title: Development of a New Pain Rating Scale for Children and Validation Against Criteria by Comparison With Faces Pain Scale - Revised (FPS-R) and Visual Analogue Scale (VAS)

acronym: NOUNOURS

summary:
In clinical practice with young children, gold standard rating scales used to evaluate the pain are VAS (Visual Analogue Scale) and FPS-R (Faces Pain Scale - Revised), which are self-assessment tools. These scales present however certain limitations: the VAS is not applicable if the child does not know how to estimate the distances, as young children, or children with mental retardation. As for FPS-R, it can be frightening for children by the aspect of faces looking like impersonal masks.

For children under 4 years, only hetero-evaluation based on typical behavioral scales as Face Legs Activity Cry Consolability (FLACC) can be used, according to the current recommendations.

We thus wanted to create a new faces scale with teddy bear faces, which are cross-cultural and timeless. Our objective is to validate the new teddy scale in its paper shape on a wide sample of children. We made the hypothesis that the teddy scale would enable to evaluate the pain in the same way that the FPS-R, being better accepted and preferred by children.

The first phase of this study will be to develop the teddy scale with a sample of 30 healthy children from 4 to 11 year-old, having already experienced pain. This stage allows the validation of the images chosen for the scale, to make sure of their relevance and their optimal recognition by the children.

The scale will then be validated with a sample of 218 hospitalized children from 2 to 11 years old, to whom pain is usually evaluated in a systematic way. Children from 4 to 11 years old will have simultaneously the teddy scale, the VAS and the FPS-R. They will be asked to determine which scale they preferred. Children from 2 to 4 years old will have the teddy scale; the FLACC will be filled in by parents.

Tested hypothesis: The discriminating characteristic of the teddy scale is superior to that of the FPS-R scale The validation of the teddy scale will enable to objectify children's pain, to facilitate the decision-making in the choice of the analgesic to prescribe, and to check the efficiency of these decisions. This teddy scale could be used in current practice as a replacement of the FPS-R.

Following this study, we planned to set up a second project in which the teddy scale will be adapted to electronic form (touchpads), to test its adaptability with the children.

location_facility: Service de Médecine Physique et Réadaptation Pédiatrique - Hôpital Femme-Mère-Enfant


type: EudraCT Number

title: Study of the Efficacy and Tolerance of Intra-vaginal Treatment With a Total Freeze-dried Culture of Lcr Regenerans® in the Prevention of Relapses of Recurrent Vulvovaginal Candidiasis. International Phase III, Randomised, Multi-centre, Parallel-group, Two Arm, Double-blind Superiority Trial Versus Placebo.

acronym: GYNOCANS

summary:
The trial medicinal product (Lcr Regenerans®) is obtained from the culture of a strain of Lactobacillus rhamnosus Lcr35®. By virtue of the freeze-drying technique, Lactobacillus rhamnosus Lcr35® is a live bacterium administered with its culture medium.

It should be noted that Lcr Regenerans® is already marketed as a medical device (EC marking: 0499). It helps to regenerate the vaginal flora thanks to its physical and chemical effects (lowering the vaginal pH).

A number of in vitro and in vivo studies have demonstrated the ability of Lactobacillus rhamnosus Lcr35®:

to establish itself in the vaginal epithelium, along with the durability of this establishment.
and to inhibit the growth of pathogenic organisms responsible for causing bacterial vaginosis (Gardnerella vaginalis and Prevotella bivia) but also for mycoses (Candida albicans), by synthesising various microbicidal substances.

This research follows on from the Candiflore observational study in which 514 patients were monitored and which demonstrated a clearly positive result in favour of the use of vaginal Lcr Regenerans® for preventing recurrences of VVC.

The purpose of this new research is thus to demonstrate the efficacy of Lcr Regenerans®, in the prevention of vulvovaginal candidiasis recurrences in patients with a history of VVC with recurrent episodes, in view of obtaining a marketing authorisation.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: Probionov

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: Comparison of MRI Sequences T1 and T2 * Cerebral Perfusion to Aid in the Diagnosis and Evaluation of Brain Therapeutic Response With Chemotherapy or Targeted Therapy(s) Lesion(s) in Patients Treated and Followed for a Pulmonary Neoplasia

acronym: METAPERF

summary:
This study therefore aims to assess current treatment recommended by scientific societies [ 6-13 ] , brain MRI with injection of contrast for the diagnosis and monitoring of brain metastases . The recommended dose of this examination gadolinium is from 0.1 to 0.3 mmol / kg [ 14 ] . Sequences infusion different from one center to the other made : some use the infusion T1, other infusion T2 * . No recommendation establishes whether it is preferable to use one or the other of these sequences.

No examination is added for the purposes of protocol. Indications for MRI and the number and timing of MRI checks under this protocol are consistent with what is done in practice . The used type of gadolinium and the injected dose will be identical for both sequences infusion . The assessment shall not in any case the contrast but the interpretation of the sequence itself. Special procedures monitoring implemented embodiment correspond to the two sequences instead of infusion (one of T1-weighted and T2 * in the other ) , in the original MRI and MRI of the first control , in order to compare their effectiveness

study_completion_date_type: Actual

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Lille

intervention_type: Other

lead_sponsor_type: academique


title: Phase I Study to Determine the Maximum Tolerated Dose and Evaluate the Pharmacokinetics of Intrapleural Bevacizumab After Pleural Drainage in Patients With Symptomatic Malignant Pleural Effusion in the Context of Breast Cancer

acronym: BEVAP

summary:
Metastatic pleural effusion is a common complication of late-stage cancer and reduces the quality of life and survival of patients. The survival of patients with recurrent pleurisy by uncontrolled local or systemic treatment is less than 6 months. It is important to develop specific therapies to improve the quality of life and survival of patients with metastatic pleurisy.

Bevacizumab is a monoclonal anti vascular endothelial growth factor (VEGF) which has proven effective in many indications in oncology. Vascular endothelial growth factor (VEGF) is an angiogenic factor which increases endothelial permeability. It plays a central role in many tumors of epithelial origin. In this context, it is legitimate to ask whether an antiangiogenic targeting VEGF may be effective in patients with metastatic pleurisy by decreasing local blood supply and over-permeability.

No study has been interested in the intra-pleural pharmacokinetics of monoclonal antibodies and there are no predictive or prognostic biomarkers for metastatic pleural effusions.

The investigators believe that intrapleural administration of bevacizumab will reduce the pleural vasculature permeability. It will neutralize VEGF present in pleural fluid and reduce the replenishment of effusion due to its prolonged half-life of 21 days.

The investigators therefore propose a phase I study to determine the maximum tolerated dose and the recommended dose for phases II, studying the pharmacokinetics of intrapleural bevacizumab administered by an implantable device after evacuating a symptomatic metastatic pleurisy as part of a mammary carcinoma. The VEGF intrapleural levels and serum will be study and the time until a new puncture. Dyspnea will be evaluated as well as its impact on quality of life.

study_start_date_type: Actual

status: Terminated

primary_purpose: Treatment

lead_sponsor: Institut Curie

status_simplified: Unknown


title: Interest of Hypnosis Before the Induction of Anesthesia. Study in Women Submitted to One Day Gynecological Surgical Procedures

summary:
Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.

Two particular aspects of this study are

the inclusion of women undergoing one day gynecological surgical procedures
the use of a closed-loop system which delivers propofol according to bispectral index to provide induction of anesthesia.

ReferenceType: background

ReferenceCitation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

ReferenceType: derived

ReferenceCitation: Bataille A, Guirimand A, Szekely B, Michel-Cherqui M, Dumans V, Liu N, Chazot T, Fischler M, Le Guen M. Does a hypnosis session reduce the required propofol dose during closed-loop anaesthesia induction?: A randomised controlled trial. Eur J Anaesthesiol. 2018 Sep;35(9):675-681. doi: 10.1097/EJA.0000000000000751.

family: Bataille

full_name: Aurélien Bataille

given: Aurélien

sequence: first

family: Guirimand

full_name: Avit Guirimand

given: Avit

sequence: additional

family: Szekely

full_name: Barbara Szekely

given: Barbara

family: Michel-Cherqui

full_name: Mireille Michel-Cherqui

given: Mireille

family: Dumans

full_name: Virginie Dumans

given: Virginie

family: Liu

full_name: Ngai Liu

given: Ngai

family: Chazot

full_name: Thierry Chazot

given: Thierry

family: Fischler

full_name: Marc Fischler

given: Marc

family: Le Guen

full_name: Morgan Le Guen

given: Morgan

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Anaesthesiology

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Hopital Foch

intervention_type: Procedure


title: Non-stick Gel Applicated After Scraping Surgery for Natural Miscarriage and Uterine Synechiae Prevention

acronym: HYFACO

summary:
The primary purpose of the study is to compare efficiency of a non-stick gel application after scraping surgery for natural miscarriage with no non-stick gel application after scraping surgery.

Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8 weeks after surgery.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Lariboisière - Service de Gynécologie-Obstétrique


title: Can Capillary Refill Time Variation Induced by Passive Leg Raising Predict Capillary Refill Time Variation After a Fluid Load in Patients With Circulatory Failure.

summary:
Fluid responsiveness in a context of circulatory failure can be assessed by different way. Microcirculatory evaluation to assess fluid responsiveness could be interesting, but the available device are expensive and the analysis are delayed. Capillary refill time (CRT) is hampered by its variability. The investigators have developed a method to standardize the pressure, the length of compression and a computerized analysis to calculate the capillary refill time. This method enables accurate measure of CRT.

The investigators will study if CRT variation induced by a passive leg raising (PLR) can predict CRT after a 500 ml Fluid Load.

About thirty patients in circulatory failure with a continuous cardiac output monitoring for whom, the attending physician has decided a fluid load, will be included. hemodynamic parameters (arterial pressure, venous pressure, cardiac output), metabolic parameters (arterial and venous blood gas and lactate), microcirculatory parameters (assessed by sublingual video-microscopy) and capillary refill time measured on the thorax and on the gingival area will be recorded. Data collection will be made before and after a passive leg raising and after a 500 ml fluid load of crystalloids.

Patients will be aposteriori sorted in two groups: responders and non responders, defined by the reduction of CRT after the fluid load. The diagnosis ability of the CRT variation after PLR to predict in which group each patient is classified will be investigate and receiver operative characteristic curve will be built. These results will be compared to the metabolic response, the macrocirculatory response, and the microcirculatory response.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Jacquet-Lagrèze M, Bouhamri N, Portran P, Schweizer R, Baudin F, Lilot M, Fornier W, Fellahi JL. Capillary refill time variation induced by passive leg raising predicts capillary refill time response to volume expansion. Crit Care. 2019 Aug 16;23(1):281. doi: 10.1186/s13054-019-2560-0.

apc_source: openAPC

family: Jacquet-Lagrèze

full_name: Matthias Jacquet-Lagrèze

given: Matthias

family: Bouhamri

full_name: Nourredine Bouhamri

given: Nourredine

family: Portran

full_name: Philippe Portran

given: Philippe

family: Schweizer

full_name: Rémi Schweizer

given: Rémi

family: Baudin

full_name: Florent Baudin

given: Florent

family: Lilot

full_name: Marc Lilot

family: Fornier

full_name: William Fornier

given: William

family: Fellahi

full_name: Jean-Luc Fellahi

given: Jean-Luc

currency_apc_doaj: GBP

journal_name: Critical Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Hopital Louis Pradel

location_facility: Hôpital Cardiologique Louis Pradel Service d'anesthésie réanimation


title: Longitudinal Followup of Patients Under Substitution Therapy From the Moment They Enter a Specialized Care Center for Addicts to the Period They Are Monitored by a General Practitioner Outside the Specialized Care Center

summary: This study is part of the french priorities of the 2007-2011 addiction plan. Priority #2 of the plan underlines the need to improve practices and access to opioid substitution treatment. Priority 3 stresses the importance of articulation and coordination between specialized structures and community medicine to optimize the quality of care and to ensure continuity in the followup of these patients. This study focuses on the followup of patients under substitution therapy from the moment they enter a specialized care center for addicts to the period they are monitored by a general practitioner outside the specialized care center. The assessment described in this study should allow to harmonize and keep a continuity in patient monitoring.

ReferenceCitation: Guillou-Landreat M, Levassor P, Guerlais M, Sebille V, Victorri-Vigneau C. Prospective Study on Factors Associated with Referral of Patients with Opioid Maintenance Therapy from Specialized Addictive Disorders Centers to Primary Care. Int J Environ Res Public Health. 2021 May 27;18(11). pii: 5749. doi: 10.3390/ijerph18115749.

family: Guillou-Landreat

full_name: Morgane Guillou-Landreat

given: Morgane

family: Levassor

full_name: Philippe Levassor

family: Guerlais

full_name: Marylène Guerlais

given: Marylène

family: Sebille

full_name: Veronique Sebille

given: Veronique

family: Victorri-Vigneau

full_name: Caroline Victorri-Vigneau

given: Caroline

currency_apc_doaj: CHF

journal_name: International Journal of Environmental Research and Public Health

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

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

publisher: MDPI AG

publisher_dissemination: MDPI

publisher_group: MDPI

publisher_normalized: MDPI

lead_sponsor: Nantes University Hospital


title: Non Invasive Evaluation of Bronchial Inflammation in Infants : a Study of the Sputum Cellularity After Hypertonic Saline Induction

acronym: CYTOASTHME

summary:
Background: Infantile asthma is composed of various phenotypes, however the definition is still based on the clinics. Namely, the infants could be classified as transitory, peristent or late and persistent asthma. Some risk factors for the persistent asthma phenotype are recognized as atopy. However all peristent asthma are not related to atopy. Regarding the pathophysiology, little is known on airways inflammation in these infants, and the current data are mostly based on the BAL analyses, or on biopsies. Consequently, BLA and biopsies should be justified by the need of an indicated fiberbronchoscopy, and therefore limited to severe infantile asthma. Airway secretion could be also collected after hypertonic saline induction and chest physiotherapy. This method has been validated in the children, but has not in the younger.
Aim : Analyses of cell profiles regarding the severity of infantile asthma.
Methods : This descriptive study compared 3 groups of infants, the first with acute exacerbation, the second with uncontrolled asthma and the third with controlled asthma. Accounting 25% of failure, the number of 40 infants per groups has been calculated. The sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. Cellularity and cell profiles were analysed as previously recommended. Safety will be evaluated.
Inclusion criteria : Any infants suffering of infantile asthma (at least 3 episodes of wheezing during the 2 first years of life), aged between 6-12months.Asthma control was evaluated on the last 4 weeks, allowing to classify the infants . Control asthma was aimed when neither exacerbation nor persistent symptoms were observed. Uncontrolled asthma was defined whether the infant presented any symptoms during the last 4 weeks. Exacerbation was defined as any acute symptoms, as cough, dyspnoea or wheezing.
Feasibility : A preliminary study has been presented in the Vienna ERS congress.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Rouen


title: Cortical Excitability Assessment of Pharmacoresistant Focal Epilepsy Using Direct Electrical Stimulation During Stereo-electroencephalography

acronym: PP

summary:
The identification of the epileptogenic zone (EZ) during pharmacoresistant focal epilepsy presurgical assessment frequently requires intracranial recordings like stereo-electroencephalography (SEEG). Cortical direct electrical stimulation (DES) is commonly used during SEEG for functional mapping or to induce seizure.

However, the recording of seizures is sometimes insufficient to circumscribe the EZ and development of new biomarkers is necessary.

The cortex within the EZ is thought to be hyperexcitable. The "paired pulses" paradigm, using transcranial magnetic stimulation (TMS), allows determining the hemispheric cortical excitability level. The investigators hypothesize that paired pulses DES during SEEG could provide useful information for EZ identification.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon


title: Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial

summary: This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain induced during lumbar puncture.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Establishment of a Non-invasive and Indirect Measure of Volitional Pimax

acronym: PI MAX STIM

summary: Respiratory failure is the main death cause in muscular diseases. Non-invasive and volitional measures of inspiratory muscles strength include the nasal pressure with an occluded nostril and the maximal inspiratory pressure (PImax).Unfortunately, volitional maneuvers depend of patient effort. The mean of this reseach is to validate a non-invasive and non-volitional technique to evaluate diaphragm strength at muscular diseases patients.The methdology consist to compar PImax measure to nerves magnetical stimulation maneuvers measure.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: INTRA-OPERATIVE CONFOCAL LASER ENDOMICROSCOPY FOR BRAIN TUMORS: A FEASIBILITY STUDY IN HUMAN

acronym: GLIOFOCAL

summary: Confocal Laser Endomicroscopy (CLE) could be a useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and real-time assessment of resections margins during surgery. Probe-based CLE using the CELLVIZIO® has never been used for glioma surgical guided resection. Before assessing the potential of this technique in improving surgical resection outcome, a feasability study has to be performed.


title: Study of the Fetoplacental BOLD Effect in Pregnant Women Using Functional MRI

acronym: BOLD-FP

summary: The purpose of this study is to evaluate the use of functional MRI in pregnant women as a non-invasive diagnostic tool to detect placental insufficiency and differentiate healthy fetuses from the intra-uterine growth restricted ones. Functional MRI in pregnant women can detect a variation of the MRI signal (called BOLD effect) from the placenta and the fetus when the mother is breathing pure oxygen. This study aims hence to demonstrate the difference in the BOLD effect between normal feto-placental units and growth restricted ones.

location_facility: Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)


title: Interest of Learning Self-hypnosis in Patients Awaiting Lung Transplantation

acronym: SelfHypTp

summary: The proposed study is designed to utilize a self-hypnosis training program for patients awaiting lung transplantation. This technique can increase their well being, particularly by decreasing postoperative pain.

intervention_type: Behavioral


title: Influence of the Surgical Approach on the Development of a Chronic Pain After Thoracic Surgery

acronym: IncisionPain

summary: The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on the surgical approach. The posterolateral approach is compared to the axillary approach especially in term of development of a chronic pain.

ReferenceCitation: Ringsted TK, Wildgaard K, Kreiner S, Kehlet H. Pain-related impairment of daily activities after thoracic surgery: a questionnaire validation. Clin J Pain. 2013 Sep;29(9):791-9. doi: 10.1097/AJP.0b013e318278d4e2.


title: Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"

acronym: Only

summary: To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.

lead_sponsor: Molnlycke Health Care AB

intervention_type: Device


title: Therapeutic Management of Acute Cephalalgia Before and After Use of a Therapeutic Protocol in Emergency Department

acronym: PEACE

summary: The purpose of this study is to determine if the use of a therapeutic and global protocol to relieve cephalalgia is helpful in the emergency department of Grenoble University Hospital.

ReferenceCitation: Rasmussen BK, Jensen R, Schroll M, Olesen J. Epidemiology of headache in a general population--a prevalence study. J Clin Epidemiol. 1991;44(11):1147-57.

ReferenceCitation: Friedman BW, Grosberg BM. Diagnosis and management of the primary headache disorders in the emergency department setting. Emerg Med Clin North Am. 2009 Feb;27(1):71-87, viii. doi: 10.1016/j.emc.2008.09.005. Review.

ReferenceCitation: Haque B, Rahman KM, Hoque A, Hasan AT, Chowdhury RN, Khan SU, Alam MB, Habib M, Mohammad QD. Precipitating and relieving factors of migraine versus tension type headache. BMC Neurol. 2012 Aug 25;12:82. doi: 10.1186/1471-2377-12-82.

ReferenceCitation: Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: a randomized trial. JAMA. 2009 Dec 9;302(22):2451-7. doi: 10.1001/jama.2009.1855.

ReferenceCitation: Ozkurt B, Cinar O, Cevik E, Acar AY, Arslan D, Eyi EY, Jay L, Yamanel L, Madsen T. Efficacy of high-flow oxygen therapy in all types of headache: a prospective, randomized, placebo-controlled trial. Am J Emerg Med. 2012 Nov;30(9):1760-4. doi: 10.1016/j.ajem.2012.02.010. Epub 2012 May 3.

ReferenceCitation: Matharu M. Cluster headache. BMJ Clin Evid. 2010 Feb 9;2010. pii: 1212. Review.

