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NCT ID: NCT03551093 Recruiting - Ischemic Stroke Clinical Trials

THE IMPACT- 24M TRIAL (IMPlant Augmenting Cerebral Blood Flow in Mild Strokes Trial 24 Hours From Stroke Onset)

ImpACT- 24M
Start date: May 14, 2018
Phase: Phase 3
Study type: Interventional

Study Population: Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset. Study objectives: 1. Identify the personal stimulation level for each patient based on physiological biomarkers 2. Identify improvement in stroke symptoms during ISS treatment at the personal stimulation level

NCT ID: NCT03530254 Recruiting - Clinical trials for Infertility of Uterine Origin

Clinical Study PGT-A vs PGT-A+ERA

PGT-A&ERA
Start date: May 15, 2018
Phase: N/A
Study type: Interventional

Patients who have shown previous implantation failures, despite transferring good quality and chromosomally normal embryos (diagnosed by PGT-A), could have a displaced Window of Implantation (WOI) and consequently, alterations in their endometrial receptivity. The correction of this displacement can improve the results of the Assisted Reproduction Treatments (ART). The ERA test (Endometrial Receptivity Analysis) evaluates the transcriptomic endometrial profile to determine if the patient's uterus is receptive when the embryo is transferred during an In Vitro Fertilization (IVF) process, and identifies the personalized WOI of the patient. This process is called Personalized Embryo Transfer (pET). The Preimplantation Genetic Test of Aneuploidies or PGT-A (Preimplantation Genetic Testing for Aneuploidy), is currently carried out using Next Generation Sequencing (NGS) and serves to identify chromosomally normal embryos prior to their transfer in an IVF treatment. Aneuploidies are rarely compatible with life or can cause congenital diseases. So, the identification of chromosomally normal embryos, improves the success of reproduction in cases in which infertility is caused by such aneuploidies. Therefore, the aim of this study is to determine, in a randomized and prospective way, the clinical benefit of adding the ERA test to the embryonic aneuploidies test for patients with a PGT-A indication.

NCT ID: NCT03469349 Recruiting - Clinical trials for Peripheral Arterial Diseases

Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB

Start date: May 1, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of actovegin in participants with peripheral arterial disease (PAD) Fontaine Stage IIB.

NCT ID: NCT03466411 Recruiting - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

GALAXI
Start date: April 13, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this program is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

NCT ID: NCT03464097 Not yet recruiting - Crohn Disease Clinical Trials

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Start date: July 31, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, placebo-controlled study to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active Crohn's Disease.

NCT ID: NCT03447912 Not yet recruiting - Smoking Clinical Trials

Smoke-free Air Coalitions in Georgia and Armenia

Start date: June 2018
Phase: N/A
Study type: Interventional

This is a matched-pairs community randomized controlled trial (CRCT) to examine the impact of coalitions promoting smoke-free air policies on individual secondhand smoke exposure (SHSe). This proposal will build the capacity of Georgia (GE) and Armenia (AM) researchers to conduct high-quality mixed methods tobacco research and test the Community Coalition Action Theory (CCAT) as a framework for impacting local community-driven policy change to inform such processes for the region more broadly. Researchers from the GE National Center for Disease Control (NCDC) and AM National Institute of Health (NIH) will collaborate with Emory to execute the proposed research, train tobacco control researchers within their organizations and partnering universities, and train practitioners within local communities to build local coalitions for tobacco control policy. Twenty-eight communities (14 per country) will participate in the population-level tobacco survey at baseline and follow-up. Within each country, 7 communities will be randomized to the intervention condition and 7 to the control condition (14 communities per condition). In the intervention communities, public health center staff will form a coalition by recruiting partner organizations from civil society and other government sectors (e.g., health care, education), conduct situational assessment, and develop and implement action plans to promote the adoption and enforcement of smoke-free policies in worksites and restaurants, settings selected based on general support for smoke-free policies in these settings and the likelihood of impacting population-level SHSe through widespread reach. The GE NCDC and AM NIH will establish subcontracts with the local public health centers in the randomly selected communities to provide funding for local staff to develop local coalitions and to support program activities. The 14 communities assigned as controls will participate in the population-level survey and be provided with a site-specific summary of findings but will not participate in any aspects of the intervention. Additionally, to examine potential contamination in the control communities, a follow-up interview will be conducted with public health center leaders to assess any local coalition or grassroots actions regarding tobacco control that may have naturally occurred or be influenced by coalition activity in other communities.

NCT ID: NCT03409614 Recruiting - Clinical trials for Non-small Cell Lung Cancer

REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

Start date: March 6, 2018
Phase: Phase 3
Study type: Interventional

The primary objective is to compare the progression-free survival (PFS) of REGN2810 plus platinum-based doublet chemotherapy combination therapy (REGN2810/chemo) and REGN2810 plus platinum-based doublet chemotherapy plus ipilimumab combination therapy (REGN2810/chemo/ipi) with standard-of-care platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) in the subgroup of patients whose tumors express programmed cell death ligand 1 (PD-L1) in 1% to <50% of tumor cells and in the overall population of study patients whose tumors express PD-L1 in <50% of tumor cells. The key secondary objectives are to compare the OS of REGN2810/chemo and REGN2810/chemo/ipi versus standard-of-care platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC in the subgroup of patients whose tumors express PD-L1 in 1% to <50% of tumor cells and in the overall population of study patients whose tumors express PD-L1 in <50% of tumor cells, to compare the ORR of REGN2810/chemo and REGN2810/chemo/ipi versus standard-of-care platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC in the subgroup of patients whose tumors express PD-L1 in 1% to <50% of tumor cells and in the overall population of study patients whose tumors express PD-L1 in <50% of tumor cells, and to evaluate the safety and tolerability of REGN2810/chemo and REGN2810/chemo/ipi compared to standard-of-care platinum-based doublet chemotherapy

NCT ID: NCT03407651 Recruiting - Clinical trials for Hemophilia A With Inhibitor

Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B

Start date: December 18, 2017
Phase: Phase 2
Study type: Interventional

Phase 2, multi-center, open-label study designed to evaluate the PK, bioavailability, PD, efficacy and safety of a daily subcutaneous [SC] treatment regimen with MarzAA for bleeding prophylaxis in 12 adult subjects with hemophilia A or B with an inhibitor and history of frequent spontaneous bleeding episodes.

NCT ID: NCT03403712 Recruiting - Clinical trials for Chemotherapy-induced Nausea and Vomiting

A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer

Start date: March 16, 2018
Phase: Phase 3
Study type: Interventional

Multicenter, randomized, double-blind, double-dummy, parallel group, stratified study assessing the safety and describing the efficacy of a single dose of intraveneous (IV) fosnetupitant/palonosetron (260 mg/0.25 mg) infusion [test] versus oral netupitant/palonosetron (300 mg/0.5 mg) combination [control]; each administered with oral dexamethasone prior to initial and repeated cycles of AC chemotherapy in female breast cancer patients.

NCT ID: NCT03396419 Recruiting - Ischemic Stroke Clinical Trials

IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)

Start date: September 25, 2017
Phase: N/A
Study type: Observational

The purpose of the ImpACT-24col sub-study is to explore effect of SPG stimulation on the augmentation of collateral blood flow and to relate it to the subject's cerebral blood flow status, the extent of the collateral vessel potency prior to the stimulation and the relation of the vessel occlusion site to the vasodilatory effect by using digital subtraction angiography (DSA), the gold standard imaging technique to demonstrate collateral blood flow dynamics. The results of this study will further promote the knowledge towards optimization of SPG stimulation to treat acute ischemic stroke patients.