Clinical trials: Safety Study
Acute Pain
A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product…
- Trial name
- NCT02081391
- Testing
- Tapentadol oral solution 4 mg/mL, Tapentadol oral solution 20 mg/mL
- Where
- 43 sites in United States, Bulgaria and 8 more
- Volunteers
- 216 people
- Sponsor
- Grünenthal GmbH
Coronary Artery Disease
Safety of High-dose Tirofiban During Coronary Angioplasty
This single-centre study is intended to retrospectively check the safety of high-dose bolus of tirofiban in patients who underwent percutaneous angioplasty.
- Trial name
- SANTISS (NCT00566891)
- Testing
- tirofiban, Clopidogrel
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- S. Anna Hospital
X-Linked Retinitis Pigmentosa
A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With XLRP
This study will evaluate and compare the safety, efficacy, and tolerability of 2 doses of a recombinant adeno-associated virus vector (AGTC-501/laruparetigene zovaparvovec )) to an untreated control group in male participants…
- Trial name
- NCT04850118
- Testing
- rAAV2tYF-GRK1-hRPGRco, Control
- Where
- 25 sites in United States, Australia and 2 more
- Volunteers
- 85 people
- Sponsor
- Beacon Therapeutics
Achondroplasia
An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia
The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia
- Trial name
- NCT03424018
- Testing
- BMN 111
- Where
- 24 sites in United States, Australia and 5 more
- Volunteers
- 119 people
- Sponsor
- BioMarin Pharmaceutical
Microtia
Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia
AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.
- Trial name
- AUR-201 (NCT06072040)
- Testing
- AUR-201
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Auregen Biotherapeutics, SA
Ulcerative Colitis, Crohn's Disease
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin…
- Trial name
- NCT06100289
- Testing
- Vedolizumab IV, Vedolizumab SC
- Where
- 54 sites in United States, Belgium and 14 more
- Volunteers
- 70 people
- Sponsor
- Takeda
HIV-1-infection
Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance
The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency…
- Trial name
- CAPELLA (NCT04150068)
- Testing
- Oral Lenacapavir, Subcutaneous Lenacapavir, Failing ARV Regimen
- Where
- 75 sites in United States, Canada and 9 more
- Volunteers
- 72 people
- Sponsor
- Gilead Sciences
Bronchopulmonary Dysplasia (BPD), Premature Births
PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Premature Births, Critical Illness
- Trial name
- PRISM (NCT07101640)
- Testing
- montelukast 4 mg granule
- Where
- 5 sites in United States
- Volunteers
- 28 people
- Sponsor
- Duke University
Motor Vehicle Injury
Traffic Safety Study at Calgary Elementary Schools
Installing specific traffic calming features designed to reduce vehicle speed and volume around schools may lead to a reduction in injury risk for child pedestrians and bicyclists, and may increase numbers of children walking and…
- Trial name
- NCT04956250
- Testing
- Traffic Calming Curbs, In-Street Pedestrian Sign
- Where
- Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Calgary
Pathological Processes in the Posterior Fossa, Dura Defects
Fibrin Sealant for the Sealing of Dura Sutures
The purpose of this study is to investigate the efficacy and safety of FS VH S/D 500 s-apr, a double virus-inactivated biological two-component fibrin sealant, for use in posterior fossa surgery as an adjunct to dura and dura…
- Trial name
- NCT00681824
- Testing
- Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), Standard of care
- Where
- 13 sites in United States, Canada
- Volunteers
- 95 people
- Sponsor
- Baxter Healthcare Corporation
HIV Infections
The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children
To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in combination with nelfinavir and nucleoside…
- Trial name
- NCT00002380
- Testing
- Nelfinavir mesylate, Saquinavir
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Hoffmann-La Roche
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
Critical Illness, Safety Issues
TraceBook: the Clinical Proof of Concept on the Intensive Care.
The effectiveness of current checklists is hampered by lack of acceptance and compliance. Recently, a new type of checklist with dynamic properties has been created to provide more specific checklist items for each individual…
- Trial name
- TraceBook (NCT03599856)
- Testing
- TraceBook
- Where
- Netherlands
- Volunteers
- 408 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
Diphtheria, Hepatitis B
Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.
The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a single injection, with respect to immunogenicity…
- Conditions
- Diphtheria, Hepatitis B, Haemophilus Influenzae Type b, Whole Cell Pertussis
- Trial name
- NCT00317161
- Testing
- DTPw-HBV/Hib-MenAC conjugate vaccine
- Where
- 3 sites in Thailand
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Intracranial Aneurysm
Safety and Performance of the Neuroform Atlas™ Stent System
The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in…
- Trial name
- ATLAS-FR (NCT04162483)
- Testing
- Neuroform Atlas Stent System
- Where
- France
- Volunteers
- 310 people
- Sponsor
- Stryker Neurovascular
Asthma
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
- Trial name
- NCT03560466
- Testing
- Dupilumab (SAR231893/REGN668), Asthma controller therapies (incl. prednisone/prednisolone), Asthma reliever therapies
- Where
- 81 sites in United States, Argentina and 16 more
- Volunteers
- 378 people
- Sponsor
- Sanofi
Allogeneic Transplantation (Non T-cell Depleted)
Phase I Clinical Trial to Assess Safety of UV Phototherapy for the Prevention of GVHD Post Allogeneic SCT
The primary goal of thos study is to assess safety of Ultraviolet (UV) Phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation (Phase I - Clinical trial).
- Trial name
- NCT00524953
- Testing
- EUMATRON - EN 600 NT
- Where
- Israel
- Sponsor
- Hadassah Medical Organization
Diphtheria, Tetanus
Immunogenicity and Safety of Pentaxim™ in an Indian Population
The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose…
- Conditions
- Diphtheria, Tetanus, Polio, Pertussis
- Trial name
- NCT00259337
- Testing
- Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
- Where
- India
- Volunteers
- 226 people, healthy volunteers welcome
- Sponsor
- Sanofi
Mucopolysaccharidosis VI
A Study in MPS VI to Assess Safety and Efficacy of Odiparcil
Mucopolysaccharidoses (MPS) are a group of rare inherited disorders characterized by a deficiency of lysosomal enzymes responsible for the normal degradation of glycosaminoglycans (GAGs).
- Trial name
- iMProveS (NCT03370653)
- Testing
- Odiparcil
- Where
- 4 sites in France, Germany and 2 more
- Volunteers
- 20 people
- Sponsor
- Inventiva Pharma
Acne Vulgaris
U0289-405: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne
This study is being conducted to obtain safety, efficacy, and satisfaction data on the combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent Salicylic Acid (SA) 0.5% in the treatment of moderate to…
- Trial name
- NCT01446237
- Testing
- acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%
- Where
- 9 sites in United States
- Volunteers
- 125 people
- Sponsor
- Stiefel, a GSK Company
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