title: Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor

acronym: GLUCORRECTOR

summary:
Cystic Fibrosis related diabetes (CFRD), a major factor of morbid-mortality in CF, is characterized by a preclinical phase of glucose intolerance particularly long reaching up to 10 years.

At the physiopathology level, insulin secretion is determinant in the glucose tolerance abnormalities in CF. Indeed insulin secretion is dependent of the CFTR activity at the beta cell surface and inhibition of CFTR leads to a decrease in insulin secretion.

Recently, the combination of the lumacaftor, a CFTR corrector, with Ivacaftor, a CFTR potentiator, was studied in patient with CF homozygous for the Phe508 del CFTR mutation patients and showed an improvement of the respiratory state in comparison with the placebo group.

These data suggests that lumacaftor in combination with ivacaftor in targeting CFTR action may have an early impact on the insulin-secretion and consequently on the glucose tolerance.

time_perspective: Other

location_facility: Clinique "Mucoviscidose" Presqu'île de Perharidy

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Hôpital NORD - Assistance Publique Hôpitaux de Marseille


title: Contribution of the Exome Sequencing in Antenatal Period Behind Ultrasound Features Suggestive of a Rare Genetic Disease

acronym: PRENATEX

summary:
Congenital malformations concern 3% of pregnancies; most of them can be seen during pregnancy. For some malformations, an invasive sample (trophoblast biopsy or amniocentesis) is proposed to search a chromosomal abnormality by the technique of DNA chip. However, some strongly suggestive signs of a genetic (and not chromosomal) pathology have a very low diagnostic rate with this technique. In the absence of an etiological diagnosis, the prognosis for the unborn child is very difficult to assess, as we can't know if the fetal malformation is really isolated or associted to other unseen features as part of a syndromic condition.

For some malformations strongly suggestive of a genetic condition, we propose to realize an exome (i.e. all coding parts of the genome) sequencing of the trio (child and the 2 parents) with a delivery time compatible with the emergency situation of a pregnancy (6 weeks maximum). We will apply bioinformatics filters to analyse only genes known to be involved in the malformation present in the unborn child and thus avoid the identification of variants in unrelated genes. These lists of genes have been previously validated by the Rare Disease Health Sectors and the affiliated diagnostic laboratories. The selected malformations are: 1) anomalies of the central nervous system (microcephaly (<- 2DS) with anomalies of gyration, anomalies of the posterior fossa, anomalies of the midline except agenesis of the corpus callosum), 2) ophthalmological anomalies (microphthalmia, hyperplasia vitreous) and 3) renal abnormalities (large hyperechoic kidneys).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Groupe Hospitalier Region Mulhouse Et Sud Alsace

intervention_type: Genetic

lead_sponsor_type: academique

status_simplified: Ongoing


title: Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia

acronym: SPREAD

summary: Focal Cortical Dysplasias (FCDs) are neurodevelopmental disorders that represent a major cause of early onset drug-resistant epilepsies with cognitive and behavioral impairments, carrying a lifelong perspective of disability and reduced quality of life. Despite a major medical and socio-economic burden, rationale therapeutic strategies are still under debate. Surgical removal of the epileptogenic brain area (Epileptogenic Zone) is the most successful treatment, yet it fails to control FCD-associated seizures in as much as 40% of cases. Precise definition and complete resection of the Epileptogenic Zone are the main determinants of outcome. In current practice of French centers, up to 80% FCD-patients require an intracranial EEG (icEEG) recording to accurately define the epileptogenic zone. However, the indications for icEEG in MRI-visible FCD remain empirical and are essentially based on expert opinion.

study_type: Observational

time_perspective: Prospective

intervention_type: Procedure


title: Acute Acetaminophen Ingestion: Does Repeated Acetaminophen Blood Test Have an Interest?

summary: Acetaminophen is the first drug involved in voluntary drug poisoning. According to the studies conducted in the USA and in the United Kingdom, it is the first cause of acute liver failure, and this poisoning is responsible of 10 percent of liver transplants each year in these countries. Mortality is about 1/3 at the stage of acute liver failure. The main risk factors are malnutrition and chronic alcoholism. Ease of access to this toxic and highly correlated with factors predisposing socio-economic field are an important issue, including the speed and appropriateness of care are key factors both in terms of reducing morbidity mortality in socio-economic terms for the community.A nomogram defines a statistical threshold from which the blood concentration of paracetamol has a significant risk of liver toxicity. The blood paracetamol dosage practiced today at the 4th hour after ingestion of a toxic dose, but there is no consensus on whether or not to repeat this dosage during the treatment, as the first result is beyond the threshold or not.The administration of the antidote NAC (N-acetyl-cysteine) in proven cases of liver toxicity is also regulated by a protocol that can vary in different services.In the absence of clear guidelines, the question of the need for iterative dosages of paracetamol blood beyond the fourth hour post-ingestion if the initial paracetamol blood measurement is below the curve nomogram remains open.Is it possible to limit blood tests to a single assay paracétamolémie to H4 when it is below the curve, and thus enable the return home of the patient's somatic point of view (excluding psychiatric care when is voluntary drug intoxication), with consequences in terms of costs (hospital days) and duration of treatment?

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

location_facility: Service des Urgences, Centre Hospitalier de Sélestat

location_facility: Service d'accueil des Urgences, Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur

location_facility: Service des Urgences, Hôpital de Hautepierre

location_facility: Service des Urgences, Centre Hospitalier Intercommunal de la Lauter

location_facility: Service de Réanimation Médicale, Nouvel Hôpital Civil

location_facility: Service d'Accueil des Urgences, Nouvel Hôpital Civil

location_facility: Service d'Accueil des Urgences, Centre Hospitalier de Haguenau

location_facility: Service de Réanimation Médicale, Hôpital de Hautepierre

status_simplified: Unknown


title: Thromboprophylaxis During Bariatric Surgery

summary:
This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types of bariatric surgery.

- gastric banding and gastric bypass on anti-Xa activity levels

The study includes two groups of 150 patients scheduled for gastric banding or gastric bypass.

Assessment of anti-Xa levels before and 4 hours after the injections from day 0 to 2 in order to determine the best prophylactic regimen allowing expected values ranged between 0.3 and 0.5 IU / ml.

status: Unknown status

design_allocation: Randomized

primary_purpose: Prevention

location_facility: Département d'Anesthésiologie Hôpital de Brabois

location_facility: Centre investigation Clinique Hôpital Civil

location_facility: Service de Chirurgie Digestive Hopital de Hautepierre

location_facility: Service de Chirurgie Générale et Endocrinienne Hôpital Civil

location_facility: Laboratoire d'Hémostase Hôpital de Brabois

location_facility: Service de Chirurgie Digestive Hôpital de Brabois

location_facility: Service de chirurgie générale et digestive,Hôpital Hôtel Dieu

location_facility: Département d'Anesthésiologie Hôpital Civil

location_facility: Laboratoire d'hémostase Hôpital de Hautepierre

intervention_type: Drug


title: Phase I Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors

acronym: RAPIRI

summary: Therapeutic solutions to treat solid tumors that are resistant to conventional treatments are now limited. Laboratory data in animals (on pediatric tumors such as brain tumors, sarcomas and neuroblastomas) have shown that the combination of irinotecan (HIF1alpha inhibitor) and rapamycin (mTOR inhibitor) allowed to block development of blood vessels in the tumor and could, in some cases, stop its progression. This drug combination has already been tested in adult patients with refractory tumors and seems to give encouraging results with stabilization of the tumor. The dose and toxicity of irinotecan and rapamycin are known when these drugs are administered separately and in a context different from that of refractory tumors. RAPIRI is a phase I clinical trial whose principal objectives are to determine the maximum dose at which these two molecules may be administered and to assess the safety of this new combination of drugs.

status: Completed

primary_purpose: Treatment

location_facility: Institut Hémato-Oncologie Pédiatrique (IHOP)

location_facility: Hôpital des Enfants - Groupe Hospitalier Pellegrin

status_simplified: Completed


title: Multicenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic Fibrosis

summary: Diabetes is a important complication of cystic fibrosis (CF). The improved life expectancy of patients with cystic fibrosis, as a result of advances in medical therapy, has resulted in an increasing prevalence of cystic fibrosis-related diabetes (CFRD). CFRD is associated with accelerated pulmonary decline and increased mortality. Pulmonary effects are seen some years before the diagnosis of CFRD implying that impaired glucose tolerance may be very early detrimental. Insulin treatment is clearly indicated in patients with CFRD to control symptoms and reduce complications. However, at the state of impaired glucose tolerance or fasting hyperglycaemia, current screening methods are not suitable for the early management of hyperglycaemia.The recent introduction of the continuous glucose monitoring system (CGMS), which provides a continuous glucose profile, has revealed to be clinically relevant in the investigation of glucose excursions over a long period. This device, widely use in diabetic non cystic fibrosis patients, has been validated in non diabetic cystic fibrosis subjects. Previous studies of continuous glucose monitoring have been realized in CF patients with normal glucose tolerance and diabetes and compared with non CF controlThe aim of our study is to evaluate the glucose profile with continuous glucose monitoring the nutritional and respiratory status in cystic fibrosis subjects, according to their glucose tolerance.

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Leclercq A, Gauthier B, Rosner V, Weiss L, Moreau F, Constantinescu AA, Kessler R, Kessler L. Early assessment of glucose abnormalities during continuous glucose monitoring associated with lung function impairment in cystic fibrosis patients. J Cyst Fibros. 2014 Jul;13(4):478-84. doi: 10.1016/j.jcf.2013.11.005. Epub 2013 Dec 17.

location_facility: Service de Réanimation Médicale - Hôpital Civil

location_facility: Service d'Endocrinologie, Diabète et Maladies Métaboliques - Hôpital Civil

location_facility: Service d'Endocrinologie et Métabolisme - CHRU de Lille

location_facility: Service de Pneumologie - Hôpital de Hautepierre


title: Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF

summary: Prevention trial of nosocomial infections in neutropenic prematures with G-CSF

ReferenceCitation: Kuhn P, Messer J, Paupe A, Espagne S, Kacet N, Mouchnino G, Klosowski S, Krim G, Lescure S, Le Bouedec S, Meyer P, Astruc D. A multicenter, randomized, placebo-controlled trial of prophylactic recombinant granulocyte-colony stimulating factor in preterm neonates with neutropenia. J Pediatr. 2009 Sep;155(3):324-30.e1. doi: 10.1016/j.jpeds.2009.03.019. Epub 2009 May 24.

location_facility:
Jean Messer
Jean-Louis Demarquez
Xavier Hernandorena
Jean-Bernard Gouyon
Marie Thieuleux
Alain Menget
André Labbe
Bernard Guillois
Pierre Andrini


title: Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.

summary:
Non-small cell lung cancer (NSCLC) is a major public health problem. New treatments as immunotherapy can improve prognosis of patients with NCLC tumors. Nevertheless, no robust biomarker is actually available.

