Clinical trials: Safety Issues
Safety Issues, Effect of Drug
ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection
The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection.
- Trial name
- ADC (NCT06342921)
- Testing
- 15 mg ADC189, 45 mg ADC189
- Where
- China
- Volunteers
- 749 people
- Sponsor
- Jiaxing AnDiCon Biotech Co.,Ltd
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
Patient Satisfaction, Drug Adherence
Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B
Chronic hepatitis B (CHB) patients may be unsatisfied to entecavir (ETV) therapy due to the inconvenience in drug taking, i.e., fasting for more than 2 hours and/or dose adjustment according to estimated glomerular filtration…
- Conditions
- Patient Satisfaction, Drug Adherence, Efficacy, Self, Safety Issues
- Trial name
- NCT05583006
- Testing
- tenofovir alafenamide (TAF)
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- Taichung Veterans General Hospital
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, Device Dislodgement
The HEALiX: Comparing the Efficacy of the HEALiX Device With Wrist Restraints in a Critical Care Setting
The treatment plan for patients requiring mechanical ventilator support is to provide the minimal amount of analgesics and sedatives necessary for the patient to tolerate the ventilator as lower amounts of these drugs has been…
- Conditions
- Safety Issues, Device Dislodgement, Device Intolerance, Device Ineffective
- Trial name
- NCT05180552
- Testing
- HEALiX is an alternative restraint patient safety device, soft wrist restraints
- Sponsor
- Milton S. Hershey Medical Center
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, 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, 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, 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
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
Surgery, Safety Issues
Development and Implementation of Patient Safety Checklists Before, During and After In-hospital Surgery
Building on the Norwegian Patient Safety Program's target areas, the Patients' Surgical Checklist (PASC) will empower surgical patients to become more involved in their own safety and contribute to preventive safety measures.
- Conditions
- Surgery, Safety Issues, Complication, Patient Safety
- Trial name
- PASC (NCT03105713)
- Testing
- Patient Safety Checklist
- Where
- 2 sites in Norway
- Volunteers
- 8,559 people
- Sponsor
- Haukeland University Hospital
Safety Issues, Efficacy, Self
Hypofraction Radiotherapy for Limited-Stage Small Cell Lung Cancer
Concurrent chemoradiotherapy is the standard modality for locally advanced small-cell lung cancer, which could achieve median overall survival of 25 mos.
- Trial name
- NCT05523908
- Testing
- High-dose hypofraction Arm, Low-dose hypofraction Arm (Standard BED)
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Anhui Provincial Hospital
Safety Issues, Efficacy, Self
Lower Silesian Orbital Atherectomy Registry (LOAR)
The Lower Silesian Orbital Atherectomy Registry (LOAR), is an observational registry collecting all consecutive cases of percutaneous coronary intervention (PCI) performed with the support of the Orbital Atherectomy Device due to…
- Trial name
- LOAR (NCT06451146)
- Testing
- PCI Facilitated with Orbital Atherectomy Device
- Where
- 2 sites in Poland
- Volunteers
- 500 people
- Sponsor
- Miedziowe Centrum Zdrowia SA
Noise Exposure, Intensive Care Unit
Effective Strategies to Reduce Noise and Related Distractions
Patients admitted to the intensive care unit (ICU) undergo complex critical care treatment and are consequently surrounded by equipment and monitors contributing to high sound pressure levels.
- Conditions
- Noise Exposure, Intensive Care Unit, Safety Issues
- Trial name
- NOISY (NCT04643652)
- Testing
- Noise Reduction Bundle
- Where
- Netherlands
- Volunteers
- 250 people
- Sponsor
- Radboud University Medical Center
Peripheral Arterial Disease, Paclitaxel Adverse Reaction
Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)
The SAFE-PAD Study aims to evaluate the long-term safety of paclitaxel-coated devices compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with…
- Conditions
- Peripheral Arterial Disease, Paclitaxel Adverse Reaction, Safety Issues
- Trial name
- SAFE-PAD (NCT04496544)
- Testing
- Retrospective data collection
- Where
- United States
- Volunteers
- 168,553 people
- Sponsor
- Beth Israel Deaconess Medical Center
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
Safety Issues
NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors
This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D-based CAR-T cells infusion in the treatment of advanced NKG2DL+ solid tumors.
- Trial name
- NCT06509490
- Testing
- KD-025 cell injection
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Inflammatory Disease, Drug Side Effect
Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)
The LOOK-UP is an investigator-initiated clinical study with the aim of monitoring the post-marketing safety of the medicine Rinvoq™ (upadacitinib), which is indicated for the treatment of rheumatoid arthritis, psoriatic…
- Conditions
- Inflammatory Disease, Drug Side Effect, Drug Use, Adverse Drug Event
- Trial name
- LOOK-UP (NCT06498167)
- Testing
- Upadacitinib
- Where
- 3 sites in Portugal
- Volunteers
- 150 people
- Sponsor
- Universidade do Porto
Drug Effect, Safety Issues
Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia
The goal of this clinical trial is to demonstrate equivalent efficacy and comparable safety of the drug GP40141 (GEROPHARM, Russia) in comparison with the drug Nplate® (Amgen, the Netherlands). the main questions are 1.
- Conditions
- Drug Effect, Safety Issues, Immunogenicity
- Trial name
- NCT06497036
- Testing
- GP404141, Nplate
- Where
- 6 sites in Russia
- Volunteers
- 160 people
- Sponsor
- Geropharm
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