title: Efficacy Assessment of Transcranial Direct Current STIMulation (tDCS) in Reducing Pain in PALliative Cancer Patients.

acronym: STIMPAL

summary:
Pain is a common symptom in palliative care cancer patients and is often insufficiently relieved. The 2010 INCA report showed that France is not an exception to this worldwide observation (synopsis of the 2010 national survey). This report shows that pain is the symptom that these patients fear the most and that it dramatically impacts their quality of life. These patients may experience nociceptive pain related to stimulation of sensory nerve endings by the tumour. When tumour resection is impossible, a symptomatic analgesic treatment is generally proposed, mainly consisting of administration of opioid analgesics. At high doses, this treatment induces adverse effects, especially drowsiness and psychomotor retardation that impair the patient's quality of life.

They may also experience neuropathic pain, secondary to anatomical lesions or functional impairment of nerve structures (peripheral nerves or cerebral or spinal tracts) related to repeated surgical procedures and/or radiotherapy. This type of pain may respond to antiepileptic or antidepressant drugs. At high doses, these treatments also induce adverse effects fairly similar to those observed during treatment of nociceptive pain. As these two types of treatment often need to be coprescribed, these patients frequently present an almost permanent state of drowsiness at the end of life, preventing all normal activities of daily living.

In recent years, noninvasive brain stimulation (NIBS) techniques (transcranial magnetic stimulation (rTMS) or transcranial direct-current stimulation (tDCS)) have been successfully used to treat chronic pain. It was shown that these NIBS techniques can improve pain in cancer patients in the palliative care setting.

primary_purpose: Supportive Care

lead_sponsor: Elsan

location_facility:
Clinique Brétéché
CHU Nantes


title: Safety and Performance Assessment of Coronary Drug-Eluting Stent CRE8 : Post-market Observationnal Study

summary:
The study is a 'real-world' study which evaluates the safety and performance of the coronary DES-CRE8 in diabetic patients.

As routine care, each patient will be followed until 12 months after stent implantation.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Alvimedica Medical Technologies France

location_facility: Centre Hospitalier Universitaire Grenoble

location_facility: Centre Hospitalier Saint-Joseph Saint-Luc

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Research of Infra Clinical Liver Injuries in Adult Patients Presented With Alpha-1 AT Deficiency

summary: This cohort study will evaluate the prevalence of the infra clinical liver injuries among a group of adult patients presenting with Alpha-1 AT deficiency followed up in a large university hospital in Lyon, France.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Screening

ReferenceType: result

ReferenceCitation: Guillaud O, Dumortier J, Traclet J, Restier L, Joly P, Chapuis-Cellier C, Lachaux A, Mornex JF. Assessment of liver fibrosis by transient elastography (Fibroscan(®)) in patients with A1AT deficiency. Clin Res Hepatol Gastroenterol. 2019 Feb;43(1):77-81. doi: 10.1016/j.clinre.2018.08.016. Epub 2019 Jan 3.

family: Guillaud

full_name: Olivier Guillaud

given: Olivier

sequence: first

family: Dumortier

full_name: Jérôme Dumortier

given: Jérôme

sequence: additional

family: Traclet

full_name: Julie Traclet

given: Julie

family: Restier

full_name: Lioara Restier

given: Lioara

family: Joly

full_name: Philippe Joly

given: Philippe

family: Chapuis-Cellier

full_name: Colette Chapuis-Cellier

given: Colette

family: Lachaux

full_name: Alain Lachaux

given: Alain

family: Mornex

full_name: Jean François Mornex

given: Jean François

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinics and Research in Hepatology and Gastroenterology

oa_host_type: repository

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

version: publishedVersion

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Assessment of liver fibrosis by transient elastography (Fibroscan®) in patients with A1AT deficiency

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Femme Mère Enfant - Hospices Civils de Lyon

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?

summary:
The main objective of this study is to assess whether the presence of abnormal vaginal flora (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of delivery. For this, the primary endpoint will be the proportion of vaginal lesions according to the presence or absence of abnormal vaginal flora.

A more precise qualitative and quantitative study of vaginal flora isolated from pregnant women and its association with vaginal lesions will also be conducted.

time_perspective: Cross-Sectional

ReferenceType: derived

ReferenceCitation: Letouzey V, Bastide S, Ulrich D, Beccera L, Lomma M, de Tayrac R, Lavigne JP. Impact of Bacterial Vaginosis on Perineal Tears during Delivery: A Prospective Cohort Study. PLoS One. 2015 Nov 6;10(11):e0139334. doi: 10.1371/journal.pone.0139334. eCollection 2015.

family: Letouzey

full_name: Vincent Letouzey

given: Vincent

family: Bastide

full_name: Sophie Bastide

given: Sophie

family: Ulrich

full_name: Daniela Ulrich

given: Daniela

family: Beccera

full_name: Laurie Beccera

given: Laurie

family: Lomma

full_name: Mariella Lomma

given: Mariella

family: de Tayrac

full_name: Renaud de Tayrac

given: Renaud

family: Lavigne

full_name: Jean Philippe Lavigne

given: Jean Philippe

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

intervention_type: Biological


title: Interest of the Alkalinization of the Adrenaline Lidocaine Solution for Conversion of Epidural Analgesia Into Epidural Anesthesia During an Emergency Caesarean

acronym: BiEpIC

summary:
During labor, pain is systematic. In France, epidural analgesia is the gold standard to fight pain.

Sometimes, emergency situations involve the maternal or fetal prognosis and require an emergency fetal extraction by caesarean. When an effective epidural analgesia is in place, an injection of adrenaline lidocaine converts this epidural analgesia into an epidural anesthesia allowing a surgical procedure. Sometimes, the time required to set up the anesthesia cannot be expected and a general anesthesia is performed.

Local anesthetics used during epidural analgesia have Pka between 7.8 and 8.1. In solution, local anesthetics exist in two forms: an un-ionized form and an ionized form. The non-ionized form is liposoluble and crosses the lipid membranes to reach the site of intracellular action. The non-ionized form conditions the time taken to install anesthesia.

When the pH of the solution is equal to Pka, un-ionized and ionized form are present in equal quantity. Commercial local anesthetic solutions have acidic pH and so contained a majority of ionized form. Alkalinization of local anesthetics solution should bring the pH closer to pKa and therefore to favor a greater proportion of non-ionized form.

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: Undecided

lead_sponsor: CHU de Reims

intervention_type: Drug


title: Tricho-hepato-enteric Syndrome: From Abnormal RNA Decay to Disease Clinical and Biological Characterization of Patients and Collection of Samples -THE-RNA

acronym: THE-RNA

summary:
Objectives: Collect clinical and biological data about patients with SD/THE, collect samples of patients; create a secure on line database to collect worldwide data about SD/THE Partners : APHM, HCL, APHP

Currently10 patients (8 with TTC37 mutations and 2 with SKIV2l mutations) present a SD/THE and are managed in France in 5 different centers (Marseille, Paris Trousseau, Paris Necker, Paris Robert Debrés, and Lyon). Most of them are followed in hepato-gastro-enterology units for their intractable diarrhea. Three aspects of the disease: intractable diarrhea, immune defect and liver disease are responsible for the main part of the burden of the disease .For each aspect, the investigators will propose a close follow-up with collection of clinical, biochemical, functional and microbial data.

Collect of clinical date: during a programmed consultation clinical data about symptom will be collected twice a year. A detailed form will be used for better delineation of the symptoms. These data included growth, symptom (diarrhea, pain …), and clinical signs. Most of these children have recurrent sample for follow up. During them some blood will be take for study the immune side but also the platelet function.

study_start_date_type: Anticipated

status: Not yet recruiting

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Patients With Peritoneal Dialysis and Peritoneal Infection

acronym: DAPTODP

summary:
Peritoneal infection is still a frequent complication in peritoneal dialysis patients . In France, It contributes to the technique failure, responsible for about 20% of cases of transfer in hemodialysis. The risk of direct mortality is estimated at 1 to 6% according to studies. Peritoneal infection is involved in the dysfunction of the peritoneal membrane.

Based on the recommendations of the International Society for Peritoneal Dialysis, the intraperitoneal route is preferentially recommended. For many antibiotics, pharmacokinetics (intravenous and intraperitoneal) was studied and protocols for IP administration were validated.

Daptomycin, is a cyclic lipopeptide natural, active only on Gram-positive bacteria. It is presented as an alternative to vancomycin in infections resistant pathogens. The stability of daptomycin in peritoneal dialysis fluids (PDF) has been tested, and antimicrobial activity as well.

Seven patients were treated with daptomycin intraperitoneally successfully. But no study has reported pharmacokinetics of daptomycin via the IP route. We propose a pharmacokinetic study of daptomycin administered intraperitoneally in 12 patients on CAPD and with Gram-positive peritoneal infection.

lead_sponsor: University Hospital, Caen


title: Evaluation of the Efficacy of Negative Pressure Wound Therapy on Incisional Wound Healing After a Total Ankle Arthroplasty: a Randomized Study.

acronym: PICO-PTC

summary:
About 500 total ankle prostheses are implanted each year in France. Wound healing issues are the most common complications after Total Ankle Arthroplasty (TAA). In 2010, a French retrospective study observed a wound infection rate of 8% among 592 prostheses implanted. Wound infection rate can vary up to 28% from the data available in the literature. Delayed wound healing is a known risk factor of surgical site infection (SSI). Even if it remains a rare event, its consequences for the patient can be severe and lead to removal and/or replacement of the prosthesis, arthrodesis, or transtibial amputation.

Negative Pressure Wound Therapy (NPWT) is an adjuvant therapy for wound management and healing: it delivers a controlled negative pressure (sub-atmospheric) applied topically onto the wound from a vacuum pump. The wound is filled with wound filler and sealed with an airtight adhesive drape. It allows creating a moist wound environment, removing exudate, and reducing edema and risk of infection.

Incisional NPWT can accelerate wound healing regardless of the surgery performed, including orthopedics. A retrospective study compared the incidence of healing complications after TAA between the administration of the NPWT PICO™ (Smith&Nephew) and the standard of care of postoperative wounds in 74 patients. A significant reduction of wound healing issues (3% vs. 24%, respectively; p=0.004) and a non-significant reduction of SSI (3% vs. 8%, respectively) were observed.

