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NCT ID: NCT03048032 Completed - Acute Heart Failure Clinical Trials

Lithuanian Echocardiography Study of Dyspnea in Acute Settings

LEDA
Start date: April 2015
Phase:
Study type: Observational

LEDA (Lithuanian Echocardiography study of Dyspnea in Acute settings) is a prospective observational cohort multicenter clinical study. Project is carried out by Vilnius University together with a partner Lithuanian University of Health Sciences, in conjunction with a research protocol of international GREAT consortium (Global Research on Acute Conditions Team). The aim of this project is to find the specific novel biomarkers of acute heart failure (AHF), to evaluate their diagnostic and prognostic role in association with echocardiographic parameters of AHF. Primary endpoint is 1-year all-cause mortality and rehospitalization. Secondary endpoints are 1) in-hospital all-cause mortality 2) post-discharge 1 and 3 month all-cause mortality and rehospitalization 3) post-discharge 1 and 3 month cardiovascular mortality and rehospitalization 4) one-year cardiovascular mortality and rehospitalization. During the project a sizeable national database (2000 Lithuanian patients) will be integrated into database of GREAT network. Novel cardiac biomarkers together with ultrasound parameters of right ventricular (RV) function are in the focus of the study. During the acute phase of heart failure, up to 15 novel cardiac, vascular, renal impairment and inflammation biomarkers in plasma samples will be investigated in Lithuania and France (INSERM laboratory). Plasma samples will be taken during 4 hours after admission and frozen at -80ºC to allow batch analysis. The extensive evaluation of innovative ultrasound parameters of right ventricular structure and function will be performed in the early hospitalization period, along with standard echocardiography examination. The first database of AHF patients in Lithuania will provide demographic data and trends of morbidity and mortality, as well as analysis of diagnostic and prognostic value of novel biomarkers and echocardiography parameters in the Baltic region. Quantitative parameters of RV systolic function and deformation will be measured. It is expected that optimal use of novel biomarkers and reproducible echocardiography parameters in the setting of emergency and critical care would reduce unnecessary hospitalizations, cost and hospital length of stay without decrease in the quality of diagnostics and treatment. An estimation of correlation of echocardiographic parameters and biomarkers could help create an accurate algorithm for risk stratification and diagnosis of AHF in an emergency setting.

NCT ID: NCT03037931 Completed - Heart Failure Clinical Trials

Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency

HEART-FID
Start date: March 15, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency

NCT ID: NCT03033511 Terminated - Clinical trials for Small Cell Lung Cancer

A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)

MERU
Start date: February 7, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

NCT ID: NCT03006068 Active, not recruiting - Clinical trials for Ulcerative Colitis (UC)

A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

U-ACHIEVE
Start date: January 31, 2017
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.

NCT ID: NCT02999633 Terminated - Clinical trials for T-lymphoblastic Lymphoma/Leukaemia

Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

ISLAY
Start date: March 8, 2017
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the efficacy of isatuximab. Secondary Objectives: - To evaluate the safety profile of isatuximab. - To evaluate the duration of response (DOR). - To evaluate progression free survival (PFS) and overall survival (OS). - To evaluate the pharmacokinetics (PK) of isatuximab in participants with T-ALL or T-LBL. - To evaluate immunogenicity of isatuximab in participants with T-ALL or T-LBL. - To assess minimal residual disease (MRD) and correlate it with clinical outcome.

NCT ID: NCT02999217 Recruiting - Clinical trials for Colorectal Neoplasms

Intravenous Iron for Correction of Anaemia After Colorectal Surgery

Start date: October 2016
Phase: Phase 4
Study type: Interventional

This 4-week prospective double blind anaemia management study evaluates the effect of high-dose postoperative intravenous iron vs placebo for patients after colorectal cancer surgery. Patients with preoperative levels of haemoglobin 90-120 g/l will be randomly assigned to receive either 1 g of intravenous iron or equal amount of saline postoperatively. Comparison will be based on the levels of haemoglobin, ferritin and other haematological parameters over time and profile of clinical recovery. The primary end point is that iron isomaltoside given postoperatively is superior to placebo in terms of increase and stability of levels of haemoglobin and other haematological parameters.

NCT ID: NCT02993406 Completed - Clinical trials for Cardiovascular Diseases

Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo

CLEAR Outcomes
Start date: December 22, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in participants who have or are at high risk for cardiovascular disease and are statin intolerant.

NCT ID: NCT02970292 Completed - Schizophrenia Clinical Trials

Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)

Start date: October 26, 2016
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia

NCT ID: NCT02964949 Completed - Atrial Fibrillation Clinical Trials

Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes

Start date: January 24, 2017
Phase: N/A
Study type: Interventional

Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart. This can lead to blood clots forming in the heart chamber. Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for up to 12 months, with a 2-4 week follow-up, after which their participation is complete. Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30, 90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).

NCT ID: NCT02962765 Completed - Hemophilia A Clinical Trials

Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ

Start date: January 2015
Phase:
Study type: Observational

Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients) and routine clinical practice. Besides aspects such as general product safety and efficacy, there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor testing in the laboratory.