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).

location_facility: Groupe Hospitalier Region Mulhouse Et Sud Alsace

location_facility: Les Hôpitaux Universitaires de Strasbourg


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_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Strasbourg, France

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


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

location_facility: Service des Urgences, Hôpital de Hautepierre

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

location_facility: Service des Urgences, Centre Hospitalier de Sélestat

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

location_facility: Service de Réanimation Médicale, Nouvel Hôpital Civil

location_facility: Service de Réanimation Médicale, Hôpital de Hautepierre

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

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

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

location_facility: Service de Chirurgie Digestive Hopital de Hautepierre

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

location_facility: Service de Chirurgie Digestive Hôpital de Brabois

location_facility: Département d'Anesthésiologie Hôpital de Brabois

location_facility: Laboratoire d'Hémostase Hôpital de Brabois

location_facility: Centre investigation Clinique Hôpital Civil

location_facility: Service de Chirurgie Générale et Endocrinienne Hôpital Civil

intervention_type: Drug


title: Assessment of Efficacy and Safety for a New Wound Dressing URGO 310 3166 in the Local Treatment of Venous or Mixed Leg Ulcers: A European, Randomised Clinical Trial

summary: Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.

primary_purpose: Treatment

lead_sponsor: Laboratoires URGO

intervention_type: Device

lead_sponsor_type: industriel


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.

status: Completed

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.

family: Leclercq

full_name: A. Leclercq

given: A.

sequence: first

family: Gauthier

full_name: B. Gauthier

given: B.

sequence: additional

family: Rosner

full_name: V. Rosner

given: V.

family: Weiss

full_name: L. Weiss

given: L.

family: Moreau

full_name: F. Moreau

given: F.

family: Constantinescu

full_name: A.A. Constantinescu

family: Kessler

full_name: R. Kessler

given: R.

full_name: L. Kessler

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Cystic Fibrosis

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

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

location_facility: Service de Réanimation Médicale - Hôpital Civil

status_simplified: Completed


title: Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction Chemotherapy and Adding Intermediate Dose Cytarabine to Consolidation in Older Patients With Acute Myeloid Leukaemia

summary: A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\m2 orally at day 1). Patients in complete remission (CR) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.

lead_sponsor: French Innovative Leukemia Organisation


title: Bloc Des Muscles Erecteurs du Rachis Pour Chirurgie d'exérèse de première côte Dans le Cadre du Syndrome du défilé Cervico-thoracique: évaluation Avant-après au CHU d'Angers.

acronym: MERCOTE

summary:
First rib resection surgery for thoracic outlet syndrome is associated with an intense postoperative pain. It leads to significant consumption of nonsteroidal anti-inflammatory drugs and opioids, and hospitalization for several days.

In our center, first rib resection surgery was usually performed under general anesthesia combined with diffuse local infiltration of the axillary fossa. Erector spinae block is an interfascial block where a local anesthetic is injected between the erector spinae muscle and the transverse process, in order to obtain a multimetameric analgesia. It has now shown its efficacy and its safety in thoracic and abdominal surgeries by decreasing the morphine consumption and pain scores. Since November 2018, this erector spinae block is systematically performed preoperatively for first rib resection in our center, in association with a general anesthesia. Patient satisfaction seems important but remains to be assessed objectively.

In a before-after study, our goal is to assess the impact of the use of erector spinae block on postoperative pain in the first rib resection surgery.

study_start_date_type: Anticipated

lead_sponsor: University Hospital, Angers

location_facility: Département d'Anesthésie-Réanimation du CHU d'Angers


title: Efficacités comparées du Bloc Des Muscles érecteurs du Rachis, du Bloc péridural et de la rachianalgésie en Chirurgie Thoracique Majeure.

acronym: SPIRIT

summary:
Pulmonary thoracic surgery is often responsible for severe postoperative pain, which is associated with an increase in postoperative morbidity and mortality. Moreover, postoperative thoracic pain has a strong impact on patient rehabilitation and is associated with an increase in hospital stay.

Various analgesic techniques allow effective management of pain in the context of thoracic surgery. Regional anesthesia, particularly, allows a powerful analgesia, and limits the use of opioids and their side effects. Among regional anesthesia techniques, thoracic epidural analgesia has become the gold standard for post-thoracotomy analgesia. However, it induces a sympathetic block that promotes in particular per and postoperative hypotension and acute urinary retentions. Thus, new regional anesthesia techniques have been developed and assessed in thoracic surgery in order to avoid side effects related to epidural analgesia, particularly paravertebral block and erector spinae block, but also intrathecal analgesia. Paravertebral block has shown analgesic efficacy after thoracic surgery, and its interest in reducing the risk of hypotension, acute urinary retention, pruritus and postoperative nausea and vomiting compared with the epidural analgesia. Erector spinae block, recently described and evaluated in this context of thoracic surgery, seems to have the same interests and to be easier to achieve than the paravertebral block, but has been little studied. Finally, intrathecal morphine is frequently used because of an easy and rapid realization, and because it allows an adequate analgesia and the reduction of the duration of stay in intensive care compared to the epidural one. However, despite its frequent use, very few studies have compared intrathecal anesthesia with the epidural and other peri-spinal blocks.

These three types of analgesia, epidural analgesia, intrathecal morphine, and erector spinae block are regional anesthesia methods regularly used for pulmonary surgery in the department of the investigators. All of these techniques have shown their analgesic efficacy, but each seems to have particular respective interests, in terms of achievement, management, or perioperative rehabilitation. The objective of the investigators study is to evaluate the effectiveness of each of its techniques to treat postoperative pain and improve the rehabilitation of these patients.

location_facility: CHU Angers - DEPARTEMENT D'ANESTHESIE REANIMATION


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.

primary_purpose: Other

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

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

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

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

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

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


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

primary_purpose: Diagnostic

location_facility: Centre Hospitalo-Universitaire Jean Minjoz


title: Assessment of Four-dimensional (4D) 18F-fluoro-deoxy-glucose (FDG) Positron Emission Tomography and Computed Tomography System (PET-CT) in Radiotherapy for Non Small Cell Lung Cancers (NSCLC)

acronym: PULMOTEP

summary: Computed tomography (CT) images, used for radiotherapy planning, are often caught out in lung target volumes delineation because of their inability to differentiate between neoplasia, inflammation and atelectasia. Positron Emission Tomography (PET) is a new functional imaging modality and is currently used in the diagnosis and the staging of lung cancers. The aim of this study is to evaluate the impact of 4D 18F-FDG-PET-CT on radiotherapy planning for lung cancers.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Bordeaux


