title: Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy

acronym: CHOLANGIOSIR

summary:
Cholangiocarcinoma (CCK) is a rare tumor (2000 new cases/year in France) with very poor prognosis (overall survival < 3% at 5 years). Less than 20% of patients may benefit from curative surgical resection and most patients have medical treatment by palliative treatment by palliative chemotherapy. It is not standard first-line chemotherapy validated for unresectable CCK, but the best objective response rate (OR) and overall survival (OS) are observed with gemcitabine and platinum associations (OR 24 to 36% and OS between 9.5 to 15.4 months). In case of tumor progression ater this first line therapy, no treatment is currently being validated.

RADIOEMBOLIZATION (RE) is a new, transarterial approach to radiation therapy using 90 Yttrium microspheres.

In the patients with unresectable CCK , the first pilot studies showed interesting results with rates of OR 45 to 90% and a median OS of 14.9 mots and an acceptable safety.

Study Hypothesis : RE could help achieve tumor stabilization in patients with intra-hepatic CCK in tumor progression after first-line therapy.

ReferenceCitation: West J, Wood H, Logan RF, Quinn M, Aithal GP. Trends in the incidence of primary liver and biliary tract cancers in England and Wales 1971-2001. Br J Cancer. 2006 Jun 5;94(11):1751-8.

ReferenceCitation: Khan SA, Thomas HC, Davidson BR, Taylor-Robinson SD. Cholangiocarcinoma. Lancet. 2005 Oct 8;366(9493):1303-14. Review. Erratum in: Lancet. 2006 May 20;367(9523):1656.

ReferenceCitation: Patel T. Increasing incidence and mortality of primary intrahepatic cholangiocarcinoma in the United States. Hepatology. 2001 Jun;33(6):1353-7.

ReferenceCitation: Gores GJ. Cholangiocarcinoma: current concepts and insights. Hepatology. 2003 May;37(5):961-9. Review.

ReferenceCitation: Khan SA, Davidson BR, Goldin R, Pereira SP, Rosenberg WM, Taylor-Robinson SD, Thillainayagam AV, Thomas HC, Thursz MR, Wasan H; British Society of Gastroenterology. Guidelines for the diagnosis and treatment of cholangiocarcinoma: consensus document. Gut. 2002 Nov;51 Suppl 6:VI1-9.

ReferenceCitation: Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.

ReferenceCitation: Ducreux M, Van Cutsem E, Van Laethem JL, Gress TM, Jeziorski K, Rougier P, Wagener T, Anak O, Baron B, Nordlinger B; EORTC Gastro Intestinal Tract Cancer Group. A randomised phase II trial of weekly high-dose 5-fluorouracil with and without folinic acid and cisplatin in patients with advanced biliary tract carcinoma: results of the 40955 EORTC trial. Eur J Cancer. 2005 Feb;41(3):398-403.

ReferenceCitation: Wagner AD, Buechner-Steudel P, Moehler M, Schmalenberg H, Behrens R, Fahlke J, Wein A, Behl S, Kuss O, Kleber G, Fleig WE. Gemcitabine, oxaliplatin and 5-FU in advanced bile duct and gallbladder carcinoma: two parallel, multicentre phase-II trials. Br J Cancer. 2009 Dec 1;101(11):1846-52. doi: 10.1038/sj.bjc.6605377. Epub 2009 Nov 10.

ReferenceCitation: André T, Reyes-Vidal JM, Fartoux L, Ross P, Leslie M, Rosmorduc O, Clemens MR, Louvet C, Perez N, Mehmud F, Scheithauer W. Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study. Br J Cancer. 2008 Sep 16;99(6):862-7. doi: 10.1038/sj.bjc.6604628.

location_facility: Hôpital Saint Antoine. Service d'Hépatologie, Pole digestif.


title: Physiological Constraints Associated With Trail Running

summary: The practice of mountain running or "trail" is in full development in France and elsewhere in the world. This sporting practice associates specific physiological constraints related in particular to the duration of the efforts made (several hours) and to the ground (important elevation, technical ground, average altitude). Some studies have allowed the last 10 years to initiate the exploration of the physiological consequences of this type of practice, especially from a muscular point of view. However, some important questions remain to be clarified such as the impact of these sports events on fatigue and muscle recovery, cardiovascular, energy and water balance disturbances caused, induced sleep changes and the kinetics of recovery of the various parameters. . These elements remain in particular to be studied in very different racing contexts as currently developed by the organizers, namely race in one stage from long to very long distances (40 to 160 km) and race in stages (4 days, 4 x 40 km) as encountered in the Grenoble UT4M race (Ultra Tour des 4 Massifs).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: University Hospital, Grenoble

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Prevalence and Development of Post-traumatic Stress Disorder and Anxiety and Depressive Symptoms Among AP-HP Staff During the Covid-19 Epidemic

acronym: Covid-Impact

summary: The epidemic of coronavirus induces a major influx of patients implying a rapid modification of the organizations, a work overload and a significant stress for the care teams and supports of the hospitals of the Assistance Publique - Hôpitaux de Paris (AP-HP) . To this is added the impact on each professional of the large number of very severe patients to be treated, of death and the anxiety of contamination, reinforced by the actual cases of staff themselves sick. Emergency phone numbers for professionals in the event of psychological suffering were quickly put in place at the AP-HP and Hospitals level. The objective of this study is to assess the psychopathological and psycho-traumatic consequences of this exceptional situation on the staff, during the epidemic and at a distance from it, in order to be able to target the solutions to be implemented. Hypothesis is that some personnel may develop one or more of the following disorders: adjustment disorder or other anxiety disorder, acute stress disorder, post-traumatic stress disorder (PTSD), and depressive episodes as defined in the DSM-5. This study also aimes to assess effect of support measures put in place, by comparing the evolution of those who benefited from those who did not use them, as well as the risk factors specific. The results will make it possible to have an estimate of the percentage of people who may require specific support, and to identify the staff most at risk, and thus predict the importance of the circuits and structures for support of staff which will be necessary in the short and long term. The main anticipated risk factors are: being a nurse, having a low number of years of professional experience, and being on the front line of care for affected patients.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

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

lead_sponsor: Assistance Publique - Hôpitaux de Paris

status_simplified: Unknown


title: TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE, Pilot Study

acronym: TELE-PEACE

summary:
More than 20,000 patients benefit from coronary bypass surgery in France each year. Median discharge without complication is eight days postoperatively, whereas by day four after surgery, hospitalization is only necessary for medical supervision of the occurrence of complications (scar infection, atrial fibrillation, pericardial effusion), waiting for a downstream bed in cardiac rehabilitation.

Some studies have shown the feasibility of a return home from day 4 after CABG in the United States and England under some conditions of selection and monitoring of patients.

However, there is currently no validated telemonitoring tool for patients in early postoperative coronary bypass surgery.

In this pilot study, during hospitalization for early postoperative coronary bypass surgery, a combination of connected devices for the measurement of physiological parameters and for clinical self-evaluation by the patient will be evaluated. The results of this project will be used as a basis for a future larger study in which an early home discharge can be proposed to patients.

status: Recruiting

primary_purpose: Other

ipd_sharing: Undecided

intervention_type: Device

status_simplified: Ongoing


title: Impact of the Shape of Plates on the Conservation of Praxis in the Food at the Old Persons Suffering From Severe Insanities of Chap Alzheimer or Mixed in Institution.

acronym: PRAXALIM

summary:
The insanities, priority of public health in 2008, have significant prevalency in Limousin, region in the ageing demography (1/3 of the population is more than 60 years old against 1/5th of average in France). To prevent the lack of therapeutic solutions, for these evolutionary diseases, the new plan Alzheimer 2008-2012 encourages the research.

The insanities deprive gradually the individual of their autonomy, their personality and their identity. The help of an institution is sometimes inevitable. In the middle of this stressful environment, the patient affected by severe insanity, need marks.

The aspect of their old objects, significant for them, has to be prioritized because the institutional universe, often depersonalized doesn't mean anything for them. In front of repeated failures, they're hurt in their self respect.

The prevention of the undernutrition, comes by a preservation of praxis and pleasure at table. The institutional plate used in certain hospital sectors, is unpersonal (rectangular, divided) and can be destabilizing for the mentally ill person.

lead_sponsor: University Hospital, Limoges


title: Constitutional Genetics to Predict Prognostic and Somatic Alterations in Follicular Lymphoma

acronym: CONPIL

summary:
Follicular lymphoma is the second most common adult B-cell lymphoma. The acquisition of the t(14;18) translocation is the genetic hallmark of Follicular lymphoma. However, 50% to 70% of healthy individuals harbor low levels of circulating t(14;18)-positive cells but will never develop Follicular lymphoma. It was observed that individuals who developed Follicular lymphoma showed a higher t(14;18) frequency than controls (Roulland et al., J Clin Oncol 2014). High t(14;18) frequency in blood from healthy individuals could be a predictive biomarker for Follicular lymphoma development. Genetic instability of those t(14;18)+ B-cells as well as failure of the micro-environment to control the proliferation of these cells are proposed mechanisms linking these lymphoma precursors to true lymphoma cells. The prognosis of Follicular lymphoma patients has been significantly improved mainly with the development of anti-CD20 monoclonal antibodies, with a current median overall survival over 15 years. However, this lymphoma remains an incurable disease. The most commonly used tool for prognostication of patients with Follicular lymphoma is the Follicular Lymphoma International Prognostic Index (FLIPI) based on conventional clinical and pathology parameters. Although it has clinical utility, the Follicular Lymphoma International Prognostic Index does not reflect the biologic heterogeneity of Follicular lymphoma. First-degree relatives of Follicular lymphoma had a fourfold increased risk of Follicular lymphoma suggesting a genetic etiology.

