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NCT ID: NCT02807636 Completed - Clinical trials for Urothelial Carcinoma

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

IMvigor130
Start date: June 30, 2016
Phase: Phase 3
Study type: Interventional

A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.

NCT ID: NCT02807077 Completed - Myelofibrosis Clinical Trials

PK of Pacritinib in Patients With Mild, Moderate, Severe Renal Impairment and ESRD Compared to Healthy Subjects

Start date: November 2014
Phase: Phase 1
Study type: Interventional

This is a Phase 1 open label, single dose, 5 parallel-group study in which a single 400 mg dose of pacritinib will be administered orally to patients with renal impairment (mild, moderate, severe, and patients with ESRD requiring hemodialysis) and sex-, age- and weight-matched healthy subjects.Patients with ESRD will receive a single 400 mg dose of pacritinib during 2 different treatment periods: Dialysis and Inter-Dialysis. The primary objective of the study is to evaluate the pharmacokinetics and safety of pacritinib in renal impairment.

NCT ID: NCT02804763 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus

Start date: June 2, 2016
Phase: Phase 2
Study type: Interventional

The purpose is to evaluate the efficacy and safety of three different doses of Dapirolizumab Pegol (DZP) versus placebo in adult subjects with moderately to severely active systemic Lupus Erythematosus.

NCT ID: NCT02798471 Completed - Pulmonary Embolism Clinical Trials

Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)

Start date: March 27, 2017
Phase: Phase 3
Study type: Interventional

This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.

NCT ID: NCT02794285 Completed - Clinical trials for Active Systemic Lupus Erythematosus

Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

TULIP SLE LTE
Start date: June 30, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.

NCT ID: NCT02787551 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

LixiLan-G
Start date: July 6, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change. Secondary Objectives: To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 [SGLT2] inhibitor) in participants with type 2 diabetes. To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.

NCT ID: NCT02786329 Recruiting - Colorectal Cancer Clinical Trials

Anesthesia and Postoperative Outcome in Colorectal Cancer Patients

Start date: June 2016
Phase: Early Phase 1
Study type: Interventional

Study aims to compare the influence of TIVA and sevoflurane anesthesia with or without lidocaine on postoperative short and long term outcome in patients with colorectal cancer undergoing surgery. As short term endpoints postoperative pain and opioid consumption, resumption of bowel function, PONV, LOS will be registered. Long term outcome parameters include: the incidence of chronic pain, 1 and 5 years cancer recurrences incidence and mortality.

NCT ID: NCT02784704 Completed - Clinical trials for Complicated Appendicitis

Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections

IGNITE4
Start date: October 13, 2016
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics (PK) of eravacycline compared with meropenem in the treatment of complicated intra-abdominal infections (cIAIs).

NCT ID: NCT02783118 Completed - Mild Depression Clinical Trials

Using a Smartphone App to Reduce Cognitive Vulnerability and Mild Depressive Symptoms

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

Depression is one of the major challenges worldwide, with significant increasing personal, economic, and societal costs. Although empirically supported treatments have been developed, they are not always available for patients in routine clinical care. Even when patients are adequately treated, they do not always respond to treatment and/or face a significant risk for recurrence. Therefore, effective and wide accessible strategies to prevent the onset of the very first depressive symptoms are necessary. Mental health apps could prove a valuable alternative for that. Although preliminary research has indicated that apps could be useful in treating depression, no study has attempted to test their utility in preventing depression symptoms. The current study aims to contrast the efficacy of a smartphone app in preventing depression compared against a waiting list condition. The app includes self-help materials and exercises based on cognitive behavioral therapy (CBT) for depression, presented in a tailored manner and incorporating gamification elements aimed at boosting the motivation to use the app. This study protocol is the first that capitalizes on the ubiquity of smartphones to large-scale dissemination of CBT-based strategies aimed at preventing depression in nonclinical populations. The objective of this study is to test an app designed to decrease general cognitive vulnerability and promote engagement in protective, adaptive activities, while counteracting the tendency of premature dropout (through gamification and customization).

NCT ID: NCT02783001 No longer available - HIV Infections Clinical Trials

Expanded Access Program for Maraviroc At Multiple Centers

Start date: n/a
Phase: Phase 3
Study type: Expanded Access

To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.