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NCT ID: NCT02006654 Completed - Alzheimer's Disease Clinical Trials

Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor

STARBRIGHT
Start date: March 2014
Phase: Phase 3
Study type: Interventional

To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's disease (AD).

NCT ID: NCT02006121 Completed - Parkinson's Disease Clinical Trials

Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease

TOLEDO
Start date: March 3, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of the trial was to investigate the efficacy of apomorphine continuous subcutaneous infusion compared to placebo in Parkinson's Disease patients with motor fluctuations not well controlled on medical treatment. The secondary objective of the study was to investigate the safety and tolerability of apomorphine continuous subcutaneous therapy.

NCT ID: NCT02006004 Completed - AML Clinical Trials

Epidemiologic Registry PETHEMA LMA 2013

Start date: January 2012
Phase: N/A
Study type: Observational

Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo or secondary AML in the PETHEMA Group institutions. This study is a non-interventional research regarding diagnosis and therapeutic approach

NCT ID: NCT02005900 Completed - Clinical trials for HIV-associated Hypertriglyceridemia

Effect of DHA on Lipid and Carbohydrate Metabolism Alterations and Body Fat Distribution in HIV Patients Under HAART.

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

Highly active antiretroviral therapy (HAART) is able to cause lipid metabolism and glucose homeostasis alterations, which are associated to the redistribution of body fat. Alterations in lipid and carbohydrate metabolism contribute to the development of a highly atherogenic profile, which together with altered fibrinolysis markers and increased presence of proinflammatory cytokines in blood (especially tumor necrosis factor alpha) that comes associated to the success of HAART can cause the development of accelerated atherosclerosis. Docosahexaenoic acid (DHA) is a polyunsaturated fatty acid that has demonstrated its ability to reduce triglyceride levels; modify cholesterol fractions and increase the size of LDL particles thereby configuring less atherogenic plasma profile. Additionally, administration of DHA has shown antiinflammatory and hypotensive activity, which contributes to reduce the risk of cardiovascular complications in these patients. At a molecular level, DHA acts as a stimulator of the nuclear receptor PPAR-gamma, which has been described to induce an increase in adipocyte differentiation. Furthermore, the anti-inflammatory effects induced by DHA, can decrease the elevated levels of TNF-alpha, which has been implicated in the pathogenesis of body fat redistribution in HIV infected patients undergoing HAART. Therefore, the hypothesis of this project is that DHA will be able to produce lipid-lowering, anti-inflammatory, hypotensive and profibrinolytic effects, which all together should improve atherogenic profile of patients with HIV-1 infection receiving HAART. In addition, their proprieties as PPAR agonist can improve the redistribution of body fat present in many of these patients. The study of the activity of DHA on dendritic cells and monocytes should indicate the absence of immunosuppressive effect of DHA in the context of HIV-1 infection. In summary, DHA is a natural product, from the omega 3 polyunsaturated fatty acids, the therapeutic properties of which have been described in recent years and has shown cardio-vascular and metabolic beneficial effects, without recognized side effects. The highly purified DHA administration at high doses could be able to reverse, at least partially, lipid abnormalities associated with HAART and to exert a beneficial effect on fat redistribution in HIV-infected patients treated with HAART. To ensure non deleterious immunological treat in these sensitive poly-medicated patients, substantial changes in the functionality of dendritic cells and monocytic will be studied.

NCT ID: NCT02005471 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

MURANO
Start date: March 17, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B).

NCT ID: NCT02005159 Completed - Clinical trials for Bacteremia by Enterobacteriaceae

Study of the Impact of the Minimum Inhibitory Concentration and Susceptible Cut-off Points (CLSI, EUCAST, and Pharmacokinetics/Pharmacodynamics)in Prognosis of Bacteremia by Enterobacteriaceae

BACTERIEMIA
Start date: March 2011
Phase: N/A
Study type: Observational

Provide scientific and validated data to help International Authorities to set susceptible to antibiotics cut-off points in bacteremia by Enterobacteriaceae

NCT ID: NCT02005146 Completed - Clinical trials for Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues

Retrospective Observational Study to Define HBsAg Loss With or Without Seroconversion to antiHBs in Patients With Chronic Hepatitis by B Virus Treated With Nucleoside/Nucleotide Analogs

Start date: December 2013
Phase: N/A
Study type: Observational

Define the patients who lost HBsAg, studying the loss predictive factors and if there was suspension of treatment, study the evolution after that

NCT ID: NCT02004873 Completed - Clinical trials for Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines

Micra Transcatheter Pacing Study

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.

NCT ID: NCT02004691 Completed - Clinical trials for Sphingomyelin Lipidosis

Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency

ASCEND
Start date: December 18, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objective: The primary objective of this phase 2/3 study is to evaluate the efficacy of olipudase alfa (recombinant human acid sphingomyelinase) administered intravenously once every 2 weeks for 52 weeks in adult participants with acid sphingomyelinase deficiency (ASMD) by assessing changes in: 1) spleen volume as measured by abdominal magnetic resonance imaging (MRI) (and, for the United States [US] only, in association with participant perception related to spleen volume as measured by splenomegaly-related score [SRS]); and 2) infiltrative lung disease as measured by the pulmonary function test, diffusing capacity of the lung for carbon monoxide (DLCO). Secondary Objectives: - To confirm the safety of olipudase alfa administered intravenously once every 2 weeks for 52 weeks. - To characterize the effect of olipudase alfa on the participant perception related to spleen volume as measured by the SRS after 52 weeks of study drug administration. (For the US, the effect of olipudase alfa on the SRS is part of the primary objective). - To characterize the effect of olipudase alfa after 52 weeks of study drug administration on the following outcome measures assessed sequentially: - The effect of olipudase alfa on liver volume; - The effect of olipudase alfa on platelet count; - The effect of olipudase alfa on fatigue; - The effect of olipudase alfa on pain; - The effect of olipudase alfa on dyspnea.

NCT ID: NCT02004522 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)

Start date: November 2013
Phase: Phase 3
Study type: Interventional

A Phase 3 clinical trial to examine the efficacy of duvelisib monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).