Clinical trials: Diagnostics
Pregnancy Related
Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy
The primary purpose of this observational study is to demonstrate the feasibility of an automated point-of-care urine diagnostic device in determining the pregnancy status of patients through urine samples collected from patients…
- Trial name
- NCT03575286
- Testing
- Pregnancy test
- Where
- United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Voyant Diagnostics, Inc.
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.
Psychoses
DNA Diagnostics for Minimizing Metabolic Side-Effects of Antipsychotics
The purpose of this study is to assess patients treated with the antipsychotics aripiprazole (Abilify®), olanzapine (Zyprexa®), quetiapine (Seroquel®), risperidone (Risperdal®), or ziprasidone (Geodon®) and to identify genetic…
- Trial name
- DIMS (NCT00752960)
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Genomas, Inc
Non Small Cell Lung Cancer, Microbiome
BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics
The goal of the project is to develop and validate the BioForte technology. Its main functionality should be to in silico determine candidates for novel microbiome-based therapeutics and diagnostics.
- Conditions
- Non Small Cell Lung Cancer, Microbiome, Metagenome, Immunotherapy
- Trial name
- NCT04136470
- Testing
- Collection of stool, blood (PBMC) and biopsy (FFPE)
- Where
- 10 sites in Poland
- Volunteers
- 130 people
- Sponsor
- Ardigen
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.
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
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.
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
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
Pleural Effusion, Lung Consolidation
Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study
This study is being conducted to collect image data and relevant clinical data from medical records of patients with suspicion of lung consolidation or pleural effusion.
- Trial name
- AI (NCT04891705)
- Testing
- Lung Ultrasound Scan
- Where
- 5 sites in United States
- Volunteers
- 554 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Solid Tumor Malignancy
Safety Trial of 68Ga/177Lu-NRT6020 in FAP-Positive Advanced Solid Tumor Patients
Stage 1 (Safety study for 68Ga-NRT6020 Injection): The goal of this clinical trial stage is to evaluate the safety of 68Ga-NRT6020 Injection in participants with advanced solid tumors.
- Trial name
- NCT06911489
- Testing
- 68Ga-NRT6020 Injection, 177Lu-NRT6020 Injection (stage 2), 177Lu-NRT6020 Injection (stage 3)
- Where
- 2 sites in China
- Volunteers
- 132 people
- Sponsor
- Chengdu New Radiomedicine Technology Co. LTD.
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
Infectious Disease, Tropical Disease
Collection of Human Biological Samples for the Development and Validation of New Methods of Diagnosis and for the Realization of Expertises Diagnostics in the Field of Infectious Diseases and Tropical
Direct constitution of collections from various samples taken on a prospective cohort of healthy volunteers, to prepare human biological samples of known characteristics (biochemical and serological in particular) and quality…
- Trial name
- Diagmicoll (NCT03912246)
- Testing
- biological samples, lumbar puncture
- Where
- 2 sites in France
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
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
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
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
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
Infectious Diseases, Immunocompromised Host
Metagenomic Sequencing Across the Infectious Disease Risk and Care Continuum
The AXIS Network is a prospective, multicenter observational registry designed to generate real-world evidence on the use of metagenomic sequencing in clinical practice across a broad range of patient populations, infectious…
- Conditions
- Infectious Diseases, Immunocompromised Host, Opportunistic Infections
- Trial name
- AXIS (NCT07825714)
- Volunteers
- 10,000 people
- Sponsor
- Karius, Inc.
Endometrial Cancer
Evaluation of MCM5 in Postmenopausal Bleeding Patients
The objective of this multi-centre, prospective study, is to evaluate the performance of a urine MCM5 ELISA test (ADXGYNAE) in the detection of endometrial cancer in patients with postmenopausal bleeding.
- Trial name
- NCT05287048
- Testing
- MCM5 ELISA
- Where
- United Kingdom
- Volunteers
- 2,000 people
- Sponsor
- Arquer Diagnostics Ltd
Endometrial Cancer
Development of a Non-invasive IVD for Endometrial Cancer Screening on High-risk Populations
CYTOMARK, a non-invasive in vitro diagnostic (IVD) test measuring a defined panel of protein biomarkers in cervical fluid, can accurately detect endometrial cancer in both symptomatic and asymptomatic women at high risk for the…
- Trial name
- NCT07148154
- Testing
- Cytology
- Where
- 2 sites in Spain
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- MiMARK Diagnostics, S.L.