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NCT ID: NCT01562158 Completed - Clinical trials for Acquired Bleeding Disorder

Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation

Start date: April 2001
Phase: Phase 2
Study type: Interventional

This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.

NCT ID: NCT01562080 Completed - Hyperlipidemia Clinical Trials

Combined Effects of Bioactive Compounds in Lipid Profile

ARM-PLUS-LDL
Start date: January 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to demonstrate whether, along with dietary recommendations, Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III (ATP III)

NCT ID: NCT01562028 Completed - Lung Cancer Clinical Trials

BELIEF (Bevacizumab and ErLotinib In EGFR Mut+ NSCLC)

BELIEF
Start date: June 2012
Phase: Phase 2
Study type: Interventional

Rationale: Advanced non-small-cell lung cancer (NSCLC) patients harbouring epidermal growth factor receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival between 9 and 14 months when treated with erlotinib. However, the presence of EGFR mutations can only imperfectly predict outcome. The investigators hypothesize that progression-free survival could be influenced both by the pretreatment EGFR T790M mutation and by components of DNA repair pathways. The investigators propose a model of treatment whereby patients with EGFR mutations (single or with T790M) can attain a benefit with longer overall PFS when treated with erlotinib plus bevacizumab. When the patients are grouped by BRCA1 mRNA levels and T790M the hypothesis is that the combination of erlotinib plus bevacizumab can improve the PFS in all subgroups.

NCT ID: NCT01562002 Completed - Clinical trials for Limbus Corneae Insufficiency Syndrome

Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome

Start date: March 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to determine whether allogenic bone marrow stem cell transplant is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic limbus stem cell transplant.

NCT ID: NCT01561053 Completed - Alzheimer's Disease Clinical Trials

A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease

AMBAR
Start date: April 19, 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral and global domains based on the different applicable psychometric batteries and scales.

NCT ID: NCT01560858 Completed - Prostate Cancer Clinical Trials

Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State

Start date: April 2012
Phase:
Study type: Observational

The purpose of the protocol is to describe treatment patterns among patients with prostate cancer prior to diagnosis of castration-resistant state.

NCT ID: NCT01560481 Completed - Healthy Clinical Trials

Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers

NTC00940472
Start date: December 2011
Phase: Phase 1
Study type: Interventional

Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in naive patients with type 2 diabetes. The objective of this study is to evaluate the safety, tolerability and pK profile of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose, in step A. In step A will be included 25 volunteers. In step B the objective is to evaluate Safety, tolerability and pK profile of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days. In step B will be included 24 volunteers.

NCT ID: NCT01559844 Completed - Clinical trials for Hepatocellular Carcinoma

Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant

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

The primary objective is to determine if the administration of a combination of sofosbuvir (SOF; GS-7977; PSI-7977) and ribavirin (RBV) to HCV-infected subjects with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation for up to 24 weeks can prevent post-transplant re-infection as determined by a sustained post-transplant virological response (HCV RNA < LLoQ) at 12 weeks post-transplant. Participants will enroll in the pretransplant treatment phase (24 or 48 weeks). Participants enrolling for 24 weeks in the pretransplant treatment phase may receive treatment for up to an additional 24 weeks in the pretransplant retreatment phase. Participants enrolling for 48 weeks in the pretransplant treatment will have a second baseline at Week 24 for combined analysis in the pretransplant retreatment phase. Participants who undergo liver transplant will stop all study drug 24 hours prior to transplant, and enter a 48-week follow-up phase to monitor for recurrent HCV infection.

NCT ID: NCT01559272 Completed - Schizophrenia Clinical Trials

A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia

Start date: February 21, 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a paliperidone palmitate 3-month formulation in patients with schizophrenia.

NCT ID: NCT01558414 Completed - Surgery Clinical Trials

Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy

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

Prospective randomized pilot clinical trial, with 3 arms and one year follow up. The study will include 60 patients, with a 1:1:1 ratio, 20 patients per group. In 40 patients a transumbilical single site incision will be performed with two different manners: single-port device SILS TM (Single Incision Laparoscopic Surgery), and flexible endoscope and accessory trocars in a single incision (FSIS-Flexible Single Incision Surgery). The third group is the control one, a conventional laparoscopic approach. The trial is designed as a pilot study to assess, as main objective, if these two endoscopic approaches have the same security and effectiveness in cholecystectomy. Hypothesis: Transumbilical approaches with single port and single incision with the flexible endoscope have the same efficacy and safety performing the endoscopic cholecystectomy. Objectives: Main objective: Assess whether both approaches are equally safe in its application to endoscopic cholecystectomy. Secondary objectives: Investigate the differences in the rate of conversion to open surgery between different surgical approaches. Investigate the differences in the rate of wound infection between the different surgical approaches. Investigate the differences in the rate of postoperative incisional hernias between different surgical approaches. Investigate whether there are differences in the rate of overall complications, all-cause mortality and the cost between different surgical approaches.