title: Prevalence and Impact of SARS-COV-2 Infection in Pregnant Women, Fetuses and Newborns

acronym: COVIPREG

summary:
A novel human coronavirus, named SevereAcute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), emerged in China, in late 2019, and is now spreading quickly causing a pandemic. It is usually responsible for a mild infectious syndrome, but patients can also develop pneumonia, acute respiratory failure and other serious complications. To date, very little and controversial literature is available on the impact of SARS-CoV-2 infection on pregnancy, and the potential risk of vertical transmission.

Therefore, the first part of the study, will evaluate the proportion of pregnant woman infected by SARS-CoV-2 during pregnancy over the next six months by performing SARS-CoV-2 serology during pregnancy and at delivery . This information will be correlated to pregnancy and neonatal outcome. The second part of the study 2 will collect sera from several mandatory screening that are kept for one year. Those will be used for assessing the time of the seroconversion and variations of susceptibility to infection with gestational age as well as the impact of social distancing measures.

Concerning neonates born to mothers with documented SARS-CoV-2 infection during pregnancy, only few cases of congenital infections were recently reported because of pneumonia related to SARS-CoV-2 infection and/or positive IgM at birth.

It remains unclear whether neonatal infection can follow transplacental transmission of SARS-CoV-2 during pregnancy and/or through early per- and postnatal exposure, including breast-feeding. In order to investigate these hypotheses, the third part of the study will perform, SARS-CoV-2 PCR tests in a variety of samples collected from infected-mother (symptomatic during the pregnancy and PCR confirmed) and child pairs, at delivery and in the postpartum period.

primary_purpose: Screening


title: Soluble CD95 Ligand Role in the Pathophysiology of Non-infectious Active Uveitis

acronym: UVE-FAS

summary: The study aims at defining the role of soluble CD95 Ligand in the physiopathology of the non-infectious uveitis. Soluble CD95 Ligand might have a prognostic interest as well as potential for the discovery of new therapeutic strategies

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Generation of Human Monoclonal Antibodies Neutralizing SARS-Cov-2 From B Cells of Convalescent Patients

summary:
Rationale : The emergence of the novel, pathogenic SARS-coronavirus 2 (SARS-CoV-2) threatens public health. To date, there are no effective drug option to prevent the infection, nor therapeutics for controlling the deadly COVID-19. However, the majority of patients infected with SARS-Cov-2 eliminate the virus by mounting a protective antiviral immune response, associated in particular with the production of neutralizing antibodies. Neutralizing antibodies could be of particular interest for therapeutic purposes, but also for preventive applications, to protect people who have never been in contact with the virus, or immunocompromised patients.

The objectives of this study are :

To generate human monoclonal antibodies neutralizing SARS-Cov-2 from immortalized B cells of convalescent patients.
To compare the serological profiles between convalescent patients that develop mild or uncomplicated illness and convalescent patients that develop a more severe disease, that required hospitalization and oxygen support.
To compare for each patient the neutralizing efficiency of plasma to the neutralizing capacities of the monoclonal antibodies generated with immortalized B cells.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

sponsor_collaborators:
Hospices Civils de Lyon
Eurobio Scientific

status_simplified: Completed


title: Relationship Between the ANI Score During Standardized Painful Stimulation and the Nociceptive Response to Laryngoscopy Intubation

summary:
The objective : to investigate a correlation between ANI following a standardized nociceptive stimulus and hemodynamic or somatic reactions during orotracheal intubation.

Piloted study. ANI and hemodynamic and somatic parameters response associated tetanus stimulation followed by orotracheal intubation were collected.

study_type: Interventional

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Jozefowicz E, Sabourdin N, Fontaine V, Lambelin V, Lejeune V, Menu H, Bourai M, Tavernier B. Prediction of reactivity during tracheal intubation by pre-laryngoscopy tetanus-induced ANI variation. J Clin Monit Comput. 2022 Feb;36(1):93-101. doi: 10.1007/s10877-020-00624-6. Epub 2021 Jan 2.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Lille

intervention_type: Device


title: Evaluation of the Management of Dental Emergencies During COVID 19 Crisis

acronym: URGDENTCOVID

summary:
"For 12 years, the odontology service of the Pitié-Salpêtrière hospital group (GHPS) has been responsible for day and night dental emergency care. Several surveys have been conducted in order to analyze the sociological characteristics of the patients and the typology of the acts performed. These studies indicate that pain is the main reason for consultations, cited by 60 to 80% of patients.

So far, very few studies have been done in the context of emergencies. Very recently, a study was undertaken on the satisfaction of patients consulting the odontological emergencies of the GHPS, during a thesis work.

This study, carried out in collaboration with the URC Pitié Salpêtrière, under analysis, relates to the satisfaction of patients consulting the odontological emergencies of the GHPS during the day and week, Monday to Friday, excluding night and week emergencies -end (WE). An additional study (URGDENT-NW) aiming at completing this study by focusing on patients consulting the emergency room at night and during the weekend is also in progress.

The COVID19 Crisis changed the organization and the venue of patients at the emergency dental service.

Therefore this project, based on the same protocol as URGENT and URGDENT-WE, aims at evaluating the Odontology Emergency Reception Service (SAUO) during the COVID 19 epidemy. It will be carried out in the form of a survey whose objective is to assess: on the one hand, the effectiveness of the care provided in this emergency functional unit, and on the other hand the satisfaction of the patients after their passage to the emergency room ."

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service d'odontologie, Hôpital Pitié-Salpêtrière


title: Evolution of the Quality of Life During a Twin Pregnancy

acronym: QUALIGEM

summary:
Quality of life has recently appeared as a component of health. Pregnancy has an impact on the quality of life of the parturient, whether through physical or psychological changes.

It is common to think that quality of life is altered in the context of a twin pregnancy, but this has never been scientifically demonstrated.

The hypothesis is to observe a decrease in the quality of life of pregnant women with twins at the end of pregnancy, in particular in case of a pregnancy-related pathology.


title: Identification of Clinical, Biometrical and Operatory Factors Related to Pain During Cataract Surgery / RECHMPL20_0210

summary:
Adults who undergo cataract surgery will be questioned after surgery about the eventual pain they experienced, about their health history, personal treatment. If they accept to be included in the study we'll record different parameters related to the surgery: type of anesthesia, duration of surgery, machines used, unexpected events, particularities noticed by the surgeon, etc.

There will be no unusual intervention, everything will be run exactly as if there was no study. No additional consultation needed.

status: Unknown status

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

collaborators: Centre Hospitalier Universitaire de Nīmes

status_simplified: Unknown


title: Comparison of the Proportion of Covid19 Seroconversion of Caregivers Working or Not in the COVID Sector

acronym: CoSigS

summary:
According to recent publications, the percentage of caregivers infected with COVID 19 is evaluated between 10 and 30% . This great variability is due, on the one hand to the intensity of the influx of covid plus patients and, on the other hand, to the disparity in the preparation of caregivers in the face of this emergency. Indeed, we can understand that the strict application of hygiene rules can be faulted in the face of the volume of patients, the lack of protective equipment and the lack of specific training for caregivers in this area. As a result, within healthcare teams, there are many questions that generate anxiety: will I be able to provide care properly while protecting myself from the risk of contamination? This anxiety is also present and sometimes manifests itself aggressively in the entourage or in the vicinity of caregivers, due to lack of scientific data adapted to the local ecology of the crisis.

Thus, the aim of this study is to show that the risk for caregivers of being contaminated by COVID in an area dedicated to COVID positive patients is no higher than being a caregiver in a non-COVID area that he either in the adult or pediatric sector.

study_start_date_type: Anticipated

lead_sponsor: University Hospital, Limoges


title: Impact of Juvenile Obesity on Emotional Memory and Functional Connectivity Between the Amygdala and the Hippocampus

acronym: OBETEEN

summary: Recent studies indicate that obese teenagers exhibit memory disturbances. Adolescence represents a crucial period in the development of the hippocampus and the amygdala, necessary for the implementation of memory and emotional functions for the rest of life. Disturbances of the interaction between amygdala and hippocampus during adolescence have been associated with the development of neuropsychiatric disorders. However, the impact of juvenile obesity on functional amygdala-hippocampus connectivity has not been evaluated yet. The main objective of this study is to compare the emotional memory performance and the level of functional connectivity between the hippocampus and the amygdala during the realization of an emotional associative memory task, in obese and control adolescents.

design_allocation: Non-Randomized

primary_purpose: Basic Science

ReferenceType: result

ReferenceCitation: Vertes PE, Bullmore ET. Annual research review: Growth connectomics--the organization and reorganization of brain networks during normal and abnormal development. J Child Psychol Psychiatry. 2015 Mar;56(3):299-320. doi: 10.1111/jcpp.12365. Epub 2014 Dec 1.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

collaborators: Equipe NeuroImagerie et Cognition Humaine CNRS UMR 5287 - INCIA

collaborators: Lab Nutrition and Integrative Neurobiology (NutriNeuro) INRA UMR 1286 - Bordeaux University

intervention_type: Behavioral


title: Evaluation of the Management of Dental Emergencies During Night and Week-ends

acronym: URGDENT-NW

summary:
For 12 years, the odontology service of the Pitié-Salpêtrière hospital group (GHPS) has been responsible for day and night dental emergency care. Several surveys have been conducted in order to analyze the sociological characteristics of the patients and the typology of the acts performed. These studies indicate that pain is the main reason for consultations, cited by 60 to 80% of patients.

So far, very few studies have been done in the context of emergencies. Very recently, a study was undertaken on the satisfaction of patients consulting the odontological emergencies of the GHPS, during a thesis work.

This study, carried out in collaboration with the URC Pitié Salpêtrière, under analysis, relates to the satisfaction of patients consulting the odontological emergencies of the GHPS during the day and week, Monday to Friday, excluding night and week emergencies -end (WE).

Attendance at night and during WE is important because it is sociologically and medically different from that of day and week. It is therefore important to complete this study by focusing on patients consulting the emergency room at night and during the weekend.

This work therefore responds to a request from the Odontology Emergency Reception Service (SAUO) of the Pitié-Salpêtrière Hospital Group. It will be carried out in the form of a survey whose objective is to assess: on the one hand, the effectiveness of the care provided in this emergency functional unit, and on the other hand the satisfaction of the patients after their passage to the emergency room .


title: Effect of Positive End Expiratory Pressure Titration on the End-expiratory Lung Volume Measured by the Nitrogen Dilution Technique in Acute Respiratory Distress Syndrome

acronym: TIPEX-VOLTEX

summary: Mechanical ventilation of the patient with acute respiratory distress syndrome is one of the first therapies.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Casserly B, McCool FD, Saunders J, Selvakumar N, Levy MM. End-Expiratory Volume and Oxygenation: Targeting PEEP in ARDS Patients. Lung. 2016 Feb;194(1):35-41. doi: 10.1007/s00408-015-9823-6. Epub 2015 Dec 8.

ReferenceCitation: Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801. doi: 10.1164/ajrccm.164.5.2006071.

ReferenceCitation: Olegard C, Sondergaard S, Houltz E, Lundin S, Stenqvist O. Estimation of functional residual capacity at the bedside using standard monitoring equipment: a modified nitrogen washout/washin technique requiring a small change of the inspired oxygen fraction. Anesth Analg. 2005 Jul;101(1):206-12, table of contents. doi: 10.1213/01.ANE.0000165823.90368.55.

ReferenceCitation: Sahetya SK, Goligher EC, Brower RG. Fifty Years of Research in ARDS. Setting Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 Jun 1;195(11):1429-1438. doi: 10.1164/rccm.201610-2035CI. Erratum In: Am J Respir Crit Care Med. 2018 Mar 1;197(5):684-685.

ReferenceCitation: Dellamonica J, Lerolle N, Sargentini C, Beduneau G, Di Marco F, Mercat A, Richard JC, Diehl JL, Mancebo J, Rouby JJ, Lu Q, Bernardin G, Brochard L. PEEP-induced changes in lung volume in acute respiratory distress syndrome. Two methods to estimate alveolar recruitment. Intensive Care Med. 2011 Oct;37(10):1595-604. doi: 10.1007/s00134-011-2333-y. Epub 2011 Aug 25.

lead_sponsor: Centre Hospitalier Intercommunal Aix-Pertuis

intervention_type: Procedure


title: Pregnant Exposure to Persistent Organic Pollutants With Endocrine Disrupting Activity and Development of Breast Cancer in the Next 15 Years: Longitudinal Prospective Cohort Nested Case-control Study

summary:
Breast cancer, the first female cancer, affects one in eight women in her lifetime. The increase and uneven distribution of its prevalence throughout the world cannot be fully explained either by the increase in life expectancy, or by genetic factors present in less than 10% of cases, or by early detection, or by the use of hormone therapy for menopause at certain periods of time.

Numerous experimental and epidemiological arguments, as well as the increased risk of breast cancer in women after 50 years of age who were exposed in utero to Distilbene prescribed for their mothers in the 1950s to 75's, suggest the involvement of environmental factors involved in early development (nutrition, alcohol, tobacco, chemical pollutants) that may act as endocrine disruptors, estrogenomimetic or intervening on other nuclear receptors such as the However, the formal demonstration of the deleterious physiopathological role of such exposure comes up against methodological difficulties in epidemiological terms: first of all, the fact that correlation is sought at the time of the discovery of breast cancer when there are critical windows of exposure (fetal, perinatal, peripubertal and pregnant) and that persistent organic products or POPs, most often lipids, are present.

The objective of this project is to correlate the per-gravidic exposure to POPs (dioxins, dioxinlike, polychlorinated bisphenyls, organochlorine pesticides and flame-retardant polybrominated derivatives) and the development, within 15 years of delivery, of breast cancer, taking into account the confounding factors of classical breast cancer risk (age, reproductive events, etc.).

This project benefits on the one hand from a cord blood bank set up between 2002 and 2005 (6,242 samples) carried out at the Nice University Hospital and the Grasse University Hospital, during a PHRC and on the other hand from the cancer observatory / CRISAP of the PACA Corsica region, exhaustive to more than 92% since 2005, registers which will be cross-referenced and whose cancer cases (N) will be compared to controls. The assays will be carried out after purification, using high-resolution mass spectrometry gas chromatography coupling, the quantification being carried out according to the principle of isotopic dilution. They will be carried out by LABERCA in Nantes, the national reference laboratory of the French Health Agencies ANSES and INVS and also involved in various European projects. Concentrations related to blood lipids will be expressed in quartile and analyzed separately or combined with a cumulative score taking into account confounding risk factors for breast cancer and the geolocation of the initial and final residence in relation to the incinerator of the City of Nice (Department of Public Health CHU of Nice).

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Randomized, Monocentric, Controlled, Superiority Phase II Trial Evaluating Clinical Hypnosis Using Virtural Reality vs Standard Pain Management Procedure During a Musculoskelettal Biopsy

acronym: REVENRI

summary: The primary objective of this trial is to evaluate the benefit of the virtual reality technology in the pain management for patients having a radio-guided musculoskeletal biopsy indication

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Centre Leon Berard


type: Registry Identifier

title: Post Operative Pain After Laparoscopic Hysterectomy Using Airseal® Versus Standard Insufflation System: A Randomized Prospective Study

acronym: AIRSEAL

summary:
Airseal® is an insufflation management system for laparoscopic surgery which provides stable pneumoperitoneum, continuous smoke evacuation and valve-free access to the abdominal cavity. It allows an optimal exposure with a low-pression pneumoperitoneum, which is rarely possible with our standard insufflation system under a pneumoperitoneum of 12 millimetres of mercury(mmHg).

The objective of this study is to compare the use of Airseal® system with a low pression pneumoperitoneum and our standard insufflation system usually used in our center in term of postoperative abdominal pain after laparoscopic hysterectomy for benign disease.

This superiority prospective randomized trial is designed to include all patients > 18 years old referred for laparoscopic total hysterectomy for benign disease (with or without uni or bilateral annexectomy). Each patient would be randomized to one of this two following groups :

" Airseal® " group : use of AIRSEAL® to obtain stable low pression laparoscopy with a 8 to 10 mmHg pneumoperitoneum.
" Standard laparoscopy " group : laparoscopy realised with our usual insufflation system and a 12 to 15 mmHg pneumoperitoneum.

The primary end point is mean intensity of abdominal pain six hours after the end of surgery (H6), measured by simple numerical scale (ENS).

The secondary end points are:

peroperative endpoints : operative time, blood loss, use of additional ways of increasing exposure, peroperative complications, conversion to laparotomy, feeling of the surgeon regarding the difficulty of the surgery (measured by a simple numerical scale)
early postoperative endpoints : intensity of abdominal pain at the entry in recovery room (H0), at twelve hours after the end of surgery (H12), twenty four hours (H24) and forty eight hours (H48) ; intensity of scapular pain at the same times (H0, H6, H12, H24 and H48), need for analgesic administration (regarding to the standardized analgesic protocol), difference in the hemoglobin level before surgery and the first day after, early postoperative complications, necessity of a second surgery and the reason, length of hospital stay.
late postoperative end points : estimated time to return to optimal quality of life, global satisfaction of patients evaluated by the Quality Of Life Questionnaire Short Form 12.

It will be estimate that the use of Airseal® will reduce the mean abdominal pain at H6 post operative of 1 point on the simple numerical scale compared to our standard insufflation system, with a standard deviation of 1,5. Type 1 and 2 errors were set to the usual levels of 0,05 and 0,20 respectively (power of 80%). Assuming a 10% withdrawal rate, the sample size would be 80 patients (40 patients in each group).

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Radiofrequency in Differentiated Thyroid Cancer Metastatic Lymph Node: Prospective Study of Safety and Efficacy

acronym: METATHYRAF

summary:
Radiofrequency (RF) could be technically feasible and effective in the treatment of lymph node metastases of differentiated thyroid cancer. It could constitute a minimally invasive and feasible therapeutic alternative in ambulatory, allowing a reduction of the tumoral volume sufficient to limit the symptoms even to induce a tumor remission, a normalization of the tumoral markers and a better quality of life.

The aim of this study is to evaluate the anti-tumor echographic efficacy at 12 months of radiofrequency on lymph node (LN) metastasis of thyroid cancer


title: Effect of a New BI-specifiC Antibody Towards Dendritic Cells on Inflammation in Rheumatoid Arthritis

summary:
First, this study will evaluate, in vitro, the cellular composition of the synovial fluid from patient with rheumatoid arthritis, gout or osteoarthritis.

Then samples will be test with a new format of bispecific antibody targeting dendritic cells. The production of IL-10 will be the principal criteria of judgment. Production of others cytokines like IL-1B, IL-6, IL-12 and IFN will be checked as well.

lead_sponsor: University Hospital, Tours

location_facility: Rheumatology Department, University Hospital, Tours


title: Place of General Medical During Oncology Care Management

summary:
The Purpose of MGPEC_ONCO is to see if patient consult their general practitioner during the management of their cancer, especially before hospitalization. The study concerns not planned hospitalizations in medicine service.

Before leaving hospital, the patient completes the survey, other data are taken in patient record

lead_sponsor: Institut de Cancérologie de Lorraine

lead_sponsor_type: industriel


title: Characterization of a Method of Fertility Preservation for Patients Diagnosed for a Cancer

summary:
Human oocyte cryopreservation is routinely used for fertility preservation of women who will be exposed to gonadotoxic effect of cancer treatment. After ovarian stimulation, matured oocytes are vitrified. However, this strategy cannot always be used, particularly for hormone-sensitive cancer or when ovarian stimulation is not possible. An approach including immature oocytes and in vitro maturation (IVM) could be considered in these cases. While some qualitative analysis of oocytes vitrified before or after IVM suggest that vitrification should be performed after IVM, little is known about vitrification effects on actin and tubulin cytoskeleton and kinetic of maturation of human ovocytes.

To answer to this question, Investigator performed quantitive analyses comparing matured oocytes from three different groups: vitrified before IVM or after IVM and non-vitrified oocytes. Non-vitrified matured oocytes were used as a control. Different parameters have been analysed during maturation and in matured oocytes.

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Origio A/S


title: Evaluation of the Prevalence of Age Related Macular Degeneration (ARMD) in Parkinson's Patients and Assesment of the Role of L-DOPA (AMD-PARK)

acronym: AMD-PARK

summary:
Age related macular degeneration (ARMD) is a major and irreversible cause of blindness among the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE) and the external segments of the retinal photoreceptors, plays a crucial role in this pathology. A recent epidemiologic study in the US, has shown that Parkinson patients treated with L-DOPA, developed only later an ARMD when compared to the untreated patients.

The L-Dopa is an endogenous ligand of the GPR43 receptor (G protein-coupled receptors), located on the RPE's cell's apical pole.

This receptor, via several intracellular mechanisms, regulates the cell's exosomal and endosomal pathways: it would appear that the L-DOPA, by stimulating this receptor, decreases significantly the RPE's exosome release.