To the investigator knowledge, no randomized study has been conducted to assess the efficacy of the NPWT PICO™ for postoperative wound healing after TAA: Investigators propose to set up this study to obtain a high level of evidence in this population and investigators assume that the use of the PICO™ system after TAA would reduce delayed wound healing compared to the standard of care with conventional dressings.

status: Recruiting

primary_purpose: Prevention

location_facility: Service de Chirurgie orthopédique - Groupement Hospitalier Lyon Sud


type: Other Identifier

title: Functional and Mechanistic Characterization of Limb Ulcers in Patients With Sickle Cell Disease

summary:
Sickle Cell Disease is the most frequent genetic disease in the world (representing one birth over 1900, in France). The polymerization of the abnormal hemoglobin (i.e., HbS) when deoxygenated is at the origin of a mechanical distortion of red blood cells (RBC) into a crescent-like shape. Sickled RBCs are very fragile and rigid, which lead patients to have severe anemia and to develop frequent and repeated painful vaso-occlusive crises. Furthermore, the repetition of sickling-unsickling cycles causes irreversible damages to the RBCs, which shorten their half-life. Accumulation of free hemoglobin and heme in the plasma is involved in blood vessels lesions in both the macro- and micro- circulation.

The resulting vascular dysfunction could explain why limb ulcers are 10 fold more frequent in patients with sickle cell disease compared to the general population and may happen at a younger age. Limb ulcers induce significant morbidity (delay of healing between 9 and 26 weeks in the french cohort), and are associated to significant pain (needing opioid pain-killer) and increase the risk of infection. Cost of care is also increased. Moreover, ulcers induce missed school and work days.

Data on cutaneous microcirculation and ulcers physiopathology in patients with sickle cell disease are scarce. We want to realise a microcirculatory and neurological functional study of patients with with and without ulcers and a characterization of biomarkers present in the blood or in the wound fluid which can participate to ulcers physiopathology.

To ensure healing, adapted therapeutics are essential. Several strategies are proposed such as: lifestyle measures (venous compression, lower limb elevation, rest), dressings, hyperbaric oxygenotherapy (also used in diabetic ulcers). The project is devoted to study the mechanisms involved in leg ulcers and the effects of therapeutical/behavioral strategies.

primary_purpose: Basic Science

intervention_type: Diagnostic Test


title: Establishment of a Database of Patients Suffering From Obesity With a Medical Treatment in the Framework of The Specialized Obesity Center Languedoc-Roussillon CHU Montpellier

acronym: Elodie Cohort

summary:
Obesity is a public health problem, given its prevalence (15% in France in 2012, Obépi survey) but also by the complications that it generates. We were firstly, intersted in bone mineral density during obesity.

We were able to confirm in an observational study that BMD (Z-score)was augmented. We also showed, for the first time, that this increase in Z-score was dependent on sex, severity of obesity and age but also bone site. If the increase in BMD at the level of the bearing zones seems logically to be explained by the hypothesis that the mechanical stresses have an osteogenic effect on the bone tissue, the latter can not in any way respond to the concomitant increase in BMD at non-bearing areas such as the radius.These results suggest that changes in certain systemic compounds induced by obesity may interfere with bone metabolism. recent data also suggest a change in the concentration of pro-glucagon peptides (GLP-1, glicentin, glucagon, etc.) in obese subjects and in bariatric surgery). Although body composition and its variation after surgery could be largely involved in the modification of these peptides, no data on these potential relationships is currently available. However, no data are available for baseline body composition and weight loss data. Finally, 80% of obesity is associated with insulin resistance, a key mechanism in the pathophysiology of type 2 diabetes. A metabolically healthy obesity phenotype is described, although the definition criteria are not consensual.The evolution of this phenotype with aging and with the duration of evolution of obesity is not well described.

Our goal is to create a database of weight-bearing patients in the care setting and to determine the "hormonal dialogue" between peripheral (muscular and adipose) and bone tissues, which may be associated with changes in body composition during obesity and aging, and that according to sex.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Mitochondrial Respiratory Chain and Peripheral Muscle Dysfunction in COPD Patients

summary: The purpose of this study is to understand the underlying mechanisms of improved exercise tolerance in COPD patients after training program.

lead_sponsor: 5 Santé

location_facility:
Clinique du Souffle La Vallonie
Clinique du Souffle la Solane


title: Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma : a Case Control Study.

acronym: PESTIPAC

summary:
Pancreatic adenocarcinoma represents more than 90% of pancreatic neoplasms. Around 14000 new cases of pancreatic adenocarcinoma are being diagnosed each year in France and about 8.6% in Grand Est region. National incidence has doubled for men and tripled for women between 1982 and 2012. Pancreatic adenocarcinoma is the deadliest digestive cancer, with only 7 to 8% all stages 5-year survival. It will become the second deadliest in Europe, behind bronchopulmonary cancer.

Several risk factors have been identified such as diabetes, tobacco, chronic pancreatitis or obesity. However, a mismatch exists between incidence forecasts and actual risk factors knowledge. Several hypothesis plead for an environnemental cause.

Plant protection products oncogenetic effects are known and have been proved to be responsible for tumors, including haematological malignancies. Its role in pancreatic carcinogenesis is still poorly studied and show heterogeneous results. They do not allow to conclude for causality. Organochlorines is a specific subset of plant protection product that store in lipids during lifetime.

The aim is to study association between organochlorine concentration in adipose tissue with pancreatic adenocarcinoma.


title: Efficacy and Safety of iStent Inject and Inject W in the Management of Primary Open-angle Glaucoma

acronym: EII

summary: Primary open-angle glaucoma (POAG) is a chronic eye disease in which the only validated treatment is to lower intraocular pressure (IOP). It is the 2nd leading cause of blindness worldwide. The iStent® inject and inject W is an implantable device that is part of a new entity of so-called minimally invasive glaucoma surgery whose goal is to lower IOP with minimal tissue disruption in order to avoid the complications of conventional glaucoma surgery. This surgery is used in conjunction with cataract surgery in France. The primary objective is to study the 1-year efficacy and safety of combined cataract and iStent inject and inject W in the management of POAG in an observational, retrospective, controlled study of a cohort of POAG patients undergoing cataract surgery only.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Procedure


title: Pilot Study of the Feasibility of Routine Inpatient Hepatitis C Screening

acronym: HOSPI-VHC

summary:
The Ministry of Health has set the target of eradicating hepatitis C (HCV) in France by 2025.

The goal is to validate the feasibility and value of conducting routine HCV screening in hospitalized patients.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée


title: Phase I/II Trial to Study the Dose, Tolerability and the Effectiveness of Imatinib in Combination With Daunorubicine and Cytarabine for Patients With Chronic Myelogenous Leukemia in Myeloid Acute Phase

summary: The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated with cytarabine and Imatinib for induction therapy in patients with chronic myelogenous leukemia in myeloid acute phase.

status: Terminated

ReferenceCitation: Rousselot P, Cony-Makhoul P, Nicolini F, Mahon FX, Berthou C, Réa D, Reiffers J, Bornand A, Saint-Jean O, Guilhot J, Guilhot F; French Intergroup For Chronic Myelogenous Leukemia (Fi-LMC). Long-term safety and efficacy of imatinib mesylate (Gleevec®) in elderly patients with chronic phase chronic myelogenous leukemia: results of the AFR04 study. Am J Hematol. 2013 Jan;88(1):1-4. doi: 10.1002/ajh.23330. Epub 2012 Sep 17.

family: Rousselot

full_name: Philippe Rousselot

family: Cony-Makhoul

full_name: Pascale Cony-Makhoul

given: Pascale

family: Nicolini

full_name: Franck Nicolini

given: Franck

family: Mahon

full_name: François Xavier Mahon

given: François Xavier

family: Berthou

full_name: Christian Berthou

given: Christian

family: Réa

full_name: Delphine Réa

given: Delphine

family: Reiffers

full_name: Josy Reiffers

given: Josy

family: Bornand

full_name: Anne Bornand

given: Anne

family: Saint-Jean

full_name: Olivier Saint-Jean

family: Guilhot

full_name: Joelle Guilhot

given: Joelle

full_name: François Guilhot

given: François

name: on behalf of the French Intergroup For Chronic Myelogenous Leukemia (Fi-LMC)

journal_name: American Journal of Hematology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Long-term safety and efficacy of imatinib mesylate (Gleevec®) in elderly patients with chronic phase chronic myelogenous leukemia: Results of the AFR04 study

ReferenceCitation: Deau B, Nicolini FE, Guilhot J, Huguet F, Guerci A, Legros L, Pautas C, Berthou C, Guyotat D, Cony-Makhoul P, Gardembas M, Michallet M, Hayette S, Cayuela JM, Weiss IR, Réa D, Castaigne S, Mahon FX, Guilhot F, Rousselot P. The addition of daunorubicin to imatinib mesylate in combination with cytarabine improves the response rate and the survival of patients with myeloid blast crisis chronic myelogenous leukemia (AFR01 study). Leuk Res. 2011 Jun;35(6):777-82. doi: 10.1016/j.leukres.2010.11.004. Epub 2010 Dec 10.

family: Deau

full_name: Bénédicte Deau

given: Bénédicte

full_name: Franck E. Nicolini

given: Franck E.

family: Huguet

full_name: Françoise Huguet

given: Françoise

family: Guerci

full_name: Agnès Guerci

given: Agnès

family: Legros

full_name: Laurence Legros

given: Laurence

family: Pautas

full_name: Cécile Pautas

given: Cécile

family: Guyotat

full_name: Denis Guyotat

given: Denis


title: Study of the Specific Seroprevalence of SARS-CoV-2 in a Sample of Patients and Salaried Staff From a French Anti-cancer Center at the End of the Containment Period of the SARS-CoV-2 Pandemic

acronym: canSEROcov

summary:
Since March 2020, France has been confronted with the SARS-COV-2 pandemic. Analysis of the data of its spread would indicate that close contact between individuals is necessary and containment would be the best way to contain this virus. France has therefore been contained since March 17, 2020 until 11 May 2020.

