title: Comparison of Gripstrength Assessment Between the Gripwise® and JAMAR® Dynamometers in Elderly Inpatients

acronym: HANDGAGES

summary:
It is recommended to screen ageing patients for sarcopenia, due to the increased risk of morbimortality if detected positive. According to the consensus of the European Working Group on Sarcopenia in Older People, the diagnosis of sarcopenia is based, among other things, on grip strength measurement.

Our study will compare the performance of the new GRIPWISE digital device with the mechanical dynamometer JAMAR, the gold standard currently used to assess the grip strength. We propose to evaluate it in an elderly hospitalized population where the prevalence of sarcopenia is likely to be high due to the high prevalence of various chronic illness, notably oncological and cardiological ones.

This cross-sectional study will include 348 patients.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Caen


title: Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery: a Pilot Study

acronym: SPECKLETHO

summary:
In postoperative thoracic surgery (lobe resection, pneumonectomy or wedge resection), cardiovascular complications are the most frequent (10 to 15%) with a significant morbi-mortality rate. Right ventricular (RV) dysfunction is a complication that can be multifactorial in post thoracic surgery. The RV longitudinal shortening fraction (RV-LSF) is a new 2D-STE parameters able to more accurately detect patients with RV dysfunction compared to conventional echocardiographic parameters.

This project is a single-center, prospective, interventional study of patients hospitalized at the Amiens University Hospital for scheduled thoracic surgery. TTE is performed preoperatively, at day 2 and day 15 following the thoracic surgery. Echocardiographic parameters will be measured by an echocardiographic expert in offline with a dedicated software. MACE criteria will be collected at day 2, day 15 and day-30 following the thoracic surgery.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Macintosh Blade Size During Laryngoscopy for Endotracheal Intubation. A Prospective Observational Study.

acronym: MacSize

summary: Endotracheal intubation is a frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital) but optimal Macintosh blade size remains unknown to date.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Device


title: Choice And Real Experience of Therapeutic deEscalation in Women Over 70 Year With Breast Cancer (CARTE)

acronym: CARTE

summary:
Standard treatment for women with early breast cancer (HR+, HER2-, T1N0) consists of the removal of the tumor from the breast by surgery with or without chemotherapy, followed by a whole-breast radiation therapy (usually one radiation treatment a day, five days a week, for 3 to 6 weeks)

In some cases, for elderly patients older than 70 years with other associated pathologies, therapeutic de-escalation might be proposed in order to reduce the radiation doses received. Two options can be considered:

Intraoperative radiotherapy: radiation is delivered in a single dose directly to the tumor bed during the surgery.
Radiotherapy omission

These three treatment options (whole-breast radiation therapy, Intraoperative radiotherapy or -Radiotherapy omission) have advantages and disadvantages. Intraoperative radiotherapy allows a targeted treatment and avoids several weeks of daily radiation. Radiotherapy omission prevents acute or late toxicities of the radiotherapy, as well as the constraints of daily travel over a period of 3 to 6 weeks.

The aim of this trial is to offer patients aged 70 and over with early breast cancer, after surgery, these three treatment options and to study the choice and experience of treatment by patients. This study will assess the reasons that prompted patients to choose one of the three treatment options, the impact of medical and personal characteristics on this choice and the experience of therapeutic de-escalation as well as its effects, in particular on the course of care.

This assessment will be carried out with self-administered questionnaires before and after the choice of treatment.

In addition, to standardize the information given to patients in order to support them in their treatment choice and promote patient involvement in treatment decision-making, an encounter decision aid will be available for the patients. This encounter will detail the advantages and disadvantages of the three treatment options and will help in discussions with the physicians to determine the best choice of treatment.

primary_purpose: Treatment

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

intervention_type: Radiation

lead_sponsor_type: industriel


title: Effects of Large Tidal Volumes Despite Minimal Inspiratory Support in Spontaneously Ventilated Intubated Resuscitation Patients. Pathophysiological Exploratory Study.

acronym: InLarge

summary:
Some ICU ventilated patients might present with large tidal volume despite very low or inexistant presser support. Patient-Self Inflicted Lung Injury (P-SILI) might appear related with large alveolar stretch an distension. Two clinical presentations are observed: patients with or without respiratory distress signs such as supra-clavicular depression and thoracic-abdominal asynchronies.

The aim of this study is to compare the pulmonary physio(-patho)logical parameters of these two types of patients (eupneic or with respiratory distress signs), and presenting important TV in spite of a minimal adjustment of the ventilatory support, except for Acute Respiratory Distress Syndrome (ARDS).


title: How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolve According to Propulsion: Control With Each mm of Advancement"

acronym: OAMMM

summary:
The OAMMM study is a mono-centrer , non interventional, prospective study, carried out in CH Valence

Oral Appliance is indicated for first line moderate sleep Apnea Syndrome or severe sleep Apnea Syndrome after failure of positive airway pressure (CPAP).

Clinical impact of each mm advancement of Oral Appliance is imperfectly assessed.

The study aim to assess clinical and paraclinical efficacy of an oral Appliance on each mm of advancement.

lead_sponsor: Centre Hospitalier de Valence

intervention_type: Behavioral


title: Evaluation of a Combined Analysis of Serum and Cerebrospinal Fluid Inflammatory Biomarkers to Help in Etiological Diagnosis of Central Nervous System Autoimmune Diseases

acronym: CyBIRD

summary:
Project rationale:

Since 2017, multiple sclerosis diagnosis should match the new McDonald criteria in which a "no better explanation than MS" should be fulfilled. However, many patients present with red flags that lead to a complex diagnostic work-up. There are no available biomarkers that permit to confirm or roll out MS diagnosis in such cases. Therefore, we lack biological markers that can help in the diagnosis of patients presenting with suspected MS.

Many studies have found that serum and cerebrospinal fluid (CSF) cytokines could help to differentiate MS from other diseases such as neuromyelitis optica spectrum disorders (i.e., IL-6) or neurosarcoidosis (i.e., sIL-2R). Serum and CSF kappa free light chains have also shown good diagnosis performance in MS. In daily practice, our MS tertiary center already perform the analysis of CSF concentrations of IL-1β, sIL-2R, IL-6, IL-10, and serum and CSF kappa and lambda free light chains to roll out other central nervous system (CNS) autoimmune diseases in patients presenting with white matter hyperintensities (WMH).

Objective:

To correlate CSF IL-1β, sIL-2R, IL-6, IL-10, serum and CSF kappa and lambda free light chains with the final diagnosis in patients presenting to our MS tertiary center with suspected MS to identify a specific inflammatory biomarker profil involved in MS and other CNS autoimmune diseases.

The methodology:

This is an observational study. All patients ongoing a routine diagnostic work-up for suspected MS from june 2020 to june 2022 in our MS tertiary center will be analyzed. Cerebrospinal fluid IL-1β, sIL-2R, IL-6, IL-10, serum and CSF kappa and lambda free light chains will be correlated with the final diagnosis to ultimately find MS associated biomarkers.

time_perspective: Retrospective

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Biological


title: EXPRESON-INTRA : Intracerebral Recordings of P3a Responses to Own-names Uttered by Expressive and Neutral Voices in Pharmacoresistant Epilepsy Adult Patients

acronym: EXPRESON-IN

summary:
Neurophysiologic evaluation of disorders of consciousness (DOC) patients in intensive care unit include late auditory evoked potentials. It allows the physicians to record cerebral responses of patients to auditory stimuli and in particularly to their own name (as the P3a response). Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm and notably using more expressive stimuli.

Here the investigators investigate the intracerebral correlates of the P3a responses recorded on the scalp with neutral and more expressive stimuli.

status: Active, not recruiting

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier St Anne


title: Impact of Von Willebrand Factor and Its Multimers on Angiogenesis

acronym: WILLANGIO

summary: The study aims to study the expression of numerous proteins involved in angiogenesis in 70 patients with von Willebrand disease in order to try to identify markers of interest. Secondly, the investigators plan to investigate whether there is a relationship between the proteins tested, the distribution of multimers and the clinical phenotype of the patients, in particular by looking for the presence of bleeding linked to the presence of angiodysplasias.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Nantes University Hospital


title: Evaluation of the Pronostic Value of Vascular Refilling Rate on Mortality in Chronic Kidney Disease Patients on Dialysis (Stage 5D)

acronym: REMVAMIR

summary:
Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) during an observational period of 3 years:

the prognostic value of vascular refilling rate on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number
the prognostic value of interdialytic weight gain on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number
the prognostic value of perdialytic weight loss on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


type: Other Identifier

title: Towards Participatory Paediatric Asthma Action Plans

acronym: PACAP

summary: Asthma is the most common chronic disease in children. The management of asthma attacks at home is based on asthma action plans that are very heterogeneous and reflect the diversity of recommendations on this subject. The purpose of this study is to observe using smartinhalers how children and their families use their emergency treatment at home in case of asthma symptoms and asthma attacks, to allow building new recommendations based not only on the literature, but also on real-world data.

ReferenceType: background

ReferenceCitation: Marguet C, Michelet I, Couderc L, Lubrano M. [Management of acute asthma exacerbation in childhood: French recommendations]. Arch Pediatr. 2009 Jun;16(6):505-7. doi: 10.1016/S0929-693X(09)74046-1. French.

ReferenceCitation: Pinnock H, Parke HL, Panagioti M, Daines L, Pearce G, Epiphaniou E, Bower P, Sheikh A, Griffiths CJ, Taylor SJ; PRISMS and RECURSIVE groups. Systematic meta-review of supported self-management for asthma: a healthcare perspective. BMC Med. 2017 Mar 17;15(1):64. doi: 10.1186/s12916-017-0823-7. Review.

ReferenceCitation: Heidi M, Emily K, Benjamin H, Michael C, Robert K, Mitch B, Chris G, Mando W, Andrew B. Patient reported outcomes for preschool children with recurrent wheeze. NPJ Prim Care Respir Med. 2019 Mar 26;29(1):7. doi: 10.1038/s41533-019-0120-3.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Comparison of the Accuracy of the Neurological Prognosis at 6 Months of Traumatic Brain Injury Between Junior and Senior Doctors.

acronym: PREDICT II

summary: PREDICT II is an observational, prospective design, single-center study aiming to determine whether the prognosis of neurological outcome at 6 months in patients undergoing traumatic brain injury established by a doctor at his initial management is more accurate in experienced doctors versus junior doctors.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

location_facility: Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière

status_simplified: Completed


title: Homemade Fenestrated Physician-modified Stent-grafts for Arch Aortic Degenerative Aneurysm

summary:
The aim was to evaluate early and medium-term outcomes of single and double fenestrated physician-modified endovascular grafts (PMEGs) for endovascular aortic arch degenerative aneursym repair.

The evolution of stent-graft technology recently has meant the development of custom-made branched stent-grafts to achieve total endovascular aortic arch repair for high-risks patients. The disadvantages of custom-made include manufacture and deliver times for urgent cases and the associated high costs. Unfortunately there is also a high rate of embolization associated with this approach probably related to the complexity of deploying a multi-branched unibody stent-graft. A further alternative is physician modified endografts (PMEGs) for zone 0 TEVAR involving the deployment of a conventional stent-graft device ex-vivo, fashioning of customized fenestrations (for supra aortic trunk) and re-constrainment into the delivery system. The authors have previously shown the feasability in vitro and they have reported their experience for arch aortic lesion. The aim of this study is to evaluate the outcomes for aortic arch degenerative aneursym repair which is the most risky procedure


title: Study of the Activity and Role of Notch1 Signalling in Glioma

acronym: GLIONOTCH

summary: The investigators showed in 2015 (Guichet et al) that the Notch1 pathway has an anti-proliferative role on glial brain tumors. In this project, the investigators investigated which genes downstream of Notch1 pathway activation produce the anti-proliferative effect. The investigators hypothesized that the SNAI2 and TAL1 genes act downstream of Notch1


title: Bio-collection for the Discovery of New Biomarkers for the Prediction of Cardiovascular Events

acronym: CDPA-Biobank

summary: The main goal of this project is to constitute a collection of biological samples, obtained through the clinical activity of the Centre for Screening and Prevention of Atherosclerosis at Toulouse University Hospital, managing patients in primary or secondary prevention for cardiovascular (CV) diseases. The main objective is to validate new biomarkers with prognostic value regarding the onset of future CV events. Besides, the biological collection will enable patho-physiological studies on atherosclerosis related diseases.

lead_sponsor: University Hospital, Toulouse


title: Evaluation of the Effect of Isonatremic (vs Conventional) Dialysis Treatment on the Control of Interdialytic Weight Gain in Chronic Kidney Disease Patients on Dialysis (Stage 5D)

acronym: DISON-IRC

summary:
Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of treatment with isonatremic dialysis (vs conventional dialysis), during an observational period of 2 months each, on:

control of interdialytic weight gain
perdialytic tolerance in terms of adverse events occurring during all of the sessions of the study
body composition and thirst measured monthly during the 4 months of follow-up.
tolerance to treatment.

intervention_type: Procedure


type: Registry Identifier

title: ANTIcoagulation in Severe COVID-19 Patients: a Multicenter, Parallel-group, Open-label, Randomized Controlled Trial

acronym: ANTICOVID

summary: Coronavirus disease 2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), may predispose patients to thrombotic disease due to a state of profound inflammation, platelet activation, and endothelial dysfunction leading to respiratory distress and increased mortality. The incidence of macrovascular thrombotic events varies from 10 to 30% in COVID-19 hospitalized patients depending on the type of arterial or vein thrombosis captured and severity of illness . Observational results in patients receiving routine low-dose prophylactic anticoagulation (LD-PA), several institutions have recently released guidance statement to prevent macrovascular thrombotic events with dose escalation anticoagulation. In these recommendations, high-dose prophylactic anticoagulation (HD-PA) and therapeutic anticoagulation (TA) can be employed either empirically or based on the body mass index and increased D-dimer values. No randomized trial has validated this approach, and other recent recommendations challenge this approach. Microvascular thrombotic events are also of major concern in critically ill patients with COVID-19, even in the absence of obvious macrovascular thrombotic events. A large review of autopsy findings in COVID-19-related deaths reported micro thrombi in small pulmonary vessels. More generally, COVID-19-induced endothelitis and coagulopathy across vascular beds of different organs lead to widespread microvascular thrombosis with microangiopathy and occlusion of capillaries. Thus, in severe COVID-19 patients requiring oxygen therapy without initial macrovascular thrombotic event, a HD-PA or a TA could be beneficial by limiting the extension of microvascular thrombosis and the evolution of the lung and multi-organ microcirculatory dysfunction. In a large observational cohort of 2,773 COVID-19 patients, a lower in-hospital mortality in ventilated patients receiving TA as compared to those receiving PA (29.1% vs. 62.7%). Our hypothesis is dual: i) first, that TA and HD-PA strategies mitigate microthrombosis and each limit the progression of COVID-19, including respiratory failure and multi-organ dysfunction, with in fine a decreased mortality and duration of disease, as compared to a low-dose PA; ii) second, that TA outperforms HD-PA in this setting.

design_allocation: Randomized

ipd_sharing_description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

intervention_type: Drug


title: Evaluation of Intubation Conditions With the Use of Atracurium After a Fixed Three-minute Delay

acronym: CINTROI

summary: The purpose of this study is to evaluate intubation conditions with the use of atracurium after a fixed three-minute delay

ReferenceCitation: Debaene B, Beaussier M, Meistelman C, Donati F, Lienhart A. Monitoring the onset of neuromuscular block at the orbicularis oculi can predict good intubating conditions during atracurium-induced neuromuscular block. Anesth Analg. 1995 Feb;80(2):360-3.

ReferenceCitation: Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808.

ReferenceCitation: Plaud B, Baillard C, Bourgain JL, Bouroche G, Desplanque L, Devys JM, Fletcher D, Fuchs-Buder T, Lebuffe G, Meistelman C, Motamed C, Raft J, Servin F, Sirieix D, Slim K, Velly L, Verdonk F, Debaene B. Guidelines on muscle relaxants and reversal in anaesthesia. Anaesth Crit Care Pain Med. 2020 Feb;39(1):125-142. doi: 10.1016/j.accpm.2020.01.005. Epub 2020 Jan 8.

location_facility: Service Anesthésie Réanimation Chirurgicale Hôpital Cochin


title: Neurovegetative Decoupling in the Visceral-brain Axis and Cognitive-emotional Vulnerability in Somatoform Disorders : Interest of Vagal Biofeedback

acronym: BIOFEESOMATO

summary: Evaluation of the physiological and clinical effects of the biofeedback training with patients suffering from somatoform disorders, depending on their neurovegetative profile related to a visceral-brain decoupling.

primary_purpose: Supportive Care

ReferenceCitation: Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65.

ReferenceCitation: Laborde S, Mosley E, Thayer JF. Heart Rate Variability and Cardiac Vagal Tone in Psychophysiological Research - Recommendations for Experiment Planning, Data Analysis, and Data Reporting. Front Psychol. 2017 Feb 20;8:213. doi: 10.3389/fpsyg.2017.00213. eCollection 2017. Review.

ReferenceCitation: Muller L, Spitz E. [Multidimensional assessment of coping: validation of the Brief COPE among French population]. Encephale. 2003 Nov-Dec;29(6):507-18. French.

ReferenceCitation: Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.

ReferenceCitation: Varon C, Morales J, Lázaro J, Orini M, Deviaene M, Kontaxis S, Testelmans D, Buyse B, Borzée P, Sörnmo L, Laguna P, Gil E, Bailón R. A Comparative Study of ECG-derived Respiration in Ambulatory Monitoring using the Single-lead ECG. Sci Rep. 2020 Mar 31;10(1):5704. doi: 10.1038/s41598-020-62624-5.

ReferenceCitation: de Vroege L, Emons WHM, Sijtsma K, van der Feltz-Cornelis CM. Psychometric Properties of the Bermond-Vorst Alexithymia Questionnaire (BVAQ) in the General Population and a Clinical Population. Front Psychiatry. 2018 Apr 23;9:111. doi: 10.3389/fpsyt.2018.00111. eCollection 2018.

ReferenceCitation: Bulut NS, Würz A, Yorguner Küpeli N, Çarkaxhıu Bulut G, Sungur MZ. Heart rate variability response to affective pictures processed in and outside of conscious awareness: Three consecutive studies on emotional regulation. Int J Psychophysiol. 2018 Jul;129:18-30. doi: 10.1016/j.ijpsycho.2018.05.006. Epub 2018 May 19.

ReferenceCitation: Schumann A, Köhler S, Brotte L, Bär KJ. Effect of an eight-week smartphone-guided HRV-biofeedback intervention on autonomic function and impulsivity in healthy controls. Physiol Meas. 2019 Jul 1;40(6):064001. doi: 10.1088/1361-6579/ab2065.

ReferenceCitation: Sarason IG, Johnson JH, Siegel JM. Assessing the impact of life changes: development of the Life Experiences Survey. J Consult Clin Psychol. 1978 Oct;46(5):932-46.

ReferenceCitation: Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70.

lead_sponsor: University Hospital, Grenoble


title: Outcome of Extremely Preterm Infants Who Received Systemic Postnatal Corticosteroid for Bronchopulmonary Dysplasia

acronym: DEPRECOD

summary: Bronchopulmonary dysplasia is a complication of prematurity. Postnatal corticosteroid is used to treat the inflammatory part of this pathology, in particular to wean premature infants from the ventilator at the end of the first month of life. However, this therapy remains controversial because it may induce suboptimal neurocognitive development. Parents of infants who receive postnatal corticosteroid should be provided with information about the risks. The objective of our work was to evaluate the respiratory, neurodevelopmental and growth outcomes at 24 months corrected age of extremely preterm infants who received postnatal corticosteroid.

lead_sponsor: Hospices Civils de Lyon


title: Bacteriological Evaluation of Spontaneous Otorrhea in Children

summary: After pneumococcal conjugate vaccine implementation, the number of acute otitis media (AOM) episodes has decreased, but AOM still remains among the most common diagnoses in childhood. From 2% to 17% of cases of AOM feature spontaneous perforation of the tympanic membrane (SPTM). The aim of this study was to describe the bacteriological causes of SPTM several years after PCV13 implementation, in 2010.

lead_sponsor: Association Clinique Thérapeutique Infantile du val de Marne


title: Post-Market Clinical Follow-up of WOVEX (Wovex® Polyester Vascular Prostheses) Bifurcated Prostheses From LEMAITRE VASCULAR Society in the Treatment of Aneurysms or Occlusive Diseases of the Abdominal Aorta

acronym: WOBIF

summary:
The Wovex bifurcated dacron vascular prostheses have been available on the French market since 2008. They are mainly used to treat aneurysmal or occlusive aortic diseases. To date, they have not been the subject of a specific clinical efficacy/safety study, unlike other Dacron prostheses used in the same field.

We purpose a monocentric, retrospective, consecutive study based on medical data, including all the patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between 2013 and 2017 and who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses).

The objective is to explore the safety (short-term postoperative morbidity and mortality at 5 years) and efficacy (primary permeability, secondary permeability and dilatation of the prosthesis at 5 years) of the WOVEX prosthesis.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia Through an Innovative Organizational Strategy

acronym: SePaRIC

summary: The project proposes to evaluate a strategy for prioritizing teleconsultation for patients with chronic inflammatory rheumatic diseases during the COVID-19 pandemia. This selection will be done through telephone contact by medical students, supervised by residents and rheumatologists on a patient database. The other objectives are to assess the impact of the pandemia on the physical and mental health of patients classified as being at risk

lead_sponsor: University Hospital, Limoges


title: Effects of Different Forms of Fatigue on Double-Task Performance in the Elderly

summary:
The dual task (walking and cognitive task at the same time) is increasingly used in geriatrics in protocols for detecting people who are falling and/or for highlighting cognitive disorders. However, frail elderly people tend to get tired quickly and a lack of awareness of the effects of fatigue on dual-task performance could alter the diagnosis.

There are two types of fatigue: mental fatigue and peripheral muscle fatigue. Each participant will do both types of fatigue over 2 appointments spaced by 7 days so that the subject can recover from induced fatigue. The sequence of fatigue tasks will be randomized.

At the first appointment (day 0):

Pre-fatigue assessment :

The subject must walk on 10m with round trip for 1min.
the subject must do the arithmetic count of 3 in 3
Then comes the evaluation in double task (walking and counting at once for 1min). The subject must walk on 10m with round trip for 1min by doing the arithmetic count of 3 in 3 at the same time.
mental fatigue task or muscle fatigue task (randomized)
post-fatigue assessment (the same as pre-fatigue assessment)

7 resting days

Second appointment (day 7)

Pre-fatigue assessment :

The subject must walk on 10m with round trip for 1min.
the subject must do the arithmetic count of 3 in 3
Then comes the evaluation in double task (walking and counting at once for 1min). The subject must walk on 10m with round trip for 1min by doing the arithmetic count of 3 in 3 at the same time.
mental fatigue task or muscle fatigue task (randomized)
post-fatigue assessment (the same as pre-fatigue assessment)


title: Retrospective Study to Investigate Rotational Stability and Clinical Outcomes After Implantation of a Monofocal Toric Intraocular Lens (IOL)

summary:
This is a monocentric retrospective, open-label clinical study in patients after unilateral or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC and executed only with standard of care examinations.

The investigational device is CE approved. The investigational device and all study products, including the devices used for the study examinations, have been used within the intended use specifications from the manufacturer. In addition, there were no invasive or other burdening examinations.

The investigator is an accredited and experienced cataract surgeon and researcher.

The primary endpoint is to determine rotational stability in a minimum of 120 eyes of patients with PODEYE TORIC IOL implantation after cataract surgery. Patients will be enrolled for the documentation and evaluation of retrospective data up to 6 months postoperatively.

status: Enrolling by invitation

lead_sponsor: Beaver-Visitec International, Inc.

status_simplified: Unknown


title: Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children and Neonates Using Transthoracic Echocardiography

acronym: PREDIPEN

summary:
"Initial fluid resuscitation remains the first treatment step for most children experiencing circulatory failure and/or systemic hypotension. Only one-half of these patients respond to fluid administration by a significant increase in cardiac output. A positive fluid balance is a poor prognostic factor that increases mortality. There are few markers validated in children to assess volume reactivity by dynamic ultrasound parameters mainly based on heart-lung interaction.

In this work, we propose to investigate whether dynamic parameters validated in adults, such as the superior vena caval collapsibility and the variability of cardiac output during an end-expiratory and end-inspiratory occlusion, are also reliable indicators of volume responsiveness in sedated children under controlled-mode ventilation."


title: Comparison of Hemodynamic and Respiratory Parameters During Physical Activity Without Mask, With Surgical Mask and General Public

acronym: PAM

summary:
The COVID-19 pandemic has completely changed societal activity, including physical activity.

Recommendations for wearing masks vary from country to country, region to region, and may be mandatory or optional in indoor or outdoor environments.

During physical activities, the latest ministerial recommendations are that wearing a mask is not mandatory even in case of close distance of less than one meter and in case of physical contact (ministerial recommendations of September 19, 2020), even in regions where wearing a mask is mandatory outdoors. This is based on elements not explained by the Ministry of Sports and partly on elements showing a limitation of respiratory capacities during exercise tests with gas exchange measurements. Indeed, subjects with FFP2 masks have their maximal capacity to effort and VO2max decreased as well as the respiratory capacities whether at rest or during effort in comparison with subjects without mask and to a lesser degree with surgical masks.

However, the FFP2 mask is not recommended by the medical or sports authorities, and surgical or general public masks are recommended. Moreover, during leisure time physical activities, it is not frequent that the subjects need to be at their maximum physical capacity. This moderate loss of physical capacity at the peak of the effort is for most amateur athletes not relevant in their practice.

In addition, airborne transmission of COVID-19 has been shown in several studies: in a choir, on a commercial airplane, on a bus, and close contact is a secondary source of contamination.

There is concern that physical activity in non-open environments is becoming a source of COVID-19 contamination. In studies in non-open environments (bus, church, airplane), the degree of contamination in a so-called confined atmosphere varies between 35 and 85%. In Miller's study, in a church choir with a distance of 0.75 m between choristers and 1.4 m between each row, after 2.5 hours of rehearsal including breaks and buffet, without wearing a mask and with social distancing, hand washing with a hydro-alcoholic solution and reduction of contacts, the contamination with a single patient was 85% on a total of 61 choristers. One can imagine what the degree of contamination would be during a physical activity in a gymnasium without wearing a mask, even with hand and foot washing and floor decontamination.

Currently, all sports activities are stopped but they will start again sooner or later.

Before the recontainment, according to the directives of the Ministry of Sports, the wearing of masks was not compulsory and it was not recommended in outdoor activities (golf...) and in gymnasiums including activities with contact (judo, dance...). Many people are reluctant to wear a mask during sports activities: discomfort, fear of loss of performance, hypoxia...

However, it seems essential to us to determine, during a physical activity, what are the cardiac and respiratory consequences of wearing a surgical or general public mask, before resuming sports activities in a few weeks or months.

It seems important to us to determine the degree of deterioration of the cardiac and pulmonary physical capacities during physical leisure activities which concern more than 99% of the leisure activities as opposed to the sports activities practised by professionals, this to enlighten the practitioners and the ministerial authorities on the possible non-deterioration of the physical capacities with the effort and the absence of deleterious effect of the wearing of a mask.

primary_purpose: Other

ReferenceType: result

ReferenceCitation: Fikenzer S, Uhe T, Lavall D, Rudolph U, Falz R, Busse M, Hepp P, Laufs U. Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity. Clin Res Cardiol. 2020 Dec;109(12):1522-1530. doi: 10.1007/s00392-020-01704-y. Epub 2020 Jul 6.

family: Fikenzer

full_name: Sven Fikenzer

given: Sven

sequence: first

family: Uhe

full_name: T. Uhe

given: T.

sequence: additional

family: Lavall

full_name: D. Lavall

given: D.

family: Rudolph

full_name: U. Rudolph

given: U.

family: Falz

full_name: R. Falz

given: R.

family: Busse

full_name: M. Busse

given: M.

family: Hepp

full_name: P. Hepp

given: P.

family: Laufs

full_name: U. Laufs

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Research in Cardiology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Miller SL, Nazaroff WW, Jimenez JL, Boerstra A, Buonanno G, Dancer SJ, Kurnitski J, Marr LC, Morawska L, Noakes C. Transmission of SARS-CoV-2 by inhalation of respiratory aerosol in the Skagit Valley Chorale superspreading event. Indoor Air. 2021 Mar;31(2):314-323. doi: 10.1111/ina.12751. Epub 2020 Oct 13.

name: Mechanical Engineering University of Colorado Boulder CO USA

family: Miller

full_name: Shelly L. Miller

given: Shelly L.

name: Civil and Environmental Engineering University of California Berkeley CA USA

family: Nazaroff

full_name: William W Nazaroff

given: William W

name: Department of Chemistry and CIRES University of Colorado Boulder CO USA

family: Jimenez

full_name: Jose L. Jimenez

given: Jose L.

name: REHVA (Federation of European Heating, Ventilation and Air Conditioning Associations) BBA Binnenmilieu Den Haag The Netherlands

family: Boerstra

full_name: Atze Boerstra

given: Atze

name: Department of Civil and Mechanical Engineering University of Cassino and Southern Lazio Cassino Italy

family: Buonanno

full_name: Giorgio Buonanno

given: Giorgio

name: Edinburgh Napier University and NHS Lanarkshire Edinburgh UK

family: Dancer

full_name: Stephanie J. Dancer

given: Stephanie J.

name: REHVA Technology and Research Committee Tallinn University of Technology Tallinn Estonia

family: Kurnitski

full_name: Jarek Kurnitski

given: Jarek

name: Civil and Environmental Engineering Virginia Tech Blacksburg VA USA

family: Marr

full_name: Linsey C. Marr

given: Linsey C.

name: International Laboratory for Air Quality and Heath (ILAQH) WHO Collaborating Centre for Air Quality and Health School of Earth and Atmospheric Sciences Queensland University of Technology Brisbane Queensland Australia

name: School of Civil Engineering University of Leeds Leeds UK

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

repository_institution: University of Colorado Boulder - CU Scholar

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

title: Transmission of SARS‐CoV‐2 by inhalation of respiratory aerosol in the Skagit Valley Chorale superspreading event

ReferenceCitation: Moser MR, Bender TR, Margolis HS, Noble GR, Kendal AP, Ritter DG. An outbreak of influenza aboard a commercial airliner. Am J Epidemiol. 1979 Jul;110(1):1-6.

ReferenceCitation: Shen Y, Li C, Dong H, Wang Z, Martinez L, Sun Z, Handel A, Chen Z, Chen E, Ebell MH, Wang F, Yi B, Wang H, Wang X, Wang A, Chen B, Qi Y, Liang L, Li Y, Ling F, Chen J, Xu G. Community Outbreak Investigation of SARS-CoV-2 Transmission Among Bus Riders in Eastern China. JAMA Intern Med. 2020 Dec 1;180(12):1665-1671. doi: 10.1001/jamainternmed.2020.5225. Erratum in: JAMA Intern Med. 2021 May 1;181(5):727.

name: Department of Epidemiology and Biostatistics, University of Georgia College of Public Health, Athens

name: Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana

name: Ningbo Municipal Center for Disease Control and Prevention, Ningbo, China

name: Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China

name: Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California

name: Hangzhou Municipal Center for Disease Control and Prevention, Hangzhou, China

name: Health Informatics Institute, University of Georgia College of Public Health, Athens

name: Center for the Ecology of Infectious Diseases, University of Georgia, Athens

name: Renmin University of China School of Statistics, Beijing, China

name: Statistical Consulting Center, Renmin University of China, Beijing, China

name: Haishu Center for Disease Control and Prevention, Ningbo, China

name: Department of Health Care Administration, California State University Long Beach, College of Health and Human Services, Long Beach

name: Department of Clinical Epidemiology and Tobacco Dependence Treatment Research, Beijing Chaoyang Hospital, Beijing, China

name: Center for Applied Statistics, Renmin University of China, Beijing, China


title: Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Carcinoma

acronym: SARVADS 1

summary:
Sarcopenia is defined by the reduction in skeletal muscle mass and physical performance. It results in a decrease in muscle strength, overall physical activity, walking and the development of balance disorders and falls. It is one of the natural consequences of aging and contributes to frailty and the appearance of geriatric syndrome (s) (Chandapasirt et al, 2015; Cruz-Jentoft et al, 2010).

Its prevalence in patients with Head & Neck cancer is 39% (Hua et al, 2020) and is associated with an increase in postoperative complications (Achim et al, 2017; Bril et al, 2019), with greater toxicity of chemotherapy. (Wendrich et al, 2017) and reduced overall survival (Hua et al, 2020).

It is measured by CT scan (assessment of muscle volume with respect to L3 using IMAGE J software) (Teigen et al, 2018) and by clinical tests (performance tests) (Swartz et al, 2016, Cruz-Jentoft et al, 2010).

Several studies have shown a possible assessment of sarcopenia by measuring skeletal muscle mass with regard to C3 (Ufuk et al, 2019; Swartz et al, 2016).

This trial aims to evaluate the prevalence of sarcopenia in head and neck cancer evaluated by CT at C3.

lead_sponsor: Weprom

location_facility: Clinique Victor Hugo / Centre Jean Bernard


title: Emotions Recognition in Multiple Sclerosis

acronym: RECODE

summary: Through this study, a group composed of multiple sclerosis patients will be compared to a healthy volunteers group to determine if the positive emotions recognitions is preserved in the first group.

lead_sponsor: Lille Catholic University

intervention_type: Diagnostic Test


title: Effects of Sage Extracts on Cognitive Function During Aerobic Exercise in Healthy Individuals

summary: Extracts of sage have been reported to interact with central nervous system (CNS) mechanisms relevant to cognitive performance but, to date, no trial has clearly demonstrated the possible effects in healthy individuals in fatiguing conditions. The current study investigates the effects of this supplementation in healthy males and females versus placebo on cognition, heart rate and perceived exertion, during a fatiguing cycling exercise.

lead_sponsor: University of Burgundy

intervention_type: Dietary Supplement


title: Assessment of the Functional Impact of a Closed-loop Controlled Prehension Neuroprosthesis in Post-stroke Patients. PREHENS-STROKE

acronym: PREHENS-STROKE

summary: The aim of the PREHENS-STROKE study is to propose a functional replacement device to restore grip capacities in patients with hemiparesis after stroke, unable to actively open the hand to seize objects. The main objective is to evaluate the impact of the use of a self-controlled prehension neuroprosthesis on the ability to perform a standardized grasping task, consisting of grasping, relocating and releasing a glass (palmar grasp) or a spoon (key-pinch), compared to a condition without the use of the prehension neuroprosthesis.

primary_purpose: Health Services Research


title: Clinical Intuition for PRedicting Evolution in Sepsis in the Emergency Department - CIPRES-ED Study

acronym: CIPRES-ED

summary:
Sepsis is a syndrome involving infection and an abnormal systemic inflammatory response in the infected organism, resulting in organ dysfunction and possibly death. It is a major cause of hospital mortality. A large proportion of sepsis diagnoses are made in emergency departments. Early diagnosis and appropriate treatment have been shown to reduce mortality from this disease.

In a context of limited resources, it is therefore important to be able to quickly stratify patients presenting to the emergency department with a suspected infection into those who require rapid and intensive management because they are at risk of developing sepsis and septic shock and those who can be managed conventionally The objective of this study is to compare the clinical intuition of emergency room physicians and nurses with the qSOFA score to predict the clinical course of patients presenting to the emergency room with potential sepsis.

lead_sponsor: Centre Hospitalier le Mans


title: Interplay Between Immune and Metabolic Programs in Myelodysplastic Syndromes: Involvement in Leukemia Transformation and Therapeutic Targeting

acronym: IMET-MDS

summary: Myelodysplastic syndromes (MDS) are a pre-leukemic condition with an extremely poor prognosis despite current treatments that justify new therapeutic approaches. Various studies have described the potential involvement of both immune compartment and cellular metabolism in the pathophysiology of MDS. The aim of this study is to determine the specific immune and metabolic profiles of the different classes of MDS and to identify predictive markers of progression/survival/response to therapy.


type: EudraCT Number

title: An Ascending Dose Tolerability Study and Pharmacokinetic Assessment in Healthy Male and Female Volunteers After Single & Multiple Oral Administration of DF2755A

summary:
Primary objective:

•To evaluate the tolerability and safety of ascending single doses of DF2755A in healthy adultmale and female volunteers.

Secondary Objectives:

To determine the pharmacokinetics parameters of DF2755A
To establish a dose concentration-response relationship over a wide range of doses in order toselect a narrower range of dose and dosing regimen to be subsequently studied in patients aftersingle administration
To evaluate the effect of ascending single doses on the pharmacodynamics parameters
To compare metabolites pathway in Human with the one observed in animals

lead_sponsor: Dompé Farmaceutici S.p.A


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

acronym: CombHADom

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

The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated. A cost-benefit analysis will be done to compare hospital-at-home programme and classical day hospitalization.

lead_sponsor: Centre Hospitalier de PAU


title: Hemodynamic Effect of Alveolar Recruitment Manoeuver Through Stepwise Increase and Decrease in Irway Pressure or Sustained 30 Secondes 30 cmH2O Continuous Positive Airway Pressure. A Randomized Study.

summary: Objective: to compare the effect of alveolar recruitment manouver through stepwise increase and decrease in airway pressure or sustained 30 secondes 30 cmH2O continuous positive airway pressure on cardiac stroke volume estimated by oesophageal doppler in preload independent anesthetized patients scheduled for surgery.

lead_sponsor: University Hospital, Caen


title: To Compare Anatomical and Functionnal Outcomes in Patients Undergoing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling

acronym: ERMP&ILM

summary: To study and compare visual acuity in patients undergoing removal of the epiretinal membrane with and without the removal of the internal limiting membrane at baseline versus 6 month.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Optimization of the Self-exclusion Procedure

acronym: OSE

summary:
It has been shown that self-excluded gamblers are very heavy gamblers, and that it is not possible to distinguish between those who report self-exclusion for addictive reasons and those who self-exclude for commercial reasons, which strongly suggests that all self-excluded people are "self-diagnosed" problem gamblers. Several studies converge in recognizing self-excluded people as problem gamblers who have lost control of their gambling and are seeking to protect themselves by taking action, self-exclusion, to change their behaviour and protect themselves.

Several reviews of the literature on interventions for problem gamblers have recently identified self-exclusion as an intervention for problem gamblers.

However, the effectiveness of the current self-exclusion system appears to be limited, particularly for short self-exclusions and for heavier gamblers.

Considering that self-exclusion is an intervention for and by people who have developed a gambling disorder, it currently consists exclusively of a behavioural intervention, in the sense that it prevents the behaviour. It would then be possible to optimize this intervention by enriching it with other components that have been shown to be effective with problem gamblers or in other addictions: a brief intervention including a motivational, cognitive approach, personalized normative feedback, referral to online help services (cresus and gambling infoservice), and repeated contact to suggest an extension of the self-exclusion period without having to return to the gambling environment. We hypothesize improved efficacy as measured by reduced gambling for longer after an initial optimized self-exclusion compared to self-exclusion with the standard procedure. Days will be randomized according to an a priori randomization list, not players.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Hemodynamic-guided Fluid Balance Neutralization During Continuous Renal Replacement Therapy in Critically Ill Patients: the GO NEUTRAL Randomized Controlled Multi-center Study

acronym: GO-NEUTRAL

summary:
Fluid overload is associated with increased mortality in critically ill patients with acute kidney injury. Fluid balance controlled is associated with improved outcome in observational studies, and is deemed safe in interventional trials.

The objective of the study is to keep fluid balance neutral by matching the net ultrafiltration rate to fluid inputs in patients with vasoplegia, and treated with continuous renal replacement therapy (CRRT), while insuring its security using advanced hemodynamic monitoring with continuous cardiac output monitoring.

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


title: Study of Somatosensory Responses During Millimeter Waves Application (RESOM)

acronym: RESOM

summary: The brain activity induced by a sensory stimulus and measured by magnetoencephalography will be compared before and after exposure to millimeter waves. We hypothesize that brain activity is modified after exposure to millimeter waves. The neuromodulatory effects of millimeter waves may lead to future development on therapeutic management in anxiety and pain.

ReferenceCitation: Fioravanti C, Kajal SD, Carboni M, Mazzetti C, Ziemann U, Braun C. Inhibition in the somatosensory system: An integrative neuropharmacological and neuroimaging approach. Neuroimage. 2019 Nov 15;202:116139. doi: 10.1016/j.neuroimage.2019.116139. Epub 2019 Aug 30.

ReferenceCitation: Radzievsky AA, Gordiienko OV, Alekseev S, Szabo I, Cowan A, Ziskin MC. Electromagnetic millimeter wave induced hypoalgesia: frequency dependence and involvement of endogenous opioids. Bioelectromagnetics. 2008 May;29(4):284-95.

ReferenceCitation: Rojavin MA, Ziskin MC. Electromagnetic millimeter waves increase the duration of anaesthesia caused by ketamine and chloral hydrate in mice. Int J Radiat Biol. 1997 Oct;72(4):475-80.


title: Optimisation of Potential Dental Implant Sites Protection for Rehabilitation in Patients With Head and Neck Cancer: Impact of Virtual Implants Visualisation on Dosimetry (OPPIDOM)

acronym: OPPIDOM

summary: This is a monocentric, non-randomized, prospective, in silico feasibility study conducted by Strasbourg Europe Cancerology Institute. The purpose of this study is to evaluate the optimisation of potential dental implant sites protection, without degrading tumor volume coverage, through designation of potential dental implant sites before volume delineation and dosimetry calculations in patients with oropharyngeal or oral cavity squamous cell carcinoma treated by radiotherapy.

lead_sponsor: Institut de cancérologie Strasbourg Europe


title: Pilot-Study for SAS Treatment in Acute Cerebral InfarctiOn: the PISTACIO Trial

acronym: PISTACIO

summary: Sleep Apnea Syndrome (SAS) is highly prevalent in acute stroke and it is related to worst outcome. We aim to assess if SAS treatment, started immediately after acute ischemic stroke, impacts infarct growing and clinical prognosis.

lead_sponsor: SOS Attaque Cérébrale


title: Collection of Medical Events Occurring During Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)

acronym: ESADAfollow-up

summary:
The European database ESADA, containing data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome, prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation.

The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean.

An additional objective is to assess the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

lead_sponsor: University Hospital, Grenoble


title: Evaluation of Patient Satisfaction and Therapeutic Impact Regarding Joint Consultation Rheumatologist/Dermatologist

acronym: RHUMPSO

summary: Current increase in the number of multidisciplinary consultations, but little documentation on their impact on patient management. More specifically, in the context of psoriatic arthritis, we are seeking to investigate the interest for the patient, through his or her satisfaction and the evolution of the activity of his or her pathology, of a global, joint management in Rheumatology and Dermatology.


title: Mucogain Matrix Versus Connective Tissue Graft: "MUCOGREFFE Project"

acronym: Mucogreffe

summary: Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft. We want to show if mucogain matrix used in tunnel technique to recover RTI Cairo recessions defects could be an alternative to connective tissue graft

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Persistent Olfactory Loss After COVID-19 : Olfactive Disorder, Psychiatric and/or Cognitive Assessments With and Without a Treatment

summary: Covid 19 cause an olfactory loss in more than 80% of cases. This loss most often regresses but leaves 20% of patients with an olfactory complaint, particularly with regard to the quality of daily life. The neuro-cognitive implications involved with COVID19 and the consequences of persistent olfactory loss remain unknown. The effectiveness of therapeutic management, in particular olfactory re-education, has not yet been clarified. Objectives are the assessment of patients olfactory disorders, psychiatrics and neurocognitives specificities after a COVID, before and after treatment or specific cares.


title: Comparison of 2 Ventilatory Support Strategies in Patients With Covid-19 Pneumonia Admitted in ICU : Retrospective Monocentric Study

acronym: STRATIC

summary: This retrospective monocentric study compares 2 ventilatory support strategies on outcomes (length of stay, intubation, mortality) in patients admitted in Intensive Care Unit with Covid-19 related pneumonia : invasive strategy used during the first period and non-invasive strategies (Continuous Positive Airway Pressure, High Flow Nasal Canula, Prone Position) used during the second period.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer


title: Association Between Early Change in PaCO2 After ECMO Initiation and Neurological Outcome in Newborns

summary: Investigation of the association between PaCO2 change after extra corporeal membrane oxygenation (ECMO) initiation and neurological outcome and mortality in neonates treated by ECMO for respiratory failure.

lead_sponsor: Nantes University Hospital


title: Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis

summary: The study aims at identifying the type of B and CD4 T cell subsets with pathogenic properties in the different clinical forms of multiple sclerosis. This research might open new therapeutic approaches for the treatment of multiple sclerosis particularly progressive MS.

lead_sponsor: University Hospital, Bordeaux


title: EXPRE-SON-REA : Expressive Versus Neutral Own Names in Neurophysiologic Prognosis Assessment of Intensive Care Unit Comatose Patients.

acronym: EXPRESONREA

summary:
Evaluating the neurologic prognosis in disorders of consciousness (DOC) patients is still a crucial issue in intensive care units.

Neurophysiology allows the investigators to record cerebral responses of patients to auditory stimuli and in particularly to their own name. Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm.

Here the investigators assess if the use of own name stimuli uttered by more expressive voices (for example smiling voices) modulates the cerebral responses recorded. They then correlate these cerebral responses to the neurologic prognosis at three months.

lead_sponsor: Centre Hospitalier St Anne


title: Integrating a Prevention Care Path Into Daily Life of Elders With Mobility Disability Risk: Introducing a Predictive Model to a Functional Exercise Response

acronym: ICARE

summary:
One of the main challenges of ageing is to prevent the onset of mobility disability and its co-morbidities. Screening the risk of mobility disability in community-dwelling elders is therefore very important and at the uppermost for the care of sarcopenia and frailty. A multicomponent intervention, integrating multidisciplinary actions and combining physical exercise and nutrition, is recognized as an effective therapy for the care of mobility disability risk factors. The diagnosis of either pre-frail/frailty and/or sarcopenia at least probable is sufficient to trigger a sustained intervention as it can prevent the onset of mobility disability. Therefore, it is difficult to identify the best responder for this type of care path. As a result, studies have been interested in exploring the predictive factors related to the functional response to exercise within lifestyle interventions. It has been shown that SPPB provides useful information when associated with demographic or physical activity factors. Those predictions are reliable to an ageing population with a SPPB ≤9 but it is still unknown if these reports are reproducible to older adults with high baseline physical function. Therefore, we hypothesized that a more inclusive SPPB score at baseline could also be related to other factors to predict the functional response to exercise. We assumed that strength, age, sex or body mass index could be interesting to elicit better predictions. It is an important issue for the development of targeted-interventions and specific care orientations.

The training has to be established through an accurate schedule to optimize the response to exercise. However, it is difficult to make consensus on the best method to apply, especially for elders with mobility disability risk. Hence, the present study also focus on a specific training method planned toward different exercises modes. We aimed to propose a training with cost-effective material and the absence of machines to transpose it into daily life participants. We expected to observe benefits on physical performance after this exercise intervention.

lead_sponsor: Hospices Civils de Lyon


title: "Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home." Tele Monitoring Ventilation At Home (TM-VAH)

acronym: TS-VAD

summary: Single-center, prospective pilot study on patients with amyotrophic lateral sclerosis fitted with noninvasive ventilation. The objective is to assess the satisfaction of remote monitoring of patients on non-invasive ventilation after 12 months.

lead_sponsor: University Hospital, Toulouse


title: Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery

acronym: SOFA

summary:
Opioid-Free Anesthesia (OFA) is an anesthesia protocol that does not use morphine, and is increasingly used routinely. Indeed, this protocol would theoretically allow a better post-operative analgesic control, a lower incidence of post-operative complications (e.g. post-operative nausea and vomiting). In the end, it would also allow a better overall post-operative recovery and a decrease in the incidence of chronic post-operative pain.

Nevertheless, the literature is poor on this issue and no randomized controlled study has evaluated the effect of the use of this type of anesthesia protocol on postoperative recovery.

ReferenceCitation: Léger M, Campfort M, Cayla C, Parot-Schinkel E, Lasocki S, Rineau E. Validation of an alternative French version of the Quality of Recovery-15 Score: the FQoR-15. Br J Anaesth. 2020 Oct;125(4):e345-e347. doi: 10.1016/j.bja.2020.05.052. Epub 2020 Jul 9.

ReferenceCitation: Mauermann E, Ruppen W, Bandschapp O. Different protocols used today to achieve total opioid-free general anesthesia without locoregional blocks. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):533-545. doi: 10.1016/j.bpa.2017.11.003. Epub 2017 Nov 24. Review.

ReferenceType: derived

ReferenceCitation: Léger M, Pessiot-Royer S, Perrault T, Parot-Schinkel E, Costerousse F, Rineau E, Lasocki S. The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial. Trials. 2021 Nov 27;22(1):855. doi: 10.1186/s13063-021-05829-x.

family: Léger

full_name: Maxime Léger

given: Maxime

family: Pessiot-Royer

full_name: Solène Pessiot-Royer

given: Solène

family: Perrault

full_name: Tristan Perrault

given: Tristan

family: Parot-Schinkel

full_name: Elsa Parot-Schinkel

given: Elsa

family: Costerousse

full_name: Fabienne Costerousse

given: Fabienne

family: Rineau

full_name: Emmanuel Rineau

given: Emmanuel

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Research Square - Research Square

repository_normalized: Research Square - Research Square

version: submittedVersion

lead_sponsor: University Hospital, Angers


title: Impact of a Multidisciplinary Consultation Program on Drug Adherence in First Oral Anticancer Treatment

acronym: IMPAM

summary: Oncology management has changed dramatically over the last decade with the approval and rapid adoption of newly targeted oral oncology medications. The movement to oral oncology medications has altered the balance of risks and adverse effects (AEs) in the treatment of cancer care. These treatments are associated with a different constellation of AEs and drug interactions. Patients receiving treatment with oral anticancer treatment (OAT) encounter several barriers to adherence, which may include limited access to specialty medications, severe adverse effects, complex medication regimens, and special handling precautions. Medication nonadherence not only reduces the efficacy of drug therapy but also has the potential to increase healthcare expenditures due to disease-related hospitalizations. The purpose of this study is to evaluate the drug adherence in cancer patients, using the medication possession ratio (MPR), before and after the implementation of a multidisciplinary consultation program (MCP), on initiation of OAT.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Respiratory Muscles and Work of Breathing in Children

summary:
Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management.

The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Effects of Controlled Physical Activity on the Fitness, Body Composition and Quality of Life of Obese Women Undergoing Bariatric Surgery

acronym: ACTIBARIA

summary:
Bariatric surgery indeed leads to significant weight loss, reduces mortality risk, obesity-associated comorbidities (Wolfe et al., 2016) and improves functional physical abilities (Herring et al., 2016). Because these benefits are related to decreased energy intake, the investigators aim to optimize them by combining them with supervised adapted physical activity practice.

So, the aim of this clinical trial is to measure the effects of a physical training program on physical fitness, body composition and quality of life of obese women who have undergone bariatric surgery.

ReferenceCitation: Baillot A, Audet M, Baillargeon JP, Dionne IJ, Valiquette L, Rosa-Fortin MM, Abou Chakra CN, Comeau E, Langlois MF. Impact of physical activity and fitness in class II and III obese individuals: a systematic review. Obes Rev. 2014 Sep;15(9):721-39. doi: 10.1111/obr.12171. Epub 2014 Apr 9. Review.

ReferenceCitation: Berggren JR, Boyle KE, Chapman WH, Houmard JA. Skeletal muscle lipid oxidation and obesity: influence of weight loss and exercise. Am J Physiol Endocrinol Metab. 2008 Apr;294(4):E726-32. doi: 10.1152/ajpendo.00354.2007. Epub 2008 Feb 5.

ReferenceCitation: Blair SN, Cheng Y, Holder JS. Is physical activity or physical fitness more important in defining health benefits? Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S379-99; discussion S419-20. Review.

ReferenceCitation: Bond DS, Phelan S, Wolfe LG, Evans RK, Meador JG, Kellum JM, Maher JW, Wing RR. Becoming physically active after bariatric surgery is associated with improved weight loss and health-related quality of life. Obesity (Silver Spring). 2009 Jan;17(1):78-83. doi: 10.1038/oby.2008.501. Epub 2008 Nov 6.

ReferenceCitation: Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.

ReferenceCitation: Wolfe BM, Kvach E, Eckel RH. Treatment of Obesity: Weight Loss and Bariatric Surgery. Circ Res. 2016 May 27;118(11):1844-55. doi: 10.1161/CIRCRESAHA.116.307591. Review.

ReferenceCitation: Herring LY, Stevinson C, Davies MJ, Biddle SJ, Sutton C, Bowrey D, Carter P. Changes in physical activity behaviour and physical function after bariatric surgery: a systematic review and meta-analysis. Obes Rev. 2016 Mar;17(3):250-61. doi: 10.1111/obr.12361. Epub 2016 Jan 18. Review.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Descriptive Bicentric Study of Moya Moya Syndrome and Disease in Sickle Cell Disease Patients and Not Sickle Cell Disease

acronym: BMM-ScD

summary:
Moya Moya disease or syndrome ar characterized by a progressive or occlusion of the intracranial carotid arteries and their mainproximal branches, followed by the development of fragile neovessels at the base of the skull, leding to a high risk of both ischemic and hemorragic stroke over time. Moya Moya syndrome are associated to a variety of disease, which main frequent is sickle cell disease (SCD).

Among patients with SCD who had suffered from at least one ischemic stroke, the prevalence of moya moya syndrome was estimated up to 43%. In general, therapeutic strategies in Moya Moya to prevent first ever ou recurrent stroke can be divided into conservative medical treatment and surgical revascularisation (direct bypass, indirect bypass or combined bypass).

The aim of this study is to compare prognosis of patients with Moya Moya syndrome associated with sickle cell disease or not. The investigators retrospectiveluy analysed medical chart from 2010 to 2021 of patients with Moya Moya disease or syndrome at two French university hospitals (including a center of the french West Indies where prevalence of sickle cell disease is high). The diagnosis was based on angiography or MRI records showing uni- or bilateral stenosis of distal intracranial internal carotide arteries or middle cerebral arteries associated wirh classic collateral network.

Main endpoint will be comparison of a composite outcome defined as time from Moya Moya diagnosis to first or recurrent stroke or bad prognosis achivement (defined by modified Rankin score >2)

lead_sponsor: University Hospital, Montpellier


title: Evaluation of the Efficacy, Tolerance of the Treatment, and Patient Satisfaction During the Management of an Arrested Pregnancy in the First Trimester According to the New Toulouse University Hospital Protocol

acronym: MYFEFACY

summary:
The clinical practice recommendations highlight the fact that the patient's choice concerning the management of her aborted pregnancy in the first trimester should be privileged, after clear and appropriate information on the available treatments, in order to improve his experience and reduce the negative psychological symptoms that can generate an alteration in the quality of life, in the aftermath of the loss of pregnancy.

The present study will describe the efficacy, satisfaction and tolerance of patients benefiting from medical treatment with Mifégyne® and MisoOne® versus those benefiting from surgical treatment by endo-uterine aspiration for the management of a pregnancy stopped during the first trimester at the Toulouse University Hospital


title: m-Rehab OSA : Impact of a Telerehabilitation Program Associated With CPAP on Severity Markers of Obstructive Sleep Apnea Syndrome. Prospective, Randomized, Controlled, Multicenter Study

acronym: mRehabOSA

summary: Obstructive sleep apnea syndrome (OSA) is a common condition associated with major repercussions such as excessive daytime sleepiness and impaired quality of life as well as metabolic and cardiovascular complications. Continuous positive airway pressure (CPAP) remains the treatment of choice but its effectiveness remains limited, especially in reducing cardio-metabolic risk. Interventions to modify the lifestyle are therefore recommended in the management of OSA. The emergence of information and communication technologies is an opportunity for patients to have tools that promote self-management and behavioral changes. The recent development of telerehabilitation (TR) is a promising approach that has only been the subject of pilot studies. In a randomized, controlled and multicenter study, we propose to test the hypothesis according to which the use of a mobile TR solution, associated with continuous positive airway pressure (CPAP), will allow obese patients to adopt behavioral modifications to improve markers of severity of OSA. The analysis of big data (data-mining) will allow a better understanding of the motivational obstacles and levers.


title: Prevalence of Renal Disease in Children With Celiac Disease

acronym: COELIGAN

summary: To assess the prevalence of renal disease in a pediatric population of patients with celiac disease by looking for the presence of hematuria and/or proteinuria.


title: Role of Individualized Versus Traditional Exercise in Combating Fatigue in Fatigued Multiple Sclerosis Patients

acronym: REEN-SEP

summary: The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Immunotherapy in MSI/dMMR Tumors in Perioperative Setting.

acronym: IMHOTEP

summary:
This trial is a multicenter, 4-cohort, prospective, Phase II trial conducted in patients with untreated resectable MSI/dMMR carcinomas or EBV+ gastric cancer and aiming to evaluate the safety and the efficacy of ICI (immune checkpoint inhibitor) as neoadjuvant treatment in these patients.

We hypothesize that immune checkpoint inhibitors (ICPi) will benefit to MSI/dMMR tumors from the early stages, whatever their anatomical origin. We assume that this neoadjuvant treatment would improve the response rate, providing even high rate of pathological complete responses and prolong patients survival.

We anticipated endometrial, colorectal and gastric cancers to be the most frequent recruited and constructed our statistical hypothesis with results in those 3 cancers. However patients with other localized MSI/dMMR tumors could be included.

lead_sponsor: Centre Leon Berard


title: Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly

acronym: HYPOXAGE

summary: In line with the ever-growing aging of Western populations, the development of preventive strategies to slow down the effects of aging on cardiovascular health represents a major challenge in order to preserve functional capacities and a sufficient quality of life in the elderly. The alteration of vascular function (at the cerebral and systemic level) with aging is an important feature in the clinical picture including a decrease in physical and cognitive capacities. Although physical activity is recognized as an essential means of combating the effects of aging, optimizing its effects by defining the most effective strategies of practice remains a key objective. Offering alternative interventions to exercise training is also necessary for people who are unwilling or unable to engage in a physical activity program. In this context, hypoxic conditioning, alone or in conjunction with rehabilitative exercise training, is a new therapeutic modality with strong preclinical validity, in particular from a cardiovascular standpoint, and used in other pathologies to improve cardiovascular function and exercise performance and quality of life. Our aim is, therefore, to investigate the effect of hypoxic conditioning (alone or in conjunction with exercise training) on cerebrovascular health in the elderly.

ipd_sharing_description: No plan at this point in time.


title: Survey of Lifestyle and Its Feelings in Families of Patients in Home Parenteral Nutrition

acronym: NPAD

summary:
Description of the life style of patients and families during the course of long term HPN.

Evaluation of the familial impact of HPN, and the way it is perceived
Evaluation of the satisfaction regarding the management by the multi-professional team (Medical, nursing, home care company and logistic, social, psychologist etc..) for improving the global management of these challenging patients
Analysis of the factors related to specific distress and the protective factors

lead_sponsor: Imagine Institute


title: Early Access Program With Inolimomab in Steroid-refractory Acute Graft Versus Host Disease Grade II-IV in Adults and in Children Over 28 Days of Age

summary:
Leukotac (inolimomab) is not approved yet for marketing in any region. In the absence of medical options and based on the safety and efficacy data obtained during the clinical development program (in a phase III (INO-107) and in a Long Term Follow Up study), the French National Agency for the Medicines and Health Products Safety (ANSM) granted a Temporary Authorisation for Use (ATU) so-called cohort ATU (cATU) for LEUKOTAC® (inolimomab) and approved the temporary use protocol .

This early access program has been granted to Leukotac (inolimomab) in adults and in children over 28 days of age, for treatment of acute cortico-resistant or cortico-dependent grades II-IV acute graft versus host disease (GvHD) according to the Glucksberg classification after allogeneic hematopoietic stem cell transplantation.

status: Available

study_type: Expanded Access

lead_sponsor: ElsaLys Biotech


title: Oral Health Assessment of Children in CP Class in REP/REP+ Areas in the Department of Hérault

summary: Few oral exams are performed on 6-year-olds (key age for carious disease). This project aims to increase the number of oral check-ups for 6-year-olds in fragile areas (REP/REP+ areas).


title: Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers

acronym: RETEVAL

summary: Alzheimer disease is hard, long and expensive to diagnose. In order to help the clinician, a new biomarker in Alzheimer disease seems to be very useful. The retina, as a window of the brain, could offer a new way to diagnose this common disease. Indeed, a retinal atrophy could especially appear in Alzheimer disease. Besides, many aspects about retinal alteration, visual function and their link with the disease deserve to be more explored. So as to fill these gaps, a new study about retinal specificity in Alzheimer disease appears to be relevant.


title: Applicability of Fluid Responsiveness Indices in Patients With Acute Circulatory Failure (AFRIC Study)

acronym: AFRIC

summary: Fluid administration is one of the main strategies for patients with acute circulatory failure. However, about half of the patients could not benefit from the fluid administration after the ICU admission. Thus predict the effect of fluid responsiveness is essential. There are sevral indices or tests can be used, such as pulse pressure variation (PPV), end-expiratory occulsion test (EEOT), passive leg raising (PLR), etc. Question of the prevalence of cases in which the different predictive indices of fluid responsiveness in intensive care unit (ICU) are not applicable.

ReferenceCitation: Benes J, Kirov M, Kuzkov V, Lainscak M, Molnar Z, Voga G, Monnet X. Fluid Therapy: Double-Edged Sword during Critical Care? Biomed Res Int. 2015;2015:729075. doi: 10.1155/2015/729075. Epub 2015 Dec 22. Review.

ReferenceCitation: Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. Review.

ReferenceCitation: Michard F, Boussat S, Chemla D, Anguel N, Mercat A, Lecarpentier Y, Richard C, Pinsky MR, Teboul JL. Relation between respiratory changes in arterial pulse pressure and fluid responsiveness in septic patients with acute circulatory failure. Am J Respir Crit Care Med. 2000 Jul;162(1):134-8.

ReferenceCitation: Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da. Review.

ReferenceCitation: Heenen S, De Backer D, Vincent JL. How can the response to volume expansion in patients with spontaneous respiratory movements be predicted? Crit Care. 2006;10(4):R102.

ReferenceCitation: Soubrier S, Saulnier F, Hubert H, Delour P, Lenci H, Onimus T, Nseir S, Durocher A. Can dynamic indicators help the prediction of fluid responsiveness in spontaneously breathing critically ill patients? Intensive Care Med. 2007 Jul;33(7):1117-1124. doi: 10.1007/s00134-007-0644-9. Epub 2007 May 17.

ReferenceCitation: Muller L, Louart G, Bousquet PJ, Candela D, Zoric L, de La Coussaye JE, Jaber S, Lefrant JY. The influence of the airway driving pressure on pulsed pressure variation as a predictor of fluid responsiveness. Intensive Care Med. 2010 Mar;36(3):496-503. doi: 10.1007/s00134-009-1686-y. Epub 2009 Oct 22.

ReferenceCitation: Malbrain ML, Reuter DA. Assessing fluid responsiveness with the passive leg raising maneuver in patients with increased intra-abdominal pressure: be aware that not all blood returns! Crit Care Med. 2010 Sep;38(9):1912-5. doi: 10.1097/CCM.0b013e3181f1b6a2.

ReferenceCitation: Delannoy B, Wallet F, Maucort-Boulch D, Page M, Kaaki M, Schoeffler M, Alexander B, Desebbe O. Applicability of Pulse Pressure Variation during Unstable Hemodynamic Events in the Intensive Care Unit: A Five-Day Prospective Multicenter Study. Crit Care Res Pract. 2016;2016:7162190. doi: 10.1155/2016/7162190. Epub 2016 Mar 31.

lead_sponsor: Bicetre Hospital


title: Programme d'Éducation Thérapeutique et d'Accompagnement Infirmier Vers Les Soins de Support, Chez Les Patientes Sous Hormonothérapie Pour un Cancer du Sein Non métastatique

acronym: ETAPH

summary: To compare the efficacy of the addition of a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone, on the management of adverse events (AEs) related to adjuvant hormone therapy during the first year of treatment in patients with non-metastatic breast cancer.

ipd_sharing_description: The study sponsor is the owner of the data and no use or transmission to a third party may be made without its prior consent. All information resulting from this clinical research protocol is considered confidential.

lead_sponsor: Centre Hospitalier Emile Roux


title: Study of Antenatal and Postnatal Data of Anorectal Malformations Diagnosed at Montpellier University Hospital Over a 10-year Period (2010-2020) : Why and How to Improve Antenatal Counseling ?

summary:
Objective :

Anorectal malformations (ARMs) are part of a spectrum of malformations due to an abnormal separation between the urogenital and digestive tracts during embryonic life. The prevalence of ARM is 1/2000 - 1/5000 live births, making it a relatively common malformation.

The impact of an ARM depends mainly on the type of malformation, which can be difficult to evaluate in the antenatal period, and whether it is isolated or associated (50-80%) with other malformations or genetic syndromes. Only 1 to 16% of ARMs are diagnosed in the antenatal period.

The objective of this study is to compare cases of prenatal diagnosis of ARM, cases of postnatal diagnosis of ARM with other antenatal ultrasound abnormalities, and those with normal antenatal ultrasound, in terms of management and functional prognosis, to identify ways to improve prenatal counseling.

Materials and methods :

In this retrospective monocentric study, the investigators have included all fetuses and newborns born between January 2010 and September 2020 with anorectal malformations, diagnosed from postnatal radiological examinations and surgical or autopsy reports at the University Hospital of Montpellier. The Krickenbeck classification was used to classify the ARMs and to assess the functional prognosis.


title: Étude Exploratoire Des Performances de Diagnostic Électrocardiographique de l'Apple Watch augmentée d'un Algorithme d'Intelligence Artificielle

summary: This observational exploratory prospective study will evaluate the performance on an Artificial Intelligence (AI) solution interpreting ECG (electrocardiogram) collected from an Apple Watch (AI-AW) in the detection of Atrial Fibrillation (AF)

lead_sponsor: Cardiologs Technologies

location_facility: Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier


title: Clinical Features Associated With Restless Legs Syndrome : Clin-RLS

acronym: Clin-RLS

summary: Restless legs syndrome (RLS) is a chronic neurological disorder characterized by an urge to move the legs at night when at rest. RLS can lead to a sleep deprivation, increased falling risk, daytime sleepiness, depression and decreased quality of life. Dopamine agonists, alpha-2-delta ligands and opiates are key medications for RLS. The natural course of RLS is very heterogeneous with a risk of increasing the severity of symptoms over the years despite the use of drugs and recommended dosages. Many comorbidities can make RLS worse. Augmentation syndrome is the main complication of dopamine agonists. However, only a few studies have addressed the clinical, biological and pharmacological factors associated with the evolution of the severity of RLS. The objective of this study is to assess the evolution of RLS symptoms severity as function of RLS phenotype, comorbidities and RLS medication, in large cohort of members of the French RLS association and other European RLS association.


title: Intra and Inter- Observer Reproducibility of Ankle Dorsiflexion Measure With a New Tool

acronym: EQUINOM

summary:
The Achilles' tendon is the largest and most resistant tendon in the body. When the triceps contracts, the Achilles' tendon is responsible for plantar flexion of the ankle. When the triceps are not contracted, the Achilles tendon is the main component in limiting dorsiflexion of the ankle, a major component of the gait pattern. The limitation of this dorsiflexion of the ankle can be caused by a shortening of the Achilles tendon.

This equine whose prevalence in the general population is greater than 50% according to Kowalski, appears to be a risk factor in many pathologies of the foot and ankle.

Currently, in clinical practice, the measurement of passive dorsiflexion of the ankle is empirically measured by the Silfverskiold test. However, the definition of a retraction varies according to the authors, in particular because of the absence of normalization of the force applied on the forefoot, or of the absence of uniformization of the angulation applied. This research is based on the hypothesis that a new measurement tool would be more efficient and more reproducible for measuring dorsiflexion of the ankle.

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: A Phase I Study to Compare Pharmacokinetic Parameters of Firibastat and Its Metabolites (EC33 and QGC515) in Healthy Subjects Versus End Stage Renal Disease (ESRD) Patients After a Single Oral Administration of Firibastat 500 mg

summary: The study is a multicentre, open label, phase I, two arms study to compare pharmacokinetic of firibastat after a single oral dose of firibastat 500 mg in fourteen healthy male volunteers and in fourteen End Stage Renal Disease (ESRD) patients not yet in dialysis.

lead_sponsor: Quantum Genomics SA


title: Preliminary Study Evaluating Feasibility and Acceptability of a Psychological Management Program Focused on Body Dissatisfaction in Eating Disorders. SABG : Secondary Alveolar Bone Grafting

summary:
The cognitive model of Eating Disorders (ED) highlights dysfunctional cognitive patterns common to the different subtypes. Body dissatisfaction, which can be defined as the negative and subjective evaluation of one's body shape, i.e., negative thoughts and emotions concerning one's body image and the origin of pathological behaviours with the aim of modifying one's weight and body shape, thus appears to be a central transdiagnostic concept in the ED. It is, moreover, described as a major factor in the development, maintenance and relapse of the various types of ED.

It is suggested that Acceptance and Commitment Therapy (ACT) may be beneficial in treating body dissatisfaction insofar as body image inflexibility appears to influence the relationship between body image appraisal and coping strategies. ACT, which aims to develop psychological flexibility, appeared to us as a promising tool to manage body dissatisfaction in ED.

The investigators therefore aim to evaluate the feasibility and acceptability of a psychological management group for body dissatisfaction (9 or 10 weekly group session), based on ACT therapy, in patients suffering from an ED.


title: Effect of 5,25% Sodium Hypochlorite Enamel Deproteinization on the Initial Shear Bond Strength and Glue Penetration in the Enamel of Orthodontic Brackets Bonded With a Self-etching Primer: An In Vitro Study on Human Bicuspids.

summary: The aim of this study was to evaluate the effects of enamel deproteinization on the initial shear bond strength (SBS) and on the bracket/adhesive failure mode of orthodontic brackets bonded with a self-etching primer (SEP) as a primary objective. As secondary objective a Raman microscopy study was performed to assess the resin penetration into the enamel according to the three bonding protocols.


title: Description of Lymphatic Damage in Encephalic Venous Thrombosis and Strictures in MRI a Reverse-recovery Sequence: a Pilot Study

acronym: ALTREVE

summary:
Inclusion (J0):

Information
Verification of inclusion and non-inclusion criteria
Collection of consent
MRI examination with injection of contrast product as part of the treatment comprising the sequences:

T1 TFE 1.0 iso 3D FLAIR injected Injected elliptical venous angiography 0.4mm iso or less 3D SWIp multiecho 3D T1 injected FABIR iso without injection (added as part of care in case of suspected ASH or meningitis) FLAIR 1.0 without injection (added as part of care for suspected ASH or meningitis) T2 BFFE XD (added by search) FABIR iso injected (added by research) 3D PD T1 0.55 MSDE iso injected (added by research)

Clinical information (SRM on inclusion, on discharge and at 3 months and recurrence within the year) will be collected from the patient's medical file

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hhopital fondation adolphe de rothschild


title: Distribution of Knee Isokinetic Angle-specific Moments and Ratios: Searching for Normative Values in Healthy Subjects

acronym: MOMANGLE

summary: The quantification of the strength-producing capacity of the knee joint muscles by isokinetic measurement is one of the most widely used tools for monitoring and deciding whether to return to sport after ACL reconstruction. However, the isokinetic evaluation performed in current practice does not exploit all the measures offered by this exploration technique, which can lead to errors in analysis and interpretation of the results and underestimate its ability to predict a return to sport under optimal conditions. Recently, more complete analysis models than those currently in use and integrating the moment-angle relationship have thus proposed the use of functional ratios sweeping the whole amplitude of the knee joint. Baumgart proposed an analysis of the variation of isokinetic force moments at each angle after ligamentoplasty. This approach seems to be the future of isokinetic performance analyses, but for the moment this has only been used in pathological populations and on small numbers of patients (less than 40). There are therefore no reference values in healthy subjects.

ReferenceCitation: Ardern CL, Taylor NF, Feller JA, Webster KE. Fifty-five per cent return to competitive sport following anterior cruciate ligament reconstruction surgery: an updated systematic review and meta-analysis including aspects of physical functioning and contextual factors. Br J Sports Med. 2014 Nov;48(21):1543-52. doi: 10.1136/bjsports-2013-093398. Epub 2014 Aug 25. Review.

ReferenceCitation: Gokeler A, Welling W, Zaffagnini S, Seil R, Padua D. Development of a test battery to enhance safe return to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):192-199. doi: 10.1007/s00167-016-4246-3. Epub 2016 Jul 16.

ReferenceCitation: Baumgart C, Welling W, Hoppe MW, Freiwald J, Gokeler A. Angle-specific analysis of isokinetic quadriceps and hamstring torques and ratios in patients after ACL-reconstruction. BMC Sports Sci Med Rehabil. 2018 Dec 6;10:23. doi: 10.1186/s13102-018-0112-6. eCollection 2018.


title: Identification of Risk Factors for the Occurrence of High-grade Rhythm Disorders in Patients With ST-segment Elevation Myocardial Infarction

acronym: STEMI

summary:
The goal of this study is to identify the risk factors for the occurrence of arrythmia in patient with stemi in prehospital management. We included 652 patients who presenting a STEMI from september 2017 to october 2020 and manage by physician in prehospital and bring to CHU of Dijon.

We analyse and compare the caracteristics of a group of STEMI patients who presenting an arrythmia to an other groupe of STEMI patient without arrythmia

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Study of the Intestinal Microbiota of Patients With Systemic Sclerosis

acronym: SCLEROMICROBIO

summary:
The term gut microbiota describes the entire intestinal microbial communities. Studies have established the important role played by the gut microbiome in modulating vital functions of the healthy host. The physiological effects of the microbiota for the host are, for the most part, beneficial. In several pathologies, an imbalance in the composition of the microbiota has been demonstrated.

Systemic sclerosis is an autoimmune, disorder of the connective tissue, characterized by vascular lesions, immunological abnormalities, and fibrosis of skin and internal organs As in many inflammatory diseases, there are painful digestive manifestations in systemic scleroderma that affect up to 90% of patients. The exact pathophysiology of the digestive involvement in systemic sclerosis is uncertain. The digestive manifestations of systemic sclerosis are frequent and can affect the entire digestive system.

However, there are few studies of the intestinal microbiota in this disease, which seems to be part of the same continuum of diseases with abnormalities of innate immunity. By analogy with chronic inflammatory bowel diseases, particularly Crohn's disease, we have raised the question of the existence of dysbiosis during scleroderma which could lead to episodes of acute, severe and recurrent inflammation of the peritoneum under the influence of triggering factors. The long-term prospects would be to look for ways to prevent attacks or to treat them more rapidly and effectively by using therapeutic targets in the intestinal microbiota.

The study population will be seen in the usual care setting, identically to all patients with systemic sclerosis treated in the department.

In case of an inflammatory disease outbreak, and depending on its severity, the patient will be seen again in consultation or hospitalized. Appropriate complementary examinations (biology, imaging, endoscopy) will be carried out and the treatment adapted.

location_facility: Hopital Saint Antoine - service de médecine interne


title: Effectiveness of Adacel Vaccination in Pregnancy at Preventing Pertussis in Infants < 2 Months of Age in the United States (US)

summary: The purpose of this study is to determine the effectiveness of Adacel against pertussis disease in infants < 2 months when administered during pregnancy following the current Advisory Committee on Immunization Practices (ACIP) recommendations, i.e., from 27 to 36 weeks of gestation, and 14 days or more before delivery.

ReferenceCitation: Skoff TH, Blain AE, Watt J, Scherzinger K, McMahon M, Zansky SM, Kudish K, Cieslak PR, Lewis M, Shang N, Martin SW. Impact of the US Maternal Tetanus, Diphtheria, and Acellular Pertussis Vaccination Program on Preventing Pertussis in Infants <2 Months of Age: A Case-Control Evaluation. Clin Infect Dis. 2017 Nov 29;65(12):1977-1983. doi: 10.1093/cid/cix724.

family: Skoff

full_name: Tami H Skoff

given: Tami H

family: Blain

full_name: Amy E Blain

given: Amy E

family: Watt

full_name: James Watt

given: James

family: Scherzinger

full_name: Karen Scherzinger

given: Karen

family: McMahon

full_name: Melissa McMahon

given: Melissa

family: Zansky

full_name: Shelley M Zansky

given: Shelley M

family: Kudish

full_name: Kathy Kudish

given: Kathy

family: Cieslak

full_name: Paul R Cieslak

given: Paul R

family: Lewis

full_name: Melissa Lewis

family: Shang

full_name: Nong Shang

given: Nong

family: Martin

full_name: Stacey W Martin

given: Stacey W

journal_name: Clinical Infectious Diseases

evidence: open (via free pdf)

license: pd

version: acceptedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi Pasteur, a Sanofi Company


title: Impact of Infectious Diseases Consultation on Vaccination Coverage Among People Waiting for a Kidney Transplant at the Clermont-Ferrand Hospital

acronym: PREVAGREF

summary: Solid-organ transplant patients are at increased risk of infectious diseases. Among this population, infectious diseases may be life-threatening or lead to graft rejection. Their prevention is an important challenge. Despite specific national recommendations, vaccination is underutilized. That is why we propose a dedicated infectious diseases consultation during pre-kidney transplantation assessment.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Assessment of One-shot Cardiac-cervical-intracranial MRI in the Etiological Work up of Ischemic Stroke and Transient Ischemic Attacks

acronym: Concise

summary: Stroke is a major public health issue in developed countries. A full etiological work up within a short time is critical to implement the appropriate preventive treatment. The etiological work up is actually based on a clinical examination and on a group of paraclinical examinations. The realization of the standard strategy is time consuming, and increase the cost of the medical care. A non-invasive one-shot examination of the heart, the aorta and the cervical and intracranial arteries (cci-MRI) could overcome these disadvantages.The investigator therefore propose to carry out an overall assessment of the performance of the cci-MR in the etiological work up of ischemic strokes and TIAs compared to the reference strategy

lead_sponsor: Hospices Civils de Lyon