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NCT ID: NCT03222973 Terminated - Multiple Sclerosis Clinical Trials

Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)

AFFINITY
Start date: November 15, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of Part 1 of this study is to evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks. The primary objective of Part 2 of this study is to evaluate the long-term safety profile of BIIB033 as an add-on therapy in participants with MS. The secondary objective of Part 1 is to evaluate the effects of BIIB033 versus placebo on additional measures of disability improvement. The secondary objective of Part 2 is to investigate long-term efficacy (disability improvement) and additional safety measures of BIIB033 as an add-on therapy in participants with MS.

NCT ID: NCT03221842 Terminated - Clinical trials for Antibody-mediated Rejection

Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients

Start date: November 6, 2017
Phase: Phase 3
Study type: Interventional

This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).

NCT ID: NCT03219164 Terminated - Cystic Fibrosis Clinical Trials

Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria

ALPINE 2
Start date: November 28, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa respiratory tract infection or colonization.

NCT ID: NCT03214809 Terminated - Dyspnea Clinical Trials

The Use of a Point-of-care Thoracic Ultrasound Protocol for Hospital Medical Emergency Teams

METUS
Start date: January 18, 2019
Phase: N/A
Study type: Interventional

Study to assess the possible effects of the use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams (MET)

NCT ID: NCT03212352 Terminated - Clinical trials for Early Pregnancy Failure

Comparing Two Medical Treatments for Early Pregnancy Failure.

Triple M
Start date: June 27, 2018
Phase: Phase 4
Study type: Interventional

This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol) are superior compared to using only one of these drugs (Misoprostol) as medical treatment for a miscarriage. Women in whom early pregnancy failure, 6-14 weeks postmenstrual, is ultrasonographically confirmed qualify for this study. It is expected that the combination of Mifepristone and Misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.

NCT ID: NCT03211494 Terminated - ARDS Clinical Trials

Does Automated Closed-Loop Ventilation Reduce the DRiving Pressure Levels in Patients With ARDS

AiRDRoP
Start date: November 3, 2017
Phase: N/A
Study type: Interventional

The objective of this crossover study and randomized controlled trial (RCT) is to compare ΔP levels during INTELLiVENT®-ASV with conventional lung protective ventilation in the acute and sub-acute phase of moderate or severe ARDS. A total of 48 adult patients admitted to intensive care units with moderate or severe ARDS will be included. In the acute phase patients will receive 4 hours of INTELLiVENT-ASV ventilation and 4 hours of conventional lung protective ventilation in random order. After these two blocks the patients are allocated into either the INTELLiVENT-ASV arm or the conventional lung protective ventilation arm. in the sub-acute phase patients will be assessed every day until day 7 or extubation, whichever comes first. Primary endpoint is the transpulmonary transpulmonary (ΔP). Secondary endpoints of both studies include other ventilator settings and ventilation parameters, as well as time spent at a ΔP level of 15 cm H2O or higher.

NCT ID: NCT03207867 Terminated - Pancreatic Cancer Clinical Trials

A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma

Start date: August 28, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.

NCT ID: NCT03192345 Terminated - Clinical trials for Malignant Solid Tumor

A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors

Start date: June 9, 2017
Phase: Phase 1
Study type: Interventional

Primary Objectives: Dose escalation (Part 1) Part 1A (SAR439459 monotherapy) - To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors. Part 1B (SAR439459 and cemiplimab combination therapy) - To determine the MTD and/or MAD of SAR439459 administered intravenously in combination with cemiplimab administered intravenously in adult patients with advanced solid tumors. Dose expansion (Part 2) Part 2A (SAR439459 monotherapy) - To determine optimal dose of SAR439459 administered intravenously in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell death-1) or anti-PD-L1. Part 2B (SAR439459 and cemiplimab combination therapy) - To determine the objective response rate (ORR) of SAR439459 in combination with cemiplimab in adult patients with selected advanced solid tumors by evaluation of antitumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). Secondary Objectives: - Pharmacokinetic (PK) profile SAR439459 monotherapy and combined with cemiplimab, PK profile of cemiplimab combined with SAR439459. - Immunogenicity of SAR439459 monotherapy and combined with cemiplimab. Dose escalation (Part 1) - Overall safety/tolerability profile of SAR439459 monotherapy and combined with cemiplimab. - Preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy or combined with cemiplimab. Dose expansion (Part 2) - Progression free survival (PFS), time to progression (TTP), ORR, and safety of SAR439459 as monotherapy and PFS, TTP, duration of response (DOR), disease control rate (DCR) and safety in combination with cemiplimab. - To confirm the optimal dose of SAR439459 administered in combination with cemiplimab.

NCT ID: NCT03190473 Terminated - Clinical trials for Acute Coronary Syndrome

OPTIMIZE IDE for the Treatment of ACS

OPTIMIZE
Start date: January 2, 2018
Phase: N/A
Study type: Interventional

Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm

NCT ID: NCT03187522 Terminated - Clinical trials for Aortic Aneurysm, Abdominal

An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft

Start date: June 22, 2017
Phase: N/A
Study type: Interventional

This is an EU sponsored trial and independent of the US trial registered under Clinicaltrials.gov ID NCT02009644. The purpose of this registry is to gather clinical data on the safety and performance of the TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms. The registry is part of TREO's EU post-market surveillance plan providing long-term systematic clinical follow-up.