Clinical trials: Safety Plan
High-risk Localized Prostate Cancer
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make…
- Trial name
- CHINANEO (NCT07450599)
- Testing
- Darolutamide, ADT
- Where
- 23 sites in China
- Volunteers
- 250 people
- Sponsor
- Bayer
Alzheimer's Disease
A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
The purpose of the study is for investigation and collection of Aricept safety information with a dose increase on Alzheimer's disease patients.
- Trial name
- AID (NCT02158910)
- Testing
- Aricept
- Where
- 13 sites in South Korea
- Volunteers
- 2,231 people
- Sponsor
- Eisai Korea Inc.
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
Allergic Rhinitis
Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children.
The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years.
- Trial name
- SIERRA (NCT06272409)
- Testing
- DEP114, Desloratadine 0.5 MG/ML
- Volunteers
- 318 people
- Sponsor
- EMS
Suicide, Suicide, Attempted
Suicide Prevention Among Recipients of Care
Randomized controlled trial to determine the best brief suicide prevention intervention for adults and adolescents who screen positive for suicidal ideation or behavior in emergency departments or primary care clinics.
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation, Social Support
- Trial name
- SPARC (NCT04893447)
- Testing
- SPI+, SP+CC (Caring Contacts)
- Where
- United States
- Volunteers
- 1,520 people
- Sponsor
- St. Luke's Health System, Boise, Idaho
Respiration Disorders
To Identify if a COPD Self-management App Can Safety and Appropriately Identify When Patients Are Not on the Best Medication Plan for Their COPD Symptoms and Support Their COPD Management.
Although COPD cannot be cured, managing COPD can help reduce symptoms control, slows progression of the disease, and may improve the quality of life.
- Trial name
- mySmartCOPD (NCT07797985)
- Testing
- MMH-LAB1 app
- Where
- United Kingdom
- Volunteers
- 746 people, healthy volunteers welcome
- Sponsor
- University of Southampton
Chronic Hepatitis B
Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.
- Trial name
- NCT01026610
- Testing
- LB80380 90 mg, LB80380 150 mg, entecavir 0.5 mg
- Where
- 10 sites in China, South Korea
- Volunteers
- 115 people
- Sponsor
- LG Life Sciences
Suicide Attempt
Safety Planning Intervention in Swedish Healthcare: A Multisite Study for Suicide Prevention
Suicide is one of the leading causes of premature death and a prioritized public health concern. Safety Planning Intervention (SPI) is a method with strong international research support for reducing suicidal behaviour by…
- Trial name
- NCT07469917
- Testing
- Safety Planning Intervention (SPI)
- Where
- 4 sites in Sweden
- Volunteers
- 8,000 people
- Sponsor
- Region Skane
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
Suicide, Suicide, Attempted
Adaptive Intervention for Adolescents Following Inpatient Psychiatric Care
This study is being completed to examine different combinations of technology-augmented strategies to identify an effective Adaptive intervention (AI) addressing post-discharge suicide risk with high implementation potential.
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation, Self Harm
- Trial name
- NCT05282225
- Testing
- MI- Safety Plan, Texts messages, Monitoring
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- University of Michigan
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
Postoperative Pain
Safety and Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Ultra-sound Guided Transversus Abdominis Plan Block in Pediatric Abdominal Cancer Surgery
To study the efficacy of magnesium sulphate as adjuvant to levobupivacaine in transversus abdominis plane (TAP) block in patient undergoing abdominal cancer surgery.
- Trial name
- NCT03979599
- Testing
- ultra-sound guided transversus abdominis plan block, magnesium sulphate& levobupivacaine, Levobupivacaine
- Where
- Egypt
- Volunteers
- 10 people
- Sponsor
- South Egypt Cancer Institute
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
The goal of this clinical trial is to learn if a multi-layered digital and pharmacogenomic intervention works to prevent suicide re-attempts in adults with depression.
- Conditions
- Depressive Disorder, Major Depressive Disorder, Suicidal Ideation, Suicide, Attempted, Suicide Prevention
- Trial name
- SMARTomicS (NCT07885722)
- Testing
- Digital Monitoring (Active/Passive EMA), Ecological Momentary Intervention (EMI) via Digital Safety Plan, Pharmacogenetic-Guided Care and Therapeutic Drug Monitoring
- Where
- Spain
- Volunteers
- 525 people
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Cardiac Surgery, Ischemia Limb
Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach
This is a first-in-human, prospective, single-arm, phase I clinical study evaluating the safety of the iPerf femoral arterial cannula in patients undergoing planned cardiac surgery requiring extracorporeal circulation (ECC) via a…
- Trial name
- FIH IPERF-01 (NCT07163234)
- Testing
- Cardiac surgery
- Where
- 2 sites in France
- Volunteers
- 15 people
- Sponsor
- IPERF SAS
Efficacy, Safety
Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME
To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.
- Trial name
- NCT06271473
- Testing
- vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
- Where
- 2 sites in Egypt
- Volunteers
- 20 people
- Sponsor
- Ain Shams University
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
Intimate Partner Violence
Examining the Effectiveness of the myPlan App to Prevent Dating Violence With Adolescents
Intimate partner violence (IPV), including violence in teen dating relationships [teen dating violence (TDV)], is a common and a serious threat to adolescent health, safety, and well-being.
- Trial name
- NCT04564261
- Testing
- Personalized Healthy Relationship and Safety Planning Tool, Usual Care Teen Relationship and Health Website
- Where
- 2 sites in United States
- Volunteers
- 617 people
- Sponsor
- Johns Hopkins University
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
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