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NCT ID: NCT02854397 Terminated - Healthy Volunteers Clinical Trials

Determination of Specific Biomarkers of Acute Attack of Angioedema Within Pediatric Population

BRADYKID
Start date: February 15, 2016
Phase:
Study type: Observational

In emergency room, this is crucial to diagnose an acute attack of hereditary angioedema (HAE) to quickly provide the efficient treatment. Currently, there is no specific biomarker for acute attack of bradykinin-mediated angioedema to help clinicians for patient care. However, previous works are carried out for that purpose. All the potential candidate biomarkers must be validated in prospective studies to estimate their specificity and sensitivity values, and to understand their potential utility in patient care. The main goal of this clinical trial is to estimate the diagnostic value of VE-cadherin in pediatric population, for the differential diagnosis between HAE crisis and angioedema resulting of mast cell activation crisis (the main differential diagnosis of HAE).

NCT ID: NCT02854319 Terminated - Clinical trials for Aortic Valve Stenosis

REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System

REPRISE EDGE
Start date: September 7, 2016
Phase: N/A
Study type: Interventional

The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transcatheter aortic valve implantation (TAVI) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

NCT ID: NCT02852200 Terminated - Healthy Volunteers Clinical Trials

Screening for Frailty at Home

SEGAm
Start date: June 2012
Phase: N/A
Study type: Observational

"Many tools to evaluate frailty have been developed. However, at the time our study was designed, none of these instruments had been validated in terms of psychometric properties. The aim of this study was to validate the modified version of the Short Emergency Geriatric Assessment (SEGAm) frailty instrument in elderly people living at home. It was an observational, longitudinal, prospective, multicentre study, set up in four departments (Ardennes, Marne, Meurthe-et-Moselle, Meuse) in two French regions (Champagne-Ardenne and Lorraine). Subjects was aged 65 years or more, living at home, and was able to read and understand French, with a degree of autonomy corresponding to groups 5, or 6 in the AGGIR autonomy evaluation scale. Assessment included demographic characteristics, comprehensive geriatric assessment, and the SEGAm instrument. Psychometric validation was used to study feasibility and acceptability, internal structure validity, reliability, and discriminant validity of the SEGAm instrument. "

NCT ID: NCT02851979 Terminated - Clinical trials for Premature Newborns With Gestational Age 28 to 33 Weeks

Odors to Insufflate Life

PREMODEUR
Start date: November 9, 2018
Phase: N/A
Study type: Interventional

Apneas concern about 85% of premature newborns (NB) born after less than 34 weeks of pregnancy. They are considered as an important risk factor for subsequent neuropsychological deficiency. Current pharmacological treatments are not very effective, and have side effects (agitation, irritability, sleep disorders, tachycardia). Some studies suggest that in NBs with apneas resisting to drugs, a permanent odorisation with a drop of vanillin on the incubator's pillow might reduce the frequency of apneas. This latin square design study will test a controlled olfactory stimulation method, i.e. an olfactometer which controls the odor duration, intensity, and sequence using three different odors, to reduce apneic episodes measured using 24-registration of heart and respiratory rates.

NCT ID: NCT02848001 Terminated - Clinical trials for Myelodysplastic Syndromes

A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes

Start date: November 14, 2016
Phase: Phase 1
Study type: Interventional

CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory higher-risk myelodysplastic syndrome.

NCT ID: NCT02847650 Terminated - Parkinson Disease Clinical Trials

Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease

Start date: October 17, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients at early stage of the disease.

NCT ID: NCT02847468 Terminated - Clinical trials for Carcinoma, Hepatocellular

Multimetabolic 18F-Fluorodeoxyglucose (FDG) and 18F-Fluorocholine (FCH) Positron Emission Tomography (PET) as an Early Predictive Factor of Overall Survival in Patients With Advanced Hepatocellular Carcinoma Treated With Sorafenib

PREMETHEP
Start date: March 27, 2017
Phase: N/A
Study type: Interventional

Hepatocellular carcinoma (HCC) is the third cause of death by cancer. For patients with inoperable advanced HCC, systematic therapy with Sorafenib, a multikinase inhibitor that has both antiangiogenic and antiproliferative effect, is the only therapeutic with proven survival benefits. However, the efficacy of Sorafenib remains inconstant with a media overall survival of 10,7 months and a disease control rate only 35 to 43%; moreover, the overall incidence of treatment-related adverse event is 80%. Thus, it appears essential to find an early and accurate way to determine which patients are best responding to therapy in order to avoid the toxicity and cost of ineffective therapy. Positron Emission Tomography (PET) with 18F-Fluorodeoxyglucose (FDG) has shown limited performance in the setting of HCC because of lack of sensitivity, in particular for well-differentiated tumours. However FDG uptake is related to proliferation rate and is an efficient marker survival following liver transplantation and selective internal radiation therapy. Moreover, the addition of a dynamic first-pass acquisition to the standard static scan provides better characterization of the tumour by adding information on tumour perfusion. FCH which reflects lipids metabolism and specifically choline kinase activity, has shown promising results for detection of HCC when compared with FDG alone. Moreover, choline activity is related to a kinase pathway in mammalian cells, which is specifically inhibited by Sorafenib. However FCH uptake remains inconstant in HCC, and is related to tumour differentiation, by opposition to FDG. Therefore, several studies have suggested that combined evaluation of tumour glucose and lipid metabolism could play a complementary role for the evaluation of HCC in the setting of detection, staging and to predict recurrence following surgical resection. Thus, the investigator hypothesize that the combination of FDG and FCH may be the most accurate imaging evaluation of HCC. Thus the aim of the present study is to determine the predictive performance of survival of lipid and glucose metabolism and perfusion changes during Sorafenib therapy in patients with advanced HCC.

NCT ID: NCT02844868 Terminated - Stroke Clinical Trials

Evaluation of the Observance and the Tolerance of a Motor Training Program

ESTIMAH
Start date: February 22, 2018
Phase: N/A
Study type: Interventional

Transcortical direct current stimulation (tDCS) is an emerging technique in the rehabilitation of hemiplegic patients after stroke. This study aims to assess the observance and the tolerance of repeated tDCS stimulation over the primary motor cortex of the lower limb coupled to a motor training program, among hemiplegic patients at the sub-acute stage. This is a prospective, randomized, double-blind, study with two parallel groups of 15 subjects each. The study will analyze first, the patient's observance considered good if 75% of the patients completed the entire protocol duration and the tolerance through a questionnaire. The secondary end point will try to estimate, if possible, the effect size of the walking performance measured with the six-minute walk test and aerobic performance measured with VO2peak of this training program compared to the same program combine with placebo stimulations. These evaluations are performed before, during and after the rehabilitation program.

NCT ID: NCT02844855 Terminated - Parkinson Disease Clinical Trials

Memory for Action in Neurological Patients

EMBODIMENT
Start date: December 26, 2016
Phase: N/A
Study type: Interventional

Memory for action is especially important in everyday life although current literature is not very abundant. The enactment effect (i.e. better memory for performed actions than for verbally encoded sentences) is usually described as a robust effect in aging and can be found in many diseases. Although the enactment effect has been studied for three decades, there is still no consensus on how it enhances memory. Therefore, in order to gain additional insight into the representational basis of the enactment effect, in the present study, the investigators propose to test neurological patients. The investigators suggested that memory for action should be better than memory for verbally encoded information in Alzheimer's disease and Parkinson's disease. If patients with Alzheimer's disease (AD) and Parkinson's disease (PD) have no cognitive assessment during the last 6 months, then they will realize different tests: MMSE (1), HAD (2), a cognitive assessment (3); (4); BREF (5); Assessment of apraxia, (6). Controls will perform the same tests to verify that they have no cognitive impairment. Then, two experimental conditions will be presented in all patients and controls: a first in which participants will have to name drawings (verbal learning) and a second in which they will have to reproduce an action associated with drawings (action learning). Immediately after this learning phase, a recognition task will be available and therefore participants will have to recognize drawings that had been presented previously. The main criteria used in the statistical analysis will be the correct recognition score.

NCT ID: NCT02844712 Terminated - Clinical trials for Drug Hypersensitivity

Negative Predictive Value of Drug Provocation Tests to Beta-lactams

NPVDPT
Start date: December 2014
Phase: N/A
Study type: Interventional

Patients with a complete drug allergy work-up to betalactam antibiotics were contacted (by mail) and asked to answer a questionnaire regarding the tolerance upon readministration of a negatively tested beta-lactam.