ReferenceCitation: B. D VEYSMAN, et al. Oxygen Therapy for the tratment of undifferentiated headache in the emergency department. ClinicalTrials.gov, NCT00856232

lead_sponsor: University Hospital, Grenoble


title: Evaluation of the Benefit Provided by the Addition of Acupunctural Analgesia With Electrostimulation to Conventional Local Anesthesia Compared to Conventional Local Anesthesia Alone in Surgery of Deep Brain Stimulation for Movement Disorders.

acronym: ACUplus

summary: The effectiveness of Deep Brain Stimulation (DBS) in certain movement disorders is widely demonstrated. The success of this procedure requires that the patient is awake and cooperative. The conditions of this intervention can be difficult to tolerate by the patient for several reasons: long procedure (from 3 to 8 hours), body immobilisation (particularly the head in the stereotactic frame), stress related to the localization of the DBS. It is therefore important to improve the comfort as well as the cooperation of the patient, during implantation of the DBS electrodes, in order to optimize the conditions of the intervention. In addition to analgesia, acupuncture should allow sedation without affecting alertness and should contribute to the regulation of any vegetative reactions during the procedure. Therefore, we hypothesize that acupuncture could improve the quality of care of the patient during a DBS procedure. In practice, this is electroacupuncture that will be used in this research to maintain the stimulation of acupuncture points to an optimal level during the time of the intervention.

primary_purpose: Supportive Care

location_facility: Centre Hospitalier Universitaire de Nantes


title: Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.

acronym: coughassistAFM

summary: A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to confirm the beneficial effects of this treatment in a larger neuromuscular population, to study its mechanisms of action and to assess whether the effects observed persist over time. A better knowledge of this treatment should help to define its position in the respiratory management of neuromuscular patients.


title: Criteria of Extubation Failure of Brain Injured Patients. Elaboration of a Prognostic Score.

acronym: GODWEAN

summary: Identification of criteria associated with extubation failure of brain injured patients. Elaboration of a prognostic score of extubation failure of brain injured patients.


title: Cognitive Biases in Decision Making in a Pharmacological Model of Psychosis : a Study in Healthy Humans Recieving Low Dose Anesthetic, Ketamine Versus Placebo

acronym: KETABI

summary:
Characterise cognitive biases resulting from low dose ketamine infusion, used as a pharmacological model of psychosis.

Our assumption is that low dose ketamine results in reasoning biases by impairing the way uncertainty is monitored and taken into account for decision making.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier St Anne


title: Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema

summary:
This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).

This study is a pilot controlled randomized study with two arms.

ReferenceType: result

ReferenceCitation: Deltombe T, Jamart J, Recloux S, Legrand C, Vandenbroeck N, Theys S, Hanson P. Reliability and limits of agreement of circumferential, water displacement, and optoelectronic volumetry in the measurement of upper limb lymphedema. Lymphology. 2007 Mar;40(1):26-34.

ReferenceCitation: Mayrovitz HN, Macdonald J, Davey S, Olson K, Washington E. Measurement decisions for clinical assessment of limb volume changes in patients with bilateral and unilateral limb edema. Phys Ther. 2007 Oct;87(10):1362-8. Epub 2007 Aug 7.

lead_sponsor: Stendo


type: Registry Identifier

title: Impact of Duodena-pancreatic Transplantation on Bile Acids and Incretins Metabolism.

acronym: ITABI

summary: Pancreas Kidney Transplantation (PKT) is the prominent treatment for type 1 diabetic patients with chronic kidney disease and improves patients' outcome. However, in spite of an optimized systemic insulin substitution, altered glucose metabolism and beta cell function are reported in these patients. The mechanisms behind these abnormalities are still unclear. Duodena-pancreatic anastomosis is performed in a heterotopic site (ileum) and thus could change physical and chemical properties of intestinal secretions, gut flora, as well as intestinal permeability. The effect of this procedure on gut derived metabolic factors, the enterohepatic cycle of bile acids, incretin secretion and intestinal flora have never been studied. This pilot prospective, study is aimed to evaluate the modification of bile acids concentrations and composition in PKT subjects, and the impact in glucose and incretin metabolism (measured by oral glucose tolerance test) one year after transplantation. The results will be compared to those of kidney transplant patients and control subjects.

primary_purpose: Other


title: Evaluation Des Performances de la Tomographie Par Emission de Positons Avec la 16α-[18F]Fluoro-17β-estradiol ([18F]-FES) Pour le Diagnostic de l'Endometriose

acronym: ENDOTEP

summary:
Endometriosis is a benign chronic disease responsible for infertility and pelvic pain. One of the main problem of endometriosis is the significant delay of diagnosis.This delay has significant consequences for patients. Currently the definitive diagnosis of endometriosis and the evaluation of its lesional extension require performing laparoscopy and a histological analysis of biopsy and pathologic areas. Lesions of endometriosis whose development and growth are estrogen-dependent, express estrogen receptor (ER). [18F]FES (16α-[18F]Fluoro-17β-estradiol) is an analog of estrogen, used in positron emission tomography (PET), and a specific tracer of ER. We propose to evaluate the performance of this functional imaging as a diagnostic tool for endometriosis.

The aim of this multicenter, prospective, open study is to assess sensitivity of PET with [18F] -FES for diagnosing endometriosis compared to the gold standard (histological confirmation on biopsy or excision of lesions performed during laparoscopy) in women care for suspected endometriosis and for whom laparoscopy is already scheduled.

lead_sponsor: University Hospital, Angers

location_facility: Nuclear medicin unit, University Hospital of Angers


title: Effect of Ketamine Versus Sufentanil on Cerebral Glutamate After Traumatic Brain Injury : a Randomized, Double-blinded, Microdialysis Study

acronym: KETABRAIN

summary:
The objective of the study is to compare the effects of 48 hours ketamine infusion versus sufentanil infusion on brain glutamate concentrations measured with microdialysis after traumatic brain injury.

We hypothesize that ketamine infusion will decrease high glutamate values faster than sufentanil.

ReferenceCitation: Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS, Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. I. Blood pressure and oxygenation. J Neurotrauma. 2007;24 Suppl 1:S7-13. Erratum in: J Neurotrauma. 2008 Mar;25(3):276-8. multiple author names added.

ReferenceCitation: Hughes S. Towards evidence based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 3: is ketamine a viable induction agent for the trauma patient with potential brain injury. Emerg Med J. 2011 Dec;28(12):1076-7. doi: 10.1136/emermed-2011-200891. Review.

ReferenceCitation: Filanovsky Y, Miller P, Kao J. Myth: Ketamine should not be used as an induction agent for intubation in patients with head injury. CJEM. 2010 Mar;12(2):154-7. Review.

ReferenceCitation: Hudetz JA, Pagel PS. Neuroprotection by ketamine: a review of the experimental and clinical evidence. J Cardiothorac Vasc Anesth. 2010 Feb;24(1):131-42. doi: 10.1053/j.jvca.2009.05.008. Epub 2009 Jul 29. Review.

ReferenceCitation: Ward JL, Harting MT, Cox CS Jr, Mercer DW. Effects of ketamine on endotoxin and traumatic brain injury induced cytokine production in the rat. J Trauma. 2011 Jun;70(6):1471-9. doi: 10.1097/TA.0b013e31821c38bd.

ReferenceCitation: Bhutta AT, Schmitz ML, Swearingen C, James LP, Wardbegnoche WL, Lindquist DM, Glasier CM, Tuzcu V, Prodhan P, Dyamenahalli U, Imamura M, Jaquiss RD, Anand KJ. Ketamine as a neuroprotective and anti-inflammatory agent in children undergoing surgery on cardiopulmonary bypass: a pilot randomized, double-blind, placebo-controlled trial. Pediatr Crit Care Med. 2012 May;13(3):328-37. doi: 10.1097/PCC.0b013e31822f18f9.

ReferenceCitation: Sakowitz OW, Kiening KL, Krajewski KL, Sarrafzadeh AS, Fabricius M, Strong AJ, Unterberg AW, Dreier JP. Preliminary evidence that ketamine inhibits spreading depolarizations in acute human brain injury. Stroke. 2009 Aug;40(8):e519-22. doi: 10.1161/STROKEAHA.109.549303. Epub 2009 Jun 11.

ReferenceCitation: Hartings JA, Bullock MR, Okonkwo DO, Murray LS, Murray GD, Fabricius M, Maas AI, Woitzik J, Sakowitz O, Mathern B, Roozenbeek B, Lingsma H, Dreier JP, Puccio AM, Shutter LA, Pahl C, Strong AJ; Co-Operative Study on Brain Injury Depolarisations. Spreading depolarisations and outcome after traumatic brain injury: a prospective observational study. Lancet Neurol. 2011 Dec;10(12):1058-64. doi: 10.1016/S1474-4422(11)70243-5. Epub 2011 Nov 3.

ReferenceCitation: Raboel PH, Bartek J Jr, Andresen M, Bellander BM, Romner B. Intracranial Pressure Monitoring: Invasive versus Non-Invasive Methods-A Review. Crit Care Res Pract. 2012;2012:950393. doi: 10.1155/2012/950393. Epub 2012 Jun 8.

ReferenceCitation: Stuart RM, Schmidt M, Kurtz P, Waziri A, Helbok R, Mayer SA, Lee K, Badjatia N, Hirsch LJ, Connolly ES, Claassen J. Intracranial multimodal monitoring for acute brain injury: a single institution review of current practices. Neurocrit Care. 2010 Apr;12(2):188-98. doi: 10.1007/s12028-010-9330-9.

ReferenceCitation: Bourgoin A, Albanèse J, Wereszczynski N, Charbit M, Vialet R, Martin C. Safety of sedation with ketamine in severe head injury patients: comparison with sufentanil. Crit Care Med. 2003 Mar;31(3):711-7.

ReferenceCitation: Bourgoin A, Albanèse J, Léone M, Sampol-Manos E, Viviand X, Martin C. Effects of sufentanil or ketamine administered in target-controlled infusion on the cerebral hemodynamics of severely brain-injured patients. Crit Care Med. 2005 May;33(5):1109-13.

ReferenceCitation: Chamoun R, Suki D, Gopinath SP, Goodman JC, Robertson C. Role of extracellular glutamate measured by cerebral microdialysis in severe traumatic brain injury. J Neurosurg. 2010 Sep;113(3):564-70. doi: 10.3171/2009.12.JNS09689.

lead_sponsor: Pierre-Julien CUNGI


title: A Study of the Balance Control During Gait : Comparison of Data Acquisition Between Force Plate and 3D Optoelectronic Gait Analysis System

summary:
Gait and balance disorders are important public health problem necessitating studies to try to prevent falls. Many studies have dealt with spatiotemporal gait parameters or balance during quiet standing (posturography). Nevertheless, falls occurred predominantly during gait, and rarely during quiet standing. We have developed a tool to measure balance during gait : the braking of the center of mass (CM), a biomechanical parameter obtained from the vertical velocity of the CM recorded with a force plate.

In previous studies, we have shown that the braking of the CM was a physiological and a active mechanism, reflecting balance during gait. Unfortunately, the braking of the CM measured on a force plate provide an important intra-individual variability.

The 3D optoelectronic gait analysis system (VICON) also provide an estimation of the CM. The primary goal of this study is to compare intra-individual variability of the braking of the CM determined by a force plate or the 3D optoelectronic gait analysis system (VICON) in healthy subjects.


title: Interest of Ultrasound Coupled to a Guidance System (GPS) for Central Venous Catheters (CVC) Insertion.

acronym: VVC and GPS

summary:
The GPS system would simplify the technical implementation of central venous catheter under ultrasound guidance. We can assume that the introduction of deep venous pathways (as a reference, the internal jugular) will be faster, and this, whatever the level of expertise. By checking this hypothesis, this technique could be applied to much less frequent situations establishment of difficult central venous catheters (hemodynamic status precarious, hypovolemia, or cardiac arrest).

