Clinical trials: Safety
Non-invasive Ventilation, Intensive Care (ICU)
An International Survey on the Use of NIV Outside the ICU
Non-invasive ventilation (NIV) is a way to support breathing using a mask or helmet instead of a breathing tube, and it is proven to reduce the need for intubation, save lives, shorten hospital stays, and lower costs.
- Conditions
- Non-invasive Ventilation, Intensive Care (ICU), Safety
- Trial name
- NIV-SAFETY (NCT07157215)
- Where
- India
- Volunteers
- 600 people
- Sponsor
- Dr. Ram Manohar Lohia Hospital
Quality of Health Care, Patient Safety
CITE: Clinical Inference Tethered to Evidence - a Retrieve-and-verify Layer for AI Care Plans
This trial evaluates CITE, a retrieve-and-verify layer that audits an AI-generated care plan against a full-text evidence corpus and flags patient-specific codifiable safety hazards to the clinician.
- Conditions
- Quality of Health Care, Patient Safety, Clinical Decision Support
- Trial name
- CITE (NCT07718893)
- Testing
- CITE evidence-grounding retrieve-and-verify layer, AI care plan with safety guardrails
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Waymark
Thrombocytopenia Related to Chronic Liver Disease, Anticoagulation Treatment
Safety of Anticoagulation Therapy in Cirrhotic Patients With PVT and Severe Thrombocytopenia
Severe thrombocytopenia (platelet count ≤ 50 × 10^9/L) can significantly increase the risk of bleeding. Safety of Anticoagulation (AC) therapy in cirrhotic patients with portal vein thrombosis (PVT) and severe thrombocytopenia is…
- Conditions
- Thrombocytopenia Related to Chronic Liver Disease, Anticoagulation Treatment, Safety, Portal Vein Thrombosis
- Trial name
- AC in PVT (NCT07885969)
- Testing
- Anticoagulation Therapy
- Where
- China
- Volunteers
- 304 people
- Sponsor
- Qilu Hospital of Shandong University
Firearm Safety, Firearm Safety Storage
Firearm Secure Storage Device Distribution RCT
This study aims to learn how to best promote safe firearm storage in the community. Firearm injuries are a major public health concern, and securely storing firearms can help prevent accidental injuries, suicide, and unauthorized…
- Trial name
- NCT07886983
- Testing
- Cable locks, Lock box, Lock box and cable locks
- Volunteers
- 1,858 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Stroke, Balance
The Validity and Reliability of an Improved Paper Grasping Test for Stroke
The study included volunteer patients diagnosed with stroke who applied to the Neurology Outpatient Clinic at SANKO University Sani Konukoğlu Application and Research Hospital.
- Conditions
- Stroke, Balance, Validity and Safety
- Trial name
- NCT07181005
- Where
- Turkey (Türkiye)
- Volunteers
- 44 people
- Sponsor
- Sanko University
Gut Health, Gastrointestinal Symptoms
IgG Binding Protein LT in Support of a Healthy Gut on the Go
PS52 is a randomized, double-blind, placebo-controlled, fully decentralized study sponsored by Bactolife A/S and conducted by People Science, Inc.
- Conditions
- Gut Health, Gastrointestinal Symptoms, Safety in Healthy Adults
- Trial name
- NCT07873957
- Testing
- IgG Binding Protein LT
- Where
- United States
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Bactolife A/S
Safety, Psychological, Acceptability of Health Care
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
This Pilot Randomized Controlled Trial (RCT) overall aim is to establish the safety, feasibility, acceptability and preliminary effects of a body-oriented psychotherapy, Somatic Experiencing (SE), on social functioning and mental…
- Conditions
- Safety, Psychological, Acceptability of Health Care, Psychological Safety, Maltreatment, Child
- Trial name
- NCT06549777
- Testing
- SE-group, Control
- Where
- Sweden
- Volunteers
- 50 people
- Sponsor
- Monique Pfaltz
Safety and Tolerability in Healthy Volunteers
Safety and Tolerability Evaluation of IgG Binding Protein LT
This study evaluates the safety and tolerability of the food ingredient IgG Binding Protein LT (BP-LT) when added to a daily diet.
- Trial name
- NCT07824011
- Testing
- IgG Binding Protein LT
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bactolife A/S
Safety, Efficiency
To Evaluate the Safety and Efficacy of Hemay5394 in Patients With Mild to Moderate Atopic Dermatitis
Evaluate the safety and efficacy of Hemay5394 in patients with mild to moderate atopic dermatitis
- Trial name
- NCT07877155
- Testing
- Hemay5394 group, Control group
- Where
- Australia
- Volunteers
- 90 people
- Sponsor
- Hemay Pharmaceutical PTY. LTD.
