Clinical trials: VALİDİTY
AI-driven, Self-directed Blood Pressure Monitoring
imPulse™ Tor System Self-Directed Cuffless Blood Pressure Monitoring
Self-measured, non-invasive accurate blood pressure monitoring continues to be a major challenge for automated vital sign measurement systems.
- Trial name
- NCT05386654
- Testing
- imPulse™ Tor System
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Level 42 AI, Inc.
Prostate Cancer
Clinical Validation of a Urinary Exosome Gene Signature in Men Presenting for Suspicion of Prostate Cancer
Validate a non-DRE exosome gene expression test, with an NPV >/= 90% certainty, will exclude the presence of high gleason grade/ score (>/=7) prostate cancer in a prostate needle biopsy.
- Trial name
- NCT02702856
- Testing
- ExoIntelliScore Prostate
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Exosome Diagnostics, Inc.
Genotyping Techniques
Spartan Cube CYP2C19 Method Comparison Study
The aim of the study is to demonstrate concordance (percent agreement) between results produced by the Spartan CYP2C19 system and bi-directional sequencing.
- Trial name
- NCT04473586
- Testing
- Spartan Cube CYP2C19 System
- Where
- Canada
- Volunteers
- 425 people, healthy volunteers welcome
- Sponsor
- Spartan Bioscience Inc.
Thoracic Cancer, Ovarian Cancer
Project CADENCE (CAncer Detected Early caN be CurEd)
With existing evidence showing the difference in miRNA expression levels between non-cancer and cancer groups, the investigators assume that levels of DNA methylation, RNA expression as well as protein concentration will also be…
- Conditions
- Thoracic Cancer, Ovarian Cancer, Liver Cancer, Prostate Cancer
- Trial name
- CADENCE (NCT05633342)
- Where
- Singapore
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- MiRXES Pte Ltd
Pleural Effusion, Lung Consolidation
Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study
This study is being conducted to collect image data and relevant clinical data from medical records of patients with suspicion of lung consolidation or pleural effusion.
- Trial name
- AI (NCT04891705)
- Testing
- Lung Ultrasound Scan
- Where
- 5 sites in United States
- Volunteers
- 554 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Asphyxia Neonatorum
Biomarkers And Neurological Outcome in Neonates 2
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their…
- Trial name
- BANON2 (NCT04714775)
- Where
- 13 sites in Germany, Turkey (Türkiye)
- Volunteers
- 500 people
- Sponsor
- InfanDx AG
Opioid-Related Disorders, Opiate Addiction
A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire
The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to identify opioid abuse and misuse behaviors among participants who have chronic pain which requires long-term opioid use.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- POMAQ (NCT02678507)
- Testing
- Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
- Volunteers
- 800 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Unipolar Depression
Validation of the Spanish Version of the Clinically Useful Depression Outcome Scale (CUDOS) Scale
The Clinically Useful Depression Outcome Scale (CUDOS) is a brief, self-administered instrument that not only evaluates depressive symptoms but also both functioning and quality of life.
- Trial name
- CUDOS (NCT01360307)
- Where
- 17 sites in Spain
- Volunteers
- 330 people
- Sponsor
- AstraZeneca
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
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
Breast Cancer
Validation of 70-gene MammaPrint Profile in Japanese Population
By using gene-expression profiling, Van't Veer and colleagues developed a 70-gene prognosis profile, MammaPrint, to identify breast cancer patients who are at low risk of developing distant metastases and therefore might safely…
- Trial name
- NCT00904566
- Where
- Japan
- Volunteers
- 102 people
- Sponsor
- Agendia
Fluid Intake in Athletes, Sweating Rate in Athletes
Validity of Smart Cap and Smart Sweat Patch
The main objectives are to determine the validity of a Smart Cap in measuring fluid intake during running and fitness exercise and the validity of a Smart Sweat Patch in measuring sweat rate and sweat chloride concentration…
- Conditions
- Fluid Intake in Athletes, Sweating Rate in Athletes, Sweat Chloride Concentration in Athletes
- Trial name
- NCT04920266
- Testing
- Smart Cap, running and fitness exercisers only, Sweat Patch, all subjects- running, fitness, cycling, Reference sweat patch, all subjects - running, fitness, cycling
- Where
- 3 sites in United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Surgery
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.
- Trial name
- NCT03123354
- Testing
- O3 regional oximeter sensor
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Masimo Corporation
Growth Hormone Deficiency
Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly probable adult growth hormone deficiency…
- Trial name
- NCT01060488
- Testing
- GHRH+Arg, GHRH+Arg, ITT, ITT, ITT, GHRH+Arg.
- Where
- France
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Atrial Fibrillation
Electrocardiogram Clinical Validation Study
The purpose of the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer…
- Trial name
- NCT04842123
- Testing
- Electrocardiogram
- Where
- 6 sites in United States
- Volunteers
- 568 people, healthy volunteers welcome
- Sponsor
- Garmin International
Myopia
Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses
The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.
- Trial name
- NCT05035017
- Testing
- Test Lens, Control Lens
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- CooperVision, Inc.
Non-invasive Blood Pressure
Non-Invasive Blood Pressure Monitor Accuracy in Neonatal Subjects
This study is being conducted to validate the accuracy of non-invasive blood pressure (NIBP) measurement technology from Mortara Instrument, Inc. (Milwaukee, Wisconsin, USA) and Zoe Medical, Inc.
- Trial name
- NCT02642198
- Testing
- Surveyor S12 and S19 patient monitor
- Where
- 2 sites in Italy
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Mortara Instrument
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
Fertility Risk
Sonograms Enable Looking Forward - Home Examinations Led by Providers Validation Study
To demonstrate that clear, interpretable quality images of the ovaries and uterus can be generated using a portable transvaginal ultrasound scanner in the home environment, and that those images are interpretable by physicians…
- Trial name
- SELF-HELP (NCT04687189)
- Testing
- Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Turtle Health, Inc.
Growth Hormone Deficiency With Pituitary Anomalies
Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency
The Macimorelin Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, 2-way crossover Trial.
- Trial name
- NCT02558829
- Testing
- Macimorelin, Insulin
- Where
- 27 sites in United States, Austria and 7 more
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- AEterna Zentaris