Clinical trials: Safety of Intervention
Growth Disorder, Idiopathic Short Stature
Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature
This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.
- Trial name
- NCT01778023
- Testing
- somatropin
- Where
- 8 sites in South Korea
- Volunteers
- 54 people
- Sponsor
- Novo Nordisk A/S
Hemophilia A
Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ
Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously…
- Trial name
- NCT02962765
- Where
- 39 sites in United States, Argentina and 11 more
- Volunteers
- 80 people
- Sponsor
- Octapharma
Thrombocythemia, Essential
Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments
This is an observational safety study being conducted in Europe comparing patients taking Xagrid to patients taking other cytoreductive treatments.
- Trial name
- NCT00567502
- Where
- 164 sites in Cyprus, Denmark and 12 more
- Volunteers
- 3,647 people
- Sponsor
- Shire
Pneumococcal Disease
Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos
Prevenar 13 is safe for administration to Filipinos.
- Trial name
- NCT01396434
- Testing
- Prevenar 13
- Where
- 119 sites in Philippines
- Volunteers
- 3,006 people, healthy volunteers welcome
- Sponsor
- Pfizer
Thrombosis
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8…
- Trial name
- UNIVERSE (NCT02846532)
- Testing
- Rivaroxaban, Acetylsalicylic Acid
- Where
- 42 sites in United States, Argentina and 8 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Fibrodysplasia Ossificans Progressiva
An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects
Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and…
- Trial name
- NCT02190747
- Testing
- Palovarotene
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 40 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Infertility
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle
This is a multicenter, prospective randomized controlled, interventional investigation to assess the safety and clinical performance of Forielle, a medical device for endometrial washing, in restoring favorable endometrial…
- Trial name
- ENDOMEDE (NCT03387059)
- Testing
- Forielle
- Where
- 7 sites in Italy
- Volunteers
- 9 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Asthma
Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)
Primary Objective: To describe the long-term safety of dupilumab in treatment of participants with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).
- Trial name
- NCT03620747
- Testing
- Dupilumab SAR231893 (REGN668)
- Where
- 132 sites in United States, Argentina and 8 more
- Volunteers
- 393 people
- Sponsor
- Sanofi
Seizures, Epilepsies, Partial
Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures.
- Conditions
- Seizures, Epilepsies, Partial, Epilepsy, Complex Partial, Epilepsy, Generalized
- Trial name
- NCT00319501
- Testing
- Vanquix Auto-Injector (Diazepam Injection)
- Where
- 86 sites in United States
- Volunteers
- 234 people
- Sponsor
- Pfizer
Juvenile Idiopathic Arthritis
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core Study
This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study.
- Trial name
- NCT01667471
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 3 sites in Germany
- Volunteers
- 6 people
- Sponsor
- Hoffmann-La Roche
Respiratory Syncytial Viruses
A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease
The purpose of this two-part designed study is to assess in the setting of a planned early interception of pediatric RSV disease, early viral and disease kinetics (observational stage) and the antiviral effects of an Respiratory…
- Trial name
- NCT04068792
- Testing
- RSV Mobile Application, JNJ-53718678 2.5 mg/kg, JNJ-53718678 3 mg/kg
- Where
- 10 sites in Argentina, Belgium and 3 more
- Volunteers
- 22 people
- Sponsor
- Janssen Research & Development, LLC
Acute Uncomplicated Plasmodium Falciparum Malaria
Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
This study was designed to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in…
- Trial name
- NCT03167242
- Testing
- KAF156, Coartem, Lumefantrine Solid Dispersion Formulation
- Where
- 11 sites in Burkina Faso, Gabon and 7 more
- Volunteers
- 524 people
- Sponsor
- Novartis Pharmaceuticals
Congenital Bleeding Disorder, Haemophilia A
Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects
This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8))…
- Trial name
- guardian™1 (NCT00840086)
- Testing
- turoctocog alfa
- Where
- 63 sites in United States, Brazil and 16 more
- Volunteers
- 150 people
- Sponsor
- Novo Nordisk A/S
Atopic Dermatitis
Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based…
- Trial name
- NCT00124709
- Testing
- Pimecrolimus, Corticosteroid
- Where
- 36 sites in United States
- Volunteers
- 1,091 people
- Sponsor
- Novartis Pharmaceuticals
Anemia
Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red…
- Trial name
- ReCePI (NCT03459287)
- Testing
- INTERCEPT, Control
- Where
- 18 sites in United States
- Volunteers
- 581 people
- Sponsor
- Cerus Corporation
Juvenile Idiopathic Arthritis
An Extension Study to WA19977 in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis
This long-term, interventional, open-label extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients from Poland and Russia with polyarticular-course juvenile idiopathic arthritis who…
- Trial name
- NCT01575769
- Testing
- RoActemra/Actemra (tocilizumab)
- Where
- 11 sites in Poland, Russia
- Volunteers
- 41 people
- Sponsor
- Hoffmann-La Roche
Treatment of Chronic Obstructive Pulmonary Disease
De-implementing Inhaled Steroids to Improve Care and Safety in COPD
This Quality Enhancement Research Initiative (QuERI) project is designed to determine efficacy and acceptance of an intervention method to provide primary care providers with patient-tailored electronic consults and corresponding…
- Trial name
- DISCUSS COPD (NCT02896257)
- Testing
- Guideline treatment recommendations
- Where
- 2 sites in United States
- Volunteers
- 181 people
- Sponsor
- VA Office of Research and Development
Ultrasound, CT Scans
Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation
The objective of this study is to evaluate the safety of dexmedetomidine in a pediatric population requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) for elective diagnostic or therapeutic…
- Conditions
- Ultrasound, CT Scans, MRIs
- Trial name
- NCT01519167
- Testing
- Dexmedetomidine, Midazolam, Fentanyl
- Where
- 11 sites in United States, Puerto Rico
- Volunteers
- 91 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Congenital Heart Disease
Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"
The purpose of this study is to evaluate the safety and the effectiveness of the device "Nit-Occlud® PDA-R" in the percutaneous closure of patent ductus.
- Trial name
- NCT01063712
- Testing
- Nit-Occlud® PDA-R
- Where
- Bolivia
- Volunteers
- 29 people
- Sponsor
- pfm S.R.L.
Hunter Syndrome
A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India
The main aim of this study is to learn more about the safety profile of Elaprase in Indian children and adults with hunter syndrome.
- Trial name
- NCT05058391
- Testing
- Elaprase
- Where
- 5 sites in India
- Volunteers
- 5 people
- Sponsor
- Takeda