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NCT ID: NCT02099409 Completed - Clinical trials for Type 1 Diabetes Mellitus

Safety and Efficacy of Overnight Closed Loop in Children With Type 1Diabetes Mellitus in Luxembourg

Start date: January 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to validate current algorithms and evaluate safety and efficacy of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1 diabetes between 6 - 12 years of age in Luxembourg .

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.

NCT ID: NCT02042144 Completed - Neoplasms Clinical Trials

Safety and Effectiveness of Regorafenib

Correlate
Start date: April 8, 2014
Phase: N/A
Study type: Observational

This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 1000 patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with other approved treatments for metastatic disease and for whom a decision has been made by the physician to treat with regorafenib according to local health authority approved label. It is the aim of this observational cohort study to further characterize safety and effectiveness of regorafenib in routine clinical practice setting. Healthcare resource utilization in the routine provision of care is becoming increasingly important from a health economics and outcomes research perspective. Therefore, another aim of this observational cohort study is to capture healthcare resource associated with the management of treatment emergent adverse events in the real world setting. The primary objective of this study is to further characterize safety of regorafenib use in routine clinical practice settings. The secondary objective of this study is to assess the effectiveness of regorafenib in routine clinical practice settings as measured by Overall Survival (OS), Progression Free Survival (PFS) and Disease control rate (DCR). Health Related Quality of Life (HRQoL) Data will be collected in applicable countries.

NCT ID: NCT02031471 Completed - Clinical trials for Rheumatoid Arthritis

TOSCARA Study: A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra Treatment

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

This open-label, single-arm study will evaluate the efficacy and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) in monotherapy and/or in combination with methotrexate and other non-biologic DMARDs in patients with active rheumatoid arthritis who are naïve to RoActemra/Actemra. Patients will receive RoActemra/Actemra 162 mg subcutaneously weekly for 24 weeks. Patients who complete the core study achieving at least a moderate EULAR response at Week 24 may enter the extension phase and receive RoActemra/Actemra for a further 28 weeks at the most.

NCT ID: NCT02018744 Active, not recruiting - Clinical trials for Safety and Performance of the Nellix Endovascular Sealing System

Nellix® Registry Study: EVAS-Global

EVAS-FORWARD 1
Start date: October 2013
Phase:
Study type: Observational [Patient Registry]

This registry has been designed as a multicenter, single arm, open label, post-market registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects will be followed up to discharge discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment). This registry of the Nellix System, which has received the market authorization of the European Union (Conformité Européenne, CE-certification) in a "real world" patient population treated in a multicenter setting will provide an assessment of the generalizability of the approach and System. Up to 300 patients diagnosed with abdominal aortic aneurysm (AAA) who are considered candidates for Endovascular Repair, in up to 30 international centers will be enrolled in the study.

NCT ID: NCT01945762 Completed - Clinical trials for Symptomatic, Aggressive, Sporadic, Unresectable, Locally

Observational Study to Evaluate Vandetanib in RET -/+ Patients With Metastatic Medullary Thyroid Cancer

Caprelsa104
Start date: February 17, 2014
Phase:
Study type: Observational

This is a European multinational, multicenter, non-interventional (observational) and prospective study. It is carried on to confirm in real life conditions the benefit/risk of vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET positive patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC.

NCT ID: NCT01874002 Active, not recruiting - Clinical trials for Coronary Artery Disease

Prospective Registry to Asses the Long-term Safety and Performance of the Combo Stent

REMEDEE Reg
Start date: June 2013
Phase: N/A
Study type: Observational [Patient Registry]

Patients with stenosis in one or more coronary artery are often treated with a percutaneous coronary intervention (PCI). As part of the PCI treatment a stent is often placed to keep the vessel open over time. The Combo-Stent is a novel stent for use during percutaneous angioplasty. In short, the Combo stent combines a drug eluting technique and an endothelial cell attracting layer. The drug coating is designed to prevent re-narrowing of the stent. The endothelial cell attracting layer is designed to ensure rapid coverage of the stent struts with vascular wall cells. The REMEDEE REGISTRY evaluates the long-term safety and performance of the Combo stent in routine clinical practice. In total 1000 patients will be registered and followed for five years.

NCT ID: NCT01856101 Terminated - Clinical trials for Carcinoma Transitional Cell

Study of BEZ235 as Monotherapy in Patients With Transitional Cell Carcinoma After Failure of Platinum Based Chemotherapy

BEZ235
Start date: February 2013
Phase: Phase 2
Study type: Interventional

The mTOR (mammalian Target of Rapamycin) protein is the center of the mTOR pathway that plays an important role in cell growth, proliferation, survival and angiogenesis through sensing and integrating energetic signals from cellular environment. The mTOR protein is composed of two complex, mTOR complex 1 (mTOR C1) and mTOR complex 2 (mTOR C2). In regards of mTOR pathway dysregulations observed in TCC development, there is a rational to test BEZ23 in advanced TCC. BEZ235 is a pan-class I PI3K inhibitor that, in addition, binds to the catalytic site of mTOR, inhibiting mTOR C1 and mTOR C2.

NCT ID: NCT01801111 Completed - Clinical trials for Non-Small-Cell Lung Carcinoma

A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment

Start date: June 20, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib.

NCT ID: NCT01702571 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment

Start date: November 27, 2012
Phase: Phase 3
Study type: Interventional

This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.