Clinical trials: Surveillance
Influenza, Human
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England
This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu…
- Trial name
- NCT03278067
- Testing
- Enhanced vaccine safety surveillance
- Where
- United Kingdom
- Volunteers
- 23,939 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Coronary Artery Bypass Surgery
CD0104 VEST II Post Marketing Surveillance Study
This study is designed to collect post market data on use of the VEST, particularly on saphenous vein grafts to the right territory of the heart.
- Trial name
- VEST II (NCT02332330)
- Testing
- VEST
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Vascular Graft Solutions Ltd.
DDD, Deformity
MaxAn Post Market Surveillance Validation
This study is being performed to document the outcomes of subjects using our MaxAn Anterior Cervical Plate and assess them for Adjacent level Disease. All subjects will be followed for 2 years.
- Conditions
- DDD, Deformity, Tumor, Fracture
- Trial name
- MaxAn (NCT01343693)
- Where
- 6 sites in United States
- Volunteers
- 119 people
- Sponsor
- Zimmer Biomet
Multiple Sclerosis
Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to siponimod during pregnancy to treat MS.
- Trial name
- NCT04933552
- Testing
- Siponimod
- Where
- United States
- Volunteers
- 867 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Cardiac Event
PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard
The purpose of this study is to determine the incidence of clinically significant rhythm and rate changes in ED patients who are not placed on conventional telemetry, and to test the user-friendliness of a automated clinician…
- Trial name
- PREVENT (NCT00750958)
- Testing
- NetGuard Automated Clinician Alert System
- Where
- 2 sites in United States
- Volunteers
- 287 people, healthy volunteers welcome
- Sponsor
- Datascope Patient Monitoring
Intracranial Aneurysms
Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
The aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks…
- Trial name
- ANCRAGE PMS (NCT06940934)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Acandis GmbH
Liver Neoplasms, Carcinoma, Hepatocellular
A Study of Lenvima (Lenvatinib) in Korean Unresectable Hepatocellular Carcinoma (uHCC) Participants
The purpose of this study is to describe the following safety and the efficacy of Lenvima for the first-line treatment indication of participants with uHHC in the post marketing setting: (1) Serious adverse events and serious…
- Trial name
- NCT05225207
- Testing
- Non-interventional
- Where
- 42 sites in South Korea
- Volunteers
- 658 people
- Sponsor
- Eisai Korea Inc.
Obesity and Overweight
A Multicentre, Prospective, Single-arm, Non-interventional Regulatory Post-marketing Surveillance (rPMS) Study to Investigate the Safety and Effectiveness of Wegovy® (Semaglutide) in Patients With Obesity and Patients With Overweight in Routine Clinical Practice in Korea
This study is conducted to investigate the safety and effectiveness of semaglutide in participants with obesity and overweight in routine clinical practice. Participants will get semaglutide as prescribed by a doctor.
- Trial name
- NCT07018544
- Testing
- semaglutide
- Where
- 8 sites in South Korea
- Volunteers
- 840 people
- Sponsor
- Novo Nordisk A/S
Generalized Pustular Psoriasis
Spesolimab Post-marketing Surveillance in Korean Patients With Flares With Generalized Pustular Psoriasis
The primary and secondary objectives are to respectively monitor the safety and effectiveness of Spesolimab IV in Korean patients with flares with generalized pustular psoriasis (GPP) in a routine medical practice.
- Trial name
- NCT06886009
- Testing
- Spevigo®
- Where
- 4 sites in South Korea
- Sponsor
- Boehringer Ingelheim
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
Acute Myeloid Leukemia
A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Mylotarg) for the potential treatment of acute myeloid leukemia (AML).
- Trial name
- NCT05189639
- Where
- South Korea
- Volunteers
- 165 people
- Sponsor
- Pfizer
Arthropathy of Hip
Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
Post-market clinical follow up investigation on the use of saphir stem and FIN Cup or Dualis system in the treatment of pathologies requiring hip arthroplasty.
- Trial name
- NCT05649007
- Testing
- hip arthroplasty with prosthesis
- Where
- France
- Volunteers
- 630 people
- Sponsor
- Gruppo Bioimpianti S.r.l.
Rhinitis, Urticaria
Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria
Eligible patients will be prescribed Desloratadine 1 tablet of 5 mg once daily. Patients will be asked to follow-up for a final visit after 14 days (Day 15) where the safety, tolerability and clinical efficacy will be measured.
- Trial name
- Aerius (NCT00724698)
- Testing
- Desloratadine
- Volunteers
- 3,011 people
- Sponsor
- Organon and Co
Chronic Lymphocytic Leukemia, Follicular Lymphoma
Observational Study to Monitor Safety and Effectiveness of Obinutuzumab in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia
This study aims to collect clinical data, mainly focused on safety, in the local target population as per the requirement of Korea Ministry of Food and Drug Safety for market authorization.
- Trial name
- NCT03374137
- Testing
- obinutuzumab
- Where
- 17 sites in South Korea
- Volunteers
- 55 people
- Sponsor
- Hoffmann-La Roche
Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax
Special Drug Use Investigation of Ciproxan Injection in Pediatrics
The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.
- Trial name
- NCT02555059
- Testing
- Cipro (Ciprofloxacin, BAYQ3939)
- Where
- Japan
- Volunteers
- 48 people
- Sponsor
- Bayer
Cytomegalovirus (CMV)
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV) is a common virus that infects many people. It can cause serious illness in people with weak immune systems especially in those undergoing transplants.
- Trial name
- NCT06555432
- Testing
- LIVTENCITY
- Where
- South Korea
- Volunteers
- 168 people
- Sponsor
- Takeda
Heart Failure
Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events
The main goal of this study is to use data from the Bodyport Cardiac Scale to help detect of worsening heart failure (HF) early.
- Trial name
- SCALE-HF1 (NCT04882449)
- Testing
- Bodyport Cardiac Scale
- Where
- 8 sites in United States
- Volunteers
- 329 people
- Sponsor
- Bodyport Inc.
Major Depressive Disorder
Korean Post Marketing Surveillance to Observe Effectiveness and Safety of PRISTIQ
On 6 Feb 2014, Pristiq was approved for the treatment of Major Depressive Disorder(MDD) in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS for 600 patients by 5 Feb 2020.
- Trial name
- PMS (NCT02548949)
- Where
- 22 sites in South Korea
- Volunteers
- 700 people
- Sponsor
- Pfizer
Nonsmall Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck
Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy
A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy
- Trial name
- NCT02972216
- Testing
- Nolbaxol, Taxotere, cisplatin
- Volunteers
- 40 people
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
Osteoporosis
BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )
This is an open label, multi-centre, non-interventional post-marketing surveillance.
- Trial name
- BONPMS (NCT01381393)
- Testing
- Ibandronate
- Where
- South Korea
- Volunteers
- 659 people
- Sponsor
- GlaxoSmithKline
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