Clinical trials: Surveillance
Hemophilia A, Prophylaxis of Bleeding
A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A
In this study, researchers will observe and study the data from participants with hemophilia A who receive damoctocog alfa pegol as prescribed by their doctors.
- Conditions
- Hemophilia A, Prophylaxis of Bleeding, Treatment of Bleeding
- Trial name
- NCT06222697
- Testing
- Damoctocog-alfa-pegol (Jivi, BAY94-9027)
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- Bayer
Glioblastoma, Glioma
Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)
The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and…
- Conditions
- Glioblastoma, Glioma, Astrocytoma
- Trial name
- NCT00723827
- Testing
- Temozolomide, Radiotherapy
- Volunteers
- 682 people
- Sponsor
- Merck Sharp & Dohme LLC
Pulmonary Disease, Chronic Obstructive
Postmarketing Surveillance Study of Atrovent® Inhalation Solution in Chronic Obstructive Pulmonary Disease
To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice
- Trial name
- NCT02238197
- Testing
- Atrovent® Inhalation Solution
- Volunteers
- 477 people
- Sponsor
- Boehringer Ingelheim
Diabetes, Diabetes Mellitus, Type 1
Post Marketing Surveillance Study of Biphasic Insulin Aspart 30
This study is conducted in Asia. The aim of this study is to review the safety and efficacy of biphasic insulin aspart 30 in post-marketing use.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT01536613
- Testing
- biphasic insulin aspart 30
- Where
- South Korea
- Volunteers
- 5,346 people
- Sponsor
- Novo Nordisk A/S
Type 2 Diabetes Mellitus
Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-stage Renal Disease"
The purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting.
- Trial name
- NCT04285983
- Testing
- Trelagliptin
- Where
- Japan
- Volunteers
- 89 people
- Sponsor
- Takeda
Hepatitis C Virus
Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
The objectives of this study are to collect and assess data related to safety and effectiveness of Sovaldi treatment regimens, per the approved prescribing information for Sovaldi, in routine clinical practice and report results…
- Trial name
- NCT02907996
- Testing
- Sofosbuvir
- Where
- 72 sites in South Korea
- Volunteers
- 2,033 people
- Sponsor
- Gilead Sciences
Heart Valve Disease
Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")
Evaluation of decellularized human heart valves for aortic heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and…
- Trial name
- ARISE (NCT02527629)
- Testing
- Decellularized human heart valves
- Where
- 8 sites in Belgium, Germany and 5 more
- Volunteers
- 144 people
- Sponsor
- corlife
Peripheral Arterial Disease (PAD)
Zilver Flex Post-Market Study in Japan
Japanese post market clinical study of the Zilver Flex device.
- Trial name
- NCT02254356
- Testing
- Zilver Flex Bare Metal Stent
- Where
- Japan
- Volunteers
- 239 people
- Sponsor
- Cook Group Incorporated
Coronary Heart Disease
PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study
The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected…
- Trial name
- PE-Prove (NCT01148329)
- Testing
- Coronary stenting
- Where
- 40 sites in Austria, Belgium and 9 more
- Volunteers
- 1,010 people
- Sponsor
- Boston Scientific Corporation
Papillomavirus Infections
GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)
This study will collect safety information on the use of GARDASIL™ in the Philippines.
- Trial name
- NCT01355003
- Volunteers
- 1,080 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal
Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study
The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the Pinnacle Acetabular MoM system.
- Conditions
- Pinnacle Metal-on-Metal, Revised Pinnacle Metal-on-Metal, Adverse Local Tissue Reaction, Metal Ions
- Trial name
- NCT01828801
- Testing
- Pinnacle Metal-on Metal
- Where
- 8 sites in United States
- Volunteers
- 276 people
- Sponsor
- DePuy Orthopaedics
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
Vaginitis, Atrophic Vaginitis
a Flexible Wound Dressing for the Management of Genital Skin Conditions
The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients
- Conditions
- Vaginitis, Atrophic Vaginitis, Lichen Planus, Lichen Sclerosus
- Trial name
- NCT05396261
- Testing
- Film forming silicone gel (7-0940)
- Where
- Australia
- Volunteers
- 54 people
- Sponsor
- Stratpharma AG
Angina, Coronary Occlusion
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and…
- Conditions
- Angina, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis
- Trial name
- NCT01721096
- Testing
- XIENCE PRIME - Long Length (LL), XIENCE PRIME - Core Size
- Where
- Japan
- Volunteers
- 536 people
- Sponsor
- Abbott Medical Devices
Type 2 Diabetes
Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone
The purpose of this study is to evaluate the safety and efficacy of long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets LD) in patients with type 2 diabetes mellitus who respond poorly to…
- Trial name
- NCT02098746
- Testing
- Pioglitazone/glimepiride
- Volunteers
- 294 people
- Sponsor
- Takeda
Hemophilia A
Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A
This study is to describe the safety and efficacy of Xyntha® during the usual care setting.
- Trial name
- NCT01790828
- Testing
- Xyntha : coagulation factor IIIV (recombinant)
- Where
- 4 sites in South Korea
- Volunteers
- 42 people
- Sponsor
- Pfizer
Diagnostic Imaging
Magnevist 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 Magnevist at a dose of more than 0.2 ml/kg for MR angiography of peripheral…
- Trial name
- NCT01376739
- Testing
- Gadopentetate dimeglumine (Magnevist, BAY86-4882)
- Where
- Japan
- Volunteers
- 2,051 people
- Sponsor
- Bayer
Peripheral Arterial Disease
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.
- Trial name
- NCT04706273
- Testing
- GORE® VIABAHN® Endoprosthesis
- Where
- Japan
- Volunteers
- 321 people
- Sponsor
- W.L.Gore & Associates
Infectious Diseases
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such…
- Trial name
- NCT00761462
- Testing
- Ciprofloxacin, Non-quinolone antibiotic
- Where
- 67 sites in United States, Canada
- Volunteers
- 1,029 people
- Sponsor
- Bayer
Restless Legs Syndrome
REQUIP RLS Post Marketing Surveillance
post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
- Trial name
- REQUIP RLS PMS (NCT01327339)
- Testing
- Ropinirole
- Volunteers
- 755 people
- Sponsor
- GlaxoSmithKline