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NCT ID: NCT02128334 Completed - Clinical trials for Advanced Prostate Carcinoma

An Observational Study Looking at How Well the Drug Eligard Works and How Well it is Tolerated by the Body of Patients With Advanced Prostate Carcinoma in the Russian Federation

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

Eligard is a 6-month depot injection formulation that combines the active ingredient leuprorelin acetate (LA) with a biodegradable polymer matrix (Atrigel® delivery system). The 6-month (45 mg) formulation was approved for the Russian market in 2009. It has been shown to reduce testosterone and prostate-specific antigen (PSA) levels and to be well tolerated in several clinical trials. However, clinical trials are limited by strict patient inclusion and exclusion criteria. Therefore, the current non-interventional study aimed at investigating whether the efficacy and tolerability of the 6-month LA depot formulation could also be confirmed in a broad and heterogeneous patient population encountered in daily clinical practice in the Russian Federation. This study will evaluate total serum PSA and testosterone levels, Quality of Life (QoL) of patients, demographic patient data, diagnosis and diagnostic findings in patients. It will provide analysis in different subgroups of patients depending on previous hormonal treatment and anamnesis of disease.

NCT ID: NCT02127970 Completed - Clinical trials for Surgical Site Infection

Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Start date: April 18, 2014
Phase: Phase 3
Study type: Interventional

To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected Gram-positive acute bacterial skin and skin structure infections (ABSSSI) at 48 -72 hours after initiation of treatment.

NCT ID: NCT02126280 Completed - Atherosclerosis Clinical Trials

Monocyte Activation in Preclinical Atherosclerosis

MAPA
Start date: November 2012
Phase: N/A
Study type: Observational

The study of proinflammatory and anti-inflammatory cytokines and chemokines expression profiles in human monocytes to identify new effective biomarkers that have the best diagnostic potential in asymptomatic atherosclerosis.

NCT ID: NCT02125877 Completed - Clinical trials for Chronic Iron Overload Due to Transfusion-dependant Anemias

Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)

Start date: July 8, 2014
Phase: Phase 2
Study type: Interventional

Assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability, satisfaction and compliance

NCT ID: NCT02124668 Completed - Prostate Cancer Clinical Trials

A Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

Start date: September 23, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to monitor the safety of enzalutamide in patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.

NCT ID: NCT02122588 Completed - Clinical trials for Ovarian, Peritoneal, Fallopian Tube Cancer, BRCAm+ in Russia

OVArian Cancer Non-Interventional Study - OVATAR

OVATAR
Start date: June 30, 2014
Phase:
Study type: Observational

This is a multicentre, non-interventional, prospective study to be carried out in representative hospitals in order to assess 1st line treatment management and diagnostic approaches applied to ovarian, peritoneal and fallopian tube cancer management in Russia and assess patients` characteristics and the occurrence of BRCA (Breast Cancer gene) mutations among Russian women with serous and endometrioid ovarian, peritoneal and fallopian tube cancer. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.

NCT ID: NCT02121210 Completed - Clinical trials for Rheumatoid Arthritis

To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)

SARIL-RA-ONE
Start date: June 2014
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the immunogenicity of sarilumab administered as monotherapy. Secondary Objectives: - To evaluate the other safety aspects of sarilumab administered as monotherapy. - To assess the exposure of sarilumab administered as monotherapy.

NCT ID: NCT02119494 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Phenotypes of COPD in Central and Eastern Europe

POPE
Start date: June 2014
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to assess the representation of COPD patients in terms of categories and phenotypes of the disease in selected countries in Central and Eastern Europe (CEE). The results of The POPE study will allow for evaluation of the differences in clinical approaches and treatment practices. The following countries are represented in The POPE study: Czech Republic, Slovakia, Austria, Poland, Hungary, Russia, Croatia, Serbia, Slovenia, Estonia, Latvia and Bulgaria.

NCT ID: NCT02115750 Completed - Clinical trials for Rheumatoid Arthritis

Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)

CHS-0214-02
Start date: May 2014
Phase: Phase 3
Study type: Interventional

This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies. Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety. Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.

NCT ID: NCT02112994 Completed - Clinical trials for Lysosomal Acid Lipase Deficiency

Safety and Efficacy Study of Sebelipase Alfa in Participants With Lysosomal Acid Lipase Deficiency

Start date: June 24, 2014
Phase: Phase 2
Study type: Interventional

This study evaluated the safety and efficacy of sebelipase alfa in a broad population of participants with lysosomal acid lipase deficiency (LAL-D).