The contents of the exosomes is still uncertain, however in addition to their signalization role, it seems they transport pro-inflammatory components, possibly helping the cellular recruitment due to the mononuclear phagocytic systems, particularly toxic for the photoreceptors.

The aim of this study is to estimate the prevalence of ARMD in a sample of Parkinson's Patients followed at Fondation Ophtalmologique Adolphe de Rothschild and to compared it to the prevalence of ARMD of the general population.

Furthermore the study aims to explore a possible causal link between L-DOPA treatment and ARMD.

location_facility: Fondation ophtalmologique Adolphe de Rothschild

intervention_type: Diagnostic Test


title: Comparison on Succinylcholine Onset Time Assessed by Train of Four Stimulation Versus Clinical Judgment During Rapid Sequence Induction

acronym: CELOTOF

summary:
Succinylcholine is a myorelaxant agent often used during rapid sequence induction for patients who need to undergo general anesthesia but who are at risk of pulmonary aspiration of gastric content. Whereas other myorelaxant agents are monitored with train of four stimulation to assess onset and duration, few anesthesiologists use train of four stimulation for onset of succinylcholine, as the anesthesiologists evaluate the effect with the time from injection (usually one minute) and the muscle fasciculation due to the release of acetylcholine.

The data available on onset duration of this drug are old and bases on only few studies, but the succinylcholine if sometime harmful (anaphylaxis , cardiac arrest, bronchospasm).

The investigators want to assess the onset time of succinylcholine with an objective toll , the train of four stimulation, and evaluate if the clinical judgment of the anesthesiologist is reliable to predict an adequate moment for endotracheal intubation.

lead_sponsor: University Hospital, Caen


title: Oral Quality of Life of Patients to be Totally Edentulous at One Arch at Least and Benefiting From the Realization of Immediate and Usual Complete Removable Prostheses.

summary:
The restorative and surgical odontological department at the Nantes University Hospital frequently hosts patients with a severely degraded oral condition who has never benefited from a removable prosthetic rehabilitation. The chosen treatment plan consists most of the time in extracting all the residual teeth at one or both arches with the immediate insertion of a complete removable prosthesis performed prior to the extractions. This prosthesis is adapted by regular relining during the osteomucosal healing and is replaced by a usage removable prosthesis on average 6 months after the extractions.

The transition from dentate state (even dilapidated) to toothless state can be a source of discomfort and impairment and lead to a decrease of life's quality for patients. The purpose of this study is to evaluate oral health of the patients at the different stages of prosthetic rehabilitation by using GOHAI (Geriatric Oral Health Assessment Index).

lead_sponsor: Nantes University Hospital


title: Impact of Food Structure on Micronutrient Biovailability in Human

summary:
The nutritional quality of foods strongly depends on the structure / texture of foods, because of the impact on food disintegration, and then on digestion process and nutrient utilization by the human body. However, this relationship between food structure and nutrient bioavailability is still widely unknown.

MicroNut project aims at demonstrating and evaluating in humans the impact of structure / texture changes on micronutrient bioavailability. In order to do this, four complex food matrices, with constant composition but different structures / textures, and as close as possible to real foods have been designed and are evaluated in the present study. A mixture of egg and plant proteins is the basis of these lipoprotein matrices in which four micronutrients will be followed up : two lipophilic (vitamin D and lutein) and 2 hydrophilic (vitamins B9 and B12).

ipd_sharing_description: De-identified individual participant data for all outcome measures will be made available, only after joined consent of promotor and investigator. Data use and transfer to a third party will be performed according to the agreement signed as part of the grant funded by Qualiment

lead_sponsor: Françoise Nau

collaborators: Centre de Recherche en Nutrition Humaine d'Auvergne

location_facility: Centre de Recherche en Nutrition HUmaine d'Auvergne


title: Evaluation of Reporting of VEGF Inhibitors Associated Cardiovasclular Adverse reactioNs Using International Pharmacovigilance Database.

acronym: VEGAN

summary: Antiangiogenics (AAs) which are vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR) inhibitors might have high grade adverse events (AEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatment including VEGF and VEGFR inhibitors using the World Health Organization (WHO) database VigiBase.

time_perspective: Cross-Sectional

ReferenceCitation: Alexandre J, Moslehi JJ, Bersell KR, Funck-Brentano C, Roden DM, Salem JE. Anticancer drug-induced cardiac rhythm disorders: Current knowledge and basic underlying mechanisms. Pharmacol Ther. 2018 Sep;189:89-103. doi: 10.1016/j.pharmthera.2018.04.009. Epub 2018 Apr 24.

publisher_dissemination: Elsevier

ReferenceCitation: Gougis P, Wassermann J, Spano JP, Keynan N, Funck-Brentano C, Salem JE. Clinical pharmacology of anti-angiogenic drugs in oncology. Crit Rev Oncol Hematol. 2017 Nov;119:75-93. doi: 10.1016/j.critrevonc.2017.08.010. Epub 2017 Sep 1.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.

intervention_type: Drug


title: Satisfaction of Using a Continuous Glucose Monitoring System to Monitor Interstitial Fluid Glucose Level in Hospitalized Insulin-dependent Diabetic Patients Treated Using a Portable Sub-cutaneous Pump

acronym: GLUCO FLASH

summary: The aim of the study is to establish whether routine usage of the FreeStyle Libre™ system (Abbott) improves satisfaction and quality of sleep in patients hospitalized for poor glycemic control with an indication for external insulin pump treatment.

status: Terminated

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Added Value of the Oculomotor and Cognitive Examination in the Management of Patients With Attention Deficit Disorder With or Without Hyperactivity. Interventional Study to Evaluate Current Care

summary:
ADHD is a neurodevelopmental disorder characterized by symptoms of inattention and / or hyperactivity-impulsivity that affects nearly 6% of school-aged children and persists into adulthood. More and more studies are interested in biomarkers of this pathology. The oculomotricity, which allows to highlight deficits motor and attention present in ADHD, is used routinely in the expert centers. In general, the pharmacological treatment of ADHD is associated with a clinical response in approximately 70% of cases. Today, there is no review to predict the individual response to treatment.

Hypotheses The investigators hypothesize that a precise analysis of the oculomotor markers will allow to measure the improvement of the symptomatology of the ADHD disorder following the introduction of the psycho-stimulatory treatment. In other words, the investigators hypothesize that these markers could be a useful aid in patient follow-up by the clinician and allow early identification of responder and non-responder patients.

Primary objective The main objective of this study is to measure the added value of oculomotor examination in the follow-up of psycho-stimulant-treated ADHD patients.

Main Evaluation Criteria The primary endpoint is oculomotor performance. Parameters analyzed for each saccade are latency, amplitude, duration, average speed, direction.

Secondary Criteria Evaluation (s) Correlations will be established between oculomotor data and scores obtained at the clinical scales assessing ADHD symptoms of inattention and hyperactivity as well as cognitive performance. The data obtained before the introduction of the psycho-stimulant treatment (V0, baseline) will be compared with those obtained after acute administration of methylphenidate (10 mg orally,V1) and during the follow-up visit at 6 months (V2).

primary_purpose: Other

ReferenceCitation: Munoz DP, Armstrong IT, Hampton KA, Moore KD. Altered control of visual fixation and saccadic eye movements in attention-deficit hyperactivity disorder. J Neurophysiol. 2003 Jul;90(1):503-14. doi: 10.1152/jn.00192.2003. Epub 2003 Apr 2.

ReferenceCitation: Kurscheidt JC, Peiler P, Behnken A, Abel S, Pedersen A, Suslow T, Deckert J. Acute effects of methylphenidate on neuropsychological parameters in adults with ADHD: possible relevance for therapy. J Neural Transm (Vienna). 2008;115(2):357-62. doi: 10.1007/s00702-008-0871-4. Epub 2008 Feb 12.

ReferenceCitation: Duval F, Erb A, Mokrani MC, Weiss T, Carcangiu R. First-Dose Methylphenidate-Induced Changes in the Anti-Saccade Task Performance and Outcome in Adults with Attention-Deficit/Hyperactivity Disorder. Psychiatr Res Clin Pract. 2021 May 19;3(4):146-152. doi: 10.1176/appi.prcp.20210010. eCollection 2021 Winter.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: gold

publisher_dissemination: American Psychiatric Association Publishing

lead_sponsor: Centre Hospitalier Rouffach


title: Aortic Stenosis: Determinants of Progression, Severity and Left Ventricular Remodeling (AS-PROGRESSION)

acronym: AS-PROGRESSION

summary:
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI).

AS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified.

The aim of the study is to evaluate prospectively the progression and impact of AS in 500 patients using clinical, biological, echocardiographic and MRI parameters performed annually.

status: Active, not recruiting

lead_sponsor: University Hospital, Rouen


title: Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement (AS-INTERVENTION)

summary:
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI).

AS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified.

The aim of the study is to characterize prospectively the left ventricular remodeling and assess its changes after AVR and within 1 year in 500 patients using clinical, biological, echocardiographic and MRI parameters.


acronym: RESARPO

summary: Prospective study of Predictive Factors of Survival With and Without Repetition With 5 and 10 Years Curative Post-oesophagectomy for Cancer of the Oesophagus

time_perspective: Retrospective

lead_sponsor: University Hospital, Brest


title: Development of an Algorithm and a Smartphone Application for the Evaluation and Prediction of Suicidal Risk

acronym: EMMA

summary:
Suicide is a major health problem that causes annually a million death worldwide. Suicide and suicide attempts are preventable.

A history of self-injuries or suicidal attempts are known to be the most important risk factor for death by suicide. Suicidal ideation is also strongly correlated with suicide attempts.

The development of Smartphones applications offers new possibilities for data collection and transmission.

Moreover, the online help function, when a suicidal crisis occurs, is the most effective strategy for prevention of suicidal behavior.

Specific technologies have been developed to analyse behaviors and experiences of patients in a natural environment, in real life.

That is the goal of Ecological Momentary Assessment.

The aim of the study is to develop an algorithm to assess and predict the risk of suicidal event occurrence, in order to detect as soon as possible the signs of suicidal crisis.

EMMA will be the first application in French, meeting the recommendations for health applications, developed by experts on suicidal behavior and in collaboration with patients which aims to predict suicidal risk.

A subsequent study, conducted on a larger population, should allow to validate the predictive algorithm of EMMA.

Long-term goal is to improve the care of patients at risk for suicidal behavior.

