Clinical trials: Surveillance
Smoking Cessation
Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients
The primary objective of this Post-Marketing Study is to monitor the safety of a novel smoking cessation drug Varenicline (Champix™) 0.5 mg and 1 mg tablets as used in clinical practice for 12 weeks among Filipino smokers.
- Trial name
- NCT00794365
- Testing
- Varenicline
- Volunteers
- 330 people
- Sponsor
- Pfizer
Pain
Fentanyl for Treatment Pain Caused by Radiotherapy
The purpose of this study is to assess the clinical utility and safety of Fentanyl for pain treatment caused by radiotherapy. Fentanyl is a synthetic pure opioid agonist with a selective activity on µ receptors.
- Trial name
- NCT00523887
- Testing
- Fentanyl transdermal therapeutic system
- Volunteers
- 163 people
- Sponsor
- Johnson & Johnson Taiwan Ltd
Stroke, PFO - Patent Foramen Ovale
Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.
- Conditions
- Stroke, PFO - Patent Foramen Ovale, Cryptogenic Stroke, TIA
- Trial name
- GSO-PFO PMS (NCT05529901)
- Testing
- GORE® CARDIOFORM Septal Occluder
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- W.L.Gore & Associates
Opioid-related Disorders, Opioid Addiction
Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers
To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02871232
- Testing
- Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion
- Volunteers
- 26,500 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Urinary Incontinence, Stress
Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape)
Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a TiLOOP® TAPE surgical mesh for stabilization of the urethra.
- Trial name
- NCT01358214
- Testing
- Questionnaire on Quality of Life.
- Where
- Germany
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- pfm medical gmbh
Hypertension
Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter
The Study objective is to assess the performance of the Vessix V2 Renal Denervation System for the treatment of uncontrolled hypertension using an innovative percutaneous Radio Frequency (RF) balloon catheter renal denervation…
- Trial name
- REDUCE-HTN (NCT01541865)
- Testing
- Renal Denervation
- Where
- 26 sites in Australia, Austria and 6 more
- Volunteers
- 146 people
- Sponsor
- Boston Scientific Corporation
Non-infectious Intermediate, Posterior and Panuveitis
Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients
The objective of this study is to evaluate the safety and effectiveness of Humira® (Adalimumab) for the treatment of non-infectious intermediate, posterior, or panuveitis patients under a routine treatment practice.
- Trial name
- NCT03339102
- Where
- 17 sites in South Korea
- Volunteers
- 158 people
- Sponsor
- AbbVie
Malaria, Malaria Vaccines
A Study Assessing the Safety, Efficacy, and Impact of GlaxoSmithKline Biologicals' RTS, S/AS01E Malaria Vaccine in Young Children Across Sub-Saharan Africa
The RTS, S/AS01E vaccine was developed to protect children in sub-Saharan Africa from malaria as part of routine immunization programs. This study aims to check the vaccine's safety after it has been introduced.
- Trial name
- EPI-MAL-003 (NCT03855995)
- Testing
- Whole blood sample
- Where
- 6 sites in Ghana, Kenya and 1 more
- Volunteers
- 77,953 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Carotid Artery Disease
Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)
The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease during peri-approval/initial commercialization in relation to the outcomes of…
- Trial name
- NCT00231231
- Testing
- -PRECISE Nitinol Stent System (5F, 5.5F and 6F), ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW)
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Cordis US Corp.
BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor
Special Drug Use-results Surveillance of Tafinlar/Mekinist
This is a prospective, multicenter, single-arm, non-interventional and observational J-PMS conducted by the central registration system and operated in Electronic data capture.
- Trial name
- NCT06262919
- Testing
- Tafinlar/Mekinist
- Where
- 70 sites in Japan
- Volunteers
- 110 people
- Sponsor
- Novartis Pharmaceuticals
Thoracoabdominal Aortic Aneurysm, Pararenal Aortic Aneurysm
TAMBE Japan Post-Marketing Surveillance
To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.
- Trial name
- NCT07147569
- Testing
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
- Where
- 5 sites in Japan
- Volunteers
- 100 people
- Sponsor
- W.L.Gore & Associates
Kidney Disease, Chronic
JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD)
The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice.
- Trial name
- NCT06287073
- Testing
- JARDIANCE®
- Where
- 12 sites in South Korea
- Volunteers
- 299 people
- Sponsor
- Boehringer Ingelheim
Prostate Cancer
Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing
This registry will evaluate treatment selection for patients with newly diagnosed, localized prostate cancer following Prolaris testing.
- Trial name
- NCT04404894
- Where
- 7 sites in United States
- Volunteers
- 500 people
- Sponsor
- Myriad Genetic Laboratories, Inc.
Non-small Cell Lung Cancer, Metastatic Colorectal Cancer
A Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Various Cancer
This is a prospective, single-arm, open-label, non-interventional, multicenter, post-marketing surveillance to assess the safety and effectiveness of Zirabev(Bevacizumab biosimilar) in domestic patients with non-small cell lung…
- Conditions
- Non-small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Breast Cancer, Metastatic Kidney Cancer
- Trial name
- NCT04889495
- Testing
- Zirabev
- Sponsor
- Pfizer
Carcinoma, Renal Cell
Nexavar Post-marketing Surveillance for Renal Cell Carcinoma 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 been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC).
- Trial name
- NCT01411423
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- Japan
- Volunteers
- 3,305 people
- Sponsor
- Bayer
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.
Degenerative Joint Disease
Post Market Clinical Follow Up of LEGION™ Primary TKS With VERILAST™
LEGION™ Primary Total Knee System is CE-marked and marketed in all study regions. This study serves as post-market surveillance for LEGION™ Primary Total Knee System with the VERILAST™ bearing surface (OXINIUM™ femoral component…
- Trial name
- NCT02380092
- Testing
- LEGION™ Primary TKS with VERILAST™ Bearing Surface
- Where
- 7 sites in Austria, Germany and 1 more
- Volunteers
- 163 people
- Sponsor
- Smith & Nephew, Inc.
Parkinson's Disease
SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)
The objective of the Post Marketing Surveillance Study is to investigate the use of the non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy in patients with Morbus Parkinson.
- Trial name
- NCT00727727
- Testing
- Piribedil
- Where
- 2 sites in Germany
- Volunteers
- 750 people
- Sponsor
- Desitin Arzneimittel GmbH
Urothelial Cancer
A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection
Enfortumab vedotin (or PADCEV Injection) is a treatment for cancer in the bladder lining (urothelial cancer). PADCEV Injection is now available to treat this cancer.
- Trial name
- NCT06011954
- Testing
- Enfortumab Vedotin
- Where
- 22 sites in South Korea
- Volunteers
- 228 people
- Sponsor
- Astellas Pharma Korea, Inc.
Graft Rejection, Heart Diseases
IMAGE: A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection
This study is designed to evaluate the safety and efficacy of a leukocyte gene expression profiling method in the monitoring of asymptomatic heart transplant patients for acute rejection.
- Trial name
- NCT00351559
- Testing
- AlloMap molecular expression testing, Right ventricular endomyocardial biopsy
- Where
- 13 sites in United States
- Volunteers
- 629 people
- Sponsor
- XDx
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