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NCT ID: NCT01296386 Completed - Clinical trials for Clostridium Difficile Infection

An Open-label Study Assessing Safety, Immunogenicity and Dose Response of IC84

Start date: December 2010
Phase: Phase 1
Study type: Interventional

An open-label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC84, A new vaccine against Clostridium Difficile (C. difficile), In healthy subjects

NCT ID: NCT01295619 Completed - Clinical trials for Cerebrospinal Fluid Leakage

Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy

Start date: February 2011
Phase: N/A
Study type: Interventional

This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.

NCT ID: NCT01295346 Completed - Clinical trials for Brain Injuries, Traumatic

Biomarkers of Mild and Moderate Traumatic Brain Injury

Start date: January 2011
Phase: N/A
Study type: Observational

The purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI. The assay will be evaluated in a sample population of subjects over the age of 18 who have been referred to the health care provider for closed head injury evaluation.

NCT ID: NCT01294410 Completed - Colitis, Ulcerative Clinical Trials

Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

Start date: March 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

NCT ID: NCT01291810 Completed - Crohn's Disease Clinical Trials

Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

Start date: February 2011
Phase: Phase 2
Study type: Interventional

The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising. The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

NCT ID: NCT01288573 Completed - Neuroblastoma Clinical Trials

A Combined Study in Pediatric Cancer Patients for Dose Ranging and Efficacy/Safety of Plerixafor Plus Standard Regimens for Mobilization Versus Standard Regimens Alone

Start date: March 3, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-site study with plerixafor in pediatric cancer patients. The study will be conducted in 2 stages: - Stage 1 is a dose-escalation study. - Stage 2 is an open-label, randomized, comparative study using the appropriate dosing regimen identified in the Stage 1 dose-escalation study. All participating patients will receive a standard mobilization regimen as per study site practice guidelines (either chemotherapy plus once daily granulocyte-colony stimulating factor (G-CSF) or once daily G-CSF alone). The only change to the standard mobilization regimen is the addition of plerixafor treatment prior to apheresis for all patients in Stage 1 (dose escalation), and for those patients randomized to the plerixafor plus standard mobilization treatment arm in Stage 2 (randomized, comparative). Stage 1 will enroll at least 27 patients. Stage 2 will enroll at least 40 patients.

NCT ID: NCT01287897 Completed - Crohn's Disease Clinical Trials

A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy

ANDANTE
Start date: February 2011
Phase: Phase 2
Study type: Interventional

This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.

NCT ID: NCT01287039 Completed - Eosinophilic Asthma Clinical Trials

A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

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

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in patients with eosinophilic asthma.

NCT ID: NCT01285752 Completed - Clinical trials for Rheumatoid Arthritis

A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)

Start date: February 2011
Phase: Phase 2
Study type: Interventional

To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.

NCT ID: NCT01285609 Completed - Clinical trials for Lung Cancer - Non Small Cell Squamous

Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

Start date: January 16, 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.