N/A N=399 Instrument Precision Study for Validation of Philips Dx
Pathology
Primary: Agreement Rate — 92.0; 93.8 percentage of agreement
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=732 Tampon Design Validation Study
Menstruation
Primary: The Percentage of Used Tampons That Have Elongated — 2; 75; 4; 48 tampons
N/A N=50 Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI
Surgery
Primary: Noninvasive Pulse Oximetry-determined SpHb Bias — 0.9 g/dL
N/A N=362 Validation of the Stayhealthy BC1 Body Comp Analyzer
Body Composition
Primary: Percent Body Fat — 20.3; 20.4; 32.8; 33.4 percent body fat — p=0.001
N/A N=450 Psychometric Properties of IntelliSpace Cognition
Cognitive Functioning of Healthy Individuals
Primary: Scores Digital (ISC) Tests — 41.3; 17.9; 19.3; 29.1 units on a scale — p=>.05
Phase 3 N=274 A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
Hydrocephalus · Normal Pressure Hydrocephalus
Primary: Percentage of Participants Who Achieved "Adjustment Complete" and a Consensus X-ray Reading — 98.33 Percentage of participants
N/A N=62 Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator
Fertility
Primary: Number of Participants With a Positive bHCG Level as Detected by a Blood Test — 19; 19 Participants
N/A N=12 TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
Subjects Presenting With Normal Eyes
Primary: TopQ Cut Off — 2.94; 1.5; 2.14; 17.54 microns
N/A N=112 Resident Supervision Index: Assessing Feasibility and Validity
Healthy
Primary: Intraclass Correlation Coefficient Between Physician Resident and Attending Physician. — .69 Intraclass Correlation Coefficient
Phase 4 N=22 Desogestrel-containing COCP Pharmacokinetic Validation Study
Contraception
Primary: Serum Etonogestrel Concentrations — 0.92 correlation coefficient (r)
N/A N=101 Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073
Healthy
Primary: Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073 — 1.38 Millimeters of mercury (mmHg)
Phase 3 N=152 Pilot Evaluation of Two Test Materials With a Positive Control When Used as a Patient Preoperative Skin Preparation
Bacteria Microflora Reduction
Primary: Change in Bacterial Microflora on the Inguinal Area — -3.7; -3.1; -3.5 log10 CFU
N/A N=73 A Confirmatory Study Confirming Performance of a New Intermittent Catheter
Urinary Retention
Primary: Residual Urine at 1st Flow Stop (HCP-led Catheterization) i.e., Total Catheterisation Volume Minus Volume at 1st Flow-stop, Both Derived From a Catheterisation Profile…
N/A N=12 In Vivo Pulse Oximeter Validation Study
Hypoxia
Primary: Measure of Accuracy (ARMS [%]) — 2.95 Percentage
N/A N=49 Alcohol Monitor Validation
Human Immunodeficiency Virus (HIV)
Primary: Transdermal Alcohol Concentration (TAC) — 38.3; 95.8 ug/L
N/A N=68 Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application
Vital Sign Evaluation
Primary: Respiratory Rate Accuracy — 0.91 breaths per minute
N/A N=155 Imagio Feasibility Multi-Reader, Multi-Case Study
Breast Cancer
Primary: The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1 — 80.9; 75.4; 78.7; 71.4 Percent of correct benign…
N/A N=306 DreamKit Diagnostic Validation
Sleep Apnea, Obstructive · Sleep Apnea, Central
Primary: Intraclass Correlation Coefficient (ICC) of the Apnea Hypopnea Index — 0.964 intraclass correlation coefficient (ICC)
N/A N=11 DreamKit Respiratory Effort Signal Validation
Sleep Apnea, Obstructive · Sleep Apnea, Central
Primary: Breath Amplitude Correlation — .66 ICC the aggregated signal amplitudes
N/A N=43 PortionSize Study 1 Laboratory-based Evaluation)
Dietary Habits
Primary: Difference in Simulated Energy (kcal) Intake Between the Criterion Measure (Weighed Food) and Two Smartphone Apps (PortionSize and MyFitness Pal). — -150.1; 79.8 kcal
N/A N=81 Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)
Obstructive Sleep Apnea
Primary: Sensitivity and Specificity — 79.0; 88.2 percentage
N/A N=233 Validation of TearLab Osmometer - Human Factor Usability Report
Dry Eye Syndromes
Primary: Tear Osmolarity in Human Measured by TearLab System — 308 mOsms/L
N/A N=16 SaliPen Human Factors Study for OTC Labeling
Xerostomia
Primary: Percentage of Participants Who Appropriately Will Self-select the Study Product for Use Under Simulated OTC Conditions [Phase I] — 100; 100 percentage
N/A N=673 Verification of Prediction Algorithm
Shortness of Breath Episode · Tachycardia · Bradycardia
Primary: Number of Subjects With a Cardiopulmonary Event — 145 Participants
N/A N=62 Clinical Equivalence of Masimo INVSENSOR00061 to RD SET Neo
Healthy
Primary: SpO2 Accuracy — 1.24 % of oxygen saturated hemoglobin
N/A N=146 Comparison Evaluation of Blood Glucose Meter Systems in a Clinical Setting
Diabetes
Primary: MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL)…
N/A N=40 Clinical Validation Study for CPM Device
Heart Failure
Primary: Accuracy of CPM System Calculated RR Versus Reference Device Via Percent of Error Accuracy of Respiration Rate — 96.3; 95.7 Percent
Phase 2 N=48 Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response
Contact Dermatitis
Primary: Diagnostic Performance: Optimal Test Allergen Concentration — 38.1; 47.6; 52.4; 30.8 percentage of participants
N/A N=79 Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality
Corneal Endothelial Cell Loss
Primary: Center Method Corneal Endothelial Cell Density — 3069.5; 2678.6; 2514 cells/mm2
N/A N=203 Potency and Precision Investigation
Depression, Anxiety
Primary: Working Alliance Inventory-Short Revised (WAI-SR), Total Scale — 3.63; 3.25; 3.95; 3.61 score on a scale