title: Effect of COVID-19 Related COntainment in ChildreN

acronym: E-COCCON

summary: The current pandemic situation (SRAS COV2) is an unprecedented event and a source of stress potentially aggravated by containment. The Child Revised Impact Event Scale (CRIES-13) was evaluated in children 8 years or older in survivors of traumatic events, flood, stay in intensive care, or war (Bosnia). In this study CRIES-13 will be used to determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020

ReferenceCitation: Claudet I, Marchand-Tonel C, Ricco L, Houze-Cerfon CH, Lang T, Brehin C. During the COVID-19 Quarantine, Home Has Been More Harmful Than the Virus for Children! Pediatr Emerg Care. 2020 Sep;36(9):e538-e540. doi: 10.1097/PEC.0000000000002205. No abstract available.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Claudet I, Marchand-Tonel C, Kelly-Irving M, Gaudron CZ, Raynaud JP, Delpierre C, Brehin C. The psychological effects of COVID-19-related containment in children: The E-COCCON French study. Arch Pediatr. 2022 Apr;29(3):188-193. doi: 10.1016/j.arcped.2022.01.011. Epub 2022 Jan 19.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific


title: Oral Low Doses Tolerance INduction Study for Peanuts

acronym: OLDTINYpeanut

summary:
Several protocols have been proposed in scientifis literature, for oral tolerance induction (OIT) protocols for peanuts. A meta-analysis showed that the data in the literature are rather in favor of the exclusion of peanuts, and that OIT doesn't allow to expect significant levels of peanut protein consumed by the patient, and is associated with an increased risk of anaphylaxis and epinephrine use. Also, in most published protocols, patients with a history of anaphylactic shock, severe asthma, or multiple history of anaphylaxis are excluded.

To date, no protocol has been validated for this type of treatment, and each center follows locally validated schemes. In our unit, the investigators use an OIT protocol that starts at low doses (first dose at 2.68 mg peanut protein) and doses increase is scheduled every 4 to 12 weeks (instead of every 2 weeks). The investigators do not exclude patients with asthma or those with a history of peanut anaphylaxis (grade 2 or 3). The investigators have noted that our protocol is associated with a good safety profile and good efficacy, probably due to the fact that the investigators start at low doses and increase the dose with a prolonged delay, compared to previously published protocols. For this reason, the investigators decided to evaluate the results the investigators obtained in our patients and to better analyze the efficacy and safety profile of our protocol.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Evaluation of Child Desire in Young Women With Premature Ovarian Failure

acronym: DESIOP

summary:
Premature ovarian failure (POF) is a rare condition, affecting 1 in 10,000 women before age 20 and 1 in 1,000 women before age 30. The two main causes of POF are congenital and acquired.

Patients with POF who carry out the desire to have a child turn to medically assisted reproduction through oocyte donation or to adoption.

The main endpoint of this study is to compare the desire to have children among women with premature ovarian failure (POF) aged 18 to 26 years vs. controls of the same age (stratified by age) without major menstruation disorder.

study_start_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other


title: Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial

acronym: LIL-APP

summary:
Introduction: Surgery performed under low insufflation pressure combined with micro-laparoscopy (incisions 4X smaller than incisions in conventional laparoscopy) is called "low impact laparoscopy" or LIL. It significantly reduces postoperative pain and reduces the average length of stay.

This technique, currently underdeveloped has never been evaluated in the literature for appendectomy.

Main objective of the study: to obtain a reduction in postoperative pain when using the low-impact laparoscopy technique for appendectomies.

Secondary objectives: to study the feasibility of LIL in appendectomies, to obtain a reduction in the average length of stay, a reduction in the consumption of analgesics, a reduction in costs, and a more rapid resumption of activities.

Material and methods :

This is a prospective, single-center, double-blind study. The inclusion criterion is the presence of acute uncomplicated appendicitis. The number of subjects to be included in each group is evaluated at 25. The subjects are divided into two groups preoperatively:

Conventional group: insufflation pressure at 12mmHg and conventional instrumentation
LIL group: insufflation pressure at 7mmHg and micro-laparoscopy instrumentation.

Identical dressings are put in place at the end of the procedure in order to hide from the patient the protocol in which he was included.

Pain assessment is recorded daily during the first postoperative week. The consumption of analgesics is also recorded. Then on the 7th day, 15th day and 30th postoperative day. During hospitalization, readings are taken by the nurse. At home, the data is entered by the patient via the Link4Life smartphone application.

Conclusion: LIL applied to appendectomy has never been evaluated in the literature. It would allow a reduction in postoperative pain, the average length of stay for patients as well as improved rehabilitation.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Procedure

status_simplified: Completed


title: FArial NErf MRI in the Preoperative Assessment of PArotide Tumors

acronym: NEFAPA

summary:
st visit: Inclusion, 3Tesla injected parotid MRI performed as part of routine care for characterization, to which two specific high resolution sequences will be added. Evaluation of the exact position of the parotid tumor relative to the trunk of the facial nerve and its first branches, classification into two categories: on contact (≤ 5 mm) or at a distance (> 5 mm).
nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as that collected by the radiologists after the MRI.
rd visit: Post-operative consultation in the week following the intervention. The surgeon will look for the occurrence of post-operative facial paralysis.

status: Recruiting

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

lead_sponsor_type: industriel

status_simplified: Ongoing


title: HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment

acronym: HLA-G-COVID

summary: The aim of the research is to study the immune checkpoint linked to the HLA-G molecule in the dysregulation of the control of COVID-19 infection.

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Hopital Foch


title: Comparison of Preoperative 3D Spine Reconstruction With the EOS System and Peroperative 3D Spine Reconstruction With SURGIVISIO

acronym: Spine-PDCA-OR

summary:
The objective is to collect data from a per-operative navigation system called SURGIVISIO during scoliosis surgeries. A research program is in progress in order super-impose pre-operative 3D reconstructions of the spine performed with the EOS system on the per-operative 3D reconstructions performed with the SURGIVISIO system.

The purpose of the study is to collect the pre and per operatives data in order to perform the research and development program.

ReferenceType: background

ReferenceCitation: Dubousset J. Scoliosis and its pathophysiology: do we understand it? Spine (Phila Pa 1976). 2001 May 1;26(9):1001. doi: 10.1097/00007632-200105010-00002. No abstract available.

ReferenceCitation: Weinstein SL, Dolan LA, Cheng JC, Danielsson A, Morcuende JA. Adolescent idiopathic scoliosis. Lancet. 2008 May 3;371(9623):1527-37. doi: 10.1016/S0140-6736(08)60658-3.

ReferenceCitation: Courvoisier A, Garin C, Vialle R, Kohler R. The change on vertebral axial rotation after posterior instrumentation of idiopathic scoliosis. Childs Nerv Syst. 2015 Dec;31(12):2325-31. doi: 10.1007/s00381-015-2891-3. Epub 2015 Sep 4.

ReferenceCitation: Merloz P, Tonetti J, Cinquin P, Lavallee S, Troccaz J, Pittet L. [Computer-assisted surgery: automated screw placement in the vertebral pedicle]. Chirurgie. 1998 Nov;123(5):482-90. doi: 10.1016/s0001-4001(99)80077-4. French.

ReferenceCitation: Merloz P, Tonetti J, Pittet L, Coulomb M, Lavallee S, Troccaz J, Cinquin P, Sautot P. Computer-assisted spine surgery. Comput Aided Surg. 1998;3(6):297-305. doi: 10.1002/(SICI)1097-0150(1998)3:63.0.CO;2-8.

ReferenceCitation: Merloz P, Troccaz J, Vouaillat H, Vasile C, Tonetti J, Eid A, Plaweski S. Fluoroscopy-based navigation system in spine surgery. Proc Inst Mech Eng H. 2007 Oct;221(7):813-20. doi: 10.1243/09544119JEIM268.

ReferenceCitation: Prod'homme M, Cavalie G, Kerschbaumer G, Valmary-Degano S, Boudissa M, Tonetti J. T1 Vertebra Pedicular Osteoid Osteoma: Minimally Invasive Surgical Resection Aided by New Integrated Navigation to 3D Imaging Device. Case Rep Orthop. 2019 Mar 18;2019:7626454. doi: 10.1155/2019/7626454. eCollection 2019.

ReferenceCitation: Ferrero E, Mazda K, Simon AL, Ilharreborde B. Preliminary experience with SpineEOS, a new software for 3D planning in AIS surgery. Eur Spine J. 2018 Sep;27(9):2165-2174. doi: 10.1007/s00586-018-5591-3. Epub 2018 Apr 24.

ReferenceCitation: Stindel E, Merloz P, Graf P, Massin P, Gruber P, Robert H, Moineau G, Colmar M. [Computer assisted orthopedics surgery]. Rev Chir Orthop Reparatrice Appar Mot. 2007 Jun;93(4 Suppl):2S11-32. French.

lead_sponsor: University Hospital, Grenoble


acronym: REHSCU

intervention_type: Drug

lead_sponsor: Nantes University Hospital

summary: The worldwide COVID-19 pandemic has led to a dramatic increase in the number of patients hospitalized in intensive care units for an acute respiratory failure in all countries. This situation has quickly led to massive shortage in masks, mechanical ventilation machines and common medications such as hypnotics. All countries over the world are currently experiencing a major shortage in basic hypnotic medications (propofol, midazolam) in the intensive care as well as in the operating theatre. The Principal Investigator proposes to perform a pilot study assessing the benefit-risk ratio of Remimazolam (a novel benzodiazepine with a short half-life) in the critical care units of Nantes University Hospital during the COVID-19 pandemic.

sponsor_collaborators:
Nantes University Hospital
Paion UK Ltd.

title: REmimazolam Infusion in the Context of Hypnotic Shortage in the Critical Care Unit During the Pandemic of COVID-19. The Non-randomized, Non-controlled, Pilot, Open, Mono-centric REHSCU Study

primary_purpose: Supportive Care

source: euctr


title: Prevalence of Transthyretin Cardiac Amyloidosis in Patients With Idiopathic Carpal Tunnel Syndrome Referred for Release Surgery

acronym: PRATHYC

summary: This study will determine the prevalence of transthyretin amyloidosis in pathology of the transverse carpal ligament and cardiac involvement using natriuretic peptides, electrocardiography and echocardiography in patients referred for carpal tunnel release surgery of idiopathic carpal tunnel syndrome. This study will describe the relationship between amyloid deposition observed on the transverse carpal ligament and the presence of cardiac involvement.

lead_sponsor: University Hospital, Toulouse


title: DWI Cerebellar Infarct Volume as Predictor of Outcomes After Endovascular Treatment of Acute Basilar Artery Occlusion

acronym: CIV-ABAO

summary: Preprocedural predictors of outcome in patients with acute basilar artery occlusion (ABAO) who underwent endovascular treatment (EVT) remain controversial. Our aim was to analyze if pre-EVT diffusion-weighted images cerebellar infarct volume (CIV) was a predictor of 90-day outcomes.

intervention_type: Device


title: Randomized Pilot Study to Measure the Effects of an Acute Intake of Fermented Fruits Flours on Postprandial Glycaemic Response and Metabolic Profile

summary:
The aim of the study is to evaluate the effects of an acute intake of two fermented fruits flours as part of a standardized breakfast, in comparison with the acute intake of a standardized breakfast without fermented fruits flour but with the same amount of available carbohydrates, on postprandial glycaemic response and overall metabolism in subjects at cardiometabolic risk.

