Clinical trials: Pharmacovigilance
Lymphoma, Leukemia
Clozapine and Haematologic Malignancies: Observational and Retrospective Study Using the WHO Pharmacovigilance Database
Clozapine may lead to various adverse reactions, including neutropenia and agranulocytosis. This study investigates reports of lymphoma and leukaemias for clozapine in the World Health Organization's (WHO) global database of…
- Trial name
- CLOZARIX (NCT04074213)
- Testing
- Clozapine
- Where
- France
- Volunteers
- 1,000,000 people
- Sponsor
- University Hospital, Caen
Child With Adverse Drug Reactions
Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center
Aim. - To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics. Methods. - An observational study on all ADR notifications recorded in the French pharmaco-vigilance database by the Regional…
- Trial name
- Pediatry ADR (NCT03316014)
- Testing
- Adverse drug reaction
- Volunteers
- 632 people
- Sponsor
- CHU de Reims
Epilepsy
A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug.
- Trial name
- NCT00631150
- Testing
- Levetiracetam (Keppra)
- Volunteers
- 35 people
- Sponsor
- UCB Pharma
Cardiac Complication, Vascular Diseases
Evaluation of Reporting of Vascular Endothelial Growth Factor and Vascular Endothelial Growth Factor Receptor Inhibitors Associated Cardiovascular Adverse reactioN.
Antiangiogenics (AAs) which are vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR) inhibitors might have high grade adverse events (AEs) on the cardio-vascular system.
- Trial name
- VEGAN (NCT03413176)
- Testing
- Cardiac complication induced by VEGF/VEGFR inhibitor
- Where
- France
- Volunteers
- 150,000 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Cardiac Affections
Comparison of Cardiotoxicity Induced by Selective Estrogen REceptor Modulators and aNti-Aromatase
Selective estrogen receptor modulators and aromatase inhibitors for the treatment of breast cancer seems to have an impact on the cardio-vascular system.
- Trial name
- SERENA (NCT03259711)
- Testing
- Hormonal therapies L02 in the ATC classification
- Where
- France
- Volunteers
- 20,000 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Brain Edema, Brain Edema Caused by Drugs
A Pharmacovigilance Study of Brain Oedema
Literature reports the development of brain oedema following the use of certain drugs. Therefore, this study aims to present a comprehensive disproportionality analysis of brain oedema cases reported to the Food and Drug…
- Trial name
- NCT04311359
- Testing
- Drugs, Generic
- Where
- Pakistan
- Volunteers
- 9,524 people
- Sponsor
- University of Peshawar
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
Myocarditis, Cardiac Complication
Evaluation of Reporting of Immune Checkpoint Inhibitor Associated Cardio-vascular Adverse Reactions
Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatment including anti-PD1…
- Trial name
- RAFALE (NCT03387540)
- Testing
- ICI
- Where
- France
- Volunteers
- 104 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Oncology, Drugs
Active Pharmacovigilance of Anti-cancer Medicines
Pharmacovigilance (PV), defined by the World Health Organization (WHO) as the "science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other drug-related problem", aims…
- Conditions
- Oncology, Drugs, Pharmacovigilance
- Trial name
- NCT05825794
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- IRCCS Burlo Garofolo
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
Malaria
Pharmacovigilance for ACTs in Africa
This is a phase IV open label study assessing the safety and effectiveness of artemisinin derivatives-based combination therapy (ACT) when used on a large scale and under "real life" conditions.
- Trial name
- PVACT (NCT01232530)
- Where
- Burkina Faso
- Volunteers
- 3,176 people
- Sponsor
- Centre Muraz
Neonatal Hypotonia, Antidepressant Drug Adverse Reaction
Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant
To better characterize the neonatal hypotonia associated with in utero exposure to antidepressants, so far limited to clinical cases, we will perform an observational retrospective pharmacovigilance study, using two databases.
- Conditions
- Neonatal Hypotonia, Antidepressant Drug Adverse Reaction, Pregnancy Related
- Trial name
- NCT04830241
- Testing
- Antidepressant
- Where
- France
- Volunteers
- 10,000 people
- Sponsor
- University Hospital, Caen
Buprenorphine, Naloxone
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic…
- Conditions
- Buprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence
- Trial name
- OPUS R (NCT00723697)
- Testing
- buprenorphine
- Volunteers
- 1,307 people
- Sponsor
- Indivior Inc.
Intra-Abdominal Infections, Skin Disease, Infectious
Post-Authorization Study Evaluating Safety Of Tigecycline
This is a study to evaluate the safety of tigecycline in patients with complicated intra-abdominal infections (cIAI) and complicated skin and soft tissue infections (cSSTI) under real practice in the usual hospital setting and…
- Conditions
- Intra-Abdominal Infections, Skin Disease, Infectious, Soft Tissues Infections
- Trial name
- HORUS (NCT00827541)
- Testing
- Tigecycline
- Volunteers
- 115 people
- Sponsor
- Pfizer
Infection
A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting
To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to assess the main side effects observed in daily…
- Trial name
- NCT00488488
- Testing
- tigecycline
- Volunteers
- 1,028 people
- Sponsor
- Pfizer
Parasitic Diseases, Bacterial Diseases
Safety of the Co-administration of Three Drugs for Trachoma and Lymphatic Filariasis Elimination
The purpose of this study is to determine whether the triple co administration of albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that consists to treat with albendazole plus ivermectin…
- Trial name
- AZIVAL (NCT01586169)
- Testing
- triple co administration at once of the combination of Albendazole + ivermectin + azithromycin
- Where
- Mali
- Volunteers
- 3,000 people
- Sponsor
- Centre d'Appui à la lutte contre la Maladie
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
Heart Failure, Fall
Cardiological Drug Classes And Falls in Older Adults
Heat failure is a fast gowing health issue with a rising incidence in older adults. Recommendations have recently been published to treat heart failure, but most clinical trials leading to these recommendations tended to exclude…
- Trial name
- NCT07150754
- Testing
- Heart failure pharmacological treatments
- Where
- France
- Volunteers
- 100,000 people
- Sponsor
- University Hospital, Caen
Bipolar Disorder, Schizophrenia
A Non-Interventional Post-Marketing Surveillance Study to Evaluate the Safety and Efficacy of Zeldox Capsule
This is a regulatory-required non-interventional pharmacovigilance study exploring the safety profile of ziprasidone HCL monohydrate 20mg, 40mg, 60mg, 80mg in the real world patient population, thus, safety (and/or efficacy)…
- Trial name
- NCT01053429
- Testing
- ziprasidone
- Volunteers
- 3,391 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypoxia
Effects of Dihydropyridine Calcium Channel Inhibitors on Respiratory Gas Exchanges in the Intensive Care Unit: a Pharmacovigilance Study in VigiBase® and a Comparison With Urapidil
Due to their effects on hypoxic pulmonary vasoconstriction (HPV), dihydropyridine calcium channel inhibitors (CCI) could lead to hypoxia in patients with a pulmonary shunt.
- Trial name
- NCT05537194
- Testing
- dihydropyridine calcium channel inhibitors use
- Where
- France
- Volunteers
- 32,000,000 people
- Sponsor
- University Hospital, Caen