Clinical trials: Surveillance
Dengue, Dengue Vaccines
This Study Will Describe the Burden of DENgue Fever Virus (DENV) Illness Among Household Members Aged 6 Months to 50 Years of Selected Communities in Latin America and Southeast Asia
The purpose of this study is to describe the burden of DENV illness among household members aged 6 months to 50 years of selected communities in Latin America and Southeast Asia.
- Trial name
- NCT02766088
- Testing
- Blood sample collection
- Where
- 2 sites in Mexico, Philippines
- Volunteers
- 1,750 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea
The purpose of this study is to collect safety information following routine vaccination with Synflorix™ among infants in Korea.
- Trial name
- NCT01248988
- Testing
- Synflorix™ Data collection
- Where
- South Korea
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Conjunctivitis, Allergic
Safety and Efficacy of Lastacaft® for the Prevention of Itching Associated With Allergic Conjunctivitis in Korea
This post-marketing surveillance study will assess the safety and efficacy of Lastacaft® Opthalmic Solution 0.25% (Alcaftadine) for the prevention of itching associated with Allergic Conjunctivitis as prescribed as standard of…
- Trial name
- NCT02555761
- Testing
- Alcaftadine Ophthalmic Solution 0.25%
- Where
- 81 sites in South Korea
- Volunteers
- 3,423 people
- Sponsor
- Allergan
Ulcerative Colitis, Crohn's Disease
Study of Oral Upadacitinib to Assess Change in Disease Activity and Adverse Events in Adult Participants With Ulcerative Colitis or Crohn's Disease
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract.
- Trial name
- NCT06459297
- Where
- 14 sites in South Korea
- Volunteers
- 105 people
- Sponsor
- AbbVie
Plantar Fasciitis
the Safety and Efficacy of Collagen Injection in Patients With Plantar Fasciitis
The primary objective of this study is to evaluate the safety and efficacy of collagen injection in patients with plantar fasciitis
- Trial name
- NCT02539082
- Testing
- Regenseal, normal saline
- Where
- 3 sites in South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Cellontech Co., Ltd.
Prostate Cancer
Study In Urology Practices Looking At Impact Of OncotypeDX GPS Test On Men Choosing And Remaining On Active Surveillance
Genomic Health's OncotypeDX® Prostate Cancer Assay is a commercially available laboratory test that measures the activity of certain genes in prostate cancer.
- Trial name
- NCT03502213
- Volunteers
- 489 people
- Sponsor
- Genomic Health®, Inc.
Otitis Media
Study of the Hummingbird TTS™ Tympanostomy Tube System
The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under…
- Trial name
- NCT03503591
- Testing
- Hummingbird Tympanostomy Tube System
- Where
- 4 sites in United States
- Volunteers
- 109 people
- Sponsor
- Preceptis Medical, Inc.
Chronic Heart Failure
Optimization of the Ambulatory Monitoring for Patients With Heart Failure by Tele-cardiology
Targeted population: Patients with heart failure causing hospitalization during the last twelve months. Hypothesis: The number of all cause deaths and hospitalizations will be smaller for the Telecardiology group than for the…
- Trial name
- OSICAT (NCT02068118)
- Testing
- Telecardiology program
- Where
- 38 sites in France, Martinique
- Volunteers
- 990 people
- Sponsor
- CDM e-Health
Avascular Necrosis, Osteoarthritis
Continuum™ Metal Bearing System in Total Hip Arthroplasty
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and outcome data on the Continuum Metal Bearing System in primary…
- Conditions
- Avascular Necrosis, Osteoarthritis, Inflammatory Arthritis, Post-traumatic; Arthrosis
- Trial name
- NCT03382652
- Testing
- Metal-on-Metal Articulation
- Where
- 3 sites in United States, Finland
- Volunteers
- 83 people
- Sponsor
- Zimmer Biomet
Prevention of Infectious Disease Caused by SARS-CoV-2
VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Subjects With Underlying Disease at High-risk for Worsening COVID-19
To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance…
- Trial name
- NCT05084755
- Where
- 3 sites in Japan
- Volunteers
- 4 people
- Sponsor
- AstraZeneca
Ulcerative Colitis
Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients
As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following…
- Trial name
- NCT04071405
- Testing
- Non-intervention
- Where
- South Korea
- Volunteers
- 110 people
- Sponsor
- Pfizer
Hodgkin Lymphoma
A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma
This study is a survey in Japan of Brentuximab Vedotin used to treat children or teenagers with Hodgkin lymphoma (HL). The study sponsor will not be involved in how the participants are treated but will provide instructions on…
- Trial name
- NCT05481437
- Testing
- Brentuximab Vedotin
- Where
- Japan
- Volunteers
- 8 people
- Sponsor
- Takeda
Breast Reconstruction After Mastectomy
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra
This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well…
- Trial name
- PRO-BRA (NCT01885572)
- Testing
- TiLOOP Bra
- Where
- 8 sites in Germany
- Volunteers
- 267 people
- Sponsor
- Pfm Medical Mepro Gmbh
Breast Cancer
The ClearCoast™ Magnetic Resonance Outcome PMS Study
Post Marketing Surveillance (PMS) study. Up to 93 patients undergoing breast conserving surgery will be enrolled in a prospective, single center, non-randomized controlled study, and a corresponding number of historical patients…
- Trial name
- NCT05458739
- Testing
- ClearCoast MR System
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 93 people
- Sponsor
- Clear Cut Medical Ltd.
Colon Procedures, Bowel Resection
MIRA Registry Study: Post Market Surveillance Using the MIRA Surgical System
The purpose of the MIRA Surgical System Registry is to accumulate and evaluate real world evidence experience as part of post-market surveillance using the MIRA Surgical System.
- Trial name
- NCT06856707
- Testing
- Use of the MIRA Surgical System during surgery
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Virtual Incision Corporation
Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis
Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients
The purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.
- Trial name
- NCT01901107
- Testing
- Kiklin capsules
- Where
- 8 sites in Japan
- Volunteers
- 1,078 people
- Sponsor
- Astellas Pharma Inc
Heart Valve Diseases
Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study
This non-randomized, prospective, interventional observational multi-center study is designed to assess the long-term clinical performance of the Medtronic Melody™ Transcatheter Pulmonary Valve (TPV) in the post market…
- Trial name
- NCT00688571
- Testing
- Melody Transcatheter Pulmonary Valve
- Where
- 7 sites in Canada, Denmark and 4 more
- Volunteers
- 63 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Prostate Neoplasms
Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Advanced Metastatic Castration Resistant Prostate Cancer
The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC) who have received prior chemotherapy…
- Trial name
- NCT01692483
- Testing
- Abiraterone acetate, Prednisone
- Sponsor
- Janssen Pharmaceutica
Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck, LA SCCHN
A Post Marketing Surveillance Study to Assess the Safety and Efficacy of Cetuximab Plus Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
This prospective, observational, multicentre, post marketing surveillance study will collect safety and efficacy information on patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN) treated with…
- Trial name
- PMS LAD SCCHN (NCT01303237)
- Testing
- Cetuximab + RT
- Where
- 25 sites in India
- Volunteers
- 88 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Endometriosis
Regulatory Post Marketing Surveillance Study in Korea
The objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a subset of patients - at optional long-term…
- Trial name
- NCT01788722
- Testing
- Dienogest (Visanne, BAY86-5258)
- Where
- South Korea
- Volunteers
- 3,223 people
- Sponsor
- Bayer
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