Clinical trials: Safety Issues
Scoliosis Idiopathic, Navigation, Spatial
Preoperative and Peroperative Comparison Between 3D Spine Reconstructions
The objective is to collect data from a per-operative navigation system called SURGIVISIO during scoliosis surgeries. A research program is in progress in order super-impose pre-operative 3D reconstructions of the spine performed…
- Conditions
- Scoliosis Idiopathic, Navigation, Spatial, Fusion of Spine, Safety Issues
- Trial name
- Spine-PDCA-OR (NCT04611490)
- Testing
- Spine Fusion
- Where
- France
- Volunteers
- 15 people
- Sponsor
- University Hospital, Grenoble
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
Using Emergency Manuals During Interprofessional Crisis Management: Are There Unintended Consequences?
Despite increasing interest in emergency manuals (EMs), relatively little is known about their effectiveness and limitations in the perioperative setting.
- Trial name
- EM (NCT03006549)
- Testing
- Emergency Manual (Crisis Checklist)
- Where
- 3 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Defibrillators, Implantable, Cardiac Arrest
Electrical Safety of Implantable Cardioverter Defibrillators
Patients at risk of developing life-threatening heart rhythms may require the implantation of a small device called a cardioverter-defibrillator (ICD), which constantly monitors the heart rhythm and delivers an electrical shock…
- Trial name
- NCT03271619
- Testing
- Surface current measurement
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Critical Illness, Safety Issues
TraceBook: the Clinical Proof of Concept on the Intensive Care.
The effectiveness of current checklists is hampered by lack of acceptance and compliance. Recently, a new type of checklist with dynamic properties has been created to provide more specific checklist items for each individual…
- Trial name
- TraceBook (NCT03599856)
- Testing
- TraceBook
- Where
- Netherlands
- Volunteers
- 408 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
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
Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.
- Trial name
- NCT06189170
- Testing
- KP405
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Kariya Pharmaceuticals
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
Safety Issues
Safety and Tolerability Trial (MVA-BN-Brachyury/FPV-Brachyury)
An open-label Phase 1 trial to evaluate the safety and tolerability of MVA-BN-Brachyury priming and FPV-Brachyury boost vaccines modified to express brachyury and T-cell costimulatory molecules in patients with a metastatic or…
- Trial name
- NCT03349983
- Testing
- MVA-BN-Brachyury/ FPV-Brachyury
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Bavarian Nordic
Safety Issues
The Safety of Paxlovid in Hemodialysis Patients With Covid-19
Infection with SARS-CoV-2 continue to threaten global health. Persons with chronic kidney disease, including dialysis treatment are at hight risk for severe Covid-19 and associated adverse outcomes.
- Trial name
- SPHPS (NCT05366192)
- Testing
- Nirmatrelvir and ritonavir stage 1, Nirmatrelvir and ritonavir stage 2
- Where
- China
- Volunteers
- 18 people
- Sponsor
- RenJi Hospital
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
Safety Issues, Efficacy, Self
The Lower Silesia Shockwave Registry
Lower Silesia Shockwave Registry (LSSR), is a observational registry collecting all consecutive cases of percutaneous coronary intervention (PCI) performed with the support of shockwave intravascular lithotripsy in two…
- Trial name
- LSSR (NCT05916898)
- Testing
- PCI with support of Shockwave Intravascular Lithotripsy
- Where
- 2 sites in Poland
- Volunteers
- 400 people
- Sponsor
- Miedziowe Centrum Zdrowia SA
Safety Issues
Safety Analysis of Implantation of Stromal Vascular Fraction
Stromal vascular fraction (SVF) can be isolated from fat (adipose) tissue in an outpatient in-clinic procedure. Platelet rich plasma (PRP) can be isolated from peripheral blood.
- Trial name
- NCT03226093
- Testing
- Stromal Vascular Fraction
- Volunteers
- 676 people
- Sponsor
- Bioheart, Inc.
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
Safety Issues
A Single-center Study Designed to Evaluate the Safety and Efficacy of Tulipon
Subjects who normally use tampons will use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.
- Trial name
- NCT04268758
- Testing
- tulipon
- Sponsor
- Hadassah Medical Organization