The main objective of this study is to evaluate the time savings provided by the ultrasound assisted GPS guidance for installing central venous catheters in the internal jugular. Central venous catheters are inserted in the operating room under conditions scheduled in advance that is to say outside emergency. The installation time for the central venous catheter is compared with that obtained by using the ultrasound machine without the GPS guide ("conventional" technique).

ReferenceCitation: Graham AS, Ozment C, Tegtmeyer K, Lai S, Braner DA. Videos in clinical medicine. Central venous catheterization. N Engl J Med. 2007 May 24;356(21):e21.

ReferenceCitation: Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. Review.

ReferenceCitation: Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care Med. 1996 Dec;24(12):2053-8.

ReferenceCitation: Hosokawa K, Shime N, Kato Y, Hashimoto S. A randomized trial of ultrasound image-based skin surface marking versus real-time ultrasound-guided internal jugular vein catheterization in infants. Anesthesiology. 2007 Nov;107(5):720-4.

ReferenceCitation: American Society of Anesthesiologists Task Force on Central Venous Access, Rupp SM, Apfelbaum JL, Blitt C, Caplan RA, Connis RT, Domino KB, Fleisher LA, Grant S, Mark JB, Morray JP, Nickinovich DG, Tung A. Practice guidelines for central venous access: a report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2012 Mar;116(3):539-73. doi: 10.1097/ALN.0b013e31823c9569.


title: Impact of Mobile Phone Short Text Messages on the Glycaemic Control of Adolescents With Poorly Controlled Type 1 Diabetes.

acronym: Diabeto-SMS

summary: The purpose of this study is to assess HbA1c reduction after supportive care by SMS among adolescents with poorly controlled type 1 diabetes.

ReferenceCitation: Louch G, Dalkin S, Bodansky J, Conner M. An exploratory randomised controlled trial using short messaging service to facilitate insulin administration in young adults with type 1 diabetes. Psychol Health Med. 2013;18(2):166-74. doi: 10.1080/13548506.2012.689841. Epub 2012 May 30.

ReferenceCitation: Benhamou PY, Melki V, Boizel R, Perreal F, Quesada JL, Bessieres-Lacombe S, Bosson JL, Halimi S, Hanaire H. One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study. Diabetes Metab. 2007 Jun;33(3):220-6. Epub 2007 Mar 28.

ReferenceCitation: Rami B, Popow C, Horn W, Waldhoer T, Schober E. Telemedical support to improve glycemic control in adolescents with type 1 diabetes mellitus. Eur J Pediatr. 2006 Oct;165(10):701-5. Epub 2006 May 3.

ReferenceCitation: Ibrahim N, Treluyer JM, Briand N, Godot C, Polak M, Beltrand J. Text message reminders for adolescents with poorly controlled type 1 diabetes: A randomized controlled trial. PLoS One. 2021 Mar 15;16(3):e0248549. doi: 10.1371/journal.pone.0248549. eCollection 2021.

family: Ibrahim

full_name: Nour Ibrahim

given: Nour

family: Treluyer

full_name: Jean-Marc Treluyer

given: Jean-Marc

family: Briand

full_name: Nelly Briand

given: Nelly

family: Godot

full_name: Cécile Godot

given: Cécile

family: Polak

full_name: Michel Polak

given: Michel

family: Beltrand

full_name: Jacques Beltrand

given: Jacques

currency_apc_doaj: USD

journal_name: PLOS ONE

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

ipd_sharing: No


title: Treatment of Rhino-Sinusal Mucormycosis Through Transnasal Endoscopic Surgery Extended to the Skull Base.

acronym: MICCA

summary: Radical endoscopic transnasal surgery associated with medical treatment with liposomal amphotericine B may increase the local control of Rhino-Sinusal Mucormycosis and the survival rate. The objective of this study is to evaluate the local control rate and survival rate at 3 months after radical endoscopic transnasal surgery extended towards the skull base in association with antifungal therapy and early surgical reevaluation of the extent of the disease.


title: Brief Administration of Cyclosporine A to Induce the Stabilisation of the Diameter of Small Diameter Abdominal Aortic Aneurysms.

summary: Aneurysms of the aorta are dilatations of the main artery in the body that distributes blood to organs. Aneurysms expose patients to aortic rupture. The risk of aortic rupture is high for large aneurysms, and low for small aneurysms. Currently, if the diameter of a small aneurysm grows up to a level at risk for rupture, surgery is indicated to prevent rupture. A drug that would stop growth of small aneurysms would obviate aortic surgery, the current treatment to prevent aortic rupture in patients. The ACA4 study aims at testing the possibility to stop growth of small aortic aneurysms in the abdomen with a drug, cyclosporine A. Patients with small aneurysms will receive cyclosporine A orally, or a placebo (fake liquid), every day during a short period of time. Efficacy of the drug will be evaluated by measuring the diameter of the aneurysm during 2 years after treatment cessation. Drug safety analysis will evaluate the impact of the drug on renal function, blood pressure, and other parameters. In case of adverse event during the drug administration phase, dose of the drug or of the placebo will be decreased or administration stopped.


title: Markers of Fetal Membranes Remodelling in Cervicovaginal Fluid and Delivery

summary:
The investigators project aims to identify, in pregnant women, discriminating molecules to allow an early detection of women who will spontaneously deliver prematurely, suitable in routine clinical practice.

Human parturition is tightly correlated with hormonal changes at the maternal-fetal interface during pregnancy, that may control cell interactions and fetal membranes (the water bag) remodelling. Precocious remodelling may lead to a premature onset of labor, associated or not with premature rupture of membrane whether the cause is infectious or not.

In this regard, remodelled fetal membranes overlying the cervix may discharge signals that could be detectable in cervico-vaginal fluids and serve as biomarkers of the imminence of delivery. Such information on delivery timing may be of great importance for an adequate prediction that would change drastically the management of threatening preterm delivery.

primary_purpose: Screening

ReferenceCitation: Larroque B, Ancel PY, Marret S, Marchand L, André M, Arnaud C, Pierrat V, Rozé JC, Messer J, Thiriez G, Burguet A, Picaud JC, Bréart G, Kaminski M; EPIPAGE Study group. Neurodevelopmental disabilities and special care of 5-year-old children born before 33 weeks of gestation (the EPIPAGE study): a longitudinal cohort study. Lancet. 2008 Mar 8;371(9615):813-20. doi: 10.1016/S0140-6736(08)60380-3.

ReferenceCitation: McLaren J, Malak TM, Bell SC. Structural characteristics of term human fetal membranes prior to labour: identification of an area of altered morphology overlying the cervix. Hum Reprod. 1999 Jan;14(1):237-41.

ReferenceCitation: Malak TM, Bell SC. Structural characteristics of term human fetal membranes: a novel zone of extreme morphological alteration within the rupture site. Br J Obstet Gynaecol. 1994 May;101(5):375-86.


title: Clinical Validation of the Diagnostic Performance of a Molecular Signature to Determine the Malignant or Benign Profile of a Thyroid Nodule With Indeterminate Cytological Analysis

acronym: CITHY

summary:
Principal objective:

The primary objective of this study is to validate the diagnostic performance of a Dx15 molecular test based on molecular transcriptomic signatures previously identified in distincts cohorts of samples to determine the malignant or benign profile of a thyroid nodule with indeterminate cytological analysis. The target population includes categories III [Follicular lesion of undetermined significance or Atypia of undetermined significance (FLUS/AUS)] and IV [Follicular neoplasm / Suspicious for follicular neoplasm (FN/SFN)] of the Bethesda classification.

The expected target performance of the Dx15 molecular test in this target population is 95% for specificity with a lower limit of the 95% confidence interval of 87%, and 75% for sensitivity.

Secondary objectives:

To assess the performance of the Dx15 test in samples collected during the study by fine-needle aspiration (FNA) in each and in all of the indeterminate Bethesda classification categories (categories III, IV and V: suspected malignancy)
To assess the performance of the TI-RADS ultrasonography score for diagnosing thyroid cancer in patients presenting with a thyroid nodule and having available cytological analysis results.
To check the potential of performance of the molecular signature as well as of its combination with other tests by applying it in a blind manner to samples collected from patients presenting with thyroid nodules and whose aspiration biopsy result is benign (Bethesda category II), malignant (Bethesda category VI) or non-diagnostic (Bethesda category I)
To assess the performance of mutation tests (isolated mutations, chromosomal rearrangements) for diagnosing thyroid cancer in patients presenting with a thyroid nodule and with available cytological results.
To estimate the performance of the combination of the Dx15 test result and other diagnostic tools such as mutation tests and/or the TI-RADS score to diagnose thyroid cancer in patients presenting with a thyroid nodule and having an indeterminate cytology result (especially AUS/FLUS and FN/SFN). The combination of Dx15 diagnostic test results with other study parameters will also be considered in order to establish the option of an algorithmic approach for the diagnosis of thyroid cancer.
To compare the results of cytological and histological analyses obtained in the centres and by centralised reading and assessment of the impact of its results on the other study analyses and parameters.
Additional analyses deemed relevant on the basis of various parameters and data collected during the study.

