title: Cross-sectional Study of the Factors Determining the Quality of Life of the Patient and the Burden of the Caregiver in Progressive Supranuclear Palsy

acronym: Qual-PSP

summary:
Progressive supranuclear palsy (PSP) is a rare neurodegenerative disease from the parkinsonian syndrome group.

PSP is characterised by the association of a non-doparesponsive parkinsonian syndrome with axial signs. The latter predominantly manifest as a psycho-motor slowness, an apathy and frontal executive deficits. Swallowing impairments may additionally provoke life-threatening situations. Today the treatment is mostly symptomatic as no cure is available. Given the limited treatment options and its clinical characteristics, PSP deeply impact on the patients' quality of life (QoL) as well as on their caregivers'. Nevertheless a limited number of studies have focused on these aspects. A better understaning of the factors determining both patient and cargiver QoL may help optimising their care.

the principal objective of this study is to identify the determinants of PSP patients' QoL.

The secondary objectives are : i) to identify the determinants (medical, behavioural, socio-economic, environmental …) of PSP patients' caregivers' QoL and burden ; ii) to validate in French language the QoL scale specific for PSP available in English (PSP-QoL).

This is a multidisciplinary transversal study. 2 subject groups will be included : i) PSP patients ; ii) caregiver of PSP patients (designated by the patient as being the person closest to them), Data collected : i) from the patient : socio-demographic, social and professionnal environment, clinical (disease duration and severity, neuropsychological evaluation), therapeutic, mood, anxiety, coping, body image, QoL ; ii) from the caregiver: socio-demographic, social and professionnal environment, connection with the patient, data relative to their own health, mood, anxiety, coping, QoL, burden.

Progress : patient information, designation of a caregiver, consent collection, collection of data Statistical analysis : To address the principal objective 'patient' QoL scores will be confronted to the other collected variables (Student's t-test, correlation coefficient). The results will be adjusted to the confounding factors using multivariate analyses.


title: Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis in the Upper Urinary Tract

acronym: EASILY

summary: In this pilot study, we wish to evaluate the performance of a robotic flexible ureteorscopy (ILY) in the treatment of nephrolithiasis in the superior excretory system

study_start_date_type: Anticipated

status: Withdrawn

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Cross Over Pilot Study for Evaluation of Pain Reduction in Patients With Chronic Low Back Pain (for More Than 3 Month) Using an Innovative Handheld Device

acronym: ATLAS

summary:
The aim of the study is to evaluate the reduction of pain by wearing the ATLAS Medical Device in standardized daily activities for patients with Chronic Low Back Pain.

This is an intervention al non blinded study with a crossover design comparing pain evaluated with an Analogue Visual Scale with and without the ATLAS device during 5 standardized daily activities.

study_start_date_type: Actual

status: Recruiting

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

lead_sponsor: University Hospital, Lille

intervention_type: Other

status_simplified: Ongoing


title: Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: Monocentric Feasibility Study MorphoBreast3D

summary: Quantitative evaluation of the breast's morphological variations during radiotherapy consisting in performing three-dimensional surface acquisitions of the breast in order to study its shape and volume. Evaluation of the dosimetric impact of these variations.

status: Completed

study_completion_date_type: Actual

primary_purpose: Other

ipd_sharing: Undecided

lead_sponsor: Centre Paul Strauss

lead_sponsor_type: industriel

status_simplified: Completed


intervention_type: Drug

lead_sponsor: Institut de Cancérologie de la Loire

acronym: TTRAP-Bleeding

location_facility: Institut de Cancérologie Lucien Neuwirth

type: EudraCT Number

source: euctr

title: Study of Thromboelastography During Tranexamic Acid Treatment in Preventing Bleeding in Patients With Haematological Malignancies Presenting Severe Thrombocytopenia (TTRAP-bleeding)

summary: Patients with hematological malignancies are at increased risk of bleeding, especially during intensive chemotherapy. The aim of this study is to compare by thromboelastography changes during the intensive chemotherapy in patients with hematological malignancies.


title: Study of the Prevalence, Nature and Contributing Factors of Painful Symptoms of the Musculoskeletal System After Lung Transplantation; Impact on Physical Activity and Quality of Life

summary:
Pulmonary transplantation (PT) is a therapeutic option now accepted in the management of selected patients who have reached the irreversible and terminal stage of their chronic respiratory insufficiency. Its main indications are: cystic fibrosis and other bronchial diseases, emphysema , interstitial lung diseases with idiopathic pulmonary fibrosis in the foreground, and severe pulmonary hypertension.

The evocation of osteo-articular and musculotendinous pain symptoms in the aftermath of PT is frequent and very diversified. These complications are poorly codified and hinder the rehabilitation and early resumption of physical activity and sports. Few data are available on this subject in the literature.

Following transplantation, improvements in respiratory function, quality of life, and exercise capacity are observed, with large inter-individual variations;

Patients are encouraged to resume physical activity, initially as part of a rehabilitation exercise.

Among the factors limiting exercise, some have been more widely studied, such as muscular deconditioning related to pre-existing chronic respiratory insufficiency , prolonged stay in intensive care, side effects of transplant-related treatments (corticosteroids and immunosuppressants).

Pain is also a factor limiting the recovery of physical activity and quality of life. Pain related directly to thoracotomy surgery has been explored but there is little data available on musculoskeletal pain.

The purpose of this study is to better understand the musculoskeletal pain occurring in the aftermath of a lung transplantation. Conducting this study for a period of 1 year will allow you to move away from the immediate post-transplant time, and the pain associated with the transplant will no longer have any interference.

The main objective of our study is to better know the prevalence of algic manifestations of the musculoskeletal system (osteo-articular, musculotendinous ...) occurring in the year following a TP, and may constitute a brake on the rehabilitation of the musculoskeletal system. effort and recovery of physical activity or sport.

status: Unknown status

study_type: Observational

time_perspective: Prospective

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille


title: DOuble tasK Test On ergometeR - Basic Research on Acceptability and Use

acronym: DOKTORBRAU

summary: The goal of the study is to show the concordance between the dual-task test achieved usually on an electronic treadmill and the dual-task test achieved with a cyclo-ergometer.

lead_sponsor: University Hospital, Angers


title: Medicinal Dependence and Chronic Pain: Addictive Evaluation in CETD

acronym: DEMDOU

summary:
prescription opioid misuse in chronic pain is a growing public health concern. few studies got interested in prevalence of misuse and of opiate use disorder in a population of patients with a non cancer chronic pain.

the investigators analyzed during 3 months opiate misuse and opiate ude disorder in a population of patients consulting a center specialized in pain management.

lead_sponsor: University Hospital, Brest


title: Ability of Changes in End Tidal Carbon Dioxide to Assess the Stroke Volume Effects of a Volume Expansion of 250ml of Crystalloid in the Operating Room

summary: Volume expansion is the cornerstone of perioperative hemodynamic optimization. The main objective of volume expansion is to increase and to maximize stroke volume. Despite national and international recommendations, stroke volume monitoring is clearly not widely adopted. This is mostly due to the cost and the invasiveness of the devices allowing stroke volume monitoring. End tidal carbon dioxide is monitored in all patients undergoing general anaesthesia and is totally non-invasive. A strong relationship between stroke volume and end tidal carbon dioxide have been already demonstrated. The aim of the present study is to determine if change in End Tidal Carbon Dioxide can assess the stroke volume effects of a volume expansion of 250ml of crystalloid in the operating room

ReferenceType: derived

ReferenceCitation: de Courson H, Chauvet J, Le Gall L, Georges D, Boyer P, Verchère E, Nouette-Gaulain K, Biais M. Utility of changes in end-tidal carbon dioxide after volume expansion to assess fluid responsiveness in the operating room: a prospective observational study. Br J Anaesth. 2020 Nov;125(5):672-679. doi: 10.1016/j.bja.2020.07.018. Epub 2020 Aug 27.

family: de Courson

full_name: Hugues de Courson

given: Hugues

sequence: first

family: Chauvet

full_name: Julie Chauvet

given: Julie

sequence: additional

family: Le Gall

full_name: Lisa Le Gall

given: Lisa

family: Georges

full_name: Delphine Georges

given: Delphine

family: Boyer

full_name: Philippe Boyer

given: Philippe

family: Verchère

full_name: Eric Verchère

given: Eric

family: Nouette-Gaulain

full_name: Karine Nouette-Gaulain

given: Karine

family: Biais

full_name: Matthieu Biais

given: Matthieu

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University Hospital, Bordeaux


title: Echinocandins Versus Azoles as First-line Therapy for the Treatment of Candidemia in Intensive Care Units

acronym: AntiCandiTreat

summary: Candidemia is the most frequent invasive fungal disease in intensive care units (ICUs). It remains a major health concern, considering its attributable mortality up to 40% in critically ill patients. Successful clinical outcome requires early diagnosis and effective antifungal therapy. Guidelines for the treatment of candidemia were published by the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). According to these guidelines, echinocandins are the preferred first-line therapy for candidemia in critically ill patients. Considering the bibliography supporting this statement, the place of triazoles still needs to be defined in candidemia therapeutic arsenal. In this context, we are setting up a retrospective cohort study using Hospital database to compare the efficacy of echinocandins and azoles for the treatment of candidemia in intensive care units.

time_perspective: Retrospective

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Hôpital de la Croix-Rousse


title: Phase-1 Study of Escalated-dose Pelvic Radiation Therapy Using Intensity-Modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB), in Combination With Xeloda, for Initially Metastatic, Low and Middle Rectal Cancer

acronym: DESIR

summary: In initially metastatic rectal carcinoma, a neo-adjuvant multi-drug chemotherapy is usually performed, followed by a pelvic chemoradiation. The surgical indications on both metastases and the pelvic site are then discussed: in the case where a complete (or near-complete) response (CR) of the rectal tumor is observed (10 to 40%), the local surgery may be omitted or poned ("wait-and-see") in a sphincter-sparing strategy, in order to minimize or avoid the surgical morbidity, to focus on metastatic disease by the continuation of chemotherapy, and to preserve a better quality of life. After 8 weeks of induction chemotherapy (mFolfox6 regimen, 4 cycles), the aim of our study is to optimize the chemoradiation step on the distal rectal tumor, thanks to Intensity-Modulated Radiotherapy (IMRT) with simultaneous integrated boost (SIB) (Phase-1 part of the study), concomitantly with oral capecitabine. According to a Fibonacci dose-escalation scheme, 3 radiation dose-levels are defined, up to the definition of the maximal tolerated dose (MTD), requiring the inclusion of a maximum of 20 patients. Further patients will be included at the recommended dose for phase-2 (RDP2) in a two-step phase-2 study, considering simultaneously as principal objective at 12 months, both the efficacy (local CR rate in the range of 10 to 25%) and the tolerance (pelvic radiation disease: grade 3-4 toxicities in the range of 30 to 10%). Overall 65 patients will be included in the phase-2 study at the RDP2 dose.

status: Terminated

lead_sponsor: Institut Cancerologie de l'Ouest

intervention_type: Combination Product


title: Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs

acronym: GT-PT

summary: The numerical ratio between the value of the thrombin generation test performed without soluble thrombomodulin and the value of the thrombin generation test performed in the presence of soluble thrombomodulin, performed pre-surgically, could predict the risk of early venous thromboembolism after placement of total hip or knee prosthesis.


title: Identification and Validation of Noninvasive Biomarkers (Virtual Biopsy) of the Diagnosis and Severity of NASH in Type 2 Diabetics: a Cross-sectional Study

acronym: Quid-Nash

summary:
Metabolic diseases of the liver are silent affections whose morbidity is important. About 70% of patients with type 2 diabetes (T2D) are concerned. Of these, 50% develop clinically significant lesions (including non-alcoholic steatohepatitis or NASH) as they are associated with an increased risk of complications; and 15% progress to severe fibrosis or cirrhosis. These diseases are slowly progressive and asymptomatic. Their pathophysiology is poorly known. Management is hampered by the absence of a specific diagnostic marker, the need for invasive diagnostic procedures (liver biopsy), and the lack of established treatment.

QUID-NASH aims to develop a virtual liver biopsy in T2D participants, based on the identification of single or combined, multimodal, non-invasive biomarkers obtained by new quantitative imaging techniques (magnetic resonance and ultrafast ultrasound UFUS); and /or extensive clinical-biological phenotyping data; and/or data obtained by different omic approaches (metabolomics, targeted genetics, transcriptomics). Extracellular vesicle and immune cell profiling will complement these phenotyping data. This approach will also enable us to improve our understanding of pathophysiology (new signaling pathways, new therapeutic targets).

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceCitation: Poynard T, Paradis V, Mullaert J, Deckmyn O, Gault N, Marcault E, Manchon P, Si Mohammed N, Parfait B, Ibberson M, Gautier JF, Boitard C, Czernichow S, Larger E, Drane F, Castille JM, Peta V, Brzustowski A, Terris B, Vallet-Pichard A, Roulot D, Laouénan C, Bedossa P, Castera L, Pol S, Valla D; Quid-Nash consortium. Prospective external validation of a new non-invasive test for the diagnosis of non-alcoholic steatohepatitis in patients with type 2 diabetes. Aliment Pharmacol Ther. 2021 Oct;54(7):952-966. doi: 10.1111/apt.16543. Epub 2021 Aug 16.

family: Poynard

full_name: Thierry Poynard

given: Thierry

family: Paradis

full_name: Valérie Paradis

given: Valérie

family: Mullaert

full_name: Jimmy Mullaert

given: Jimmy

family: Deckmyn

full_name: Olivier Deckmyn

given: Olivier

family: Gault

full_name: Nathalie Gault

given: Nathalie

family: Marcault

full_name: Estelle Marcault

given: Estelle

family: Manchon

full_name: Pauline Manchon

given: Pauline

family: Si Mohammed

full_name: Nassima Si Mohammed

given: Nassima

family: Parfait

full_name: Beatrice Parfait

given: Beatrice

family: Ibberson

full_name: Mark Ibberson

given: Mark

family: Gautier

full_name: Jean‐Francois Gautier

given: Jean‐Francois

family: Boitard

full_name: Christian Boitard

given: Christian

family: Czernichow

full_name: Sébastien Czernichow

given: Sébastien

family: Larger

full_name: Etienne Larger

given: Etienne

family: Drane

full_name: Fabienne Drane

given: Fabienne

family: Castille

full_name: Jean Marie Castille

given: Jean Marie

family: Peta

full_name: Valentina Peta

given: Valentina

family: Brzustowski

full_name: Angélique Brzustowski

given: Angélique

family: Terris

full_name: Benoit Terris

given: Benoit

family: Vallet‐Pichard

full_name: Anais Vallet‐Pichard

given: Anais

family: Roulot

full_name: Dominique Roulot

given: Dominique

family: Laouénan

full_name: Cédric Laouénan

given: Cédric

family: Bedossa

full_name: Pierre Bedossa

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

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

title: Prospective external validation of a new non‐invasive test for the diagnosis of non‐alcoholic steatohepatitis in patients with type 2 diabetes


title: Phase I / II Study Evaluating the Efficacy and Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer Who Have Failed With Standard Chemotherapy Protocols (FOLFIRINOX 3)

summary:
In patients in progression after oxaliplatin and irinotecan, the study FOLFIRINOX 3 proposes to evaluate the interest of modifying the standard pattern of administration of the molecule of irinotecan in order to make it more efficient. In combination with other chemotherapy drugs (5-fluorouracil, oxaliplatin, folinic acid and bevacizumab), irinotecan will be administered at the beginning and end of each cycle of chemotherapy, whereas it is normally administered at one time in the regimen. standard of treatment.

The hypothesis of this study is an increase in the objective response rate at 2 months of 10 to 30% with a scheme by FOLFIRINOX3 - bevacizumab compared to an optimal treatment to date by FOLFIRINOX-bevacizumab.

lead_sponsor: Centre Georges Francois Leclerc


title: Relationship Between Complexity and Pain in a Walking Task With Distraction in the Chronic Low Back Pain Patient by Fractal Analysis: Pilot Study

acronym: CoDiLoBP

summary:
Motor control, notably expressed through the complexity of the variability of the locomotor pattern, is disturbed at the central level by an apprehension of pain and movement, more than pain itself (or by biomechanical / structural damage of the spine) in chronic low back pain (cLBP) patients.

The aim of this study is to control that variability is reduced during gait at comfortable level and to test that distraction can reduce pain avoidance and therefore increase variability in cLBP patients.

intervention_type: Behavioral


title: Evaluation of the Links Between Sleep Disorders and the Risk of Suicide Attempt

acronym: HYPNOS

summary:
Several studies have demonstrated an association between sleep disorders such as insomnia and nightmares to suicidal ideations and behaviors.

Nevertheless, some of these studies are methodologically questionable especially in the exploration of sleep disorders. Furthermore, confounding factors such as depressive symptomatology are not controlled and the measurement of suicidal behavior has often been taken into account as a historical measure, not as a current event, which introduces uncertainties and a lack of precision regarding the temporality of the phenomena.

Today, while the links between sleep disorders and suicidal risk are well known, we have a lack of information on the importance and the role of sleep disorders as a precipitating factor. Indeed, few studies have evaluated the temporal link between sleep disorders and suicidal acts.

The objective of this study is to evaluate the links between acute and chronic sleep disorders and the risk of suicide attempt


title: Adaptation of the Questionnaire "Regarding Patient's Quality of Life With Mastocytosis" in the French Language

summary:
Mastocytosis is a heterogeneous rare disease. A 27-item questionnaire to assess the quality of life of patients with cutaneous/ indolent systemic mastocytosis was developed in the German language and validated in the English language in 2015.

The team of the University Charité Berlin and the company Moxie - intellectual proprietor of the questionnaire - proposed the use of the recommendations of Baiardini et al. 2010, for linguistic adaptation of this questionnaire in other languages.

lead_sponsor: University Hospital, Toulouse


title: High Flow Oxygen (HFO) VERSUS Non Invasive Ventilation (NIV) Associated to Automated Flow Oxygen Titration (AFOT) After Extubation in Patient With Respiratory Risk: Non-inferiority Prospective Comparative Study

acronym: RespiFLOW

summary:
Extubation stay at high risk of reintubation even scheduled and in the best condition of hematosis. Re-intubation's rate in main studies in chronic obstructive diseases reach to 20% and it is associated to a higher mortality, higher pneumonia under mechanic ventilation, and higher duration of hospitalization especially in intensive care units.

Place of NIV in this situation is still on evaluation. A recent meta-analysis demonstrates that use of NIV in post-extubation in COPD seems to decrease re-intubation rate.

HFO, thanks to its properties (oxygen, humidification and heat with high flow) could be useful in this population in ventilatory weaning. Compared to oxygen conventional therapy with high-concentration mask, HFO seems to be as efficient and better tolerated. A recent study shows that HFO is non-inferior to NVI in post-extubation in patient with high risk of re-intubation.

Furthermore, oxygenation in post-extubation should be optimized to avoid hypoxemia and hypercapnia in this patient at risk of hypoventilation. Place of AFOT could improve hematosis by providing adapted flow of oxygen to each patient.

The investigator choose the hypothesis for this study that HFO is as effective and tolerated in post-extubation than NIV with AFOT.

ReferenceType: background

ReferenceCitation: Bajaj A, Rathor P, Sehgal V, Shetty A. Efficacy of noninvasive ventilation after planned extubation: A systematic review and meta-analysis of randomized controlled trials. Heart Lung. 2015 Mar-Apr;44(2):150-7. doi: 10.1016/j.hrtlng.2014.12.002. Epub 2015 Jan 13. Review.

ReferenceCitation: Tiruvoipati R, Lewis D, Haji K, Botha J. High-flow nasal oxygen vs high-flow face mask: a randomized crossover trial in extubated patients. J Crit Care. 2010 Sep;25(3):463-8. doi: 10.1016/j.jcrc.2009.06.050. Epub 2009 Sep 24.

ReferenceCitation: Brotfain E, Zlotnik A, Schwartz A, Frenkel A, Koyfman L, Gruenbaum SE, Klein M. Comparison of the effectiveness of high flow nasal oxygen cannula vs. standard non-rebreather oxygen face mask in post-extubation intensive care unit patients. Isr Med Assoc J. 2014 Nov;16(11):718-22.

