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NCT ID: NCT01657604 Completed - Clinical trials for Chronic Myeloid Leukemia

TKI and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group - the TIGER Study

TIGER
Start date: August 24, 2012
Phase: Phase 3
Study type: Interventional

Advances in Chronic Myeloid Leukemia (CML) therapy led to an expected survival prolongation of > 20 years after diagnosis. So far, discontinuation of tyrosine kinase inhibitors led to recurrence of disease in the majority of patients. The trial aims to improve treatment strategies in CML by improving induction therapy and deescalating maintenance therapy using low dose IFN as inducer of immunosurveillance. The trial will provide important data on the duration of active therapy in CML patients. Considering the rapidly increasing prevalence of CML this is of individual but also socioeconomic importance.

NCT ID: NCT01657292 Completed - Burns Clinical Trials

Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds

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

The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10 in the acceleration of wound healing of grade 2a burn wounds.

NCT ID: NCT01656902 Completed - Clinical trials for Traumatic Articular Cartilage Defects in the Knee Joint

Phase III Study to Evaluate Safety and Effectiveness of NOVOCART 3D Plus vs. Microfracture in Knee Cartilage Defects

N3D
Start date: May 2013
Phase: Phase 3
Study type: Interventional

In this phase 3 clinical trial, a second generation ACI (autologous chondrocyte implantation technique) is compared to standard of care therapy (microfracture) to treat traumatic cartilage defects of the knee for efficacy and safety. The investigated study treatment NOVOCART 3D plus is a biphasic biological scaffold which contains cultivated chondrocytes derived from the patient in a previous tissue harvest procedure. Allocation to the study treatment is done by randomization in a ration of 2:1 in favor to ACI (investigational product). Follow-up data for efficacy is collected for 2 years: follow-up visits are performed 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months after treatment; additional data for safety will be collected for up to 5 years: 36, 48, and 60 months after treatment. The study involves knee surgery (by arthroscopy, or mini-arthrotomically for implantation surgery), and blood withdrawal for safety within the first year after treatment. Initial imaging is required at baseline. Optional MRI imaging and biomarker collection is done as substudy at specific sites only.

NCT ID: NCT01654003 Terminated - Surgery Clinical Trials

Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery

Start date: April 2010
Phase: N/A
Study type: Interventional

This study wants to compared the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in septic patients requiring emergency surgery.

NCT ID: NCT01653977 Terminated - Surgery Clinical Trials

Impact of Early Goal-directed Fluid Therapy in Hypovolemic Patients Undergoing Emergency Surgery

Start date: February 2010
Phase: N/A
Study type: Interventional

This study compares the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in trauma patients requiring emergency surgery.

NCT ID: NCT01653353 Completed - Aging Clinical Trials

Swiss Study on Vitamin D and Calcium in Nursing Homes

Start date: July 2012
Phase: N/A
Study type: Interventional

Residents of nursing homes are endangered by malnutrition and vitamin D deficiency. Our study checks compliance with Swiss federal recommendations on vitamin D and calcium supplementation among residents of a Swiss nursing home. A peer physician-applied recommendation on compliance with the federal recommendations with individual evaluation of the residents will be sent to the physicians in care. After one year, data will be collected again.

NCT ID: NCT01652547 Completed - Clinical trials for Metastatic Melanoma and Merkel Cell Carcinoma

A Phase I, Exploratory, Intra-patient Dose Escalation Study to Investigate the Preliminary Safety, Pharmacokinetics, and Anti-tumor Activity of Pasireotide (SOM230) s.c.Followed by Pasireotide LAR in Patients With Metastaticmelanoma or Metastatic Merkel Cell Carcinoma

Start date: November 2012
Phase: Phase 1
Study type: Interventional

This study will evaluate the preliminary safety, pharmacokinetics, and anti-tumor activity of pasireotide s.c. in patients with metastatic melanoma or metastatic Merkel cell carcinoma. The study consists of three phases: screening, intra-patient dose-escalation, and follow-up phases. In the screening phase patient will be informed of all aspects of the study and sign informed consent forms and then be screened for study eligibility. During the intra-patient dose escalation phase, 18 patients will be treated with pasireotide s.c. 300 μg t.i.d. for 2 weeks. If there are no unacceptable AEs, defined as drug-related clinically meaningful, uncontrolled grade 3 or any grade 4 toxicities, patients will be dose escalated to 600 μg t.i.d. for 2 more weeks, then 900 μg t.i.d. for 2 weeks and then 1200 μg for 2 weeks provided that there are no unacceptable AEs. Each patient will be in the dose escalation phase for a maximum of 8 weeks. At end of the intra-patient dose escalation phase, patients will be allowed to switch to 80 mg pasireotide LAR i.m. q 28 d (or a lower dose in case of toxicity) for an additional 6 months or until disease progression, or unacceptable AEs, or patient withdraws consent. In addition, all patients will keep their pasireotide s.c. t.i.d. treatment (same dose as that at the end of the 8-week dose escalation phase) during the first 2 weeks of the LAR follow-up phase, except on the day receiving the first LAR dose because of an anticipated initial burst of drug release.

NCT ID: NCT01652469 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.

EMPHASIS
Start date: August 2012
Phase: Phase 3
Study type: Interventional

Using a laboratory test (VeriStrat), patients with relapsed squamous cell lung cancer are assigned to two strata, VSG (VeriStrat Good) and VSP (VeriStrat Poor). They are then randomized between an EGFR-TK inhibitor (erlotinib) and chemotherapy (Docetaxel). It is hypothesized that the VeriStrat test results are able to predict the benefit of treatment with erlotinib vs docetaxel. This would suggest a significant improvement in progression-free survival for VSG patients when treated with Erlotinib, and no significant improvement in VSP patients who receive the same treatment.

NCT ID: NCT01651780 Completed - Clinical trials for Aortic Valve Insufficiency

Open-label, Randomized Trial in Patients Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH

BRAVO-2/3
Start date: October 2012
Phase: Phase 3
Study type: Interventional

This is an international, multicenter, open-label, randomized controlled trial. All patients undergoing transfemoral TAVR at the participating centers will be eligible. All sites will initiate enrolment with 2 feasibility roll-in bivalirudin treated patients and thereafter patients will be randomly assigned to either standard dosing of bivalirudin or UFH as control. The 2 roll-in cases per site will constitute the feasibility cohort that will be followed and analyzed separately. Patients will undergo TAVR according to current standard of care practices at the treating centers. Use of antiplatelet agents pre, during, and post procedure, and possibly oral anticoagulants post procedure, will be according to the sites' standard practice. ALL available data will be collected in the eCRF prospectively

NCT ID: NCT01651143 Completed - Systemic Sclerosis Clinical Trials

Proof of Biological Activity of SAR100842 in Systemic Sclerosis

Start date: January 2013
Phase: Phase 2
Study type: Interventional

Primary Objective: - To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis. Secondary Objectives: - To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis as measured by disease related biomarkers and Lysophosphatidic acid (LPA) receptor signaling markers in blood and skin - To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis as measured by the Modified Rodnan Skin score (mRSS) - To explore the effect of SAR100842 on quality of life as measured by the Scleroderma Modified Health Assessment Questionnaire (SHAQ).