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NCT ID: NCT02602613 Completed - Clinical trials for Mitral Regurgitation

AMENDTM Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method

Start date: December 2015
Phase: N/A
Study type: Interventional

A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and its ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted in a minimally invasive trans-catheter method.

NCT ID: NCT02601950 Completed - Synovial Sarcoma Clinical Trials

A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma

Start date: December 22, 2015
Phase: Phase 2
Study type: Interventional

This study will include participants with various types of cancer known as soft-tissue sarcomas. Tissues that can be affected by soft tissue sarcomas include fat, muscle, blood vessels, deep skin tissues, tendons and ligaments. Soft tissue cancers are rare and can occur almost anywhere in the body. Part 1 of this trial will study the safety and the level that adverse effects of the study drug tazemetostat in combination with doxorubicin (current front line treatment) can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study. Part 2 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug plus doxorubicin versus doxorubicin plus placebo (dummy treatment).

NCT ID: NCT02601937 Completed - Synovial Sarcoma Clinical Trials

A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

Start date: January 7, 2016
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, dose escalation and dose expansion study with BID (suspension) and TID (tablet) oral dose of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned first dose of tazemetostat. A treatment cycle will be 28 days. Response assessment will be evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study. The study has two parts: Dose Escalation and Dose Expansion. Dose escalation for subjects with the following relapsed/refractory malignancies: - Rhabdoid tumors: - Atypical teratoid rhabdoid tumor (ATRT) - Malignant rhabdoid tumor (MRT) - Rhabdoid tumor of kidney (RTK) - Selected tumors with rhabdoid features - INI1-negative tumors: - Epithelioid sarcoma - Epithelioid malignant peripheral nerve sheath tumor - Extraskeletal myxoid chondrosarcoma - Myoepithelial carcinoma - Renal medullary carcinoma - Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) (with Sponsor approval) - Synovial Sarcoma with a SS18-SSX rearrangement Dose Escalation cohorts are closed to enrollment. Dose Expansion at the MTD or the RP2D - Cohort 1 - ATRT (closed to enrollment) - Cohort 2 - MRT/RTK/selected tumors with rhabdoid features (closed to enrollment) - Cohort 3 - INI-negative tumors: - Epithelioid sarcoma - Epithelioid malignant peripheral nerve sheath tumor - Extraskeletal myxoid chondrosarcoma - Myoepithelial carcinoma - Renal medullary carcinoma - Chordoma (poorly differentiated or de-differentiated) - Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) with Sponsor approval - Cohort 4 - Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement (closed to enrollment)

NCT ID: NCT02601898 Completed - Miscarriage Clinical Trials

Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

Start date: January 2015
Phase: Phase 4
Study type: Interventional

The aim of this study was to compare the therapeutic efficacy of lipoic acid versus progesterone by vaginal administration on subchorionic hematoma resorption in women at the first trimester of pregnancy with threatened miscarriage.

NCT ID: NCT02600364 Completed - Clinical trials for Intracranial Aneurysm

Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device

Start date: December 2015
Phase:
Study type: Observational

The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.

NCT ID: NCT02600013 Completed - Clinical trials for Spinal Cord Injuries

Locomotor Training With Exoskeleton EKSO-GT in Patients With Incomplete Motor Spinal Cord Injury in a Hospital Setting

Start date: December 2015
Phase:
Study type: Observational

The aim of this observational, non-controlled, non-profit study is to describe the responses to rehabilitative training with the robotic exoskeleton EKSO-GT in patients with incomplete motor Spinal Cord Injury (AIS C or D). Such rehabilitative tool is employed during inpatient intensive rehabilitation in a 3rd level Italian hospital. Safety and tolerability of the device are also assessed and described.

NCT ID: NCT02599402 Completed - Melanoma Clinical Trials

Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma

CheckMate 401
Start date: December 20, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.

NCT ID: NCT02598960 Completed - Solid Tumors Clinical Trials

An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.

Start date: October 14, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.

NCT ID: NCT02598557 Completed - Clinical trials for Stage IIB Breast Cancer AJCC v6 and v7

Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer

Start date: December 6, 2016
Phase: Phase 2
Study type: Interventional

This phase IIb trial studies how well alternative dosing of exemestane before surgery works in treating in postmenopausal patients with stage 0-II estrogen positive breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing the exemestane standard dose regimen versus two alternative, less frequent dose regimens may decrease undesirable symptoms and have similar efficacy in reducing serum estradiol.

NCT ID: NCT02598505 Completed - Heart Failure Clinical Trials

Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation

Start date: September 2015
Phase: Phase 3
Study type: Interventional

The purposes of this study are: 1. To confirm safety of Indacaterol in stable Heart Failure. 2. To determine whether beta 2 alveolar receptor stimulation by Indacaterol is able to ameliorate lung diffusion in heart Failure patients treated with beta blockers. 3. To compare the effects of Indacaterol in patients treated with a non-selective beta blocker (Carvedilol) and a beta 1-selective beta blocker (Bisoprolol).