The hypothesis of the trial is to realize a longitudinal molecular monitoring of NSCLC patients treated by immunotherapy using a quantitative analysis of cell-free DNA.

The primary purposes is to study the predictive value of quantification of cell-free DNA at the first reevaluation time, on the clinical benefit, in NSCLC patients treated by immunotherapy (regardless of line, or associated treatments) The secondary purposes in this population of patients is to study the earlier predictive value (before the second treatment by immunotherapy ) of quantification of cell-free DNA, and its relationship with refractory disease and pseudo-progressive disease.

primary_purpose: Other

ipd_sharing: No

location_facility: Hopitaux Civils de Colmar - service de Pneumologie

location_facility: GHR Mulhouse Sud-Alsace - Service de Pneumologie

location_facility: CHU de Besancon - Service de pneumologie


title: Validation of the RADIAL Algorithm for Diagnosis of Autosomal Recessive Cerebellar Ataxia

acronym: RADIAL-VALID

summary: RADIAL is an algorithm which has been developed following a review of the literature on 67 autosomal recessive cerebellar ataxias (ARCA) and personal clinical experience. Frequency and specificity of each feature were defined for each autosomal recessive cerebellar ataxia, and corresponding prediction scores were assigned. Clinical and paraclinical features of patients are entered into the algorithm, and a patient's total score for each ARCA is calculated, producing a ranking of possible diagnoses. Sensitivity and specificity of the algorithm were assessed by blinded analysis of a multinational cohort of 834 patients with molecularly confirmed autosomal recessive cerebellar ataxia. The performance of the algorithm was assessed versus a blinded panel of autosomal recessive cerebellar ataxia experts. The correct diagnosis was ranked within the top 3 highest-scoring diagnoses at a sensitivity and specificity of >90% for 84% and 91% of the evaluated genes, respectively. Mean sensitivity and specificity of the top 3 highest-scoring diagnoses were 92% and 95%, respectively. Our aim is now to validate in a prospective cohort of ARCA, the performance of RADIAL to predict the correct genetic diagnosis.

location_facility: CHRU de Strasbourg - Neurology/Pediatrics

intervention_type: Diagnostic Test


title: Medico-economic Evaluation of the Balloon Sinuplasty as Mini-invasive Treatment of Frontal Sinusitis by a Randomized Multicenter Prospective Trial

acronym: SIBA

summary:
The sinuplasty balloon offers a more physiological first of the sinuses which minimizes risks associated to traditional surgery. Its atraumatic characteristic also helps to reduce the risk of bleeding (so any use of Pack), limit scarring ransom, reduce the post-operative pain, ensure faster return to daily life activities (reduction of the average length of hospitalization). Patient's quality of life would be improved (SNOT-22 questionnaire) and reduction of post-operative pain score seams decrease on EVA.

The economic impact of the sinuplasty balloon appears very favourable and fits into the strategy of development of the ambulatory practice.

location_facility: Service ORL et de Chirurgie Cervico-Faciale Hôpital Larrey

location_facility: ORL and facial surgery department, Hautepierre Hospital, Strasbourg's University Hospitals

location_facility: Service ORL, chirurgie maxillo-faciale et audiophonologie CHU - Hôpital de la Miletrie

location_facility: Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin

location_facility: Service ORL, stomatologie et de Chirurgie Cervico-Faciale Centre Hospitalier Intercommunal de Créteil

location_facility: Service ORL et de Chirurgie Maxillo-Faciale et Plastique Hôpital Lariboisière


title: Lyme Borreliosis and Early Cutaneous Diagnostic

acronym: DIABOLYC

summary:
Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with the early skin manifestation (erythema migrans).

This new proteomic method will be compared to the two existing method: culture of Borrelia and PCR detection of Borrelia (DNA detection of the bacteria).

status: Active, not recruiting

location_facility: Centre Hospitalo-Universitaire Jean Minjoz


title: Study of Multi-site Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient Carrying Severe Inactive: Randomized Controlled Trial vs Placebo

acronym: STIMOBIII

summary:
The study was designed to test the following hypotheses:

Main Objective:

To compare the level of spontaneous physical activity at 3 months after re-entrainment by multi-site electrical stimulation (m-ES), measured by actigraphy over 7 days, compared to conventional care (lifestyle and dietary advice and placebo (simulated) electrostimulation) (control arm).

Secondary Objectives:

To compare the metabolic, inflammatory, cardiovascular and functional parameters, physical activity, quality of life and quality of sleep, at 3 months and at 2 years in the two groups.

Design:

We will conduct a multicenter controlled study vs. reference care with randomization into two parallel groups and double-blind (placebo electrostimulation). Patients will have the ES material available at home and will be supervised by monthly visits over 3 months and by telephone follow-up for two years. The study size calculation is based on physical activity, the percentage of lean body mass and arterial stiffness measured in the OBEX study.

This project will determine whether the training strategy is effective for increasing physical activity and/or in inducing significant metabolic and cardiovascular effects in these patients after 2 years. In addition, it provides a solid base of investigation for the study of the interactions between muscle contraction and cardio-metabolic health with greater precision.

lead_sponsor: University Hospital, Grenoble

location_facility:
Hôpital Universitaire de Grenoble
Hôpital universitaire de Lyon
Hôpital universitaire de Saint Etienne

intervention_type: Other


title: Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Exercise Tolerance During Walk in Patients With COPD, Oxygen Therapy and Hypercapnia

summary:
The purpose of this study is to investigate the benefit of Closed-loop System for Oxygen Delivery (FreeO2) as compared with fixed oxygen flow during endurance shuttle walking test in patients with Chronic obstructive pulmonary disease (COPD), oxygen therapy and hypercapnia.

The study was designed to test the following hypotheses:

As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to higher exercise tolerance (distance during ESWT) and lower desaturation events without increase in hypercapnia in patients with COPD, oxygen therapy and hypercapnia.

As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower dyspnea and leg fatigue scores at a given endurance time during the shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.

As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower cardiac and respiratory frequencies at a given endurance time during the shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.

ReferenceCitation: Vivodtzev I, L'Her E, Vottero G, Yankoff C, Tamisier R, Maltais F, Lellouche F, Pépin JL. Automated O(2) titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial. Thorax. 2019 Mar;74(3):298-301. doi: 10.1136/thoraxjnl-2018-211967. Epub 2018 Aug 30.

lead_sponsor: AGIR à Dom

location_facility:
Hopital Universitaire
Centre Henri BAZIRE
Centre ATRIR

intervention_type: Device

lead_sponsor_type: industriel


title: Early Assessment of Anthracycline-induced Cardiotoxicity: Usefulness of Biochemical Markers and Ventricular Function Assessment.

summary:
Anthracycline-based chemotherapy is a key point of the treatment of patients with Hodgkin's and non-Hodgkin's lymphomas. However, cumulative doses are limited by cardiotoxicity, resulting in a marked left ventricular function impairment that may lead to heart failure.

The standard clinical approach to monitoring for anthracycline cardiotoxicity is based on cardiac function monitoring using echocardiography or radionuclide angiography. The aim of this study is to evaluate the usefulness of biochemical markers of cardiac injury (troponin and NT-proBNP) and structural changes on cardiac MR in predicting anthracycline cardiotoxicity.

ReferenceType: background

ReferenceCitation: Cardinale D, Sandri MT, Martinoni A, Borghini E, Civelli M, Lamantia G, Cinieri S, Martinelli G, Fiorentini C, Cipolla CM. Myocardial injury revealed by plasma troponin I in breast cancer treated with high-dose chemotherapy. Ann Oncol. 2002 May;13(5):710-5.

ReferenceCitation: Singal PK, Iliskovic N. Doxorubicin-induced cardiomyopathy. N Engl J Med. 1998 Sep 24;339(13):900-5. Review.

ReferenceCitation: Okumura H, Iuchi K, Yoshida T, Nakamura S, Takeshima M, Takamatsu H, Ikeno A, Usuda K, Ishikawa T, Ohtake S, Matsuda T. Brain natriuretic peptide is a predictor of anthracycline-induced cardiotoxicity. Acta Haematol. 2000;104(4):158-63.

ReferenceCitation: Mitani I, Jain D, Joska TM, Burtness B, Zaret BL. Doxorubicin cardiotoxicity: prevention of congestive heart failure with serial cardiac function monitoring with equilibrium radionuclide angiocardiography in the current era. J Nucl Cardiol. 2003 Mar-Apr;10(2):132-9.

lead_sponsor: Centre Henri Becquerel

location_facility:
University Hospital of Rouen
Centre Henri Becquerel


title: Air Pollution and COVID-19 Mortality in Geriatric Patients: a Multicenter Study

summary: Epidemiological data have related particulate matter (PM), nitrogen dioxide (NO2) and ozone (O3) to COVID-19 morbidity and mortality at the population level. Air pollution may be related to an increase in the COVID-19 severity and lethality through its impact on chronic diseases such as cardiovascular and respiratory diseases and diabetes that are also the main comorbidities associated with COVID-19. Epidemiological studies using individual data are needed to provide more precise estimate of the association between air pollution exposure and COVID-19. In this multicenter prospective study, the investigators will analyze the number of deaths in COVID-19 confirmed cases in geriatric patients according to long-term exposure to air pollution, taking into account confounders such as diabetes, hypertension, age, and BMI. Exposure to air pollution will be estimated as the mean concentration of air pollutants at the residential address during the previous two years. In addition, the investigators will explore the relationship between short-term variations in air pollutants, relative humidity, temperature, UV radiations, pollen and the occurrence of COVID-19.

location_country: France Belgium

location_facility: Unité de soins palliatifs gériatriques, Centre Hospitalier Départemental de Bischwiller

location_facility: Service de Gériatrie, Hôpitaux Bichat et Bretonnaux, Assistance Publique des Hôpitaux de Paris

location_facility: Service de Médecine Interne et Gériatrie, Hôpitaux Universitaires de Reims

location_facility: Service de médecine aigüe gériatrique, Hôpital Nord Laennec, Hôpitaux Universitaires de Nantes

location_facility: Service de médecine gériatrique, Hôpitaux Universitaires de Tours

location_facility: Service de Gériatrie, Hôpital de la Robertsau, Hôpitaux Universitaires de Strasbourg

location_facility: Unité de neurologie-gériatrie, Hôpital Erasme, Cliniques Universitaires de Bruxelles

location_facility: Service de Gériatrie, Centre Hospitalier Départemental de Vendée


type: Other Identifier

title: Point-of-care Haemostasis Testing of Von Willebrand Factor Function Embedded in Catheterization Laboratory to Improve Real-time Management of Paravalvular Regurgitation During Minimally Invasive TAVI

acronym: WITAVI-REAL

summary:
Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform corrective procedures during TAVI, but it requires general anesthesia (GA). With such approach (TEE+GA), the PARTNERII trial has demonstrated that very low rate of PVR (3,5%) can be achieved with current devices. Registries have demonstrated a strong trend for using a mini-invasive approach in which the procedure is performed under conscious sedation (CS) without TEE. However, several studies raised concerns on the safety of this mini-invasive approach concerning the PVR rate. Thus, the accurate and real-time assessment of the presence and severity of PVR is an unmet clinical need to optimize TAVI without TEE guidance. A recent study reported that a blood biomarker reflecting the Von Willebrand factor (VWF) activity, i.e. the closure time with adenosine diphosphate (CT-ADP), is a valuable non-invasive, highly reproducible, and easy to perform alternative to TEE for PVR evaluation.

The hypothesis is that the measurement of CT-ADP during TAVI performed without TEE guidance can improve both the detection of significant PVR and thus the procedural and clinical outcomes (primary objective).

lead_sponsor: University Hospital, Lille


title: Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children

summary: Purpose of this study: assess the maximum tolerated bolus dose of erythritol, delivered in a clear beverage, compared with placebo (saccharose) in 4-6 year old children.

primary_purpose: Supportive Care

ReferenceCitation: Bornet FR, Blayo A, Dauchy F, Slama G. Plasma and urine kinetics of erythritol after oral ingestion by healthy humans. Regul Toxicol Pharmacol. 1996 Oct;24(2 Pt 2):S280-5.

ReferenceCitation: Arrigoni E, Brouns F, Amadò R. Human gut microbiota does not ferment erythritol. Br J Nutr. 2005 Nov;94(5):643-6.

ReferenceCitation: Bornet FR, Blayo A, Dauchy F, Slama G. Gastrointestinal response and plasma and urine determinations in human subjects given erythritol. Regul Toxicol Pharmacol. 1996 Oct;24(2 Pt 2):S296-302.

ReferenceCitation: Tetzloff W, Dauchy F, Medimagh S, Carr D, Bär A. Tolerance to subchronic, high-dose ingestion of erythritol in human volunteers. Regul Toxicol Pharmacol. 1996 Oct;24(2 Pt 2):S286-95.

ReferenceCitation: Munro IC, Berndt WO, Borzelleca JF, Flamm G, Lynch BS, Kennepohl E, Bär EA, Modderman J. Erythritol: an interpretive summary of biochemical, metabolic, toxicological and clinical data. Food Chem Toxicol. 1998 Dec;36(12):1139-74. Review. Erratum in: Food Chem Toxicol 1999 Jun;37(6):I-II. Bernt WO [corrected to Berndt WO].

ReferenceCitation: Storey D, Lee A, Bornet F, Brouns F. Gastrointestinal tolerance of erythritol and xylitol ingested in a liquid. Eur J Clin Nutr. 2007 Mar;61(3):349-54. Epub 2006 Sep 20.

ReferenceCitation: Lifshitz F, Ament ME, Kleinman RE, Klish W, Lebenthal E, Perman J, Udall JN Jr. Role of juice carbohydrate malabsorption in chronic nonspecific diarrhea in children. J Pediatr. 1992 May;120(5):825-9. Review.

ReferenceCitation: Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4.

lead_sponsor: Cargill

location_facility: Clinical Investigation Centre Louis Pradel Hospital

location_facility: Clinical Investigation Centre Robert Debré Hospital


title: Evaluation of the Effects of Laying Early (Between 12 and 16) a Gastric Band on the Prevention of Morbid Obesity in Late Adolescence. Randomized Checked Against Standard Management of Obesity in This Population.

acronym: CHADO

summary:
MAIN OBJECTIVE To compare the effects of the placement of an adjustable gastric band with "conventional" treatment of obesity.

SECONDARY OBJECTIVES

Compare the effects of the placement of a gastric band with "conventional" treatment of obesity on quality of life, body composition and parameters of the metabolic syndrome.
Identify predictors of "good answer to the ring" to determine the best future indications.
Study of the gastric tolerance.

INCLUSION CRITERIA

Adolescents 12 to 16 years and with BMI and weight gain according to sex and age is greater than IMCZ-score > 4 DP> 8 kg
Obesity "common" non-syndromic.
Medical decision of surgical placement of laparoscopic gastric banding.
Adolescent and family who understand and accept the need for medical and surgical follow long term.
Adolescent and family who fully understood the oral and written information explaining the study and the need for prolonged follow-up.
Obtention of oral and written consent of the adolescent and the parents.
Parents and adolescents affiliated with the social security system.

NONINCLUSION CRITERIA

Intellectual Deficit.
psychiatrics contraindication of surgical placement of laparoscopic gastric banding.
Obesity with severe binge eating.
Pregnancy or wishes of pregnancy in the following year.
Non accession adolescent and / or family in the process of medical care before inclusion.
Predictable post surgical monitoring difficulties.
Suspicion of physical abuse, verbal or negligence / deficiency in care of the family.
Participation in a clinical study evaluating a treatment during the 2 years of the study.

EXCLUSION CRITERIA

Anesthetic contre indication for placement of a gastric laparoscopic.
IMC> 50 kg/m2 the day of inclusion.

STRATEGIES / PROCEDURES During a routine visit, the study will be presented to the patient and his family. Patients will then be enrolled and randomized. Patients in group A (surgery group) will follow the usual multidisciplinary bariatric surgery in adolescents. Patients in group B start conventional monitoring dietary medical and physical. For both groups follow-up visits will occur every 3 months for 2 years.

ReferenceCitation: Pourcher G, De Filippo G, Ferretti S, Piquard C, Dagher I, Bougnères P. Short-term results of single-port sleeve gastrectomy in adolescents with severe obesity. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):65-9. doi: 10.1016/j.soard.2014.05.029. Epub 2014 Jun 3.

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital of Lille
University Hospital of Angers
University Hospital of Necker
University Hospital of Toulouse
University Hospital of Caen
University hospital Bicêtre


title: Efficacy of Rotational Atherectomy System Associated With Drug Coated Balloon Angioplasty (With or Without Stent Placement) in the Management of Lower Limb Ischemia (ELLIPSE): "Real Life" Observational Study

acronym: ELLIPSE

summary:
Lower extremity peripheral artery disease (PAD) is a major health problem leading to significant morbidity and even mortality. Patients with superficial femoral artery stenosis make up an important proportion of patients with PAD, and since this type of involvement was reported to be most commonly associated with intermittent claudication, this patient population has been subject to intensive research on methods to prevent disease progression and further complications.

Endovascular treatment has become the first-line treatment for low-complexity femoropopliteal (FP) lesions classified as TASC (Trans Atlantic Inter-Societal Consensus) A and B. Conversely, in case of more extensive lesions (TASC C), this treatment is still under debate because of a primary permeability that is difficult to maintain over time. Recently, studies have shown the interest of drug eluting technologies in the treatment of TASC A & B femoral-popliteal lesions, by significantly improving patency rates compared to uncoated balloons or stents.

In this context, the endovascular treatment of FP complex lesions (TASC C) continues to develop widely.

During endovascular treatment, the quality of the artery preparation has recently been identified as a factor improving outcomes. The dilatation of the artery with an uncoated balloon or POBA (Plain Old Balloon Angioplasty) is the reference method performed before stent placement or drug-coated balloons. However, some new alternatives to prepare the artery have emerged, using no more dilatation but atherectomy (Jetstream™ system).

Atherectomy appears to reduce the risk of dissections and bailout stenting and improve the acute procedural results. Its long term outcome, when associated with drug coated balloons (DCB), has recently been demonstrated in the USA to be superior to angioplasty in a single center study JET-SCE.

The purpose of this study is to evaluate the efficacy and the feasibility of atherectomy, using the Jetstream™ artery preparation associated to DCB treatment (Ranger™ Paclitaxel-Coated balloon), in symptomatic patients with claudication (Rutherford 2 and 3) and with complex de novo FP arterial lesions (TASC C).

lead_sponsor: Hospital St. Joseph, Marseille, France

location_facility:
Polyclinique Les Fleurs
Polyclinique Notre Dame
Clinique Les Franciscaines
Hôpital Saint Joseph
Clinique Saint Georges
Hopital Europeen
Clinique Rhône Durance
Hopital Prive de Provence


title: Preliminary Evaluation of the AIFib Software in Real Time as a Medical Decision Aid for the Detection of Atrial Fibrillation Driver

summary: To evaluate the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.

location_facility: Groupe Hopitaux Institut Catholique de Lille


type: EudraCT Number

title: Effects of the Addition of Metyrapone to Antidepressant Therapy in Depression With Dexamethasone Suppression Test Non-suppression.

summary:
The hypothesis of a link between depression and Hypothalamic-Pituitary Axis (HPA) dysfunction is now experienced. Since a first description in 1949 this link has made the HPA one of the most investigated hormonal axis in depression.

Many studies have demonstrated quantitative variations of circulating cortisol in situation of depression including increasing of basal concentration of blood cortisol or Adrenocorticotropic Hormone (ACTH). Furthermore there is an attenuated negative feedback performance of the blood cortisol on the release of ACTH and cortisol. This attenuation seems to be a consequence of a bluntness of sensibility of the hypothalamic cells and their Glucocorticoids Receptors type 2. Actually it seems that these phenomena are included in a diversion of the cortisol's action. From a function of acute stress management, with short-time exposures, the cortisol become one of the factors increasing an allostatic load, or resulting of this increase, maintaining a permanent state of stress, an inertia delay to adaptation and facilitating the emergence of psychiatric disorders.

This lack of function can be estimated by the Dexamethasone Suppression Test (DST) which, by stimulation attempting of feedback mechanisms by Dexamethasone (which has cortisol-like properties), can show a non-suppressor population with HPA bluntness. If this biological feature isn't a biological marker of depression, because of a lack of specificity and sensibility, is notably associated with a poor outcome and higher risks of suicidal behaviors and pharmacological resistance.

Many studies have explored possibilities of action on the HPA to treat depression or improve antidepressant specific therapeutics, with inconstant results. One of the most promising molecule seems to be Metyrapone, a reversible inhibitor of the 11ß-hydroxylase enzyme which transform desoxycorticosterone and 11deoxycortisol to respectively corticosterone and cortisol. There have been several open label studies which aim to explore the possibility of an effect of the combination between Metyrapone and antidepressant molecules. This led to two randomized double blind controlled versus placebo studies whose conclusions are divergent.

These conclusions and their heterogeneity lead to think that there is a sub-population which could be better responder to this type of association. Physiopathological knowledges and preliminary observations in DST non-suppressor population by using anti-glucocorticoids therapies , makes it possible to consider possible that responsive sub-population can be defined by the feature " DST non-suppressor ".

ReferenceCitation: Thase ME, Entsuah AR, Rudolph RL. Remission rates during treatment with venlafaxine or selective serotonin reuptake inhibitors. Br J Psychiatry. 2001 Mar;178:234-41.

ReferenceCitation: Cowen PJ. Not fade away: the HPA axis and depression. Psychol Med. 2010 Jan;40(1):1-4. doi: 10.1017/S0033291709005558.

ReferenceCitation: Stetler C, Miller GE. Depression and hypothalamic-pituitary-adrenal activation: a quantitative summary of four decades of research. Psychosom Med. 2011 Feb-Mar;73(2):114-26. doi: 10.1097/PSY.0b013e31820ad12b. Epub 2011 Jan 21.