Safety, Tolerability
A First-in-Human SAD and MAD Study in HV to Evaluate Oral YR011 Tablet
This is a Phase I clinical trial (protocol number: YR-011-B07) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel…
- Conditions
- Safety, Tolerability, Pharmacokinetic
- Trial name
- NCT07878481
- Testing
- Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug)
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., Ltd
To Evaluate the Clinical Efficacy and Safety of the New ALSS
Clinical Observation of CABA System in the Treatment of End-stage Liver Disease With Inflammation
End-stage liver disease (ESLD) refers to the late stage of liver disease caused by various chronic liver damage. ESLD is an important cause of global incidence rate and mortality, which has a significant impact on the health care…
- Trial name
- NCT05780190
- Testing
- New artificial liver CABA system (BS330+CA280) +PE
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Qin Ning
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.
Randomized, Open-label
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial…
- Conditions
- Randomized, Open-label, Safety, Tolerability
- Trial name
- NCT07663838
- Testing
- GenSci142 capsule, clindamycin phosphate vaginal cream
- Where
- 9 sites in China
- Volunteers
- 42 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Patient Handoff, Healthcare Team
Handoffs and Transitions in Critical Care - Understanding Scalability
The investigators will leverage implementation science and engineering to adapt, implement, and rigorously evaluate tailored postoperative handoff protocols and implementation strategies.
- Conditions
- Patient Handoff, Healthcare Team, Communication, Patient Safety
- Trial name
- HATRICC-US (NCT04571749)
- Testing
- Customized handoff
- Where
- 5 sites in United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Safety, Tolerability
Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors
This is a multi-center, open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HY07121 in participants with advanced solid tumors.
- Conditions
- Safety, Tolerability, Efficacy
- Trial name
- NCT06639256
- Testing
- Test Product HY07121
- Where
- China
- Volunteers
- 258 people
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Birth Outcomes, Safety
Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study
This study is a prospective, randomized clinical trial. During this study, pregnant women will be randomly assigned to receive IIV and mRNA COVID-19 vaccine either simultaneously or sequentially (7-14 days apart).
- Conditions
- Birth Outcomes, Safety, Adverse Event Following Immunization
- Trial name
- NCT06503900
- Testing
- mRNA COVID-19 vaccine, IIV4 (quadrivalent inactivated influenza vaccine)
- Where
- 6 sites in United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Duke University
Locally Advanced Non-Small Cell Lung Cancer, Thoracic Radiotherapy
Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT
Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients with negative epidermal growth factor receptor (EGFR)-mutated unresectable locally advanced non-small cell lung cancer (LA-NSCLC).
- Conditions
- Locally Advanced Non-Small Cell Lung Cancer, Thoracic Radiotherapy, Safety
- Trial name
- NCT07037680
- Testing
- Anlotinib
- Where
- China
- Volunteers
- 44 people
- Sponsor
- JIANYANG WANG
Suicidal Ideation, Suicide Attempt
Youth Suicide Prevention: CAMS-BI vs. Safety Planning in a Randomized Trial
This study outlines a randomized controlled trial evaluating two brief suicide-specific interventions for adolescents aged 12-17 who are hospitalized for suicidal ideation or attempts.
- Conditions
- Suicidal Ideation, Suicide Attempt, Safety Plan, Depression / Major Depressive Disorder
- Trial name
- NCT07628192
- Testing
- CAMS Brief Intervention, Stanley-Brown Safety Planning Intervention
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- The Cleveland Clinic
Clinical Outcomes, Functional Outcomes
Prospective G7 Dual Mobility Total Hip PMCF
This is a prospective multi-center clinical evaluation following recipients of the G7 Dual Mobility hip device. The primary objective is to characterize survivorship of the G7 hip at five years post-index procedure.
- Conditions
- Clinical Outcomes, Functional Outcomes, Radiological Outcomes, Survivorship
- Trial name
- NCT03308929
- Testing
- G7 Dual Mobility hip
- Where
- 6 sites in United States
- Volunteers
- 250 people
- Sponsor
- Zimmer Biomet
Early Onset Sepsis, Preterm Neonates
Optimizing PreTerm Infant Ampicillin Dosing
The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safely receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours).
- Conditions
- Early Onset Sepsis, Preterm Neonates, NICU, Ampicillin
- Trial name
- OPTI-Amp (NCT07610486)
- Testing
- Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Duke University