Clinical trials: Surveillance
Osteoporosis
BONVIVA(Ibandronate) Injection PMS(Post-marketing Surveillance)
This is an open label, multi-centre, non-interventional post-marketing surveillance
- Trial name
- BONINJPMS (NCT01376102)
- Testing
- BONVIVA(ibandronate) injection
- Where
- South Korea
- Volunteers
- 657 people
- Sponsor
- GlaxoSmithKline
Aortic Stenosis, Calcific, Aortic Valve Stenosis
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.
- Trial name
- PROGRESS (NCT04889872)
- Testing
- SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,250 people
- Sponsor
- Edwards Lifesciences
Psoriasis
Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis
This is an observational safety study tracking psoriasis patients on etanercept (Enbrel) for 5 years.
- Trial name
- NCT00322439
- Testing
- Etanercept
- Volunteers
- 2,511 people
- Sponsor
- Amgen
Breast Cancer
An Observational Study of Herceptin SC Safety in Breast Cancer
This is a phase IV, prospective, multicenter, observational study (regulatory post-marketing surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab, subcutaneous administration) per approved…
- Trial name
- NCT02305628
- Where
- 23 sites in South Korea
- Volunteers
- 600 people
- Sponsor
- Hoffmann-La Roche
Treatment of Obesity
A Post-Market Surveillance Study of Using the g-Cath EZ for Treating Obesity
This is a multi-center, prospective study evaluating a treatment for obesity.
- Trial name
- NCT03721731
- Testing
- Obesity treatment with a Plication device
- Where
- 2 sites in Spain
- Volunteers
- 39 people
- Sponsor
- USGI Medical
Blepharospasm, Hemifacial Spasm
Post Marketing Surveillance Study of Dysport
The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.
- Conditions
- Blepharospasm, Hemifacial Spasm, Cervical Dystonia, Spasmodic Torticollis
- Trial name
- NCT00210431
- Where
- 36 sites in France, Germany and 1 more
- Volunteers
- 783 people
- Sponsor
- Ipsen
Lupus Erythematosus, Systemic
SAPHNELO Systemic Lupus Erythematosus Japan Post-Marketing Surveillance (PMS)
To collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus in the real-world post-marketing setting.
- Trial name
- NCT05141201
- Where
- 47 sites in Japan
- Volunteers
- 1,620 people
- Sponsor
- AstraZeneca
Maternal Complications, Pregnancy Complication
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.
- Conditions
- Maternal Complications, Pregnancy Complication, Birth Outcomes, Adverse, Pregnancy
- Trial name
- NCT06113237
- Testing
- Epidiolex
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 50 people
- Sponsor
- Jazz Pharmaceuticals
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
Healthy
Acute Respiratory Illness Surveillance (AcRIS) With Mobile Application in a Low-Interventional Decentralized Study.
The purpose of the AcRIS study is to obtain data to characterize the relationship between symptoms and voice features for (reverse transcription polymerase chain reaction (RT-PCR) confirmed severe acute respiratory syndrome…
- Trial name
- NCT04748445
- Testing
- SARS-CoV-2/Influenza/RSV RT-PCR
- Where
- United States
- Volunteers
- 9,151 people, healthy volunteers welcome
- Sponsor
- Pfizer
Diabetes Mellitus, Type 2
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information
- Trial name
- AVANDAMETPMS (NCT01294553)
- Testing
- Administration of rosiglitazone/metformin
- Volunteers
- 717 people
- Sponsor
- GlaxoSmithKline
Hepatocellular Carcinoma, Hepatocellular Cancer
ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.
- Conditions
- Hepatocellular Carcinoma, Hepatocellular Cancer, Hepatitis B, Cirrhosis
- Trial name
- NCT05064553
- Testing
- Study CT/MRI Imaging, Standard of Care CT/MRI Imaging, Oncoguard™ Liver Test
- Where
- 76 sites in United States
- Volunteers
- 2,990 people
- Sponsor
- Exact Sciences Corporation
Pulmonary Disease, Chronic Obstructive
Post-marketing Surveillance of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease
Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice
- Trial name
- NCT02233894
- Testing
- Atrovent® - inhalets
- Volunteers
- 526 people
- Sponsor
- Boehringer Ingelheim
Pregnancy Related
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12…
- Trial name
- NCT06258902
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ipsen
Alopecia
AVODART® Alopecia Post-marketing Surveillance (PMS)
Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients
- Trial name
- AVODART®PMS (NCT01004809)
- Testing
- Dutasteride
- Where
- South Korea
- Volunteers
- 712 people
- Sponsor
- GlaxoSmithKline
Malignant Glioma
Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma
The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study).
- Trial name
- NCT02300506
- Testing
- No intervention
- Where
- 2 sites in Japan
- Volunteers
- 507 people
- Sponsor
- Eisai Co., Ltd.
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
Diabetes Mellitus, Type 2
Korean Post-marketing Surveillance for Onglyza®
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 Onglyza® so that the regulatory…
- Trial name
- NCT01575483
- Testing
- No Intervention (subjects were previously treated with Onglyza®)
- Where
- South Korea
- Volunteers
- 3,433 people
- Sponsor
- AstraZeneca
Peritoneal Neoplasms
An Observational Study of Avastin (Bevacizumab) in Combination With Carboplatin/Paclitaxel in First Line in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (OTILIA)
This observational study will evaluate the safety, efficacy, quality of life and predictive/selection factors for Avastin (bevacizumab) in combination with carboplatin/paclitaxel in first line in patients with advanced epithelial…
- Trial name
- NCT01697488
- Where
- Germany
- Volunteers
- 1,090 people
- Sponsor
- Hoffmann-La Roche
Chronic Heart Failure
Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
Medtronic is sponsoring the Apogee study to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation/ antiplatelet therapy in patients receiving a Medtronic…
- Trial name
- NCT03697980
- Testing
- HeartWare Ventricular Assist Device
- Where
- 33 sites in United States
- Volunteers
- 136 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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