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NCT ID: NCT02095691 Completed - Hypertension, Renal Clinical Trials

RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157

RENABLATE-II
Start date: October 2013
Phase: Phase 1
Study type: Interventional

This is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.

NCT ID: NCT02094742 Completed - Clinical trials for Metastatic Breast Cancer

BIG Molecular Screening Feasibility Study

BIG MS Pilot
Start date: May 2013
Phase: N/A
Study type: Interventional

This pilot study examines the feasibility and turnaround time of performing and obtaining data from a few key molecular assays. These assays will be performed using different laboratories and technologies from core biopsies taken from patients diagnosed with invasive recurrent or metastatic breast cancer. All results will be uploaded, stored and assessed using the IT Molecular Screening Prototype Platform (MSPP). The MSPP will also be evaluated for ease of use to screen patients for participation in future molecularly defined clinical trials in breast cancer.

NCT ID: NCT02094326 Completed - Clinical trials for Rheumatoid Arthritis

Study to Assess the Management of Synthetic Disease-modifying Antirheumatic Drug (DMARD) at the Onset of Adverse Events, Intolerance or Lack of Efficacy in Rheumatoid Arthritis (RA)

SAR-FAME
Start date: March 2014
Phase: N/A
Study type: Observational

The purpose of this study is to find patterns in the use of non-biological DMARDs as the initial treatment of RA and how adverse events (AEs), intolerance or lack of efficacy may impact therapeutic decisions in real life in the Spanish Andalusian region.

NCT ID: NCT02094261 Completed - Clinical trials for Non Small Cell Lung Cancer

Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours

AURA2
Start date: May 20, 2014
Phase: Phase 2
Study type: Interventional

A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive

NCT ID: NCT02093897 Completed - Clinical trials for Congenital Hemophilia A

Pharmacokinetic, Efficacy, and Safety Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) in Children With Severe Hemophilia A

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

This is an international, multicenter, open-label study to assess the efficacy, safety, and pharmacokinetic (PK) profile of rVIII-SingleChain in pediatric patients with severe hemophilia A. A minimum of 25 previously treated subjects ≥ 6 to < 12 years of age and at least 25 subjects < 6 years of age who have undergone > 50 exposure days (EDs) with a previous Factor VIII (FVIII) product are planned to be enrolled. Subjects will be assigned to either an on-demand or prophylaxis treatment regimen for the treatment of bleeding episodes and will receive rVIII-SingleChain at a dose to be determined by the investigator. Hemostatic efficacy will be assessed by the subject/caregiver and the investigator who will assess overall efficacy by a 4-point scale.

NCT ID: NCT02093598 Completed - Clinical trials for Carcinoma, Endometrioid

POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus

POEM
Start date: May 2012
Phase: Phase 2
Study type: Interventional

Type of Application: Clinical trial of new indication. Experimental drug: The study dose of temsirolimus will be 25 mg administered intravenously, infused over a 30- to 60-minute period once weekly for 28 days (Total doses: 4 doses). Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin). Pharmacotherapeutic group: Protein Kinase Inhibitors; ATC code: L01X E09. Primary Objective: - To identify in tumor samples future biomarkers associated with a short term exposure to temsirolimus. - This is an exploratory clinical study. No efficacy objectives are included in this clinical trial. Secondary Objectives: - To estimate the tolerability for all temsirolimus-treated patients throughout the study and up to 28 days after the last dose of temsirolimus. - To correlate observed changes with the different type of endometrial carcinoma (type I and type II), with regard to proteins related to mTOR (p4EBP1, pS6K1, c-MYC, cyclin D, p27, BAD, p53, Bcl-2 PTEN, pAKT, mTOR), - To estimate the potential predictive value of some biomarkers (immunostaining for PTEN, pAKT, mTOR), relevant mutations in PTEN, PI3KCA, k-RAS, CTNNB1, and microsatellite instability status. - To estimate the prognostic value of Ki67 expression after short-term presurgical therapy exposure - To collect data about the differences in expression profile, assessed by RNA microarrays

NCT ID: NCT02093338 Completed - Breast Pain Clinical Trials

L.Fermentum CECT5716 in Treatment of Breast Pain

Start date: July 2011
Phase: N/A
Study type: Interventional

The main objective of this intervention study is to evaluate the efficacy of Lactobacillus fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and Streptococcus as risk factors for mastitis in women with breast pain

NCT ID: NCT02093026 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Assess the Efficacy and Safety of Retreatment With MabThera (Rituximab) in Patients With Active Rheumatoid Arthritis (RA)

Start date: August 2002
Phase: Phase 2
Study type: Interventional

This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into studies WA16291 or WA17043. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

NCT ID: NCT02092922 Completed - Clinical trials for Advanced Multiple Myeloma

A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)

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

The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma will receive single-agent investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160 patients from North America and Europe will be enrolled in this study. Eligible patients will have received at least two prior lines of therapy; have received prior bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide.

NCT ID: NCT02092818 Completed - Clinical trials for Hypertension, Pulmonary

EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

EXPERT
Start date: May 31, 2014
Phase:
Study type: Observational

In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.