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NCT ID: NCT02641392 Terminated - Crohn's Disease Clinical Trials

A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

Start date: July 25, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study. The GED-0301-CD-003 trial was not initiated; see detailed description.

NCT ID: NCT02633644 Terminated - Heart Failure Clinical Trials

Endovascular NeuromoDulation Treatment fOr Heart Failure Patients (ENDO-HF)

Start date: September 2015
Phase: Phase 2
Study type: Interventional

The purpose of the ENDO-HF study is to determine the safety & performance of the Harmony System for the treatment of heart failure

NCT ID: NCT02626455 Terminated - Clinical trials for Lymphoma, Non-Hodgkin

Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)

CHRONOS-4
Start date: January 6, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents.

NCT ID: NCT02617160 Terminated - Type 1 Diabetes Clinical Trials

Evaluation of Automated Insulin Pump Settings Using the Advisor Pro (Previously Called) MD-Logic Pump Advisor-three Segments Study

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

Pump therapy is gaining popularity as a treatment mode for patients with type 1 diabetes. Utilizing pump therapy requires the development and application of a new spectrum of theoretical knowledge and practical skills by the patient. Furthermore, occasionally there is a need to tailor the pump settings, i.e. the insulin correction factor, carbohydrate ratio, basal plan and insulin activity time, in order to optimize and improve glucose control. These adjustments are based on collected information including insulin delivery, blood glucose measurements, continuous glucose monitoring data, meals and so on. Analyzing this multitude of information and data is overwhelming for many of the patients, caregivers and health care providers. Unfortunately, not all physicians have the needed expertise to fully fulfill this task, and for those who do, it is time consuming. Thus, a summary of the data with insulin dose adjustment suggestions is missing. An automated tool for pump setting adjustments will improve glycemic control without escalating the burden on patients and the health care system. Such advisor can assist the professional team during routine follow-up and the patients between visits. To address this challenge, the investigators developed the MD-Logic Pump Advisor (MDPA), which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing. The MDPA uses information gathered from glucose monitoring, insulin dosing and meal data during daily routine home care. Following a 5 minute data collection and analysis, the algorithm learns and suggests pump-setting changes for optimization of glucose control. This study aims to evaluate the efficacy and safety of the Advisor Pro. The study will include three segments: Segment A - a randomized controlled parallel study, Segment B- a clinic prospective study during which the Advisor Pro will be evaluated during routine clinical visits as an added tool for physicians and Segment C- a clinical prospective parallel study for patients treated with pump therapy and SMBG only.

NCT ID: NCT02612311 Terminated - Clinical trials for Chronic Lymphocytic Leukemia

Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia

UNITY-CLL
Start date: November 19, 2015
Phase: Phase 3
Study type: Interventional

This study evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) participants.

NCT ID: NCT02598297 Terminated - Clinical trials for Myelofibrosis With High Molecular Risk Mutations

Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations.

ReTHINK
Start date: February 3, 2016
Phase: Phase 3
Study type: Interventional

Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive disease with increased risk of leukemic transformation and reduced overall survival. As there are no therapies currently established in the subset of high molecular risk patients with early myelofibrosis, the study aimed to evaluate ruxolitinib in this patient population.

NCT ID: NCT02596893 Terminated - Crohn Disease Clinical Trials

Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

Start date: December 8, 2015
Phase: Phase 3
Study type: Interventional

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks.

NCT ID: NCT02595814 Terminated - Acute Heart Failure Clinical Trials

Global Non-interventional Heart Failure Disease Registry

REPORT-HF
Start date: July 23, 2014
Phase:
Study type: Observational [Patient Registry]

The clinical characteristics, initial presentation, management, and outcomes of patients hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic HF are poorly understood worldwide. REPORT-HF is a global, prospective, and observational HF disease registry designed to characterize patient trajectories longitudinally during and following an index hospitalization for acute HF.

NCT ID: NCT02574637 Terminated - Crohn's Disease Clinical Trials

Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease

Start date: January 5, 2016
Phase: Phase 2
Study type: Interventional

A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor necrosis factor-alpha (anti-TNFα) therapy.

NCT ID: NCT02562443 Terminated - Clinical trials for Myelodysplastic Syndrome

Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA

INSPIRE
Start date: December 2, 2015
Phase: Phase 3
Study type: Interventional

The study's primary objective [in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.