title: Etude Pilote Randomisee Versus Placebo Evaluant l'Efficacite de la Stimulation Electrique Transcranienne de Faible Intensite (Tdcs) Dans le Soulagement de la Dyspnee Chez Les Patients Sous Ventilation Mecanique en Reanimation

acronym: tDCS-DYSP-REA

summary: Nearly half (47%) of patients with mechanical ventilation in the intensive care unit report having dyspnea. This respiratory distress, with a feeling of "thirst for air", often reaches unbearable limits and is a major factor in the deterioration of the quality of life and the prognosis of patients. Physiopathological mechanisms of dyspnea are beginning better understood and have analogies with those of pain. Like pain, dyspnea often persists despite appropriate treatment of the cause, because of perceptual dysfunction related to changes in cortical excitability and neuronal plasticity and requires specific treatments. Studies have shown that Transcranial Stimulation by low Current (tDCS) was able to modulate the perception of acute pain induced and chronic pain. The tDCS modulates the functioning of a whole set of brain structures including the anterior cingulate gyrus, the prefrontal cortex, the thalamus and the brain stem, some of which have an established role in the central integration of pain and dyspnea. The investigators have recently demonstrated that the application of tDCS on the primary cortical motor area reduces the excitability of the central neurological pathways dedicated to the respiratory muscles in healthy subjects. The investigators therefore hypothesize that tDCS could relieve dyspnea in intensive care. In this research project, the investigators propose to evaluate the efficiency of tDCS on dyspnea in patients admitted to intensive care unit, having sepsis and mechanically ventilated.

ReferenceCitation: Azabou E, Bao G, Heming N, Bounab R, Moine P, Chevallier S, Chevret S, Resche-Rigon M, Siami S, Sharshar T, Lofaso F, Annane D. Randomized Controlled Study Evaluating Efficiency of Low Intensity Transcranial Direct Current Stimulation (tDCS) for Dyspnea Relief in Mechanically Ventilated COVID-19 Patients in ICU: The tDCS-DYSP-COVID Protocol. Front Med (Lausanne). 2020 Jun 26;7:372. doi: 10.3389/fmed.2020.00372. eCollection 2020.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: Other Identifier

title: Psychometric Validation of the Competitive Attention Test (CAT) : Simultaneous and Separated Measures of Voluntary and Involuntary Attention

acronym: CAT

summary:
This project aims at validating a new neuropsychological test to measure voluntary and involuntary attention for clinical use to diagnose attentional deficits.

This project proposes:

a test-retest procedure in healthy subjects aged from 6 to 90 year-old;
testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment;
testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Neurosciences de Lyon, INSERM U1028

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: COGSTIM 2 Study: Management by Individual Cognitive Remediation of Cognitive Disorders of HIV Infected Patients Controlled by Antiretroviral Treatment

summary:
Despite sustained inhibition of viral replication in plasma undergoing treatment, nearly 30% of HIV-infected patients have HIV-related cognitive impairment. To date, no therapeutic strategy has demonstrated clinical efficacy. The initial hypothesis is to use the non-medical techniques of cognitive remediation commonly practiced in the treatment of Alzheimer's disease to allow improvement or even regression of cognitive disorders in HIV-infected people (PHAs) who are virologically tested on antiretroviral combination therapy (ART). Some recent pilot studies using individual computer-based cognitive remediation strategies show improved test performance. However, none have studied the impact of this strategy on PPHIV with cognitive impairment.

A single-center pilot study evaluating the efficacy of an individual cognitive remediation program for 6 months on the improvement of cognitive impairment in patients with stable plasma HIV viral load that is undetectable under stable antiretroviral combination (cART) cognitive disorders related to HIV infection.

The primary objective is to demonstrate improvement through a 6-month individual cognitive remediation program on cognitive impairment (1 standard deviation variations on 2 M6 neuropsychological tests) in controlled HIV-positive individuals under cART with cognitive disorders related to HIV.

Methodology: Monocentric, prospective, pilot study of 40 patients performed in an open period of 25 months. The inclusion period is 13 months and the participation duration per patient is 12 months. After an inclusion visit, patients start 15 days of individual cognitive remediation sessions. The cognitive remediation will be led by a psychologist specialized in neuropsychology, trained and experienced in this method. Cognitive remediation will be performed at a rate of 1 to 2 sessions per week. Each patient will be assessed initially (M0) at 6 months (M6) and 12 months (M12: 6 months after stopping cognitive remediation) with a battery of standardized neuropsychological (NP) tests performed by a neuropsychologist.

Primary endpoint: Improved cognitive impairment after 6 months of cognitive remediation, with each patient being their own control, defined by improvement on at least 2 tests of 1 standard deviation minimum.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille


title: A Prospective, Mono-center, Interventional Study Evaluating the Effect of One Year Initial Care by Hygieno-dietary Advices With or Without Phlebotomy on Glycemia After at Least 5 Years in Patients With Dysmetabolic Iron Overload Syndrome

acronym: EvoHSD

summary: A prospective, mono-center, interventional study evaluating the effect of one year initial care by hygieno-dietary advices with or without Phlebotomy on glycemia after at least 5 years in Patients with dysmetabolic iron overload syndrome

status: Completed

lead_sponsor: Rennes University Hospital

intervention_type: Biological

status_simplified: Completed


title: Psychological Impact of a Sophrological Accompaniment During the Announcement of Thyroid Cancer Compared With Usual Initial Management: Multicenter Randomized Prospective Study

summary:
Follicular thyroid cancers are excellent prognoses. However, there is a very clear negative impact of the diagnosis on patients' quality of life, partly because of initial care. The therapeutic sequence is often the following: surgery and complementary administration of radioactive iodine 131. This treatment will destroy all thyroid cells remaining and thus minimize the risk of recurrence and facilitate future controls.

Radioactive iodine uptake is optimized by stimulating thyroid cells that fix iodine better when the level of TSH is high. For this purpose, hypothyroidism is induced by weaning in hormone replacement therapy or injected with recombinant TSH.

Then, a full-body scintigraphy extension is performed followed by a medical consultation. This scintigraphy shows the tissues that fixed the iodine 131, the residual tissues after surgery and / or possible distant metastases.

It is recognized that when a patient learns that he has thyroid cancer, he is subject to increasing anxiety between the time of diagnosis and post-treatment scintigraphy. These patients and their loved ones are often distraught and anticipate their future in a negative way, while long-term survival is excellent. How to get these patients to consider their pathology more objectively and thus reduce their anxiety?

Sophrology is a psychocorporal method aimed at balancing our emotions, thoughts and behaviors. We suppose that if these patients could benefit from a sophrological accompaniment between the announcement of the diagnosis and the scintigraphy, they could apprehend their pathology with more serenity and reality.

No studies providing sophrological support to patients with thyroid cancer have been performed. The anxiety of these patients being largely linked to a feeling of isolation and excessive danger, we think that this care will have an immediate favorable effect on their anxiety, or even in the longer term on their quality of life.

