Clinical trials: Surveillance
Osteoarthritis, Traumatic Arthritis
The Post-marketing Surveillance to Evaluate the Efficacy of CHONDRON (Autologous Cultured Chondrocyte) by Arthroscopy
A clinical trial to evaluate the long-term efficacy and safety of Chondron (Autologous cultured Chondrocyte) administered through arthroscopy from the drug's 48 weeks efficacy and safety evaluation with 96 weeks follow-up in…
- Trial name
- NCT02539069
- Testing
- Chondron Implantation
- Where
- South Korea
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Cellontech Co., Ltd.
Diphtheria, Tetanus
Regulatory Post-Marketing Surveillance Study for TETRAXIM™
The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT01437423
- Testing
- TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
- Where
- South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Screening Colonoscopy, Surveillance Colonoscopy
Study to Evaluate the Diagnostic Performance of of MAGENTIQ-COLO During Colonoscopy.
This is an international, multicenter, study to evaluate the diagnostic performance of the CADx polyp sizing modality of the MAGENTIQ-COLO.
- Trial name
- NCT06568523
- Testing
- MAGENTIQ-COLO.
- Where
- 5 sites in United States, Israel and 1 more
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Magentiq Eye LTD
Colonoscopy, Colorectal Cancer Screening
Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagnosis of Lower Gastrointestinal Conditions
This study is a prospective, single-arm, non-randomized, single site first-in-human study and will be conducted in two phases, where Phase A will serve to evaluate the safety of the Triton 4.0 System to perform screening…
- Conditions
- Colonoscopy, Colorectal Cancer Screening, Colorectal Neoplasms, Gastrointestinal Endoscopy
- Trial name
- CARE I (NCT06935734)
- Testing
- Diagnostic Colonoscopy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Neptune Medical
Influenza, Human
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England
This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu…
- Trial name
- NCT03278067
- Testing
- Enhanced vaccine safety surveillance
- Where
- United Kingdom
- Volunteers
- 23,939 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Infection
Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
Primary Objective: To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).
- Trial name
- NCT04843111
- Testing
- Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Dengue
An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Brazil
The purpose of this study is to estimate the incidence of dengue infection in children and adults in geographically distinct locations of Brazil.
- Trial name
- NCT01751139
- Testing
- Blood sample collection, Data collection
- Where
- 5 sites in Brazil
- Volunteers
- 3,300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Colorectal Cancer
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.
- Trial name
- NCT01694966
- Testing
- Methylene Blue MMX®
- Where
- 19 sites in United States, Belgium and 6 more
- Volunteers
- 1,249 people, healthy volunteers welcome
- Sponsor
- Cosmo Technologies Ltd
Neoplasms, Rectal
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea
The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30…
- Trial name
- NCT03671369
- Testing
- Safety data collection (following routine vaccination) by a continuous surveillance method.
- Where
- 29 sites in South Korea
- Volunteers
- 670 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Dengue Fever, Fever
Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia
The purpose of this study is to detect acute febrile episodes and dengue infection in five Asian countries, to assess dengue seroprevalence, and to assess surveillance infrastructure at investigational sites in anticipation of a…
- Trial name
- NCT01218906
- Where
- 11 sites in Indonesia, Malaysia and 3 more
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Sanofi
Coronavirus Disease 2019 (COVID-19)
Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated With AZD1222
This is a Phase IV real-world, observational, non-interventional, prospective cohort study of adults vaccinated with AZD1222. The purpose of this study is to assess the safety and tolerability of AZD1222 in adults vaccinated in…
- Trial name
- COVID-19 (NCT04877743)
- Testing
- None (Observational study)
- Where
- Germany
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Japanese Encephalitis
Postmarketing Surveillance Study for IMOJEV® in Republic of Korea
The purpose of the study is to perform the re-examination of IMOJEV® in routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.
- Trial name
- NCT02933710
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza, Human
Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season
The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and aims to assess adverse events of interest…
- Trial name
- NCT03688620
- Testing
- Passive enhanced safety surveillance
- Where
- 9 sites in Belgium, Germany and 1 more
- Volunteers
- 1,060 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Malaria Vaccines
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
This epidemiology study was conducted in parallel with the EPI-MAL-002 (NCT02374450) and EPI-MAL-003 (NCT03855995) studies, enrolling participants from the same health and demographic surveillance system (HDSS) (or equivalent…
- Trial name
- NCT02251704
- Testing
- Assessment of body temperature, Blood sampling
- Where
- 12 sites in Burkina Faso, Ghana and 4 more
- Volunteers
- 54,115 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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
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
Dengue, Dengue Vaccines
This Study Will Describe the Burden of DENgue Fever Virus (DENV) Illness Among Household Members Aged 6 Months to 50 Years of Selected Communities in Latin America and Southeast Asia
The purpose of this study is to describe the burden of DENV illness among household members aged 6 months to 50 years of selected communities in Latin America and Southeast Asia.
- Trial name
- NCT02766088
- Testing
- Blood sample collection
- Where
- 2 sites in Mexico, Philippines
- Volunteers
- 1,750 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea
The purpose of this study is to collect safety information following routine vaccination with Synflorix™ among infants in Korea.
- Trial name
- NCT01248988
- Testing
- Synflorix™ Data collection
- Where
- South Korea
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Plantar Fasciitis
the Safety and Efficacy of Collagen Injection in Patients With Plantar Fasciitis
The primary objective of this study is to evaluate the safety and efficacy of collagen injection in patients with plantar fasciitis
- Trial name
- NCT02539082
- Testing
- Regenseal, normal saline
- Where
- 3 sites in South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Cellontech Co., Ltd.