Clinical trials: Safety of Intervention
Gun Violence Prevention
Distribution and Randomization of Gun Safety Devices to Measure Uptake and Preferences
This study aims to enhance workplace safety by implementing a firearm safety program at Penn Medicine Pennsylvania Hospital (PAH). The option to store firearms securely during visits is offered to firearm owners.
- Trial name
- NCT06682403
- Testing
- Received cable lock as default, Choice between cable lock or lock box
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Von Willebrand Disease
Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery
The purpose of the study is to assess the efficacy and safety of recombinant von Willebrand factor (rVWF) with or without ADVATE in major and minor elective surgical procedures in adult patients with hereditary severe von…
- Trial name
- NCT02283268
- Testing
- Recombinant von Willebrand Factor (rVWF)
- Where
- 34 sites in United States, Australia and 11 more
- Volunteers
- 24 people
- Sponsor
- Baxalta now part of Shire
Gaucher Disease
A Study of Enzyme Replacement Therapy (VPRIV) in People With Type 1 Gaucher Disease Who Were Previously Treated With Substrate Reduction Therapy
The study will provide information on outcomes in people with type 1 Gaucher disease when they are treated with velaglucarase alfa (also called VPRIV), under standard care.
- Trial name
- SWITCH (NCT04718779)
- Testing
- Digital Engagement Application (GD App), No Intervention
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Takeda
Elective Cranial Procedures With Dural Incision
Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures
The purpose of the study is to demonstrate the safety and effectiveness of the Adherus Dural Sealant System when used as a dural sealant in conjunction with standard methods of dural repair in cranial procedures.
- Trial name
- NCT01158378
- Testing
- Adherus Dural Sealant
- Where
- 17 sites in United States
- Volunteers
- 250 people
- Sponsor
- HyperBranch Medical Technology, Inc
Osteoarthritis, Rheumatoid Arthritis
Reciprocating Medical Devices - a Study of a New Safety Device
The study design is a randomized study to directly compare the performance and the outcome of syringe and needle procedures with a standard syringe or the new reciprocating procedure device (RDP), which is a type of safety…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Trauma, Thyroid Nodule
- Trial name
- RPD (NCT00651625)
- Testing
- Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001, conventional syringe - BD Ref 309604
- Where
- United States
- Volunteers
- 437 people
- Sponsor
- University of New Mexico
Significant Bleeding Risk
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex®…
- Trial name
- NCT02740335
- Testing
- Octaplex, Beriplex P/N (Kcentra)
- Where
- 86 sites in United States, Belarus and 9 more
- Volunteers
- 208 people
- Sponsor
- Octapharma
Diabetes Mellitus, Type 2
Regulatory Request NIS in Korea
To monitor the safety profile and effectiveness of JARDIANCE DUO® in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting
- Trial name
- NCT03642717
- Testing
- JARDIANCE DUO®
- Where
- 20 sites in South Korea
- Volunteers
- 658 people
- Sponsor
- Boehringer Ingelheim
Bariatric Surgery Candidate, Cholelithiases
Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)
- Conditions
- Bariatric Surgery Candidate, Cholelithiases, Other Disease
- Trial name
- MARS GI (NCT05695989)
- Testing
- Dual Robotic Arm Accessory (DRAA)
- Where
- 3 sites in Chile
- Volunteers
- 22 people
- Sponsor
- Levita Magnetics
Hypertension
Open-label inteRventional Clinical Trial to Assess Efficacy and Safety of the exteMporaneous combInation of Nebivolol and Ramipril in hypertenSIve pAtients
Open-label, inteRventional clinical Trial to assess EffIcacy and safety of the exteMporaneous combInation of Nebivolol and Ramipril in hypertenSIve pAtients.
- Trial name
- ARTEMISIA (NCT06104423)
- Testing
- Nebivolol 5 mg, Ramipril 2.5/5/10 mg
- Where
- Hungary
- Volunteers
- 266 people
- Sponsor
- Menarini International Operations Luxembourg SA
Acute Uncomplicated Plasmodium Falciparum Malaria
Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
This study was designed to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in…
- Trial name
- NCT03167242
- Testing
- KAF156, Coartem, Lumefantrine Solid Dispersion Formulation
- Where
- 11 sites in Burkina Faso, Gabon and 7 more
- Volunteers
- 524 people
- Sponsor
- Novartis Pharmaceuticals
Thrombocytopenia
Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure
Phase 3b open-label, multicenter study to evaluate the safety and efficacy of avatrombopag in subjects with thrombocytopenia scheduled for operations to critical sites or operations with a high risk of bleeding.
