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NCT ID: NCT00927212 Terminated - Atopic Dermatitis Clinical Trials

Topical Application of AS101 for the Treatment of Atopic Dermatitis

Start date: June 2009
Phase: Phase 2
Study type: Interventional

Atopic Dermatitis is a chronic non contagious disease that causes itchy, inflamed skin. The purpose of this study is to evaluate the safety and efficacy of topical AS101 ointment for the treatment of Atopic dermatitis.

NCT ID: NCT00926354 Terminated - Clinical trials for Chemotherapy Induced Thrombocytopenia

Application of AS101 for the Treatment of Thrombocytopenia in Solid Tumor Patients

Start date: August 2009
Phase: Phase 2
Study type: Interventional

Chemotherapy Induced Thrombocytopenia is a common side-effect of bone marrow suppression as a result of a chemotherapy treatment. AS101 is a tellurium based small compound with immunomodulating characteristics which attributed to the direct inhibition of the anti-inflammatory cytokine IL-10. AS101 was previously shown to induce a significant reduction in thrombocytopenia that accompany cancer therapy with no major toxicity . This phase II randomized open study will evaluate the efficacy of AS101 for the treatment of chemotherapy induced thrombocytopenia in patients with various solid tumors.

NCT ID: NCT00925977 Terminated - Diabetes Type 1 Clinical Trials

Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents

Start date: July 2009
Phase: N/A
Study type: Interventional

A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents with type 1 diabetes. The study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with insulin NPH ad than 12 weeks with insulin Glargine. Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.

NCT ID: NCT00925548 Terminated - Breast Cancer Clinical Trials

STRIDE - STimulating Immune Response In aDvanced brEast Cancer

STRIDE
Start date: September 2009
Phase: Phase 3
Study type: Interventional

EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the indication of breast cancer following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).

NCT ID: NCT00920582 Terminated - Clinical trials for Type 1 Diabetes Mellitus

Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Start date: September 2009
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.

NCT ID: NCT00914979 Terminated - Clinical trials for Bifurcation Coronary Disease

AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study)

ABC
Start date: September 2008
Phase: Phase 3
Study type: Interventional

Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of bifurcation lesions in native coronary arteries.

NCT ID: NCT00914628 Terminated - Clinical trials for Acute Leukemia (Category)

Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia

TK008
Start date: April 12, 2010
Phase: Phase 3
Study type: Interventional

The main objective of this randomized trial is to compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT

NCT ID: NCT00908063 Terminated - Clinical trials for Traumatic Brain Injury

Safety and Tolerability of Oxycyte in Patients With Traumatic Brain Injury (TBI)

STOP-TBI
Start date: October 2009
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of a single administration of Oxycyte in patients with severe non-penetrating traumatic brain injury (TBI). In the first dose level (Cohort 1), 11 patients were randomized 2:1 to receive either 1.0 mL/kg Oxycyte (0.6 g/kg; n=8) or NS (n=3). A total of 8 patients received Oxycyte. The Data Safety Monitoring Board (DSMB) reviewed the safety data for patients in Cohort 1 through Day 14, and approved escalation to the next dose. In Cohort 2, 18 patients will be randomized 2:1 to receive either 2.0 mL/kg Oxycyte (1.2 g/kg; n=12) or NS (n=6). The DSMB will then review the safety data for all patients in Cohort 2 through Day 14 and either approve escalation to the highest dose or remain at the current dose. If remaining at the current dose level (Cohort 2) an additional 50 patients will be randomized 1:1 to Oxycyte (n=25) or NS (n=25) and treated. If escalation occurs to Cohort 3, 18 patients would be randomized 2:1 to Oxycyte (n=12) or NS (n=6) to receive the 3.0 mL/kg dose. The DSMB would again review the safety data and decide whether to treat an additional 50 patients at this dose or to decrease the dose back to 2.0 mL/kg. This group would be randomized 1:1 to receive Oxycyte (n=25) or NS.

NCT ID: NCT00893867 Terminated - Clinical trials for Acute Ischemic Stroke

Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke

MACSI
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to determine if intravenous administration of the metal ion trapping agent DP-b99 up to 9 hours following acute ischemic stroke onset, and then for 3 additional days (4 consecutive days in total) is effective in improving long term outcome. Patients will be followed up for 3 months after the stroke.

NCT ID: NCT00886769 Terminated - Clinical trials for Systemic Juvenile Idiopathic Arthritis

Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)

ß-SPECIFIC 1
Start date: July 2009
Phase: Phase 3
Study type: Interventional

This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.