The aim is to offer patients a sophrological support provided by each of the 3 participating centers. These group sessions will allow them to understand the place of their future hospitalization, to share with other patients, to obtain answers to their questions, to be listened to with neutrality and empathy, and to learn management techniques. their anxiety in order to reproduce them at home. They will be followed and will not feel abandoned in the face of their distress.

design_allocation: Randomized


type: EudraCT Number

title: 35RC17_8826_NEPHROPAIN Phase APRES : Interest of the Equimolar Oxygen Nitride Mixture (MEOPA) in the Treatment of Pain in Patients Presenting to the Emergency Department for Suspected Renal Colic: a Study BEFORE AFTER

acronym: NEPHROPAIN

summary: MEOPA (Equimolar Oxygen-Nitrogen Protoxide Mix) is a gas used in emergencies for short-term painful acts. It is often very effective with an analgesic, anxiolytic and muscle relaxant action. It is often combined with other analgesic medicines. It has already been proven in emergency medicine for short-term pain and trauma. It seems that it could be used more particularly for pains of medical origin. A study has already proved its effectiveness in the treatment of migraines in emergencies. The first phase of the NEPHROPAIN study began in 2016 after a favorable opinion from the Regional Ethics Committee. NEPHROPAIN phase AVANT was a prospective non-interventional study on the use of analgesic drugs in nephritic colic in emergencies by Dr. Alexandre Tanneau. This study was conducted at the University Hospital of Rennes and included 60 patients admitted to the emergency department for suspected renal colic. It made it possible to recruit the control group of the NEPHROPAIN study. Its main objective was to describe the suspected population of renal colic in Rennes emergencies, to determine NEPHROPAIN's primary endpoint and the number of NEPHROPAIN needed subjects.

primary_purpose: Treatment

ipd_sharing: No

intervention_type: Drug


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

acronym: LENOX

summary: Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a scheduled setting, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety. The goal of this trial is to confirm these results in a more heterogeneous group of patients having a LP, in an emergency setting.

ReferenceType: background

ReferenceCitation: Herres J, Chudnofsky CR, Manur R, Damiron K, Deitch K. The use of inhaled nitrous oxide for analgesia in adult ED patients: a pilot study. Am J Emerg Med. 2016 Feb;34(2):269-73. doi: 10.1016/j.ajem.2015.10.038. Epub 2015 Oct 24.

ReferenceCitation: Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56.

ReferenceCitation: Koscielniak-Nielsen Z, Hesselbjerg L, Brushøj J, Jensen MB, Pedersen HS. EMLA patch for spinal puncture. A comparison of EMLA patch with lignocaine infiltration and placebo patch. Anaesthesia. 1998 Dec;53(12):1218-22.

ReferenceCitation: Lavi R, Yarnitsky D, Rowe JM, Weissman A, Segal D, Avivi I. Standard vs atraumatic Whitacre needle for diagnostic lumbar puncture: a randomized trial. Neurology. 2006 Oct 24;67(8):1492-4. Erratum in: Neurology. 2007 Feb 27;68(9):711. Yernitzky, D [corrected to Yarnitsky, D].

ReferenceCitation: Lukas A, Niederecker T, Günther I, Mayer B, Nikolaus T. Self- and proxy report for the assessment of pain in patients with and without cognitive impairment: experiences gained in a geriatric hospital. Z Gerontol Geriatr. 2013 Apr;46(3):214-21. doi: 10.1007/s00391-013-0475-y.

ReferenceCitation: Moisset X, Ruet A, Brochet B, Planche V, Jaffeux P, Gilleron V, Ong N, Clavelou P. Who Performs Lumbar Puncture, How Many Do They Perform, How and Why? A Retrospective Study of 6,594 Cases. Eur Neurol. 2016;76(1-2):8-11. doi: 10.1159/000447452. Epub 2016 Jun 24.

ReferenceCitation: Moisset X, Sia MA, Pereira B, Taithe F, Dumont E, Bernard L, Clavelou P. Fixed 50:50 mixture of nitrous oxide and oxygen to reduce lumbar-puncture-induced pain: a randomized controlled trial. Eur J Neurol. 2017 Jan;24(1):46-52. doi: 10.1111/ene.13127. Epub 2016 Sep 25.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Clermont-Ferrand


title: Musinduc : Impact of Music During the Period of Anaesthetic Induction - a Randomized Controlled Clinical Trial

acronym: MUSINDUC

summary:
Anesthetic induction requires the use of, among other things, hypnotic drugs that can lead to hemodynamic disorders, postoperative cognitive dysfunctions and delayed awakening. A strategy to reduce the doses of hypnotics administered could improve patients' postoperative outcomes and is part of the current strategy of accelerated postoperative rehabilitation. Music has shown its effectiveness in reducing the doses of hypnotics administered during sedation procedures.

Objective :

We propose a study of this anesthetic period evaluating the effectiveness of music as an adjuvant agent for anesthetic drugs allowing hypnotic savings.

Materials and methods :

Randomized, prospective, monocentric study

2 groups will be compared. The experimental group will benefit from musical listening during the induction period of the anesthesia. The control group will have a usual care.

The primary endpoint is the amount of hypnotic (propofol®) used during anesthesia induction. The main secondary criteria are the duration of induction, the cost of induction, and the postoperative pain score and the proportion of patients with postoperative nausea and vomiting.

This study should include 104 subjects (52 in each group) requiring general anesthesia.

Hypothesis tested:

Listening to music reduces the amount of hypnotic product used in the induction of anesthesia by 0.5 mg/kg.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Caen


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

status: Withdrawn

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Device


title: Evaluation of the Clinical Performance of 18F-FDOPA PET-CT in the Preoperative Initial Assessment of Medullary Thyroid Carcinoma: Multicenter Prospective Study

acronym: TEPCMT

summary:
Medullary thyroid carcinoma (MTC) develops at the expense of calcitonin cells and is often characterized by lymph node metastases and sometimes visceral metastases. Improvement of preoperative diagnosis is of major importance in CMT because the quality of the initial surgery determines the prognosis. In recent years, 18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET / CT was considered the most sensitive functional imaging tool in the evaluation of persistent CMT. To date, 18F-FDOPA PET at initial diagnosis has been reported in a few clinical cases.

The main objective is to demonstrate that 18F-FDOPA PET provides additional information compared to conventional imaging on the initial diagnosis of CMT patients.

The secondary objectives are to describe the nature of the information provided by PET / CT imaging, the main factors influencing tracer uptake and the positivity of PET / CT, and the impact of the examination on the care of the patient.

This is a prospective, multicenter and open study.

Patients with TCM who have serum calcitonin> 150 pg / ml at initial diagnosis and have performed baseline imaging examinations within the last 3 months will be included in the study . A PET at 18F-FDOPA will be performed according to a very powerful acquisition protocol. Image analysis will be performed blindly from the results of conventional imaging. All exams will be compared, in accordance with the gold standard. Therapeutic intentions will be collected before and after the PET imaging, as well as the actual management in place.

primary_purpose: Diagnostic


title: Effect of High-Intensity Interval Training Combined With Resistance Training on Body Composition and Gut Microbiota in Postmenopausal Women

acronym: PACWOMan

summary:
Postmenopausal women, as men, are more prone to central or android obesity than premenopausal women. Recently, some studies have shown that obesity is associated with gut microbiota dysbiosis and gut microbiota could be responsible of fat mass accumulation. Moreover, abdominal fat mass accumulation is associated with an increase of cardiovascular disease risks.

Recent studies suggest that physical activity may positively alter gut microbiota composition. Accumulating evidence suggests that high intensity interval training (HIIT) is an effective strategy for reducing body fat of overweight individuals, especially at the abdominal level. Resistance Training (RT) is associated with increased muscle mass and strength gain in main muscle groups. Thus, RT is also an interesting modality to fight against deconditioning and autonomy loss with age.

The aim of the study was to observed the effects of a 12-week high intensity interval training (HIIT) combined with resistance training (RT) program on gut microbiota and body composition changes in postmenopausal women.

