Clinical trials: Validity
Clostridium Difficile Infection
Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument.
- Trial name
- NCT02968758
- Testing
- Comparison between GenePOC PCR and Reference Method
- Where
- 7 sites in United States, Canada
- Volunteers
- 2,461 people
- Sponsor
- Meridian Bioscience, Inc.
Influenza Human
Clinical Validation of the Point-of-Care MSD Influenza Test
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
- Trial name
- NCT00863343
- Testing
- Public Health Notification
- Where
- 3 sites in United States
- Volunteers
- 391 people
- Sponsor
- Meso Scale Diagnostics, LLC.
Bronchiolitis, Bronchiolitis, Viral
Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis
This study will compare the novel methods of NS and BS with the standard technique of nasophayngeal aspiration (NPA) and routine ETT suction.
- Conditions
- Bronchiolitis, Bronchiolitis, Viral, RSV Infection, Respiratory Failure
- Trial name
- RSV-SAM (NCT03062917)
- Testing
- Nasal and Bronchial Sampling
- Where
- United Kingdom
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Imperial College Healthcare NHS Trust
Autism
Validation of Indiana's Early Evaluation Hub System
The investigators' objective is to test an innovative method of autism diagnosis that integrates clinical evaluation and assessment of biobehavioral markers in a large high-risk community-referral sample of children in the…
- Trial name
- EAER21 (NCT06586788)
- Testing
- Eyelink Portable Duo, Integrated PCP Diagnosis and Eye-tracking Biomarker
- Where
- 7 sites in United States
- Volunteers
- 154 people
- Sponsor
- Indiana University
Pediatric Congenital Heart Surgery
Predictive Value of the FORE-SIGHT™ Monitor for Hemodynamic Deterioration
The postoperative period after congenital heart surgery in children can be a very critical episode, where it is of utmost importance to closely monitor the circulation in these patients.
- Trial name
- NCT01706497
- Testing
- Cerebral tissue oxygen saturation monitoring, blinded
- Where
- Belgium
- Volunteers
- 300 people
- Sponsor
- KU Leuven
SARS-CoV-2 Infection, Influenza A
SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings
The Metrix COVID/Flu Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein.
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B
- Trial name
- NCT06191393
- Testing
- Aptitude Medical Systems Metrix COVID/Flu Test
- Where
- 3 sites in United States
- Volunteers
- 614 people
- Sponsor
- Aptitude Medical Systems
Malaria Diagnosis
Validation of RealAmp Method for the Diagnosis of Malaria in Endemic Areas of Brazil
Worldwide, approximately 2 billion people live in areas at risk for malaria with morbidity surpassing 250 million cases, with approximately 800,000 deaths, per year.
- Trial name
- NCT02371395
- Testing
- Realtime amplification (RealAmp)
- Where
- Brazil
- Volunteers
- 1,000 people
- Sponsor
- Centers for Disease Control and Prevention
Fever
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts
This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining temperature measurements.
- Trial name
- NCT05787782
- Testing
- Masimo INVSENSOR00063
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Sleep Apnea
A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software.
- Trial name
- NCT04191668
- Testing
- NightOwl
- Where
- 3 sites in United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
Well-being
Develop and Validation of Measurement-Based Transition Assistance
Although some Veterans seek help when they experience post-military readjustment challenges, many do not. One factor that stands in the way of Veterans' willingness to seek help for these challenges is their lack of knowledge…
- Trial name
- MBTA (NCT05384171)
- Testing
- Measurement-Based Transition Assistance (MBTA)
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- VA Office of Research and Development
Measure Accuracy of Respiratory Rate
Respiratory Rate Validation Study
The purpose of this study is to conduct a Respiratory Rate accuracy validation on pediatrics population comparing the Gabi SmartCare Gabi Band to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex- Ohmeda)…
- Trial name
- NCT05856422
- Testing
- Respiratory rate measure based on PPG
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
Severe to Profound Mixed Hearing Loss
Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
The purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech…
- Trial name
- NCT02156167
- Testing
- CP810 and Codacs™ system test
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Cochlear
Child
Development and Validation of a Cloak Shape Device for Sham Pediatric Tuina
This study aims to evaluate the effectiveness of a Cloak Shape sham Pediatric Tuina device which can be applied in randomized controlled trials for Pediatric Tuina research.
- Trial name
- NCT03474172
- Testing
- Cloak Shape Device for Genuine Tuina
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Guangzhou University of Traditional Chinese Medicine
Coronary Artery Disease
Validation of a Vital Signs Monitoring Wristband
Today, continuous monitoring of vital signs remains a challenge since it generally requires the patient to be connected to multiple wired sensors, which restricts patient mobility in the intra-mural setting and complicates home…
- Trial name
- MULTI-VITAL (NCT05566886)
- Testing
- Continuous measurement of photoplethysmography at the wrist
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Corsano Health B.V.
Pathologic Processes
Pivotal Study for Validation of Philips Dx (PDx)
The primary objective of this study is to show safety and effectiveness of the PDx for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.
- Trial name
- NCT02529137
- Where
- 4 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Philips Digital & Computational Pathology
Pathology
Instrument Precision Study for Validation of Philips Dx
The objective of this study is to evaluate precision of the Philips Dx system.
- Trial name
- NCT02699970
- Where
- United States
- Volunteers
- 399 people
- Sponsor
- Philips Digital & Computational Pathology
Validation Studies
d13C Added Sugar Intake Biomarker: Determining Validity in Children
Added sugars (AS) constitute a significant source (~ 16%) of the total daily calories consumed by youth. The role of AS in health is contentious, and the reliance on self-reported dietary data is an often-cited flaw in existing…
- Trial name
- NCT02455388
- Testing
- High added sugar diet, Low added sugar diet
- Where
- United States
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Virginia Polytechnic Institute and State University
Myopia
Clinical Validation of the New Print on Focus DAILIES Toric
The purpose of this study is to validate the improvements to the inversion indicator.
- Trial name
- NCT01097863
- Testing
- nelfilcon A contact lens, modified inversion indicator, nelfilcon A contact lens, no inversion indicator, nelfilcon A contact lens, inversion indicator
- Volunteers
- 280 people
- Sponsor
- CIBA VISION
Cerebral Palsy
Validity of Bispectral Index Monitoring During Deep Sedation
During Intramuscular botulinum toxin injections for children with cerebral palsy, immobility is essential to inject botulinum toxin to the right muscle.
- Trial name
- NCT02096549
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- Yeungnam University College of Medicine
Testing a Computational Model to Estimate Patient Size
Estimating Patient Size From a Single Radiograph
A computational model has been created to estimate the abdominal depth of a patient from a single x-ray image. The model has been tested using phantoms and found to be accurate; this study aims to test the accuracy of the model…
- Trial name
- VocMepAdar (NCT03341546)
- Testing
- A single measurement of the patient's abdominal depth
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- NHS Tayside