Clinical trials: Safety Issues
Device Ineffective, Safety Issues
The HEALiX™ Intubated Patient (IP) Pilot Study
The current standard of care for limiting the movement of mechanically ventilated critical care patients is the use of physical wrist restraints, which are both ineffective in preventing removal of invasive and adjunct…
- Trial name
- NCT04759066
- Testing
- HEALiX
- Where
- United States
- Sponsor
- Lancaster General Hospital
Metastatic Triple Negative Breast Cancer, Safety Issues
Effect of Bevacizumab in Metastatic Triple Negative Breast Cancer
Evaluating efficacy and safety of bevacizumab when combined with chemotherapy (carboplatin and Paclitaxel ) in treatment of patient with metastatic triple negative breast cancer
- Conditions
- Metastatic Triple Negative Breast Cancer, Safety Issues, Efficacy
- Trial name
- NCT03577743
- Testing
- Bevacizumab
- Where
- Egypt
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Assiut University
Safety Issues, Immunogenicity
Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants
- Trial name
- NCT03680417
- Testing
- Measles-Rubella (MR) Vaccine
- Where
- Indonesia
- Volunteers
- 590 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Musculoskeletal Disorder, Mental Health Issue
An Integrated Approach to Health, Wellbeing, and Productivity at Work
The goal of the workplace intervention study 'An Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)' is to examine the effect of the Australian WorkHealth Improvement Network (WIN) program in a Danish…
- Conditions
- Musculoskeletal Disorder, Mental Health Issue, Work-related Illness, Safety Issues
- Trial name
- ITASPA (NCT05866978)
- Testing
- Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)
- Where
- Denmark
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Holbaek Sygehus
Safety Issues, Immunogenicity
Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.
- Trial name
- NCT04051268
- Testing
- Vi-DT Typhoid Conjugate Vaccine, PQed Typhoid Conjugate Vaccine, Vi Polysaccharide Vaccine
- Where
- Indonesia
- Volunteers
- 3,071 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Morbid Obesity, Sleeve Gastrectomy
Safety of an Early Discharge Protocol After Sleeve Gastrectomy
Evaluate the safety and efficacy of an early discharge protocol (23 hours, overnight stay) after scheduled sleeve gastrectomy.
- Conditions
- Morbid Obesity, Sleeve Gastrectomy, Early Discharge, Safety Issues
- Trial name
- NCT03070457
- Testing
- Early discharge, Conventional protocol
- Where
- Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hospital Universitari de Bellvitge
Safety Issues
Effect of Lean Leadership Training Program on Head Nurses' Lean Performance and Staff Nurses' Workplace Safety at Mansoura Children Hospital
Effect of Lean Leadership Training Program on Head Nurses' Lean Performance and Staff Nurses' Workplace Safety at Mansoura Children Hospital
- Trial name
- leadership (NCT06989294)
- Testing
- Lean Leadership
- Where
- Egypt
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Mansoura University
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
Aortic Valve Stenosis, Heart Failure
The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
A study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement
- Conditions
- Aortic Valve Stenosis, Heart Failure, Inotropic Agents, Safety Issues
- Trial name
- NCT04573049
- Testing
- Levosimendan
- Where
- China
- Volunteers
- 124 people
- Sponsor
- China National Center for Cardiovascular Diseases
Safety Issues, Quality of Life
Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander
The experimental hypothesis of this randomized controlled study was to demonstrate that early drain removal in patients who underwent immediate breast reconstruction with tissue expander is a safety procedure to improving…
- Trial name
- NCT04188821
- Testing
- breast drain removal
- Volunteers
- 124 people
- Sponsor
- University of Foggia
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
Surgery-Complications, Nephrolithiasis Staghorn Calculus
Comparison of Total Tubeless Mini-PCNL Versus Tubeless Mini-PCNL
Limited literature has focused on the use of totally tubeless mini-percutaneous nephrolithotomy (Mini-PCNL) for the treatment of large renal stones.
- Conditions
- Surgery-Complications, Nephrolithiasis Staghorn Calculus, Safety Issues
- Trial name
- NCT06288022
- Testing
- total tubeless mini-PCNL, tubeless mini-PCNL
- Where
- Thailand
- Volunteers
- 130 people
- Sponsor
- Mahidol University
Safety Issues, Effect of Drugs
The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells
To study the effect and saftey of intratracheal instillation of mesenchymal stem cells for treatment BPD
- Trial name
- NCT03683953
- Testing
- mesenchymal stem cells therapy, 0.9% sodium chloride
- Volunteers
- 200 people
- Sponsor
- Guangdong Women and Children Hospital
Safety Issues
Trimodal Therapy Plus Atezolizumab in Muscle-invasive Bladder Cancer
This is a single arm phase II trial to (1) evaluate safety and toxicity profile of intravenous Atezolizumab (anti-PDL-1) administered in combination with TMT in patients with MIBC, (2) To determine the loco-regional control rate…
- Trial name
- NCT03620435
- Testing
- Atezolizumab
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Intubation Complication, Intubation; Difficult or Failed
Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment
The safety and efficacy of a laryngoscopy as a primary intubation tool in urgent endotracheal intubation of cardiac arrest patients with suspected/confirmed COVID-19 has not been well-described in the literature.
- Conditions
- Intubation Complication, Intubation; Difficult or Failed, Cardiac Arrest, Influenza
- Trial name
- NCT04365608
- Testing
- Direct laryngoscopy, Vie Scope laryngoscopy
- Where
- 2 sites in Poland
- Volunteers
- 90 people
- Sponsor
- Lazarski University
Health Knowledge, Attitudes, Practice, Safety Issues
The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident
Following the serious adverse events that occurred in January 2016 during the BIA 10 2474 First-in-Human study, the French Ministry of Health asked the Regional Health Agencies to inspect operations at all Authorized Research…
- Conditions
- Health Knowledge, Attitudes, Practice, Safety Issues, Health, Subjective
- Trial name
- HARMONY (NCT03943017)
- Testing
- Inspection and safety evaluation by 3 longstanding experience physicians of early clinical researches
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
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
Medication Errors and Other Product Use Errors and Issues, Adverse Drug Event
Reducing Errors In The Neonatal Intensive Care Unit
This is a monocentric prospective pre and post-intervention study, aiming at analyzing the efficacy of the Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA) as compared to paper order entry…
- Trial name
- SAPHET-i (NCT04193839)
- Testing
- Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
Lupus Nephritis, Remission
Trial of Belimumab Combined With Multi-target Induction Therapy in Lupus Nephritis
The goal of this single-center, prospective clinical trial is to test the safety and efficacy of belimumab combined with multi-target therapy in the treatment of severe lupus nephritis.
- Conditions
- Lupus Nephritis, Remission, Safety Issues
- Trial name
- BEAM (NCT05863936)
- Testing
- Methylprednisolone Injectable Suspension, Belimumab Injection, Immunosuppressive Agents
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Nanjing University School of Medicine
Bariatric Surgery Candidate, Covid19
Obesity Surgery During 2020 Italian Pandemic
The first person-to-person Coronavirus disease (COVID-19) transmission in Italy was reported on Feb 21st, 2020, causing one of the most massive outbreak in Europe so far that stopped immediately all elective surgical procedures.
- Conditions
- Bariatric Surgery Candidate, Covid19, Complication of Surgical Procedure, Pneumonia, Viral
- Trial name
- NCT04480034
- Testing
- Bariatric procedures
- Where
- Italy
- Volunteers
- 1,600 people
- Sponsor
- University of Roma La Sapienza