It is hypothesized that HIIT +RT will improve gut microbiota and body composition (including whole body and (intra)-abdominal fat mass) in a concomitant and parallel way.

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Dupuit M, Rance M, Morel C, Bouillon P, Boscaro A, Martin V, Vazeille E, Barnich N, Chassaing B, Boisseau N. Effect of Concurrent Training on Body Composition and Gut Microbiota in Postmenopausal Women with Overweight or Obesity. Med Sci Sports Exerc. 2022 Mar 1;54(3):517-529. doi: 10.1249/MSS.0000000000002809.

lead_sponsor: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

lead_sponsor_type: industriel


title: Innovative Biomarkers in de Novo Parkinson's Disease

acronym: INNOBIOPARK

summary: This study aims at identifying potential new and innovative biomarkers in de novo Parkinson's disease patients. New finding will help phenotyping patients since the diagnosis of the disease and potentially also in the preclinical phase.

lead_sponsor: University Hospital, Grenoble


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.

study_type: Observational

time_perspective: Prospective


title: Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment

summary: The authors hypothesize that there is a correlation between the percentage of CD4+ T cells expressing CD32a and/or X and the quantity of DNA found in peripheral blood mononuclear cells in patients infected with HIV-1. Also, that there is a correlation between expression of CD32a and/or X and proviral load.

status: Recruiting

status_simplified: Ongoing


title: Adherence to Anti-infectious Treatment Protocols in Emergencies and Short-term Hospitalization at the Infectious Disease Department"

summary:
Consensual antibiotic protocols have been developed and validated locally by infectious disease specialists, internists and emergency physicians, in order to encourage their compliance. A preliminary study was conducted from June 2015 to February 2016, including 622 patients admitted to the emergency department for infectious syndrome such as /

Pneumoniae
Urinary tract infection
Cellulitis
Meningitis
Malaria
Febrile neutropenia
Febrile acute diarrhea
Fever back to the tropics
Angina
sexually transmitted infection This prospective study will observe and analyze the adherence of prescribers to these protocols. With description of patients who benefited or not the antibiotic protocol, according to a syndromic approach and analysis of the causes of non-adherence to the protocols. In order to limit the length of stay and reduce the cost of hospitalization..


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: The Efficiency of Using Supportive Postures and Holding Techniques in Order to Minimize Premature Infant Pain During Naso-gastric Tube Insertion, in the Presence or Absence of the Mother.

acronym: PAPS

summary: Out of the most commonly performed procedures in neonates, naso-gastric tube insertion is rated as the fifth most painful. The pain is often under estimated due to the frequency with which the procedure is carried out. It has been shown that the environment in which the procedure is performed (e.g with skin to skin contact and specific positioning), reduces the discomfort felt by the newborn. However, this has not yet been proven with regards to naso-gastric tube insertion.

status: Suspended

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound

acronym: PROMONOTECHO

summary:
Indirect promontofixation with prostheses is the standard surgical technique for the reference of uterine prolapse. There is no validated examination to control the position of the prostheses postoperatively.

These prostheses are echogenic and perineal ultrasound could be a means of postoperative monitoring. There is no data in the literature on the relationship between prosthesis position and postoperative symptoms

lead_sponsor: Poitiers University Hospital


title: Genetical Characterization of Patients Presenting With Dyslipidemia

acronym: GENELIP

summary:
The mechanism of the majority of the dyslipidemia is multifactorial at the molecular level and remains elusive in more than 50% of the patients in many clinical conditions. Next generation sequencing, a booming strategy, improves the molecular diagnosis efficiency in both monogenic and polygenic dyslipidemia.

In order to decipher the mechanisms involved in the occurrence of dyslipidemia, in addition to the exploration of known candidate genes and Single Nucleotide Polymorphisms (SNP) involved in polygenic modulation, new genes involved in the regulation of lipoprotein metabolism or associated with lipids concentrations need to be sequenced in large groups of dyslipidemic patients.

The goal of this project is to gain new insight into genotype/phenotype correlation.

location_facility: Laboratoire de Biologie Médicale Multi Sites, Centre de Biologie et de Pathologie Est, Département de biochimie et biologie moléculaire Grand Est


title: Analyse de la Marche de Patients Atteints de Dystonie Focale Avant et après Traitement Par Toxine Botulique

acronym: GAIT-TOX

summary:
Efficient gait requires effective postural control, both static and dynamic. Hence, postural disorders may affect gait. Yet, very little is known about the specific effects of focal postural disorders such as cervical dystonia (CD) and blepharospasm (BS) on patients' mobility.

The present research therefore aims at analyzing gait characteristics in patients presenting with these conditions in order to document possible gait alterations.

In addition, the investigators will explore the effect of botulinum toxin treatment, which the most frequently used therapeutic option, on the patients' gait characteristics. Indeed, while the treatment improves both dystonia and pain, and therefore quality of life, its influence on gait is presently unknown. the investigators aim at filling this knowledge gap

ReferenceCitation: Tarsy D, Simon DK. Dystonia. N Engl J Med. 2006 Aug 24;355(8):818-29. Review.

ReferenceCitation: Barr C, Barnard R, Edwards L, Lennon S, Bradnam L. Impairments of balance, stepping reactions and gait in people with cervical dystonia. Gait Posture. 2017 Jun;55:55-61. doi: 10.1016/j.gaitpost.2017.04.004. Epub 2017 Apr 4.

ReferenceCitation: Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, Hallett M, Jankovic J, Jinnah HA, Klein C, Lang AE, Mink JW, Teller JK. Phenomenology and classification of dystonia: a consensus update. Mov Disord. 2013 Jun 15;28(7):863-73. doi: 10.1002/mds.25475. Epub 2013 May 6. Review.


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).

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.

intervention_type: Diagnostic Test


title: Attitude of the Dentist to the Detection of Calcification of the Carotid Region on an Orthopantomogram

acronym: ADCACO

summary: Observational study.

time_perspective: Retrospective


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: Feasibility of a Home HD Program Assisted by a Nurse Coming at Home for Arterio-venous Fistula (AVF) Cannulation

acronym: DIADIDEAL

summary: Home HD (HHD) is associated with better outcome in end-stage renal disease patients compared to in-center HD, in particular in terms of quality of life. However fear of AVF cannulation is a known barrier for patient's choice and adoption of a HHD program. Providing nurse assistance for the cannulation can help developing HHD programs. The aim of this study is to evaluate the feasibility of assisted home hemodialysis, with the intervention of a nurse at home for arterio-venous fistula cannulation.

intervention_type: Procedure


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.

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.

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.

ReferenceCitation: Monna F, Ben Messaoud R, Navarro N, Baillieul S, Sanchez L, Loiodice C, Tamisier R, Joyeux-Faure M, Pépin JL. Machine learning and geometric morphometrics to predict obstructive sleep apnea from 3D craniofacial scans. Sleep Med. 2022 Jul;95:76-83. doi: 10.1016/j.sleep.2022.04.019. Epub 2022 Apr 29.


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.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: OCS-Tapering-Delphi: Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma: A Delphi Consensus Study

summary: The objectives of this study are to use the Delphi method to assemble an expert panel representing innovation in asthma treatment, to collect freely suggested recommendation statements concerning OCS tapering (and sub-topics) among severe asthma patients from this panel for peer evaluation, and finally to determine the level of consensus for each statement from the panel as a whole.

