Clinical trials: VALİDİTY
Breast Pumping
Clinical Validation of the Ameda Pearl - An Electric, Hospital Grade, Multi-User Breast Pump
This study introduces a new Ameda electric multi-user, hospital-grade breast pump, the Ameda Pearl, to mothers who choose to exclusively breast pump until their infants are able to breastfeed.
- Trial name
- NCT05297799
- Testing
- Ameda Pearl breast pump
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ameda, Inc.
Allergic Rhinitis, Rhinoconjunctivitis
Red Maple Trials Cat Allergen Natural Exposure Chamber Validation in Cat-allergic Subjects
To assess the reproducibility of the allergic response in the cat allergic subjects, measured as the change from baseline of the Total Nasal Symptom Score (TNSS) on the two challenge days.
- Conditions
- Allergic Rhinitis, Rhinoconjunctivitis, Exposure
- Trial name
- NEC (NCT03414801)
- Testing
- Allergen Exposure
- Where
- Canada
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Red Maple Trials Inc.
Severe Sepsis
Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis
Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing.
- Trial name
- NCT05048927
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Bluejay Diagnostics, Inc.
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
Stroke
Validation of Sensitivity and Specificity of a Multi-Omic Precision Diagnostic for Acute Stroke Evaluation
Valtari Bio has early proof of concept clinical data of a multi-omic peripheral blood biomarker profile that can be used to determine stroke from no stroke in the emergency setting.
- Trial name
- VALISS (NCT02753257)
- Testing
- Non-Interventional
- Where
- 2 sites in United States
- Volunteers
- 500 people
- Sponsor
- Valtari Bio
Breast Cancer, Early Breast Cancer
Independent, External, Blinded Retrospective Validation of an AI-based Prognostic Assay in ER-Positive/HER2-Negative Early Breast Cancer
This retrospective observational study evaluates the prognostic performance of a locked Artificial Intelligence (AI)-based assay in patients with Estrogen Receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2…
- Conditions
- Breast Cancer, Early Breast Cancer, ER-Positive HER2-Negative Breast Cancer
- Trial name
- NCT07541703
- Testing
- Locked AI-based prognostic assay
- Where
- Austria
- Volunteers
- 2,200 people
- Sponsor
- Spotlight Medical
Performance and Safety
Clinical Study of CT 5400 RT for System Validation
The purpose of this clinical trial is to evaluate the efficacy and safety of the CT 5400 RT System.
- Trial name
- NCT06466577
- Testing
- CT 5400 RT System
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Gambling Addiction
Validation of Kaihani Score for Gambling Addiction
The Kaihani Score is a blood based means of assessing molecules believed to be associated with gambling addiction. The current clinical trial will assess the Kaihani Score in 3 groups: Group 1: 10 patients with no personal or…
- Trial name
- NCT04648007
- Testing
- Kaihani Score
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Therapeutic Solutions International
Stroke, Gait Disorders, Neurologic
REEV SENSE for Gait Analysis in Post-stroke Gait Impairment (SENS-AG)
The purpose of this study is to evaluate the clinical performance of the investigational REEV SENSE gait tracker to measure gait features in subjects with post-stroke gait impairment.
- Trial name
- SENS-AG (NCT06234878)
- Testing
- REEV SENSE, Motion capture system
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- REEV LLC
Chronic Kidney Diseases, Protein-Energy Malnutrition
Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
Patients whit chronic kidney disease (CKD) there is a high prevalence of nutritional disorders and negative changes in body composition, which is strongly associated with an increased risk of morbidity and mortality.
- Trial name
- NCT06576479
- Testing
- Nutritious Shake, Nutritional counseling
- Where
- Mexico
- Volunteers
- 50 people
- Sponsor
- NIN Institute
OSA
Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device
This is a pre-marketing, single-centre, prospective clinical trial with the aim of comparison the effectiveness and safety of the SOUNDI medical device compared to polysomnography in detecting parameters for the diagnosis of…
- Trial name
- SOUNDI (NCT06320795)
- Testing
- SOUNDI
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Biocubica srl
Urinary Tract Infection Complicated, Urinary Tract Infection (cUTI)
Clinical Utility of a PCR Compared to Culture and Sensitivity Testing for the Management of cUTI in Adults.
