Clinical trials: System Validation
Drug Mechanism, Healthy
Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples - a Validation Study for a Novel Technique
The main objective is to assess whether a novel electrochemical tool is reliable in detecting concentration of paracetamol in fingerprick- , saline-, urine-, and serum samples. We will recruit 12 healthy volunteers aged 18-45.
- Trial name
- NCT04690673
- Testing
- Paracetamol, Paracetamol concentration measurements and lipidomic assessment
- Where
- Finland
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Johanna Kujala
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
Mild Cognitive Impairment, Dementia
Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)
The Self-Administered Gerocognitive Examination (SAGE) is a valid and reliable cognitive assessment tool used to identify both Mild Cognitive Impairment (MCI) and early dementia.
- Trial name
- eSAGE (NCT02544074)
- Testing
- neuropsychological testing, eSAGE testing
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Ohio State University
Flat Feet, High Arched Foot
Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System
The goal of this project is to validate a new non-invasive clinical imaging system to evaluate the efficacy of plantar orthotics and to assess the biomechanical efficiency of plantar orthotics for people with flat or high arch…
- Trial name
- NCT05163418
- Testing
- Foot orthosis for flat feet, Foot orthoses for high arches feet
- Where
- Canada
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- TOPMED
Asthma
Validation of the BREATHE Asthma Intervention Trial
The overall goal of this study to preliminarily validate a novel intervention delivered by primary care providers (PCPs) to their Black adult patients with uncontrolled asthma in federally qualified health centers (FQHCs).
- Trial name
- NCT03300752
- Testing
- BREATHE Intervention, Control Intervention
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Columbia University
Device Validation of In-vivo Performance
An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System
This is an in vivo 24-hour recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.
- Trial name
- NCT05239455
- Testing
- Reveos® Automated Blood Processing System
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Deglutition Disorders
Wearable Monitoring Systems for Swallowing Function and Disorders
Wearable tele-rehabilitation technology allows for the efficient provision of rehabilitation services from a distance, facilitating tele-management of many disorders.
- Trial name
- NCT04243577
- Testing
- Tele-EaT Sensors, Conventional Sensors
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Purdue University
Gastroenteritis
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.
- Trial name
- NCT05972733
- Testing
- HIL-214
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- HilleVax
Dementia, Alzheimer Disease
The Brain Health Study: A Pragmatic, Patient-Centered Trial
The eRADAR Brain Health Study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.
- Trial name
- NCT05356702
- Testing
- Brain Health Assessment
- Where
- 5 sites in United States
- Volunteers
- 3,417 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
Cerebral Palsy, Hemiplegic Cerebral Palsy
Dynamic Gait Index in Hemiplegic Cerebral Palsy
The purpose of this study is to assess validity and reliability of Dynamic Gait Index (DGI) in patients with unilateral spastic cerebral palsy
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy, Gait Disorders, Neurologic
- Trial name
- NCT03662139
- Testing
- Dynamic Gait Index
- Where
- Turkey (Türkiye)
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Marmara University
Obstructive Sleep Apnea
Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea
This study aims to determine the overall accuracy, sensitivity, and specificity of the Belun Ring device in evaluating obstructive sleep apnea by comparing the device to the attended overnight in-lab polysomnography which is the…
- Trial name
- NCT03997916
- Testing
- Belun Ring, PSG
- Where
- 2 sites in United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Dyspepsia
Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath test and scintigraphy in healthy subjects and subjects with dyspepsia.
- Trial name
- NCT01248221
- Testing
- [13C]-Spirulina platensis and 99mTc sulfur colloid
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
System Validation
Wetness Sensing System
The investigational product to be evaluated in this study is FitRight® ConnectTM Wetness Sensing System which includes: the FitRight® ConnectTM Pod, the FitRight® ConnectTM App, the FitRight® ConnectTM charger/adapter and the…
- Trial name
- NCT05454813
- Testing
- Wetness Sensing System Validation
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Medline Industries
Alzheimer's Disease, Amnestic Mild Cognitive Impairment
[18F]MK-6240 Positron Emission Tomography (PET) Tracer First-in-Human Validation Study (MK-6240-001)
This 2-part, open-label study was designed to investigate the safety, tolerability, and efficacy of [18F]MK-6240, a Positron Emission Tomography (PET) imaging agent, for the quantification of neurofibrillary tangle (NFT)…
- Trial name
- NCT02562989
- Testing
- [18F]MK-6240, ~185 MBq, [18F]MK-6240, ~160 MBq
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Sleep Apnea Syndromes, Sleep Disorder
WatchPAT Device Validation Study Compared to Polysomnography
Validation study of a novel sleep Device compared to a traditional sleep study.
- Conditions
- Sleep Apnea Syndromes, Sleep Disorder, Sleep
- Trial name
- WPAT (NCT03188718)
- Testing
- WatchPAT Intervention
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Hearing Loss
Clinical Validation of the Lexie Lumen Hearing Aid
More than half a billion people globally have hearing loss. Most hearing loss is sensorineural, meaning that the hearing loss is irreversible and requires rehabilitation.
- Trial name
- NCT05337748
- Testing
- Lexie Self Test and Fit Group, Lexie Professional Test and Fit Group
- Where
- South Africa
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- hearX Group
Alzheimer's Disease
[11C]MK-6884 Positron Emission Tomography (PET) Tracer Validation Trial (MK-6884-001)
The purpose of this open-label, 3-part study is to investigate the safety and efficacy of [11C]MK-6884 as a positron emission tomography (PET) imaging agent for quantifying muscarinic 4 (M4) positive allosteric modulator (PAM)…
- Trial name
- NCT02621606
- Testing
- [11C]MK-6884
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Liver Diseases
Magnetic Resonance Spectroscopy (MRS) Validation Study in Individuals With Nonalcoholic Fatty Liver Disease (NAFLD)
The purpose of this study is to see how effective the investigators' optimized magnetic resonance spectroscopy (MRS) sequence in quantifying hepatic triglyceride content (HTGC) to enhance MRS as a diagnostic tool in non-alcohol…
- Trial name
- NAFLD (NCT00940537)
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Sleep Disordered Breathing
User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application
This pilot study is intended to evaluate the acceptance and performance of the DreamMapper application and the Therapist Assist educational tool in naïve patients with Obstructive Sleep Apnea who have been prescribed Positive…
- Trial name
- NCT03748264
- Testing
- Standard of Care, DreamMapper Application, DreamMapper Application with Therapist Assist
- Where
- 5 sites in United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Philips Respironics
Colorectal Cancer, High Cholesterol
Online Trial Examining Validity of the Shared Decision Making Process Survey With Video Vignettes
This study will recruit subjects online and randomly assigned them to one of four arms. The arms vary by clinical decision (colorectal cancer screening or treatment of high cholesterol) by video order (poor shared decision making…
- Trial name
- NCT04317274
- Testing
- Good high cholesterol video, Poor high cholesterol video, Good colon cancer screening video
- Where
- United States
- Volunteers
- 401 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital