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NCT ID: NCT01233960 Completed - Crohn's Disease Clinical Trials

Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease

Start date: November 29, 2010
Phase: Phase 3
Study type: Interventional

To provide open-label re-treatment with PROCHYMAL to subjects enrolled in companion Protocol 603 to evaluate the safety in subjects with active Crohn's disease who are resistant to standard Crohn's disease therapies.

NCT ID: NCT01233869 Completed - Clinical trials for Polycystic Kidney, Autosomal Dominant

Bosutinib For Autosomal Dominant Polycystic Kidney Disease

Start date: December 2010
Phase: Phase 2
Study type: Interventional

This purpose of this study is to determine if bosutinib reduces the rate of kidney enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or equal to 60 mL/min/1.73m2.

NCT ID: NCT01233622 Completed - Clinical trials for Type 2 Diabetes Mellitus

Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride

Vildagliptin
Start date: October 2010
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).

NCT ID: NCT01232569 Completed - Clinical trials for Rheumatoid Arthritis

A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

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

This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.

NCT ID: NCT01231620 Completed - Influenza, Human Clinical Trials

A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza

ZORO
Start date: January 15, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the safety and efficacy of zanamivir given intravenously and how well it works at two different doses in hospitalized adolescents and adults with flu. Zanamivir will be compared with oseltamivir, which is used for treating flu.

NCT ID: NCT01231594 Completed - Cancer Clinical Trials

A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors

Start date: November 5, 2010
Phase: Phase 1
Study type: Interventional

This rollover study is designed to provide continued access to GSK2118436 for eligible subjects with BRAF mutation-positive tumors who have previously participated in a GlaxoSmithKline (GSK)-sponsored GSK2118436 study (parent study), who have no evidence of progressive disease and who have tolerated GSK2118436 in the parent study without significant toxicities. Subjects will be enrolled into the appropriate cohort based upon the treatment received in their parent study. Safety assessments (physical examinations, vital signs, 12-lead electrocardiograms, echocardiograms, clinical laboratory assessments, and monitoring of adverse events) will be made throughout the study. Clinical activity will be assessed using local standard of care imaging practices and the appropriate response criteria as determined by the investigator.

NCT ID: NCT01231516 Completed - HIV Infections Clinical Trials

A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults

SAILING
Start date: October 26, 2010
Phase: Phase 3
Study type: Interventional

ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.

NCT ID: NCT01231139 Completed - Clinical trials for Traumatic Brain Injury

The Paracetamol AfteR Traumatic Brain InjurY Study

PARITY
Start date: October 2010
Phase: Phase 2
Study type: Interventional

This primary aim is to investigate the effect of paracetamol in reducing body temperature in patients who have sustained traumatic brain injury. This study is also investigating the safety of paracetamol in this patient population.

NCT ID: NCT01230801 Completed - Pompe Disease Clinical Trials

Safety/Tolerability/Pharmacokinetic (PK)/Pharmacodynamics (PD) Study of BMN701 in Patients With Late-Onset Pompe Disease

Start date: January 17, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2, open-label, multicenter, multiple dose escalation study of BMN 701 administered by intravenous infusion every 2 weeks over a 24-week treatment period to patients with late-onset Pompe disease.

NCT ID: NCT01230632 Completed - Diabetes Clinical Trials

Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques

IMPART
Start date: September 2010
Phase: N/A
Study type: Interventional

This study is to compare the effects of high fat overfeeding on metabolic risk factors in children born though assisted reproduction technologies (ART) versus children conceived naturally (controls). The investigators will utilize state of the ART measures to characterize the physiological, endocrine and molecular responses to high fat overfeeding. The investigators hypothesize that children conceived following ART will have greater responses to high fat dietary challenge and that this will be associated with DNA hypermethylation of genes that are involved in lipid metabolism.