In order to assess the impact of the measures taken (containment) to protect patients and salaried staff of a french anti-cancer center on the spread of the virus, this observational study assesses the specific seroprevalence of SARS-COV-2 in all caregivers and non-carers of this hospital and in patients treated in consultation, day hospitalization, full hospitalization at the end of the containment period.

The objective for the staff cohort is to describe the seroprevalence and the link between the seroprevalence and sociological / demographic factors relating to the category of profession, to the contacts with the patients, to the presence in the hospital during the period of containment, to the conditions of home containment.

The objective for the patient cohort is to describe the seroprevalence and the link between the seroprevalence and factors relating to the type of cancer treated, the type of treatment and their possible modification during the period of containment, to the conditions of home containment.

lead_sponsor: Centre Georges Francois Leclerc


title: Gynaecological Emergencies: Validation of Indicators of Activity and Quality of Care for Creation of a Network Sentinel

acronym: URGO

summary:
There is no large-scale data in France or internationally, on the quality of care in gynecological emergencies, or the consequences of delay or misdiagnosis of women's health or on determinants of these delays or misdiagnosis. The creation of a sentinel network for gynecological emergencies could help quantify these links and test strategies to avoid the worst effects by implementing simple diagnostic tools from clinical research.

The network will be designed to promote research in women's health and the emergency reception by focusing on:

(i) Assessment of the quality and organization of care and professional practice for the management of gynecological emergencies.

(ii) The study of severe morbidity and its determinants (iii) comparison of organizational practices and health outcomes of women over time within the same department or between services having substantially the same recruitment (iv) Comparison of organization systems gynecological emergencies departement between different high resource francophone countries (France, Switzerland, Belgium).

(v) The assessment of new diagnostic strategies (sorting or diagnostic aid) or therapeutic derived from clinical research.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Impact of a Front-of-pack Nutrition Labelling on the Nutritional Quality of Purchases of Customers in Contract Catering - a Controlled Trial

summary: This controlled trial investigates the impact of the implementation of a front-of-pack nutrition label, namely Nutri-Score, on foods and beverages sold in a contract catering in France on the nutritional quality of purchases.

primary_purpose: Other

lead_sponsor: University of Paris 13

location_facility: Equipe de Recherche en Epidémiologie Nutritionnelle

intervention_type: Behavioral


title: Analgesic Non Inferiority of the Thoracic Bi-block Combining an Erector Spinae Muscle Plane Block and a Serratus Anterior Muscle Plane Block in Comparison With Thoracic Epidural for Video-Assisted Thoracic Surgery.

acronym: ANESSTEVATS

summary:
Video-Assisted thoracic surgery (VATS) is the standard treatment for localized lung cancer. However, there is no consensus on analgesic management in patients undergoing VATS.

The aim of the study is to compare the analgesic efficacy of thoracic epidural with that a "Bi-block" combining an Erector Spinae muscle plane Block (ESP) and a Serratus Anterior Block (SAP) in patients undergoing VATS for lung or pleural surgery.

Our main hypothesis is that the analgesic efficacy of the Bi-block, assessed by morphine consumption, is not inferior to that provided by a thoracic epidural during the first 48 hours after VATS. We conducted a age, gender and type of surgery-matched retrospective cohort study in the Department of Thoracic Anesthesia of the Montpellier University Hospital (France).

location_facility: Intensive Care Unit, D - University hospital of Montpellier


title: Multicentrique Prospective Evaluation of Radiofrequency Surgical Treatment of Homorrhoidal Disease

acronym: RF-GREP

summary:
Hemorrhoids consist of a tissue rich in blood vessels and are present in all individuals inside the anus. Hemorrhoidal disease (HD) is when hemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or seepage.

The first steps in the treatment of HD involve either drugs or instrumental gestures (sclerosis, ligation). In the event of failure or of a disease that is significant from the outset, it is possible to envisage a surgical treatment.

The use of a radiofrequency is a new technique, already used frequently by vascular surgeons in the treatment of varicose veins of the lower limbs. This technique has been developed for radiofrequency destruction of hemorrhoidal vascular tissue.

In France, no studies have been carried out to evaluate this new technique.

status: Unknown status

lead_sponsor: Ramsay Générale de Santé

status_simplified: Unknown


ReferenceCitation: Blanchon T, Mentré F, Charlois-Ou C, Dornic Q, Mosnier A, Bouscambert M, Carrat F, Duval X, Enouf V, Leport C; Bivir Study Group. Factors associated with clinical and virological response in patients treated with oseltamivir or zanamivir for influenza A during the 2008-2009 winter. Clin Microbiol Infect. 2013 Feb;19(2):196-203. doi: 10.1111/j.1469-0691.2011.03751.x. Epub 2012 Jan 20.

family: Blanchon

full_name: T. Blanchon

given: T.

family: Mentré

full_name: F. Mentré

given: F.

family: Charlois-Ou

full_name: C. Charlois-Ou

given: C.

family: Domic

full_name: Q. Domic

given: Q.

family: Mosnier

full_name: A. Mosnier

given: A.

family: Bouscambert

full_name: M. Bouscambert

given: M.

family: Carrat

full_name: F. Carrat

family: Duval

full_name: X. Duval

given: X.

family: Enouf

full_name: V. Enouf

given: V.

family: Leport

full_name: C. Leport

family: Bivir Study Group

full_name: Bivir Study Group

journal_name: Clinical Microbiology and Infection

oa_colors: green hybrid

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

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

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

title: Factors associated with clinical and virological response in patients treated with oseltamivir or zanamivir for influenza A during the 2008–2009 winter

ReferenceCitation: Galimard JE, Chevret S, Curis E, Resche-Rigon M. Heckman imputation models for binary or continuous MNAR outcomes and MAR predictors. BMC Med Res Methodol. 2018 Aug 31;18(1):90. doi: 10.1186/s12874-018-0547-1.

apc_source: openAPC

family: Galimard

full_name: Jacques-Emmanuel Galimard

given: Jacques-Emmanuel

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Curis

full_name: Emmanuel Curis

given: Emmanuel

family: Resche-Rigon

full_name: Matthieu Resche-Rigon

given: Matthieu

currency_apc_doaj: GBP

journal_name: BMC Medical Research Methodology

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

ReferenceCitation: Flicoteaux R, Protopopescu C, Tibi A, Blanchon T, Werf SV, Duval X, Mosnier A, Charlois-Ou C, Lina B, Leport C, Chevret S. Factors associated with non-persistence to oral and inhaled antiviral therapies for seasonal influenza: a secondary analysis of a double-blind, multicentre, randomised clinical trial. BMJ Open. 2017 Jul 10;7(7):e014546. doi: 10.1136/bmjopen-2016-014546.

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

ReferenceCitation: Duval X, van der Werf S, Blanchon T, Mosnier A, Bouscambert-Duchamp M, Tibi A, Enouf V, Charlois-Ou C, Vincent C, Andreoletti L, Tubach F, Lina B, Mentré F, Leport C; Bivir Study Group. Efficacy of oseltamivir-zanamivir combination compared to each monotherapy for seasonal influenza: a randomized placebo-controlled trial. PLoS Med. 2010 Nov 2;7(11):e1000362. doi: 10.1371/journal.pmed.1000362. Erratum in: PLoS Med. 2010;7(12) doi: 10.1371/annotation/ca448e7c-fbbc-43e9-9981-108c9bfa8bce.

title: Correction: Efficacy of Oseltamivir-Zanamivir Combination Compared to Each Monotherapy for Seasonal Influenza: A Randomized Placebo-Controlled Trial

title: Evaluation of Combination Therapy With Oseltamivir and Zanamivir Versus Monotherapy in the Treatment of Virologically Confirmed Influenza in Primary Care a Randomises Double Blind Controlled Trial Study

summary: In order to prevent the high mortality due to an hypothetic pandemic caused by a newly emerging influenza A virus, antiviral drugs are seen as essential requirements for control of initial influenza outbreaks.Two antivirals are available for the treatment oseltamivir and zanamivir. Emergence of Oseltamivir resistance has been recently reported. . It appeared opportune to assess the efficacy and safety of biotherapy of neuraminidase inhibitors ,will be investigated by a randomized, placebo controlled, double blind study in France, during the next winter season . This study will be conducted in 300 centres of primary care with 900 adults with a virologically suspected influenza A infection. Individuals will be randomized to 1 of the 3 treatment groups: oseltamivir +zanamivir, or oseltamivir+placebo or placebo +zanamivir.The primary judgment criteria will be the proportion of patients with negative RT PCR negative in nasal secretions at Day 2.


title: FRATHEMO: Quality of Life and Adjustment Among Siblings of Children and Adolescents With Severe Hemophilia.

acronym: FRATHEMO

summary:
Severe hemophilia is a rare and chronic disease characterized by spontaneous bleedings from early childhood, which may lead to various complications especially in joints. The diagnosis of this disease, but also its long term care have an impact on the relatives of the affected persons, including the siblings who bear daily the cognitive, emotional and social impacts of the disease.

Studies conducted in the framework of pediatric chronic diseases showed that siblings of affected children presented a higher prevalence of physical and psychological troubles (emotional distress, behavioral disorders, etc.) than siblings who were not concerned by a disease. Few studies have been conducted in the framework of severe hemophilia, and to our knowledge, no study addresses this issue in France.

location_facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille


title: Management of Coagulopathy During Orthotopic Liver Transplantation. Comparison Between ROTEM-based Management and Standard Biological Assessment.

summary:
In current practice, management of coagulation during liver transplantation is performed either through standard coagulation status or with ROTEM® depending on practitioner choice and availability of materials. In this context, the ROTEM® is used since over 2 years by anesthesiologists in the digestive surgery department of the Croix Rousse hospital in Lyon, France.

Indeed liver transplantation surgery is at high risk of bleeding due to coagulopathy developed by patients who are eligible, due to coagulation factor synthesis deficiencies in the cirrhotic liver. On the other hand the standard coagulation profile is a poor reflection of coagulopathy in such patients because the imbalance between pro- and anti-coagulant factors are not taken into account by PT and aPTT measures. Management of intraoperative hemorrhage may be facilitated by the ROTEM® which is performed from whole blood and which allows the detection of abnormalities in the balance between pro- and anti-coagulant factors.

