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NCT ID: NCT01330576 Terminated - Clinical trials for Necrotizing Enterocolitis

Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis

CoolNEC
Start date: August 2, 2010
Phase: N/A
Study type: Interventional

Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.

NCT ID: NCT01324115 Terminated - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

NG-Nitro-L-Arginine in Treating Patients With Advanced Solid Tumors

Start date: April 2011
Phase: Phase 1
Study type: Interventional

RATIONALE: NG-nitro-L-arginine may stop the growth of tumor cells by disrupting blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of NG-nitro-L-arginine in treating patients with advanced solid tumors.

NCT ID: NCT01318993 Terminated - Crohn's Disease Clinical Trials

Open-Label Extension Study of GSK1605786A

SHIELD-3
Start date: April 2011
Phase: Phase 3
Study type: Interventional

An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.

NCT ID: NCT01318642 Terminated - Clinical trials for Adenocarcinoma of the Pancreas

Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas

Start date: May 2012
Phase: Phase 2
Study type: Interventional

This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1). Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.

NCT ID: NCT01318447 Terminated - Clinical trials for Colorectal Liver Metastases

CyberKnife® for Hepatic Metastases From Colorectal Cancer

Start date: January 2011
Phase: Phase 2
Study type: Interventional

This prospective, multicenter study is intended to establish the efficacy and toxicity of treating unresectable colorectal liver metastases with accurately administered radiation using the CyberKnife stereotactic radiosurgery system.

NCT ID: NCT01316939 Terminated - Crohn's Disease Clinical Trials

GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

SHIELD-2
Start date: May 2011
Phase: Phase 3
Study type: Interventional

A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.

NCT ID: NCT01315899 Terminated - Clinical trials for Raynaud's Phenomenon

Efficacy of ORM-12741 for Prevention of Raynaud's Phenomenon

REINO
Start date: March 2011
Phase: Phase 2
Study type: Interventional

Raynaud's phenomenon (RP) is a disorder of the digital blood vessels resulting in episodic impairment of blood flow. During an attack of RP which commonly affects the hands and feet these arteries contract briefly which limits the blood flow (this is called a vasospasm) and deprived of blood the skin turns white then blue. The aim of this study is to prove the concept that ORM-12741 can prevent these blood vessel spasms.

NCT ID: NCT01313390 Terminated - Clinical trials for Head and Neck Cancer

Everolimus and Docetaxel in Treating Patients With Recurrent, Locally Advanced, or Metastatic Head and Neck Cancer

DORA
Start date: June 2009
Phase: Phase 1/Phase 2
Study type: Interventional

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving everolimus together with docetaxel is more effective than giving docetaxel alone in treating patients with head and neck cancer. PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus given together with docetaxel in treating patients with recurrent, locally advanced, or metastatic head and neck cancer.

NCT ID: NCT01310855 Terminated - Glioblastoma Clinical Trials

Cediranib Maleate With or Without Gefitinib in Treating Patients With Recurrent or Progressive Glioblastoma

Start date: May 2011
Phase: Phase 2
Study type: Interventional

RATIONALE: Cediranib Maleate and gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cediranib maleate given together with gefitinib is more effective than cediranib maleate given alone in treating patients with recurrent or progressive glioblastoma. PURPOSE: This randomized phase II trial is studying the side effects of giving cediranib maleate together with gefitinib and to see how well it works compared with giving cediranib maleate together with a placebo in treating patients with recurrent or progressive glioblastoma.

NCT ID: NCT01303718 Terminated - Heart Failure Clinical Trials

INcrease Of VAgal TonE in CHF

INOVATE-HF
Start date: February 2011
Phase: Phase 3
Study type: Interventional

The purpose of the INOVATE-HF study is to demonstrate the long-term safety and efficacy of vagus nerve stimulation with the CardioFit® system for the treatment of subjects with Heart Failure.