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NCT ID: NCT01227824 Completed - Clinical trials for Infection, Human Immunodeficiency Virus I

A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily

SPRING-2
Start date: October 19, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult subjects.

NCT ID: NCT01227694 Completed - Clinical trials for Osteoarthritis, Knee

Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis

Start date: October 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15 patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the study with the primary objective of assessing the feasibility and safety of the knee articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary objectives are to assess the efficacy by imaging procedures and clinical questionnaires. MSC obtained from each patient's bone marrow will be isolated and expanded "Ex-Vivo" under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, patients will be implanted a single-dose of approximately 40 millions of autologous MSC in the knee by articular injection, and followed up for 12 month. Articular cartilage changes will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36) at 3, 6 and 12 month. The working hypothesis proposes that the expected regenerative articular cartilage effect of the MSC will be produced to a measurable degree by imaging procedures and clinical questionnaires.

NCT ID: NCT01227291 Completed - Glaucoma Clinical Trials

SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With Intraocular Pressure (IOP) >= 21 mm Hg

Start date: October 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP.

NCT ID: NCT01227278 Completed - COPD Clinical Trials

A Study to Evaluate the Effectiveness of a Drug (MEDI-563) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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

To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) in Adults

NCT ID: NCT01226563 Completed - Clinical trials for Acute Myocardial Infarction

IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction

PRESERVATION-1
Start date: April 2012
Phase: N/A
Study type: Interventional

The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous coronary intervention with stent placement after ST segment elevation MI (STEMI).

NCT ID: NCT01225562 Completed - Stroke Clinical Trials

Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin

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

This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).

NCT ID: NCT01225393 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis

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

This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study enrolling patients with active rheumatoid arthritis (RA).

NCT ID: NCT01225380 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

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

This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.

NCT ID: NCT01224106 Completed - Alzheimer's Disease Clinical Trials

A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease

Scarlet Road
Start date: November 30, 2010
Phase: Phase 3
Study type: Interventional

This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo. Participants who consent to be part of the sub study will undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2, followed by an open-label extension (Part 3) until July 2020. The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a low probability of meeting the primary outcome measure with the doses studied. The study has converted to open-label to investigate higher gantenerumab doses.

NCT ID: NCT01224093 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

An Observational Study on the Safety Profile of MabThera/Rituxan (Rituximab) in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (MABERYC)

Start date: October 2010
Phase: N/A
Study type: Observational

This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.