This technique was already evaluated in liver, cardiac, and obstetric surgery but also in traumatology. Randomized trials in liver transplantation surgery have shown changes in transfusion practices but did not focus on the consequences of such changes.

ReferenceCitation: Bonnet A, Gilquin N, Steer N, Gazon M, Quattrone D, Pradat P, Maynard M, Mabrut JY, Aubrun F. The use of a thromboelastometry-based algorithm reduces the need for blood product transfusion during orthotopic liver transplantation: A randomised controlled study. Eur J Anaesthesiol. 2019 Nov;36(11):825-833. doi: 10.1097/EJA.0000000000001084.

family: Bonnet

full_name: Aurélie Bonnet

given: Aurélie

family: Gilquin

full_name: Nathalie Gilquin

given: Nathalie

family: Steer

full_name: Nadia Steer

given: Nadia

family: Gazon

full_name: Mathieu Gazon

given: Mathieu

family: Quattrone

full_name: Diego Quattrone

given: Diego

family: Pradat

full_name: Pierre Pradat

given: Pierre

family: Maynard

full_name: Marianne Maynard

given: Marianne

family: Mabrut

full_name: Jean-Yves Mabrut

given: Jean-Yves

family: Aubrun

full_name: Frederic Aubrun

given: Frederic

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health


title: COVID-19 Infection in Healthcare Workers: a Cohort Study

acronym: HOP-COVID

summary:
Introduction: The SARS-Cov-2 outbreak in France and the concomitant massive increase in the number of cases requiring hospital management create a major risk of COVID-19 infection for hospital staff. In addition to nosocomial transmission, the health care workers (HCWs), defined as persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials, are also exposed to community transmission. Whether HCWs acquire infection at work or in the community is important to adapt protection measures. A few studies investigated COVID-19 infection among medical and nursing personnel. However, none have analyzed all categories of hospital staff. As of April 9, 2020, a total of 9,282 US HCWs with confirmed COVID-19 had been reported to CDC (US), however description of occupational activities was not available. Therefore, limited information is available about COVID-19 infection among HCWs.

Thus, the objectives of the sdudy are to estimate the incidence of symptomatic SARS-CoV-2 infection in HCWs in five university hospitals (including geriatric hospitals) of the great Paris area and to estimate both nosocomial and community risk factors.

Method: A prospective and retrospective cohort study that includes all hospital staff (including medical and nursing personnel, health care managers, laboratory, radiology, reception staffs, stretcher-bearers, etc.) working in different departments of five university hospitals (acute medical centers and geriatric hospitals) in the great Paris area (9 000 HCWs). Incidence of symptomatic SARS-CoV-2 infection will be estimated with its 95%CI. Individual and contextual risk factors will be analyzed using multilevel multivariate logistic regression modelling to account for clustering and confounding.

Conclusion This study should make it possible to better characterize SARS-Cov-2 contamination of HCWs and to estimate the share of nosocomial transmission.

time_perspective: Other

ipd_sharing_description: Datas are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information.

location_facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor


type: EudraCT Number

title: Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance (PIONeeR Clinical Study)

acronym: PIONeeR

summary:
Research Hypothesis Lung cancer is the leading cause of cancer-related mortality in France and in western countries, accounting for more than 1.8 million new cases and 1.5 million deaths worldwide in 2012. Recent advances in the management of patients with Non-small Cell Lung Cancer Patients (NSCLC) include the use of therapies targeting oncogenes but a molecular alteration is currently found in only the half of the non-squamous NSCLC . More recently, immune check point inhibitors (ICI), firstly targeting PD-(L)1, became available and demonstrate an overall survival advantage over standard second-line chemotherapy both in squamous and non-squamous NSCLC. Unfortunately, this global overall survival benefit is driven by approximately 20% of the patient's population while a large majority of patients is in fact progressing in the first weeks of treatment.

In the context of personalized medicine, innovative immunotherapy strategies in oncology are based on the principle of immune-contexture and require:

The identification of biomarkers for assessing the specific immune-contexture of each patient (microenvironment, tumors and effector cells)
The development of new treatments targeting their appropriate effector cells in monotherapy or combination treatments.

The current PIONEER-Clinical study is aimed at assessing how to overcome resistance to ICIs monotherapies or ICI in combination with platinum-based chemotherapies, with experimental precision immunotherapies combined to Durvalumab in 2nd, 3rd or 4th line, in advanced NSCLC progressors patients after up to 18more than 6 w. of anti PD (L) 1. for ICIs monotherapies and after more than 12w. of anti PD(L)1 in combination with chemotherapies.

Some supplementary blood and tissue samples are aimed at identification of personalized patients' biomarkers, correlation of them with the efficacy endpoints, in order to better understand mechanisms of resistance and improve their future treatment.


title: Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis

acronym: INTRA-OBS

summary:
Due to screening, T1N0 early-stage breast cancer now accounts for more than 50% of the tumors diagnosed in France. The prognosis of these tumors is good, even excellent in women ≥ 65 years of age, with specific survival of 98% at 5 years.

The treatment of these tumors combines breast-conserving surgery and external whole breast irradiation for 6.5 weeks.

A true de-escalation of treatment is taking place with these tumors, both surgically and medically. Surgery therefore now prefers breast-conserving methods in combination with exeresis of the sentinel lymph node only. In the same way, in many international studies, radiotherapy has been evaluating the possibility of reducing both:

the irradiation volume at the excision site (partial irradiation)
the duration of this irradiation (accelerated radiotherapy)

Between 2004 and 2007, the CRLC [Regional Anti-Cancer Center] evaluated the feasibility and the oncological results of intra-operative partial irradiation via a phase II study in women 65 years of age and older with T1N0M0 hormone-sensitive tumors with a good prognosis.

From 2010 to 2013, the ICM carried out an observational study of these tumors with an excellent prognosis.

In July 2009, the American Society for Radiation Oncology (ASTRO) published a consensus statement with specific recommendations and indications for accelerated partial breast irradiation (APBI).

This APBI technique has been developing in France over the past 5 years within the framework of clinical studies and in compliance with the 2012 recommendations of the French National Cancer Institute. This APBI can be given by 3D external radiotherapy or, as in this study, by intra-operative radiotherapy (IORT) in order to obtain optimal precision and spare as much of the surrounding healthy tissue as possible.

The Investigator therefore propose a cohort study to prospectively analyze the results of this technique applied to the indications strictly defined by the ASTRO.

ReferenceType: background

ReferenceCitation: Grosclaude P, Colonna M, Hedelin G, Tretarre B, Arveux P, Lesec'h JM, Raverdy N, Sauvage-Machelard M. Survival of women with breast cancer in france: variation with age, stage and treatment. Breast Cancer Res Treat. 2001 Nov;70(2):137-43.

ReferenceCitation: van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, van der Schueren E, Helle PA, van Zijl K, Bartelink H. Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst. 2000 Jul 19;92(14):1143-50.

ReferenceCitation: Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32.

ReferenceCitation: Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. Review.

ReferenceCitation: Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Wárlám-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. Epub 2007 Jun 18.

ReferenceCitation: Dubois JB, Hay M, Gely S, Saint-Aubert B, Rouanet P, Pujol H. IORT in breast carcinomas. Front Radiat Ther Oncol. 1997;31:131-7.

ReferenceCitation: Lemanski C, Azria D, Thezenas S, Gutowski M, Saint-Aubert B, Rouanet P, Fenoglietto P, Ailleres N, Dubois JB. Intraoperative radiotherapy given as a boost for early breast cancer: long-term clinical and cosmetic results. Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1410-5. Epub 2006 Jan 25.

ReferenceCitation: Lemanski C, Azria D, Gourgon-Bourgade S, Gutowski M, Rouanet P, Saint-Aubert B, Ailleres N, Fenoglietto P, Dubois JB. Intraoperative radiotherapy in early-stage breast cancer: results of the montpellier phase II trial. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):698-703. doi: 10.1016/j.ijrobp.2009.02.039. Epub 2009 May 23.

ReferenceCitation: Smith BD, Arthur DW, Buchholz TA, Haffty BG, Hahn CA, Hardenbergh PH, Julian TB, Marks LB, Todor DA, Vicini FA, Whelan TJ, White J, Wo JY, Harris JR. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). J Am Coll Surg. 2009 Aug;209(2):269-77. doi: 10.1016/j.jamcollsurg.2009.02.066. Epub 2009 Apr 24.

ReferenceCitation: Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41.

ReferenceCitation: Vlastos G, Mirza NQ, Meric F, Hunt KK, Kuerer HM, Ames FC, Ross MI, Buchholz TA, Hortobagyi GN, Singletary SE. Breast conservation therapy as a treatment option for the elderly. The M. D. Anderson experience. Cancer. 2001 Sep 1;92(5):1092-100.

ReferenceCitation: Vinh-Hung V, Verschraegen C. Breast-conserving surgery with or without radiotherapy: pooled-analysis for risks of ipsilateral breast tumor recurrence and mortality. J Natl Cancer Inst. 2004 Jan 21;96(2):115-21.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

intervention_type: Radiation


title: CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections

acronym: CLAZI

summary:
MAC lung infections are a growing public health problem. The ATS / IDSA 2007 guidelines for the treatment of these non-tuberculous mycobacterial infections recommend the use of a macrolide or azalide (clarithromycin or azithromycin), rifampicin or rifabutin and ethambutol.

For MAC disseminated infections, several studies have compared combinations containing clarithromycin or azithromycin and found no significant difference in efficacy. No randomized controlled trials have been performed for pulmonary infections to compare clarithromycin and azithromycin in terms of efficacy. Clarithromycin is often used as a first-line treatment in France, but its tolerance is often poor, particularly in terms of risk of hepatitis, metallic taste in the mouth, nausea or vomiting, and it interacts with many drugs via cytochrome p450 . In particular, it increases the toxicity of rifabutin, in particular in terms of uveitis. Azithromycin has fewer side effects especially less digestive toxicity and drug interactions than clarithromycin.

