Clinical trials: Pharmacovigilance
Osteoarthritis, Knee, Osteoarthritis, Hip
Helping Osteoarthritis Patients to Walk With NSAID
There is a lack of effective analgesic treatments to help walking patients with painful hip/knee osteoarthritis. Our team therefore imagined a new strategy lying on a multimodal rehabilitation walking program with the help of a…
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Chronic Pain
- Trial name
- PERIPATEI (NCT05761015)
- Testing
- therapeutic program including intermittent drug intake and multimodal rehabilitation program
- Where
- France
- Volunteers
- 55 people
- Sponsor
- University Hospital, Clermont-Ferrand
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
Diabetes, Depression
e-Pharmacovigilance II - Surveillance for Safety and Effectiveness - Calling for Earlier Detection of Adverse Reactions
Specific Aim 1: To develop a patient-reported, EHR-integrated system to actively monitor the safety and effectiveness of treatment for patients taking FDA-approved medications for one of four common chronic conditions (diabetes…
- Conditions
- Diabetes, Depression, Insomnia, Hypertension
- Trial name
- CEDAR (NCT02087293)
- Testing
- Intervention arm - automated call and phone-based pharmacist counseling
- Where
- United States
- Volunteers
- 38,400 people
- Sponsor
- Brigham and Women's Hospital
Cancer
Myelodysplastic Syndrome and Acute Myeloid Leukemia Related to PARP Inhibitors (MyeloRIB)
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but life-threatening adverse events such as myelodysplastic syndrome (MDS) and/or acute myeloid…
- Trial name
- NCT04326023
- Testing
- PARP Inhibitors
- Where
- France
- Volunteers
- 178 people
- Sponsor
- University Hospital, Caen
Malignancies, Cardiovascular Diseases
Cancer Therapy-related Cardiac Dysfunction Occuring in Children Treated by Anticancer Drugs for Malignancies
Little is known about cancer therapy-related cardiac dysfunction occuring in children treated by anticancer drugs for malignancies.
- Conditions
- Malignancies, Cardiovascular Diseases, Children, Only
- Trial name
- NCT05602103
- Testing
- use of anticancer drugs in monotherapy or in combination therapy
- Volunteers
- 10,000 people
- Sponsor
- University Hospital, Caen
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
Atrial Fibrillation
Identification of Immunomodulators Associated With Atrial Fibrillation Reporting: Analysis of the WHO Pharmacovigilance Database
Atrial fibrillation is the most prevalent sustained arrhythmia worldwide with a great morbimortality. Some populations are more at risk to develop atrial fibrillation like patients suffering from inflammatory diseases or patients…
- Trial name
- NCT06095791
- Testing
- Immunomodulators with FDA approval on the 1st January 2023.
- Where
- France
- Volunteers
- 4,000,000 people
- Sponsor
- University Hospital, Caen
Psychosis
Psychosis Associated With Methylphenidate in Children and Adolescents
perform a study in VigiBase® to assess if methylphenidate was associated with an over-reporting of psychosis including hallucinations in children and adolescents and to characterize those psychosis.
- Trial name
- NCT06518330
- Testing
- Intake of Methylphenidate
- Where
- France
- Volunteers
- 46,233 people
- Sponsor
- University Hospital, Caen
Immunoglobulins, Intravenous, Hemolysis
Isoagglutinins in the Development of IVIG-associated Hemolysis
Patients at high risk of IVIG-associated hemolysis (defined as receipt of a 28-day cumulative dose of ≥ 2 g/kg, adjusted for ideal body weight, and non-O blood group) will be prospectively monitored using a standardized protocol…
- Trial name
- NCT02259478
- Where
- 6 sites in Canada
- Volunteers
- 144 people
- Sponsor
- Toronto Transfusion Medicine Collaborative
Hemophilia A
Study Evaluating Refacto For Pharmacovigilance
The purpose of this study is to investigate the effectiveness and safety of treatment with ReFacto under conditions of routine therapy. Furthermore a continuous benefit/risk assessment will be done.
- Trial name
- NCT00195442
- Testing
- Moroctocog alfa
- Where
- 26 sites in Austria, Germany
- Volunteers
- 288 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Dementia, Depression
Geriatric Psychiatry and Pharmacovigilance
The purpose of this observational multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients.
- Conditions
- Dementia, Depression, Schizophrenia, Psychosomatic Disorders
- Trial name
- GAP (NCT01858857)
- Where
- 5 sites in Germany
- Volunteers
- 4,000 people
- Sponsor
- Hannover Medical School
Epilepsy, Partial
Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy
Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the…
- Trial name
- NCT00643500
- Testing
- Levetiracetam
- Volunteers
- 342 people
- Sponsor
- UCB Pharma
Benign Prostatic Hyperplasia
Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia
This study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after treatment initiation), and end of treatment phase (visit 3 - end of year 1).
- Trial name
- NCT00593593
- Volunteers
- 1,000 people
- Sponsor
- GlaxoSmithKline
Heart Diseases
CardioTOxicity Induced by andRogeNICS and Their Antagonists (TORNICS)
Anti-androgenic therapies relying on peripheral and/or central blockade for the treatment of prostate cancer seems to have an impact on the cardio-vascular system.
- Trial name
- TORNICS (NCT03193138)
- Testing
- Hormonal therapies: G03, H01C and L02 in the ATC classification
- Where
- France
- Volunteers
- 3,096 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Malaria, Falciparum, HIV Infections
Interactions Between Artemether-lumefantrine and Antiretrovirals in HIV-patients With Uncomplicated Malaria in Tanzania
As HIV/AIDS is spreading in malaria-endemic countries, many patients here will need concomitant treatment for both infections. Effective combination treatments are available for both malaria (artemisinin-based combination…
- Trial name
- InterACT (NCT00885287)
- Testing
- Artemether-lumefantrine (AL)
- Where
- Tanzania
- Volunteers
- 830 people
- Sponsor
- University of Copenhagen
Cancer
Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events
Although immune checkpoint inhibitors (ICIs) have proved effective in treating many cancers, patients receiving ICIs may experience immune-related adverse events (irAEs).
- Trial name
- 19-916 (NCT04169503)
- Testing
- Immune Checkpoint Modulator
- Where
- France
- Volunteers
- 17,562 people
- Sponsor
- University Hospital, Caen
Pharmacovigilance, Oncology
Responsible Side Effects Management in Oncology
Study of pharmacovigilance in oncology. Monitoring and management of AEs during antineoplastic treatment.
- Conditions
- Pharmacovigilance, Oncology, Antineoplastic Treatment
- Trial name
- R-SEMO (NCT04623437)
- Where
- Croatia
- Volunteers
- 267 people
- Sponsor
- University Hospital Sestre Milosrdnice
Von Willebrand Disease
A Canadian Study to Assess the Safety of Humate-P® Ivr (Infusion Volume Reduced)
As part of CSL Behring Canada's continued commitment to ensuring the safety of the new low volume preparation of Humate-P®, CSL Behring Canada proposes to conduct a prospective, multi-center structured data collection of routine…
- Trial name
- NCT00701545
- Where
- Canada
- Volunteers
- 21 people
- Sponsor
- CSL Behring
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
Arthritis, Cancer
Immune CHeckpoint Inhibitors Monitoring of Adverse Drug ReAction
Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) from rhumatologic, endocrinologic, cardiac or other system origin.
- Conditions
- Arthritis, Cancer, Cardiac Disease, Endocrine System Diseases
- Trial name
- CHIMeRA (NCT03492242)
- Testing
- Immune checkpoint inhibitor
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere