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NCT ID: NCT03466411 Not yet 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 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: 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: 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: 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.

NCT ID: NCT03390842 Recruiting - Metabolic Acidosis Clinical Trials

Long-term Safety Extension to Study TRCA-301

Start date: December 20, 2017
Phase: Phase 3
Study type: Interventional

This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.

NCT ID: NCT03371251 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care

Start date: February 7, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams [mg], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on limited background standard of care treatment, in order to estimate the optimal dose. BOS161721 at the chosen dose will be compared to placebo for response on the SLE Responder Index 4, with sustained reduction of oral corticosteroids, in the same participant population.

NCT ID: NCT03317444 Active, not recruiting - Metabolic Acidosis Clinical Trials

Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease

Start date: September 26, 2017
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily. The maximum study duration is anticipated to be up to 16 weeks.

NCT ID: NCT03315143 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

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

Primary Objectives: To demonstrate that, when compared to placebo in patients with type 2 diabetes (T2D), cardiovascular (CV) risk factors, and moderately impaired renal function, sotagliflozin: - Does not increase the risk of cardiovascular events including death from cardiovascular disease, non-fatal heart attack and non-fatal stroke; - Reduces the risk of death from CV disease or hospitalization for heart failure. Secondary Objectives: - To demonstrate that, when compared to placebo in patients with T2D, CV risk factors, and moderately impaired renal function, sotagliflozin: - Reduces cardiovascular events including death from cardiovascular disease, non-fatal heart attack and non-fatal stroke; - Reduces risk of progression of kidney disease; - Reduces cardiovascular events including death from cardiovascular disease and emergency treatment for heart failure; - Reduces death from cardiovascular disease; - Reduces death from any cause. - To assess the safety and tolerability of sotagliflozin.

NCT ID: NCT03303313 Recruiting - Clinical trials for Atypical Hemolytic Uremic Syndrome

A Study of an Investigational Drug, Cemdisiran (ALN-CC5), in Patients With Atypical Hemolytic Uremic Syndrome

Start date: September 19, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Cemdisiran in patients with aHUS.

NCT ID: NCT03296163 Recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

STELLA
Start date: February 6, 2018
Phase: Phase 3
Study type: Interventional

This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group, equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel) in subjects with Stage IIIB/IV non-squamous NSCLC