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NCT ID: NCT03653377 Completed - Mucoviscidosis Clinical Trials

Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis (VACCIN-HPV-MUC2)

Start date: December 17, 2018
Phase:
Study type: Observational

Background The main risk factor for cervical cancer is the infection by human papillomavirus (HPV). Vaccination against HPV, offered to all girls aged 11 to 14 is an effective method of prevention against cervical pathology. Despite this, vaccination coverage against HPV remains low in France. A proportion of women with cystic fibrosis may be involved in transplantation, a factor associated with a higher risk of HPV carriage and cervical pathology. An over-risk of cervical pathology would also be present in women with non-transplanted cystic fibrosis. Particular attention to vaccination should therefore be included in this population. Objectives of the study The main objective of the study is to estimate the frequency of HPV vaccination in young girls with CF over 9 years and followed in a pediatric CF center. The secondary objectives are to know: - The type of vaccine used (bivalent / quadrivalent / nonavalent) - The proportion of vaccinated girls with respect of the vaccination schedule (number of injections / spacing between doses) - Reasons for non-use of vaccination Study design The study will last 12 months. It is a cross-sectional, non-interventional, multicenter conducted by self-administered questionnaire. Population - young girls aged 9 years or older with Cystic fibrosis - Followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region) - With parents who did not object to participation in the study Number of subject: 62 patients Expected results - Knowledge of HPV vaccination coverage in young girls with CF. - Sensitization of patients, their parents and health professionals to HPV vaccination. Understand the barriers and reasons for refusing vaccination to promote actions to improve immunization coverage.

NCT ID: NCT03653026 Completed - Clinical trials for Ulcerative Colitis (UC)

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

U-Accomplish
Start date: December 6, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT03652883 Completed - Clinical trials for Implementation as Usual

ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth

ImpleMentAll
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The ImpleMentAll (IMA) project aims to examine the effectiveness of tailored implementation compared to usual implementation of Internet-based Cognitive Behavioural Therapy (iCBT) for patients suffering from common mental disorders in routine practice. Common mental health disorders account for an alarming proportion of the global burden of disease. Being regarded as an evidence-based psychotherapeutic eHealth intervention, Internet- based Cognitive Behavioural Therapy (iCBT), has the potential to answer to this societal challenge by providing an efficacious and efficient treatment from which more people can benefit. ImpleMentAll will develop, apply, and evaluate tailored implementation strategies in the context of on-going eHealth implementation initiatives in the EU and beyond. The objectives are: 1. To develop a generic Integrated Theory-based Framework for Intervention Tailoring Strategies (the ItFits-toolkit) for data-driven tailored implementation of evidence-based eHealth services. 2. To demonstrate the impact of the ItFits toolkit on the implementation of eHealth for common mental disorders. 3. To disseminate the validated toolkit in various healthcare contexts across Europe. Following a stepped-wedge trial design, the ItFits-toolkit will be introduced in twelve implementation sites in nine countries, and evaluated for its effectiveness in obtaining implementation success. An in-depth process evaluation using a realist evaluation methodology will provide information about the particularities of tailored implementation and the application of the ItFits-toolkit in real implementation work. The resulting ItFits-toolkit will enable data driven evaluation of eHealth implementation projects and its methods, materials, and strategies will provide concrete guidance on tuning implementation interventions to local determinant of practice across a variety of health care systems.

NCT ID: NCT03652402 Completed - Clinical trials for Kidney Transplantation

Precision Risk Stratification in Kidney Transplant Patients - EU-TRAIN

EU-TRAIN
Start date: November 27, 2018
Phase:
Study type: Observational

Main objective: To design a precision risk stratification system that predicts individual risk of rejection

NCT ID: NCT03652246 Completed - Clinical trials for Epileptic Encephalopathy of Unindentified Genetic Origin

Evaluation of the Diagnostic Contribution of High-throughput Exome Sequencing for Patients With Convulsive Encephalopathy of Unknown Etiology: Pilot Study to Improve Genetic Counselling

SHD-EE
Start date: September 2013
Phase:
Study type: Observational

Congenital epileptic encephalopathies (EE) are predominantly genetic in origin. Their diagnosis is hampered by the large number of genes involved and their low recurrence. Genetic study in routine diagnosis is limited by the existing techniques and the development costs. The routine diagnostic implementation of high throughput sequencing pushes these limits. High throughput exome sequencing (ES) showed superior diagnostic performance in all diagnostic settings studied. This pilot study is dedicated to evaluating the diagnostic performance of high throughput ES in EE, with an implementation and analysis strategy allowing for a direct transfer to routine diagnostics. This novel approach should improve the diagnostic rate while reducing the diagnostic cost per patient.