ReferenceCitation: Linkowski P. Neuroendocrine profiles in mood disorders. Int J Neuropsychopharmacol. 2003 Jun;6(2):191-7.

ReferenceCitation: Pariante CM, Miller AH. Glucocorticoid receptors in major depression: relevance to pathophysiology and treatment. Biol Psychiatry. 2001 Mar 1;49(5):391-404. Review.

ReferenceCitation: Gray JD, Kogan JF, Marrocco J, McEwen BS. Genomic and epigenomic mechanisms of glucocorticoids in the brain. Nat Rev Endocrinol. 2017 Nov;13(11):661-673. doi: 10.1038/nrendo.2017.97. Epub 2017 Sep 1. Review.

ReferenceCitation: Weaver IC, Cervoni N, Champagne FA, D'Alessio AC, Sharma S, Seckl JR, Dymov S, Szyf M, Meaney MJ. Epigenetic programming by maternal behavior. Nat Neurosci. 2004 Aug;7(8):847-54. Epub 2004 Jun 27.

ReferenceCitation: Herbert J, Goodyer IM, Grossman AB, Hastings MH, de Kloet ER, Lightman SL, Lupien SJ, Roozendaal B, Seckl JR. Do corticosteroids damage the brain? J Neuroendocrinol. 2006 Jun;18(6):393-411. Review.

ReferenceCitation: McEwen BS. Mood disorders and allostatic load. Biol Psychiatry. 2003 Aug 1;54(3):200-7. Review.

ReferenceCitation: Carroll BJ, Feinberg M, Greden JF, Tarika J, Albala AA, Haskett RF, James NM, Kronfol Z, Lohr N, Steiner M, de Vigne JP, Young E. A specific laboratory test for the diagnosis of melancholia. Standardization, validation, and clinical utility. Arch Gen Psychiatry. 1981 Jan;38(1):15-22.

ReferenceCitation: Ribeiro SC, Tandon R, Grunhaus L, Greden JF. The DST as a predictor of outcome in depression: a meta-analysis. Am J Psychiatry. 1993 Nov;150(11):1618-29.

ReferenceCitation: Gallagher P, Malik N, Newham J, Young AH, Ferrier IN, Mackin P. Antiglucocorticoid treatments for mood disorders. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD005168. doi: 10.1002/14651858.CD005168.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;6:CD005168.

ReferenceCitation: Maric NP, Adzic M. Pharmacological modulation of HPA axis in depression - new avenues for potential therapeutic benefits. Psychiatr Danub. 2013 Sep;25(3):299-305. Review.

ReferenceCitation: Murphy BE, Ghadirian AM, Dhar V. Neuroendocrine responses to inhibitors of steroid biosynthesis in patients with major depression resistant to antidepressant therapy. Can J Psychiatry. 1998 Apr;43(3):279-86.

ReferenceCitation: Rogóz Z, Skuza G, Wójcikowski J, Daniel WA, Wróbel A, Dudek D, Zieba A. Effect of metyrapone supplementation on imipramine therapy in patients with treatment-resistant unipolar depression. Pol J Pharmacol. 2004 Nov-Dec;56(6):849-55.

ReferenceCitation: Jahn H, Schick M, Kiefer F, Kellner M, Yassouridis A, Wiedemann K. Metyrapone as additive treatment in major depression: a double-blind and placebo-controlled trial. Arch Gen Psychiatry. 2004 Dec;61(12):1235-44.

ReferenceCitation: McAllister-Williams RH, Anderson IM, Finkelmeyer A, Gallagher P, Grunze HC, Haddad PM, Hughes T, Lloyd AJ, Mamasoula C, McColl E, Pearce S, Siddiqi N, Sinha BN, Steen N, Wainwright J, Winter FH, Ferrier IN, Watson S; ADD Study Team. Antidepressant augmentation with metyrapone for treatment-resistant depression (the ADD study): a double-blind, randomised, placebo-controlled trial. Lancet Psychiatry. 2016 Feb;3(2):117-27. doi: 10.1016/S2215-0366(15)00436-8. Epub 2015 Dec 23.

ReferenceCitation: Duval F, Mokrani MC, Erb A, Gonzalez Opera F, Calleja C, Paris V. Relationship between chronobiological thyrotropin and prolactin responses to protirelin (TRH) and suicidal behavior in depressed patients. Psychoneuroendocrinology. 2017 Nov;85:100-109. doi: 10.1016/j.psyneuen.2017.07.488. Epub 2017 Jul 28.

lead_sponsor: Centre Hospitalier Rouffach

location_facility:
Centre Hospitalier de Rouffach
Hopitaux Universitares de Strasbourg


title: Early Plasma Protein Levels and Neonatal Hemodynamics: a Prospective Evaluation in Very Preterm Infants

acronym: ProHémie

summary: The primary aim of this study is to investigate the relationship between early plasma protein levels and hemodynamics in very preterm infants during postnatal transition. Secondary aims are the following: i) to evaluate maternal and neonatal factors affecting plasma protein level at birth; ii) to evaluate the relationship between plasma protein level and albumin level on the first day of life; iii) to evaluate the association between early hypoproteinemia and neonatal mortality and morbidity in very preterm infants.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility: Centre Hopsitalier Universitaire de La Réunion


title: Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease

acronym: Starter-GPS

summary: The maximal walking distance (MWD) performed on treadmill (TT) remains the gold standard in estimating the walking capacity of patients suffering from peripheral arterial disease (PAD) with intermittent claudication, although treadmills are not accessible to most physicians. We hypothesized that global positioning system (GPS) recordings could monitor community-based outdoor walking and provide valid information on walking capacity in PAD patients.

ReferenceCitation: Noury-Desvaux B, Abraham P, Mahé G, Sauvaget T, Leftheriotis G, Le Faucheur A. The accuracy of a simple, low-cost GPS data logger/receiver to study outdoor human walking in view of health and clinical studies. PLoS One. 2011;6(9):e23027. doi: 10.1371/journal.pone.0023027. Epub 2011 Sep 13.

ReferenceCitation: Le Faucheur A, Noury-Desvaux B, Mahé G, Sauvaget T, Saumet JL, Leftheriotis G, Abraham P. Variability and short-term determinants of walking capacity in patients with intermittent claudication. J Vasc Surg. 2010 Apr;51(4):886-92. doi: 10.1016/j.jvs.2009.10.120.


title: Determinants of Muscle Strength in Chronic Kidney Disease

summary:
Aim of this study is to determine in chronic kidney disease patients:

the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C reactive protein and decrease in serum albumin) on voluntary muscle strength impairment
the relationship between voluntary muscle strength and muscle mass
the relationship between voluntary muscle strength and lean body mass
the correlation between voluntary muscle strength and physical activity

ReferenceCitation: Souweine JS, Kuster N, Chenine L, Rodriguez A, Patrier L, Morena M, Badia E, Chalabi L, Raynal N, Ohresser I, Leray-Moragues H, Mercier J, Hayot M, Le Quintrec M, Gouzi F, Cristol JP. Physical inactivity and protein energy wasting play independent roles in muscle weakness in maintenance haemodialysis patients. PLoS One. 2018 Aug 1;13(8):e0200061. doi: 10.1371/journal.pone.0200061. eCollection 2018.

lead_sponsor: University Hospital, Montpellier

location_facility:
GCS Help Lapeyronie, CHU Montpellier
AIDER

intervention_type: Biological


title: Assessment of the Interest of a Peri-operative Antibiotic Strategy Applied to Patients With Asymptomatic Bacteriuria Undergoing Intra-vesical Botulinum Toxin A Injections

acronym: ANTIBIOBONTA

summary:
The study aims to demonstrate that the "thrifty antibiotic strategy" applied to MS or SCI patients with asymptomatic bacteriuria prior to BoNTA intravesical injections does not increase the rate of symptomatic post-injection UTIs compared to the current peri-operative antibiotic strategy.

Patients included in the study will be randomized in two balanced-parallel groups, 4 days (+/- 2 days) before intra-vesical BoNTA injections.

Group 1: Experimental group: "Sparing antibiotic strategy" No antibiotic therapy will be administered during the peri-operative period.

Group 2: Control group: Recommendations - Peri-operative antibiotic strategy An antibiotic therapy will be administered during the peri-operative period. The antibiotic will be selected according to the type of bacteria isolated and the antibiotic susceptibility testing, and started two days before and pursued until two days following intra-vesical BoNTA injections.

The main objective is to demonstrate the non-inferiority of "antibiotic saving strategy" compared to peri-operative antibiotic strategy (current recommendations) for occurrence of symptomatic UTI after intra-vesical BoNTA injections in the management of asymptomatic bacteriuria (AB) among multiple sclerosis (MS) and spinal cord injured (SCI) patients undergoing clean intermittent self-catheterization (CISC).

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Leitner L, Sammer U, Walter M, Knüpfer SC, Schneider MP, Seifert B, Tornic J, Mehnert U, Kessler TM. Antibiotic prophylaxis may not be necessary in patients with asymptomatic bacteriuria undergoing intradetrusor onabotulinumtoxinA injections for neurogenic detrusor overactivity. Sci Rep. 2016 Sep 12;6:33197. doi: 10.1038/srep33197.

ReferenceCitation: Weglinski L, Rouzaud C, Even A, Bouchand F, Davido B, Duran C, Salomon J, Perronne C, Denys P, Chartier-Kastler E, Dinh A. Prospective evaluation of antibiotic treatment for urological procedure in patients presenting with neurogenic bladder. Med Mal Infect. 2016 Sep;46(6):300-7. doi: 10.1016/j.medmal.2016.04.001. Epub 2016 May 27.

ReferenceCitation: Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010 May 18;340:c2096. doi: 10.1136/bmj.c2096. Review.

ReferenceCitation: Kang MS, Lee BS, Lee HJ, Hwang SW, Han ZA. Prevalence of and Risk Factors for Multidrug-Resistant Bacteria in Urine Cultures of Spinal Cord Injury Patients. Ann Rehabil Med. 2015 Oct;39(5):686-95. doi: 10.5535/arm.2015.39.5.686. Epub 2015 Oct 26.

ReferenceCitation: Hansson S, Jodal U, Lincoln K, Svanborg-Edén C. Untreated asymptomatic bacteriuria in girls: II--Effect of phenoxymethylpenicillin and erythromycin given for intercurrent infections. BMJ. 1989 Apr 1;298(6677):856-9.

ReferenceCitation: Cai T, Mazzoli S, Mondaini N, Meacci F, Nesi G, D'Elia C, Malossini G, Boddi V, Bartoletti R. The role of asymptomatic bacteriuria in young women with recurrent urinary tract infections: to treat or not to treat? Clin Infect Dis. 2012 Sep;55(6):771-7. doi: 10.1093/cid/cis534. Epub 2012 Jun 7.


title: Efficacy and Safety of Total Pancreatectomy With Intraportal Islet Autotransplantation for Resectable Adenocarcinoma of the Cephalic Region of the Pancreas at High-risk of Postoperative Fistula and Requiring Systemic Adjuvant Chemotherapy

summary:
Curative management of locally resectable invasive adenocarcinomas located in the cephalic region of the pancreas (pancreas, duodenum and ampulla of Vater) requires a pancreaticoduodenectomy followed by adjuvant chemotherapy. Pancreaticoduodenectomy is a major surgery that often leads to major complications including approximately 20% of relevant clinical postoperative pancreatic fistula.