ReferenceCitation: Suehs CM, Bourdin A. Tapering of Oral Corticosteroids for the Treatment of Asthma. Arch Bronconeumol (Engl Ed). 2021 Feb 17. pii: S0300-2896(21)00054-5. doi: 10.1016/j.arbres.2021.01.029. [Epub ahead of print] English, Spanish.

ReferenceType: result

ReferenceCitation: Suehs CM, Menzies-Gow A, Price D, Bleecker ER, Canonica GW, Gurnell M, Bourdin A; Oral Corticosteroids Tapering Delphi Expert Panel. Expert Consensus on the Tapering of Oral Corticosteroids for the Treatment of Asthma. A Delphi Study. Am J Respir Crit Care Med. 2021 Apr 1;203(7):871-881. doi: 10.1164/rccm.202007-2721OC.

ipd_sharing: Yes

ipd_sharing_description: Anonymized data will be shared on an appropriate public platform at the time of publication.

lead_sponsor: University Hospital, Montpellier


title: Non-invasive Home Ventilation in Patients With Severe Hypercapnic COPD: Standard Versus Löwenstein Mode of Management of Dynamic Hyperinflation; Effects on Hematosis and Sleep.

acronym: SOMNOVENT'

summary:
In COPD patients with chronic hypercapnic respiratory failure, the prognosis is poor and the treatment with non invasive ventilation is actually well established. However the best mode of ventilation is not well known.

In severe COPD patients various disorders of respiratory mechanics result in insufficient ventilation, which can be life-threatening or create NIV discomfort. The main characteristic of these disorders is a cyclical closing of small airways that can limit an expiratory flow and provoked some fluctuations in flow curve. To our knowledge, the management of dynamic hyperinflation seems to play an important role in explaining the effect of the NIV. Few studies have examined the effects of the machine's adjustments on dynamic hyperinflation.

The main objective of this study is to analyze the impact of specific ventilatory modes supposed to reduce the dynamic hyperinflation on the hematosis, by studying transcutaneous pressure of carbon dioxide, in severe hypercapnic COPD patients ventilated by NIV. Two modes of ventilation will be compared. First one is an algorithmic mode developed by the company Löwenstein (AirTrap Control, Trigger Lockout and the Expiratory Pressure Ramp). The second one is a standard algorithmic mode, used in the same ventilator. These two ventilatory modes will be evaluated in each patient, during two consecutive nights in current living conditions at home.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: L'Etude préopératoire de la Microcirculation Pour la prédiction Des Complications après Une Chirurgie Cardiaque Sous Circulation Extracorporelle.

acronym: MONS

summary:
Cardiac surgery is responsible for many complications. Microcirculation is involved in many of them. The objective of this study is to prospectively investigate the prognostic value of preoperative microcirculatory assessment in patients scheduled for cardiac surgery with CPB for the occurrence of postoperative complications.

Microvascular dysfunction is suspected of being involved in postoperative psycho-cognitive decline. The influence of microcirculation on the evolution of psycho-cognitive assessment is also analyzed in this study.

ReferenceCitation: Abrard S, Fouquet O, Riou J, Rineau E, Abraham P, Sargentini C, Bigou Y, Baufreton C, Lasocki S, Henni S. Preoperative endothelial dysfunction in cutaneous microcirculation is associated with postoperative organ injury after cardiac surgery using extracorporeal circulation: a prospective cohort study. Ann Intensive Care. 2021 Jan 7;11(1):4. doi: 10.1186/s13613-020-00789-y.

lead_sponsor: University Hospital, Angers


title: Retrospective Study of Carotid Surgery in Dijon

acronym: RESCADI

summary:
The results in carotid surgery are an indicator of the functioning of an academic surgical team, making it possible to evaluate and improve practices, as much among surgeons in training as among senior surgeons.

The indications have evolved with the development of symptomatic stenosis surgery, and results analysis has allowed us to improve our practices.

It would be of great use to have the statistics obtained in previous years to continue improving our practices.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of Information Campaign's Alongside Maternity Staff About Bedding Infant

summary: It is now well established that infants should be placed on the back only in a SleepSack without coverage or plush or pillow on a firm mattress in a bedroom. Despite these old recommendations of good practice, deviations are observed and some infants are most always lying according to the recommended position. The goal is to assess the impact of an information campaign of staffs maternity of the CHU of Reims on the practices of the sleeping of infants to motherhood, and then at the home of the parents.

lead_sponsor: CHU de Reims


type: Registry Identifier

title: Experimentation of a Protocol of Psychiatric Advance Directives: Randomized Controlled Multi-site Trial

acronym: DAiP

summary:
Severe mental illness is accompanied by cognitive fluctuations that can alter decision-making skills and lead to coerced care. Taking into account, on the one hand, the health, social and economic impact of forced hospitalization, on the other hand the importance of self-determination, the reinforcement of the power to act in the evolution of these disorders, new strategies to better reflect the views of people have been developed.

Among these, the drafting of Advanced Directives in Psychiatric (ADP), allows people with mental disorders to write while their decision-making skills are restored care instructions in case of decompensation.

It is a tool of "advanced therapeutic education" and early prevention of relapses.

It is hypothesized that the implementation of drafting accompanied by advance directives to people with severe psychiatric disorders decreases in the short term the number of forced hospitalization care pathway of these people, compared to the subjects having not benefited from this device.

This research will take the form of a randomized controlled trial on 3 sites. The "quantitative" evaluation component of results and processes will be completed with a qualitative anthropological and socio-political evaluation component documenting the trajectories of individuals and the implementation of the program, as well as a "participatory research" component aimed at a dialogue between users, researchers and professionals.

The patient who is a beneficiary of the "Advanced Directives in Psychiatric" program will be encouraged to complete the " Advanced Directives in Psychiatric" document and will receive support in drafting them. The non-beneficiary patient of the program will follow up with his psychiatrist unchanged.

The experimental design of the quantitative component is based on an experimental, randomized, prospective, controlled, parallel study, comparing two groups of subjects with severe psychiatric disorders.

This research will assess the effectiveness, efficiency and impact of the " Advanced Directives in Psychiatric" program compared to conventional psychiatric care alone.

Ultimately, the objective of describing the effects of the program on health organizations and on the representations and practices of professionals, caregivers and users is at the service of a better understanding of the conditions of possibility of the generalization of this experimentation.

ReferenceCitation: Tinland A, Loubière S, Mougeot F, Jouet E, Pontier M, Baumstarck K, Loundou A, Franck N, Lançon C, Auquier P; DAiP Group. Effect of Psychiatric Advance Directives Facilitated by Peer Workers on Compulsory Admission Among People With Mental Illness: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Aug 1;79(8):752-759. doi: 10.1001/jamapsychiatry.2022.1627.

ReferenceCitation: Tinland A, Leclerc L, Loubière S, Mougeot F, Greacen T, Pontier M, Franck N, Lançon C, Boucekine M, Auquier P. Psychiatric advance directives for people living with schizophrenia, bipolar I disorders, or schizoaffective disorders: Study protocol for a randomized controlled trial - DAiP study. BMC Psychiatry. 2019 Dec 27;19(1):422. doi: 10.1186/s12888-019-2416-9.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study

acronym: NBHS

summary:
Hair toxicological analysis is nowadays a complementary technique to blood and urinary analyses because it allows a better detection of xenobiotics in time.

The detection of xenobiotics is expressed in hours in blood and in days in urines; it is several months in the hair. So, hair makes it possible to establish a retrospective timetable of consumption and exposure to xenobiotics.

In newborns, hair has different morphological characteristics than adults' hair. It is thinner, more porous and the development phases are not the same.

