Clinical trials: Surveillance
Alzheimer's Disease
Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Factors That Affect Aricept Medication Persistence Rate and the Safety and Efficacy in Patients With Alzheimer's Disease in Clinical Practice
To investigate the factors that affect Aricept medication persistence rate and the safety and efficacy in patients with Alzheimer's Disease in clinical practice
- Trial name
- NCT02162264
- Testing
- Donepezil Hydrochloride
- Where
- Japan
- Volunteers
- 8,662 people
- Sponsor
- Eisai Co., Ltd.
Growth Disorders
National Cooperative Growth Study (NCGS): A Post-marketing Surveillance Program for Nutropin, Nutropin AQ, Nutropin Depot, and Protropin
The purpose of this multicenter, open-label, observational, post-marketing surveillance study is to collect long term safety and efficacy information on growth hormone (GH) products: Protropin (somatrem for injection), Nutropin…
- Trial name
- NCT00097539
- Testing
- Somatrem, Somatropin
- Volunteers
- 65,205 people
- Sponsor
- Genentech, Inc.
Spinal Deformity
Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \& Trivium 3D Spinal Deformity Correction System.
- Trial name
- NCT01220505
- Testing
- Surgery
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 66 people
- Sponsor
- Zimmer Biomet
Cardiovascular Procedures, Thoracic Aortic Aneurysm
Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery
This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery.
- Conditions
- Cardiovascular Procedures, Thoracic Aortic Aneurysm, Aortic Valve Replacement, Type A Aortic Dissection
- Trial name
- NCT02164201
- Where
- 2 sites in Germany, Italy
- Volunteers
- 75 people
- Sponsor
- CryoLife Europa
Pneumonia, Meningitis
Colombia Epidemiologic Surveillance Study
The study will determine the reduction in invasive pneumococcal disease (IPD) after the introduction of a National Immunization Program with PCV-7 in Bogota.
- Conditions
- Pneumonia, Meningitis, Bacteremia, Sepsis
- Trial name
- LEAP II (NCT00428051)
- Testing
- Surveillance
- Where
- 3 sites in Brazil, Colombia and 1 more
- Volunteers
- 32,867 people
- Sponsor
- Pfizer
Degenerative Spondylolisthesis, Pseudoarthrosis
Dynesys Spinal System Post Market 522 Study
The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.
- Trial name
- NCT01528072
- Testing
- Dynesys Spinal System
- Where
- 9 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
Breastfeeding, Hypertrophic Cardiomyopathy
Mavacamten Pregnancy Surveillance Program
The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.
- Conditions
- Breastfeeding, Hypertrophic Cardiomyopathy, Pregnancy Related
- Trial name
- NCT05939700
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Bristol-Myers Squibb
Osteoarthritis, Post-traumatic Arthritis
A Randomised Study to Compare Metal Ion Release and Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-Metal or a Metal-on-Metal Bearing
The purpose of this study is to monitor the performance and compare the metal ion release of two bearing combinations, ceramic-on-metal and metal-on-metal in the treatment of patients with hip joint disease requiring a total hip…
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis
- Trial name
- NCT00873444
- Testing
- Pinnacle™ Acetabular System
- Where
- Germany
- Volunteers
- 5 people
- Sponsor
- DePuy International
Fertilization in Vitro
Post-Marketing Surveillance of the Safety and Efficacy of Orgalutran (Ganirelix)®
The purpose of this post-marketing surveillance is to identify problems and questions regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of premature luteinizing hormone (LH) surges in women…
- Trial name
- NCT01304511
- Testing
- Orgalutran
- Volunteers
- 711 people
- Sponsor
- Organon and Co
Renal Transplantation
Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)
The purpose of this observational study is to examine the clinical outcomes of the use of sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD) under conditions of routine clinical practice.
- Trial name
- NCT00697112
- Testing
- Sirolimus
- Where
- 8 sites in Argentina
- Volunteers
- 53 people
- Sponsor
- Pfizer
Breast Augmentation, Breast Reconstruction
A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical…
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants
- Trial name
- NCT07679594
- Testing
- Breast augmentation surgery, Breast reconstruction surgery
- Where
- 2 sites in France, Spain
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- GCA (Eurosilicone)
Prostate Cancer
Evaluation of a Blood Biomarker to Try and Distinguish Between the Presence or Absence of Aggressive Prostate Cancer
A Laboratory Study to Evaluate Urine and Blood Biomarkers That Can Distinguish Between the Presence or Absence of Aggressive Prostate Cancer
- Trial name
- NCT03256630
- Where
- United States
- Volunteers
- 128 people
- Sponsor
- Genomic Health®, Inc.
Pneumococcal Infections
Safety and Local Tolerability of Prevenar in Indian Children
This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children. Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against…
- Trial name
- NCT00488800
- Testing
- pneumococcal conjugate vaccine
- Volunteers
- 1,000 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Gastrointestinal Stromal Tumors
Regorafenib Post-marketing Surveillance in Japan
The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice
- Trial name
- NCT01933958
- Testing
- Regorafenib (Stivarga, BAY73-4506)
- Where
- Japan
- Volunteers
- 72 people
- Sponsor
- Bayer
Diphtheria, Acellular Pertussis
Post Market Surveillance for Infanrix™
The purpose of this study was to investigate the following questions through post-marketing surveillance: Unknown/Unexpected adverse events and the serious adverse events.
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus
- Trial name
- NCT00908115
- Testing
- GSK Biologicals' Infanrix™
- Where
- South Korea
- Volunteers
- 1,258 people
- Sponsor
- GlaxoSmithKline
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
Multiple Sclerosis, Clinically Isolated System
Betaferon® Regulatory Post-Marketing Surveillance
To identify problems/questions about following items in the clinical practice using Betaferon 1. Unknown adverse event (especially serious adverse event) 2. Identification of adverse event occurred in the real practice 3.
- Trial name
- NCT01414816
- Testing
- Interferon beta-1b (Betaseron, BAY86-5046)
- Where
- South Korea
- Volunteers
- 355 people
- Sponsor
- Bayer
COVID-19, Vaccines
Korea Comirnaty Post-marketing Surveillance
This study will collect information on the safety of BNT162b2 products for subjects who have been administered in a routine clinical practice from 05Mar2021 to 04Mar2027 in Korea, and will be conducted in accordance with the New…
- Conditions
- COVID-19, Vaccines, Adverse Effects, SARS-CoV-2
- Trial name
- NCT05032976
- Testing
- Tozinameran 12 Years of age and older, Tozinameran 5 to 11 Years of age, Tozinameran 6 months to 4 years of age
- Where
- South Korea
- Volunteers
- 12,000 people
- Sponsor
- Pfizer
Non-small Cell Lung Cancer
Post Marketing Surveillance of Nintedanib in Indian Patients With Non-small Cell Lung Cancer (NSCLC) After First-line Therapy
This active surveillance aims to collect the safety data of 100 NSCLC patients treated with nintedanib per the approved Indian label within 2 years from the date of commercial availability of the drug in India (23rd January…
- Trial name
- NCT03017885
- Where
- 11 sites in India
- Volunteers
- 28 people
- Sponsor
- Boehringer Ingelheim
Benign Prostatic Hyperplasia, Prostatic Hyperplasia
AVODART(Dutasteride) Post-marketing Surveillance(PMS)
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVODART administered in Korean BPH patients according to the prescribing information
- Trial name
- AVO PMS (NCT01299571)
- Testing
- Dutasteride
- Where
- South Korea
- Volunteers
- 3,977 people
- Sponsor
- GlaxoSmithKline
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