Clinical trials: Performance, Detection
Pulmonary Tuberculoses
Time-to-Detection in Culture of Mycobacterium Tuberculosis
determination if time-to-detection in cultures of M. tuberculosis samples is more discriminating than acid-fast staining in transmission
- Trial name
- NCT05568368
- Testing
- No intervention
- Where
- France
- Volunteers
- 705 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Acute Febrile Illness
Evaluation of the DPP II Assay in Laos
Fever is the most frequent symptom in patients seeking care globally. Several causative agents of febrile illness have been described with a high prevalence in South East Asia.
- Trial name
- NCT04299607
- Testing
- DPP Fever Panel II assay and DPP Micro Readers
- Where
- Laos
- Volunteers
- 300 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Breast Cancer Detection, Dense Breast Parenchyma
Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Conditions
- Breast Cancer Detection, Dense Breast Parenchyma, Benign Breast Findings, Normal Breast Screening
- Trial name
- DMT SV RRS3 (NCT04260620)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Delphinus Medical Technologies, Inc.
SARS-CoV-2, Covid-19
Performance Evaluation of SARS-COV-2 (Covid-19) Antigen Rapid Test
The SARS-CoV-2 Antigen Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the SARS-CoV-2 Antigen Rapid Test assay will be assessed by comparison to a reference method.
- Conditions
- SARS-CoV-2, Covid-19, Coronavirus
- Trial name
- NCT04808921
- Testing
- Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test
- Where
- United States
- Sponsor
- Sky Medical Supplies & Equipments, LLC
Aspergillosis, Infection in an Immunocompromised Host
Aspergillus-specific PCR Assay in Cerebrospinal Fluid Samples for Detection of Central Nervous System Aspergillosis
Central nervous system (CNS) invasive aspergillosis (IA) is a fatal complication in immunocompromised patients. Confirming the diagnosis is rarely accomplished as invasive procedures are hampered by neutropenia and low platelet…
- Trial name
- NCT01617759
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Heidelberg University
Ovarian Neoplasms, Ovarian Cancer
Prospective Sample Collection Study for a Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
The goal of this observational study is to learn whether a blood-based cell-free DNA (cfDNA) methylation assay can help detect ovarian cancer, especially early-stage ovarian cancer, in women undergoing clinical evaluation for…
- Conditions
- Ovarian Neoplasms, Ovarian Cancer, Early Detection of Cancer
- Trial name
- NCT07593833
- Testing
- Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Tongji Hospital
Diquat Poisoning
Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples
This is an observational, non-interventional diagnostic accuracy study designed to evaluate a diquat quantitative detection kit (ambient ionization mass spectrometry method) and a portable mass spectrometry analysis system for…
- Trial name
- NCT07399574
- Testing
- Portable Mass Spectrometry Analysis System for Quantitative Diquat Detection (with Diquat Quantitative Detection Kit; In-Situ/Ambient Ionization Mass Spectrometry Method)
- Where
- China
- Volunteers
- 60 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sepsis
Evaluating the Diagnostic Performance and Impact on Clinical Outcomes of the NuRapid-CRISPR Pathogen Profile Assay in ICU Patients With Sepsis
This study is a prospective, multicenter, integrated trial designed to evaluate, from the perspectives of diagnostic performance and clinical utility, whether a diagnostic and treatment strategy based on the NuRapid-CRISPR rapid…
- Trial name
- NCT07580001
- Testing
- NuRapid-CRISPR Rapid Pathogen Detection Technology, Traditional pathogen culture
- Where
- 3 sites in China
- Volunteers
- 396 people
- Sponsor
- Shanghai 10th People's Hospital
Spinal Muscular Atrophy, Neonatal Hyperbilirubinemia
Establishing Novel Detection Techniques for Various Genetic-Related Diseases by Applying DHPLC Platform.
In this, here we want to present a new method for analysis variation in gene copy number for patients and carriers of SMA. This is a relative quantitation method and, therefore, relies on the inclusion of one or more internal…
- Conditions
- Spinal Muscular Atrophy, Neonatal Hyperbilirubinemia, Colon Cancer
- Trial name
- NCT00154960
- Where
- Taiwan
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Fever Malaria
Clinical Evaluation of the STANDARD™ Q Malaria/CRP Duo Test
The aim of this study is to assess the clinical performance (sensitivity, specificity, positive and negative predictive values) of the STANDARD™ Q Malaria/CRP Duo Test when used by health care workers (HW) in a point of care…
- Trial name
- NCT04791800
- Testing
- Malaria/CRP combination test
- Where
- India
- Volunteers
- 1,808 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
High Sensitivity and Specificity (With 95% Confidence Interval) of RealDetect™ COVID-19 RT-PCR Kit
Performance Evaluation of RealDetect™ COVID-19 RT-PCR Kit for the Detection of SARS-CoV-2 Virus
The novel Severe acute respiratory syndrome coronavirus 2 (SARS-C0V 2) originated in Wuhan, China in December 2019. As of April 15 2020, the virus has spread across 213 countries/territories with 1,914,916 cases and 123,010…
- Trial name
- NCT04403672
- Testing
- performance evaluation study of RealDetect RT-PCR Kit for COVID-19 detection
- Where
- Bangladesh
- Volunteers
- 120 people
- Sponsor
- Bangladesh Medical Research Council (BMRC)
Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
This clinical trial aims to systematically evaluate the clinical performance and accuracy of the HepaAiQ test kit, a multi-gene methylation assay based on PCR with fluorescent probe detection.
