Clinical trials: Surveillance
Post Operative Endophthalmitis
Effectiveness and Safety of 0.5% Moxifloxacin Hydrochloride Ophthalmic Solution in Perioperative Sterilization in Patients Undergoing Ophthalmic Surgery
This is a non-interventional, uncontrolled, prospective, multicenter, post marketing surveillance study.
- Trial name
- NCT05413980
- Testing
- Moxifloxacin hydrochloride ophthalmic solution
- Where
- 9 sites in India
- Volunteers
- 102 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes, Diabetes Mellitus, Type 1
Post Marketing Surveillance Study of Biphasic Insulin Aspart 30
This study is conducted in Asia. The aim of this study is to review the safety and efficacy of biphasic insulin aspart 30 in post-marketing use.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT01536613
- Testing
- biphasic insulin aspart 30
- Where
- South Korea
- Volunteers
- 5,346 people
- Sponsor
- Novo Nordisk A/S
Community Acquired Infections
Tigecycline In-Vitro Surveillance Study In Taiwan
In-vitro surveillance study of tigecycline (Tygacil) in Taiwan.
- Trial name
- NCT00488397
- Testing
- In-vitro testing
- Where
- China
- Volunteers
- 7,902 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Biventricular Failure
SynCardia CardioWest TAH-t Postmarket Surveillance Study
The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites that complete the staff training…
- Trial name
- NCT00614510
- Testing
- CardioWest temporary Total Artificial Heart (TAH-t)
- Volunteers
- 196 people
- Sponsor
- SynCardia Systems. LLC
Adult Growth Hormone Deficiency
Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®
Participants are invited to take part in this study because they have AGHD (only severe case). The purpose of this study is to assess long term safety and effectiveness of Sogroya® in patients with AGHD (only severe case) under…
- Trial name
- NCT05230550
- Testing
- Somapacitan
- Where
- 47 sites in Japan
- Volunteers
- 200 people
- Sponsor
- Novo Nordisk A/S
Candidemia
A Laboratory-based Surveillance Study of Candida Bloodstream Infections (MK-0991-093)
This study will evaluate the incidence rate of Candida blood stream infection (candidemia) among people hospitalized in participating medical centers in Brazil, and will assess the antifungal drug susceptibility patterns of…
- Trial name
- NCT01174147
- Volunteers
- 436 people
- Sponsor
- Merck Sharp & Dohme LLC
Inoperable or Recurrent Breast Cancer
Post-marketing Surveillance for the Clinical Safety and Effectiveness of Eribulin Mesylate in Patients With Inoperable or Recurrent Breast Cancer (Study HAL01S)
To investigate of the clinical safety and effectiveness of eribulin mesylate in patients with inoperable or recurrent breast cancer
- Trial name
- NCT01463891
- Testing
- Eribulin Mesylate
- Where
- 223 sites in Japan
- Volunteers
- 963 people
- Sponsor
- Eisai Co., Ltd.
Colonoscopy (Procedure)
Use of GI Genius™ XR Software in Virtual Reality Headset During Routine Colonoscopy
This pilot study will evaluate the usability and safety of software GI Genius™ XR in the Apple Vision Pro™ virtual reality headset when used in conjunction with the GI Genius™ system during routine screening and surveillance…
- Trial name
- NCT07220174
- Testing
- software GI Genius™ XR on headset
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Cosmo Artificial Intelligence-AI Ltd
Stenosis
PMS Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention
The objective of this study is to collect data on the use of the WIRION system in Patients undergoing Percutaneous Intervention of Saphenous Vein Graft (SVG).
- Trial name
- NCT02373852
- Testing
- Saphenous vein graft (SVG) stenting
- Where
- Israel
- Volunteers
- 12 people
- Sponsor
- Gardia Medical
Contraception
Mirena Post-marketing Surveillance in Japan
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of women who are inserted Mirena for intrauterine contraception.
- Trial name
- NCT01414140
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028)
- Where
- Japan
- Volunteers
- 567 people
- Sponsor
- Bayer
Moderate to Severe Chronic Non-cancer Pain
A Safety and Effectiveness Study of Prolonged Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Chronic Non-Cancer Pain
The purpose of this study is to evaluate the safety and effectiveness of prolonged release tapentadol hydrochloride for the relief of moderate to severe chronic non-cancer pain among Filipino patients.
- Trial name
- NCT01719588
- Testing
- No intervention
- Sponsor
- Janssen Pharmaceutica
Influenza
A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older
This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women aged 65 years and older.
- Trial name
- NCT01222403
- Testing
- Fluad_MF59-adjuvanted trivalent influenza subunit vaccine, Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine
- Where
- 23 sites in South Korea
- Volunteers
- 767 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Osseous Paget's Disease
Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -
The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets administered once daily (one tablet per dose) in patients with osseous Paget's disease for 48 weeks from baseline in daily medical…
- Trial name
- NCT02106455
- Testing
- Sodium risedronate
- Where
- 2 sites in Japan
- Volunteers
- 315 people
- Sponsor
- Takeda
Dwarfism, Pituitary
A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.
The purpose of this study is to learn about the safety of Somatrogon for the treatment of pediatric growth hormone deficiency (p GHD) in India.
- Trial name
- NCT06587035
- Testing
- Somatrogon
- Where
- 4 sites in India
- Volunteers
- 50 people
- Sponsor
- Pfizer
Hypercholesterolemia
Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
Primary Objective: To estimate the overall combined rate of major structural birth defects in infants of mothers with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent®…
- Trial name
- NCT03379558
- Testing
- ALIROCUMAB SAR236553 (REGN727)
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Osteoarthritis of the Knee, Avascular Necrosis of the Femoral Condyle
Multicentre GMK UNI Anatomical Cementless Study - FR
Unicompartmental Knee Arthroplasty (UKA) is the principal surgical alternative to Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee.
- Conditions
- Osteoarthritis of the Knee, Avascular Necrosis of the Femoral Condyle, Revision Surgery
- Trial name
- NCT06715917
- Where
- 5 sites in France, Switzerland
- Volunteers
- 249 people
- Sponsor
- Medacta International SA
Osteoporosis, Postmenopausal
Wellnara Post-marketing Surveillance in Japan
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Wellnara for postmenopausal osteoporosis.
- Trial name
- WELLNARA (NCT01401114)
- Testing
- E2/LNG oral (Wellnara, BAY86-5029)
- Where
- Japan
- Volunteers
- 411 people
- Sponsor
- Bayer
Familial Hypercholesterolemia
Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy
The objectives of this post-surveillance study are to continue to evaluate the safety and effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by evaluating the occurrence of death, cardiovascular…
- Trial name
- Secura (NCT00916643)
- Testing
- HELP Secura (apheresis treatment)
- Volunteers
- 113 people
- Sponsor
- B. Braun Medical Inc.
Mitral Valve Insufficiency, Heart Valve Diseases
NeoChord TACT Post-Market Surveillance Registry
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
- Conditions
- Mitral Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT01784055
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 126 people
- Sponsor
- NeoChord
Influenza
Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)
The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the…
- Trial name
- NCT02567721
- Testing
- Vaccine safety surveillance
- Where
- United Kingdom
- Volunteers
- 11,530 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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