Search clinical trials for: Regulatory

Total 569 results

Bristol-Myers Squibb

Completed

ELIQUIS (APIXABAN) Regulatory Post-Marketing Surveillance In Clinical Practice for Venous Thromboembolism (VTE) Treatment and Prevention Of Recurrent VTE

Venous Thromboembolism

Japan
Pfizer
Medivation, Inc.

Completed

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) (EMBRACA)

Breast Neoplasms | BRCA 1 Gene Mutation | BRCA 2 Gene Mutation

Korea, Republic of, United States, Australia, Spain, Belgium, France, Ireland, Taiwan, Poland, Germany, Israel, Brazil, United Kingdom, Italy, Russian Federation, Ukraine
Ascensia Diabetes Care
Regulatory and Clinical Research Institute Inc

Completed

User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)

Diabetes Mellitus

United States
Gilead Sciences

Completed

Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

HIV-1-infection

United States, Puerto Rico, France, Germany, Austria, Canada
Assistance Publique - Hôpitaux de Paris
Iltoo Pharma

Completed

Low-dose IL-2 to the Kinetics of Regulatory T-cell in Healthy Volunteers (HEALTHIL-2)

Healthy Volunteers

France
University Hospital, Montpellier
Centre Hospitalier Universitaire de Nīmes; Institut de Génétique Moléculaire...

Completed

Characterization of Breg Cells (Breg)

Arthritis, Rheumatoid | Healthy Volunteers

France
Novo Nordisk A/S

Completed

A Regulatory Post Marketing Surveillance (rPMS) Study of Ryzodeg® FlexTouch® (Insulin Degludec /Insulin Aspart) to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice in Korea

Diabetes Mellitus, Type 2 | Diabetes | Diabetes Mellitus, Type 1

Korea, Republic of
Novartis Pharmaceuticals

Terminated

Systemic Corticosteroids Avoidance Study in Severe Asthma Patients

Asthma

Germany, Belgium, South Africa, United States, Russian Federation, France, Slovakia, Spain, Thailand, Czechia, Greece, Argentina, Peru, United Kingdom, Bulgaria, Turkey, Hungary, Vietnam, Philippines, Colombia, Chile
Novartis Pharmaceuticals

Completed

Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma (THUNDER)

Nasal Polyps

Germany, Belgium, Italy, Argentina, Canada, Netherlands, Czechia, Poland, United States
Novartis Pharmaceuticals

Completed

Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer (EarLEE-1)

Breast Cancer

United States
The Methodist Hospital Research Institute
Massachusetts General Hospital; The Center for Clinical and Translational Sciences... and other collaborators

Active, not recruiting

T-regulatory Cells in ALS (Tregs in ALS)

ALS (Amyotrophic Lateral Sclerosis)

United States
Pfizer

Completed

Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

Rheumatoid Arthritis

Japan
Laura Johnston
National Institutes of Health (NIH)

Completed

Phase 1 Infused Donor T Regulatory Cells in Steroid Dependent/Refractory Chronic GVHD

Graft Versus Host Disease | Allogeneic Hematopoietic Cell Transplant Recipient

United States
Nantes University Hospital

Completed

Study of the Frequency and of the Regulatory Function of Positive T Lymphocytes Dual CD4CD8aa (DP8a) Specific to a Bacteria of the Intestinal Microbiota (Faecalibacterium Prausnitzii) in Atopic Dermatitis, Asthma and Allergic Rhinitis (Prévall-DP)

Allergic Rhinitis | Atopic Dermatitis | Allergic Asthma

France
Nantes University Hospital
Institut National de la Santé Et de la Recherche Médicale, France

Completed

Myeloid Derived Suppressor Cells Control by Signal Regulatory Protein-alpha: Investigation in Hepatocellular Carcinoma (MDScan)

Hepatocellular Carcinoma
Dow University of Health Sciences

Completed

Ethanolic Extract of Sapindus Mukorrossi as Final Endodontic Irrigant.

Apical Periodontitis | Irreversible Pulpitis | Root Canal Infection

Pakistan
Duke University
Georgetown University; University of Michigan

Withdrawn

Impact of New Product Standards for JUUL Among Dual JUUL/Combusted Cigarette Users

Smoking | Cigarette Smoking | E-cigarette Use
Novartis Pharmaceuticals

Completed

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin) (RADIANT-4)

Neuroendocrine Tumors | Advanced NET of GI Origin | Advanced NET of Lung Origin

United States, Colombia, Italy, Taiwan, United Kingdom, Belgium, Czechia, Germany, Japan, Saudi Arabia, Canada, Netherlands, Spain, Korea, Republic of, Lebanon, Austria, China, Greece, South Africa, Thailand, Hungary, Turkey, Poland, ... and more
NYU Langone Health

Completed

Optimizing the Tobacco Cessation Clinical Decision Support Tool.

Tobacco Use Cessation

United States
Assistance Publique - Hôpitaux de Paris
Iltoo Pharma

Completed

Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases (TRANSREG)

Rheumatoid Arthritis | Systemic Lupus Erythematosus | Psoriasis | Systemic Sclerosis | Crohn's Disease | Ulcerative Colitis | Idiopathic Thrombocytopenic Purpura | Autoimmune Hepatitis | Wegener's Granulomatosis | Ankylosing Spondylitis | Behcet's Disease | Takayasu's Disease | Sclerosing Cholangitis | Gougerot-sj...

