess adult primary care patients for tobacco, alcohol, prescription drug, and drug use and problems related to their use.
- Trial name
- CTN0059 (NCT02110693)
- Testing
- Interviewer and tablet administration of the TAPS Tool
- Where
- 4 sites in United States
- Volunteers
- 2,057 people, healthy volunteers welcome
- Sponsor
- Friends Research Institute, Inc.
Robotic Cardiac Surgery Simulation
Robotic Cardiac Surgery Wet Lab Simulation Study
The goal of this study is to investigate validity of the wet lab robotic cardiac surgery model used for training in robotic cardiac surgery and to evaluate learning curves in trainees of different surgical specialities.
- Trial name
- NCT05043064
- Testing
- Wet lab tasks
- Where
- Denmark
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Aalborg University Hospital
Blood Pressure
Validation Study of CONTEC08C Electronic Sphygmomanometer
The purpose of this study is to assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in the general population for clinical use according to the Association for the Advancement of Medical…
- Trial name
- NCT06457568
- Testing
- Blood pressure measurement
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Manual Dexterity
Validation and Test-retest Study of the Star-shaped Manual Dexterity Test.
The purpose of this study is to measure test-retest reliability and validate the star shaped test of manual dexterity. The purpose of this is to see if there is any significant learning effect, and if the test can discriminate…
- Trial name
- NCT02146443
- Testing
- Stretched arm test, Stress, Star shaped manual dexterity test
- Where
- Denmark
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Herlev Hospital
Gut Microbiome
Neonatal Microbiome Validity Study
This is a validation study to compare proposed field collection methods with a gold standard collection technique for microbiome analysis of stool and breast milk samples.
- Trial name
- NCT02655250
- Testing
- Microbiome
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- State University of New York at Buffalo
ECG, Electrocardiography
Validation of Perin Health Patch ECG Monitoring Device Performance and Placement Accuracy
The goal of this clinical trial is to test how accurately and reliably a new chest-worn device called the Perin Health Patch measures heart rhythms (ECG) in adults aged 22 and older.
- Conditions
- ECG, Electrocardiography, Monitoring, Physiologic
- Trial name
- NCT07147920
- Testing
- Chest-Worn ECG Monitoring Device
- Where
- United States
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- Perin Health Devices
Mouth Feel in Relation to Food Preference and Energy Intake
Acoustic Tribology Validation Study
Dairy-based beverages contain fat and sugars. As both contribute to the energy intake upon consumption, food industry strives to reduce these ingredients while maintaining the taste, texture and aroma properties of the beverages.
- Trial name
- NCT02244476
- Where
- Netherlands
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- NIZO Food Research
Diarrhea
Low-dose Challenge Model With Enterotoxigenic E Coli
This study will validate a model for testing new vaccines designed to protect against intestinal infections with enterotoxigenic Escherichia coli (ETEC).
- Trial name
- NCT00844493
- Testing
- E coli strain H10407 and buffer, E coli H10407 and buffer
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health