Objective of exploratory research:

The use of all or part of the FNA samples for the purpose of research as part of thyroid cancers, especially with the objective of optimising or identifying additional molecular signatures.

lead_sponsor: Diaxonhit


summary: The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.

lead_sponsor: BBraun Medical SAS


title: Influence of Chronic Renal Failure and Hemodialysis on Liking and Wanting for Foods

summary: A study conducted in the laboratory revealed the existence of a "window" during which patients with renal failure appreciate the protein-rich foods. This period, located immediately after the dialysis, is likely related to the purification of plasma products resulting from protein catabolism. It therefore appears necessary to understand the mechanisms that may explain these changes by measurements of ghrelin (orexigenic hormone), leptin (anorectic hormone) and plasma amino acids.

time_perspective: Cross-Sectional

ReferenceCitation: Mouillot T, Filancia A, Boirie Y, Brindisi MC, Hafnaoui N, Van Wymelbeke V, Teillet E, Meintani I, Jacquin-Piques A, Leloup C, Pénicaud L, Mousson C, Brondel L. Hemodialysis Affects Wanting and Spontaneous Intake of Protein-Rich Foods in Chronic Kidney Disease Patients. J Ren Nutr. 2021 Mar;31(2):164-176. doi: 10.1053/j.jrn.2020.05.006. Epub 2020 Jul 25.

family: Mouillot

full_name: Thomas Mouillot

given: Thomas

family: Filancia

full_name: Anna Filancia

given: Anna

family: Boirie

full_name: Yves Boirie

given: Yves

family: Brindisi

full_name: Marie-Claude Brindisi

given: Marie-Claude

family: Hafnaoui

full_name: Noureddine Hafnaoui

given: Noureddine

family: Van Wymelbeke

full_name: Virginie Van Wymelbeke

given: Virginie

family: Teillet

full_name: Eric Teillet

given: Eric

family: Meintani

full_name: Ioanna Meintani

given: Ioanna

family: Jacquin-Piques

full_name: Agnès Jacquin-Piques

given: Agnès

family: Leloup

full_name: Corinne Leloup

given: Corinne

family: Pénicaud

full_name: Luc Pénicaud

given: Luc

family: Mousson

full_name: Christiane Mousson

given: Christiane

family: Brondel

full_name: Laurent Brondel

given: Laurent

journal_name: Journal of Renal Nutrition

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University of Burgundy


title: Phase I Dose Escalation of Velcade (Bortezomib) Daily Dose in Patients With Advances or Metastatic Solid Tumors

acronym: VELDAY

summary:
VELCADE has demonstrated marked activity in haematological cancers leading to registration (MM, MCL).

Currently only biweekly or weekly regimens have been explored. Key signalling pathways which are aberrant in haematological cancers are also present in solid tumors.

VELCADE covers a broad spectrum of proteins, which are pivotal in carcinogenesis.VELCADE as a single agent & in combination with chemotherapy in solid cancers has shown modest and real anti-tumor activity but insufficient for Phase III development.

VELCADE PK exposure may be inadequate in solid tumors compared to "liquid cancers." VELCADE daily low dose administration may allow a greater PK exposure to be achieved, which is tolerated

Hypotheses:

VELCADE daily dosing (5-days on, 2-days off) is tolerable at biologically active doses VELCADE daily dosing (5-days on, 2-days off) results in increased PK (AUC)/PD (20S proteasome inhibition) VELCADE daily dosing (5-days on, 2-days off) with increased PK/PD results in improved anti-tumor activity (Increased tolerable VELCADE AUC may potentially cross the threshold required for clinically significant anti-tumor activity in solid cancers).

Some preclinical data suggest that: VELCADE daily dosing results in increased proteasome inhibition in tumor tissues Combination of VELCADE + XRT/other daily dosing agent may have increased anti-tumor activity compared to monotherapy alone.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


acronym: HUNTEXPERT

summary: The study hypothesis is that caregivers experience allows them to develop a lot of knowledge and know-how about behavioural problems in Huntington Disease and its consequences. The purpose of this study is to collect, describe and analyse caregivers experience in order to find and enhance their knowledge related to the adaptation to behavioural problems of Huntington Disease patients.


title: Phase I Study of Cisplatin Hyperthermic Intraperitoneal Chemotherapy Dose Escalation After Surgery in Patients With Unresectable Stage IIIC Ovarian, Tube or Peritoneal Primary Adenocarcinoma Previously Treated by Chemotherapy and Completed by Bevacizumab for 15 Months

acronym: CHIPASTIN

summary: HCIP has shown efficacy in treatment of peritoneal carcinosis from colorectal background. Few studies have been published on the use of HCIP in peritoneal carcinosis from ovarian background but most of them were non-randomized phase II studies on a small population using different type of drugs and dosage. before this heterogeneity it seems necessary to standardize the utilization modalities of HCIP in peritoneal carcinosis from ovarian background


title: Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity

acronym: VEILLETDAH

summary:
In a previous protocol, we highlighted an excessive daytime sleepiness at the Maintenance of Wakefulness Tests (MWT) in 36% of adult Attention Deficit Disorder with or without Hyperactivity (ADHD) patients. In 40% of cases this sleepiness was associated with a sleep disorder objectified by polysomnography (PSG): apnea hypopnea syndrome (AHI) ≥ 10/h and / or Periodicals Movements of Lower Limb (PLMI) ≥ 15/h. However, among patients with no sleep disorder PSG, we can question the central origin of the Excessive Daytime Sleepiness. Thus, we wish to determine potential changes in the regulation of sleep / wake cycle through a protocol of extended wake.

The principal objective is to compare the objective sleepiness in sleepy patients with ADHD and healthy subjects during a protocol of extended wake.

It's an observational study of interventional type realized in patient with ADHD syndrome deprived of psychostimulant treatment (for 72 hours) and healthy subject, investigating the implication of the homeostatic and circadian systems in the preservation of awakening.

ReferenceCitation: Bioulac S, Sagaspe P, Tron E, Benard A, Berthomier C, Brandewinder M, Philip P, Taillard J. Does Homeostatic Sleep Pressure Buildup Explain Objective Excessive Daytime Sleepiness in Adults With ADHD? An Exploratory Study. Front Psychiatry. 2021 Feb 19;12:586528. doi: 10.3389/fpsyt.2021.586528. eCollection 2021.

family: Bioulac

full_name: Stéphanie Bioulac

given: Stéphanie

family: Sagaspe

full_name: Patricia Sagaspe

given: Patricia

family: Tron

full_name: Eléonore Tron

given: Eléonore

family: Benard

full_name: Antoine Benard

given: Antoine

family: Berthomier

full_name: Christian Berthomier

given: Christian

family: Brandewinder

full_name: Marie Brandewinder

given: Marie

family: Philip

full_name: Pierre Philip

given: Pierre

family: Taillard

full_name: Jacques Taillard

journal_name: Frontiers in Psychiatry

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

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: University Hospital, Bordeaux


title: A Phase I Study Evaluating the Combination Afatinib With Docetaxel and Cisplatin (TPA) in Induction Chemotherapy in Locally Advanced Squamous Cell Carcinoma of the Upper Aerodigestive Tract

acronym: TAPIS

summary:
The purpose of the study is to determine the maximum tolerated dose (MTD) of afatinib administrated in combination with docetaxel (Taxotere®) and cisplatin in induction chemotherapy of locally advanced head and neck carcinoma in order to move to a phase II, allowing the comparison with standard induction chemotherapy TPF.

It is a multicentric, national, opened, not-randomized phase Ib. Three doses of afatinib (20, 30 and 40 Mg per day) will be studied in combination with the fixed standard doses of docetaxel and cisplatin. For each dose level, beginning with smallest (20 Mg per day of afatinib), 3 to 6 patients will be treated at maximum, i.e. 3 cycles of three weeks treatment each one (9 weeks on the whole). The next dose level will be studied only if the previous dose is well tolerated for the period of the first 4 weeks observation of the treatment (1st cycle more first week of the 2nd cycle). Once the MTD is determined, four additional patients will be treated with this dose. A maximum of 22 patients should be included in this study. The total duration of the study is estimated at 18 months. In case of major safety problems, the study may be stopped earlier. In short, the preclinical data, pharmacological and clinical on afatinib indicate that the benefit-risk ratio can be regarded as positive and that the association of afatinib with cisplatin and docetaxel could be effective in patients with head and neck squamous cell carcinoma potentially resulting in an extension of time to progression.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou


title: PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program Including a Regular Physical Training, a Medical and Nutritional Follow-up, on Adjuvant Hormonal Treatment Compliance in Breast Cancer Patients Over 70 Years.

acronym: PROACTIVE

summary:
PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric intervention on treatment compliance, measured regularly by blood dosing of drug metabolites.

Patients in the intervention group will be proposed:

A regular geriatric follow up including an attentive screening of joint symptoms and functionality,
An adapted treatment of join pain,
Weekly sessions of adapted physical activity (Taï Chi),
And a systematic correction of vitamin D deficits.


title: Diagnostic Interest of Leukocyte Immunophenotyping Using Multiparameter 8-color Flow Cytometry in Heart Surgery

acronym: INFLUX

summary: In septic patients, Septiflux1 study identified immature granulocytes which may have a diagnostic and prognostic interest. However, with these preliminary results it is not possible to make a difference between what is linked to the infection and what is a consequence of the inflammation which goes along with the septic process. Using flow cytometry, the study of leukocytes in a pure inflammatory model such as cardiopulmonary bypass in heart surgery could make possible to test the diagnostic interest of the immature granulocytes but also to attribute a prognostic value for the occurrence of post-operative infections.

lead_sponsor: University Hospital, Limoges

location_facility: CHU de Limoges - Service de réanimation polyvalente


title: Phase I Study of Temsirolimus and Cetuximab in Adults Patients With Advanced or Metastatic Solid Tumors

acronym: TORERO

summary:
Cetuximab is an EGFR inhibitor that has shown efficacy alone or in combination in colorectal cancer or head and neck cancer in several phase II/III studies.

Temsirolimus is a new mTOR inhibitor that has shown interesting results in several Phase I/II studies in advance kidney cancer of bad prognosis.

Study hypothesis is that combination of those two compounds and the inhibition of two pathways at the same time will have more efficiency on tumoral growth than the inhibition of those pathways in isolation.


title: Observational Study of High Flow Nasal Canula Oxygen to Preoxygenate ARDS Patients That Require Intubation

acronym: HIGHER

summary: Tracheal intubation in the ICU is associated with significant complications and morbidity. Desaturation is among the most frequent and hazardous complication, occurring in almost one out of four intubations, that may in some instances lead to cardiac arrest; despite appropriate preoxygenation. Non-invasive ventilation may help improve preoxygenation but does not allow for apneic oxygenation and may not be performed in patients with neurological impairment. High flow nasal canula oxygen is increasingly used in the ICU in patients with acute hypoxemic respiratory failure and may be used to improve preoxygenation. It is currently used in our ICU for that purpose. Because high flow nasal canula oxygen is our first line oxyten therapy for patients with acute respirtory distress syndrome, we sought to determine its use as a means to ensure preoxygenation in those ARDS patients that require intubation.

ReferenceCitation: Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24. Review.

ReferenceCitation: Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.

ReferenceCitation: Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.

ReferenceCitation: Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.

lead_sponsor: Hôpital Louis Mourier

location_facility: Medico-surgical ICU, Louis Mourier Hospital


title: Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells

acronym: MSC

summary: The main ailm of this phase I-II study is to evaluate toxicity and efficacy of allogenic mesenchymal stem cell therapy to treat severe systemic sclerosis. In practice this treatment will be given to patients with a rapidly evolutive disease or refractory to cyclophosphamide.

status: Active, not recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Biological

status_simplified: Ongoing


title: Potentiation of the Effects of Prismatic Adaptation by Transcranial Direct Current Stimulation (tDCS) : Evaluation of Functional Interest in Negligence Rehabilitation

summary:
Following stroke, over 50% of patients keep severe neurological deficiency whose unilateral neglect, mostly following a right hemispheric lesion. The prismatic adaptation involves to pointing movements toward visual targets wearing prismatic glasses. These prismatic glasses induce a shift to the right visual field for improving symptoms in short term.