The metabolic parameters will be assessed in fasting and in postprandial period after the consumption of the standardized breakfast.

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes


title: Micronutrient Status Involved in Immunity in Elderly Patients With COVID-19

acronym: MicroCovAging

summary:
During the ongoing COVID-19 pandemic, age was clearly the major factor of mortality. Increasing age was strongly associated with this risk, with the upper 80 years age group having more than 12-fold increased risk compared with those aged 50-59 years. Male gender was also associated with a doubling of risk.

The elderly subject is particularly exposed to global denutrition with risk of micronutrients deficiencies such as vitamins and trace elements. Those deficits expose to lower immunity. In addition, viral infection as COVID-19 can also worsen these deficits.

In general, low levels or intakes of micronutrients such as Zn, Se and vitamin A have been associated with adverse clinical outcomes during viral infections. This notion has been confirmed in a recent review proposing that besides vitamins A and D also B vitamins, vitamin C, omega-3 polyunsaturated fatty acids, as well as selenium, zinc and iron should be considered in the assessment of micronutrients in COVID-19 patients.

In this context, the MicroCovAging study will evaluate copper, zinc and selenium, vitamin A, D and E status in elderly subjects affected by COVID- 19 and to correlate this status with prognosis of this disease.

time_perspective: Other

intervention_type: Biological


title: Pilot Study on the Care for Children With Moderate to Severe Agitation, With or Without the Use of a Semi-supervised Support Solution

acronym: ESSAIMS

summary: The objective is to compare the care including the solution of ambient sensory biofeedback "Inner Garden", compared to the care without this solution, on the regulation of behavioral disorders during a crisis requiring to take the child out of group care. The nursing support with the "Inner Garden" tool in three care units will be compared with the practice in six other units not equipped with this tool.

ReferenceCitation: Domon-Archambault V, Terradas MM, Drieu D, De Fleurian A, Achim J, Poulain S, Jerrar-Oulidi J. Mentalization-Based Training Program for Child Care Workers in Residential Settings. J Child Adolesc Trauma. 2019 Jun 21;13(2):239-248. doi: 10.1007/s40653-019-00269-x. eCollection 2020 Jun.

ReferenceCitation: Niquille M, Gremion C, Welker S, Damsa C. [Agitation in prehospital setting: view of emergency physicians]. Rev Med Suisse. 2007 Aug 15;3(121):1839-46. French.

ReferenceCitation: Tereno S, Soares I, Martins C, Celani M, Sampaio D. Attachment styles, memories of parental rearing and therapeutic bond: a study with eating disordered patients, their parents and therapists. Eur Eat Disord Rev. 2008 Jan;16(1):49-58. doi: 10.1002/erv.801.

ReferenceCitation: Lewis GF, Hourani L, Tueller S, Kizakevich P, Bryant S, Weimer B, Strange L. Relaxation training assisted by heart rate variability biofeedback: Implication for a military predeployment stress inoculation protocol. Psychophysiology. 2015 Sep;52(9):1167-74. doi: 10.1111/psyp.12455. Epub 2015 Jun 11.

ReferenceCitation: Zeman J, Shipman K, Suveg C. Anger and sadness regulation: predictions to internalizing and externalizing symptoms in children. J Clin Child Adolesc Psychol. 2002 Sep;31(3):393-8. doi: 10.1207/S15374424JCCP3103_11.

ReferenceCitation: Chicchi Giglioli IA, Pallavicini F, Pedroli E, Serino S, Riva G. Augmented Reality: A Brand New Challenge for the Assessment and Treatment of Psychological Disorders. Comput Math Methods Med. 2015;2015:862942. doi: 10.1155/2015/862942. Epub 2015 Aug 3.

ReferenceCitation: Baus O, Bouchard S. Moving from virtual reality exposure-based therapy to augmented reality exposure-based therapy: a review. Front Hum Neurosci. 2014 Mar 4;8:112. doi: 10.3389/fnhum.2014.00112. eCollection 2014.

ReferenceCitation: Gold G, Fazio L, Stolz JH, Herrman FR, Gattelet P, Zekry D. [Assessment of behavior in non-psychiatric settings: use of a simple and reliable method]. Rev Med Suisse. 2012 Nov 7;8(361):2119-21. French.

ReferenceCitation: Kay SR, Wolkenfeld F, Murrill LM. Profiles of aggression among psychiatric patients. I. Nature and prevalence. J Nerv Ment Dis. 1988 Sep;176(9):539-46. doi: 10.1097/00005053-198809000-00007.

ipd_sharing: Yes

ipd_sharing_description:
Data will be made available with publication. Keyword are Child Behavior, Psychomotor Agitation, Psychiatric Nursing, Child Day Care Center, Tool Use Behavior, Emotional Regulation.

The available version will be the locked database. The database will be made available by the study director upon request up to 15 years after publication.

Medical Subject Headings (MESH) terms will be used to describe clinical data. Methodology for will be provided in the publication.

International standard unit will be used.

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: Comparative Randomized Study of Virtual Reality Technology on Pain Perception and Anxiety Levels in Adolescents and Young Adults During Third Molar Germ Avulsion Surgery

acronym: VIDAMO

summary:
For a long time, the fear of the dental surgeon has been the main reason why a percentage of the population avoids regular consultation.

There are many techniques to manage anxiety (tell-show-do, positive reinforcement, live modeling, etc). Now, virtual reality offers this possibility as a non-drug alternative technique.

Few studies have assessed the value of virtual reality in peroperative during an oral surgery procedure.

It is interesting to compare the immediate post-operative anxiety level between groups using virtual reality headset (RV) versus standard protocol (hydroxyzine + music with headphones : SMP)

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Impact of Immune Checkpoint Inhibitor Therapy on Type 2 Inflammation

acronym: ImmunEO

summary: The primary objective of this study is to determine the impact of anti-checkpoint immunotherapy on type 2 inflammation via a retrospective analysis of % eosinophilia.


title: Reference Values of Aerobic Fitness in the Contemporary Paediatric Population: VO2max Z-scores

acronym: SAIN&NORMES

summary:
In most pediatric medical conditions, tremendous progress in pediatrics has significantly improved the overall prognosis and transferred the mortality from childhood to adulthood. Nevertheless, chronic diseases remain the leading cause of death and physical inactivity appears to be a major aggravating factor. Yet, a good physical activity has a positive impact on quality of life and prevents future health morbidities, such as obesity and cardiovascular disease. Therefore, after focusing on the survival of children with chronic diseases, more attention is being given to health-related quality of life and secondary prevention.

In this context, the cardio-pulmonary exercise test (CPET), which is a non-invasive and dynamic examination, has become the gold standard to identify subjects with impaired physical capacity and to identify the causes of their limitations (muscular, cardiac, respiratory, behavioral, etc.). Moreover, CPET is the key examination to enroll patients in personalized physical rehabilitation programs (muscle deconditioning, respiratory limitation, etc.).

Despite a growing interest in CPET and individualized rehabilitation programs for chronic diseases, the investigators still face the lack of reference values for pediatric CPET. In current practice, many CPET pediatric laboratories use the reference values of maximum oxygen uptake (VO2max) defined by Cooper et al. in 1984, from a cohort of 109 healthy children. However, their equations are linear and based on weight only. Non linear equations and the use of other anthropometric variables may be relevant in pediatrics. For instance, in the current era, normal CPET pediatric values should consider the prevalence of overweight and obesity in childhood general population (respectively 30% and 10% in Europa and 35% and 25% in North America), as well as in the population of children with chronic disease.

In the past decade, our group has developed a research program on physical capacity in children, with a focus on pediatric CPET and physical rehabilitation, from a cohort of nearly 1000 exercise tests in children. The lack of reliable pediatric reference values for VO2max, and all CPET variables as well, has become an important issue.

In this study, the investigators aim to define pediatric reference CPET values from a large cohort of 6 to 17 year-old children, using several anthropometric variables to define the most appropriate Z-scores equations (part 1). The investigators will also validate the Z-scores equations using an independent population (part 2).

ReferenceCitation: Amedro P, Matecki S, Pereira Dos Santos T, Guillaumont S, Rhodes J, Yin SM, Hager A, Hock J, De La Villeon G, Moreau J, Requirand A, Souilla L, Vincenti M, Picot MC, Huguet H, Mura T, Gavotto A. Reference Values of Cardiopulmonary Exercise Test Parameters in the Contemporary Paediatric Population. Sports Med Open. 2023 Aug 1;9(1):68. doi: 10.1186/s40798-023-00622-3.

ReferenceCitation: Gavotto A, Mura T, Rhodes J, Yin SM, Hager A, Hock J, Guillaumont S, Vincenti M, De La Villeon G, Requirand A, Picot MC, Huguet H, Souilla L, Moreau J, Matecki S, Amedro P. Reference values of aerobic fitness in the contemporary paediatric population. Eur J Prev Cardiol. 2023 Jul 12;30(9):820-829. doi: 10.1093/eurjpc/zwad054.

collaborators: Department of Paediatric Cardiology and Congenital Heart Disease, German Heart Centre Munich, Germany.

collaborators: Department of Cardiology Children's Hospital, Boston, United State.


title: Physical Exercise and Self-esteem: a Randomized Controlled Trial in Domestic Violence Victims

summary: The current study is a randomized controlled trial comparing the effects of 6 weeks of physical exercise training versus group therapy on self-esteem as well as on the various subdomains of physical self-esteem among women who have experienced domestic violence within the last two months at the time of data collection

lead_sponsor: Université de Reims Champagne-Ardenne

intervention_type: Behavioral


title: Can Non-invasive Haemodynamic Monitoring With Clearsight(r) Predict Spinal Hypotension During Caesarian Section? A Prospective Observational Study

summary:
Spinal anaesthesia for elective caesarean section is associated with maternal hypotension, secondary to alteration of sympathetic tone and hypovolemia, in up to 70% of cases.

Our objective, in this prospective single-centre observational study, was to assess the ability of change in systolic ejection volume after 45° passive leg raising to predict hypotension after spinal anaesthesia. Systolic ejection volum was monitored with non-invasive Clearsight Device just before elective caesarean section in third trimester pregnant women.

lead_sponsor: Hospital Nord

location_facility: Departement anesthesie reanimation hopital nord


title: Evaluation of the Efficacy, Safety and Tolerability of Alisporivir for the Treatment of Hospitalised Patients With Infections Due to SARS-CoV-2 (COVID-19). A Randomised, Open-label, Proof of Concept, Phase 2 Study

acronym: CYCLOVID

summary:
COVID-19 is a viral respiratory and systemic disease that has been rapidly spreading globally since the first cases were reported in December 2019 and has now become pandemic. The causative agent of COVID-19 was identified as a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, first designated as 2019-nCoV).

The disease manifestations of COVID-19 can range from mild, self-resolving respiratory disease to severe pneumonia, ARDS, multiorgan failure, and ultimately death. In early reports, the mortality rate among patients admitted to hospital and with confirmed SARS-CoV-2 infection was reported to be between 4 and 15%. Although the disease can afflict all age groups, elderly patients and patients with underlying comorbidities such as high body mass index, hypertension, diabetes, cardiovascular disease, or cerebrovascular disease are at risk of developing severe disease and dying.

There are currently no etiologic treatments for COVID-19, and efforts are underway to identify therapeutics that could be effective in controlling this disease.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Debiopharm International SA

location_facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor


type: EudraCT Number

title: Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Hospitalized Patients

acronym: NICOVID

summary:
The coronavirus disease (COVID-19) epidemic represents a major therapeutic challenge. The highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) and the long duration of the disease have led to a massive influx of patients admitted in health services and intensive care units. To current knowledge, there is no treatment yet that that can prevent infection from SARS-COV-2 virus, nor the disease progression to a severe form.

Daily active smokers are rare among outpatients or hospitalized COVID-19 patients.

Several arguments suggest that nicotine could be responsible for this protective effect thank to the nicotinic acetylcholine receptor (nAChR).

Based on epidemiological data and experimental data from scientific literature, we hypothesize that nicotine could inhibit the penetration and spread of the virus and improve the management of COVID19 , particularly in hospitalized patients to prevent adverse outcomes (death, transfer to intensive care unit, care limitation, mechanical ventilation an high flow oxygen).


title: Classification and Functional Stratification of the Patients With Ciliopathy and Identification of Biomarkers to Improve Their Prognosis

acronym: CILLICORIRCM

summary:
The purpose of the C'IL-LICO RICM study is to develop innovative and transformative diagnostic and prognostic for patients suffering from ciliopathies leading to renal failure.

The objectives is to decipher disease mechanisms and highlight signaling pathways altered in at-risk to develop renal failure patient groups and to produce a prognostic biomarker-based kit to predict the evolution of ciliopathy patients towards renal impairment.

primary_purpose: Diagnostic


title: PRONing to Facilitate Weaning From ECMO in Patients With Refractory Acute Respiratory Distress Syndrome

acronym: PRONECMO

summary:
ECMO has emerged as a promising intervention that may provide more efficacious supportive care to patients with refractory severe acute respiratory distress syndrome (ARDS). The largest randomized trial of ECMO for severe forms of ARDS was recently published and demonstrated no significant benefit from early initiation of ECMO with respect to 60-day mortality, when compared with a strategy of conventional mechanical ventilation (MV) (ref EOLIA). However, a rescue ECMO option was used by 28% of the controls, which is likely to have diluted the potential positive effect of ECMO. One may argue that a less restrictive primary endpoint, such as death or rescue ECMO, would have yielded positive findings.

Meanwhile, improvements in technology have made ECMO safer and easier to use, allowing for the potential of more widespread application in patients with ARDS. VV-ECMO can be used as a life-saving rescue therapy in patients with ARDS when MV cannot maintain adequate oxygenation or CO2 elimination. Alternatively, VV-ECMO may be used in patients who remain hypoxemic during MV (i.e., PaO2/FiO2<80 mmHg) despite optimization of MV (including the application of high levels of positive end-expiratory pressure (PEEP), neuromuscular blockers, and prone positioning) and allow "lung rest" by lowering airway pressures and tidal volume to ameliorate ventilator-induced lung injury (VILI).

Prone positioning (PP) has been used for more than 30 years in patients with acute hypoxemic respiratory failure and in particular with ARDS. Initially, PP in ARDS patients was proposed as an efficient mean to improve oxygenation, sometimes dramatically, in a large number of patients. In addition, it is now clear, and data are still accumulating, that PP is also able to prevent VILI which is as important as maintaining safe gas exchange in mechanical ventilation. Therefore, PP is a strategy that covers the two major goals of ventilator support in ARDS patients, maintaining safe oxygenation and preventing VILI and reducing mortality at the end. This latter objective makes sense on ECMO as one of the main objective of this device is to markedly reduce VILI by resting the lung.

Considering that PP is a valuable and safe therapy to reduce VILI, its combination with ECMO could enhance VILI prevention. In recent preliminary studies, it was reported that the combination of VV-ECMO and PP was associated with a dramatic improvement in oxygenation, in pulmonary and thoracic compliance and in chest X-ray findings. It may thus facilitate the weaning of ECMO and can be performed without compromising the safety of the patients. Lung recruitment and improvement in ventilation/perfusion mismatch on prone position may both contribute to improve oxygenation. PP may therefore be efficient to hasten the weaning of VV-ECMO when atelectasis and ventilation/perfusion mismatch occur under ultra-protective ventilation even in patients in whom pre-ECMO PP failed. In addition, it could also enhance ventilator induced lung injury prevention on ECMO.

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: PRONECMO

titre: Benefice du décubitus ventral sur le sevrage de l'assistance extracorporelle (ECMO) chez les patients ayant un syndrome de détresse respiratoire aiguë réfractaire.

discipline_principale: anesthesiology / resuscitation

nom_porteur: SCHMIDT

prenom_porteur: Matthieu


title: Pre-operative Radiograph of Deep Carious Lesions as a Predictive Tool for Pulpal Exposure.

summary:
Preserving pulpal vitality is a major challenge when excavating deep caries lesions without severe symptomatology. Pulpal exposure alters success of the treatment (dropping from 93% for indirect pulp treatment with selective excavation to 11% for direct pulpotomy) and thus prognosis of dental organ and cost-effectiveness of the treatment. The preoperative x-ray is a complementary examination which allows to estimate the depth of the carious lesion. In clinical practice, it is currently difficult to accurately measure this depth on preoperative radiographs. This lack of precision leads to a decrease in the effective capacity of the operator to predict the risk of pulpal exposure. Their interpretation is considered imprecise and is not used as a diagnostic element.

The aim of this study was to determine if the use of pre-operative retroalveolar radiographs can help to predict pulpal exposure risk.

ReferenceType: derived

ReferenceCitation: Gasqui MA, Perard M, Decup F, Monsarrat P, Turpin YL, Villat C, Gueyffier F, Maucort-Boulch D, Roche L, Grosgogeat B. Place of a new radiological index in predicting pulp exposure before intervention for deep carious lesions. Oral Radiol. 2022 Jan;38(1):89-98. doi: 10.1007/s11282-021-00530-w. Epub 2021 May 5.

repositories_concat: closed

publisher_dissemination: Springer-Nature

location_facility: Professeur des Universités- Praticien Hospitalier

intervention_type: Radiation


title: Working Memory Training With Attention Process Training (APT-II) in Older Adults With Mild Cognitive Impairment : Impacts on Cognition and Ecological Activities

acronym: APT-II

summary: Older adults with Mild Cognitive Impairment (MCI) have an increased risk of developing dementia but do not meet the criteria for dementia. Cognitive rehabilitation makes it possible to compensate, at least in part, for cognitive deficits with the ultimate goal of reducing their impact in everyday life. The objective of the research is to evaluate the short- and long-term effectiveness and generalization of an attention and working memory training program (APT-II) on cognition and ecological activities in MCI patients with a randomized controlled trial. Thirty MCI patients will be randomly assigned between a "cognitive training with APT-II" condition and a control (routine care) condition. The intervention will consist of an 8-week individual cognitive training program (2 sessions/week), training different attentional components and working memory. This has the advantage of insisting on the transfer of the acquired knowledge in sessions to daily activities. To evaluate the effectiveness of the treatment, cognitive and functional follow-up measures (including a virtual reality task) are administered at several time intervals. This project should contribute to better management of cognitive disorders by offering a new standardized rehabilitation tool in French to clinical practice.

primary_purpose: Prevention

ReferenceCitation: Baddeley A, Logie R, Bressi S, Della Sala S, Spinnler H. Dementia and working memory. Q J Exp Psychol A. 1986 Nov;38(4):603-18. doi: 10.1080/14640748608401616. No abstract available.

ReferenceCitation: Barker-Collo SL, Feigin VL, Lawes CM, Parag V, Senior H, Rodgers A. Reducing attention deficits after stroke using attention process training: a randomized controlled trial. Stroke. 2009 Oct;40(10):3293-8. doi: 10.1161/STROKEAHA.109.558239. Epub 2009 Jul 23.

ReferenceCitation: Belleville S, Boller B. Comprendre le stade compensatoire de la maladie d'Alzheimer et agir pour promouvoir la cognition et la plasticite cerebrale. Can J Exp Psychol. 2016 Dec;70(4):288-294. doi: 10.1037/cep0000087.

ReferenceCitation: Blanchet S, McCormick L, Belleville S, Gely-Nargeot MC, Joanette Y. [Mild cognitive impairments in the elderly: a critical review]. Rev Neurol (Paris). 2002 Jan;158(1):29-39. French.

ReferenceCitation: Kim H, Chey J, Lee S. Effects of multicomponent training of cognitive control on cognitive function and brain activation in older adults. Neurosci Res. 2017 Nov;124:8-15. doi: 10.1016/j.neures.2017.05.004. Epub 2017 Jun 1.

ReferenceCitation: Palmese CA, Raskin SA. The rehabilitation of attention in individuals with mild traumatic brain injury, using the APT-II programme. Brain Inj. 2000 Jun;14(6):535-48. doi: 10.1080/026990500120448.

ReferenceCitation: Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999 Mar;56(3):303-8. doi: 10.1001/archneur.56.3.303. Erratum In: Arch Neurol 1999 Jun;56(6):760.

ReferenceCitation: Petersen RC, Lopez O, Armstrong MJ, Getchius TSD, Ganguli M, Gloss D, Gronseth GS, Marson D, Pringsheim T, Day GS, Sager M, Stevens J, Rae-Grant A. Author response: Practice guideline update summary: Mild cognitive impairment: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018 Aug 21;91(8):373-374. doi: 10.1212/WNL.0000000000006042. No abstract available.

ReferenceCitation: Plancher G, Gyselinck V, Piolino P. The Integration of Realistic Episodic Memories Relies on Different Working Memory Processes: Evidence from Virtual Navigation. Front Psychol. 2018 Jan 30;9:47. doi: 10.3389/fpsyg.2018.00047. eCollection 2018.

ReferenceCitation: Saba M, Blanchet S. [Working memory training in normal and pathological aging: neurocognitive gains and generalization]. Geriatr Psychol Neuropsychiatr Vieil. 2020 Jun 1;18(2):187-195. doi: 10.1684/pnv.2020.0860. French.

ReferenceCitation: Simon SS, Tusch ES, Feng NC, Hakansson K, Mohammed AH, Daffner KR. Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial. J Alzheimers Dis. 2018;65(3):931-949. doi: 10.3233/JAD-180455.

ReferenceCitation: Telonio A, Blanchet S, Maganaris CN, Baltzopoulos V, Villeneuve S, McFadyen BJ. The division of visual attention affects the transition point from level walking to stair descent in healthy, active older adults. Exp Gerontol. 2014 Feb;50:26-33. doi: 10.1016/j.exger.2013.11.007. Epub 2013 Nov 27. Erratum In: Exp Gerontol. 2015 Jan;61:156.

ReferenceCitation: Murray LL, Keeton RJ, Karcher L. Treating attention in mild aphasia: evaluation of attention process training-II. J Commun Disord. 2006 Jan-Feb;39(1):37-61. doi: 10.1016/j.jcomdis.2005.06.001. Epub 2005 Jul 21.

ReferenceCitation: Unsworth N, Fukuda K, Awh E, Vogel EK. Working memory and fluid intelligence: capacity, attention control, and secondary memory retrieval. Cogn Psychol. 2014 Jun;71:1-26. doi: 10.1016/j.cogpsych.2014.01.003. Epub 2014 Feb 14.

lead_sponsor: University of Paris 5 - Rene Descartes

sponsor_collaborators:
University of Paris 5 - Rene Descartes
Assistance Publique - Hôpitaux de Paris


title: Infrared Thermography Associated With Cutaneous Microcirculation for Detection of Brown-adipose Tissue: Proof of Concept Against PET-CT in Patients Affected by Pheochomocytoma and/or Paraganglioma

acronym: MICROBAT

summary: Patients affected by pheochromocytoma (PHEO) have brown-adipose tissue (BAT) hyperactivation. They perform, in routine settings, a FDG PET-CT scan. The high metabolic activity of BAT and its ability to consume both glucose and fatty acid suggest that it may have potential as a therapeutic target in the treatment of obesity. However, alternative non-invasive techniques to PET-CT BAT detection still need more validation. Accordingly, our aim will be to measure the temperature and microcirculation of the skin overlaying BAT depots in the region of FDG-uptake detected by 18F-FDG PET/CT before and after a cold test in PHEO patients.

lead_sponsor: University of Avignon

collaborators: Centre Hospitalier Henri Duffaut - Avignon

collaborators: Assistance Publique Hopitaux De Marseille

intervention_type: Diagnostic Test


type: Registry Identifier

title: Rare Obesity Cohorts With Food Behavioral Disorders : Better Diagnosis for Better Treatment

acronym: ObeRar

summary:
Hypothalamic obesity (HO) is defined as obesity secondary to functional or anatomical alterations of the hypothalamus, the central organ of energy homeostasis. The causes of HO are related either to hypothalamic lesions (eg craniopharyngioma) either to genetic diseases (syndromic obesity such as Prader-Willi syndrome or monogenic non syndromic obesity such as variants on leptin/melanocortin pathway). HO, which accounts for about 5 to 10% of obesity, groups complex disorders characterized by severe obesity associated with eating disorders, cognitive and behavioral disorders, endocrine and metabolic alterations and sometimes a visual deficit, with a major impact on quality of life, morbidity and mortality. There is currently no specific treatment of HO.

Clinical management is essentially behavioral, based on daily support of eating behavior and physical activities. HO is characterized by an intense and almost permanent hunger; a satiety disorder and an obsessive interest in food.

The education regarding food intake behavior of the caregivers and relateds is critical with advices concerning the control of the access to food and the setting up of a precise food frame on the quantities, with low energetic density, and schedules. HO are complex medical situations, often refractory to current lifestyle therapies. However innovative therapies with molecules targeting the hypothalamus are emerging. The investigator's main hypothesis is that HO have alterations in eating behavior that can be improved by innovative treatments such as, for example, molecule targeting the melanocortin pathway. The response to therapy could depend on hypothalamic origin and especially on the genotype. ObeRar cohort aims to i) improve early diagnosis of HO and ii) characterize the natural history of obesity and eating disorders, the associated phenotypes and "lifestyle" profiles (physical activity, sleep, nutrition) and cardio-metabolic and neuropsychological parameters. Defining profiles will help personalize individual care management and target patients who can participate in clinical trials with innovative therapeutics. ObeRar-cohort will thus improve the early diagnosis, prognosis, medical management and innovative therapies of these particularly severe forms of rare obesities.

location_facility: Pitié-Salpêtrière Hospital, AP-HP -Nutrition department


title: Evaluation of Quality of Life and Its Influencing Factors After VA-ECMO in Refractory Cardiac Arrest Based on SF-36 Score : A Grenoble Cohort Study From 2006 Through 2018

acronym: AQUA

summary: If the ExtraCorporeal Membrane Oxygenation (ECMO) improves survival in the management of refractory cardiac arrest (RCA), this technique is still an invasive technique, not devoid of complications and requiring intensive care that can have serious consequences for patients. If the studies so far show an acceptable quality of life post ECMO in refractory cardiac arrest, the study looks about the quality of life of our patients in Grenoble who survived a refractory cardiac arrest between 2006 and 2018 at the hospital university Grenoble Alps and the factors influencing this quality of life.

time_perspective: Cross-Sectional


title: Advantage of a Fast-recovery Protocol for Minimally Invasive Kidney Surgery

acronym: RREIN

summary:
Shorten the time spent in the hospital (hospitalization duration) by optimizing the pre, per and postoperative care is of major medical and economic importance.

Minimally invasive surgery allows a faster recovery than open surgery. However, we need to ensure an early and secure return to normality in order to discharge patients safely from the hospital.

Clinical and biological parameters need to be controlled post-surgery.

This work is going to evaluate the efficacity of a fast - recovery program with incoming patients receiving minimally invasive surgery (laparoscopic or robotic) of partial and total nephrectomy.

The implementation of a medical and surgical fast-recovery program could

Lower the average duration of stay in hospital (at least by 1 day) with no increase of morbidity
Insure the absence of complications after 6 months home

lead_sponsor: University Hospital, Lille


title: Incidence of Commuting Accidents Among Non-physician Staff of a Large University Hospital Center From 2012 to 2016

summary: Over the past thirty years, risk of road traffic accidents has decreased but remains high and accounts for 44% of fatal work-related accidents for commuting and mission-related accidents. The aims of this study were to estimate the overall incidence of commuting accidents for non-physician professionals in a major university hospital and by gender and different professional categories, and to assess its evolution over a 5-year period. A descriptive analysis was performed on 390 commuting accidents from 2012 to 2016 extracted from the university hospital's occupational health service.


title: RV3278AET0943 Cosmetic Product Efficacy Applied for 8 Weeks in Adults Having Oily and Acne Prone Skin: Comparative Study Versus Not Treated Group

summary:
The aim of this study is to evaluate, at different times, the RV3278A - ET0943 cosmetic product efficacy after 8 weeks of application on the face (twice-daily application). At T1 (Baseline), T2 (4 weeks) and T3 (8 weeks), the following assessments are performed:

The reduction of the pilosebaceous follicular ostium size in vivo (pores) on the forehead
The clinical evaluation (count of non inflammatory and inflammatory acne lesions, IGA score) of the face
The reduction in visible follicles
The standardized numerical photographs of face and ¾ right and left profile in normal, parallel polarized, cross polarized and UV light
The analysis of the skin lipids of the forehead
The qualitative and quantitative analysis of the sebum and comedones constituents (nose wings)

This is a comparative, open-labelled study, on subjects with oily and acne prone skins on the face.

Each group includes 18 subjects.

lead_sponsor: Pierre Fabre Dermo Cosmetique


title: Observational Study to Define Patient Preferences Toward the Attributes of Treatment Used for Inflammatory Bowel Disease, Including Efficacy Profile, Safety Profile, Frequency and Route of Administration, in Europe

summary: The purpose of this survey is to describe Crohn's disease (CD) participants' as well as ulcerative colitis (UC) participants' preferences towards the attributes of treatment with advanced therapies for IBD, including safety and efficacy profiles, frequency and route of administration (RoA) in a real-world setting.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda


title: Study of the Impact of Severe Brain Injury on the Neuro-vascular and Endothelial Regulation of Peripheral Microcirculation.

acronym: MicroTC

summary:
Severe brain injury (SBI) is one of the world's leading causes of death and disability in young adults, but its peripheral vascular consequences in humans are poorly understood.

This prospective, monocentric, pathophysiological study aims to investigate differences in vasoreactivity in the anterior aspect of the contralateral forearm at the most injured cerebral hemisphere between patients with severe head trauma and patients with severe trauma without associated brain injury matched on sex and age (+/- 5 years).


title: Multicenter, Prospective, Longitudinal and Randomized Comparison of Both the Clinical and Economic Impact of Biosynthetic Absorbable Mesh to the Surgical Standard of Care in Contaminated Incisional Hernia Repair

acronym: COMpACT-BIO

summary: Incisional hernia is one of the most common complications of abdominal surgery and carries a significant burden for both patients and the economic health service. However, no consensus for the surgical treatment of incisional hernia in contaminated field is currently available. The purpose of the COMpACT-BIO study is to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair.

ReferenceCitation: Passot G, Margier J, Kefleyesus A, Rousset P, Ortega-Deballon P, Renard Y, Bin S, Villeneuve L. Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluation. BMJ Open. 2022 Aug 25;12(8):e061184. doi: 10.1136/bmjopen-2022-061184.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

appel_a_projets: PHRCI

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: COMpACT-BIO

titre: Comparaison de l'impact de 2 stratégies standardisées de Cure d'éventratiOn MédiAne en milieu chirurgical « Contaminé » : ProThèse BIOsynthétique versus soins standards. Essai randomisé de phase III avec évaluation médico-économique

discipline_principale: hors cancer

nom_porteur: PASSOT

prenom_porteur: Guillaume


title: Assessement of Cardiac and Lung Consequences of COVID-19 Infection in the Professional Soccer Players: A Prospective Observational Study

summary: During this world COVID-19 outbreak, and according to the experience of team doctors, after their return, some players could have been affected by the SARS-cov2. Also, this study aims to clearly determine the condition of athletes at the end of lockdown after this COVID-19 crisis and the cardiorespiratory consequences in particular in those who have been affected by COVID-19 and the prevalence of acute myocarditis. The investigators assess in this observational study the cardiac and lung consequences of COVID-19..

ReferenceCitation: Fang Y, Zhang H, Xie J, Lin M, Ying L, Pang P, Ji W. Sensitivity of Chest CT for COVID-19: Comparison to RT-PCR. Radiology. 2020 Aug;296(2):E115-E117. doi: 10.1148/radiol.2020200432. Epub 2020 Feb 19. No abstract available.

ReferenceCitation: Toresdahl BG, Asif IM. Coronavirus Disease 2019 (COVID-19): Considerations for the Competitive Athlete. Sports Health. 2020 May/Jun;12(3):221-224. doi: 10.1177/1941738120918876. Epub 2020 Apr 6. No abstract available.

ReferenceCitation: Eirale C, Bisciotti G, Corsini A, Baudot C, Saillant G, Chalabi H. Medical recommendations for home-confined footballers' training during the COVID-19 pandemic: from evidence to practical application. Biol Sport. 2020 Jun;37(2):203-207. doi: 10.5114/biolsport.2020.94348. Epub 2020 Apr 10.

ReferenceCitation: Schellhorn P, Klingel K, Burgstahler C. Return to sports after COVID-19 infection. Eur Heart J. 2020 Dec 7;41(46):4382-4384. doi: 10.1093/eurheartj/ehaa448. No abstract available.

ReferenceCitation: Kochi AN, Tagliari AP, Forleo GB, Fassini GM, Tondo C. Cardiac and arrhythmic complications in patients with COVID-19. J Cardiovasc Electrophysiol. 2020 May;31(5):1003-1008. doi: 10.1111/jce.14479. Epub 2020 Apr 13.

