Clinical trials: Pharmacovigilance
SARS-CoV-2 Acute Respiratory Disease
Active Pharmacovigilance Study of Adsorbed COVID-19 (Inactivated) Vaccine
This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.
- Trial name
- NCT04845048
- Testing
- Adsorbed COVID-19 (Inactivated) Vaccine
- Where
- 3 sites in Brazil
- Volunteers
- 2,549 people, healthy volunteers welcome
- Sponsor
- Butantan Institute
COVID-19 Vaccine Adverse Reaction
Safety Study About the mRNA Vaccines Against COVID-19 in Children (PEDIVACOV-HCSC)
Drugs side effects in children need to be evaluated in a different way because of their constant growth and body changes. The use of COVID-19 vaccines (mRNA vaccines) is worldwide spread as a safety measure against the pandemic.
- Trial name
- PEDIVACOV-HCSC (NCT06646744)
- Testing
- mRNA COVID-19 vaccine
- Where
- Spain
- Volunteers
- 2,100 people, healthy volunteers welcome
- Sponsor
- Ana Belen Rivas Paterna
Qt Interval, Preterm Birth
QTc Intervals in Former Preterm/Extreme Low Birth Weight Infants: a Pooled Study Proposal
Pooling effort to collect previously reported data on QTc time in former preterm neonates, and compare these data to controls. At present and based on a recently conducted systematic search, there are conflicting data on the…
- Trial name
- NCT05243537
- Testing
- ECG (diagnostic)
- Where
- 2 sites in Belgium, Canada
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Vaccine Adverse Reaction
COVID-19 Vaccines Associated Malaise
COVID-19 vaccines induced malaise have recently been reported in the literature. Our study aims to identify risk factors associated with the onset of COVID-19 vaccines induced malaise and to assess if certain COVID-19 vaccines…
- Trial name
- NCT05234333
- Testing
- SARS-CoV-2 vaccine
- Where
- France
- Volunteers
- 1,534,706 people, healthy volunteers welcome
- Sponsor
- University Hospital, Caen
Adverse Drug Reactions
A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women
This was a retrospective cohort study of pregnant women who had received the AdimFlu-S (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed by chart review.
- Trial name
- NCT01354730
- Volunteers
- 398 people, healthy volunteers welcome
- Sponsor
- Adimmune Corporation
Adverse Drug Event
Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing
HYPOTHESIS An advanced practice nursing intervention in the area of pharmacovigilance performed on patients and professionals improves the identification and reporting of suspected adverse drug reactions (ADR) and improves the…
- Trial name
- IMPACTO (NCT05402254)
- Testing
- Pharmacovigilance Program
- Where
- Spain
- Volunteers
- 395 people, healthy volunteers welcome
- Sponsor
- Natalia Rodriguez Galan
Controlled Drug Dependence
Evaluation of the Effectiveness of a Continuing Education Program in Community Pharmacies
Preventable failures in the drug chain are related to Drugs Problems Related Use and are associated with medication errors (prescription, dispensing, administration or use by the patient or caregiver), including failures In the…
- Trial name
- NCT03388567
- Testing
- Staff pharmacy whith intervention
- Where
- Colombia
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Universidad de Antioquia
Tuberculosis
Safety of doTBal® in Patients With Tuberculosis: Conduction of an Intensive Pharmacovigilance Program
Phase IV, observational, cohort, prospective study. With duration according to the indicated scheme, 6 months of treatment (2 intensive months and 4 months of sotén) for pulmonary tuberculosis.
- Trial name
- NCT04916899
- Testing
- Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol
- Where
- Mexico
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
Vaccine Adverse Reaction
Transverse Myelitis Related to SARS-CoV-2 Vaccines
Few patients receiving SARS-CoV-2 vaccines may experience rare but serious adverse events such as transverse myelitis (TM). Today, data about TM are scarce.
- Trial name
- NCT05178264
- Testing
- SARS-CoV-2 vaccines
- Where
- France
- Volunteers
- 580 people, healthy volunteers welcome
- Sponsor
- University Hospital, Caen
Human Immunodeficiency Virus, Tuberculosis
Usability Study of IeHS in Indonesia
Technology that has a particular focus on patients' needs and ease-of-use and -access plays a significant role in the development of e-health and m-health.
- Conditions
- Human Immunodeficiency Virus, Tuberculosis, Interpersonal Relations, Mobile Phone Use
- Trial name
- NCT04179344
- Testing
- Integrated e-healthcare services (IeHS) web-based app
- Where
- 3 sites in Indonesia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Bekasi City Public Hospital
Malaria in Pregnancy, Pregnancy Related
MiMBa Pregnancy Registry
The MiMBa (Malaria in Mothers and Babies) Pregnancy Registry aims to generate robust evidence on the safety of a range of antimalarials when used in pregnancy, particularly in the first trimester.
- Conditions
- Malaria in Pregnancy, Pregnancy Related, Congenital Anomaly
- Trial name
- NCT04825782
- Where
- 2 sites in Burkina Faso, Kenya
- Volunteers
- 15,391 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Drug Reaction, Drug Hypersensitivity
An Evaluation of Healthcare Providers' Adherence to Pharmacovigilance Practices in an African Community
Egypt's several regions-rural, mixed, and urban-were given pre-designed surveys pertaining to drug adverse events and the role of pharmacovigilance in detection and reporting.
- Conditions
- Drug Reaction, Drug Hypersensitivity, Drug Abuse, Drug Interaction
- Trial name
- NCT06428162
- Testing
- questionner
- Where
- Egypt
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Deraya University