ReferenceCitation: Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Béduneau G, Delétage-Métreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

family: Frat

full_name: Jean-Pierre Frat

given: Jean-Pierre

family: Thille

full_name: Arnaud W. Thille

given: Arnaud W.

family: Mercat

full_name: Alain Mercat

given: Alain

family: Girault

full_name: Christophe Girault

given: Christophe

family: Ragot

full_name: Stéphanie Ragot

given: Stéphanie

family: Perbet

full_name: Sébastien Perbet

family: Prat

full_name: Gwénael Prat

given: Gwénael

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Morawiec

full_name: Elise Morawiec

given: Elise

family: Cottereau

full_name: Alice Cottereau

given: Alice

family: Devaquet

full_name: Jérôme Devaquet

given: Jérôme

family: Nseir

full_name: Saad Nseir

given: Saad

family: Razazi

full_name: Keyvan Razazi

given: Keyvan

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Argaud

full_name: Laurent Argaud

given: Laurent

family: Chakarian

full_name: Jean-Charles Chakarian

given: Jean-Charles

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Wittebole

full_name: Xavier Wittebole

given: Xavier

family: Chevalier

full_name: Stéphanie Chevalier

family: Herbland

full_name: Alexandre Herbland

given: Alexandre

family: Fartoukh

full_name: Muriel Fartoukh

given: Muriel

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

title: High-Flow Oxygen through Nasal Cannula in Acute Hypoxemic Respiratory Failure

ReferenceCitation: Hernández G, Vaquero C, Colinas L, Cuena R, González P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernández R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194. Erratum in: JAMA. 2016 Nov 15;316(19):2047-2048. Erratum in: JAMA. 2017 Feb 28;317(8):858.


title: Localization and Mismatch Negativity in Subjects With Single-sided Deafness Ads Subjects With Unilateral Cochlear Implant

acronym: MMNLocA

summary:
This descriptive and observational research project aims to characterize MMN as a neuronal marker of localization deficit in single-sided deafened subjects and subjects with bilateral profound deafness treated by a cochlear implant (CI). It includes several electro-physiological and psychoacoustic assessments performed on subjects with single-sided deafness and cochlear implanted subjects, with normal-hearing subjects as control:

Evaluation of the characteristics of the MMN involved in sound localization by EEG.
Evaluation of the spatial localization abilities for a sound source presented in the open field.
Assessment of performance for speech recognition in noise. These evaluations are performed in subjects with symmetrical hearing, in a natural binaural condition and a monaural condition (with a plugged ear), in subjects with single-sided deafness and in subjects with unilateral CI

ReferenceCitation: Avan P, Giraudet F, Büki B. Importance of binaural hearing. Audiol Neurootol. 2015;20 Suppl 1:3-6. doi: 10.1159/000380741. Epub 2015 May 19. Review.

ReferenceCitation: Baguley DM, Humphriss RL, Axon PR, Moffat DA. The clinical characteristics of tinnitus in patients with vestibular schwannoma. Skull Base. 2006 May;16(2):49-58.

ReferenceCitation: Bennemann J, Freigang C, Schröger E, Rübsamen R, Richter N. Resolution of lateral acoustic space assessed by electroencephalography and psychoacoustics. Front Psychol. 2013 Jun 11;4:338. doi: 10.3389/fpsyg.2013.00338. eCollection 2013.

ReferenceCitation: Budinger E, Brechmann A, Brosch M, Heil P, König R, Ohl FW, Scheich H. Auditory cortex 2014 - towards a synthesis of human and animal research. Eur J Neurosci. 2015 Mar;41(5):515-7. doi: 10.1111/ejn.12832.

ReferenceCitation: Chan JC, Freed DJ, Vermiglio AJ, Soli SD. Evaluation of binaural functions in bilateral cochlear implant users. Int J Audiol. 2008 Jun;47(6):296-310. doi: 10.1080/14992020802075407.


title: Non-invasive Device for the Screening and Diagnosis of Sleep Apnea Syndrome

acronym: Episas

summary: This prospective study aims to establish and evaluate a predictive model to diagnose OSA with maxillofacial characteristics 3D acquisition.

lead_sponsor: University Hospital, Grenoble

intervention_type: Diagnostic Test


title: Improvement of the Nutritional Course of Care After Surgical Treatment at the Patients Affected by a Cancer of the Head and by the Neck

acronym: NUTRIMAX

summary:
Whatever are the strategies of coverage, the consideration of the state of bad nutrition is not often the priority. According to the last recommendations (2012) of the French Society Clinical Nutrition and Metabolism (SFNEP), the surgeries of the cancers of the VADS are not listed among surgeries with high morbidity. So the specific recommendations for the patients undernourished with surgery with low morbidity, only a personalized dietary advice and oral nutritional supplements are recommended in preoperative. There is no specific recommendation in post-operative.

Two groups of cancer patients of the VADS will be compared: a control group benefiting from a nutritional coverage based on the current recommendations of the SFNEP, an experimental group benefiting from an improved nutritional coverage.

In preoperative, all the patients of experimental group will benefit from dietary advice during a multidisciplinary specific consultation. In post-operative, a dietetic consultation will be set up in 7 days at the exit of hospitalization and call phone at M1, M2, M4 and M5. And for the undernourished patient will benefit a multidisciplinary consultation at the rate of a consultation a month during 6 months.

In the Group control, the patients will be followed according to the current recommendations of the SFNEP.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas: Phase 1 Study

acronym: ALTREM

summary:
Aggressive growing meningiomas resistant to multiple surgeries and radiotherapy constitute an unmet pharmaceutical need in neurooncology, leading to a fatal issue within a few months. Grade II-III meningiomas progression-free survival (PFS) 6 is at 10-15%. Median PFS grade III meningioma is approximate 3 years.

Alpelisib is a well-tolerated Phosphoinositide 3-kinase α (Pi3Kα) specific inhibitor. However, phosphatidylinositol-3-kinase (PI3K) and the mammalian target of rapamycin (mTOR) inhibition does not induce apoptosis in vitro and induces an antiproliferative effect without any radiologic response in most treated patients.

Trametinib, a mekinist (MEK) inhibitor is currently used in combined treatment for recurrent melanomas in clinical practice with a good clinical tolerance at 1-2 mg daily. In vitro, on meningioma primary cell culture, Trametinib induces cell apoptosis via caspase activity.

These results strongly suggest the relevance to combine Alpelisib and Trametinib in aggressive and recurrent meningiomas.

Alpelisib and Trametinib combination has not been studied to date, despite each drugs have been separately studied in phase 3.

Multicenter, open label, dose-finding phase I study of Alpelisib in combination with Trametinib administered at a fixed dose (1.5 mg daily), both drugs will be administered daily. Starting dose of Alpelisib will be 160mg/day and will be increased to 200mg/day or decreased to 120mg/day depending of grade 3-4 adverse events occurrence, to determine maximal tolerated dose (MTD) and recommended dose.

Primary Objective is to determine the safety profile and tolerability of Alpelisib and Trametinib given in combination in patients with aggressive and refractory meningiomas in terms of Dose-Limiting Toxicities (DLT, assessed during cycle 1).

location_facility: Assistance Publique Hôpitaux de Marseille


title: Epstein-Barr Virus Implication in Peri-implantitis: Towards an Innovative Etiopathogenic Model Involved in Implant-supported Prostheses Loss.

acronym: PERIVIR

summary: Peri-implantitis is a high prevalence disease that affects Dental Implants, and can lead to the implant loss if untreated. This condition isn't really well known, and treatments can't provide predictable results. The aim of this study will be to establish a link between the Epstein Barr Virus and the Peri-implantitis, as suggested by recent studies.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Phase I Study of Monoclonal Antibondy (GS) 5745, an Matix Metalloproteinase 9 (MMP9) Mab Inhibitor, in Combination With Bevacizumab in Patients With Recurrent Glioblastoma

summary:
Despite surgery and first-line standard of care which consist of radiotherapy with concomitant and adjuvant temozolomide, all patients with glioblastoma (GB) will experience relapse. At the time of recurrence, therapeutic options include surgery or reirradiation in selected cases, while in other cases, bevacizumab, approved by Food and Drug Administration (FDA) but not European Medicines Agency (EMA), is the preferred option worldwide. Primary and acquired resistance to bevacizumab has been explored without definitive finding.

Biomarkers able to predict response to antiangiogenic agents and particularly to bevacizumab are an unmet medical need. We have showed that a low Matrix metallopeptidase 9 (MMP9) or a high Matrix metallopeptidase 2 (MMP2) baseline plasma levels were associated with a high response rate and a prolonged Progression-free survival (PFS) and overall survival (OS) in recurrent GB patients treated with bevacizumab but not with cytotoxic chemotherapy. We also observed that MMP9 plasma level decreased during bevacizumab treatment and tend to increase at progression. Finally, in a retrospective analysis performed in the Avaglio trial (a randomized phase III trial that tested bevacizumab versus placebo in addition to standard of care in patients with newly diagnosed glioblastoma), a low plasma level of MMP9 at baseline predicted consistently PFS and OS gain associated to bevacizumab.

These results are consistent with the role of MMP9 in vasculogenesis, since MMP9 contribute to the recruitment of circulating endothelial and myeloid precursors, an alternative vascularization process which is in part independent of the vascular endothelial growth factor (VEGF) pathway.

Monoclonal Antibody (GS) 5745 is specifically directed against MMP9. First in human phase I study has been completed. Development is ongoing.

Our results strongly support a role for MMP9 in the primary or acquired resistance to bevacizumab. Therefore, we hypothesize that the Monoclonal Antibody GS5745 may overcome resistance to bevacizumab through a specific inhibition of MMP9. While a preclinical program is initiated in our lab, the proposed phase I study is the first step to analyze the tolerance, determine the recommended dose of the combination and explore the impact of GS5745 on MMP9 plasma levels and multimodal imaging in patients with recurrent glioblastoma.

Objective:

Determine the safety profile and tolerability of GS5745 given in combination with a fixed dose of bevacizumab in patients with recurrent GB in terms of Dose-Limiting Toxicities.

Multicenter, open label, dose-finding study of GS5745 in combination with bevacizumab administered at a fixed dose; both drugs will be administered once every two weeks for a total treatment duration of a maximum of 12 months.

