Clinical trials: Patient Safety
Endoscopy, Insufflation
Safety and Efficacy of CO2 for Endoscopy
Hypothesis: Carbon dioxide gas use for endoscopic insufflation is safe and results in less abdominal distension and discomfort; it is equally effective as air in pediatric patients undergoing endoscopic procedures.
- Trial name
- NCT03287687
- Testing
- Carbon dioxide (CO2) gas insufflation, Air insufflation
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Warren Bishop
Hemophilia A
BAX 855 Continuation
To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.
- Trial name
- NCT01945593
- Testing
- BAX855
- Where
- 89 sites in United States, Australia and 21 more
- Volunteers
- 218 people
- Sponsor
- Baxalta now part of Shire
Follicular Lymphoma, Marginal Zone Lymphoma
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.
This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an…
- Trial name
- InMIND (NCT04680052)
- Testing
- tafasitamab, rituximab, lenalidomide
- Where
- 261 sites in United States, Australia and 26 more
- Volunteers
- 654 people
- Sponsor
- Incyte Corporation
Heart Valve Diseases
Dabigatran Etexilate in Patients With Mechanical Heart Valves
To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.
- Trial name
- RE-ALIGN (NCT01452347)
- Testing
- warfarin 1mg, dabigatran etexilate intermediate dose, dabigatran etexilate low dose
- Where
- 40 sites in Belgium, Canada and 8 more
- Volunteers
- 328 people
- Sponsor
- Boehringer Ingelheim
Systemic Lupus Erythematosus, Connective Tissue Disease
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.
- Conditions
- Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease
- Trial name
- NCT01205438
- Testing
- LY2127399
- Where
- 185 sites in United States, Australia and 19 more
- Volunteers
- 1,124 people
- Sponsor
- Eli Lilly and Company
Childhood Absence Epilepsy
Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
The primary purpose of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in pediatric participants with treatment-resistant childhood absence seizures.
- Trial name
- NCT03355300
- Testing
- Cannabidiol Oral Solution
- Where
- 9 sites in United States
- Volunteers
- 11 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Chronic Kidney Disease, Anemia
Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.
- Trial name
- NCT01244763
- Testing
- Roxadustat
- Where
- 38 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Kyntra Bio
Mycobacterium Avium Complex, Non-tuberculous Mycobacterium Pulmonary Disease
Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
To evaluate the pharmacokinetics (PK) of SPR719, the active moiety, generated from the orally (po) administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (NTM-PD)
- Trial name
- NCT04553406
- Testing
- SPR720, Open-label Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 2 people
- Sponsor
- Spero Therapeutics
Opioid Use Disorders
Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and…
- Trial name
- NCT02651584
- Testing
- CAM2038 SC injection, SL BPN/NX tabs
- Where
- 36 sites in United States
- Volunteers
- 428 people
- Sponsor
- Braeburn Pharmaceuticals
Hypertension
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients
This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.
- Trial name
- EnligHTN-I (NCT01438229)
- Testing
- St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)
- Where
- 4 sites in Australia, Greece
- Volunteers
- 47 people
- Sponsor
- Abbott Medical Devices
Type 2 Diabetes Mellitus
Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
The study subjects will be separated into 2 groups, depending on their previous insulin therapy with approximately 50% of subjects from each group, continuous glucose monitoring (CGM) naive.
- Trial name
- NCT04617795
- Testing
- Omnipod 5 Automated Insulin Delivery System
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Insulet Corporation
Glaucoma, Ocular Hypertension
A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH, in order to show superiority of Xalacom over Xalatan in efficacy and similarity of safety between…
- Trial name
- NCT00383019
- Testing
- Xalatan, Xalacom
- Where
- 54 sites in Japan
- Volunteers
- 300 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Age-Related Macular Degeneration
Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections
This clinical study was designed to compare the safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those neovascular age-related macular degeneration (nAMD) patients with…
- Trial name
- MERLIN (NCT03710564)
- Testing
- Brolucizumab, Aflibercept
- Where
- 61 sites in United States, Puerto Rico
- Volunteers
- 535 people
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease
Safety and Dose Finding Study of Xigris in Hemodialysis Patients
The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD).
- Trial name
- Xigris1003 (NCT01227187)
- Testing
- Drotrecogin alfa activated (Xigris)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- George Washington University
Venous Thromboembolism
RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism
RE-COVERY is a large, multi-national, multi-center observational study based on new data collection. The study will enroll and characterize patients within 30 days of being diagnosed with an acute DVT and/or PE.
- Trial name
- NCT02596230
- Where
- 222 sites in United States, Argentina and 35 more
- Volunteers
- 7,797 people
- Sponsor
- Boehringer Ingelheim
Neoplasms, Advanced Solid
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Trebananib (AMG 386 ) in Adult Japanese Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profile of trebananib (AMG 386) after intravenous administration in adult Japanese participants with advanced solid tumors.
- Trial name
- NCT02525536
- Testing
- Trebananib 3 mg/kg, Trebananib 10 mg/kg, Trebananib 30 mg/kg
- Volunteers
- 18 people
- Sponsor
- Takeda
Thrombocythemia, Hemorrhagic
A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients
Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to be produced. Platelets are small cells carried around in the blood, which help form blood clots.
- Trial name
- NCT00202644
- Testing
- Anagrelide, Hydroxyurea
- Where
- 15 sites in Bulgaria, France and 4 more
- Volunteers
- 150 people
- Sponsor
- Shire
Non-Small Cell Lung Cancer, Anemia
Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy
This is a study in patients with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV non-small cell lung cancer (NSCLC).
- Conditions
- Non-Small Cell Lung Cancer, Anemia, Cancer, Lung Cancer
- Trial name
- NCT00858364
- Testing
- Darbepoetin alfa
- Where
- 566 sites in United States, Argentina and 35 more
- Volunteers
- 2,549 people
- Sponsor
- Amgen
Multiple System Atrophy
Safinamide for Multiple System Atrophy (MSA)
The study is a placebo controlled study, with two parallel arms, in which participants will be randomly assigned in a 2:1 ratio to receive either active (200 mg safinamide) or placebo in a double blind manner.
- Trial name
- NCT03753763
- Testing
- Safinamide Methanesulfonate
- Where
- 19 sites in Italy, Spain
- Volunteers
- 49 people
- Sponsor
- Zambon SpA
Non-Small-Cell Lung
A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)
This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based…
- Trial name
- NCT03456063
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Nab-paclitaxel, Pemetrexed
- Where
- 117 sites in United States, Australia and 22 more
- Volunteers
- 453 people
- Sponsor
- Hoffmann-La Roche
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