Clinical trials: VALİDİTY
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.
G6PD Deficiency
Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US
The primary objective of this study is to assess the accuracy of the SD Biosensor STANDARD G6PD Analyzer in measuring G6PD activity when used by trained health care workers.
- Trial name
- NCT04010695
- Testing
- SD Biosensor G6PD Analyzer, Pointe Scientific Test Kit, HemoCue System
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- PATH
Cardiovascular Diseases, Blood Pressure
VicorderCS NIBP Validation Study to Review The Ability to Capture Blood Pressure Measurements
80 Beats Medical introduces the VicorderCS, the next generation of our Vicorder technology designed to manage hypertension and cardiovascular risks.
- Conditions
- Cardiovascular Diseases, Blood Pressure, Hypertension
- Trial name
- NCT06560034
- Testing
- VicorderCS
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- 80 Beats Medical
Hearing Loss
Littlears Auditory Questionnaire: Validation Study in CI Children
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years.
- Trial name
- LittlEars (NCT00785707)
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Med-El Corporation
Chronic Urticaria
The Validity, Reliability and Interpretability of Thai-version of Chronic Urticaria Quality of Life Questionnaire
In the majority of patients with the chronic urticaria, the etiology is unclear, leading to difficulties in treatment and high rates of recurrence.
- Trial name
- CU-Q2oL (NCT02285023)
- Testing
- CU-Q2oL
- Where
- Thailand
- Volunteers
- 166 people
- Sponsor
- Mahidol University
Post Partum Hemorrhage, Blood Loss
Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial
This study will be a prospective cohort study. Patients who meet criteria for inclusion in the study will be approached for participation at same day of admission.
- Conditions
- Post Partum Hemorrhage, Blood Loss, Vaginal Bleeding, Vaginal Delivery
- Trial name
- ELUSIVE (NCT04277962)
- Testing
- Triton L and D system for estimation of blood loss at time of vaginal delivery
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Heart Failure
Clinical Validation Study for CPM Device
This study is designed to be a clinical validation study to ready the CPM System for FDA 510(k) submission. This study will be conducted as a prospective non-randomized.
- Trial name
- NCT05445206
- Testing
- CardioPulmonary Management Device (CPM)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Analog Device, Inc.
Type 2 Diabetes
Validation Study for the Alertgy Non-invasive Continuous Glucose Monitor (ANICGM)
Diabetes mellitus (DM) affects 30 million people in the United States. To achieve glucose control, most patients are prescribed glucose meters by their physicians.
- Trial name
- NCT04166032
- Testing
- Alertgy non-invasive continuous glucose monitoring device (ANICGM)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- The Cleveland Clinic
Inflammatory Bowel Disease, Perianal Fistula
Perianal Fistula (PAF) Validation and Burden of Illness Study
The purpose of this study is to gain a better understanding of the disease burden and unmet need of perianal fistulas within Crohn's disease (CD) in Ontario.
- Conditions
- Inflammatory Bowel Disease, Perianal Fistula, Crohns Disease
- Trial name
- NCT03981939
- Testing
- No intervention
- Where
- Canada
- Volunteers
- 3,032 people
- Sponsor
- Takeda
Stroke, Acute Ischemic Stroke
Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
This study is a multi-center, multi-phase, multi-cohort, prospective, randomized, open, blinded endpoint (PROBE), non-significant risk (NSR) device study including up to 420 evaluable subjects measured with the study device(s)…
- Trial name
- VOICE (NCT05547412)
- Testing
- NovaGuide 2 Intelligent Ultrasound System
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- NeuraSignal Inc dba NovaSignal
Bipolar Disorder, Alcoholism
Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder
The purpose of this study is determine whether the use of topiramate is effective in the treatment of alcohol dependence (i.e. decreases drinking) in patients with bipolar disorder.
- Conditions
- Bipolar Disorder, Alcoholism, Alcohol Dependence
- Trial name
- NCT00572117
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stanford University
Heart Failure
LifeVest Trends Validation Protocol
This study will evaluate the accuracy of data on body position, daily activity, heart rate, 6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator (WCD).
- Trial name
- TRENDS (NCT02149290)
- Testing
- Trends-equipped LifeVest 4000
- Where
- 21 sites in United States, Austria and 1 more
- Volunteers
- 198 people
- Sponsor
- Zoll Medical Corporation
Sleep Apnea
A Validation Study of the NightOwl PAT-based 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
- NCT04191668
- Testing
- NightOwl
- Where
- 3 sites in United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
Diabetes Mellitus
Continuous Glucose Monitoring in the Intensive Care Unit
The aim of the proposed clinical trial is to study the use of the Dexcom G7 continuous glucose monitor (CGM) within the intensive care unit (ICU) environment.
- Trial name
- NCT06190808
- Testing
- Dexcom G7 Continuous Glucose Monitor
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of Massachusetts, Worcester
Drug-induced QT Prolongation, Pharmacokinetics
CiPA Phase 1 ECG Biomarker Validation Study
This study will assess whether exposure response analysis of the electrocardiographic QTc and J-Tpeakc intervals in Phase 1 clinical pharmacology studies can be used to confirm that drugs that predominantly block the potassium…
- Conditions
- Drug-induced QT Prolongation, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT03070470
- Testing
- Ranolazine, Verapamil, Lopinavir / Ritonavir
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
This is a Pilot Study Which Aims to Assess the Validity and Applicability of Lateral Flow Assays (LFAs) Which Can be Used as a Point of Care Test for COVID-19, Covid19
The LAVA (Lateral Flow Antigen Validation and Applicability) Study for COVID-19
This is a pilot study which aims to assess the validity and applicability of lateral flow assays (LFAs) which can be used as a point of care test for COVID-19.
- Trial name
- LAVA (NCT04629157)
- Testing
- Innova Lateral Flow Device
- Where
- 2 sites in United Kingdom
- Volunteers
- 400 people
- Sponsor
- Alder Hey Children's NHS Foundation Trust
Eating Behavior
Development and Validation of a Brief Food Noise Questionnaire
The purpose of the research is to develop and test the reliability and validity of a brief questionnaire to measure food noise.
- Trial name
- NCT06315907
- Testing
- Responses to survey questions
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Cardiopulmonary Disease
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
The ADI At-Home CPM (Cardiopulmonary Management) System is a non-invasive device that measures and trends a variety of biological parameters.
- Trial name
- NCT04865640
- Testing
- Noninterventional and noninvasive
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Analog Device, Inc.
Dietary Habits
PortionSize Study 2 Free-Living Evaluation
The objective is to test the accuracy of the PortionSize™ app and the MyFitnessPal© app at measuring energy and nutrient intake in free-living conditions.
- Trial name
- NCT05166226
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Sleep Apnea Central, Cheyne-Stokes Respiration
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy of the continuous positive airway pressure (CPAP) device compared to simultaneous, attended clinical polysomnography (PSG) in identifying…
- Conditions
- Sleep Apnea Central, Cheyne-Stokes Respiration, Obstructive Sleep Apnea
- Trial name
- NCT01175031
- Testing
- Manipulation of Positive Airway Pressure (PAP)
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Philips Respironics