Clinical trials: Validation Studies
Breast Cancer
Case Collection Study for Collecting Images for the Development and Validation of Computer Aided Detection Software
The study objective is to assess the performance of the MammoDetector Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat Novation FFDM system compared to conventional film-screen mammography.
- Trial name
- NCT00756834
- Testing
- Screening
- Where
- United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions
Rheumatoid Arthritis
Tocilizumab Real-Life Human Factors (RLHFs) Validation Study
This study is designed to evaluate RLHFs concerning administration of the tocilizumab autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving subcutaneous (SC) tocilizumab using the commercially…
- Trial name
- NCT02682823
- Testing
- AI-1000 G2, Tocilizumab
- Where
- 8 sites in United States
- Volunteers
- 91 people
- Sponsor
- Hoffmann-La Roche
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
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
Alzheimer's Disease
Memantine and Validation of a New Alzheimer's Disease Scale
To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine.
- Trial name
- NCT00804271
- Testing
- memantine
- Where
- Germany
- Volunteers
- 487 people
- Sponsor
- Merz Pharmaceuticals GmbH
Epilepsy, Seizures
EpiCare@Home Validation Study for Focal Onset Seizures
The goal of this clinical trial is to validate a wearable seizure monitoring device, EpiCare@Home, as an objective seizure monitoring tool for people with focal onset epileptic seizures.
- Conditions
- Epilepsy, Seizures, Seizures, Focal, Seizure, Refractory
- Trial name
- NCT05738226
- Testing
- EpiCare@Home, wearable multimodal seizure monitoring system
- Where
- United States
- Sponsor
- Byteflies
ATTR-CM
A Retrospective Validation Study To Identify Chart-Based Clinical Diagnosis Of Wild-Type Transthyretin Amyloid Cardiomyopathy (Attrwt-CM) And Non-Amyloid Heart Failure Among Patients With Heart Failure (HF).
This is an observational, retrospective non-inferiority study with a study sample from a large national database. A machine learning (ML) model will use a national database to predict the clinical diagnosis of ATTRwt-CM among HF…
- Trial name
- NCT06029452
- Testing
- Machine learning algorithm
- Where
- United States
- Volunteers
- 558 people
- Sponsor
- Pfizer
Atopic Dermatitis
A Non-Drug Study Detecting And Quantifying Nocturnal Scratch Behaviors From Wrist Actigraphy Data In Adult Healthy Volunteers And Participants With Atopic Dermatitis (AD)
Sleep disturbance is very common in patients with atopic dermatitis (AD) and is a major factor leading to impaired quality of life. Nocturnal scratching is one of the factors causing sleep disturbance in AD patients.
- Trial name
- NCT04262791
- Testing
- Wrist Actigraphy Device, Sleep Headband
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AbbVie
Blood Pressure
Optical Blood Pressure Monitoring Via Mobile Application, 3 Arms Swiss Clinical Study
Validation of an existing algorithm designed to estimate blood pressure based on collected optical signals on patients against two reference methods, which are the arterial catheter (arm 1) and the ausculatory sphygmomanometer…
- Trial name
- OPTIBP (NCT03875248)
- Testing
- Blood pressure measurement
- Where
- 2 sites in Switzerland
- Volunteers
- 350 people
- Sponsor
- Biospectal
Cognitive Decline, Cognitive Deficit
Validation Study SCOBES-AR
Purpose of the study The purpose of this study is to evaluate five tests to see if they are suitable for the early detection of cognitive impairment in people over the age of 60.