Using the Genome wide association studies (GWAS) approach on Follicular lymphoma cohorts of 1,565 patients, the project plan to identify new prognostic markers. These markers will then be analyzed to decipher the impact of host genetics on somatic alterations and tumor biology, using public or matched patient data. The investigators also plan to analyze the influence of single-nucleotide polymorphisms on circulating t(14;18) levels in 318 healthy individuals included in EPIC cohort that will develop Follicular lymphoma later on, and assess if these biomarkers are helpful to refine the identification of high-risk Follicular lymphoma individuals.

study_start_date_type: Anticipated

time_perspective: Retrospective

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

intervention_type: Genetic


title: Analysis of the Specific Onco-geriatric Multidisciplinary Team Meeting (RCP) at E.Herriot Hospital (Hospices Civils de Lyon)

acronym: EROG

summary:
In France, cancer incidence increases over the course of life and therefore it is considered as an important pathology of the elderly. Cancers are the second leading cause of death for patients over 70 years old.

In 2015, 233,343 new cases of cancer were estimated for patients of 65 years and over (60.9% of estimated cancers of all ages), 42,547 new cases for older people over 85 years old (about 11% of all diagnosed cancer cases).

With the expected aging of the population in the coming years, the number of patients over the age of 70 will continue to increase. Life expectancy will also increase (12 years for the people above 75 years old and more than 8 years for the people above 80 years old).

The elderly are a heterogeneous population. Some people age well with few chronic diseases and a preserved autonomy. Others have several pathologies, geriatric syndromes (malnutrition, functional disorders, sensory deficits or psycho-cognitive diseases). Poly-medication is therefore common with an increased risk of iatrogenic disease. All these factors, in addition to social and economic conditions, determine the health status of the elderly. The presence of comorbidities decreases life expectancy and may itself be a contraindication to treatment. Patients in this age group are therefore particularly exposed to the risks of over- or under-treatment.

The multidisciplinary team meeting (RCP) is widely used for decision making in oncology. Various official texts govern it (Plan Cancer, HAS). However, the onco-geriatric decision is usually only a complementary opinion after a RCP of a specific organ.

Since 2006, the E. Herriot Hospital's Multidisciplinary team meeting has been organized to discuss cases of patients over 70 years old. The specificity is the association of a real multidisciplinary geriatric oncology discussion. The latter between medical specialist : geriatrician, oncologist, surgeon, radiotherapist, pharmacist, onco-geriatric nurse allows the development of an appropriate individualized therapeutic project for the patient.

The onco-geriatric multidisciplinary team is implementing a descriptive study of the RCP for the management of patients above 70 with cancer. The Regional Network of Oncology Auvergne-Rhône-Alpes is a partner.

The main aim is to describe the feasibility of the assessment of the follow-up of onco-geriatric recommendations 4 months after the onco-geriatric RCP of E. Herriot Hospital concerning patients with or with suspicion of cancer.

The secondary aims are : 1/ To describe the process of RCP: participants, patient's characteristics and conclusions with recommendations, 2/ To assess the implementation of oncological and geriatric recommendations 4 months after RCP 3/ To assess the survival, autonomy and quality of life of patients 4 months after RCP.

The hypothesis is that onco-geriatric RCP's recommendations improve the outcome for the patient.

The purpose of this pilot study is to ensure that the assessment of the recommendations' follow-up at 4 months is feasible.

location_facility: Oncologie radiothérapie - Hôpital Privé Jean Mermoz Ramsay Général de Santé Lyon

location_facility: Médecine Gériatrique/équipe mobile de gériatrie - Hôpital Edouard Herriot


title: Epidemiological Study of the Spread of SARS-CoV-2 in the Household of a Person Who Has Had a COVID-19 Disease

acronym: FAMICOV

summary:
Evaluating the rate of exposure to the virus in the close contact population who shared the home of a person infected with SARS-CoV-2 at the time of infection of the index case - adults or children - is a major factor in assessing the spread. virus in the family environment, assess the factors of circulation and determine whether immunity has been acquired. Screening for specific antibodies to SARS-CoV-2 will determine the exposure and protection acquired against this virus.

