A Randomized, Open-Label, Multicenter, Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B Cell Subtype of Diffuse Large B-Cell Lymphoma The primary objective is to determine the complete response (CR) rate following treatment with VR-CAP (VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone) or standard R-CHOP (rituximab...

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A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants with Treatment-resistant Depression The primary objective of this study is to evaluate the efficacy of switching adult subjects with TRD from a prior antidepressant treatment (to which they have not responded) to intranasal esketamine (...

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A study of multiple different dosages of JNJ 39758979 and placebo in patients with active Rheumatoid Arthritis The primary objectives are to assess the efficacy (as measured by the reduction of the signs and symptoms of RA) and the safety and tolerability of JNJ-39758979 at doses of 10, 30, 100, or 300 mg/d co...

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Tolerability, Safety and Treatment Response of Flexible Doses of Paliperidone ER in Acutely Exacerbated Subjects with Schizophrenia To explore the response to flexible doses of paliperidone ER in acutely exacerbated subjects with schizophrenia. Response is defined as a decrease of at least 30% in total Positive and Negative Syndro...

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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Topiramate for the Prophylaxis of Migraine in Pediatric Subjects 12 to 17 Years of Age. Estudio aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de topiramato en la profilaxis de la migraña en población pediátrica de 12 a 17 años de edad The objective of this study are to evaluate the efficacy of 2 dosages of topiramate, 50 and 100 mg/day, compared with placebo in the prevention of migraine attacks in subjects 12 to 17 years of age, a...

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An Efficacy And Safety Study of CNTO6785 In Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy To assess the efficacy of CNTO 6785 on the signs and symptoms in subjects with active RA compared with placebo despite concomitant methotrexate (MTX) therapy

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An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Doripenem in Infants (Term and Preterm), Less Than 12 Weeks Chronological Age Protocol DORI-PED-1003; Phase 1 The primary objective of this study is to evaluate the pharmacokinetics of doripenem after single-dose administration of doripenem to infants (term and preterm), <12 weeks chronological age (CA). Safe...

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A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression Studie esketaminu v nosním spreji v kombinaci s ústním antidepresivem pro prevenci návratu příznaků deprese u pacientů s depresí resistentní vůči léčbě The primary objective of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in d...

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A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise •To assess the effect of the co-administration of canagliflozin and metformin XR compared with canagliflozin alone on HbA1c •To assess the effect of the co-administration of canagliflozin and metfor...

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A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress after Bortezomib Therapy The primary objective of the study is to evaluate the overall response rate of ibrutinib, as assessed by the Independent Review Committee (IRC), in subjects with MCL who received at least 1 prior ritu...

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