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NCT ID: NCT01203228 Terminated - Clinical trials for Myelodysplastic Syndromes

Dose-reduced Versus Standard Conditioning in MDS/sAML

RICMAC
Start date: May 2004
Phase: Phase 3
Study type: Interventional

In this trial dose reduced conditioning is compared to standard conditioning followed by allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or secondary AML. Conditioning is the very high dose chemotherapy treatment that is given in the days before the stem cell transplant. The hypothesis is that a dose reduced conditioning will reduce the non-relapse mortality from 40% to 20% at one year after allogeneic stem cell transplantation.

NCT ID: NCT01202773 Terminated - Clinical trials for Rheumatoid Arthritis

A Study in Participants With Rheumatoid Arthritis

FLEX V
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors. This study is comprised of 2 periods: Period 1: 24-week blinded treatment Period 2: 48-week post-treatment follow-up

NCT ID: NCT01201564 Terminated - Umbilical Hernia Clinical Trials

Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia

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

This study is designed to compare two techniques for operative care of umbilical hernia in adults regarding wound complications, wound side fluid collections, recurrence rate, postoperative pain, duration of hospitalization and quality of life. The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind the rectus muscle after small incision close to the belly button.

NCT ID: NCT01200992 Terminated - Bladder Neoplasm Clinical Trials

Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer

EMBARC-RF
Start date: November 2010
Phase: Phase 3
Study type: Interventional

This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide. Subjects with either recurrent or refractory NMIBC (Ta high grade, T1 low or high grade, CIS) will be eligible for participation in this study. Refractory disease is defined as evidence of persistent high grade bladder cancer (Ta HG, T1, and/or CIS) at least 6 months from the start of a full induction course of BCG with or without maintenance/re-treatment at 3 months. Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months following a full induction course of BCG with or without maintenance/re-treatment at 3 months. Subjects with recurrent disease must have recurred within 18 months following the last dose of BCG. Approximately 450 subjects will be randomized. The primary objective of this study is to evaluate the efficacy of intravesical EN3348 as compared with mitomycin C in the treatment of subjects with recurrent or refractory NMIBC. The secondary objective is to evaluate the safety of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent or refractory NMIBC. This study will consist of 4 phases: Screening, Induction, Maintenance and Follow-Up and will be conducted over 3 years.

NCT ID: NCT01200212 Terminated - Breast Cancer Clinical Trials

A Randomized Study to Determine the Efficacy of a Taxane and Bevacizumab With or Without Capecitabine as First Line Chemotherapy in Patients With Metastatic Breast Cancer

TABEA
Start date: July 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether - Paclitaxel and bevacizumab showed improved PFS compared to paclitaxel alone. Recent results of the AVADO study report a similar result for the combination of docetaxel and bevacizumab. The AVADO study furthermore confirmed the dose of 15 mg/kg BW of bevacizumab. - As in metastatic breast cancer (MBC) poly-chemotherapies are frequently used, regimens with bevacizumab and at least 2 cytotoxic agents should be investigated. - Docetaxel and capecitabine showed a benefit in PFS and survival. This combi- nation is therefore a reasonable choice. - Dose of capecitabine and docetaxel should be reduced to 1800 mg/m2 and 75 mg/m2 to improve tolerability without compromising efficacy. - Paclitaxel and capecitabine is well tolerated and showed a PFS of 10.3 months. - Docetaxel 100 mg/m2 as monotherapy in MBC not very often used b/o toxicity. 75 mg/m2 much more accepted in daily practice. Better comparability with DBX, if both arms have 75mg/m2 docetaxel as assumed.

NCT ID: NCT01199783 Terminated - Diabetic Foot Clinical Trials

Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment

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

Objective of the study is to test whether Daptomycin (6 mg/kg bodyweight) is non-inferior in treatment of severe diabetic foot infections (MRSA) in comparison to antibiotic treatment with Vancomycin (effective blood-plasma concentration of 15 mg/l). In case of microbiologically confirmed gram-negative co-infection effective antibiotic treatment according to microbiologic analysis will be administered upon medical decision in both therapy groups. The study will be carried out as a randomized, open label study.

NCT ID: NCT01198626 Terminated - Clinical trials for Community-Acquired Bacterial Pneumonia (CABP)

Efficacy and Safety Study of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia

Start date: October 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy, safety and tolerability of JNJ-32729463 compared to moxifloxacin for the treatment of subjects requiring hospitalization for Community-Acquired Bacterial Pneumonia (CABP).

NCT ID: NCT01198522 Terminated - Clinical trials for Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection

Combination Therapy of L19IL2 and Gemcitabine in Advanced Pancreatic Cancer Patients

Start date: June 2007
Phase: Phase 1
Study type: Interventional

Systemic treatment for advanced, non-resectable pancreatic cancer still having minimal impact on the survival of patients. Even with the application of more potent gemcitabine-based regimens, survival of more than 1 year is uncommon for advanced disease. Accordingly, there is substantial unmet needs for the improvement of treatment options. The combination and simultaneous application of tumor-targeted L19IL2 with gemcitabine could result in improved anti-cancer efficacy, based on preliminary clinical and strong preclinical data. The primary purpose of this Phase I study is to define a safe and potentially more active treatment regimen of L19IL2 (escalating doses) combined with gemcitabine for advanced pancreatic cancer patients. Also, early signs of anticancer responses of the L19IL2/gemcitabine regimen will be assessed and compared to historical controls (gemcitabine monotherapy).

NCT ID: NCT01197482 Terminated - Clinical trials for Severe Persistent Asthma

Inhaled Steroids and Control of Severe Asthma

INHALE
Start date: September 2010
Phase:
Study type: Observational

Investigational device: AKITA 2 device versus conventional metered-dose inhaler (MDI) Objectives: To explore if inhalative fluticasone application by means of the AKITA technology would result in a better symptom control in patients with severe persistent asthma as compared to inhalative application of fluticasone by a conventional MDI. Study design: open label, cross-over (one AKITA, one MDI arm) Patients: 20 Patients with severe persistent asthma

NCT ID: NCT01195480 Terminated - Clinical trials for Acute Lymphoblastic Leukemia

CD19-CAR Immunotherapy for Childhood Acute Lymphoblastic Leukemia (ALL)

CD19TPALL
Start date: May 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this clinical trial is to evaluate the feasibility, safety and biological effect of adoptive transfer of CD19ζ chimaeric receptor transduced donor-derived EBV-specific cytotoxic T-lymphocytes (EBV-CTL) in patients with high-risk or relapsed B cell precursor ALL after allogeneic Haematopoietic Stem Cell Transplantation (HSCT).