Clinical trials: Validation Studies
Sacroiliac Joint Pain, Sympathetically Maintained Pain
Effect of Sedation on Diagnostic Injections
Interventional pain procedures have diagnostic, prognostic and therapeutic value. It is well-documented that the reference standard for identifying a pain generator is a low-volume block performed with local anesthetic, with or…
- Trial name
- NCT01472835
- Testing
- Midazolam, Fentanyl
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Johns Hopkins University
Clinical Indication for Brain MRI, Healthy Volunteers
Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain
This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,
- Trial name
- NCT05425927
- Testing
- SyMRI 15 (3D)
- Where
- 6 sites in United States
- Volunteers
- 189 people, healthy volunteers welcome
- Sponsor
- SyntheticMR
Dietary Habits
PortionSize Study 2 Free-Living Evaluation
The objective is to test the accuracy of the PortionSize™ app and the MyFitnessPal© app at measuring energy and nutrient intake in free-living conditions.
- Trial name
- NCT05166226
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Atrial Fibrillation
ECG App Algorithms Clinical Validation Study
The purpose of the study is to evaluate the performance of ECG classification algorithms and their ability to classify heart rhythms into multiple categories of rhythms and heart rates
- Trial name
- NCT04247581
- Testing
- 1-lead ECG
- Where
- 4 sites in United States
- Volunteers
- 546 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Rheumatoid Arthritis
Tocilizumab Real-Life Human Factors (RLHFs) Validation Study
This study is designed to evaluate RLHFs concerning administration of the tocilizumab autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving subcutaneous (SC) tocilizumab using the commercially…
- Trial name
- NCT02682823
- Testing
- AI-1000 G2, Tocilizumab
- Where
- 8 sites in United States
- Volunteers
- 91 people
- Sponsor
- Hoffmann-La Roche
ATTR-CM
A Retrospective Validation Study To Identify Chart-Based Clinical Diagnosis Of Wild-Type Transthyretin Amyloid Cardiomyopathy (Attrwt-CM) And Non-Amyloid Heart Failure Among Patients With Heart Failure (HF).
This is an observational, retrospective non-inferiority study with a study sample from a large national database. A machine learning (ML) model will use a national database to predict the clinical diagnosis of ATTRwt-CM among HF…
- Trial name
- NCT06029452
- Testing
- Machine learning algorithm
- Where
- United States
- Volunteers
- 558 people
- Sponsor
- Pfizer
Dementia, Alzheimer Disease
The Brain Health Study: A Pragmatic, Patient-Centered Trial
The eRADAR Brain Health Study is an embedded, pragmatic clinical trial to determine whether targeted screening for dementia using the eRADAR algorithm increases dementia detection within primary care compared to usual care.
- Trial name
- eRADAR (NCT05905796)
- Testing
- Brain Health Assessment
- Where
- 3 sites in United States
- Volunteers
- 1,261 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Coronary Artery Disease
Prasugrel Versus Ticagrelor in Patients With CYP2C19 Loss-of-function: a Validation Study
Polymorphisms of the cytochrome P450 (CYP) 2C19 enzyme has been consistently shown to modulate clopidogrel response. Accordingly, the Food and Drug Administration (FDA) has issued a warning on the potential for reduced efficacy…
- Trial name
- NCT03489863
- Testing
- Prasugrel, Ticagrelor
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of Florida
Contraception
Desogestrel-containing COCP Pharmacokinetic Validation Study
This study aims to validate prior pharmacokinetic research with combined oral contraceptive pill users that supports utilizing a 24-hour trough concentration as an accurate proxy for the intensive pharmacokinetic parameter of…
- Trial name
- NCT05002738
- Testing
- Desogestrel and Ethinyl Estradiol Tablets
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Pathology
Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
The primary objective of this study is to evaluate the safety and accuracy of the Hamamatsu WSI compared to those of the reference method (conventional light microscope (Glass)) under clinical use conditions as an aid for…
- Trial name
- NCT03991468
- Testing
- Whole Slide Imaging, Light Microscopy
- Where
- 4 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Hamamatsu Photonics K.K.
Essential Hypertension
Hybrid Blood Pressure Monitor Validation
Assessment of the accuracy of a Blood Pressure Measuring Device with a digital display-column, NISSEI DM 3000, according to an adaptation of the "European Society of Hypertension International Protocol Revision 2010 for the…
- Trial name
- NISSEI (NCT01120990)
- Testing
- Blood Pressure Measurement
- Where
- Greece
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- University of Athens
Rhinitis, Allergic, Perennial
Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
The Protocol section needs to be updated using the following text "The main goal of the study was to validate the Preference Module of the EARNS-Q and to test the reliability using Treatment Satisfaction Questionnaire for…
- Trial name
- NCT00346775
- Testing
- Beclomethasone dipropionate, Flunisolide
- Where
- 7 sites in United States
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline
Presbyopia
Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.
- Trial name
- NCT03417557
- Testing
- Comfilcon A lens (test), Omafilcon B lens (control)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- CooperVision, Inc.
Device Validation of In-vivo Performance
Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study
This is an in vivo 24-hour in-vivo recovery study of leukoreduced red blood cells (RBCs) collected on the Trima Accel System using Non-DEHP disposable sets and stored for 42 days.
- Trial name
- NCT06602804
- Testing
- Trima Accel Auto RBC Collection
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Helicobacter Pylori Infection
Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection
The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori…
- Trial name
- NCT02528721
- Testing
- Dual Mode BreathID Hp System
- Where
- 13 sites in United States, Israel
- Volunteers
- 282 people
- Sponsor
- Meridian Bioscience, Inc.
Sleep-disordered Breathing
ApneaLink Air Home Sleep Testing (HST) Device Validation Study
This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.
- Trial name
- NCT03470493
- Testing
- ApneaLink Air
- Where
- 2 sites in United States
- Volunteers
- 130 people
- Sponsor
- ResMed
Atrial Fibrillation
Atrial Fibrillation Algorithms Clinical Validation Study
The purpose of the study is to evaluate the performances of investigational Irregular Rhythm Notification Feature (version 2.0) and Atrial Fibrillation History Feature algorithms.
- Trial name
- NCT04699812
- Testing
- ELECTROCARDIOGRAM (ECG) PATCH WEAR
- Where
- 4 sites in United States
- Volunteers
- 573 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
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.
Menstruation
Tampon Design Validation Study
This prospective multi-center, open-label, randomized, cross-over study is designed to validate the user needs of a tampon design. The hypothesis is that user needs are met.
- Trial name
- NCT05553600
- Testing
- Tampon BR, Tampon CR, Tampon BS
- Where
- 9 sites in United States
- Volunteers
- 732 people, healthy volunteers welcome
- Sponsor
- Kimberly-Clark Corporation
Alzheimer Disease, Dementia
A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)
The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer's disease and to validate neuropsychological assessments administered over…
- Conditions
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases
- Trial name
- NCT04640077
- Testing
- No Intervention, donanemab
- Where
- 27 sites in United States, Canada
- Volunteers
- 95 people
- Sponsor
- Eli Lilly and Company