ReferenceCitation: Morgieve M, Genty C, Aze J, Dubois J, Leboyer M, Vaiva G, Berrouiguet S, Courtet P. A Digital Companion, the Emma App, for Ecological Momentary Assessment and Prevention of Suicide: Quantitative Case Series Study. JMIR Mhealth Uhealth. 2020 Oct 9;8(10):e15741. doi: 10.2196/15741.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Bretagne Occidentale

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: JMIR Publications

lead_sponsor: University Hospital, Montpellier

collaborators: University Hospital Saint jacques, Besançon

collaborators: University Hospital, Henri Mondor/Albert Chenevier, Créteil


title: Evaluation of Intraoperative Ultrasound for the Positioning of Prostheses in Laparoscopic Surgery of Genital Prolapse

acronym: SONOMESH

summary: This study is conducted in order to determinate the faisability of an intraoperative ultrasound to mesure the positioning of prostheses during laparoscopic promontofixation.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Metastatic Breast Carcinoma: Evaluation of Women Sexual Quality of Life

acronym: SexoMBC

summary:
Sexual health is one of the relevant parameters for assesing the quality of life.

Improvement sexual and emotional function improves quality of life scores and depression or anxiety in curative phase.

The purpose of the study is to assess the quality of sexual life of postmenopausal women with metastatic breast cancer in couples and to establish links with overall quality of life and the quality of the relationship.


type: EudraCT Number

title: Multicenter Randomized Phase III Study Evaluating the Efficacy and Safety of Systemic Treatments of Bone Metastases From Kidney Cancer in Patients Treated With Targeted Therapies

acronym: MOSCAR

summary: Multicenter, randomized, open-label, 2-arm, parallel-group, phase III study whose goal is to assess the efficacy and safety profile of bone-targeted treatments (Arm A: denosumab or zoledronic acid) versus the control arm (Arm B: no specific treatment) in patients with bone metastases under targeted therapy for Metastatic Renal Cell Carcinoma.


title: Impact of Platelet Activation in Intracranial Aneurysm Rupture Risk - PLAQRAN

acronym: PLAQRAN

summary: Sub arachnoid hemorrhage consecutive to intracranial aneurysm rupture is a devastating disease. Predictors of intracranial aneurysm rupture are limited and focus mainly on size and location. Platelet activation may have a deleterious role on aneurysm rupture. The assumption is that patients with ruptured intracranial aneurysm will present a higher rate of platelet activation compared to patients with non ruptured aneurysms.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Value of an Integral Color Scale on Urine Collection Bags Versus Use of a Strip in Description of Hematuria.

acronym: HEMAPOCHE

summary: The investigators hypothesize that incorporation of a colorimetric scale on urine collection bags to estimate degree of hematuria would allow better characterization of urine by healthcare staff thus leading to improved patient care.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


title: Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study

acronym: CAPEMBOL

summary: The authors hypothesize that, in patients with low volume tumors identified according to anatomo-pathological criteria and imaging, and under active surveillance focal, therapy by unilateral embolization of prostatic arteries will provide local control of the tumor via selective ischemia


title: Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia : Impact on the Capacities of Autonomy

acronym: IPT+

summary: Schizophrenia is a chronic disease with deficit in social interaction and lost of autonomy in daily life. Negative symptoms as blunted affect, avolition, social deficit and anhedonia and cognition were prognosis and functioning key's factors. Psychotropic medications have shown only poor effect to improve negative symptoms and cognition as attention, memory and cognitive flexibility. So, cognitive remediation programs were developped to focus cognitive disorders. The IPT (Integrated Psychological Treatment) is one of the most complete program with modules on cognitive and social abilities. The aim of this study is to evaluate the efficacy of IPT+ program to improve autonomy capacities of long stay inpatients suffering from schizophrenia 6 at the end of the program With IPT+ this study will improve autonomy capacities for patients suffering from deficit schizophrenia and allowed patients to go out hospital earlier than before.

status: Withdrawn

appel_a_projets: PHRCI

region: Occitanie

nom_etablissement: CHU MONTPELLIER

type_etablissement: CH

acronyme: IPT-plus

titre: Programme de remédiation cognitive et émotionnelle destiné aux patients souffrant de Schizophrénie déficitaire hospitalisés au long cours : impact sur les capacités d'autonomie.

discipline_principale: autre

nom_porteur: LARUE

prenom_porteur: Aurore


title: Isolated Fetal Splenic Cyst : Prenatal Diagnosis and Postnatal Evolution

summary: The aim of this study was to describe prevalence, radiologic and ultrasound evolution during pregnancy, postnatal evolution and treatment strategy in case of isolated fetal spelnic cyst


title: Compared Efficacy of Patient-controlled Epidural Analgesia With or Without Automatic Boluses

acronym: FREE BOLI

summary:
Epidural analgesia is a significant feature of the everyday experience of the delivery room. Its benefits on the maternal experience and in terms of security has been widely demonstrated.

However, some women under epidural analgesia have experienced motor block, which has been found to contribute in the lengthening of the duration of labor, dystocia and instrumental delivery. Therefore, in recent years, reducing these side effects by modifying local anesthetics, concentration of local anesthetic and injected volume has been a priority, with one aim: optimize analgesia without motor blockage.

Although epidural analgesia was first provided by continuous epidural infusion, the efficacy of intermittent epidural bolus has been demonstrated. Small regularly spaced intermittent boluses lead to a more extensive and symmetrical spread of local anesthetic in the epidural space. These findings have led to a new kind of administration combining epidural intermittent boluses with patient-controlled boluses called PEIB (Patient Epidural Intermittent Bolus). On clinical grounds, PEIB is associated with reduced local anesthetic consumption and higher maternal satisfaction.

While PEIB is experimentally and clinically approved, incidence of maternal motor block and instrumental vaginal delivery don't decrease significantly with this programming. We hypothesized that automatic intermittent boluses can lead to an accumulation of local anesthetic overlapping with patient bolus. This accumulation can be the source of motor block, dystocia and instrumental delivery. Therefore, we propose to lead a monocentric prospective randomized study upon 308 patients in order to compare PEIB to epidural analgesia totally controlled by the patient. We expect a lower consumption of local anesthetic and a lower incidence of motor block, dystocia and instrumental delivery with the free automatic bolus programming.


title: Neuropsychological Development and Functional Outcome Sin Children With Hirschsprung Disease at School Age - Hirschsprung

acronym: Hirschsprung

summary:
Hirschsprung's disease (HD) is a rare congenital disease (1:5000) characterized by neonatal functional low bowel obstruction that is caused by aganglionosis of the distal bowel. HD treatment consists in surgery of colonic reduction in the early childhood, requiring afterward a long-term follow-up. In the long term complications (incontinence, constipation, enterocolitis, soiling)but also iterative anesthesia in childhood and repeated hospitalizations can have negative effects on child's development.

The main aim of the study is to estimate neuropsychological development at school age (6-10 years). Of children operated of HD Secondary aims are evaluation of the neuro-driving development and global health, comparison of quality of life levels to those of French population standards as well as to study the complex relations between on one hand the quality of life of these children and on the other hand the socio-demographic data, the initial clinical elements and the surgical coverage, as well as their health and current cognitive profile.

This multicenter study included pediatric surgery departments of Marseille. All children born between 1/1/2005 and 31/12/2010 and presenting HD represent the population. All the families will be contacted resting on the networks of set up follow-up. A written agreement will be collected with the parents. For all the participating children, a consultation will be organized: quality of life data (reported by children and by their parents in validated standardized questionnaires), clinical examination of the child, cognitive profile of the child. The duration of inclusion is scheduled for 12 months.

This is the first French study using auto-reported data on children's quality of life at school age affected by a HD. The results of this study will allow developing hypotheses on predictive risk factors for neuropsychological development disorders. Besides a better knowledge of the relation existing between these children quality of life and their functional results due to the disease could help clinicians in their medical reflections.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille


title: Comparison of High Flow Nasal Cannula Oxygen and Conventional Oxygen Therapy on Ventilatory Support Duration During Acute-on-chronic Respiratory Failure: a Multicenter, Randomized, Controlled Trial

acronym: HIGH FLOW ACRF

summary:
Chronic respiratory insufficiency and COPD are the third leading cause of death worldwide. Patients decompensate at various stages of their disease and exhibit acute-on-chronic respiratory failure (ACRF), a frequent cause of ICU hospitalization for hypercapnic acute respiratory failure (ARF). Non-invasive ventilation (NIV) is the first line ventilatory treatment for hypercapnic ARF. It is applied intermittently, separated by periods of spontaneous breathing (SB) with standard oxygen (O2).

Standard O2 has drawbacks that limit the benefit of intermittent NIV in hypercapnic ARF: limited gas flow which is well below the patient's inspiratory flow rate, limited capacity and efficiency of oxygenation with non-controlled FiO2 (risk of excessive oxygen and induced hypercapnia), and cold and dry gas leading to discomfort and under-humidification of the airways and tracheobronchial secretions. Benefits in terms of work of breathing and CO2 removal resulting from PEEP and pressure support applied during NIV periods could be rapidly lost during standard O2.

Recently, use of high-flow heated and humidified nasal oxygen therapy (HFHO) has gained enthusiasm among intensivists to manage ARF. HFHO delivers high flows (up to 60L/min, that generate moderate PEEP) of heated and humidified oxygen at a controlled and adjustable FiO2 (21 to 100%) that rapidly improve respiratory distress symptoms, oxygenation, respiratory comfort and outcome of patients with hypoxemic ARF.

These unique features of HFHO could overcome some of the drawbacks of standard O2 during SB periods in hypercapnic ARF. Indeed, PEEP effect, washout of nasopharyngeal dead-space limiting CO2 re-breathing and inspired gas conditioning preserving adequate mucosal function and secretion removal, could potentially contribute to decrease airways resistance, intrinsic PEEP and work of breathing, while improving patient comfort. Investigators aim to determine if the use of HFHO, as compared to standard O2, increases the number of ventilator-free days (VFDs) and alive at day 28 in patients with hypercapnic ARF admitted in an ICU, an intermediate care, or a respiratory care unit, and requiring NIV.

