Clinical trials: Surveillance
Meningitis, Meningococcal Infection
Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children
This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose.
- Trial name
- NCT01689155
- Testing
- Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Overactive Bladder
Toviaz Post Marketing Surveillance Study
The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.
- Trial name
- NCT00879398
- Testing
- Toviaz treatment
- Where
- 82 sites in South Korea
- Volunteers
- 3,000 people
- Sponsor
- Pfizer
Malaria, Malaria Vaccines
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
This epidemiology study was conducted in parallel with the EPI-MAL-002 (NCT02374450) and EPI-MAL-003 (NCT03855995) studies, enrolling participants from the same health and demographic surveillance system (HDSS) (or equivalent…
- Trial name
- NCT02251704
- Testing
- Assessment of body temperature, Blood sampling
- Where
- 12 sites in Burkina Faso, Ghana and 4 more
- Volunteers
- 54,115 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lymphoma, Non-Hodgkin, Lymphocytic Leukemia
Symbenda Post-Marketing Surveillance (PMS)
This is a PMS of Symbenda Injection (bendamustine hydrochloride) in Korean Patients. The main objective is to obtain safety information related to Symbenda treatment from clinical practice.
- Conditions
- Lymphoma, Non-Hodgkin, Lymphocytic Leukemia, Multiple Myeloma
- Trial name
- NCT02434484
- Where
- 9 sites in South Korea
- Volunteers
- 84 people
- Sponsor
- Eisai Korea Inc.
Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"
The purpose of this study is to determine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to diet therapy and exercise therapy alone, or…
- Trial name
- NCT01945216
- Testing
- Alogliptin
- Where
- Japan
- Volunteers
- 3,317 people
- Sponsor
- Takeda
Osteoarthritis(Primary)
A Randomised Multi-centre Study to Compare the Short-term Outcomes of Minimally Invasive and Conventional Surgery in Primary Total Hip Replacement
The purpose of this study is to compare the short-term outcomes of two surgical techniques, minimally invasive and conventional, when used in the treatment of patients with hip joint disease requiring a total hip replacement.
- Trial name
- NCT00208416
- Testing
- DePuy MI System, Conventional surgical technique
- Where
- 2 sites in United Kingdom
- Volunteers
- 58 people
- Sponsor
- DePuy International
Actinic Keratosis
PMS to Evaluate the Safety and Efficacy of Picato® Gel
This study is a mandatory post launch observational study in South Korea of 3.000 patients receiving treatment for the first time with a new medicinal product, ingenol mebutate gel (Picato®), approved for topical treatment of…
- Trial name
- NCT02421471
- Testing
- Ingenol mebutate 0.015 percent or 0.05 percent gel
- Where
- South Korea
- Volunteers
- 1,324 people
- Sponsor
- LEO Pharma
Open-angle Glaucoma, Ocular Hypertension
Travacom Post Marketing Surveillance Study
The purpose of this multi-center, open label, single arm, post-marketing surveillance study is to assess the safety of Travacom in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to…
- Trial name
- NCT01510132
- Testing
- Travoprost/timolol fixed combination (Travacom)
- Sponsor
- Alcon Research
Familial Adenomatous Polyposis
Trial of eRapa to Prevent Progression in Familial Adenomatous Polyposis Patients Under Active Surveillance
Patients with Familial Adenomatous Polyposis (FAP) who are undergoing endoscopic surveillance will be given Encapsulated Rapamycin (eRapa) at one of three escalating doses/schedules for 12 months with the aim of reducing polyp…
- Trial name
- NCT04230499
- Testing
- Encapsulated Rapamycin (eRapa)
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Rapamycin Holdings Inc.
Cervical Dystonia
Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition and Safety in Patients With Cervical Dystonia
Investigation of the clinical condition and safety in patients with cervical dystonia
- Trial name
- NCT02175693
- Where
- 2 sites in Japan
- Volunteers
- 1,647 people
- Sponsor
- Eisai Co., Ltd.
Aspergillosis, Mucormycosis
Post Marketing Surveillance (PMS) Study of Cresemba in Korea.
The purpose of this study is to observe safety and effectiveness of Cresemba in patients with invasive Aspergillosis or invasive Mucormycosis in Korea during the post-marketing surveillance period as required by Ministry of Food…
- Trial name
- NCT04744454
- Testing
- Isauvuconazole group
- Where
- South Korea
- Volunteers
- 94 people
- Sponsor
- Pfizer
Severe Asthma, Chronic Rhinosinusitis With Nasal Polyps(CRSwNP)
Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea
The objectives of this study are to describe the incidence of adverse events and the effectiveness of tezepelumab in patients receiving tezepelumab as indicated for severe asthma or CRSwNP in South Korea.
- Trial name
- Tezepelumab (NCT06998095)
- Volunteers
- 210 people
- Sponsor
- AstraZeneca
Microcephaly, Congenital Infection
Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia
This study will explore whether ZIKV is currently responsible for neurological complications, and particularly microcephaly, in Aedes-infested regions of Sub-Saharan Africa (SSA) and Asia.
- Trial name
- NCT03922594
- Testing
- Differential diagnosis for infectious causes of microcephaly
- Where
- 8 sites in Cameroon, China and 3 more
- Volunteers
- 150 people
- Sponsor
- Institut Pasteur
Diabetes Mellitus, Type 2
Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus
Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
- Trial name
- NCT02367131
- Testing
- JARDIANCE®
- Where
- Japan
- Volunteers
- 419 people
- Sponsor
- Boehringer Ingelheim
Chronic Obstructive Pulmonary Disease
Post Marketing Surveillance of Roflumilast in Korea
The purpose of this study is to evaluate the safety and efficacy of roflumilast in the real-use conditions with its registered indications.
- Trial name
- NCT02068456
- Testing
- Roflumilast
- Where
- South Korea
- Volunteers
- 1,837 people
- Sponsor
- AstraZeneca
HIV-1
Korean Post-marketing Surveillance for Reyataz®
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 Reyataz® so that the regulatory…
- Trial name
- NCT01450605
- Testing
- No Intervention
- Where
- South Korea
- Volunteers
- 601 people
- Sponsor
- Bristol-Myers Squibb
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)
Ulcerative Colitis
A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea
The purpose of this observational study is to assess the real-world safety of ozanimod in Korean participants with moderate to severe active ulcerative colitis.
- Trial name
- NCT06073873
- Testing
- Ozanimod
- Where
- South Korea
- Volunteers
- 3,000 people
- Sponsor
- Bristol-Myers Squibb
Meningococcal Disease, Infections, Meningococcal
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study
This safety surveillance study of GlaxoSmithKline's quadrivalent meningococcal ACWY conjugate vaccine (Meningococcal quadrivalent CRM-197) among children 2 months through 23 months of age is a post-marketing study required by the…
- Trial name
- NCT02287688
- Testing
- Meningococcal quadrivalent CRM-197 conjugate vaccine
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- GlaxoSmithKline
Rhinitis, Allergic, Perennial and Seasonal
Regulatory AVAMYS Nasal Spray PMS
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients according to the prescribing information.
- Trial name
- NCT01001130
- Testing
- fluticasone furoate group
- Where
- South Korea
- Volunteers
- 3,244 people
- Sponsor
- GlaxoSmithKline
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