ReferenceCitation: Siripanthong B, Nazarian S, Muser D, Deo R, Santangeli P, Khanji MY, Cooper LT Jr, Chahal CAA. Recognizing COVID-19-related myocarditis: The possible pathophysiology and proposed guideline for diagnosis and management. Heart Rhythm. 2020 Sep;17(9):1463-1471. doi: 10.1016/j.hrthm.2020.05.001. Epub 2020 May 5.

ReferenceCitation: Kim JH. Screening Athletes for Myocarditis With Cardiac Magnetic Resonance Imaging After COVID-19 Infection-Lessons From an English Philosopher. JAMA Cardiol. 2021 Aug 1;6(8):950-951. doi: 10.1001/jamacardio.2020.7463. No abstract available.

ReferenceCitation: Martinez MW, Tucker AM, Bloom OJ, Green G, DiFiori JP, Solomon G, Phelan D, Kim JH, Meeuwisse W, Sills AK, Rowe D, Bogoch II, Smith PT, Baggish AL, Putukian M, Engel DJ. Prevalence of Inflammatory Heart Disease Among Professional Athletes With Prior COVID-19 Infection Who Received Systematic Return-to-Play Cardiac Screening. JAMA Cardiol. 2021 Jul 1;6(7):745-752. doi: 10.1001/jamacardio.2021.0565.

lead_sponsor: American Hospital of Paris


title: Reliability of a New Pulse Contour Technique for Diagnosing an Increase in Stroke Volume During a Fluid Challenge for Hemodynamic Optimization in Patients Scheduled for High-risk Abdominal Surgery: Comparison With Transthoracic Echocardiography: COMPARE Study

acronym: COMPARE

summary: The present study aims at assessing the ability of a new pulse contour device for diagnosing a >15% stroke volume (SV) increase during patient hemodynamic optimization by fluid challenge in high risk abdominal surgery.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Salvage Therapy for Patients With Inadequate Response to Standard of Care Therapy in Granulomatosis With Polyangiitis

acronym: SATELITE

summary: The purpose of this study is to identify the most promising therapeutic strategy for patients with granulomatosis with polyangiitis and inadequate response to standard of care therapy. It will evaluate the efficacy to induce remission of three different salvage strategies including: a combination of rituximab with addition of a conventional disease-modifying antirheumatic drugs (either methotrexate, azathioprine or mycophenolate mofetil, but preferentially methotrexate); tocilizumab; or abatacept.

status: Not yet recruiting

ReferenceCitation: Yates M, Watts RA, Bajema IM, Cid MC, Crestani B, Hauser T, Hellmich B, Holle JU, Laudien M, Little MA, Luqmani RA, Mahr A, Merkel PA, Mills J, Mooney J, Segelmark M, Tesar V, Westman K, Vaglio A, Yalcindag N, Jayne DR, Mukhtyar C. EULAR/ERA-EDTA recommendations for the management of ANCA-associated vasculitis. Ann Rheum Dis. 2016 Sep;75(9):1583-94. doi: 10.1136/annrheumdis-2016-209133. Epub 2016 Jun 23. Erratum In: Ann Rheum Dis. 2017 Aug;76(8):1480. Ann Rheum Dis. 2022 Jun;81(6):e109.

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

ReferenceCitation: Holle JU, Dubrau C, Herlyn K, Heller M, Ambrosch P, Noelle B, Reinhold-Keller E, Gross WL. Rituximab for refractory granulomatosis with polyangiitis (Wegener's granulomatosis): comparison of efficacy in granulomatous versus vasculitic manifestations. Ann Rheum Dis. 2012 Mar;71(3):327-33. doi: 10.1136/ard.2011.153601. Epub 2011 Oct 21.

ReferenceCitation: Hellmich B, Flossmann O, Gross WL, Bacon P, Cohen-Tervaert JW, Guillevin L, Jayne D, Mahr A, Merkel PA, Raspe H, Scott DG, Witter J, Yazici H, Luqmani RA. EULAR recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis: focus on anti-neutrophil cytoplasm antibody-associated vasculitis. Ann Rheum Dis. 2007 May;66(5):605-17. doi: 10.1136/ard.2006.062711. Epub 2006 Dec 14.

ReferenceCitation: Sakai R, Kondo T, Kurasawa T, Nishi E, Okuyama A, Chino K, Shibata A, Okada Y, Takei H, Nagasawa H, Amano K. Current clinical evidence of tocilizumab for the treatment of ANCA-associated vasculitis: a prospective case series for microscopic polyangiitis in a combination with corticosteroids and literature review. Clin Rheumatol. 2017 Oct;36(10):2383-2392. doi: 10.1007/s10067-017-3752-0. Epub 2017 Jul 21.

ReferenceCitation: Berti A, Cavalli G, Campochiaro C, Guglielmi B, Baldissera E, Cappio S, Sabbadini MG, Doglioni C, Dagna L. Interleukin-6 in ANCA-associated vasculitis: Rationale for successful treatment with tocilizumab. Semin Arthritis Rheum. 2015 Aug;45(1):48-54. doi: 10.1016/j.semarthrit.2015.02.002. Epub 2015 Feb 20.

ReferenceCitation: Berti A, Warner R, Johnson K, Cornec D, Schroeder DR, Kabat BF, Langford CA, Kallenberg CGM, Seo P, Spiera RF, St Clair EW, Fervenza FC, Stone JH, Monach PA, Specks U, Merkel PA; RAVE-ITN Research Group. The association of serum interleukin-6 levels with clinical outcomes in antineutrophil cytoplasmic antibody-associated vasculitis. J Autoimmun. 2019 Dec;105:102302. doi: 10.1016/j.jaut.2019.07.001. Epub 2019 Jul 15.

ReferenceCitation: Langford CA, Monach PA, Specks U, Seo P, Cuthbertson D, McAlear CA, Ytterberg SR, Hoffman GS, Krischer JP, Merkel PA; Vasculitis Clinical Research Consortium. An open-label trial of abatacept (CTLA4-IG) in non-severe relapsing granulomatosis with polyangiitis (Wegener's). Ann Rheum Dis. 2014 Jul;73(7):1376-9. doi: 10.1136/annrheumdis-2013-204164. Epub 2013 Dec 9.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin

acronyme: SATELITE

titre: Traitement de sauvetage pour les patients ayant une réponse inadéquate au traitement de référence dans la granulomatose avec polyangéite

discipline_principale: médecine interne

nom_porteur: LONDON

prenom_porteur: Jonathan


title: Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock

acronym: NOVECAR

summary: The purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

lead_sponsor: Bicetre Hospital


title: Comparison of 4 Tactical Tourniquets Used in War Medicine

summary:
Bleeding remains the leading cause of death in combat, and the literature suggests that tourniquetable hemorrhage is the second leading cause of preventable death, behind non- tourniquetable hemorrhage.

Currently, most Western armed forces recommend the use of the tactical tourniquet in combat for the management of tourniquetable hemorrhage.

The SOFTT® tourniquet (Tactical Medical Solutions, Anderson) is the tactical tourniquet currently in use by the French armed forces. As the contract will soon come to an end, the question of its renewal arises.

The purpose of this study is to compare 4 commercially available tactical tourniquets in healthy volunteers.

The hypothesis of the research is that one of the 4 tourniquets compared is faster to set up than the others.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Desgenettes


title: Clinical and Mechanistic Study of Patients With a Recent Acrosyndrome

acronym: ACROCOVID

summary:
The recent and unexpected occurrence of patients with the development of skin lesions on the hands and/ or feet has been described recently. As these cases occurred contemporaneously with the Coronavirus Disease 2019 (COVID-19) and as it was the most often occurrence of de novo frostbites, the question raised of whether there is a direct link between the occurrence of these lesions and infection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) the responsible for CoVID-19. Indeed, mechanisms of these lesions and the precise correlation with Sars-CoV-2 remains poorly understood. Therefore, this study aim to:

Determine the possible link with this virus,
Understand the mechanisms involved in the pathogenesis of these lesions.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Institut Cochin

location_facility: Department of Dermatology, Tarnier hospital, AP-HP


title: Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment

summary:
The intraoperative recognition of target structures, which need to be preserved or selectively removed, is of paramount importance during surgical procedures. This task relies mainly on the anatomical knowledge and experience of the operator. Misperception of the anatomy can have devastating consequences. Hyperspectral imaging (HSI) represents a promising technology that is able to perform a real-time optical scanning over a large area, providing both spatial and spectral information. HSI is an already established method of objectively classifying image information in a number of scientific fields (e.g. remote sensing).

Our group recently employed HSI as intraoperative tool in the porcine model to quantify perfusion of the organs of the gastrointestinal tract against robust biological markers. Results showed that this technology is able to quantify bowel blood supply with a high degree of precision. Hyperspectral signatures have been successfully used, coupled to machine learning algorithms, to discriminate fine anatomical structures such as nerves or ureters intraoperatively (unpublished data).

The i-EX-MACHYNA3 study aims at translating the HSI technology in combination with several deep learning algorithms to differentiate among different classes of human tissues (including key anatomical structures such as BD, nerves and ureters).

ReferenceCitation: Goetz AF, Vane G, Solomon JE, Rock BN. Imaging spectrometry for Earth remote sensing. Science. 1985 Jun 7;228(4704):1147-53. doi: 10.1126/science.228.4704.1147.

ReferenceCitation: Lu G, Fei B. Medical hyperspectral imaging: a review. J Biomed Opt. 2014 Jan;19(1):10901. doi: 10.1117/1.JBO.19.1.010901.

ReferenceCitation: Jansen-Winkeln B, Maktabi M, Takoh JP, Rabe SM, Barberio M, Kohler H, Neumuth T, Melzer A, Chalopin C, Gockel I. [Hyperspectral imaging of gastrointestinal anastomoses]. Chirurg. 2018 Sep;89(9):717-725. doi: 10.1007/s00104-018-0633-2. German.

ReferenceCitation: Kohler H, Jansen-Winkeln B, Maktabi M, Barberio M, Takoh J, Holfert N, Moulla Y, Niebisch S, Diana M, Neumuth T, Rabe SM, Chalopin C, Melzer A, Gockel I. Evaluation of hyperspectral imaging (HSI) for the measurement of ischemic conditioning effects of the gastric conduit during esophagectomy. Surg Endosc. 2019 Nov;33(11):3775-3782. doi: 10.1007/s00464-019-06675-4. Epub 2019 Jan 23.

ReferenceCitation: Jansen-Winkeln B, Holfert N, Kohler H, Moulla Y, Takoh JP, Rabe SM, Mehdorn M, Barberio M, Chalopin C, Neumuth T, Gockel I. Determination of the transection margin during colorectal resection with hyperspectral imaging (HSI). Int J Colorectal Dis. 2019 Apr;34(4):731-739. doi: 10.1007/s00384-019-03250-0. Epub 2019 Feb 2.

ReferenceCitation: Akbari H, Kosugi Y, Kojima K, Tanaka N. Detection and analysis of the intestinal ischemia using visible and invisible hyperspectral imaging. IEEE Trans Biomed Eng. 2010 Aug;57(8):2011-7. doi: 10.1109/TBME.2010.2049110. Epub 2010 May 10.

