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NCT ID: NCT00582426 Completed - Clinical trials for Chemotherapy-induced Diarrhea

Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea

LARCID
Start date: April 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of Octreotide LAR in preventing chemotherapy-induced diarrhea (with regimens that contain 5 fluorouracil, irinotecan and capecitabine)in patients with colorectal cancer.

NCT ID: NCT00578786 Completed - Clinical trials for Pulmonary Arterial Hypertension

A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)

Start date: February 2004
Phase: Phase 3
Study type: Interventional

AMB-320/321-E was designed to provide long-term, controlled monitoring of pulmonary arterial hypertension (PAH) patients treated with ambrisentan (AMB) in order to properly define the adverse event profile associated with this endothelin receptor antagonist (ERA), including the incidence and severity of elevated serum liver function tests (LFTs). In addition, this study continued the efficacy assessments of the previous studies, examined long-term AMB treatment success, and compared long-term survival of subjects treated with AMB to the NIH registry of patients with PAH.

NCT ID: NCT00578305 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

SCORE
Start date: November 2007
Phase: Phase 3
Study type: Interventional

This 3 arm study assessed the efficacy of rituximab (MabThera®/Rituxan®) in the prevention of progression of structural joint damage in participants with active rheumatoid arthritis who had an inadequate clinical response to methotrexate. Participants were randomized to receive rituximab 500 mg intravenously (iv), rituximab 1000 mg iv, or placebo iv on days 1 and 15 every 24 weeks in the main study; all participants received concomitant methotrexate at a stable dose of 12.5-25 mg/week throughout the study. Further courses of rituximab were provided to eligible participants. Structural joint damage was assessed by magnetic resonance imaging (MRI) at baseline and at intervals during the study.

NCT ID: NCT00576758 Completed - Clinical trials for Non-Hodgkin's Lymphoma

GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma

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

This study will investigate the efficacy of weekly intravenous obinutuzumab [GA101 (RO5072759)] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma. Patients will be randomized to receive either GA101 or rituximab, given as four weekly infusions. At the conclusion of the initial trial patients may be eligible to continue therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00576485 Completed - Cataract Clinical Trials

Spherical Aberration and Contrast Sensitivity in IOLs

IOLs
Start date: February 2005
Phase: Phase 4
Study type: Interventional

Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified anterior aspheric surface results in reduced spherical aberration and improved contrast sensitivity after cataract surgery. Design: Prospective, comparative, interventional case series. Methods: In an intraindividual randomized prospective study of 25 patients with bilateral cataract, an IOL with a modified anterior surface (Tecnis Z9001, AMO- Group 1) was compared with biconvex lens with spherical surfaces (ClariFlex®, AMO- Group 2). Ocular aberrations for a 5.0 mm pupil and 6.0 mm pupil were measured with Hartmann-Shack aberrometer. Quality of vision was measured by visual acuity and contrast sensitivity under mesopic and photopic conditions. All patients were followed for 3 months.

NCT ID: NCT00574873 Completed - Clinical trials for Chronic Myeloid Leukemia

Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

Start date: February 5, 2008
Phase: Phase 3
Study type: Interventional

Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.

NCT ID: NCT00573443 Completed - Clinical trials for Pseudobulbar Affect (PBA)

Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS

STAR
Start date: December 2007
Phase: Phase 3
Study type: Interventional

Objectives of the study are to evaluate the safety, tolerability, and efficacy of two different doses of AVP-923 (capsules containing either 30 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate [AVP-923-30] or 20 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate [AVP-923-20]) when compared to placebo, for the treatment of PBA in a population of patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS) over a 12-week period. An additional objective is to determine the pharmacokinetic parameters of the two different doses of AVP-923 in a subset of the study population. Pseudobulbar Affect (PBA) is a condition characterized by involuntary, sudden and frequent episodes of laughing and/or crying out of proportion or incongruous to the underlying emotion of happiness or sadness Other terms used to describe this condition include emotional lability, emotionalism, emotional incontinence, emotional discontrol, excessive emotionalism, and pathological laughing and crying. The outbursts can occur spontaneously or in response to provocative stimuli such as questions or events. A body of evidence suggests that PBA can be modulated through pharmacologic intervention. Dextromethorphan (DM) is a low-affinity uncompetitive antagonist of the N-Methyl-D-aspartate (NMDA) receptor, reducing the level of excitatory activity. DM also acts at the phencyclidine-binding site, which is part of the NMDA receptor complex. DM is a sigma receptor agonist, suppressing the release of excitatory neurotransmitters. Quinidine (Q) is a known potent inhibitor of cytochrome P450 2D6 (CYP2D6), that decreases the metabolism of dextromethorphan and helps to achieve sustained and therapeutic levels of this drug.

NCT ID: NCT00571649 Completed - Clinical trials for Venous Thromboembolism

Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

MAGELLAN
Start date: December 2007
Phase: Phase 3
Study type: Interventional

This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

NCT ID: NCT00570115 Completed - Clinical trials for Sleep Apnea Syndromes

Left Atrial Volume and Function Evaluation in Patients With Obstructive Sleep Apnea

Start date: June 2007
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left atrial morphology and function evaluated by echocardiography three dimensional

NCT ID: NCT00568737 Completed - Sepsis Clinical Trials

The Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis at a Low Risk of Death

Start date: November 2002
Phase: Phase 3
Study type: Interventional

Adult Patients with Severe Sepsis