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NCT ID: NCT01671007 Completed - Stroke Clinical Trials

GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)

Start date: August 22, 2012
Phase:
Study type: Observational

In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.

NCT ID: NCT01669265 Completed - Breast Cancer Clinical Trials

Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer

SOLO-1
Start date: June 2012
Phase: N/A
Study type: Observational

This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection. The aim of the present study is to assess the intraoperative positive SLN total tumor load (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN metastasis in patients with clinically node-negative early-stage breast cancer.

NCT ID: NCT01669252 Completed - Breast Cancer Clinical Trials

Pharmacogenomic Study of Neoadjuvant Eribulin for HER2 Non-overexpressing Breast Cancer

NeoEribulin
Start date: August 2012
Phase: Phase 2
Study type: Interventional

This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory pharmacogenomic study of single agent eribulin as neoadjuvant therapy in patients with operable Stage III HER2 non-overexpressing breast cancer.

NCT ID: NCT01669239 Completed - Breast Cancer Clinical Trials

Study of Neoadjuvant Myocet®, Paclitaxel, Pertuzumab, and Trastuzumab in HER2-positive Breast Cancer

Opti-HER
Start date: June 2013
Phase: Phase 2
Study type: Interventional

This is a prospective, multicenter, single-arm, phase II study to evaluate the safety of neoadjuvant liposomal doxorubicin plus paclitaxel, trastuzumab, and pertuzumab in patients with HER2-positive breast cancer

NCT ID: NCT01668784 Completed - Clinical trials for Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

Start date: October 9, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy

NCT ID: NCT01667419 Completed - Melanoma Clinical Trials

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

BRIM8
Start date: September 24, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than [>] 1 millimeter [mm] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.

NCT ID: NCT01666977 Completed - Clinical trials for Non Small Cell Lung Cancer

Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer

Start date: August 2012
Phase: Phase 2
Study type: Interventional

The purpose of phase 2 of this this study is to estimate the treatment effect of study drug measuring progression free survival.

NCT ID: NCT01666106 Completed - Clinical trials for Osteonecrosis of the Jaw

Osteonecrosis of the Jaw (ONJ) Case Registry

Start date: October 1, 2012
Phase:
Study type: Observational

Osteonecrosis of the Jaw (ONJ) Case Registry

NCT ID: NCT01665391 Completed - Clinical trials for Primary Focal Segmental Glomerulosclerosis

A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)

FSGS
Start date: August 2012
Phase: Phase 2
Study type: Interventional

The primary objectives of this trial are as follows: - to compare the achievement of a partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab versus placebo - to compare the safety profile of patients treated with fresolimumab versus placebo The secondary objectives are as follows: - To compare the reduction in proteinuria in patients treated with fresolimumab versus placebo - To evaluate fresolimumab dose-dependent reduction in proteinuria - To compare the change in renal function (estimated glomerular filtration rate [eGFR]) in patients treated with fresolimumab versus placebo - To evaluate the multiple-dose pharmacokinetics of fresolimumab

NCT ID: NCT01665144 Completed - Clinical trials for Secondary Progressive Multiple Sclerosis

Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

Start date: December 20, 2012
Phase: Phase 3
Study type: Interventional

Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).