Before initiation of each new dose level, a meeting between the sponsor, the coordinator, the investigators and an independent external expert will take place to decide jointly the next dose.

status: Not yet recruiting

location_facility: Assistance Publique des Hôpitaux de Marseille


title: Smoking Tobacco Cessation Integrated Program of Patients Treated for the Head and the Neck Cancer: a Controlled Randomized Study

acronym: INTENT

summary: Head and neck squamous cell carcinomas (HNSCCs) arise in the mucosa of the upper aero-digestive tract. They are the 6th most prevalent type of cancer worldwide. The risk related to tobacco is particularly high in the case of HNSCC, as the prevalence of heavy smoking for long periods is high in this population. The investigators' aim is to compare two models: one is a specific model of tobacco cessation intervention designed for health care teams treating patients with HNSCC; the other is the current standard of care for these patients, namely referral to external care after general advice on tobacco cessation. The investigators will evaluate the efficacy of this intervention 12 months after randomization. This intervention will be implemented into otolaryngology (ENT) care by training ENT nurses with a specific program for tobacco cessation delivered to patients diagnosed with HNSCC.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Systems Analysis of Antigen Presenting Cells in Human Sepsis.

acronym: DENDRISEPSIS

summary:
Sepsis is a common life-threatening inflammatory response to infection and is the leading cause of death in the intensive care unit. Septic patients exhibit a complex immunosuppressive response affecting both innate and adaptive components of immunity, with a possible link to nosocomial infections. However, the molecular and cellular mechanisms resulting in secondary immunosuppression remain poorly understood, but may involve the antigen-presenting cells (APC, including dendritic cells and monocytes/macrophages) that link innate and adaptive immunity. Furthermore, the increasing phenotypic and functional heterogeneity of APC subsets raise the question of their respective role in sepsis. We propose to address the pathophysiologal role of APC using systems biology approaches in human sepsis.

The objective is to go from low- to high-resolution analysis of APC subset diversity and underlying molecular and functional features in sepsis. The global objective will be reached through:

Systematic description and phenotypic analysis of circulating APC subsets in sepsis
Association of APC subsets distribution, phenotype and function with severe sepsis physiopathology and relevant clinical outcomes (ICU-acquired infections and death)
High-resolution molecular profiling of circulating APC subsets using population level and single cell RNAseq.

To this aim, the investigator designed a prospective interventional study in order to collect blood samples at significant time points in patients with sepsis or septic shock (the population of interest) and relevant control subjects, either critically ill patients with non-septic acute circulatory failure or age-matched healthy subjects. The study's intervention is limited to additional blood samples. The risks and constraints are related to additional blood samples (maximum 120mL), which will be performed either from an arterial catheter when present in ICU patients, or from a venous puncture for patients without arterial catheters and for healthy volunteers.

primary_purpose: Basic Science


type: Registry Identifier

title: Establishment of a Signature of Circulating microRNA as a Tool to Aid Diagnosis of Primary Brain Tumors in Adults

acronym: MIRNA

summary: MIRNA is a prospective multi-center observational study designed to explore 762 plasma microRNAs in patients with malignant CNS tumours: 60 primary glioblastoma (GBM), 20 primary CNS lymphomas and 40 brain metastases in an attempt to establish plasma microRNA signatures specific to GBM capable of distinguishing them from malignant non-glial brain tumours. 20 patients with cerebral stroke and 20 healthy volunteers will also participate in the study, and for each patient, a panel of 762 microRNAs will be screened in plasma.


title: Patient-ventilator Synchronisation Study in Non Invasive Ventilation for Intensive Care Unit Patients: Comparison Between Manual and Automated Ventilator Settings.

acronym: SyncAutoVNI

summary:
This cross-over study will compare the asynchrony index between standard manual ventilator settings, optimized manual ventilator settings, and automated ventilator setting in intensive care patients ventilated in non-invasive ventilation with a high asynchrony index. The hypothesis is that both manual optimized ventilator settings and automated ventilator settings are associated with a lower patient-ventilator asynchrony index as compared to manual standard ventilator settings.

A randomized cross-over design method will be used. Patient requiring NIV with an asynchrony index over 35% will be included. An esophageal catheter with a balloon will be inserted to monitor esophageal pressure. Patients will be ventilated during 3 periods of 30 min, with 10 minutes of washout in between. Recordings of airway pressure, airway flow, and esophageal pressure will be analyzed by two investigators blinded of the trigger settings.

The primary outcome will be the asynchrony index. The secondary outcome will be the ineffective inspiratory effort index, autotrigering index, double triggering index, inspiratory trigger delay, cycling delay, total time spent in asynchrony, patient comfort, and blood gas results.

ReferenceCitation: Demoule A, Chevret S, Carlucci A, Kouatchet A, Jaber S, Meziani F, Schmidt M, Schnell D, Clergue C, Aboab J, Rabbat A, Eon B, Guérin C, Georges H, Zuber B, Dellamonica J, Das V, Cousson J, Perez D, Brochard L, Azoulay E; oVNI Study Group; REVA Network (Research Network in Mechanical Ventilation). Changing use of noninvasive ventilation in critically ill patients: trends over 15 years in francophone countries. Intensive Care Med. 2016 Jan;42(1):82-92. doi: 10.1007/s00134-015-4087-4. Epub 2015 Oct 13.

family: Demoule

full_name: Alexandre Demoule

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Carlucci

full_name: Annalisa Carlucci

given: Annalisa

family: Kouatchet

full_name: Achille Kouatchet

given: Achille

family: Jaber

full_name: Samir Jaber

given: Samir

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

family: Schmidt

full_name: Matthieu Schmidt

given: Matthieu

family: Schnell

full_name: David Schnell

given: David

family: Clergue

full_name: Céline Clergue

given: Céline

family: Aboab

full_name: Jérôme Aboab

family: Rabbat

full_name: Antoine Rabbat

given: Antoine

family: Eon

full_name: Béatrice Eon

given: Béatrice

family: Guérin

full_name: Claude Guérin

given: Claude

family: Georges

full_name: Hugues Georges

given: Hugues

family: Zuber

full_name: Benjamin Zuber

given: Benjamin

family: Dellamonica

full_name: Jean Dellamonica

given: Jean

family: Das

full_name: Vincent Das

given: Vincent

family: Cousson

full_name: Joël Cousson

given: Joël

family: Perez

full_name: Didier Perez

given: Didier

family: Brochard

full_name: Laurent Brochard

family: Azoulay

full_name: Elie Azoulay

given: Elie

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

ReferenceCitation: Demoule A, Girou E, Richard JC, Taillé S, Brochard L. Increased use of noninvasive ventilation in French intensive care units. Intensive Care Med. 2006 Nov;32(11):1747-55. Epub 2006 Jun 24.

ReferenceCitation: Keenan SP, Sinuff T, Burns KE, Muscedere J, Kutsogiannis J, Mehta S, Cook DJ, Ayas N, Adhikari NK, Hand L, Scales DC, Pagnotta R, Lazosky L, Rocker G, Dial S, Laupland K, Sanders K, Dodek P; Canadian Critical Care Trials Group/Canadian Critical Care Society Noninvasive Ventilation Guidelines Group. Clinical practice guidelines for the use of noninvasive positive-pressure ventilation and noninvasive continuous positive airway pressure in the acute care setting. CMAJ. 2011 Feb 22;183(3):E195-214. doi: 10.1503/cmaj.100071. Epub 2011 Feb 14.

ReferenceCitation: Ferrer M, Valencia M, Nicolas JM, Bernadich O, Badia JR, Torres A. Early noninvasive ventilation averts extubation failure in patients at risk: a randomized trial. Am J Respir Crit Care Med. 2006 Jan 15;173(2):164-70. Epub 2005 Oct 13.

ReferenceCitation: El-Solh AA, Aquilina A, Pineda L, Dhanvantri V, Grant B, Bouquin P. Noninvasive ventilation for prevention of post-extubation respiratory failure in obese patients. Eur Respir J. 2006 Sep;28(3):588-95. Epub 2006 May 31.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer


title: "Impact of a Programme to Improve Interaction Among Professionals on the Management of Task Interruptions"

acronym: IMPACTT

summary:
In 2017, all IMPACTT investigators experimented in coordinated manner on multifacet intervention program, proposed by the present research protocol, with 2 teams from healthcare units from the PDL region. This experiment followed collaborative work aiming to raise team awareness on task interruptions. Given the existing data in the literature, the investigators hypothesise that the implementation of a multifacet program focusing on interactions within a team could enable the percentage of task interruptions linked to interactions between coordination functions and healthcare provision activities to be decreased by 33%. This decrease would concern task interruptions that are avoidable, in order to improve healthcare safety and teamwork.

Also, the main objective of this project is to measure the impact of a program on the evolution of the characteristics of avoidable task interruptions. The project combines quantitative data (observations, questionnaire) and qualitative data (interviews).

lead_sponsor: Nantes University Hospital


title: Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting - ImHADom

acronym: ImHADom

summary:
This observational prospective monosite study aims to describe, for the first time, management in a hospital-at-home programme of patients treated by immunotherapy for bronchial cancer.

The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated.

lead_sponsor: RENAULT Patrick Aldo


title: Improvement of in Vitro Fertilization Implantation by Soluble CD146 Dose in Embryonic Culture Environment : Multicenter Prospective Study

acronym: AMIFIV

summary:
The study of implantation potential of the embryo stay a priority in In Vitro Fertilization (IVF). Indeed, the selection of embryos to transfer is actually based in routine check on morphologic criteria, approved by literature but not perfect. Implantation's markers identification, allowing to choose the embryo(s) to transfer and then decrease pregnancy failure, represent a major issue in IVF, not any biomarker being approved yet.

Among factors regulating embryonic implantation, investigators have recently proposed soluble CD146, coming from proteolytic cleavage of the CD146 membrane, angiogenic bond molecule.

In a monocentric study about 222 transferred embryos at the end of IVF try, investigators showed that the sCD146 dose in the embryonic culture environment reflected the implantation ability of embryo, a high rate showing a low implantation potential and this independently of the embryonic quality. A multicentric prospective study is now required to confirm the utility of this dosage in clinical practice.

Primary objective : Compared 2 frozen embryo transfer (FET) strategies in terms of implantation efficiency, according to choice method of embryo to be transferred :

Group A : Standard strategy : Depending on embryonic quality according to criteria currently selected.
Group B : Experimental strategy : Association of embryonic quality according to criteria currently selected and of sCD146 rate.

Expected Results :

Demonstrate a beginning pregnancy test significantly superior in Group B compared to Group A.
Confirmed that sCD146 is an independent biomarker of morphologic embryonic quality (actual selection criteria) and represent a complementary criteria to choose embryos to transfer.

Methodology :

- Multicentric prospective study with 2 groups of Frozen Embryo Transfer (FET); The calculation of the number of staff required includes 151 couples per group.

For this will be include for 24 months, couples benefiting of freezing at least one of the two embryos and transfer of only one FET.

