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

European Prospective Cohort Study on Enterobacteriaceae Showing Resistance to Carbapenems

EURECA
Start date: April 2016
Phase: N/A
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: NCT02021318 Recruiting - Clinical trials for Anemia in Chronic Kidney Disease in Non-dialysis Patients

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa

Dolomites
Start date: March 12, 2014
Phase: Phase 3
Study type: Interventional

This study is conducted to explore a new therapy for anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of the study is to see if Roxadustat is effective and safe to treat anemia in patients with chronic kidney disease. Roxadustat will in this study be compared to darbepoetin alfa, a commercially available medicine for treatment of anemia (tradename Aranesp).

NCT ID: NCT01964560 Enrolling by invitation - Epilepsy Clinical Trials

Long-term Extension Study to Investigate Lacosamide as an Add-on Therapy in Children With Partial Onset Seizures

Start date: March 2014
Phase: Phase 3
Study type: Interventional

Study to evaluate the long-term safety and tolerability of Lacosamide (LCM) administered in addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥1 month to ≤18 years who currently have uncontrolled partial onset seizures.

NCT ID: NCT01921205 Completed - Epilepsy Clinical Trials

Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures

Start date: August 29, 2013
Phase: Phase 3
Study type: Interventional

Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥4 years to <17 years of age who currently have uncontrolled partial onset seizures.

NCT ID: NCT01830647 Completed - Colorectal Cancer Clinical Trials

An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum

Start date: April 2013
Phase: N/A
Study type: Observational

This prospective observational study will evaluate the safety and efficacy of first-line Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice in patients with metastatic cancer of the colon and/or rectum. Patients will be followed for the duration of their treatment and a 30-day follow-up after the last dose of study drug.

NCT ID: NCT01747915 Recruiting - Clinical trials for Generalized Tonic Clonic Seizures

A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.

Start date: April 3, 2013
Phase: Phase 3
Study type: Interventional

The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.

NCT ID: NCT01707992 Completed - Multiple Sclerosis Clinical Trials

The Efficacy, Safety, and Tolerability of Laquinimod in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

CONCERTO
Start date: February 28, 2013
Phase: Phase 3
Study type: Interventional

This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in subjects with RRMS. . The study has periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).

NCT ID: NCT01667380 Completed - Anemia Clinical Trials

An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)

Start date: April 2012
Phase: N/A
Study type: Observational

This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of treatment.

NCT ID: NCT01617005 Completed - Clinical trials for Rheumatoid Arthritis

An Observational Study of RoActemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Non-Biological DMARDs

Start date: May 2012
Phase: N/A
Study type: Observational

This observational study will evaluate the safety and efficacy of RoActemra (tocilizumab) in patients with active moderate to severe rheumatoid arthritis and an inadequate response to non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Data will be collected from each eligible patient initiating RoActemra treatment over 6 months.

NCT ID: NCT01578785 Terminated - Clinical trials for Relapsing-Remitting Multiple Sclerosis

An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

GLOW
Start date: March 2012
Phase: Phase 3
Study type: Interventional

This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).