Clinical trials: Surveillance
Infant Death, Serious Injury
The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
This postmarket surveillance study will evaluate the safety of the SNOO Smart Sleeper Bassinet when used for infants who are at high risk for Sudden Unexpected Infant Death (SUID).
- Trial name
- NCT06361303
- Testing
- SNOO Bassinet
- Where
- United States
- Volunteers
- 1,900 people, healthy volunteers welcome
- Sponsor
- Happiest Baby, Inc.
Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy Syndrome)
Mucopolysaccharidosis (MPS) VI Clinical Surveillance Program (CSP)
The objectives of this program are: to further characterize the natural progression of MPS VI disease; to generate and disseminate information on the care and management of MPS VI patients to clinical and medical professionals…
- Trial name
- NCT00214773
- Where
- 50 sites in United States, Australia and 11 more
- Volunteers
- 237 people
- Sponsor
- BioMarin Pharmaceutical
Rheumatoid Arthritis
Korean Post-marketing Surveillance for Orencia®
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Orencia® so that the regulatory…
- Trial name
- NCT01583244
- Testing
- No Intervention (subjects were previously treated with Orencia®)
- Where
- South Korea
- Volunteers
- 701 people
- Sponsor
- Bristol-Myers Squibb
Venous Thromboembolism
Eliquis (VTE Treatment and Prevention of Recurrent VTE) rPMS
To assess the real-world safety/effectiveness of Eliquis in Korean venous thromboembolism (VTE) patients and patient characteristics that are associated with bleeding among patients taking Eliquis.
- Trial name
- NCT02546817
- Where
- South Korea
- Volunteers
- 29 people
- Sponsor
- Bristol-Myers Squibb
Contrast-enhanced MRI With Dotarem
Post-marketing Surveillance Study for Evaluation of Dotarem Safety
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine).
- Trial name
- NCT03048006
- Testing
- MRI with Dotarem
- Volunteers
- 44,456 people, healthy volunteers welcome
- Sponsor
- Guerbet
Colonic Polyp
A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies
The objective of this study is to collect colonoscopy data for use in the development and testing of artificial intelligence (AI) devices for colonoscopies.
- Trial name
- CODACO (NCT05869838)
- Testing
- Colonoscopy
- Where
- 2 sites in Germany, Spain
- Volunteers
- 600 people
- Sponsor
- Olympus Europe SE & Co. KG
Colonoscopy (Procedure)
Use of GI Genius™ XR Software in Virtual Reality Headset During Routine Colonoscopy
This pilot study will evaluate the usability and safety of software GI Genius™ XR in the Apple Vision Pro™ virtual reality headset when used in conjunction with the GI Genius™ system during routine screening and surveillance…
- Trial name
- NCT07220174
- Testing
- software GI Genius™ XR on headset
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Cosmo Artificial Intelligence-AI Ltd
Zika Virus Disease
Zika Case Definition and Surveillance Study
This prospective, surveillance study will assess the operational Zika virus definition for use in future Zika purified inactivated virus (ZIKV) vaccine efficacy trials in order to identify Zika virus disease (ZVD) cases among the…
- Trial name
- NCT03158233
- Where
- 6 sites in Colombia, Honduras and 2 more
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Renal Cell Carcinoma
Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice
This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern, safety and effectiveness in Taiwan real world routine practice.
- Trial name
- NCT02533258
- Volunteers
- 13 people
- Sponsor
- Pfizer
Diabetes Mellitus, Type 2
Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin
This protocol is for a series of comparative effectiveness and safety analyses within periodically updated cohorts of patients initiating linagliptin, other DPP-4 inhibitors, and other oral hypoglycemic medications, followed…
- Trial name
- NCT02197078
- Where
- United States
- Volunteers
- 189,426 people
- Sponsor
- Boehringer Ingelheim
Diabetes, Diabetes Mellitus, Type 2
An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)
This study is conducted in the United States of America (USA). The aim of the study is to monitor the number of annual new adult cases of medullary thyroid carcinoma (MTC) and to establish a registry for these new cases in order…
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Medullary Thyroid Carcinoma, Weight Management
- Trial name
- NCT01511393
- Testing
- No treatment given
- Where
- United States
- Volunteers
- 6,750 people
- Sponsor
- Novo Nordisk A/S
Hypervolemic and Euvolemic Hyponatremia
Samsca Post Marketing Surveillance Study
This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011~31Aug2017).
- Trial name
- Samsca PMS (NCT02722863)
- Where
- 4 sites in South Korea
- Volunteers
- 908 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Non-Hodgkin's Lymphoma (NHL)
Zevalin Post-marketing Surveillance for Adequateness of Image Interpretation Criteria in Japan
This study is a regulatory post-marketing surveillance of Zevalin (ibritumomab tiuxetan) in Japan. In-111 Zevalin is, at first, injected to patient for gamma scan imaging to assess biodistribution of the Zevalin.
- Trial name
- ZEVALIN-SDUI (NCT01479387)
- Testing
- [111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)
- Where
- Japan
- Volunteers
- 72 people
- Sponsor
- Bayer
Pain
Fentanyl for Treatment Pain Caused by Radiotherapy
The purpose of this study is to assess the clinical utility and safety of Fentanyl for pain treatment caused by radiotherapy. Fentanyl is a synthetic pure opioid agonist with a selective activity on µ receptors.
- Trial name
- NCT00523887
- Testing
- Fentanyl transdermal therapeutic system
- Volunteers
- 163 people
- Sponsor
- Johnson & Johnson Taiwan Ltd
Autism
Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in patients with autism in the real world clinical setting in Japan.
- Trial name
- NCT03179787
- Testing
- Aripiprazole oral product
- Where
- Japan
- Volunteers
- 528 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Cytomegalovirus (CMV)
A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection
This study is a survey in Japan of Maribavir tablets used to treat participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell…
- Trial name
- NCT06577363
- Testing
- Maribavir
- Where
- Japan
- Volunteers
- 250 people
- Sponsor
- Takeda
Lung Neoplasms
Korea Post Marketing Surveillance (PMS) Study of Vizimpro
Vizimpro will be approved for the treatment of EGFR NSLCL 1L in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS.
- Trial name
- NCT04721106
- Testing
- Vizimpro
- Where
- South Korea
- Volunteers
- 188 people
- Sponsor
- Pfizer
Pertussis (Whooping Cough), Tetanus
Safety Monitoring of Boostagen® Vaccine in Thailand
This study is designed to monitor the safety of Boostagen® after it has been approved for use in Thailand. The study follows people who receive the vaccine in routine medical practice to identify and record any side effects.
- Conditions
- Pertussis (Whooping Cough), Tetanus, Diphtheria
- Trial name
- BOOSTg001 (NCT07444502)
- Where
- Thailand
- Volunteers
- 10,727 people, healthy volunteers welcome
- Sponsor
- BioNet-Asia Co., Ltd.
HIV Infection
Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients
The investigation will be conducted for the purpose of determining the condition of occurrence of Adverse Events under the actual post-marketing use of Zithromac 600mg Tablet, verifying the therapeutic effects, detecting unknown…
- Trial name
- NCT01227395
- Testing
- Azithromycin
- Volunteers
- 476 people
- Sponsor
- Pfizer
Metastatic ALK+ Non Small Cell Lung Cancer
Post Marketing Surveillance(PMS) Study of Lorviqua in Korea
The objective of this study is to monitor the usage of Lorviqua in real practice within label, including the adverse events associated with Lorviqua
- Trial name
- NCT05599412
- Testing
- Lorviqua
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Pfizer
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