- Trial name
- NCT03326843
- Testing
- Avatrombopag 60 mg
- Where
- 27 sites in United States
- Volunteers
- 4 people
- Sponsor
- Sobi, Inc.
Diabetes Mellitus, Type 2
JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus
To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting
- Trial name
- NCT02848833
- Testing
- JARDIANCE 10mg, JARDIANCE 25mg
- Where
- South Korea
- Volunteers
- 3,368 people
- Sponsor
- Boehringer Ingelheim
Congenital Hemangioma, Hemangioendothelioma
A Study to Evaluate How Safe and Effective is the Mixture of Lipiodol® Ultra Fluid and Glue When Used for Embolization Procedures
This was a multicenter phase IV Post-Marketing Study. The study is designed to investigate the safety of Lipiodol® Ultra Fluid in association with surgical glues used according to each site medical practice of vascular…
- Conditions
- Congenital Hemangioma, Hemangioendothelioma, Angiosarcoma, Arteriovenous Malformations
- Trial name
- NCT02625389
- Testing
- Lipiodol Ultra Fluid with surgical glues
- Where
- 16 sites in India
- Volunteers
- 132 people
- Sponsor
- Guerbet
Parkinson Disease
An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients
To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson's Disease.
- Trial name
- NCT02649608
- Testing
- 0.04 mg Lu AE04621, 0.08 mg Lu AE04621, 0.2 mg Lu AE04621
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- H. Lundbeck A/S
Painful Diabetic Neuropathy, Diabetic Neuropathy, Painful
Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy
The purpose of this study is to explore the overall safety profile and durability of efficacy of Engensis (VM202) in painful diabetic peripheral neuropathy.
- Trial name
- NCT04055090
- Testing
- Long-Term Follow-Up of Patients who Received Engensis (VM202)
- Where
- 14 sites in United States
- Volunteers
- 101 people
- Sponsor
- Helixmith Co., Ltd.
Type 2 Diabetes
Safety and Feasibility of a Novel Endoscopic Intervention for the Treatment of Type II Diabetes
This is an open-label study to assess the safety and feasibility of the DyaMX device for endoscopic duodenal mucosal regeneration in individuals with type 2 diabetes inadequately controlled on glucose-lowering medications.
- Trial name
- REGENT-1 (NCT04725890)
- Testing
- The DyaMX Device
- Where
- 2 sites in Australia
- Volunteers
- 65 people
- Sponsor
- Endogenex, Inc.
Neovascular Age-related Macular Degeneration
Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.
Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials.
- Trial name
- MACULA (NCT00858208)
- Testing
- pegaptanib sodium
- Where
- 8 sites in Greece
- Volunteers
- 86 people
- Sponsor
- Pfizer
Spray, Pain
Safety of Gebauer's Pain Ease and Gebauer's Ethyl Chloride
This study aims to determine if Gebauer's Pain Ease or Gebauer's Ethyl Chloride topical anesthetic sprays are safe for use as numbing agents prior to placing epidurals and arterial lines, based on whether they introduce increased…
- Conditions
- Spray, Pain, Safety Issues
- Trial name
- NCT04207710
- Testing
- Gebauer's Pain Ease Top Aerosol Mist Spray, Gebauer's Ethyl Chloride
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Henry Ford Health System
Hemorrhoid
Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure
Trial Objectives The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set: overall performance defined by the successful creation of a normal staple line safety as…
- Trial name
- NCT01169311
- Testing
- Hemorrhoidopexy
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Medtronic - MITG
Dravet Syndrome
Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
To investigate the long-term safety and tolerability of clobazam when administered for 1 year as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.
- Trial name
- NCT02187809
- Testing
- Clobazam
- Where
- 9 sites in United States, Mexico
- Volunteers
- 3 people
- Sponsor
- H. Lundbeck A/S