The hypothesis is therefore that the efficacy of azithromycin would be non-inferior in comparison with that of clarithromycin.

location_facility:
CHU Amiens Picardie
Saint Joseph Hospital


title: Observational Study Evaluating the Impact of the Covid-19 Pandemic on the Management of Patients With Head and Neck Cancer in the Maxillofacial Surgery Department

acronym: VADS-Covid

summary:
Since its emergence in late December 2019, the SARS-CoV-2 coronavirus has spread rapidly, causing a global health crisis. The disease caused by this highly contagious respiratory virus is called COVID-19. At the beginning of August 2020, there were more than 194,000 confirmed cases in France - including approximately 16,000 cases in the Hauts-de-France area - and more than 30,300 deaths.

Cancer patients are generally susceptible to respiratory infections, and CoV-2-SARS is no exception. Early Chinese studies reported a higher rate of CoV-2-SARS infection in people with cancer (or a history of cancer) than in the general population, with more severe forms and with an increased risk if surgery or chemotherapy is performed in the month prior to infection. The purpose of this study is to describe the management modalities of patients with H&N (Head and Neck) cancer during the COVID-19 pandemic in the Maxillofacial Surgery Department of CHU Amiens-Picardie.


title: Social Cognitive Assessment in Psychiatry - Validation of a New Battery: ClaCoS

acronym: (ClaCoS)

summary: In people with schizophrenia or people with autism, impairments of social cognition are a core feature of the disease and, according to researchers who represent valuable references on this subject for the international community, three to five processes of social cognition are usually altered in those diseases: (1) emotional processing which is the ability to identify emotions through facial expressions, gestures, and tone of voice, (2) theory of mind (ToM), which is defined as "the ability to attribute mental states (beliefs, intents, desires, …) to oneself and others, and to understand that others have beliefs, intentions, and desires that are different from one's own", (3) attributional style which refers to how people explain the causes of positive and negative events, and corresponding, in schizophrenia, to self-serving and personalizing bias that means a tendency to blame others for negative life events rather than sharing the responsibilities between different sources; and (4 and 5) social perception and knowledge, which can be defined as decoding and interpreting social cues from others, taking the social context into account, and knowing social rules, roles, and goals. Components of social cognition appear to be related to both symptomatology and functioning in everyday life. The present study aims to assess a new social cognitive battery developed by several teams in France: ClaCoS.

lead_sponsor: Hôpital le Vinatier


title: Health Related Quality of Life of Patients With Gynecologic Cancers: Feasibility Study of a Prospective and Pragmatic Cohort

acronym: GYNEQOL-Pilot

summary:
Gynecologic cancers (cancers of cervix, endometrium, ovary, vagina, and vulva) represent an important part of the female cancer in France with more than 15 000 new cases in 2012. As considerable progress have been made in diagnostic and therapeutic strategies, an important part of the gynecologic cancers are diagnosed at an early stage and globally, the after treatment overall survival rate is estimated to more than 80% at five years. Thus, it is of evident interest to study health related Quality of Life (QoL) among these patients who will continue to live after their cancer and to consider QoL as a primary end-point, beyond overall survival.

The GYNEQOL (health related Quality Of Life of women with GYNEcologic cancer) group is a working group initiated in Besançon and whose goal is to investigate QoL of gynecologic cancers' patients. It gathers several entities from the hospital of Besançon, namely the Methodology and Quality of Life in Oncology Unit, the Gynecologic Unit and the Oncology Unit. The GYNEQOL study is a project of a prospective cohort study, in a pragmatic clinical practice, with the main objective of longitudinally collecting and analyzing QoL data of these women.

The pilot phase, GYNEQOL-Pilot, restricted to the hospital of Besançon, has started in September 2015 with the goal of assessing the feasibility of the cohort. The feature of this study is that patients answer to QoL questionnaires using tablets computer and the Computer-based Health Evaluation System software (CHES). Indeed, use of electronic solutions to collect patient reported outcomes is drastically increasing those last years. It has been underlined that routinely collecting symptoms could increase both QoL and survival among cancer patients. It enables to use these data in real-time in routine practice by presenting QoL scores to physicians in simple graphical histograms for both transversal and longitudinal measurements and it ensures a reliable data collection.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Visual Exploration and Attention : Studies in Patients With Schizophrenia and Autism Spectrum Disorders

summary: The aim of the protocol is to better understand the impairments in visual processing, as such impairments may induce social interaction difficulties in subjects with autism spectrum disorders (adults and children) and schizophrenia, like face exploration.The same protocol will be used for the three populations, each population being compared with matched controls. The explorations are designed to test two different hypotheses regarding the mechanisms of the visual perception difficulties of the two populations. Even though difficulties to extract the global form of objects have been described in both subjects with autism and schizophrenia, we will test two different hypotheses for the two populations. We will test the hypothesis that subjects with autism display an advantage for the processing of local information arising at an early level of processing, whereas disorders observed in patients with schizophrenia originate from attention disorders. The protocol includes three consecutive studies, each one being applied in each of the three populations.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: INSERM U666 ; Pôle de Psychiatrie - Service de Psychiatrie Adulte- HUS

location_facility: Centre de Ressources Autisme Pôle adultes (68) - Espace Autisme 68

location_facility: Pôle départemental du Centre de Ressources Autisme pour adultes (67) - Etablissement public de santé Alsace-Nord (site de Brumath)

location_facility: Pôle régional du Centre de Ressources Autisme pour enfants et adolescents - Unité d'évaluation des troubles du développement Hôpital de l'Elsau - Pôle de Psychiatrie - Unité d'évaluation des troubles du développement Hôpital de l'Elsau - HUS


title: ACTIVHOP: Adapted Physical Activity, Health-related Quality of Life and Satisfaction With Care in Hospitalized Children; a Randomized Controlled Study

acronym: ACTIVHOP

summary:
The aim of this study is to assess the efficacy of adapted physical activity intervention on health-related quality of life and satisfaction with care in hospitalized children and adolescents.

This is a randomized controlled study. The hypothesis is that children practicing adapted physical activity during their hospitalization present a higher health-related quality of life and satisfaction with care than those who do not.

lead_sponsor: Central Hospital, Nancy, France

location_facility: University Hospital, Children's Hospital


ReferenceCitation: Aparicio T, Cozic N, de la Fouchardière C, Meriaux E, Plaza J, Mineur L, Guimbaud R, Samalin E, Mary F, Lecomte T, Gomez-Roca C, Haineaux PA, Gratet A, Selves J, Menu Y, Colignon N, Johnson L, Legrand F, Vassal G. The Activity of Crizotinib in Chemo-Refractory MET-Amplified Esophageal and Gastric Adenocarcinomas: Results from the AcSé-Crizotinib Program. Target Oncol. 2021 May;16(3):381-388. doi: 10.1007/s11523-021-00811-8. Epub 2021 Apr 13.

family: Aparicio

full_name: Thomas Aparicio

given: Thomas

family: Cozic

full_name: Nathalie Cozic

family: de la Fouchardière

full_name: Christelle de la Fouchardière

given: Christelle

family: Meriaux

full_name: Emeline Meriaux

given: Emeline

family: Plaza

full_name: Jérome Plaza

given: Jérome

family: Mineur

full_name: Laurent Mineur

given: Laurent

family: Guimbaud

full_name: Rosine Guimbaud

given: Rosine

family: Samalin

full_name: Emmanuelle Samalin

given: Emmanuelle

family: Mary

full_name: Florence Mary

given: Florence

family: Lecomte

full_name: Thierry Lecomte

given: Thierry

family: Gomez-Roca

full_name: Carlos Gomez-Roca

given: Carlos

family: Haineaux

full_name: Paul-Arthur Haineaux

given: Paul-Arthur

family: Gratet

full_name: Alain Gratet

given: Alain

family: Selves

full_name: Jannick Selves

given: Jannick

family: Menu

full_name: Yves Menu

given: Yves

family: Colignon

full_name: Nikias Colignon

given: Nikias

family: Johnson

full_name: Laetitia Johnson

given: Laetitia

family: Legrand

full_name: Frédéric Legrand

given: Frédéric

family: Vassal

full_name: Gilles Vassal

given: Gilles

journal_name: Targeted Oncology

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

ReferenceCitation: Moro-Sibilot D, Cozic N, Pérol M, Mazières J, Otto J, Souquet PJ, Bahleda R, Wislez M, Zalcman G, Guibert SD, Barlési F, Mennecier B, Monnet I, Sabatier R, Bota S, Dubos C, Verriele V, Haddad V, Ferretti G, Cortot A, De Fraipont F, Jimenez M, Hoog-Labouret N, Vassal G. Crizotinib in c-MET- or ROS1-positive NSCLC: results of the AcSé phase II trial. Ann Oncol. 2019 Dec 1;30(12):1985-1991. doi: 10.1093/annonc/mdz407.

title: AcSé CRIZOTINIB : Secured Access to Crizotinib for Patients With Tumors Harboring a Genomic Alteration on One of the Biological Targets of the Drug.

summary:
This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients with identified activating molecular alterations in the crizotinib target genes. A cohort is defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET amplification).

For each cohort a two-stage design will be implemented. In the situation where expected accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that the target number may not be achievable in a reasonable timeframe; for these cohorts, the alpha and beta errors will be fixed at 15%. Consequently three different statistical designs will be a priori considered according to the expected response rate and incidence.


acronym: TOXOGEST

source: euctr

title: Multicenter, Randomized Clinical Trial to Compare the Efficacy and Tolerance of Prenatal Therapy With Pyrimethamine + Sulfadiazine vs Spiramycine to Reduce Vertical Transmission of Toxoplasma Gondii Following Primary Infection in Pregnancy

summary:
Background : When a mother contracts toxoplasmosis during pregnancy, the parasite may be transmitted from to her unborn child. This results in congenital toxoplasmosis, which may cause damage to the eyes and nervous system of the child. To date, no method has been proved effective to prevent this transmission. In France, spiramycin is usually prescribed to women who have toxoplasma seroconversion in pregnancy, however its efficacy has not been determined. The standard treatment for toxoplasmosis is the combination of the antiparasitic drugs pyrimethamine and sulfadiazine, but this strategy has not been evaluated for the prevention of mother-to-child transmission.

