Clinical trials: Adverse Event
Vaccination Adverse Event, Immunogenicity, Vaccine
Study Interchangeability Hep-B Vaccine Administered at Birth Dose
This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.
- Trial name
- NCT07854847
- Testing
- In-house Hepatitis B Vaccine, Registered Hepatitis B Vaccine
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Helicobacter Pylori Infection, Gastrointestinal Dysbiosis
Bacillus Probiotics With Bismuth Quadruple Therapy for Helicobacter Pylori Infection
Helicobacter pylori (H. pylori) is a very common gastrointestinal disease that colonises the human gastric mucosa and is a primary risk factor for chronic gastritis, peptic ulcer disease, and gastric cancer.
- Conditions
- Helicobacter Pylori Infection, Gastrointestinal Dysbiosis, Antibiotic-associated Adverse Events
- Trial name
- NCT07827170
- Testing
- RO water, LiveSpo CLAUSY, LiveSpo DIA30
- Where
- Vietnam
- Volunteers
- 336 people
- Sponsor
- Anabio R&D
Growth, Tolerance
Human Milk Oligosaccharides (HMOs) - Post Marketing Study on Infants (NeHMO)
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT).
- Conditions
- Growth, Tolerance, Adverse Event
- Trial name
- NCT07302477
- Testing
- HMO Supplemented Infant Formula
- Where
- 4 sites in Pakistan
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Tumor Infiltrating Lymphocytes, Safety
A Study of GC101 TIL in Advanced Melanoma (BZ)
20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 20 months.
- Conditions
- Tumor Infiltrating Lymphocytes, Safety, Melanoma, Efficacy
- Trial name
- MIZAR-002 (NCT06120712)
- Testing
- GC101 TIL
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Shanghai Juncell Therapeutics
Tumor Infiltrating Lymphocytes, Safety
A Phase I Study of GC101 TIL in Advanced Solid Tumors
20-60 participants are expected to be enrolled for the Phase I clinical trial which is further divided into two parts: a "3+3" dose escalation study and an expanded enrollment study.
- Conditions
- Tumor Infiltrating Lymphocytes, Safety, Advanced Solid Tumor, Immunotherapy
- Trial name
- MIZAR-001 (NCT05417750)
- Testing
- TIL therapy
- Where
- China
- Volunteers
- 43 people
- Sponsor
- Shanghai Juncell Therapeutics
Adverse Drug Event
NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden
A study using medical records to evaluate safety issues for the NOCDURNA drug using national register data from Denmark and Sweden, and a health care register covering parts of Germany.
- Trial name
- NCT04740645
- Testing
- NOCDURNA Cohort, LUTS Cohort
- Where
- 3 sites in Denmark, Germany and 1 more
- Volunteers
- 1,099,551 people
- Sponsor
- Ferring Pharmaceuticals
Coronary Artery Disease, Clopidogrel Resistance
The Study of CYP2C19 Genotype-Guided Clopidogrel Treatment Models
The study purposed to learn how clopidogrel-based antiplatelet treatment for preventing adverse cardiovascular events after ePCI works in chronic coronary artery disease when guided by personal genetic characteristics for drug…
- Conditions
- Coronary Artery Disease, Clopidogrel Resistance, Coronary Thrombosis, Adverse Cardiac Events
- Trial name
- NCT06665919
- Testing
- CYP2C19 Genotype-Guided Clopidogrel Treatment, CYP2C19 Genotype Guided Antiplatelet Treatment Alternative to Clopidogrel, The Conventional Clopidogrel Treatment
- Where
- 4 sites in Georgia
- Volunteers
- 283 people
- Sponsor
- Vistamedi Ltd.
COVID-19, Vaccine Adverse Events of Special Interest
EU Secondary Data Post-Authorisation Safety Study of AZD1222
A study based on electronic heath records will evaluate the incidence and relative risk of safety concerns and adverse events of special interest (AESIs) following immunisation by AZD1222 in the real-world setting.