- Conditions
- Cognitive Decline, Cognitive Deficit, Cognitive Impairment
- Trial name
- NCT04204239
- Where
- Austria
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- FH Joanneum Gesellschaft mbH
No History of ADHD, Attention Deficit Hyperactivity Disorder (ADHD)
An Investigational Study Examining the Cross-Validation of QbMobile in ADHD and Normative Populations
The purpose of this study is to investigate QbMobile ability to collect and provide accurate and objective data which can be used to facilitate assessment and treatment procedures for ADHD in a clinical setting as well as…
- Conditions
- No History of ADHD, Attention Deficit Hyperactivity Disorder (ADHD), Healthy Volunteer
- Trial name
- NCT07220330
- Testing
- QbMobile
- Where
- 3 sites in United States
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Qbtech AB
Presbyopia, Near Vision
Comparative Study and Validation of New Methodologies for Measuring Addition
The aim of this research is to collect comprehensive data on a presbyopic population that may require near vision correction, in order to identify the most useful tests to accurately determine the value of an addition.
- Conditions
- Presbyopia, Near Vision, Refraction Error
- Trial name
- NCT06963138
- Testing
- Visual Acuity, Objective refraction, Standard Subjective refraction
- Where
- France
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Essilor International
Pulmonary Disease, Chronic Obstructive
Shortness Of Breath Questionnaire Validation Study
This study will last for approximately 8 weeks and will involve 4 visits. The study is being carried out to validate a shortness of breath questionnaire
- Trial name
- NCT00411372
- Testing
- fluticasone propionate/salmeterol 250/50mcg combination, salmeterol 50mcg
- Sponsor
- GlaxoSmithKline
Device Performance, Healthy Adult Volunteers
SpO2 Validation Study - All.Health Algo Oximeter Software
The clinical use of pulse oximeters has reduced the frequency and necessity of invasive arterial blood sampling and has helped to improve patient safety by providing continuous information to clinicians about patients'…
- Trial name
- NCT07527000
- Testing
- No intervention (observational study)
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- All Health, Inc.
Cancer
a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Detection（PROFOUND）
This study is a multi-center, case-control study aiming at developing and blinded testing machine learning-based multiple cancers early detection model by prospectively collecting blood samples from newly diagnosed cancer…
- Trial name
- PROFOUND (NCT06217900)
- Where
- 8 sites in China
- Volunteers
- 16,666 people, healthy volunteers welcome
- Sponsor
- Shanghai Weihe Medical Laboratory Co., Ltd.
Respiration Rate, Monitoring, Physiologic
Respiratory Rate Validation Study
The goal of this clinical trial is to test how accurately a new chest-worn device called the Perin Health Patch measures breathing rate in adults aged 22 and older.
- Trial name
- NCT07147907
- Testing
- Chest Worn Respiratory Rate Monitor
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Perin Health Devices
Cancer Colonic
Clinical Validation of C-REX Device for Adaptive Anastomoses
In colorectal surgery, hand suturing and stapling are routine methods for performing intestinal anastomoses, and these methods appear to be similar in terms of clinical safety.
- Trial name
- C-REX (NCT04836676)
- Testing
- C-REX Device
- Where
- 5 sites in Sweden
- Volunteers
- 200 people
- Sponsor
- Carponovum AB
Pathology
Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
The primary objective of this study is to evaluate the safety and accuracy of the Hamamatsu WSI compared to those of the reference method (conventional light microscope (Glass)) under clinical use conditions as an aid for…
- Trial name
- NCT03991468
- Testing
- Whole Slide Imaging, Light Microscopy
- Where
- 4 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Hamamatsu Photonics K.K.
Endometriosis
Multicenter Validation of the Salivary miRNA Signature of Endometriosis
ENDOmiARN Salive Test is a multicentre external validation study of a salivary signature of endometriosis carried out in France in Obstetrics and Reproductive Medicine departments, in order to evaluate its performance and discuss…
- Trial name
- NCT05244668
- Where
- 18 sites in Canada, France
- Volunteers
- 1,140 people
- Sponsor
- ZIWIG
Blood Pressure
Polso™ Watch Blood Pressure Accuracy With Blood Pressure Change Validation
Up to 185 adult test subjects to evaluate blood pressure measurement accuracy and stability of the Polso™ Watch compared to a reference blood pressure measurement.
- Trial name
- BP (NCT05735210)
- Testing
- Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement
- Where
- Germany
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- ChroniSense Medical Ltd.