Clinical trials: Validation Study
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
Cardiopulmonary Bypass
Validation of Near Infrared Spectroscopy (NIRS) During Heart-Lung Bypass in Children
Non-invasive assessment of blood flow to organs has long challenged clinicians. Recently, near infrared spectroscopy (NIRS) has been recognized as a methodology that may achieve this goal.
- Trial name
- NIRS (NCT00745394)
- Where
- United States
- Sponsor
- University of Texas Southwestern Medical Center
Hemoglobin, Cerebral Oxygenation
Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics
This study will enroll children and young adults who are scheduled to undergo planned heart surgery or a heart catheterization procedure while under general anesthesia.
- Conditions
- Hemoglobin, Cerebral Oxygenation, Congenital Heart Disease
- Trial name
- NCT07706140
- Testing
- Noninvasive hemoglobin monitoring
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Children's Hospital
Necrotizing Enterocolitis
A Biologic Validation of Biomarkers of Progressive NEC & Sepsis
Necrotizing enterocolitis (NEC) is a severe, sometimes life-threatening inflammation of the intestine that occurs most often in premature babies.
- Trial name
- NEC (NCT00588718)
- Where
- United States
- Volunteers
- 740 people
- Sponsor
- R. Lawrence Moss
Sleep Apnea Syndromes, Sleep Disorder
WatchPAT Device Validation Study Compared to Polysomnography
Validation study of a novel sleep Device compared to a traditional sleep study.
- Conditions
- Sleep Apnea Syndromes, Sleep Disorder, Sleep
- Trial name
- WPAT (NCT03188718)
- Testing
- WatchPAT Intervention
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
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
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
Test-Retest Reliability
Validity and Reliability Study of the Motor Accuracy Test
The Motor Accuracy-Revised Test's validity and reliability in Turkey was studied in this paper.
- Trial name
- VRMAT (NCT03781180)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Istanbul Demiroglu Bilim University
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
Cystic Fibrosis
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
- Trial name
- NCT03502070
- Testing
- Tobi Podhaler
- Where
- 9 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mylan Inc.
Glioma
Development and Validation of a Deep Learning-Based Survival Prediction Model for Pediatric Glioma Patients: A Retrospective Study Using the SEER Database and Chinese Data
Accurately predicting the survival of pediatric glioma patients is crucial for informed clinical decision-making and selecting appropriate treatment strategies.
- Trial name
- NCT06199388
- Testing
- Survival state
- Where
- China
- Volunteers
- 9,532 people
- Sponsor
- Tang-Du Hospital
Segmentation; Bone
Accuracy of Open-source Software in Semi-automatic 3-Dimensional Reconstruction of the Mandible
Concomitant to the evolution of CBCT devices, several post-processing software packages were developed for producing 3D-printed models of anatomical structures.
- Trial name
- NCT05055986
- Testing
- Semiautomatic segmentation of open-source software
- Where
- Egypt
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cairo University
Acute Respiratory Distress Syndrome
Validation of a Simple Approach to Estimate Alveolar Recruitability in ARDS Patients
This study will test the validity of a new approach to assess alveolar recruitability at the bedside in comparison to direct measurements of lung volume and derecruitment.
- Trial name
- NCT02457741
- Where
- 3 sites in Canada, China and 1 more
- Volunteers
- 45 people
- Sponsor
- Unity Health Toronto
Head Injury
Validation of the PECARN Clinical Decision Rule for Children With Minor Head Trauma
To date, the Pediatric Emergency Care Applied Research Network (PECARN) rule for identifying children who are at very low risk of clinically-important traumatic brain injuries after minor head trauma has not been validated…
- Trial name
- NCT02752711
- Testing
- the PECARN clinical decision rule
- Where
- 3 sites in France
- Volunteers
- 1,499 people
- Sponsor
- Nantes University Hospital
Minor Head Injury
The Value of the Canadian CT Head Rule and the New Orleans Criteria in Minor Head Trauma
The New Orleans Criteria (NOC) and the Canadian CT Head Rules (CCHR) have been developed to decrease the number of normal computed tomography (CT) in mild head injury (MHI).
- Trial name
- NCT01619943
- Testing
- no intervention
- Where
- 3 sites in Tunisia
- Volunteers
- 1,600 people
- Sponsor
- University of Monastir
Fall Prevention
Validation Study of the Speedy Meyer Fall Scale for Determining the Fall Risk of the Paediatric Patient
Fall prevention is an essential element in ensuring safe care for paediatric patients. The first step in building a risk reduction programme is the adoption of an assessment tool to identify those most at risk at an early stage.
- Trial name
- NCT06311409
- Where
- 3 sites in Italy
- Volunteers
- 332 people
- Sponsor
- Meyer Children's Hospital IRCCS
Congenital Heart Diseases, Cardiac Diseases
An International Multicenter, Multivendor Evaluation of the Free-Running Framework for Cardiac Function
This project aims to evaluate a new cardiac MRI technique called the Free-Running Framework (FRF), which could simplify and accelerate the process of acquiring cardiac images.
- Trial name
- FAST-CMR (NCT07613398)
- Where
- 20 sites in United States, Australia and 8 more
- Volunteers
- 300 people
- Sponsor
- Matthias Stuber
Femoroacetabular Impingement Syndrome
AI-Based Screening and Diagnostic Models for Femoroacetabular Impingement Syndrome (FAIS-AI)
Femoroacetabular impingement syndrome (FAIS) is the leading cause of hip pain in young adults and frequently progresses to osteoarthritis, often exacerbated by delayed diagnosis in primary care.
- Trial name
- FAIS-AI (NCT07737223)
- Where
- China
- Volunteers
- 2,617 people
- Sponsor
- ChunBao Li
Phenylketonuria (PKU) and Hyperphenylalaninemia
PheCheck™ Validation Study
The goal of this observational study is to evaluate the performance of the PheCheck™ test for the rapid detection of phenylalanine (Phe) from a fingerstick sample, in patients 1 year or older with phenylketonuria (PKU) or…
- Trial name
- NCT07551921
- Testing
- PheCheck, Dried Blood Spot Cards.
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Aptatek BioSciences, Inc
Scoliosis
Study of 3D Scanning for Adolescent Scoliosis
The investigators aim to validate three-dimensional topographical scanning technology as a tool for evaluation of scoliosis. Through the incorporation of 3D topographical technology in the measurement of deformity, the…
- Trial name
- NCT06035952
- Testing
- 3D topographical scan
- Where
- 2 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- NSite Medical