Clinical trials: VALİDİTY
Covid19
Saliva-based COVID-19 DNA Aptamer Test
This study aims to conduct formative usability and internal validation of the COVID-19 rapid diagnostic test tool based on DNA aptamers, involving 200 patients to assess aspects of experimental setup, testing center, testing kit…
- Trial name
- NCT04974203
- Testing
- AptameX
- Where
- Indonesia
- Volunteers
- 200 people
- Sponsor
- Achiko AG
Cardiac Disease
MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram
Clinical validation study of the MyoVista wavECG.
- Trial name
- NCT04804969
- Testing
- MyoVista wavECG Test
- Where
- 5 sites in United States
- Volunteers
- 575 people
- Sponsor
- Heart Test Laboratories, Inc.
Non-Small Cell Lung Cancer
Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects
The purpose of this study is to collect information about how a doctor uses the results of the VeriStrat® blood test to guide treatment for non-small cell lung cancer (NSCLC) patients.
- Trial name
- INSIGHT (NCT03289780)
- Where
- 42 sites in United States
- Volunteers
- 5,006 people
- Sponsor
- Biodesix, Inc.
No History of ADHD, Attention Deficit Hyperactivity Disorder (ADHD)
An Investigational Study Examining the Cross-Validation of QbMobile in ADHD and Normative Populations
The purpose of this study is to investigate QbMobile ability to collect and provide accurate and objective data which can be used to facilitate assessment and treatment procedures for ADHD in a clinical setting as well as…
- Conditions
- No History of ADHD, Attention Deficit Hyperactivity Disorder (ADHD), Healthy Volunteer
- Trial name
- NCT07220330
- Testing
- QbMobile
- Where
- 3 sites in United States
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Qbtech AB
CAD - Coronary Artery Disease
Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study
In the present study we aim at validating the computation of FFRangio values from the angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a completely blinded manner.
- Trial name
- NCT03005028
- Where
- Israel
- Volunteers
- 184 people
- Sponsor
- CathWorks Ltd.
Healthy
Hemodilution Validation of INVSENSOR00026
In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously.
- Trial name
- NCT03677375
- Testing
- INVSENSOR00026
- Where
- United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
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
No Specific Medical Conditions or Disease States
Dozee Validation for Contactless Heart Rate and Respiration Monitoring in Clinical Settings
The Dozee VS system (K221555) is a contactless device that tracks heart rate and breathing rate using a sensor sheet placed under the mattress.
- Trial name
- NCT07735403
- Testing
- Telemetry monitoring
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Turtle Shell Technologies Pvt. Ltd.
Fracture
Clinical Validation of Boneview for FDA Submission
The goal of this clinical validation is to assess comparative performances of physicians with and without the assistance of BoneView for the diagnosis of fractures on radiographs.
- Trial name
- NCT04532580
- Testing
- Diagnosis of fracture on X-Ray Radiographs
- Where
- United States
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Gleamer
Growth Hormone Deficiency in Children
Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy
The aim of the study is to examine the suitability, the so-called validation, of a questionnaire, with which one can grasp the reasons why injections of growth hormones are omitted by patients ("non-adherence").
- Trial name
- NCT03672617
- Testing
- No treatment given
- Where
- Germany
- Volunteers
- 321 people
- Sponsor
- Novo Nordisk A/S
Blood Pressure
Polso™ Watch Blood Pressure Accuracy With Blood Pressure Change Validation
Up to 185 adult test subjects to evaluate blood pressure measurement accuracy and stability of the Polso™ Watch compared to a reference blood pressure measurement.
- Trial name
- BP (NCT05735210)
- Testing
- Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement
- Where
- Germany
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- ChroniSense Medical Ltd.
Cytomegalovirus, Kidney Transplantation
Clinical Validation of Lophius Biosciences Kit T-Track® CMV in Kidney Transplant Recipients
This study aims to validate whether Lophius Biosciences Kit T-Track® CMV is suitable to assess the functionality of CMV-specific cell-mediated immunity (CMI) and to determine a protective cut-off value for CMV…
- Conditions
- Cytomegalovirus, Kidney Transplantation, CMV Specific Immune Response
- Trial name
- CMValue (NCT02083042)
- Where
- Germany
- Volunteers
- 97 people
- Sponsor
- Lophius Biosciences GmbH
Cardiovascular Disease
Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization
The purpose of this study is to validate the Nonin Near-infrared spectroscopy (NIRS) device to measure regional oxygen saturation in a cohort of children with cardiovascular disease undergoing cardiac catheterization.
- Trial name
- NCT00939224
- Testing
- Model 7600 Regional Oximeter System
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Nonin Medical, Inc
Myopia
Comparison of New Contact Lens With Current Marketed Lens
The purpose of this study is to validate the clinical performance of a new contact lens design.
- Trial name
- NCT03360110
- Testing
- Phoebe test lens, stenfilcon A lens (control)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- CooperVision, 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
Alzheimer Disease, Mild Cognitive Impairment
Optina Diagnostics' Cerebral ß-Amyloid Status (CAS) Test
This observational, cross-sectional study is designed to validate a novel diagnostic test for the detection of phenotypic changes in the retina that correlate with likely PET amyloid status (negative or positive), to aid in the…
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia
- Trial name
- REPHRASE (NCT05107882)
- Where
- 7 sites in United States, Canada
- Volunteers
- 466 people, healthy volunteers welcome
- Sponsor
- Optina Diagnostics Inc.
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
Acute Coronary Syndrome, Acute Myocardial Infarction
Evaluation of a New Cardiac Biomarker Assay
The objective of the study is to evaluate the performance and intended use of a new cardiac biomarker test, Troponin I, in an intended use population.
- Trial name
- NCT01608100
- Testing
- ARCHITECT STAT High Sensitive Troponin I Assay
- Where
- 12 sites in United States
- Volunteers
- 1,101 people
- Sponsor
- Abbott Diagnostics Division
Healthy
Oxygen Reserve Index Validation for RD Lite Sensors
Oxygen Reserve Index (ORI) is a parameter that provides information on arterial partial pressure of oxygen (PaO2). In this study, the PaO2 is varied by controlling the concentration of oxygen the study volunteer breathes.
- Trial name
- NCT03128892
- Testing
- Oxygen Reserve Index - RD Lite Sensors
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Colorectal Neoplasms, Digestive System Diseases
Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing
The objective of this study is to confirm the sensitivity and specificity of a stool DNA test for detection of colorectal cancer and pre-cancer.
- Conditions
- Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer
- Trial name
- NCT01600209
- Where
- 13 sites in United States
- Volunteers
- 674 people, healthy volunteers welcome
- Sponsor
- Exact Sciences Corporation