ReferenceCitation: Ricard JD, Dib F, Esposito-Farese M, Messika J, Girault C; REVA network. Comparison of high flow nasal cannula oxygen and conventional oxygen therapy on ventilatory support duration during acute-on-chronic respiratory failure: study protocol of a multicentre, randomised, controlled trial. The 'HIGH-FLOW ACRF' study. BMJ Open. 2018 Sep 19;8(9):e022983. doi: 10.1136/bmjopen-2018-022983.

publisher_dissemination: British Medical Journal

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Direction Générale de l'Offre de Soins

location_facility: Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: High Flow ACRF

titre: Comparaison de l'oxygénothérapie à haut débit et de l'oxygénothérapie conventionnelle sur la durée de l'assistance ventilatoire au cours de l'insuffisance respiratoire aiguë hypercapnique : Etude randomisée contrôlée multicentrique

discipline_principale: anesthésiologie / réanimation

nom_porteur: RICARD

prenom_porteur: Jean Damien


title: Adjuvant Immunotherapy After Salvage Surgery in Head and Neck Squamous Cell Carcinoma : Phase 2 Trial Evaluating the Efficacy and the Toxicity of Nivolumab Alone, and of the Combination Nivolumab and Ipilimumab

summary: Two randomized trials of reirradiation after salvage surgery have been conducted by the GETTEC and GORTEC collaborative groups, both members of the French HN Intergroup: The first trial compared reirradiation and a "wait and see attitude" and was published in 2008 [1]. The second trial compared two modalities of reirradiation. Our hypothesis is that adjuvant treatment with immunotherapy will lead to a DFS similar to that observed in previous trials of post-operative reirradiation with possibly lower toxicity.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

appel_a_projets: PHRCK

nom_etablissement: INSTITUT GUSTAVE ROUSSY

type_etablissement: CLCC

titre: Immunothérapie adjuvante après chirurgie de rattrapage dans les cancers des voies aéro-digestives supérieures : phase 2 évaluant l'efficacité et la toxicité du nivolumab seul, et de l'association nivolumab et ipilimumab

discipline_principale: cancer

nom_porteur: GUERLAIN

prenom_porteur: Joanne


title: Efficiency of Botulinum Toxin Injection for Spastic Equinovarus Foot in Post Stroke Hemiparetic Patients Randomized Controlled Trial Versus Placebo

summary: Botulinum toxin is the main treatment for focal spasticity but the effects of botulinum toxin injections with respect to limitations of gait activities are still discussed. The aim of this study is to to investigate the effects of intramuscular Botulinum toxin type A injections on quantitative gait parameters (gait speed, step length and width, single support time) and posture, in hemiparetic post stroke patients with lower limb spasticity.

ReferenceCitation: Kerzoncuf M, Viton JM, Pellas F, Cotinat M, Calmels P, Milhe de Bovis V, Delarque A, Bensoussan L. Poststroke Postural Sway Improved by Botulinum Toxin: A Multicenter Randomized Double-blind Controlled Trial. Arch Phys Med Rehabil. 2020 Feb;101(2):242-248. doi: 10.1016/j.apmr.2019.04.024. Epub 2019 Aug 27.

oa_host_type: publisher

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

location_facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille


title: Hypokalemia in Hospitalized Patients for Heart Failure in the Therapeutic Cardiac Failure Unit: Morbidity-mortality Impact

acronym: HYPIC

summary: Hypokalemia is very common in heart failure patients. Deleterious effects have been report on the cardiovascular system. Most of the clinical data concerning this ionic trouble are based on post-hoc study and some findings seemed disjointed.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Prone Position Impact in Patients With Acute Respiratory Distress Syndrome on the Incidence of Central Venous Catheter Colonizations in Reanimation

acronym: ILCDV

summary: Catheter colonization, catheter-associated infection and catheter-associated bacteremia are a major challenge for resuscitation unit. This study wishes to explore the impact of the central venous catheter colonization on the ARDS patient with and without prone position.

sponsor_collaborators: Centre Hospitalier Régional Metz-Thionville


title: Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to Adherent-Invasive Escherichia Coli

acronym: ROMAN

summary:
The M2iSH laboratory showed with two previous clinical trials that Crohn's Disease (CD) macrophages present i) a defect to control Adherent-Invasive Escherichia coli (AIEC) infection related to polymorphisms associated with CD; ii) a CD - specific cytokine secretion profile after an AIEC infection and intestinal inflammation dependent; iii) a modification of the response of CD macrophages at a basal state and after the AIEC infection. These results consolidate the hypothesis of a defect specific to CD macrophages.

That's why, the primary purpose of this study is to realize a proteomic analysis of macrophages of CD patients infected or not with AIEC and to compare them to Ulcerative Colitis (UC) patients and healthy volunteers.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Laboratoire M2Ish


title: Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension

acronym: Rehab-HTP

summary: Clinical improvement has been demonstrated after cardiorespiratory rehabilitation in patients with pulmonary hypertension. Rehabilitation is therefore now part of the recommendations for good practice. However, no data is available to elucidate the mechanism of this improvement: an improvement in myocardial reserve or an improvement in peripheral muscular capacity? The main objective of this study is to evaluate the difference in right ventricular contractile reserve before and after cardiorespiratory rehabilitation during stress ultrasound in pulmonary hypertension in 10 patients with pulmonary hypertension.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Effects of Sleep Privation on Sensorimotor Integration of the Upper Limb During a Manual Endurance Test in Healthy Volunteers-Physiological Study

summary:
The investigator showed that a night of sleep deprivation halved the duration of an inspiratory endurance test and that this loss of endurance could be secondary to a lack of activation of the pre-motor cortex. However, the inspiratory endurance test is associated with a feeling of dyspnea that could lead to premature arrest, and the inspiratory drive is complex, both automatic and voluntary. The investigator can reproduce this results on a simpler drive.

During the execution of an exercise involving repeated contractions of the hand it is possible to record the activation of the pre-motor cortex corresponding to the phase of preparation of the movement. The amplitude of these premotor potentials is proportional to the developed motive force.

The purpose of this study is to assess the impact of sleep deprivation on the muscular endurance of non-dominant in healthy subjects.

Hypothesis: Sleep deprivation causes a decrease in manual motor endurance by decreasing cortical pre-motor control.

Main objective: To compare the motor endurance of healthy subjects after a night's sleep and after a sleepless night.

Secondary objective: To compare the amplitude of premature cortical control at the beginning of the endurance test after a night's sleep and after a sleepless night.

lead_sponsor: Poitiers University Hospital


title: Bedside Therapeutic Monitoring of β-Lactam Levels in Newborns, Children and Adolescents Admitted to Intensive Care: Study of a Pharmacokinetics Monitoring Method.

summary: This study evaluate the capacity of the MON4STRAT device for drug monitoring of β- lactam antibiotic concentrations in newborns, children, and adolescents admitted in intensive care units with a health care-associated infection.

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
European Commission


title: Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea

summary:
Every year, at the Nice University Hospital, about sixty deliveries take place before 24 weeks of amenorrhea. The child is not viable because of his extreme immaturity. In most cases, a child born before 24 years of age is stillborn, but in about one in three cases, it shows signs of life such as heartbeat, breathing, gasps or limb movements.

With these too small children showing signs of life, three attitudes are possible: doing nothing and waiting for this life to stop by themselves, setting up palliative care to ensure the child's comfort, or administering a medication to shorten his or her life. The attitude to have is not univocal and the feeling of the teams confronted with their management is difficult even if the goal of the caregivers is always to act as best as possible.

The main objective of the study is to describe the clinical state of the child and the practices implemented in the birth room at the Nice University Hospital when children showing signs of life before 24 weeks of amenorrhea are born.

The secondary objective is to describe caregivers' experiences, their experiences of these situations and attitudes towards children and their parents, and to identify ethical dilemmas in these situations.

This study is an observational cohort study including all births of live children before 24 weeks of amenorrhea at Nice University Hospital for 12 months. It consists of two parts: a quantitative study describing the child's condition and caregiving practices, and a qualitative study of caregivers' experiences and the determinants of their attitudes towards the child.

The investigator will coordinate the collection of the data necessary to conduct the quantitative study, and then conduct individual semi-directive interviews with each of the caregivers present at the birth of the child. The qualitative study will be based on the analysis of these interviews.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Subcutaneous Suppressive Antibiotic Therapy for Bone and Joint Infections

summary:
For patients having a bone or joint infections, with or without device, optimal surgical therapy could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening.

Subcutaneous (SC) administration of injectable intravenous antibiotics as prolonged suppressive antibiotic therapy could be a convenient way when oral treatment is not available to facilitate ambulatory care, this practice being considered as routine care.

The aim of this study is to evaluate tolerance and efficacy of subcutaneous administration of antibiotics for prolonged suppressive antibiotic therapy in patients having this treatment as part of their routine care.

ReferenceCitation: Pouderoux C, Becker A, Goutelle S, Lustig S, Triffault-Fillit C, Daoud F, Fessy MH, Cohen S, Laurent F, Chidiac C, Valour F, Ferry T; Lyon Bone and Joint Infection Study Group. Subcutaneous suppressive antibiotic therapy for bone and joint infections: safety and outcome in a cohort of 10 patients. J Antimicrob Chemother. 2019 Jul 1;74(7):2060-2064. doi: 10.1093/jac/dkz104.

oa_host_type: repository

evidence: oa repository (semantic scholar lookup)

unpaywall_oa_status: green

publisher_dissemination: Oxford University Press

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon)


title: General Practitioner's Place in the Treatment of Fracture Osteoporosis in the Elderly

acronym: GEOFRAGE

summary: Osteoporosis is a major public health problem. Its screening and its treatment remain largely insufficient while therapies have demonstrated their effectiveness. In the event of a severe fracture, the update of the 2016/2017 recommendations, prepared by the Research and Information Group on Osteoporosis and the French Rheumatology Society, concerning osteoporosis recommends a specific treatment with bisphosphonates as first-line treatment, without bone densitometry, regardless of age. The frequency of prescribing anti-osteoporotic treatment as an outpatient after a fracture of the upper extremity of the femur is very low (2% to 21% according to the studies). The main factors associated with non-prescription found are co-morbidities (charlson score> 6), dementia, obesity (BMI> 30), chronic alcoholism, male sex, polypharmacy> 4, age. Conversely, the factors associated with prescribing are recurrent falls (> 2 / year), a history of osteoporotic fracture, an Iso Resource Group> 3, female sex, and corticosteroid therapy.

lead_sponsor: Rennes University Hospital


title: Impact of a Fourth Hexavalent Vaccine Dose During Primary Vaccination After Haematopoietic Stem Cell Transplantation

acronym: EVaxAll

summary: It is recommended for patients who underwent an hematopoietic stem cell transplantation to receive 6 months after the graft 3 injections of hexavalent vaccine (diphteria-tetanus- poliomyelitis-pertussis-Hib-HBV) within 2 months followed by a booster dose one month after. The patients included in the study will have a measure of their antibody level against 5 pathogens (diphteria toxin, tetanus toxin, Haemophilus influenza b, hepatitis B virus, poliomyelitis virus) one month after the 3rd injection of hexavalent vaccine. If the antibody response is not sufficient, they will be randomized for a 4th dose in the following month. The antibody response will be again measured one month after the 1 year booster dose.

primary_purpose: Prevention

lead_sponsor: University Hospital, Grenoble

collaborators: Centre Hospitalier Universitaire de Nice

collaborators: Centre Hospitalier Universitaire de Besancon

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU GRENOBLE ALPES

acronyme: Evaxall

titre: Vaccination après allogreffe de cellules souches hématopoïétiques : Etude randomisée évaluant l'intérêt d'une injection supplémentaire chez les patients non répondeurs à M3.

discipline_principale: hors cancer

nom_porteur: EPAULARD

prenom_porteur: Olivier


title: Long Term Clinical and Echographic Follow Up After TAVI: A Pro-spective Cohort Study.

summary:
Transcatheter Aortic Valve Implantation (TAVI) is became the gold-standard therapy for patients with severe and symptomatic aortic stenosis with high operative risk or not suitable for surgery.

