title: Efficacy and Safety of Radiofrequency Ablation Under Endoscopic Ultrasonography Guidance in Pancreatic Neuroendocrine and Cystic Tumor

summary:
Advances in conventional imaging (abdominal ultrasound, CT scan, MRI) are so great that chance to discover a incidental solid or cystic pancreatic lesion is becoming usual. Endocrine tumors have variable malignant potential depending on their size, some malignancy for lesions larger than 2 cm and indefinite for a smaller size. The branch-duct like IPMN (intraductal papillary mucinous pancreatic tumor) involving the pancreatic secondary ducts represent half of pancreatic cystic tumors and may degenerate into 5 to 10% of cases. Signs and risk of degeneration are the presence of mural nodules greater than 5 mm and size > 3 cm, although the latter criterion is discussed. Mucinous cystadenomas could degenerate between 30 and 50% of cases even though the role of size is much discussed (<4 cm). The follow-up imaging is performed using MRI and endoscopic ultrasonography (EUS). A fine needle aspiration for cytology and histology is possible and determination of biological markers is useful. But cytology is often unprofitable due to the poor cellular profile of the cystic pancreatic tumor. Once the diagnosis of suspected malignancy, the patient should be referred to the surgeon for pancreatic resection more or less extensive. But this attitude is facing a significant operative risk with up to 30% of morbidity and mortality between 1 and 3 % for cephalic resections. Some patients with high post operative risks are inoperable. For these reasons, some teams have proposed the destruction of the walls of the cyst under EUS, US or CT control by washing with absolute alcohol content of cystic tumor.

An interesting alternative endoscopic destruction would be the use of radio frequency ablation technique (RFA). RFA is a recognized technique for local tumor destruction by delivering thermal energy to obtain coagulation necrosis of the lesion. Taewong Medical ™ recently developed a radiofrequency needle EUSRA® coupled with a combo VIVA ™ generator for applying RFA sub EUS control. But no prospective study is available at this date regarding the treatment of the cystic or solid tumoral pancreatic lesion with this technique. The primary endpoint of the present study is to investigate the feasibility and safety of this guided radiofrequency probe EUS for the treatment of pancreatic endocrine tumors or inoperable pancreatic cystic tumors. The secondary objective will be the efficiency.

ReferenceCitation: Barthet M, Giovannini M, Lesavre N, Boustiere C, Napoleon B, Koch S, Gasmi M, Vanbiervliet G, Gonzalez JM. Endoscopic ultrasound-guided radiofrequency ablation for pancreatic neuroendocrine tumors and pancreatic cystic neoplasms: a prospective multicenter study. Endoscopy. 2019 Sep;51(9):836-842. doi: 10.1055/a-0824-7067. Epub 2019 Jan 22.

name: Aix Marseille Université, Service de Gastro-entérologie, Hôpital Nord, Marseille, France

family: Barthet

full_name: Marc Barthet

given: Marc

name: Endoscopy Unit, Institut Paoli Calmettes, Marseille, France

family: Giovannini

full_name: Marc Giovannini

name: Centre d’Investigation Clinique, Hôpital Nord, Marseille, France

family: Lesavre

full_name: Nathalie Lesavre

given: Nathalie

name: Service d’Hépato-gastroentérologie, Hôpital Saint-Joseph, Marseille, France

family: Boustiere

full_name: Christian Boustiere

given: Christian

name: Hôpital privé Jean Mermoz, Ramsay Générale de Santé, Lyon, France

family: Napoleon

full_name: Bertrand Napoleon

given: Bertrand

name: Department of Gastroenterology, CHRU Minjoz, Besançon, France

family: Koch

full_name: Stéphane Koch

given: Stéphane

family: Gasmi

full_name: Mohamed Gasmi

given: Mohamed

name: Centre Hospitalier Universitaire de Nice, Hôpital L’Archet 2, Nice, France

family: Vanbiervliet

full_name: Geoffroy Vanbiervliet

given: Geoffroy

family: Gonzalez

full_name: Jean-Michel Gonzalez

given: Jean-Michel

journal_name: Endoscopy

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

lead_sponsor: Société Française d'Endoscopie Digestive


title: Acute Heart Graft Rejection Screening by Cardiac Magnetic Resonance Imaging

acronym: DRAGON

summary: Acute heart allograft rejection is a common complication after orthotopic heart transplantation. Primary objective of this study is to assess cardiac MRI as a tool for acute heart graft rejection screening, by detecting changes in myocardium structure especially extracellular volume.

status: Withdrawn

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Screening

enrollment_type: Actual

lead_sponsor: University Hospital, Rouen

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


title: Study About Contamination of Ovarian Tissue by RT-PCR in Children With Solid Tumors.

acronym: OVAMAR

summary: For prepubertal patients, cryopreservation of ovarian tissue is the only option available to preserve their fertility before cancer treatment. But ovarian autograft raises the issue of the risk of reintroduction of potentially malignant cells. The aim of our study is to develop a specific and sensitive method for residual disease detection in the ovarian tissue from patients treated for a solid tumor during infancy, whose fertility may have been compromised by treatments and who benefited of ovarian tissue cryopreservation.

status: Unknown status

study_type: Observational

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Other


title: Prospective Evaluation of Neuropsychological and Clinical Impact of Cognitive Remediation Program Among Children and Adolescents Treated for Anorexia Nervosa

acronym: RECOGAMEA

summary: The aim of research is to test in a randomized clinical trial with active sessions, the efficacy of cognitive remediation therapy in children anorexia nervosa compared to a controlled group. The investigators want to confirm the efficacy of cognitive remediation treatment in children's flexibility problems.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris

status_simplified: Completed


title: Prevention of Ventilator Associated Pneumonia With Toothbrushing in Oral Care of Critically Ill Mechanically Ventilated Patients

summary: Effect of toothbrushing in oral care of mechanically ventilated critically ill patients on prevention of ventilator associated pneumonia

time_perspective: Cross-Sectional

ReferenceType: derived

ReferenceCitation: Ory J, Mourgues C, Raybaud E, Chabanne R, Jourdy JC, Belard F, Guérin R, Cosserant B, Faure JS, Calvet L, Pereira B, Guelon D, Traore O, Gerbaud L. Cost assessment of a new oral care program in the intensive care unit to prevent ventilator-associated pneumonia. Clin Oral Investig. 2018 Jun;22(5):1945-1951. doi: 10.1007/s00784-017-2289-6. Epub 2017 Nov 30.

family: Ory

full_name: Jérôme Ory

given: Jérôme

sequence: first

family: Mourgues

full_name: Charline Mourgues

given: Charline

sequence: additional

family: Raybaud

full_name: Evelyne Raybaud

given: Evelyne

family: Chabanne

full_name: Russell Chabanne

given: Russell

family: Jourdy

full_name: Jean Christophe Jourdy

given: Jean Christophe

family: Belard

full_name: Fabien Belard

given: Fabien

family: Guérin

full_name: Renaud Guérin

given: Renaud

family: Cosserant

full_name: Bernard Cosserant

given: Bernard

family: Faure

full_name: Jean Sébastien Faure

given: Jean Sébastien

family: Calvet

full_name: Laure Calvet

given: Laure

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Guelon

full_name: Dominique Guelon

given: Dominique

family: Traore

full_name: Ousmane Traore

given: Ousmane

family: Gerbaud

full_name: Laurent Gerbaud

given: Laurent

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Oral Investigations

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


intervention_type: Drug

lead_sponsor: Rennes University Hospital

acronym: DEXA OP

type: EudraCT Number

type: Other Identifier

source: euctr

title: Dexamethasone, Can it Replace Ketoprofen in the Strategy of Intraoperative Multimodal Analgesia in Paediatric Surgery ? A Prospective Randomized Double-blinded Study. DEXA OP

summary:
Postoperative pain and nausea-vomiting (PONV) are the first causes of failure in ambulatory care in pediatric surgery. Actually, the paracetamol/ketoprofen combination in intraoperative care is recommended for effective postoperative analgesia in children. However, intravenous ketoprofen doesn't have the marketing authorization for use in children less than 15 years old and its use is mainly justified by the absence of therapeutic alternatives. Recently, findings from published studies suggest that dexamethasone (DXM), which is actually recommended to prevent PONV for children "at risk", at a dose of 0.1mg/kg, would have analgesic properties above 0.15 mg/kg comparable to non-steroidal anti-inflammatories (NSAI).

Main objective :

To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) on the intensity of postoperative pain in the post-anaesthetic care unit (PACU) compared to ketoprofen (1mg/kg).

Secondary objectives :

To examine the effects of intraoperative DXM (0.2mg/kg and 0.4mg/kg) compared to ketoprofen (1mg/kg) on the anesthesia emergence delirium, the intensity of postoperative pain, the consumption of rescue analgesics and the side effects in the first 24 hours after surgery.


title: Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis: Analysis of Phonatory and Ventilatory Results

acronym: SEQLAR

summary:
Selective laryngeal bilateral reinnervation as a secondary treatment in patients with bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids ankylosis.

The surgical procedure is : functional reinnervation with the upper root of one phrenic nerve, is used for reinnervation of both cricoarytenoid muscles (laryngeal inspiratory muscles), and simultaneous reinnervation of adductor laryngeal muscles is performed by right and left thyro -hyoid nerves (coming from the hypoglossi) on both sides.

Results are obtained after 6 to 9 months delay. In case of good inspiratory arytenoid abduction, and residual dysphonia, a secondary vocal fold medialization is done by an endoscopic approach 12 months after reinnervation (included in the protocol).

Improvement is expected in voice and breathing, without aspiration.


title: Pilot Randomized Double Blind, Placebo Controlled Trial of the Efficacy of Simvastatin for Smoking Cessation

acronym: ADDICSTATINE

summary:
Tobacco smoking is the number one preventable cause of disease worldwide. Unfortunately, there are few smoking cessation agents and their effectiveness has been shown to be relatively limited and is associated with potential unwanted effects. Therefore, the discovery of new medications that can facilitate abstinence and reduce relapse to cigarette use represents a pressing necessity. In the attempt to find molecules that could reduce drug-seeking behavior, we discovered that simvastatin reduces cocaine and nicotine, but not food, seeking behavior in rats. This discovery of a new therapeutic application for an already marketed class of compounds may greatly facilitate the translation from preclinical to clinical setting. In this project, we aim at investigating whether simvastatin is an effective smoking cessation agent in humans.