Nevertheless, it is recognized that the absorption mechanisms of xenobiotics in newborns' hair are similar to those of adults. On the other hand, some difficulties of interpretation and discernment are observed between in utero exposure and environmental exposure after birth.

It is interesting to have data to estimate the absorption of psychoactive substances in newborns' hair following an utero exposure.

The main objective of this project is to study the mechanisms of incorporation of psychoactive substances administered to the mothers during pregnancy in newborns' hair.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Hôpital Archet 2 - Service de Gynécologie - Obstétrique - Reproduction


title: Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration

summary:
Anti-VEGF intravitreal injections are the treatment of choice in age-related macular degeneration (AMD). However 37% of patients are unresponsive or poorly responsive to these therapies. It is still not possible to foresee the patient's response to anti-VEGF injections. A poor response may be related to an activation of alternative pro-angiogenic pathways with over expression of many other pro-angiogenic cytokines.

The primary goal of this study is to measure the aqueous humor concentration of pro-angiogenic cytokines in AMD patients.

location_facility: Hôpital Pasteur 2 - Service d'Ophtalmologie


title: Contribution of Functional Imaging to the Diagnostic and Assesment of the Acute Phase of Transient Ischemic Attacks : a Preliminary Study

acronym: IMAGE AIT

summary: The aim of the study is to find a radiological biomarker of Transient Ischemic Attacks (TIA) thanks to functional Magnetic Resonance Imaging (fMRI) done within the 24 hour after symptoms onset.


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.


title: Efficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber

summary: The aim of this study is to determine the efficacy of Rowenta® "Intense Pure Air XL" air cleaner on the early and late bronchial response, in cat-allergic asthmatic patients during an allergen exposure in ALYATEC environmental chamber (EEC)

ReferenceCitation: Khayath N, Doyen V, Gherasim A, Radu C, Choual I, Beck N, Jacob A, Schoettel F, Vecellio L, Domis N, de Blay F. Validation of Strasbourg environmental exposure chamber (EEC) ALYATEC(®) in mite allergic subjects with asthma. J Asthma. 2020 Feb;57(2):140-148. doi: 10.1080/02770903.2018.1563902. Epub 2019 Mar 28.

ReferenceCitation: Gherasim A, Jacob A, Schoettel F, Domis N, de Blay F. Efficacy of air cleaners in asthmatics allergic to cat in ALYATEC(®) environmental exposure chamber. Clin Exp Allergy. 2020 Feb;50(2):160-169. doi: 10.1111/cea.13511. Epub 2019 Nov 6.

lead_sponsor: Alyatec


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.


title: Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma

acronym: UMATH

summary: Study of traumatized patients treated in emergency departments of Tours, seeking to optimize the management of trauma pain in an inpatient setting, with the opportunity to integrate inhaled methoxyflurane (Penthrox®) into the arsenal analgesics useful in the analgesic protocol of the Reception and Orientation Nurse.

lead_sponsor: University Hospital, Tours

location_facility: Emergency Medical Service, University Hospital, Tours


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


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.


title: Telemonitoring Impact by the ApTelecare Software in Dialysis Patient

acronym: MEDIA

summary: The investigators proposed to conduct a retrospective study to evaluate the impact of the implementation of apTeleCare software on the management of dialysis patients at home in terms of the number and duration of hospitalizations. For this purpose, the investigators will compare patients' data over a 2-year interval before the introduction of Telemonitoring (January 2012 and December 2013 inclusive - Group 1) with patients data who have benefited from this application (between August 2016 and July 2018).

time_perspective: Other

lead_sponsor: Tmm Software


title: Predictive Factors of Good Pulmonary Penetration of Antibiotics : AntiBiotics Dosage in Broncho-Alveolar Lavage

acronym: ABBA

summary: Respiratory infections are common and sometimes very severe. An insufficient dosage of the antibiotic could lead to a treatment failure A correct plasmatic antibiotic concentration is not a guarantee of a clinical success as it could not be a reflect of pulmonary concentration. The aim of this study is to determinate the predictive factors of pulmonary penetration of antibiotics in patients with a beta lactamines failure and who undergoes a flexible bronchoscopy.


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: Prognostic Factors of Carbon Monoxide-induced Coma Treated by Hyperbaric Oxygen: a Retrospective Study

acronym: Coma-CO

summary: The primary objective of the study is to determine prognostic factors for hospital-mortality following carbon monoxide (CO)-induced coma. The secondary objective is to determine prognostic factors of CO related cognitive sequelae, at the time of hospital discharge.

ReferenceCitation: Resche-Rigon M, White IR. Multiple imputation by chained equations for systematically and sporadically missing multilevel data. Stat Methods Med Res. 2018 Jun;27(6):1634-1649. doi: 10.1177/0962280216666564. Epub 2016 Sep 19.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Intensive Care Unit, Raymond Poincaré hospital


title: Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia in the Maxillo-Facial Surgery Department of the CHU Amiens-Picardie.

acronym: HYPNOFACE

summary:
Many clinical trials assessing the effectiveness of hypnosis have been conducted in recent years, some of which show that hypnosis reduces pain perception better than drug treatments administered to control groups, and that it is at least as effective as other complementary therapies (such as massage, acupuncture, yoga). However, their conclusions are limited by a significant risk of bias, and further studies with rigorous methodology remain necessary. The hypothesis of this study is that hypnosis support methods can reduce anxiety in patients requiring facial surgery under local anaesthesia, and thus improve their medical management.

The purpose of this study is to evaluate the effectiveness of hypnosis support on the patient's state of anxiety before and after outpatient surgery under local anaesthesia in the Maxillofacial Surgery Department.


title: Clinical Aspect of Erosive Pustular Dermatosis of the Leg

acronym: Clin-EPDL

summary:
Erosive pustular dermatosis of the leg is a fairlyrecent clinical entity that was described the first time in 1987.

Diagnosis of erosive pustular dermatosis of the leg is made on clinical grounds. It presents as non-follicular pustules of variable size and numbers that rapidly give way to erosions and crusts on one or both legs, and which are found in particular on the anterior aspect of the middle third of the leg (. The lesions are of chronic progression, despite topical therapy. Erosive pustular dermatosis of the leg is seen in elderly patients, mainly female, and may be associated with chronic venous insufficiency or cutaneous atrophy. In the absence of specific criteria and because of the existence of misleading clinical forms, diagnosis is based upon exclusion.

ReferenceCitation: Nicol P, Perceau G, Barbe C, Bernard P; members of GAD. Erosive pustular dermatosis of the leg: A prospective, multicentre, observational study of 36 cases. Ann Dermatol Venereol. 2017 Oct;144(10):582-588. doi: 10.1016/j.annder.2017.02.007. Epub 2017 May 19.


title: Influence of the Radiological Stage on the Efficiency of Intra-articular Injection of Hyaluronic Acid in Basal Thumb Arthritis

acronym: INSTINCT

summary:
The rhizarthrose is the most frequent affection of the hand at the age fifty 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 rhizarthrose.

It is an open observational multicentrical prospective study realized by 10 investigators rheumatologists and liberal orthopedic surgeons. The recruitment is competitive and the study will be ended when 55 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: 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: Ventilatory Adaptation to Concentric Versus Eccentric Exercise in Patients With Severe COPD

acronym: CONvEX

summary:
Pulmonary rehabilitation (PR) based on concentric exercise training has become an integral component in the treatment of patients with chronic obstructive pulmonary disease (COPD), improving functional capacities while diminishing symptoms and improving quality of life.

