Clinical trials: Validation Studies
Contraception
Desogestrel-containing COCP Pharmacokinetic Validation Study
This study aims to validate prior pharmacokinetic research with combined oral contraceptive pill users that supports utilizing a 24-hour trough concentration as an accurate proxy for the intensive pharmacokinetic parameter of…
- Trial name
- NCT05002738
- Testing
- Desogestrel and Ethinyl Estradiol Tablets
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Device Validation of In-vivo Performance
Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study
This is an in vivo 24-hour in-vivo recovery study of leukoreduced red blood cells (RBCs) collected on the Trima Accel System using Non-DEHP disposable sets and stored for 42 days.
- Trial name
- NCT06602804
- Testing
- Trima Accel Auto RBC Collection
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Surgery, One-lung Ventilation
Esophageal Pressure Measurements During One-lung Ventilation
The investigators will assess the feasibility and validity of esophageal pressure measurements during one-lung ventilation in the lateral position for surgery by comparing to lung collapse estimated from electrical impedance…
- Trial name
- NCT04725318
- Testing
- One-lung ventilation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Beth Israel Deaconess Medical Center
Blood Pressure
Comparison of Non-Invasive Blood Pressure Methods
The primary objective of the study is to demonstrate the accuracy in healthy adults with Vital USA Device by comparison to a non-invasive (auscultatory) reference sphygmomanometer.
- Trial name
- NIBP (NCT04296227)
- Testing
- The Vital Detect blood pressure monitor
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Vital USA, Inc.
Healthy
Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073
The aim of the study is to validate the Mean Arterial Pressure (MAP) parameter of Masimo INVSENSOR00073 against the gold standard blood pressure measurements from the arterial line while subject undergo a blood pressure variation…
- Trial name
- NCT06334055
- Testing
- Masimo INVSENSOR00073
- Where
- United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque
This study will investigate the reliability and validity of an inline 'pull-type' dynamometer for measuring peak knee extensor torque.
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- Trial name
- NCT05109871
- Testing
- KForce Link
- Where
- United Kingdom
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Liverpool University Hospitals NHS Foundation Trust
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.
Social Anxiety Disorder (SAD)
A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.
This study is to compare two Virtual Reality (VR)-based interventions, BVR-100 and BES-100, for the treatment of Social Anxiety Disorder (SAD).
- Trial name
- BVR-100-102 (NCT06037668)
- Testing
- BVR-100, BES-100
- Where
- 6 sites in United States
- Volunteers
- 56 people
- Sponsor
- Sumitomo Pharma America, Inc.
Sleep Apnea
Clinical Validation of New Commercial Sleep Monitoring Devices
This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), which is considered the gold standard for sleep…
- Trial name
- NCT02779543
- Testing
- Fitbit, Jawbone UP, Microsoft Band
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Weill Medical College of Cornell University
Subjects Presenting With Normal Eyes
TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.
- Trial name
- NCT02447133
- Testing
- 3D OCT-1 Maestro
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Topcon Medical Systems, Inc.
Bacterial Vaginosis, Urogenital Infection by Trichomonas Vaginalis
A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests to diagnose common vaginal infections.
- Trial name
- NCT00682851
- Testing
- OSOM Trichomonas Rapid Test, OSOM BVBlue Test
- Where
- United States
- Volunteers
- 519 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Opioid Use Disorder
Assessment of Methadone and Buprenorphine in Interstitial Fluid
The purpose of this research is to determine if common medications for opioid use disorder (i.e., buprenorphine/naloxone, buprenorphine, methadone) and their metabolites (norbuprenorphine [a metabolite of buprenorphine]…
- Trial name
- NCT05546229
- Testing
- Microneedle based interstitial fluid collection
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Cari Health Inc.
Fluid Retention Tissue
Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System
The purpose of this study is to measure the fluid changes in the body using a device called the µ-Cor System, an investigational device.
- Trial name
- MaTcH (NCT03072732)
- Testing
- u-Cor System, ZOE Fluid Status Monitor
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Zoll Medical Corporation
Pathology
Instrument Precision Study for Validation of Philips Dx
The objective of this study is to evaluate precision of the Philips Dx system.
- Trial name
- NCT02699970
- Where
- United States
- Volunteers
- 399 people
- Sponsor
- Philips Digital & Computational Pathology
Sneddon-Wilkinson, Acrodermatitis Continua of Hallopeau
Anakinra for Inflammatory Pustular Skin Diseases
Background: Inflammatory pustular skin diseases are a type of autoinflammatory disease in which the immune system attacks the bodys tissues.
- Conditions
- Sneddon-Wilkinson, Acrodermatitis Continua of Hallopeau, Pustular Psoriasis, Palmoplantar Pustulosis
- Trial name
- NCT01794117
- Testing
- Anakinra
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Menstruation
Tampon Design Validation Study
This prospective multi-center, open-label, randomized, cross-over study is designed to validate the user needs of a tampon design. The hypothesis is that user needs are met.
- Trial name
- NCT05553600
- Testing
- Tampon BR, Tampon CR, Tampon BS
- Where
- 9 sites in United States
- Volunteers
- 732 people, healthy volunteers welcome
- Sponsor
- Kimberly-Clark Corporation
Tobacco Dependence
UW Withdraw From Tobacco Study
It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success.
- Trial name
- NCT04969198
- Testing
- Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)
- Where
- United States
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Chronic Angina
An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Female-specific Angina Questionnaire in Women With Chronic Angina Treated With Ranolazine Extended-release Tablets (CVT 3041)
According to the American Heart Association (AHA) 2011 update of heart disease and stroke statistics, more than 9 million adult patients in the United States (US) have angina.
- Trial name
- NCT00644332
- Testing
- Ranolazine
- Where
- 29 sites in United States
- Volunteers
- 172 people
- Sponsor
- Gilead Sciences
Atrial Fibrillation
Atrial Fibrillation Algorithms Clinical Validation Study
The purpose of the study is to evaluate the performances of investigational Irregular Rhythm Notification Feature (version 2.0) and Atrial Fibrillation History Feature algorithms.
- Trial name
- NCT04699812
- Testing
- ELECTROCARDIOGRAM (ECG) PATCH WEAR
- Where
- 4 sites in United States
- Volunteers
- 573 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Validation Studies
d13C Added Sugar Intake Biomarker: Determining Validity in Children
Added sugars (AS) constitute a significant source (~ 16%) of the total daily calories consumed by youth. The role of AS in health is contentious, and the reliance on self-reported dietary data is an often-cited flaw in existing…
- Trial name
- NCT02455388
- Testing
- High added sugar diet, Low added sugar diet
- Where
- United States
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Virginia Polytechnic Institute and State University