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NCT ID: NCT01348139 Completed - Asthma Clinical Trials

Evaluation of the Pharmacokinetics and the Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 in Patients With Asthma

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

The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single doses of three different dry powder inhalation formulations of AZD3199 administered via Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhalerâ„¢ Inhaler and compared to placebo in patients with persistent asthma.

NCT ID: NCT01347996 Completed - Clinical trials for Acute Myeloid Leukemia

Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Immune Response and MRD in Acute Myeloid Leukemia

Start date: July 2009
Phase: Phase 4
Study type: Interventional

Ceplene/IL-2 remission maintenance therapy has been shown to significantly prolong Leukemia Free Survival in patients with Acute Myeloid Leukemia (AML) in first complete remission. This is an international, multicenter, open-label study to evaluate the effects of remission maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune system cells (T and NK cells) and prospectively defined markers of immune response that are known to reflect T and NK cell ability to combat AML.

NCT ID: NCT01347697 Active, not recruiting - Rectal Cancer Clinical Trials

Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer

NEAPE
Start date: September 5, 2011
Phase: N/A
Study type: Interventional

The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer. The alternative reconstruction techniques in the trial are: - a technique using a gluteus maximus myocutaneous flap or - a technique using an acellular porcine collagen implant (biological mesh) The primary endpoint will be physical performance six months from operation and our hypothesis is that the technique using an acellular porcine implant will cause less impaired physical performance compared to the technique using a myocutaneous flap. The study is interventional, randomized and by definition a comparative effectiveness research project.

NCT ID: NCT01347580 Completed - Clinical trials for Myocardial Infarction

A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI)

ATLANTIC
Start date: September 2011
Phase: Phase 4
Study type: Interventional

The aim of this study is to determine whether initiation of ticagrelor as early as in the ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the patient. The study will assess the efficacy and safety of pre-hospital compared to in-hospital administration of ticagrelor in co-administration with aspirin, on restoring the blood flow in the occluded heart artery and improving the myocardial perfusion in patients suffering from myocardial infarction and planned to have a PCI. Patients can be randomised in either one of the 2 arms: re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for the pre-hospital administration and placebo for in-hospital administration. or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital administration and 180 mg ticagrelor loading dose for in-hospital administration. Patients are initially managed by ambulance physician/personnel in pre hospital settings. They are then transferred into a Catheterization room to undergo a PCI. After the administration of the loading dose of ticagrelor (double blind), patients will continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.

NCT ID: NCT01347567 Completed - Heart Failure Clinical Trials

Heart Failure (HF) Outpatient Monitoring Evaluation (HOME) Study

HOME
Start date: April 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if heart failure subjects whose treatment is assisted by home BNP measurements integrated into a home health management system will have better clinical outcomes than subjects whose treatment includes home health management without BNP or than subjects treated by standard care.

NCT ID: NCT01347099 Completed - Clinical trials for Obsessive Compulsive Disorder

Internet-based Cognitive Behavior Therapy (CBT) for Obsessive Compulsive Disorder (OCD)

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

Cognitive behavior therapy (CBT) is an effective treatment for obsessive compulsive disorder (OCD) but there is a lack of properly trained CBT therapists. One possible treatment alternative is Internet-based CBT (ICBT) with minimal therapist input. The aim of this study was therefore to evaluate ICBT for OCD.

NCT ID: NCT01345799 Completed - Crohn's Disease Clinical Trials

A Study of TRK-170 for the Treatment of Crohn's Disease

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

In Crohn's Disease Patients - To evaluate the efficacy of TRK-170 - To evaluate the PK characteristics of TRK-170 - To assess the safety of TRK-170

NCT ID: NCT01345682 Completed - Clinical trials for Head and Neck Neoplasms

LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Start date: January 5, 2012
Phase: Phase 3
Study type: Interventional

This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate

NCT ID: NCT01345669 Terminated - Clinical trials for Head and Neck Neoplasms

LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Start date: October 17, 2011
Phase: Phase 3
Study type: Interventional

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

NCT ID: NCT01345656 Completed - Heart Failure Clinical Trials

BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease

ARTS
Start date: May 9, 2011
Phase: Phase 2
Study type: Interventional

A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally