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NCT ID: NCT02500550 Completed - Clinical trials for Acute Myeloid Leukemia

Safety and Efficacy of Two Doses of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor

Start date: October 9, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether a repeat dose administration of ATIR101 is safe and effective when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor. All patients are planned to receive two ATIR101 doses of 2×10E6 viable T-cells/kg, unless the second dose is reduced or halted for safety reasons.

NCT ID: NCT02500043 Completed - Clinical trials for Refractory Metastatic Gastric Cancer

Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer

Start date: February 24, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.

NCT ID: NCT02497469 Completed - Colitis, Ulcerative Clinical Trials

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

Start date: June 29, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

NCT ID: NCT02496767 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year

VITALITY-ALS
Start date: September 3, 2015
Phase: Phase 3
Study type: Interventional

This study assessed the effect of tirasemtiv versus placebo on respiratory function in patients with ALS.

NCT ID: NCT02495974 Completed - Clinical trials for Metastatic Castration Resistant Prostate Cancer

European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

PREMISE
Start date: September 8, 2015
Phase:
Study type: Observational

The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as measured by time to treatment failure defined as the time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.

NCT ID: NCT02495181 Completed - Clinical trials for Polypoidal Choroidal Vasculopathy

Randomized, Double-masked, Sham-controlled Phase 4 Study, Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With Polypoidal Choroidal Vasculopathy

ATLANTIC
Start date: November 23, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept plus standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV).

NCT ID: NCT02492711 Completed - Clinical trials for HER-2 Positive Breast Cancer

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

SOPHIA
Start date: August 24, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy. A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.

NCT ID: NCT02492217 Completed - Clinical trials for Ankylosing Spondylitis

Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) α Agent's Efficacy in Ankylosing Spondylitis Patients

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

To identify new candidate genes and proteins that are differentially expressed in responders' vs non-responders to anti-TNF alpha therapy at the several time points the investigators will use the transcriptomic and proteomic analyses. Demonstrate a link between gene expression and protein markers regarding prediction to anti-TNF alpha therapy efficacy.

NCT ID: NCT02490826 Completed - Speech Disorders Clinical Trials

Table to Tablet (T2T): A Novel Intervention Framework for Children With Speech Sound Disorders

Start date: October 2014
Phase: N/A
Study type: Interventional

The primary aim of this study is to develop software as a tool in speech and language therapy for the treatment of children (Portuguese and English) with phonologically based Speech Sound Disorders (SSD). Further, this project aims to test the effectiveness of this approach with two groups of preschool and school aged children with phonologically based SSD, with one group consisting of European Portuguese (EP) speakers and one group of British English (BE) speakers. Performance across the two groups will be compared. The total duration of the project will be 30 month.

NCT ID: NCT02488044 Completed - Hyperargininemia Clinical Trials

A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency

Start date: June 2016
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2 Open-label Study in Patients with Arginase I Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous AEB1102. This study is designed to evaluate the safety and tolerability of IV administration of AEB1102 for the treatment of pediatric and adult patients with Arginase I deficiency and hyperargininemia. This study will be conducted in 2 parts: Part 1 (Single Ascending Dose Escalation) and Part 2 (Repeated Dosing). Each part will be preceded by a baseline assessment of arginine levels. All patients who participate in Part 1 may continue AEB1102 dosing in Part 2 if they qualify for continued dosing. A data safety monitoring board (DSMB) will provide independent review of study safety data and recommend whether the sponsor should continue the study as planned, modify the study protocol, or discontinue the study.