Clinical trials: Validation Studies
ESRD, Extracellular Fluid Alteration
Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration
This study is an open label randomized clinical trial that comparing intradialytic blood pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid management of maintenance hemodialysis patients.
- Conditions
- ESRD, Extracellular Fluid Alteration, Hypertension
- Trial name
- IBPS (NCT03303391)
- Testing
- Intradialytic Blood Pressure Slope Based Ultrafiltration
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of Texas Southwestern Medical Center
Dietary Habits
PortionSize Study 1 Laboratory-based Evaluation)
The objective is to test the accuracy and user satisfaction of the PortionSize™ app and the MyFitnessPal© app during laboratory controlled test meals.
- Trial name
- NCT04700904
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
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
Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery
Assisted Fluid Management IDE Study
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.
- Conditions
- Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery, Pelvic Surgery, Major Peripheral Vascular Surgery
- Trial name
- AFM (NCT03469570)
- Testing
- EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature
- Where
- 10 sites in United States
- Volunteers
- 330 people
- Sponsor
- Edwards Lifesciences
Substance Use Disorder
The Tobacco, Alcohol, Prescription Medication and Other Substances Tool
The purpose of the study is to develop and validate a questionnaire to screen and assess adult primary care patients for tobacco, alcohol, prescription drug, and drug use and problems related to their use.
- Trial name
- CTN0059 (NCT02110693)
- Testing
- Interviewer and tablet administration of the TAPS Tool
- Where
- 4 sites in United States
- Volunteers
- 2,057 people, healthy volunteers welcome
- Sponsor
- Friends Research Institute, Inc.
Newborn Jaundice
BiliCam Clinical Validation Study
The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based on analysis of digital images obtained with an app installed on a commercial smartphone, in estimating total serum bilirubin levels in…
- Trial name
- NCT03246503
- Testing
- BiliCam estimated bilirubin (BCB)
- Where
- United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- BiliCam, LLC
Proof Of Concept Study
Measuring Hydrogen Peroxide in Exhaled Breath Condensate in HV
The purpose of this study is to evaluate the performance of an Exhaled Breath Condensate (EBC) device. EBC measurements can be used for the assessments of lung inflammation in asthma and chronic obstructive pulmonary disease…
- Trial name
- NCT05844553
- Testing
- Measurement of inhaled measuring hydrogen peroxide in exhaled breath
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Cystic Fibrosis
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
- Trial name
- NCT03502070
- Testing
- Tobi Podhaler
- Where
- 9 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mylan Inc.
Chronic Angina
An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Female-specific Angina Questionnaire in Women With Chronic Angina Treated With Ranolazine Extended-release Tablets (CVT 3041)
According to the American Heart Association (AHA) 2011 update of heart disease and stroke statistics, more than 9 million adult patients in the United States (US) have angina.
- Trial name
- NCT00644332
- Testing
- Ranolazine
- Where
- 29 sites in United States
- Volunteers
- 172 people
- Sponsor
- Gilead Sciences
Fertility
Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator
The purpose of this study is to evaluate the safety and efficacy of the MIRI-TL time-lapse incubator and CultureCoin dish compared to standard big-box incubators and standard culture dishes used for embryo culture.
- Trial name
- TiMMI (NCT02852356)
- Testing
- MIRI-TL Incubator
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Ovation Fertility
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
Liver Cancer
Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
The goal of this clinical research study is to test the accuracy of magnetic resonance elastogram (MRE) and 2-point dixon magnetic resonance imaging (2PD MRI) using new computer software (called "phase correction algorithm") in…
- Trial name
- NCT00543777
- Testing
- Magnetic Resonance Elastogram, 2-Point Dixon Magnetic Resonance Imaging
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- M.D. Anderson Cancer Center
Healthy
A Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study
The purpose of the research study is (1) to rate the taste, texture, appearance, and mixability of 2 different doses of orange flavored cholestyramine compared to orange flavored Tang, (2) rank the importance of the taste…
- Trial name
- NCT01062269
- Testing
- Cholestyramine, Tang
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Louisville Metabolic and Atherosclerosis Research Center
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
Vascular Diseases
X-ray Dose Reduction Study for Cardiac Angiography and Intervention
ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly.
- Trial name
- NCT01684826
- Testing
- Angiographic run with new algorithm and low dose (50% dose), Angiographic run with predecessor algorithm and dose (100%)
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Healthy
Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073
The aim of the study is to validate the Mean Arterial Pressure (MAP) parameter of Masimo INVSENSOR00073 against the gold standard blood pressure measurements from the arterial line while subject undergo a blood pressure variation…
- Trial name
- NCT06334055
- Testing
- Masimo INVSENSOR00073
- Where
- United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Hypoxia
In Vivo Pulse Oximeter Validation Study
The goal of this clinical trial is to compare values of SpO2 provided by the DUT and the SaO2 used as a reference in healthy adults.
- Trial name
- NCT05873335
- Testing
- Mixtures of nitrogen, air, and carbon dioxide
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
Bipolar Disorder I or II
Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine
A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.
- Trial name
- NCT00259272
- Testing
- olanzapine
- Where
- 16 sites in France
- Volunteers
- 141 people
- Sponsor
- Eli Lilly and Company
Lymphoma, Non-Hodgkin
Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies
Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry, dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients with low-grade or transformed low-grade…
- Trial name
- RIT-II-001 (NCT01224821)
- Testing
- Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab
- Volunteers
- 47 people
- Sponsor
- GlaxoSmithKline
Ventricular Tachyarrhythmias
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system.
- Trial name
- Chronic II (NCT00853645)
- Testing
- Subcutaneous Implantable Defibrillator (S-ICD) System
- Where
- 2 sites in New Zealand
- Volunteers
- 6 people
- Sponsor
- Boston Scientific Corporation