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NCT ID: NCT02441400 Terminated - GERD Clinical Trials

EndoStim Patient Registry

RESTORE
Start date: May 2013
Phase:
Study type: Observational [Patient Registry]

To provide a research tool enabling physicians to monitor long term clinical outcomes for patients undergoing gastroesophageal reflux disease (GERD) treatment with EndoStim LES Stimulation System.

NCT ID: NCT02441309 Terminated - Osteosarcoma Clinical Trials

A Eurosarc Study of Mifamurtide in Advanced Osteosarcoma (MEMOS)

MEMOS
Start date: October 2014
Phase: Phase 2
Study type: Interventional

This is a Bayesian designed multi-arm, multi-centre, open label phase II study. The target sample size of 40 patients will be recruited from up to 8 EU countries, but this may be revised in light of the interim analysis. Patients with relapsed or metastatic osteosarcoma will be divided into three treatment groups. They will all either have surgery or a biopsy before and after six weeks exposure to either Mifamurtide alone, Ifosfamide alone, or Mifamurtide combined with Ifosfamide. They will then receive further treatment to a maximum of 42 or 36 weeks in total (depending on Arm), with all patients being able to receive 36 weeks of Mifamurtide treatment.

NCT ID: NCT02440646 Terminated - Clinical trials for Coronary Artery Disease

Natural History of Coronary Atherosclerosis in Real-World Stable Chest Pain Patients Underwent Computed Tomography Angiography in Comparison With Invasive Multimodality Imaging

REALITY
Start date: May 2015
Phase:
Study type: Observational [Patient Registry]

In a prospective international multicenter observational study, 1080 stable chest pain patients (REALITY Advanced registry of CCTA patients) with the suspected chronic coronary syndrome will be enrolled. All of them will undergo computed tomography angiography, CMR and/ or SPECT, and Echo. One of the cohorts will be examined with multimodality invasive imaging including quantitative coronary angiography, FFR, QFR with or without further percutaneous coronary intervention, OCT, and some of them - with IVUS, VH-IVUS. The plaque size and relevant stenosis, a composition of the atherosclerotic lesion, major adverse cardiovascular events (all-cause death, death from cardiac causes, myocardial infarction, or rehospitalization due to unstable or progressive angina, ischemia-driven revascularization) will be judged to be related to either originally treated (culprit) lesions or untreated (non-culprit) lesions. Moreover, the clinical potential of both non-invasive and invasive imaging, as well as anatomical vs functional modalities in two real-world patient flows, will be estimated with the special focus on the natural progression of atherosclerosis, clinical outcomes, and safety (contrast-induced nephropathy, radiocontrast-induced thyroid dysfunction, and radiation dose). The diagnostic accuracy will be analyzed. The follow-up period will achieve 12 months prospectively with collected clinical events and imaging outcomes which will be determined at the baseline and 12-month follow-up. The independent ethics expertise will be provided by the Ural State Medical University (Yekaterinburg, Russia) and Central Clinical Hospital of the Russian Academy of Sciences (Moscow, Russia). The monitoring of the clinical data with imaging as well as further CoreLab expertise (expert-level post-processing multimodal imaging software of Medis Imaging B.V., Leiden, The Netherlands) will be provided by De Haar Research Task Force, Amsterdam-Rotterdam, the Netherlands. FFR-CT is scheduled to be assessed by the ElucidVivo Research Edition software from Elucid Bio, Boston, MA, U.S.A. The REALITY project is a part of the JHWH (Jahweh) International Advanced Cardiovascular Imaging Consortium. The main objective of the Consortium that is uniting international efforts of both Academia and Industry is a synergistic development of the advanced machine-learning imaging software in order to integrate benefits of both non-invasive and invasive imaging providing the daily clinical practice with the robust tool for the anatomical and functional examination of coronary atherosclerosis, PCI-related arterial remodeling, and relevant myocardial function.

NCT ID: NCT02432664 Terminated - Healthy Clinical Trials

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ODM-108: in Healthy Male Volunteers

FIMTRIP
Start date: April 14, 2015
Phase: Phase 1
Study type: Interventional

The purpose of the study is to investigate to what extent this new study drug is tolerated in humans. The study is divided into 3 parts (Part III is optional and may go ahead depending on the results of Parts I and II). The volunteers will only be enrolled to one part of the study. In parts I and II the volunteer will receive active study drug or placebo. In part I the volunteers will receive a single dose of one of the eight planned escalating dose levels. In part II volunteers will receive 4 planned dose levels based on the results obtained in Part 1 of the study, with the option to include an additional dosing group. In optional part III the volunteer will receive ODM-108 and an already registered drug so that interactions with other drugs can be studied. It will be investigated how quickly and to what extent the study drug is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, in parts I and II the effect of the compound on the sensation of pain and on cognition (activities of thinking, understanding, learning, and remembering) will be investigated (this is called pharmacodynamics).

NCT ID: NCT02430532 Terminated - Clinical trials for Multiple Sclerosis, Secondary Progressive

BG00012 and Disability Progression in Secondary Progressive Multiple Sclerosis (SPMS)

INSPIRE
Start date: May 2015
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with SPMS; The secondary objective of the study is to assess the effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function.

NCT ID: NCT02421458 Terminated - Clinical trials for Head and Neck Neoplasms

Comparing Two Palliative Schemes of Radiotherapy for Head and Neck Cancer

COOPERATION
Start date: November 2015
Phase: N/A
Study type: Interventional

RCT to compare two radiation schemes for palliative HeadNeck cancer

NCT ID: NCT02414750 Terminated - Metastatic Melanoma Clinical Trials

Vemurafenib Plus Cobimetinib in Metastatic Melanoma

REPOSIT
Start date: December 2014
Phase: Phase 2
Study type: Interventional

This is a single arm explorative phase II clinical trial in 90 subjects with advanced stage melanoma harbouring a BRAFV600 mutation. PET imaging and molecular diagnostics are combined in order to monitor response to treatment with vemurafenib plus cobimetinib, examine development of resistance and correlate changes in metabolic/proliferative activity with extend of target inhibition.

NCT ID: NCT02413489 Terminated - Clinical trials for Lymphoma, Large B-Cell, Diffuse

An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma

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

The purpose of this study is to assess overall response rate [ORR, including complete response (CR) and partial response (PR)], of daratumumab in participants with non-Hodgkin's lymphoma [a cancer of the lymph nodes (or tissues)-NHL] and to evaluate association between ORR and CD38 expression level in order to determine a threshold for CD38 expression level in each NHL subtype, above which daratumumab activity is enhanced in participants with relapsed or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.

NCT ID: NCT02407795 Terminated - Spinal Metastases Clinical Trials

Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases

RACOST
Start date: May 2015
Phase: N/A
Study type: Interventional

A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal metastases.

NCT ID: NCT02406027 Terminated - Alzheimer Disease Clinical Trials

An Extension Study to Evaluate the Long-Term Safety and Tolerability of JNJ-54861911 in Participants in the Early Alzheimer's Disease Spectrum

Start date: July 2, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 in participants in the early Alzheimer's disease (AD [progressive brain disease that slowly destroys memory and thinking skills, and eventually even the ability to carry out the simplest tasks]) spectrum that have completed a Phase 1b or Phase 2 clinical trial with JNJ-54861911, who are willing to continue their assigned treatment.