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NCT ID: NCT02941926 Completed - Breast Cancer Clinical Trials

Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

COMPLEEMENT-1
Start date: November 30, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..

NCT ID: NCT02937818 Completed - Clinical trials for Platinum Refractory Extensive-Stage Small Cell Lung Carcinoma

A Phase II, Study to Determine the Preliminary Efficacy of Novel Combinations of Treatment in Patients With Platinum Refractory Extensive-Stage Small-Cell Lung Cancer

Start date: November 28, 2016
Phase: Phase 2
Study type: Interventional

Study design This is a Phase II, open-label, multi-drug, multi-center, multi-arm, signal-searching study in patients with extensive-stage small-cell lung cancer (SCLC) who have refractory or resistant disease from prior platinum-based chemotherapy.

NCT ID: NCT02937701 Completed - Clinical trials for Arthritis, Rheumatoid

Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab

Start date: October 10, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of the study was to compare rheumatoid arthritis symptom improvement in participants who were given ABP 710 to those who were given infliximab, 22 weeks after starting treatment.

NCT ID: NCT02931409 Completed - Clinical trials for Inflammatory Response

Intraoperative PEEP Optimization: Effects on Postoperative Pulmonary Complications and Inflammatory Response

Start date: October 2016
Phase: N/A
Study type: Interventional

The purpose of this prospective randomized controlled trial is to determine the effects of intraoperative lung protective mechanical ventilation using an individual optimal PEEP value on postoperative pulmonary complications and inflammatory response. A total number of 40 patients undergoing open radical cystectomy and urinary diversion will be enrolled and randomized into two groups. Standard lung protective ventilation using a PEEP of 6 cmH2O will be performed in control group and an optimal PEEP value determined during a static pulmonary compliance (Cstat) directed PEEP titration procedure will be applyed in study group. Low tidal volumes (6mL/Kg IBW) and a fraction of inspired oxygen (FiO2) of 0.5 will be applyed in both groups. Procalcitonin kinetics will be monitored during and after surgery until the third postoperative day as well as postoperative pulmonary complications. Clinical condition and extrapulmonary complications will be evaluated by the Sequential Organ Failure Assessment (SOFA) Score and in-hospital stay, 28-days and in-hospital mortality will also be followed.

NCT ID: NCT02929329 Completed - Heart Failure Clinical Trials

Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction

GALACTIC-HF
Start date: January 6, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).

NCT ID: NCT02928406 Completed - Clinical trials for Urinary Tract Cancer

A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

Start date: November 30, 2016
Phase: Phase 3
Study type: Interventional

This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab.

NCT ID: NCT02928224 Completed - Clinical trials for BRAF V600E-mutant Metastatic Colorectal Cancer

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

BEACON CRC
Start date: October 13, 2016
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.

NCT ID: NCT02927262 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission

Start date: January 10, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who were randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a two-year period.

NCT ID: NCT02927067 Completed - Clinical trials for Cytomegalovirus (CMV)

A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants

Start date: April 14, 2017
Phase: Phase 3
Study type: Interventional

This study is about treatment options for cytomegalovirus infections in people who have received stem cell transplants. The main aim of the study is to check if the cytomegalovirus infection can no longer be detected after treatment with marivabir or valganciclovir. Participants will take 2 tablets of marivabir or valganciclovir and 2 tablets of placebo twice a day for 8 weeks. A placebo will look like marivabir or valganciclovir but will not have any medicine in it. After treatment, each participant will be followed up for up to 12 weeks. Participants will visit their study clinic up to 18 times during the study.

NCT ID: NCT02926950 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin

Start date: November 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the superiority of Sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: - To compare Sotagliflozin versus placebo for. - Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal. - Change from baseline in fasting plasma glucose (FPG). - Change from Baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter of mercury (mmHg). - Change from baseline in SBP for all participants. - Change from baseline in body weight. - Proportion of participants with HbA1c <6.5% and <7.0%. - To evaluate the safety of Sotagliflozin versus placebo.