Postoperative complications following pancreaticoduodenectomy can lead to early discontinuation of the complete oncologic strategy, i.e., chemotherapy for malignancy is performed in only about a third of patients who experienced a grade C fistula.

A total pancreatectomy rather than a pancreaticoduodenectomy is an alternative procedure that involves the complete and definitive resection of all pancreatic tissue, eliminating any risk of postoperative pancreatic fistula but is associated with unavoidable endocrine insufficiency and potentially severe metabolic complications, such as "brittle diabetes".

Total Pancreatectomy following by intraportal Islet AutoTransplantation (TPIAT) can prevent "brittle diabetes" and improve the quality of life. The endocrine islets can be isolated from the pancreatic surgical specimen with standardized procedures and transplanted in the liver through intraportal infusion, in absence of immunosuppression and allow adequate control of glucose metabolism with a reduced need for exogenous insulin and an effective graft function in 70% of cases at 3 years Thereby, the investigators hypothesize that total pancreatectomy with intraportal Islet autotransplantation rather than classical pancreaticuduodenectomy, in patients with high-risk of postoperative fistula will increase the rate of complete access to adjuvant chemotherapy, while maintaining an adequate metabolic control.


ipd_sharing: Yes

acronym: IRONCEL

title: Effect of Intravenous Iron Supplementation on Celiac Disease Remission in Patients With Iron Deficiency and Intestinal Villous Atrophy: a Randomized Trial

lead_sponsor: Assistance Publique - Hôpitaux de Paris

type: Other Grant/Funding Number

source: euctr

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

summary:
The study aims is to evaluate the efficacy of intravenous iron supplementation on celiac disease remission (total intestinal mucosal recovery). This randomized multicenter trial compare the administration of intravenous iron by infusion (Ferinject©: 15 mg/kg in NaCl solution in 30 min) and oral iron in combination; to patients receive only oral iron as standard care.

The first benefit with IV Iron supplementation is to correct iron deficiency more rapidly than oral iron alone because of trouble of absorption in case of intestinal villous atrophy.


acronym: ACTIVE

title: ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.

location_facility: AP-HP, Hôpital Européen Georges Pompidou

summary:
The study aims is to verify the hypothetize that inhaled Tranexamic Acid (TXA) or Terlipressin (TER) will be associated with an increase in the rapid control of hemoptysis without side-effects.

This randomized double-blind multicenter triple arm trial compares the administration of TXA to TER to placebo in patients with mild to severe hemoptysis.


title: DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule

summary: Febrile neutropenia (NF) is the leading cause of unscheduled hospitalization in children with cancer. Management classically involves emergency admission to hospital for intravenous antibiotic treatment until resolution of fever and neutropenia. However, children with NF are a heterogeneous group with varying risks of severe infection (10-29%). This approach, which is recognized as excessive for low-risk episodes of severe infection, particularly in terms of quality of life and cost, is no longer recommended. Management should move to a more personalized model that takes into account the individual probability of severe infection. Clinical decision rules (CDRs) have been proposed to facilitate risk stratification, but none are useful in our French population because of insufficient reproducibility or effectiveness.


title: Occupational Insertion and Educational Level of Adult Patients With Pediatric Early Inflammatory Bowel Disease (IBD)

acronym: PROMICI

summary:
The main objective of this project is to assess the occupational insertion of these adult patients with pediatric-onset IBD and to compare it with the general population.

The secondary objectives are:

to assess the level of education and compare it to that of the general population

to assess occupational insertion and the educational level according to:

The disease (Crohn's disease, ulcerative colitis or unclassified colitis)
sex
Age at diagnosis (<or ≥ 10 years)
The occurence of surgery, the location of the disease, the treatments undertaken
Quality of life
Evaluate the patient's feelings about the impact of his illness on occupational insertion and the educational level
To describe the quality of life of patients in relation to disease activity and health states (QALY calculation)
To assess the responsivness to change of the functional handicap score IBD-DI (n = 200 patients)

time_perspective: Cross-Sectional


title: Quality of Life for Patients With Chronic Paediatric Onset Inflammatory Bowel Disease (IBD)

acronym: QALY-ECOPED

summary: The main objective of the present study is to describe the quality of life of patients under 25 years of age with pediatric-onset IBD. The quality of life will be described according to the age and the activity of the disease in order to make it possible to associate with the different states of health a measure of quality of life (utility score) from utility values established in the French context. These data are essential for the realization of medico-economic models.


title: Rehabilitation of Executive Functions in the Activities of the Daily Living of Chronic Post-stroke Patients: Using Virtual Reality and Computerized Rehabilitation to Simulate Real Environment for Rehabilitation.

acronym: RéFEx

summary: This research aims to evaluate the effects of a cognitive reeducation carried out with the COVIRTUA Cognition software using a virtual environment, on real-life execution of activities of daily living (ADL) for patients with post-stroke dysexecutive disorders. We will assess patients' performances in achieving ADLs by the Goal Attainment Scaling (GAS) throughout the follow-up (3 months), based on the goals set at the beginning of management with each patient.

lead_sponsor: University Hospital, Toulouse


title: A Pilot Study on the Feasibility and Tolerance of Neoadjuvant Hypofractionated, Stereotactic Body Radiation Therapy Prior to Surgical Resection of Uninodular Hepatocellular Carcinoma.

summary:
Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection. Moreover, surgical resection is associated with a high risk of tumor recurrence, because of the tumor seeding through microscopic intrahepatic vessels that surround the tumor, the so-called "microvascular invasion".

To adequately deal with this phenomenon, the surgeon has to perform either an 'anatomical' liver resection, which remove not only the tumor but also the whole corresponding vascular network, or a 'tumorectomy' with resection margins of at least 2 cm. Unfortunately, these principles cannot always be achieved due to underlying liver cirrhosis that is present in more than 80% of patients.

Stereotactic body radiation therapy (SBRT) has been proven to efficiently necrotize or stabilize HCC nodules when surgery is not possible. Our hypothesis is that pre-treatment with SBRT prior to surgical resection of HCC might improve the results through the destruction of possible seeding in the peritumoral environment.

Given the novelty of this therapeutic strategy, it is necessary to verify its feasibility and safety, prior to test its efficacy in patients with HCC. The KARCHeR-1 study aims at making sure that preoperative SBRT would not result in important delays or serious adverse events such as to cancel the planned surgical resection, in patients who otherwise could have benefited from it. This issue is commonly called 'drop-out'. Thirty patients are expected to be included in the KARCHeR-1 study, which would be in favor of continuing to evaluate this therapeutic strategy if less than 3 drop-outs occur, and would be immediately discontinued if 3 drop-outs occur. Other outcomes will also been studied, like intraoperative issues, postoperative morbi-mortality, pathological features on the surgical specimen and its correlation with preoperative imaging, and finally, tumor recurrence and survival.

intervention_type: Combination Product


type: Registry Identifier

title: Prospective Study Evaluating the Combination of Positron Emission Tomography (PET) With 18F-FDG and 18 F-Fluorocholine for Optimization of Staging and Treatment Modification in Patients With Hepatocellular Carcinoma

summary: The objective of this protocol is to obtain a better match between the actual staging and the proposed treatment in order to avoid inadequate treatments at risk of complications. In patients with HCC classified as BCLC A to C, the combination of 18F-FDG and 18F-Fluorocholine PET- TomoDensitoMetry (TDM) with conventional imaging would clinically significantly modify the therapeutic strategy initially planned by conventional imaging alone. This change in therapeutic strategy would be from curative to palliative treatment or from loco-regional palliative to systemic palliative treatment. 18F-FDG and 18F-Fluorocholine PET-CT scans will be performed after inclusion of the patient in the study and prior to multidisciplinary consultation meeting for treatment discussion.

ReferenceCitation: Nault JC, Sutter O, Nahon P, Ganne-Carrié N, Séror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13. Review.

ReferenceCitation: Cadier B, Bulsei J, Nahon P, Seror O, Laurent A, Rosa I, Layese R, Costentin C, Cagnot C, Durand-Zaleski I, Chevreul K; ANRS CO12 CirVir and CHANGH groups. Early detection and curative treatment of hepatocellular carcinoma: A cost-effectiveness analysis in France and in the United States. Hepatology. 2017 Apr;65(4):1237-1248. doi: 10.1002/hep.28961. Epub 2017 Feb 8.

ReferenceCitation: Bertagna F, Bertoli M, Bosio G, Biasiotto G, Sadeghi R, Giubbini R, Treglia G. Diagnostic role of radiolabelled choline PET or PET/CT in hepatocellular carcinoma: a systematic review and meta-analysis. Hepatol Int. 2014 Oct;8(4):493-500. doi: 10.1007/s12072-014-9566-0. Epub 2014 Sep 3.

intervention_type: Radiation


title: Effect of Individualized Versus Standard Blood Pressure Management During Mechanical Thrombectomy for Anterior Ischemic Stroke

acronym: DETERMINE

summary: DETERMINE is a multicenter, prospective, randomised, open, blinded end-point assessed (PROBE) trial, to evaluate two approaches of blood pressure (BP) management during mechanical thrombectomy for acute ischemic stroke due to an anterior large vessel occlusion.

ReferenceCitation: Maïer B, Gory B, Chabanne R, Tavernier B, Balanca B, Audibert G, Thion LA, Le Guen M, Geeraerts T, Calviere L, Degos V, Lapergue B, Richard S, Djarallah A, Mophawe O, Boursin P, Le Cossec C, Blanc R, Piotin M, Mazighi M, Gayat E; DETERMINE Investigators. Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial. Trials. 2022 Jul 26;23(1):598. doi: 10.1186/s13063-022-06538-9.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Prevention of pneumonIA in Nursing hOme

acronym: PIANO

summary: Infections in nursing home are associated with high morbidity and mortality. Pulmonary infections are known to be the most problematic. In our INCUR observational study of 773 residents, 20.13% of residents had pneumonia during the year of follow-up. On average, the extra cost of pneumopathies was 4,467 euros / patient for the long-term care facility and 3,044 euros for the hospital.


title: Impact of Joint Crisis Plan on the Duration of Isolation Measures in Psychiatry.

acronym: PLANCO-ISO

summary:
For some patients in department psychiatric, isolation measures are put in place. But the measures is not pleasant for the patient or for the care team.

That's why care team are trying to find ways to improve patient care, including asking them how they would like to be treated.

