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NCT ID: NCT03417349 Completed - Stroke, Acute Clinical Trials

Safety and Effectiveness of SOFIA™/SOFIA™ PLUS for Direct Aspiration in Acute Ischemic Stroke

SESAME
Start date: October 1, 2017
Phase:
Study type: Observational

Sesame is a European, multi-center, single arm, prospective, observational registry. Sesame aims to demonstrate that use of SOFIA™/SOFIA™ PLUS catheter for direct aspiration as a first line treatment technique is fast, safe and effective in patients suffering an Acute Ischemic Stroke when assessed at 24 hours, discharge and 90 days after treatment. 250 patients will be enrolled. All patients will be followed for 90 days or until death.

NCT ID: NCT03417011 Completed - Clinical trials for Aortic Valve Stenosis

FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

Start date: February 26, 2018
Phase:
Study type: Observational

Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system. The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.

NCT ID: NCT03416270 Completed - Heart Failure Clinical Trials

ERtugliflozin triAl in DIabetes With Preserved or Reduced ejeCtion FrAcTion mEchanistic Evaluation in Heart Failure

ERADICATE-HF
Start date: June 28, 2018
Phase: Phase 2
Study type: Interventional

This study aims to elucidate the mechanisms whereby the SGLT2i "ertugliflozin" modifies cardiorenal interactions that regulate fluid volume and neurohormonal activation in patients with type 2 diabetes and heart failure (T2D-HF).

NCT ID: NCT03415880 Completed - Diabetes Mellitus Clinical Trials

Light Intensity Physical Activity Trial

LiPAT
Start date: November 8, 2018
Phase: N/A
Study type: Interventional

In type 2 diabetes (T2D), physical activity is an important modifiable risk factor of cardiovascular disease (CVD). Unfortunately (long-term) compliance to exercise programs in patients with T2D is poor. Light-intensity physical activity (LiPA) such as walking slowly, household activities or taking a flight of stairs might be a potential target for lowering the CVD risk in patients with T2D since it can perhaps be more be incorporated into daily life. To assess cardiovascular disease risk in this single-blinded RCT, the investigators settled on measuring arterial stiffness as the primary outcome. Arterial stiffness has independent predictive value for cardiovascular events and can be measured reliably and non-invasively. The investigators hypothesize that light intensity physical activity intervention program based upon increasing LiPA by replacing sedentary time is effective in lowering arterial stiffness as estimated by aortic pulse wave velocity (PWV) and carotid distensibility in individuals with T2D.

NCT ID: NCT03415672 Completed - Hepatitis B Clinical Trials

Hepatitis B Vaccine for Non-responders

Start date: October 11, 2017
Phase: Phase 2
Study type: Interventional

In the current study, the investigators study the efficacy of the HBAI20 vaccine to induce seroprotection in registered non-responders (adults who were previously vaccinated with the HBVaxPro-10μg but did not achieve seroprotection). The study will further assess the safety of the HBAI20 vaccine in comparison with HBVaxPro-10μg.

NCT ID: NCT03411161 Completed - Clinical trials for Metastatic Breast Cancer

S 81694 Plus Paclitaxel in Metastatic Breast Cancer

Start date: January 4, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety profile, the maximum tolerated dose (MTD) and the associated dose-limiting toxicities (DLTs) of S 81694 in combination with paclitaxel in metastatic breast cancer (mBC) patients, and to investigate the antitumour activity of the combination in metastatic triple negative breast cancer (mTNBC) patients.

NCT ID: NCT03410979 Completed - Healthy Clinical Trials

A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2737 in Healthy Subjects

Start date: November 25, 2016
Phase: Phase 1
Study type: Interventional

This study is a first-in-human (FIH), Phase I, single center, randomized, double-blind, placebo-controlled, sequential group study in healthy male subjects to assess the safety, tolerability and PK of single ascending oral doses of GLPG2737 and multiple ascending oral doses of GLPG2737 administered for 14 days.

NCT ID: NCT03410693 Completed - Clinical trials for Carcinoma, Transitional Cell

Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma

FORT-1
Start date: May 31, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.

NCT ID: NCT03409744 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

Start date: March 13, 2018
Phase: Phase 3
Study type: Interventional

The primary objectives of the study are: - To evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH) - To evaluate the long-term safety and tolerability of evinacumab in adolescent patients with HoFH The secondary objectives of the study are: - To evaluate the effect of evinacumab on lipid parameters in patients with HoFH - To evaluate the effect of evinacumab on lipid parameters in adolescent patients with HoFH - To evaluate the potential development of anti-evinacumab antibodies

NCT ID: NCT03409666 Completed - Clinical trials for Rheumatoid Arthritis

Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.

Start date: May 12, 2017
Phase: N/A
Study type: Interventional

This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.