Clinical trials: Validation Studies
Cardiac Arrhythmia
Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II
This trial assesses the wear performance of the Zio monitor, a long-term continuous ambulatory patch ECG monitor, in a representative population by evaluating (1) the wear duration (up to 30 days) of the device, (2) the…
- Trial name
- NCT07205367
- Testing
- Zio Monitor
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- iRhythm Technologies, Inc.
Bipolar Disorder
Imaging 5HT7 Antagonist Effects in Bipolar Disorder
The main aim of this research is to examine the potential of 5HT7 antagonists for the treatment of cognitive impairment in bipolar disorder by determining the effect of the 5HT7 antagonist JNJ-18038683 on cognitive and emotional…
- Trial name
- NCT03633357
- Testing
- JNJ-18038683
- Where
- United Kingdom
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- King's College London
Gastric Cancer
Gastric Cancer Early Detection by Multi-dimensional Analysis of cfDNA
To facilitate the early gastric cancer diagnosis, an assay based on assessing large-scale methylation and fragmentation profiles of the plasma cell free (cfDNA) will be developed and validated.
- Trial name
- NCT05668910
- Testing
- whole genomic methylation and fragmentation profile analysis of cfDNA
- Where
- China
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- GeneCast Biotechnology Co., Ltd.
Alzheimer Disease, Mild Cognitive Impairment
Optina Diagnostics' Cerebral ß-Amyloid Status (CAS) Test
This observational, cross-sectional study is designed to validate a novel diagnostic test for the detection of phenotypic changes in the retina that correlate with likely PET amyloid status (negative or positive), to aid in the…
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Mild Dementia
- Trial name
- REPHRASE (NCT05107882)
- Where
- 7 sites in United States, Canada
- Volunteers
- 466 people, healthy volunteers welcome
- Sponsor
- Optina Diagnostics Inc.
Lower Respiratory Tract Infection, Acute Bronchitis
Evaluating a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Patients With Lower Respiratory Tract Infection (LRTI)
The purpose of this study is to validate the diagnostic accuracy of a novel host-response based diagnostic tool for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical…
- Conditions
- Lower Respiratory Tract Infection, Acute Bronchitis, Pneumonia, Chronic Obstructive Pulmonary Disease (COPD)
- Trial name
- OBSERVER (NCT03011515)
- Where
- Israel
- Volunteers
- 583 people, healthy volunteers welcome
- Sponsor
- MeMed Diagnostics Ltd.
Sweat Rate, Heat Effect
Time Onset Sweat Sodium (TOSS) Study
Prior to each trial, you will be provided with urine jugs and food/fluid logs to record food and drink intake for 24hr. You will be asked to log food/fluid intake 24hr leading into trials.
- Conditions
- Sweat Rate, Heat Effect, Sweat Sodium Concentration
- Trial name
- TOSS (NCT07464743)
- Testing
- Exercise in the heat
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Arkansas, Fayetteville
Breast Cancer
Multicentric Study for External Validation of a Deep Learning Model for Mammographic Breast Density Categorization
The correct categorization of breast density is essential to adapt the diagnostic examination to the needs of each patient. Assessment of breast density is performed visually by radiologists.
- Trial name
- NCT05021055
- Volunteers
- 277 people, healthy volunteers welcome
- Sponsor
- Hospital Italiano de Buenos Aires
Alzheimer Disease, Subjective Cognitive Decline
German Validation Study of the Subjective Cognitive Decline Questionnaire (SCD-Q)
The SCD-Q (Subjective Cognitive Decline-Questionnaire) is an established instrument to quantify self-perceived cognitive decline. Both self- and informant-rated versions of the SCD-Q are available.
- Trial name
- NCT06711952
- Testing
- Subjective Cognitive Decline-Questionnaire (SCD-Q), Cognitive Failure Questionnaire (CFQ), biomarkers
- Where
- Germany
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Ludwig-Maximilians - University of Munich
Pneumococcal Disease, Invasive, Pneumococcal Disease
Serum Collection Study for Assay Development
The study will collect serum from 12 participants vaccinated with Gamma-PN to assist with assay development and validation
- Trial name
- NCT07205289
- Testing
- Gamma-PN
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GPN Vaccines
Functional Movement Disorders, Reproducibility of Results
Aspects of Validity of the Single Leg Squat Test: A Cohort Study of Female Soccer Players.
