Clinical trials: Safety Issues
Safety Issues
NOPARK Open Label Extension Study
This protocol describes the NOPARK Open Label Extension Study. The NOPARK Open Label Extension study is an optional extension of the clinical phase II NOPARK study.
- Trial name
- NCT05546567
- Testing
- Nicotinamide Riboside
- Where
- Norway
- Volunteers
- 400 people
- Sponsor
- Haukeland University Hospital
Firearm Injury, Safety Issues
Pediatric Trauma Centers RE-AIM at Gun Safety
Universal firearm injury and violence prevention counseling of parents and patients has been recommended by multiple national organizations for over a decade, yet clinicians rarely deliver this counseling.
- Trial name
- ACTFAST (NCT06123611)
- Testing
- Adopting Comprehensive Training for FireArm Safety in Trauma centers
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Johns Hopkins University
Safety Issues
Post Marketing Surveillance of Diphtheria Antitoxin (DAT)
The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin
- Trial name
- NCT06053853
- Testing
- Diphtheria Antitoxin
- Where
- Indonesia
- Volunteers
- 68 people
- Sponsor
- PT Bio Farma
Infant Development, Safety Issues
Safety of Bifidobacterium Breve PS1 for Infants
The objective of this work was the characterization of the probiotic potential of Bifidobacterium breve PS1, a strain originally isolated from human milk.
- Trial name
- NCT05973812
- Testing
- Infant formula supplemented with Bifidobacterium breve PS1, Infant formula NOT supplemented with Bifidobacterium breve PS1
- Where
- 3 sites in Spain
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Universidad Complutense de Madrid
Safety Issues, Immunogenicity
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants
This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
- Trial name
- NCT03460405
- Testing
- Vi-DT Vaccine, Vi Polysaccharide Vaccine, IPV Vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues, Emergencies
Automated Early Warning Scoring on Surgical Normal Wards
Establishment of early warning systems in hospitals was strongly recommended in recent guidelines to detect deteriorating patients early and direct them to adequate care.
- Trial name
- NCT03461133
- Testing
- Intervention
- Where
- Germany
- Volunteers
- 3,827 people
- Sponsor
- University Hospital Carl Gustav Carus
Safety Issues
Awareness of Operating Room Staff About WHO OR Checklist
to understand and analyze awareness of proper timing of when to sing in, time out, and sign out for patients who will be operated in Hail multidisciplinary centers, Saudi Arabia.
- Trial name
- NCT04921839
- Where
- Saudi Arabia
- Volunteers
- 400 people
- Sponsor
- Imam Mohammad ibn Saud Islamic University
Safety Issues, Anticoagulant Toxicity
Clinical Pharmacist Anticoagulant Stewardship
Initiative to improve direct anticoagulant utilization involving programmatic review by clinical pharmacists in collaboration with multidisciplinary team.
- Trial name
- NCT03527615
- Testing
- Clinical Pharmacist Medication Review
- Where
- Israel
- Volunteers
- 4,000 people
- Sponsor
- Hadassah Medical Organization
Safety Issues
Tolerance of a Probiotic Formula
Evaluate the tolerance of a probiotic formula in infants
- Trial name
- NCT03925558
- Testing
- Probiotics
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Probi AB
Safety Issues, Effect of Drugs
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy
To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of cerebral palsy.
- Trial name
- NCT03791372
- Testing
- 0.9% Sodium Chloride, Autologous Umbilical Cord Blood
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Guangdong Women and Children Hospital
Safety Issues, Chronic Kidney Diseases
Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
The benefits of renin angiotensin system (RAS) blockers and diuretics for blood pressure control are well-established in chronic kidney diseases (CKD) patients; however, these agents may become hazardous on "sick-days" that lead…
- Trial name
- NCT03141905
- Testing
- Sick-Day Protocol, Usual Care
- Where
- United States
- Volunteers
- 342 people
- Sponsor
- University of Maryland, Baltimore
Safety Issues
Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.
- Trial name
- NCT03462108
- Testing
- Rotavirus (Bio Farma) Vaccine
- Where
- 4 sites in Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues
Dexmedetomidine for Sedation Undergoing Bronchoscopy
Several sedatives or analgesics can be used to achieve appropriate levels of sedation for endoscopic procedures. Dexmedetomide is notable for providing sedation without respiratory depression.
- Trial name
- NCT04169685
- Testing
- bronchoscopy
- Where
- Taiwan
- Volunteers
- 80 people
- Sponsor
- Kaohsiung Medical University
Safety Issues
Safety of Immediate Skin-to-Skin Contact After Vaginal Birth in Vigorous Late-Preterm Neonates
Late-preterm neonates are born between 34 and 36 weeks 7 days gestational age (GA). Neonates born less than 34 weeks GA are at increased risk for morbidity and directly admitted to the Neonatal Intensive Care Unit (NICU).
- Trial name
- NCT03585192
- Testing
- Skin Group, Warmer Group
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Noise Exposure, Intensive Care Unit
Effective Strategies to Reduce Noise and Related Distractions
Patients admitted to the intensive care unit (ICU) undergo complex critical care treatment and are consequently surrounded by equipment and monitors contributing to high sound pressure levels.
- Conditions
- Noise Exposure, Intensive Care Unit, Safety Issues
- Trial name
- NOISY (NCT04643652)
- Testing
- Noise Reduction Bundle
- Where
- Netherlands
- Volunteers
- 250 people
- Sponsor
- Radboud University Medical Center