Clinical trials: Safety Issues
Safety Issues, Efficacy, Self
TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss
The PI3K, protein kinase B (AKT), and mTOR signaling network promotes cell growth, survival, metabolism, and motility, but becomes a critical oncogenic driver under aberrant conditions that control the tumor microenvironment and…
- Trial name
- TQBSP (NCT04690725)
- Testing
- TQB3525
- Where
- China
- Volunteers
- 29 people
- Sponsor
- Peking University People's Hospital
Safety Issues
Study to Assess the Impact of Medication Reconciliation at Hospital Admission on Healthcare Outcomes
Medication reconciliation is a systematic process by which health care professionals obtain the most complete and accurate information about the drugs regularly taken by patients.
- Trial name
- MedRec (NCT03654963)
- Testing
- Medication reconciliation
- Where
- 2 sites in Switzerland
- Volunteers
- 1,702 people
- Sponsor
- Ente Ospedaliero Cantonale, Bellinzona
Safety Issues
Tolerability and Modulatory Action of the Butyrate Releaser N-(1-carbamoyl-2-phenyl-ethyl) Butyramide
Accumulating evidence is showing that gut microbiota could play a key role in gastrointestinal tract and immune system development and function. Many beneficial effects elicited by gut microbiota are mediated its metabolites.
- Trial name
- NCT04491266
- Testing
- FBA
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Federico II University
COVID, Safety Issues
Facial Hair, PPE and COVID-19
An observational cross sectional questionnaire study looking into facial hair of hospital doctors during the COVID-19 pandemic, and how personal protective equipment guidance has affected this.
- Trial name
- FACIAL HAIR (NCT04579627)
- Testing
- Questionnaire
- Where
- United Kingdom
- Volunteers
- 358 people, healthy volunteers welcome
- Sponsor
- Royal Cornwall Hospitals Trust
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
Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population
- Trial name
- NCT03336593
- Testing
- Quadrivalent Influenza Vaccine, Trivalent Influenza Vaccine
- Where
- 3 sites in Indonesia
- Volunteers
- 810 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues
Safety, Tolerability and Pharmacokinetics of ETD-001 Gel
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study, which comprises two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) in healthy subjects.Three dose groups are…
- Trial name
- ETD-001 gel (NCT07674862)
- Testing
- Dose 1, dose 2, dose 3
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Etern Therapeutics Wuxi Limited
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, Effect of Drugs
Safety of Autologous Cord Blood Cells for Preterm Infants.
To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
- Conditions
- Safety Issues, Effect of Drugs, Neonatal Death
- Trial name
- NCT03760900
- Testing
- Autologous Umbilical Cord Blood Stem Cells Therapy
- Volunteers
- 15 people
- Sponsor
- Guangdong Women and Children Hospital
Safety Issues
Safety Analysis of Implantation of Stromal Vascular Fraction
Stromal vascular fraction (SVF) can be isolated from fat (adipose) tissue in an outpatient in-clinic procedure. Platelet rich plasma (PRP) can be isolated from peripheral blood.
- Trial name
- NCT03226093
- Testing
- Stromal Vascular Fraction
- Volunteers
- 676 people
- Sponsor
- Bioheart, Inc.
Safety Issues
Safety Evaluation of Lactobacillus Salivarius AP-32 and Bifidobacterium Animalis Subsp. Lactis CP-9 in Healthy Infants.
This is a three-arm, double-blind, placebo-controlled study to investigate the safety of Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9 used individually in healthy infants.
- Trial name
- NCT04140604
- Testing
- Lactobacillus salivarius AP-32, Bifidobacterium animalis subsp. lactis CP-9
- Where
- Taiwan
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Hsieh-Hsun Ho
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;Effect of Drugs
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder
To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of autism spectrum disorder.
- Trial name
- NCT04768816
- Testing
- 0.9% Sodium Chloride, Autologous Umbilical Cord Blood
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Guangdong Women and Children Hospital
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
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
Paracetamol Hypothermia Children
Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia
- Trial name
- NCT04608669
- Testing
- Paracetamol
- Where
- Lebanon
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Saint George Hospital
Safety Issues, Immunogenicity
Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.
- Trial name
- NCT04051268
- Testing
- Vi-DT Typhoid Conjugate Vaccine, PQed Typhoid Conjugate Vaccine, Vi Polysaccharide Vaccine
- Where
- Indonesia
- Volunteers
- 3,071 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Medication Errors and Other Product Use Errors and Issues
Meds@HOME App to Support Medication Safety
This study determines whether the mHealth intervention, Meds@HOME, helps caregivers improve medication administration to Children with Medical Complexity (CMC) who use high-risk medications.
- Trial name
- NCT05816590
- Testing
- Med@HOME Mobile App
- Where
- United States
- Volunteers
- 336 people
- Sponsor
- University of Wisconsin, Madison
Medication Errors and Other Product Use Errors and Issues, Adverse Drug Event
Reducing Errors In The Neonatal Intensive Care Unit
This is a monocentric prospective pre and post-intervention study, aiming at analyzing the efficacy of the Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA) as compared to paper order entry…
- Trial name
- SAPHET-i (NCT04193839)
- Testing
- Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
Safety Issues, Effect of Drugs
The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells
To study the effect and saftey of intratracheal instillation of mesenchymal stem cells for treatment BPD
- Trial name
- NCT03683953
- Testing
- mesenchymal stem cells therapy, 0.9% sodium chloride
- Volunteers
- 200 people
- Sponsor
- Guangdong Women and Children Hospital