Purpose : Randomized phase 3 trial to determine whether pyrimethamine + sulfadiazine is more effective than spiramycin to prevent congenital toxoplasmosis.


title: Non-COVID Patient-safety Incidents Reported by General Practitioners in Time of Lockdown: Protocol for a Cross-sectional Descriptive Study.

acronym: PSI-RECORd-GP

summary:
The COVID-19 epidemic is causing a global health crisis. In France, it has imposed a major reorganization of the healthcare system. This emergency reorganization is unprecedented. It involved first, second and third line care. Following this reorganization and from the first days of confinement, a decrease in care activity not related to COVID-19 was observed in médical offices, in emergency services, and in secondary and tertiary care services. This decrease in activity could indicate a decrease in pathologies related to work, transportation or non-COVID-19 infections, due to a favourable effect of lockdown. Nevertheless, some health professionals report the opposite in the media and on social networks, an unusual increase in events (appendicular peritonitis treated late, increase in domestic violence, etc.), while others are surprised by a decrease in activity that is difficult to explain (leukaemia diagnoses by biologists, for example). One hypothesis is that such changes could be related to the reorganisation of the health care system or to the consequences of lockdown.

The World Health Organization (WHO) recommends a systematic collection and analysis of patient safety incidents (also called "adverse events" in France). The objective is to assess the roles of the system and human factors in patient safety, in order to propose changes to the global system and local organisation. In France, there is a system for reporting serious adverse events related to care. Only 4% of the 820 serious adverse events reported in 2018 were reported by primary healthcare professionals (1). However, patient safety incidents in primary care are known to have specific mechanisms, types and mechanisms (2).

We hypothesize that the COVID-19 health crisis may have induced unusual patient safety incidents through new mechanisms in a context associating reorganization of the healthcare system and population lockdown. Such a scenario requires the implementation of a massive collection of potential incidents and their systematic and well-structured analysis.

Thus, the objective of our study is to describe patient safety incidents related to the reorganization of care and/or lockdown in the context of the COVID-19 health crisis (types, severity, mechanisms) reported by general practitioners in France.

HAS. Retour d'expérience sur les événements indésirables graves associés à des soins (EIGS) [Internet]. [cited 2020 Apr 7]. Available from: https://www.has-sante.fr/jcms/c_2882289/fr/retour-d-experience-sur-les-evenements-indesirables-graves-associes-a-des-soins-eigs
Carson-Stevens A, Hibbert P, Avery A, Butlin A, Carter B, Cooper A, et al. A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice. BMJ Open. 2015 Dec 1;5(12):e009079.

ReferenceCitation: Fournier JP, Amélineau JB, Hild S, Nguyen-Soenen J, Daviot A, Simonneau B, Bowie P, Donaldson L, Carson-Stevens A. Patient-safety incidents during COVID-19 health crisis in France: An exploratory sequential multi-method study in primary care. Eur J Gen Pract. 2021 Dec;27(1):142-151. doi: 10.1080/13814788.2021.1945029.

name: Department of General Practice, Faculty of Medicine, University of Nantes, Nantes, France

family: Fournier

full_name: Jean-Pascal Fournier

given: Jean-Pascal

family: Amélineau

full_name: Jean-Baptiste Amélineau

given: Jean-Baptiste

family: Hild

full_name: Sandrine Hild

given: Sandrine

family: Nguyen-Soenen

full_name: Jérôme Nguyen-Soenen

given: Jérôme

family: Daviot

full_name: Anaïs Daviot

given: Anaïs

family: Simonneau

full_name: Benoit Simonneau

given: Benoit

name: Medical Directorate, NHS Education for Scotland, Glasgow, UK

name: Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK

name: School of Health and Social Care, Staffordshire University, Stafford, UK

family: Bowie

full_name: Paul Bowie

given: Paul

name: London School of Hygiene and Tropical Medicine, London, UK

family: Donaldson

full_name: Liam Donaldson

given: Liam

name: Division of Population Medicine, Cardiff University, Cardiff, UK

family: Carson-Stevens

full_name: Andrew Carson-Stevens

given: Andrew

currency_apc_doaj: EUR

journal_name: European Journal of General Practice

repository_institution: Cardiff University - ORCA Online Research @Cardiff

repository_normalized: https

version: acceptedVersion

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

repositories:
HAL
PubMed Central
https

repositories_pmh: HAL https

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Nantes University Hospital


title: Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak

acronym: PRPsyCOVID

summary:
Clinical data about psychological impact of quarantine are well studied in transient event or more prolonged situation like jail incarceration.

In recent metaanalysis, psychological impact of quarantine was well documented in a specific population during first SARS epidemy. Even after the end of quarantine several patients were still with symptom of avoiding mainly agoraphobia, frequent hand washing and a carefull return to normal life COVID-19 infection is already associated with psychological symptom like anxiety, depression, sleep disorders and symptoms of acute stress However psychological impact of quarantine is on none in chronic painful inflammatory rheumatism in France. The prevalence of rheumatoid arthritis is 0.5% of the population with frequent comorbidity such as anxiety and depression.

During the quarantine secondary to COVID-19 pandemic it's possible to evaluated the psychological impact of adult RA patients.

The present study is an "emergency" being realize before the end of the quarantine.

lead_sponsor: University Hospital, Lille


title: Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence

summary: Experimental and epidemiologic studies have suggested that aspirin intake reduces the risk for colorectal cancer. In the APACC study we randomly assigned 291 patients to daily Aspirin or Placebo for 4 years. However, the available data are not sufficient to serve as the basis for firm recommendations

ReferenceCitation: Benamouzig R, Deyra J, Martin A, Girard B, Jullian E, Piednoir B, Couturier D, Coste T, Little J, Chaussade S. Daily soluble aspirin and prevention of colorectal adenoma recurrence: one-year results of the APACC trial. Gastroenterology. 2003 Aug;125(2):328-36.

ReferenceCitation: Benamouzig R, Uzzan B, Deyra J, Martin A, Girard B, Little J, Chaussade S; Association pour la Prévention par l'Aspirine du Cancer Colorectal Study Group (APACC). Prevention by daily soluble aspirin of colorectal adenoma recurrence: 4-year results of the APACC randomised trial. Gut. 2012 Feb;61(2):255-61. doi: 10.1136/gutjnl-2011-300113. Epub 2011 Sep 2. Erratum in: Gut. 2012 Mar;61(3):472.

family: Benamouzig

full_name: Robert Benamouzig

given: Robert

family: Uzzan

full_name: Bernard Uzzan

given: Bernard

family: Deyra

full_name: Jacques Deyra

given: Jacques

family: Martin

full_name: Antoine Martin

given: Antoine

family: Girard

full_name: Bernard Girard

family: Little

full_name: Julian Little

given: Julian

family: Chaussade

full_name: Stanislas Chaussade

given: Stanislas

name: for the Association pour la Prévention par l'Aspirine du Cancer Colorectal Study Group (APACC)*

journal_name: Gut

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility: Hôpital COCHIN Service d'Hépato-Gastro-Entérologie


title: Evaluation of Urine Pregnancy Test, CHECK TOP Test, Compared to Transvaginal Ultrasound During Control Visit Post Drug Abortion (CHECK-TOP).

acronym: CHECK-TOP

summary:
According to a study of the DREES (Direction de la Recherche, des Etudes, de l'Evaluation et des Statistiques), in 2013, nearly 229 000 abortions were performed in France, an increasing number.

The success rate of drug abortion before 49 days of amenorrhea, defined by the National Health Autority as a complete abortion not requiring surgery, varies from 92 to 98% depending on the pregnancy term and the dose used.

The control visit is performed between the 14th day and the 21th day post abortion. Its role is to monitor the effectiveness of the method, to verify absence of complication and to better adapt contraception to prevent another unwanted pregnancy. The choice of the method is left to the physician's discretion: β-HCG dosage, pelvic or transvaginal ultrasound.

In the Orthogenic Departement of the Croix-Rousse Hospital Lyon, France, the method performed during the control visit is transvaginal ultrasound.

To simplify the monitoring of drug abortion, a urine pregnancy test would be an attractive alternative to transvaginal ultrasound: simplicity of use, speed, ease of interpretation and low cost.

The main objective of this study is to evaluate the diagnostic value of urine pregnancy test CHECK TOP compared to transvaginal ultrasound in monitoring the outcome of drug abortion during the control visit.

This is a monocentric observational study.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse


title: Prospective Cohort Follow-up of French Patients With Profound and Multiple Disabilities: Healthcare Pathways and Quality of Life Among Patients and Their Families

acronym: Eval-PLH

summary:
The studies conducted so far concerning the medical and paramedical cares provided to patients with profound and multiple disabilities (PMD) often show important limitations: samples are too small or very heterogeneous, generally constituted of children only; studies are mainly cross-sectional and retrospective, focusing on very specific issues instead of assessing health and quality of life from a more global perspective… So far, the investigators found no published data from a prospective cohort study involving a representative sample of patients with PMD. The present project aims to set up such a cohort so as to describe for the first time the natural history of French patients with PMD as well as the cares they receive at home or within the different dedicated structures in France. This cohort will also make it possible to identify the factors responsible for differences in the cares patients are provided, the consequences of these differences on their health and their quality of life (and those of their relatives) as well as the evolutions of these data over time. It will then allow for assessing the effectiveness of the French healthcare system to care for patients with PMD as well as building a frame of reference regarding the best cares to provide to these patients.

The primary goal of this study is to identify the determinants of health among patients with PMD.

