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NCT ID: NCT00775710 Completed - Clinical trials for Hypercapnic Respiratory Failure

Clinical Trial Assessing Two Protocols to Withdraw Non-invasive Ventilation in Hypercapnic Respiratory Failure

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

The purpose of the study is to determine the optimal method to withdraw non-invasive ventilation after an episode of hypercapnic respiratory failure.

NCT ID: NCT00774397 Completed - Clinical trials for Hepatitis C, Chronic

Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)

Start date: October 2008
Phase: Phase 2
Study type: Interventional

The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.

NCT ID: NCT00774345 Completed - Clinical trials for B-cell Chronic Lymphocytic Leukemia

A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy

Start date: January 27, 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response. This study will compare the effects (good and bad) of lenalidomide with the dummy drug.

NCT ID: NCT00773708 Completed - HIV Infections Clinical Trials

Pilot Opened Trial in HIV-infected Patients Including an Investigational Marketed Product

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

This study aims to provide new knowledge about the pathogenesis of HIV infection, specifically, the role that immune activation and apoptotic activity play in immune recovery, and in particular, in the paradoxical immunologic response of some patients on antiretroviral therapy despite achievement of sustained and complete viral suppression. In this regard, the investigators will prospectively evaluate the impact of intensification with Raltegravir in those "discordants" patients with high index of immune activation, measured as the percentage of CD8+HLADR+CD38+ cells. This will provide relevant information on the effectiveness of this drug in guided intensification regimens.

NCT ID: NCT00773526 Completed - Neoplasms Clinical Trials

A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.

Start date: November 2008
Phase: Phase 1
Study type: Interventional

This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors. In the first part of the study, groups of patients will by sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with selected tumor types will be randomized to receive either the optimal biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

NCT ID: NCT00773513 Completed - Clinical trials for Chronic Renal Anemia

A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)

Start date: December 12, 2008
Phase: Phase 4
Study type: Interventional

This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.

NCT ID: NCT00772902 Completed - HIV-1 Clinical Trials

ROCKET II - Randomized Open Label Switch for Cholesterol Elevation on Kivexa + Kaletra Evaluation Trial

ROCKET II
Start date: October 2008
Phase: Phase 4
Study type: Interventional

This study investigated whether human immunodeficiency virus type 1 (HIV-1) infected subjects with raised cholesterol switching their nucleoside reverse transcriptase inhibitor (NRTI) backbone from Kivexa (Epzicom) to Truvada had an improvement in their fasting total cholesterol after 12 weeks of treatment. The study also investigated whether any improvement had a beneficial effect on the overall cardiovascular risk.

NCT ID: NCT00771927 Completed - Epilepsies, Partial Clinical Trials

Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures

PASS
Start date: October 2008
Phase: N/A
Study type: Observational

SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in patients with Epilepsy 16 years and older with partial-onset seizures who are uncontrolled on current therapy. Using reported adverse events, the incidence of certain cardiovascular and psychiatric events will be evaluated.

NCT ID: NCT00771667 Completed - Crohn's Disease Clinical Trials

A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy

Start date: December 2008
Phase: Phase 2
Study type: Interventional

A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.

NCT ID: NCT00770978 Completed - ICU Clinical Trials

Open Label Study of Ceftobiprole to Evaluate Pharmacokinetics in Adults Hospitalized in the ICU

Start date: November 2008
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to measure the levels of ceftobiprole in the blood and urine during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.