Complicated urinary tract infections (cUTIs) often lead to the overuse of empiric antibiotics, risking inappropriate treatment and contributing to antimicrobial resistance.
- Conditions
- Urinary Tract Infection Complicated, Urinary Tract Infection (cUTI), Urinary Tract Infection (Diagnosis)
- Trial name
- PCR (NCT06996301)
- Testing
- Treatment guided by the PCR results, Treatment guided by the C&S results
- Where
- 6 sites in United States
- Volunteers
- 773 people
- Sponsor
- Doc Lab Inc
Atopic Dermatitis, Pruritus
Observational Analytical Validation Study of the Replior ScratchSense
Nocturnal scratching is a frequent and meaningful symptom in dermatological conditions such as atopic dermatitis. It may reflect underlying disease activity and can substantially disrupt overall sleep and quality of life.
- Conditions
- Atopic Dermatitis, Pruritus, Chronic Pruritus of Unknown Origin
- Trial name
- NCT07909967
- Testing
- Scratch and sleep research tracking
- Where
- France
- Volunteers
- 35 people
- Sponsor
- Replior AB
Healthy
Desaturation Validation of INVSENSOR00028
This study is designed to measure the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation. Two large sensors (adult sensors) will be placed on the subject's forehead.
- Trial name
- NCT03704636
- Testing
- INVSENSOR00028
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Apnea, Restless Legs Syndrome
Validation Study for an Unobtrusive Online Sleep Measurement System
The purpose of the study is to determine the precision of an unobtrusive sleep measurement system. The system measures a force sensor signal under the mattress and analyzes sleep quality.
- Conditions
- Apnea, Restless Legs Syndrome, Sleep Fragmentation
- Trial name
- NCT01633151
- Where
- Finland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Beddit.com Ltd
Atrial Fibrillation
Withings ECG-Monitor Study
The aim of the study is to evaluate the performance of Withings WBS08 with embedded Withings ECG Monitor in the automatic detection of atrial fibrillation
- Trial name
- NCT05316337
- Testing
- Electrocardiogram recording
- Where
- 10 sites in United States, France
- Volunteers
- 650 people
- Sponsor
- Withings
Amputation
Hand Prosthesis Usability and Performance
This study asks individuals with upper limb absence to use a new hand prosthesis, and compare it's performance to their own hand prosthesis
- Trial name
- NCT07915700
- Testing
- Prototype hand prosthesis, Baseline Comparator Device
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Össur Iceland ehf
Obstructive Sleep Apnea
Patient Perception Questionnaire Validation
Validation of the patient perception questionnaire relating to CPAP use
- Trial name
- NCT02067000
- Testing
- Obstructive Sleep Apnea
- Where
- United States
- Volunteers
- 217 people
- Sponsor
- Fisher and Paykel Healthcare
Clinical Accuracy of Vital Sign Pressure Sensor
V-Sensors for Vitals: Assessment of the Accuracy of a Vital Sign Sensor Mounted on a Smartphone
This trial seeks to demonstrate clinical accuracy and safety of the integrated V-Sensor when used by the general, healthy adult population interested in measuring their vital signs outside of the clinical setting.
- Trial name
- NCT03321851
- Testing
- V-sensor device user
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Léman Micro Devices SA
Cow Milk Allergy
Symptoms Based Awareness Confirmation Study - CoMiSS Validation
The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to recognize cow's milk related symptoms in infants and young children.
- Trial name
- MOSAIC (NCT03004729)
- Testing
- CoMiSS questionnaire
- Where
- 10 sites in China
- Volunteers
- 300 people
- Sponsor
- Société des Produits Nestlé (SPN)