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NCT ID: NCT01297322 Completed - Surgical Wound Clinical Trials

RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)

RESPECT
Start date: September 2011
Phase: N/A
Study type: Interventional

The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis: The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA) results that are less than manual compression by a clinically meaningful and statistically significant margin. The rate of major access site-related complications with the Cardiva VASCADE™ VCS is non-inferior to the major complication rates of manual compression for sealing femoral arterial access sites.

NCT ID: NCT01295710 Completed - Clinical trials for Myelodysplastic Syndrome

Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)

Start date: October 10, 2011
Phase: Phase 3
Study type: Interventional

The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival.

NCT ID: NCT01294566 Completed - Gastroparesis Clinical Trials

FTIH to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of GSK1322888 in Healthy Caucasian and Japanese Volunteers

Start date: November 29, 2010
Phase: Phase 1
Study type: Interventional

This study is the First Time In Human study for the motilin receptor agonist, GSK1322888. GSK1322888 is a potent and selective small molecule motilin receptor agonist, distinct from the motilide compound structures. The aims of this study are to assess the safety, tolerance, and pharmacokinetics of single oral doses of GSK1322888 and to identify a well-tolerated and safe dose that will accelerate gastric emptying of a 13C stable isotope-labeled test meal in healthy volunteers. The study will include assessment of ECGs, vital signs, safety laboratory sampling, adverse events, pharmacokinetics, and the 13C-Octanoic Acid Breath Test to measure gastric emptying.

NCT ID: NCT01294410 Completed - Colitis, Ulcerative Clinical Trials

Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

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

The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

NCT ID: NCT01294384 Completed - Dry Eye Syndromes Clinical Trials

Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease

Start date: May 1, 2011
Phase: Phase 3
Study type: Interventional

This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.

NCT ID: NCT01294150 Completed - Clinical trials for Benign Prostatic Hyperplasia

The Safety and Effectiveness of UroLift: LIFT Pivotal Study

LIFT
Start date: February 2011
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R) System when used in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the improvement of International Prostate Symptom Score (IPSS) and safety will be reviewed based on pertinent adverse events.

NCT ID: NCT01292655 Completed - Cancer Clinical Trials

Study to Evaluate the Safety and Tolerability of IV Doses of BMS-906024 in Subjects With Advanced or Metastatic Solid Tumors

Start date: March 3, 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in subjects with advanced or metastatic solid tumors who no longer respond to or have relapsed from standard therapies.

NCT ID: NCT01292603 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia

Start date: April 18, 2011
Phase: Phase 1
Study type: Interventional

This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.

NCT ID: NCT01290861 Completed - Clinical trials for Huntington's Disease

Cognitive Assessment Battery (CAB) Beta Study

CAB
Start date: February 2011
Phase: N/A
Study type: Observational

The overall objective of this study is to identify a 60 minute cognitive battery, for subsequent use in clinical trials, that detects cognitive deficits in early HD and late pre-manifest HD compared to controls, and that has a potential to show drug induced improvements.

NCT ID: NCT01290367 Completed - Clinical trials for Degenerative Disc Disease

Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain

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

The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain due to moderate Degenerative Disc Disease (DDD) at one lumbar level from L1 to S1. All investigational subjects in this study will undergo injection of either 6 million (M) or 18M cells in a hyaluronic acid carrier into the degenerated lumbar disc's nucleus pulposus. All control subjects will undergo an intradiscal control injection with either saline or hyaluronic acid only