Clinical trials: Safety Issues
Pharmacokinetics, Safety Issues
Pharmacokinetics, Safety and Efficacy Study of GP30341 (GEROPHARM, Russia)
Pharmacokinetics, safety and efficacy study of GP30341, 200 mg capsules (GEROPHARM LLC, Russia) in healthy volunteers and patients with novel coronavirus infection 2019 (COVID-19) with a high risk of adverse outcome
- Conditions
- Pharmacokinetics, Safety Issues, Efficacy
- Trial name
- NCT05648799
- Testing
- GP30341 capsules 200 mg, Standard therapy
- Where
- 5 sites in Russia
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- Geropharm
Motor Vehicle Injury, Safety Issues
Safety-Enhancing Motor Vehicle Child Safety Seat
This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle.
- Trial name
- NCT06384989
- Testing
- Child restraint system with load leg feature
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Minnesota HealthSolutions
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
Safety Issues, Tolerance
Safety and Tolerability of Soy Fiber
This is a dose escalation trial in the elderly with obesity to determine the maximum tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods.
- Trial name
- NCT04499482
- Testing
- Food
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Toxicity, Safety Issues
Safety Assessment of P2Et Extract in Healthy Voluntary Subjects in Colombia
Caesalpinia spinosa extract is rich in gallotannins and other well characterized polyphenols and has a major antioxidant activity.
- Trial name
- NCT03663881
- Testing
- P2Et extract
- Where
- Colombia
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario San Ignacio
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
Morbid Obesity, Sleeve Gastrectomy
Safety of an Early Discharge Protocol After Sleeve Gastrectomy
Evaluate the safety and efficacy of an early discharge protocol (23 hours, overnight stay) after scheduled sleeve gastrectomy.
- Conditions
- Morbid Obesity, Sleeve Gastrectomy, Early Discharge, Safety Issues
- Trial name
- NCT03070457
- Testing
- Early discharge, Conventional protocol
- Where
- Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hospital Universitari de Bellvitge
Effect of Drugs, Safety Issues
PK-PD Comparative Study of Lansoprazole Capsules and Lansoprazole Enteric-coated Capsules in Healthy Chinese Volunteers
The objective of this study was to compare the relative PK-PD of Lansoprazole Capsules and Lansoprazole DR Capsules in healthy Chinese volunteers.
- Trial name
- NCT03488186
- Testing
- Lansoprazole Capsules
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Zhejiang University
Safety Issues
Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers
This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.
- Trial name
- NCT03565861
- Testing
- NP10679
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Neurop Inc.
Sedentary Lifestyle, Occupational Exposure
Active Workplace Study
Exposure to sedentary work is an occupational hazard with significant health and safety consequences. Sedentary behavior is an independent predictor of heart disease, diabetes, early mortality, and accounts for the majority of…
- Conditions
- Sedentary Lifestyle, Occupational Exposure, Health Behavior, Safety Issues
- Trial name
- NCT03556670
- Testing
- Total Worker Health, Control
- Where
- United States
- Volunteers
- 264 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Poisoning, Safety Issues
Evaluating the Impact of a Safe Medication Storage Device
Despite the initial success of the 1970s Poison Prevention Packaging Act, the incidence of pediatric medication poisonings in the United States remains high.
- Conditions
- Poisoning, Safety Issues, Accidents Injury
- Trial name
- NCT04729894
- Testing
- Medication Lockbox, Education
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Binghamton University
Reproductive Issues
Female Autologous Platelet-Rich Plasma (PRP) Co-incubation With Husband's Sperm
Hypotheses: We hypothesize that infertility patients undergoing IUI who receive female autologous platelet-rich plasma (PRP) co-incubation with husband's sperm would have higher clinical pregnancy rate.
- Trial name
- NCT07282327
- Testing
- Female PRP co-incubation with husband's sperm in the IUI
- Where
- China
- Volunteers
- 288 people
- Sponsor
- Chinese University of Hong Kong
Safety Issues
The Safety of Paxlovid in Hemodialysis Patients With Covid-19
Infection with SARS-CoV-2 continue to threaten global health. Persons with chronic kidney disease, including dialysis treatment are at hight risk for severe Covid-19 and associated adverse outcomes.
- Trial name
- SPHPS (NCT05366192)
- Testing
- Nirmatrelvir and ritonavir stage 1, Nirmatrelvir and ritonavir stage 2
- Where
- China
- Volunteers
- 18 people
- Sponsor
- RenJi Hospital
Safety Issues, Quality of Life
Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander
The experimental hypothesis of this randomized controlled study was to demonstrate that early drain removal in patients who underwent immediate breast reconstruction with tissue expander is a safety procedure to improving…
- Trial name
- NCT04188821
- Testing
- breast drain removal
- Volunteers
- 124 people
- Sponsor
- University of Foggia
Diaphragm Issues, Ventilator-Induced Lung Injury
Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.
- Conditions
- Diaphragm Issues, Ventilator-Induced Lung Injury, Tracheostomy
- Trial name
- NCT04457427
- Testing
- NeuRx Diaphragm Pacing System (DPS)
- Where
- Turkey (Türkiye)
- Sponsor
- Synapse Biomedical
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
A Phase1 Study of VIB9600
Overall design: Single-center, randomized, blinded, placebo-controlled single- and multiple-ascending dose study in healthy adult subjects.
- Trial name
- NCT03621605
- Testing
- VIB9600
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
Safety Issues
Direct Acting Anti-Viral's In Chronic HCV Patients
The objective of the study is to determine the safety of DAA's among chronic HCV patients. The outcomes of the study are; To determine the frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated…
- Trial name
- NCT04664894
- Testing
- Sofosbuvir
- Where
- Pakistan
- Volunteers
- 511 people
- Sponsor
- Getz Pharma
Safety Issues, Efficacy, Self
Trial of Befizal® 200 mg for the Treatment of Leber Hereditary Optic Neuropathy
Study of the efficiency of Béfizal® 200 mg in 14 adult patients with a LHON that occurred for less than 5 years. Patient must have certain specific mutations
- Trial name
- Béfinohl (NCT04561466)
- Testing
- Béfizal
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Hôpital Necker-Enfants Malades
Laparoscopic Surgery, Operative Surgical Procedure
Blade Finger Technique for Safe Laparoscopic Entery
blade-finger technique is a new technique for laparoscopic access which is safe
- Conditions
- Laparoscopic Surgery, Operative Surgical Procedure, Insufflation, Safety Issues
- Trial name
- new technique (NCT05475470)
- Testing
- finger-blade technique, Hasson's technique, veress needle technique
- Where
- Egypt
- Volunteers
- 1,005 people
- Sponsor
- Zagazig University