Knowing the intra-family secondary transmission rate is essential for supporting the strategies for lifting the confinement envisaged and implementing a personalized approach.

As of March 8, a platform for the home management of COVID + patients was set up when they, pauci or moderately symptomatic, do not require hospitalization. As of May 6, 2020, 881 patients have been registered in COVID and followed, constituting the active COVIDOM / PSL file. Of the 512 patients included between March 1 and 31, 45% have a household consisting of 3 people.

All patients had weekly clinical follow-up by telephone for the duration of the disease with a maximum of 4 weeks having been achieved.

If the recommendations of barrier gestures, isolation in an apartment were made during the symptomatic phase, the absence of masks available to all did not allow, in practice, to achieve the isolation and quarantine recommended ideally. to break the transmission of the virus.

The FAMI-CoV study proposes to assess the rate of exposure to the virus in contacts sharing the same focus of index cases. A sub-study will assess the proportion of antibodies that have been neutralizing.

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

intervention_type: Diagnostic Test

lead_sponsor_type: industriel


title: Spinal Cord Stimulation for Neuropathic Pain Relief : Efficacy Study Using the Specific NPSI Questionnaire

acronym: NPSI

summary:
Several studies have shown the efficacy of spinal cord stimulation in reducing the intensity of neuropathic pain. This efficacy is defined as obtaining relief of at least 50% of the preoperative pain intensity assessed by the visual analog scale or the digital pain scale. No study has evaluated the efficacy of stimulation specifically on the different components of neuropathic pain, only an overall improvement in pain has been described.

A specific questionnaire for neuropathic pain has been extensively validated in neuropathic pain: the Neuropathic Pain Symptom Inventory (NPSI).

Thanks to the multidimensional structure of this questionnaire, investigators propose to evaluate separately and in a much more specific way the efficacy of spinal cord stimulation in the short and long term on the different components of neuropathic pain and to define responders subgroups.

lead_sponsor: Hopital Foch


title: Feedback in Augmented Reality to Control the Gait Parameters in Children With Cerebral Palsy (BestOf_ARRoW)

summary:
Cerebral palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing fetal or infant brain. The motor disorder of CP are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour; by epilepsy, and by secondary musculoskeletal problems.

Motor activities, especially walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity.To provide feedback, during gait rehabilitation is a complementary approach to improve motor learning during the rehabilitation protocol. However, the feedback modalities are multiple and no study has compared these modalities. This study aims to test which feedback modalities could control the gait parameters (speed, cadence, step length) of the child with CP in real-time, through an augmented reality environment.

primary_purpose: Screening

ReferenceType: derived

ReferenceCitation: Guinet AL, Bouyer G, Otmane S, Desailly E. Visual Feedback in Augmented Reality to Walk at Predefined Speed Cross-Sectional Study Including Children With Cerebral Palsy. IEEE Trans Neural Syst Rehabil Eng. 2022;30:2322-2331. doi: 10.1109/TNSRE.2022.3198243. Epub 2022 Aug 22.

lead_sponsor: Fondation Ellen Poidatz


title: Evaluation of the Release of Monomers From Composite Bonding Resins in Orthodontics

acronym: MONORTHO

summary:
In recent decades, the field of public health has become increasingly interested in endocrine disruptors, and their effects on humans. Indeed, various scientific studies have highlighted an evolution in the frequency of pathologies due to these substances, affecting in particular the reproductive organs. Many concerns are expressed about the impact of these substances, present in the environment or in consumer products, on the hormonal system. Effects have been observed in animals in experimental studies, but the question of extrapolating these results to humans arises, especially for exposures at low doses.

In orthodontics, the composite is the material of choice mainly for bonding fasteners, then bonding a compression wire. These composite materials contain many monomers. The polemics launched on Bisphenol A and the questions of our patients on the nature and toxicity of dental products oblige us to reflect on their harmfulness after their placement in the oral cavity. Many questions arise today about dental composites and their participation in the release of endocrine disruptors. Indeed, Bisphenol A is used in the manufacturing process of the monomers of orthodontic composites, as precursors of Bis-GMA and Bis-DMA. The objective of this study is to search for the presence of BPA, TEGDMA, BisGMA, BisDMA and UDMA monomers, and to carry out the samples and their analysis at different clinical times (at T0, after the removal of orthodontic attachments, after the placement of the compression, one hour later, one week later, one month later and 6 months later) and the comparison of this quantification to that without orthodontic restraint. Studies have been performed in vitro, but very little in vivo. In addition, these studies are only carried out on release at the time of installation, but few are interested in the continuation of the phenomenon over time and the deterioration of the composite. Although the short-term toxicity of BPA is low, its dangerousness lies in its potential endocrine disrupting effect and which can induce long-term chronic toxicity.

Compounds such as TEGDMA, BisGMA, BisDMA and UDMA differ greatly in their volatility due to their different chemical structures as well as in their stability in saliva; Many methods have been developed to study each monomer individually or to study them simultaneously using different analytical techniques to determine their presence and to quantify them after their release from dental products. The analysis of the samples is carried out by liquid chromatography (HPLC).

location_facility: Service Odontology, Hôpital Pitié-Salpêtrière


title: Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection

acronym: ImmuCoV

summary:
The SARS-CoV-2 (COVID-19) infection is causing a global pandemic and a major health crisis in France.

Immunity is the body's ability to defend itself against infectious agents such as viruses. The progressive acquisition by a large part of the population of immunity to defend itself against the COVID-19 virus is one of the main mechanisms by which a resolution of this pandemic is hoped for. Recovery from infection and protection from the virus is likely to depend on the development of antibodies (proteins produced by the body to neutralize infectious agents) and T-cells (a type of white blood cell in the immune system) that can stop the virus from multiplying and killing it.

To date, the way and speed at which the T-lymphocytes active against the virus appear are not known. The development of biological tests to detect T-cells active against the virus in the blood of infected patients is therefore necessary.

In this context, we propose you to participate in a study that will study the immune system's response against the sars-CoV-2 virus during and after COVID-19 infection.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Rouen


title: Comparison of the Efficacy of Hypnosis on Pain and Anxiety Versus Standard Care During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment

acronym: POESY

summary: Lumbar puncture is a diagnostic procedure performed as part of the etiological assessment of cognitive disorders. Despite good tolerance and very rare complications, lumbar puncture is still perceived as being painful or anxiety-provoking by patients. Hypnosis could improve pain and anxiety when performing lumbar puncture.

design_allocation: Randomized

primary_purpose: Supportive Care

ReferenceCitation: Courtois-Amiot P, Cloppet-Fontaine A, Poissonnet A, Benit E, Dauzet M, Raynaud-Simon A, Paquet C, Lilamand M. Hypnosis for pain and anxiety management in cognitively impaired older adults undergoing scheduled lumbar punctures: a randomized controlled pilot study. Alzheimers Res Ther. 2022 Sep 2;14(1):120. doi: 10.1186/s13195-022-01065-w.

lead_sponsor: Gérond'if

intervention_type: Behavioral


title: Assessment of Vulnerability to Carotid Stenosis by MultiModal Imaging and Cellular and Molecular Biology Analysis Pilot Study

summary:
Cerebrovascular accidents (CVA) are the second leading cause of death in France, and the most frequent cause of acquired physical and mental disability. Up to 90% of strokes are ischemic, among which about 15% are due to the presence of stenosis of the carotid sinus, at the base of the extracranial internal carotid artery.

For many years, only the degree of stenosis was used to assess the risk of stroke, based on the results of original studies from the 1990s. However, the significant improvement in medical treatments since then has significantly reduced the risk of stroke, and the benefits of carotid intervention are becoming increasingly debatable.

Since the publication of the latest recommendations, the degree of stenosis alone is no longer sufficient to propose an intervention, since most of them will never lead to a neurological event. In addition to stenosis greater than 60%, for the first time, other criteria must be sought to decide on treatment. For example, so-called carotid plaque "vulnerability" criteria, defining patients "at high risk of stroke," should be sought.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Link Between Eosinopenia and Bacterial Infections in the Elderly Subject Hospitalized in Geriatrics

acronym: ELISA

summary: The main purpose of this monocentric, non-interventional, prospective study carried out in acute geriatrics (UGA) and post-rehabilitation care, is to determine if eosinopenia is associated with bacterial infections.

location_facility: Geriatric Department, Paul Brousse Hospital


title: Efficacy of PRADO Heart Failure in Occitania

acronym: PRADO-IC

summary:
Patients with heart failure (IC), after hospitalization, have a marked fragility: in France, in the first year, 29% die and 45% are readmitted to IC. Interventions improving the coordination of care providers at the time of discharge from hospitalization were tested; they showed a reduction in readmissions for IC (relative risk (RR) from 0.51 to 0.74) and all-cause mortality (RR 0.75 to 0.87). The Patient Return Program IC (PRADO IC), set up by the Health Insurance, offers assistance in the initiation of outpatient medical monitoring, and a nursing follow-up of 2 to 6 months depending on the patient's severity. The trial of PRADO began in the second half of 2013, and the first evaluation showed that the time to first treatment was significantly shorter, and that the readmissions rate and the 6-month death rate were unchanged.

