Clinical trials: Validation Studies
Alzheimer Disease, MCI
Validation Study of a New Digital Treatment Test
Oculomotor behavior and cognitive processing of visual information are intimately connected. AD patients show ocular movement problems.
- Trial name
- NCT04897464
- Testing
- BGaze therapy Alzheimer
- Where
- Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Braingaze
CAD - Coronary Artery Disease
Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study
In the present study we aim at validating the computation of FFRangio values from the angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a completely blinded manner.
- Trial name
- NCT03005028
- Where
- Israel
- Volunteers
- 184 people
- Sponsor
- CathWorks Ltd.
Helicobacter Pylori Infection
Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori
A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.
- Trial name
- NCT02010112
- Testing
- Breath Test Collection bags
- Where
- 9 sites in United States
- Volunteers
- 193 people
- Sponsor
- Meridian Bioscience, Inc.
Prostate Cancer Detection
Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent, up to 20 mL of whole blood will be collected from each subject.
- Trial name
- PRIME (NCT07543757)
- Testing
- Proclarix
- Where
- 7 sites in United States
- Volunteers
- 500 people
- Sponsor
- Sequenom, Inc.
Compartment Syndromes
SWISS_CLEARANCE - Compartment Compressibility Monitoring Using CPM#1
Compartment syndrome is a very serious musculoskeletal disorder, which can lead to potentially devastating consequences, such as limb amputation and life- threatening conditions.
- Trial name
- NCT05483946
- Testing
- Measurement of compartment compressibility
- Where
- Switzerland
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Compremium AG
Atrial Fibrillation, Arrythmia, Cardiac
Validation Study of a Watch for the Detection of Atrial Fibrillation
The proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF).
- Trial name
- MOVE-ECG (NCT04041466)
- Testing
- AF detection by ECG
- Where
- 2 sites in France
- Volunteers
- 140 people
- Sponsor
- Withings
Pharyngitis, Infective
Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene.
- Trial name
- NCT03422341
- Testing
- Comparison between GenePOC CR and Reference Method
- Where
- 8 sites in United States, Canada
- Volunteers
- 497 people
- Sponsor
- Meridian Bioscience, Inc.
Diabetic Retinopathy, Diabetic Eye Problems
Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device
Diabetes affects approximately 35 million Americans, each of whom needs at least one retinal exam per year. However, majority do not get their eye exam due to multiple prohibitive factors such as cost, transportation, difficulty…
- Conditions
- Diabetic Retinopathy, Diabetic Eye Problems, Diabetic Macular Edema
- Trial name
- NCT04774822
- Testing
- Color Fundus Photography, Mydriatics Agent, Optical Coherence Tomography (OCT)
- Where
- 3 sites in United States
- Volunteers
- 397 people
- Sponsor
- RETINA-AI Health, Inc.
Aging, Mortality
Human Observatory Study
The Human Observatory Study is a prospective observational and ecological surveillance study building a continuously-updating world model for human health, disease, and death at the individual and population level.
- Conditions
- Aging, Mortality, All-cause Mortality, Life Expectancy
- Trial name
- HOS (NCT07646782)
- Testing
- Multi-Domain Ecological and Clinical Data Linkage
- Where
- United States
- Volunteers
- 1,000,000 people, healthy volunteers welcome
- Sponsor
- Longevity Metrics, Inc.
Herpes Zoster
VZV PCR Sampling Validation Study
This study will evaluate and compare various methods for collecting lesion samples from subjects with clinically diagnosed herpes zoster for the laboratory confirmation of herpes zoster.
- Trial name
- NCT00501670
- Testing
- Herpes zoster sampling procedure for VZV PCR, Blood sampling
- Where
- 3 sites in Germany
- Volunteers
- 41 people
- Sponsor
- GlaxoSmithKline
Kidney Transplantation, Liver Transplantation
A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients
The purpose of this study is to assess relationship between tacrolimus concentrations determined via whole blood MITRA assay method with those determined using the established and validated whole blood venepuncture method using…
- Trial name
- MITRA (NCT03465969)
- Testing
- tacrolimus
- Where
- 4 sites in France, United Kingdom
- Volunteers
- 80 people
- Sponsor
- Astellas Pharma Europe Ltd.