ReferenceCitation: Rousseau MC, Baumstarck K, Valkov M, Felce A, Brisse C, Khaldi-Cherif S, Loundou A, Auquier P, Billette de Villemeur T; French Polyhandicap Group. Impact of severe polyhandicap cared for at home on French informal caregivers' burden: a cross-sectional study. BMJ Open. 2020 Feb 2;10(1):e032257. doi: 10.1136/bmjopen-2019-032257.

family: Rousseau

full_name: Marie-Christine Rousseau

given: Marie-Christine

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

family: Valkov

full_name: Maria Valkov

given: Maria

family: Felce

full_name: Agnés Felce

given: Agnés

family: Brisse

full_name: Catherine Brisse

given: Catherine

family: Khaldi-Cherif

full_name: Sherezad Khaldi-Cherif

given: Sherezad

family: Loundou

full_name: Anderson Loundou

given: Anderson

family: Auquier

full_name: Pascal Auquier

given: Pascal

family: Billette de Villemeur

full_name: Thierry Billette de Villemeur

given: Thierry

journal_name: BMJ Open

repositories:
HAL
PubMed Central

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

title: Impact of severe polyhandicap cared for at home on French informal caregivers’ burden: a cross-sectional study

ReferenceCitation: Rousseau MC, Billette de Villemeur T, Khaldi-Cherif S, Brisse C, Felce A, Baumstarck K, Auquier P; French Polyhandicap Group. Adequacy of care management of patients with polyhandicap in the French health system: A study of 782 patients. PLoS One. 2018 Jul 6;13(7):e0199986. doi: 10.1371/journal.pone.0199986. eCollection 2018.

name: on behalf of the French Polyhandicap Group

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Phenotype and Genotype Analysis in Congenital Hypothyroidism Due to Thyroid Dysgenesis. The Use of Genetic Analysis in the Early Care of Children With Thyroid Dysgenesis

acronym: HYPOTYGEN

summary:
Congenital hypothyroidism (CH) is a rare disease that affects 1 in 3500 newborn. This condition is detected consistently since the late 1970s in France, which has led to early care and a significant improvement in prognosis and intellectual stature of these children. However neurodevelopmental disorders persist in 10-15% of cases. More associated diseases have been reported in approximately 10% of cases. These observations are in most cases poorly understood. The family nature of the CH is now well recognized and a dozen genes involved up to now. However, in the majority of cases (HC not due to a disorder of the organification of iodine), few mutations have been found in the reported number of patients (5-10%), suggesting the involvement of other genes. Some of the genes have been implicated in particular specific syndromic forms but many pathological associations remain unexplained. Also, a more complete genetic elucidation of CH would enable a better understanding of its etiology and thus its risk of familial recurrence (frequently asked questions by parents of children with CH) and secondly the presence of associated pathologies.

Main goal: to describe the population with CH (not due to a disorder of the organification of iodine) not only on clinical, biological and radiological (phenotypic analysis) but also on the genetic level to establish a genotype / phenotype correlation.

ReferenceCitation: Stoupa A, Adam F, Kariyawasam D, Strassel C, Gawade S, Szinnai G, Kauskot A, Lasne D, Janke C, Natarajan K, Schmitt A, Bole-Feysot C, Nitschke P, Léger J, Jabot-Hanin F, Tores F, Michel A, Munnich A, Besmond C, Scharfmann R, Lanza F, Borgel D, Polak M, Carré A. TUBB1 mutations cause thyroid dysgenesis associated with abnormal platelet physiology. EMBO Mol Med. 2018 Dec;10(12). pii: e9569. doi: 10.15252/emmm.201809569.

name: INSERM U1016 Faculté de Médecine Cochin Institute Université Paris Descartes, Sorbonne Paris Cité Paris France

name: IMAGINE Institute Affiliate Paris France

name: RARE Disorder Center: Centre des Maladies Endocriniennes Rares de la Croissance et du Développement Paris France

name: Pediatric Endocrinology, Gynecology and Diabetology Unit Hôpital Universitaire Necker‐Enfants Malades AP‐HP Paris France

family: Stoupa

full_name: Athanasia Stoupa

given: Athanasia

name: INSERM UMR_S1176 Paris‐Sud University, Université Paris‐Saclay Le Kremlin‐Bicêtre France

family: Adam

full_name: Frédéric Adam

given: Frédéric

family: Kariyawasam

full_name: Dulanjalee Kariyawasam

given: Dulanjalee

name: INSERM EFS Grand Est BPPS UMR‐S 1255 FMTS Université de Strasbourg Strasbourg France

family: Strassel

full_name: Catherine Strassel

name: Department of Biomedicine Pediatric Immunology University of Basel Basel Switzerland

family: Gawade

full_name: Sanjay Gawade

given: Sanjay

name: Pediatric Endocrinology University Children's Hospital Basel University of Basel Basel Switzerland

family: Szinnai

full_name: Gabor Szinnai

given: Gabor

family: Kauskot

full_name: Alexandre Kauskot

given: Alexandre

name: Necker Children's Hospital Biological Hematology Service Assistance Publique—Hôpitaux de Paris Paris France

family: Lasne

full_name: Dominique Lasne

given: Dominique

name: Institut Curie CNRS UMR3348 PSL Research University Orsay France

name: Institut Curie CNRS UMR3348 Université Paris Sud, Université Paris‐Saclay Orsay France

family: Janke

full_name: Carsten Janke

given: Carsten

family: Natarajan

full_name: Kathiresan Natarajan

given: Kathiresan

family: Schmitt

full_name: Alain Schmitt

given: Alain

name: Genomic Platform INSERM UMR 1163  IMAGINE Institute Paris Descartes University, Sorbonne Paris Cité Paris France

family: Bole‐Feysot

full_name: Christine Bole‐Feysot

given: Christine

name: Bioinformatics Platform IMAGINE Institute Paris Descartes University Paris France

family: Nitschke

full_name: Patrick Nitschke

given: Patrick

name: Pediatric Endocrinology Unit Hôpital Universitaire Robert Debré AP‐HP Paris France

name: Paris Diderot University, Sorbonne Paris Cité Paris France

name: INSERM UMR 1141 DHU Protect Paris France

family: Léger

full_name: Juliane Léger

given: Juliane

family: Jabot‐Hanin

full_name: Fabienne Jabot‐Hanin

given: Fabienne

family: Tores

full_name: Frédéric Tores

family: Michel

full_name: Anita Michel

given: Anita

name: INSERM U1163 IMAGINE Institute Translational Genetics Université Paris Descartes, Sorbonne Paris Cité Paris France

name: Department of Genetics Hôpital Universitaire Necker‐Enfants Malades AP‐HP Paris France

family: Munnich

full_name: Arnold Munnich

given: Arnold

family: Besmond

full_name: Claude Besmond

given: Claude

family: Scharfmann

full_name: Raphaël Scharfmann

given: Raphaël

family: Lanza

full_name: François Lanza

given: François

family: Borgel

full_name: Delphine Borgel

given: Delphine

name: Fédération Parisienne pour le Dépistage et la Prévention des Handicaps de l'Enfant (FPDPHE) Paris France

family: Polak

full_name: Michel Polak

given: Michel

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

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

title: TUBB 1 mutations cause thyroid dysgenesis associated with abnormal platelet physiology

ReferenceCitation: Carré A, Stoupa A, Kariyawasam D, Gueriouz M, Ramond C, Monus T, Léger J, Gaujoux S, Sebag F, Glaser N, Zenaty D, Nitschke P, Bole-Feysot C, Hubert L, Lyonnet S, Scharfmann R, Munnich A, Besmond C, Taylor W, Polak M. Mutations in BOREALIN cause thyroid dysgenesis. Hum Mol Genet. 2017 Feb 1;26(3):599-610. doi: 10.1093/hmg/ddw419.

location_facility: Pediatric endocrinology gynecology and diabetology, Hôpital Necker Enfants Malades, Assistance Publique - Hôpitaux de Paris , Université Paris Descartes, INSERM unit U 845


title: Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)

acronym: ALYCEmolecular

summary:
Central nervous system lymphoma (PCNSL) is a diffuse large B cell lymphoma (DLBCL) entity with a particularly poor prognosis (median survival less than 3 years). They are still poorly characterized biologically, largely because of their rarity (300 cases / year in France) and the difficulty for obtaining a material of sufficient quality and quantity. It is nevertheless assumed that their pathophysiology is particular, since they develop exclusively in an immunological sanctuary, and that they present some characteristic molecular abnormalities (mutation of MYD88 or TBL1XR1 for example).

A collection of 74 PCNSLs has created, clinically annotated, from which frozen material is available in addition to the material fixed and included in paraffin (cohort ALYCE). Informed consent was gathered for all patients. Comparative Genomic Hybridization-array analysis of this cohort has already revealed abnormalities associated with a poor prognosis (unpublished data). The objective of this study is to complete this analysis by sequencing a panel of 96 mutant genes recurrently in DLBCLs and PCNSLs, and the molecular determination of the original cell by the (RT-MLPA) Reverse Transcriptase-Multiplex Ligation-dependent Probe Amplification technique.

The integration of genetic, molecular and transcriptomic data may define prognostic markers and open perspectives for translational research in PCNSL.

location_facility: Service d'hématologie biologique - Centre Hospitalier Lyon Sud - HCL


title: Using, Efficacity and Safety of Intranasal Fentanyl for the Treatment of Acute Severe Pain on the Pediatric Emergency Department of Mercy Hospital.

acronym: FENTANYLIN

summary: The treatment of acute severe pain in pediatric emergencies required a quick and effective therapeutic support. Actually in France, only peripheral venous access or oral therapies with onset of action are commonly used and only few treatments can be used to manage the acute severe pain in children. In June 2017, an intranasal fentanyl use protocol has been established in the pediatric emergency department of Mercy hospital-Metz. The intranasal fentanyl treatment has proved his effectiveness and safe condition in many countries since few years even though has not yet obtained a marketing authorization for use in children in France. In view of the information, parental permission was obtained before the intranasal administration. The efficacy and surveillance data in all patient records of children who benefited this analgesic protocol were retrospectively collected between June 2017 and August 2018. This retrospective study wants to describe the efficacy and safety of intranasal fentanyl on the pediatric emergency department.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Études Observationnelles Des conséquences néonatales et pédiatriques de l'Infection à Virus Zika au Cours de la Grossesse Pendant l'épidémie Des départements français d'Amérique de l'année 2016

acronym: ZIKA-DFA-BB

summary:
The Zika epidemic has spread into the three French Overseas Departments in the Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for the evaluation of potential complications due to having ZIKV infection during pregnancy.

This study is meant to collect, within usual care practices, clinical and paraclinical information (including imaging and laboratory results) as well as biological samples allowing the precise description of the consequences of ZIKV infection during pregnancy.

This study is the 2nd arm of a global research program in the 3 French Overseas Departments in the Caribbean. It is complementary to the first arm (ZIKA-DFA-FE) consisting in the follow-up of women in the French Overseas Departments who are pregnant during the Zika epidemic period.

