Clinical trials: Validation Studies
Psychological Well Being
Test-Retest Reliability of the WB6Dim Digital Well-Being Tool: A 3-Day Interval Study
This study aims to establish the test-retest reliability of the WB6Dim digital self-assessment tool across its eight well-being dimensions, using a 3-day interval protocol designed to minimize the probability of genuine…
- Trial name
- WB6Dim-TRT (NCT07433764)
- Where
- France
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Clover Link
Pain, Inflammation
UVB Model Validation Study
Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy…
- Conditions
- Pain, Inflammation, Healthy Volunteers
- Trial name
- NCT01055249
- Testing
- Ibuprofen, Hydrocortisone, Hydrocortisone
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- X-pert Med GmbH
Constipation
Colonic Transit Time Validation Study
The protocol described herein is designed to provide clinical evidence of the substantial equivalence of SmartPill GI Monitoring System (SP) to the Sitzmarks (Konsyl Pharmaceuticals, Easton, MD) radio-opaque markers (ROM).
- Trial name
- CTT (NCT00857363)
- Where
- 13 sites in United States, United Kingdom
- Volunteers
- 210 people
- Sponsor
- The SmartPill Corporation
Clostridium Difficile Infection
Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument.
- Trial name
- NCT02968758
- Testing
- Comparison between GenePOC PCR and Reference Method
- Where
- 7 sites in United States, Canada
- Volunteers
- 2,461 people
- Sponsor
- Meridian Bioscience, Inc.
Sepsis, Shock, Septic
Sepsis Assessment in Belgian Emergency Rooms
To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.
- Conditions
- Sepsis, Shock, Septic, Severe Sepsis
- Trial name
- SABER (NCT02424721)
- Where
- 4 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Axis Shield Diagnostics Ltd
Spasticity, Muscle
Validation of the Spasticity Related Quality of Life Questionnaire
The purpose of the study is to describe the psychometric properties (validity, reliability and responsiveness) of the SQOL-6D instrument in the context of routine clinical treatment of upper limb spasticity.
- Trial name
- SQOL-6D (NCT03442660)
- Testing
- Data collection
- Where
- 8 sites in United Kingdom
- Volunteers
- 104 people
- Sponsor
- Ipsen
Obstructive Sleep Apnea
TipTraQ Home Sleep Test Validation Study, VGH
A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional…
- Trial name
- NCT06474390
- Where
- Taiwan
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Alzheimer Disease, Dementia
Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease
This is a 24-month, monocentric, exploratory and observational clinical study aimed at developing and validating a blood-based diagnostic test for Alzheimer's disease (AD).
- Conditions
- Alzheimer Disease, Dementia, Neurodegenerative Disorders, Cognitive Decline
- Trial name
- ADKIT (NCT07294586)
- Where
- France
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Amoneta Diagnostics SAS
Gastroesophageal Reflux
Validation of RDQ Questionnaire
The primary objective of this study is to determine the accuracy of the Reflux Disease Questionnaire (RDQ) as a diagnostic test for gastroesophageal reflux disease.
- Trial name
- NCT00291746
- Testing
- Esomeprazole, Bravo technique
- Where
- 30 sites in Canada, Denmark and 4 more
- Volunteers
- 350 people
- Sponsor
- AstraZeneca
Rectal Adenocarcinoma, Anal Adenocarcinoma
Prospective Validation Study for the Proprietary Rectal and Anal Cancer Protein Expression Assays
Patients with locally advanced rectal and esophageal carcinomas typically undergo neoadjuvant chemoradiation therapy prior to surgical resection.
- Conditions
- Rectal Adenocarcinoma, Anal Adenocarcinoma, Anal Squamous Cell Carcinoma
- Trial name
- NCT02407561
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Castle Biosciences Incorporated
Eye Disease
iCam Clinical Validation Study
Comparison study to assess photo image quality of a new color fundus camera compared to that of a commercially available color fundus camera.
- Trial name
- NCT01600261
- Where
- 2 sites in United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Optovue
Hypogonadism, Male
Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
- Trial name
- DV (NCT03242590)
- Testing
- LPCN 1021
- Volunteers
- 95 people
- Sponsor
- Lipocine Inc.
Hypoxia
RDS MultiSense® SpO2 Validation Study
The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of the RDS MultiSense® Pulse Oximetry during non-motion conditions over the range of 70-100% arterial oxygen saturation (SaO2) as compared to…
- Trial name
- NCT05359328
- Testing
- Pulse Oximeter, Respiratory Rate, Heart Rate and Arterial line
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Rhythm Diagnostic Systems
Sleep Apnea
A Validation Study of the NightOwl Home Sleep Apnea Test
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software.
- Trial name
- NCT04764734
- Testing
- NightOwl
- Where
- 4 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
Keratoconjunctivitis Sicca
TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease
This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective…
- Trial name
- CVS (NCT00848198)
- Where
- 10 sites in United States, France and 3 more
- Volunteers
- 314 people, healthy volunteers welcome
- Sponsor
- TearLab Corporation
Breast Cancer
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
- Trial name
- NCT04480814
- Testing
- PIK3CA kit
- Where
- 4 sites in Greece
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharmassist Ltd
Allergic Rhinitis, Rhinitis, Allergic, Seasonal
Investigate Two Trial Models; Vienna Challenge Chamber (in and Out of Season) and Park Study (in Season) Using a Drug for Seasonal Allergic Rhinitis
The aim of the study is to investigate the trial models, Vienna Challenge Chamber (VCC), in and out of season, and Park Study in season and the clinical efficacy of repeat doses of fluticasone propionate in subjects with seasonal…
- Trial name
- NCT00400998
- Testing
- Fluticasone Propionate
- Where
- Austria
- Volunteers
- 41 people
- Sponsor
- Research Consult GmbH
Cervical Cytology, PAP
Techcyte SureView Cervical Cytology System Clinical Validation Study
The clinical study is a multi-center, retrospective, blinded, matched-pair, two-arm clinical study in which one test assessment and a control assessment of liquid-based cytology (LBC) pap tests are performed and compared to a…
- Trial name
- NCT06767111
- Testing
- Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) device
- Where
- United States
- Volunteers
- 4,596 people, healthy volunteers welcome
- Sponsor
- Techcyte, Inc.
Non-small Cell Lung Cancer, Neoantigen
Multi-Omics Testing for Immunotherapy Efficacy Evaluation (MOTIVATION)
This multicenter prospective observational and exploratory study aims to develop and validate a novel multi-omics-based computational method for neoantigen prediction in non-small cell lung cancer (NSCLC), and discover biomarkers…
- Conditions
- Non-small Cell Lung Cancer, Neoantigen, Next-generation Sequencing, Biomarker
- Trial name
- MOTIVATION (NCT04923802)
- Where
- China
- Volunteers
- 13 people
- Sponsor
- GeneCast Biotechnology Co., Ltd.
Over Active Bladder
A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment
This study is to evaluate change of over active bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.
- Trial name
- RESORT-2 (NCT01318837)
- Testing
- solifenacin
- Where
- 2 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- Astellas Pharma Inc