Transcranial direct stimulation (tDCS) has been evaluated for different types of deficiency resulting from stroke with encouraging results. The hypothesis of the study is to evaluate the usefulness of brain stimulation as an adjunctive intervention to optimize and increase the rehabilitation of unilateral neglect to long-term.

Thus, the main objective is to evaluate the effectiveness of standard treatment with prismatic adaptation with anodal tDCS or sham tDCS.

ReferenceCitation: Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7:CD003586. doi: 10.1002/14651858.CD003586.pub4.

name: Faculty of Health, Psychology and Social Care; Manchester Metropolitan University; Manchester UK

family: Longley

full_name: Verity Longley

given: Verity

name: Nursing, Midwifery and Allied Health Professions Research Unit; Glasgow Caledonian University; Glasgow UK

family: Hazelton

full_name: Christine Hazelton

given: Christine

name: Centre for Biostatistics, Manchester Academic Health Science Centre; University of Manchester; Manchester UK

family: Heal

full_name: Calvin Heal

given: Calvin

family: Pollock

full_name: Alex Pollock

given: Alex

name: Research & Innovation; Northern Care Alliance NHS Group; Salford UK

family: Woodward-Nutt

full_name: Kate Woodward-Nutt

given: Kate

name: Division of Human Communication, Development & Hearing, Manchester Academic Health Science Centre; University of Manchester; Manchester UK

family: Mitchell

full_name: Claire Mitchell

given: Claire

name: Geoffrey Jefferson Brain Research Centre, The Manchester Academic Health Science Centre; Northern Care Alliance & University of Manchester; Manchester UK

family: Pobric

full_name: Gorana Pobric

given: Gorana

name: Centre For Biostatistics, Manchester Academic Health Science Centre, Manchester, UK; University of Manchester; Manchester UK

family: Vail

full_name: Andy Vail

given: Andy

family: Bowen

full_name: Audrey Bowen

given: Audrey

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11:CD009645. doi: 10.1002/14651858.CD009645.pub4.

name: Department of Public Health; Dresden Medical School, Technical University Dresden; Dresden Germany

name: Department of Physiotherapy; SRH Hochschule für Gesundheit Gera; 07548 Gera Germany

family: Elsner

full_name: Bernhard Elsner

given: Bernhard

name: Department of Public Health, Dresden Medical School; Technical University Dresden; Dresden Germany

family: Kugler

full_name: Joachim Kugler

given: Joachim

name: Neurological Rehabilitation; Helios Klinik Schloss Pulsnitz; Pulsnitz Germany

family: Pohl

full_name: Marcus Pohl

given: Marcus

family: Mehrholz

full_name: Jan Mehrholz

given: Jan

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital henri Gabriel (Hospices Civils de Lyon)


title: Effects of Premedication by Midazolam on Preoperative Anxiety for Emergency Surgery

summary: Preoperative anxiety is a subjective and painful experience and may have adverse psychological consequences and complicate anesthetic management. The aim of the study is to show the effect of premedication by midazolam on preoperative anxiety assessed by a visual analog scale and by measuring salivary cortisol levels. This study was a monocentric, prospective, blind randomized placebo controlled clinical study. Sixty patients, aged 18 to 79 years, to undergo elective surgery under general anesthesia with tracheal intubation must be enrolled and randomized to receive midazolam (0.02mg/kg) or placebo. The primary outcome is the reduction in anxiety assessed by a visual analog scale. The secondary outcomes are the reduction in salivary cortisol levels, the overall level of anxiety and the evaluation of respiratory and hemodynamic adverse effects of midazolam.

ReferenceCitation: Sun GC, Hsu MC, Chia YY, Chen PY, Shaw FZ. Effects of age and gender on intravenous midazolam premedication: a randomized double-blind study. Br J Anaesth. 2008 Nov;101(5):632-9. doi: 10.1093/bja/aen251. Epub 2008 Sep 4.

family: Sun

full_name: G.-C. Sun

family: Hsu

full_name: M.-C. Hsu

family: Chia

full_name: Y.-Y. Chia

family: Chen

full_name: P.-Y. Chen

family: Shaw

full_name: F.-Z. Shaw

journal_name: British Journal of Anaesthesia

oa_colors: green hybrid

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

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

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

ReferenceCitation: Vogelsang J. The Visual Analog Scale: an accurate and sensitive method for self-reporting preoperative anxiety. J Post Anesth Nurs. 1988 Aug;3(4):235-9.

ReferenceCitation: Bauer KP, Dom PM, Ramirez AM, O'Flaherty JE. Preoperative intravenous midazolam: benefits beyond anxiolysis. J Clin Anesth. 2004 May;16(3):177-83.

ReferenceCitation: Jerjes W, Jerjes WK, Swinson B, Kumar S, Leeson R, Wood PJ, Kattan M, Hopper C. Midazolam in the reduction of surgical stress: a randomized clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Nov;100(5):564-70.

ReferenceCitation: Wattier JM, Barreau O, Devos P, Prevost S, Vallet B, Lebuffe G. [Measure of preoperative anxiety and need for information with six issues]. Ann Fr Anesth Reanim. 2011 Jul-Aug;30(7-8):533-7. doi: 10.1016/j.annfar.2011.03.010. Epub 2011 May 23. French.

family: Wattier

full_name: J.-M. Wattier

family: Barreau

full_name: O. Barreau

given: O.

family: Devos

full_name: P. Devos

given: P.

family: Prevost

full_name: S. Prevost

given: S.

family: Vallet

full_name: B. Vallet

given: B.

family: Lebuffe

full_name: G. Lebuffe

given: G.

journal_name: Annales Françaises d'Anesthésie et de Réanimation

title: Mesure de l’anxiété et du besoin d’informations préopératoire en six questions

ReferenceCitation: Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51.

ReferenceCitation: Reves JG, Fragen RJ, Vinik HR, Greenblatt DJ. Midazolam: pharmacology and uses. Anesthesiology. 1985 Mar;62(3):310-24. Review.

ReferenceCitation: Zalunardo MP, Ivleva-Sauerborn A, Seifert B, Spahn DR. [Quality of premedication and patient satisfaction after premedication with midazolam, clonidine or placebo : Randomized double-blind study with age-adjusted dosage]. Anaesthesist. 2010 May;59(5):410-8. doi: 10.1007/s00101-010-1695-9. German.

family: Zalunardo

full_name: M.P. Zalunardo

family: Ivleva-Sauerborn

full_name: A. Ivleva-Sauerborn

given: A.

family: Seifert

full_name: B. Seifert

family: Spahn

full_name: D.R. Spahn

journal_name: Der Anaesthesist

repository_institution: University of Zurich - Zurich Open Repository and Archive

title: Prämedikationsqualität und Patientenzufriedenheit nach Prämedikation mit Midazolam, Clonidin oder Placebo


title: Phase II Multicentric Study of Digoxin Per os in Classic or Endemic Kaposi' s Sarcoma

acronym: KADIG 01

summary:
Classic and endemic Kaposi's sarcoma (KS) are lymph angio proliferations associated with human herpes virus 8 (HHV8) which treatment is poorly codified. Chemotherapies give at best 30-60% of transient responses. While interferon responses are frequent, this drug is often poorly tolerated in elderly patients. Therefore new therapies are needed. Classic KS represents an ideal model for evaluating new drugs since patients do not receive concomitant immunosuppressive regimens nor antiviral therapies.

Hypoxia-inducible factor 1(HIF-1 alpha) is a major regulator of solid tumor growth and therefore a suitable target currently explored in many cancers. Moreover HIF-1 alpha enhances HHV-8 gene expression in KS and induces lytic replication cycle. Digoxin has anti cancer effect in vivo through HIF-alpha down regulation in several preclinical tumor models including KS. The identification of HIF-1 alpha as a key factor in HHV8 replication prompt us to explore inhibition of HIF-1 alpha by digoxin as a potential therapeutic approach for KS treatment it has and consequently may down regulate HHV-8 replication in KS. This latter approach is heightened by recent data suggesting that Digoxin has some efficacy in vitro against others human herpes virus i.e. Herpes simplex and Cytomegalovirus (8) (9)

In this study the investigators shall evaluate the benefit and safety profile of digoxin in classic and endemic KS (serum drug concentration of 0.6 to 1.2 ng/ml for patients <75 years and between 0.5-0.8 ng/ml in patients older than 75 years The participants will take study drug digoxin, for a total of 6 cycles (4 weeks/cycle).


title: Open Study of Phase I / II Evaluating Tolerance and Efficacy of Mobilization and Collection of Peripheral Hematopoietic Stem Cells Device After a Single Injection of 0.24mg/kg of Plerixafor in Sickle Cell Patients

acronym: DrepaMob

summary: The purpose of this study is to assess the tolerance and efficacy of mobilizing hematopoietic stem cells after a single injection of plerixafor (0.24mg/kg) in 3 adult patients (or 5, if results of the first 3 patients are not reproducible) affected by sickle cell disease.

