Clinical trials: Surveillance
Rheumatoid Arthritis -Exposure During Pregnancy
An Observational Study on Sarilumab-exposed Pregnancies
Primary Objective: To evaluate the relative risk of major structural birth defects, specifically a pattern of anomalies, in sarilumab-exposed pregnancies compared to disease-matched unexposed pregnancies.
- Trial name
- NCT03378219
- Testing
- Sarilumab SAR153191 (REGN88)
- Where
- 2 sites in United States, Canada
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Sanofi
Psoriasis
Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database
The patients included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan.
- Trial name
- NCT01081730
- Testing
- anti-TNF biologics, general population, non-anti-TNF biologics
- Volunteers
- 2,040 people
- Sponsor
- Janssen Biotech, Inc.
Rheumatoid Arthritis, Osteoarthritis
A Multi-centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
The purpose of this study is to monitor the performance and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders
- Trial name
- NCT00208377
- Testing
- DePuy ASR Hip System
- Where
- 3 sites in Australia, Germany and 1 more
- Volunteers
- 228 people
- Sponsor
- DePuy International
Prostate Cancer
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"
The purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.
- Trial name
- NCT03209492
- Testing
- Leuprorelin acetate
- Where
- Japan
- Volunteers
- 333 people
- Sponsor
- Takeda
Pneumonia, Meningitis
Colombia Epidemiologic Surveillance Study
The study will determine the reduction in invasive pneumococcal disease (IPD) after the introduction of a National Immunization Program with PCV-7 in Bogota.
- Conditions
- Pneumonia, Meningitis, Bacteremia, Sepsis
- Trial name
- LEAP II (NCT00428051)
- Testing
- Surveillance
- Where
- 3 sites in Brazil, Colombia and 1 more
- Volunteers
- 32,867 people
- Sponsor
- Pfizer
Advanced or Recurrent Colorectal Cancer
Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)
The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied. Specifically, information will be collected on the following as events of interest: skin disorders, interstitial lung disease…
- Trial name
- NCT02089737
- Testing
- Panitumumab
- Volunteers
- 3,091 people
- Sponsor
- Takeda
MR Mammography With Dotarem
Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from September 2011 to December 2013.
- Trial name
- NCT03041298
- Testing
- MR mammography with Dotarem
- Volunteers
- 1,537 people, healthy volunteers welcome
- Sponsor
- Guerbet
Diphtheria, Acellular Pertussis
Post Market Surveillance for Infanrix™
The purpose of this study was to investigate the following questions through post-marketing surveillance: Unknown/Unexpected adverse events and the serious adverse events.
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus
- Trial name
- NCT00908115
- Testing
- GSK Biologicals' Infanrix™
- Where
- South Korea
- Volunteers
- 1,258 people
- Sponsor
- GlaxoSmithKline
Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis
Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
The purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.
- Trial name
- NCT03214952
- Testing
- Vonoprazan
- Where
- Japan
- Volunteers
- 3,183 people
- Sponsor
- Takeda
Intussusception, LRTI-related Post Neonatal Deaths
Implementing Hospital-based Active Surveillance Procedures for Vaccine Safety Monitoring at IMSS Hospitals in Mexico
This is an epidemiology study designed to implement hospital-based active surveillance for intussusception (IS) in children <1 year of age and lower respiratory tract infection (LRTI)-related deaths among children between 29 days…
- Trial name
- NCT00436358
- Testing
- Not applicable: none
- Where
- Mexico
- Volunteers
- 134 people
- Sponsor
- GlaxoSmithKline
Venous Disease
US Post-Market Surveillance Study of the Surfacer System
Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. Treating patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central…
- Trial name
- NCT05050799
- Testing
- Central Venous Access
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- Merit Medical Systems, Inc.
Alopecia
AVODART® Alopecia Post-marketing Surveillance (PMS)
Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients
- Trial name
- AVODART®PMS (NCT01004809)
- Testing
- Dutasteride
- Where
- South Korea
- Volunteers
- 712 people
- Sponsor
- GlaxoSmithKline
NonValvular Atrial Fibrillation
Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
The primary objectives of this study are: To estimate the incidence rate of unexpected adverse events To characterize the bleeding events and assess risk factors of bleeding To identify ancillary baseline variables that may also…
- Trial name
- NCT02007655
- Testing
- Eliquis
- Where
- Japan
- Volunteers
- 6,372 people
- Sponsor
- Bristol-Myers Squibb
Community Acquired Pneumonia
A Global Active Surveillance for Community Acquired Pneumonia
This study is an observational surveillance study to identify adults 50 years and older who present to a study healthcare facility with signs and symptoms of Community-Acquired Pneumonia.
- Trial name
- NCT00929721
- Testing
- Blood draw, Chest X-ray, urine specimen
- Where
- Poland
- Volunteers
- 5,172 people
- Sponsor
- Pfizer
Lennox-Gastaut Syndrome
Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome
This surveillance's objectives are 1. Unknown adverse reactions 2. Incidences of adverse drug reaction 3. Efficacy during long-term administration 4. Factors considered to have effect to safety and effectiveness 5.
- Trial name
- NCT02175173
- Testing
- Rufinamide
- Where
- 2 sites in Japan
- Volunteers
- 707 people
- Sponsor
- Eisai Co., Ltd.
Lung Diseases, Interstitial
Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
The primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of Ofev Capsules under the real world setting in patients with Chronic fibrosing Interstitial Lung Diseases with a…
- Trial name
- NCT04559581
- Testing
- Nintedanib
- Where
- Japan
- Volunteers
- 425 people
- Sponsor
- Boehringer Ingelheim
PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer Stage I
Observational Registry Evaluating the Clinical Impact of the Blood-Based Biomarker Test for Early-Stage Pancreatic Ductal Adenocarcinoma
The goal of this observational registry is to examine the changes made to pancreatic cancer surveillance management following the real-world clinical use of PancreaSure testing among individuals at increased risk for pancreatic…
- Conditions
- PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, Cancer Diagnosis
- Trial name
- ASSURE (NCT07805681)
- Volunteers
- 400 people
- Sponsor
- Immunovia, Inc.
Thoracoabdominal Aortic Aneurysm, Pararenal Aortic Aneurysm
TAMBE Japan Post-Marketing Surveillance
To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.
- Trial name
- NCT07147569
- Testing
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
- Where
- 5 sites in Japan
- Volunteers
- 100 people
- Sponsor
- W.L.Gore & Associates
Respiratory Syncytial Virus Infections
Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers
The study is a multi-center, multi-national, prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed for acute respiratory disease…
- Trial name
- NCT05964582
- Where
- 15 sites in United States, Finland and 5 more
- Volunteers
- 344 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Type 2 Diabetes Melitus
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"
The purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to…
- Trial name
- NCT01945242
- Testing
- Alogliptin
- Volunteers
- 1,374 people
- Sponsor
- Takeda
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