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NCT ID: NCT01567085 Completed - Clinical trials for Stage V Chronic Kidney Disease

Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor

Start date: August 29, 2012
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.

NCT ID: NCT01566786 Completed - Clinical trials for Acquired Bleeding Disorder

Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage

Start date: August 2001
Phase: Phase 2
Study type: Interventional

This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) in preventing early haematoma growth in acute Intracerebral Haemorrhage (ICH).

NCT ID: NCT01566721 Completed - Breast Neoplasms Clinical Trials

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

SafeHER
Start date: May 17, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).

NCT ID: NCT01566695 Completed - Clinical trials for Myelodysplastic Syndrome

The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)

Start date: April 26, 2013
Phase: Phase 3
Study type: Interventional

Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).

NCT ID: NCT01566292 Completed - Clinical trials for Benign Prostatic Hyperplasia (BPH)

Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy

Start date: September 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The injection of botulinum neurotoxin A into the prostate represents an alternative, minimal invasive treatment in patient with lower urinary tract symptoms (LUTS) associated to benign prostatic hyperplasia (BPH). Objective: To evaluate the effectiveness of BTA in treating patients with symptomatic BPH and unsatisfactory response to combined medical therapy.

NCT ID: NCT01566162 Completed - Schizophrenia Clinical Trials

A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

Start date: April 2012
Phase: Phase 3
Study type: Interventional

This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.

NCT ID: NCT01565967 Completed - Trauma Clinical Trials

Registry AutoLog Lipid Removal and Blood Component Characterization

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

The purpose of this study is to show the success of the AutoLog System in removing lipids to less than 10mg/dl in vivo. The Autolog registry has two objectives: 1. to determine the lipid removal capabilities of the Medtronic AutoLog System. 2. to obtain in vivo data on blood component removal and washing capabilities of the Medtronic AutoLog System.

NCT ID: NCT01565668 Completed - Clinical trials for Leukemia, Myeloid, Acute

Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Start date: April 2012
Phase: Phase 2
Study type: Interventional

This study will evaluate two doses of Quizartinib in patients with relapsed or refractory acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication ( FLT3-ITD) positive. Patient will be randomly assigned in a 1:1 ratio to one of two treatment arms. Both treatment arms will receive Quizartinib but at different doses. The study treatment is taken orally in 28 day cycles until either disease progression occurs or an unacceptable toxicity occurs. In addition to the study assessments to evaluate the disease, blood will be drawn to measure drug levels and biomarkers. Patients will be followed for survival at three month intervals after the end of treatment.

NCT ID: NCT01565083 Completed - Breast Cancer Clinical Trials

A Study of Pertuzumab in Combination With Herceptin (Trastuzumab) And Vinorelbine in First Line in Patients With Metastatic or Locally Advanced HER2-Positive Breast Cancer

Start date: April 2012
Phase: Phase 2
Study type: Interventional

This two-cohort, open-label, multicenter, phase II study will assess the safety and efficacy of pertuzumab given in combination with Herceptin (trastuzumab) and vinorelbine in first line in patients with metastatic or locally advanced HER2-positive breast cancer. Patients will receive pertuzumab 840 mg and Herceptin 8 mg/kg administered sequentially as separate iv infusions on Days 1 and 2, respectively, of Cycle 1. From Cycle 2 onwards, patients will receive pertuzumab 420 mg and Herceptin 6 mg/kg, administered either sequentially as separate iv infusions on Day 1 and Day 1 or 2, respectively (Cohort 1) or together in one infusion bag on Day 1 (Cohort 2) every 3 weeks. Vinorelbine will be administered at 25 mg/m2 iv on Days 2 and 9 of Cycle 1, and at 30-35 mg/m2 on Days 1 and 8 (or Days 2 and 9) of each following 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs, or withdrawal of consent or death.

NCT ID: NCT01564784 Completed - Clinical trials for Acute Lymphoblastic Leukemia

A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia

Start date: August 2, 2012
Phase: Phase 3
Study type: Interventional

This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.