One of the solutions is called the Joint Crisis Plan. A Joint Crisis Plan is a personalized procedure for a patient. It describes the attitude, the care, the measures in case of crisis with the patient and his family. Patients indicate their wishes regarding their care. However, there is no real scientific proof of the effectiveness of this Joint Crisis Plan, especially to reduce isolation measures.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Biomechanical Analysis, Complementary Examinations and Rehabilitative Management of Chronic Ankle Instability

acronym: CAIDiag

summary: Chronic ankle instability is a common condition in the active adult population and characterized by the occurrence of repeated giving way and/or recurrent ankle sprains. Multiple underlying deficits have been proposed, among which ankle muscle strength deficits, proprioception deficits, ( static and dynamic balance disorders, and articular laxity. Unfortunately, no consensus exists on which clinical tests should be realized to determine if one of these underlying deficits is predominant and as a result could guide the rehabilitation process. The study hypothesis is that people with chronic ankle instability might be heterogenous and could be divided in different subgroups as a function of underlying deficits. Therefore, this study aims to evaluate the capacity of different clinical tests to differentiate people with chronic ankle instability from healthy people as well as between each other.

location_facility: CH Saint-Omer, institut audomarois de la chirurgie orthopédique et du sport


title: Evaluation Genotypic, Phenotypic and Prognosis Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED) Syndrome

acronym: APECED

summary: The objective of the study will define the mutational spectrum in this French cohort, in patients with APECED syndrome genetically authenticated


title: Enteral Versus Parenteral Nutrition in the Conservative Treatment of Upper Gastrointestinal Fistula After Surgery: a Multicenter, Randomized, Parallel-group, Open Label

acronym: NUTRILEAK

summary:
The incidence of clinically significant anastomotic leaks (AL) after upper gastrointestinal (GI) surgery is approximately 4 % - 20 %, and the associated mortality can be as high as 80 % . Nutritional support is a key component of therapy in such cases, related to high prevalence of malnutrition and nil per month required for leak treatment.

In the prophylactic setting, before the occurrence of any AL, a literature review based on seven randomised trials showed that enteral nutrition (EN) is associated with shorter hospital stay, lower incidence of severe of infectious complications, lower severity of complications and decreased cost compared to parenteral nutrition (TPN) following major upper GI surgery .

In the curative setting, after the AL occurrence, very few evidence is available. Only one randomized clinical trial suggested the superiority of EN versus TPN after pancreatic surgery with a increase of the 30-day fistula closure rate from 37% in the TPN group to 60% in the EN group .

This sole randomised study available did not include all postoperative upper GI AL (PUGIAL) that can occur after esophageal, gastric, duodenal, pancreatic surgery (including obesity surgery), whereas the concept of enteral nutritional support is highly relevant for all these situations.

However surgeons are usually reluctant to provide EN in case of AL. A randomized study suggested the feasibility of EN in 47 patients with upper GI AL but no randomized study to date has been designed to test the superiority of EN versus TPN in PUGIAL.

The study aim is to demonstrate the superiority of EN versus TPN to accelerate AL healing after upper GI surgery.

Hypothesis:

EN increases the 30-day fistula closure rate in PUGIAL, allowing better HRQOL without increasing morbi-mortality.

ReferenceCitation: Gronnier C, Chambrier C, Duhamel A, Dervaux B, Collet D, Vaudoyer D, Régimbeau JM, Jougon J, Théréaux J, Lebreton G, Veziant J, Valverde A, Ortega-Deballon P, Pattou F, Mathonnet M, Perinel J, Beyer-Berjot L, Fuks D, Rouanet P, Lefevre JH, Cattan P, Deguelte S, Meunier B, Tuech JJ, Pessaux P, Carrere N, Salame E, Benaim E, Dousset B, Msika S, Mariette C, Piessen G; FRENCH association. Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study). Trials. 2020 Jun 2;21(1):448. doi: 10.1186/s13063-020-04366-3.


title: Study of the Risk of PREMaturité According to the Balance of Bacterial Flora VAginale (PREMEVA2)

summary:
Objective

To compare vaginal microbiota in the first trimester of pregnancy between spontaneous preterm and term deliveries


title: Prospective Multicentric, Open Label, Randomized Clinical Trial of Superiority, With Two Arms, Comparing Bariatric Surgery to the Recommended Medical Treatment for NASH

acronym: NASHSURG

summary: The aim of the study is to demonstrate the superiority of bariatric surgery on the disappearance of NASH without worsening of fibrosis in comparison to medical standard treatment in obese patients (35 kg/m² > BMI ≥ 30 kg/m²) with NASH complicated of advanced fibrosis (F3 and F4 fibrosis grade according to Brunt score).


title: Does Nurse Semi - Structured Interview Added to a Repeated Transcranial Magnetic Stimulation Improve Patients With Major Depressive Disorder? A Single Center Study, Randomized, Controlled and Single Blind

acronym: DESTIMCARE

summary:
Repeated Transcranial Magnetic Stimulation - R.TMS - is currently part of the treatment for depressive illness. This non-invasive technique is designed to stimulate certain areas of the cerebral cortex involved in this pathology. FDA approved this treatment in routine for depressive illness. R.TMS still remains in assessment. Due to the heterogeneity of methods and the weakness of the cohorts therapeutic superiority can not concluded .

Stimulation parameters remain numerous even if a consensus is beginning to emerge. The therapeutic target is the left dorso - lateral prefrontal cortex. The lack of efficacy is probably due of the inaccuracy. The empirically location of the target does not take into account the inter-individual anatomical differences. The neuronavigation is becoming widespread in routine clinical practice.

The referent nurse stays with the patient all along the rTMS sessions. His role is to set up treatment, to ensure the safety and the well-being of the patient. An rTMS session is an average of 30 minutes and is a very special moment to create a specific therapeutic relationship.

No study was conducted to evaluate the therapeutic relationship. The assumption is made that rTMS with a semi - structured interview provides a qualitative and quantitative clinical response greater than a semi - structured rTMS without this nursing care. The investigators therefore propose to patients not receiving a semi-structured interview to listen to music with eyes closed.

lead_sponsor: Rennes University Hospital


title: MOther-Child Interaction Assessment TRAINING for Pediatricians

acronym: MOCITRAINING

summary: The originality of the MOCITRAINING study lies in the integration of infant and maternal care during the pediatric consultation and the assessment of the impact of this type of care in the short and medium term on The MOCITRAINING program could contribute to improving the quality of parent-child interactions.


title: Determinants of Patients' Uptake of Therapeutic Education Programme

acronym: UTEP

summary:
Therapeutic Patient Education (TPE) refers to programs that help patients to manage life with a chronic disease in the best possible way. In spite of the effectiveness of Therapeutic Patient Education, few patients uptake TPE when it is proposed to them. Therefore, our main aim was to identify patients' beliefs that will predict patients' uptake of TPE. According to the Health Belief Model, patient will participate in TPE if they perceive their disease as a serious threat (with possible serious complications), but which can be controlled however, and that TPE is efficient and represents little burden.

Secondary aims are as follows:

To test whether the way TPE is presented to patients impact patients' decision to uptake TPE. The way TPE is presented comprises the time between diagnosis and the proposal of TPE, whether patient is a remission or crisis period in the disease, the time between the proposal and the next TPE session, and what is said by healthcare professionals to present TPE.
To test whether healthcare professionals' empathy impact patients' decision to participate in TPE
To test whether patients' intention to participate in TPE will predict their actual participation.

The ultimate goal of the study is to identify patients whose beliefs will not favor participation in TPE in order to accompany those patients more carefully. Best practices will be proposed according the results.


title: Antenatal Detection by Array CGH Genomic Rearrangements Unbalanced Front Uninsulated Thick Neck or a Combination of Two Signs of Ultrasound Calling Normal Karyotype

acronym: CGH Array

summary:
This is the first study with a real diagnostic and prognostic focus in prenatal. In addition to this innovative aspect, the identification of cryptic imbalances in fetuses with malformative syndrome would be an invaluable resource for the identification of new genes involved in development, as is already the case for postnatal studies.

This research aims to:

to test the feasibility of this protocol, ie the practical application of this new technology in the context of prenatal diagnosis,
demonstrate and evaluate the possible involvement of cryptic chromosomal abnormalities in fetuses with a thick neck associated with other malformations and recruited on the strict criteria mentioned above,
assist in the diagnosis of these fetuses and genetic information for their families,
identify new regions of the genome potentially involved in the occurrence of congenital malformations.

location_facility: Hôpital Jeanne de Flandre - CHRU de Lille


title: Image Transmission Applied to Organ Transplant: Before-after Study of the Device of the Effectiveness

summary:
In the complex process of organ transplant, two of the major steps are:

evaluation of the organs of potential donors in health institutions:
proposing grafts to the transplant teams, according to rules defined at the national level.

In the absence of the possibility of transmitting the images between the deceased donor sites and the transplant teams, the visualization of these examinations does not take part in the decision-making of the transplant team. This leads in the displacement of the transplant team in order to verify the grafts after acceptance of the graft proposal.

The "Cristal Image" project is a visualisation project for the transplant teams, in real time, at the time of the proposal of the graft so that they can give an opinion (acceptance, refusal) in less than 20 minutes (legal delay for a vital organ) after analyzing the medical records provided and the imaging data (scanner, ultrasound (s), coronary angiography, etc.).

The hypothesis of the project is that the implementation of a secure image transmission (complete anonymisation of the data of the donor) before the acceptance by the team, will allow an optimization of the use of the qualified organs by reducing risks, unnecessary displacement of transplant surgical teams, and securing the allocation of organs to recipient patients.

ReferenceCitation: Reddy MS, Bhati C, Neil D, Mirza DF, Manas DM. National Organ Retrieval Imaging System: results of the pilot study. Transpl Int. 2008 Nov;21(11):1036-44. doi: 10.1111/j.1432-2277.2008.00720.x.

ReferenceCitation: Rosenkrantz AB, Campbell N, Wehrli N, Triolo MJ, Kim S. New OPTN/UNOS classification system for nodules in cirrhotic livers detected with MR imaging: effect on hepatocellular carcinoma detection and transplantation allocation. Radiology. 2015 Feb;274(2):426-33. doi: 10.1148/radiol.14140069. Epub 2014 Oct 7.

ReferenceCitation: Furlow B. Solid organ donation and transplantation. Radiol Technol. 2012 Mar-Apr;83(4):371-89. Review. Erratum in: Radiol Technol. 2012 May-Jun;83(5):446.

ReferenceCitation: Fregeville A, De Bazelaire C, Zagdanski A, Albiter M, Desgrandchamps F, De Kerviler E. [Value of whole body CTA in the management of brain-dead patients]. J Radiol. 2010 Jan;91(1 Pt 1):37-44. French.