France
Pfizer

Completed

Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication (DREAM)

Deep Mycosis
Galmed Research and Development, Ltd.
Medical University of Graz; Tel-Aviv Sourasky Medical Center; Fondazione IRCCS... and other collaborators

Completed

A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH (Aramchol_005)

Liver Diseases | Fatty Liver | Non-Alcoholic Steatohepatitis | Liver Fibroses

United States, Chile, Israel, Italy, France, Germany, Mexico, Georgia, Lithuania, Hong Kong, Romania
Peking University Third Hospital

Completed

The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease

Coronary Microvascular Dysfunction | Obstructive Coronary Heart Disease

China
Novo Nordisk A/S

Completed

A Regulatory Post-marketing Surveillance (rPMS) Study to Evaluate the Safety and Effectiveness of Saxenda®(Liraglutide 3.0 mg) in Obese Patients and Overweight Patients With Obesity-related Comorbidities in Routine Clinical Practice in Korea.

Obesity | Overweight

Korea, Republic of
Nova Laboratories Limited
Syne Qua Non Limited; Medicines Evaluation Unit Ltd; Alderley Analytical Ltd; Black... and other collaborators

Completed

Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®) (AZA)

Therapeutic Equivalency

United Kingdom
Pfizer

Completed

Drug Use Investigation for Toviaz

Overactive Bladder (OAB)
Novartis Pharmaceuticals

Completed

Safety and Efficacy of RAD001 in Participants With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® Therapy (PILLAR-1)

Lymphoma, Mantle- Cell

United States
Boehringer Ingelheim

Completed

Regulatory Request NIS in Korea

Diabetes Mellitus, Type 2

Korea, Republic of
Nestlé
Nestec Ltd.; Regulatory and Clinical Research Institute Inc; Cytel Inc.

Terminated

Videofluoroscopic Swallowing Study (VFSS) (PORSCHE)

Stroke | Multiple Sclerosis | Parkinson Disease | Dementia | Alzheimer Disease | Oropharyngeal Dysphagia

United States, Finland
Novartis Pharmaceuticals

Completed

Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor. (TRINITI-1)

Breast Cancer

United States
Novartis Pharmaceuticals

Completed

Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

Asthma

United States, India, Spain, Italy, Israel, Netherlands, Russian Federation, Lebanon, South Africa, Czechia, Greece, Serbia, Argentina, Mexico, Slovakia, Canada, Taiwan, Malaysia, Japan
Genervon Biopharmaceuticals, LLC
Massachusetts General Hospital; Columbia University

Completed

GM604 Phase 2A Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS) (GALS)

Amyotrophic Lateral Sclerosis

United States
The Hospital for Sick Children
C17 Council (regulatory sponsor)

Withdrawn

Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children (CONCOR-KIDS)

Covid-19 Infection | Hospitalized Children

Canada
Stanford University

Withdrawn

Safety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome

Covid19 | Acute Respiratory Distress Syndrome

United States
The Nordic Network For Clinical Islet Transplantation

Active, not recruiting

Infusion of Autologous T Regulatory Cells (T Reg) at the Time of Transplantation of Allogenic Islets of Langerhans

Type1diabetes

Sweden
Northwestern University
Icahn School of Medicine at Mount Sinai; Mount Sinai Hospital, New York

Completed

Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease

Autoimmune Hepatitis

United States
Pfizer's Upjohn has merged with Mylan to form Viatris...

Completed

A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule

Schizophrenia | Bipolar Disorder
Indiana University
Eunice Kennedy Shriver National Institute of Child Health and Human Development...

Completed

Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease

Graft-Versus-Host Disease

United States
Pfizer

Completed

MEK162 for Patients With RAS/RAF/MEK Activated Tumors (SIGNATURE)

Solid Tumor and Hematologic Malignancies

United States
Xeris Pharmaceuticals
Integrated Medical Development

Terminated

Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses

Diabetes Mellitus, Type 1 | Hypoglycemia Unawareness

United States
Jennifer Victory, RN, CCRC
Baylor University

Completed

Role of Podocan and Wnt Pathway Regulatory Molecules in Coronary Artery Disease

Coronary Artery Disease

United States
The Federal Office for Radiation Protection, Germany
Seibersdorf Labor GmbH

Completed

Radiofrequency Electromagnetic Field (RF-EMF) Effects on Brain Activity During Sleep and Waking in Healthy Elderly Women (EMF60+women)

Nervous System Effects

Germany
National Institute of Allergy and Infectious Diseases...
Rho Federal Systems Division, Inc.; Clinical Trials in Organ Transplantation...

Completed

Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction (ARTEMIS)

Liver Transplant Recipient | Living Donor (of the Respective Liver Transplant Recipient)

United States
Pfizer's Upjohn has merged with Mylan to form Viatris...

Completed

Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)

Epilepsies, Partial
Pfizer's Upjohn has merged with Mylan to form Viatris...

Completed

Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)

Pulmonary Hypertension
Pfizer's Upjohn has merged with Mylan to form Viatris...

Completed

Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Hypertension | Angina Pectoris | Hypercholesterolemia | Familial Hypercholesterolemia
Oklahoma State University
University of Oklahoma; University of Minnesota; Case Western Reserve University and other collaborators

Completed

Cognitive and Self-regulatory Mechanisms Of Obesity Study (COSMOS)

Obesity
Lisata Therapeutics, Inc.
California Institute for Regenerative Medicine (CIRM); Sanford Health

Completed

Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)

Diabetes Mellitus

United States
Yale University
National Institute on Drug Abuse (NIDA)

Completed

Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention

Drug Use Disorders

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI); Cancer Prevention Research Institute of Texas

Completed

Fucosylated T Cells for Graft Versus Host Disease (GVHD) Prevention

Lymphoma | Leukemia

United States

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