Clinical trials: System Validation
Pancreatic Cancer
GTX-RT in Borderline Resectable Pancreatic Cancer
The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at participant's tumor followed by more…
- Trial name
- NCT01754623
- Testing
- Capecitabine, Gemcitabine, Docetaxel
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Obstructive Sleep Apnea
Adherence Risk Indicator Validation Study
While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally.
- Trial name
- ARI (NCT02230085)
- Testing
- Administration of the questionnaire and monitoring of CPAP adherence
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Fisher and Paykel Healthcare
Coronary Artery Disease, Coronary Stenosis
FUnctional diagnoSIs of corONary Stenosis (FUSION)
The purpose of the FUSION study is to validate the diagnostic performance of Virtual Flow Reserve (VFR) by comparing it against a reference standard, fractional flow reserve (FFR).
- Trial name
- FUSION (NCT04356027)
- Testing
- ICA (Invasive Coronary Angiography), OCT, FFR
- Where
- 28 sites in United States
- Volunteers
- 312 people
- Sponsor
- Abbott Medical Devices
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
Sleep Apnea
Clinical Validation of New Commercial Sleep Monitoring Devices
This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), which is considered the gold standard for sleep…
- Trial name
- NCT02779543
- Testing
- Fitbit, Jawbone UP, Microsoft Band
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Weill Medical College of Cornell University
Cardiac Catheterization
Validation of Brain Oxygenation Monitor on Pediatric Patients
The aim of this study is calibrate (adjust and tune) the CAS FORE-SIGHT Near-Infrared Spectroscopy (NIRS) monitor when used to measure the tissue oxygen saturation of internal organs (StO2).
- Trial name
- NCT00849940
- Testing
- CAS NIRS FORE-SIGHT oximeter
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Duke 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
Cerebrovascular Disorders, Deglutition Disorders
Stroke Swallowing Screening Tool Validation
Stroke is a major medical problem in the United States, and veterans are at significant risk given that the most critical risk factors of stroke, older age and associated medical problems such as high blood pressure, are common.
- Trial name
- SSST (NCT01559649)
- Testing
- Establishing Validity and Reliability
- Where
- United States
- Volunteers
- 284 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Device Validation of In-vivo Performance
Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study
This is an in vivo 24-hour in-vivo recovery study of leukoreduced red blood cells (RBCs) collected on the Trima Accel System using Non-DEHP disposable sets and stored for 42 days.
- Trial name
- NCT06602804
- Testing
- Trima Accel Auto RBC Collection
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Sleep Apnea, Obstructive, Sleep Apnea, Central
DreamKit Diagnostic Validation
This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography.
- Trial name
- NCT04671342
- Testing
- DreamKit
- Where
- 7 sites in United States
- Volunteers
- 306 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Breast Cancer, Colorectal Cancer
Validation of a Screening Tool in Geriatric Oncology
RATIONALE: A screening questionnaire may help doctors plan better treatment for older patients with cancer. PURPOSE: This clinical trial is studying a questionnaire in screening older patients with cancer.
- Conditions
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Lung Cancer
- Trial name
- ONCODAGE (NCT00963911)
- Testing
- Geriatric screening tests, Multidimensional geriatric assessment
- Where
- France
- Volunteers
- 1,674 people
- Sponsor
- Institut Bergonié
Obstructive Sleep Apnea
Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating…
- Trial name
- NCT00354614
- Testing
- ApneaLink Sleep Screener
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
PMP-300E (Smart Watch): Portable Monitoring Device Study
Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.
- Trial name
- PMP-300E (NCT01364740)
- Testing
- PMP-300E, In-lab PSG
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Stanford University
Type 1 Diabetes
Pancreatic Islet Cell Transplantation
The purpose of this study is to assess a novel approach to immunosuppression in allogenic pancreatic islet cell transplant recipients.
- Trial name
- NCT00214786
- Testing
- Islet cell transplantation
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Baylor Research Institute
Pain, Acute, Pain, Chronic
Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries
This study will test the effectiveness of an evidence-based, multi-modal, "digital pain-reduction kit" as a non-pharmacological supplement to managing patients with pain due to musculoskeletal injuries.
- Trial name
- NCT03187132
- Testing
- Digital Pain Reduction Kit, Active Control
- Where
- United States
- Volunteers
- 245 people
- Sponsor
- Cedars-Sinai Medical Center
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
Spinal Cord Injuries
Extending Veteran Participation in the Validation of the SCI-QOL/CAT
The field of spinal cord injury rehabilitation medicine lacks a reliable, patient reported, health-related quality of life measurement tool.
- Trial name
- NCT01238549
- Where
- 2 sites in United States
- Volunteers
- 284 people
- Sponsor
- VA Office of Research and Development
Idiopathic Growth Hormone Deficiency, Turner Syndrome
First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study
PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to confirm that some genes can be used to predict how well a subject diagnosed with idiopathic growth hormone deficiency (IGHD) or turner…
- Trial name
- NCT01419249
- Testing
- Blood sampling
- Where
- 31 sites in Argentina, Canada and 7 more
- Volunteers
- 458 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Autism
Validation of Indiana's Early Evaluation Hub System
The investigators' objective is to test an innovative method of autism diagnosis that integrates clinical evaluation and assessment of biobehavioral markers in a large high-risk community-referral sample of children in the…
- Trial name
- EAER21 (NCT06586788)
- Testing
- Eyelink Portable Duo, Integrated PCP Diagnosis and Eye-tracking Biomarker
- Where
- 7 sites in United States
- Volunteers
- 154 people
- Sponsor
- Indiana University