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

ReferenceCitation: Zarca K, Dupont JK, Jacoud L, Bulsei J, Huot O, Logerot H, Durand-Zaleski I. Effectiveness and efficiency of teleimaging in the transplantation process: a mixed method protocol. BMC Health Serv Res. 2019 Sep 18;19(1):672. doi: 10.1186/s12913-019-4488-0.


title: Evaluation of the Impact of Locoregional Treatment of Soft Tissue Sarcoma on the Functional Status of Patients Aged 70 Years and Over

acronym: SARCOLD

summary: In order to describe functional impact of surgery in elderly patients treated for lower-limb soft-tissue sarcoma, the investigators set up this project which aims to identify prognostic factors among geriatric and functional assessment.

lead_sponsor: Institut Bergonié


title: Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis: a Prospective Randomized Placebo-controlled Double-blind Multicenter Trial

summary: Antimicrobial treatment could be beneficial in patients with ventilator-associated tracheobronchitis (VAT). The hypothesis of this study is that antibiotic treatment for VAT (3 or 7 days), compared with no antibiotic treatment, would reduce the incidence of transition from VAT to ventilator-associated pneumonia (VAP).


title: Effect of Fluconazole on the Levels of Anti-Saccharomyces Cerevisiae Antibodies (ASCA) After Surgical Resection for Crohn's Disease. Multicenter, Randomized, and Controlled in Two Parallel Groups Versus Placebo

acronym: AscaMC

summary: This was prospective study randomized in two controlled parallel groups verum versus placebo. The objectives were to assess the influence of antifungal treatment with Fluconazole (FCZ) on the rate of ASCA and endoscopic recurrence at 6 months. The rational was based on our previous research having established i) a link between intestinal inflammation and the opportunistic fungal pathogen C. albicans -a yeast colonizing the human digestive tract- ii) the demonstration that this yeast species could be at the origin of ASCA, a prominent serological marker of CD. It was therefore hypothesized that the FCZ could lower the rate of ASCA and/or reduce the occurrence of recurrences.

ReferenceCitation: Sendid B, Salvetat N, Sarter H, Loridant S, Cunisse C, François N, Aijjou R, Gelé P, Leroy J, Deplanque D, Jawhara S, Weissmann D, Desreumaux P, Gower-Rousseau C, Colombel JF, Poulain D. A Pilot Clinical Study on Post-Operative Recurrence Provides Biological Clues for a Role of Candida Yeasts and Fluconazole in Crohn's Disease. J Fungi (Basel). 2021 Apr 22;7(5). pii: 324. doi: 10.3390/jof7050324.


title: Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery - ePPOP Study

acronym: ePPOP-ID

summary: The purpose of this study is to assess the efficacy of an electronic-based intervention to help pregnant overweight and obese women gain an appropriate amount of weight and improve their delivery i.e. to reduce the rate of labour procedures and interventions. We chose a composite outcome including instrumental delivery and Caesarean section, as clinically relevant outcomes because the mode of delivery is one of the major goals of the obstetrical management and is is strongly associated with body mass index and gestational weight gain.

ReferenceCitation: Deruelle P, Lelorain S, Deghilage S, Couturier E, Guilbert E, Berveiller P, Sénat MV, Vayssière C, Sentilhes L, Perrotin F, Gallot D, Chauleur C, Sananes N, Roth E, Luton D, Caputo M, Lorio E, Chatelet C, Couster J, Timbely O, Doret-Dion M, Duhamel A, Pigeyre M. Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for obesity in pregnancy to improve delivery. BMC Pregnancy Childbirth. 2020 Oct 7;20(1):602. doi: 10.1186/s12884-020-03288-x.

intervention_type: Behavioral


title: Comparison of Rates DMBT1 ( Glycoprotein) in Sputum of CF Patients Colonized Patients Between Chronic and Non-chronic Patients Colonized With Pseudomonas Aeruginosa

summary: Rates of DMBT1 (Glycoprotein like) in Sputum of CF Patients with or without may be different according to their Pseudomonas Aeruginosa chronic colonization status. The aim of this study is to compare rates of DMBT1 (Glycoprotein like) in Sputum of CF patients with or without a Pseudomonas Aeruginosa chronic colonization.


title: EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest With no Obvious Non Cardiac Cause of Arrest

acronym: EMERGE

summary:
Sudden cardiac death (SCD) remains a major public health issue with a low survival rate. The most common cause of SCD is acute coronary artery occlusion. Several registry based studies suggest that coronary angiography (CA) performed at admission followed if necessary by coronary angioplasty improves in-hospital and long term survival. Recent guidelines recommend performing an immediate CA in all survivors of SCD with no obvious non cardiac cause of arrest. However there is a lack of randomized data on this topic.

Several retrospective studies have shown that if the post-resuscitation electrocardiogram (ECG) shows ST segment elevation, the probability of finding an acute coronary artery lesion during the CA is high (70-80%). In contrast, if no ST segment elevation is present the probability is low (15-20%).

Performing an immediate CA in all survivors of SCD can be challenging. It requires admitting these patients to centers with an intensive care unit and facilities allowing 24/24 7/7 CA. It may increase the delay of performing other therapeutic modalities such as CT brain or thorax scan to determine the cause of SCD. Performing the CA 48 to 96 hours after admission would facilitate the management of these difficult patients. However if the cause of the arrest is a coronary artery occlusion and there is a delay in reperfusion, the rate of post-arrest shock and the mortality may increase. Therefore a randomized study comparing immediate versus delayed (between 48 to 96 hours) CA in survivors of SCD with no obvious non-cardiac cause of arrest is warranted.

ReferenceCitation: Hauw-Berlemont C, Lamhaut L, Diehl JL, Andreotti C, Varenne O, Leroux P, Lascarrou JB, Guerin P, Loeb T, Roupie E, Daubin C, Beygui F, Boissier F, Marjanovic N, Christiaens L, Vilfaillot A, Glippa S, Prat JD, Chatellier G, Cariou A, Spaulding C; EMERGE Investigators. Emergency vs Delayed Coronary Angiogram in Survivors of Out-of-Hospital Cardiac Arrest: Results of the Randomized, Multicentric EMERGE Trial. JAMA Cardiol. 2022 Jul 1;7(7):700-707. doi: 10.1001/jamacardio.2022.1416.


acronym: ACTICAS

title: A Randomized Crossover TrIal to Compare Recombinant Human rhPTH(1-34) to the ASsociation Alfacalcidol/Hydrochlorothiazide in the Treatment of Severe Primary Hypoparathyroidism

summary:
Hypoparathyroidism is a rare condition in which the parathyroid glands fail to produce sufficient amount of parathyroid hormone or the parathyroid hormone produced lacks biologic activity. The most common cause of hypoparathyroidism is damage to or removal of the parathyroid glands due to neck surgery for another condition. Occurrence of hypercalciuria under treatment is a frequent concern in primary hypoparathyroidism, limiting correction of hypocalcemia.

Hypoparathyroidism can also be caused by an autoimmune process. In rare cases, hypoparathyroidism may occur as a genetic disorder inherited as an autosomal recessive, autosomal dominant or X-linked recessive trait. The autosomal dominant hypocalcemia (ADH) is mainly caused by heterozygous activating mutations in the CASR gene encoding CaSR). As other severe presentation of primary hypothyroidism, ADH is characterized by the increased risk to develop hypercalciuria and nephrolithiasis. The purpose of the study is to compare two therapeutic approaches in severe hypoparathyroidism in order to limit the risk of nephrocalcinosis and renal failure when attempting to correct hypocalcemia: rhPTH(1-34) vs association of active vitamin D and hydrochlorothiazide. The European Society of Endocrinology Clinical has indeed recently published guidelines for the treatment of chronic hypoparathyroidism in adults. These guidelines suggest considering treatment with a thiazide diuretic In a patient with hypercalciuria and replacement therapy with PTH in patients who do not stably and safely maintain their serum and urinary calcium in the target range.


title: Participation in Screening for Cervical Cancer: Interest of a Human Papillomavirus (HPV) Self-sampling Device Provided by the General Practitioner; a Cluster Randomized Clinical Trial

acronym: PaCUDAHL-Gé

summary: This study evaluates the benefit in women aged from 30 to 65 years, who do not participate to the French opportunistic cervical cancer screening program, of an organized screening with the proposition by the family physician of a pap-test (usual care) versus a self-collected vaginal sample (and a HPV-test). 24 family physicians will participate and will be randomized in the usual care arm (12) or in the self-sampling arm (12). Our hypothesis is that organizing the screening for these women involving their family physician will major participation, and that the self-sampling option will amplify this increase.

ReferenceCitation: Fishbein M. A reasoned action approach to health promotion. Med Decis Making. 2008 Nov-Dec;28(6):834-44. doi: 10.1177/0272989X08326092. Epub 2008 Nov 17.

ReferenceCitation: van Baars R, Bosgraaf RP, ter Harmsel BW, Melchers WJ, Quint WG, Bekkers RL. Dry storage and transport of a cervicovaginal self-sample by use of the Evalyn Brush, providing reliable human papillomavirus detection combined with comfort for women. J Clin Microbiol. 2012 Dec;50(12):3937-43. doi: 10.1128/JCM.01506-12. Epub 2012 Sep 26.

ReferenceCitation: Viguier J, Calazel-Benque A, Eisinger F, Pivot X. Organized colorectal cancer screening programmes: how to optimize efficiency among general practitioners. Eur J Cancer Prev. 2011 Jan;20 Suppl 1:S26-32. doi: 10.1097/01.cej.0000391567.49006.af.

ReferenceCitation: Verhoef VM, Bosgraaf RP, van Kemenade FJ, Rozendaal L, Heideman DA, Hesselink AT, Bekkers RL, Steenbergen RD, Massuger LF, Melchers WJ, Bulten J, Overbeek LI, Berkhof J, Snijders PJ, Meijer CJ. Triage by methylation-marker testing versus cytology in women who test HPV-positive on self-collected cervicovaginal specimens (PROHTECT-3): a randomised controlled non-inferiority trial. Lancet Oncol. 2014 Mar;15(3):315-22. doi: 10.1016/S1470-2045(14)70019-1. Epub 2014 Feb 13.

ReferenceCitation: Duport N, Serra D, Goulard H, Bloch J. [Which factors influence screening practices for female cancer in France?]. Rev Epidemiol Sante Publique. 2008 Oct;56(5):303-13. doi: 10.1016/j.respe.2008.07.086. Epub 2008 Oct 31. French.

ReferenceType: result

ReferenceCitation: Anhang R, Nelson JA, Telerant R, Chiasson MA, Wright TC Jr. Acceptability of self-collection of specimens for HPV DNA testing in an urban population. J Womens Health (Larchmt). 2005 Oct;14(8):721-8.

ReferenceCitation: Haguenoer K, Giraudeau B, Gaudy-Graffin C, de Pinieux I, Dubois F, Trignol-Viguier N, Viguier J, Marret H, Goudeau A. Accuracy of dry vaginal self-sampling for detecting high-risk human papillomavirus infection in cervical cancer screening: a cross-sectional study. Gynecol Oncol. 2014 Aug;134(2):302-8. doi: 10.1016/j.ygyno.2014.05.026. Epub 2014 Jun 3.