However, the response to concentric exercise training is heterogeneous from one COPD patient to another. The inability of some COPD patients to achieve the exercise intensities required to stress limb muscles due to severe ventilatory limitation could partially explain their poor response to training.

Endurance exercise with eccentric muscle contractions could be an interesting alternative to concentric exercise because it produces greater muscle force through its lower metabolic cost. Eccentric exercise could allow patients with severe airflow limitation to perform prolonged exercise sessions with sufficient intensity to improve muscle function.

Nevertheless, a recent study performed in healthy young subjects reported that eccentric exercise induced a more hyperpneic breathing pattern (i.e., lower tidal volume and higher breathing frequency) that concentric for a given minute ventilation.

The main objective of CONvEX study is to compare ventilatory adaptation between two modalities of exercise performed on cycle ergometer (concentric versus eccentric) in severe COPD patients.


title: A Comparative Pharmacokinetic Study in Healthy Volunteers to Evaluate the Ability of TURMIPURE GOLD Formulation to Enhance the Bioavailability of Curcuminoids

acronym: TURBIO

summary:
The rhizome of Curcuma longa (turmeric) is commonly used as a spice and for its medicinal properties traditionally in Asian countries. Turmeric extract usually contains 95% curcuminoids with a specific ratio (approximately 75-80% curcumin, 15-20% demethoxycurcumin (DMC), and 0-10% bisdemethoxycurcumin (BDMC)).

Curcuminoids have higher solubility in organic solvents than in water. As a consequence, curcuminoids have low aqueous solubility and poor gastrointestinal absorption. They also exhibit rapid metabolism and systemic elimination and are therefore known to have limited bioavailability, which limits the use of turmeric extract in general health care and as an adjunct in managing various diseases. In order to improve the bioavailability of curcumin, several approaches have been undertaken. The use of adjuvant like piperine that interferes with glucuronidation; liposomal curcumin, nanoparticles, phospholipid complex; and structural analogues of curcumin.

Recently, Naturex has developed a dried emulsion formulation using a turmeric extract mixed together with a quillaja extract, sunflower oil and arabic gum. This formulation is highly dispersible in water and should therefore improve the bioavailability of curcuminoids. The aim of this study is to assess the bioavailability of curcuminoids and their metabolites after oral intake of 4 turmeric extract-based formulations in comparison to a standard unformulated turmeric extract.

ReferenceCitation: Fança-Berthon P, Tenon M, Bouter-Banon SL, Manfré A, Maudet C, Dion A, Chevallier H, Laval J, van Breemen RB. Pharmacokinetics of a Single Dose of Turmeric Curcuminoids Depends on Formulation: Results of a Human Crossover Study. J Nutr. 2021 Jul 1;151(7):1802-1816. doi: 10.1093/jn/nxab087.

lead_sponsor: Naturex SA

intervention_type: Dietary Supplement


title: High B Value Diffusion and Stroke

acronym: HBS

summary: This study will include 100 stroke patients with significant penumbra at the acute stage and successfully recanalized thanks to thrombectomy, intravenous thrombolysis or spontaneously. Patients will be explored with the multi-b diffusion sequence on a new 3T research magnet equipped with high gradient system. In this project the investigators hypothesize that diffusion MRI at high and ultra-high b-values could be sensitive enough to quantify selective neuronal loss in the rescued penumbra and to study its relationship with the initial hypoperfusion and its impact in terms of clinical recovery.

lead_sponsor: University Hospital, Bordeaux


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.

lead_sponsor: Hospices Civils de Lyon


title: Production et Perception émotionnelle Chez Les Patients paralysés Faciaux: Marqueurs Respiratoires, Phonatoires et expressivité Faciale.

acronym: ResPPF

summary:
Respiratory function, phonation and facial expressivity are related to emotional reaction through neurophysiological process. Specific emotional respiratory, vocal and facial patterns had been described in literature. Respiratory cycles variation is modulated by stimulus arousal. Furthermore, inspiratory-to-expiratory time ratio in abdominal area is modulated by emotional valence. Inextricably linked to respiration, vocal production depends on emotional arousal and valence too.

According to embodied cognition, the effector pattern of an emotion initiates the corresponding subjective activation. Facial recognition is influenced by automatic mimicry and facial feedback. Most facial feedback studies included patients with diplegia but few studies dealt with emotional perception in Bell's palsy.

The aim of the present study is to understand production and perception of emotion in Bell's palsy with respiratory, vocal and facial markers. What impact lack of mimicry have on physiological emotional reaction in Bell's palsy? To this end, prospective monocentric study will be conducted with 60 patients with Bell's Palsy from grade II to grade VI of House & Brackmann's scale. During production and perception of vocal and facial expression, respiratory rate and thoraco-abdominal movements will be analyzed. The investigators hypothesize that severity of facial deficit is negatively correlated with variation of respiratory cycles, lower segmental and suprasegmental changes during vocal expression, and lower facial perception (congruency and arousal).

primary_purpose: Screening

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

location_facility: Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation


title: Effect of Administration of 3rd Generation Cephalosporin (Ceftriaxone Versus Cefotaxime) on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (EB C3G-R)

acronym: CEF-IMPACT

summary: The aim of this study was to compare the frequency of occurrence of digestive carrying of 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R), acquired during hospitalization in one of the participating departments, between patients treated with ceftriaxone and patients treated with cefotaxime


title: Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery : a Prospective, Randomised, Double Blind Study

acronym: Plantar-block

summary:
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.

Sciatic popliteal nerve block is widely used despite the risk of falling due to prolonged motor blockade.

Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.

This study aims to determine the quality of deambulation following hallux valgus surgery.

Block quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.

Patients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited.

Consenting patients will be randomized the day of surgery to one of those two groups :

Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).
Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)

All patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously.

During PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption.

Temporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital.

Deambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet.

Pain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.

lead_sponsor: University Hospital, Montpellier


title: Non Invasive Evaluation of Muscle Hypoxia in Chronic Obstructive Pulmonary Disease Patient

acronym: EVANIMUS

summary:
Peripheral muscle oxidative function is altered in COPD(chronic obstrutive pulmonary disease) patients. Multiple factors could contribute to this dysfunction including chronic hypoxia and deconditioning (sedentarity).

The evaluation of mitochondrial function is based on invasive method (muscle biopsy and in vitro respirometry) or magnetic resonance spectroscopy limited to small muscle groups. Recently, a non invasive method has been described using Near InfraRed Spectroscopy (NIRS). During arterial occlusion, muscle deoxygenation is only dependent of local oxygen consumption. The time constant recovery (k) of the deoxygenation during repeated ischemia periods has been shown to be correlated to measurements of maximal mitochondrial capacity.

k is lower in COPD patients compared to smokers without bronchial obstruction. However, the influence of arterial hypoxia has never been studied precisely, no more than the confounding effect of deconditioning on k.

So , the aim is to compare k in COPD patients with chronic hypoxemia (treated with long term oxygenotherapy, LTOT+ group) and patients without hypoxia, matched for their physical activity (LTOT- group).

