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NCT ID: NCT02713282 Completed - Schizophrenia Clinical Trials

A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation

Start date: April 28, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to estimate the proportion of participants fulfilling criteria for symptomatic remission following a transition to 12 months treatment with flexible-dose paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at least 4 months.

NCT ID: NCT02709408 Completed - Clinical trials for Carbapenem Resistant Bacteria Infection

European Prospective Cohort Study on Enterobacteriaceae Showing Resistance to Carbapenems

EURECA
Start date: April 27, 2016
Phase:
Study type: Observational [Patient Registry]

Among antibiotic-resistant organisms, the Gram-negative bacteria are now the most important challenge because of the rapid worldwide spread of mechanisms conferring resistance to multiple drugs. The most recent and worrying problem is the emergence and spread of carbapenemases. Additionally, carbapenem-resistance is known to be very frequent among Acinetobacter baumannii isolates for many years. Overall, the therapeutic options available against carbapenem-resistant Enterobacteriaceae (CRE) and A. baumannii (CRAB) are very limited. The best available treatment (BAT) against CRE is unknown, which is a challenge for therapeutic decisions and also for the design of randomized trials with new drugs. The generic objectives of EURECA are to obtain high-quality observational data to inform the design of randomized controlled trials for complicated intraabdominal infections, pneumonia, complicated urinary tract infections and bloodstream infections due to Carbapenem-resistant Enterobacteriaceae (CRE) and carbapenem-resistant Acinetobater baumannii, and to provide cohort data that could eventually be used as historical controls for future comparisons with new drugs targeting CRE. This will be achieved by a prospective, multinational cohort study of patients with targeted infections due to CRE and CRAB, and by matched case-control-control studies.

NCT ID: NCT02706873 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

SELECT-EARLY
Start date: February 23, 2016
Phase: Phase 3
Study type: Interventional

The objectives of Period 1 were the following: - To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in methotrexate-naïve adults with moderately to severely active RA; - To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD monotherapy versus weekly methotrexate monotherapy for prevention of structural progression in methotrexate-naïve adults with moderately to severely active RA. The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults with RA who have completed Period 1.

NCT ID: NCT02704429 Completed - Pemphigus Vulgaris Clinical Trials

A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris

Start date: January 22, 2016
Phase: Phase 2
Study type: Interventional

Open-label cohort study in adult patients with newly diagnosed or relapsing pemphigus vulgaris, with intra-patient dose-adjustment based on clinical response and BTK occupancy, and with conventional immunosuppressive "rescue treatment", if indicated. The duration of therapy in Part A will be 12 weeks, followed by 12 weeks of follow up. The extension phase, Part B includes 24 weeks of therapy, followed by 4 weeks of follow-up.

NCT ID: NCT02698137 Completed - Clinical trials for Cholangiopancreatography, Endoscopic Retrograde

Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

QUASIE2
Start date: March 2016
Phase:
Study type: Observational

The investigators will prospectively collect patient and procedure-related data in an observational study in order to detect patient and procedure-related risk factors for poor outcome (i.e. technical failure of the procedure; procedure-related complications). Data will be prospectively reported using standard report forms and patients will be followed up to 30 days to detect late-onset complications.

NCT ID: NCT02696902 Completed - Clinical trials for Pseudomonas Aeruginosa

Effort to Prevent Nosocomial Pneumonia Caused by Pseudomonas Aeruginosa in Mechanically Ventilated Subjects

EVADE
Start date: March 25, 2016
Phase: Phase 2
Study type: Interventional

Clinical trial looking to evaluate the efficacy and safety of MEDI3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.

NCT ID: NCT02686658 Completed - Clinical trials for Macular Degeneration

Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Start date: January 20, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

NCT ID: NCT02678312 Completed - Clinical trials for Pediatric Heart Failure

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure

Start date: November 3, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study. The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.

NCT ID: NCT02675426 Completed - Clinical trials for Rheumatoid Arthritis

A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

SELECT-NEXT
Start date: December 17, 2015
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.

NCT ID: NCT02674308 Completed - Clinical trials for Ulcerative Colitis and Crohn's Disease

Entyvio (Vedolizumab) Long Term Safety Study

Entyvio PASS
Start date: March 24, 2015
Phase:
Study type: Observational

The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).