Phase 4 N=7 MEthylene Blue In Patients With Acquired Methemoglobinemia
Acquired Methaemoglobinaemia
Primary: Primary Efficacy Endpoint: Number of Participants With and Without 50% Reduction in metHb Level — 3; 3 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=25 Accuracy of Methemoglobin Measurement for Rainbow DCI Sensors
Healthy
Primary: Accuracy of Sensor by Arms Calculation — 0.87 percentage
N/A N=51 Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor
Healthy
Primary: Accuracy of Sensor by Arms Calculation — 0.63 Percentage of total hemoglobin
N/A N=28 Accuracy of Methemoglobin Measurement of Various Rainbow Pulse Oximeter Sensors
Healthy
Primary: Accuracy of Methemoglobin Measurement by Arms Calculation — 0.48 percentage of total hemoglobin
N/A N=91 Methemoglobin Levels in Generally Anesthetized Pediatric Dental Patients Receiving Local Anesthetics
Methemoglobinemia
Primary: Peak Methemoglobin Blood Levels — 3.55; 1.63; 1.60 percentage of methemoglobin in blood — p=<.001
Phase 2 N=10 A Proof of Concept Study of Inhaled Nitric Oxide for Adults With Pulmonary Non-Tuberculous Mycobacterial Infection
Nontuberculous Mycobacterium Infection
Primary: Percent Patients With Negative Sputum Culture — 40 percentage of participants
N/A N=102 European Survey: Risk of Cyanide Poisoning in Smoke Inhalation
Smoke Inhalation Patients
Primary: Overall Survival After 24 Hours — 96 participants
Phase 2 N=18 Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis
Cystic Fibrosis
Primary: Safety and Tolerability of Drug, Assessed by Change in Methemoglobin Levels — 0.4; 0.5; 0.3; 0.3 Percent of Methemoglobin Level
N/A N=50 Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis
Allergic Contact Dermatitis
Primary: Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0) — 14.53; 16.03; 109.1; 110.7 pg/ml
Phase 1 N=11 Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults
Focus of Study of Healthy Adults
Primary: Peak Plasma Nitrate Concentration Over 24 Hour Study Period — 769; 41 microMolar (microM)
Phase 2 N=21 N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study)
Transposition of Great Vessels · Congenital Heart Disease
Primary: Maximum Decline in Measured Cardiac Output — 0.68; 0.29 L/min/m2
Phase 2 N=32 Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism
Aldehyde Dehydrogenase-2 (ALDH2) Deficiency
Primary: Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation — 13; 6; 8; 21 Participants
Phase 2 N=30 Sodium Nitrite in Acute Myocardial Infarction
Acute Myocardial Infarction
Primary: Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi.
Phase 4 N=7,112 The ENIGMA II Trial:Nitrous Oxide Anaesthesia and Cardiac Morbidity After Major Surgery: a Randomised Controlled Trial
Coronary Artery Disease
Primary: The Primary Endpoint is a Composite of Death and Cardiovascular Events (Clinical and Silent MI, Cardiac Failure, Cardiac Arrest, Pulmonary Embolism, and Stroke) Measured…
N/A N=687 Vitamins in Nitrous Oxide Study
Major Surgery · Coronary Artery Disease
Primary: Myocardial Ischemia — 33; 34; 17; 217 Participants
Phase 2 N=41 Rapid Acclimatization to Hypoxia at Altitude
Physiological Function in Low Oxygen Environment
Primary: Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen). — 22.3; 25.2; 22.2; 24.0 minutes
Phase 2 N=20 Oral Nitrite in Adults With Metabolic Syndrome and Hypertension
Metabolic Syndrome · Hypertension
Primary: Change in Insulin Stimulated Glucose Disposal Over 12 Week Study Period — 0.76 mg/kg lean body mass/minute — p=0.2068
Phase 2 N=13 Effect of Oral Administration of Methylene Blue MMX Tablets on Double Stranded DNA
Colorectal Cancer
Primary: Gamma H2AX Histone Levels in Colonic Biopsy During Standard White Light Colonoscopy and Colonoscopy for Which Methylene Blue MMX Was Taken Prior to Initiating the…
Phase 2 N=100 Methylene Blue Against Falciparum Malaria in Burkina Faso
Malaria, Falciparum
Primary: Change in Haemoglobin Compared to the Baseline — 0.18; 0.54 g/dl
Phase 3 N=160 A Safety and Efficacy Study of NAC in Patients With TA-TMA
Thrombotic Microangiopathies · Hematologic Diseases
Primary: The Incidence of TA-TMA. — 5; 15 Participants
Phase 1 N=12 Safety, Tolerability, and Pharmacokinetic Study of Methylene Blue Following a 1 mg/kg Intravenous Dose in Healthy Adults
Methemoglobinemia · Congenital Methemoglobinemia
Primary: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t) — 2600.09 ng*hr/mL
Phase 2 N=48 Inhaled Nitrite in Subjects With Pulmonary Hypertension
Pulmonary Hypertension · Heart Failure, Diastolic
Primary: Change in Pulmonary Vascular Resistance (PVR) — 0.77; 0.40; -0.39 Woods units — p=0.002
Phase 2 N=26 Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction
Heart Failure
Primary: Change in Pulmonary Capillary Wedge Pressure During Exercise — -1; -4 millimeters of mercury — p=0.002
Phase 3 N=13 Inhaled Nitric Oxide in Brain Injury
Traumatic Brain Injury
Primary: PaO2 — 115; 95 mmHg — p=<0.05
Phase 2 N=28 Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction
Heart Disease · Heart Failure With Preserved Ejection Fraction · Exercise Intolerance
Primary: Exercise Pulmonary Capillary Wedge Pressure (PCWP) — 19.0; 28.0 mm Hg — p=0.0003
N/A N=23 The Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia
Hypoxia
Primary: Acute Mountain Sickness (AMS-C) as Assessed by the Environmental Symptoms Questionnaire. — 0.36; 0.21 scores on a scale
Phase 2 N=78 Nitric Oxide to Treat Pulmonary Embolism
Pulmonary Embolism
Primary: Number of Participants With Normal Right Ventricular (RV) Function and Viability — 9; 5 Participants
Phase 2 N=21 Oral Nitrite for Older Heart Failure Patients
Heart Failure
Primary: Skeletal Muscle Bioenergetics- Polymerase Chain Reaction (PCR) — 12.04; 11.91; 11.79; 11.76 Relative Expression
Phase 2 N=10 Nitric Oxide, GeNO Nitrosyl Delivery System
Pulmonary Arterial Hypertension
Primary: Number of Participants With Side Effects and/or Adverse Events — 0 participants
Phase 4 N=19 Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
Vasoplegic Syndrome · Liver Transplant; Complications
Primary: Systemic Vascular Resistance (SVR) — 480; 410; 588; 420 dyne*sec/cm^5