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NCT ID: NCT02394080 Active, not recruiting - Clinical trials for Acute Humerus Fractures

Safety and Efficacy Study of the Treatment of Humerus Fractures

Start date: February 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to collect safety and performance data on the use of the Photodynamic Bone Stabilization System (PBSS) when used to provide stabilization and alignment for the treatment of acute humerus fractures.

NCT ID: NCT02394028 Completed - Crohn Disease Clinical Trials

A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease

BERGAMOT
Start date: March 20, 2015
Phase: Phase 3
Study type: Interventional

This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs. The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.

NCT ID: NCT02393885 Active, not recruiting - Atrial Fibrillation Clinical Trials

Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach

DEEP
Start date: February 2015
Phase: N/A
Study type: Interventional

The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation

NCT ID: NCT02393859 Completed - Clinical trials for Leukemia, Acute Lymphoblastic

Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)

Start date: November 10, 2015
Phase: Phase 3
Study type: Interventional

B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according to risk characteristics to ensure that appropriate treatment is administered to patients with high-risk of relapse. In general, pediatric treatment regimens are more intense than those employed in adults and include courses of combination chemotherapy. Standard of care chemotherapy is associated with considerable toxicity. There is a lack of novel treatment options for subjects who relapse or are refractory to treatment. Therefore, innovative therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. This study will evaluate the event-free survival (EFS) after treatment with blinatumomab when compared to standard of care (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal residual disease compared to SOC chemotherapy will also be investigated.

NCT ID: NCT02393781 Completed - Septic Shock Clinical Trials

Adrenomedullin and Outcome in Severe Sepsis and Septic Shock

AdrenOSS
Start date: June 2015
Phase: N/A
Study type: Observational

The aim of this prospective study is to assess the prognostic value of bioactive plasma adrenomedullin (ADM) in 600 patients with severe sepsis or septic shock in an international multicenter study and to validate the findings concerning the association of ADM concentration and the use of vasopressor therapy, organ failure and outcome.

NCT ID: NCT02393768 Recruiting - Atherosclerosis Clinical Trials

Epigenetic Reprogramming of Monocytes in Patients With Coronary Atherosclerosis

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

In this study, the investigators will determine whether patients with documented atherosclerosis are characterized by specific epigenetic changes in circulating cells of the innate immune system, compared to patients without atherosclerosis.

NCT ID: NCT02393651 Recruiting - Stroke Clinical Trials

Late LTP-like Plasticity Effects of tDCS in Subacute Stroke Patients

Start date: March 2015
Phase: N/A
Study type: Interventional

Rationale: About 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. Therefore, investigating new potential therapeutic approaches is crucial. Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive electrical stimulation where a weak current is applied through electrodes over the scalp. This stimulation is known to (1) induce changes in neuronal excitability -which can last up to one day with late LTP-like plasticity protocols in a polarity and site-specific manner, and (2) facilitate motor learning and stroke recovery. So far, several pilot studies have reported beneficial results from tDCS in both subacute and chronic stroke patients, but it's still unclear how tDCS should be repeated over multiple days to optimally enhance recovery and training effects. Using a late LTP-like plasticity protocol could increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the effects of rehabilitation. Therefore, the investigators want to investigate how late LTP-like plasticity tDCS affects rehabilitation in subacute stroke patients. The outcome of this study can provide important guidelines on effective motor therapy during stroke rehabilitation. Objective: Identify the effect of late LTP-like plasticity on motor rehabilitation during the subacute phase after stroke. Study design: Double-blinded, randomized between-subjects trials. Study population: Subacute stroke patients. Main study parameters/endpoints: The primary outcome measure is the upper limb motor function during the subacute phase after stroke.

NCT ID: NCT02393209 Terminated - Clinical trials for Non-small Cell Lung Cancer

Docetaxel With or Without TAK-117 (MLN1117) in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Start date: June 3, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the recommended phase 2 dose (RP2D) of TAK-117 when administered in combination with docetaxel in participants with non-small cell lung cancer (NSCLC) and to evaluate efficacy, safety, and tolerability of TAK-117 administered alone and in combination with docetaxel at the RP2D in participants with locally advanced or metastatic non-small cell lung cancer.

NCT ID: NCT02392689 Terminated - Heart Failure Clinical Trials

Improve Management of Heart Failure With Procalcitonin

IMPACT-EU
Start date: March 2015
Phase: N/A
Study type: Interventional

Patients presenting to the Emergency Department with shortness of breath and (suspected) heart failure will be screened and randomized to either a standard of care or a procalcitonin-guided arm. Procalcitonin-guided arm: a procalcitonin level (cutoff 0.2 ng/ml) will be used to support decision on antibiotic therapy initiation. Standard of care arm: the decision on antibiotic therapy will be based on the physicians intent to treat. The patients will be followed up 30 and 90 days after randomization to evaluate the survival status, re-hospitalizations and further antibiotic therapies.

NCT ID: NCT02392559 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders

HAUSER-RCT
Start date: March 24, 2016
Phase: Phase 3
Study type: Interventional

A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.