This study was of epidemiological type, comparative before-elsewhere. The difficulty of controlling for confounders in this type of study limits the scope of these conclusions. The efficacy hypothesis of PRADO IC is therefore always posed in the French context

status: Active, not recruiting

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Montpellier


title: Bipolar 15 Charrières (Ch.) Office Resectoscope : Polypectomy Without Anesthesia - Prospective Evaluation

acronym: HSC

summary: This study aimed to the feasibility of polypectomy without anesthesia using a 15 Ch. resectoscope in women with uterine polyps.

intervention_type: Procedure


title: The DNA and Cell Bank of IFR of Neurosciences: Clinical and Genetic Study of Parkinson's Disease and Epilepsies

summary:
The DNA and Cell Bank of Instituts Federatifs de Recherche (IFR) of Neurosciences has been running for the last 15 years at the Institut National de la Santé Et de la Recherche Médicale (INSERM) Unit 679 (former unit 289). Since its creation, this structure has been the support of research projects in genetics for neurological and psychiatric disorders. The cohorts established have led to discoveries in monogenic disorders, such as cerebellar ataxias, spastic paraplegias, frontotemporal dementias, epilepsies, Parkinson's and Alzheimer's disease, Charcot-Marie-Tooth disease and related entities. The research projects based on the study of the genetic bases in Parkinson's disease and epilepsies are especially developed for this grant.

Concerning Parkinson's disease, the project is based on the extension of the existing cohort throughout the French Parkinson's Disease Study Group network. Concerning epilepsies, this project is the occasion to build this network with the constitution of a new cohort.

The specific aims of the scientific projects are the following for Parkinson's disease:

to evaluate the frequency, the nature and the phenotype associated with parkin mutations in familial or sporadic forms of the disease, according to the age at onset, and
to identify the genetic susceptibility factors in Parkinson's disease with the study of affected sibpairs and with case/controls association studies.

For epilepsies, the aims are:

to evaluate the frequency, the nature and the phenotype associated with SCN1A, SCNab and GABR2 gene mutations in familial or sporadic forms of the affection associated with febrile seizures, and
to search for an intervention SCN1A, SCN1B and GABRG2 as susceptible genes in these forms of epilepsies.

status: Terminated

ReferenceType: result

ReferenceCitation: Ibáñez P, Bonnet AM, Débarges B, Lohmann E, Tison F, Pollak P, Agid Y, Dürr A, Brice A. Causal relation between alpha-synuclein gene duplication and familial Parkinson's disease. Lancet. 2004 Sep 25-Oct 1;364(9440):1169-71.

ReferenceCitation: Lesage S, Leutenegger AL, Ibanez P, Janin S, Lohmann E, Dürr A, Brice A; French Parkinson's Disease Genetics Study Group. LRRK2 haplotype analyses in European and North African families with Parkinson disease: a common founder for the G2019S mutation dating from the 13th century. Am J Hum Genet. 2005 Aug;77(2):330-2.

ReferenceCitation: Lesage S, Ibanez P, Lohmann E, Pollak P, Tison F, Tazir M, Leutenegger AL, Guimaraes J, Bonnet AM, Agid Y, Dürr A, Brice A; French Parkinson's Disease Genetics Study Group. G2019S LRRK2 mutation in French and North African families with Parkinson's disease. Ann Neurol. 2005 Nov;58(5):784-7.

ReferenceCitation: Lesage S, Leutenegger AL, Brice A. [LRRK2: a gene belonging to the ROCO family is implicated in the Parkinson's disease]. Med Sci (Paris). 2005 Dec;21(12):1015-7. French.

ReferenceCitation: Ibáñez P, Lesage S, Lohmann E, Thobois S, De Michele G, Borg M, Agid Y, Dürr A, Brice A; French Parkinson's Disease Genetics Study Group. Mutational analysis of the PINK1 gene in early-onset parkinsonism in Europe and North Africa. Brain. 2006 Mar;129(Pt 3):686-94. Epub 2006 Jan 9.