All studies assessed TAVI showed excellent results at short and mid-term follow-up. The current and future development of the devices predict an extension of indications to "intermediate-risk" and younger patients.

Therefore, long-term evaluation of these valves is a priority to determine their durability.

However, standardized echographic follow-up of patients implanted with TAVI is lacking.

Indeed, there was not consensual definition of TAVI degeneration until now. Recently, European Society of Cardiology published echographic criteria to precise and standardized TAVI deterioration based on simple hemodynamic and morphological criteria.

In addition, very few studies have been interested in monitoring more than 5 years of these devices.

Finally, nowadays we did not know if TAVI evolution is the same as surgical bioprosthesis.


title: Impact of the Diameter on the Performance of Two Bipolar Resectors 18.5Fr and 26Fr

acronym: DIAPER

summary:
Hysteroscopic resection of type 0, 1 or 2 myoma is frequent. The more frequent resector used for myoma resection is 26Fr hysteroscope. Actual miniaturization of resector led to 18.5Fr resector with a potential benefit because of less dilatation. These resectors are often used but no scientific evaluation has been performed.

Hypothesis of this non inferiority trial is that complete resection in a unique surgical time will be comparable with both resectors.

lead_sponsor: Bicetre Hospital


title: Drug Use During a Very Long Distance Mountain Trail: a Study Using Automated Urine Collection

acronym: Ultra-Trail

summary:
Hypothesis: To verify whether the use of drugs, in particular performance-enhancing drugs, is prevalent amongst participants in a very long distance mountain trail.

Primary objective : To qualify and quantify drug use amongst participants in a very long distance mountain trail, by targeting the molecules most likely used by the runners.

ReferenceCitation: de Hon O, Kuipers H, van Bottenburg M. Prevalence of doping use in elite sports: a review of numbers and methods. Sports Med. 2015 Jan;45(1):57-69. doi: 10.1007/s40279-014-0247-x.

ReferenceCitation: Dietz P, Ulrich R, Dalaker R, Striegel H, Franke AG, Lieb K, Simon P. Associations between physical and cognitive doping--a cross-sectional study in 2.997 triathletes. PLoS One. 2013 Nov 13;8(11):e78702. doi: 10.1371/journal.pone.0078702. eCollection 2013.

ReferenceCitation: McAnulty S, McAnulty L, Nieman D, Morrow J, Dumke C, Henson D. Effect of NSAID on muscle injury and oxidative stress. Int J Sports Med. 2007 Nov;28(11):909-15. doi: 10.1055/s-2007-964966. Epub 2007 May 31.

ReferenceCitation: Millet GY, Banfi JC, Kerherve H, Morin JB, Vincent L, Estrade C, Geyssant A, Feasson L. Physiological and biological factors associated with a 24 h treadmill ultra-marathon performance. Scand J Med Sci Sports. 2011 Feb;21(1):54-61. doi: 10.1111/j.1600-0838.2009.01001.x.

ReferenceCitation: Robach P, Trebes G, Lasne F, Buisson C, Mechin N, Mazzarino M, de la Torre X, Roustit M, Kerivel P, Botre F, Bouzat P. Drug Use on Mont Blanc: A Study Using Automated Urine Collection. PLoS One. 2016 Jun 2;11(6):e0156786. doi: 10.1371/journal.pone.0156786. eCollection 2016.


title: Investigation of the Prevalence of Fecal Carriage of Extended Spectrum bêta-lactamase Producing Enterobacteriaceae (ESBL) and Carbapenemase Producing Enterobacteriaceae (CPE) in Nursing Homes

acronym: CARBEHPAD

summary:
CARBEHPAD is a multicentric randomized prevalence study aiming to assess the frequency of Enterobacteriaceae (ESLB) and carbapenemase producing Enterobacteriaceae (CPE) carriage in Pays de la Loire nursing homes.

A sample of 50 nursing homes (NH) in Pays de la Loire will be randomly selected for inclusion, and a sample of 1/3 of residents of these NH will be screened for ESBL and/or CPE fecal carriage. Epidemiological data on each resident will be collected to identify risk factors for such carriage.

lead_sponsor: Nantes University Hospital


title: Descriptive Study of Buccodental Manifestations in a Group of Acromegalic Patients (AcroDent) Followed in the Endocrinology/Diabetology Service in the CHU of Clermont-Ferrand

acronym: AcroDent

summary:
Context: Acromegaly is the rare condition (3 to 4 new cases per million per year) due to Growth Hormone (GH) overproduction by a somatotrope pituitary adenoma, resulting in Insulin Growth Factor 1 (IGF-1) excess. Consequently, many tissues of the organism become hypertrophied. Hypertrophy of gingival and dental tissues can lead to alteration of oral health. However, there are very few published data concerning oral impact of acromegaly.

Objective: To do the most accurate clinical and radiological state of oral manifestations in the series of prevalent acromegaly patients followed in the endocrinology service of the CHU of Clermont-Ferrand.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Treatment of Chronic Refractory Pain by Combined Deep Brain Stimulation of the Anterior Cingulum and Sensory Thalamus: a Feasibility and Safety Study

acronym: EMOPAIN

summary:
Deep brain stimulation (DBS) of the sensory thalamus has been proposed for 40 years to treat medically refractory neuropathic pain, but its efficacy remains partial and unpredictable. Recently, bilateral DBS of the dorsal anterior cingulate cortex (ACC), a brain region involved in the integration of the affective and cognitive aspects of pain, has been successively proposed to treat few patients suffering from refractory chronic pain, by decreasing the emotional impact of their chronic pain. ACC-DBS could be an alternative or complementary approach to thalamic DBS in these patients, but the consequences of chronic dACC-DBS on cognition and affects have not been studied specifically.

The primary objective is to evaluate the feasibility and safety of bilateral ACC-DBS combined with unilateral thalamic DBS in patients suffering from chronic unilateral pain, refractory to medical treatment. Secondary objective will evaluate the efficacy of this combined DBS compared to thalamic DBS only.


title: Comparison of Efficacy and Tolerance of Preoxygenation Using High Flow Oxygen and Face Mask Breathing in Healthy Volunteers.

acronym: PreOx-OHD

summary:
High flow nasal cannula oxygen has been proposed to perform preoxygenation in patients with acute respiratory failure requiring orotracheal intubation in intensive care units. However, its use for preoxygenation before the induction of general anaesthesia in operating room has never been evaluated in term of end tidal oxygen fraction which is the gold standard measurement during preoxygenation before general anaesthesia.

The goal of the present study is to measure end tidal oxygen after 3 min of preoxygenation using the recommended method (spontaneous breathing of 100% inhaled oxygen through a face mask) and using high flow nasal canula oxygen, in healthy volunteers.

ReferenceCitation: Hanouz JL, Lhermitte D, Gerard JL, Fischer MO. Comparison of pre-oxygenation using spontaneous breathing through face mask and high-flow nasal oxygen: A randomised controlled crossover study in healthy volunteers. Eur J Anaesthesiol. 2019 May;36(5):335-341. doi: 10.1097/EJA.0000000000000954.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: University Hospital, Caen


title: Incidence of Post Cystography Urinary Tract Infections in the Pediatric Population

acronym: IUCPED

summary:
Cystography is a frequent pediatric examination, although indications have been recently restricted .

Current indications in our center are:

The occurrence of 2 episodes of acute pyelonephritis
or 1 episode of pyelonephritis if dilatation of the pelvic ureter> 5 mm for male children Urinary tract infections that occurred in the month following this test are considered secondary to cystography.

However, no recent study has investigated the prevalence of urinary tract infections post cystography.

There is no recent epidemiological data on this risk of infection, especially since the management of infections has changed and aseptic precautions during retrograde cystography have evolved with most of the time coverage. antibiotic.

The main objective of this multi-center epidemiological prospective study is to perform a recent analysis of the retrograde post-cystographic urinary tract infection rate.

Material and methods:

Epidemiological, observational, multicenter, prospective study over a period from January 2018 to January 2019. No therapeutic modification will be undertaken at the end of the study.

Parents will be called one months after the exam to check if their child had a urinary infection.

collaborators:
CH Lisieux
CH Avranches

sponsor_collaborators:
University Hospital, Caen
CH Lisieux
CH Avranches


title: Cervicobrachial Neuralgia and Sagital Balance of the Cervical Spine

acronym: CNSBS-NCBES

summary: The aim of this observational study is to establish estimation of global lordosis of the cervical spine (from C3 to C7) in patients with cervicobrachial neuralgia.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Quantification of Nerve Stiffness in Patients With Peripheral Neuropathies

summary: This project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls.

sponsor_collaborators:
Nantes University Hospital
Université de Nantes


title: Characterization of the Immunological Profile Patients With Post-polio Syndrome in Comparison With These Control Subjects

summary: Many patients with polio sequelae have persistent and progressive worsening more than 15 years after the initial damage, with loss of muscle strength, asthenia and musculoskeletal pain. In these patients, there is a denervation process associated with insufficient reinnervation. The frequency of this syndrome post-polio (SPP) is of the order of 20 to 60% according to the studies. In the literature, several studies have advanced the hypothesis of immune dysregulation to this late degradation, with greater expression of pro-inflammatory cytokines, and abnormal phenotypic expression of T cells in the bloodstream. In this context, the use of immunomodulatory immunoglobulin IV treatment was studied several times, with no significant result on pain, fatigue and muscle strength scores. In the absence of significant efficacy of immunoglobulin treatment, the objective of this study is therefore to define the immunological profile of patients with post-polio syndrome, compared with control subjects, in order to support the pathophysiology of this syndrome. to study the possible presence of an inflammatory syndrome associated with this syndrome. On the other hand, depending on the results found, referral to targeted therapies could be considered.


title: Impact of the Early Hemodynamic Evaluation Guided by Urinary Biomarkers on the Acute Kidney Injury After Cardiac Surgery

acronym: NEPHROCAR

summary:
Acute kidney injury (AKI) is common after cardiac surgery. The diagnosis is based on the criteria defined by the Kidney Disease Improving Global Outcomes (KDIGO) classification: oliguria and elevation of serum creatinine. However, oliguria is not specific of AKI and elevation of serum creatinine is too late. Therefore, new methods have been developed to earlier assess the risk of AKI.