Magnetic Resonance Imaging
The Clinical Validity and Safety of IOP Injection MRI Contrast Agent in Hepatocellular Carcinoma
This study is an exploratory study aiming to collect data on sensitivity and positive predictive value of IOP-enhanced (MPB-1523) MRI compared to dynamic multiphase MDCT for the detection of HCC.
- Trial name
- NCT03407495
- Testing
- IOP Injection (MPB-1523)
- Where
- 5 sites in Taiwan
- Volunteers
- 52 people
- Sponsor
- MegaPro Biomedical Co. Ltd.
Drug Interactions
Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation
The purpose of this study is to identify and validate a probe cocktail for use in future drug-drug interaction studies. Cytochrome P450 enzymes and transport proteins play important roles in the disposition of drugs.
- Trial name
- NCT00964106
- Testing
- Caffeine, Rosiglitazone, Flurbiprofen
- Where
- 2 sites in South Korea
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Asthma COPD
Clinical and Medico-economic Validation of the HEPHAI Solution.
In a context where the use of inhalation devices for respiratory medications is associated with a high frequency of critical errors, our primary hypothesis is that the use of the HEPHAÏ solution reduces this frequency compared to…
- Trial name
- VAL-HEPHAI (NCT06099145)
- Testing
- Hephaï
- Where
- 5 sites in France
- Volunteers
- 238 people
- Sponsor
- Hephai
Rhinitis, Allergic, Perennial
Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
The Protocol section needs to be updated using the following text "The main goal of the study was to validate the Preference Module of the EARNS-Q and to test the reliability using Treatment Satisfaction Questionnaire for…
- Trial name
- NCT00346775
- Testing
- Beclomethasone dipropionate, Flunisolide
- Where
- 7 sites in United States
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline
Psoriatic Arthritis
A Study in Participants With Psoriatic Arthritis Attending Dermatology Clinics
The purpose of this study is to conduct full psychometric testing of the Early Arthritis for Psoriatic Patients (EARP) questionnaire in Australian, Korean and Chinese populations
- Trial name
- PARIS (NCT02470481)
- Testing
- No Intervention
- Where
- 5 sites in Australia, China and 1 more
- Volunteers
- 250 people
- Sponsor
- Janssen Research & Development, LLC
Heart Failure, High Blood Pressure
BVA-200 vs BVA-100 Validation Study
The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device.
- Conditions
- Heart Failure, High Blood Pressure, High Cholesterol, Anemia
- Trial name
- NCT06227819
- Testing
- BVA-200
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Daxor Corporation
Respiratory Rate
Bora Band Respiration Rate Study
The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the BORA BAND™ Wristband Monitoring System to the Reference.
- Trial name
- NCT04064645
- Testing
- Measurement of respiratory rate with DUT and comparison with reference
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Biosency
Presbyopia
Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.
- Trial name
- NCT03417557
- Testing
- Comfilcon A lens (test), Omafilcon B lens (control)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- CooperVision, Inc.
Quality of Life, Epilepsy (treatment Refractory)
Evaluation of the Epilepsy-related Quality of Life, Seizure-related Accidents and Validation of the Mjn-SERAS Solution in the Normalised Patient Environment with Real-World Data
The study will be prospective, multicentre, postmarketing clinical study, with a controlled and randomized design, to perform the analysis of 130 subjects with a clinical diagnosis of epilepsy, patients whose clinical semiology…
- Trial name
- SERAS_Home_RWD (NCT05845255)
- Testing
- mjn-SERAS
- Where
- 6 sites in Germany, Spain and 1 more
- Volunteers
- 130 people
- Sponsor
- MJN Neuroserveis, S.L