Clinical trials: Exposure
Hypothyroidism
Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure
To investigate the incidence of detected hypothyroidism after iodinated contrast exposure in pediatric patients from birth to 3 years of age (inclusive) in a routine clinical practice setting.
- Trial name
- NCT02766283
- Testing
- iodinated contrast agents
- Where
- Israel
- Volunteers
- 843 people
- Sponsor
- Bayer
Malaria
Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children
This study is a single site, randomized, double-blind, placebo-controlled trial. The trial will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ Vaccine in Gabonese children that are naturally…
- Trial name
- NCT03521973
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Gabon
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Multiple Sclerosis
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks…
- Trial name
- NCT05658497
- Testing
- Diroximel Fumarate, Avonex, Tysabri
- Where
- 8 sites in United States, Australia and 5 more
- Volunteers
- 908 people
- Sponsor
- Biogen
Botulism
BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin
The purpose of the Registry was to evaluate patient safety following Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric patients with a confirmed or suspected exposure to…
- Trial name
- NCT02055183
- Testing
- BAT
- Volunteers
- 162 people
- Sponsor
- Emergent BioSolutions
Infections, Papillomavirus
Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix Residing in UK
This study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e.
- Trial name
- NCT01905462
- Testing
- Data Collection, Cervarix
- Where
- United Kingdom
- Volunteers
- 1,046 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Inflammatory Bowel Disease
Analysis of Birth Outcomes of Swedish, Danish and Finnish Women Exposed to Remicade With Inflammatory Bowel Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Psoriasis
The purpose of this study is collection and analysis of information pertaining to pregnancy outcomes in women exposed to infliximab during pregnancy, relative to the background risk in similar but non-biologic exposed patients…
- Trial name
- NCT00658827
- Testing
- No intervention
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Janssen Biotech, Inc.
Rabies
Immunogenicity and Safety of Verorab™ in Indian Population
To demonstrate that rabies vaccine administered according to the Thai Red Cross, (TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according to the ESSEN IM regimen in terms of Geometric Mean Titers…
- Trial name
- NCT00260351
- Testing
- Purified Verocell Rabies Vaccine
- Where
- 3 sites in India
- Volunteers
- 405 people
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Maternal Outcomes, Infant Outcomes
Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy
The primary objectives of this study are: In infants of women exposed to SPIKEVAX during pregnancy, to assess: If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital…
- Conditions
- Maternal Outcomes, Infant Outcomes, Pregnancy
- Trial name
- NCT06369272
- Where
- United States
- Volunteers
- 1,192 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Hypothyroidism
Thyroid Function of Pediatric Subjects Following Isovue® Administration
This is a Phase IV prospective, multicenter, observational study to estimate the proportion of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to intravascular administration of ISOVUE for the…
- Trial name
- NCT03779906
- Testing
- Isovue
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- Bracco Diagnostics, Inc
Radiation Exposure
Prospective Evaluation of Strontium in Patients After CardioGen-82 PET MPI Scanning at Two Clinical Sites
This study is to be performed at two clinical sites where patients received CardioGen-82 during the time period January to June, 2011 and where patients were scanned chronologically near to the index patients (2 days before or…
- Trial name
- NCT01430975
- Testing
- CardioGen-82
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Bracco Diagnostics, Inc
Multiple Sclerosis
The Gilenya Pregnancy Registry
The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to…
- Trial name
- NCT01285479
- Testing
- Fingolimod
- Where
- 61 sites in United States, Argentina and 32 more
- Volunteers
- 312 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis, Pregnancy
Fampridine Pregnancy Exposure Registry
This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged-release fampridine since the first day of their last menstrual period prior to…
- Trial name
- NCT01532154
- Testing
- Fampridine
- Where
- France
- Volunteers
- 1 people
- Sponsor
- Biogen
Rheumatoid Arthritis
Abatacept Pregnancy Exposure Registry
The purpose of the abatacept pregnancy registry is to monitor planned and unplanned pregnancies exposed to abatacept, to evaluate the possible teratogenic effects (that is, any abnormal development) of this medication in the…
- Trial name
- NCT01087125
- Testing
- No Interventions
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Bristol-Myers Squibb
Multiple Sclerosis, Progressive Multifocal Leukoencephalopathy
Risk of Progressive Multifocal Leukoencephalopathy Among Patients With Multiple Sclerosis Exposed to Zeposia
This study will evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection caused by John Cunningham virus (JCV), among people with multiple sclerosis who have been treated with ozanimod.
- Trial name
- NCT07732907
- Testing
- Ozanimod
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Bristol-Myers Squibb
SARS-CoV-2, COVID-19
eVusheld Assessment reaL wORld Effectiveness in the VA Health System
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and…
- Trial name
- VALOR-VA (NCT05663957)
- Testing
- Evusheld
- Where
- United States
- Volunteers
- 5,814 people
- Sponsor
- AstraZeneca
Infections, Streptococcal
Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age.
The purposes of this study: To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants following a…
- Trial name
- NCT00829010
- Testing
- Pneumococcal vaccine GSK1024850A, Tritanrix-HepB/Hib, measles
- Where
- South Africa
- Volunteers
- 489 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Liver Injury
Acute Liver Injury in Patients on Dapagliflozin
To compare, by insulin use at the index date, the incidence of hospitalization for acute liver injury (ALI) among patients with type 2 diabetes mellitus who are new users of dapagliflozin with those who are new users of…
- Trial name
- NCT02695095
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 424,091 people
- Sponsor
- AstraZeneca
Migraine
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
The purpose of the study is to evaluate the risk of pregnancy and infant outcomes among women with migraine exposed to rimegepant during pregnancy and in two rimegepant unexposed comparator groups.
- Trial name
- NCT05198245
- Testing
- Rimegepant, Various, No intervention
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
Infections, Meningococcal
Safety of 4CMenB Exposure During Pregnancy
4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January 2015 for people aged 10 through 25 years of age.
- Trial name
- NCT02640677
- Testing
- 4CMenB
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- GlaxoSmithKline
Thrombocythemia, Essential
Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments
This is an observational safety study being conducted in Europe comparing patients taking Xagrid to patients taking other cytoreductive treatments.
- Trial name
- NCT00567502
- Where
- 164 sites in Cyprus, Denmark and 12 more
- Volunteers
- 3,647 people
- Sponsor
- Shire