Clinical trials: Surveillance
Hypervolemic and Euvolemic Hyponatremia
Samsca Post Marketing Surveillance Study
This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011~31Aug2017).
- Trial name
- Samsca PMS (NCT02722863)
- Where
- 4 sites in South Korea
- Volunteers
- 908 people
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
Type 1 Diabetes
The iLet Experience Study
A one-year, prospective single-arm cohort study to collect safety and effectiveness data on the iLet Dosing Decision Software during real-world use in people 6 years of age or older with type 1 diabetes (T1D) with 12 months…
- Trial name
- NCT06891898
- Testing
- iLet Dosing Decision Software
- Where
- United States
- Volunteers
- 1,875 people
- Sponsor
- Beta Bionics, Inc.
Rhinitis, Allergic, Perennial and Seasonal
Regulatory AVAMYS Nasal Spray PMS
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients according to the prescribing information.
- Trial name
- NCT01001130
- Testing
- fluticasone furoate group
- Where
- South Korea
- Volunteers
- 3,244 people
- Sponsor
- GlaxoSmithKline
Unresectable Hepatocellular Carcinoma
Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
This investigation will be conducted to collect information of safety in patients with unresectable hepatocellular carcinoma (HCC) treated with the combination therapy of IMJUDO 25 mg, 300 mg and IMFINZI Intravenous Infusion 120…
- Trial name
- NCT05667064
- Volunteers
- 1,200 people
- Sponsor
- AstraZeneca
Hemophilia B
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
To provide safety and effectiveness information of BeneFIX during the post-marketing period as required by Korea FDA regulations, to identify any potential drug related treatment factors in Korean population including: 1) Unknown…
- Trial name
- NCT00484185
- Testing
- BeneFIX (coagulation factor IX (recombinant))
- Where
- South Korea
- Volunteers
- 183 people
- Sponsor
- Pfizer
Viral Gastroenteritis Due to Rotavirus
Canadian Rotavirus Surveillance Through the Immunization Monitoring Program Active (IMPACT)
Rotavirus Hospital Admissions Surveillance Retrospective surveillance for 2010 and 2011 for hospital admissions in children aged 0 to 16 years due to rotavirus gastroenteritis will be completed by all centers of the IMPACT…
- Trial name
- NCT01633190
- Where
- 12 sites in Canada
- Volunteers
- 2,500 people
- Sponsor
- Canadian Paediatric Society
HIV Infection
Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe
The purpose of this study is to monitor adverse events in HIV-infected children <18 years old who are exposed to Atazanavir in a real-world setting in Europe.
- Trial name
- NCT01389310
- Where
- 9 sites in Belgium, Germany and 5 more
- Volunteers
- 249 people
- Sponsor
- Bristol-Myers Squibb
Myocarditis, Myocarditis Acute
MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
Myocarditis is inflammation of the heart muscle. Pericarditis is inflammation of the lining surrounding the heart muscle. Symptoms of these conditions can include pain in the chest and rapid or irregular heartbeat.
- Conditions
- Myocarditis, Myocarditis Acute, Pericarditis, Pericarditis Acute
- Trial name
- MYCOVACC (NCT06103123)
- Testing
- Stand of care ECG, Holter, MRI, ECHO, Quality of life questionnaire, Baseline Quality of Life questionnaire
- Where
- Canada
- Volunteers
- 500 people
- Sponsor
- Cardiology Research UBC
Prevention of Infectious Disease Caused by SARS-CoV-2
VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Long-term Safety of VAXZEVRIA
This survey will be conducted for the subjects who participate in the priority survey (cohort survey) conducted by the Scientific Research Group of the Ministry of Health, Labour and Welfare at the initial stage of administration…
- Trial name
- NCT05135455
- Where
- 6 sites in Japan
- Volunteers
- 467 people
- Sponsor
- AstraZeneca
Attenuated Familial Adenomatous Polyposis, Deleterious Familial Adenomatous Polyposis
Non-Surgical Management of Attenuated and Deleterious (Classical) Familial Adenomatous Polyposis: A Long-term Surveillance Program
The primary objective of this chart review study is to evaluate the outcomes of subjects with Attenuated Familial Adenomatous Polyposis (AFAP) and Deleterious Familial Adenomatous Polyposis (FAP) who have not undergone surgical…
- Trial name
- NCT02747862
- Testing
- Chart Review
- Where
- United States
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other
Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"
The purpose of this study is to evaluate the safety and efficacy on participants receiving first-line eradication and second-line eradication including vonoprazan (Takecab) tablets (triple therapy) in the routine clinical setting.