NCT ID: NCT03651999 Completed - Anesthesia Clinical Trials

Influence of the "Atelier du rêve" (Dream Workshop) on the Quality of Falling Asleep in the Operating Room.

REVA
Start date: December 1, 2017
Phase:
Study type: Observational

A "dream workshop" is organized for the children by nurses specialized in anesthesia in the CHI Creteil. During this workshop, the anesthesia process is explained to the children using games, drawings, songs, etc. The impact of this workshop on the child stress and acceptance of the mask during induction is studied in this research.

NCT ID: NCT03651960 Completed - Stroke Sequelae Clinical Trials

Mobile and Interactive Robot's Social Acceptability for Balance and Gait Rehabilitation

ROBO-K
Start date: November 2015
Phase: N/A
Study type: Interventional

The recovery of a balance and gait is a primary objective for geriatric, neurological or orthopedic rehabilitation. Since the 80s, many walking robots were proposed. Despite encouraging results, the use of robotic equipment for gait training remains limited, even if they meet a strong social demand. The reasons for this situation are economic, but also related to the non consideration of the context of utilization . It is therefore important to involve the users of the innovation in the development process because it is the latter that will broadcast. Psychosocial perspective of the acceptability of the technology meets this need by including the users' perceptions toward device (s). The ROBO-K project aimed at developping a mobile and interactive robot, dedicated to the rehabilitation of balance and gait at an early stage. It was intended for patients with impaired walking vascular neurological, traumatic or associated with chronic neurological disease. The first step for its developement was conducted with the psychosocial approach of Technology acceptability which has required specific methods for collecting the views of users and analysis of the activity. This process allowed the design and the development of robot prototypes. The aim of the present study is now to establish the degree of social acceptability of the robot and to analyze balance and gait training activity.

NCT ID: NCT03651843 Completed - Clinical trials for Pregnancy, High Risk

Perception of Risks Into Work During Pregnancy Among Post-partum Women in the Lille Metropolis

PERISTRAG
Start date: September 4, 2018
Phase:
Study type: Observational

In ten years, the labor force has grown by 1.4 million people according to French national institute for statistical and economic studies. This increase is partly due to the increased presence of women in the labor market. Thus, the majority of some 800,000 annual births come from working women. However, some women in professional activity may be exposed to occupational risks, which may have effects on the develop-ment of the fetus during pregnancy. France benefits from protective legislative measures against pregnant women. Recommendations already exist. But with medical desertification, pregnant women may have more difficulty contacting their occupational doctor or treating physician and to access information about the risks to her work-related pregnancy. It seems to us important to be able to better quantify the information needs of women in this problem.

NCT ID: NCT03651388 Completed - Clinical trials for New Phenotype (Combining Premature White Hair, Polycystic Kidney Disease, Aortic Dilation/Dissection and Lymphopenia)

Research Into the Molecular Bases of a New Phenotype Combining Premature White Hair, Polycystic Kidney Disease, Aortic Dilation/Dissection and Lymphopenia

BCL-2
Start date: June 1, 2010
Phase:
Study type: Observational

This study involves a single family, including 1 patient, father, mother and sister. The patient presented with a new phenotype associating premature white hair, renal polycystosis, aortic dilation/dissection and lymphopenia. Samples were taken in order to identify the origin of the symptomatology highlighted in the index case. In addition, it was observed that mice invalidated for bcl-2, normal at birth and indistinguishable from control mice, showed, after one week, a phenotype similar to that observed in this patient. The overlap between the patient's main clinical signs (lymphopenia, white hair and polycystic renal disease) and the manifestations presented by the invalidated murine model for BCL2 suggests that its phenotype may be secondary to a Bcl-2 expression defect.

NCT ID: NCT03651258 Completed - Feeding Behavior Clinical Trials

Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play

ALIJEU
Start date: September 19, 2017
Phase:
Study type: Observational

The approach described here is based both on theoretical concepts and on the work of several teams of researchers. By positioning the baby and the appropriate adult, a speech bath, a sustained look and an expressive face, it is hypothesized that this early communication exercise will significantly improve the transition from passive feeding, active feeding of the premature child, from a qualitative and quantitative point of view.