ReferenceCitation: Lesage S, Dürr A, Tazir M, Lohmann E, Leutenegger AL, Janin S, Pollak P, Brice A; French Parkinson's Disease Genetics Study Group. LRRK2 G2019S as a cause of Parkinson's disease in North African Arabs. N Engl J Med. 2006 Jan 26;354(4):422-3.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Pitié-Salpêtrière Hospital - Centre of Clinical Investigations


type: Other Identifier

title: Digital Intervention Promoting Physical Activity Among Obese People Randomized Controlled Trial: Assessing the Effects of a Digital Intervention to Promote Physical Activity in Patients With Obesity and/or Type 2 Diabetes Mellitus

acronym: DIPPAO

summary:
Overweight and obesity are today considered among the most important health risks facing humanity with more than one in two adults overweight or obese in western countries. In addition, Type 2 diabetes mellitus (T2DM) is a common comorbidity associated with overweight and obesity and counts for 5% of the French population under 65 years of age and 15% in people over 65 years old. Despite the accumulation of scientific evidence supporting the benefits of physical activity, obese and diabetic people remain insufficiently active and current programs struggle to engage and sustain physical activity of patients over long periods of time. It is therefore urgent to develop interventions that can effectively change individuals' behavior. In this context, "e-health" interventions and gamification appear to be a particularly promising avenue to improve physical activity and reduce attrition rates of current programs.

This clinical trial aim to test the effectiveness of a digital intervention based on gamification and teamwork in comparison to a supervised physical activity program. The investigators hypothesized that the intervention will be efficient by the development of a self-determined motivation through the process of gamification on the one hand. On the other hand, through the in-group collaboration with other people who share the same stigmatized criteria that will help participants to overcome weight stigmas, acting generally as physical activity barriers.

primary_purpose: Treatment

ReferenceCitation: Mazéas A, Chalabaev A, Blond M, Pereira B, Duclos M. Digital intervention promoting physical activity among obese people (DIPPAO) randomised controlled trial: study protocol. BMJ Open. 2022 Jun 16;12(6):e058015. doi: 10.1136/bmjopen-2021-058015.

ipd_sharing: Yes

ipd_sharing_description: We will share de-identified data associated with the collected samples by depositing these data at the Open Science Framework (OSF) repository. The storage will be in Germany (Frankfurt). Data will include demographic, anthropometric, and physical measurements along with data from questionnaires and intervention adherence. We agree that we will identify where the data will be available and how to access the data in any publications and presentations that we author about these data.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Data Acquisition Study in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Balanced With Oral Antidiabetic Agents and Basal Insulin

summary: The aim of this study is to collect continuous glucose monitoring (CGM) data, coupled with physical activity and everyday day life data. The purpose of this data collection is to help diabetologists to make recommendations to optimize type 2 diabetic patient management.

lead_sponsor: ValoTec


acronym: RiskofADR

summary:
Objective: To identify risk factors for the occurrence of adverse drug reactions (ADRs) based on geriatric evaluation.

Design: Longitudinal prospective study from May 2010 to November 2011. Setting: Dedicated acute geriatric care unit specializing in the management of patients with dementia at the University Hospital of Reims, France.

Measurements: Sociodemographic variables and comprehensive geriatric assessment were recorded. Occurrence of ADRs was noted. Risk factors for ADR were identified by multivariate logistic regression.

ReferenceType: background

ReferenceCitation: Kanagaratnam L, Dramé M, Novella JL, Trenque T, Joachim C, Nazeyrollas P, Jolly D, Mahmoudi R. Risk Factors for Adverse Drug Reactions in Older Subjects Hospitalized in a Dedicated Dementia Unit. Am J Geriatr Psychiatry. 2017 Mar;25(3):290-296. doi: 10.1016/j.jagp.2016.07.002. Epub 2016 Sep 1.

lead_sponsor: CHU de Reims


title: Eye-ECG Approach to Emergencies : Diagnostic Performance of the HINTS Test Performed by Emergency Physicians to Distinguish a Central Cause From a Peripheral Cause of Isolated Acute Vestibular Syndrome

summary:
Vertigo integrated with acute vestibular syndrome (AVS) is a frequent reason for emergency visits. The French and international literature estimates between 2 to 4% of vertigo prevalence among reasons for coming to emergencies. International classifications define AVS as vertigo or acute dizziness (less than one month) and persistent, gait instability, nausea or vomiting, nystagmus or an intolerance to head movements.

In emergency departments, the clinical approach of vertiginous patients is difficult because the "vertigo" term is sometimes used in by patients, or because they use the terms "uneasiness", "vertigo", or "dizziness" without distinction. These terms sometimes include various sensations of "sleeping head", "blurred vision", "instability", "pitch" etc. A first difficulty is therefore to clarify these terms and organize syndrome expressed by the patient. A rigorous interrogation is therefore essential and can be time-consuming.

