Clinical trials: Safety Plan
Suicide, Mental Health Disorder
Optimizing a Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents
Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be…
- Conditions
- Suicide, Mental Health Disorder, Anhedonia
- Trial name
- NCT06665620
- Testing
- ViraBrite nudges
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Ksana Health
Fertility, Fertility, Male
Plan A Occlusion and Reversal System Feasibility Study
Prospective, multicenter, single-arm, open label, interventional clinical trial investigating the safety and effectiveness of the Plan A Male Contraceptive System to occlude the vas deferens to block the passage of sperm and then…
- Conditions
- Fertility, Fertility, Male, Healthy Male Adults
- Trial name
- NCT07361120
- Testing
- Occlusion System
- Where
- 3 sites in Australia, Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Next Life Sciences
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
Stomach Neoplasms, Rectal Neoplasms
Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing a Treatment Plan of Preoperative Chemotherapy and Radiation Therapy, Followed by Surgery
The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa on the reduction in red blood cell transfusions needed in gastric cancer patients and rectal cancer patients undergoing a treatment plan of…
- Trial name
- NCT00036400
- Testing
- epoetin alfa
- Volunteers
- 60 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Red-Cell Aplasia, Pure, Chronic Renal Failure
Study to Monitor the Incidence of Pure Red Cell Aplasia (PRCA) and/or Antibodies to Erythropoietin Among Participants Receiving Epoetin Alfa or Another Erythropoietin
The purpose of this study is to assess the incidence of pure red cell aplasia (PRCA [suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production]) among participants with chronic renal failure…
- Trial name
- NCT00210951
- Testing
- No Intervention
- Volunteers
- 4,761 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Diabetes Mellitus, Type 2
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 14332 CL as Tablet in Female and Male Patients With Type 2 Diabetes
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 14332 CL following administration of multiple rising oral doses over 10 days in patients with type 2 diabetes.
- Trial name
- NCT02212925
- Testing
- BI 14332 CL
- Volunteers
- 38 people
- Sponsor
- Boehringer Ingelheim
Vaginal Dysbiosis
Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle
The goal of this clinical trial is to evaluate FB301 during a mock frozen embryo transfer (FET) cycle in pre-menopausal women aged 18 to 45 years with a prior failed FET and a defined vaginal bacterial imbalance (dysbiosis).
- Trial name
- NCT07453069
- Testing
- FB-301, Chlorhexidine (0.5%) Vaginal Cleanse
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Freya Biosciences ApS
Suicide, Mental Health Disorder
A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents
Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be…
- Conditions
- Suicide, Mental Health Disorder, Anhedonia
- Trial name
- ViraSafeRCT (NCT07348666)
- Testing
- ViraSafe: Treatment pushes, BRITE
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Ksana Health
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
Large Hole Percutaneous Arterial Closure
Safety and Performance Study for Arterial Large Hole Vascular Closure Device
To study will assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients…
- Trial name
- ELITE (NCT05951634)
- Testing
- PerQseal ELITE
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Vivasure Medical Limited
Chronic Myelogenous Leukemia
Safety And Efficacy Of Bosutinib
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 3.
- Trial name
- BLF (NCT02501330)
- Testing
- Bosutinib
- Volunteers
- 702 people
- Sponsor
- Pfizer
Anticoagulation
Patient and Physician Knowledge of Key Safety Messages
This cross-sectional epidemiologic study measured physician and patient awareness and understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert card.
- Trial name
- NCT01907048
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 4 sites in France, Germany and 2 more
- Volunteers
- 2,227 people
- Sponsor
- Bayer
Epilepsy, Partial
Meta-Analysis Plan for Pooled Data for Studies VRX-RET-E22-303 and VRX-RET-E22-304
The objective of this meta-analysis is to provide data on long-term safety and efficacy following the recent positive Committee for Medicinal Products for Human Use (CHMP) opinion for retigabine using pooled data from ongoing…
- Trial name
- NCT01457989
- Testing
- retigabine/ezogabine
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Stable Angina, Myocardial Infarction
Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned
Primary objective: To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interest in patients with stable angina (SA) or old myocardial infarction (OMI) to which…
- Trial name
- CLEAN (NCT00821834)
- Testing
- clopidogrel (SR25990), ticlopidine
- Where
- Japan
- Volunteers
- 1,003 people
- Sponsor
- Sanofi
Critical Limb Ischemia, Peripheral Vascular Disease
Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to…
- Conditions
- Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers, Rest Leg Pain
- Trial name
- NCT00060996
- Testing
- Remodulin® (treprostinil sodium) Injection
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- United Therapeutics
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.
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.
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
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