Clinical trials: Safety Plan
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
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
Epilepsies, Partial
Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
This investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study: The frequency of treatment related adverse events.
- Trial name
- NCT01441401
- Testing
- gabapentin
- Volunteers
- 82 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Tuberculosis, Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
Safety And Efficacy Of Rifabutin In Patients For Non-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…
- Trial name
- NCT00810407
- Testing
- rifabutin
- Volunteers
- 628 people
- Sponsor
- Pfizer
Violence, Domestic, Violence, Sexual
Dissemination and Implementation of a Web-based Relationship Safety App, myPlanKenya, for Women at Risk for Intimate Partner Violence in Nairobi, Kenya
This effectiveness-implementation hybrid-3 study evaluates dissemination, implementation, and effectiveness of myPlanKenya. myPlanKenya will be disseminated through formal and informal sectors.
- Conditions
- Violence, Domestic, Violence, Sexual, Violence, Gender-Based
- Trial name
- myPlanKenya (NCT05609786)
- Testing
- Personalized safety planning tool
- Where
- Kenya
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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.
CCR5-tropic HIV-1 Infection
Safety And Efficacy Of Maraviroc In Patients For HIV Patients (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
- NCT00864474
- Testing
- CELSENTRI® Tablets
- Volunteers
- 68 people
- Sponsor
- ViiV Healthcare
Neuropathic Pain
Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)
The objective of this investigation is to evaluate the safety and efficacy of long term use with Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will…
- Trial name
- RAINBOW-L (NCT01279850)
- Testing
- Pregabalin (Lyrica) capsule
- Volunteers
- 891 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Suicide
Suicide Prevention for Sexual and Gender Minority Youth (Case Series)
The overarching goal of this study is to develop a suicide prevention program for sexual-and-gender-minority youth and emerging adults.
- Trial name
- NCT04757649
- Testing
- Safety Planning Intervention with Navigation Services
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- San Diego State University
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
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
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.
Depression, Suicidal Ideation
BRITEPath- Phase 2
BRITEPath (BP) aims to support co-located mental health clinicians in the development of a high quality, effective, and personalized safety plan for referred patients who screen positive for depression and/or suicidal ideation.
- Trial name
- NCT04672798
- Testing
- BRITEPath, Treatment As Usual (TAU)
- Where
- 6 sites in United States
- Volunteers
- 101 people
- Sponsor
- University of Pittsburgh
Mental Health Issue, Depressive Symptoms
Piloting +Connection is Medicine / The Healing Spirits Program
This study aims to assess what benefit, if any, an individualized coping plan and facilitating connections to care through referral coordination in conjunction with culturally tailored caring messages, (herein called the…
- Conditions
- Mental Health Issue, Depressive Symptoms, Anxiety
- Trial name
- NCT05424679
- Testing
- Safety Planning Intervention, Caring Contacts
- Where
- 4 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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
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
Hypertension
Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.
- Trial name
- ESSENCE (NCT00749775)
- Testing
- Selara
- Volunteers
- 3,338 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
Suicidal Ideation, Suicide, Attempted
Establishing Efficacy of an Inpatient Intervention and Phone App to Reduce Suicidal Risk
In this 2-site study, University of Texas Southwestern Medical Center (UTSW) and Western Psychiatric Institute and Clinic (WPIC), the investigators will conduct a randomized clinical trial (RCT) in 240 psychiatrically…
- Trial name
- ASAP+BRITE (NCT03825588)
- Testing
- ASAP (As Safe As Possible), BRITE smart phone app, TAU (treatment as usual)
- Where
- 2 sites in United States
- Volunteers
- 241 people
- Sponsor
- University of Texas Southwestern Medical Center
Suicidal Ideation, Suicide, Attempted
Safety Planning in Juvenile Justice for Suicidal Youth
This study will examine the feasibility and acceptability of a program designed to conduct safety planning with youth in the juvenile justice system who are at risk for a suicide attempt and/or self-injury and to increase the…
- Conditions
- Suicidal Ideation, Suicide, Attempted, Nonsuicidal Self-injury
- Trial name
- Safety (NCT03655470)
- Testing
- Safety Planning, Standard care
- Where
- 2 sites in United States
- Volunteers
- 59 people
- Sponsor
- Brown University