The hypothe is that k will be lower in LTOT+ group compared to LTOT- group and that short term O2 supplementation will improve it, which would suggest a muscle hypoxia. By contrast, O2 should not influence k in LOT- group, in whom it is mainly determined by muscle conditioning.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Phase I/II Study of the Decrease of Length of Stereotactic Body Radiation Therapy in the Treatment of Stage IA - IB Non Small Cell Lung Cancer (T1N0M0 or T2aN0M0)

acronym: PNEUMOFRAC

summary:
Purpose :

Non small cell lung cancer (NSCLC) is among the most common cancers in the werstern world. Patients with stage I have the most satisfactory outcomes. The gold standard for treatment is still surgery, but this approach has recently been challenged by hypofractionnated stereotactic body radiation therapy (SBRT). Therefore, for patients who are not eligible for surgery due to their significant co-morbidity, or for those who refuse surgical resection, stereotactic radiotherapy is an efficient practical alternative. SBRT is well tolerated and efficient, in fact local control rate at 3 years reaches more than 90%. Most of guidelines recommand a dose between 48 and 60 Gy delivered in 3 at 8 fractions and 3 weeks. Biological effect depends on the dose distribution in time and decreases when the number of fractions or length of radiation treatment increase. Decreasing the length of treatment and the interval between fractions may improve efficiency of treatment and local control rate. Moreover, it may improve quality of life of patients. Nevertheless, an evaluation of safety of such shorter treatment course, with a phase I-II clinical study is needed.

lead_sponsor: Centre Paul Strauss

intervention_type: Radiation


title: Interest of Clomiphene Citrate (CC) Associated With a Second Testicular Sperm Extraction (TESE) in Patients With Non-obstructive Azoospermia (NOA) After Failure of a First TESE, on the Quantity of Sperm Cells Available for Intracytoplasmic Sperm Injection (ICSI). Randomized Double Blind Trial Versus Placebo.

acronym: CLOMINOA

summary:
In the absence of sperm in the semen (azoospermia), there is no chance of natural paternity. It is found in about 1% of men and is either due to an obstruction of the seminal tracks (obstructive azoospermia (OA)) in 1/3 of the cases, or a spermatogenic failure (non-obstructive azoospermia (NOA)) in 2/3 of the cases. To date, no medical treatment had proved its efficiency to induce spermatogenesis in case of NOA.

The development of Intracytoplasmic sperm injection (ICSI) in 1992 allowed to obtain pregnancies from a small number of spermatozoa. The next year, testicular sperms were extracted from testicular tissue obtained surgically in cases of OA , allowing paternity for azoospermic men. In case of NOA, TESE allowed to obtain few sperms in an unexpected number of cases. It was shown that spermatogenesis remains active in rare portions of seminiferous tubules, a phenomenon called focal spermatogenesis, which allows to extract testicular sperms with an average SRR of 50%, and to obtain pregnancy by ICSI. Thus, TESE-ICSI revolutionized the prognosis of NOA, however, half of the cases of NOA had no sperm extracted and remained sterile . Since sperm donation and adoption are unacceptable for several of these couples, there is a real demand for additional treatment.

Two ways to improve chances of paternity in case of NOA are currently discussed:

Proceed to a second attempt of TESE. Since the first attempt could have missed a focus of active spermatogenesis, the chance for a positive second TESE is not null even. Reviewing the few articles published on this issue , the SRR for the second attempt, after a first negative attempt averaged 25%.
Based upon the decrease of testosterone production within the testis in case of NOA and the potential increased of the focal spermatogenesis by gonadotropins, few reports of hormonal therapy in case of NOA have been published and suggested a positive effect of hormonal therapy.

This prompted us to develop this clinical trial to investigate the effect of Clomiphene Citrate versus placebo on the results of a second TESE in NOA.

Results of hormonal therapy in case of NOA were heterogeneous and of poor methodological quality, none was randomized versus placebo: Anti-aromatases or Gonadotropins administered before the first TESE or the second TESE gave positive results. Hussein at al in 2013, suggested a positive effect of Clomiphene citrate (CC), administrated before the first TESE (57% of the CC treated group versus 33.6% in not treated group) but with drop out of patient positive to sperm analysis. However, in these positive studies, sample sizes were small or selected patients on hormonal status or histology criteria suggesting subgroup of favourable NOA. Thus, there is no strong evaluation of the interest of hormonal treatment in NOA, after a negative first TESE.

The investigators decided to evaluate the effect of the CC, the most convincing and convenient hormonal treatment, in patients with negative first TESE for NOA. It is of main interest to known if CC could enhance the SRR of a second TESE, that is the ultimate possibility to have their own child for these patients.

status: Not yet recruiting

location_facility: Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant


title: Assessment of Self-esteem According to the Practice of a Sport Activity in a Population of Adults Living With HIV

summary:
Adapted athletic activity has shown benefits in patients with certain chronic diseases, including improving fatigue and pain in patients with cancer, and improving the symptoms of severe depression.

Among Patients Living with Human Immunodeficiency Virus (PLHIV), sport appears to be less common than for people who do not live with HIV. In fact, 44% of PLHIV in a Swiss cohort (10,500 patients) were inactive in 2014, whereas this percentage was 26% in the general population in Switzerland. We did not find any French data on the prevalence of sports activity among PLHIV.

The benefits of sport in PLHIV are numerous: meta-analyzes on interventional studies of aerobic and resistance exercises show a significant improvement in maximum oxygen consumption, muscle strength, percentage of body fat, quality of life and symptoms of depression. An improvement in cognitive function was noted in a randomized study. An Iranian randomized study of 2017 showed an improvement in the CD4 count, after 8 weeks of resistive exercise, but two meta-analyzes of 2016 and 2017 did not find a significant change in CD4 or viral load with physical exercise.

On the other hand, several studies have shown that sports practice improves self-esteem. In addition, an Australian randomized study in 2006 showed an improvement in self-efficacy in PLHIVs after a six-month exercise (aerobic and resistance) program. Furthermore, self-esteem (defined as positive self-esteem) is a factor facilitating adherence to antiretroviral therapy.

The objective of this descriptive study is to evaluate the prevalence of sports activity in a French adult population infected with HIV and to seek an association with self-esteem. In addition, the investigators will look for an association between sport and fatigue, pain, sleep, lymphocyte T CD4 cell levels, viral load.

lead_sponsor: Centre Hospitalier le Mans


status: Active, not recruiting

acronym: RITUXGOPRO

title: Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis

source: euctr

ReferenceCitation: Guillevin L, Pagnoux C, Karras A, Khouatra C, Aumaître O, Cohen P, Maurier F, Decaux O, Ninet J, Gobert P, Quémeneur T, Blanchard-Delaunay C, Godmer P, Puéchal X, Carron PL, Hatron PY, Limal N, Hamidou M, Ducret M, Daugas E, Papo T, Bonnotte B, Mahr A, Ravaud P, Mouthon L; French Vasculitis Study Group. Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med. 2014 Nov 6;371(19):1771-80. doi: 10.1056/NEJMoa1404231.

ReferenceCitation: Specks U, Merkel PA, Seo P, Spiera R, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Fessler BJ, Ding L, Viviano L, Tchao NK, Phippard DJ, Asare AL, Lim N, Ikle D, Jepson B, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh K, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Mueller M, Sejismundo LP, Mieras K, Stone JH; RAVE-ITN Research Group. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med. 2013 Aug 1;369(5):417-27. doi: 10.1056/NEJMoa1213277.

ReferenceCitation: Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U; RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221-32. doi: 10.1056/NEJMoa0909905.

ReferenceCitation: Jones RB, Tervaert JW, Hauser T, Luqmani R, Morgan MD, Peh CA, Savage CO, Segelmark M, Tesar V, van Paassen P, Walsh D, Walsh M, Westman K, Jayne DR; European Vasculitis Study Group. Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med. 2010 Jul 15;363(3):211-20. doi: 10.1056/NEJMoa0909169.