- Trial name
- NCT03219723
- Testing
- Vonoprazan, Amoxicillin hydrate, Clarithromycin
- Where
- Japan
- Volunteers
- 560 people
- Sponsor
- Takeda
Soil-transmitted Helminth Infections
Monitoring Drug Efficacy and Anthelmintic Resistance in Soil-transmitted Helminth Programs
Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retardation and cognitive…
- Trial name
- StarwormsWP2 (NCT04177654)
- Testing
- Benzimidazoles
- Where
- 8 sites in Bangladesh, Cambodia and 6 more
- Volunteers
- 9,457 people
- Sponsor
- University Ghent
Osteoarthritis, Traumatic Arthritis
The Post-marketing Surveillance to Evaluate the Efficacy of CHONDRON (Autologous Cultured Chondrocyte) by Arthroscopy
A clinical trial to evaluate the long-term efficacy and safety of Chondron (Autologous cultured Chondrocyte) administered through arthroscopy from the drug's 48 weeks efficacy and safety evaluation with 96 weeks follow-up in…
- Trial name
- NCT02539069
- Testing
- Chondron Implantation
- Where
- South Korea
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Cellontech Co., Ltd.
Chronic Idiopathic Constipation (CIC)
Post-Marketing Study of Prucalopride Safety In Pregnancy
This study collects information on pregnant women with ongoing constipation who took prucalopride and those who did not take prucalopride.
- Trial name
- NCT04869280
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Takeda
PFO - Patent Foramen Ovale
Amplatzer PFO Occluder Post-marketing Surveillance Study
The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical…
- Trial name
- PFO PMS Jpn (NCT04349995)
- Testing
- Amplatzer PFO Occluder
- Where
- Japan
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
Growth & Development, Child Development
Resident Surveillance of Pediatric Patient Developmental Status at the Two Month Preventive Care Visit
The purpose of this study is to evaluate the efficacy of individualized performance feedback coupled with an educational module in improving resident performance of the physical and developmental examination component of…
- Conditions
- Growth & Development, Child Development, Internship and Residency, Education, Medical
- Trial name
- NCT00465361
- Testing
- performance feedback with an educational module
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Children's Mercy Hospital Kansas City
Alzheimer's Desease
Post-marketing Surveillance of Donepezil Hydrochloride Investigation of the Safety and Effectiveness of Combination Therapy of Donepezil Hydrochloride and Memantine Hydrochloride in Patients With Alzheimer's Disease
To investigate the safety and effectiveness about administration of both donepezil hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical practice.
- Trial name
- NCT02162251
- Testing
- Donepezil Hydrochloride
- Where
- Japan
- Volunteers
- 3,482 people
- Sponsor
- Eisai Co., Ltd.
Diphtheria, Tetanus
Regulatory Post-Marketing Surveillance Study for TETRAXIM™
The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT01437423
- Testing
- TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
- Where
- South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pulmonary Disease, Chronic Obstructive
Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease
The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions…
- Trial name
- NCT02231424
- Testing
- Drug: Berodual®
- Volunteers
- 713 people
- Sponsor
- Boehringer Ingelheim
Gastric or Duodenal Ulcers
Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin
The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin
- Trial name
- NCT02099682
- Testing
- Lansoprazole
- Volunteers
- 3,366 people
- Sponsor
- Takeda