Test the same day of environment freezing where frozen embryos were cultivated. sCD146 dosage by ELISA technic (Enzyme Linked ImmunoSorbent Assay) in thus culture environment before FET.
Implantation potential analyze of each transfer embryo (FET) according to sCD146 rate.
Following of the FET future(pregnancy, childbirth) : maximum 9 months after attempt to each included couple.


title: Renal Effects of Fluid Resuscitation With Plasmalyte Viaflo Versus Saline in Trauma Patients (the ASTRAU Study)

acronym: ASTRAU

summary:
Fluid resuscitation remains the cornerstone for the care of severe trauma patients to compensate for blood loss, to compensate for capillary leak induced by systemic inflammation but also to prevent the detrimental consequences of traumatic rhabdomyolysis. Isotonic saline (NaCl 0.9%), called "physiological serum" is the standard fluid for the resuscitation of severely injured patients. However, the formulation of NaCl 0.9% is not really physiological since its chloride concentration is 1.5 higher than the one of human plasma. This excessive chloride concentration leads to hyperchloremic acidosis and to a drop in renal perfusion after isotonic saline infusion. For this reason, we wonder whether fluid resuscitation with Plasmalyte would be beneficial for renal function of trauma patients in comparison with NaCl 0.9%. Our research question is:

In a population of trauma patients at high risk of acute kidney injury, does a fluid resuscitation with Plasmalyte Viaflo lower the incidence of severe acute kidney injury (stage 2 or 3 according to the KDIGO classification) compared with a resuscitation with isotonic saline (NaCl 0.9%)?

ReferenceCitation: Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte® 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012 Jul;256(1):18-24. doi: 10.1097/SLA.0b013e318256be72. Erratum in: Ann Surg. 2013 Dec;258(6):1118.

ReferenceCitation: Shaw AD, Bagshaw SM, Goldstein SL, Scherer LA, Duan M, Schermer CR, Kellum JA. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012 May;255(5):821-9. doi: 10.1097/SLA.0b013e31825074f5.

ReferenceCitation: Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.

ReferenceCitation: Shaw AD, Raghunathan K, Peyerl FW, Munson SH, Paluszkiewicz SM, Schermer CR. Association between intravenous chloride load during resuscitation and in-hospital mortality among patients with SIRS. Intensive Care Med. 2014 Dec;40(12):1897-905. doi: 10.1007/s00134-014-3505-3. Epub 2014 Oct 8.

ReferenceCitation: Raghunathan K, Shaw A, Nathanson B, Stürmer T, Brookhart A, Stefan MS, Setoguchi S, Beadles C, Lindenauer PK. Association between the choice of IV crystalloid and in-hospital mortality among critically ill adults with sepsis*. Crit Care Med. 2014 Jul;42(7):1585-91. doi: 10.1097/CCM.0000000000000305.

ReferenceCitation: Shaw AD, Schermer CR, Lobo DN, Munson SH, Khangulov V, Hayashida DK, Kellum JA. Impact of intravenous fluid composition on outcomes in patients with systemic inflammatory response syndrome. Crit Care. 2015 Sep 12;19:334. doi: 10.1186/s13054-015-1045-z. Erratum in: Crit Care. 2016;20:17.

ReferenceCitation: Krajewski ML, Raghunathan K, Paluszkiewicz SM, Schermer CR, Shaw AD. Meta-analysis of high- versus low-chloride content in perioperative and critical care fluid resuscitation. Br J Surg. 2015 Jan;102(1):24-36. doi: 10.1002/bjs.9651. Epub 2014 Oct 30. Review.

ReferenceCitation: Young P, Bailey M, Beasley R, Henderson S, Mackle D, McArthur C, McGuinness S, Mehrtens J, Myburgh J, Psirides A, Reddy S, Bellomo R; SPLIT Investigators; ANZICS CTG. Effect of a Buffered Crystalloid Solution vs Saline on Acute Kidney Injury Among Patients in the Intensive Care Unit: The SPLIT Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1701-10. doi: 10.1001/jama.2015.12334. Erratum in: JAMA. 2015 Dec 15;314(23):2570.

ReferenceCitation: Bagshaw SM, George C, Gibney RT, Bellomo R. A multi-center evaluation of early acute kidney injury in critically ill trauma patients. Ren Fail. 2008;30(6):581-9. doi: 10.1080/08860220802134649.

ReferenceCitation: Bihorac A, Delano MJ, Schold JD, Lopez MC, Nathens AB, Maier RV, Layon AJ, Baker HV, Moldawer LL. Incidence, clinical predictors, genomics, and outcome of acute kidney injury among trauma patients. Ann Surg. 2010 Jul;252(1):158-65. doi: 10.1097/SLA.0b013e3181deb6bc.

location_facility: Département d'Anesthésie Réanimation - Kremlin Bicêtre


title: Type 2 Innate Lymphoid Cells in Severe Pediatric Asthma

acronym: CLASSE

summary: The main objectives of this study are to show that the number of type 2 innate lymphoid cells (ILC2) of the bronchial mucosa and in bronchoalveolar lavages (BAL) are higher in asthmatic children than in non-asthmatics, that the number of ILC2 of the bronchial mucosa and in BAL correlate with the number of bronchial and BAL eosinophils, and to determine whether there is a correlation between plasma and bronchial and BAL ILC2.

time_perspective: Cross-Sectional

intervention_type: Biological


title: Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome

acronym: SAHOS-TIME

summary: Presently, there isn't any international recommendation to evaluate vigilance in Obstructive Sleep Apnea Syndrome. The French Society of Sleep Research and Medicine (SFRMS) recommend evaluating professional driver with a MWT but no recommendation exists for other patients. After a minimal treatment of 4 weeks, the physician has to evaluate the drowsiness risk of these patients using either an objective test like the MWT or a subjective one. In the university hospital Amiens-Picardie, since the 01/01/2015, every patient with an Obstructive Sleep Apnea Syndrome diagnosed by a polysomnography or a ventilatory polygraphy had a MWT after 4 weeks of treatment. At each time of the evaluation, Epworth Sleepiness Scale, tiredness score of Pichot, and depressive score of Beck are performed.

ReferenceCitation: Basille D, Baud ME, Andrejak C, Basille-Fantinato A, Jounieaux V. Correlation between the Epworth Sleepiness Scale and the Maintenance of Wakefulness Test in Obstructive Sleep Apnea Patients Treated with Positive Airway Pressure. Respir Med Res. 2020 Nov;78:100787. doi: 10.1016/j.resmer.2020.100787. Epub 2020 Aug 28.

family: Basille

full_name: D. Basille

given: D.

family: Baud

full_name: M.E. Baud

family: Andrejak

full_name: C. Andrejak

given: C.

family: Basille-Fantinato

full_name: A. Basille-Fantinato

given: A.

family: Jounieaux

full_name: V. Jounieaux

given: V.

journal_name: Respiratory Medicine and Research


title: Upper-limb Active Function and Botulinum Toxin A

acronym: ULAFBoT-Stroke

summary: This study in an observational, prospective and longitudinal study. The aim of the study is to evaluate the effect of botulinum toxin type A (BTX) injections into the elbow flexors on the reduction of spastic co-contractions (spastic co-contraction index, SCCI) during an active elbow extension in chronic post-stroke patients.TBA injections are performed as part of routine care


title: Valvular Aortic Stenosis Prognosis Study: Prospective and Retrospective Follow-up of a Cohort of Patients With Aortic Valve Narrowing

acronym: EPRAoV

summary:
Aortic stenosis is the most common valvulopathy in Western countries. Cardiac EchoDoppler is the reference method for assessment of aortic stenosis and provides prognostic elements. However, it is imperfect with many inconsistencies between measures. On the other hand, the prognosis of patients with low flow and low gradient aortic retraction is discussed.

The main objective of this work is to study the prognosis of asymptomatic and symptomatic aortic retraction.


title: Quality of Life of Frail Aged Patients in Incremental Hemodialysis: a Phase III Study

acronym: Qualifragilys

summary:
End stage renal disease (ESRD) is a major public health problem. The dialysis population is aging. As a result we observe a high prevalence of frailty among dialysis patients (ranges from 3 to 10 fold higher than in the comparably aged general public). Frailty is a medical syndrome characterized by diminished strength, endurance, and reduced physiologic function that increases an individual's vulnerability for developing increased dependency and/or death. Without systematic approach it is difficult for physicians to detect frailty phenotype which however might be reversible or attenuated by interventions. Fried et al. developed a frailty phenotype consisting of 3 or more of: unintentional weight loss, exhaustion, physical inactivity, slow gait speed, and weak grip strength. The primary care of hemodialysis patient is often supported by the nephrologist. Identification of frailty is integrated into the primary care setting as one of the steps necessary for the overall assessment of the person and planning to formal prevention interventions in an individualized care plan. Thrice-weekly hemodialysis (HD) schedules are the standard default hemodialysis prescription in Western countries, imposed in the 70s. For incremental HD, the weekly dose of dialysis is based on variety of clinical factors such as residual kidney function, volume status, cardiovascular symptoms, potassium level, nutritional status and, comorbid conditions. Incremental HD scheme generally starts with 2 weekly sessions and then periodic monitoring of criteria mentioned above are used to determine the timing for increasing dialysis dose and frequency to 3 weekly sessions.

An approach that integrates systematic frailty phenotype assessment by nephrologists and individualized incremental HD therapy can be beneficial within the first year of HD. It could optimize health-related quality of life and other pertinent outcomes without affecting negatively the quality of dialysis. The purpose of this study is to evaluate for frail aged incidents hemodialysis patients the impact of implementation of an incremental HD on HRQoL compared to conventional HD.

ReferenceCitation: Fiteni F, Pam A, Anota A, Vernerey D, Paget-Bailly S, Westeel V, Bonnetain F. Health-related quality-of-life as co-primary endpoint in randomized clinical trials in oncology. Expert Rev Anticancer Ther. 2015;15(8):885-91. doi: 10.1586/14737140.2015.1047768. Epub 2015 May 31.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Is EMG-based Serious Games Effective in Improving Gait in Children With Cerebral Palsy ? Interest of Electromyography Feedback (EMG)

acronym: SERIOUS GAME

summary:
Cerebral palsy (CP) is a major motor dysfunction manifesting early in childhood, with severe consequences to performance in daily functions. CP children are typically unable to voluntarily activate individual muscles, hindering motor coordination and therefore the ability to produce movements as smooth as those seen in control cohorts. Muscles spanning distal joints are more likely affected by CP, resulting in abnormal gait patterns.