ReferenceCitation: Lagresle-Peyrou C, Lefrère F, Magrin E, Ribeil JA, Romano O, Weber L, Magnani A, Sadek H, Plantier C, Gabrion A, Ternaux B, Félix T, Couzin C, Stanislas A, Tréluyer JM, Lamhaut L, Joseph L, Delville M, Miccio A, André-Schmutz I, Cavazzana M. Plerixafor enables safe, rapid, efficient mobilization of hematopoietic stem cells in sickle cell disease patients after exchange transfusion. Haematologica. 2018 May;103(5):778-786. doi: 10.3324/haematol.2017.184788. Epub 2018 Feb 22.

family: Lagresle-Peyrou

full_name: Chantal Lagresle-Peyrou

given: Chantal

family: Lefrère

full_name: François Lefrère

given: François

family: Magrin

full_name: Elisa Magrin

given: Elisa

family: Ribeil

full_name: Jean-Antoine Ribeil

given: Jean-Antoine

family: Romano

full_name: Oriana Romano

given: Oriana

family: Weber

full_name: Leslie Weber

given: Leslie

family: Magnani

full_name: Alessandra Magnani

given: Alessandra

family: Sadek

full_name: Hanem Sadek

given: Hanem

family: Plantier

full_name: Clémence Plantier

given: Clémence

family: Gabrion

full_name: Aurélie Gabrion

given: Aurélie

family: Ternaux

full_name: Brigitte Ternaux

given: Brigitte

family: Félix

full_name: Tristan Félix

given: Tristan

family: Couzin

full_name: Chloé Couzin

given: Chloé

family: Stanislas

full_name: Aurélie Stanislas

family: Tréluyer

full_name: Jean-Marc Tréluyer

given: Jean-Marc

family: Lamhaut

full_name: Lionel Lamhaut

given: Lionel

family: Joseph

full_name: Laure Joseph

given: Laure

family: Delville

full_name: Marianne Delville

given: Marianne

family: Miccio

full_name: Annarita Miccio

given: Annarita

family: André-Schmutz

full_name: Isabelle André-Schmutz

given: Isabelle

family: Cavazzana

full_name: Marina Cavazzana

given: Marina

currency_apc_doaj: EUR

journal_name: Haematologica

publisher: Ferrata Storti Foundation (Haematologica)


title: Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis

summary: Ve-cadherin is expressed in endothelial cells. Systemic slerosis is a rare auto-immune disease with a endothelial dysfunction. This study is to evaluated the level of soluble VE-cadherin and VE-cadherin antibody in patients with systemic slerosis.


title: Relations Between Cognitive Complaints and Cognitive Scores Goals in Cancer: Assessment of Metamemory

summary: This pilot study is, in this new and original approach in cancer pathology, measure and explain the correspondence between perceived cognitive impairment (cognitive complaint) by cancer patients and their cognitive scores goals with tasks metamemory while controlling the anxiety and depression and fatigue factors of patients.

lead_sponsor: Centre Francois Baclesse


title: Impact of Intravitreal Glucose Rate in Macular Thinning Following Retinal Detachment or Epimacular Membrane Surgery

acronym: GLU-MAC

summary: Comparison between intravitreous glucose rate and macular thinning measured by Ocular Coherence Tomography (OCT) at 3 months post vitrectomy for retinal detachment or epimacular membrane. Hypothesis : Association between post-operative macular thickness and intravitreous glucose rate

lead_sponsor: CHU de Reims

location_facility: Centre Hospitalier Universitaire de Reims


title: Blood Biomarkers in Major Depression

summary: Depression is a leading cause of disability worldwide, affecting nearly 16% of the general population. Its physiopathology remains unclear. Based on gene-environment studies and epigenetic studies, a main hypothesis proposed that the major depressive episode (MDE) results from the convergence of multiple factors including biological factors such as multi-genic vulnerability, hormonal and immunological variations as well as environmental factors. As a consequence, mRNA could define a biological signature of the MDE.

ReferenceCitation: Belzeaux R, Gorgievski V, Fiori LM, Lopez JP, Grenier J, Lin R, Nagy C, Ibrahim EC, Gascon E, Courtet P, Richard-Devantoy S, Berlim M, Chachamovich E, Théroux JF, Dumas S, Giros B, Rotzinger S, Soares CN, Foster JA, Mechawar N, Tall GG, Tzavara ET, Kennedy SH, Turecki G. GPR56/ADGRG1 is associated with response to antidepressant treatment. Nat Commun. 2020 Apr 2;11(1):1635. doi: 10.1038/s41467-020-15423-5.

family: Belzeaux

full_name: Raoul Belzeaux

given: Raoul

family: Gorgievski

full_name: Victor Gorgievski

given: Victor

family: Fiori

full_name: Laura M. Fiori

given: Laura M.

family: Lopez

full_name: Juan Pablo Lopez

given: Juan Pablo

family: Grenier

full_name: Julien Grenier

given: Julien

family: Lin

full_name: Rixing Lin

given: Rixing

family: Nagy

full_name: Corina Nagy

given: Corina

family: Ibrahim

full_name: El Chérif Ibrahim

given: El Chérif

family: Gascon

full_name: Eduardo Gascon

given: Eduardo

family: Courtet

full_name: Philippe Courtet

given: Philippe

family: Richard-Devantoy

full_name: Stéphane Richard-Devantoy

given: Stéphane

family: Berlim

full_name: Marcelo Berlim

given: Marcelo

family: Chachamovich

full_name: Eduardo Chachamovich

family: Théroux

full_name: Jean-François Théroux

given: Jean-François

family: Dumas

full_name: Sylvie Dumas

given: Sylvie

family: Giros

full_name: Bruno Giros

given: Bruno

family: Rotzinger

full_name: Susan Rotzinger

given: Susan

family: Soares

full_name: Claudio N. Soares

given: Claudio N.

family: Foster

full_name: Jane A. Foster

given: Jane A.

family: Mechawar

full_name: Naguib Mechawar

given: Naguib

family: Tall

full_name: Gregory G. Tall

given: Gregory G.

family: Tzavara

full_name: Eleni T. Tzavara

given: Eleni T.

family: Kennedy

full_name: Sidney H. Kennedy

given: Sidney H.

family: Turecki

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

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Two-years Follow-up of Post-spinal Implantable Neurostimulator PRECISION®

acronym: PRECISION

summary: Assessing the long-term efficacy, complications, revision rates and final explantation of the device

ipd_sharing_description: Individual participant data will not be shared; Only aggregated data will be communicated

lead_sponsor: Cemka-Eval

location_facility: Hospitals implanting the neurostimulator Precision


title: Prognostic Value of Myocardial Perfusion Heterogeneity Assessed by Stress Single Photon Emission Computed Tomography

acronym: EVAPERF

summary:
Endothelial dysfunction has been demonstrated to be an early marker of coronary artery disease (CAD). On the other hand, myocardial perfusion single photon emission computed tomography (MP-SPECT) is a widely used technique for evaluation of patients with suspected or known CAD.

Preliminary data suggest that myocardial perfusion heterogeneity (a potential surrogate marker of endothelial dysfunction) can be assessed on conventional MP-SPECT, but its additive and independent prognostic value over the presence of myocardial ischemia remain unknown.

More over, factual data demonstrate that inhalation of particulate matters and gaz (NO2, CO) from air pollution contributes to the development of cardiovascular diseases in the short and long term. The role of air pollution in endothelial dysfunction has been suggested.

Accordingly, the purpose of this study is to evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a new automatized image processing method applied to routine MP-SPECT.

The second purpose is to evaluate the role of air pollution exposure in pathogenesis of cardiovascular disease.

The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive of 2-year cardiovascular events in patients referred to the Nuclear Cardiology Department for routine evaluation of known or suspected CAD.

The second hypothesis is that microcirculatory coronary dysfunction is a causal link between air pollution and cardiovascular disease.

ReferenceCitation: Verma S, Buchanan MR, Anderson TJ. Endothelial function testing as a biomarker of vascular disease. Circulation. 2003 Oct 28;108(17):2054-9. Review.

ReferenceCitation: Schindler TH, Nitzsche EU, Schelbert HR, Olschewski M, Sayre J, Mix M, Brink I, Zhang XL, Kreissl M, Magosaki N, Just H, Solzbach U. Positron emission tomography-measured abnormal responses of myocardial blood flow to sympathetic stimulation are associated with the risk of developing cardiovascular events. J Am Coll Cardiol. 2005 May 3;45(9):1505-12.

ReferenceCitation: Vanzetto G, Ormezzano O, Fagret D, Comet M, Denis B, Machecourt J. Long-term additive prognostic value of thallium-201 myocardial perfusion imaging over clinical and exercise stress test in low to intermediate risk patients : study in 1137 patients with 6-year follow-up. Circulation. 1999 Oct 5;100(14):1521-7.

ReferenceCitation: Johnson NP, Gould KL. Clinical evaluation of a new concept: resting myocardial perfusion heterogeneity quantified by markovian analysis of PET identifies coronary microvascular dysfunction and early atherosclerosis in 1,034 subjects. J Nucl Med. 2005 Sep;46(9):1427-37.

lead_sponsor: University Hospital, Grenoble


title: Diaphragmatic Dysfunction in Cardiac Surgery: Observational Study

summary:
Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical ventilation and cause respiratory distress.

The investigators' main objective is to determine the incidence of diaphragm dysfunction ( using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic thickening fraction) in a selected population of cardiac surgery patients during weaning from mechanical ventilation.

The second endpoints are to determine the associated risk factors to post-operative diaphragm weakness and the consequence on the patient outcome.

ReferenceCitation: DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.

ReferenceCitation: McCool FD, Tzelepis GE. Dysfunction of the diaphragm. N Engl J Med. 2012 Mar 8;366(10):932-42. doi: 10.1056/NEJMra1007236. Review. Erratum in: N Engl J Med. 2012 May 31;366(22):2138.

ReferenceCitation: Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.

family: Jaber

full_name: Samir Jaber

given: Samir

family: Petrof

full_name: Basil J. Petrof

given: Basil J.

family: Jung

full_name: Boris Jung

given: Boris

family: Chanques

full_name: Gérald Chanques

given: Gérald

family: Berthet

full_name: Jean-Philippe Berthet

given: Jean-Philippe

family: Rabuel

full_name: Christophe Rabuel

given: Christophe

family: Bouyabrine

full_name: Hassan Bouyabrine

given: Hassan

family: Courouble

full_name: Patricia Courouble

given: Patricia

family: Koechlin-Ramonatxo

full_name: Christelle Koechlin-Ramonatxo

given: Christelle

family: Sebbane

full_name: Mustapha Sebbane

given: Mustapha

family: Similowski

full_name: Thomas Similowski

given: Thomas

family: Scheuermann

full_name: Valérie Scheuermann

given: Valérie

family: Mebazaa

full_name: Alexandre Mebazaa

given: Alexandre

family: Capdevila

full_name: Xavier Capdevila

given: Xavier

family: Mornet

full_name: Dominique Mornet

given: Dominique

family: Mercier

full_name: Jacques Mercier

given: Jacques

family: Lacampagne

full_name: Alain Lacampagne

given: Alain

family: Philips

full_name: Alexandre Philips

family: Matecki

full_name: Stefan Matecki

given: Stefan

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Rapidly Progressive Diaphragmatic Weakness and Injury during Mechanical Ventilation in Humans

ReferenceCitation: Moury PH, Cuisinier A, Durand M, Bosson JL, Chavanon O, Payen JF, Jaber S, Albaladejo P. Diaphragm thickening in cardiac surgery: a perioperative prospective ultrasound study. Ann Intensive Care. 2019 Apr 24;9(1):50. doi: 10.1186/s13613-019-0521-z.

family: Moury

full_name: Pierre-Henri Moury

given: Pierre-Henri

family: Cuisinier

full_name: Adrien Cuisinier

given: Adrien

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

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

location_facility: Unité de Réanimation Cardio-vasculaire et Thoracique


title: Assessment of Patient Satisfaction in Palliative Cancer When They Return Home After Hospitalization in Palliative Care

summary:
The proposed work is part of a multidisciplinary approach to continuity of care in the particular context of the palliative phase of cancer. In conducting this study, we would like to characterize, at the regional level, satisfaction with the care of patients and their families in their care home situations palliative cancer. This evaluation will be based on questionnaires adapted versions in French language satisfaction questionnaires recently validated for patients in palliative situation and supported home care.

