Clinical trials: Safety Issues
Firearm Injury, Safety Issues
Adult Trauma Centers RE-AIM at Gun Safety
The goal of this interventional study is to evaluate the implementation and effectiveness of a comprehensive a universal firearm injury prevention program, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma…
- Trial name
- ACTFAST (NCT06302452)
- Testing
- Adopting Comprehensive Training for FireArm Safety in Trauma Centers
- Where
- 3 sites in United States
- Volunteers
- 1,776 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Safety Issues
Safety of Cell-free Adipose Tissue Product in Healthy Volunteers
The study is a randomized, double blinded, bilaterally controlled trial.The aim is to evaluate the short- and mid term safety of cell-free adipose tissue product.
- Trial name
- SAFETY (NCT05518084)
- Testing
- Liponovo tissue product
- Where
- Finland
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Linio Biotech Oy
Safety Issues
MIST3: Active Patient Safety Reporting
This study will seek to describe and understand adverse events (AE) severity ratings.
- Trial name
- MIST3 (NCT04161677)
- Where
- United States
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Parker University
Bone Regeneration, Safety Issues
Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as…
- Trial name
- NCT06383377
- Testing
- Tooth extraction and bone graft procedure
- Where
- 5 sites in Belgium
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Wishbone SA
Cataract Senile, Endophthalmitis
Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin
Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis
- Conditions
- Cataract Senile, Endophthalmitis, Antibiotic Side Effect, Safety Issues
- Trial name
- NCT04403334
- Testing
- Levofloxacin Ophthalmic, Moxifloxacin Ophthalmic
- Where
- Philippines
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Peregrine Eye and Laser Institute
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
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, Tolerance
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144
This is a randomised, double-blind, placebo-controlled, single ascending dose study in healthy volunteer subjects. Each dose level will be investigated with eight 20-50-year-old male subjects (6 on active drug and 2 on placebo).
- Trial name
- NCT04689035
- Testing
- AVLX-144
- Where
- Finland
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Avilex Pharma
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
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, Infant Nutrition Disorders
Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT
This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.
- Trial name
- NCT03035721
- Testing
- Low protein formula, Standard protein formula
- Where
- Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Safety Issues
Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert
MATRIX-001 will examine the safety, PK, modeled PD, and acceptability of inserts containing the combination of TAF and EVG applied vaginally, daily for 3 days, then every other day for 14 days.
- Trial name
- NCT06087913
- Testing
- TAF/EVG vaginal insert
- Where
- 3 sites in United States, Kenya and 1 more
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
Safety Issues
Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers
The object of this study was to evaluate safety of cream containing sericin and turmeric in healthy volunteers.
- Trial name
- NCT05869357
- Testing
- cream containing 2.5% sericin and 2%turmeric, cream containing 5%sericin and 2%turmeric, cream containing 10%sericin and 2%turmeric
- Where
- Thailand
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
Safety Issues
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
This study is to assess the safety of Vi-DT vaccine in adults and children.
- Trial name
- NCT03109600
- Testing
- Vi-DT (Bio Farma), Vi polysaccharide vaccine, Influenzae vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues
Phase I Study of PH100 (Ecklonia Cava Phlorotannins)
The purpose of this study was to determine the safety and tolerability of PH100, a purified phlorotannins from a brown alga Ecklonia cava and the pharmacokinetics of its major compounds 8,8'-bieckol, dieckol, and…
- Trial name
- NCT04335045
- Testing
- PH100 100mg, PH100 200mg, PH100 400mg
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Phloronol Inc.
Safety Issues, Pharmacokinetic
Evaluation of Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes
A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release…
- Trial name
- NCT06378125
- Testing
- controlled-ileal-release nicotinic acid (SAD/ MAD/MD) single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD), immediate-release nicotinic acid (SAD)
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University Hospital Schleswig-Holstein
Safety Issues
Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study
This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days.
- Trial name
- RITE PrEP (NCT06274398)
- Testing
- TAF/EVG rectal insert
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Eastern Virginia Medical School
Type II Diabetes Mellitus, Efficacy, Self
Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
Study Objective To evaluate the safety and tolerability of Empagliflozin with or without metformin in patients with Type II Diabetes Mellitus in the Pakistani population.
- Conditions
- Type II Diabetes Mellitus, Efficacy, Self, Safety Issues
- Trial name
- EASE (NCT05164263)
- Testing
- Empagliflozin
- Where
- 6 sites in Afghanistan, Kenya and 3 more
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Getz Pharma
Safety Issues, Patient Acceptance of Health Care
Operating Room WHO Surgical Safety Checklist Process Completion: an Observational Study
The WHO Surgical Safety Checklist is a simple tool designed to improve the safety of surgical procedures by bringing together the whole operating team (surgeons, anaesthesia providers and nurses) to perform key safety checks…
- Trial name
- NCT04965285
- Testing
- quality assesment
- Where
- Nepal
- Volunteers
- 322 people, healthy volunteers welcome
- Sponsor
- Nepal Mediciti Hospital
Pharmacokinetics, Safety Issues
Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221 (GEROPHARM LLC, Russia) and Ozempic®.
Study of comparative pharmacokinetics and biosimilarity of drugs containing semaglutide - GP40221 and Ozempic® in healthy volunteers.
- Conditions
- Pharmacokinetics, Safety Issues, Bioequivalence
- Trial name
- NCT06497049
- Testing
- GP40221, ozempic
- Where
- Russia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Geropharm