ReferenceCitation: Barberio M, Longo F, Fiorillo C, Seeliger B, Mascagni P, Agnus V, Lindner V, Geny B, Charles AL, Gockel I, Worreth M, Saadi A, Marescaux J, Diana M. HYPerspectral Enhanced Reality (HYPER): a physiology-based surgical guidance tool. Surg Endosc. 2020 Apr;34(4):1736-1744. doi: 10.1007/s00464-019-06959-9. Epub 2019 Jul 15.

ReferenceCitation: Akbari H, Halig LV, Schuster DM, Osunkoya A, Master V, Nieh PT, Chen GZ, Fei B. Hyperspectral imaging and quantitative analysis for prostate cancer detection. J Biomed Opt. 2012 Jul;17(7):076005. doi: 10.1117/1.JBO.17.7.076005.

ReferenceCitation: Baltussen EJM, Kok END, Brouwer de Koning SG, Sanders J, Aalbers AGJ, Kok NFM, Beets GL, Flohil CC, Bruin SC, Kuhlmann KFD, Sterenborg HJCM, Ruers TJM. Hyperspectral imaging for tissue classification, a way toward smart laparoscopic colorectal surgery. J Biomed Opt. 2019 Jan;24(1):1-9. doi: 10.1117/1.JBO.24.1.016002.

ReferenceCitation: Han Z, Zhang A, Wang X, Sun Z, Wang MD, Xie T. In vivo use of hyperspectral imaging to develop a noncontact endoscopic diagnosis support system for malignant colorectal tumors. J Biomed Opt. 2016 Jan;21(1):16001. doi: 10.1117/1.JBO.21.1.016001. No abstract available.

ReferenceCitation: Li Y, Deng L, Yang X, Liu Z, Zhao X, Huang F, Zhu S, Chen X, Chen Z, Zhang W. Early diagnosis of gastric cancer based on deep learning combined with the spectral-spatial classification method. Biomed Opt Express. 2019 Sep 9;10(10):4999-5014. doi: 10.1364/BOE.10.004999. eCollection 2019 Oct 1.

ReferenceCitation: Hu B, Du J, Zhang Z, Wang Q. Tumor tissue classification based on micro-hyperspectral technology and deep learning. Biomed Opt Express. 2019 Nov 19;10(12):6370-6389. doi: 10.1364/BOE.10.006370. eCollection 2019 Dec 1.

ReferenceCitation: Fabelo H, Ortega S, Ravi D, Kiran BR, Sosa C, Bulters D, Callico GM, Bulstrode H, Szolna A, Pineiro JF, Kabwama S, Madronal D, Lazcano R, J-O'Shanahan A, Bisshopp S, Hernandez M, Baez A, Yang GZ, Stanciulescu B, Salvador R, Juarez E, Sarmiento R. Spatio-spectral classification of hyperspectral images for brain cancer detection during surgical operations. PLoS One. 2018 Mar 19;13(3):e0193721. doi: 10.1371/journal.pone.0193721. eCollection 2018.

ReferenceCitation: Ma L, Lu G, Wang D, Wang X, Chen ZG, Muller S, Chen A, Fei B. Deep Learning based Classification for Head and Neck Cancer Detection with Hyperspectral Imaging in an Animal Model. Proc SPIE Int Soc Opt Eng. 2017 Feb;10137:101372G. doi: 10.1117/12.2255562. Epub 2017 Mar 13.

ReferenceCitation: Fei B, Lu G, Wang X, Zhang H, Little JV, Patel MR, Griffith CC, El-Diery MW, Chen AY. Label-free reflectance hyperspectral imaging for tumor margin assessment: a pilot study on surgical specimens of cancer patients. J Biomed Opt. 2017 Aug;22(8):1-7. doi: 10.1117/1.JBO.22.8.086009.

ReferenceCitation: Halicek M, Lu G, Little JV, Wang X, Patel M, Griffith CC, El-Deiry MW, Chen AY, Fei B. Deep convolutional neural networks for classifying head and neck cancer using hyperspectral imaging. J Biomed Opt. 2017 Jun 1;22(6):60503. doi: 10.1117/1.JBO.22.6.060503.

ReferenceCitation: Halicek M, Dormer JD, Little JV, Chen AY, Fei B. Tumor detection of the thyroid and salivary glands using hyperspectral imaging and deep learning. Biomed Opt Express. 2020 Feb 18;11(3):1383-1400. doi: 10.1364/BOE.381257. eCollection 2020 Mar 1.

ReferenceCitation: Barberio M, Felli E, Seyller E, Longo F, Chand M, Gockel I, Geny B, Swanstrom L, Marescaux J, Agnus V, Diana M. Quantitative fluorescence angiography versus hyperspectral imaging to assess bowel ischemia: A comparative study in enhanced reality. Surgery. 2020 Jul;168(1):178-184. doi: 10.1016/j.surg.2020.02.008. Epub 2020 Mar 27.

ReferenceCitation: Zuzak KJ, Naik SC, Alexandrakis G, Hawkins D, Behbehani K, Livingston E. Intraoperative bile duct visualization using near-infrared hyperspectral video imaging. Am J Surg. 2008 Apr;195(4):491-7. doi: 10.1016/j.amjsurg.2007.05.044.

ReferenceCitation: Nawn CD, Souhan BE, Carter R 3rd, Kneapler C, Fell N, Ye JY. Distinguishing tracheal and esophageal tissues with hyperspectral imaging and fiber-optic sensing. J Biomed Opt. 2016 Nov 1;21(11):117004. doi: 10.1117/1.JBO.21.11.117004.

ReferenceCitation: Wisotzky EL, Uecker FC, Arens P, Dommerich S, Hilsmann A, Eisert P. Intraoperative hyperspectral determination of human tissue properties. J Biomed Opt. 2018 May;23(9):1-8. doi: 10.1117/1.JBO.23.9.091409.

ReferenceCitation: Nouri D, Lucas Y, Treuillet S. Hyperspectral interventional imaging for enhanced tissue visualization and discrimination combining band selection methods. Int J Comput Assist Radiol Surg. 2016 Dec;11(12):2185-2197. doi: 10.1007/s11548-016-1449-5. Epub 2016 Jul 4.

lead_sponsor: IHU Strasbourg

sponsor_collaborators:
IHU Strasbourg
ARC Foundation for Cancer Research

location_facility: Service de Chirurgie Digestive et Endocrinienne, NHC


title: Behav'Robot: Understanding the Surgeon Behavior During Robot-assisted Surgery (a Qualitative Study)

summary:
Robot-assisted surgery is spreading since the last decade, but little is known about the impact of the use of the robot on surgeon practices and behavior in the operation theatre.

Interviewing senior surgeons trained for doing robot-assisted surgery, this qualitative study is expected to provide new insights to understand the surgeons' behavioral changes when using a robot.

This study will contribute to improving training programs in robot-assisted surgery.

ReferenceCitation: Cormi C, Parpex G, Julio C, Ecarnot F, Laplanche D, Vannieuwenhuyse G, Duclos A, Sanchez S. Understanding the surgeon's behaviour during robot-assisted surgery: protocol for the qualitative Behav'Robot study. BMJ Open. 2022 Apr 7;12(4):e056002. doi: 10.1136/bmjopen-2021-056002.

lead_sponsor: Centre Hospitalier de Troyes


title: Analysis of the Periodontal Microbiota in Elderly Subjects With and Without Alzheimer's Disease: a Case Control Study

acronym: ORAMICAL

summary: The neurological disorders that accompany aging represent a major public health problem. The management of these diseases is a major medical and social priority. This project is based on the assumption that the oral cavity represents a privileged observation space to address these issues. The mouth is a site of easy access for painless sampling; there is therefore a major interest in identifying early oral infectious markers of the development or evolution of senile dementia. In addition to the interest of an early oral diagnosis, the mapping of the oral microbial flora in the demented elderly would allow a better understanding, prevention or even control of the evolution of neurodegenerative diseases. The final objective of our approach is to characterize the oral pathogens, or more probably the group of oral pathogens, which are significantly associated with Alzheimer's disease.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Contribution of Whole Body Muscle MRI for Early Diagnosis of Amyotrophic Lateral Sclerosis.

acronym: MIDALS

summary: Nearly 60% of Amyotrophic Lateral Sclerosis (ALS) patients have a low level of diagnostic certainty (possible, probable) at the time of diagnosis. In the absence of biomarkers, this diagnosis is based, among other things, on the demonstration of the diffusion of signs of denervation by electroneuromyography (ENMG). The objective of this study is to improve the earliness and the level of diagnostic certainty by better demonstrating the diffusion of the denervation process by whole body muscular MRI.

lead_sponsor: University Hospital, Toulouse


title: Heterogeneity in Rhabdoid Tumors : Proteomic and Single-Cell Analyses to Identify New Therapeutic Targets

summary: The investigators aim to explore the inter tumor heterogeneity by a proteomic approach of a wide series of rhabdoid tumors, from both intra and extra cranial origins.

collaborators:
Institut Curie
Sainte Anne hospital

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Institut Curie
Sainte Anne hospital

location_facility: Service de neurochirurgie - Hôpital Necker Enfants malades


title: Efficacy of Self-administered Hypnosis for the Complementary Management of Anxiety and Dyspnea During Pulmonary Rehabilitation: A 2-armed Randomized Controlled Trial

summary: Patients with chronic obstructive pulmonary disease (COPD) are prone to breathlessness, chest tightness and other anxiety-inducing symptoms. Medical therapy for the condition focus on improving these symptoms and preventing exacerbations. However, as the disease progresses, pharmacological therapies become less and less effective. Patients with advanced COPD often feel less benefit from the treatment in terms of relief from their symptoms and relief from anxiety about their breathing. Hypnosis is known to induce immediate changes in how a person thinks and experiences their body. These changes can break vicious cycles of anxiety. Hypnosis has already been used successfully people with breathing problems to reduce anxiety and improve breathing. This trial aims to investigate the effect of hypnosis as a complementary technique for the self-management of breathlessness and anxiety during a Pulmonary Rehabilitation Program (PRP). As a secondary measure, the investigators aim to uncover whether the use of self-hypnosis remains useful during the three months following the PRP, after discharge from hospital.

ReferenceCitation: Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary. Respirology. 2017 Apr;22(3):575-601. doi: 10.1111/resp.13012. Epub 2017 Mar 7.

ReferenceCitation: Han MK, Muellerova H, Curran-Everett D, Dransfield MT, Washko GR, Regan EA, Bowler RP, Beaty TH, Hokanson JE, Lynch DA, Jones PW, Anzueto A, Martinez FJ, Crapo JD, Silverman EK, Make BJ. GOLD 2011 disease severity classification in COPDGene: a prospective cohort study. Lancet Respir Med. 2013 Mar;1(1):43-50. doi: 10.1016/S2213-2600(12)70044-9. Epub 2012 Sep 3.

ReferenceCitation: Pumar MI, Gray CR, Walsh JR, Yang IA, Rolls TA, Ward DL. Anxiety and depression-Important psychological comorbidities of COPD. J Thorac Dis. 2014 Nov;6(11):1615-31. doi: 10.3978/j.issn.2072-1439.2014.09.28.

ReferenceCitation: Hegerl U, Mergl R. Depression and suicidality in COPD: understandable reaction or independent disorders? Eur Respir J. 2014 Sep;44(3):734-43. doi: 10.1183/09031936.00193213. Epub 2014 May 29.