While commercially available and customised games have been considered for CP rehabilitation in the last decade, they are mainly based on the analysis of movement kinematics and none seems to deal directly with the key source of motor impairment: the skeletal muscle. Surface electromyograms (EMGs), on the other hand, provide clinicians with the possibility of directly assessing and controlling the neural drive or command to muscles.

The benefits of surface EMG as a feedback tool for improving posture control and for stroke rehabilitation are well established.

The treatment with EMG-based "serious games" is expected to assist CP children in activating the ankle muscles in both paretic and healthy limbs at similar instants within the gait cycle. Given such EMG-oriented rehabilitation applies directly to the muscle, its effect on muscle and therefore gait function is likely to be greater than that achieved with conventional means. If this hypothesis is verified, it will be further expect to observe a smoother gait, that is smoother changes in gait kinematics and morphology of the paretic foot, in CP children treated with EMG-based serious game than otherwise.

Primary objective consists in verifying whether Surface electromyography (sEMG)-based games are effective in reducing the degree of muscular hyperactivity in the ankle plantar flexor and thus improve the ankle dorsi flexor function in children with cerebral palsy.

The study design is an open, prospective, monocentric, randomized and controlled trial. Participants will be randomly assigned to either the first group or to the second group.

For the first group, the design will be: "physical therapy + serious games" during the first month then "physical therapy" during the second month.

For second group, the the design will be: "physical therapy" during the first month then "physical therapy + serious games" during the second month.


title: Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery - A Single-center Feasibility Pilot Study.

acronym: AMIREMBOL

summary: The investigators hypothesize that a primary embolization, 3-4 weeks before surgery, would allow development of vascular collaterality, in particular for the marginal artery which will ensure a better colonic perfusion.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Procedure


title: Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work

acronym: PROCTB

summary: Thoracic outlet syndrome may associate neurologic, arterial and venous symptoms. The responsibility of repetitive movements and postural factors has been mentioned for long. Some tasks are hard to perform, and it seemed interesting to assess the consequences of this syndrome on the work capacity by a questionnaire, at the moment of diagnosis by Echo-Doppler

lead_sponsor: University Hospital, Lille


title: Treatment of Temporomandibular Joint Osteoarthritis by an Intra-articular Injection of Hyaluronic Acid. Study of Patient Satisfaction Predictive Factors, 6 Months After a Single Injection of Hyaluronic Acid.

acronym: ARTEMIS

summary:
The arthritis of temporomandibular joint is the most frequent degenerative disease of the jaw joint. Several clinical studies recommend the recourse to the viscosupplement because of its efficiency in the long term.

The present research has for objective to find clinical factors predictive of success or failure of viscosupplementation in ATM such as clinical severity before injection, the presence of a limited mouth opening or lenght of symptoms.

It is an open observational monocentrical prospective study. The recruitment is competitive and the study will be ended when 44 patients will have been included by taking into account a risk of trial exits or of lost of sight of 10 %.The main criterion is the influence of the radiological stage on the answer to the treatment.

Duration of inclusion 6 months. Duration of follow-up 6 months. Total duration of the study 12 months.

lead_sponsor: Labrha


acronym: MMELPOAF

title: Microcirculatory and Macrocirculatory Effects of Landiolol in Prevention of Postoperative Atrial Fibrillation: a Randomized Study.

summary: Postoperative atrial fibrillation is a common complication after cardiac surgery and is associated with an elevation of morbidity and mortality. The recommended treatment includes heart rate control with a beta blocker. Landiolol is a new-generation beta-blocker with favourable pharmacologic properties making an interesting drug to treat postoperative atrial fibrillation. However, Landiolol micro and macrocirculatory effects in the setting of atrial fibrillation are yet to describe. The aim of this study is to describe microcirculatory effects of incremental doses of landiolol in postoperative atrial fibrillation compared to a placebo. Our hypothesis is Landiolol will improve microcirculation disorders.


title: Identification of Protein Markers of Epidemiological and Clinical Interest by MALDI-TOF

acronym: SPECTRASURV

summary:
Not all infectious agents have the same epidemic potential, and this can vary widely within the same species. Rapid determination of this potential is essential to optimize control of infectious diseases. It is now accepted that identification with the species is clearly insufficient to identify an epidemic and to carry out epidemiological analyzes. Indeed, if the same bacterial species can present a great diversity of strains, it is organized in clonal complexes having strong variations of clinical and epidemiological expression.

More specifically, on a bio-epidemiological level, the clonal identification of the bacterial agent is a real asset because it can make it possible to identify the highly virulent strains or known to be resistant, the clones associated with nosocomial infections, the source of the infection. an epidemic and to follow its spatio-temporal extension, to know the epidemiological antiquity of the clone, to follow or rebuild a chain of transmission, to discover epidemic clusters.

There are rapid identification techniques, for example by polymerase chain reaction (PCR), but which are targeted at particular genomic compositions previously identified.

Routine bacterial identification now rests on the determination of the protein composition by mass spectrometry (MALDI-TOF). The bacterial spectrum is compared to a reference library of protein composition, thus obtaining an identification equivalent to that based on the 16s RNA (ribonucleic acid 16s) and can descend to an infra-species level.

The aim of this work is to use the proteome part of the MALDI-TOF spectrum to identify peaks that signal clonality and to determine proteomic fingerprintings that can be used for epidemiological and clinical purposes.

Instead of relying on expensive genomic methods, the identification of the clonal characteristics of the strains will rely on the bacterial proteome present on the MALDI-TOF spectrum that is produced during the routine identification of the bacterium.

The results are intended to feed a complementary knowledge base

ReferenceCitation: Giraud-Gatineau A, Texier G, Fournier PE, Raoult D, Chaudet H. Using MALDI-TOF spectra in epidemiological surveillance for the detection of bacterial subgroups with a possible epidemic potential. BMC Infect Dis. 2021 Oct 28;21(1):1109. doi: 10.1186/s12879-021-06803-3.

family: Giraud-Gatineau

full_name: Audrey Giraud-Gatineau

given: Audrey

family: Texier

full_name: Gaetan Texier

given: Gaetan

family: Fournier

full_name: Pierre-Edouard Fournier

given: Pierre-Edouard

family: Raoult

full_name: Didier Raoult

family: Chaudet

full_name: Hervé Chaudet

given: Hervé

currency_apc_doaj: GBP

journal_name: BMC Infectious Diseases

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 title and first author match)

host_type: repository

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Study of Awareness of Hospices Civils de Lyon Workers About Breast Cancer Screening

summary:
Breast cancer is the most common cancer in French women, with 52000 new cases each year.

Shift work and night work is recognized by International Agency for Research on Cancer as a potential risk factor. Epidemiological studies find, for most of them, an increased risk of breast cancer compared with general population. Physiological hypothesis rely on the melatonin role in defense against tumorigenesis.

According to High Authority of Health clinical good practice guidelines, the risk does not justify more screening than the organized screening. We do not have information about awareness level of workers in health structures, specially in the Hospices Civils de Lyon.

Investigators would like to know how employees take part to breast cancer screening, specially in night workers.

This study, as a survey, is a first step to evaluate the need for specific actions to increase the participation to breast cancer screening.

location_facility: Service de Gynécologie - Hôpital de la Croix-Rousse - Hospices Civils de Lyon


title: Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study

acronym: POLLAR

summary:
It has been demonstrated that allergic rhinitis (AR) reduces sleep quality by some components such as nasal obstruction. Pollution and allergen exposure worsening AR, sleep quality is deteriorated.

Sleep is associated to physical and mental health, alterations in sleep could explain the link between AR and work productivity diminution, impairment in daily activities or emotional problems.

However, interactions between air pollution, sleep and allergic diseases are insufficiently understood.

The main objective of this study is to determine the impact of pollution and pollens on sleep parameters.


title: What is the Regional and Remote Effect of Spinal Manipulation on Pressure Pain Threshold in Asymptomatic Subjects Over Time: A Randomized Placebo-controlled Study

summary: Spinal manipulation is often used for its effect on pain, but more information is needed concerning its mechanisms of action.

lead_sponsor: Institut Franco Europeen de Chiropratique

location_facility: Institut Franco Européen de chiropraxie (iFEC)


title: Ex Vivo Study of the Role of Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State

acronym: EXERCISE

summary:
Cirrhosis is a condition in which the liver does not function properly due to long-term damage. This damage is characterized by the replacement of normal liver tissue by scar tissue.

The liver carries out several necessary functions, including synthesis of proteins participating in blood coagulation process. Some of these proteins contribute to coagulation and others make blood more fluid. In healthy people there is a balance between the two.

In cirrhotic patient, there is an imbalance inducing hypercoagulation (hypercoagulability state). Cirrhotic patients are so known to be at risk of vein thrombosis (for example portal vein thrombosis: clot in hepatic vein).

Mechanisms leading to this imbalance are unclear. Studies need to be completed to improve patient's management.

The EPCRs (Endothelial Protein C Receptor soluble) takes part in blood coagulation process. Previous studies have shown that blood levels of EPCRs are increased in patients with cirrhosis.

The primary purpose of the study is to evaluate if the EPCRs could play a role in cirrhosis-associated hypercoagulability state.

primary_purpose: Screening

lead_sponsor: University Hospital, Clermont-Ferrand


title: Epidemiological, Clinical, Microbiological and Therapeutic Aspects of Sexually Transmitted Bacterial Ano-rectitis in a Specialized Consultation Center

acronym: IST

summary:
Infectious ano-rectitis is poorly described. Their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly corrected in gastroenterology and new diagnostic tools are now available) and therapeutic aspects.

Analysis of data from this large population of patients referred to the proctology center for suspicion of Neisseria gonorrhoeae and / or Chlamydia trachomatis ano-rectitis will help identify risk factors and target prevention strategies and optimized therapeutic management.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer

acronym: CAMARA

summary:
In oncology, anemia is a frequent symptom, leading to complication of patient management for, more or less, a long term but often poorly evaluated by medical teams.