ReferenceCitation: Samson M, Puéchal X, Devilliers H, Ribi C, Cohen P, Bienvenu B, Ruivard M, Terrier B, Pagnoux C, Mouthon L, Guillevin L; French Vasculitis Study Group (FVSG). Long-term follow-up of a randomized trial on 118 patients with polyarteritis nodosa or microscopic polyangiitis without poor-prognosis factors. Autoimmun Rev. 2014 Feb;13(2):197-205. doi: 10.1016/j.autrev.2013.10.001. Epub 2013 Oct 23.

summary: The purpose of the study is to determine wether a rituximab-based treatment compared to standard therapy (glucocorticoid alone) in patients with microscopic polyangiitis without any bad prognosis marker increases the remission and reduces the relapse free survival rate.


title: Analysis of the Nasal Mucosal Immune Response in HIV Infection

acronym: HYSOPE

summary: The principal objective is to define and compare the viral reservoir, mucosal immune responses and the microbiota of different HIV infection stages; viremic, aviremic (under treatment), natural elite controllers; The secondary objective is to compare the mucosal immune response and microbiota of HIV patients with the healthy control population of Milieu Interieur;

ipd_sharing_description: Data will be entered electronically via a web browser in Electronic Case Report Form Data will be analysed by Pasteur Institute of Paris with the biological results


title: Association Between Toe-brachial Index and Coronary Calcification in Asymptomatic Patients With Type 1 and Type 2 Diabetes Mellitus

acronym: ACCoDiab

summary:
Diabetes is not a coronary risk equivalent, despite cardiovascular disease is the most common cause of death in diabetes. So, to identify diabetic patients at high cardiovascular risk is necessary. Coronary artery calcification score predicts major coronary events, and improves risk reclassification in asymptomatic diabetic patients. But, cornary artery calcification score is expensive and exposes patients to radiation. So, it cannot be used for large-scale screening. It could be interesting to identify the predictive factors of coronary artery calcification score.

Toe-brachial index is relevant in diabetic patients for the screening of peripheral arterial disease, and predicts cardiovascular events.

The aim of this study is to evaluate the association between toe-brachial index and coronary artery calcification score in asymptomatic patients with type 1 or 2 diabetes. The hypothesis is that toe-brachial index is associated with high coronary artery calcification score. It could be performed first to identify patients who require a coronary artery calcification score. It measurement is reliable, fully automated, repoducible ans cost-effectiveness.

This is a cross-sectional study, with restrospective data collection. All patients addressed to a one-day hospitalization to assess cardiovascular comorbidities are eligible.

Data are collected in patients'medical records. Clinical, biological and imaging data were collected previously during their one-day hospitalization

location_facility: Diabetology department, Pitié-Salpêtrière hospital


title: Evaluation of a Physical Activity Programme Using an Intelligent Electric Bike for Health in Healthy Volunteers.

summary:
The walk and bike practice are two physical activities the most cited for benefits of physical activity thanks to their progressive and soft characters adapted to patients suffering from chronic diseases (diabetes, obesity, cancer...) with muscular deficit cardio-respiratory.

However, cycling may, depending on the natural land, imply efforts and articular-muscular-tendon pressions more important particularly in hilly natural land.

Moreover, lots of physical and physiological barriers oppose to the bike practice in the population of patients with chronic diseases. The electric bike can be useful.

This electric bike will be powerful but safe, totally programmable to adapt to patients, slope, rehabilitation objectives but very easy to use.

From medicine, it is necessary to ensure a moderate and regular effort regarding patients.

To do this, it is necessary to individualize adjustments of electric bike to have a progressive rehabilitation program and a progressive load force.

It needs to dispose monitoring and evaluation tools in real situations outside (lots of physiological and technical sensors). The intelligent electric bike for health proposes to be in accordance to this specifications.

ReferenceCitation: Pavey TG, Anokye N, Taylor AH, Trueman P, Moxham T, Fox KR, Hillsdon M, Green C, Campbell JL, Foster C, Mutrie N, Searle J, Taylor RS. The clinical effectiveness and cost-effectiveness of exercise referral schemes: a systematic review and economic evaluation. Health Technol Assess. 2011 Dec;15(44):i-xii, 1-254. doi: 10.3310/hta15440. Review.

ReferenceCitation: Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A; American College of Sports Medicine; American Heart Association. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1081-93. Epub 2007 Aug 1.

ReferenceCitation: Peterman JE, Morris KL, Kram R, Byrnes WC. Pedelecs as a physically active transportation mode. Eur J Appl Physiol. 2016 Aug;116(8):1565-73. doi: 10.1007/s00421-016-3408-9. Epub 2016 Jun 14.

ReferenceCitation: Gojanovic B, Welker J, Iglesias K, Daucourt C, Gremion G. Electric bicycles as a new active transportation modality to promote health. Med Sci Sports Exerc. 2011 Nov;43(11):2204-10. doi: 10.1249/MSS.0b013e31821cbdc8.

ReferenceCitation: Welker J, Cornuz J, Gojanovic B. [Electrically assisted bicycles: health enhancement or "green" gadget?]. Rev Med Suisse. 2012 Jul 25;8(349):1513-7. French.

lead_sponsor: Laboratoire TIMC-IMAG


title: Markers of Microvascular Lesion in Adult Patients With Acquired Sudden Cochelo-vestibular Deficiency

acronym: SSNHL

summary: The roles of thrombophilia and cardiovascular risk factors in sudden sensorineural hearing loss (SSNHL) remain controversial. Cochlear micro-thrombosis has been hypothesized as a possible pathogenic mechanism of SSNHL. The objective was thus to measure the levels of markers of macrovascular thrombosis and microvascular risk factors

ReferenceCitation: Callebert J, Esteve JM, Hervé P, Peoc'h K, Tournois C, Drouet L, Launay JM, Maroteaux L. Evidence for a control of plasma serotonin levels by 5-hydroxytryptamine(2B) receptors in mice. J Pharmacol Exp Ther. 2006 May;317(2):724-31. Epub 2006 Feb 3.

ReferenceCitation: Brand T, Anderson GM. The measurement of platelet-poor plasma serotonin: a systematic review of prior reports and recommendations for improved analysis. Clin Chem. 2011 Oct;57(10):1376-86. doi: 10.1373/clinchem.2011.163824. Epub 2011 Aug 22. Review.

ipd_sharing_description: it will be decided at completion of patient recruitement

lead_sponsor: Hopital Lariboisière


title: Pathophysiological Study of Central Sleep Apnea in Adults With Preserved LVEF

acronym: PHENOSAX

summary: Sleep apnea is classically divided into obstructive and central apnea, according to the persistence or otherwise of respiratory movements and the existence or not of pharyngeal collapse during apnea. However, there is evidence to suggest that some mechanisms are common to both types of apnea. Although the pathophysiology of obstructive apnea has been the subject of much work and now seems fairly well known, there is much less data on central apnea. These apneas can occur in different comorbid contexts. They are more frequently present in patients with heart failure, regardless of the etiology, and are associated with an adverse prognosis. The investigators hypothesize that the physiopathology of adult central apnea syndrome involves, in addition to ventilatory control abnormalities, upper airway abnormalities (VAS). The objective is to study the pathophysiology of central SAS, by first comparing the collapse of VAS of central apneic patients to those of patients with simple snoring or obstructive sleep apnea. In a second step, the investigators will analyze the cardiorespiratory coupling and will establish a map of the respiratory neural network in patients with central apnea. The investigators will focus their study on patients with central SAS (with preserved systolic heart function) due to the epidemiology of SAS.