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NCT ID: NCT01336959 Terminated - Acute Kidney Injury Clinical Trials

Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery

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

This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass.

NCT ID: NCT01320566 Terminated - Lung Diseases Clinical Trials

A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema

Start date: March 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the long term safety and efficacy of AeriSeal System treatment administered at up to 4 subsegments during a single treatment session for lung volume reduction in patients with advanced emphysema through 48 weeks after treatment.

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: 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: 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.

NCT ID: NCT01290887 Terminated - Eosinophilic Asthma Clinical Trials

Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.

NCT ID: NCT01285557 Terminated - Clinical trials for Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction

Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial

DIGEST
Start date: April 14, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy.

NCT ID: NCT01274247 Terminated - Clinical trials for Neonatal Latch Difficulties

Use of Topical Benzocaine for Analgesia in Lingual Frenotomy of the Newborn

Start date: February 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Frenotomy of tongue-tie is commonly performed to resolve breastfeeding difficulties, eg maternal nipple pain and infant's latching difficulties. The procedure carries minor discomfort for the infants. It is not known whether the use of topical benzocaine, a very bitter tasting material' applied to the tongue-tie would decrease the length of cry. We will measure the duration of crying in infants treated with topical benzocaine to the duration in those not treated with the mediation.

NCT ID: NCT01269450 Terminated - Preterm Birth Clinical Trials

Progesterone and Second Trimester Bleeding

Start date: March 2011
Phase: N/A
Study type: Interventional

Working hypothesis and aims: To investigate whether progesterone treatment affects the incidence of preterm labor compared to placebo, among women with 2nd trimester bleeding. The participants will be allocated through randomization to a study or control group. Women in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an intra-vaginal tablet once daily while the control group will receive placebo. Both women and medical staff will be blinded to group allocation. Treatment will commence on the day of inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation. Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal outcome.

NCT ID: NCT01267318 Terminated - Clinical trials for Gastrointestinal Bleeding

Evaluation of Gastric Juice Samples During Standard Gastroscopy Procedure

Start date: January 2011
Phase:
Study type: Observational

Development of a new diagnostic detection tool for gastrointestinal bleeding.