Clinical trials: Surveillance
Cystocele, Uterine Prolapse
Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6
The purpose of this study is to determine the influence of Anterior Pelvic Prolapse Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live.
- Trial name
- NCT01084889
- Testing
- surgical mesh implantation (TiLOOP® Total 6)
- Where
- 9 sites in Germany
- Volunteers
- 292 people
- Sponsor
- pfm medical gmbh
Major Depressive Disorder
Post Marketing Study for the Evaluation of Predictix Antidepressant Clinician Software Support Tool in Prescribing Antidepressant Medication/s for the Treatment of Patients Suffering From Major Depressive Disorder
The study is designed as an open label, one arm study. Up to 30 eligible patients will be enrolled, for whom the Predictix Antidepressant Software tool will be used when prescribed with a medication for their Major Depressive…
- Trial name
- NCT04138290
- Testing
- Predictix Antidepressant Software tool
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Taliaz Ltd.
Infectious Diseases
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such…
- Trial name
- NCT00761462
- Testing
- Ciprofloxacin, Non-quinolone antibiotic
- Where
- 67 sites in United States, Canada
- Volunteers
- 1,029 people
- Sponsor
- Bayer
Kidney Transplantation
Study Investigating Rapamune For Post-Marketing Surveillance
To provide safety and effectiveness information for Rapamune during the post-marketing period as required by Korea Food and Drug Administration (KFDA) regulations in order to identify any potential drug related treatment factors…
- Trial name
- NCT00484094
- Testing
- sirolimus
- Where
- 11 sites in South Korea
- Volunteers
- 209 people
- Sponsor
- Pfizer
Candidemia, Other Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV
The objective of this study is to collect the safety and efficacy data of Eraxis IV (anidulafungin) 100 mg according to Korea Ministry of Food and Drug Safety regulations.
- Trial name
- NCT00802854
- Where
- 10 sites in South Korea
- Volunteers
- 244 people
- Sponsor
- Pfizer
Ankylosing Spondylitis
Study Investigating Enbrel Treatment for Ankylosing Spondylitis
To identify the following problems and questions with respect to the safety and effectiveness of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulations. 1.
- Trial name
- NCT00195416
- Testing
- Etanercept
- Where
- 3 sites in South Korea
- Volunteers
- 526 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Active Moderate to Severe Rheumatoid Arthritis, Active Ankylosing Spondylitis
Korean Post-marketing Surveillance for Xeljanz XR
Xeljanz XR extended-release tablets 11 mg (Tofacitinib citrate) is a drug subject to the risk management plan in accordance with Article 4-1-11 of the "Regulation on Safety of Medicinal Products, etc." in Korea.
- Conditions
- Active Moderate to Severe Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis
- Trial name
- XRPMS (NCT04876781)
- Testing
- Tofacitinib XR
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Pfizer
Relapsing-Remitting Multiple Sclerosis
A Postmarketing Surveillance (PMS) Study to Evaluate the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis (MS) With Interferon Beta 1a (Rebif®)
This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study on the extent to which subject compliance is influenced by use of a variable titration regimen at the start of treatment of relapsing MS…
- Trial name
- TOURIMS (NCT01142492)
- Testing
- Interferon beta-1a
- Volunteers
- 403 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Multiple Myeloma, Myelodysplastic Syndromes
A Study of Special Use Results Surveillance of Revlimid 5mg Capsules
To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval. 1.
- Trial name
- NCT02921802
- Where
- Japan
- Volunteers
- 4,626 people
- Sponsor
- Celgene
Acute and Chronic Wounds
Post-Marketing Surveillance of Vliwazell® Prowound Dressing
This PMCF study is conducted to confirm the effectiveness and safety of the wound dressing Vliwazell® Pro. The aim of the study is to validate the performance of Vliwazell® Pro within its intended purpose and certified…
- Trial name
- Vliwazell (NCT07316556)
- Where
- 8 sites in Germany
- Volunteers
- 208 people
- Sponsor
- Lohmann & Rauscher
Diabetes Mellitus, Type 2
JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus
To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting
- Trial name
- NCT02848833
- Testing
- JARDIANCE 10mg, JARDIANCE 25mg
- Where
- South Korea
- Volunteers
- 3,368 people
- Sponsor
- Boehringer Ingelheim
Japanese Encephalitis
Safety Surveillance After Immunization With IXIARO
This is an active electronic surveillance using data from the Defense Medical Surveillance System (DMSS) to detect and characterize serious, rare adverse events occurring within 42 days after vaccination with the Japanese…
- Trial name
- NCT01335412
- Testing
- Japanese Encephalitis Virus vaccine, inactivated, adsorbed
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Valneva Austria GmbH
Kidney Failure, Graft vs Host Disease
Study Evaluating Sirolimus in Kidney Transplant Recipients in India
To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.
- Trial name
- NCT00195481
- Testing
- Rapamune
- Where
- 5 sites in India
- Volunteers
- 100 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Prostate Cancer Aggressiveness
Active Surveillance SNEP Assay Registry Trial for Prostate Cancer
A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.
- Trial name
- NCT04052048
- Testing
- Subtraction Normalized Expression of Phagocytes Blood Test
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Immunis.AI
Hepatitis C
Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea
The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life…
- Trial name
- NCT02727933
- Where
- South Korea
- Volunteers
- 1,941 people
- Sponsor
- Bristol-Myers Squibb
Polyarticular Juvenile Idiopathic Arthritis
Surveillance of Humira in Korean JIA Patients
Approximately 600 pediatric patients prescribed Humira Injection in usual practice according to the approved Korean product label will be registered into this observational study.
- Trial name
- NCT02141984
- Volunteers
- 28 people
- Sponsor
- AbbVie
Hidradenitis Suppurativa (HS)
Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Subjects
The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis Suppurativa (HS) participants in normal medical practice.
- Trial name
- HS rPMS (NCT03001115)
- Where
- 19 sites in South Korea
- Volunteers
- 17 people
- Sponsor
- AbbVie
Dementia With Lewy Body Disease
Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies (DLB).
To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil hydrochloride in clinical practice as well as its proper use information in participants with DLB.
- Trial name
- NCT02448784
- Testing
- Donepezil Hydrochloride
- Where
- Japan
- Volunteers
- 591 people
- Sponsor
- Eisai Co., Ltd.
Uterine Prolapse Without Vaginal Wall Prolapse
The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse
The objective of the study is to assess the long term safety, durability of clinical effectiveness and cost effectiveness of the NeuGuide™ system when used for vaginal colpopexy in the treatment of uterine prolapse.
- Trial name
- NCT03436979
- Testing
- NeuGuide™ System
- Where
- 15 sites in United States, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Pop Medical Solutions
Pelvic Organ Prolapse
Xenform Postmarket Surveillance Study
To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
- Trial name
- Xenform (NCT01945580)
- Testing
- Prolapse Repair
- Where
- 25 sites in United States
- Volunteers
- 374 people
- Sponsor
- Boston Scientific Corporation
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