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NCT ID: NCT02007473 Completed - Clinical trials for Adverse Effects in the Therapeutic Use of Plasma Substitutes

A Prospective Non-interventional Study to Evaluate the Safety of Methylene Blue Plasma

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

The objective of this non-interventional study is to gather data on adverse reactions occurring with Methylene Blue plasma administered in a routine clinical practice environment; to know more about their characteristics and behaviour and the possible factors that may influence their presentation and evolution.

NCT ID: NCT02007135 Completed - Clinical trials for Proprioceptive Postural Control

Comparison of Pneumatic and Electromagnetic Muscle Vibrators to Stimulate Muscle Proprioceptors

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

The purpose of this study is to determine the concurrent validity of a newly developed pneumatic, fMRI compatible muscle vibrator as compared to a electromagnetic muscle vibrator in the stimulation of muscle proprioceptors.

NCT ID: NCT02006758 Completed - Clinical trials for Uncontrolled Hypertension

Observational Study of the EnligHTN Renal Denervation System in Europe

Start date: November 2013
Phase:
Study type: Observational

The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of participants with uncontrolled hypertension in clinical routine practice.

NCT ID: NCT02006693 Completed - Clinical trials for Primary Open Angle Glaucoma

Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants

Start date: December 5, 2013
Phase: Phase 4
Study type: Interventional

The objective of this study was to evaluate the AqueSys XEN Implant [XEN® Gel Stent (XEN45 Implant)] for the treatment of moderate primary open angle glaucoma (POAG) participants when medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by comparing medicated preoperative IOP to postoperative values. Additionally, the number of topical IOP-lowering medications at screening were compared to the number of IOP-lowering medications at 1 year.

NCT ID: NCT02006277 Completed - Healthy Clinical Trials

A Study To Taste Three New Types Of Crizotinib Formulation In Comparison Of An Oral Solution And To Measure The Amount Of Crizotinib In The Body After These Formulations Are Orally Given, Relative To Capsule Formulation

Start date: December 2013
Phase: Phase 1
Study type: Interventional

This study is intended to evaluate the sensory attributes and estimate the relative bioavailability of three prototype oral formulations. Subjects will either taste 75-mg doses by "swirl and spit" (Cohort 1) or will receive five oral single 250-mg doses with a washout period of at least 14 days (Cohort 2).

NCT ID: NCT02006212 Completed - Clinical trials for Cardiac Surgical Procedures

Impact of Cerebral Monitoring on Neurologic Outcome in Cardiac Surgery

Start date: January 2014
Phase: N/A
Study type: Interventional

Neurologic complications after cardiac surgery range over a wide spectrum including postoperative delirium (PD), postoperative cognitive dysfunction (POCD) and cerebrovascular accidents (CVA). The incidence of these neurologic events varies depending on the type of surgery and the population studied. The incidence of PD and/or POCD is further influenced by the type of the neurologic tests used. Moreover, the timing of these tests seems to influence the results. Intraoperative cerebral monitoring is gaining importance in the anesthesia field. Recent findings have pointed out that cerebral hypoperfusion on one hand and deep levels of anesthesia on the other hand are major sources of adverse neurological outcomes, both of which can be detected with different non-invasive cerebral monitors.The present investigators are currently using the NeuroSENSE®, a processed electroencephalogram (pEEG) monitor together with cerebral near-infrared spectroscopy (NIRS) on a daily basis in every cardiac patient. This large, prospective, observational study will investigate whether the short- and mid-term neurologic outcome of adult patients undergoing cardiac surgery are in line with observations made on the basis of the pEEG monitor NeuroSENSE® and cerebral NIRS.

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: NCT02004704 Completed - Clinical trials for Sphingomyelin Lipidosis

A Long-Term Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency

Start date: December 4, 2013
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to obtain data regarding the safety of olipudase alfa in patients with acid sphingomyelinase deficiency (ASMD) who are exposed to long term treatment with olipudase alfa. The secondary objectives of this study are to obtain data regarding the efficacy of olipudase alfa and to characterize olipudase alfa pharmacodynamics (PD) and pharmacokinetics (PK) following long-term administration.

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).