ReferenceCitation: Cadman L, Ashdown-Barr L, Waller J, Szarewski A. Attitudes towards cytology and human papillomavirus self-sample collection for cervical screening among Hindu women in London, UK: a mixed methods study. J Fam Plann Reprod Health Care. 2015 Jan;41(1):38-47. doi: 10.1136/jfprhc-2013-100705. Epub 2014 Feb 12.

ReferenceCitation: Waller J, Bartoszek M, Marlow L, Wardle J. Barriers to cervical cancer screening attendance in England: a population-based survey. J Med Screen. 2009;16(4):199-204. doi: 10.1258/jms.2009.009073.

ReferenceCitation: Cox JT, Castle PE, Behrens CM, Sharma A, Wright TC Jr, Cuzick J; Athena HPV Study Group. Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing, and genotyping for HPV 16/18: results from the ATHENA HPV study. Am J Obstet Gynecol. 2013 Mar;208(3):184.e1-184.e11. doi: 10.1016/j.ajog.2012.11.020. Epub 2012 Nov 19.

ReferenceCitation: Park Y, Lee E, Choi J, Jeong S, Kim HS. Comparison of the Abbott RealTime High-Risk Human Papillomavirus (HPV), Roche Cobas HPV, and Hybrid Capture 2 assays to direct sequencing and genotyping of HPV DNA. J Clin Microbiol. 2012 Jul;50(7):2359-65. doi: 10.1128/JCM.00337-12. Epub 2012 Apr 18.

ReferenceCitation: TOMBOLA Group. Cytological surveillance compared with immediate referral for colposcopy in management of women with low grade cervical abnormalities: multicentre randomised controlled trial. BMJ. 2009 Jul 28;339:b2546. doi: 10.1136/bmj.b2546.

ReferenceCitation: Rigal L, Saurel-Cubizolles MJ, Falcoff H, Bouyer J, Ringa V. Do social inequalities in cervical cancer screening persist among patients who use primary care? The Paris Prevention in General Practice survey. Prev Med. 2011 Sep;53(3):199-202. doi: 10.1016/j.ypmed.2011.06.016. Epub 2011 Jun 25.

ReferenceCitation: Chan Chee C, Begassat M, Kovess V. [Factors associated with cervical cancer screening in women covered by national health insurance]. Rev Epidemiol Sante Publique. 2005 Feb;53(1):69-75. French.

ReferenceCitation: Zehbe I, Moeller H, Severini A, Weaver B, Escott N, Bell C, Crawford S, Bannon D, Paavola N. Feasibility of self-sampling and human papillomavirus testing for cervical cancer screening in First Nation women from Northwest Ontario, Canada: a pilot study. BMJ Open. 2011 Feb 26;1(1):e000030. doi: 10.1136/bmjopen-2010-000030.

ReferenceCitation: Goodman A. HPV testing as a screen for cervical cancer. BMJ. 2015 Jun 30;350:h2372. doi: 10.1136/bmj.h2372. Review.

ReferenceCitation: Gök M, Heideman DA, van Kemenade FJ, Berkhof J, Rozendaal L, Spruyt JW, Voorhorst F, Beliën JA, Babovic M, Snijders PJ, Meijer CJ. HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study. BMJ. 2010 Mar 11;340:c1040. doi: 10.1136/bmj.c1040. Erratum in: BMJ. 2016 May 18;353:i2823.

ReferenceCitation: Broberg G, Gyrd-Hansen D, Miao Jonasson J, Ryd ML, Holtenman M, Milsom I, Strander B. Increasing participation in cervical cancer screening: offering a HPV self-test to long-term non-attendees as part of RACOMIP, a Swedish randomized controlled trial. Int J Cancer. 2014 May 1;134(9):2223-30. doi: 10.1002/ijc.28545. Epub 2013 Oct 31.

ReferenceCitation: Grillo F, Vallée J, Chauvin P. Inequalities in cervical cancer screening for women with or without a regular consulting in primary care for gynaecological health, in Paris, France. Prev Med. 2012 Mar-Apr;54(3-4):259-65. doi: 10.1016/j.ypmed.2012.01.013. Epub 2012 Jan 24.

ReferenceCitation: Elfström KM, Smelov V, Johansson AL, Eklund C, Nauclér P, Arnheim-Dahlström L, Dillner J. Long term duration of protective effect for HPV negative women: follow-up of primary HPV screening randomised controlled trial. BMJ. 2014 Jan 16;348:g130. doi: 10.1136/bmj.g130.

ReferenceCitation: Gök M, Heideman DA, van Kemenade FJ, de Vries AL, Berkhof J, Rozendaal L, Beliën JA, Overbeek L, Babović M, Snijders PJ, Meijer CJ. Offering self-sampling for human papillomavirus testing to non-attendees of the cervical screening programme: Characteristics of the responders. Eur J Cancer. 2012 Aug;48(12):1799-808. doi: 10.1016/j.ejca.2011.11.022. Epub 2011 Dec 13.

ReferenceCitation: Bulk S, Bulkmans NW, Berkhof J, Rozendaal L, Boeke AJ, Verheijen RH, Snijders PJ, Meijer CJ. Risk of high-grade cervical intra-epithelial neoplasia based on cytology and high-risk HPV testing at baseline and at 6-months. Int J Cancer. 2007 Jul 15;121(2):361-7. Erratum in: Int J Cancer. 2007 Oct 15;121(8):1873.

ReferenceCitation: Lazcano-Ponce E, Lorincz AT, Cruz-Valdez A, Salmerón J, Uribe P, Velasco-Mondragón E, Nevarez PH, Acosta RD, Hernández-Avila M. Self-collection of vaginal specimens for human papillomavirus testing in cervical cancer prevention (MARCH): a community-based randomised controlled trial. Lancet. 2011 Nov 26;378(9806):1868-73. doi: 10.1016/S0140-6736(11)61522-5. Epub 2011 Nov 1.

ReferenceCitation: Cullen J, Schwartz MD, Lawrence WF, Selby JV, Mandelblatt JS. Short-term impact of cancer prevention and screening activities on quality of life. J Clin Oncol. 2004 Mar 1;22(5):943-52. Review.

ReferenceCitation: C Kitchener H, Canfell K, Gilham C, Sargent A, Roberts C, Desai M, Peto J. The clinical effectiveness and cost-effectiveness of primary human papillomavirus cervical screening in England: extended follow-up of the ARTISTIC randomised trial cohort through three screening rounds. Health Technol Assess. 2014 Apr;18(23):1-196. doi: 10.3310/hta18230.

ReferenceCitation: Giorgi Rossi P, Marsili LM, Camilloni L, Iossa A, Lattanzi A, Sani C, Di Pierro C, Grazzini G, Angeloni C, Capparucci P, Pellegrini A, Schiboni ML, Sperati A, Confortini M, Bellanova C, D'Addetta A, Mania E, Visioli CB, Sereno E, Carozzi F; Self-Sampling Study Working Group. The effect of self-sampled HPV testing on participation to cervical cancer screening in Italy: a randomised controlled trial (ISRCTN96071600). Br J Cancer. 2011 Jan 18;104(2):248-54. doi: 10.1038/sj.bjc.6606040. Epub 2010 Dec 21.

ReferenceCitation: Favre J, Rochoy M, Raginel T, Pelletier M, Messaadi N, Deken-Delannoy V, Duhamel A, Berkhout C. The Effect of Cervical Smears Performed by General Practitioners on the Cervical Cancer Screening Rate of their Female Patients: A Claim Database Analysis and Cross-Sectional Survey. J Womens Health (Larchmt). 2018 Jul;27(7):933-938. doi: 10.1089/jwh.2017.6656. Epub 2018 Mar 27.

ReferenceCitation: Rochoy M, Raginel T, Favre J, Soueres E, Messaadi N, Deken V, Duhamel A, Berkhout C. Factors associated with the achievement of cervical smears by general practitioners. BMC Res Notes. 2017 Dec 8;10(1):723. doi: 10.1186/s13104-017-2999-5.


title: Effect of the Type of Maternal Pushing During the Second Stage of Labor on Obstetric and Neonatal Outcome: a Multicenter Randomized Trial

acronym: EOLE

summary: The objective of this randomized clinical trial is to assess and compare the effectiveness of directed closed-glottis (Valsalva) pushing (pushing while holding one's breath) vs. directed open-glottis pushing (pushing during a prolonged exhalation) during the second stage of labor. The study hypothesis is that open-glottis pushing results in better maternal and neonatal outcomes, in particular for maternal pelvic floor and continence function.

ReferenceCitation: Barasinski C, Debost-Legrand A, Savary D, Bouchet P, Curinier S, Vendittelli F. Does the type of pushing at delivery influence pelvic floor function at 2 months postpartum? A pragmatic randomized trial-The EOLE study. Acta Obstet Gynecol Scand. 2022 Nov 9. doi: 10.1111/aogs.14461. [Epub ahead of print]

ReferenceCitation: Barasinski C, Vendittelli F. Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial-the EOLE study protocol. BMJ Open. 2016 Dec 20;6(12):e012290. doi: 10.1136/bmjopen-2016-012290.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Opioid System Cerebral Activity in Endurance Sportswomen - Addiction or Denutrition ? [11C]Diprenorphine PET Study

summary:
Abnormal opioid system have been identified in addictive behavior and activity of the opioid system has also shown a strong link with the nutritional balance. A significant increase in endorphin levels was noticed after exercise, proportional to the duration and intensity of this activity. One brain imaging study showed an increase in opioid activity in athletes after endurance training. However , a decrease in opioid tone related to receptor desensitization in the brain has been raised in the sport and it is possible to feel like , the subject must perform physical exercise more frequently . Consequently, in order to deepen the hypothesis of addiction in high-level sport , the brain opioid activity should be assessed pre- training compared to a group of sedentary control subjects .

Preliminary results of a previous study the investigators are conducting on anorexia nervosa (AN ) show abnormalities that appear to be involved in self addiction anorexia nervosa and the regulation of gonadal function. However, the relation of cause and effect between these anomalies and undernutrition remains to be determined . Given the addictive component in the endurance sport and the variability of the nutritional status of its practitioners , evaluation of brain activity in these subjects could provide additional answers.

design_allocation: Non-Randomized

location_facility: Service d'Endocrinologie - CHU Saint-Etienne


title: Evaluation of Local Anesthesia Before Arterial Puncture for Blood Gas Analysis Randomized, Control Placebo Study

acronym: GAEL

summary: The aim of the study is to evaluate the interest of Local Anesthesia (lidocaïne/prilocaïne versus placebo)before arterial puncture for Blood Gas Analysis. The pain is measured with a numeric Pain Intensity for all patients included.

ReferenceCitation: Beaumont M, Goret M, Orione C, Fauche A, Nowak E, Dion A, Darnois V, Tromeur C, Cogulet V, Leroyer C, Couturaud F, Le Mao R. Effect of Local Anesthesia on Pain During Arterial Puncture: The GAEL Randomized Placebo-Controlled Trial. Respir Care. 2021 Jun;66(6):976-982. doi: 10.4187/respcare.08328. Epub 2021 Mar 23.

lead_sponsor: University Hospital, Brest