Clinical trials: Safety Plan
Percutaneous CFA Arteriotomy Closure
Safety and Performance Study of Large Hole Vascular Closure Device FIV
The purpose of this Clinical Investigation Plan (CIP) is to: 1. Confirm the safety and performance of the PerQseal® large hole closure system. 2.
- Trial name
- Frontier-IV (NCT03423602)
- Testing
- PerQseal®
- Where
- 11 sites in Germany, Ireland
- Volunteers
- 75 people
- Sponsor
- Vivasure Medical Limited
Suicide
Group ("Project Life Force") vs. Individual Suicide Safety Planning RCT
The management of suicide risk is a pressing national public health issue especially among Veterans. This grant consists of two arms: the novel treatment and treatment-as-usual.
- Trial name
- PLF (NCT03653637)
- Testing
- Project Life Force, Treatment as Usual
- Where
- 2 sites in United States
- Volunteers
- 294 people
- Sponsor
- VA Office of Research and Development
Glaucoma, Ocular Hypertension
Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension
The objective of this Investigation is to evaluate the safety and efficacy of long-term treatment with Xalacom in medical practice.
- Trial name
- NCT01191008
- Testing
- Latanoprost-timolol maleate fixed combination ophthalmic solution
- Volunteers
- 661 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Pneumococcal Infections
Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)
The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs)…
- Trial name
- PNEU-PLAN (NCT03885934)
- Testing
- V114, Prevnar 13®
- Where
- 26 sites in Finland, Malaysia and 3 more
- Volunteers
- 606 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1 Infection
Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this…
- Trial name
- NCT00823966
- Testing
- Rescriptor
- Volunteers
- 3 people
- Sponsor
- Pfizer
Violence, Domestic, Violence-Related Symptom
It's WeWomen Plus Intervention for Health, Safety and Empowerment
This study evaluates the impact of adaptive technology-based intervention (online, text and phone) "weWomenPlus" on safety, mental health and empowerment of abused immigrant women.
- Conditions
- Violence, Domestic, Violence-Related Symptom, Violence, Physical, Violence, Sexual
- Trial name
- IWWP (NCT04098276)
- Testing
- WeWomen Plus technology based intervention
- Where
- United States
- Volunteers
- 1,265 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Neuralgia
Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan)
The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored…
- Trial name
- RAINBOW (NCT01256593)
- Testing
- Pregabalin (Lyrica) capsule
- Volunteers
- 3,827 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Suicide, Self Harm
An Adaptive Intervention for Adolescents at Risk for Suicide: A Pilot SMART
To inform the development of a technology-augmented adaptive intervention for adolescents at risk for suicide, the goal of this study is to conduct a Sequential, Multiple Assignment, Randomized Trial (SMART) pilot of a…
- Trial name
- NCT03838198
- Testing
- MI-Enhanced Safety Plan at Hospitalization (1st Component), MI-Enhanced Text Boosters (2nd Component), MI-Enhanced Booster Call (3rd Component)
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- University of Michigan
Healthy Male Adults Participants, Vasectomy
Plan A Novel Delivery Device Study
This study will evaluate the safety and usability of the Delivery Lumen Access Device (DLAD) in accessing the vas deferens in up to 30 healthy males. This is a prospective, non-randomized, open label interventional study.
- Trial name
- NCT06891729
- Testing
- Delivery Lumen Access Device, DLAD
- Where
- 2 sites in Australia, Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Next Life Sciences
Suicide
Suicide Prevention for Sexual and Gender Minority Youth (Open Trial)
The overarching goal of this study is to develop a suicide prevention program for sexual-and-gender-minority youth and emerging adults.
- Trial name
- NCT05087966
- Testing
- Safety Planning Intervention with Navigation Services
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- San Diego State University
Non-tuberculous Mycobacterial Diseases, Tuberculosis
Safety And Efficacy Of Rifabutin In HIV Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Conditions
- Non-tuberculous Mycobacterial Diseases, Tuberculosis, Inhibition of Disseminated Mycobacterium Avium Complex Disease Associated With HIV Infections
- Trial name
- NCT00810446
- Testing
- rifabutin
- Volunteers
- 72 people
- Sponsor
- Pfizer
Adhesion
Safety and Tolerability of Seroguard Use
The performed study of safety and tolerability of Seroguard, solution (JSC Pharmasyntez, Russia) in patients, undergoing planned laparoscopic cholecystectomy, demonstrated that patients from the both groups had the similar safety…
- Trial name
- NCT03640559
- Testing
- Seroguard
- Volunteers
- 50 people
- Sponsor
- Pharmasyntez
HIV
Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services
The purpose of this study is to assess the effectiveness of an implementation model which integrates tenofovir gel provision into existing family planning services.
- Trial name
- NCT01691768
- Testing
- 1% tenofovir gel
- Where
- 2 sites in South Africa
- Volunteers
- 372 people, healthy volunteers welcome
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
Non-small Cell Lung Cancer
Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT01597258
- Testing
- Crizotinib (Xalkori)
- Volunteers
- 2,029 people
- Sponsor
- Pfizer
Pneumococcal Vaccine, Streptococcus Pneumoniae
Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months…
- Trial name
- NCT01521897
- Testing
- 7-valent vaccine injection
- Where
- Japan
- Volunteers
- 1,143 people
- Sponsor
- Pfizer
Open-Angle Glaucoma, Ocular Hypertension
Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%
The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual active components in subjects with open-angle…
- Trial name
- NCT01297920
- Testing
- Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, Brinzolamide ophthalmic suspension, 1%, Brimonidine tartrate ophthalmic solution, 0.2%
- Volunteers
- 1,062 people
- Sponsor
- Alcon Research
Renal Cell Carcinoma
Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing: 1. Confirmation of efficacy and safety for medical practice use. 2.
- Trial name
- NCT01210482
- Testing
- Temsirolimus
- Where
- Japan
- Volunteers
- 1,050 people
- Sponsor
- Pfizer
Cardiac Disease, Coronary Artery Disease
Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)
The objective of the CELT ACD® Vascular Closure Device study is to evaluate the safety and effectiveness of the CELT ACD® device to achieve hemostasis of the common femoral artery access site in patients on anticoagulation who…
- Trial name
- NCT01600482
- Testing
- CELT ACD
- Where
- 5 sites in United States, Germany and 1 more
- Volunteers
- 241 people
- Sponsor
- Vasorum Ltd
Suicidal Ideation, Suicide, Attempted
The Acceptability and Feasibility of an ED-based, Peer-delivered, Suicide Safety Planning Intervention
Safety planning is a brief, ED-feasible intervention which has been demonstrated to save lives, and has been universally recommended by every recent expert consensus panel on suicide prevention strategies.
- Conditions
- Suicidal Ideation, Suicide, Attempted, Mental Health Issue
- Trial name
- NCT04068142
- Testing
- Peer Supporter Safety Planning
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- University of Arkansas
Myocardial Infarction, Segment Elevation Myocardial Infarction (STEMI)
A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI)
The aim of this study is to determine whether initiation of ticagrelor as early as in the ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore facilitating the Percutaneous Coronary Intervention…
- Trial name
- ATLANTIC (NCT01347580)
- Testing
- Ticagrelor
- Where
- 96 sites in Algeria, Australia and 11 more
- Volunteers
- 1,875 people
- Sponsor
- AstraZeneca