Clinical trials: Safety of Intervention
Acute Coronary Syndromes
A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart
The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a…
- Trial name
- NCT02415400
- Testing
- Apixaban, vitamin K antagonist, Acetylsalicylic acid
- Where
- 626 sites in United States, Argentina and 35 more
- Volunteers
- 4,614 people
- Sponsor
- Bristol-Myers Squibb
Spinal Procedure Requiring Dura Incision
Study to Evaluate Safety and Effectiveness of Spinal Sealant
To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery.
- Trial name
- NCT00594035
- Testing
- Spinal Sealant System, Standard of care
- Where
- United States
- Volunteers
- 158 people
- Sponsor
- Integra LifeSciences Corporation
Discoid Lupus Erythematosus
Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients
The purpose of this study is to determine the clinical and immunological effects of the phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous lupus erythematosus.
- Trial name
- NCT00708916
- Testing
- CC-10004
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- NYU Langone Health
Cataract
Cataract Surgery: Femto LDV Z8 Versus Conventional
The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract…
- Trial name
- COMFORT (NCT02351271)
- Testing
- Femto LDV Z8, Manual capsulorhexis&lens fragmentation
- Volunteers
- 130 people
- Sponsor
- Ziemer Ophthalmic Systems AG
Alimentary Obesity
The PRIMAVERA Study: Reduxine Safety Monitoring in Patients With Alimentary Obesity
The aim of this study is to summarize the data on efficacy and safety of Reduxine administration in the routine clinical practice according to the approved indications.
- Trial name
- Primavera (NCT01773733)
- Volunteers
- 98,774 people
- Sponsor
- Promomed, LLC
Diabetes Mellitus, Type 2
A Non Interventional Study to Monitor the Safety and Effectiveness of Trajenta (Linagliptin, 5 mg, q.d) in Korean Patients With Type 2 Diabetes Mellitus
The aim of this study is to monitor safety and efficacy of treatment with linagliptin in Korean patients with type 2 diabetes mellitus in routine clinical settings.
- Trial name
- NCT01707147
- Testing
- Trajenta tablet
- Where
- South Korea
- Volunteers
- 3,219 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
SMART China, A Multi-center Clinical Registry Study
This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.
- Trial name
- NCT02485925
- Testing
- THERMOCOOL® SMARTTOUCH™
- Volunteers
- 200 people
- Sponsor
- Biosense Webster, Inc.
Head and Neck Squamous Cell Carcinoma
A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010)
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell…
- Trial name
- NCT04199104
- Testing
- Lenvatinib, Pembrolizumab
- Where
- 152 sites in United States, Australia and 17 more
- Volunteers
- 511 people
- Sponsor
- Merck Sharp & Dohme LLC
Anesthesia, General
Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)
The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium…
- Trial name
- NCT00298831
- Testing
- Sugammadex, Rocuronium
- Volunteers
- 224 people
- Sponsor
- Merck Sharp & Dohme LLC
Gram-Positive Bacterial Infections
Post Marketing Surveillance Study on Linezolid
The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.
- Trial name
- A5951090 (NCT01564758)
- Testing
- Linezolid
- Volunteers
- 99 people
- Sponsor
- Pfizer
Dermatitis, Atopic
A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
The purpose of this study is to evaluate the efficacy of Bermekimab, compared with placebo, in participants with moderate-to-severe atopic dermatitis (AD).
- Trial name
- NCT04990440
- Testing
- Bermekimab
- Where
- 11 sites in United States, Argentina
- Volunteers
- 6 people
- Sponsor
- Janssen Research & Development, LLC
Ischemic Stroke
Assess the Penumbra System in the Treatment of Acute Stroke
The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA)in patients with acute ischemic stroke…
- Trial name
- THERAPY (NCT01429350)
- Testing
- intravenous (IV) recombinant human tissue plasminogen activator (rtPA), Penumbra System
- Where
- 4 sites in United States
- Volunteers
- 108 people
- Sponsor
- Penumbra Inc.
Surgical Wound
The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.
- Trial name
- Closer (NCT02136004)
- Testing
- Closer VSS
- Where
- 12 sites in United States
- Volunteers
- 220 people
- Sponsor
- Rex Medical
Malignant Melanoma
Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advanced Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)-China Extension Study
The purpose of the China Extension study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line…
- Trial name
- NCT04889118
- Testing
- Pembrolizumab, Lenvatinib
- Where
- 11 sites in China
- Volunteers
- 131 people
- Sponsor
- Merck Sharp & Dohme LLC
Rosacea
Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea
This study will evaluate the safety and tolerability of oxymetazoline HCl cream 1.0% when used as an adjunctive treatment to energy-based therapy for participants with moderate to severe persistent facial erythema associated with…
- Trial name
- NCT03380390
- Testing
- Oxymetazoline HCL 1.0% Cream, Energy-Based Therapy
- Where
- 4 sites in United States
- Volunteers
- 46 people
- Sponsor
- Aclaris Therapeutics, Inc.
Atrial Fibrillation
Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy in subjects with atrial fibrillation (AF) following percutaneous intervention (PCI) with stenting.
- Trial name
- ENTRUST-AF-PCI (NCT02866175)
- Testing
- Edoxaban, Clopidogrel, Prasugrel
- Where
- 200 sites in Austria, Belgium and 16 more
- Volunteers
- 1,506 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Otorhinolaryngologic Surgical Procedures, Laser Therapy
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Laser Laryngeal Surgery
The purpose of this study is to investigate whether laser laryngeal surgery can be safely and potentially more effectively performed without the use of tracheal intubation or jet ventilation, under completely tubeless conditions.
- Trial name
- NCT03086265
- Testing
- THRIVE, Endotracheal tube
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Stanford University
Diabetes Mellitus, Type 2
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information
- Trial name
- AVANDAMETPMS (NCT01294553)
- Testing
- Administration of rosiglitazone/metformin
- Volunteers
- 717 people
- Sponsor
- GlaxoSmithKline
Wet Age Related Macular Degeneration
Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye
The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).
- Trial name
- TWEYES (NCT01986907)
- Testing
- ranibizumab
- Where
- 101 sites in Italy
- Volunteers
- 1,049 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Arterial Hypertension
A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin
The Thelin Patient Safety Registry is a post-marketing program in the European Union (EU) that is designed to supplement the reporting of spontaneous adverse events (AE) and better characterize known and potential safety signals…
- Trial name
- PROSE (NCT00995566)
- Testing
- Sitaxentan sodium
- Where
- 4 sites in Belgium, France and 1 more
- Volunteers
- 54 people
- Sponsor
- Pfizer