In oncology, anemia is induced by multiple causes. Iron deficiency appears to be a leading cause of anemia, especially in people with solid cancer. Iron deficiency is characterized by a low level of iron . Iron is a trace element required for life. It is a major component of hemoglobin allowing the transport of oxygen in red blood cells. There are in fact 2 types of iron deficiency: an absolute iron deficiency with a deficiency of true iron and a functional iron deficiency. Since end of January 2014, intravenous iron-based injections have been reclassified for cancer patients at ICO Paul Papin. The monitoring of iron deficiency with or without anemia is currently done in our institute, the ICO-Paul Papin. There is a procedure for the management of anemia with or without iron deficiency but there is still no traceability of treatments performed, their compliance or even their impact on the rate hemoglobin and the quality of life of patients during their treatment. This observatory also makes it possible to evaluate the impact of this treatment on the quality of life of the patients and thus allows them a personalized care of the tiredness during their treatment

lead_sponsor: Institut Cancerologie de l'Ouest


title: A Randomized Comparative Study of Assisted Promontofixation Using Glue Versus Promontofixation Using Threads

acronym: PROCOL

summary: The treatment of gynecological prolapse (organ removal) can be done by laparoscopy or vaginally. Laparoscopy is used in 1 out of 2 cases, but learning is difficult and operation time is long. One of the technical difficulties is related to the sutures to the threads. Some surgeons therefore use a glue to fix prosthetic reinforcements more easily and quickly, but this sizing technique has only been evaluated very little. Our study proposes to compare the technique of suture with the thread at the gluing of the prostheses in order to validate the merits of this new technique

primary_purpose: Health Services Research

lead_sponsor: Clinique Beau Soleil


title: Determine Immunoglobulin G4 (IgG4) Standards for Cow's Milk and Egg in Different Populations of Allergic and Non-allergic Children

summary:
The study objectives are :

Determine standards of plasma levels of casein-specific immunoglobulin G4 (IgG4) and egg-specific immunoglobulin G4 (IgG4) as a function of age, in non-allergic children, in allergic children, and in cured former allergic patients.

Analyze the plasma IgG4 / IgE ratio, according to the result of the oral provocation test (tolerance versus allergy) and, in the event of a reaction, according to the reactogenic dose (dose which caused the reaction).Determine whether analysis of the plasma metabolome can identify children with a cured allergy to cow's milk protein or to egg from those with a persistent allergy.

ReferenceCitation: Adel-Patient K, Lezmi G, Castelli FA, Blanc S, Bernard H, Soulaines P, Dumond P, Ah-Leung S, Lageix F, de Boissieu D, Cortes-Perez N, Hazebrouck S, Fenaille F, Junot C, Dupont C. Deep analysis of immune response and metabolic signature in children with food protein induced enterocolitis to cow's milk. Clin Transl Allergy. 2018 Sep 28;8:38. doi: 10.1186/s13601-018-0224-9. eCollection 2018.


title: LYMPHOSPIR : Impact of Surgery in Addition to Optimal Management of Lymphedema.

acronym: LYMPHOSPIR

summary:
Lymphedema is a chronic pathology with a real impact on the quality of life of patients. Despite optimal medical management of patients, some patients still have no pitting edema on which the medical treatment has no effect.

It is adipose tissue secondary to the evolution of lymphedema. It is often painful and important in terms of volume with the resulting functional consequences. The investigators propose to these patients a surgical management complementary to the optimal medical treatment by microlipoaspiration associated or not with a dermolipectomy. This surgical management began in 2014 in our service. The investigators want to evaluate the impact on quality of life of patients in this surgical management in addition to medical care.

time_perspective: Other

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease

acronym: HYPNOCROHN

summary: Evaluation of hypnosis therapy efficacy in addition to pharmacologic standard treatment of Croh disease during remission by the evaluation of quality of life;

lead_sponsor: University Hospital, Grenoble


title: Activity and Tolerability of Maintenance Avelumab Immunotherapy After First Line Polychemotherapy Including Platinum in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma

acronym: PULSE

summary:
Patients with unresectable locally advanced or metastatic squamous cell penile carcinoma (SPC) who are in response or with stable disease after first line platinum containing polychemotherapy who meet the inclusion/exclusion criteria will be offered to take part in the study.

The patients may be pre-screened at the time of the 1st line chemotherapy.

In order for patients to be enrolled, the investigator must have carried out a radiological assessment of the disease during first line systemic treatment (a maximum of between 3 and 6 cycles): the cancer must be controlled. Patients with disease progression cannot be included in the PULSE study as this is a maintenance study.

After inclusion, Avelumab will be administered at a dose of 10 mg/kg, at a frequency of once every 2 weeks with appropriate supportive care.

ReferenceCitation: Gassian N, Frontczak A, Mouillet G, Vernerey D, Manseur O, Goujon M, Meurisse A, Berthod D, Robert E, Calcagno F, Thiery-Vuillemin A. Activity and tolerability of maintenance avelumab immunotherapy after first line polychemotherapy including platinum in patients with locally advanced or metastatic squamous cell penile carcinoma: PULSE. Bull Cancer. 2020 Jun;107(5S):eS16-eS21. doi: 10.1016/S0007-4551(20)30282-4.

family: Gassian

full_name: Noémie Gassian

given: Noémie

family: Frontczak

full_name: Alexandre Frontczak

given: Alexandre

family: Mouillet

full_name: Guillaume Mouillet

given: Guillaume

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

family: Manseur

full_name: Ouiza Manseur

given: Ouiza

family: Goujon

full_name: Morgan Goujon

given: Morgan

family: Meurisse

full_name: Aurelia Meurisse

given: Aurelia

family: Berthod

full_name: Diane Berthod

given: Diane

family: Robert

full_name: Elise Robert

given: Elise

family: Calcagno

full_name: Fabien Calcagno

given: Fabien

family: Thiery-Vuillemin

full_name: Antoine Thiery-Vuillemin

given: Antoine

journal_name: Bulletin du Cancer


title: A Non-Randomized, Open Label, One Sequence, Two-Period Cross-Over Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants

summary: The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers.

lead_sponsor: Hoffmann-La Roche


title: A Comparison of Radiofrequency Catheter Ablation With or Without Contact-force and Cryoablation for Paroxysmal Atrial Fibrillation Ablation

acronym: ARCFA

summary: The study aims to compare 3 techniques routinely used for paroxysmal atrial fibrillation ablation: radiofrequency catheter ablation without contact-force, radiofrequency catheter ablation with contact-force and cryoablation. The hypothesis is the non-inferiority between the 3 techniques in terms of free-from atrial fibrillation survival (primary criteria). It will also compare lenght of procedure, radioscopy time and immediate complications (secondary criteria).

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Does the Radiological Stage Allow to Predict the Efficacy of an Intra-articular Injection of Hyaluronic Acid Among Patients Affected by a Hallux Rigidus ?

acronym: REPAR

summary:
The hallux rigidus is the most frequent type of arthrosis at the age of 50 and beyond. For the moderate forms of the disease, the majority of the studies recommend the recourse to the viscosupplement because of its efficiency in the long term.

On the other hand, no study was focused on the impact of the anatomical severity on the clinical result of the treatment by intra-articular injection of hyaluronic acid.

The present research has for objective to study the influence of the radiological severity on the result of the viscosupplement, in the conditions of daily practice, in patients affected by Hallux rigidus.

It is an open observational multicentrical prospective study realized by 20 investigators rheumatologists and liberal orthopedic surgeons. The recruitment is competitive and the study will be ended when 66 patients will have been included by taking into account a risk of trial exits or of lost of sight of 10 %.The main criterion is the influence of the radiological stage on the answer to the treatment.

Duration of inclusion 6 months. Duration of follow-up 3 months. Total duration of the study 9 months.


title: Characterization of Gut Microbiota Composition and Activity After a Daily Supplementation of 4.5 g/Day of ChitinGlucan Fibre During 3 Weeks in At-cardiometabolic Risk Volunteers

acronym: FITACHITIN

summary: The aim of this study is to demonstrate the beneficial effects on gut microbiota composition and activity of the diary intake of insoluble fiber (extract from Aspergillus Niger) for three weeks. The first studies about the fiber have shown a favorable gut microbiota modulation and an improvement of metabolic parameters like LDL cholesterol. In addition to fecal measurements, several biomarkers of colic fermentation will be assessed: expired gases, PolyUnsaturated Fatty Acid, Short Chain Fatty Acid (SCFA) after a rich-fiber breakfast (= 15 grams) and a nutritional challenge test at lunch. The gastrointestinal tolerance of fiber intake and the intestinal transit modification will be also followed during all the study.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud

intervention_type: Dietary Supplement


title: Clinic, Pathologic and Genetic Characterization of Patients With Familial Carcinoid Tumors (Study From the GTE, Groupe d'étude Des Tumeurs Endocrines)

summary:
Small intestine carcinoid tumors are rare. Small intestine Familial Carcinoid Tumors (FCT) are defined by the occurrence of at least 2 cases of this tumor type in first- or second-degree relatives. The estimated prevalence of FCT is 2.6%-3.7% in patients with small intestine carcinoid tumors. Because of its rarity, epidemiologic, clinic and pathologic features of FCT have been scarcely described. Molecular abnormalities associated with FCT have been poorly explored. Constitutional genetic factors predisposing to FCT have not been discovered to date. Only one abnormality (mutation of the IPMK gene) has been reported in one FCT family only, but not found in other series.

The main objective of this study is to identify the constitutional factors predisposing to small-intestine FCT (and other midgut localizations: ascending colon and appendix). The secondary objectives are to describe the clinic and pathologic features associated with FCT.

lead_sponsor: CHU de Reims

intervention_type: Genetic


title: Effectiveness of Energy Resonance by Skin Stimulation in the Management of Anxious Patients Who Require Scheduled Orthopaedic Surgery

acronym: ERESCAO

summary:
The need for a surgical procedure may cause a patient to experience reactive anxiety. This reaction is appropriate if it is of low to moderate intensity. On the other hand, various studies have shown that postoperative awakening is more complicated if the patient experiences major preoperative anxiety. Thus, reducing anxiety could be a tool for preventing chronic pain.

For several years now, the investigator's facility has been implementing Energy Resonance through Cutaneous Stimulation (ERCS), a method based on "listening" to the body's vibrations through the fingers on points based on the mapping of meridians in Chinese medicine.

