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NCT ID: NCT02730299 Active, not recruiting - Lymphoma Clinical Trials

Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS

Start date: December 16, 2016
Phase: Phase 3
Study type: Interventional

This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.

NCT ID: NCT02727764 Active, not recruiting - Clinical trials for Arthritis, Rheumatoid

A Single Dose Clinical Trial to Study the Safety of ART-I02 in Patients With Arthritis

Start date: April 20, 2017
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety and tolerability of a single intra-articular administration of ART-I02 (AAV5.NF-kB.IFN-β), a recombinant adeno-associated virus (AAV) type 2/5 vector in subjects with Rheumatoid Arthritis (RA) or Osteoarthritis (OA) and active arthritis of the carpometacarpal (CMC), metacarpophalangeal (MCP), proximal interphalangeal (PIP), or distal interphalangeal (DIP) joints.

NCT ID: NCT02726698 Active, not recruiting - Atrial Fibrillation Clinical Trials

Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of Atrial Fibrillation

RACE V
Start date: July 2016
Phase:
Study type: Observational

The purpose of this study is to study clinical factors and (blood) biomarkers related to progression of Atrial Fibrillation (AF) in patients diagnosed with self-terminating AF with special reference to hypercoagulability. All patients will be continuously monitored for their atrial rhythm to assess AF progression, either through an implantable loop recorder (Reveal LinQ) or via the atrial lead of a cardiac implantable electronic device (CIED), both in combination with the CareLink home monitoring system. Remote monitoring and interrogation will be installed and used on a daily basis.

NCT ID: NCT02718664 Active, not recruiting - Clinical trials for Drug Safety Biomarkers

Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity

Start date: April 2016
Phase: N/A
Study type: Interventional

Healthy volunteer food-effect study to determine the effect of food on uracil and dihydrouracil levels in plasma

NCT ID: NCT02710435 Active, not recruiting - Angina Pectoris Clinical Trials

REDUCER-I: An Observational Study of the Neovasc Reducer™ System

Start date: March 2016
Phase:
Study type: Observational

The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.

NCT ID: NCT02701283 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

Start date: March 2016
Phase: N/A
Study type: Interventional

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

NCT ID: NCT02698579 Active, not recruiting - Clinical trials for Cerebral Adrenoleukodystrophy (CALD)

Long-term Follow-up of Participants With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product

Start date: January 22, 2016
Phase:
Study type: Observational

This is a multi-center, long-term safety and efficacy follow-up study for participants with cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product (eli-cel) in a parent clinical study. After completing a parent clinical study (approximately 2 years), eligible participants will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in this study.

NCT ID: NCT02695459 Active, not recruiting - Clinical trials for Neuroendocrine Carcinomas

Cisplatinum and Everolimus in Patients With Metastatic or Unresectable NEC of Extrapulmonary Origin

Start date: March 30, 2016
Phase: Phase 2
Study type: Interventional

Phase II, open-label, multicentre national study. Patients with metastatic neuroendocrine carcinomas of extrapulmonary origin will be eligible. Treatment will be performed as indicated in the section "Investigational drug and reference therapy". Cisplatinum and everolimus dosing is based upon earlier phase 1 studies (Fury et al. 2012). CTs will be done at 9 weekly intervals (after 3 courses of chemotherapy;). Patients will be treated until documented progression according to RECIST 1.1. Enrolment is expected to take between 14 - 16 months. The total study duration is estimated to be 2 to 3 years until publication. Three NET centres in The Netherlands will participate, (Erasmus Medical Center in Rotterdam, Netherlands Cancer Institute in Amsterdam and , the University Medical Center of Groningen) A pre-treatment (and optional post-treatment) tumour biopsy will be included for DNA/RNA analyses and organoid culture. An additional 5cc of blood will be withdrawn as a germline DNA reference. A second 5 cc of blood will be included for measuring circulating tumour transcripts to identify all types of GEP-NET (NETTest).

NCT ID: NCT02695277 Active, not recruiting - Atrial Fibrillation Clinical Trials

Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation

CEASE-AF
Start date: November 2015
Phase: N/A
Study type: Interventional

This is a prospective, randomized (2:1) multicenter trial to investigate the optimal treatment of Persistent and Longstanding Persistent AF referred for Radiofrequency (RF) ablation.The study objective is to compare the efficacy and safety of two interventional approaches, in preventing the recurrence of AF in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.

NCT ID: NCT02688140 Active, not recruiting - Clinical trials for Acute Promyelocytic Leukemia

Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia

TUD-APOLLO-064
Start date: June 2016
Phase: Phase 3
Study type: Interventional

Acute promyelocytic leukemia (APL) is a rare subtype of acute myeloid leukemia (AML) characterized by consistent clinical, morphologic, and genetic features. According to the FAB classification APL is designated as"M3 leukemia" and assigned to the WHO defined type of AML with recurrent cytogenetic abnormalities, "acute promyelocytic leukemia with t(15;17)(q22;q12), (PML/RARα) and variants". Despite the dramatic progress achieved in frontline therapy of APL with ATRA plus anthracycline-based regimens, relapses still occur in approximately 20% of patients. Moreover, these regimens are associated with significant toxicities due to severe myelosuppression frequently associated with life-threatening infections and potentially serious late effects including development of secondary MDS/AML. In a recent randomized clinical trial in low/intermediate-risk APL (WBC ≤ 10 GPt/l APL0406 trial) a combination of arsenic trioxide (ATO) and ATRA has been shown to result into better survival with significantly lower toxicity rates compared to the standard ATRA + idarubicin (AIDA) therapy. Inspired by the results of this trial the investigators intend to perform a randomized study in high-risk APL (WBC at diagnosis > 10 GPt/l) comparing standard AIDA-based treatment with ATO/ATRA combination including low-doses idarubicin during induction. The investigators propose a modified ATO/ATRA protocol with the addition of two doses of IDA (50% compared to standard AIDA induction) for induction because of the anticipated need of adding anthracyclines to control hyperleukocytosis and to achieve long-term disease control in this high-risk APL population. This is followed by 4 cycles of ATO/ATRA consolidation therapy. As in the APL0406 study for low/intermediate-risk patients the investigators expect less severe hematologic toxicity and treatment-related mortality resulting in an improved outcome for patients in the experimental arm. Furthermore, from the start of consolidation, these patients (in contrast to the standard arm) can be treated on an outpatient basis, which is also considered to be associated with an improved quality of life. The study will be conducted as a European intergroup study.