Clinical trials: Safety Plan
Percutaneous Arteriotomy Closure
Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER V Study
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 90 patients in up to 8 European investigational sites.
- Trial name
- NCT04799769
- Testing
- Percutaneous arterial closure device
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 90 people
- Sponsor
- Vivasure Medical Limited
Acute Anterior ST-Segment Elevation Myocardial Infarction
A Research Study to Evaluate the Efficacy and Safety of SGC001 in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction
This is a multicenter, randomized, double-blind, placebo-controlled, single-dose, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of SGC001 injection administered in addition to…
- Trial name
- NCT07306182
- Testing
- SGC001 injection
- Where
- China
- Volunteers
- 210 people
- Sponsor
- Beijing Sungen Biomedical Technology Co., Ltd
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
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
Postoperative Nausea and Vomiting (PONV)
A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery
Some adults are at a higher risk of feeling sick (nausea) or being sick (vomiting) after they have surgery. In this study, these adults will have planned surgery.
- Trial name
- NCT04557189
- Testing
- TAK-951, Ondansetron
- Where
- 7 sites in United States
- Volunteers
- 89 people
- Sponsor
- Takeda
Atopic Dermatitis (AD), Asthma
Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy
The objective is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison…
- Trial name
- NCT04173442
- Testing
- dupilumab
- Where
- United States
- Volunteers
- 581 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
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.
Surgery, Gastric Cancer
Clinical Study to Prove Safety and Effectiveness When Applying RUS™ Surgical Navigation
By uploading pre-operative patient information and patient CT data to RUS™, a virtual surgical environment with patient-specific relief prediction models can be provided.
- Trial name
- NCT05039333
- Testing
- RUS(TM) software : surgical navigation
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Hutom Corp
Hepatocellular Carcinoma (HCC)
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.
- Trial name
- ADVANCE-MCD (NCT07669727)
- Testing
- TheraSphere
- Volunteers
- 140 people
- Sponsor
- Boston Scientific Corporation
Red-Cell Aplasia, Pure
A Study to Observe the Number of Patients Who Develop Pure Red Cell Aplasia (PRCA, a Rare Form of Anemia) While Receiving Epoetin Alfa or Other Recombinant Erythropoietins
The purpose of this study is to record the number of participants with chronic renal disease who are receiving treatment with epoetin alfa or other recombinant erythropoietins who develop pure red cell aplasia (PRCA, a rare form…
- Trial name
- NCT00211029
- Volunteers
- 4,670 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
Glioma
ExAblate Blood Brain Barrier Disruption (BBBD) for Planned Surgery in Suspected Infiltrating Glioma
This study is designed to assess the safety and feasibility of using the ExAblate, Type 2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma.
- Trial name
- NCT03322813
- Testing
- ExAblate 4000 - Type 2
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- InSightec
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.
Multivessel Coronary Artery Disease
A Multicentre, Pilot Study to Evaluate the Safety and the Feasibility of Planning and Execution of Surgical Revascularization in Patients With Complex Coronary Artery Disease, Based Solely on MSCT Imaging Utilizing GE Healthcare Revolution CT and HeartFlow FFRCT.
The CABG-REVOLUTION study is an investigator-initiated single-arm, multicentre, prospective study for patients with 3-vessel disease (with or without left-main involvement) referred to CABG treatment.
- Trial name
- CABGRevolution (NCT03851276)
- Testing
- Multi-sliced computed tomography (MSCT)
- Where
- 4 sites in Belgium, Germany and 2 more
- Sponsor
- ECRI bv
Postoperative Pain
PK and Safety After C-Section
The main goal of the study was to measure the amount of the active ingredients and other components of HTX-011 in plasma and expressed breast milk over time following postpartum administration in women undergoing a planned…
- Trial name
- NCT03955211
- Testing
- HTX-011, ZYNRELEF kit components for administration, MMA regimen
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Heron Therapeutics
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
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
Uveal Melanoma, Choroid Neoplasm
Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma
The purpose of this study is to evaluate the safety, tolerability, biological activity, pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal doses of ICON-1 in patients with primary uveal…
- Trial name
- NCT02771340
- Testing
- ICON-1
- Where
- 8 sites in United States
- Volunteers
- 10 people
- Sponsor
- Iconic Therapeutics, Inc.
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.
Hepatocellular Carcinoma, Metastatic Liver Cancer
Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures (PANORAMA2)
Pilot study planned to demonstrate the safety and effectiveness of the use of BioTraceIO 360 for Planning, Monitoring and Assessment of liver tissue ablation procedures Single-center prospective single-arm clinical investigation.
- Trial name
- PANORAMA2 (NCT05641922)
- Testing
- BioTraceIO 360
- Sponsor
- Techsomed Medical Technologies LTD