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NCT ID: NCT01813422 Completed - Clinical trials for Hypercholesterolemia

GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound

GLAGOV
Start date: April 18, 2013
Phase: Phase 3
Study type: Interventional

This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.

NCT ID: NCT01811576 Completed - Clinical trials for Growth Hormone Deficiency

Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency

Start date: March 31, 2013
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the clinical effect of TV-1106.

NCT ID: NCT01810939 Completed - Clinical trials for Chronic Kidney Disease (CKD)

A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)

OPAL
Start date: February 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.

NCT ID: NCT01809665 Completed - Clinical trials for Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs

ProMRI PROVEN Master Study

Start date: June 2013
Phase: N/A
Study type: Observational

This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.

NCT ID: NCT01809327 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

Start date: June 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise. The safety and tolerability of canagliflozin will also be assessed.

NCT ID: NCT01809314 Completed - Anemia Clinical Trials

An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients Receiving Chemotherapy

Start date: April 2008
Phase: N/A
Study type: Observational

This observational study will evaluate the efficacy and safety of NeoRecormon (epoetin beta) in cancer patients receiving chemotherapy. Patients receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics will be followed for 4 months.

NCT ID: NCT01808092 Completed - Clinical trials for Ventilator-associated Pneumonia (VAP)

A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia

Start date: April 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia

NCT ID: NCT01807221 Completed - Heart Failure Clinical Trials

Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

ARTS-HF
Start date: June 17, 2013
Phase: Phase 2
Study type: Interventional

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

NCT ID: NCT01806597 Completed - Clinical trials for Moderate to Severe Palmoplantar Psoriasis

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis

GESTURE
Start date: June 19, 2013
Phase: Phase 3
Study type: Interventional

Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab.

NCT ID: NCT01804309 Completed - Breast Cancer Clinical Trials

Functional Anatomical Examination of Axillary Sentinel Lymph Node Drainage in the Axillary Subregions in Early Breast Cancer

Start date: March 2013
Phase: N/A
Study type: Observational

Regional lymph node status is the most important prognostic factor for disease-free and overall survival in breast cancer. Accurate nodal staging can be achieved only by surgery. Today, in early-stage invasive breast cancers with clinically negative lymph nodes, minimally invasive sentinel lymph node biopsy (SLNB) is considered the gold standard of regional lymph node staging. To optimize the effectiveness of SLNB, precise pre-and intraoperative mapping of lymphatic drainage is important. The (SLNB) technique is not standardized. The most common and most accurate way of lymphatic mapping is performed with the combined application of a gamma-emitting isotope labeled substance and blue dye, the so-called double labeling technique. Functional lymphatic drainage of SLNB double staining in the mammary gland, skin and axilla present a number of uncertainties. According to the axillary, lateral thoracic and thoracodorsal veins, Ibusuki et al. divided the axillary region into four subregions: brachial (lateral), pectoral (anterior), central and subscapular (posterior) zones. They revealed clear relationship between the anatomic location and status of the SLN, also confirmed by Gallowitsch et al. SLN was detected in Level I in 96% and in Level II in 4% by SPECT/CT. Knowedge of relationships between the drainage of sentinel lymph node staining into the axillary subregions, location of the primary tumor, tumor size, SLN positivity and its location within the subregion are of particular importance in the decision making whether or not axillary lymphadenectomy (ALND) needs to be performed. In the prospective randomized phase 3 trial by Giuliano et al. (ACOSOG Z-11) ALND was not performed in early breast cancer patients with clinically negative axilla and breast-conserving surgery, for 1-2 macroscopically positive SLNs (10). After an average follow-up of 6.3 years, data were compared to the traditional ALND group and no difference was detected in 5-year overall survival or disease-free survival at 5 years. Aims of the investigation: To examine the location of SLN in the axillary subregion (anterior, posterior, central, lateral, apical) in patients with early breast cancer (T <5 cm). To statistically assess correlations between the location, size, histological parameters of primary breast tumor and the subregion of the SLN. To statistically assess SLN positivity and its location within the sbregion. To statistically assess subregional localisation of positive SLN and the number of all positive regional lymph nodes, to predict a limited number of cases with lymph node metastasis, based on the test results of the ACOSOG Z-11 trial, by which ALND could be omitted.