Clinical trials: Serious Adverse Events
Healthy Volunteer Study
Safety Study of CZ10 in Healthy Volunteers
A randomized, double-blind, placebo-controlled, parallel group, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and initial effectiveness of a novel intravenous CT contrast…
- Trial name
- NCT06708767
- Testing
- Contrast Media
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Nextrast, Inc.
Unexpected Hospital Mortality, Death, Sudden, Cardiac
Prevention of Serious Adverse Events in Acute Care Hospitals by Afferent Limb and Response Method Intervention - the ALARM Intervention Study.
1. Summary Growing evidence suggests that a significant proportion of in-hospital patient deaths occur after serious adverse events (SAE's).
- Conditions
- Unexpected Hospital Mortality, Death, Sudden, Cardiac, Unplanned Intensive Care Unit Admission
- Trial name
- ALARM (NCT01949025)
- Testing
- ALARM intervention
- Where
- Belgium
- Volunteers
- 69,656 people, healthy volunteers welcome
- Sponsor
- Universiteit Antwerpen
Infections, Papillomavirus
Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in…
- Trial name
- NCT01190189
- Testing
- GSK580299 (Cervarix)
- Where
- 28 sites in United States, Canada
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neoplasms, Rectal
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea
The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30…
- Trial name
- NCT03671369
- Testing
- Safety data collection (following routine vaccination) by a continuous surveillance method.
- Where
- 29 sites in South Korea
- Volunteers
- 670 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections, Gonorrhea
Cellulose Sulfate (CS) Gel and HIV in Nigeria
This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection.
- Conditions
- HIV Infections, Gonorrhea, Chlamydia Infections
- Trial name
- NCT00120770
- Testing
- Cellulose Sulfate Vaginal Gel (Microbicide)
- Where
- 2 sites in Nigeria
- Volunteers
- 2,160 people, healthy volunteers welcome
- Sponsor
- FHI 360
HIV
HPTN 073 Black Men Who Have Sex With Men (MSM) Pre-Exposure Prophylaxis (PrEP)
Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client Centered Care Coordination (C4) Component.
- Trial name
- NCT01808352
- Testing
- Observational
- Where
- 3 sites in United States
- Volunteers
- 226 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
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
Drug-Related Side Effects and Adverse Reactions
Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers
It concerns an investigation aiming to investigate genetic biological(s) marker(s) which allow to identify individuals who have risk of serious adverse events to the yellow fever vaccine.
- Trial name
- NCT03938597
- Where
- Brazil
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Contraception
Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6
Evaluation of preference for three female condoms (FC).
- Trial name
- NCT01452503
- Testing
- Path Women's Condom, FC2 female condom, Reddy 6 female condom (V-Amour)
- Where
- South Africa
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- FHI 360
Vaccine-induced Thrombotic Thrombocytopenia Syndrome, Guillain-Barre Syndrome
Gene Sequencing as a Strategy for Identifying Genetic Factors Associated With Serious Adverse Events After Covid-19 Vaccines in Use in Brazil
This protocol proposes to investigate genetic factors that may be involved in the pathogenesis of adverse events of interest with selected covid-19 vaccines: vaccine-induced immune thrombotic thrombocytopenia, and neurological…
- Conditions
- Vaccine-induced Thrombotic Thrombocytopenia Syndrome, Guillain-Barre Syndrome, Acute Disseminated Encephalomyelitis, Transverse Myelitis
- Trial name
- NCT05630313
- Where
- Brazil
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
HIV
Male Engagement in PMTCT Services
The study employs a quasi-experimental design in 8 public health centers in southwest Uganda offering care and treatment (C\&T) services.
- Trial name
- NCT01903889
- Testing
- clinic based intervention, clinic and community based intervention
- Where
- 7 sites in Uganda
- Volunteers
- 3,806 people, healthy volunteers welcome
- Sponsor
- FHI 360
Contraception
A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan.
- Trial name
- NCT01463254
- Where
- Pakistan
- Volunteers
- 724 people, healthy volunteers welcome
- Sponsor
- FHI 360
Long-term and Permanent Contraceptive Methods
A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar.
- Trial name
- NCT01200576
- Where
- Madagascar
- Volunteers
- 621 people, healthy volunteers welcome
- Sponsor
- FHI 360
Infections, Papillomavirus
Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study
This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and received a placebo in the HPV-001 (NCT00689741)…
- Trial name
- NCT01418937
- Testing
- CervarixTM (GSK580299)
- Where
- 5 sites in Brazil
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
The Study Goal is to Assess the Introduction of Sustainable Family Planning/Reproductive Health Information and Services Through, Land O' Lakes-supported Dairy Cooperatives
Family Planning Through Dairy Cooperatives
This observational study will assess a model for providing family planning through quarterly events organized by dairy cooperatives supported by Land O'Lakes in Kenya.
- Trial name
- NCT01226433
- Where
- Kenya
- Volunteers
- 319 people, healthy volunteers welcome
- Sponsor
- FHI 360
Sexually Transmitted Diseases
Madagascar Female Condom Study
The study was designed to measure the effects of male and female condom promotion on STI prevalence and reported condom use by sex workers and their partners.
- Trial name
- NCT00272974
- Testing
- Clinic-based counseling
- Where
- 2 sites in Madagascar
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- FHI 360
Pregnancy Prevention
Continuous Use of COCs
The primary objective is to determine if continuous COC use leads to higher continuation rates over 12 months of follow up than use of the standard 28-day COC regimen.
- Trial name
- NCT00570440
- Testing
- Oral contraceptives--ethinyl estradiol, levonorgestrel
- Where
- 2 sites in Dominican Republic, Nicaragua
- Volunteers
- 362 people, healthy volunteers welcome
- Sponsor
- FHI 360
HIV Infections
Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
This Phase 2a study involving Tenofovir Disoproxil Fumarate (TDF) will provide extended safety data for high-risk men. Secondarily, the study will assess the feasibility of conducting the trial and evaluate the preliminary…
- Trial name
- NCT00122512
- Testing
- Tenofovir Disoproxil Fumarate
- Where
- Malawi
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- FHI 360
Infections, Papillomavirus
The Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
This extension study is designed to assess the safety of GSK Biological's HPV vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the…
- Trial name
- NCT01249365
- Testing
- GSK580299 (Cervarix)
- Where
- 15 sites in Australia, Portugal and 2 more
- Volunteers
- 199 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Contraceptive Usage
A Prospective Observational Study of the Performance of Zarin in Kenya
This will be a non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya.
- Trial name
- NCT01334190
- Where
- Kenya
- Volunteers
- 602 people, healthy volunteers welcome
- Sponsor
- FHI 360