Clinical trials: Safety Issues
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
Safety Issues, Tolerance
Phase 1 SAD/MAD Study of CVN766 in Healthy Volunteers
Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Doses of CVN766 in Healthy participants.
- Trial name
- NCT05105243
- Testing
- CVN766
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Cerevance
Safety Issues
A Phase 1 Study to Evaluate the Safety/Tolerability, PK/PD of RG002C0106 Injection in Healthy Adults
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and PK/PD profiles of RG002C0106 injection in healthy adult subjects.
- Trial name
- NCT06494527
- Testing
- RG002C0106
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd.
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
Model for Safety Culture by Empowering the Family at Home: a Mixed-methods Study Protocol
Background: The elderly are a vulnerable group for health problems as they age. Safe care is essential when caring for the elderly at home because adverse events can happen there, such as falls, pressure ulcers, injuries, or…
- Trial name
- NCT05487482
- Testing
- Ageing Safe from the Risk (ASRi) Model of safety culture
- Where
- Indonesia
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Gadjah Mada University
Bioequivalency, Safety Issues
Bioequivalence Study of Iron Sucrose Injection in Healthy Subjects
The goal of this clinical trial is to compare the pharmacokinetic profile of the single intravenous injection of the test product and reference product in healthy subjects and to evaluate the bio-equivalence and safety of these…
- Trial name
- NCT06622148
- Testing
- Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer), Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd)
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Rheumatic Disease, HIV Infections
COVID-19 CoronaVac in Patients With Autoimmune Rheumatic Diseases and HIV/AIDS
Patients with chronic rheumatic diseases (such as systemic lupus erythematosus [SLE], rheumatoid arthritis [RA], ankylosing spondylitis [AS], juvenile idiopathic arthritis [JIA], poly/dermatomyositis [PM/DM], systemic sclerosis…
- Conditions
- Rheumatic Disease, HIV Infections, AIDS, Safety Issues
- Trial name
- CoronavRheum (NCT04754698)
- Testing
- CoronaVac
- Where
- Brazil
- Volunteers
- 2,196 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Safety Issues, Tolerance
Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
Randomized, double-blind and placebo-controled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy adult volunteers.
- Conditions
- Safety Issues, Tolerance, Pharmacokinetics, Food Effect
- Trial name
- NCT05217732
- Testing
- ZX-7101A
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Nanjing Zenshine Pharmaceuticals
Satisfaction, Safety Issues
Same Day Discharge vs. Overnight Stay After Hysterectomy
In this study patients are randomized between same-day discharge and overnight stay after undergoing a minimally invasive hysterectomy or myomectomy.
- Conditions
- Satisfaction, Safety Issues, Quality of Life
- Trial name
- SDD (NCT03627234)
- Testing
- Same Day Discharge, Overnight Stay
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- George Washington University
Newborn; Fit, Safety Issues
The Effects Of Safe Swadding On Newborns' Oxygen Saturation And Comfort Level
Objective: This study was conducted as a randomized controlled experimental study to determine the effects of safe swaddling on oxygen saturation and comfort in preterm newborns born between 30-36 weeks of gestation.
- Trial name
- NCT06900127
- Testing
- Safe Swaddling
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Ayse Sonay Turkmen, Prof.Dr
Tolerance, Safety Issues
Buck Institute Ketone Ester RCT
This study is to investigate the tolerability and safety of a ketone promoting ingredient, called a ketone ester (KE), in healthy older adults.
- Conditions
- Tolerance, Safety Issues, Aging
- Trial name
- BIKE (NCT05585762)
- Testing
- Ketone ester
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Buck Institute for Research on Aging
Myopia, Safety Issues
The Safety and Effectiveness of Breath-O Lenses
In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression.
- Trial name
- NCT03616600
- Testing
- Breath-O-Correct Lens
- Where
- Hong Kong
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- The Hong Kong Polytechnic University
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
Phase 1A Safety Trial of Inhaled PK10571 (GB002)
This is a phase 1A randomized double blind placebo controlled single ascending dose and multiple ascending dose trial of inhaled PK10571 (GB002) in healthy adult subjects.
- Trial name
- NCT03473236
- Testing
- GB002, Generic Dry Powder Inhaler
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Safety Issues, Tolerance
Study to Evaluate LPH-5 in Healthy Subjects
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of LPH-5.
- Trial name
- NCT06722820
- Testing
- LPH-5
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Lophora
Safety Issues
Safety and Efficacy of Longan and Lingzhi Mushroom Syrup on Immune and Inflammatory Responses in Healthy Volunteers
This study aimed to preliminarily determine safety and efficacy of longan and lingzhi mushroom syrup on immune and inflammatory responses.
- Trial name
- NCT04728009
- Testing
- Longan and lingzhi mushroom syrup
- Where
- Thailand
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
Safety Issues, Immunogenicity
Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants
- Trial name
- NCT03680417
- Testing
- Measles-Rubella (MR) Vaccine
- Where
- Indonesia
- Volunteers
- 590 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
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
Exposure Occupational, Safety Issues
Health Belief Model-Based Educational Intervention on Safe Pesticide Use and Biomarkers in Agricultural Workers
Brief Summary: Purpose: This clinical trial aims to investigate the effect of educational interventions (HeBSaPU) based on the Health Belief Model on safe pesticide use and biomarkers among greenhouse agricultural workers.
- Conditions
- Exposure Occupational, Safety Issues, Health Behavior, Nurse's Role
- Trial name
- HeBSaPU (NCT06173479)
- Testing
- HeBSaPU
- Where
- Turkey (Türkiye)
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Dilek AYAZ
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