Among those methods, it has been shown that the increase of urinary dosage, in the hours following the surgery, of two proteins (Tissue Inhibitor of Metallo-Protease 2 (TIMP2) and Insulin Growth Factor Binding Protein 7 (IGFBP7)) is associated with an increased risk of occurrence of AKI in patients hospitalized in intensive care unit. The Nephrocheck® test combines the urinary dosage of those two proteins TIMP2 and IGFBP7.

Insofar as post-surgery low cardiac output is one curable cause of AKI, the early detection of early kidney risk allows corrective measures to stabilize hemodynamic state and thus to reduce the risk of AKI.

sponsor_collaborators:
Rennes University Hospital
JRAR Association


title: Bright Light Therapy in the Treatment of Non-seasonal Bipolar Depressive Episode of Bipolar Disorder: A Dose Research Phase I/II Trial

acronym: LUBI

summary: Bipolar disorder (BD) is a severe brain disorder characterized by the recurrence of mood episodes. Depressive episodes in BD are frequently refractory and clinicians have few treatment options. Bright light therapy (BLT, also named phototherapy) is a promising emerging antidepressant strategy that is lacking evidence-based guidelines for its prescription in BD, including to avoid side effects such as manic switches. In this context, this study aimed to evaluate modalities of the BLT dosage (time of exposure) escalation depending on the tolerance (manic symptoms) in two groups exposed either during the morning or at mid-day.

ReferenceCitation: Geoffroy PA, Abbassi EMBE, Maruani J, Etain B, Lejoyeux M, Amad A, Courtet P, Dubertret C, Gorwood P, Vaiva G, Bellivier F, Chevret S. Bright Light Therapy in the Morning or at Mid-Day in the Treatment of Non-Seasonal Bipolar Depressive Episodes (LuBi): Study Protocol for a Dose Research Phase I / II Trial. Psychiatry Investig. 2018 Dec;15(12):1188-1202. doi: 10.30773/pi.2018.09.27.1. Epub 2018 Nov 26.

evidence: open (via page says license)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Korean Neuropsychiatric Association


title: PEF-Block & Ribs Fractures Effect of Posterior Exo-thoracic Fascia Block in the Pain Management of Ribs Fractures: a Prospective, Randomized Study

acronym: PEF

summary: Rib fractures are frequent injuries found approximately in 10% severe trauma patient. Rib fractures were correlated in many studies with a higher morbidity and mortality. This impaired outcome is mainly due to pulmonary complications consequences including especially pulmonary contusions. Frequently, patients present difficulty deep breathing and coughing. These adverse effects can lead to the development of atelectasis, hypoxia, and respiratory failure with mechanic ventilation recourse. Effective pain management may prevent these complications and reduce the likelihood of developing chronic pain. A multi-modal analgesia regimen is widely employed combining regional and systemic analgesia. Epidural analgesia is considered by many authors to be the gold standard of pain relief although many side-effects are frequently describe including hypotension, urinary retention nausea and vomiting. Paravertebral nerve blockade is an adequate alternative that provide similar quality of analgesia with lower incidence of complication. However, the failure rate associates with PVB is about 13% and it may be associated with hypotension (4.6%), accidental vascular puncture (3.8%), accidental pleural puncture (1.1%) and rarely pneumothorax (0.5%). Recently, a description of the intercostal paraspinal nerve block. This technic was performed for patients undergoing thoracic surgery without complications.More recently, a description of a new approach to provide thoracic analgesia named the Posterior Paramedian subchoroidal (PoPS) block. The authors consider this technique provide an analgesia of the anterior and the posterior branch of adjacent thoracic nerves. The investigators propose to investigate the effect of Posterior exothoracic fascial block.


title: Can Ultrasound-detected Subclinical Inflammation Explain Patient's Global Assessment of Disease Activity in Psoriatic Arthritis Considered in Remission ?

acronym: PARURE

summary: Comparison of the proportion of Psoriatic arthritis patients in ultrasound remission (i.e. no power Doppler synovitis, tenosynovitis, dactylitis, enthesitis, PD=0) depending on whether patient and physician's global assessment of disease activity are in agreement or in disagreement.


title: Impact of a Mobile Tele-rehabilitation Solution on Body Composition of Obese Patients.

summary:
Published data indicate that rehabilitation in obese patients can result in a loss of body fat and weight that is correlated to improved physical and psychological condition and reduced morbidity and mortality.

the Ivestigators hypothezise that the use of a mobile telerehabilitation solution will encourage the patient to adopt behavioral modifications allowing a reduction of fat mass

ReferenceCitation: Bughin F, Bui G, Ayoub B, Blervaque L, Saey D, Avignon A, Brun JF, Molinari N, Pomies P, Mercier J, Gouzi F, Hayot M. Impact of a Mobile Telerehabilitation Solution on Metabolic Health Outcomes and Rehabilitation Adherence in Patients With Obesity: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 6;9(12):e28242. doi: 10.2196/28242.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes


title: Assay for the Pancreatic Polypeptide: an Help for Clinical Practice Guidelines in Classification of the Diabetes

acronym: DIAPP

summary: The purpose of this study is to evaluate global endocrine function within type 1 and type 3c diabetic patients, helping pancreatic polypeptide measurement.

ReferenceCitation: Larger E, Philippe MF, Barbot-Trystram L, Radu A, Rotariu M, Nobecourt E, Boitard C. Pancreatic exocrine function in patients with diabetes. Diabet Med. 2012 Aug;29(8):1047-54. doi: 10.1111/j.1464-5491.2012.03597.x.

ReferenceCitation: Philippe MF, Benabadji S, Barbot-Trystram L, Vadrot D, Boitard C, Larger E. Pancreatic volume and endocrine and exocrine functions in patients with diabetes. Pancreas. 2011 Apr;40(3):359-63. doi: 10.1097/MPA.0b013e3182072032.

ReferenceCitation: Rickels MR, Bellin M, Toledo FG, Robertson RP, Andersen DK, Chari ST, Brand R, Frulloni L, Anderson MA, Whitcomb DC; PancreasFest Recommendation Conference Participants. Detection, evaluation and treatment of diabetes mellitus in chronic pancreatitis: recommendations from PancreasFest 2012. Pancreatology. 2013 Jul-Aug;13(4):336-42. doi: 10.1016/j.pan.2013.05.002. Epub 2013 May 17.

ReferenceCitation: Khandekar N, Berning BA, Sainsbury A, Lin S. The role of pancreatic polypeptide in the regulation of energy homeostasis. Mol Cell Endocrinol. 2015 Dec 15;418 Pt 1:33-41. doi: 10.1016/j.mce.2015.06.028. Epub 2015 Jun 27.

ReferenceCitation: Hennig R, Kekis PB, Friess H, Adrian TE, Buchler MW. Pancreatic polypeptide in pancreatitis. Peptides. 2002 Feb;23(2):331-8. doi: 10.1016/s0196-9781(01)00605-2.

ReferenceCitation: Wang X, Zielinski MC, Misawa R, Wen P, Wang TY, Wang CZ, Witkowski P, Hara M. Quantitative analysis of pancreatic polypeptide cell distribution in the human pancreas. PLoS One. 2013;8(1):e55501. doi: 10.1371/journal.pone.0055501. Epub 2013 Jan 31.

ReferenceCitation: Simonian HP, Kresge KM, Boden GH, Parkman HP. Differential effects of sham feeding and meal ingestion on ghrelin and pancreatic polypeptide levels: evidence for vagal efferent stimulation mediating ghrelin release. Neurogastroenterol Motil. 2005 Jun;17(3):348-54. doi: 10.1111/j.1365-2982.2004.00634.x.

ReferenceCitation: Veedfald S, Plamboeck A, Hartmann B, Svendsen LB, Vilsboll T, Knop FK, Holst JJ. Pancreatic polypeptide responses to isoglycemic oral and intravenous glucose in humans with and without intact vagal innervation. Peptides. 2015 Sep;71:229-31. doi: 10.1016/j.peptides.2015.07.020. Epub 2015 Jul 26.

ReferenceCitation: Batterham RL, Le Roux CW, Cohen MA, Park AJ, Ellis SM, Patterson M, Frost GS, Ghatei MA, Bloom SR. Pancreatic polypeptide reduces appetite and food intake in humans. J Clin Endocrinol Metab. 2003 Aug;88(8):3989-92. doi: 10.1210/jc.2003-030630.

ReferenceCitation: Brunicardi FC, Chaiken RL, Ryan AS, Seymour NE, Hoffmann JA, Lebovitz HE, Chance RE, Gingerich RL, Andersen DK, Elahi D. Pancreatic polypeptide administration improves abnormal glucose metabolism in patients with chronic pancreatitis. J Clin Endocrinol Metab. 1996 Oct;81(10):3566-72. doi: 10.1210/jcem.81.10.8855802.

ReferenceCitation: Rabiee A, Galiatsatos P, Salas-Carrillo R, Thompson MJ, Andersen DK, Elahi D. Pancreatic polypeptide administration enhances insulin sensitivity and reduces the insulin requirement of patients on insulin pump therapy. J Diabetes Sci Technol. 2011 Nov 1;5(6):1521-8. doi: 10.1177/193229681100500629.

ReferenceCitation: Henquin JC, Rahier J. Pancreatic alpha cell mass in European subjects with type 2 diabetes. Diabetologia. 2011 Jul;54(7):1720-5. doi: 10.1007/s00125-011-2118-4. Epub 2011 Apr 5.

