Clinical trials: Diagnostics
Hematologic Malignancy, Leukemia
Better Leukemia Diagnostics Through AI (BELUGA)
To the best of our knowledge, BELUGA will be the first prospective trial investigating the usefulness of deep learning-based hematologic diagnostic algorithms.
- Conditions
- Hematologic Malignancy, Leukemia, Minimal Residual Disease, Lymphoma
- Trial name
- BELUGA (NCT04466059)
- Testing
- Automated AI-Guided Diagnosis of Hematological Malignancies
- Where
- Germany
- Volunteers
- 25,000 people, healthy volunteers welcome
- Sponsor
- Munich Leukemia Laboratory
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
Heart Failure
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
- Trial name
- NCT04790344
- Testing
- Investigational LUX-Dx ICM Implant
- Where
- 57 sites in United States
- Volunteers
- 557 people
- Sponsor
- Boston Scientific Corporation
Substance Use Disorders, Treatment Adherence and Compliance
RAE (Realize, Analyze, Engage)
The proposed study will evaluate the detection of digital biomarkers of stress, and drug craving in a population of individuals undergoing treatment for substance use disorder
- Trial name
- NCT05227339
- Testing
- RAE
- Where
- United States
- Volunteers
- 209 people
- Sponsor
- ContinueYou, LLC
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
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
Heart Failure
Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure
The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only), investigational, feasibility study. The purpose of this study is to characterize safety of managing heart failure patients with integrated device…
- Trial name
- NCT02698241
- Testing
- Diagnostic & Medication Management
- Where
- 8 sites in United States
- Volunteers
- 79 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
AIDS/HIV PROBLEM
Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients
This study has been designed to evaluate a new oral test for therapeutic monitoring of HIV/AIDS patients that are receiving the combination Anti-Retroviral Therapy (cART).
- Trial name
- NCT01507142
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Gaia Medical Institute
Heart Failure, Congestive
Multiple Cardiac Sensors for the Management of Heart Failure
The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.
- Trial name
- MANAGE-HF (NCT03237858)
- Testing
- HeartLogic ON, HeartLogic OFF
- Where
- 30 sites in United States, France and 1 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Osteoporosis
Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX
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 several fractures.
- Trial name
- NCT01998737
- Where
- 6 sites in Finland
- Volunteers
- 1,011 people, healthy volunteers welcome
- Sponsor
- Bone Index Finland Ltd
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
Prostate Cancer, Benign Prostatic Hyperplasia
Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
Emerging from a differential proteomic study of sample pairs of prostate cancer and benign tissue, annexin A3 (ANXA3) was chosen as a potential novel biomarker for the early and non-invasive diagnosis of prostate cancer.
- Conditions
- Prostate Cancer, Benign Prostatic Hyperplasia, Prostatic Intraepithelial Neoplasia
- Trial name
- NCT00400894
- Volunteers
- 750 people
- Sponsor
- ProteoSys AG
Metastatic Colorectal Cancer (mCRC)
Evaluation of a Diagnostic Test to Identify the Best Drugs for Treatment of Metastatic Colorectal Cancer
DSEE-CRC is a top-tier Norwegian and Swedish public-private partnership for the development of µCAN, a unique patient-centric, therapy-guiding in vitro diagnostic test to improve cancer treatment outcomes for metastatic…
- Trial name
- DSEE-CRC (NCT07171554)
- Testing
- µCAN drug screen test, Standard-of-Care Therapy
- Where
- Norway
- Volunteers
- 75 people
- Sponsor
- Oncosyne AS
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.
Periprosthetic Joint Infection
Clinical Validation of CD Diagnostics Synovasure PJI ELISA Test and Synovasure PJI Lateral Flow Test for Detection of Periprosthetic Joint Infection in Synovial Fluid
To demonstrate the tests' performance when compared to the detection of PJI using the Musculoskeletal Infection Society (MSIS) criteria-based definition of PJI for diagnosing PJI.1 This criteria-based definition of PJI places…
- Trial name
- NCT02868736
- Testing
- Synovasure PJI Lateral Flow test and Synovasure PJI ELISA Test
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- CD Diagnostics
Amyotrophic Lateral Sclerosis (ALS)
A Study to Evaluate the Performance of a Diagnostic Test in ALS
Prospective multicenter study of subjects who were recently diagnosed with amyotrophic lateral sclerosis (ALS) or another neurodegenerative disease (including spinal cord diseases, muscle diseases and neurological diseases such…
- Trial name
- NCT02759913
- Testing
- Lumbar puncture
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Iron Horse Diagnostics, Inc.
Sleep Disorder (Disorder)
US Development and Evaluation Study of a Patch-Based PSG System
The purpose of this study is continue the development and evaluation of the Onera system as well as the procedures and best practices for dispensing, instruction, use and reportability of results.
- Trial name
- NCT06881667
- Testing
- Home PSG Assessment
- Where
- 2 sites in United States
- Volunteers
- 70 people
- Sponsor
- Onera BV
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.
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
MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
AGED Diagnostics Clinical Validation Study
Validation of Blood-Based Tests for the Diagnosis of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Liver Fibrosis: This study aims to validate two investigational blood tests developed by AGED Diagnostics for the…
- Conditions
- MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Fibrosis and Cirrhosis of Liver, MetALD
- Trial name
- NCT07867574
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Active Genomes Expressed Diagnostics, Corp