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NCT ID: NCT03181360 Not yet recruiting - Ischemic Stroke Clinical Trials

Tenecteplase in Wake-up Ischaemic Stroke Trial

Start date: June 12, 2017
Phase: Phase 3
Study type: Interventional

Stroke is a leading causes of death and disability. At least 20% of strokes occur during sleep, so- called 'wake up stroke'. Thrombolysis with the clot-busting drug alteplase is effective for acute ischaemic stroke, provided that it is given within 4.5 hours of symptom onset. Patients with wake-up stroke are currently ineligible for clot-busting therapy. Previous studies indicate that many wake-up strokes occur just before awakening. In this study, patients with wake-up stroke will be randomized to thrombolysis with tenecteplase and best standard treatment or to best standard treatment without thrombolysis. Tenecteplase has several potential advantages over alteplase, including very rapid action and that it can be given as a single injection. Prior to thrombolysis, a brain scan must be done to exclude bleeding or significant brain damage as a result from the stroke. We will use a CT scan to inform this decision. CT is used as a routine examination in all stroke patients. Other studies testing clot-busting treatment in wake-up stroke are using alteplase and more complex brain scans, which are not routinely available in the emergency situation in all hospitals.

NCT ID: NCT03161457 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis

Start date: February 27, 2017
Phase: Phase 1
Study type: Interventional

This is a multicentre, randomised, double-blind, parallel group study to compare the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, safety, tolerability and efficacy of JHL1101 versus MabThera in subjects with moderate to severe RA who have previously failed at least 1 tumour necrosis factor alpha (TNF) inhibitor (i.e., intolerance or documented active disease despite at least 12 weeks treatment according to the TNF inhibitor-approved treatment and dosage), and are on concomitant treatment with MTX.

NCT ID: NCT03158285 Not yet recruiting - Clinical trials for Arthritis, Psoriatic

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

Start date: July 7, 2017
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

NCT ID: NCT03100448 Recruiting - Implant Clinical Trials

A 1-year Clinical Investigation on the On1 Concept

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

A 1-year Clinical Investigation on the On1 Concept.

NCT ID: NCT03097133 Recruiting - Clinical trials for Depressive Disorder, Major

A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide

Aspire II
Start date: June 15, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.

NCT ID: NCT03076177 Recruiting - Knee Osteoarthritis Clinical Trials

The Effectiveness of Kinesio Taping Method for Knee Osteoarthritis.

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

Purpose of our study is to evaluate effectiveness of Kinesio Taping method for knee osteoarthritis. Using simple concealed randomization procedure to form two groups (kinesio taping and control-nonspecific taping) of 100 knee osteoarthritis patients in each. 1 month all patients (depending on the group they will be allocated to) will receive either kinesio taping applications or non-specific taping: 4 applications per subject. Three times: before taping, after a month with tapes, and after 1 month without tapes evaluation of knee function, mobility, quality of life will be evaluated, including clinical examination of knee joint, measurements of knee flexion and extension by goniometer, circumference of leg over the knee, in ½ of thigh and in ½ of calf (to evaluate edema); pain will be evaluated by questionnaire, patella tendon algometry; force of calf flexors and extensors will be evaluated using Lovett manual muscle testing scale, goniometry for knee flexion/extension; for mobility, knee function, life quality evaluations - 10 Meter Walk , Five Times Sit to Stand Tests will be performed, Knee injury and Osteoarthritis Outcome Score (KOOS) and Medical Outcomes Study Short Form 36 2 version (SF-36 2v) questionnaires will be used. Also data about the need of analgesic medicament will be collected from subjects.

NCT ID: NCT03048032 Recruiting - Acute Heart Failure Clinical Trials

Lithuanian Echocardiography Study of Dyspnea in Acute Settings

Start date: April 2015
Phase: N/A
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: NCT02999633 Recruiting - Clinical trials for T-cell Type Acute Leukemia-Precursor T-lymphoblastic Lymphoma/Leukaemia

Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

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 patients with T-ALL or T-LBL. - To evaluate immunogenicity of isatuximab in patients 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: NCT02979431 Recruiting - Clinical trials for Respiratory Syncytial Virus Lower Respiratory Tract Infection

Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection

Start date: December 2016
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity, pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different doses of inhaled ALX-0171.