The study design is a multicenter, randomized, double blind 2 parallel groups, clinical trial with an intention-to-treat analysis. Smokers will randomly be assigned to receive simvastatin or placebo for 3 months. 200 smokers (100 receiving simvastatin and 100 receiving placebo) will be recruited through already established networks of general practitioners. The primary outcome of the efficacy of simvastatin will be the rate of smoking abstinence during the last month of the 3-month treatment period, defined as reported continuous abstinence from smoking and confirmed by expired air carbon monoxide and urinary cotinine concentration. The last assessment will be done 6 months after the predefined quit date.

The results of this proof-of-concept study may open new perspectives in the treatment of tobacco use and dependance.

lead_sponsor: Poitiers University Hospital


title: Follow-up of Oncology Patients After Hospitalization in ICU

acronym: SALTO

summary:
"Purpose: The overall prognosis of oncology patients admitted to intensive care has improved greatly in recent years, leading to a wider admission policy. Due to a decrease in mortality in intensive care, more and more patients returning oncological circuit for the continuation of treatment of the underlying disease The existence of sequelae after the ICU (Intensive Care Unit) stay, whether renal, cardiac, respiratory or other, may influence the continuation of the optimal anti -cancer treatments and thus reduce the chances of recovery or evolution without tumor progression. However, no studies have evaluated the effects of resuscitation on subsequent cancer treatment strategies. It would thus become better appreciate the long-term oncology patients discharged alive from the hospital after a stay in intensive care.

Main purpose of research :

Assess the feasibility of a anti-tumor therapy for patients with progressive solid tumors, after an intensive care stay for other reason than elective surgery monitoring or securing an invasive procedure. The possibility of making an anti -cancer treatment will be evaluated by the treating oncologist and classified total, partial or absent from that defined before or during the ICU stay

Secondary objective of the research :

Evaluate the percentage of patients discharged alive from the ICU and dying in the hospital.

Evaluate survival, lifestyle and physical and psychological effects of these patients after discharge from the hospital over a period of one year. It is understood that all these secondary endpoints will interfere with the existence of an evolutionary neoplasia not only with the ICU stay. They will therefore be interpreted with caution.

Study Type: observational Study Design: Prognostic study of routine care, national, prospective, cohort type "

time_perspective: Prospective


title: Intérêt du TFP (Transversalis Fascia Plane) Bloc échoguidé Pour l'analgésie du prélèvement Osseux de crête Iliaque

acronym: TFP

summary:
Iliac crest bone graft harvest is associated with acute pain that can lead to chronic postoperative pain. Local anesthetic infiltration and regional anesthesia could be of interest to reduce opioid consumption during and after surgery, reduce hyperalgesia and the associated risk of chronic postoperative pain. In this surgery, local anesthetic infiltration of the iliac crest is associated with a pain reduction compare with placebo.

Some studies have shown the benefit of a TAP (transversus abdominal block) for postoperative analgesia after iliac crest bone graft harvest. The TFP block (transversalis fascia plane block) has been recently described. Considering the nerves trajectories, the TFP block is probably anatomically the most appropriate block for analgesia after iliac crest bone graft harvest.

The aim of this study is therefore to assess the benefit of an ultrasound TFP block for analgesia after iliac crest bone graft harvest compare with local anesthetic infiltration Design is prospective, randomized, double blind, controlled study


type: Registry Identifier

title: Analysis of Cerebral Spinal Fluid and Plasma After Aneurysmal Subarachnoid Hemorrhage by Evaluating a Metabolomic Profile and the Proteasic Activity as Biomarkers for Early Detection of Arterial Vasospasm

summary:
The subarachnoid hemorrhage (SAH) from ruptured aneurysm is a situation that is life-threatening, which is largely dependent on the occurrence of vasospasm from the 4th day after the bleeding. This vasopasm is responsible of clinical morbidity in 30 to 50% of patients. It occurs in 40% of patients with severe SAH.

Despite knowing this, the clinician has no biomarker for identifying patients at risk.

The project presented is original and includes a screening method without a priori to identify predictive biomarkers of vasospasm, likely to become therapeutic targets. In secondary objective we will focus on the protease activity of cerebrospinal fluid (CSF) and blood as a biomarker potential of vasoconstriction at the waning of subarachnoid hemorrhage.

This study will take place over a year prospectively. The inclusion of patients will be in the SAR 1 Hospital of Timone. Patients with severe severe SAH by rupture requiring the establishment of an external ventricular derivation (EVD) will be divided into two groups and compared to one group of patients without necessitating a EVD subarachnoid hemorrhage.

Group 1: Patients with vasopasm
Group 2: Patient presenting no vasopasm Detection of vasopasm was defined using a consensual definition. CSF samples (through EVD) and blood will be made upon arrival of the patient in intensive care and then between the 3rd and 4th day.

As the main criterion, we will identify biomarkers of vasospasm in blood and CSF without a priori assumption by metabolomics. Analysis will be by chromatography system coupled to a high resolution mass spectrometer. This method does not justify effective calculation because it is a step of generating hypotheses requiring further biological validation based on the identified targets.

The secondary criteria, we will study in the blood and CSF association between matrix metalloproteinases (MMP) 2 and 9 and the occurrence of vasopasm.

RESULTS: After comparative analysis of groups 1 and 2 in two phases of the study, we will define a metabolic profile that could identify predictive biomarkers vasopasm.

primary_purpose: Diagnostic

ReferenceCitation: Triglia T, Mezzapesa A, Martin JC, Verdier M, Lagier D, Dufour H, Bruder N, Alessi MC, Velly LJ. Early matrix metalloproteinase-9 concentration in the first 48 h after aneurysmal subarachnoid haemorrhage predicts delayed cerebral ischaemia: An observational study. Eur J Anaesthesiol. 2016 Sep;33(9):662-9. doi: 10.1097/EJA.0000000000000494.

family: Triglia

full_name: Thibaut Triglia

given: Thibaut

family: Mezzapesa

full_name: Anna Mezzapesa

given: Anna

family: Martin

full_name: Jean Charles Martin

given: Jean Charles

family: Verdier

full_name: Monique Verdier

given: Monique

family: Lagier

full_name: David Lagier

given: David

family: Dufour

full_name: Henry Dufour

given: Henry

family: Bruder

full_name: Nicolas Bruder

given: Nicolas

family: Alessi

full_name: Marie-Christine Alessi

given: Marie-Christine

family: Velly

full_name: Lionel J. Velly

given: Lionel J.

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpiital de la TIMONE ASSISTANCE PUBLIQUE HOPITAUX de MARSEILLE


title: PET/CT Molecular Imaging of Angiogenesis in Pulmonary or Head and Neck Cancers Prior to or During Chemotherapy Including Agent With Antiangiogenic Effect. A Prospective Multicentric Study of Efficacy and Tolerability.

acronym: MLAPOCHI

summary:
The primary objective of this Phase II study is to evaluate the use of labelled RGD ligand in PET/CT to predict and/or to early assess the efficacy of chemotherapy including an agent with antiangiogenic effect.

The predictive value of this approach will be determined by independent assessors on basis of data at the end of the treatment: RECIST 1.1 criteria for CT or MRI, PERCIST criteria for FDG PET/CT, clinical, endoscopic and histological findings.

status: Suspended

location_facility: Hôpital Tenon - Assistance Publique-Hôpitaux de Paris


title: Search for the Measles Vaccine Virus Excretion in Breast Milk of Breastfeeding Women After Postpartum Vaccination With a Combined Measles-mumps-rubella (MMR) Vaccine

acronym: BREMEAVAC

summary: In order to assess the safety of breastfed infants after their mother's postpartum immunization with a combined measles-mumps-rubella (MMR) vaccine, the purpose of this study is to investigate whether measles vaccine strain is excreted in breast milk of breastfeeding women with negative rubella and measles serologies.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Alain S, Dommergues MA, Jacquard AC, Caulin E, Launay O. State of the art: Could nursing mothers be vaccinated with attenuated live virus vaccine? Vaccine. 2012 Jul 13;30(33):4921-6. doi: 10.1016/j.vaccine.2012.05.047. Epub 2012 May 31. Review.

ReferenceCitation: Chen LH, Zeind C, Mackell S, LaPointe T, Mutsch M, Wilson ME. Yellow fever virus transmission via breastfeeding: follow-up to the paper on breastfeeding travelers. J Travel Med. 2010 Jul-Aug;17(4):286-7. doi: 10.1111/j.1708-8305.2010.00430.x.

ReferenceCitation: Losonsky GA, Fishaut JM, Strussenberg J, Ogra PL. Effect of immunization against rubella on lactation products. I. Development and characterization of specific immunologic reactivity in breast milk. J Infect Dis. 1982 May;145(5):654-60.

ReferenceCitation: Losonsky GA, Fishaut JM, Strussenberg J, Ogra PL. Effect of immunization against rubella on lactation products. II. Maternal-neonatal interactions. J Infect Dis. 1982 May;145(5):661-6.

location_facility: Cochin Port Royal Hospital - Centre d'Investigation Clinique Cochin-Pasteur

intervention_type: Biological


title: Prospective Study Evaluating the Clinical Impact of the Breast Cancer Intrinsic Subtype-Prosigna Test (Assay) in the Management of Early-stage Breast Cancers

summary: The primary objective of this study is to evaluate the impact of the result of the Prosigna Test (assay) on the therapeutic decision of adjuvant therapy (chemotherapy and hormone therapy) in patients suffering from early-stage breast cancer.

ipd_sharing: No

lead_sponsor: NanoString Technologies, Inc.

lead_sponsor_type: industriel


title: Full Field Optical Coherence Tomography of Prostate Biopsies for the Diagnosis of Prostate Cancer

summary:
Primary objective :

The primary objective is to evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation.

Secondary objective:

Evaluate predictive values of FFOCT for cancer detection on prostate biopsy cores
Evaluate the value of FFOCT for cancer characterization on prostate biopsy cores
Evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores
Evaluate the learning curve of FFOCT evaluation on prostate biopsy cores
Evaluate FFOCT procedure time

location_facility: Assistance Publique - Hôpitaux de Paris Cochin Hospital


type: Other Grant/Funding Number

title: A Randomised Controlled Multicenter Trial Evaluating the Efficacy of Acupuncture Versus Placebo on the Caesarean Section Rate in Case of Cervical Dystocia in Full-term Pregnancy

acronym: ACUCESAR

summary:
The principal objective of the trial is to demonstrate that acupuncture could reduce the caesarean section rate for cervical dystocia.

Secondary objectives:

To demonstrate that acupuncture can:

reduce morbidity, fetal mortality and duration of childbirth;
reduce the cost of care, due to diminution of caesarean sections and duration of obstetric labor;
to evaluate the tolerance.

status: Terminated

location_facility: Department of Obstetrics, Hôpital Saint-Cloud

intervention_type: Device


title: Functional MRI Study of the Involvement of Cortico-cerebellar and Cortico-striatal Networks in Children With a Developmental Coordination Disorder (DCD) and/or Developmental Dyslexia (DD)

acronym: FMRI-DCD-DD

summary: All the studies underlined the high frequency of co-morbid associations in specific learning disorders. Understanding the reasons for these associations could enable us to determine the cerebral bases that underlie each disorder. Their frequent association suggests the etiological bases are partly common, it seems logical to turn to explanatory models of various common specific disorders. The model recently proposed by Nicholson & Fawcett (2007) suggests a specific disorder of procedural learning. But the brain networks involved in this learning could be achieved separately. We intend therefore to study the neural networks involved in learning procedural and compare networks recruited among children with specific learning disorder alone or in combination (co-morbidity). The children included in the study have either a Developmental Dyslexia or a Developmental Coordination Disorder, or both. The procedure includes a neuropsychological evaluation and a brain MRI study with a morphological and a functional part. During fMRI the child realizes a automated motor task contrasting with a task involving learning procedural.

primary_purpose: Other

ReferenceType: result

ReferenceCitation: Biotteau M, Péran P, Vayssière N, Tallet J, Albaret JM, Chaix Y. Neural changes associated to procedural learning and automatization process in Developmental Coordination Disorder and/or Developmental Dyslexia. Eur J Paediatr Neurol. 2017 Mar;21(2):286-299. doi: 10.1016/j.ejpn.2016.07.025. Epub 2016 Aug 12.

family: Biotteau

full_name: Maëlle Biotteau

given: Maëlle

family: Péran

full_name: Patrice Péran

given: Patrice

family: Vayssière

full_name: Nathalie Vayssière

given: Nathalie

family: Tallet

full_name: Jessica Tallet

given: Jessica

family: Albaret

full_name: Jean-Michel Albaret

given: Jean-Michel

family: Chaix

full_name: Yves Chaix

given: Yves

journal_name: European Journal of Paediatric Neurology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Biotteau M, Albaret JM, Lelong S, Chaix Y. Neuropsychological status of French children with developmental dyslexia and/or developmental coordination disorder: Are both necessarily worse than one? Child Neuropsychol. 2017 May;23(4):422-441. doi: 10.1080/09297049.2015.1127339. Epub 2016 Jan 4.

family: Lelong

full_name: Sandrine Lelong

given: Sandrine

bso_classification: Biology (fond.)

journal_name: Child Neuropsychology

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: University Hospital, Toulouse


title: Activité Physique et prévention de la Chute du Patient âGé hospItalisé en Court séjouR: Etude de faisabilité (AGIR)

acronym: AGIR

summary: This study aims to evaluate the feasibility and the impact on physical performance and falls occurence among geriatric inpatients hospitalized in acute care unit.

lead_sponsor: University Hospital, Angers


title: Optimize the Requirements and Preparations in Outpatient Chemotherapy

summary:
A prescription of injectable anticancer therapy requires the collection of medical data (interview and physical examination) and often allied (laboratory tests). This requirement is made on the day of the arrival of the patient to not prepare these treatments incorrectly.

After receiving the prescription of treatment, it will take about 1 hour to prepare for pharmacy and more in times of high activity, to provide the day hospital pockets treatment, incompressible time when the patient waits to have his treatment.

A process has been selected (Optima) to anticipate prescribing injectable cancer treatments and their manufacturing to reduce patient waiting times on the day of his coming François BaclesseCentre day hospital.

lead_sponsor: Centre Francois Baclesse


title: THERAPEUTIC PATIENT EDUCATION AND CANCER PAIN

acronym: EFFADOL

summary: Describe the expectations of therapeutic education for patients in management of cancer pain.


title: Study of Immunological, Virological, Serological Characteristics of HIV+ Patients Harboring Isolated Anti-HBc Profile and Response to Hepatitis B Vaccination

summary: The aim of study is to describe the clinical, immunological, serological, virological and therapeutic characteristics of HIV+ patients harboring isolated anti-HBc profile and to assess the response to vaccination in these patients.

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Neurophysiological Measures During Sound and Speech Perception in Cochlear Implanted Patients and Development of New Speech Rehabilitation Tools

acronym: NEUROSYLLABIC

summary: This study aims at investigating new automatic fitting techniques for cochlear implant patients based on objective measures. For this reason, the evolution of these neurophysiological measures, expressing the encoding of pure tones and speech, will be characterized in cochlear implanted patients as a function of post-implantation time and will be compared to those of normal hearing subjects. Moreover, the effect of auditory training with new tools based on serious games will be assessed.

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hopital Edouard Herriot


title: Clinical Interest of the Temporary Urethral Stent Allium " Bulbar Urethral Stent " in the Treatment of Detrusor Sphincter Dyssynergia

acronym: ALLIUM

summary:
Detrusor striated sphincter dyssynergia (DSSD) is defined as the persistence or increasing of the striated sphincter activity during voiding and characterizes the spinal cord injuries located under the protuberance. The standard treatment for DSSD is medical, either pharmacological or by clean intermittent self-catheterisation (CISC). Some patients are unable to perform CISC and require alternative surgical techniques such as external sphincterotomy which is invasive, irreversible and with no adjustment period for the patient.

Urethral stents have been developed as an alternative to surgical sphincterotomy. Temporary stents provide a non-definitive treatment, especially for evolutionary pathologies, for patients refusing a destructive surgery (psychosocial impact), or for patients having not defined yet their therapeutic preference. The Allium company has developed the " Bulbar Urethral Stent " (BUS) system, which advantages are the possibility to perform the procedure under local anesthesia and to remove more easily the stent, with similar performances compared to the other devices. In order to quantify the interest of the BUS system, the investigators propose to perform a prospective study aimed at describing its technical and clinical results in terms of efficacy and safety.

location_facility: Service de Chirurgie-Urologie - Centre Hospitalier Lyon Sud


title: Single Arm Phase II Trial Evaluating the Efficacy of Radium 223 in Radioactive Iodine Refractory Bone Metastases From Differentiated Thyroid Cancer

acronym: RAD-THYR

summary:
The purpose of this Phase II single-arm study is to evaluate the efficacy of Radium-223 in treating bone lesions from differentiated thyroid cancer that are I-131 refractory. Based on the results of the phase III trial, the protocol using an injection of Radium-223 activity of 50 kBq/kg b.w. given 6 times at 4 weeks interval will be applied. The end point of this study will be the evaluation of Radium-223 efficacy one month after 3 administrations, i.e. at 3 months after the first injection. If disease progression at that time is excluded, patients will be treated with 3 further injections for a total of 6 administrations of Radium-223. The principal response criterion at 3 and 6 months will be the metabolic response on FDG PET/CT, but other imaging techniques will also be performed: axial skeleton MRI, 99mTc-HMDP bone scan and FNa PET/CT. Axial skeleton MRI is the reference for soft tissue study. 99mTc- HMDP bone scan is the most used and available routine tool to detect bone metastases in cancer patients, but its sensitivity in patients with bone metastases from thyroid cancer is low, because most lesions are lytic [23]. 18FNa PET/CT shows higher sensitivity than 99mTc-HMDP bone scan to detect bone lesions in cancer patients and is able to detect micrometastases that are not seen on bone scan [24] [25]. Preliminary results show some interest of using this tracer to evaluate the sclerotic component of bone metastases from thyroid cancer [26]. Furthermore preliminary data show that FNa PET/CT can be useful to quantify response to Radium-223 in prostate cancer. In only five patients evaluated by FNa PET/CT at baseline, 6 weeks and 12 weeks after 100 KBq/Kg of Radium-223, semiquantitative analysis by SUV max showed a relationship between PSA and SUV max level decrease in 3 patients (-44%, -31%, -27% vs -52%, -75, and -49% respectively) [27].

Finally bone metastases that are visible on morphological imaging (CT scan or on RI) are frequently submitted to local treatment modalities, and this may induce fibrosis and recalcification. Therefore, already treated metastases and not treated metastases will be studied separately as two separate subgroups of target lesions.

ReferenceCitation: Deandreis D, Maillard A, Zerdoud S, Bournaud C, Vija L, Sajous C, Terroir M, Leenhardt L, Schlumberger M, Borget I, Leboulleux S. RADTHYR: an open-label, single-arm, prospective multicenter phase II trial of Radium-223 for the treatment of bone metastases from radioactive iodine refractory differentiated thyroid cancer. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3238-3249. doi: 10.1007/s00259-021-05229-y. Epub 2021 Feb 23.

family: Deandreis

full_name: Désirée Deandreis

given: Désirée

family: Maillard

full_name: Aline Maillard

given: Aline

family: Zerdoud

full_name: Slimane Zerdoud

given: Slimane

family: Bournaud

full_name: Claire Bournaud

given: Claire

family: Vija

full_name: Lavinia Vija

given: Lavinia

family: Sajous

full_name: Christophe Sajous

given: Christophe

family: Terroir

full_name: Marie Terroir

given: Marie

family: Leenhardt

full_name: Laurence Leenhardt

given: Laurence

family: Schlumberger

full_name: Martin Schlumberger

given: Martin

family: Borget

full_name: Isabelle Borget

given: Isabelle

family: Leboulleux

full_name: Sophie Leboulleux

given: Sophie

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

repository_institution: University of Turin - Institutional Research Information System University of Turin

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central
iris.unito.it

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Radiation


title: Prenatal Endoscopic Repair of Fetal Spina Bifida

acronym: ENDOSPIN

summary: The purpose of this study is to determine the feasibility of prenatal minimally-invasive fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch

status: Active, not recruiting

ReferenceCitation: Kohl T. Percutaneous minimally invasive fetoscopic surgery for spina bifida aperta. Part I: surgical technique and perioperative outcome. Ultrasound Obstet Gynecol. 2014 Nov;44(5):515-24. doi: 10.1002/uog.13430.

ReferenceCitation: Adzick NS, Thom EA, Spong CY, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Dabrowiak ME, Sutton LN, Gupta N, Tulipan NB, D'Alton ME, Farmer DL; MOMS Investigators. A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med. 2011 Mar 17;364(11):993-1004. doi: 10.1056/NEJMoa1014379. Epub 2011 Feb 9.

ReferenceCitation: Degenhardt J, Schürg R, Winarno A, Oehmke F, Khaleeva A, Kawecki A, Enzensberger C, Tinneberg HR, Faas D, Ehrhardt H, Axt-Fliedner R, Kohl T. Percutaneous minimal-access fetoscopic surgery for spina bifida aperta. Part II: maternal management and outcome. Ultrasound Obstet Gynecol. 2014 Nov;44(5):525-31. doi: 10.1002/uog.13389.

ReferenceCitation: Verbeek RJ, Heep A, Maurits NM, Cremer R, Hoving EW, Brouwer OF, van der Hoeven JH, Sival DA. Fetal endoscopic myelomeningocele closure preserves segmental neurological function. Dev Med Child Neurol. 2012 Jan;54(1):15-22. doi: 10.1111/j.1469-8749.2011.04148.x. Epub 2011 Nov 29. Review.

status_simplified: Ongoing


title: Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015

acronym: HEMATO-BIO

summary:
HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies.

HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic, pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or relapse:

tumor samples: marrow aspiration, blood sampling.
non-tumor samples: skin biopsy, buccal swab . from 650 patients treated at our cancer center.

status: Recruiting

ReferenceCitation: Chretien AS, Devillier R, Granjeaud S, Cordier C, Demerle C, Salem N, Wlosik J, Orlanducci F, Gorvel L, Fattori S, Hospital MA, Pakradouni J, Gregori E, Paul M, Rochigneux P, Pagliardini T, Morey M, Fauriat C, Dulphy N, Toubert A, Luche H, Malissen M, Blaise D, Nunès JA, Vey N, Olive D. High-dimensional mass cytometry analysis of NK cell alterations in AML identifies a subgroup with adverse clinical outcome. Proc Natl Acad Sci U S A. 2021 Jun 1;118(22). pii: e2020459118. doi: 10.1073/pnas.2020459118.

family: Chretien

full_name: Anne-Sophie Chretien

given: Anne-Sophie

family: Devillier

full_name: Raynier Devillier

given: Raynier

family: Granjeaud

full_name: Samuel Granjeaud

given: Samuel

family: Cordier

full_name: Charlotte Cordier

given: Charlotte

family: Demerle

full_name: Clemence Demerle

given: Clemence

family: Salem

full_name: Nassim Salem

given: Nassim

family: Wlosik

full_name: Julia Wlosik

given: Julia

family: Orlanducci

full_name: Florence Orlanducci

given: Florence

family: Gorvel

full_name: Laurent Gorvel

given: Laurent

family: Fattori

full_name: Stephane Fattori

given: Stephane

family: Hospital

full_name: Marie-Anne Hospital

given: Marie-Anne

family: Pakradouni

full_name: Jihane Pakradouni

given: Jihane

family: Gregori

full_name: Emilie Gregori

given: Emilie

family: Paul

full_name: Magali Paul

given: Magali

family: Rochigneux

full_name: Philippe Rochigneux

given: Philippe

family: Pagliardini

full_name: Thomas Pagliardini

given: Thomas

family: Morey

full_name: Mathieu Morey

given: Mathieu

family: Fauriat

full_name: Cyril Fauriat

given: Cyril

family: Dulphy

full_name: Nicolas Dulphy

given: Nicolas

family: Toubert

full_name: Antoine Toubert

given: Antoine

family: Luche

full_name: Herve Luche

given: Herve

family: Malissen

full_name: Marie Malissen

family: Blaise

full_name: Didier Blaise

given: Didier

journal_name: Proceedings of the National Academy of Sciences


title: Internet Addiction and Sleep Disorders

acronym: ADDICSOM

summary: This is an open label randomized controlled trial, comparing two modes of treatment for internet addiction (gaming or gambling online) with sleep disorders associated.

ipd_sharing_description:
At the end of the study, patient could be informed of result of the study if they wish.

No individual result will be communicate.

intervention_type: Behavioral


title: PRIMARY PREVENTION OF HEPATOCELLULAR CARCINOMA BY METFORMIN IN PATIENTS WITH VIRAL C CIRRHOSIS : PROSPECTIVE MULTICENTER STUDY, RANDOMIZED CONTROL TRIAL. Ancillary Study of the ANRS CO12 CirVir Cohort

acronym: METFOVIR

summary:
Metformin treatment during 36 months could be associated with decreased risk of HCC occurrence and liver related death in patients with compensated HCV cirrhosis and insulinoresistance.

This study is an ancillary of the observational study from the CIRVIR cohort in which more than 1200 patients with compensated HCV cirrhosis are currently included.

participating centers : 26

ReferenceCitation: Nkontchou G, Cosson E, Aout M, Mahmoudi A, Bourcier V, Charif I, Ganne-Carrie N, Grando-Lemaire V, Vicaut E, Trinchet JC, Beaugrand M. Impact of metformin on the prognosis of cirrhosis induced by viral hepatitis C in diabetic patients. J Clin Endocrinol Metab. 2011 Aug;96(8):2601-8. doi: 10.1210/jc.2010-2415. Epub 2011 Jul 13.

ReferenceCitation: Sangiovanni A, Prati GM, Fasani P, Ronchi G, Romeo R, Manini M, Del Ninno E, Morabito A, Colombo M. The natural history of compensated cirrhosis due to hepatitis C virus: A 17-year cohort study of 214 patients. Hepatology. 2006 Jun;43(6):1303-10.

ReferenceCitation: N'Kontchou G, Mahamoudi A, Aout M, Ganne-Carrié N, Grando V, Coderc E, Vicaut E, Trinchet JC, Sellier N, Beaugrand M, Seror O. Radiofrequency ablation of hepatocellular carcinoma: long-term results and prognostic factors in 235 Western patients with cirrhosis. Hepatology. 2009 Nov;50(5):1475-83. doi: 10.1002/hep.23181.

ReferenceCitation: Perseghin G, Calori G, Lattuada G, Ragogna F, Dugnani E, Garancini MP, Crosignani P, Villa M, Bosi E, Ruotolo G, Piemonti L. Insulin resistance/hyperinsulinemia and cancer mortality: the Cremona study at the 15th year of follow-up. Acta Diabetol. 2012 Dec;49(6):421-8. doi: 10.1007/s00592-011-0361-2. Epub 2012 Jan 4.

ReferenceCitation: Goodwin PJ, Ennis M, Pritchard KI, Trudeau ME, Koo J, Taylor SK, Hood N. Insulin- and obesity-related variables in early-stage breast cancer: correlations and time course of prognostic associations. J Clin Oncol. 2012 Jan 10;30(2):164-71. doi: 10.1200/JCO.2011.36.2723. Epub 2011 Dec 12.

ReferenceCitation: Nkontchou G, Bastard JP, Ziol M, Aout M, Cosson E, Ganne-Carrie N, Grando-Lemaire V, Roulot D, Capeau J, Trinchet JC, Vicaut E, Beaugrand M. Insulin resistance, serum leptin, and adiponectin levels and outcomes of viral hepatitis C cirrhosis. J Hepatol. 2010 Nov;53(5):827-33. doi: 10.1016/j.jhep.2010.04.035. Epub 2010 Jul 14.

ReferenceCitation: Salmon D, Bani-Sadr F, Loko MA, Stitou H, Gervais A, Durant J, Rosenthal E, Quertainmont Y, Barange K, Vittecoq D, Shoai-Tehrani M, Alvarez M, Winnock M, Trinchet JC, Dabis F, Sogni P. Insulin resistance is associated with a higher risk of hepatocellular carcinoma in cirrhotic HIV/HCV-co-infected patients: results from ANRS CO13 HEPAVIH. J Hepatol. 2012 Apr;56(4):862-8. doi: 10.1016/j.jhep.2011.11.009. Epub 2011 Dec 13.

ReferenceCitation: Svegliati-Baroni G, Faraci G, Fabris L, Saccomanno S, Cadamuro M, Pierantonelli I, Trozzi L, Bugianesi E, Guido M, Strazzabosco M, Benedetti A, Marchesini G. Insulin resistance and necroinflammation drives ductular reaction and epithelial-mesenchymal transition in chronic hepatitis C. Gut. 2011 Jan;60(1):108-15. doi: 10.1136/gut.2010.219741. Epub 2010 Oct 21.

ipd_sharing: Undecided


title: Advanced Approach to Arterial Stiffness (AAA Study - Triple A Study)

acronym: AAA

summary: The aim of the 3A Study is to assess the role of MetS on the arterial mechanics and vascular health in different age groups using the Cardio Ankle Vascular Index (CAVI) of the Vasera system and the "classic" carotid-femoral Pulse Wave Velocity (PWV).

lead_sponsor: International Society for Vascular Health


title: Treatment of Port-wine Stains by Bosentan in Addition to Pulsed Dye Laser (PDL) in Children or Young Adults Who Previously Failed to Respond to PDL Alone: a Monocentric Pilot Study

summary: Pulsed dye laser (PDL) is the gold standard treatment for port-wine stains (PWS). However, the outcomes are highly variable due to the new angiogenesis occurring after laser irradiation. Studies suggest that endothelin is involved in the neoangiogenesis that occurred after treatment of port-wine stains by PDL. The main objective of this pilot clinical trial is to evaluate the effectiveness and safety of an inhibitor of endothelin orally taken, the Bosentan, following PDL treatment. Four patients with facial port-wine stain resistant to the PDL treatment will be included. The treatment by Bosentan (2 mg/kg twice daily, maximum 62,5 mg twice daily) will be given one day before the PDL irradiation and continued for 14 days. Only one test area of PWS will be treated with PDL. The primary outcome measure will be an important or complete improvement (Investigator Global Assessment 3 or 4) between treated area and non treated one, 14 days after the end of the treatment which corresponds to one month after the laser PDL session. The evaluation will been performed on standardized pictures by 2 independent physicians blinded to the region treated or not.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Nice - Dermatologie - Hôpital Archet


title: Optically Pumped 4He Magnetometers Performances Compared With Medical Reference Methods : Electrocardiography (ECG) and Magnetoencephalography (MEG)

acronym: MINIMAG

summary: Optically Pumped 4He Magnetometers operability for cerebral and cardiac magnetic fields measurement.

lead_sponsor: University Hospital, Grenoble


title: " Anemil Trial ": Phase I/II Clinical Trial Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment

acronym: ANEMIL

summary: The investigators have demonstrated that the mean percentage of circulating CD8+ regulatory T (CD8 Tregs) cells is significantly higher in patients with warm hemolytic anemia (wAHAI) in remission than in controls and is correlated to hemoglobin levels. In vitro, low dose of interleukine-2 (IL2) induce the expansion of CD8 Tregs. The objective is to demonstrate that, over a 9 week treatment period; low doses of IL2 can induce the expansion of CD8Tregs in patients with active wAHAI.

lead_sponsor: University Hospital, Bordeaux


title: Reduction de la Morbi-mortalité Cardiovasculaire Chez l'artériopathe Claudicant Par le Sildenafil

summary: Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in term of morbi-mortality in patients with arterial claudication on a multicenter prospective double blind study.


title: A Phase I Trial Assessing Several Schedules of Oral S-1 in Combination With a Fixed Dose of Oxaliplatin and Irinotecan in Patients With Advanced or Metastatic Digestive Adenocarcinoma as First- or Second-line Treatment

acronym: SIRINOX

summary: This study is to determine the Maximal Tolerated Dose (MTD), the Dose Limitant Toxicities (DLTs) and the safety profile of S-1 combined with fixed doses of Irinotecan (SIRI schedule) and fixed doses of Irinotecan and Oxaliplatin (SIRINOX schedule).

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


title: OLYMPE - Prospective Cohort Study on the Management of Patients With Relapsed Follicular Lymphoma

summary: This French national, multicenter, prospective, longitudinal, observational study will describe the treatment modalities of a cohort of patients with relapsed or refractory follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to the presence or not of MabThera® (rituximab) maintenance therapy. Actively participating physicians will enroll patients and collect therapeutic management data in a real-life setting up to 5 years.

lead_sponsor: Hoffmann-La Roche


title: Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation on the Primary Motor Cortex (M1) in Central Neuropathic Pain

summary: The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Ultrasound Assessment of Gastric Content for Semi Emergency Surgery

acronym: ECHO-GAST

summary: Aspiration of gastric content is a rare but serious complication of anesthesia. In this context, preoperative fasting for elective surgery is well defined. In an emergency situation, international guidelines recommend rapid sequence of anesthesia to reduce the risk of aspiration. In semi emergency situation, there is no consensus about the anesthetic procedure even if a preoperative fasting has been observed due to uncertainty of gastric emptying related to stress or painful condition. The choice of anesthesia induction technique depends mainly on the anesthetist. Ultrasonography is a non invasive bedside tool that can provide reliable quantitative information about the volume of gastric content.


title: Study Evaluating the Utility of 18F-FDG PET in Assessing Early Response to Neoadjuvant Treatment in Patients With Mammary Gland Cancer

acronym: TREN

summary:
Neoadjuvant chemotherapy is frequently proposed to patients with mammary gland cancer. The aim is to reduce tumor volume before surgical therapy. Obtaining a pathologic Complete Response (pCR) is regarded as a good prognostic factor with less risk of recurrence. The rate of pCR is about 20%, although there are important variations according to tumor subtype and the type of treatment. The objective of the new therapeutic strategies is to increase this response rate.

The purpose of this study is to investigate the possibility of early evaluation of neoadjuvant chemotherapy response after one cycle of neoadjuvant chemotherapy by positron emission tomography (PET) with (18) F-fluorodeoxyglucose (FDG) in patients.

lead_sponsor: Centre Georges Francois Leclerc


title: Activity of Regorafenib in Combination With Modified Gemcitabine - Oxaliplatin Chemotherapy (mGEMOX) in Patients With Advanced Biliary Tract Cancer (BTC): A Phase Ib-II Trial (BREGO)

acronym: BREGO

summary: This study is to determine the Regorafenib Dose (RD) for the phase II trial of Regorafenib administered in combination with mGEMOX in patients with advanced biliary tract cancer.


acronym: Flammacérium

summary: Ischemia of an area may lead to a necrotic wound. In lower limb, it especially happens in diabetic or artheriopatic patients. It can lead to an amputation need. Revascularization procedure cannot be provide in all cases. Flammacerium, by a crust training and its anti-inflammatory effect, could stabilize necrosis extension, avoid bacterial contamination and then improve some incapacitating symptoms like odor or pain. This product may allow to delay amputation ruling for patients on who this procedure is unsafe. During 6 months, the investigators evaluate Flammacerium against standard dressing procedure in necrotic wound of the lower limb in patients where no revascularization can be provide. The investigators observed its effect on amputation need, symptoms as pain, infection, wound aspect evolution, wound size decrease.

lead_sponsor: University Hospital, Montpellier


title: Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation

acronym: TEG-PKT

summary:
Type of study:Prospective, single-center, non-therapeutic, of routine care No randomization, no modifications of the usual care, study results are not available for the physicians in charge of the patient.

Objectives:

The main objective of this study is to evaluate the ability of the thromboelastogram (ROTEM®) to detect clotting disorders related to pancreas-kidney transplantation, comparing ROTEM ® profiles during the perioperative period of two different types of transplantation (kidney alone and simultaneous pancreas-kidney)

The secondary objectives are:

To assess the incidence and type of coagulation disorders during the perioperative period of these two types of transplantation
To study correlation values between thrombolelastogram and standard coagulation parameters

Population study:

Evaluated group: 40 pancreas-kidney recipients
Control group: 80 kidney recipients
Recruitment periods: 24 months
Patient Monitoring: 48 hours
Total duration of the study: 36 months.
Ethics: Study of routine care. Oral and written information given to patients. Validation of the study protocol by the local ethics committee (CPP Sud Est II: Protocol No. HCL / P 2012.727)

location_facility: Anesthesiology and Critical Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon


title: Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Study to Assess Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis

acronym: BRASS

summary:
This study aims to assess whether or not a single injection schedule of botulinum toxin A (BTX-A) in both hands improves Raynaud phenomenon (RP) secondary to systemic sclerosis (SSc) better than a placebo at 4, 12 and 24 weeks after the treatment.

This study's hypothesis is that the number of RP attacks per week from baseline to 4 weeks after treatment is significantly lower in the group treated with BTX-A than in the control group treated by the placebo. Furthermore, BTX-A in both hands is expected to improve both symptomatic (attack frequency, digital ulcer healing) and functional (pain, hand function, quality of life) symptoms of RP secondary to SSc more than placebo.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: LEukoaraiosis and blOod Pressure Reduction in OLD People

acronym: LEOPOLD

summary: The purpose of the study is to test the hypothesis of slowing the progression of White Matter Lesions (WML) by lowering blood pressure (BP) in patients with cognitive complaints and a moderate to high grade of WML on brain MRI.

location_facility: Memory Resources Centre and South of Ile de France Search - Broca Hospital

location_facility: Memory for Research and Resources Center / Neuroscience pole


title: Study of the Genetic Susceptibility to Ankylosing Spondylitis by Functional Genomics Approach

acronym: GENOSPA

summary: The main objective is to identify in the candidate regions of differentially expressed genes by comparing the transcriptome of dendritic cells derived from circulating monocytes between cases and controls. Cases and family controls will be matched on the presence of HLA-B27 and depending on haplotype association studies to correlate the differences of gene expression and genetic variations with susceptibility to AS.

time_perspective: Retrospective


title: Prospective Study of Patients Treated for Prosthetic Hip Infection and Followed for at Least 2 Years

acronym: PHIPS

summary:
Data from large prospective cohort studies of prosthetic joint infections are lacking.

Aim of this study: analyzing prospectively the incidence of reinfection in patients with prosthetic hip infections who underwent surgery and received antibiotic therapy.

Hypothesis: to confirm in a large group that the incidence of reinfection after excision -synovectomy in acute prosthesis hip infection is 30% and 15% for chronic infection after exchange arthroplasty (one or two stage exchange).

ReferenceCitation: Tsukayama DT, Estrada R, Gustilo RB. Infection after total hip arthroplasty. A study of the treatment of one hundred and six infections. J Bone Joint Surg Am. 1996 Apr;78(4):512-23.

lead_sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Diaconesses Croix Saint-Simon Hospital Group


title: Spinal Anaesthesia for Caesarean Section: Descriptive Multicentre Study

acronym: CesAR

summary: Most of caesarean sections can be performed under spinal anaesthesia. Its major advantages are reliability and fast onset. However, dose of hyperbaric bupivacaine used, combination with adjuvants, hemodynamic management, and impact of these measures on maternal experience are not uniform. This study aims to describe practices of spinal anaesthesia for caesarean section in France to improve practices, guide new studies and establish protocols.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
APHP Cochin
Hôpital Jacques Puel
Hôpital Emile Roux
HCL
CHU
APHP Trousseau
APHP Necker


title: Estimated Cumulative Incidence of Zika Infection at the End of the First Epidemic in the French West Indies in a Sample of Patients Followed for HIV Infection.

acronym: ZIKAVIH

summary: This study will estimate the cumulative incidence of Zika infection at the end of the first epidemic in the French West Indies in a sample of patients followed for HIV infection.

lead_sponsor: University Hospital Center of Martinique

location_country: France Guadeloupe

location_facility:
University Hospital of Martinique
University Hospital of Guadeloupe


title: Translational 22q11.2:"Molecular Variants Associated With Schizophrenia: Differential Analysis of Monozygotic Twins With Variable Phenotypic 22q11.2 Microdeletional Syndrom"

summary: The 22q11.2 microdeletion syndrome (22q11.2DS) is a rare disease with a psychiatric phenotype. Indeed, the diagnosis of schizophrenia is made in 5 to 10% of adolescents and 25 to 40% of adults carrying the 22q11DS. Thus, although this pathology has been able to provide a genetically homogeneous model for the study psychosis etiology, it is not currently possible to establish a link between genomic rearrangement and psychotic symptoms. However, this robust model of genetic vulnerability could provide us a lot of translational informations about schizophrenia genetics. To go furthermore, twin studies have provided us precious data for the study of hereditary diseases. Combining this two approaches, the translational 22q11.2 project proposes a molecular study of two monozygotic 22q11.2DS twins discordant for the psychiatric phenotype -one carrying schizophrenia and the other having no psychiatric symptoms-.

lead_sponsor: Hôpital le Vinatier

intervention_type: Genetic


title: Influence of Resveratrol and Resvega Versus Placebo on Incidence of Bilateralisation of Exudative AMD: a Double Masked Prospective Study.

acronym: AGED

summary: This is an interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration.

lead_sponsor: Poitiers University Hospital

intervention_type: Dietary Supplement


title: IBD Cancer and Serious Infection in Europe

acronym: I-CARE

summary:
The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers, especially, lymphoma, and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.

We will stratify the risk of cancers and serious infections according to IBD phenotype and disease activity (clinical, radiologic and endoscopic).

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives


title: One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated

acronym: SENIOREA

summary:
Elderly patients are increasingly admitted in the Intensive Care Unit. Short-term outcome (e.g. hospital survival) of an ICU stay is improving in this population but little data have been published on long-term outcome. Beyond survival, outcome assessment in the elderly requires to evaluate several aspects of health: mental status, activity of daily living, pain, depression, frailty… referred by geriatrician as "comprehensive geriatric assessment' (CGA).

The purpose of the SENIOREA study is to evaluate one year outcome of elderly patients mechanically ventilated in the ICU by performing CGA one year after ICU admission. CGA will be performed on the patients' site of living.

This prospective multicentric trial will be conducted over 8 medico-surgical ICUs.

ReferenceCitation: Demiselle J, Duval G, Hamel JF, Renault A, Bodet-Contentin L, Martin-Lefèvre L, Vivier D, Villers D, Lefèvre M, Robert R, Markowicz P, Lavoué S, Courte A, Lebas E, Chevalier S, Annweiler C, Lerolle N. Determinants of hospital and one-year mortality among older patients admitted to intensive care units: results from the multicentric SENIOREA cohort. Ann Intensive Care. 2021 Feb 17;11(1):35. doi: 10.1186/s13613-021-00804-w.

family: Demiselle

full_name: Julien Demiselle

given: Julien

family: Duval

full_name: Guillaume Duval

given: Guillaume

family: Hamel

full_name: Jean-François Hamel

given: Jean-François

family: Renault

full_name: Anne Renault

given: Anne

family: Bodet-Contentin

full_name: Laetitia Bodet-Contentin

given: Laetitia

family: Martin-Lefèvre

full_name: Laurent Martin-Lefèvre

family: Vivier

full_name: Dominique Vivier

given: Dominique

family: Villers

full_name: Daniel Villers

given: Daniel

family: Lefèvre

full_name: Montaine Lefèvre

given: Montaine

family: Robert

full_name: René Robert

given: René

family: Markowicz

full_name: Philippe Markowicz

family: Lavoué

full_name: Sylvain Lavoué

given: Sylvain

family: Courte

full_name: Anne Courte

family: Lebas

full_name: Eddy Lebas

given: Eddy

family: Chevalier

full_name: Stéphanie Chevalier

given: Stéphanie

family: Annweiler

full_name: Cédric Annweiler

given: Cédric

family: Lerolle

full_name: Nicolas Lerolle

currency_apc_doaj: GBP

journal_name: Annals of Intensive Care

oa_colors: green gold

evidence: oa journal (via doaj)

lead_sponsor: University Hospital, Angers


title: Comparison of the Bilateral Transversus Abdominis Plane (TAP) Block Versus Curare in Muscle Relaxation of the Abdominal Wall During Laparoscopic Digestive Surgery: Prospective Randomized Study

summary: This is a Biomedical Research, prospective, randomized, controlled single-blind mono centric, phase IV comparison trial of the bilateral TAP block versus curare in muscle relaxation of the abdominal wall during laparoscopic digestive surgery.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Impact of a Phone-based Cognitive and Behavioral Therapy on Food Addiction in Patients With Severe or Morbid Obesity

acronym: ADALOB

summary:
Morbid or severe obesity is a chronic pathology of multifactorial etiology that affects 4.3% of the French population. In these patients, eating disorders are frequent and must be managed as they are considered risk factors with poorer weight prognosis and lower quality of life.

Some authors have proposed that the concept of food addiction (i.e., the existence of an addiction to certain foods rich in sugar, fat and/or salt) may make it possible to identify, among obese patients, a subgroup of patients that is more homogeneous in terms of diagnosis and prognosis.

Food addiction is common in obese patients and is associated with higher levels of depression, anxiety, impulsivity, emotional eating and poorer quality of life. Nevertheless, we do not know the impact of managing this addiction on the future of these patients (food addiction, weight, comorbidities, quality of life). Telephone-based cognitive behavioral therapy intervention (Tele-CBT) is a treatment of choice for addictions, but there are inequalities in access to this treatment (distance between home and hospital, limited local resources of caregivers, constraints in patient availability) which require the therapeutic framework to be adapted to these constraints. A short Tele-CBT program has demonstrated its effectiveness in reducing bulimic hyperphagia in these patients (Cassin et al. 2016), but its effectiveness on food addiction, Body Mass Index and the evolution of metabolic complications related to obesity is still unknown. The evaluation of this program was limited to 6 weeks (American study), and we do not know if these results can also be extrapolated to France.

The main hypothesis of this study is that in patients suffering from severe or morbid obesity and with food addiction, the performance of tele-CBT (intervention group: 12 sessions for 18 weeks) will be accompanied by a significant medium-term decrease in the prevalence of food addiction compared to usual management (control group).

lead_sponsor: University Hospital, Tours

location_facility: Endocrinology, diabetology and nutrition department, University Hospital, Reims

location_facility: Nutrition Department, University Hospital, Brest

location_facility: Department of endocrinology-diabetology-nutrition, University Hospital, Angers

location_facility: Metabolic and nutritional exploration, University Hospital, Tours

location_facility: Nutrition Department, University Hospital, Nantes

location_facility: Endocrinology, diabetology and nutrition department, University Hospital, Rennes

location_facility: Department of Internal Medicine, Endocrinology and Metabolic Diseases, University Hospital, Poitiers


title: Ankle Osteoarthritis and Its Treatments : Impact on Foot & Ankle Biomechanics

acronym: AO-IFAB

summary:
Ankle osteoarthritis is a progressive degenerative joint disease that is characterized by severe pain, loss of autonomy, diminished health-related quality of life, functional disability and diminished physical ability to fulfill occupational duties of life in its end-stage. Current surgical treatments for ankle osteoarthritis are ankle arthrodesis and total ankle replacement. Despite the good pain relief provided by these procedures, patients are still experiencing post-operatively important functional limitations in their activities of the daily living which affect their independency and quality of life. In order to remain capable of performing primary activities of the daily living, those patients have to make functional compensatory adaptations in the ipsilateral adjacent joints that will cause additional degenerative joint disease in those joints.

Currently, the outcome of foot and ankle surgery is primarily based on clinical, radiographic and questionnaire outcomes. However, these outcome measures have been criticized for not being sensitive enough to detect clinically meaningful change in foot function. To tackle these shortcomings, an advanced clinical examination platform integrating pressure-force-kinematic measurement devices was developed and showed its clinical value for the detection of intrinsic foot mobility impairments. Surprisingly, up-to-now, no study has included this integrated use of three-dimensional multi-segment foot models, plantar pressure platform and a force platform to report on the functional outcome of an ankle arthrodesis or a total ankle replacement.

Therefore, a multi-centre study will be conducted with two foot & ankle surgery centres. Both centres are equipped with the same advanced clinical examination platform. It is believed that proposed approach has the potential to provide further insight in the true functional changes related to ankle arthrodesis and total ankle replacement. This may in turn result in improved rehabilitation, less risk for post-operative complications, earlier discharge and quicker resumption of normal activities of the daily living, which would make ankle arthrodesis and total ankle replacement more cost-efficient and could potentially affect thousands of patients each year. Therefore, the hypotheses of the present study are:

Hypothesis (H1): Subjects with an ankle arthrodesis require a greater reorganization of foot and lower limb kinematic and kinetic patterns to respond to mechanical requirements of level walking compared to subjects with a total ankle replacement.
Null hypothesis (H0): Subjects with an ankle arthrodesis do not require a greater reorganization of foot and lower limb kinematic and kinetic patterns to respond to mechanical requirements of level walking compared to subjects with a total ankle replacement.

lead_sponsor: Hospices Civils de Lyon


title: Functional and Structural Characterization of the Peripheral Arteriopathy in Pseudoxanthoma Elasticum (PXE)

acronym: Ca-Art-PXE

summary: To determine the specific structural and functional features of the peripheral arteriopathy in the Pseudoxanthoma Elasticum (PXE), an inherited autosomal disease.

ReferenceCitation: Naouri M, Boisseau C, Bonicel P, Daudon P, Bonneau D, Chassaing N, Martin L. Manifestations of pseudoxanthoma elasticum in childhood. Br J Dermatol. 2009 Sep;161(3):635-9. doi: 10.1111/j.1365-2133.2009.09298.x. Epub 2009 Jun 9.

ReferenceCitation: Martin L, Maître F, Bonicel P, Daudon P, Verny C, Bonneau D, Le Saux O, Chassaing N. Heterozygosity for a single mutation in the ABCC6 gene may closely mimic PXE: consequences of this phenotype overlap for the definition of PXE. Arch Dermatol. 2008 Mar;144(3):301-6. doi: 10.1001/archderm.144.3.301.

ReferenceCitation: Martin L, Hoppé E, Kauffenstein G, Omarjee L, Navasiolava N, Henni S, Willoteaux S, Leftheriotis G. Early arterial calcification does not correlate with bone loss in pseudoxanthoma elasticum. Bone. 2017 Oct;103:88-92. doi: 10.1016/j.bone.2017.06.017. Epub 2017 Jun 27.

family: Martin

full_name: Ludovic Martin

given: Ludovic

family: Hoppé

full_name: Emmanuel Hoppé

given: Emmanuel

family: Kauffenstein

full_name: Gilles Kauffenstein

given: Gilles

family: Omarjee

full_name: Loukman Omarjee

given: Loukman

family: Navasiolava

full_name: Nastassia Navasiolava

given: Nastassia

family: Henni

full_name: Samir Henni

given: Samir

family: Willoteaux

full_name: Serge Willoteaux

given: Serge

family: Leftheriotis

full_name: Georges Leftheriotis

given: Georges

journal_name: Bone


title: Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years

acronym: STOP-I-SEP

summary: Further controlled and randomized prospective studies in Multiple sclerosis, analyzing the potential impact of treatment discontinuation on disability progression, focal disease activity and quality of life are needed. The optimum patient age and duration of inactive SPMS before treatment withdrawal and the monitoring procedures also need to be specified, the ultimate goal being to provide evidence-based recommendations for clinical practice. Following the previous retrospective experience, we decided to drive a multicenter prospective study in France based on the hypothesis that stopping disease modifying therapy will not induce an increased risk of disability progression and relapse in selected SPMS patients (older patients without lesion activity) but will improve the quality of life and may reduce treatment-related costs.

lead_sponsor: Rennes University Hospital

location_facility:
CHU Strasbourg
CHU Poitiers
CHU Clermont-Ferrand
CHU Montpellier
CHU Nantes
Hospices Civils Lyon
CH Quimper
AP-HP (La Pitié Salpêtrière)
CHU Dijon
CHU Brest
CH Poissy
CHU de Nîmes
Fondation de Rothschild
CHU Nancy
CHU Angers
AP-HM
CHU Tours
CHU Grenoble
CHU Lille
CHU Nice
CHU Rennes


title: Severe Leptospirosis in Non-tropical Areas: a Nationwide, Multicentre, Retrospective Study in French ICUs

acronym: LEPTOREA

summary:
Leptospirosis is a worldwide zoonosis. The mortality of the disease is between 3,6% to 13%, and up to 48% for the severe leptospirosis.

Only few studies exist on severe leptospirosis and none major multicentre on leptospirosis in intensive care units in Europe. The investigators conduct a retrospective multi centric study in metropolitan France in order to identify the characteristic, the treatments and the prognostic factors associated with mortality of sever leptospirosis.

ReferenceCitation: Haake DA, Levett PN. Leptospirosis in humans. Curr Top Microbiol Immunol. 2015;387:65-97. doi: 10.1007/978-3-662-45059-8_5. Review.

ReferenceCitation: Picardeau M. Virulence of the zoonotic agent of leptospirosis: still terra incognita? Nat Rev Microbiol. 2017 May;15(5):297-307. doi: 10.1038/nrmicro.2017.5. Epub 2017 Mar 6. Review.

ReferenceCitation: Delmas B, Jabot J, Chanareille P, Ferdynus C, Allyn J, Allou N, Raffray L, Gaüzere BA, Martinet O, Vandroux D. Leptospirosis in ICU: A Retrospective Study of 134 Consecutive Admissions. Crit Care Med. 2018 Jan;46(1):93-99. doi: 10.1097/CCM.0000000000002825.

ReferenceCitation: Costa F, Hagan JE, Calcagno J, Kane M, Torgerson P, Martinez-Silveira MS, Stein C, Abela-Ridder B, Ko AI. Global Morbidity and Mortality of Leptospirosis: A Systematic Review. PLoS Negl Trop Dis. 2015 Sep 17;9(9):e0003898. doi: 10.1371/journal.pntd.0003898. eCollection 2015. Review.

lead_sponsor: Nantes University Hospital

location_facility: Hopital Edouard Herriot, Hospices civils de Lyon

location_facility: hopital saint Leon, CH de la Cote Basque


title: Study of Parameters of Infracyanine Angiography as Diagnostic Tool of Critical Limb Ischemia

acronym: FLUORESCENCE

summary: Investigators conduct a monocentric pilot study with the objective to determine the hemodynamic parameter of fluorescence angiography (slope, amplitude, saturation time ) best correlated with toe pressure in patients with suspicion of critical limb ischemia.

ReferenceCitation: Becker F, Robert-Ebadi H, Ricco JB, Setacci C, Cao P, de Donato G, Eckstein HH, De Rango P, Diehm N, Schmidli J, Teraa M, Moll FL, Dick F, Davies AH, Lepäntalo M, Apelqvist J. Chapter I: Definitions, epidemiology, clinical presentation and prognosis. Eur J Vasc Endovasc Surg. 2011 Dec;42 Suppl 2:S4-12. doi: 10.1016/S1078-5884(11)60009-9. Review.

ReferenceCitation: Bloch C, Richard JL. [Risk factors for atherosclerotic diseases in the Prospective Parisian Study I. Comparison with foreign studies]. Rev Epidemiol Sante Publique. 1985;33(2):108-20. Review. French.

ReferenceCitation: Braun JD, Trinidad-Hernandez M, Perry D, Armstrong DG, Mills JL Sr. Early quantitative evaluation of indocyanine green angiography in patients with critical limb ischemia. J Vasc Surg. 2013 May;57(5):1213-8. doi: 10.1016/j.jvs.2012.10.113. Epub 2013 Jan 24.

ReferenceCitation: Chung J, Modrall JG, Valentine RJ. The need for improved risk stratification in chronic critical limb ischemia. J Vasc Surg. 2014 Dec;60(6):1677-85. doi: 10.1016/j.jvs.2014.07.104. Epub 2014 Sep 8. Review.

ReferenceCitation: Ciardella AP, Prall FR, Borodoker N, Cunningham ET Jr. Imaging techniques for posterior uveitis. Curr Opin Ophthalmol. 2004 Dec;15(6):519-30. Review.

ReferenceCitation: Constans J, Bura-Rivière A. [Lower limb occlusive arterial disease: Diagnosis problems in 2014]. Presse Med. 2014 Jul-Aug;43(7-8):823-6. doi: 10.1016/j.lpm.2014.03.013. Epub 2014 Jun 2. French.

ReferenceCitation: Cull DL, Manos G, Hartley MC, Taylor SM, Langan EM, Eidt JF, Johnson BL. An early validation of the Society for Vascular Surgery lower extremity threatened limb classification system. J Vasc Surg. 2014 Dec;60(6):1535-41. doi: 10.1016/j.jvs.2014.08.107. Epub 2014 Oct 3.

ReferenceCitation: Elsayed S, Clavijo LC. Critical limb ischemia. Cardiol Clin. 2015 Feb;33(1):37-47. doi: 10.1016/j.ccl.2014.09.008. Review.

ReferenceCitation: Terasaki H, Inoue Y, Sugano N, Jibiki M, Kudo T, Lepäntalo M, Venermo M. A quantitative method for evaluating local perfusion using indocyanine green fluorescence imaging. Ann Vasc Surg. 2013 Nov;27(8):1154-61. doi: 10.1016/j.avsg.2013.02.011. Epub 2013 Aug 20.

ReferenceCitation: Igari K, Kudo T, Toyofuku T, Jibiki M, Inoue Y, Kawano T. Quantitative evaluation of the outcomes of revascularization procedures for peripheral arterial disease using indocyanine green angiography. Eur J Vasc Endovasc Surg. 2013 Oct;46(4):460-5. doi: 10.1016/j.ejvs.2013.07.016. Epub 2013 Aug 21.

ReferenceCitation: Kang Y, Lee J, Kwon K, Choi C. Application of novel dynamic optical imaging for evaluation of peripheral tissue perfusion. Int J Cardiol. 2010 Dec 3;145(3):e99-101. doi: 10.1016/j.ijcard.2008.12.166. Epub 2009 Feb 23.

ReferenceCitation: Kang Y, Lee J, Kwon K, Choi C. Dynamic fluorescence imaging of indocyanine green for reliable and sensitive diagnosis of peripheral vascular insufficiency. Microvasc Res. 2010 Dec;80(3):552-5. doi: 10.1016/j.mvr.2010.07.004. Epub 2010 Jul 15.

ReferenceCitation: Kannel WB, McGee DL. Update on some epidemiologic features of intermittent claudication: the Framingham Study. J Am Geriatr Soc. 1985 Jan;33(1):13-8.

ReferenceCitation: Labs KH, Dormandy JA, Jaeger KA, Stuerzebecher C, Hiatt WR. Trans-atlantic conference on clinical trial guidelines in PAOD (Peripheral arterial occlusive disease) clinical trial methodology. Eur J Vasc Endovasc Surg. 1999 Sep;18(3):253-65.

ReferenceCitation: Levesque E, Hoti E, Azoulay D, Adam R, Samuel D, Castaing D, Saliba F. Non-invasive ICG-clearance: a useful tool for the management of hepatic artery thrombosis following liver transplantation. Clin Transplant. 2011 Mar-Apr;25(2):297-301. doi: 10.1111/j.1399-0012.2010.01252.x.

ReferenceCitation: Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group, Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. Epub 2006 Nov 29.

ReferenceCitation: Pestana IA, Coan B, Erdmann D, Marcus J, Levin LS, Zenn MR. Early experience with fluorescent angiography in free-tissue transfer reconstruction. Plast Reconstr Surg. 2009 Apr;123(4):1239-1244. doi: 10.1097/PRS.0b013e31819e67c1.

ReferenceCitation: Rashid H, Slim H, Zayed H, Huang DY, Wilkins CJ, Evans DR, Sidhu PS, Edmonds M. The impact of arterial pedal arch quality and angiosome revascularization on foot tissue loss healing and infrapopliteal bypass outcome. J Vasc Surg. 2013 May;57(5):1219-26. doi: 10.1016/j.jvs.2012.10.129. Epub 2013 Mar 21.

ReferenceCitation: Schaafsma BE, Mieog JS, Hutteman M, van der Vorst JR, Kuppen PJ, Löwik CW, Frangioni JV, van de Velde CJ, Vahrmeijer AL. The clinical use of indocyanine green as a near-infrared fluorescent contrast agent for image-guided oncologic surgery. J Surg Oncol. 2011 Sep 1;104(3):323-32. doi: 10.1002/jso.21943. Epub 2011 Apr 14. Review.

ReferenceCitation: Yamada T, Ohta T, Ishibashi H, Sugimoto I, Iwata H, Takahashi M, Kawanishi J. Clinical reliability and utility of skin perfusion pressure measurement in ischemic limbs--comparison with other noninvasive diagnostic methods. J Vasc Surg. 2008 Feb;47(2):318-23. doi: 10.1016/j.jvs.2007.10.045.

ReferenceCitation: Zimmermann A, Roenneberg C, Reeps C, Wendorff H, Holzbach T, Eckstein HH. The determination of tissue perfusion and collateralization in peripheral arterial disease with indocyanine green fluorescence angiography. Clin Hemorheol Microcirc. 2012;50(3):157-66. doi: 10.3233/CH-2011-1408.

lead_sponsor: University Hospital, Grenoble


title: Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy: Prospective Longitudinal Study Over 12 Months.

acronym: LYMPHOS

summary: The purpose of this study is to assess changes of bone mineral density (BMD) at 12 months during the therapeutic management of patients with lymphoma.


title: Comparison of Two Noninvasive Positive Pressure Ventilation Devices Using Target Volume Modes in Obesity Hypoventilation Syndrome (OHS): A Pilot Randomized Crossover Controlled Trial

acronym: CIBLE

summary: Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a pre-determined "ideal tidal volume" or "ideal ventilation". However algorithms used to achieve these ideal targets are different among different commercialized devices and the relative efficacy from an algorithm compared to another remains unknown. The main objective is this study is to compare two commercialized NIPPV that have this option

lead_sponsor: AGIR à Dom

location_facility: Sleep Laboratory, Grenoble Univeristy Hospital


title: Phase II Trial of Oral Vinorelbine in Children With Recurrent or Progressive Unresectable Low-Grade Glioma

summary: The purpose of this study is to determine whether oral vinorelbine is effective in the treatment of children with progressive or recurrent unresectable low grade glioma.

lead_sponsor: Centre Oscar Lambret

location_facility:
CHRU Arnaud de Villeneuve
Centre Léon Bérard
Institut Gustave Roussy
CHU de Reims
Centre Oscar Lambret
CHU de Nancy
CHU d'Angers
CHU de Bordeaux
CHU de Limoges
Hôpital des Enfants
CHU de Rennes - Hôpital Sud
CHU de Grenoble
Institut Curie
CHU de Rouen
Hôpital Hautepierre
Hôpital de la TIMONE


title: Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study

summary:
There are still uncertainties about the existence of protective immunity and the duration of protective antibodies in patients infected with SARS-CoV-2. Serological testing is an appropriate tool for epidemiological investigations to assess the persistence of antibodies over time. The nature of the immune response induced by this virus is also poorly understood. This ancillary study aims at assessing the immunological characteristics of patients that participated in the NOSO-COR study at Hospices Civils de Lyon six and twelve months after the initial infectious episode.

Two visits will be scheduled at 6 and 12 months (± 1 month) after the initial SARS-CoV-2 infectious episode, Blood, saliva and nasopharyngeal samples will be collected for seroprevalence and immunological investigation.

location_facility: Service épidémiologie, Hopital édouard Herriot


title: Prospective KTD-innov Cohort of Kidney Transplants Patients

acronym: KTD-innov

summary:
Main objective: To constitute a prospective multicentre French cohort of kidney transplant recipients including clinical, biological and immunological evaluation combined with non-invasive biomarkers in peripheral blood and urine, and gene expression assessment in allograft biopsy in order to increase the performance of rejection diagnosis in kidney transplant patients.

the investigators hypothesise that the addition of non-invasive biomarkers and intragraft assessment of gene expression profiles will improve the diagnosis capacity of histology in kidney transplant recipients as it reveals pathophysiological pathways that are not captured by light microscopy.


title: A Prospective, Randomized, Multi-center Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization in a Population of Unrestricted Patients

acronym: PLATINUM+

summary:
The PROMUS Element™ clinical trial (PLATINUM-PLUS) consists of a randomized controlled trial (RCT) in the European Union (EU) which will enroll approximately 2980 subjects (2:1 randomization PROMUS Element™: Xience™ Prime) in a Population of consecutive, all comers in the reimbursed indications per-country

All subjects will be screened per the protocol required inclusion/exclusion criteria.

lead_sponsor: European Cardiovascular Research Center

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Azienda ULSS 9 Treviso; Ospedale "S. Maria di Ca' Foncello"

location_facility: Institut Hospitalier Jacques Cartier - ICPS

location_facility: Azienda Ospedaliero-Universitaria Pisana - MCV I°

location_facility: Azienda Ospedaliera "Ordine Mauriziano di Torino"


title: High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents

summary:
High sensitivity to targeted agents has been observed in patients whose tumor cells present a genetic/genomic deregulation of the target (Kit mutation, ERBB2 amplification, EGFR mutations) together with addiction to the given target. More recently, activation of "alternative pathways" (Kras mutation, PI3K mutations) have been reported as a common resistance mechanism to single agent tyrosine kinase inhibitors (trastuzumab, cetuximab).

From these data has emerged the hypothesis that identification of the deregulated pathway through new molecular tools could allow to propose a more tailored targeted regimen.

Based on these concepts, numbers of phase I/II trials enrich their populations in patients presenting specific molecular alterations.

High throughput technologies (array CGH, sequencing, gene expression array) identify deregulated genes. In addition, these technologies determine whether such genomic alterations are single (expected efficacy of single agent) or multiple (rationale for combination). In a pilot study that included 135 patients, we recently performed a combination of array CGH and hot spot mutation array in order to drive patients into phase I/II clinical trials. This study led to the conclusions that high throughput technologies i. are feasible (80%) and robust, ii. identify "targetable" genomic alterations in around 40% of samples.

In the present study, the investigators will perform high throughput technologies to drive 400 metastatic breast cancer patients into specific phase I/II trials.

ReferenceCitation: Andre F, Delaloge S, Soria JC. Biology-driven phase II trials: what is the optimal model for molecular selection? J Clin Oncol. 2011 Apr 1;29(10):1236-8. doi: 10.1200/JCO.2010.31.6877. Epub 2011 Feb 22.

ReferenceCitation: André F, Bachelot T, Commo F, Campone M, Arnedos M, Dieras V, Lacroix-Triki M, Lacroix L, Cohen P, Gentien D, Adélaide J, Dalenc F, Goncalves A, Levy C, Ferrero JM, Bonneterre J, Lefeuvre C, Jimenez M, Filleron T, Bonnefoi H. Comparative genomic hybridisation array and DNA sequencing to direct treatment of metastatic breast cancer: a multicentre, prospective trial (SAFIR01/UNICANCER). Lancet Oncol. 2014 Mar;15(3):267-74. doi: 10.1016/S1470-2045(13)70611-9. Epub 2014 Feb 7.

family: André

full_name: Fabrice André

given: Fabrice

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Commo

full_name: Frederic Commo

given: Frederic

family: Campone

full_name: Mario Campone

given: Mario

family: Arnedos

full_name: Monica Arnedos

given: Monica

family: Dieras

full_name: Véronique Dieras

given: Véronique

family: Lacroix-Triki

full_name: Magali Lacroix-Triki

given: Magali

family: Lacroix

full_name: Ludovic Lacroix

family: Cohen

full_name: Pascale Cohen

given: Pascale

family: Gentien

full_name: David Gentien

given: David

family: Adélaide

full_name: Jose Adélaide

given: Jose

family: Dalenc

full_name: Florence Dalenc

given: Florence

family: Goncalves

full_name: Anthony Goncalves

given: Anthony

family: Levy

full_name: Christelle Levy

given: Christelle

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

family: Bonneterre

full_name: Jacques Bonneterre

given: Jacques

family: Lefeuvre

full_name: Claudia Lefeuvre

given: Claudia

family: Jimenez

full_name: Marta Jimenez

given: Marta

family: Filleron

full_name: Thomas Filleron

family: Bonnefoi

full_name: Hervé Bonnefoi

given: Hervé

journal_name: The Lancet Oncology

lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie de l'Ouest/ René Gauducheau


title: Stimulation magnétique transcrânienne répétitive Dans le Traitement Des Troubles Obsessionnels Compulsifs

acronym: MAGTOC

summary: Evaluate the therapeutic effect of a functional Magnetic Resonance Imaging (fMRI)-guided and robotized neuronavigated theta burst Transcranial Magnetic Stimulation (TMS) targeting right inferior frontal region in resistant obsessive compulsive disorder (OCD) in a double-blind, randomized, placebo-controlled, monocentric study.

ReferenceCitation: Heyman I, Mataix-Cols D, Fineberg NA. Obsessive-compulsive disorder. BMJ. 2006 Aug 26;333(7565):424-9. Review.

ReferenceCitation: Denys D. Pharmacotherapy of obsessive-compulsive disorder and obsessive-compulsive spectrum disorders. Psychiatr Clin North Am. 2006 Jun;29(2):553-84, xi. Review.

ReferenceCitation: Barker AT, Jalinous R, Freeston IL. Non-invasive magnetic stimulation of human motor cortex. Lancet. 1985 May 11;1(8437):1106-7.

ReferenceCitation: Baxter LR Jr, Phelps ME, Mazziotta JC, Guze BH, Schwartz JM, Selin CE. Local cerebral glucose metabolic rates in obsessive-compulsive disorder. A comparison with rates in unipolar depression and in normal controls. Arch Gen Psychiatry. 1987 Mar;44(3):211-8. Erratum in: Arch Gen Psychiatry 1987 Sep;44(9):800.

ReferenceCitation: Li CT, Chen MH, Juan CH, Huang HH, Chen LF, Hsieh JC, Tu PC, Bai YM, Tsai SJ, Lee YC, Su TP. Efficacy of prefrontal theta-burst stimulation in refractory depression: a randomized sham-controlled study. Brain. 2014 Jul;137(Pt 7):2088-98. doi: 10.1093/brain/awu109. Epub 2014 May 10.

ReferenceCitation: Plewnia C, Pasqualetti P, Große S, Schlipf S, Wasserka B, Zwissler B, Fallgatter A. Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. J Affect Disord. 2014 Mar;156:219-23. doi: 10.1016/j.jad.2013.12.025. Epub 2013 Dec 28.

ReferenceCitation: Di Lazzaro V, Pilato F, Dileone M, Profice P, Oliviero A, Mazzone P, Insola A, Ranieri F, Meglio M, Tonali PA, Rothwell JC. The physiological basis of the effects of intermittent theta burst stimulation of the human motor cortex. J Physiol. 2008 Aug 15;586(16):3871-9. doi: 10.1113/jphysiol.2008.152736. Epub 2008 Jun 19.

ReferenceCitation: Prasko J, Pasková B, Záleský R, Novák T, Kopecek M, Bares M, Horácek J. The effect of repetitive transcranial magnetic stimulation (rTMS) on symptoms in obsessive compulsive disorder. A randomized, double blind, sham controlled study. Neuro Endocrinol Lett. 2006 Jun;27(3):327-32.

ReferenceCitation: Sarkhel S, Sinha VK, Praharaj SK. Adjunctive high-frequency right prefrontal repetitive transcranial magnetic stimulation (rTMS) was not effective in obsessive-compulsive disorder but improved secondary depression. J Anxiety Disord. 2010 Jun;24(5):535-9. doi: 10.1016/j.janxdis.2010.03.011. Epub 2010 Mar 29.

ReferenceCitation: Sack AT, Cohen Kadosh R, Schuhmann T, Moerel M, Walsh V, Goebel R. Optimizing functional accuracy of TMS in cognitive studies: a comparison of methods. J Cogn Neurosci. 2009 Feb;21(2):207-21. doi: 10.1162/jocn.2009.21126.

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location_facility: CHU de Grenoble - Pavillon Dominique Villars


title: Quality of Life and Dynamic Visual Acuity in Patients With Bilateral Vestibulopathy: the Impact of Covert-saccades

acronym: COSQOL

summary: Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. However, correcting saccades during rapid head movement, called covert-saccades, have been more recently identified. These saccades, which occur during the head movement in patients with vestibular hypofunction, present a very short latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease oscillopsia and visual impairment. The objective of this study is to evaluate the potential functional benefice of these compensatory movements in a population of 20 patients with chronic bilateral areflexia, in a cross-sectional study.

location_facility: Unité de Neuro-Ophtalmologie Hôpital Neurologique