Clinical trials: Diagnostic Accuracy
Fever, Respiratory Tract Infections
Diagnostic Accuracy of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients
This is a prospective clinical validation study of a novel regulatory approved (CE-IVD) diagnostic assay called ImmunoXpert™ that will enroll 1222 pediatric patients.
- Trial name
- AutoPilot (NCT03052088)
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,140 people
- Sponsor
- MeMed Diagnostics Ltd.
Allergy, Hypersensitivity, Immediate
Head-to-Head Comparison Study Between Different FDA Registered Allergy Skin Test Applicators
This clinical study, titled "Head-to-Head Comparison Study between Different FDA Registered Allergy Skin Test Applicators," aims to compare the reliability and clinical performance of three skin prick test (SPT) devices…
- Conditions
- Allergy, Hypersensitivity, Immediate, Ig-E Mediated Food
- Trial name
- NCT07400718
- Testing
- AllerTest-10 Multi-Head Skin Test Device, Skintestor OMNI Multi-Head Skin Test Device, Multi-Test II Multi-Head Skin Test Device
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- QHSLab, Inc.
Tuberculosis (TB)
QuantiFERON Access Clinical Performance Study Protocol
Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.
- Trial name
- NCT04243031
- Testing
- QFT Access
- Volunteers
- healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc
Asthma, COPD
Assess Accuracy of Primary Care Asthma and COPD Diagnosis Using Oscillometry and FeNO vs Specialist Diagnosis
Current diagnostic methods for asthma and chronic obstructive pulmonary disease mostly depend on pulmonary function tests, especially spirometry.
- Trial name
- Care4All (NCT07245576)
- Where
- 12 sites in Argentina, Egypt and 5 more
- Volunteers
- 600 people
- Sponsor
- AstraZeneca
Acute Myocardial Infarction (AMI)
SpinChip Hs-cTnI Multisite Precision
During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack.
- Trial name
- HEAT-1 (NCT06851013)
- Testing
- SpinChip hs-cTnI
- Where
- 3 sites in Norway
- Volunteers
- 37 people
- Sponsor
- SpinChip Diagnostics ASA
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.
Normal Pressure Hydrocephalus
ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients
The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic Intracranial Hypertension (IIH) undergoing…
- Trial name
- NCT00793416
- Testing
- Shunt flow detection
- Where
- United States
- Sponsor
- NeuroDx Development
Influenza -Like Illness, Influenza A
Home Testing of Respiratory Illness
The main goal of this research study is to use data from activity trackers (such as Fitbits), lab tests, and surveys to see if activity, sleep, and heart rate data can tell the difference between when someone has a respiratory…
- Conditions
- Influenza -Like Illness, Influenza A, Influenza Type B, Respiratory Viral Infection
- Trial name
- NCT04245800
- Where
- United States
- Volunteers
- 5,233 people, healthy volunteers welcome
- Sponsor
- Evidation Health
Coronary Artery Disease
Evaluation of Diagnostic Accuracy of MCG(Magnetocardiography) Scan in Suspected Coronary Artery Disease
This multicenter clinical trial is designed to evaluate the diagnostic accuracy of MCG scan in detecting significant CAD compared to the reference standard CAG.
- Trial name
- EDAM-CAD (NCT05825911)
- Testing
- Rest/Stress MCG scan, Rest MCG scan
- Where
- 2 sites in South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- AMCG
Intracranial Neoplasm
Accuracy of Robotically Assisted Cranial Biopsies
This is an observational post-market study determining biopsy accuracy in a clinical environment using Cirq® Robotic Alignment Module Cranial.
- Trial name
- NCT05891002
- Testing
- Cirq® Robotic Alignment Module Cranial
- Where
- France
- Volunteers
- 4 people
- Sponsor
- Brainlab AG
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Diagnostic Accuracy Of Seismocardiography for Coronary Artery Disease
This study aims to evaluate a new, non-invasive method for detecting coronary artery disease (CAD) using seismocardiography (SCG) and gyrocardiography (GCG).