ERCS practitioners have noted the benefits of this method, particularly in soothing patients. It therefore seems necessary to detect and manage this anxiety beforehand and ERCS seems appropriate in this situation.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Genital Haemorrhage in Woman of Childbearing Age Treated for Venous Thromboembolism Disease : Comparison According to Oral Anticoagulant and Impact on Quality of Life.

acronym: GENB-OAB

summary:
Little data are available on the genital haemorrhages in woman of childbearing age treated for venous thromboembolic disease by oral anticoagulant, especially the impact on the quality of life. A recent systematic review in 2016 described for the first time in patients with venous thromboembolic a lower incidence in men of major haemorrhages and minor haemorrhages but clinically significant compared with women (5,3% and 7,9% respectively; RR: 0,635, 95%CI 0,54-0,74 ; p<0,001). It appears that this difference is related to genital haemorrhages and some direct oral anticoagulants are more associated with hemorrhagic surge. In post-hoc analyzes of phases III trials, rivaroxaban was most of the time associated with genital haemorrhages compared to vitamine K antagonists, effect not found with apixaban. Four other retrospective studies seem to find the same conclusions with a higher haemorrhagic risk with the rivaroxaban than with vitamine K antagonist or apixaban.

However, haemorrhagic risk is defined in these studies with criteria of severity (anemia, transfusion, use of a health professional, menstrual periods of more than 8 days, inter mentrual bleeding, presence of blood clots) and these studies do not take into account of minor haemorrhages that may affect on the quality of life and asthenia due to anemia.

Our objective is : 1- studying the proportion of women with abnormal genital haemorrhages among women of childbearing age treated for venous thromboembolism disease by oral anticoagulant including using a semi quantitative score of menorrhagia. 2- To compare this proportion according to the four molecules of oral anticoagulants (fluindione, warfarin, rivaroxaban and apixaban) and 3- to evaluate the impact of these haemorrhages on the quality of life. Our study would have a control group of women of childbearing age followed in vascular medicine for superficial venous insufficiency without thrombosis and without oral anticoagulant because the proportion of genital haemorrhages in women of childbearing age in PACA region is not known.


title: Evaluation of the Use of an Analog Scale to Estimate Dietary Intakes, EPA, for Hemodialysis Patients

acronym: EDDEN

summary:
The aim of this clinical research is to evaluate the relevance of using the EPA slide to estimate dietary intakes in dialysis patients. The obtained results will be compared with the reference technique validated by the HAS: food intake over 3 days.

The aim is also to improve the global management of dialysis patients and improve their quality of life. The aim is to evaluate a quick and easy-to-use tool whose use has been demonstrated in hospitals but for which no study has been carried out in an ambulatory hospitalization context.

lead_sponsor: University Hospital, Caen


title: Anatomopathology of the Subscapularis and Infraspinatus Muscles in Children With Brachial Plexus Obstetric Paralysis

acronym: POPB

summary:
POPB is a consequence of the stretching of the nerve roots (C5, C6 + / C7, C8 or T1) of the brachial plexus at birth. One third of patients will have sequelae. The most common is the appearance of a deficit of passive and active mobilities in the movements in external rotation of the shoulder especially in external rotation (RE) elbow to the body, despite daily rehabilitation. At present, this stiffness is attributed to an imbalance between the external rotator muscles (mainly infraspinatus) that would be atrophied and the internal rotator muscles (subscapularis, pectoralis major, latissimus dorsi) that would be slightly affected In case of no or negative RE from the age of 1 year, there is a surgical indication to operate these children. At present, surgery to lift internal retractions is the only therapy used, but despite this surgery and intensive rehabilitation, in some patients mobility deficits re-occur in a few years. Thus, some teams systematically perform a muscle transfer to strengthen the outer rotator muscles deficit during the initial operation. Other teams (of which principal investigator is part) do this transfer only secondarily and in some patients. Investigators lack objective and scientific criteria for the indication of this second muscle transfer surgery and the etiology of retractions is not clearly defined.

In humans, subscapularis is innervated by the C5 and C6 roots, which are constantly affected in POPB. It can be assumed that subscapularis may have an atrophy in POPB patients. To date, no anatomopathological study has been performed on the internal / external rotator muscles of patients with POPB that can give indications on recurrences.

Based on our clinical observations and literature data, the main hypothese is there is amyotrophy of subscapularis and / or infraspinatus in POPB patients with shoulder stiffness.


title: Long Term Outcome on Brain and Lung of Different Oxygen Strategies in ARDS Patients

acronym: LTO-BLOXY

summary:
Acute respiratory distress syndrome (ARDS) is a serious disease with high mortality. In patients who survive ARDS, respiratory, neurological and motor sequelae are frequent, negatively impacting on the patient's quality of life, and engendering substantial healthcare costs (rehabilitation, long-term care, delayed return to work). There may also be repercussions on the patient's family and entourage. The severity of ARDS and the burden it represents have underpinned intensive research to identify treatment strategies that could improve mortality. However, it is important to ensure that any improvement in mortality does not come at the price of an excess of sequelae and disability in survivors.

The oxygenation strategy used to treat ARDS may have an impact on mortality in these patients. The CLOSE study, in which our group participated, recently demonstrated the feasibility of two oxygenation strategies in intensive care unit (ICU) patients with ARDS. We have also initiated the LOCO-2 study (NCT02713451), whose aim is to show a reduction in mortality in ARDS using a "conservative" oxygenation strategy (PaO2 maintained between 55 and 70 mmHg) as compared to a classical "liberal" oxygenation strategy (PaO2 between 90 and 105 mmHg).

The LTO-BLOXY study is a substudy of the on-going LOCO-2 study

lead_sponsor: Centre Hospitalier Universitaire de Besancon


type: Other Grant/Funding Number

title: Rheumatism and Dietetic: RHUMADIET Study (Food Practices and Beliefs)

acronym: RHUMADIET

summary: Cross sectional study assessing food practices and beliefs in RA, AS and DA (digital arthritis)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Rhumatologie - Hôpital Saint Antoine


title: Descriptive Study of the Physiological and Oral Parameters of the Young Child to the Adolescent

acronym: PhyDentchild

summary: The aim of this study is to measure some oral and maxillofacial physiological parameters, with a view to creating a modular prototype articulator from young children to adolescents by 3D printing.


title: Comparison of Two Techniques of Locoregional Analgesia in Total Knee Prosthesis Surgery : Block to the Adductor Channel Versus Peri-articular Local Infiltrations

acronym: SALIA

summary:
The post-operative pain generated by prosthetic knee replacement surgery is known to be moderate to severe during two or three days following surgery.

The most popular analgesic technique after prosthetic knee replacement surgery remains the femoral block (FB), whether in single injection or continuous infusion. In major knee surgery, FBs provide better analgesia compared to systemic morphine and FBs provide the same analgesia that obtained with epidural analgesia but with fewer associated adverse effects.

Although FBs provide excellent post-operative analgesia after total knee prosthesis, they also provide a significant quadricepsia weakness that increases the risk of severe falls and complications, and hinders the rapid rehabilitation process. For these reasons, alternative analgesic techniques have emerged in recent years.

To avoid the quadricipital motor block generated by FBs, some authors proposed the administration of local anesthetics in the adductor channel, also known as the Hunter channel, in order to produce a pure sensory block. With the development of ultrasound, the adductor channel is easily visualized in the middle of the thigh. This allows the adductor channel block (ACB) to be realized with a high success rate. ACB appears to decrease postoperative pain and morphine consumption. It also significantly improves the ability of patients to walk around after Total Knee Arthroplasty (TKA) surgery.

With the same goal of quadricipital savings, the use of the analgesic technique by periarticular infiltration of local anesthetics (ILA) has spread in recent years, due to the fact that an analgesic technique of simple realization and without apparent danger, and this despite limited evidence of its effectiveness.

The Croix-Rousse Hospital is a university hospital in Lyon with a highly developed orthopedic surgery center, producing approximately 550 TKA per year. During the year 2016, approximately half were benefited from post-operative analgesia management by ACB, and the other half by the implementation of the ILA.

To date few studies have been interested in comparing these two analgesic techniques in knee prosthesis surgery.


title: Everyday Life Cognition and Non-conventional Magnetic Resonance Markers in RRMS Patients Treated With Aubagio® in a Real-life Setting

acronym: AUBACOG

summary:
Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease which contributes largely to disability. Cognitive assessment using classical neuropsychological tests are poorly correlated with patient's complaints and daily functioning. Ecological evaluations, recent and innovative way to assess cognitive functions with the true impact of cognitive impairment in everyday daily life of patients. One goal of an ecological test could be to identify MS patients in whom cognitive impairment has a strong interaction with daily life. Different type of ecological evaluation have been recently proposed in MS, including assessment cognitive tasks in a virtual reality environment using the Urban DailyCog® software developed in our laboratory (Hamel et al, 2015). Virtual reality environment assessments are promising in detecting cognitive impairment while providing friendly assessments for patients and simulating daily activities. . Cognitive dysfunction is correlated with white matter diffuse injury in relapsing-remitting MS (RRMS) patients and brain atrophy However, the relationships between structural brain damage and brain connectivity with cognitive functioning assessed by ecological evaluation are also unknown. The use of new techniques for morphological and functional MRI can study the contribution of diffuse white matter (WM) alteration and diffuse gray matter (GM) alterations in cognitive impairment and on their evolution.

The objectives are to evaluate the ecological assessment (Urban DailyCog® and actual reality) to detect cognitive impairment in everyday daily life of patients and their changes and to investigate structural WM and GM damages and the dynamic of functional connectivity for explaining and predicting cognitive disability during two years in RRMS patients treated by the same treatment Aubagio®.

lead_sponsor: University Hospital, Bordeaux


title: Voice Tessitura and Size of the Required Laryngeal Mask

acronym: EVG

summary:
The choice of the size of the laryngeal mask (i-gel) is based on the weight. Even following the weight recommendations, it is quite common to choose a mask that is too big or too small, which leads to ventilation leaks (too small), or insertion failures (too big) and leads to a change of mask for bigger or smaller.

The i-gel are laryngeal masks (2nd generation) which consist of gel and have been designed by molding on larynx corpses. The masks are not inflatable (so not adaptable).

I-gel masks are used in adult and pediatric patients for weights ranging from 2 Kg to over 90 Kg to provide ventilation during general anesthesia.

Patients with a deep voice probably need a larger laryngeal mask than their weight alone suggests.

The investigators propose to measure the lowest sound emitted by the patient because it would seem logical that the larger the larynx is, the more the voice is serious.

This hypothesis will be verified a posteriori by the size of the laryngeal mask used and adapted by comparing it to the range of the voice.

lead_sponsor: Centre Hospitalier Intercommunal Creteil