The study population is made up of infants born during and up to 9 months after the end of the Zika epidemic period in the French Overseas Departments.

The data and biological specimens collected for this project will be done so through the recommended standard of care which has been put in place considering the ZIKV epidemic in the 3 French Overseas Departments, upholding existing recommendations (profession and/or recommendation from the public health authorities)

ReferenceCitation: Grant R, Fléchelles O, Tressières B, Dialo M, Elenga N, Mediamolle N, Mallard A, Hebert JC, Lachaume N, Couchy E, Hoen B, Fontanet A. In utero Zika virus exposure and neurodevelopment at 24 months in toddlers normocephalic at birth: a cohort study. BMC Med. 2021 Jan 21;19(1):12. doi: 10.1186/s12916-020-01888-0.

family: Grant

full_name: Rebecca Grant

given: Rebecca

family: Fléchelles

full_name: Olivier Fléchelles

given: Olivier

family: Tressières

full_name: Benoît Tressières

given: Benoît

family: Dialo

full_name: Mama Dialo

given: Mama

family: Elenga

full_name: Narcisse Elenga

given: Narcisse

family: Mediamolle

full_name: Nicolas Mediamolle

given: Nicolas

family: Mallard

full_name: Adeline Mallard

given: Adeline

family: Hebert

full_name: Jean-Christophe Hebert

given: Jean-Christophe

family: Lachaume

full_name: Noémie Lachaume

given: Noémie

family: Couchy

full_name: Elvire Couchy

given: Elvire

family: Hoen

full_name: Bruno Hoen

given: Bruno

family: Fontanet

full_name: Arnaud Fontanet

given: Arnaud

journal_name: BMC Medicine

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

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

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: CH de l'Ouest Guyanais Franck Joly (CHOG)


title: Psychological Impact of the Covid-19 Pandemic on Student Nurses :Prevalence and Risk Factors of Acute Post-traumatic Stress Symptoms 1 Month After the Epidemic Peak

acronym: StudentCov

summary: The World Health Organization (WHO) declared in early 2020 the emergence of a new highly contagious SARS-CoV-2 coronavirus responsible for a global public health emergency. In France, the first cases of contamination have been reported since the end of January 2020, and the first death in mid-February 2020. Then, data published by Public Healh France reported an increasing and rapidly exponential number of contaminations. First cases have been identified on a cluster mode, then rapidly spreading in some French departments and regions, indicating rapid kinetics of virus spread. Given the magnitude of the situation both French territory and neighboring European territories (mainly Italy), the government mobilized the entire health system to critically manage this epidemic. This exceptional and unprecedented pandemic deeply impacted the health structures, disrupting healthcare organizations. All caregivers, including all student nurses, actively participated in the mobilization and strengthening of care teams. The health crisis exposed the population of caregivers to potentially traumatic events which can have major repercussions on their health state. The description and identification of the risk factors of the occurrence of post traumatic stress disorders in student nurses during the health crisis would allow to provide avenues for improving training devices and to facilitate health workers access to specific psychological care particularly dedicated to the student nurses population needs.

lead_sponsor: Versailles Hospital

location_facility:
Versailles hospital
Toulouse University Hospital


title: Volatil Organic Compounds in Exhaled Air and Sweat After Thoracic Surgery for Carcinological Resection

acronym: Onco-VOC

summary:
Bronchopulmonary cancer, with 39 000 new cases and 30 000 deaths per year, is a main issue in public health in France. It is the leading cause of cancer death in France. A lot of progress in medical care has been made, but surgery remains the most effective treatment, when it is still possible. The goal is to detect and manage the lung cancer as early as possible. Alongside screening strategies by annual thoracic scanner, new approaches with innovative technologies open up for cancer detection and therapeutic follow-up.

The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The volatolomic analysis can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.

The composition of VOC in exhaled air and sweat is altered in patients with lung cancer. The VOC analysis and their variation could be used particularly in the follow-up of patients treated for lung cancer.

The purpose of this clinical research is to identify the VOCs related to lung cancers by comparing the VOC profiles in exhaled air and in sweat from patients diagnosed with localized lung cancer before and after resection surgery.

lead_sponsor: Hopital Foch


title: Evaluation of an Osteopathic Procedure in the Management of Pain in Palliative Care Patients in a Mobile Palliative Care Support Team (EMASP): Controlled, Randomized, Single-blind Study

acronym: OSTEOPAL

summary:
The culture of the palliative is anchored more and more in France. In 2009, nearly 9 out of 10 French people (89%) believe that palliative care can reduce the suffering of people at the end of their lives. Despite the rise of palliative care in France, their access is not homogeneous between regions. In 2010, it is estimated that 2 French out of 3 likely to receive palliative care could not access it. Palliative care remains essential at the end of the patient's life, as well as for the family and caregivers.

The French government has put in place three national palliative care development programs: 2002-2005, 2008-2012, 2015-2018. The last program has unlocked a budget of 190 million euros for their development. It has been estimated from Social Security reimbursements, that the costs per patient over their last years of life are 26,000 euros, for a total of 13.5 million euros.

One of the most important aspects of palliative care is the comfort of the patients as well as their feelings in the care.

In order to best meet the expectations of cancer patients, some offer early palliative care that is effective in improving both the quality of life of the patient and its life expectancy.

Osteopathy is a manual alternative medicine whose goal is to restore the lack of mobility of tissues. It can be used as a complementary treatment when a specific support is put in place. The purpose of this study is to examine the effectiveness of osteopathy in the reduction of pain in adult patients in palliative care.

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Effectiveness of Methylphenidate Late Formula to Reduce Cannabis Use in Young Cannabis-Related Patients and Attention Deficit Disorder Hyperactivity

acronym: METHACAN

summary:
Abuse of psychoactive substances is a behavior belonging to the field of risk behaviors that begins and takes place during adolescence. These risk behaviors are a major public health problem in France and worldwide.

Cannabis is the first illicit drug consumed by adolescents in France. His experimentation progresses rapidly between 11 and 17 years. The relationship between cannabis use and mental health has been shown by several studies. In particular Attention Deficit Hyperactivity Disorder (ADHD), characterized by attention deficit, impulsivity and disabling motor hyperactivity and beginning before 12 years of age (DSM-5), is a major risk factor for the consumption of cannabis. ADHD is a common condition (9% of children and 5% of adults), but often undiagnosed or untreated. It has been shown that the treatment of ADHD in childhood protects the consumption of psychoactive products during adolescence or adulthood. However, to our knowledge there is no study showing that treatment with methylphenidate in an ADHD patient - not treated - but already a cannabis user, was a positive prognostic factor in the decrease in cannabis use.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: An Observational Study for CML Patients Who Discontinued Tyrosine Kinase Inhibitors Intentionally After Achieving a Deep Molecular Response

acronym: A-STIM

summary: Treatment of Chronic Myeloid Leukemia (CML) has been revolutionized by the use of tyrosine kinase inhibitors including imatinib mesylate (Gleevec, Novartis Laboratories). Two other inhibitors of the BCR-ABL kinase are currently on the market in France, nilotinib (Tasigna®, Novartis Laboratories) in the first and second-line treatment and dasatinib (SPRYCEL®, Bristol-Myers Squibb Laboratories) in second line. Achieving a complete molecular response (CMR) in patients with Chronic Myeloid Leukemia (CML) treated with tyrosine kinase inhibitors may be currently regarded as the ultimate level of reduction of residual disease. The pilot Stop Imatinib study has opened the way for a french prospective study of stopping imatinib, the STIM study. The results of the STIM study showed that almost 60% of patients exhibited molecular relapse, most frequently within the first 6 months after discontinuation. The parameters that are statistically associated with the loss of complete molecular response are the Sokal score at diagnosis and the total duration of treatment with imatinib. Criteria to define molecular relapse in treatment free remission patients are not well defined and validated. The aim of the study is to validate the loss of major molecular response as a robust criteria for TKI resumption. The patient's population will be CML patients who are offered to discontinue therapy outside the STIM strial.

ReferenceCitation: Rousselot P, Loiseau C, Delord M, Cayuela JM, Spentchian M. Late molecular recurrences in patients with chronic myeloid leukemia experiencing treatment-free remission. Blood Adv. 2020 Jul 14;4(13):3034-3040. doi: 10.1182/bloodadvances.2020001772.

name: Department of Hematology and Oncology, Centre Hospitalier de Versailles, Le Chesnay, France;

name: Unité Mixte de Recherche (UMR) 1184, Institut de Biologie François Jacob, Commissariat à lÉnergie Atomique (CEA), University of Versailles-Saint-Quentin-en-Yvelines and Paris-Saclay, France;

family: Rousselot

full_name: Philippe Rousselot

given: Philippe

family: Loiseau

full_name: Clémence Loiseau

given: Clémence

name: Clinical Research Center, Centre Hospitalier de Versailles, Le Chesnay, France;

family: Delord

full_name: Marc Delord

given: Marc

name: Department of Molecular Biology and EA3518, University Hospital Saint-Louis Assistance Publique–Hôpitaux de Paris (AP-HP), University of Paris, Paris, France; and

family: Cayuela

full_name: Jean Michel Cayuela

given: Jean Michel

name: Department of Molecular Biology, Centre Hospitalier de Versailles, Le Chesnay, France

family: Spentchian

full_name: Marc Spentchian

journal_name: Blood Advances

evidence: open (via free article)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology


title: Online Survey on Psychological Impact of COVID-19 Epidemic on School-age Children

acronym: PSICOcs

summary:
The coronavirus outbreak is a stressful event for the whole population. Confinement measures are protective against the risk of dissemination of the virus, but they can also lead to several psychological symptoms. In children, a study in China has reported about 20% of depressive or anxious troubles in school-age children after a 4-week period of confinement.

In France, confinement lasted about 8 weeks. School resumed on May 11th for primary school children and on June 2nd for secondary school children.

In this survey, we aim at exploring the psychological status of these children and the impact on their schooling, for better understanding, support and prevention. Through this online questionnaire, we also aim at giving some psycho-education advices. Finally, we could identify some subgroups of children particularly vulnerable, and organise some specific support for them in coming months.