ReferenceCitation: Kellner R, Samet J, Pathak D. Dyspnea, anxiety, and depression in chronic respiratory impairment. Gen Hosp Psychiatry. 1992 Jan;14(1):20-8. doi: 10.1016/0163-8343(92)90022-3.

ReferenceCitation: Maurer J, Rebbapragada V, Borson S, Goldstein R, Kunik ME, Yohannes AM, Hanania NA; ACCP Workshop Panel on Anxiety and Depression in COPD. Anxiety and depression in COPD: current understanding, unanswered questions, and research needs. Chest. 2008 Oct;134(4 Suppl):43S-56S. doi: 10.1378/chest.08-0342.

ReferenceCitation: Di Marco F, Verga M, Reggente M, Maria Casanova F, Santus P, Blasi F, Allegra L, Centanni S. Anxiety and depression in COPD patients: The roles of gender and disease severity. Respir Med. 2006 Oct;100(10):1767-74. doi: 10.1016/j.rmed.2006.01.026. Epub 2006 Mar 13.

ReferenceCitation: Cafarella PA, Effing TW, Usmani ZA, Frith PA. Treatments for anxiety and depression in patients with chronic obstructive pulmonary disease: a literature review. Respirology. 2012 May;17(4):627-38. doi: 10.1111/j.1440-1843.2012.02148.x.

ReferenceCitation: Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.

ReferenceCitation: Basoglu M. Effective management of breathlessness: a review of potential human rights issues. Eur Respir J. 2017 May 25;49(5):1602099. doi: 10.1183/13993003.02099-2016. Print 2017 May. No abstract available.

ReferenceCitation: Tselebis A, Pachi A, Ilias I, Kosmas E, Bratis D, Moussas G, Tzanakis N. Strategies to improve anxiety and depression in patients with COPD: a mental health perspective. Neuropsychiatr Dis Treat. 2016 Feb 9;12:297-328. doi: 10.2147/NDT.S79354. eCollection 2016.

ReferenceCitation: Smith SM, Sonego S, Ketcheson L, Larson JL. A review of the effectiveness of psychological interventions used for anxiety and depression in chronic obstructive pulmonary disease. BMJ Open Respir Res. 2014 Nov 3;1(1):e000042. doi: 10.1136/bmjresp-2014-000042. eCollection 2014.

ReferenceCitation: Hynninen MJ, Bjerke N, Pallesen S, Bakke PS, Nordhus IH. A randomized controlled trial of cognitive behavioral therapy for anxiety and depression in COPD. Respir Med. 2010 Jul;104(7):986-94. doi: 10.1016/j.rmed.2010.02.020. Epub 2010 Mar 25.

ReferenceCitation: Lolak S, Connors GL, Sheridan MJ, Wise TN. Effects of progressive muscle relaxation training on anxiety and depression in patients enrolled in an outpatient pulmonary rehabilitation program. Psychother Psychosom. 2008;77(2):119-25. doi: 10.1159/000112889. Epub 2008 Jan 25.

ReferenceCitation: Volpato E, Banfi P, Rogers SM, Pagnini F. Relaxation Techniques for People with Chronic Obstructive Pulmonary Disease: A Systematic Review and a Meta-Analysis. Evid Based Complement Alternat Med. 2015;2015:628365. doi: 10.1155/2015/628365. Epub 2015 Aug 3.

ReferenceCitation: Vickers A, Zollman C. ABC of complementary medicine. Hypnosis and relaxation therapies. BMJ. 1999 Nov 20;319(7221):1346-9. doi: 10.1136/bmj.319.7221.1346. No abstract available.

ReferenceCitation: Montgomery GH, Sucala M, Baum T, Schnur JB. Hypnosis for Symptom Control in Cancer Patients at the End-of-Life: A Systematic Review. Int J Clin Exp Hypn. 2017 Jul-Sep;65(3):296-307. doi: 10.1080/00207144.2017.1314728.

ReferenceCitation: Anllo H, Herer B, Delignieres A, Bocahu Y, Segundo I, Mach Alingrin V, Gilbert M, Larue F. Hypnosis for the Management of Anxiety and Dyspnea in COPD: A Randomized, Sham-Controlled Crossover Trial. Int J Chron Obstruct Pulmon Dis. 2020 Oct 22;15:2609-2620. doi: 10.2147/COPD.S267019. eCollection 2020.

ipd_sharing_description: The anonymized data will be available for free, upon request to the Centre Hospitalier de Bligny. The Centre Hospitalier de Bligny will only share the data to inquirers capable of respecting the conditions established by the Commission Nationale de l'Informatique et des Libertés for data protection (CNIL, https://www.cnil.fr/). Please address any questions to the corresponding author at hernan.anllo@cri-paris.org.

lead_sponsor: Centre Hospitalier de Bligny


title: Psychiatric Manifestations Associated With Behcet's Disease

summary: The psychoBehçet'study is aimed at evaluating the psychological and neurocognitive symptoms in 25 consecutive patients followed for Behçet's disease. This is a monocentric, observational, non interventional study.


title: Effect of Ultrasound-guided Intermediate Cervical Block on Recurrent Laryngeal Nerve Monitoring During Thyroid Surgery : a Randomised Non-inferiority Study

summary: Non-inferiority study aimed to assess the impact of cervical block on recurrent laryngeal nerve monitoring during thyroid surgery Secondary outcomes will assess post-operative recovery, post-operative pain and post-operative dysphonia

lead_sponsor: University Hospital, Caen

sponsor_collaborators:
University Hospital, Caen
Centre Francois Baclesse


title: Assessment of the Presence, and Characterization, of Tumor-associated Neutrophils in Bone Sarcomas: Pilot Study

acronym: TANOs

summary:
Hypothesis: Tumor infiltrating neutrophils are present in osteosarcomas and chondrosarcomas and

Experimental design: Exploratory observational research

Population: Adult patients with osteosarcoma or chondrosarcoma

Assessment criteria: Determination of the presence of TANs within tumors and their N1 or N2 profile, the presence of other immune cells, and the PDL-1 status of the tumor.

Investigation plan: Proposal to participate at all eligible patient during the preoperative consultation. If the patient agrees to participate in the study he/she will be included. Participation in the study will not affect its coverage. Patient participation will lead to:

Taking samples from an operative part,
The collection of demographic data (age, sex, height, weight, body mass index), family history of cancer, history of bone trauma, sports practice, clinical and anatomopathology reports and data, medical history (Diabetes, Cardiovascular Diseases, Infectious Diseases, Autoimmune Diseases, Bone Metabolism Disorders, Allergies, Menopause, Drug treatments followed, Psychiatric disorders).

Statistical analysis plan: Description in frequency of the presence of TANs, of N1 and N2 profiles, of the presence of other immune cells both qualitatively and quantitatively. Analysis in subgroups on relevant criteria (age, sex, location, type of tumor).

lead_sponsor: Université de Reims Champagne-Ardenne


title: Study of the Viral Load and Humoral and Cellular B and T Responses in Patients With Rheumatoid Arthritis and Spondyloarthritis Under Immunosuppressive Treatments

acronym: COVIRIC

summary: The purpose of this study is to assess whether immunosuppressive therapies used by patients with chronic inflammatory rheumatic diseases have an impact on the viral load and the humoral and cellular responses during viral infection with SarSCoV2, compared to members of their family cluster infected with the same viral strain.

status: Terminated


title: Prevalence and Incidence of Iron Deficiency in Cystic Fibrosis

summary:
Iron is a biologically essential micronutrient. Iron deficiency alters erythropoiesis and is considered as a major cause of disability worldwide. Interestingly, iron overload is never observed in cystic fibrosis contrarily to others chronic respiratory diseases. Moreover, iron deficiency reported prevalence in CF is very high (up to 60% in retrospective series) and is correlated to an alteration of respiratory function.

Cystic fibrosis patients should be tested annually for iron deficiency. Serum ferritin is the best diagnosis tool for iron deficiency (specificity 87% for a threshold < 30 µg/L). Previously published studies used less performant markers such as serum iron (< 12 µmol/L) or transferrin saturation (< 12%), which are markedly influenced by the systemic inflammation. CF patients experiences frequent pulmonary exacerbations leading to systemic inflammation: iron stores should therefore be assessed at optimal time with no inflammation.

The I-MUCO study aims to determine the exact prevalence of iron deficiency in CF patients. We aimed to identify risk factors for iron deficiency onset.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Ressources et de Compétences de la Mucoviscidose adulte de Lyon - Centre Hospitalier Lyon Sud


title: Evaluation of the Diagnostic Performance of Specialized Fetal Cardiac Ultrasound in the CPDPN - Arc Alpin Network From 2015 to 2019 Descriptive, Retrospective, Single-center Study Over 5 Years.

acronym: Qualicard

summary:
To evaluate the diagnostic performance of antenatal echocardiography with regard to the main diagnosis of heart disease made by cardio-pediatricians at the couple-child hospital in Grenoble according to the ACC-CHD classification, in pregnant women who have had a fetal heart ultrasound between 2015 and 2019.

*ACC-CHD : Anatomic and Clinical Classification of Congenital Heart Defects

lead_sponsor: University Hospital, Grenoble

location_facility: Centre Hospitalier Universitaire GRENOBLE ALPES


title: Dyspnea in Idiopathic Pulmonary Fibrosis (IPF): Multidimensional Assessment and Correlations With Lung Function

acronym: DYS-PID

summary: Longitudinal prospective exploratory study on the evolution of dyspnea, in its sensory and affective dimensions, in patients followed for idiopathic pulmonary fibrosis (IPF), between inclusion and a 6-month evaluation

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Santelys Association


title: Eye Movement During Autobiographical Memory in Alzheimer's Disease

acronym: EMAM

summary: This study aims at the assessment of eye movement during autobiographical retrieval (i.e., retrieval of personal memories) in patients with Alzheimer's Disease.

ReferenceType: result

ReferenceCitation: El Haj M, M J Janssen S, Gallouj K, Lenoble Q. Autobiographical Memory Increases Pupil Dilation. Transl Neurosci. 2019 Dec 19;10:280-287. doi: 10.1515/tnsci-2019-0044. eCollection 2019.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: HAL

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: De Gruyter

lead_sponsor: Nantes University Hospital


title: Changes in the MRI Signal in Patients With Benign Tumors of the Brain and Meninges Treated With Proton Therapy: Impact of TEL and the Biological Dose Received

acronym: BRAIN TEL

summary: The main objective is to detect with TESLA multiparametric 3 MRI, the MRI secondary changes to protontherapy irradiation and to correlate them with TEL mapping, physical dose and biological dose. A model should thus be able to be proposed at the end of the study.

lead_sponsor: Centre Francois Baclesse


title: Energy Adaptations During Active Workstation Use: Strategy for Individualization of Active Desk Programs

acronym: PROFILE

summary: The recent literature has highlighting the importance of the time of SB and the level of physical activity (PA) as predictors of metabolic cardio risks. Now, sedentary lifestyles are well recognized as one of the causes of mortality. As with physical activity, a dose-response relationship appears to exist: mortality would increase with time spent in sedentary behaviors. However, this relationship would not be linear: the more the daily sitting time increases, the more the consequences on mortality are important. It is now well demonstrated that time spent in sedentary adult behaviour finds primarily its origin in the work, characterized by prolonged and uninterrupted periods of sitting. Many strategies have been settled to break the prolonged sitting time. The most promising one seem to be the use of active workstations (standing, walking, cycling, stepping) because they reduce sedentary time at work and increase physical activity with positive effects on the global health. However inter variability in energy response have been identified during a sit to stand allocation with subject "savers" profile showing an increase in energy expenditure while others categorized as "non-savers" increased significantly their energy expenditure between sitting and standing position. As others active workstation strategies exist, this study aim to first, better characterize energy response to posture and activity allocation (15min sit-15min stand-15min sit-15min low intensity cycling), secondly to identify parameters that could explain different energy profile.

