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NCT ID: NCT02018991 Completed - Clinical trials for Late Acquired Stent Malaposition

Late Acquired Malaposition and Different Polymers

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

The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.

NCT ID: NCT02018939 Completed - Clinical trials for Infections During Organ Replacement Therapy

Multiple-dose Pharmacokinetics of Doripenem During Continuous Venovenous Hemodiafiltration and Molecular Adsorbent Recirculating System in ICU Patients and During Hemodialysis in Longterm Hemodialysis Patients.

Start date: March 2010
Phase: Phase 3
Study type: Interventional

The study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System) and intermittent hemodialysis.

NCT ID: NCT02017691 Completed - Oxygen Saturation Clinical Trials

Cerebral Oxygenation to Guide Supplemental Oxygen

COSGOD
Start date: December 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Objective: Objective of this pilot feasibility study is to monitor crSO2 using NIRS INVOS 5100 (Somanetics, USA) in addition to SpO2 monitoring to guide supplemental oxygen delivery and respiratory support based on both measurements in preterm neonates during the first 15 minutes after birth. Patients: Preterm neonates <34+0 weeks of gestation born via caesarean section and/or who require respiratory support will be eligible for the study. Design: A prospective two-centre randomized controlled pilot feasibility study Methods: Study group: Pulse oximetry will be used to measure SpO2 and heart rate as routine non-invasive monitoring in the first minutes of resuscitation. In addition during the first 15 minutes NIRS measurements will be recorded. crSO2 measurements in addition SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth. Control group: Only SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth. Hypothesis: Supplemental oxygen support and respiratory support guided by crSO2 and SpO2 measurements will reduce the time in % minutes of crSO2 <10th or >90th centile in preterm neonates during the first 15 minutes after birth Outcome Parameter: Primary outcome parameter will be duration in % minute of crSO2 <10th or >90th centile.

NCT ID: NCT02013817 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy

Start date: October 2005
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.

NCT ID: NCT02013648 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™)

Start date: July 2014
Phase: Phase 3
Study type: Interventional

This is a randomized phase III open-label, multicenter trial evaluating standard induction therapy (daunorubicin [DNR] and cytarabine [Ara-C]) and consolidation therapy (high-dose cytarabine [HDAC]) with or without dasatinib in adult patients with newly diagnosed CBF-AML

NCT ID: NCT02013271 Completed - Clinical trials for Femoral Artery Occlusion

Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries

Start date: December 2013
Phase:
Study type: Observational

To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA

NCT ID: NCT02013193 Completed - Atherosclerosis Clinical Trials

Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries

RANGER-SFA
Start date: January 7, 2014
Phase: N/A
Study type: Interventional

The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months post-procedure when comparing Late Lumen Loss (LLL). Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by angiography at six months follow-up after treatment of the femoropopliteal artery with Ranger DCB study devices is lower than the %-mean loss of luminal diameter after treatment with uncoated PTA balloon control devices.

NCT ID: NCT02012582 Completed - Clinical trials for Traumatic Brain Injury

Phase 2 a Study to Assess Safety and Pharmacokinetics of VAS203 in Patients With Traumatic Brain Injury

NOSTRA
Start date: November 2009
Phase: Phase 2
Study type: Interventional

In the exploratory multi-center Phase 2 a study safety, tolerability, pharmacodynamics and pharmacokinetics of the Nitric Oxide Synthase inhibitor VAS203 is assessed in patients with moderate and severe traumatic brain injury. Traumatic brain injury patients (32 males) receive 15, 20 and 30 mg/kg VAS203, respectively, by continuous infusion in three cohorts (Cohort 1 open; Cohorts 2 and 3 double blind, randomised placebo-controlled). End of Study for all patients will be Day 14; adverse events and concomitant medications will be documented throughout the study. Objectives are to assess safety and tolerability of VAS203, to evaluate concentrations of metabolites of VAS203 in plasma and microdialysate and to assess pharmacodynamic effects of VAS203 on surrogate parameters. Safety parameter will include vital signs (blood pressure heart rate, respiration rate, oxygen saturation and blood gases), fluid balance, ECG, laboratory examinations (clinical chemistry, liver function, haematology/coagulation, urinalysis, renal parameters) and adverse events. Concentration of VAS203 will be determined in plasma and microdialysate. Pharmacodynamic parameters will include intracranial pressure (ICP), biochemical parameters in microdialysate (nitrite/nitrate, arginine, citrulline, pyruvate, lactate, glucose), Partial Oxygen Pressure in brain parenchyma and Therapy Intensity Level (TIL).

NCT ID: NCT02010723 Completed - Varicose Veins Clinical Trials

Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis

Start date: June 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare two therapeutic procedures in the treatment of isolated varicosis of the anterior accessory great saphenous vein (AAGSV): crossectomy and avulsion of the varicose AAGSV versus foam sclerotherapy of the AAGSV.

NCT ID: NCT02010255 Completed - Clinical trials for Chronic HCV Infection

Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

Start date: January 2014
Phase: Phase 2
Study type: Interventional

This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection. - Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant; - Cohort B: post-liver transplant, with or without cirrhosis; - Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups) - Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.