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.

time_perspective: Other

ipd_sharing: No

location_country: Belgium France

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

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

location_facility: Service de Gériatrie, Centre Hospitalier Départemental de Vendée

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

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

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


title: Low Grade Inflammation in Type 1 Diabetes Children

acronym: Coccinelle

summary: The study propose to measure the inflammation level in type 1 diabetes children with the cytokine analysis compared to non diabetic children of the same sibling and to healthy children.


title: Definition of Crises in Medical Oncology: a Two-way Perspective of Patients and Caregivers, a Prospective Observational Study.

acronym: COPE

summary: Our objective is to identify the main crises facing the patients and caregivers in medical oncology and rank them by order of importance. Each group of participant will also express its perception of other participants' list of crises.

ReferenceType: background

ReferenceCitation: Carnevale FA, Farrell C, Cremer R, Canoui P, Séguret S, Gaudreault J, de Bérail B, Lacroix J, Leclerc F, Hubert P. Struggling to do what is right for the child: pediatric life-support decisions among physicians and nurses in France and Quebec. J Child Health Care. 2012 Jun;16(2):109-23. doi: 10.1177/1367493511420184. Epub 2012 Jan 13.

ReferenceCitation: Coast J, Bailey C, Orlando R, Armour K, Perry R, Jones L, Kinghorn P. Adaptation, Acceptance and Adaptive Preferences in Health and Capability Well-Being Measurement Amongst Those Approaching End of Life. Patient. 2018 Oct;11(5):539-546. doi: 10.1007/s40271-018-0310-z.

ReferenceCitation: Hong P, Maguire E, Purcell M, Ritchie KC, Chorney J. Decision-Making Quality in Parents Considering Adenotonsillectomy or Tympanostomy Tube Insertion for Their Children. JAMA Otolaryngol Head Neck Surg. 2017 Mar 1;143(3):260-266. doi: 10.1001/jamaoto.2016.3365.

ReferenceCitation: Bochatay N, Bajwa NM, Cullati S, Muller-Juge V, Blondon KS, Junod Perron N, Maître F, Chopard P, Vu NV, Kim S, Savoldelli GL, Hudelson P, Nendaz MR. A Multilevel Analysis of Professional Conflicts in Health Care Teams: Insight for Future Training. Acad Med. 2017 Nov;92(11S Association of American Medical Colleges Learn Serve Lead: Proceedings of the 56th Annual Research in Medical Education Sessions):S84-S92. doi: 10.1097/ACM.0000000000001912.

ReferenceCitation: Walrath JM, Dang D, Nyberg D. An organizational assessment of disruptive clinician behavior: findings and implications. J Nurs Care Qual. 2013 Apr-Jun;28(2):110-21. doi: 10.1097/NCQ.0b013e318270d2ba.

ReferenceCitation: Knickle K, McNaughton N, Downar J. Beyond winning: mediation, conflict resolution, and non-rational sources of conflict in the ICU. Crit Care. 2012 Jun 19;16(3):308. doi: 10.1186/CC11141.

ReferenceCitation: Back AL, Arnold RM. Dealing with conflict in caring for the seriously ill: "it was just out of the question". JAMA. 2005 Mar 16;293(11):1374-81.

ReferenceCitation: Chiarchiaro J, White DB, Ernecoff NC, Buddadhumaruk P, Schuster RA, Arnold RM. Conflict Management Strategies in the ICU Differ Between Palliative Care Specialists and Intensivists. Crit Care Med. 2016 May;44(5):934-42. doi: 10.1097/CCM.0000000000001583.

ReferenceCitation: Park M, Jeon SH, Hong HJ, Cho SH. A comparison of ethical issues in nursing practice across nursing units. Nurs Ethics. 2014 Aug;21(5):594-607. doi: 10.1177/0969733013513212. Epub 2014 Jan 21.

ReferenceCitation: Breslin JM, MacRae SK, Bell J, Singer PA; University of Toronto Joint Centre for Bioethics Clinical Ethics Group. Top 10 health care ethics challenges facing the public: views of Toronto bioethicists. BMC Med Ethics. 2005 Jun 26;6:E5.

ReferenceCitation: Killen AR, Fry ST, Damrosch S. Ethics and human rights issues in perioperative nurses: a subsample of Maryland nurses. Semin Perioper Nurs. 1996 Apr;5(2):77-83.

ReferenceCitation: Hsu C-C, Sandford BA. The Delphi Technique: Making Sense Of Consensus n.d.;12:8.

ReferenceCitation: Blackwood B, Albarran JW, Latour JM. Research priorities of adult intensive care nurses in 20 European countries: a Delphi study. J Adv Nurs. 2011 Mar;67(3):550-62. doi: 10.1111/j.1365-2648.2010.05512.x. Epub 2010 Nov 23.

ReferenceCitation: Meskell P, Murphy K, Shaw DG, Casey D. Insights into the use and complexities of the Policy Delphi technique. Nurse Res. 2014 Jan;21(3):32-9. doi: 10.7748/nr2014.01.21.3.32.e342.

ReferenceCitation: Démographie des professionnels de santé : qui sont les médecins en 2018 ? Quelle accessibilité aux médecins généralistes ? Combien d'infirmiers en 2040 ? Un outil de projections d'effectifs de médecins - Ministère des Solidarités et de la Santé n.d. http://drees.solidarites-sante.gouv.fr/etudes-et-statistiques/publications/communiques-de-presse/article/demographie-des-professionnels-de-sante-qui-sont-les-medecins-en-2018-quelle.

ReferenceCitation: La profession d'infirmière : situation démographique et trajectoires professionnelles - Data.gouv.fr n.d. /fr/datasets/la-profession-d-infirmiere-situation-demographique-et-trajectoires-professionnelles-30378340/ .

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: APHP Assistance Publique des Hôpitaux de Paris


title: Measurement of Glomerular Filtration Rate With Contrast-enhanced Dynamic MR Imaging in Renal Transplant Recipients: Evaluation of the Agreement With the Cr51 -EDTA Method and of Reproducibility

acronym: IREN

summary: The aim of the study is to optimize and validate this MR-based GFR measurement in patients with a renal transplant, compared with the reference method, the Cr51- EDTA method: to select the most accurate combination of post-treatment of renal MR images and then evaluate its intra- and inter-rater reliability.

location_facility: Service d'imagerie Diagnostique et interventionelle de l'adulte, Hôpital Pellegrin, CHU de Bordeaux


title: Double-Blind Placebo-Controlled Study of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

summary: To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet v1 and birch pollen licenced extract used for subcutaneous immunotherapy.

lead_sponsor: Stallergenes Greer

intervention_type: Biological


title: Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg

summary: Efficacy and safety of morphine titration on acute pain in emergency medical mobile units with initial bolus of 0.1 mg/kg plus 0.05 mg/kg versus morphine titration with initial bolus of 0.05 mg/kg plus 0.025 mg/kg

ReferenceCitation: Ricard-Hibon A, Leroy N, Magne M, Leberre A, Chollet C, Marty J. [Evaluation of acute pain in prehospital medicine]. Ann Fr Anesth Reanim. 1997;16(8):945-9. French.

ReferenceCitation: Ricard-Hibon A, Marty J. Prise en charge de la douleur en milieu préhospitalier, In SFAR, Conférences d'actualisation 2001, Paris, Elsevier,2001;pp 709-22

ReferenceCitation: SFAR. Quelles sont les modalités de réalisation d'une sédation et/ou d'une analgésie du malade en ventilation spontanée. In : SFAR eds. Modalités de la sédation et/ou de l'analgésie en situation extrahospitalière : Conférence d'experts. Paris, Elsevier;2000;pp 37-51

ReferenceCitation: SFUM. Troisième conférence de consensus en médecine d'urgence de la Société francophone d'urgence médicale. Le traitement médicamenteux de la douleur de l'adulte dans un service d'accueil et d'urgence. Réan Urg 1993; 2:321-7

ReferenceType: result

ReferenceCitation: Bounes V, Charpentier S, Houze-Cerfon CH, Bellard C, Ducassé JL. Is there an ideal morphine dose for prehospital treatment of severe acute pain? A randomized, double-blind comparison of 2 doses. Am J Emerg Med. 2008 Feb;26(2):148-54. doi: 10.1016/j.ajem.2007.04.020.

family: Bounes

full_name: Vincent Bounes

given: Vincent

family: Charpentier

full_name: Sandrine Charpentier

given: Sandrine

family: Houze-Cerfon

full_name: Charles-Henri Houze-Cerfon

given: Charles-Henri

family: Bellard

full_name: Cédric Bellard

given: Cédric

family: Ducassé

full_name: Jean Louis Ducassé

given: Jean Louis

journal_name: The American Journal of Emergency Medicine

lead_sponsor: University Hospital, Toulouse


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.

lead_sponsor: Hospital St. Joseph, Marseille, France

location_facility: Groupe Hopitaux Institut Catholique de Lille

intervention_type: Diagnostic Test


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.

family: Vivodtzev

full_name: Isabelle Vivodtzev

given: Isabelle

family: L’Her

full_name: Erwan L’Her

given: Erwan

family: Vottero

full_name: Gabrielle Vottero

given: Gabrielle

family: Yankoff

full_name: Claire Yankoff

given: Claire

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Maltais

full_name: François Maltais

given: François

family: Lellouche

full_name: François Lellouche

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

journal_name: Thorax

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Automated O2 titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial

lead_sponsor: AGIR à Dom

location_facility:
Centre ATRIR
Centre Henri BAZIRE
Hopital Universitaire


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.

family: Pourcher

full_name: Guillaume Pourcher

given: Guillaume

family: De Filippo

full_name: Gianpaolo De Filippo

given: Gianpaolo

family: Ferretti

full_name: Stefano Ferretti

given: Stefano

family: Piquard

full_name: Catherine Piquard

given: Catherine

family: Dagher

full_name: Ibrahim Dagher

given: Ibrahim

family: Bougnères

full_name: Pierre Bougnères

given: Pierre

journal_name: Surgery for Obesity and Related Diseases

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


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.

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


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:
Hopitaux Universitares de Strasbourg
Centre Hospitalier de Rouffach


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: Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy

acronym: ADIPRAT

summary: The aim of this study is to analyze the variation of adiponectinemia and its molecular forms in RA patients receiving tocilizumab therapy.

ReferenceCitation: Toussirot E, Marotte H, Mulleman D, Cormier G, Coury F, Gaudin P, Dernis E, Bonnet C, Damade R, Grauer JL, Abdesselam TA, Guillibert-Karras C, Lioté F, Hilliquin P, Sacchi A, Wendling D, Le Goff B, Puyraveau M, Dumoulin G. Increased high molecular weight adiponectin and lean mass during tocilizumab treatment in patients with rheumatoid arthritis: a 12-month multicentre study. Arthritis Res Ther. 2020 Sep 29;22(1):224. doi: 10.1186/s13075-020-02297-7.

family: Toussirot

full_name: Eric Toussirot

given: Eric

family: Marotte

full_name: Hubert Marotte

given: Hubert

family: Mulleman

full_name: Denis Mulleman

given: Denis

family: Cormier

full_name: Grégoire Cormier

given: Grégoire

family: Coury

full_name: Fabienne Coury

given: Fabienne

family: Gaudin

full_name: Philippe Gaudin

given: Philippe

family: Dernis

full_name: Emmanuelle Dernis

given: Emmanuelle

family: Bonnet

full_name: Christine Bonnet

given: Christine

family: Damade

full_name: Richard Damade

given: Richard

family: Grauer

full_name: Jean-Luc Grauer

given: Jean-Luc

family: Abdesselam

full_name: Tassadit Ait Abdesselam

given: Tassadit Ait

family: Guillibert-Karras

full_name: Caroline Guillibert-Karras

given: Caroline

family: Lioté

full_name: Frédéric Lioté

given: Frédéric

family: Hilliquin

full_name: Pascal Hilliquin

given: Pascal

family: Sacchi

full_name: Antoinette Sacchi

given: Antoinette

family: Wendling

full_name: Daniel Wendling

given: Daniel

family: Le Goff

full_name: Benoît Le Goff

given: Benoît

family: Puyraveau

full_name: Marc Puyraveau

given: Marc

family: Dumoulin

full_name: Gilles Dumoulin

given: Gilles

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

lead_sponsor: Centre Hospitalier Universitaire de Besancon


status: Not yet recruiting

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

acronym: IRONCEL

ipd_sharing: Yes

type: Other Grant/Funding Number

source: euctr

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

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.


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: 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.


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


title: Sport as a Treatment in Chronic Diseases and Healthcare Sustainability: Sport 4 Health

summary: Obesity, associated with obstructive sleep apnea (OSA) is often involved in cardiovascular diseases. In our study, we want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. The aim of this clinical trial is to determine which type of program, conducted in a digital environment associating a mobile application and individual coaching, better improves exercise habits over a 3-month period in overweight or moderate obese OSA patients.

design_allocation: Non-Randomized

ReferenceCitation: Andrade FM, Pedrosa RP. The role of physical exercise in obstructive sleep apnea. J Bras Pneumol. 2016 Nov-Dec;42(6):457-464. doi: 10.1590/S1806-37562016000000156. Review. English, Portuguese.

apc_source: doaj

family: Andrade

full_name: Flávio Maciel Dias de Andrade

given: Flávio Maciel Dias de

family: Pedrosa

full_name: Rodrigo Pinto Pedrosa

given: Rodrigo Pinto

name: Instituto de Medicina Integral Professor Fernando Figueira, Brazil

currency_apc_doaj: EUR

journal_name: Jornal Brasileiro de Pneumologia

oa_colors: green diamond

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: PubMed Central - Europe PMC

publisher: FapUNIFESP (SciELO)

publisher_dissemination: FapUNIFESP (SciELO)

publisher_group: FapUNIFESP (SciELO)

publisher_normalized: FapUNIFESP (SciELO)

ReferenceCitation: Borjesson M, Urhausen A, Kouidi E, Dugmore D, Sharma S, Halle M, Heidbüchel H, Björnstad HH, Gielen S, Mezzani A, Corrado D, Pelliccia A, Vanhees L. Cardiovascular evaluation of middle-aged/ senior individuals engaged in leisure-time sport activities: position stand from the sections of exercise physiology and sports cardiology of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2011 Jun;18(3):446-58. doi: 10.1097/HJR.0b013e32833bo969. Review.

family: Borjesson

full_name: M. Borjesson

given: M.

family: Urhausen

full_name: A. Urhausen

given: A.

family: Kouidi

full_name: E. Kouidi

given: E.

family: Dugmore

full_name: D. Dugmore

given: D.

family: Sharma

full_name: S. Sharma

given: S.

family: Halle

full_name: M. Halle

family: Heidbuchel

full_name: H. Heidbuchel

given: H.

family: Bjornstad

full_name: H. H. Bjornstad

given: H. H.

family: Gielen

full_name: S. Gielen

family: Mezzani

full_name: A. Mezzani

family: Corrado

full_name: D. Corrado

family: Pelliccia

full_name: A. Pelliccia

family: Vanhees

full_name: L. Vanhees

journal_name: European Journal of Cardiovascular Prevention & Rehabilitation

title: Cardiovascular evaluation of middle-aged/senior individuals engaged in leisure-time sport activities: position stand from the sections of exercise physiology and sports cardiology of the European Association of Cardiovascular Prevention and Rehabilitation


title: Impact of the Obstructive Sleep Apnea Syndrome Treatment and Ventricular Function in Heart Failure Patients Undergoing Coronary Artery Bypass Surgery or Other Coronary Reperfusion

acronym: PAC-IC-SAOS

summary: The aim of this clinical trial is to evaluate the effect of obstructive sleep apnea syndrome (OSAS) treatment in heart failure patients following coronary artery bypass graft (CABG) surgery or other coronary reperfusion.


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.

family: Gronnier

full_name: Caroline Gronnier

given: Caroline

family: Chambrier

full_name: Cécile Chambrier

given: Cécile

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Dervaux

full_name: Benoît Dervaux

family: Collet

full_name: Denis Collet

given: Denis

family: Vaudoyer

full_name: Delphine Vaudoyer

given: Delphine

family: Régimbeau

full_name: Jean-Marc Régimbeau

given: Jean-Marc

family: Jougon

full_name: Jacques Jougon

given: Jacques

family: Théréaux

full_name: Jérémie Théréaux

given: Jérémie

family: Lebreton

full_name: Gil Lebreton

given: Gil

family: Veziant

full_name: Julie Veziant

given: Julie

family: Valverde

full_name: Alain Valverde

family: Ortega-Deballon

full_name: Pablo Ortega-Deballon

given: Pablo

family: Pattou

full_name: François Pattou

given: François

family: Mathonnet

full_name: Muriel Mathonnet

given: Muriel

family: Perinel

full_name: Julie Perinel

family: Beyer-Berjot

full_name: Laura Beyer-Berjot

given: Laura

family: Fuks

full_name: David Fuks

given: David

family: Rouanet

full_name: Philippe Rouanet

given: Philippe

family: Lefevre

full_name: Jérémie H. Lefevre

given: Jérémie H.

family: Cattan

full_name: Pierre Cattan

given: Pierre

family: Deguelte

full_name: Sophie Deguelte

given: Sophie

family: Meunier

full_name: Bernard Meunier

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

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

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

evidence: oa repository (via OAI-PMH title and first author match)

repositories:
HAL
PubMed Central
Research Square
univOAK


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


type: Registry Identifier

title: Efficacy of Varenicline Associated With Intensive Counselling Versus Placebo of Varenicline Associated With Intensive Counselling on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease (COPD). A Multicenter Randomized Double-blind Trial

acronym: SAVE

summary: Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the bronchi with an increasing prevalence. By 2020, the mortality related to COPD is expected to become the 3rd leading death worldwide. COPD is caused by smoking in approximately 90 % of the cases. Nevertheless, COPD remains under-diagnosed and more than half of patients remain active smokers. Brittany is the second region of France facing an abnormal high death rate related to COPD. Smoking cessation is the most effective therapeutic approach to reduce the evolution of the disease, the frequency of the exacerbations and the the mortality. Besides, smoking cessation is associated with a reduced risk of cardiovascular events and cancer. Given the COPD patients' strong addiction, smoking cessation is not easily obtained in such population. Furthermore, smoking cessation has been underestimated in several studies. Most of these studies evaluated various methods of smoking cessation in COPD patients performed after an exacerbation, which has a hospitalization related mortality of approximately 10%. Thus, there is an urgent need to find effective pharmacotherapies to help COPD patients to cease smoking. Varenicline, a partial agonist at a4ß2 nicotinic acetylcholine receptors is reported to be one of the most effective pharmacotherapies for smoking cessation. However, it has never been evaluated at the acute phase of an exacerbation of COPD requiring hospitalization.

ReferenceCitation: Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10:CD006219. doi: 10.1002/14651858.CD006219.pub4. Review.

name: Nuffield Department of Primary Care Health Sciences; University of Oxford; Oxford UK

family: Hartmann-Boyce

full_name: Jamie Hartmann-Boyce

given: Jamie

family: Theodoulou

full_name: Annika Theodoulou

given: Annika

name: Public Health, Epidemiology and Biostatistics; University of Birmingham; Birmingham UK

family: Farley

full_name: Amanda Farley

given: Amanda

name: Wolfson Institute of Preventive Medicine; Barts & The London School of Medicine and Dentistry, Queen Mary University of London; London UK

family: Hajek

full_name: Peter Hajek

given: Peter

family: Lycett

full_name: Deborah Lycett

given: Deborah

family: Jones

full_name: Laura L Jones

given: Laura L

family: Kudlek

full_name: Laura Kudlek

family: Heath

full_name: Laura Heath

family: Hajizadeh

full_name: Anisa Hajizadeh

given: Anisa

family: Schenkels

full_name: Marika Schenkels

given: Marika

family: Aveyard

full_name: Paul Aveyard

given: Paul

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Le Mao R, Tromeur C, Paleiron N, Sanchez O, Gagnadoux F, Jouneau S, Magnan A, Hayem-Vannimenus C, Dansou A, Proust A, Dion A, Larhantec G, Brestec AL, Dewitte JD, Roche N, Leroyer C, Couturaud F. Effect of Early Initiation of Varenicline on Smoking Cessation in COPD Patients Admitted for Exacerbation: The Save Randomized Clinical Trial. COPD. 2020 Feb;17(1):7-14. doi: 10.1080/15412555.2019.1703928. Epub 2019 Dec 19.

name: Département de Médecine Vasculaire, Interne et Pneumologie, EA3878, Groupe D’Etude de la Thrombose de Bretagne Occidentale, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France;

name: Centre d’Investigation Clinique, INSERM 1412, Brest, France;

family: Le Mao

full_name: Raphael Le Mao

given: Raphael

family: Tromeur

full_name: Cécile Tromeur

given: Cécile

name: Service de Pneumologie, HIA Toulon, Toulon, France;

family: Paleiron

full_name: Nicolas Paleiron

given: Nicolas

name: Service de Pneumologie, Hôpital Européen Georges Pompidou, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, and INSERM UMR S 1140, Paris, France;

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

name: Département de Pneumologie, Angers Université Bretagne Loire, INSERM UMR 1063, Angers, France;

family: Gagnadoux

full_name: Frédéric Gagnadoux

given: Frédéric

name: Service de Pneumologie, Hôpital Pontchaillou, UMR 1085, Université de Rennes 1 (IRSET), Centre Hospitalo-Universitaire de Rennes, Rennes, France;

family: Jouneau

full_name: Stéphane Jouneau

given: Stéphane

name: CHU de Nantes, Service de Pneumologie, Institut du Thorax, INSERM, UMR1087, CNRS, UMR6291, Université de Nantes, Nantes, France;

family: Magnan

full_name: Antoine Magnan

given: Antoine

name: Service de Pneumologie, Centre Hospital-Universitaire de Lille, Lille, France;

family: Hayem-Vannimenus

full_name: Corinne Hayem-Vannimenus

given: Corinne

name: Département de Pneumologie, Université François Rabelais CEPR/INSERM UMR1100, CHU de Tours, Tours, France;

family: Dansou

full_name: Anne Dansou

given: Anne

name: Service de Pneumologie, Centre Hospitalo-Universitaire de Nîmes, France;

family: Proust

name: Service de Pharmacie Central, Centre Hospitalo-Universitaire de Brest, Brest, France;

name: Service de Pathologie Professionnelle, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France;

name: Pneumologie et Soins Intensifs Respiratoires, Groupe Hospitalier Cochin, Université Paris Descartes (EA2511), AP-HP, Paris, France

journal_name: COPD: Journal of Chronic Obstructive Pulmonary Disease

location_facility:
CHU Angers
HEGP Hospital
CHRU Lille
Pontchaillou
Hotel Dieu Hospital
Bretonneau Hospital
Saint Brieuc Hospital
Hôpital HIA Clermont Tonnerre
Laennec Hospital
Cornouaille Hospital
Caremeau Hospital
Poitiers Hospital
Cavale Blanche Hospital


title: National Follow-up of Dialysis Patients With Sodium Thiosufate-treated Calciphylaxis Under Temporary Use Authorization

summary: The national drug safety agency authorizes nominatively the use of sodium thiosulfate in dialysis patients with calciphylaxis. To date, it is the largest global cohort (more 600 patients from 2012 to 2016). We wanted to study retrospectively the fate of these patients at 6 months including mortality. Early use improves effectiveness.

time_perspective: Retrospective

ReferenceCitation: Weenig RH, Sewell LD, Davis MD, McCarthy JT, Pittelkow MR. Calciphylaxis: natural history, risk factor analysis, and outcome. J Am Acad Dermatol. 2007 Apr;56(4):569-79. Epub 2006 Dec 1.

ReferenceCitation: Perceau G. [Uraemic and non-uraemic calcific arteriopathy: The need for rapid diagnosis and therapy]. Ann Dermatol Venereol. 2015 Aug-Sep;142(8-9):506-12. doi: 10.1016/j.annder.2015.06.009. Epub 2015 Aug 5. French.

ReferenceCitation: Nigwekar SU, Brunelli SM, Meade D, Wang W, Hymes J, Lacson E Jr. Sodium thiosulfate therapy for calcific uremic arteriolopathy. Clin J Am Soc Nephrol. 2013 Jul;8(7):1162-70. doi: 10.2215/CJN.09880912. Epub 2013 Mar 21.

ReferenceCitation: Brandenburg VM, Kramann R, Rothe H, Kaesler N, Korbiel J, Specht P, Schmitz S, Krüger T, Floege J, Ketteler M. Calcific uraemic arteriolopathy (calciphylaxis): data from a large nationwide registry. Nephrol Dial Transplant. 2017 Jan 1;32(1):126-132. doi: 10.1093/ndt/gfv438.

ReferenceCitation: Sood AR, Wazny LD, Raymond CB, Leung K, Komenda P, Reslerova M, Verrelli M, Rigatto C, Sood MM. Sodium thiosulfate-based treatment in calcific uremic arteriolopathy: a consecutive case series. Clin Nephrol. 2011 Jan;75(1):8-15.

lead_sponsor: Centre Hospitalier St Esprit


title: Comparative Monocentric Randomized Study Evaluating the Satisfaction and Quality of Life of Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGRF) in Carcinomas Squamous Cells of the Head and Neck, Colorectal Cancers or Lung Cancers

acronym: CICAFIX

summary: This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary

lead_sponsor: Centre Leon Berard


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: Bevacizumab in Patients With Metastatic Renal Cell Carcinoma or Others Advanced Solid Tumors

acronym: PARASOL

summary:
This is an open-label, multicenter dose-escalation phase I study using a 3+3+3 design (i.e., 3 to 9 patients per dose level) in patients with mRCC or others advanced refractory solid tumors. Enrolment will be performed to include approximately ½ of patients with mRCC.

The primary endpoint is the occurrence of limiting toxicities leading to definitive discontinuation of the study drugs during the first 24 weeks in absence of progression of the disease.

Secondary endpoints included the occurrence of Dose Limiting Toxicities (DLTs) evaluated during the first two cycles; overall response rate, 6-months progression-free survival rate and Pharmacokinetic assessments.

ReferenceCitation: Ferrara N, Gerber HP, LeCouter J. The biology of VEGF and its receptors. Nat Med. 2003 Jun;9(6):669-76. Review.

ReferenceCitation: Dvorak HF. Vascular permeability factor/vascular endothelial growth factor: a critical cytokine in tumor angiogenesis and a potential target for diagnosis and therapy. J Clin Oncol. 2002 Nov 1;20(21):4368-80. Review.

ReferenceCitation: Kumar R, Knick VB, Rudolph SK, Johnson JH, Crosby RM, Crouthamel MC, Hopper TM, Miller CG, Harrington LE, Onori JA, Mullin RJ, Gilmer TM, Truesdale AT, Epperly AH, Boloor A, Stafford JA, Luttrell DK, Cheung M. Pharmacokinetic-pharmacodynamic correlation from mouse to human with pazopanib, a multikinase angiogenesis inhibitor with potent antitumor and antiangiogenic activity. Mol Cancer Ther. 2007 Jul;6(7):2012-21.

ReferenceCitation: Hutson TE, Davis ID, Machiels JP, De Souza PL, Rottey S, Hong BF, Epstein RJ, Baker KL, McCann L, Crofts T, Pandite L, Figlin RA. Efficacy and safety of pazopanib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2010 Jan 20;28(3):475-80. doi: 10.1200/JCO.2008.21.6994. Epub 2009 Dec 14.

ReferenceCitation: Escudier B, Pluzanska A, Koralewski P, Ravaud A, Bracarda S, Szczylik C, Chevreau C, Filipek M, Melichar B, Bajetta E, Gorbunova V, Bay JO, Bodrogi I, Jagiello-Gruszfeld A, Moore N; AVOREN Trial investigators. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007 Dec 22;370(9605):2103-11.

ReferenceCitation: Rini BI, Halabi S, Rosenberg JE, Stadler WM, Vaena DA, Ou SS, Archer L, Atkins JN, Picus J, Czaykowski P, Dutcher J, Small EJ. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. J Clin Oncol. 2008 Nov 20;26(33):5422-8. doi: 10.1200/JCO.2008.16.9847. Epub 2008 Oct 20.

ReferenceCitation: Belot A, Grosclaude P, Bossard N, Jougla E, Benhamou E, Delafosse P, Guizard AV, Molinié F, Danzon A, Bara S, Bouvier AM, Trétarre B, Binder-Foucard F, Colonna M, Daubisse L, Hédelin G, Launoy G, Le Stang N, Maynadié M, Monnereau A, Troussard X, Faivre J, Collignon A, Janoray I, Arveux P, Buemi A, Raverdy N, Schvartz C, Bovet M, Chérié-Challine L, Estève J, Remontet L, Velten M. Cancer incidence and mortality in France over the period 1980-2005. Rev Epidemiol Sante Publique. 2008 Jun;56(3):159-175. doi: 10.1016/j.respe.2008.03.117. Epub 2008 Jun 10.

ReferenceCitation: Remontet L, Estève J, Bouvier AM, Grosclaude P, Launoy G, Menegoz F, Exbrayat C, Tretare B, Carli PM, Guizard AV, Troussard X, Bercelli P, Colonna M, Halna JM, Hedelin G, Macé-Lesec'h J, Peng J, Buemi A, Velten M, Jougla E, Arveux P, Le Bodic L, Michel E, Sauvage M, Schvartz C, Faivre J. Cancer incidence and mortality in France over the period 1978-2000. Rev Epidemiol Sante Publique. 2003 Feb;51(1 Pt 1):3-30.

ReferenceCitation: Diaz JI, Mora LB, Hakam A. The Mainz Classification of Renal Cell Tumors. Cancer Control. 1999 Nov;6(6):571-579.

ReferenceCitation: Nelson EC, Evans CP, Lara PN Jr. Renal cell carcinoma: current status and emerging therapies. Cancer Treat Rev. 2007 May;33(3):299-313. Epub 2007 Feb 27. Review.

ReferenceCitation: Lam JS, Belldegrun AS, Pantuck AJ. Long-term outcomes of the surgical management of renal cell carcinoma. World J Urol. 2006 Aug;24(3):255-66. Epub 2006 Feb 15. Review.

ReferenceCitation: Mickisch G, Carballido J, Hellsten S, Schulze H, Mensink H; European Association of Urology. Guidelines on renal cell cancer. Eur Urol. 2001 Sep;40(3):252-5.

ReferenceCitation: Yagoda A, Abi-Rached B, Petrylak D. Chemotherapy for advanced renal-cell carcinoma: 1983-1993. Semin Oncol. 1995 Feb;22(1):42-60. Review.

ReferenceCitation: Negrier S, Perol D, Ravaud A, Chevreau C, Bay JO, Delva R, Sevin E, Caty A, Escudier B; French Immunotherapy Intergroup. Medroxyprogesterone, interferon alfa-2a, interleukin 2, or combination of both cytokines in patients with metastatic renal carcinoma of intermediate prognosis: results of a randomized controlled trial. Cancer. 2007 Dec 1;110(11):2468-77.

ReferenceCitation: Négrier S, Perol D, Ravaud A, Bay JO, Oudard S, Chabaud S, Fargeot P, Delva R, Deplanque G, Gravis G, Escudier B; French Immunotherapy Group. Randomized study of intravenous versus subcutaneous interleukin-2, and IFNalpha in patients with good prognosis metastatic renal cancer. Clin Cancer Res. 2008 Sep 15;14(18):5907-12. doi: 10.1158/1078-0432.CCR-08-0236.

ReferenceCitation: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203.

ReferenceCitation: Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, Negrier S, Szczylik C, Pili R, Bjarnason GA, Garcia-del-Muro X, Sosman JA, Solska E, Wilding G, Thompson JA, Kim ST, Chen I, Huang X, Figlin RA. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009 Aug 1;27(22):3584-90. doi: 10.1200/JCO.2008.20.1293. Epub 2009 Jun 1.

ReferenceCitation: Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I, Kovacevic Z, Lesovoy V, Schmidt-Wolf IG, Barbarash O, Gokmen E, O'Toole T, Lustgarten S, Moore L, Motzer RJ; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007 May 31;356(22):2271-81.

ReferenceCitation: Ellis LM, Hicklin DJ. VEGF-targeted therapy: mechanisms of anti-tumour activity. Nat Rev Cancer. 2008 Aug;8(8):579-91. doi: 10.1038/nrc2403. Epub 2008 Jul 3. Review.

ReferenceCitation: Azad NS, Posadas EM, Kwitkowski VE, Steinberg SM, Jain L, Annunziata CM, Minasian L, Sarosy G, Kotz HL, Premkumar A, Cao L, McNally D, Chow C, Chen HX, Wright JJ, Figg WD, Kohn EC. Combination targeted therapy with sorafenib and bevacizumab results in enhanced toxicity and antitumor activity. J Clin Oncol. 2008 Aug 1;26(22):3709-14. doi: 10.1200/JCO.2007.10.8332. Erratum in: J Clin Oncol. 2008 Sep 10;26(26):4363. Figg, William D [added].

ReferenceCitation: Rini BI, Garcia JA, Cooney MM, Elson P, Tyler A, Beatty K, Bokar J, Mekhail T, Bukowski RM, Budd GT, Triozzi P, Borden E, Ivy P, Chen HX, Dolwati A, Dreicer R. A phase I study of sunitinib plus bevacizumab in advanced solid tumors. Clin Cancer Res. 2009 Oct 1;15(19):6277-83. doi: 10.1158/1078-0432.CCR-09-0717. Epub 2009 Sep 22.

ReferenceCitation: Feldman DR, Baum MS, Ginsberg MS, Hassoun H, Flombaum CD, Velasco S, Fischer P, Ronnen E, Ishill N, Patil S, Motzer RJ. Phase I trial of bevacizumab plus escalated doses of sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009 Mar 20;27(9):1432-9. doi: 10.1200/JCO.2008.19.0108. Epub 2009 Feb 17.

ReferenceCitation: Katavetin P, Katavetin P. VEGF inhibition and renal thrombotic microangiopathy. N Engl J Med. 2008 Jul 10;359(2):205-6; author reply 206-7. doi: 10.1056/NEJMc080770.

ReferenceCitation: Ratain MJ, Sargent DJ. Optimising the design of phase II oncology trials: the importance of randomisation. Eur J Cancer. 2009 Jan;45(2):275-80. doi: 10.1016/j.ejca.2008.10.029. Epub 2008 Dec 6.

ReferenceCitation: Motzer RJ, Bacik J, Murphy BA, Russo P, Mazumdar M. Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol. 2002 Jan 1;20(1):289-96.

ReferenceCitation: Coppin C, Porzsolt F, Awa A, Kumpf J, Coldman A, Wilt T. Immunotherapy for advanced renal cell cancer. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD001425. Review. Update in: Cochrane Database Syst Rev. 2015;12:CD001425.

ReferenceCitation: Coppin C, Le L, Porzsolt F, Wilt T. Targeted therapy for advanced renal cell carcinoma. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD006017. doi: 10.1002/14651858.CD006017.pub2. Review.

ReferenceCitation: Négrier S, Pérol D, Bahleda R, Hollebecque A, Chatelut E, Boyle H, Cassier P, Metzger S, Blanc E, Soria JC, Escudier B. Phase I dose-escalation study of pazopanib combined with bevacizumab in patients with metastatic renal cell carcinoma or other advanced tumors. BMC Cancer. 2017 Aug 15;17(1):547. doi: 10.1186/s12885-017-3527-7.

family: Négrier

full_name: Sylvie Négrier

given: Sylvie

family: Pérol

full_name: David Pérol

given: David

family: Bahleda

full_name: Rastislav Bahleda

given: Rastislav

family: Hollebecque

full_name: Antoine Hollebecque

family: Chatelut

full_name: Etienne Chatelut

given: Etienne

family: Boyle

full_name: Helen Boyle

given: Helen

family: Cassier

full_name: Philippe Cassier

given: Philippe

family: Metzger

full_name: Séverine Metzger

given: Séverine

family: Blanc

full_name: Ellen Blanc

given: Ellen

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

family: Escudier

full_name: Bernard Escudier

given: Bernard

journal_name: BMC Cancer

ReferenceCitation: Imbs DC, Négrier S, Cassier P, Hollebecque A, Varga A, Blanc E, Lafont T, Escudier B, Soria JC, Pérol D, Chatelut E. Pharmacokinetics of pazopanib administered in combination with bevacizumab. Cancer Chemother Pharmacol. 2014 Jun;73(6):1189-96. doi: 10.1007/s00280-014-2455-3. Epub 2014 Apr 6.


title: Vision II: Non Randomized French Evaluation of GALILEO Intravascular Radiotherapy System in Patients With de Novo Coronary Arteries Lesions by Restenosis on Angioplasty or Restenosis on Endoprosthesis

summary: To assess the safety and effectiveness of intravascular brachytherapy for the treatment of intrastent restenosis of coronary lesions with the Galileo system

lead_sponsor: Abbott Medical Devices


title: Study of the Effect of the Food Supplement PERMEAPROTECT on the Quality of Life of Patients With Fibromyalgia (a Pilot, Double-blind, Randomized, Placebo-controlled Study)

summary:
Fibromyalgia is a medical disorder characterized by chronic widespread pain, and a heightened and painful response to pressure. Fibromyalgia symptoms are not restricted to pain, leading to the use of the alternative term fibromyalgia syndrome for the condition. Other symptoms include functional gastrointestinal pain and discomfort.

The origin of these symptoms is not yet known, and a few hypotheses have been stated. One of the supposed mechanisms that may lead to gastrointestinal hypersensitivity is a chronic, low-grade, intestinal inflammation due to an increased intestinal permeability.

In this study, we hypothesise that the food supplement PERMEAPROTECT (that contains, amongst other nutrients, glutamine and curcumin) contributes to reducing the intestinal permeability and low-grade inflammation, thus improving gastrointestinal quality of life.

lead_sponsor: Lescuyer Laboratory

location_facility: Unité de Recherche Clinique en Immunologie de Lyon Sud

intervention_type: Dietary Supplement


title: BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions

acronym: BATTLE

summary:
Over the past years, endovascular interventions have become an important part of treatment in patients with peripheral arterial disease.1 Indication for endovascular repair of femoropopliteal lesions has been considerably enlarged as shown in the TASC classification.1 Enlargement of endovascular therapy indication was based on patient choice for a less invasive technique and evidence based medicine. Consequently, TASC classification of lesions has been modified to reflect increased evidence for endovascular treatment of more extensive femoropopliteal lesions, and indication for endovascular repair has been enlarged to more severe TASC types. In summary, endovascular treatment is indicated for TASC A and B lesions which correspond to femoropopliteal lesions ≤15-cm. To treat these lesions, the interventionalists have at their disposal a huge tool box. Evaluation of these tools is crucial to determine the right treatment strategy to avoid further reinterventions and overcosts.

The objective of the BATTLE trial is to compare a bare metal self expandable nitinol stent (Misago RX) versus a paclitaxel eluting stent (Zilver PTX) in the treatment of above-the-knee intermediate length femoropopliteal lesions.

From hospitals in Europe (France, Switzerland) we will randomly assign patients with symptomatic atherosclerotic femoropopliteal lesions to be treated either by bare metal stent or paclitaxel eluting stent. In total, 186 patients will be randomized (93 per group).

primary_purpose: Health Services Research

ReferenceCitation: Gouëffic Y, Kaladji A, Guyomarch B, Montagne C, Fairier D, Gestin S, Riche VP, Vent PA, Chaillou P, Costargent A, Patra P. Bare metal stent versus paclitaxel eluting stent for intermediate length femoropopliteal arterial lesions (BATTLE trial): study protocol for a randomized controlled trial. Trials. 2014 Oct 30;15:423. doi: 10.1186/1745-6215-15-423.

family: Gouëffic

full_name: Yann Gouëffic

given: Yann

family: Kaladji

full_name: Adrien Kaladji

given: Adrien

family: Guyomarch

full_name: Béatrice Guyomarch

given: Béatrice

family: Montagne

full_name: Carine Montagne

given: Carine

family: Fairier

full_name: Damien Fairier

given: Damien

family: Gestin

full_name: Simon Gestin

given: Simon

family: Riche

full_name: Valéry-Pierre Riche

given: Valéry-Pierre

family: Vent

full_name: Pierre Alexandre Vent

given: Pierre Alexandre

family: Chaillou

full_name: Philippe Chaillou

family: Costargent

full_name: Alain Costargent

given: Alain

family: Patra

full_name: Philippe Patra

journal_name: Trials

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Nantes University Hospital

location_facility: Centre Hospitalier Pierre Oudot Bourgoin Jallieu


title: Understanding and Modelling Reservoirs, Vehicles and Transmission of ESBL-producing Enterobacteriaceae in the Community and Long Term Care Facilities

acronym: MODERN

summary: The continuing spread of extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE) is among the most important problems in antimicrobial resistance. It is also a good model to investigate the epidemiological complexity of resistance in Enterobacteriaceae. Available data on the transmission determinants of ESBL-PE in community settings are scarce, methodologically limited and mostly based on single centre studies. A comprehensive investigation using present typing and modelling techniques is warranted to develop a sound quantitative understanding of the interactions involved. A consortium of investigators with diverse expertise from countries with high and low endemicity of ESBL-EP has been created. Transmission and persistence of ESBL-PE within households and long-term care facilities will be studied. Individual and group-level determinants for transmission and persistence will be quantified, together with other ecological variables including environmental, food and wastewater contamination. Advanced molecular typing techniques and state of the art analytical methods will be used. Data generated in this project will directly inform a suite of mathematical models which, in addition to encapsulating current understanding of the processes, will be used to explore the potential effectiveness of different interventions to control ESBL-PE spread. The expected outputs are a comprehensive characterisation of ESBL-PE transmission considering bacterial clones and mobile genetic elements, as well as individual and ecologic-level factors in different settings, to inform public health authorities about interventions that should be prioritised to control transmission of these organisms.

status: Enrolling by invitation