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Laboratory AME2P UR3533
Université d'Auvergne


title: Evaluation of the Nasal and Conjunctival Response in Subjects Allergic to Birch Pollen in the ALYATEC Environmental Exposure Chamber

summary: The aim of this study is to assess the nasal and conjunctival response in subjects allergic to birch pollen during controlled exposures in the ALYATEC environmental exposure chamber (EEC)

lead_sponsor: Alyatec


title: Primitive Immunodeficiency and Pregnancy

acronym: PREPI

summary:
The management of patients with primary immune deficiency is increasingly codified, however contraception and pregnancy have not yet extensively studied or codified, and the medical monitoring and the prevention of infectious complications thus remains at the discretion of the practitioner.

The aim the research is to study the obstetric features and outcome of patients with primary immune defects.

ReferenceCitation: Mallart E, Francoise U, Driessen M, Blanche S, Lortholary O, Lefort A, Caseris M, Fischer A, Mahlaoui N, Charlier C; PREPI study group. Pregnancy in primary immunodeficiency diseases: The PREPI study. J Allergy Clin Immunol. 2023 Sep;152(3):760-770. doi: 10.1016/j.jaci.2023.05.006. Epub 2023 May 18.

publisher_dissemination: Elsevier

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Frequency of Clonal Hematopoiesis in Patients Over 75 With a First Cardio Vascular Event. Consequences on Inflammation and Atherosclerosis

acronym: CHATH

summary: This study aims at evaluating the prevalence of Clonal Hematopoiesis of Indeterminate Potential (CHIP) in patients over 75 presenting with a first cardio-vascular event (CVE). The investigators will also determine if CHIPs are more frequent in this population compared to a control cohort without CVE. An association between CHIP, a systemic inflammation and increased atherosclerosis will also be assessed.

lead_sponsor: University Hospital, Bordeaux


title: Assessment of Serum Neurofilament-light Chain (NfL) and Glial Fibrillary Acidic Protein (GFAP) Levels, Atrophy of the Macular Ganglion Cell Complex (GCC) by Optical Coherence Tomography (OCT) and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in Multiple Sclerosis Patients

acronym: NFL OCT

summary: The investigators hypothesize that serum neurofilament-light chain (NfL) levels at baseline and decrease of the macular ganglion cell complex (GCC) thickness at one year vs. baseline are as good as progression of whole brain atrophy at one year vs. baseline to predict later evolution of neurological disability in multiple sclerosis patients.

status: Active, not recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Prospective Monocentric Study of Taste in Patients With Minor or Major Cognitive Disorders Such as Alzheimer's, Through the Analysis of Gustatory Evoked Potentials

acronym: MAPEG

summary:
Approximately 24 million people worldwide suffer from dementia, with Alzheimer's disease being the most common cause. Alzheimer's disease typically progresses in three stages: presymptomatic, prodromal ("early onset" or minor cognitive impairment) and major cognitive impairment with loss of autonomy and significant psycho-behavioral symptoms. Efforts to counteract its expansion are increasing, and there is a need for biomarkers to identify the disease in its earliest stage in order to provide prompt treatment.

Faced with a episodic memory disorder, it is possible, thanks to certain criteria, highlighted by neuroimaging, or by biomarkers obtained by biological analysis of cerebrospinal fluid (during a lumbar puncture), to detect Alzheimer's disease from the prodromal stage, or even earlier. The main limitation of these criteria is their invasive nature. Other non-invasive biomarkers would therefore be useful to help diagnose Alzheimer's disease at an early stage. Gustatory evoked potentials (GEP), a technique for exploring taste sensory pathways, could meet these needs.

Indeed, GEPs are a method of exploring the gustatory sensory pathway based on the recording of cerebral electrical activity by electroencephalography (EEG). It is a painless, accessible, inexpensive and non-invasive technique. The alteration of gustatory functions is present in many neurological conditions, but often takes second place to sensory or motor symptoms. Rare studies have studied taste in patients with Alzheimer's disease, but they have demonstrated, using subjective tests only, an early gustatory impairment linked to a degeneration of the gustatory cortex. It was observed that the performance of subjects with minor or major cognitive impairment was weaker than that of healthy subjects, without the patient being aware of these taste disorders.

The aim of the study is to explore taste functions in patients with minor cognitive impairment, major cognitive impairment such as mild Alzheimer's disease, by comparing them to healthy subjects. For this purpose, we wish to compare the results of subjective taste tests (tasting solutions, especially salty ones, answering food preference questionnaires), parameters of taste evoked potentials recorded by electrodes stuck on the scalp and hormonal parameters obtained by blood sampling, between the three groups of subjects mentioned.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range and Followed for 2 Years.

summary:
As part of Medical Devices CE marking regulatory process, an appropriate post-market clinical follow-up (PMCF) is required. This PMCF study is in the framework of CE mark renew of FHK® total knee prosthesis, it aims to answer specific questions related to safety and performance of the device, when used in accordance with the approved instructions for use.

This study is based on a quality of life self-assessment from the preoperative to postoperative phases and up to two years of follow-up.

lead_sponsor: FH ORTHO


title: Benefit of an at Home Telephone Follow-up After a Stay in an Intensive Rehabilitation Center for Patients With Chronic Swallowing Disorders Following a Upper Aero-digestive Tract Cancer Treatment : Open, Controlled, Randomized Study

acronym: E-CRIL

summary: Prospective, open-label, randomized, single-center study evaluating the benefit of a months long monthly telephone follow-up for patients with chronic disorders following the after-effects of anti-cancer treatments after an intensive rehabilitation stay versus standard follow-up.

sponsor_collaborators:
University Hospital, Toulouse
Fondation de l'Avenir


title: Prospective Study : Long-term Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma EQUI-GAMMA

acronym: EQUI-GAMMA

summary:
Vestibular schwannomas are benign lesions of the ponto-cerebellar angle that are potentially dangerous because of their growth in a cramped space and the compressive phenomena they can cause. Stereotactic Gammaknife radiosurgery is a treatment option that can be offered for evolutive schwannomas smaller than 2.5-3 cm in size. It allows tumor stabilisation in 85% of cases with less than 1% facial nerve damage risk.

There are controversial results regarding hearing preservation : percentages vary between 25 and 80% in the literature, depending on the criteria used and the post-treatment delay.

Few studies have investigated changes in vestibular function and the impact on balance of radiosurgery, and their results are variable.

These controversial results lead us to comprehensively assess the vestibular function and balance of these patients using a balance-specific quality of life questionnaire, in addition to objective overall vestibular assessments of vestibular function.

primary_purpose: Health Services Research


title: Effects of Self-myofascial Release and Manual Massage on Psychometric, Behavioural and Neurophysiological Indexes of Performance and Well-being: a Randomized Control Trial

acronym: AUTOMASSEEG

summary: The present double-blinded randomized controlled design aims at comparing the effects of a full-body manual massage and foam rolling intervention. Sixty-five healthy individuals were randomly allocated to foam rolling, manual massage or a control intervention consisting in an autogenic relaxation routine.

lead_sponsor: Laboratoire Interuniversitaire de Biologie de la Motricité


title: Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19.

acronym: Pro-Co-HPA

summary:
Coronavirus disease 2019 (COVID-19) is an acute infection of the respiratory tract that emerged in late 2019.

In several studies, the cardinal signs of COVID-19 associated fever, cough, sputum and dyspnea occurring in the first days of infection. In addition, myalgia was frequent (14.9-32.3%) and digestive signs which may be inaugural were also reported, such as diarrhea (3.8-5%) and nausea/vomiting (4-5%).

An increase in medical consultations for anosmia and ageusia without nasal obstruction has also been reported in the context of the COVID-19.

Mild or non-existent symptoms, but also serious forms leading to death or a long stay in intensive care, within a few months, the multiple clinical signs of SARS-CoV-2 infection were identified. But, beyond the acute symptoms, doctors and patients are discovering a whole range of disorders occurring more distantly, in hospitalized patients or not. In this context of an emerging viral infection such as SARS-CoV-2, many unknowns are still present such as the duration of symptoms or post-infectious sequelae in patients.

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


title: Use of the WALANT Anesthesia Technique for Forefoot Surgery.

acronym: WALANT

summary: To compare the perioperative pain level with WALANT anesthesia versus general anesthesia during forefoot surgery.

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


title: Early Prenatal Interview : Throwback to the Hospital of Montpellier's Experience and Description of the Psychiatric Care Pathway of Pregnant Women.

summary:
Pregnancy and postpartum are recognized as periods of psychic fragility. However, the psychiatric disorders of women that can emerge during these periods are underdiagnosed and have consequences in particular on the development of the child, his relationship with his parents.

The need for an early diagnosis to allow appropriate treatment seems to be essential.

The pregnancy monitoring is centered on the somatic and little on psychological evaluation of the mother and the father.

In this context, the Early Prenatal Interview (EPP) was created through the perinatal plan of 2005-2007 in order to allow a more precise research of the factors of vulnerabilities likely to be predictive of a somatic, psychological or social disorder.

However, until now, only few pregnant women benefited of this interview. In May 2020, EPP became mandatory for all pregnant women. It now seems important to clearly identify the place, function, organization and usefulness of this interview in order to maximize its benefit in the monitoring of pregnancy

lead_sponsor: University Hospital, Montpellier


title: A Prospective, Observational (Non-interventional), International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease

acronym: VEIN STEP

summary: The primary objective of this study is to assess in real-life settings the effectiveness of conservative treatments on symptoms, signs and quality of life, in patients consulting for CVD

lead_sponsor: Servier Affaires Médicales


title: Chronic Effects of Wide-pulse Neuromuscular Electrostimulation on Neuromuscular and Functional Properties in Healthy Subjects

acronym: ELECTRO-WP

summary: Neuromuscular electrostimulation (NMES) is a technique used in the clinical and training fields to increase the strength of a muscle group.The recent use of wide-pulse (WP) stimulations allows, in addition to the direct activation of the muscle fibers, the use of sensory pathways. This more global solicitation of the neuromuscular system (i.e. information going back to the spinal cord and even to the brain) prejudges more nervous adaptations and therefore a greater functional benefit. The first aim of this study is to evaluate and compare the force gains induced by 2 NMES training programs (CONV, WP) applied on knee extensors in healthy subjects for 6 weeks.The second aim is to understand the neuromuscular adaptations involved in these gains, as well as the functional benefit resulting from these improvements.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne