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NCT ID: NCT02041533 Completed - Clinical trials for Stage IV or Recurrent Non-Small Cell Lung Cancer

An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)

Start date: March 27, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy

NCT ID: NCT02040441 Completed - Clinical trials for Diabetic Retinopathy

Proteomic Prediction and Renin Angiotensin Aldosterone System Inhibition Prevention Of Early Diabetic nephRopathy In TYpe 2 Diabetic Patients With Normoalbuminuria

PRIORITY
Start date: March 2014
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective, multicenter, randomized, double blind, placebo-controlled and a prospective observational study. This study will be conducted at 15 study centers in various European countries. 1777 participant between 18 to 75 years old with Type 2 diabetes mellitus and normoalbuminuria participate in the study. The study period is 2 - 4.5 years (excluding the 6 week screening period). Depending on the risk score of the urinary protein pattern, participants have been stratified into an observational group or an interventional group. Participants with the low risk pattern (observational group) attend visits annually after screening and baseline. Participants with the high risk pattern (interventional group) attend study visits every 13 weeks after screening and baseline. The interventional group has been allocated into one treatment group either receiving spironolactone or placebo. A placebo is a medicine without a pharmaceutical substance. The allocation to one of the two treatment groups has been done by a random distribution procedure established before the study start. The results of the urine sample from the Screening visit has been analysed and the urine proteomic pattern is determined to be either low- or high risk pattern and will determine the further study program. Participants with a low-risk pattern (observational group): During the study period, participants attend an annual project visit, were regular diabetes care is performed and three urine samples are analysed for albuminuria. Participants with a high-risk pattern (intervention group): Participants with a high-risk pattern have been randomized to either spironolactone treatment or placebo. The treatment is one tablet for oral use to be taken once a day for the entire study period. Four times each year (every 13th week) a study visit is conducted including examination of three urine samples for albuminuria. This study aims to: 1. Confirm in a prospective multicenter study of normoalbuminuric type 2 DM patients that the urinary proteome test identifies patients with a high risk for development of microalbuminuria. 2. Demonstrate the clinical utility of the test by showing that aldosterone blockade in high-risk patients can reduce progression to microalbuminuria in comparison to placebo, on the top of standard treatment in a randomized double-blind, placebo-controlled multicenter study.

NCT ID: NCT02040428 Completed - Clinical trials for Cardiovascular Disease

The Fibrin Pad CV Phase III Study

Start date: January 1, 2014
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of the EVARRESTâ„¢ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.

NCT ID: NCT02039726 Completed - AML Clinical Trials

(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive

Start date: May 2014
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.

NCT ID: NCT02039388 Completed - Ovarian Cancer Clinical Trials

Lavage of the Uterine Cavity for the Diagnosis of Serous Tubal Intraepithelial Carcinoma

LUSTIC
Start date: November 2013
Phase: N/A
Study type: Interventional

The current study aims at answering the scientific question, whether exfoliated cells from STICs get transported into the uterine cavity via the fallopian tube, and whether it is possible to detect those cells in the lavage fluid from the uterine cavity and proximal fallopian tubes. To address this question, the investigators will study 20 lavage samples and their 20 corresponding STIC-positive tissue samples in women who opt for risk-reducing bilateral salpingo-oophorectomy (rrBSO) because of increased risk of high grade serous carcinoma of the pelvis (HGSC) (mostly carrying a BRCA mutation), without a history of tubal occlusion for sterilization. Women who opt to have the fallopian tubes removed but the ovaries preserved are eligible for the study too, as are women who opt for rrBSO plus hysterectomy.

NCT ID: NCT02038946 Completed - Lymphoma Clinical Trials

Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)

Start date: March 26, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.

NCT ID: NCT02038933 Completed - Clinical trials for Lymphoma. Non-Hodgkin

Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139)

Start date: March 5, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT

NCT ID: NCT02038907 Completed - Healthy Volunteers Clinical Trials

Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine

NOR-107
Start date: March 28, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP), Aluminum Hydroxide and MPL adjuvant (3-O-desacyl-4'-monophosphoryl lipid A) for further development.

NCT ID: NCT02038647 Completed - Clinical trials for Small Cell Lung Cancer

Phase 2 Study of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC)

Start date: May 12, 2014
Phase: Phase 2
Study type: Interventional

This is a two-arm, randomized, double-blind, placebo-controlled, multicenter, phase 2 study designed to is to determine if the combination treatment can improve progression free survival (defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first) when compared with placebo + paclitaxel.

NCT ID: NCT02038036 Completed - Polycythemia Vera Clinical Trials

Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy.

RESPONSE-2
Start date: March 25, 2014
Phase: Phase 3
Study type: Interventional

This study compared the efficacy and safety of ruxolitinib to Best Available Therapy (BAT) in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and did not have a palpable spleen.