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NCT ID: NCT03042260 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous

Start date: March 1, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether trimethoprim/sulfamethoxazole is effective in preventing serious infectious complications (those that require hospitalization or lead to death) in patients with lupus erythematosus that receive intermediate or high dose steroids.

NCT ID: NCT03036280 Active, not recruiting - Alzheimer's Disease Clinical Trials

A 24-Month Study to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease_

MissionAD2
Start date: December 29, 2016
Phase: Phase 3
Study type: Interventional

The name of this trial is MissionAD2. This phase 3 study consists of a Core and Open Label Extension (OLE) Phase in participants with Early Alzheimer's Disease (EAD), and will be conducted to evaluate the efficacy and safety of E2609. The Core is a 24-month treatment, multicenter, double blind, placebo controlled parallel group study. The OLE is a 24-month treatment, one group study. The data for end points for the studies E2609-G000-301 (NCT02956486) and E2609-G000-302 (NCT03036280) will be pooled for a combined total of 1900 participants.

NCT ID: NCT03036150 Completed - Clinical trials for Chronic Kidney Disease

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease

Dapa-CKD
Start date: February 2, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.

NCT ID: NCT03036098 Active, not recruiting - Urothelial Cancer Clinical Trials

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

CheckMate901
Start date: March 24, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

NCT ID: NCT03034915 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: June 16, 2017
Phase: Phase 4
Study type: Interventional

COPD is characterized by an airflow limitation, which is not fully reversible, usually progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a major cause of disability and anxiety associated with the disease. In addition, COPD is associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used to improve lung function, reduce symptoms, reduce the frequency and severity of exacerbations, and also to improve health status and exercise tolerance. This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study to compare umeclidinium/vilanterol (62.5/25 microgram [mcg], once daily), umeclidinium (62.5 mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD. The primary purpose of this study is to demonstrate improvements in lung function for subjects treated with UMEC/VI compared with UMEC for 24 weeks. Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio. Subjects will be stratified based on long-acting bronchodilator usage during the run-in period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either UMEC/VI inhalation powder (62.5/25 microgram [mcg] once daily) administered via the ELLIPTA® dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol (50 mcg twice daily [BID]) administered via the DISKUS DPI and placebo once daily via ELLIPTA DPI. The duration of the study will be 29 to 31 weeks including a pre-screening period of 2 weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up period of 1 week. ELLIPTA and DISKUS are trademarks of GSK group of companies.

NCT ID: NCT03033511 Terminated - Clinical trials for Small Cell Lung Cancer

A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)

MERU
Start date: February 7, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

NCT ID: NCT03031717 Recruiting - Clinical trials for Portal Vein Thrombosis

Clinical Course of Cirrhotic Patients With Portal Vein Thrombosis Treated With TIPS

Start date: January 1, 2017
Phase:
Study type: Observational

Portal vein thrombosis (PVT) is defined as an obstruction of the portal vein. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. PVT leads to increased intrahepatic resistance, decreased portal velocities, splanchnic vasodilatation, and stagnant flow. Portal vein recanalization (PVR) with transjugular intrahepatic portosystemic shunt (TIPS) is aimed at restoring main portal vein (PV) flow in chronic PVT. In this study, we will review the safety and outcomes of this approach.

NCT ID: NCT03029390 Active, not recruiting - Prediabetes Clinical Trials

Effect of Berberine Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes

Start date: March 2016
Phase: Phase 4
Study type: Interventional

Pre diabetes (PD) is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), Imparied glucose tolerance (IGT) or both, involving a higher risk to develop type 2 diabetes mellitus (T2DM) in 10 years. The efficacy of pharmacotherapy in the prevention of diabetes in adults with prediabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, the traditional Chinese and Ayurverica medicine offer potential active substances for the treatment of hyperglucemia like berberine. Berberine is an extract with hypoglycemic effects in animal models as well as in clinical trials in type 2 diabetes mellitus even compared to metformin, for this reason comparing it's activity against metformin in prediabetes would provide impact information on a new alternative treatment and compare with the standard pharmacological treatment. The aim of the study evaluate the effect of administration of berberine versus metaformine on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes. The investigators hypothesis is that the administration of berberine versus metformin modifies glycemic control, insulin sensitivity and insulin secretion in patients with prediabetes.

NCT ID: NCT03029208 Completed - Anaemia Clinical Trials

Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)

Start date: May 11, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.

NCT ID: NCT03028740 Terminated - Clinical trials for Nonalcoholic Steatohepatitis

AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)

AURORA
Start date: April 5, 2017
Phase: Phase 3
Study type: Interventional

The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.