- Trial name
- NCT06842563
- Where
- China
- Volunteers
- 900 people
- Sponsor
- Singlera Genomics Inc.
Paraneoplastic Neurological Syndrome, Autoimmune Encephalitis
Diagnostic Performance of a Commercial Assay for the Detection of Neuronal Antibodies
Detection of autoantibodies targeting neuronal surface or intracellular antigens is a keystone for the diagnosis and the treatment of auto-immune encephalitis and paraneoplastic neurological syndromes.
- Trial name
- IFINEURO (NCT05783947)
- Testing
- Indirect immunofluorescence assay on tissue slides and cell-based assays with CSF and/or sera
- Where
- 2 sites in France
- Volunteers
- 34 people
- Sponsor
- Hospices Civils de Lyon
TB - Tuberculosis
Start Taking Action for Tuberculosis in Kids
Start4Kids: Evaluating the performance, feasibility, acceptability and cost effectiveness of computer-aided detection (CAD) of chest X-ray (CXR) and concurrent testing using novel diagnostics and non-sputum specimens for…
- Trial name
- Start4Kids (NCT07248423)
- Testing
- Xpert MTB/RIF Ultra, Truenat, MTB, Truenat MTB Plus
- Volunteers
- 7,920 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Skin Cancer
Multi-Center Study to Evaluate the Performance of DermDx for Primary Care Physicians in the Detection of Skin Cancers
The proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin…
- Trial name
- NCT06463860
- Testing
- DermDx
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- MetaOptima Technology Inc.
Intracranial Embolism and Thrombosis, Postoperative Complications
TCD Detection of Gas and Solid Micro-Emboli in Patients Undergoing Coronary Artery Bypass Grafting (CABG): The Influence of Proximal Anastomosis Technique
The purpose of this study is to test the hypothesis that using three different techniques to anastomose coronary grafts to the aorta: partial occlusion, single cross clamp, or using the Heartstring anastomotic device, will change…
- Trial name
- NCT00294814
- Testing
- Proximal anastomosis using Heartstring anastomotic device
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Rambam Health Care Campus
Refractive Errors, Amblyopia
Performance of 2WIN Photoscreener With Corneal Reflex Compared to School Bus Retinoscopy by AAPOS Guidelines
Pediatric eye patients receive infrared photoscreener screening and skiascopy as a part of routine examination to compare ability to detect amblyopia risk factors.
- Conditions
- Refractive Errors, Amblyopia, Strabismus, Development Delay
- Trial name
- 2WINbus (NCT03668067)
- Testing
- 2WIN photoscreener
- Where
- United States
- Volunteers
- 471 people
- Sponsor
- Alaska Blind Child Discovery
Helicobacter Pylori Infection
Performances of a Fast Test for the Detection of Helicobacter Pylori Antigens in Child Stool
The diagnostic tests used to detect Helicobacter pylori (H. pylori) infection are either direct and invasive, as in culture, histology and the rapid urease test (RUT) or noninvasive, such as serology, the 13C-Urea breathe test or…
- Trial name
- DISPOSE (NCT03324763)
- Testing
- stool sampling
- Where
- France
- Volunteers
- 158 people
- Sponsor
- Lille Catholic University
Hepatitis C
A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection
To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test using known anti-HCV seropositive and seronegative specimens. Registration for license application
- Trial name
- NCT01582594
- Where
- 4 sites in China
- Volunteers
- 795 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical, China
Covid19, RSV Infection
Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVID-19 Virus POC Test
Collection of Nasal Swabs, Throat Swabs and Saliva Samples from patients presenting at their designated care or testing facility displaying symptoms of either Influenza, Respiratory Syncytial Virus (RSV), SARS-CoV-2 or those who…
- Conditions
- Covid19, RSV Infection, Influenza Type A, Influenza Type B
- Trial name
- INFORM (NCT04782336)
- Testing
- Sample Collection
- Where
- 6 sites in United Kingdom
- Volunteers
- 79 people
- Sponsor
- LumiraDx UK Limited