Clinical trials: Diagnostics
B-cell Acute Lymphoblastic Leukemia
Evaluation of ProALL miRs in Blood Specimen for Prediction of ALL Relapse Risk
Previous findings have shown that a biomarker comprised of the three microRNAs (miRs) miR-451, miR-151-5p and miR-1290 can independently predict precursor B-cell acute lymphoblastic leukemia (B- ALL) patients' risk for relapse…
- Trial name
- NCT03000335
- Where
- 2 sites in Israel
- Volunteers
- 65 people
- Sponsor
- Curewize Health Ltd.
Infectious Gastroenteritis
Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study
BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common microorganisms responsible for infectious…
- Trial name
- IMPACT (NCT02248285)
- Testing
- FilmArray™ Gastrointestinal (GI) Panel
- Where
- 5 sites in United States
- Volunteers
- 1,545 people
- Sponsor
- BioFire Diagnostics, LLC
COVID-19, Asymptomatic COVID-19
A Clinical Evaluation of Proof Diagnostics Test System Including the Proof Diagnostics Reader and COVID-19 Test
To determine the accuracy of Proof Diagnostics COVID-19 Test in the intended, symptomatic and suspected/at-risk asymptomatic population and point-of-care use as compared to a standard molecular comparator, Quidel Lyra SARS-CoV-2…
- Trial name
- NCT05331976
- Testing
- Proof Lab Test System
- Where
- 3 sites in United States
- Volunteers
- 276 people
- Sponsor
- Proof Diagnostics
Cardiac Transplant Failure, Cardiac Transplant Rejection
Utility of Donor-Derived Cell Free DNA in Association With Gene Expression Profiling
Plasma donor-derived cell-free DNA (dd-cfDNA) is measured as a % of the total plasma cfDNA in association with the measurement of AlloMap, a non-invasive gene expression test to aid in heart transplant management.
- Conditions
- Cardiac Transplant Failure, Cardiac Transplant Rejection, Heart Diseases
- Trial name
- D-OAR (NCT02178943)
- Where
- 28 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CareDx
Congenital Anomalies, Neonatal Complications
AI-Powered Neonatal Risk Assessment for Improved Perinatal Outcomes
This study aims to develop advanced artificial intelligence (AI) models that predict neonatal risks and complications based on historical multimodal health data, including ultrasound and MRI scans.
- Conditions
- Congenital Anomalies, Neonatal Complications, Perinatal Outcomes, Perinatal Outcomes of the Mother and Fetus
- Trial name
- NCT07064356
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- FetalFirst Limited
Upper Respiratory Infections
Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's instructions by personnel in laboratories…
- Trial name
- NCT02232711
- Where
- 4 sites in United States
- Volunteers
- 1,082 people
- Sponsor
- BioFire Diagnostics, LLC
Acute Respiratory Infections (ARIs)
FebriDx® Method Comparison Study Protocol
The goal of this observational study is to learn about the performance and ease of use of FebriDx when operated by persons without laboratory experience or training in patients with acute respiratory symptoms.
- Trial name
- NCT06746259
- Testing
- Rapid point of care test to detect host immune response in ARI
- Where
- 8 sites in United States
- Volunteers
- 800 people
- Sponsor
- Lumos Diagnostics
Parkinson's Disease
Tele-diagnostics for Remote Parkinson's Monitoring
The purpose of this research study is to design, implement, and clinically assess a portable, user worn system for monitoring Parkinson's disease (PD) motor symptoms.
- Trial name
- NCT01356056
- Testing
- Kinesia HomeView
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Great Lakes NeuroTechnologies Inc.
HEPATITIS C (HCV)
Lay User Evaluation of the Panbio™ HCV Self-Test
This is a prospective, multi-centre study designed to evaluate the usability of the Panbio™ HCV Self Test, when performed by untrained lay users in an observed study setting.
- Trial name
- NCT06605573
- Testing
- Panbio™ HCV Self Test
- Volunteers
- 1,185 people, healthy volunteers welcome
- Sponsor
- Abbott Rapid Dx
Viral Infection, Bacterial Infections
A Controlled, Blinded Study to Validate the Diagnostic Accuracy and Assess the Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the ED With Suspicion of Acute Infection
To externally validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in pediatric patients >3…
- Conditions
- Viral Infection, Bacterial Infections, Antibiotic Misuse, Host Response Diagnostics
- Trial name
- ROSETTA (NCT04254991)
- Testing
- ImmunoXpert™
- Volunteers
- 525 people
- Sponsor
- MeMed Diagnostics Ltd.
