Clinical trials: Safety Issues
Infectious, Gastro-Intestinal Disorder
Aerosolization During Upper Endoscopy
Given the current Covid-19 pandemic alongside the lack of evidence on aerosolization during upper endoscopy the investigators are conducting a randomized controlled trial seeking to assess both the level of aerosolization that…
- Conditions
- Infectious, Gastro-Intestinal Disorder, Safety Issues
- Trial name
- NCT06006078
- Testing
- Endoscopic Patient Facemask
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Anthony Lembo
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, Injuries
An Interactive Web Platform to Teach Children Hunting, Shooting and Firearms Safety
Firearms injuries present a major pediatric public health challenge, killing >800 children ages 0-15 annually and leading to lifelong disability among >1000 survivors.
- Conditions
- Safety Issues, Injuries, Firearm Injury
- Trial name
- NCT04622943
- Testing
- firearms safety, nutrition
- Where
- United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Safety Issues
A Phase 1 Study of EXT608 in Healthy Adults
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants.
- Trial name
- NCT05408663
- Testing
- EXT608
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Extend Biosciences Inc.
Safety Issues, Tolerance
First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects
This is a FIH, double-blind, placebo-controlled, within-group randomised, trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of compound 106 (C106) in…
- Conditions
- Safety Issues, Tolerance, Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension
- Trial name
- NCT05427253
- Testing
- C106 solution
- Where
- Sweden
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Vicore Pharma AB
Drink Too Much, Drinking, Binge
Group-based Intervention for Club Patrons
The purpose of this study is to develop and test a group-based strategy for encouraging groups of young adults who are engaged in party behaviors at nightclubs to intervene with each other to reduce harms associated with overuse…
- Conditions
- Drink Too Much, Drinking, Binge, Drunk, Drug Use
- Trial name
- NCT03652688
- Testing
- Nightlife Safety Plans (NSP), Fire Safety
- Where
- 2 sites in United States
- Volunteers
- 959 people, healthy volunteers welcome
- Sponsor
- Pacific Institute for Research and Evaluation
Safety Issues, Pharmacokinetics
Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam
This is a phase I, open-label, fixed sequence design, drug-drug-interaction (DDI) study divided in 2 parts. Part I is designed to evaluate whether concomitant treatment with linaprazan glurate and clarithromycin, a strong…
- Conditions
- Safety Issues, Pharmacokinetics, Drug Interaction, Tolerability
- Trial name
- NCT05633147
- Testing
- Linaprazan glurate, Drug drug interaction (DDI) - Clarithromycin (Part I), Drug drug interaction (DDI) - Midazolam (Part 2)
- Where
- Sweden
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
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
Spray, Pain
Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride
This study aims to determine if Gebauer's Pain Ease or Gebauer's Ethyl Chloride topical anesthetic sprays are safe for use as numbing agents prior to placing epidurals and arterial lines, based on whether they introduce increased…
- Conditions
- Spray, Pain, Safety Issues
- Trial name
- NCT04207710
- Testing
- Gebauer's Pain Ease Top Aerosol Mist Spray, Gebauer's Ethyl Chloride
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Henry Ford Health System
Pharmacokinetics, Safety Issues
A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab
The aim of the Clinical study is to evaluate the pharmacokinetic and safety profile of a new formulation of Bevacizumab (Zutrab®, Argentinian origin) when compared to two already marketed formulations of Bevacizumab Avastin®…
- Trial name
- NCT03919448
- Testing
- Bevacizumab
- Where
- Argentina
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
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, 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
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
Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations
To study the oral mucosal effects in adult smokers associated with the use of two Nicotine Lozenge formulations.
- Trial name
- NCT03087786
- Testing
- Nicotine Bitartrate Lozenge 4mg, Nicotine Polacrilex 4Mg Lozenge
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Niconovum USA
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, Chronic Kidney Disease
Care Coordination/Home Telehealth to Safeguard Care in CKD
Home telehealth monitoring of veterans with chronic kidney disease, with a disease management protocol and safety-specific decision support, will increase the detection of adverse safety events, and in turn, reduce the need for…
- Trial name
- CCHT in CKD (NCT03038126)
- Testing
- CCHT, Usual care
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- University of Maryland, Baltimore
Safety Issues, Pharmacokinetics
Safety and Pharmacokinetics of an Extract of Naringenin
This study evaluates the safety of administering single ascending doses (150, 300, 600, and 900 mg) of a citrus extract of the flavonoid narigenin, and assesses the blood concentrations of naringenin following oral administration…
- Trial name
- Citrus (NCT03582553)
- Testing
- Naringenin
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center