Movement screening tests to identify deficits or poor movement quality is commonly used in soccer and other sports to assess injury, to evaluate rehabilitation goals and return to sport after injury.
- Conditions
- Functional Movement Disorders, Reproducibility of Results, Sports Medicine
- Trial name
- NCT05289284
- Testing
- No intervention
- Where
- Sweden
- Volunteers
- 269 people, healthy volunteers welcome
- Sponsor
- Karolinska Institutet
Adolescent Mental Health, Adolescent - Emotional Problem
A Validation Study of the Neuro-cognitive Emotion Monitoring-Intervention (NEMO-I) Application in Adolescents
This study aims to evaluate the validity and effectiveness of NEMO-I (Neuro-cognitive Emotion Monitoring-Intervention), a mobile application designed to help adolescents monitor and manage their cognitive and emotional…
- Conditions
- Adolescent Mental Health, Adolescent - Emotional Problem, Cognition Improvement
- Trial name
- NCT07700264
- Testing
- NEMO-I (Neuro-cognitive Emotion Monitoring-Intervention)
- Where
- South Korea
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Seoul Women's University
Pregnancy Related, Pre-Eclampsia
CONNEQT Pulse Validation Study
The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmomanometer in a pregnant…
- Conditions
- Pregnancy Related, Pre-Eclampsia, Gestational Hypertension
- Trial name
- NCT06002971
- Testing
- Blood pressure measurement
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Mount Carmel Health System
Hypertension
Lifelight Non-Invasive Blood Pressure and Heart Rate Validation Study
Lifelight is a novel, calibration-free, software-only medical device that contactlessly measures pulse rate and blood pressure by measuring remote photoplethysmography (rPPG) signals of a patient's face using a standard…
- Trial name
- NCT06535152
- Testing
- Lifelight, Manual sphygmomanometer
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Xim Limited
Sarcopenia, Old Age; Debility
Study of the Validity and Reliability of Two Digital Dynamometers in Older People
It is a cross-sectional, randomized, and single-center study with a duration of 6 months. The study will follow the STROBE guidelines for cross-sectional studies and CONSORT 2024.
- Conditions
- Sarcopenia, Old Age; Debility, Frailty
- Trial name
- SOVARDDIOP (NCT06623019)
- Testing
- Validation and reliability
- Where
- Spain
- Volunteers
- 413 people, healthy volunteers welcome
- Sponsor
- University of Salamanca
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.
Neck Pain, Pain Knowledge
Reliability of the Neurophysiology of Pain Questionnaire in the Neck Pain the Cross-validation Study
The aim of this study is to study the validity and reliability of the Modified Pain Neurophysiology Questionnaire in patients with neck pain.
- Trial name
- NCT05606666
- Testing
- reliability of the NPQ
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Istanbul Arel University
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
Complete Blood Count Review
Multi-center Validation Study of a Large Language Model-based Intelligent Agent for Blood Cell Analysis
I. Study Background: Currently, in most medical institutions, the review of blood cell analysis still heavily relies on manual verification by laboratory staff.
- Trial name
- NCT07607184
- Testing
- LLM-Assisted Review Group
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Huashan Hospital
Renal Insufficiency, Chronic, Kidney Diseases
Validation of New Markers of Glomerular Filtration Rate: Dota Gadolinium and Calcium EDTA (MultiGFR)
The purpose of this study is to validate in comparison to a reference method (inuline) two novel non-radioactive biomarkers for glomerular filtration rate (GFR) measurement in chronic-kidney disease (CKD) patients and in healthy…
- Trial name
- MultiGFR (NCT02286258)
- Testing
- Calcium EDTA, Gd-DOTA
- Where
- 4 sites in France
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Biofilm
Dentures Biofilm and Artificial Biofilm Substitute
The biofilm on oral surfaces can lead to oral diseases. The correlation between oral biofilm and diseases and general health is well known.
- Trial name
- KÜBI (NCT04247438)
- Testing
- 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it.
- Where
- Germany
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Technische Universität Dresden