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NCT ID: NCT02569450 Completed - Digestive Surgery Clinical Trials

Evaluation of Control Chart Impact on Surgical Outcomes

SHEWHART
Start date: October 2015
Phase:
Study type: Observational

This two arms parallel cluster-randomized trial will evaluate the impact of monitoring surgical outcomes using Shewhart control chart (intervention) on the occurence of major adverse events, among a large sample of French surgical departments. Trends in surgical outcomes before and after the intervention will be compared between arms.

NCT ID: NCT02569424 Completed - Clinical trials for Ventilated Patient in Intensive Care

Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins

PEEPUS
Start date: September 2015
Phase: N/A
Study type: Interventional

There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a single vessel every time or by not displaying the right or left side in the evaluation. Another study showed that there could be unpredictable size differences between the 2 subclavian veins. In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous return and thus possibly a superior vena cava dilation, located outside the pleura, depending on their capacitance. Different pressure levels showed an increase of AST with the increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner. The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area of the jugular and subclavian veins.

NCT ID: NCT02568982 Completed - Cushing's Disease Clinical Trials

Cushing's Disease Complications

COMPLICUSHING
Start date: September 21, 2015
Phase:
Study type: Observational

This study aims at investigating the complications of Cushing's disease in "de novo" patients. A series of investigations will assay before treatment and every year thereafter during a 3 years follow-up period the various complications of the disease. These investigations will determine the presence and severity of cardiovascular, metabolic, and bone complications as well as the Quality of Life. Outcome of these complications after treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.

NCT ID: NCT02568722 Completed - Acute Kidney Injury Clinical Trials

Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)

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

The objectives of this trial are to determine whether, in critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared to standard initiation, leads to: 1. Improved survival (primary outcome); and 2. Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days

NCT ID: NCT02568631 Completed - Autistic Disorder Clinical Trials

Improving Social Cognition for Adults With ASD by the Serious Game JeStiMulE Versus Controls

Start date: September 22, 2015
Phase: N/A
Study type: Interventional

The serious game "JeStiMulE" (Educational Game for Multisensory Stimulation of Children with developmental disorders), developed by the Autism Resources Center of Nice, was created to teach social cognition including emotion recognition in context, for children and adolescents with autism. In a previous study, JeStiMulE has demonstrated efficacy in a population of young people aged 6-17 years old with high and low levels of autism. According to the recommendations of the 2011 HAS, disorders of social interactions are the most persistent troubles of the autistic triad in life. It seems essential to us to be able to offer young adults with autism, rehabilitation methods adapted to their trouble, and to observe whether JeStiMulE could be one of them. This study researches the effectiveness of the serious game JeStiMulE in the improvement social cognition for adults with autism versus controls. The main goal is: - Comparing the improvement in social cognition among adults with autism using the serious game JeStiMulE or not. Two groups will be formed: a first one of fifteen adults with a diagnosis of autism objectified, this group will use JeStiMulE and will be compared to a control group of adults with autism, using another video game, not aimed to improve social cognition. The objective of JeStiMulE players will be ending the game after a learning period and two playing periods (with emotional words and idioms, including three modules each). The groups will be matched with their nonverbal IQ through Raven matrices and visual memory tasks (WAIS). The control group will also be stimulated through a video game, not specialized in improving social cognition. The primary outcome will be assessed by the emotion recognition at the FEEST of Ekman test: by the number of emotions recognized on faces, compared to the number of emotion presented through this test. The secondary outcomes will be: - The rest of social cognition improvement by several tests (the theory of mind with the score of the Tom-15, the intention with the score Sarfati cartoons, empathy with a self-administered questionnaire: EQ / AQ). - The impact on the quality of life, verbal fluency of emotional words, and the feedback from JeStiMulE players will also be seen as a secondary outcome.

NCT ID: NCT02568371 Completed - Healthy Clinical Trials

Biobank Based on the i-Share Student Cohort

bio-Share
Start date: October 6, 2015
Phase:
Study type: Observational

The bio-Share project aims at collecting blood samples in students participating in the i-Share cohort (www.i-share.fr). Investigators aim at setting up a platform that will enable investigators in the future to study biological determinants of conditions that affect young adults and to test certain hypotheses on the pathophysiology and mechanisms underlying diseases occurring both at a young age and later in life (as early exposures may also impact late onset diseases)

NCT ID: NCT02567500 Completed - Clinical trials for Auditory Hallucinations

The Physalis Child : Identification of Cognitive and Emotional Factors

Start date: July 7, 2015
Phase: N/A
Study type: Interventional

The aim of this study is to show presence of cognitive and emotional factors on the beginning and persistence of auditory hallucinations in non-psychotic children. Investigators will describe a significant link between this factors and hallucinations in a sample of non-psychotic children. The results of this sample will be comparing to another group of children of the same age, sex and diagnosis, but without hallucination. Finally, investigators will control the persistence of hallucination on the first group after a six month period.

NCT ID: NCT02567071 Completed - Clinical trials for Insufficient Intestinal Microbiota Diversity After C-section Birth

Natural Microbiota Restoration After C-section Birth

RESTORE
Start date: April 6, 2016
Phase: N/A
Study type: Interventional

The proportion of cesarean deliveries reached 30% of births in the US in 2008, while in the 1970s, it rarely reached 15%, as recommended by WHO. According to recent reports in some hospitals in China the use of cesarean section increased from 5% in the 1970s to over 60%. The use of C-section continues to grow in every countries of the world despite that current knowledge leads us to think that the vaginal birth, retained through millennia during mammalian evolution, guarantees the implementation of the best suited intestinal microbiota to build immunity and beneficial protective functions under the balanced mutual association between the host and its microbiota. Oral administration of a previously impregnated swab, by vaginal and maternal perineal secretions, following birth by planned C-section, would restore the normal development of the newborn intestinal microbiota mimicking exposure to these secretions during vaginal delivery. The expected benefit is the establishment of a rich and diverse microbiota in individuals in the intervention group and by extension improving the overall health of these individuals.

NCT ID: NCT02567058 Completed - Clinical trials for Alterations of the Achilles Tendon

Biomechanical and Ultrasonic Assessment of the Achilles Tendon in Vivo (MEDUSAA)

MEDUSAA
Start date: December 2012
Phase: N/A
Study type: Interventional

Among Musculoskeletal disorders (MSD) the rupture of the Achilles tendon is the most common. Up today, the mechanical and elastic properties of the Achilles tendon are still unknown, and that both in healthy subjects in pathology. The viscoelastic properties or dynamic mechanical properties are directly related to the tendon of the health status and its elongation capacity. The laboratory UMR Inserm U930 - CNRS ERL 3106 in Tours has developed a non-invasive ultrasonic device, named Achillus, which, via an ultrasonic probe, allowing to access the viscoelastic properties of the tendon during the contraction of the sural triceps. This is what we want to do in this first protocol: in vivo observation of the normal values and variations, looking for changes related to hyper solicitation and finally trying to highlight a tendon fragility parameter for patients who have experienced of a Achilles tendon rupture.

NCT ID: NCT02566993 Completed - Clinical trials for Small-cell Lung Cancer

Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

ATLANTIS
Start date: August 30, 2016
Phase: Phase 3
Study type: Interventional

Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line.