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NCT ID: NCT01865110 Active, not recruiting - Clinical trials for Mantle Cell Lymphoma

R-CHOP + R-HAD vs R-CHOP Followed by Maintenance Lenalidomide + Rituximab vs Rituximab for Older Patients With MCL

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

This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance improves progression free survival (PFS) compared to standard rituximab maintenance after induction treatment consisting of R-CHOP + R-HAD vs R-CHOP alone in older patients (≥ 60 year old) with mantle cell lymphoma. The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28 alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab).

NCT ID: NCT01865084 Terminated - Clinical trials for Muscular Dystrophy, Duchenne

A Study of Tadalafil for Duchenne Muscular Dystrophy

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

The main purpose of this study is to determine if tadalafil can slow the decline in walking ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the safety of tadalafil and any side effects that might be associated with it in boys who have DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks of the study, and can then continue into an open label extension (OLE) that consists of two periods during which all participants will receive tadalafil. In OLE period 1, all participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will continue into OLE period 2 and will receive tadalafil for at least another 48 weeks.

NCT ID: NCT01864980 Completed - Clinical trials for Undetected Intraoperative Blood Loss

Intra-operative Monitoring of Blood Loss

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

Certain types of surgery are associated with occult blood loss, which is hard to detect intraoperatively by intermittent conventional, invasive Hb concentration measurements using the clinical standard of Hb monitoring by satellite laboratory analysis (Hbsatlab). The investigators want to see whether continuous non-invasive transcutaneous Hb measurement using a finger sensor (SpHb), (a) reduces the total time (area under the curve, AUC) a patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate (RBC), and (b) prevents a decrease in total oxygen delivery (DO2) possibly associated with transfusion below a critical haemoglobin concentration. Furthermore, the investigators want to study if SpHb monitoring changes the timing of RBC administration and reduces the need for intra- and post-operative RBC transfusion.

NCT ID: NCT01864226 Completed - Healthy Volunteer Clinical Trials

A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 in Healthy Volunteers

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

This single-center, randomized, investigator/subject-blind, adaptive multiple ascending-dose, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5545965 in healthy volunteers. Subjects will be randomized to receive either RO5545965 or matching placebo daily for 12 days.

NCT ID: NCT01864148 Completed - Multiple Sclerosis Clinical Trials

Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex

SYNERGY
Start date: August 2013
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing MS when used concurrently with Avonex. Secondary objectives of this study in this study population are to assess the safety, tolerability, and population PK of BIIB033 when used concurrently with Avonex

NCT ID: NCT01863888 Completed - Multiple Sclerosis Clinical Trials

Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis

TERI-DYNAMIC
Start date: October 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing forms of multiple sclerosis as compared with baseline values and those of a reference population of untreated healthy subjects. Secondary Objectives: To assess if Teriflunomide treatment results in biased T cell clonal diversity. To assess the effect of Teriflunomide on the function of peripheral blood mononuclear cells (proliferation and cytokine production in situ). To assess the circulating cytokines profile in the serum of Relapsing Multiple Sclerosis (RMS) patients during a 24-week treatment versus baseline and healthy controls. To assess the reversibility of all parameter changes in patients who discontinue treatment after accelerated elimination procedure with cholestyramine or activated charcoal.

NCT ID: NCT01863732 Completed - Clinical trials for Spondylitis, Ankylosing

Extension in AS: Sustainability of Benefits, Safety and Tolerability

MEASURE 1 ext
Start date: November 6, 2013
Phase: Phase 3
Study type: Interventional

This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.

NCT ID: NCT01862666 Completed - Clinical trials for Intramucosal Adenocarcinoma

A Comparison of Volumetric Laser Endomicroscopy (VLE) and Endoscopic Mucosal Resection (EMR) in Patients With Barrett's Dysplasia or Intramucosal Adenocarcinoma

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

Barrett's esophagus (BE) is a pre-neoplastic condition formed by the metaplasia of the normal squamous mucosa of the distal esophagus into a specialized intestinal mucosa. Its development is mostly associated with chronic injury from gastroesophageal reflux. BE is widely considered the leading risk factor for the development of esophageal adenocarcinoma (EAC). Volumetric laser endomicroscopy (VLE) can be thought of as an analogous technique to ultrasound, however, instead of producing an image from the scattering of sound waves, it utilizes optical scattering based on differences in tissue composition to form a two-dimensional image. The benefit of VLE over ultrasound is that it is capable of generating cross-sectional images of tissues with an axial-resolution of up to 10 micrometers, which is comparable to low-power microscopy. The proposed trial will evaluate the ability of physicians to use VLE to visualize high grade intraepithelial neoplasia (HGIN) or intramucosal adenocarcinoma (IMC) in both the ex-vivo and in-vivo setting and correlate those images to standard histology of endoscopic mucosal resection specimens as the gold standard.

NCT ID: NCT01861886 Completed - Contraception Clinical Trials

The Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women

Start date: January 31, 2013
Phase: N/A
Study type: Interventional

To evaluate the safety and long-term (approximately one year) effectiveness of the Essure System for Permanent Birth Control ESS505 device in preventing pregnancy.

NCT ID: NCT01859481 Completed - Clinical trials for Migraine Without Aura

Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study

Start date: March 2000
Phase: Phase 3
Study type: Interventional

Evaluation of headache response at 2 hours for active treated attacks for increasing dose.