Clinical trials: Diagnostics
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
Breast Cancer Diagnosis
Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics
Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems
- Trial name
- NCT05989022
- Testing
- Injection of contrast enhancing agent Gadovist for MRI investigation, Injection of contrast enhancing agent Imeron for B-CT investigation
- Where
- 4 sites in Germany, Netherlands
- Volunteers
- 293 people, healthy volunteers welcome
- Sponsor
- AB-CT - Advanced Breast-CT GmbH
Lyme Disease
Novel Diagnostics for Early Lyme Disease
There are more than 300,000 new cases of Lyme disease every year in the US. Lyme disease is a dangerous bacterial infection transmitted by tick bites and it becomes increasingly severe as the infection progresses.
- Trial name
- NCT03963635
- Testing
- MicroB-plex Lyme Immunoassay
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- MicroB-plex, Inc.
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
Osteoporosis
Bindex Ultrasonometer for Osteoporosis Diagnostics
Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are diagnosed only after a fracture.
- Trial name
- NCT01935232
- Where
- United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Bone Index Finland Ltd
Vitamin D Deficiency, Vitamin D Insufficiency
ALPCO 25(OH) Vitamin D CLIA Kit - Fresh Versus Frozen Serum and Plasma Stability Study
This study evaluates the stability of 25-hydroxyvitamin D [25(OH)D] measurements in human serum and plasma using the ALPCO 25(OH) Vitamin D CLIA Kit.
- Conditions
- Vitamin D Deficiency, Vitamin D Insufficiency, Healthy Volunteers
- Trial name
- NCT07565064
- Testing
- ALPCO 25(OH) Vitamin D CLIA Kit
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
Diabetes Mellitus, Type 2, Liver Diseases
Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Metabolic Disorders
This is a prospective, multicentric, non-treatment study to build and validate a portable, non-invasive smart breath analyzer that can screen underlying health issues using exhaled breath.
- Conditions
- Diabetes Mellitus, Type 2, Liver Diseases, Kidney Diseases, Lung Diseases
- Trial name
- RESPYR-SBA (NCT07646015)
- Where
- India
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Respyr
Breast Cancer
Detecting Circulating Tumor Cells (CTCs) and Cell Free DNA (cfDNA) in Peripheral Blood of Breast Cancer (BC) Patients to Develop the Clinical Application for Early Detection and Diagnostics
Utilization of circulating-tumor-cell (CTC) and cell free DNA (cfDNA) as novel and noninvasive tests for diagnosis confirmation, therapy selection, and cancer surveillance is a rapidly growing area of interest.
- Trial name
- NCT03511859
- Where
- Taiwan
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- CellMaxLife
Brest Cancer, Lung Cancer (NSCLC)
The CCANED-CIPHER Study: Early Cancer Detection and Treatment Response Monitoring Using AI-Based Platelet and Immune Cell Transcriptomic Profiling
The purpose of the CCANED-CIPHER study is to develop and validate an AI-based blood test for early cancer detection and to monitor treatment effectiveness in cancer patients.
- Conditions
- Brest Cancer, Lung Cancer (NSCLC), Pancreatic Cancer, Adult, Prostate Cancers
- Trial name
- CCANED-CIPHER (NCT06717295)
- Testing
- DiNanoQ: A multi-cancer early detection (MCED) blood test, DiNanoTrack: Therapeutic Response Monitoring Blood Test
- Where
- 4 sites in Argentina, Nigeria and 1 more
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Javier Toledo
Lung Cancer, Non-Small Cell
Novel Epigenetic Mapping in Cell-Free DNA for the Detection of Lung Cancer
This trial is a multicenter, open-label, non-interventional controlled study to identify and characterize epigenetic signatures of lung cancer.
- Trial name
- LumenDx (NCT06963307)
- Where
- Israel
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- JaxBio Ltd
Combined Point of Care Diagnostic of HIV, HBV and HCV
Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV…
- Trial name
- MAGICIEN (NCT06082336)
- Testing
- MagIA IBC test in capillary blood, MagIA IBC test in other blood matrices
- Where
- 2 sites in France
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- MagIA Diagnostics
N. Meningitidis Carriage
Novartis Vaccine and Diagnostics Carriage Trial
The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal vaccines on carriage of Neisseria meningitidis in a young adult population.
- Trial name
- NCT01214850
- Testing
- Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ), MenACWY-CRM conjugate vaccine, Japanese Encephalitis vaccine
- Where
- 10 sites in United Kingdom
- Volunteers
- 2,968 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
COPD
Comparing Pressure Based and Dilution Based Total Lung Capacity Measurements in COPD Patients for Lung Function Diagnostics
Total Lung Capacity (TLC) of the lungs can be determined using a pressure based method (i.e. by body plethysmography) or it can be determined using a dilution based method (i.e.
- Trial name
- NCT04531293
- Testing
- Respiratory Analysis System
- Where
- Switzerland
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- ndd Medizintechnik AG
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
HIV Infections, Hepatitis B Infections
Rapid Diagnostics for HIV and Hepatitis
The purpose of this study is to determine the efficacy of two rapid diagnostic tests in plasma, venipuncture whole blood, and fingerstick whole blood.
- Conditions
- HIV Infections, Hepatitis B Infections, Hepatitis C Infections
- Trial name
- NCT02190305
- Testing
- Multiplo HBc/HIV/HCV and Reveal HBsAg
- Where
- 4 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- MedMira Laboratories Inc.
Oncology, Breast Cancer
Real-time Diagnosis and Visualization of Tumor Margins in Excised Breast Specimens Using Zenith FLIM Diagnostics
Our investigational team has developed a technology to visualize the operative margins in 'real time,' in other words during the operation while the patient is still on the table.
- Conditions
- Oncology, Breast Cancer, Cancer Diagnosis, Margins of Excision
- Trial name
- NCT04683120
- Testing
- Zenith FLIM Diagnostics
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Laser LabCorp
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.
Cervical Cancer Screening
Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System
Quality assurance of the laboratory examinations. Retrospective non-interventional study with ThinPrep slides collected as part of the German Co-Screening Program for routine diagnostic.
- Trial name
- NCT05000125
- Testing
- Hologic's Genius Digital Diagnostics System
- Where
- Germany
- Volunteers
- 1,994 people, healthy volunteers welcome
- Sponsor
- Hologic Deutschland GmbH
Inpatient Hospitalization, Intensive Care Unit Admission, Inpatient Mortality, Sepsis and Septic Shock
Linking Novel Diagnostics With Data-Driven Clinical Decision Support in the Emergency Department
The primary objective of this study is to validate the use of an electronic clinical decision support (CDS) tool, TriageGO with Monocyte Distribution Width (TriageGO-MDW), in the emergency department (ED).
- Trial name
- NCT05335135
- Testing
- TriageGO-MDW Clinical Decision Support, Usual Care
- Where
- 2 sites in United States
- Volunteers
- 300,000 people, healthy volunteers welcome
- Sponsor
- Stocastic, LLC
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.