Blood Stream Infection, Blood Stream Infections
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (BSI) Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance…
- Conditions
- Blood Stream Infection, Blood Stream Infections, Sepsis, Fungemia
- Trial name
- B-RAPID (NCT07859852)
- Testing
- UllCORE BSI Test
- Where
- 20 sites in United States, France and 3 more
- Volunteers
- 1,500 people
- Sponsor
- Deepull Diagnostics S.L.
COVID-19
COVID-19 Volumetric Quantification on Computer Tomography Using Computer Aided Diagnostics
The aim of the study is to asses the influence of computer aided diagnostic to the process of lung affection quantification on computer tomography in COVID-19 confirmed patients.
- Trial name
- NCT05282056
- Testing
- CAD analysis
- Where
- Romania
- Volunteers
- 200 people
- Sponsor
- Bogdan Bercean
Cardiac Transplant Failure, Cardiac Transplant Rejection
Outcomes AlloMap Registry: the Long-term Management and Outcomes of Heart Transplant Recipients With AlloMap Testing
The objective of this registry is to observe short and long term clinical outcomes in heart transplant recipients who receive regular AlloMap testing as part of allograft rejection surveillance.
- Conditions
- Cardiac Transplant Failure, Cardiac Transplant Rejection, Heart Diseases
- Trial name
- OAR (NCT01833195)
- Where
- 36 sites in United States
- Volunteers
- 2,444 people, healthy volunteers welcome
- Sponsor
- CareDx
Influenza, Human
Clinical Performance Study of the Ultra Influenza A&B Test Using Nasal Swabs for Identifying Subjects Who Are Infected With the Influenza Virus Strain Type A or Type B
The clinical performance of the Ultra Influenza A\&B Test will be demonstrated during a clinical trial in which prospectively collected nasal swabs are used in identifying subjects who are infected with the influenza virus strain…
- Trial name
- NCT01753531
- Testing
- Flu Symptoms
- Where
- 3 sites in United States
- Volunteers
- 677 people
- Sponsor
- Sekisui Diagnostics, LLC
Brain Injuries, Traumatic
Biochemical Diagnostics of Mild Traumatic Brain Injury (TBI) and Concussion in Children and Adolescents
The study will enroll children and adolescents (0 - 17 years) suspected of having concussion or mild traumatic brain injury (TBI).
- Trial name
- NCT04288167
- Testing
- Sample collection
- Where
- Finland
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Medicortex Finland Oy
Respiratory Tract Infections (RTI), Influenza-like Illness
Clinical Assessment of Respiratory Events for Kids: Integrating Diagnostics and Stewardship
This study, called Care4Kids, aims to improve the management of respiratory infections in children visiting emergency departments.
- Conditions
- Respiratory Tract Infections (RTI), Influenza-like Illness, Children
- Trial name
- CARE4KIDS (NCT07453914)
- Testing
- SPOTFIRE R
- Where
- 3 sites in France, Greece and 1 more
- Volunteers
- 720 people
- Sponsor
- BioMérieux
Adenovirus, Other Mycoses
Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients
This study is designed to determine the rate at which stem cell transplant patients can develop infection caused by a group of viruses, known as adenovirus, and common fungi.
- Trial name
- NCT00448994
- Where
- 2 sites in United States
- Sponsor
- Steven B. Kleiboeker
HIV Infections
Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test
This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid…
- Trial name
- NCT01032902
- Testing
- In Vitro Diagnostic Device
- Where
- 5 sites in United States
- Volunteers
- 2,808 people, healthy volunteers welcome
- Sponsor
- Chembio Diagnostic Systems, Inc.
Urinary Tract Infections
POCARED Diagnostics, LTD, Field Study Protocol
This study is designed to compare the performance of the P-1000 System, POCARED's Rapid Diagnostic System which uses optical fluorescence analysis, to standard methods of uropathogen quantification and identification.
- Trial name
- NCT01487148
- Where
- 5 sites in United States, Israel
- Volunteers
- 40,000 people, healthy volunteers welcome
- Sponsor
- Pocared Diagnostics
Parkinson's Disease
Automated Telehealth Diagnostics for Remote Parkinson Monitoring
The objective is to clinically assess the Kinesia HomeView system for automated and remote monitoring of Parkinson's disease (PD) motor symptoms.
- Trial name
- PDRemote (NCT02152319)
- Testing
- KHV reporting, Standard care
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Great Lakes NeuroTechnologies Inc.