Clinical trials: Safety Issues
Thromboembolic Disease, Lower Extremity Problem
The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.
Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, More and more acute or subacute thromboembolic occlusions of lower extremity included stage IIb…
- Conditions
- Thromboembolic Disease, Lower Extremity Problem, Endovascular Treatment, Safety Issues
- Trial name
- NCT04861506
- Testing
- endovascular treatment
- Where
- China
- Volunteers
- 400 people
- Sponsor
- First People's Hospital of Hangzhou
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
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
Efficacy, Self, Safety Issues
I Can sEe Left Atrial Appendage (ICELAA) Clinical Study
The primary objective of this study is to assess the efficacy and safety of using intra-procedural intracardiac echocardiography (ICE) for WATCHMAN FLX Device implants in subjects with non-valvular atrial fibrillation to reduce…
- Trial name
- ICELAA (NCT04196335)
- Testing
- intra-procedural intracardiac echocardiography
- Where
- 7 sites in Denmark, Italy and 2 more
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Safety Issues, Effect of Drug
Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients
The aim of this study is evaluating safety and effectiveness of Ovine Enoxaparin Sodium in Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS) Patients
- Trial name
- NCT06114641
- Testing
- Enoxaparin sodium injection
- Where
- 3 sites in Indonesia
- Volunteers
- 220 people
- Sponsor
- PT Bio Farma
Safety Issues
NOPARK Open Label Extension Study
This protocol describes the NOPARK Open Label Extension Study. The NOPARK Open Label Extension study is an optional extension of the clinical phase II NOPARK study.
- Trial name
- NCT05546567
- Testing
- Nicotinamide Riboside
- Where
- Norway
- Volunteers
- 400 people
- Sponsor
- Haukeland University Hospital
Safety Issues, Tolerance
Phase1 First in Human Ascending Dose Study to Evaluate the Safety and Tolerability of FC-12738 in Health Adults
A Phase I, Randomized, Double-Blind, Placebo-Controlled, First-in-human, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of retro enversio (RT) thymopentin in Healthy Adult…
- Trial name
- NCT05978908
- Testing
- FC-12738, Saline
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Neurodegenerative Disease Research Inc
Safety Issues
Safety of Propofol Sedation ( > 200 mg) for Colonoscopy.
This study examines that the use of >200 mg of propofol sedation enables patients to drive home safely after outpatient colonoscopy.
- Trial name
- NCT05213208
- Testing
- Propofol
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- Showa Inan General Hospital
Healthy, Safety Issues
Effect of an Polyphenolic Beverage in Healthy Volunteers
Currently, there are different strategies to prevent the effect of beverages and foods on blood glucose levels after ingestion. In this sense, polyphenols are a promising field; these compounds are secondary metabolites produced…
- Trial name
- PB (NCT05802472)
- Testing
- Polyphenolic beverage from extract of Vachellia farnesiana
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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
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, Tolerability
Single Ascending Dose and Multiple Ascending Dose Study of AVR-48
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and…
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT06847698
- Testing
- AVR-48
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AyuVis Research, Inc.
Safety Issues, Dengue
Safety, Virological and Immunological Assessment of the Controlled Dengue Human Infection Model in Dengue-Immune Participants in Thailand (DHIT-Immune)
rDEN2Δ30-7169 is a dengue challenge strain that previously reports its viremia induction effect in participants with minimal symptoms in US flavivirus naïve participants.
- Conditions
- Safety Issues, Dengue, Viremia, Immune-related Adverse Event
- Trial name
- DHIT-Immune (NCT06908018)
- Testing
- rDEN2Δ30-7169
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Anesthesia, Safety Issues
Sonographic Predictors of Difficult Epidural Placement.
Epidural placement is a commonly used procedure for pain management during labor, delivery, and surgeries. However, epidural placement is often considered a technically challenging and complex procedure that requires a high level…
- Conditions
- Anesthesia, Safety Issues, Epidural; Anesthesia, Headache
- Trial name
- PREC-EPI (NCT05893264)
- Testing
- Data collection
- Where
- Italy
- Sponsor
- University of Padova
Bioequivalency, Safety Issues
Bioequivalence Study of Iron Sucrose Injection in Healthy Participants
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
- NCT06674486
- 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
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
Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever
This is a randomized study to evaluate the safety and feasibility of early de-escalation of empirical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (HSCT).
- Trial name
- NCT04270786
- Testing
- Early de-escalation, Standard
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Safety Issues, HPV Infection
BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects
This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies.
- Trial name
- NCT04528407
- Testing
- Observation without intervention
- Where
- Austria
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- BlueSky Immunotherapies GmbH
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