Clinical trials: System Validation
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
GERD, Acid Reflux Disease
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).
- Conditions
- GERD, Acid Reflux Disease, Heartburn, Regurgitation
- Trial name
- C27 (NCT00703534)
- Testing
- AZD3355, Gelusil®
- Where
- 84 sites in United States
- Volunteers
- 478 people
- Sponsor
- AstraZeneca
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
Skin Diseases, Skin Condition
Clinical Validation of AI-Based System for Continuous Remote Monitoring of Patient Severity - Experts' Opinion
The goal of this observational study is to learn if an artificial intelligence (AI) tool, called Legit Health Plus, can track the severity of chronic skin conditions from a distance.
- Trial name
- COVIDX_EVCDAO (NCT06237036)
- Where
- Spain
- Volunteers
- 160 people
- Sponsor
- AI Labs Group S.L
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
Sleep Apnea
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
The study is to compare the performance of a CPAP (continuous positive airway pressure) device to a clinical polysomnography (PSG) in identifying breathing events in patients with obstructive sleep apnea.
- Trial name
- NCT00836758
- Testing
- Analysis with AED and manual PSG scoring
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- Philips Respironics
Epilepsy, Non-Epileptic Seizure
Validation of Criteria for Identification of Epileptiform Discharges in EEG Recordings of Patients With Epilepsy
Electroencephalography (EEG) records electric activity of the brain using electrodes placed on the scalp. EEG is an important tool in the diagnostic work-up of patients with epilepsy.
- Trial name
- CIED (NCT03533374)
- Testing
- Electroencephalogram (EEG) and visual evaluation
- Volunteers
- 100 people
- Sponsor
- Sándor Beniczky
Growth Hormone Deficiency With Pituitary Anomalies
Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency
The Macimorelin Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, 2-way crossover Trial.
- Trial name
- NCT02558829
- Testing
- Macimorelin, Insulin
- Where
- 27 sites in United States, Austria and 7 more
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- AEterna Zentaris
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
SARS-CoV-2 Infection, Influenza A
SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings
The Metrix COVID/Flu Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein.
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B
- Trial name
- NCT06191393
- Testing
- Aptitude Medical Systems Metrix COVID/Flu Test
- Where
- 3 sites in United States
- Volunteers
- 614 people
- Sponsor
- Aptitude Medical Systems
Sleep-disordered Breathing
ApneaLink Air Home Sleep Testing (HST) Device Validation Study
This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.
- Trial name
- NCT03470493
- Testing
- ApneaLink Air
- Where
- 2 sites in United States
- Volunteers
- 130 people
- Sponsor
- ResMed
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
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
Hypogonadism, Male
Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
- Trial name
- DV (NCT03242590)
- Testing
- LPCN 1021
- Volunteers
- 95 people
- Sponsor
- Lipocine Inc.
Rhinitis, Allergic, Perennial
Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
The Protocol section needs to be updated using the following text "The main goal of the study was to validate the Preference Module of the EARNS-Q and to test the reliability using Treatment Satisfaction Questionnaire for…
- Trial name
- NCT00346775
- Testing
- Beclomethasone dipropionate, Flunisolide
- Where
- 7 sites in United States
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline
Parkinson's Disease
Multi-chip Meta-analysis of Parkinson's Disease for Clinical Validation of Small Samples of Key Genes in Disease
The research team used meta-analytical statistical methods to integrate the results of different research groups on Parkinson's disease, using meta-analysis to find key genes related to the pathogenesis and development of…
- Trial name
- NCT03848455
- Testing
- genetic diagnosis
- Where
- China
- Volunteers
- 238 people, healthy volunteers welcome
- Sponsor
- Zhujiang Hospital
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.
Helicobacter Pylori Infection
Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection
The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori…
- Trial name
- NCT02528721
- Testing
- Dual Mode BreathID Hp System
- Where
- 13 sites in United States, Israel
- Volunteers
- 282 people
- Sponsor
- Meridian Bioscience, Inc.
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
Parkinson's Disease
Validation of Dyskinesia Rating Scales
This study will evaluate the responsiveness of a variety of available dyskinesia rating scales to treatment with amantadine or placebo in Parkinson's disease patients with dyskinesia.
- Trial name
- NCT01071395
- Testing
- Amantadine
- Where
- 8 sites in United States, Austria and 2 more
- Volunteers
- 68 people
- Sponsor
- Rush University Medical Center