- Trial name
- HF-CAD (NCT06880120)
- Testing
- Seismocardiography (SCG) and Gyrocardiography (GCG) Diagnostic Testing
- Where
- Uzbekistan
- Volunteers
- 1,534 people, healthy volunteers welcome
- Sponsor
- Heart Force Medical Inc.
Sepsis
Adult MDW Dual Cut-Off Accuracy Study
This study will establish the clinical performance of the Monocyte Distribution Width (MDW) parameter on the DxH 900/ DxH 690T hematology analyzers to aid in the detection and risk assessment of patients in the Emergency…
- Trial name
- MDW (NCT06885528)
- Testing
- Complete Blood Count with differential
- Where
- 5 sites in United States
- Volunteers
- 524 people
- Sponsor
- Beckman Coulter, Inc.
Fractures, Musculoskeletal
Enhancing Diagnostic Accuracy in Fracture Identification on Musculoskeletal Radiographs Using Deep Learning
This retrospective study aims to evaluate the effectiveness of artificial intelligence (AI) in identifying fractures on musculoskeletal X-rays.
- Trial name
- NCT06644391
- Testing
- Carebot AI Bones
- Where
- Czechia
- Volunteers
- 600 people
- Sponsor
- Carebot s.r.o.
Breast Cancer
Case Collection Study to Support Digital Mammography Image Software Change
The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.
- Trial name
- LIP2SIP (NCT00756496)
- Testing
- Mammography screening and diagnosis
- Volunteers
- 442 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions USA - CSG
Otitis Media Acute
Clinical Development of Deep Learning for the OtoSight
The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the…
- Trial name
- NCT04722770
- Testing
- PhotoniCare OtoSight Middle Ear Scope
- Where
- United States
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- PhotoniCare, Inc.
Coronary Artery Disease, Cardiovascular Diseases
Functional Diagnostic Accuracy of Quantitative Flow Ratio in Tandem Lesions and Virtual Stenting
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Virtual stent implantation technique combined with QFR was recently developed to predict the functional significance…
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia, Arterial Occlusive Diseases
- Trial name
- FORTRESS (NCT03405506)
- Testing
- Quantitative Flow Ratio (QFR)
- Where
- China
- Volunteers
- 308 people
- Sponsor
- Pulse Medical Imaging Technology (Shanghai) Co., Ltd
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.
Glioma, 18F-Fluoroethyl-l-tyrosine
Clinical Benefit of 18F-FET in Glioma.
This Phase II clinical trial, sponsored by Primo Biotechnology Co., Ltd., evaluates the clinical benefit of $^{18}$F-FET PET/CT in diagnosing glioma.
- Trial name
- NCT07698457
- Testing
- 18F-Fluoroethyl-l-tyrosine
- Where
- 4 sites in Taiwan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Primo Biotechnology Co., Ltd
Autism, Autism Spectrum Disorder
Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
This observational study aims to evaluate how patterns of behavioral and sensorimotor responses measured using the BlinkLab Dx1 smartphone application relate to autism diagnoses in children ages 2 to 11.
- Conditions
- Autism, Autism Spectrum Disorder, Autism Spectrum Disorder (ASD), Neurodevelopmental Conditions
- Trial name
- NCT07590973
- Testing
- BlinkLab Dx1, Retrospective Neurodevelopmental Diagnostic Assessment
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Blinklab Limited
Atopic Asthma
Determination of Accuracy in Measurement of Total Immunoglobulin E Using a Test Device in Atopic Subjects
The purpose of this study is to determine the accuracy of the Novel point of care test (POCT) total IgE assay in atopic patients. 120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled.
- Trial name
- NCT02758548
- Testing
- Blood sample, POCT device
- Where
- 12 sites in Germany, Italy and 3 more
- Volunteers
- 193 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals