title: Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of Hypersomnolence

acronym: Somnobank

summary: Chronic sleep disorders result from multiple pathophysiological mechanisms and are often associated with severe hypersomnolence, responsible for major disability. Hypersomnolence may be secondary to sleep disturbances at night by sleep fragmentation, both overall in restless leg syndrome (RLS) or specific to slow or paradoxical sleep in parasomnias (sleepwalking, sleep behavior disorder). paradoxical). Attention-Deficit / Hyperactivity Disorder (ADHD) is another cause of secondary hypersomnolence, unsolved pathophysiology, leading to a major disturbance of alertness. More rarely, hypersomnolence may be primary (central hypersomnia), representing then the most severe form existing in humans. The best-known central hypersomnia is narcolepsy type 1 (NT1), affecting 0.02% of the population. It is thanks to the existence of well-characterized clinical, biological and neuropathological patients that its pathophysiology is better understood. It is due to a selective loss of hypothalamic neurons secreting orexin / hypocretin, in connection with a probable autoimmune process, in genetically predisposed subjects. Narcolepsy type 2 (NT2), idiopathic hypersomnia (HI) and Kleine-Levin syndrome (SKL), are rarer forms of central hypersomnia, the pathophysiology of which is still unknown, due to the small number of patients studied.


title: Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery: Multicenter Prospective Registry of the Research in Vascular Surgery University Association (AURC)

acronym: VAP-AURC

summary: This multicentric, prospective study will evaluate the medium-term outcomes of patients implanted with GORE VIABAHN® stent grafts for popliteal artery aneurysms in scheduled elective surgery with the registry of the Research in Vascular Surgery University Association (AURC)

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital pneumologique et cardiovasculaire Louis Pradel (HCL)

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: Myocardial Perfusion, Coronary Flow Reserve and Kinetic Analysis During Dobutamine Stress Echocardiography

acronym: TRIPLESTRESS

summary:
Stress echocardiography is a screening test for coronary heart disease that already has good sensitivity and specificity (both around 70%). This examination is mainly offered to stable patients, consulting externally, in order to detect ischemic heart disease in the same way as would a myocardial scintigraphy or MRI stress. This examination is an echocardiographic modality consisting in visualizing and analyzing the modifications of the contraction of the cardiac muscle during a stress constituted by an effort or by injection of certain drugs. Stress echocardiography is performed by injection of drugs to reproduce the conditions of the effort. The products used to perform this examination are initially an intravenous infusion of dobutamine, atropine whose effect is to increase the heart rate, and in a second time, an intravenous infusion of beta-blockers or a bradycardic calcium channel blocker at the end of the procedure whose effect is to slow down the heart rate.

The use of echographic contrast medium, allowing a better visibility, is recommended for the realization of a stress ultrasound, since the echogenicity is judged insufficient on two segments (segmentation of the left ventricle in 17 segments).

The analysis of dobutamine stress echocardiography currently relies solely on the analysis of segmental kinetics, namely the quality of the thickening of the endocardium. When segmental kinetics are abnormal, patients benefit from a coronary CT scan or coronary angiography to visualize all the coronary arteries and to check whether there is a narrowing of the arteries.

Moreover, stress echocardiography performed using a contrast medium makes it possible to analyze two other indices in addition to segmental kinetics.

Thus, the second parameter that can be analyzed corresponds to the Coronary Flow Reserve measurement, thanks to the easy identification of the Doppler flow in the anterior interventricular at rest and peak of dobutamine. The coronal reserve is well validated with adenosine, but much less well known under dobutamine.

The third parameter that can be analyzed is myocardial perfusion. By using appropriate settings, it is possible to see the microbubbles in the thickness of the myocardium. These bubbles are then destroyed by an ultrasonic flash of high mechanical index. This results in the destruction of all intra-myocardial bubbles. The analysis of the myocardial perfusion is based on the rate of reappearance of these bubbles (through the coronary arteries) at rest and peak stress. In case of significant stenosis or coronary occlusion, there is a delay or complete absence of perfusion in the territory concerned.

Joint analysis of segmental kinetics, coronary reserve and myocardial perfusion has already been described with adenosine, but not with dobutamine. Studies in the literature suggest that the analysis of coronary reserve on the one hand, and myocardial perfusion on the other hand would increase the sensitivity and specificity of the examination. In addition, other studies suggest that among the tests considered normal for segmental kinetics analysis, there are patients with myocardial perfusion abnormality and / or coronary reserve abnormality that strike (s) on prognosis (alteration of the coronary microcirculation).

This is why it seems interesting to compare the results of these 3 indices obtained during stress echocardiography under dobutamine.

study_start_date_type: Actual

status: Recruiting

study_type: Interventional

primary_purpose: Diagnostic

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

intervention_type: Diagnostic Test


title: What Are the Palliative Care Needs of the Mahoran Population Take Into Consideration the Socio-anthropological Specificities of This Population, But Also the Demographic, Social, Health and Geographical Characteristics of Mayotte Island

acronym: SP-MAYOTTE

summary:
This qualitative study aims to explore the assessment of palliative care needs of the population living in Mayotte, French territory of the Comoros.

The aim is to offer a palliative care service tailored to the needs of the population in this area.

status: Completed

study_completion_date_type: Actual

time_perspective: Other

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Other

status_simplified: Completed


title: Study of the Effectiveness of a Venous Illumination System for Peripheral Venous Pathways in Cirrhotic Patients

acronym: CIRRVVUS

summary: The objective of this study is to evaluate the effectiveness of AccuVein AV400 to facilitate placement of peripheral intravenous catheters in cirrhotic adults by comparing the success rate of the first attempt to install a peripheral venous catheter with or without AccuVein AV400®.

design_allocation: Randomized

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Caen


title: Research of Anatomo-functional Biomarkers in Schizophrenia

acronym: CLOZAREST

summary: To objectify UR biomarkers, we propose a longitudinal follow-up of resistant patients with schizophrenia, starting before the onset of clozapine and including a multimodal brain imaging assessment (T1 and T2 weighted sequences, DTI, ASL-Perfusion, fMRI- Rest) associated with clinical and biological monitoring. In order to correct the MRI signal of clozapine hemodynamic effects, we will develop a new MRI methodology based on the concomitant collection of physiological parameters (blood pressure, electrocardiogram and respiration).

status: Unknown status

ipd_sharing: No

status_simplified: Unknown


title: Etude Observationnelle Biologique Sur le Syndrome de Sevrage Des Inhibiteurs de Tyrosine Kinase Dans la Leucémie Myéloïde Chronique.

acronym: KIWIS

summary: Patients who suffer from chronic myeloid leukemia are treated by tyrosin kinase inhibitors (TKI) saying imatinib, nilotinib, dasatinib, bosutinib and ponatinib. These drugs are highly efficient with excellent response allowing some patients to definitely stop their cancer treatment. However, in 30% of cases, when the treatment is stopped, pains could arise in shoulders, hips, joints… These symptoms occurring after the withdrawal of a drug are odd and biologically unexplained so far. This study seeks to discover the biological factors behind these symptoms called 'TKI withdrawal syndrome' by the scientific community.

ReferenceType: background

ReferenceCitation: Mahon FX, Réa D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Français des Leucémies Myéloïdes Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19.

family: Mahon

full_name: François-Xavier Mahon

given: François-Xavier

sequence: first

family: Réa

full_name: Delphine Réa

given: Delphine

sequence: additional

family: Guilhot

full_name: Joëlle Guilhot

given: Joëlle

full_name: François Guilhot

given: François

family: Huguet

full_name: Françoise Huguet

given: Françoise

family: Nicolini

full_name: Franck Nicolini

given: Franck

family: Legros

full_name: Laurence Legros

given: Laurence

family: Charbonnier

full_name: Aude Charbonnier

given: Aude

family: Guerci

full_name: Agnès Guerci

given: Agnès

family: Varet

full_name: Bruno Varet

given: Bruno

family: Etienne

full_name: Gabriel Etienne

given: Gabriel

family: Reiffers

full_name: Josy Reiffers

given: Josy

family: Rousselot

full_name: Philippe Rousselot

given: Philippe

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Rousselot P, Charbonnier A, Cony-Makhoul P, Agape P, Nicolini FE, Varet B, Gardembas M, Etienne G, Réa D, Roy L, Escoffre-Barbe M, Guerci-Bresler A, Tulliez M, Prost S, Spentchian M, Cayuela JM, Reiffers J, Chomel JC, Turhan A, Guilhot J, Guilhot F, Mahon FX. Loss of major molecular response as a trigger for restarting tyrosine kinase inhibitor therapy in patients with chronic-phase chronic myelogenous leukemia who have stopped imatinib after durable undetectable disease. J Clin Oncol. 2014 Feb 10;32(5):424-30. doi: 10.1200/JCO.2012.48.5797. Epub 2013 Dec 9.

ReferenceCitation: Richter J, Söderlund S, Lübking A, Dreimane A, Lotfi K, Markevärn B, Själander A, Saussele S, Olsson-Strömberg U, Stenke L. Musculoskeletal pain in patients with chronic myeloid leukemia after discontinuation of imatinib: a tyrosine kinase inhibitor withdrawal syndrome? J Clin Oncol. 2014 Sep 1;32(25):2821-3. doi: 10.1200/JCO.2014.55.6910. Epub 2014 Jul 28.

ReferenceCitation: Galimberti S, Fontanelli G, Barsotti S, Ricci F, Guerrini F, Baratè C. Increased values of the circulating PDGFβ sustains the "withdrawal syndrome" after tyrosine kinase inhibitor discontinuation in patients affected by chronic myeloid leukemia. Blood Cells Mol Dis. 2015 Oct;55(3):211-2. doi: 10.1016/j.bcmd.2015.06.010. Epub 2015 Jun 23.

ipd_sharing_description: Not apllicable


type: Other Identifier

title: Neurological Outcomes of Primary Intracerebral Haemorrhage Admitted in Intensive Care Unit at the University Hospital of Grenoble Alpes

acronym: HIP-REA

summary: The main objective of this study is to determine the one-year neurological outcome of patients admitted to an intensive care unit (ICU) for a primary and spontaneous supratentorial intracerebral hemorrhages (ICH).

time_perspective: Cross-Sectional

ipd_sharing: Undecided

lead_sponsor: University Hospital, Grenoble


title: Perceived Spasticity and Treatment Satisfaction Among Stroke Survivors Over the Course of a Complete Treatment Cycle With Botulinum Neurotoxin A (BoNT-A): an Ethnographic Study.

acronym: REBOT

summary: To investigate, through ethnography, changes in symptom burden and disability and their effects/interference on patient functioning, ability to perform activities of daily living (ADL) and quality of life (QoL) throughout the duration of one BoNT-A treatment cycle.

lead_sponsor: Ipsen

lead_sponsor_type: industriel


title: Deportalization, Venous Deprivation, Venous Congestion: Impact on Liver Volume and Function

summary:
Patients with multiple primary or secondary liver tumors have a low survival rate unless they can benefit from curative extended hepatic resections with R0 or R1 marge resection. Post-operative acute liver failure may occur after such surgery when the remnant liver is insufficient, leading to high morbimortality.

The future remnant liver (FRL) preoperative evaluation is then the key consideration before performing extended liver resection. The FRL volume measurement on computed tomography (CT) imaging is the most widespread method of FRL evaluation. Threshold values of acceptable FRL volume depend on the underlying liver function, it ranges from 20-30% in healthy liver to 40% in cirrhotic liver. However, it recently appeared that the FRL function would be more valuable in predicting post-operative liver failure. 99mTc-mebrofenin hepatobiliary scintigraphy (HBS) combined with SPECT/CT enables reliable FRL function measurement with a threshold value calculated at 2.69%/min/m2, to predict post-hepatectomy liver failure.

When the FRL evaluation does not reach the acceptable threshold values to avoid liver failure, portal vein embolization (PVE), consisting of portal branches occlusion of the future removed liver, can be performed. It is now the standard of care to induce FRL regeneration before surgery. Right PVE induces right hemiliver (S5-8) deportalization (portal input deprivation with hepatic venous drainage preservation) leading to left hemiliver (S2-4) regeneration.

To optimize PVE results, recent effective techniques have been developed such as the simultaneous embolization of the right portal branch and the right hepatic vein (HV), and the right accessory HV if so, which is called liver venous deprivation technique. Additional simultaneous embolization of the middle HV defined the extended liver venous deprivation (ELVD) technique. ELVD induces right liver (S5-8) venous deprivation (deprivation of both portal input and venous drainage) and leads to rapid increase in FRL function. After ELVD, segment IV (S4) portal input from left portal branch is preserved while its venous drainage through the middle HV is disrupted, resulting in venous congestion.

The aim of this study is to analyze the volumetric and functional evolutions after embolization procedures in deportalized liver (S5-8 after PVE), vein-deprived liver (S5-8 after ELVD) and congestive liver (S4 after ELVD).

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Interest of the Study of Electroencephalogram and Peripheral Vegetative Markers for the Evaluation of Nociception Under General Anesthesia.

acronym: BRAIN

summary:
General anesthesia (GA) is a state of loss of consciousness induced by anesthetic products. In a GA, two classes of products are usually used: on the one hand, hypnotics that are responsible for the sleep component (hypnosis) and memory loss (amnesia), and on the other hand opioids that have an analgesic role.

The doses of hypnotic and morphine necessary to achieve this state of loss of consciousness and lack of response to painful stimulation vary from subject to subject, and during surgery depending on the intensity of the stimulus, requiring permanent adaptation to avoid overdose or underdosing, responsible for morbidity.

Several monitors of the hypnotic component have been developed in recent years, which can now be used routinely, such as the Bispectral Index (BIS) or Spectral Entropy.

However, there is currently no clinically validated technique for monitoring pain or the effect of opioids in the operating room.

Spectral analysis of the electroencephalogram (EEG) revealed a significant decrease (-30%) in alpha spectral power, observed specifically in painful experimental conditions in healthy awake subjects. On the other hand, a painful experience is accompanied by transient changes in various parameters under vegetative control, whether cardiovascular, cutaneous or pupillary, essentially underpinned by the activation of the sympathetic system.

The investigators hypothesize that a real-time dynamic analysis of the spectral power of EEG combined with that of cardiovascular vegetative parameters, cutaneous conductance and pupillary diameter is likely to be a marker of nociception under GA.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Study of Shame Propensity as a Prognostic Factor of Suicidal Behaviors in Patients With Borderline Personality Disorder

acronym: SHOO

summary:
Borderline Personality Disorder (BPD) is a common psychiatric disorder occurring in 2 to 6% of the population. 70% of patients with BPD do at least one Suicide Attempt (SA) in their lives. It makes BPD the most related to SA condition.

Negative interpersonal events are among the main stressor inducing a SA. Patients with BPD are characterized by emotional dysregulation, impulsivity (repeated parasuicidal and suicidal behaviors), and instability in interpersonal relationships. The feeling of shame related to this psychiatric disorder could be one of the causes of the high SA rate. In this study, patients with BPD will be follow-up during 5 years.

The main objective is to study the propensity to feel shame as a predictor of SA.

This include:

Study of shame propensity as a predictive factor of suicidal behavior - Identify homogeneous subgroups of patients with BPD based on SA, and overall functioning.
Identify biological markers predicting SA
Identify predictive and protective treatments (pharmacological and psychotherapeutic) for SA

primary_purpose: Other


title: Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)

acronym: APSTOX

summary: Several drugs and chemotherapies seem to have an impact on the immune system. This study investigates reports of immune toxicities such as antiphospholipid syndrome, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

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

intervention_type: Drug


title: Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures

summary:
A specialized osteoporosis clinic has existed in our hospital since 2010. The descriptive retrospective analysis of patients included in this pathway was the subject of a first study on patients included between January 2010 and January 2011 and reported to the Congress of the French Society of Rheumatology (SFR) in December 2011, then a second study on patients included between January 2012 and December 2016, presented as an e-poster at the SFR Congress in December 2017 and in a poster at the American Society of Bone and Mineral Research Conference (ASBMR) in October 2018 and published in 2019 in Archives of Osteoporosis.

The effectiveness specialized osteoporosis clinics is the subject of numerous publications.

It therefore seems important to evaluate the effectiveness of our management, 3 years from the date of inclusion of patients in the osteoporosis clinic of our hospital.

lead_sponsor: Centre Hospitalier le Mans


title: Evaluation of the Impact of Coding the Fine Structure of the Sound on the Musical Perception in New Cochlear Implanted Subjects. Prospective Randomized Crossover Study.

summary:
Main objective:

Show the superiority of Fine Structure (FS4) strategy compared to Continuous Interleaved Sampling (HDCIS) strategy on the qualitative preference for the listening of musical pieces.

Secondary objectives

Show the superiority of FS4 strategy compared to the HDCIS strategy on the perception of musical elements (contour test).
Analyze the link between the results of musical perception tests and the subjective preference of musical listening.
Show the non inferiority of FS4 strategy compared to the HDCIS strategy on the perception of speech elements.
Analyze the link between the results of musical perception tests and the results of the perception of speech elements.
Analyze the qualitative multidimensional perception with HDCIS and FS4

lead_sponsor: MED-EL Elektromedizinische Geräte GesmbH


title: New Perioperative and Non-pharmacological Practices in Endometriosis at the Crossroad of Gynecology and Chronic Pain

acronym: EndoDOL

summary:
Endometriosis is a condition affecting about 10% of childbearing age women. It can begin a few months to a few years after puberty. It causes abdominal and pelvic pain that can be extremely debilitating, affecting the quality of patients life by affecting sexuality and fertility. Psychological repercussions are very important and underestimated. Patient care focuses most often on the "organ pathology treatment ".

This study proposes to evaluate a multidisciplinary patient care by insisting on anatomo-physiological pain management, psychological and bodily, in the perioperative phase.

The main objective is to evaluate benefit of psychological and corporal group management on the overall quality of life of patients with severe endometriosis in terms of endometriotic damage and/or functional and painful repercussions, requiring surgery, before or after this study

intervention_type: Behavioral


title: Validation of Optical Transcutaneous Sensors to Measure Capnia and Tissue Oxygenation

acronym: CTCO

summary: This study aims at validating new optical transcutaneous sensors to evaluate tissue capnia (CO2 partial pressure) and oxygenation (blood oxygen saturation) by comparing them to standard laboratory measurements (end tidal CO2 measurements and oxygen saturation by near-infrared spectroscopy).


title: Prevention of the Older Adult's Loss of Autonomy at Home Through a Physical Exercise Program Targeted at Adapted Muscle Strengthening Devices

acronym: PREPAD

summary:
Physical exercise program (PEP) have demonstrated their benefit to the health of older people. They are effective in functional performance and in the incidence and severity of falls.

We hypothesize that intervention with targeted Physical exercise programs PEP on appropriate muscle strengthening devices allows, through its action on the muscle, to slow down the loss of autonomy in the elderly living in the home. Our main objective is to evaluate the impact of a PEP, targeted on adapted muscle strengthening devices, on the loss of autonomy for the acts of daily life in the person aged over 70 living at home.

status: Active, not recruiting

primary_purpose: Prevention

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction

acronym: TELEMETRIE

summary: The aim of the study is to show that an ambulatory ECG telemetry monitoring of some patients hospitalized for cerebral infarction increases the frequency of the diagnosis of atrial fibrillation, cause of their stroke, and reinforces the protection against recurrences.

status: Terminated

lead_sponsor: Hopital Foch


title: Evaluation of Psychosomatic Spa Treatment With Crenotherapy to Potentiate the Implementation of Behavioral Measures for Insomnia Disorder Management

acronym: SOMNOTHERM

summary:
Persistant insomnia is a common sleep disorder that affects approximately 20% of the French population. The standard treatment for chronic insomnia is Cognitive-Behavioral Therapy (CBT).

Behavioral measures can be difficult to implement for the patient alone at home.

Spa therapy with psychosomatic orientation allows to implement hygiene rules and structure rhythms of life. In addition, recent studies have shown that spa treatment, including crenotherapy, is effective in somatic complaints related to anxiety and benzodiazepine withdrawal.

The spa treatment could therefore provide ideal conditions for the implementation of behavioral measures for insomnia management.

The objective of SOMNOTHERM study is to measure efficiency on insomnia complaints at 8 weeks of a the implementation of a Behavioral therapy program for insomnia delivered by an internet software combined to a spa treatment compared to implementation of the same program at home (standard care).

primary_purpose: Treatment

ipd_sharing_description: Patient could request investigator or Data Protection Officer an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004) and he EU General Data Protection Regulation (GDPR) of 27 april 2016 applicable since 25 May 2018.

lead_sponsor: Association Francaise pour la Recherche Thermale


title: Controlled Mean Arterial Pressure of Brain Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial in Critically Ill Patients in the Intensive Care Unit

acronym: COMAT

summary: The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in brain injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP (+/- 5 mmHg of the target MAP) compared to patients managed without any automated system (manually management)


title: Observed Pharmacokinetic of Piperacillin/Tazobactam in ICU Patients Compared to Therapeutic Drug Monitoring of Amikacin

acronym: OPTIMA

summary: The pharmacokinetics of antimicrobials is profoundly modified in Intensive care unit (ICU) patients. To adapt the treatment, it is recommended to measure blood levels of antibiotics. Some antibiotics, such as amikacin, are easy to monitor, while for other molecules, such as piperacillin/tazobactam, the drug monitoring is more difficult to obtain. These two molecules have similar physicochemical characteristics (hydrophilicity) and therefore have closed pharmacokinetic properties. OPTIMA is a study aiming at criteria will be used to judge whether the pharmacokinetic (PK) parameters of amikacin are predictive of those of piperacillin and tazobactam.

location_facility: Service d'Anesthésie et Réanimation - Secteur de Soins Critiques, Groupement Hospitalier Sud, HCL

intervention_type: Biological


title: Exploration of Cerebral Metabolism and Connectivity in Post Traumatic Stress Disorder (PTSD): Exploratory Study of Neurofunctional Modulation of Emotions by Music Therapy

acronym: TRACER

summary:
PTSD is a debilitating mental disorder that may develop after experiencing or witnessing a life-threatening event. With appropriate care, treatment efficiency is variable and around 20% of the patients do not respond to psychological treatment. Complementary treatments are needed.

as PTSD implied autonomic nervous system (ANS) dysfonction, complementary treatment focusing on ANS regulation, as welle as musicotherapy, may have an interest.

lead_sponsor: Institut de Recherche Biomedicale des Armees


title: Ovarian Reserve and Embryo Implantation

acronym: IRO

summary: Compare, in young patients with In vitro fertilization (IVF), the rate of embryo implantation by early culture transfer (J2-J3) between 2 groups of patients: "normo responders" vs. "poor responders".

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Is Cryopreserved Embryo Replacement is Associated With Higher Birthweight Compared With Fresh Embryo ? Sibling Embryo Cohort Study

summary: Birth weight (BW) is higher after frozen embryo transfer (FET) than after fresh embryo replacement. No study has compared the BW of siblings conceived using the same oocyte/embryo cohort. The aim of this study was to determine whether the freezing-thawing procedure is involved in such difference.


title: Is There a Place for Pre-operative Temporary Embolization of Uterine Fibroids

acronym: EMBOFIB

summary:
Uterine fibroids are the most common benign tumors of the female genital tract, with an estimated incidence of 25-80% during the reproductive period in the general population.

If the affected patients do not usually have any symptoms, uterine fibroids may also, depending on their location, be responsible for acute and chronic pelvic pain, bleeding and infertility.

Symptomatic uterine fibroids are now treated in the first line by surgery (hysterectomy, laparotomy myomectomy, laparoscopy or hysteroscopy). When conservative treatment is indicated and the fibroid is not hysteroscopically accessible, myomectomy can be performed by laparotomy or laparoscopy.

Excision of myomas often richly vascularized exposes the surgeon and the patient to a risk of bleeding per- and / or post-operative sometimes severe, resulting in an increase in operating times, an increased risk of postoperative complications and need transfusion.

The literature is rather poor on this subject but some factors favoring bleeding have been identified: the history of myomectomy, a uterine volume equivalent to more than 20 weeks of amenorrhea, the excision of more than 10 fibroids, or an incisional approach.

In order to reduce these intraoperative bleeds, numerous therapeutic strategies have been developed, using drug alternatives (GnRH agonists, Ullipristal) or interventional radiology (embolisation of the uterine arteries).

The improvement of interdisciplinary collaboration is now seeing the emergence of numerous therapeutic strategies combined.

The effectiveness of uterine artery embolization has been demonstrated for several years in the treatment of fibroids, alone or in combination with surgical myomectomy.

Some studies on preoperative embolization (maximum 24 hours before the intervention) have shown encouraging results with regard to the volume of bleeding, the need for per or post-operative transfusion or the need for surgical revision, or even decision to hystérectomie.

In 2011, Butori et al. propose the use of absorbable spongy particles (Curaspon type) for preoperative embolization. The use of these resorbable particles would reduce the risk of postoperative synechia. Some studies indicate that embolization of the uterine arteries using non-absorbable material would be responsible for ovarian failure by hypo-infusion. The use of absorbable material would avoid this adverse effect while preserving its effectiveness for the surgical procedure, but to date no study clearly demonstrates this.

This retrospective case-control study aims to compare the occurrence of per-and post-operative adverse effects between a test group consisting of patients who had undergone preoperative embolization (with resorbable material) before myomectomy (intervention group) and a control group with myomectomy without embolization (control group).


title: Evaluation of Response to Monoclonal Antibody Therapy in Severe Asthma: Research of Predictive Biomarkers in Exhaled Air

acronym: Zina-VOC

summary: This study evaluates the change in the composition of Volatil Organic Compounds (VOC) in patients treated by monoclonal antibody for severe asthma.


title: Perception and Representation of Internal Body in Anorexia Nervosa

acronym: PERCEPCOR

summary: This study focuses on representations of the interior of the body and interoceptive awareness in women with anorexia nervosa in comparison with women without eating disorders.

design_allocation: Non-Randomized

lead_sponsor: Centre Hospitalier Esquirol


title: Volatile Organic Compounds in Exhaled Air and Sweat of Patients Treated by Immunotherapy for Lung Cancer: Research on Biomarkers for Early Therapeutic Response

acronym: Immuno-VOC

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

Immunotherapy is a new therapeutic approach used in non small cell lung cancer in a late stage.

VOC analysis could allow to identify biomarkers of early response to immunotherapy. The study of VOC could help in the optimisation of immunotherapy prescription in lung cancer.


type: Registry Identifier

title: Bed Rest and Muscle Strength in Resuscitation Patients: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization

acronym: AFMPR

summary:
Muscles atrophy and weakness are common in intensive care units, their origin is multifactorial. Passive then active mobilization with cyclo-ergometer have shown to improve functional abilities and limit muscle weakness among intensive care unit patients. Electrical muscle stimulation should limit the atrophy and muscle weakness in intensive care unit associated with early mobilization.

This study aims to compare the association early cyclo-ergometer mobilization with electrical muscle stimulation versus cyclo-ergometer mobilization only to prevent muscle atrophy and weakness in intensive care unit.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'intruction des armées Clermont-Tonnerre


title: Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning

acronym: Endoth-Exvivo

summary:
The study population will be patients with planned double-lung transplant, with preoperative ex-vivo reconditioning procedure.

The ex-vivo procedure will be performed for lungs considered as limit to be directly implanted according to the national classification or in case of Maastrich 3 decision. They required a rehabilitation procedure like ex-vivo to determine their quality. Once the procedure initiated, the unused remaining liquid will be retrieved for the first gasometry usually performed. This will be the time T1 of sampling.

The unused remaining liquid will be retrieved for the gasometry of end of procedure usually performed, before the graft cooling. This will be the time T2.

The purge liquid of first lung at the declamping of the pulmonary artery will be retrieved at the time of unclamping (time T3 of sampling).

The purge liquid of the second lung at the declamping of the pulmonary artery will be retrieved with the same procedure (time T4 of sampling).

The samples will be analysed with ELISA technique. The endothelial dysfunction will be evaluated with plasma concentration of heparan sulphate, syndecan-1, endothelin-1 and i-NOS.


title: Population Pharmacokinetics of Amoxicillin in Neonates: Evaluation and Optimization of the Dose

acronym: NEOPOPI

summary:
The objective of NEOPOPI is to conduct a population pharmacokinetic study of amoxicillin in neonates, in order to evaluate and optimize neonatal dose regimen.

There will be no change to the medication treatment received by participants. An opportunistic pharmacokinetic sampling approach will be followed: samples will be scavenged from blood or cerebrospinal fluid drawn for routine biochemical tests. In this way, no additional invasive tests will be needed.

lead_sponsor: Rennes University Hospital


title: Cirrhotic Patients Admitted to the ICU With Septic Shock: Factors Predicting Short and Long-term Outcome

summary: Cirrhotic patients have a poor outcome in intensive care unit (ICU). Septic shock is a leading cause of ICU admission and death in this specific population. We performed a monocentric retrospective study; all cirrhotic patients admitted in the ICU with septic shock from 2002 to 2013 were included. The aim of the study was to identify prognostic factors for both short- and long-term mortality in these patients. Demographic, clinical and biological data, organ supports, and outcomes were collected. Univariate and multivariate analysis were carried out regarding both ICU and one-year mortality.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Médecine Intensive-Réanimation, Hôpital Edouard Herriot (HCL)


title: Effet de l'Impesanteur Sur la Distribution du débit Sanguin cérébral.

acronym: GraCer

summary:
When astronauts return from space flight, they manifest a set of symptoms, the most striking of which is orthostatic intolerance, that is, the inability to stay upright. This orthostatic intolerance is related to cardiovascular adaptation and disappears in a few days, but the prospect of long-term space travel makes this maladaptation a major concern of space agencies, at a time when there is serious consideration to make " land "a ship on Mars.

Previous studies suggest that brain vessel adaptation may contribute to spatial post-flight orthostatic intolerance. The question remains controversial because not all studies are consistent. These studies are all based on the measurement of blood flow in a single artery of the brain (the average cerebral, see cerebral circulation diagram) easily accessible with a Doppler ultrasound machine. Our team has good reason to believe that the adaptation of the cerebral vessels is not carried out in the same way in all the arteries of the brain and that in particular the arteries that irrigate the posterior and inferior parts of the brain are a major determinant. from cerebrovascular adaptation to orthostatism and that orthostatic intolerance is more specifically related to a decrease in blood flow in these arteries. On the other hand our team has shown that the external carotid artery plays, under certain conditions, a buffer role of the sudden variations of perfusion pressure of the brain.

During the weightless phase of parabolic flight, part of the blood from the legs and abdomen "rises" to the thorax and this transfer of fluid induces changes in blood pressure and cardiac output that affect the cerebral circulation. From a cardiovascular point of view, it is the same thing for a seated subject to lie down, but the parabolic flight offers the unique possibility of achieving this transfer in a fraction of a second and thus allowing to study the immediate response of the cerebral circulation. .

Investigators goal is therefore to quantify the changes in blood flow in the posterior and anterior territories of the brain (transcranial ultrasound) as well as in the internal carotid and vertebral (Doppler ultrasound) during changes in blood pressure and cardiac output induced by transfers. liquid resources associated with the transition to weightlessness.

The oxidative stress generated by weightlessness has been identified as a determining factor in cerebrovascular deconditioning associated with orthostatic intolerance. In order to quantify the biochemical markers of this stress, a venous sample will be taken before and just after the parabolic flight.

status: Enrolling by invitation

primary_purpose: Basic Science

lead_sponsor: University Hospital, Caen


title: A Prospective Study to Collect Images in Patients Treated With Iodine-131 as Part of a European Research Project in Radiation Protection.

acronym: MEDIRAD

summary:
This trial is a prospective, non-interventional, monocentric study aiming to collect standard of care imaging of patients treated with Iodine-131 for the determination of dosimetric studies.

Data from this study will be collected as part of an European research project called MEDIRAD.

The overall objectives of this project are to enhance the scientific bases and clinical practice of radiation protection in the medical field, and more specifically to develop and implement the tools necessary to establish the range of absorbed doses delivered to healthy organs in patients undergoing thyroid ablation and the threshold absorbed dose required for thyroid ablation. This will enable patient specific treatment planning that will minimize risk to the patient while ensuring a successful outcome and will facilitate development of a large scale epidemiological study of the effect of low absorbed doses from irradiation of normal organs with internal sources of radionuclides.

Patients will be followed as part of their standard of care. Imaging (SPECT/CT (Single Photon Emission Computed Tomography-Computerized Tomography) and Whole Body scintigraphy) performed at 48 hours post Iodine-131 treatment will be collected. Measures of external gamma radiation will also be collected in the European database.

lead_sponsor: Institut Claudius Regaud


title: Nosocomial Infections During Total Prostatic Cystectomies (TPC) With Replacement Enterocystoplasty: Prophylactic Role of Urell®, Cranberry Fruit Juice Extract (Vaccicium Macrocarpon)

acronym: Cranberry

summary:
Total prostatic cystectomy with enterocystoplasty is the most extensive urological surgical procedure and one with the highest complication rate, especially infectious complication. The mortality rate remains substantial (2 to 5%).

Examination of hundreds of TPCs made every year in the Urology Department of Foch Hospital, shows that nosocomial urinary infection is constant, especially when the TPC is followed by the constitution of an ileal bladder replacement.

This is due to the intervention itself and duration of postoperative urinary cathéters (ureteral and bladder). This leads to increase surveillance and antibiotic treatment, given the risks of declared infection in this context.

Detailed analysis of the last 20 TPCs with enterocystoplasty showed the presence of germs in significant numbers, in all cases.

Urell® (also sold under the Trademark Ellura®) contains a cranberry juice extract with a high content of bioactive, soluble Proanthocyanidins (PACs) . The daily dose is 36 mg total PACs measured by the DMAC/A2 method. The PACs prevent uropathogenic E.col bacteria from adhering to uroepithelial cells . Their long term use does not create any resistance of the bacteria.

The excellent prophylactic effet of Urell® had been previously observed in the same Center under different conditions.

Therefore a further demonstration was justified, of the prophylactic efficacy of Urell® in the perioperative setting of total prostato-cystectomy with substitute enterocytoplasty, where the slightest urinary infection, symptomatic or not, prolongs hospitalization and requires antibiotic treatment because of its harmful and sometimes major consequences.


title: Evaluation of the Effect of Custom Compression Garments on Standing Static Balance in Ehlers Danlos Syndrome

acronym: EDS

summary:
Studies have shown the existence of a proprioceptive deficit in patients with Ehlers Danlos Syndrome (EDS) (genetic pathology of connective tissue with hypermobility, multifactor joint instability). A study dating from 2010 showed a qualitative improvement in disability when wearing compression garments (CG) in this pathology, particularly in the fields of proprioception and balance.

The purpose of this study is to quantify the effect of CG on standing static balance in patients with EDS.

lead_sponsor: University Hospital, Toulouse

location_facility: Service de Medecine physique et réadaptation


type: EudraCT Number

title: Phase 1, Open-label Study, in Healthy Male Volunteers to Evaluate the Potential Effect of Indomethacin on the Pharmacokinetics Parameters of Elafibranor

summary: The enzyme responsible for the conversion of elafibranor into its active metabolite, GFT1007, has not been formally identified, but it is believed to have similar characteristics to an α,β-ketoalkene reductase previously identified in rat liver cytosol. In vitro studies in human liver cytosol fractions have shown that indomethacin inhibits the enzyme responsible of the transformation of elafibranor into GFT1007. As a result, indomethacin was included in the list of prohibited co-medications in all clinical trials with elafibranor, and a formal Drug-Drug Interaction (DDI) clinical study is being conducted to elucidate the effect of indomethacin on elafibranor pharmacokinetics.

lead_sponsor: Genfit

location_facility: Eurofins Optimed Clinical Pharmacology Unit


title: Exosomes and Resistance to Immunotherapy in Aggressive Non-Hodgkin B-cell Lymphomas (B-NHL)

acronym: ExoReBLy

summary: Diffuse large B-cell lymphomas (DLBCL) are highly aggressive and heterogeneous B-cell lymphoma that would imminently be fatal without treatment. Monoclonal anti-CD20 antibody, rituximab, in combination of CHOP chemotherapy (R-CHOP) is widely used with favourable results. Although more than half of patients achieve long-term remission, many are not cured with this immunotherapy. Suboptimal response and/or resistance to rituximab have remained a challenge in the therapy of DLBCL but also of all B-NHL. Exosomes are microvesicles released from tumor B cells that are found in plasma of patients with B-NHL. Exosomes carry therapeutic targets (as CD20, PDL-1) and could act as "decoy-receptors" for immunotherapy. Our objective is to precise, in aggressive B-NHL, the role of exosomes in immunotherapy escape.

lead_sponsor: University Hospital, Limoges


title: Identification of the Cutaneous Microbiota in Patients With Cutaneous Infection Admitted in the Department of Acute Infectious Diseases

summary: Identify the cutaneous microbiota on a cutaneous lesion (cellulite, wound, rash, etc.) on a swab, biopsies or abscess puncture and on "healthy" skin on a skin swab performed for cutaneous mapping to search for staphylococcal deposits.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Role of the Balano-preputial Furrow 's Microbiota, in Circumcised Patients or Not, in the Acquisition or Transmission of HIV

summary:
The human immunodeficiency virus (HIV) remains at the moment a major public health problem. The figures currently report 37 million people infected with HIV worldwide, as well as 2 million new infections every year, the majority of which are men who have sex with men (MSM).

HIV research has accounted for more than 335,000 publications on PubMed since its first description in 1981. However, many questions remain unanswered, especially regarding the risk factors and protective factors, its transmission and acquisition, during sexual intercourse. By creating a background on PubMed with the keyword "HIV", we can see that at the end of the 80's, it was already established that male circumcision decreased the risk of transmission of HIV by 50 to 60%. Multiple hypotheses have been studied to justify this discovery, such as the reduction of micro-traumatisms, the modification of keratinization, the modification of penile anatomy induced by foreskin removal. In parallel, the rise of the study of the human microbiota, which refers to all microorganisms (bacteria, viruses, archaea, fungi and parasites) living in a specific environment, the human body, and this in a healthy or pathological situation. There is evidence that the microbiota may be involved in the pathogenesis of various diseases and may play a major role in the homeostasis of the human body. This implication has also interested researchers in the field of HIV : the protective role of circumcision in the acquisition and transmission of HIV has therefore begun to be studied in terms of the modification of the penile microbiome.

The first studies showed that circumcision had an impact on the abundance of bacteria present in the penis in humans, and modified the aerobic / anaerobic ratio in favor of the increase of aerobic bacteria. The first hypothesis was that circumcision played a protective role in the acquisition and transmission of HIV through a decrease in the diversity of the penile microbiota and in particular anaerobes.

This discovery was disrupted by the emergence of studies tending to question a microbiota predisposing to the risk of HIV acquisition in both men and women.

Indeed, it has been shown that certain bacteria (Prevotella, Dialister, ...) could favor the acquisition of the virus by the attraction in their wake of inflammation cells such as CD4 and Langerhans cells which would facilitate by their presence. , the penetration of the virus. This hypothesis has been proven in studies of bacterial vaginosis, which is known to be a risk factor for HIV acquisition and transmission. In 2012, results showed that the loss of Lactobacillus, in favor of anaerobic increases such as Gardnerella, Atopobium, and Prevotella, increased this risk against the HIV virus. Similarly, 7 bacteria have recently been incriminated in this phenomenon of susceptibility to HIV acquisition (Parvimonas, Gemella asaccharolytica, Mycoplasma hominis, Leptotrichia / Sneathia, Eggerthellaspecies and Megasphaeraspecies).Being committed to the exploration of the human microbiota in particular by culture, we propose to extend the knowledge of balano-preputial furrow 's microbiota in patients infected by HIV or not and supported in department Infectious Diseases. It is in this context, that a preliminary study carried out at the IHU between January and July 2018 made it possible to describe the existence of variability of the microbiota according to various criteria such as circumcision, HIV infection and sexual practices.


title: Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction (STAND : iSchemic sTroke evAluated at Bed Side With ultrasouND)

acronym: STAND

summary:
The management of patients with ischemic stroke or transient ischemic attack is based on the preservation of a brain area by maintaining sufficient intracranial hemodynamics (IH) and with rapid recanalization.

The impact of the patient's position (supine or seated position) on the IH in the event of narrowing or occlusion of an artery is poorly assessed but may be of particular importance. Variations in blood flow according to the positioning of the patient's body are measurable using a transcranial Doppler.

The main objective is to verify whether intracerebral hemodynamic changes during early verticalization after ischemic stroke or transient ischemic attack are more frequent in patients with carotid stenosis or occlusion compared to those without stenosis or occlusion.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmique Adolphe de Rothschild


title: (1,3)-Béta-D-Glucan Levels at Diagnosis of Juvenile Idiopathic Arthritis and Its Correlation With Activity's Disease : a Cohort Sudy

acronym: BDG -JIA

summary: Juvenile idiopathic arthritis (JIA) is the most common pediatric rheumatic disease of childhood. Most children still experience prolonged periods of active disease, however, there is still lack of effective and specific markers for early diagnosis of relapse. The pathogenesis of JIA is thought to be the result of a combination of host genetic and environmental triggers and The microbiota is a potential contributing factor to the development of the disease. (1-3)-ß-D-Glucan (BDG), a component of most fungal cell walls, possess immunomodulatory activities. Latest studies demonstrate that it acts as a trigger for autoimmune arthritis in adult. However the relation with JIA is not clearly defined. The objective of this study was to evaluate the (1,3)-Béta-D-Glucans level in patients with JIA and whether higher serum BDG levels are correlated with JIA activity of disease, comparatively with usual markers.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit.

acronym: SERRATUS

summary: Pleural drainage under local anesthesia is a frequent practice in resuscitation, experienced as an unpleasant and painful event for patients. Pain management is an important issue for early rehabilitation, decrease hospitalisation's cost and shortening the length of stay in intensive care unit (ICU). A new type of locoregional anesthesia called Serratus plane block described by Blanco in 2013 showed a benefit in per and postoperative analgesia in thoracic surgery and carcinologic breast surgery, allowing a decrease in morphine use and an improvement of the patient's general satisfaction. Serratus plane block is a very effective technique in chest wall analgesia, easy and safe to perform, with few complications. No studies to date have evaluated this anesthetic practice in intensive care for pleural drainage. This technique could be used outside the operating room to improve the intensive care patients, who often have heavier pathologies and greater pain, such as patients with chest trauma or patients with cardiac or respiratory disease. The investigators would like to conduct a preliminary study of superiority in the CHU Amiens intensive care unit, to study the interest of the Serratus plane block in comparison with local anesthesia on the management of acute pain during pleural drainage.


title: Development of an Application for the Monitoring and Evaluation of Raynaud's Phenomenon

acronym: RaynaudMoni

summary: To evaluate the feasibility of using a smartphone application for monitoring and evaluation of Raynaud's Phenomenon.

ReferenceCitation: Wigley FM, Flavahan NA. Raynaud's Phenomenon. N Engl J Med. 2016 Aug 11;375(6):556-65. doi: 10.1056/NEJMra1507638. Review.

ReferenceCitation: Herrick AL. The pathogenesis, diagnosis and treatment of Raynaud phenomenon. Nat Rev Rheumatol. 2012 Aug;8(8):469-79. doi: 10.1038/nrrheum.2012.96. Epub 2012 Jul 10. Review.

ReferenceCitation: Seibold JR, Wigley FM. Editorial: Clinical Trials in Raynaud's Phenomenon: A Spoonful of Sugar (Pill) Makes the Medicine Go Down (in Flames). Arthritis Rheumatol. 2017 Dec;69(12):2256-2258. doi: 10.1002/art.40307. Epub 2017 Nov 10.

ReferenceCitation: Roustit M, Giai J, Gaget O, Khouri C, Mouhib M, Lotito A, Blaise S, Seinturier C, Subtil F, Paris A, Cracowski C, Imbert B, Carpentier P, Vohra S, Cracowski JL. On-Demand Sildenafil as a Treatment for Raynaud Phenomenon: A Series of n-of-1 Trials. Ann Intern Med. 2018 Nov 20;169(10):694-703. doi: 10.7326/M18-0517. Epub 2018 Oct 30.

name: Université Grenoble Alpes and Grenoble Alpes University Hospital, Grenoble, France (M.R., O.G., C.K., M.M., A.L., S.B., C.S., A.P., C.C., B.I., P.C., J.C.)

family: Roustit

full_name: Matthieu Roustit

given: Matthieu

name: Université de Lyon and Hospices Civils de Lyon, Lyon, France (J.G., F.S.)

family: Giai

full_name: Joris Giai

given: Joris

family: Gaget

full_name: Olivier Gaget

given: Olivier

family: Khouri

full_name: Charles Khouri

given: Charles

family: Mouhib

full_name: Myriam Mouhib

given: Myriam

family: Lotito

full_name: Adrien Lotito

given: Adrien

family: Blaise

full_name: Sophie Blaise

given: Sophie

family: Seinturier

full_name: Christophe Seinturier

given: Christophe

family: Subtil

full_name: Fabien Subtil

given: Fabien

family: Paris

full_name: Adeline Paris

given: Adeline

family: Cracowski

full_name: Claire Cracowski

given: Claire

family: Imbert

full_name: Bernard Imbert

given: Bernard

family: Carpentier

full_name: Patrick Carpentier

given: Patrick

name: University of Alberta, Edmonton, Alberta, Canada (S.V.)

family: Vohra

full_name: Sunita Vohra

given: Sunita

full_name: Jean-Luc Cracowski

given: Jean-Luc

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

ReferenceCitation: Fava A, Wung PK, Wigley FM, Hummers LK, Daya NR, Ghazarian SR, Boin F. Efficacy of Rho kinase inhibitor fasudil in secondary Raynaud's phenomenon. Arthritis Care Res (Hoboken). 2012 Jun;64(6):925-9. doi: 10.1002/acr.21622. Epub 2012 Jan 24.

ReferenceCitation: Denton CP, Hachulla É, Riemekasten G, Schwarting A, Frenoux JM, Frey A, Le Brun FO, Herrick AL; Raynaud Study Investigators. Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Randomized, Placebo-Controlled, Phase II Study. Arthritis Rheumatol. 2017 Dec;69(12):2370-2379. doi: 10.1002/art.40242.

family: Denton

full_name: Christopher P. Denton

given: Christopher P.

name: National Referral Centre for Rare Systemic Auto-immune Diseases; Department of Internal Medicine; Hôpital Huriez; University of Lille; Lille France

family: Hachulla

full_name: Éric Hachulla

given: Éric

name: Charité University of Medicine; Berlin Germany

family: Riemekasten

full_name: Gabriela Riemekasten

given: Gabriela

name: Johannes Gutenberg University; Mainz, and ACURA Rheumatology Centre RLP; Bad Kreuznach Germany

family: Schwarting

full_name: Andreas Schwarting

given: Andreas

name: Actelion Pharmaceuticals Ltd.; Allschwil Switzerland

family: Frenoux

name: The University of Manchester; Salford Royal NHS Foundation Trust and NIHR Manchester Musculoskeletal Biomedical Research Centre; Central Manchester NHS Foundation Trust; Manchester Academic Health Science Centre; Manchester UK

name: on behalf of the Raynaud Study Investigators

repository_institution: The University of Manchester - Research Explorer

ReferenceCitation: Maricq HR, Carpentier PH, Weinrich MC, Keil JE, Franco A, Drouet P, Ponçot OC, Maines MV. Geographic variation in the prevalence of Raynaud's phenomenon: Charleston, SC, USA, vs Tarentaise, Savoie, France. J Rheumatol. 1993 Jan;20(1):70-6.


title: Regulation of IL33, Endocan and Their Targets in Primary Human Endothelial Cells

summary:
The study aims to investigate the inflammatory response of endothelial cells to various stimulations, in particular the production of IL33 and of endocan in response to allergens, agonists of microorganisms and pollutants.

For that purpose, this project attempts to set up a biological collection of lung and umbilical cord endothelial cells.

Lung endothelial cells are resected from a surgical specimen, resulting from a lung cancer surgery.

Umbilical cord-derived endothelial cells are taken from the umbilical cord collected during the delivery.

lead_sponsor: University Hospital, Lille


title: Predictive Markers of Immune-related Adverse Events in Patients Treated With Immune Stimulatory Drugs

acronym: PREMIS

summary: The prospect of effective immunotherapies for the treatment of patients with cancer is now a clinical reality thanks to the approval of monoclonal antibodies (mAbs) specifically blocking immune checkpoints or ligands such as CTLA-4, PD-1 and PD-L1. However, these drugs can also induce inflammatory and/or auto-immune complications (Immune-related Adverse Events; IrAE). IrAE can affect all tissues and sometimes irreversibly. IrAE may be severe or fatal in the absence of timely and adequate care with anti-inflammatory drugs (steroids) or more specific immunosuppressants. Thus, IrAE are a new type of toxicities in oncology and represent one of the major limitations for the development of immunotherapy combination therapies. These IrAE are yet unpredictable. Indeed, the induction of immunity relies on the host's immune status and it differs from one patient to another and so far nobody has identified the underlying mechanisms responsible for irAE outbreaks.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Procedure


title: Comparison of the Study Was to Compare Sequential Fluoroscopy Guidance With Spiral Guidance in Terms of Safety (Number of Major Complications), Effectiveness (Number of Targets Reached), Speed (Procedural Time) and Radiation (DLP) in Interventional Chest-abdomen-pelvic Procedures.

acronym: APIR-TDM

summary: The purpose of the study was to compare sequential fluoroscopy guidance with spiral guidance in terms of safety (number of major complications), effectiveness (number of targets reached), speed (procedural time) and radiation (DLP) in interventional chest-abdomen-pelvic procedures.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?

acronym: FatSEP

summary:
Chronic fatigue is the most common and debilitating symptom in multiple sclerosis patients. This chronic fatigue affects their quality of life by decreasing their capacity to perform simple tasks of daily life.

The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in this feeling of chronic fatigue. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology will allow to optimize rehabilitation treatments to decrease the apparition/persistence of chronic fatigue and in fine improve quality of life.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Analgesia Nociception Index (ANI) for Pain and Anxiety Assessment in Palliative Care : a Pilot Study in University Hospital of Rennes

acronym: ADA-Pallia

summary:
The main objective of this study is to evaluate the correlation between ANI and pain scores and the correlation of ANI and anxiety scores in communicative patients in palliative care.

The chosen event with a risk of pain and/or anxiety is the first bed bath after admission. The secondary objectives aim to identify ANI score thresholds which would be predictive of pain and/or anxiety and to figure out some individual factors influencing ANI scores.

location_facility: Centre Hospitalier Universitaire de Rennes


title: Use of Imaging Flow Cytometry for Immunophenotyping Coupled With Cytogenetic Abnormalities Detection by Fluorescent in Situ Hybridization (FISH) and Applicability in Cytogenetic Risk Stratification of Multiple Myeloma (CIF-PM)

acronym: CIF-PM

summary: A pioneer study demonstrated a proof of concept for IS-FISH with the new ISX technology. This state of the art technology has been recently acquired by the CHU of Amiens. In the present study the investigators want to establish a workflow for simultaneous immunostaining and characterization of FISH cytogenetic pathological signals with the imaging flow cytometer ISX, such as chromosomic gains, losses and translocations in multiple myeloma (MM). The gold standard technology for the detection of prognostic cytogenetic aberrations in MM is a FISH analysis after bone marrow (BM) plasma cells sorting (PCS).2,3 In MM, plasma cells isolation is usually based on CD38 and/or CD138 expression. Cytogenetic risk stratification is guided by the detection of 4 chromosomal aberrations: TP53 and CDKN2C deletions, CKS1B gains and t(4;14) translocation. Thanks to ISX technology the investigators may avoid cumbersome task of cell sorting (outsourced service for our hospital) meanwhile measuring precisely and qualitatively aberrant FISH signals on a large amount of cells.

status: Withdrawn


title: Dupilumab Impact on Skin Resident Memory T Cells

acronym: DupiTrem

summary:
The main objective of the study consists in characterizing the immune cells that are present/persist in the skin and the blood of atopic dermatitis (AD) patients treated with Dupilumab, as well as with potent/very potent topical corticosteroids (TCS: betamethasone valerate cream 0.1% or clobetasol propionate cream 0.05%). A specific attention will be paid on the presence/persistence of skin Trm and ILCs.

The study population will consist of 20 adult patients suffering from moderate to severe Atopic Dermatitis and eligible for Dupilumab treatment. (Patients should have inadequate response, intolerance or contraindication to systemic anti-inflammatory treatments).

This is an exploratory, prospective, single-site, randomized, open labeled study. There is a treatment period of 168 days (24 weeks) and a post-treatment follow-up period of maximum 102 days.

lead_sponsor: Association pour la Recherche Clinique et Immunologique

location_facility: Service d'Allergologie et Immunologie Clinique - Hôpital Lyon Sud


title: Multicenter Double Blind Randomized Placebo-controlled Trial Assessing the Efficacy of Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults Treated for a Tumoral Disease

acronym: MUCILA

summary: To assess the efficacy of preventive Low-Level Laser Therapy (LLLT) for reducing the incidence of WHO's grade 3-4 oral mucositis in children and young adults receiving chemotherapy regimens associated with a high rate ofmucositis: conventional chemotherapy or High Dose Chemotherapy (HDC) conditioning regimens with Hematological Stem Cell Transplantation (HSCT).


title: Comparison of Two Methods for Assessing Cough Capacity in Intensive Care Unit After Cardiac Surgery: Parietal Ultrasound vs. Peak Expiratory Cough Flow

acronym: DEPT

summary:
Weaning from mechanical ventilation represents 50% of the time spent under mechanical ventilation (1). The risk factors identified in the failure to wean from mechanical ventilation are:

left heart dysfunction with LVEF < 30%.
an ineffective cough
presence of resuscitation neuromyopathy
mechanical ventilation time >7 days
presence of a delirium
age >65 years old
abundant bronchial secretion
presence of underlying lung pathology An ineffective cough is found in 40% of patients requiring reintubation. However, cough assessment is most often approximate, based on a subjective assessment of cough strength by asking the patient to cough spontaneously on his or her tube).

The objective evaluation of cough is based on the measurement of the peak expiratory flow rate at cough, commonly referred to as peak expiratory flow rate at cough (PEFD), the patient is asked to take a deep breath and then cough as hard as possible.

Subjective cough assessment does not predict the occurrence of ventilatory withdrawal failure. Conversely, all studies that objectively assessed the strength of cough before extubation by measuring the PEFD found a significant association with the outcome of extubation: a low PEFD increases the risk of extubation failure by a factor of 5 to 9.

The investigators hypothesize that the increase in parietal abdominal muscle contraction obtained by using a non-invasive ultrasound method indicates an effective cough. Conversely, an ineffective cough can be detected by this simple ultrasound criterion, which can be performed at the patient's bedside and extrapolated to all intensive care units equipped with an ultrasound scanner. This evaluation will be carried out before extubation: during the spontaneous ventilation test on a tube in a half-seated position (>45°) and within 24 hours after extubation.

lead_sponsor: Centre Chirurgical Marie Lannelongue


title: A Phase II Whole Exome Secquencing-based Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors

acronym: MATILDA

summary: To determine the efficacy (as measured by overall tumour response rate) of the combination of durvalumab and tremelimumab when given to previously treated patients with solid tumors harboring a high mutational load.


title: ISILI (In Situ Immunotherapy of LIver Metastases): An Openlabel, Dose-finding, Phase I Study of Intratumoral Ipilimumab and TLR4 Agonist GLA-SE in Combination With Systemic Nivolumab and Chemotherapy (FOLFOX Regimen) in Patients With Colorectal Liver Metastases.

acronym: ISILI

summary: To determine the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D) and the toxicity profile (NCI CTCAE v5.0 and immune related adverse events) of i.t. administration of anti-CTLA4 antibody (ipilimumab) and TLR4 agonist (synthetic glucopyranosyl lipid A formulated in a stable emulsion [GLA-SE]) in colorectal LM (CRLM) in combination with intravenous (i.v.) administration of anti-PD-1 antibody (nivolumab) and chemotherapy (FOLFOX regimen).


title: Assessment of the Quality of Life for Patients Suffering From Isolated Endometriosic Lesion of Utero-sacral Ligaments Diagnosed by MRI, Before and After Surgical Treatment by Using French Version of Endometriosis Health Profile 30 (EHP30)

acronym: ENDOLUS

summary:
Assessment of the quality of life for patients suffering from isolated endometriosic lesion of utero-sacral ligaments diagnosed by MRI, before and after surgical treatment by using French version of Endometriosis Health Profile 30 (EHP 30).

This is prospective, non-controlled, non-randomized, monocentric, observational feasibility study.

lead_sponsor: University Hospital, Grenoble


title: Study of the Neuronal Substrates of the Cognitive Action Control in Parkinson's Disease Using High Density EEG

acronym: EEGControl

summary: Cognitive action control allows resisting to irrelevant information to easily produce desired goal-directed behaviors. This cognitive process is disturbed in patients with Parkinson's disease (PD). However, the neural signature of this impairment has not been clarified yet. Several studies using electroencéphalography (EEG) showed that conflict situations in healthy participants are inevitably associated with a power increase of neuronal oscillations in the theta frequency band (~4-8Hz) in the medial frontal cortex (MFC). Conflict situations are also associated with theta functional connectivity between the MFC and task-relevant brain areas. The theta power increase and connectivity are respectively interpreted as a marker of the integration of conflicting information and as a candidate for communication between the brain areas involved in implementing cognitive action control. The objective of this project is to test the hypothesis that the deficit of cognitive action control observed in PD comes from a lack of integration of the conflict information and / or communication of this information between the MFC and other task-relevant brain areas. Investigators willl study this cognitive process using a classic conflict task, the Simon task, and by recording brain activity using high density EEG coupled with cortical source connectivity analyses. The results will allow us to evaluate whether theta oscillations can serve as a marker of cognitive control disorders in Parkinson's disease.

lead_sponsor: Rennes University Hospital


title: Comparative Study of Peripheral Facial Paralysis Sequelae Based on the Initial Medical Care of Lyme Disease Among Children

acronym: LYMEPED

summary:
Neuroborreliosis (NB) is the second most frequent manifestation of Lyme disease. Painful meningoradiculitis is the most common neurologic manifestation in adults while facial nerve palsy (FP) and lymphocytic meningitis is predominant in children. FP is a common reason for pediatric consultation and FP due to Lyme borreliosis (LB) represents about 50% of the child's FP in an endemic area.

The action to be taken is not formally defined for a child consulting for FP in a Lyme disease endemic area.

The new recommendations of the High Authority of Health of June 2018 recommend to carry out a blood serology in first intention, in search of a NB in a child consulting for a peripheral facial paralysis. If this is positive, a lumbar puncture will be performed in search of meningitis. In the case of negative serology, a close clinical surveillance and sometimes serological control is necessary, in order to reassess the diagnosis. In adult recommendations, a lumbar puncture is performed first in any patient consulting for facial paralysis in LB endemic area.

The main objective of this study was to describe the clinical and biological characteristics of pediatric NB with FP. Others objectives were to describe the diagnostic and therapeutic behavior of a child consulting at university hospital for a facial nerve palsy, to compare the initial gravity of facial nerve palsy, the duration of the paralysis and sequels depending on the diagnosis and treatment initiated.


title: Management of Perioperative Anxiety by the Fixed Rate Guided Breathing Technique (Cardiac Coherence) Coupled With a Hypnosis Session, as Part of the Improved Pre-habilitation After Surgery

acronym: COHEC

summary: the investigator proposes to use the cardiac coherence technique coupled with a hypnosis session to improve post-operative recovery.

ReferenceCitation: Pekcan M, Celebioglu B, Demir B, Saricaoglu F, Hascelik G, Yukselen MA, Basgul E, Aypar U. The effect of premedication on preoperative anxiety. Middle East J Anaesthesiol. 2005 Jun;18(2):421-33.

ReferenceCitation: Van den Bosch JE, Moons KG, Bonsel GJ, Kalkman CJ. Does measurement of preoperative anxiety have added value for predicting postoperative nausea and vomiting? Anesth Analg. 2005 May;100(5):1525-1532. doi: 10.1213/01.ANE.0000149325.20542.D4.

ReferenceCitation: Muñoz HR, Dagnino JA, Rufs JA, Bugedo GJ. Benzodiazepine premedication causes hypoxemia during spinal anesthesia in geriatric patients. Reg Anesth. 1992 May-Jun;17(3):139-42.

ReferenceCitation: Agelink MW, Majewski TB, Andrich J, Mueck-Weymann M. Short-term effects of intravenous benzodiazepines on autonomic neurocardiac regulation in humans: a comparison between midazolam, diazepam, and lorazepam. Crit Care Med. 2002 May;30(5):997-1006.

ReferenceCitation: Lepousé C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. Epub 2006 May 2.

ReferenceCitation: McCraty R, Atkinson M, Tiller WA, Rein G, Watkins AD. The effects of emotions on short-term power spectrum analysis of heart rate variability . Am J Cardiol. 1995 Nov 15;76(14):1089-93. Erratum in: Am J Cardiol 1996 Feb 1;77(4):330.

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

location_facility: Institut régional du cancer de Montpellier


title: Systematic Self-screening of Insomnia and Proposition of a Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors: A Pilot Study

summary:
SLEEP-4-ALL-1 is a pilot and ecological study corresponding to the developpement phase of a randomized controlled multicentric trial SLEEP-4-ALL-2. The main objective of this second study will be the validation of a stepped-care model in the treatment of persistant insomnia in cancer patients.

The primary objective of SLEEP-4-ALL-1 is to determine the acceptability of a self-screening for insomnia in cancer outpatients at Gustave Roussy.


title: Identification of the Physical and Dietary Profile on Constitutionally Lean People: the NUTRILEAN Study

acronym: Nutrilean

summary: The aim of this study will be to identify the physical and dietary profile of adult women presenting constitutional leanness (CL), comparatively with normal-weight peers and BMI-matched women with anorexia nervosa. After an evaluation of their daily energy intake, physical activity level, body composition, aerobic capacities and muscle strength, women from the normal weight and CL groups will be asked to realized laboratory sessions to evaluate their energy intake and appetite feelings responses to acute exercise

lead_sponsor: University Hospital, Clermont-Ferrand


title: Study of the Quality of Life in Patients With Standard External Breast Prosthesis Compared to Patients With Custom-made Breast Prosthesis. MEAVANTI Project.

acronym: MEAVANTI

summary: Despite improvements in surgical techniques, approximately 30% of mastectomies are still performed. Definitively or temporarily, one of the alternatives to restore a volume in the bra is the external breast prosthesis. The main objective is to evaluate whether the "custom-made" MEAVANTI prosthesis improves the quality of life of patients who have had a mastectomy compared to the external standard prosthesis.


title: Comparison Between the Neuromuscular Blockade Onset Monitoring and the Expectation of a Fixed Delay After Curarization on the Quality of Laryngoscopy During Intubation in Elective Surgery (MONITURARE)

acronym: MONITURARE

summary: During anesthetic induction, the relevance of neuromuscular blockade (NMB) onset monitoring cannot be asserted and its superiority over waiting for a fixed delay (corresponding to pharmacokinetic knowledge of the neuromuscular blocking agent used) has not been proven. However, many studies have shown a large inter-individual variability on the delay of the NMB onset. The main objective of othe investigator's study is to compare the quality of laryngoscopy during intubation between the NMB onset monitoring and the expectation of a fixed delay after curarization

lead_sponsor: Poitiers University Hospital


title: Collection of Biological Samples for Stydy of Unusual Toxicity Induced by Radiotherapy

acronym: CRYOTOX

summary: In order to evaluate the physiopathological knowledge of the different pathological manifestations associated with individual radiosensitivity, it seems essential to carry out this pilot study. It has agglomerated homogeneous tissue samples to identify new biomarkers for patient diagnosis and follow-up, and may predict the therapeutic response. These knowledge will help to treatment customization.

lead_sponsor: Institut de Cancérologie de Lorraine


title: Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase

summary:
There are very few data on the safety of Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs), especially abatacept which compared to Tumor Necrosis Factor α (TNFα) inhibitors has distinct mechanism of action. Abatacept is a recombinant fusion protein of human Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) and the Fc region of human immunoglobulin gamma-1 (IgG1). This CTLA4-fusion protein blocks the signal of T cell activation by binding to CD80 and CD86.

Recently, the investigator's study found in a US cohort of 64,000 patients with Rheumatoid Arthritis (RA) a potential signal for a higher risk of cancer overall and particularly non-melanoma skin cancer with abatacept compared to other bDMARDs (article in press). These results were in accordance with another prospective cohort study of the public health care system in Sweden, showing an increased risk of NMSC in abatacept users compared with TNFα inhibitors. As these results warrant replication, the present study will assess whether abatacept is associated with an increased risk of reporting overall cancer and specific cancer, including breast, lung, lymphoma, cervical, melanoma and NMSC, compared to other bDMARDs.

ReferenceType: derived

ReferenceCitation: de Germay S, Bagheri H, Despas F, Rousseau V, Montastruc F. Abatacept in rheumatoid arthritis and the risk of cancer: a world observational post-marketing study. Rheumatology (Oxford). 2020 Sep 1;59(9):2360-2367. doi: 10.1093/rheumatology/kez604.

name: Department of Medical and Clinical Pharmacology, Centre of Pharmacovigilance and Pharmacoepidemiology, Toulouse University Hospital, Faculty of Medicine, Toulouse, France

name: INSERM, UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, CIC 1426 - University Paul Sabatier Toulouse, Toulouse, France

family: de Germay

full_name: Sibylle de Germay

given: Sibylle

family: Bagheri

full_name: Haleh Bagheri

given: Haleh

name: Clinical Unit of Cancer Pharmacology, Toulouse University Hospital, Faculty of Medicine, Toulouse, France

family: Despas

full_name: Fabien Despas

family: Rousseau

full_name: Vanessa Rousseau

given: Vanessa

family: Montastruc

full_name: François Montastruc

given: François

journal_name: Rheumatology

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: University Hospital, Toulouse


title: Effect of Hyperbaric Oxygen Therapy on Healthy Volunteers Microcirculation

acronym: MICROHB

summary:
Previous studies shoes that hyperoxia alters microcirculation.The investigators hypothesize that hyperbaric may restore microcirculation integrity. This hypothesis is supported by a recent study in rabbits, but no data exists for humans.

The study will expose fifteen healthy volunteers to a succession of different fraction of inspired oxygen and barometric pressure and assess microcirculatory and macrocirculatory changes via sidestream dark field videomicroscopy, near-infrared spectroscopy, Laser Doppler, transthoracic echocardiography and bio-impedancemetry at every step.


title: Role of Surgery in Advanced Ovarian Cancer

summary: To demonstrate that ultra-radical surgery with multiple visceral resections and high tumor burden prior to surgery independently reduces the survival of patients with advanced ovarian cancer treated with complete cytoreductive surgery.

ReferenceType: result

ReferenceCitation: Bristow RE, Chi DS. Platinum-based neoadjuvant chemotherapy and interval surgical cytoreduction for advanced ovarian cancer: a meta-analysis. Gynecol Oncol. 2006 Dec;103(3):1070-6. Epub 2006 Jul 27.

ReferenceCitation: Vergote I, Tropé CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806.

family: Vergote

full_name: Ignace Vergote

given: Ignace

family: Tropé

full_name: Claes G. Tropé

given: Claes G.

family: Amant

full_name: Frédéric Amant

given: Frédéric

family: Kristensen

full_name: Gunnar B. Kristensen

given: Gunnar B.

family: Ehlen

full_name: Tom Ehlen

given: Tom

family: Johnson

full_name: Nick Johnson

given: Nick

family: Verheijen

full_name: René H.M. Verheijen

given: René H.M.

family: van der Burg

full_name: Maria E.L. van der Burg

given: Maria E.L.

family: Lacave

full_name: Angel J. Lacave

given: Angel J.

family: Panici

full_name: Pierluigi Benedetti Panici

given: Pierluigi Benedetti

family: Kenter

full_name: Gemma G. Kenter

given: Gemma G.

family: Casado

full_name: Antonio Casado

given: Antonio

family: Mendiola

full_name: Cesar Mendiola

given: Cesar

family: Coens

full_name: Corneel Coens

given: Corneel

family: Verleye

full_name: Leen Verleye

given: Leen

family: Stuart

full_name: Gavin C.E. Stuart

given: Gavin C.E.

family: Pecorelli

full_name: Sergio Pecorelli

given: Sergio

family: Reed

full_name: Nick S. Reed

given: Nick S.

journal_name: New England Journal of Medicine

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

version: publishedVersion

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

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

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

title: Neoadjuvant Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Cancer

ReferenceCitation: du Bois A, Reuss A, Pujade-Lauraine E, Harter P, Ray-Coquard I, Pfisterer J. Role of surgical outcome as prognostic factor in advanced epithelial ovarian cancer: a combined exploratory analysis of 3 prospectively randomized phase 3 multicenter trials: by the Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR) and the Groupe d'Investigateurs Nationaux Pour les Etudes des Cancers de l'Ovaire (GINECO). Cancer. 2009 Mar 15;115(6):1234-44. doi: 10.1002/cncr.24149.

title: Role of surgical outcome as prognostic factor in advanced epithelial ovarian cancer: A combined exploratory analysis of 3 prospectively randomized phase 3 multicenter trials

ReferenceCitation: Eisenkop SM, Spirtos NM, Friedman RL, Lin WC, Pisani AL, Perticucci S. Relative influences of tumor volume before surgery and the cytoreductive outcome on survival for patients with advanced ovarian cancer: a prospective study. Gynecol Oncol. 2003 Aug;90(2):390-6.

ReferenceCitation: Chi DS, Franklin CC, Levine DA, Akselrod F, Sabbatini P, Jarnagin WR, DeMatteo R, Poynor EA, Abu-Rustum NR, Barakat RR. Improved optimal cytoreduction rates for stages IIIC and IV epithelial ovarian, fallopian tube, and primary peritoneal cancer: a change in surgical approach. Gynecol Oncol. 2004 Sep;94(3):650-4.

ReferenceCitation: Chi DS, Eisenhauer EL, Zivanovic O, Sonoda Y, Abu-Rustum NR, Levine DA, Guile MW, Bristow RE, Aghajanian C, Barakat RR. Improved progression-free and overall survival in advanced ovarian cancer as a result of a change in surgical paradigm. Gynecol Oncol. 2009 Jul;114(1):26-31. doi: 10.1016/j.ygyno.2009.03.018. Epub 2009 Apr 23.

ReferenceCitation: Chi DS, Zivanovic O, Levinson KL, Kolev V, Huh J, Dottino J, Gardner GJ, Leitao MM Jr, Levine DA, Sonoda Y, Abu-Rustum NR, Brown CL, Barakat RR. The incidence of major complications after the performance of extensive upper abdominal surgical procedures during primary cytoreduction of advanced ovarian, tubal, and peritoneal carcinomas. Gynecol Oncol. 2010 Oct;119(1):38-42. doi: 10.1016/j.ygyno.2010.05.031. Epub 2010 Jul 6.

ReferenceCitation: Schulman-Green D, Ercolano E, Dowd M, Schwartz P, McCorkle R. Quality of life among women after surgery for ovarian cancer. Palliat Support Care. 2008 Sep;6(3):239-47. doi: 10.1017/S1478951508000497.

location_facility: Institut Claudius Regaud - IUCT-Oncopole


title: Development and Validation of a Simple Diagnostic Tool Predictive of the Aseptic Character of Joint Effusion

acronym: PRASEPT

summary: Development and validation of a simple diagnostic tool predictive of the aseptic character of joint effusion in the primary care setting.

lead_sponsor: Centre Hospitalier le Mans


title: Evaluation of Double HER2 Blocking by Pertuzumab-Trastuzumab and Taxane in the Standard Treatment of Metastatic Breast Cancer

acronym: EPTTCSM

summary: This retrospective study evaluated the efficacy and the safety of use of this treatment combined with a taxane for the treatment of HER2-positive metastatic breast cancer and compared the clinical and demographic characteristics of real life patients to the patients of CLEOPATRA.

lead_sponsor: University Hospital, Brest


title: Evaluation of the Adhesion to the Network of Care of People at Genetic Risk of Cancer in Midi-Pyrénées (GENEPY)

acronym: GENEPY

summary: In order to best meet the needs of all those affected by the genetic risk of cancer in our region, it is important to identify the factors likely to influence the course leading to the GENEPY surveillance network. The aim of this study is to evaluatie the adhesion to the network of care of people at genetic risk of cancer in Midi-Pyrénées (GENEPY).

ReferenceCitation: Eisinger F, Bressac B, Castaigne D, Cottu PH, Lansac J, Lefranc JP, Lesur A, Noguès C, Pierret J, Puy-Pernias S, Sobol H, Tardivon A, Tristant H, Villet R. [Identification and management of hereditary breast-ovarian cancers (2004 update)]. Pathol Biol (Paris). 2006 May;54(4):230-50. Epub 2006 May 2. Review. French.

ReferenceCitation: Landsbergen K, Verhaak C, Kraaimaat F, Hoogerbrugge N. Genetic uptake in BRCA-mutation families is related to emotional and behavioral communication characteristics of index patients. Fam Cancer. 2005;4(2):115-9.

lead_sponsor: Institut Claudius Regaud

intervention_type: Genetic


title: Intradermal Delivery of Fractional CO2 Laser-assisted Hyaluronic Acid in Facial Skin Remodeling

summary: The main endpoint will be to evaluate the efficacy of laser-assisted hyaluronic acid delivery by fractional CO2 laser in facial skin remodeling. The secondary endpoint will be to confirm the safety of this protocol compared to a standard treatment by fractional CO2 laser.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach

acronym: ProReRePro

summary: Nephrology care continues to progress and recommendations are now focused on delaying as much as possible the need for renal replacement therapy ("intent-to-defer"strategy). Protein restriction is a valuable tool for stabilizing chronic kidney disease (CKD) and retarding the need for renal replacement therapy, but the best diet to be prescribed is still matter of discussion. This study is aimed at identifying implementation strategies for nutritional management of advanced CKD.


title: Detecting Oligoclonal Bands Through Isoelectric Focusing of Tears in Children With Radiologically Isolated Syndrome or Clinically Isolated Syndrome: a Diagnostic, Prospective, Multicentric Study With a 2-year Longitudinal Follow-up

acronym: OBIT

summary: The main gold of this study is to lead a multicentric, prospective study, to evaluate the diagnostic quality of tears in children with clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS) during a longitudinal follow-up.

lead_sponsor: Lille Catholic University