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NCT ID: NCT03081403 Completed - Sensitive Skin Clinical Trials

Quantitative Sensory Testing in Subjects With Sensitive Skin or Not

SENSISKIN
Start date: April 14, 2017
Phase: N/A
Study type: Interventional

Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have sensitive skin. The Quantitative sensory testing (QST) is a physico-psychic method that uses gradients stimuli of different modalities to measure a subjective somatosensory response. This allows to characterize sensory dysfunction by assessing the participation of small and large nerve fibers. The aim of this project is to characterize the presence or absence of a neurological disorder in patients with sensitive skin. This discovery would be a decisive argument to reinforce the suspicion that sensitive skins is linked to a small fiber neuropathy.

NCT ID: NCT03081273 Completed - Clinical trials for Corynebacterium Infections

Corynebacterium Spp Bone and Joint Infection: Retrospective Study of Microbiological, Diagnostic and Therapeutic Features

Start date: June 2016
Phase: N/A
Study type: Observational

Corynebacterium spp have been considered as innocuous commensals of human skin, but are now accepted as important opportunistic pathogens responsible for various nosocomial infections, especially implicating foreign materials. In particular, they accounted for up to 10% of prosthetic joint infection (PJI), and are mostly identified in chronic forms of bone and joint infections (BJI). However, little is known about the pathophysiological pathway implicated in Corynebacterium BJI, species distribution and antimicrobial susceptibility, and the management of these difficult-to-treat clinical entities. This study aims to report a retrospective cohort of patients with Corynebacterium spp BJI, aiming to : i) describe microbiological characteristics of the implicated clinical isolates, including species identification and antimicrobial susceptibility (and especially according to previous antimicrobial exposure); ii) assess pathophysiological mechanisms associated with BJI chronicity, including biofilm formation and bone cell invasion, to better understand mechanisms of Corynebacterium spp and to evaluate their ability to distinguished colonizing and infective isolates; iii) describe the medical (nature and duration of antimicrobial therapy) and surgical management of these patients; and iv) evaluate the patient outcome according to this management strategy, and highlight risk factor for treatment failure in order to improve patient's management.

NCT ID: NCT03081260 Completed - Arthroplasty Clinical Trials

Long-term Evaluation Protocol (12 Months Postoperative) of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty

Start date: April 3, 2017
Phase: N/A
Study type: Interventional

Total knee arthroplasty is a frequent surgery in France. It currently represents 70,000 interventions per year. The total knee prosthesis is also called tri-compartmental because it allows articulation between the femur and the tibia but also between the femur and the patella. The patella belongs to the extensor system. It articulates with the femoral trochlea in which it slides. It has an important biomechanical role on the quadriceps strength in addition to allowing flexion-extension movements. In the case of resurfacing, the joint face of the patella is cut off; A convex polyethylene implant is sealed with cement using studs on the same face. In case of non-resurfacing, the surgeon leaves in place the cartilage of the patella which will be in direct contact with the femoral prosthetic trochlea. Both methods have advantages and disadvantages. For some implants, it is recommended to resurface the patella because the implant is not very tolerant with the native patella. Other implants have been designed to be better adapted to the preservation of patellar cartilage. There is currently no evidence that one method is superior to the other on new generation implants known as "patellar friendly". It seems necessary to compare both methods in terms of long-term postsurgery results.

NCT ID: NCT03080675 Completed - Cognitive Decline Clinical Trials

Trial of a Nutritional Blend to Prevent Cognitive Decline in Older Adults

Start date: November 2016
Phase: N/A
Study type: Interventional

To demonstrate the beneficial effects of 1-year intervention with a nutritional blend of ingredients on blood levels of nutritional biomarkers known to be linked with cognitive decline in non-demented adults with subjective memory concerns aged 70+ years

NCT ID: NCT03079232 Completed - Skin Cancer Clinical Trials

Optical Coherence Microscopy in Dermato-oncology

GALAXY
Start date: March 28, 2017
Phase: N/A
Study type: Interventional

OCTAV is a medical device class I, not CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).

NCT ID: NCT03078920 Completed - Cochlear Implants Clinical Trials

Benefits of a Contralateral Routing of Signals (CROS) System in Unilateral CI-recipients

Start date: March 23, 2017
Phase: N/A
Study type: Interventional

The objective is to investigate the new Naida CROS device in adult recipients including chronic phases and to generate some preliminary pre-launch data. The formal study objectives are to compare the speech intelligibility in quiet and noise when using the CROS device with the Naida CI Q70 processor versus the Naida CI processor alone in quiet and noise conditions. Subjects will be tested with and without CROS at the baseline visit and then at follow-up visits taking place one month and three months after baseline. Subjects will use the new device at home between the first two visits appointments and then will only use the Naida CI processor for two additional weeks to better evaluate the handicap of not having access to contralateral signal input. There will be four visits to the centre in total. Subjective feedback will be collected through questionnaire like the APHAB and Speech, Spatial and Qualities of Hearing Scale (SSQ). A customised questionnaire focusing usability and benefit of the CROS will also be administered. Additional interest of the study will be to evaluate any acclimatisation effect with the CROS device both objectively and subjectively.

NCT ID: NCT03078907 Completed - Clinical trials for Pulmonary Arterial Hypertension

Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.

TRACE
Start date: November 8, 2017
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient's real environment. In addition, the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient's real environment. Patients will be assigned randomly to either selexipag or placebo.

NCT ID: NCT03078439 Completed - Very Preterm Birth Clinical Trials

EPIPAGE2 Cohort Study Follow up at Five and a Half Years

EPIPAGE2
Start date: September 2, 2016
Phase:
Study type: Observational [Patient Registry]

Epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study implemented to improve our knowledge of the outcome of preterm children in France. This study was launched on March 28, 2011 and includes three groups of preterm children, all born before 35 weeks: extremely preterm infants (born between 22 and 26 completed weeks of gestation), very preterm children (born between 27 and 31 completed weeks) and moderately preterm children (born between 32 and 34 completed weeks). These children are being studied from their birth up to the age of 12 years. At birth, data on maternal and infants' characteristics were collected from medical records. At one and two years, questionnaires sent to families and to physicians (at two years only) allowed to collect data about the children's life and health. At five and a half years, medical and psychological assessments are specifically implemented for the study in order to evaluate motor and cognitive disorders in this population.

NCT ID: NCT03078426 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Lung MRI in the Management of Idiopathic Pulmonary Fibrosis

PIC'IRM
Start date: February 16, 2017
Phase: N/A
Study type: Interventional

High resolution computed tomography (HRCT) plays a major role in the management of idiopathic pulmonary fibrosis (IPF) by identifying characteristic lesions of usual interstitial pneumonia (UIP). Though HRCT is the standard reference to describe pulmonary structural alterations using a non invasive technique, it is nonetheless a radiating exam which provides limited functional information regarding inflammation. In this trial, the investigators aimed to evaluate whether MRI (Magnetic Resonance Imaging) using ultra-short echotime could be an alternative to HRCT in the assessment of the four morphological criteria required to define an UIP pattern. The investigators also planned to study the clinical value of the additional informations derived from MRI such as contrasts and lung perfusion using functional MRI.

NCT ID: NCT03078218 Completed - Clinical trials for Critical Congenital Heart Disease

Health-economic Impact of Pulse Oximetry Systematic Screening of Critical Congenital Heart Disease in Asymptomatic Newborns

OXYNAT
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Persistant hypoxemia in the newborn confers, even isolated, an abnormal clinical situation, that needs to be addressed for an adequate diagnosis and an optimal treatment. If during the first hours of life, hypoxemia is frequent and often transient, beyond that, it is necessary to search the various etiological conditions such as a critical congenital heart disease (CCHD) or a non cardiac affection (sepsis, anemia, respiratory disease). Newborn pulse oximetry screening identifies babies with critical congenital heart disease (CCHD) based on the rational that they frequently have a degree of hypoxemia that may be clinically undetectable. CCHDs are life-threatening forms of congenital heart disease (CHD) occuring in 2-3/1000 live births but accounting for 3%-7.5% of infant deaths. Early detection is beneficial because of acute collapse, if not resulting in death, is associated with a worse surgical and neurodevelopmental outcome. Currently, screening for CCHD involves antenatal ultrasound scanning and post-natal physical examination. Although antenatal detection rates have improved over recent years and can be as high as 70%-80% in some centers, this is not consistent. Indeed, in "Nouvelle Aquitaine" overall <50% of CCHDs are detected before birth. In addition, up to a third of infants with CCHD may be missed on post-natal examination. Pulse oximetry screening can help to close the "diagnostic gap' that is, increase the detection of babies who slip through the current screening net. Several large European studies and a subsequent meta-analysis have shown that pulse oximetry screening is a highly specific (99.9%) and moderately sensitive (76.5%) test which increases CCHD detection rates. The high specificity results in a low false-positive rate 0.05% to 0.5%. But those babies with a Positive Test, if they may not have CCHD, they may be diagnosed with other causes of hypoxemia (congenital pneumonia, sepsis, persistent pulmonary hypertension,...). As with CCHD, delayed recognition of these conditions can result in postnatal collapse and significant morbidity and mortality. It is also more useful to consider these conditions as secondary targets of screening and to remember they constitute 30%-70% of false positives. In 2011, the US Health and Human Services Secretary recommended that pulse oximetry screening for CCHD be added to the Recommended Uniform Screening Panel. In Europe, implementation is advanced in such countries as North European Countries, and Switzerland. There isn't yet any European guidance. In France, the implementation is limited to local and transient experiments. The feasibility, usefulness and cost-effectiveness of routine pulse oximetry screening have not been evaluated so far. The French setting has two specificities : 1/ the antenatal detection rate is considered to be rather high. 2/ in contrast to a lot of other European countries, early discharge from the maternity ward before 48 hours of life is not common, decreasing the risk of discharging a baby with undiagnosed CCHD, but not saving babies from collapse. - The Investigators hypothesis is that routine pulse oximetry screening in asymptomatic newborns would allow to reduce the incidence of complications related to CCHDs as well as those related to non cardiac pathologies for a reasonable cost for the French Health Care System.