ReferenceCitation: Diedisheim M, Mallone R, Boitard C, Larger E. beta-cell Mass in Nondiabetic Autoantibody-Positive Subjects: An Analysis Based on the Network for Pancreatic Organ Donors Database. J Clin Endocrinol Metab. 2016 Apr;101(4):1390-7. doi: 10.1210/jc.2015-3756. Epub 2016 Feb 1.

ReferenceCitation: Gerich JE, Langlois M, Noacco C, Karam JH, Forsham PH. Lack of glucagon response to hypoglycemia in diabetes: evidence for an intrinsic pancreatic alpha cell defect. Science. 1973 Oct 12;182(4108):171-3. doi: 10.1126/science.182.4108.171.

ReferenceCitation: Lund A, Bagger JI, Wewer Albrechtsen NJ, Christensen M, Grondahl M, Hartmann B, Mathiesen ER, Hansen CP, Storkholm JH, van Hall G, Rehfeld JF, Hornburg D, Meissner F, Mann M, Larsen S, Holst JJ, Vilsboll T, Knop FK. Evidence of Extrapancreatic Glucagon Secretion in Man. Diabetes. 2016 Mar;65(3):585-97. doi: 10.2337/db15-1541. Epub 2015 Dec 15. Erratum In: Diabetes. 2016 Jun;65(6):1752.

ReferenceCitation: Tiengo A, Bessioud M, Valverde I, Tabbi-Anneni A, Delprato S, Alexandre J, Assan R. Absence of islet alpha cell function in pancreatectomized patients. Diabetologia. 1982 Jan;22(1):25-32. doi: 10.1007/BF00253865.

ReferenceCitation: Haldorsen IS, Raeder H, Vesterhus M, Molven A, Njolstad PR. The role of pancreatic imaging in monogenic diabetes mellitus. Nat Rev Endocrinol. 2011 Nov 29;8(3):148-59. doi: 10.1038/nrendo.2011.197.

ReferenceCitation: Bellanne-Chantelot C, Chauveau D, Gautier JF, Dubois-Laforgue D, Clauin S, Beaufils S, Wilhelm JM, Boitard C, Noel LH, Velho G, Timsit J. Clinical spectrum associated with hepatocyte nuclear factor-1beta mutations. Ann Intern Med. 2004 Apr 6;140(7):510-7. doi: 10.7326/0003-4819-140-7-200404060-00009.

ReferenceCitation: Andersen BN, Hagen C, Klein HC, Stadil F, Worning H. Correlation between exocrine pancreatic secretion and serum concentration of human pancreatic polypeptide in chronic pancreatitis. Scand J Gastroenterol. 1980;15(6):699-704. doi: 10.3109/00365528009181517.

ReferenceCitation: Matsumoto M, Wakasugi H, Ibayashi H. Plasma human pancreatic polypeptide response in chronic pancreatitis. Gastroenterol Jpn. 1982;17(1):25-30. doi: 10.1007/BF02774757.

ReferenceCitation: Vu MK, Vecht J, Eddes EH, Biemond I, Lamers CB, Masclee AA. Antroduodenal motility in chronic pancreatitis: are abnormalities related to exocrine insufficiency? Am J Physiol Gastrointest Liver Physiol. 2000 Mar;278(3):G458-66. doi: 10.1152/ajpgi.2000.278.3.G458.

ReferenceCitation: Sobngwi E, Boudou P, Mauvais-Jarvis F, Leblanc H, Velho G, Vexiau P, Porcher R, Hadjadj S, Pratley R, Tataranni PA, Calvo F, Gautier JF. Effect of a diabetic environment in utero on predisposition to type 2 diabetes. Lancet. 2003 May 31;361(9372):1861-5. doi: 10.1016/S0140-6736(03)13505-2.

ReferenceCitation: Chia CW, Odetunde JO, Kim W, Carlson OD, Ferrucci L, Egan JM. GIP contributes to islet trihormonal abnormalities in type 2 diabetes. J Clin Endocrinol Metab. 2014 Jul;99(7):2477-85. doi: 10.1210/jc.2013-3994. Epub 2014 Apr 8.

ReferenceCitation: Belinova L, Kahleova H, Malinska H, Topolcan O, Vrzalova J, Oliyarnyk O, Kazdova L, Hill M, Pelikanova T. Differential acute postprandial effects of processed meat and isocaloric vegan meals on the gastrointestinal hormone response in subjects suffering from type 2 diabetes and healthy controls: a randomized crossover study. PLoS One. 2014 Sep 15;9(9):e107561. doi: 10.1371/journal.pone.0107561. eCollection 2014.

ReferenceCitation: Hart PA, Baichoo E, Bi Y, Hinton A, Kudva YC, Chari ST. Pancreatic polypeptide response to a mixed meal is blunted in pancreatic head cancer associated with diabetes mellitus. Pancreatology. 2015 Mar-Apr;15(2):162-6. doi: 10.1016/j.pan.2015.02.006. Epub 2015 Feb 24.

ReferenceCitation: Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.

ReferenceCitation: Nealon WH, Townsend CM Jr, Thompson JC. The time course of beta cell dysfunction in chronic ethanol-induced pancreatitis: a prospective analysis. Surgery. 1988 Dec;104(6):1074-9.

ReferenceCitation: Brunicardi FC, Druck P, Sun YS, Elahi D, Gingerich RL, Andersen DK. Regulation of pancreatic polypeptide secretion in the isolated perfused human pancreas. Am J Surg. 1988 Jan;155(1):63-9. doi: 10.1016/s0002-9610(88)80259-9.

collaborators: Cochin Hospital's Hormonology Laboratory


title: Controlled Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II

acronym: NAVASI

summary:
The new NAVA® ventilatory mode with the SERVO-i ventilator (Maquet®) uses the electrical activity of the diaphragm (EADi) as a marker for triggering the respiratory cycle. The EADi is captured by the electrodes of a specific catheter (the Edi® catheter) placed in the esophagus as a regular gastric feeding tube, and relayed to the SERVO-i who displays it and delivers respiratory assistance according to measured Edi signal which allows synchronous assistance, proportional to the respiratory efforts of the patient.

To date, no measure of the effectiveness of NAVA NAV has been performed in children with neuromuscular pathology whereas this technique could reduce the use of invasive ventilation, very iatrogenic in these fragile subjects.

location_facility: Service de pédiatrie, Hôpital Raymond Poincaré

acronyme: NAVASI

titre: Essai contrôlé croisé évaluant l'intérêt de la ventilation non invasive en mode NAVA dans les décompensations respiratoires des enfants atteints d'amyotrophie spinale infantile

nom_porteur: ESSID

prenom_porteur: Aben


title: Pilot Study Describing the Early Evolution of the Sexual Function of Patients Receiving Adjuvant Hormone Therapy for Breast Cancer

summary:
The 2014-2019 cancer plan emphasizes the need to "reduce the impact of cancer on personal life".

The impact of cancer on sexuality is multifactorial: fatigue, anxiety, impaired body image, chemotherapy treatment.

None of these studies specifically assessed the early impact on the quality of sexual life of patients.

The purpose of this study is to describe to describe the early evolution of the quality of sexual life of patients receiving adjuvant hormone therapy for breast cancer.

lead_sponsor: Centre Hospitalier Departemental Vendee


acronym: MEBIPAM

lead_sponsor: Provepharm SAS

summary:
This is an open label, uncontrolled, Phase 4 study including 10 patients who present in hospital/urgent care setting with acquired methemoglobinemia. The population may include pediatric and adult patients (males and females of all ages are included).

The study will run in both the EU and the US. The aim of the study is to confirm safety and efficacy of ProvayBlueTM for the treatment of acquired methemoglobinemia and has been requested by the US-FDA as a Post-Marketing requirements.

title: Open Label Clinical Study to Evaluate the Safety and Efficacy of ProvayBlueTM (Methylene Blue) for the Treatment of Acquired Methemoglobinemia

source: euctr


title: Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Population of Adult Obese Patients

acronym: OBESAR

summary: This project aims first to determine the prevalence of sarcopenia in a population of obese people of extended age group (18-70 years). In a second step, the factors determining and / or predisposing to sarcopenic obesity will be identified as well as plasmatic and urinary biomarkers specific to this phenotype.


title: Which Needs for Premature New-born Babies' Parents Facing Environmental and Social Difficulties ? A Qualitative Study in Besancon University Hospital.

acronym: PrémaSoin

summary: This study aims to understand parents' needs regarding social difficulties faced in a child's preterm birth context.

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon


title: Respiratory Variations of the Diameter of Superior Vena Cava for Predicting Fluid Responsiveness After Cardiac Surgery

summary:
In a recent study (Vignon 2017), respiratory variations of the diameter of superior vena cava had a greater diagnostic accuracy than pulse pressure variations and inferior vena cava respiratory variations in 540 medical and surgical ICU patients. But this indicator has not been investigated yet in cardiac surgery. The investigator aim to study respiratory variations of superior vena cava for predicting fluid responsiveness after cardiac surgery.

In post-operative cardiac surgery patients with hemodynamic failure, the investigator will measure respiratory vena caval variations with TEE (Trans oesophageal echocardiography). Then, the investigator will evaluate fluid responsiveness after a fluid challenge (Trendelenburg).

A ROC curve will be constructed in order to assess the optimal sensitivity and specificity of this parameter.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Evolution of Maternal & Infantile Health Following Parental Refusal of Termination of Pregnancy Despite Such Option Being Allowable by the Centre Pluridisciplinary de Diagnostic Prenatal (Interdisciplinary Center for Prenatal Diagnostics)

summary:
More and more parents decide to maintain pregnancy which could have been interrupted because of serious fetal pathologies.

In this observational study, the investigators examine obstetrical and pediatric evolution of these pregnancies, from 2006 to 2016 in Montpellier University Hospital.

lead_sponsor: University Hospital, Montpellier


title: Impact of the Systematic Use of the Criteria STOPP/START in Short Stay Geriatric: Study of Superiority, Randomized, Controlled, Prospective, Single Blind

acronym: REVOR

summary: Assess the impact of the systematic use of STOPP/START tool during medication conciliation on the evolution of hospitalised elderly people's quality of life at 2 months.

lead_sponsor: Lille Catholic University


lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary: This is a multicenter, open-label phase II study, assessing the efficacy of elotuzumab in elderly patients with multiple myeloma undergoing peripheral stem cell autologous graft

location_facility: Hématologie et thérapie cellulaire, Hôpital Saint Antoine

title: Induction and Consolidation With Elotuzumab Before and After Peripheral Stem Cell Autologous Graft in Elderly Patients With Multiple Myeloma