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NCT ID: NCT01185340 Completed - Clinical trials for Major Depressive Disorder

A Study in Participants With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor

Start date: March 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess whether LY2216684 12 milligrams (mg) or 18 mg flexible dose once daily is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who are partial responders to their selective serotonin reuptake inhibitor (SSRI) treatment.

NCT ID: NCT01185301 Completed - Clinical trials for Early Rheumatoid Arthritis

Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)

CONCERTO
Start date: October 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effects of different doses of methotrexate (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).

NCT ID: NCT01184989 Completed - Clinical trials for Arthroplasty, Replacement

Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate

Start date: August 2010
Phase: Phase 4
Study type: Interventional

To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on coagulation parameters, including a calibrated thrombin time test, in patients with moderate renal impairment undergoing elective total hip- or knee-replacement surgery, this PK/PD study will be conducted.

NCT ID: NCT01184872 Completed - Infections Clinical Trials

Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections

Start date: March 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide data documenting the efficacy of daptomycin in elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.

NCT ID: NCT01183780 Completed - Colorectal Cancer Clinical Trials

A Study in Second Line Metastatic Colorectal Cancer

Start date: December 2, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare overall survival in participants with metastatic colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.

NCT ID: NCT01182844 Completed - Metabolic Syndrome Clinical Trials

Obesity - Inflammation - Metabolic Disease: Effect of Lactobacillus Casei Shirota

Start date: January 2010
Phase: N/A
Study type: Interventional

Obesity and metabolic syndrome are linked by inflammation. Gut flora seems to play an important role in the development of inflammation and metabolic syndrome in obesity. Modulation of gut flora by probiotics has been shown in animal studies to positively influence inflammation and metabolic disturbances. Lactobacillus casei Shirota is able to decrease metabolic endotoxemia by altering gut flora composition and gut permeability which leads to an improvement in neutrophil function and insulin resistance in obesity. The aim of the current study is to investigate the effect of Lactobacillus casei Shirota supplementation over 12 weeks on neutrophil function (phagocytosis, oxidative burst and TLR expression) in patients with metabolic syndrome. Furthermore the investigators aim to investigate the effect of Lactobacillus casei Shirota supplementation over 12 weeks on glucose tolerance, insulin resistance, inflammation, gut flora composition, gut permeability, and endotoxemia in metabolic syndrome

NCT ID: NCT01182493 Completed - Clinical trials for Diabetes Mellitus, Type 2

OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy

OpT2mise
Start date: December 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the comparative effectiveness of insulin pump therapy versus multiple daily injections in insulin-taking type 2 Diabetes Mellitus who are sub optimally controlled with multiple daily injections (MDI).

NCT ID: NCT01182428 Completed - Clinical trials for Coronary Artery Disease

XIENCE V: SPIRIT WOMEN Sub-study

Start date: September 2008
Phase: Phase 4
Study type: Interventional

The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

NCT ID: NCT01181128 Completed - Severe Hemophilia A Clinical Trials

Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.

NCT ID: NCT01180322 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

Trial Evaluating Induction Therapy With Idarubicin and Etoposide Plus Sequential or Concurrent Azacitidine and Maintenance Therapy With Azacitidine

azacitidine
Start date: November 2010
Phase: Phase 2
Study type: Interventional

This is a randomized phase II, four-arm, open-label, multi-center study in adult patients with acute myeloid leukemia (AML) as defined in inclusion/exclusion criteria. The primary efficacy objective is to evaluate the impact of sequential or concurrent addition of 5-azacytidine to intensive induction chemotherapy with idarubicin and etoposide on the complete remission (CR) rate Sample size: 336 patients The treatment duration of an individual patient randomized into one of the three experimental arms (Arm B, C, D) (in case of application of induction, consolidation and maintenance therapy with Azacitidine) is about 30 months. The treatment duration for patients randomized into the standard arm of the study (Arm A) is about 7 months (in case of application of induction, consolidation and 2-yrs observation as maintenance (without treatment with Azacitidine)). In case of induction followed by consolidation with allogeneic Stem cell transplantation (SCT) the treatment duration per patient is about 6 months. Every patient will be followed until month 54 after inclusion into the study. Duration of the study for an individual patient including treatment (induction, consolidation [chemotherapy or allogeneic SCT], maintenance [experimental arm with Azacitidine or observation]) and follow-up period: 54 months