Clinical trials: Surveillance
Renal Cell Carcinoma
A Post Marketing Surveillance As Required By Philippine Food And Drug Administration
This is a post marketing surveillance which determines the safety profile of the product to Filipinos. This is a FDA requirement for registration.
- Trial name
- NCT01781442
- Testing
- Temsirolimus
- Sponsor
- Pfizer
Carcinoma, Squamous Cell of Head and Neck
A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
This is a prospective, observational, non-interventional, multicenter, post-marketing surveillance study to mainly collect safety information from subjects with locally advanced and recurrent/metastatic Squamous Cell Carcinoma of…
- Trial name
- NCT01080066
- Testing
- No Intervention
- Where
- Taiwan
- Volunteers
- 215 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Genetic Disorder, Noonan Syndrome
Post Marketing Surveillance on Long-term Use With Norditropin® (Short Stature Due to Noonan Syndrome)
The purpose of this study is to collect information about safety and effectiveness for long term use of Norditropin®. Participants will attend the medical institution according to usual practice and receive medical care, as…
- Trial name
- NCT03435627
- Testing
- Somatropin
- Where
- 22 sites in Japan
- Volunteers
- 71 people
- Sponsor
- Novo Nordisk A/S
Hepatitis C
Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the safety and efficacy of SOF administered in…
- Trial name
- NCT02562742
- Testing
- SOF, REB
- Where
- 45 sites in Japan
- Volunteers
- 554 people
- Sponsor
- Gilead Sciences
Ischemic Heart Disease, Angina Pectoris
Absorb GT1 Japan PMS
The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for…
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion
- Trial name
- NCT03409731
- Testing
- ABSORB GT1 BVS
- Where
- 15 sites in Japan
- Volunteers
- 135 people
- Sponsor
- Abbott Medical Devices
Peripheral Vascular Disease, Hemorrhage
The Evicel Post-Authorization Surveillance Study
The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.
- Trial name
- NCT01158261
- Testing
- EVICEL ™ Fibrin Sealant (Human)
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Ethicon, Inc.
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.
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
Obstructive Hypertrophic Cardiomyopathy
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea.
- Trial name
- NCT06146660
- Testing
- Mavacamten
- Where
- 2 sites in South Korea
- Volunteers
- 600 people
- Sponsor
- Bristol-Myers Squibb
Diabetes Mellitus, Type 2
Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics of patients with type 2 diabetes mellitus…
- Trial name
- NCT01650259
- Testing
- OAD, Trazenta
- Where
- Japan
- Volunteers
- 4,876 people
- Sponsor
- Boehringer Ingelheim
Arthritis, Rheumatoid
Safety and Efficacy of Mobic® Ampoules in the Initiation of Treatment of Painful Exacerbations of Osteoarthritis, Rheumatoid Arthritis and Other Similar Painful Inflammatory Conditions
Study to determine the safety and efficacy of Mobic® ampoules in the initiation of treatment of painful exacerbations of osteoarthritis, rheumatoid arthritis and other similar painful inflammatory conditions.
- Trial name
- NCT02184052
- Testing
- Meloxicam
- Volunteers
- 121 people
- Sponsor
- Boehringer Ingelheim
Dengue Virus Infection
Dengvaxia US Pregnancy Registry
The primary objective of this study is to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women and their offspring(s) vaccinated with Dengvaxia during their pregnancy
- Trial name
- DNG00044 (NCT04486638)
- Testing
- Dengue Tetravalent Vaccine, Live
- Where
- Puerto Rico
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Disease
Safety Surveillance of MenACWY-CRM Vaccine in Children
The purpose of this study is to summarize the occurrence of incident serious medically attended events and events of interest up to 1 year following MenACWY-CRM vaccination administered as part of routine clinical care.
- Trial name
- NCT01452438
- Testing
- MenACWY-CRM
- Where
- United States
- Volunteers
- 393 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Obstructive Sleep Apnea of Adult
Real World Experiences of the iNAP® Lite in OSA Adults in Taiwan
A Prospective, Observational, Post-market Surveillance Study to Evaluate the Long-term Safety and Efficacy of the iNAP® Lite Sleep Therapy System in Adults with Obstructive Sleep Apnea
- Trial name
- NCT03559322
- Testing
- iNAP® Lite Sleep Therapy System
- Where
- Taiwan
- Volunteers
- 76 people
- Sponsor
- Somnics, Inc.
Diabetes Mellitus, Type 2
Regulatory Post Marketing Surveillance (rPMS) Study of Ozempic (Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea
The aim of this study is to assess the safety and effectiveness of Ozempic initiated according to label in adults with Type 2 Diabetes Mellitus (T2DM) under routine clinical practice conditions.
- Trial name
- NCT05689372
- Testing
- Semaglutide
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Novo Nordisk A/S
Intracranial Aneurysm
COMPLEX Post Market Surveillance Electronic Registry
To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.
- Trial name
- COMPLEX (NCT00663299)
- Testing
- Endovascular Embolization Device
- Where
- Japan
- Volunteers
- 299 people
- Sponsor
- Codman & Shurtleff
Carcinoma, Non-Small-Cell Lung
A Multicenter Observational PMS Study Assessing Durvalumab Safety in Indian Adults With Resectable NSCLC
This will be a single-arm, multicenter, prospective, observational, real-world study and the data source is the patients' medical record at each site. A total of 78 patients will be enrolled in the study.
- Trial name
- NCT07760519
- Testing
- IMFINZI
- Volunteers
- 78 people
- Sponsor
- AstraZeneca
Growth Hormone Disorders
A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency
This study is a multicenter, open-label, observational, post marketing surveillance program to collect information on the use of NutropinAq® in adults suffering from Growth Hormone Deficiency in Germany, Italy, and United Kingdom
- Trial name
- NCT00455884
- Where
- United Kingdom
- Volunteers
- 546 people
- Sponsor
- Ipsen
Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis
A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential…
- Conditions
- Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Trial name
- NCT06073847
- Testing
- Fedratinib
- Where
- 3 sites in South Korea
- Volunteers
- 137 people
- Sponsor
- Bristol-Myers Squibb
Hypertension, Pulmonary
Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension
The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.
- Trial name
- NCT00185315
- Testing
- Ventavis (Iloprost, BAYQ6256)
- Where
- 16 sites in Belgium, France and 5 more
- Volunteers
- 71 people
- Sponsor
- Bayer
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