It will also identify the challenges faced by both patients, caregivers attending physicians.

The evaluation of these elements is a prerequisite to propose ways of improving at a hospital palliative care for output relay and anticipate the coordination of care for optimal care of the patient at home, to meet the expectations of different stakeholders, or even prevent certain readmissions "avoidable".


title: Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery : a Multicentric Prospective Randomized Controlled Study

acronym: OPVI

summary: The purpose of this study is to determine whether an operative hemodynamic optimization using the plethysmographic variability index during orthopedic surgery could decrease the length of hospital stay and the postoperative morbidity.

ReferenceCitation: Fischer MO, Daccache G, Lemoine S, Tavernier B, Compère V, Hulet C, Bouchakour CE, Canevet C, Gérard JL, Guittet L, Lorne E, Hanouz JL, Parienti JJ. The OPVI trial - perioperative hemodynamic optimization using the plethysmographic variability index in orthopedic surgery: study protocol for a multicenter randomized controlled trial. Trials. 2015 Nov 4;16:503. doi: 10.1186/s13063-015-1020-7.

family: Fischer

full_name: Marc-Olivier Fischer

given: Marc-Olivier

family: Daccache

full_name: Georges Daccache

given: Georges

family: Lemoine

full_name: Sandrine Lemoine

given: Sandrine

family: Tavernier

full_name: Benoît Tavernier

given: Benoît

family: Compère

full_name: Vincent Compère

given: Vincent

family: Hulet

full_name: Christophe Hulet

family: Bouchakour

full_name: Chems Eddine Bouchakour

given: Chems Eddine

family: Canevet

full_name: Christophe Canevet

family: Gérard

full_name: Jean-Louis Gérard

given: Jean-Louis

family: Guittet

full_name: Lydia Guittet

given: Lydia

family: Lorne

full_name: Emmanuel Lorne

given: Emmanuel

family: Hanouz

full_name: Jean-Luc Hanouz

given: Jean-Luc

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

journal_name: Trials

title: The OPVI trial – perioperative hemodynamic optimization using the plethysmographic variability index in orthopedic surgery: study protocol for a multicenter randomized controlled trial

lead_sponsor: University Hospital, Caen


title: Effect of Weight Loss on Postural Changes in Pulmonary Function : a Longitudinal Study in Morbidly Obese to Obese Subjects Following Gastroplasty

summary: Postural changes are known to affect normal lung volumes. A reduction in sitting to supine functional residual capacity (FRC) is well-described in non-obese subjects adopting a supine position. However, postural changes in lung volumes in the obese require further exploration. We aimed to longitudinally address the effects of weight loss on postural changes in lung volumes and pulmonary function, in obesity. We tested the hypothesis that supine reduction in FRC would be absent in morbid obesity and recovered upon weight loss.

ReferenceCitation: Sebbane M, El Kamel M, Millot A, Jung B, Lefebvre S, Rubenovitch J, Mercier G, Eledjam JJ, Jaber S, Hayot M. Effect of Weight Loss on Postural Changes in Pulmonary Function in Obese Subjects: A Longitudinal Study. Respir Care. 2015 Jul;60(7):992-9. doi: 10.4187/respcare.03668. Epub 2015 Apr 7.

family: Sebbane

full_name: M. Sebbane

given: M.

family: El Kamel

full_name: M. El Kamel

family: Millot

full_name: A. Millot

given: A.

family: Jung

full_name: B. Jung

given: B.

family: Lefebvre

full_name: S. Lefebvre

given: S.

family: Rubenovitch

full_name: J. Rubenovitch

given: J.

family: Mercier

full_name: G. Mercier

given: G.

family: Eledjam

full_name: J.-J. Eledjam

family: Jaber

full_name: S. Jaber

family: Hayot

full_name: M. Hayot

journal_name: Respiratory Care

evidence: open (via free pdf)

publisher: Daedalus Enterprises

publisher_dissemination: Daedalus Enterprises

publisher_group: Daedalus Enterprises

publisher_normalized: Daedalus Enterprises

lead_sponsor: Association pour la Formation du Personnel à la Medecine d'Urgence


title: Observational Registry Study for Symbotex™ Composite Mesh in Ventral Hernia Repair

acronym: SymCHro

summary: The aim of this Observational Registry Study is to assess the short- and long-term clinical outcomes following the use of Symbotex™ Composite Mesh in primary and incisional abdominal wall hernia surgeries by open or laparoscopic approach, according to the Instruction for use (IFU).

lead_sponsor: Medtronic - MITG

location_facility: Club Hernie association represented by Dr Gillion, in his capacity as President


title: EFFECTS OF THE MICRO REINJECTION OF AUTOLOGOUS ADIPOSE TISSUE IN THE FACE OF PATIENTS WITH SYSTEMIC SCLEROSIS

acronym: FACE

summary:
This prospective single-center study evaluates a current care procedure. It includes 14 patients diagnosed with SSc according to the ACR/EULAR criteria or the Leroy & Medsger criteria of the disease. Patients are enrolled if they wish for a therapeutic care of their face, have a Mouth Handicap in Systemic Sclerosis (MHISS) score greater than 20 (scale 0-48), a modified Rodnan skin score upper or equal to 1 on the face (scale 0-3), and a mouth opening less than 55 millimeters. They should not have anticoagulant, anti-platelets aggregation medication or a daily steroid dose upper 20mg per day. Their BMI should exceed 17.

Micro fat grafting is a minimally invasive and usual procedure performed under local anesthesia. Fat tissue is harvested (around 50 milliliters) using a 14 gauge or 2 mm diameter cannula from areas around the knees, the abdomen or the hips under a gentle aspiration. Lipoaspirated fat is then filtrated by the PureGraft system that offers a sterile, closed, single-use system, leading to a fast, consistent and controlled preparation. Then, 10 to 25 milliliters of this purified fat product is transferred through a 21 gauge or 0.8 mm diameter cannula in two or four points of the face, with the entry points located around the mouth.


title: ACETAMINOPHEN ANTINOCICEPTIVE EFFECT WHEN ASSOCIATED WITH N-ACETYLCYSTENEINE

acronym: PANACE

summary:
Acetaminophen is one of the most widely used analgesic in the world, recommended for the symptomatic treatment of fever and pain.

The purpose of this study is to assess the effectiveness of acetaminophen in association with N-acetylcysteine.

The objective of this study is to evaluate if the association in healthy volunteers of acetaminophen and N-acétylcystéine

- decrease the antinociceptive effect of acetaminophen in comparison to a group control
- and if this antinociceptive effect may depend of the genetic polymorphism of GSH enzyme.

lead_sponsor: University Hospital, Clermont-Ferrand


title: REMIFENTANIL AND LOCAL ANESTHESIA COMPARED WITH LOCAL ANESTHESIA FOR THE INSERTION OF CENTRAL VENOUS CATHETERS IN AWAKE PATIENTS

acronym: REMIDOLCATH

summary: At present, there is no reference protocol for Central Venous Catheter (CVC) insertion assuring analgesia, anxiolysis and safety. Medical teams use various levels of analgesia and anesthesia to realize this gesture, from single local anesthesia to general anesthesia. Remifentanil has been shown to decrease pain scores for insertion and removal of long-term central venous access. Remifentanil is also often employed for pediatric or labor analgesia for short acts as procedural sedation.

ReferenceCitation: Vardon Bounes F, Pichon X, Ducos G, Ruiz J, Samier C, Silva S, Sommet A, Fourcade O, Conil JM, Minville V. Remifentanil for Procedural Sedation and Analgesia in Central Venous Catheter Insertion: A Randomized, Controlled Trial. Clin J Pain. 2019 Aug;35(8):691-695. doi: 10.1097/AJP.0000000000000725.

family: Vardon Bounes

full_name: Fanny Vardon Bounes

given: Fanny

family: Pichon

full_name: Xavier Pichon

given: Xavier

family: Ducos

full_name: Guillaume Ducos

given: Guillaume

family: Ruiz

full_name: Jean Ruiz

given: Jean

family: Samier

full_name: Caroline Samier

given: Caroline

family: Silva

full_name: Stein Silva

given: Stein

family: Sommet

full_name: Agnès Sommet

given: Agnès

family: Fourcade

full_name: Olivier Fourcade

given: Olivier

family: Conil

full_name: Jean-Marie Conil

given: Jean-Marie

family: Minville

full_name: Vincent Minville

journal_name: The Clinical Journal of Pain

lead_sponsor: University Hospital, Toulouse


summary:
Lutein ans zeaxanthin, carotenoids provided by dietary intake are mainly located in the macular area.

Its absorption peak at 460 nm may reduce photic damages. The macular pigment density can be evaluated by its optical density.

Reduced macular pigment level is a significant risk factor for age-macular degeneration. The nutritional intake can minimise the risk of age-macular degeneration.

lead_sponsor: Poitiers University Hospital

location_facility: ophthalmology department, Poitiers University Hospital


title: Interventionnal and Randomized Study Measuring Virtual Reality Cue Exposure for the Relapse Prevention of Tobacco Consumption Versus Cognitive and Behavioral Approaches Therapy

summary: The therapeutic efficacy of virtual reality has been validated for the treatment of various mental disorders ,smoking behavior is the first preventable cause of death in developed countries However, after a successful withdrawal, a high relapse rate (between 40 and 70%)has been observed, which emphasize the urgent need to implement new strategies. Virtual reality cue exposure for the relapse of tobacco consumption

ReferenceCitation: Giovancarli C, Malbos E, Baumstarck K, Parola N, Pélissier MF, Lançon C, Auquier P, Boyer L. Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial. Trials. 2016 Feb 19;17:96. doi: 10.1186/s13063-016-1224-5.

family: Giovancarli

full_name: Camille Giovancarli

given: Camille

family: Malbos

full_name: Eric Malbos

given: Eric

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

family: Parola

full_name: Nathalie Parola

given: Nathalie

family: Pélissier

full_name: Marie-Florence Pélissier

given: Marie-Florence

family: Lançon

full_name: Christophe Lançon

given: Christophe

family: Auquier

full_name: Pascal Auquier

given: Pascal

family: Boyer

full_name: Laurent Boyer

given: Laurent