- Trial name
- D8111R00006 (NCT05126992)
- Testing
- AZD1222
- Where
- 4 sites in Netherlands, Spain and 1 more
- Volunteers
- 5,321,930 people
- Sponsor
- AstraZeneca
Ventilator Adverse Event, Ventilator Associated Pneumonia
Effect of Angulus on Patient-elevation Compliance
Ventilator-associated events (VAE) are a scourge of critical care settings and hospital systems at large. There is extensive evidence that ventilator-associated pneumonia (VAP) and related VAEs increase mortality rates in…
- Conditions
- Ventilator Adverse Event, Ventilator Associated Pneumonia, Hospital Acquired Condition, Hospital-acquired Pneumonia
- Trial name
- NCT03496220
- Testing
- Angulus
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Angulus, LLC
Adverse Events
Retrospective Independent Safety Review of Closed Irrisept Study
The purpose of CLP-01 was to complete the safety endpoint of the closed trial and ensure that all safety data generated by IRR-CT-901-2013-01 was accounted for and accurately identified, verified, and independently adjudicated.
- Trial name
- NCT05359666
- Testing
- Irrisept, Standard of Care
- Where
- 17 sites in United States
- Volunteers
- 592 people
- Sponsor
- Irrimax Corporation
Acute Lymphoblastic Leukemia, Pediatric, Adverse Drug Event
Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia
This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.
- Trial name
- NCT04770922
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Cipherome, Inc.
Adverse Drug Event, Effect of Drug
Research on Human Insulin rDNA Safety and Efficacy in Patients With Type 2 Diabetes Mellitus
Objective: To evaluate the safety and efficacy of Human Insulin rDNA (Insuget) in patients with Type II Diabetes Mellitus. Study Design: Open-label, prospective, observational, single arm, multi-center, post-marketing…
- Conditions
- Adverse Drug Event, Effect of Drug, Type 2 Diabetes Treated With Insulin
- Trial name
- RISE (NCT05161741)
- Testing
- Insulin
- Where
- Pakistan
- Volunteers
- 238 people
- Sponsor
- Getz Pharma
Adverse Drug Event, Drug Drug Interaction
Implementation of a Pharmacist-led Pharmacogenomic Clinical Service
Tabula Rasa HealthCare (TRHC), doing business as CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services.
- Conditions
- Adverse Drug Event, Drug Drug Interaction, Pharmacogenomics, Elderly
- Trial name
- NCT04984538
- Testing
- Pharmacogenomic Testing
- Where
- United States
- Sponsor
- Tabula Rasa HealthCare
COVID, Drug Effect
Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Frail Elderly Adults With Polypharmacy
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in elderly people enrolled…
- Conditions
- COVID, Drug Effect, Drug Interaction, Adverse Drug Event
- Trial name
- NCT04339634
- Testing
- Simulation of Repurposed Drugs for COVID-19
- Where
- United States
- Volunteers
- 12,873 people
- Sponsor
- Tabula Rasa HealthCare
Lack of Adverse Events, Reduced Pain Response
Feasibility of BabyGentleStick- Adult Pilot Study
This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStick™; BGS, Actuated Medical, Inc).
- Trial name
- NCT02947646
- Testing
- BabyGentleStick™ ON, BabyGentleStick™ OFF
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Actuated Medical, Inc.
COVID, Drug Effect
Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Adults With Polypharmacy Using Data From Large Medicare and Commercially Insured Populations
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in a health insurance…
- Conditions
- COVID, Drug Effect, Drug Interaction, Adverse Drug Event
- Trial name
- NCT04378881
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Tabula Rasa HealthCare
Growth, Tolerance
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants (NEHMO)
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT).
- Conditions
- Growth, Tolerance, Adverse Event, Disorder of Intestine
- Trial name
- NeHMO DACH (NCT05150288)
- Testing
- HMO-supplemented infant formula
- Where
- 17 sites in Austria, Germany and 1 more
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Optim Lead Insulation Related Adverse Events
Lead Registry for Optim Leads
This is a prospective, multi-center, actively monitored, long term data collection registry. Any Patient that receives a market released St.
- Trial name
- OPTIMUM (NCT01722188)
- Where
- 261 sites in United States, Belgium and 1 more
- Volunteers
- 14,124 people
- Sponsor
- Abbott Medical Devices
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction.
- Conditions
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Satisfaction
- Trial name
- NCT03673566
- Testing
- NICU Dashboard
- Where
- United States
- Sponsor
- Philips Healthcare
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction.
- Conditions
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Satisfaction
- Trial name
- NCT03673579
- Testing
- NICU Dashboard
- Where
- United States
- Sponsor
- Philips Healthcare