Clinical trials: Surveillance
Peripheral Arterial Disease (PAD)
Zilver PTX Post-Market Study in Japan
Japanese post market clinical study of the Zilver PTX device.
- Trial name
- NCT02254837
- Testing
- Zilver PTX Drug-Eluting Stent
- Volunteers
- 909 people
- Sponsor
- Cook Group Incorporated
Epilepsies, Partial
Drug Use Investigation Of Gabapentin
The objective of the this surveillance is to collect information about 1)adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3)…
- Trial name
- NCT00567268
- Testing
- Gabapentin
- Volunteers
- 1,273 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Intracranial Aneurysm
The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial…
- Trial name
- SUNRISE (NCT00486226)
- Testing
- Vascular Reconstruction Device
- Where
- Belgium
- Volunteers
- 105 people
- Sponsor
- Codman & Shurtleff
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
Respiratory Syncytial Virus Infections
A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance
The purpose of this study is to assess pregnancy outcomes, and maternal, as well as neonatal events of interest in healthy pregnant women and their new-borns.
- Trial name
- PEPNI (NCT03614676)
- Testing
- Blood sample collection, Cord blood sample collection, Maternal Diary Card
- Where
- 40 sites in Argentina, Bangladesh and 8 more
- Volunteers
- 4,493 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Immunization
Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants
In June 2024, the German Standing Committee on Vaccination (STIKO) recommended the universal immunization of infants with nirsevimab during their first RSV season.
- Trial name
- Vakzimeter RSV (NCT06824207)
- Where
- Germany
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Peripheral T Cell Lymphoma, Pediatric Hodgkin Lymphoma
Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"
The purpose of this survey is to examine the safety of adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with…
- Trial name
- NCT04213209
- Testing
- Brentuximab Vedotin (Genetical Recombination)
- Where
- Japan
- Volunteers
- 95 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
Diabetes, Diabetes Mellitus, Type 1
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
The purpose of this study is to collect information about safety and effectiveness of Ryzodeg® FlexTouch® in participants with diabetes mellitus requiring insulin therapy under routine clinical practice conditions with the aim of…
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT03416855
- Testing
- Insulin degludec /insulin aspart
- Where
- 27 sites in South Korea
- Volunteers
- 768 people
- Sponsor
- Novo Nordisk A/S
Menorrhagia, Dysmenorrhea
Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea
The primary objective in this study is collecting post-marketing information on the safety. Thus, it includes information under the routine clinical practice on adverse events (AEs) and adverse drug reactions (ADRs) including…
- Trial name
- J-MIRAI (NCT02475356)
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028)
- Where
- Japan
- Volunteers
- 601 people
- Sponsor
- Bayer
Hodgkin Lymphoma
A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma
This study is a survey in Japan of Brentuximab Vedotin used to treat children or teenagers with Hodgkin lymphoma (HL). The study sponsor will not be involved in how the participants are treated but will provide instructions on…
- Trial name
- NCT05481437
- Testing
- Brentuximab Vedotin
- Where
- Japan
- Volunteers
- 8 people
- Sponsor
- Takeda
Urothelial Cancer
A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection
Enfortumab vedotin (or PADCEV Injection) is a treatment for cancer in the bladder lining (urothelial cancer). PADCEV Injection is now available to treat this cancer.
- Trial name
- NCT06011954
- Testing
- Enfortumab Vedotin
- Where
- 22 sites in South Korea
- Volunteers
- 228 people
- Sponsor
- Astellas Pharma Korea, Inc.
Brain Ischemia
Xarelto [SPAF] Post-marketing Surveillance in Japan
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.
- Trial name
- NCT01582737
- Testing
- Rivaroxaban(Xarelto, BAY59-7939)
- Where
- Japan
- Volunteers
- 11,310 people
- Sponsor
- Bayer
Ovarian Neoplasms
A Study for Post-Marketing Surveillance of Niraparib in the Treatment of Adult Participants for Approved Indications in South Korea
The purpose of this study is to estimate the cumulative incidence of all adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESI), among participants who have been administered…
- Trial name
- NCT04589039
- Where
- South Korea
- Volunteers
- 662 people
- Sponsor
- Takeda
Hypertension
Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting.
- Trial name
- NCT02092025
- Testing
- Azilsartan
- Where
- 2 sites in Japan
- Volunteers
- 3,437 people
- Sponsor
- Takeda
Growth Hormone Deficiency in Children
Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed
The purpose of the study is to investigate the safety and effectiveness of Sogroya® in children with short stature due to growth hormone deficiency where epiphysial discs are not closed under real-world clinical practice in…
- Trial name
- NCT06109935
- Testing
- Somapacitan
- Where
- 86 sites in Japan
- Volunteers
- 200 people
- Sponsor
- Novo Nordisk A/S
Wound
Post Market Surveillance Study to Confirm Safety and Performance of Silicone PHMB Foam
Post market surveillance study to confirm the safety and performance of Silicone Subcategory of PHMB Foam Dressings in Chronic and Acute Wounds.
- Trial name
- NCT04621825
- Testing
- ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing.
- Where
- 3 sites in South Africa
- Volunteers
- 187 people
- Sponsor
- Advanced Medical Solutions Ltd.
Head and Neck Cancer
Prospective, Post Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck in Korea
After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551.
- Trial name
- NCT01075828
- Testing
- Cetuximab
- Where
- South Korea
- Volunteers
- 221 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Heart Transplant, Immunosuppression
HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)
This is an unblinded, randomized, controlled, two-arm interventional research study enrolling patients who are undergoing heart transplantation.
- Conditions
- Heart Transplant, Immunosuppression, Allograft
- Trial name
- MOSAIC (NCT05459181)
- Testing
- HeartCare
- Volunteers
- 930 people
- Sponsor
- CareDx
Ischemic Heart Disease, Angina Pectoris
XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE Xpedition SV Japan PMS)
The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Myocardial Ischemia
- Trial name
- NCT02513732
- Testing
- XIENCE Xpedition 2.25 mm stent
- Where
- 11 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Abbott Medical Devices
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