Another difficulty is to carry out an exhaustive clinical examination including the assessment of the general condition and hydration, an ENT examination and a neurological examination. However, at the end of these steps, the orientation central or peripheral etiology is not simple. In the last consensus conference of the Barany Society (2014) the classification of VAS into three types was not sufficient to distinguish "benign" vertigo from "risky" dizziness (related to a central cause).

ReferenceCitation: Tarnutzer AA, Berkowitz AL, Robinson KA, Hsieh YH, Newman-Toker DE. Does my dizzy patient have a stroke? A systematic review of bedside diagnosis in acute vestibular syndrome. CMAJ. 2011 Jun 14;183(9):E571-92. doi: 10.1503/cmaj.100174. Epub 2011 May 16. Review.

ReferenceCitation: Kerber KA, Meurer WJ, Brown DL, Burke JF, Hofer TP, Tsodikov A, Hoeffner EG, Fendrick AM, Adelman EE, Morgenstern LB. Stroke risk stratification in acute dizziness presentations: A prospective imaging-based study. Neurology. 2015 Nov 24;85(21):1869-78. doi: 10.1212/WNL.0000000000002141. Epub 2015 Oct 28.

ReferenceCitation: Kene MV, Ballard DW, Vinson DR, Rauchwerger AS, Iskin HR, Kim AS. Emergency Physician Attitudes, Preferences, and Risk Tolerance for Stroke as a Potential Cause of Dizziness Symptoms. West J Emerg Med. 2015 Sep;16(5):768-76. doi: 10.5811/westjem.2015.7.26158. Epub 2015 Oct 20.

ReferenceCitation: Kattah JC, Talkad AV, Wang DZ, Hsieh YH, Newman-Toker DE. HINTS to diagnose stroke in the acute vestibular syndrome: three-step bedside oculomotor examination more sensitive than early MRI diffusion-weighted imaging. Stroke. 2009 Nov;40(11):3504-10. doi: 10.1161/STROKEAHA.109.551234. Epub 2009 Sep 17.

ReferenceCitation: Newman-Toker DE, Kerber KA, Hsieh YH, Pula JH, Omron R, Saber Tehrani AS, Mantokoudis G, Hanley DF, Zee DS, Kattah JC. HINTS outperforms ABCD2 to screen for stroke in acute continuous vertigo and dizziness. Acad Emerg Med. 2013 Oct;20(10):986-96. doi: 10.1111/acem.12223.

ReferenceCitation: Becares-Martinez C, Lopez-Llames A, Arroyo-Domingo MM, Marco-Algarra J, Morales Suarez-Varela MM. [What do MRI and CT scan provide us in patients with vertigo and dizziness? A cost-utility analysis]. Rev Neurol. 2019 Apr 16;68(8):326-332. doi: 10.33588/rn.6808.2018399. Spanish.

ReferenceCitation: Dumitrascu OM, Torbati S, Tighiouart M, Newman-Toker DE, Song SS. Pitfalls and Rewards for Implementing Ocular Motor Testing in Acute Vestibular Syndrome: A Pilot Project. Neurologist. 2017 Mar;22(2):44-47. doi: 10.1097/NRL.0000000000000106.

ReferenceCitation: Vanni S, Nazerian P, Casati C, Moroni F, Risso M, Ottaviani M, Pecci R, Pepe G, Vannucchi P, Grifoni S. Can emergency physicians accurately and reliably assess acute vertigo in the emergency department? Emerg Med Australas. 2015 Apr;27(2):126-31. doi: 10.1111/1742-6723.12372. Epub 2015 Mar 10.

ReferenceCitation: Gerlier C, Hoarau M, Fels A, Vitaux H, Mousset C, Farhat W, Firmin M, Pouyet V, Paoli A, Chatellier G, Ganansia O. Differentiating central from peripheral causes of acute vertigo in an emergency setting with the HINTS, STANDING, and ABCD2 tests: A diagnostic cohort study. Acad Emerg Med. 2021 Dec;28(12):1368-1378. doi: 10.1111/acem.14337. Epub 2021 Jul 20.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Prospective and Retrospective Neoadjuvant Breast Cancer Database

acronym: NEOADJ

summary:
The NEOADJ Database base contains data collected during the regular clinical patient management (sociodemographic, clinical, pathological, radiological, biological, disease evolution...). This database allows easy access to information in a centralized and structured way.

This cohort is used to gather insights for research purposes. All data collected come from medical files of patients managed at Centre Georges Francois Leclerc, Dijon, France.

lead_sponsor: Centre Georges Francois Leclerc

location_facility: Methodology, Biostatistics and Data Management Unit

intervention_type: Drug


title: Randomized, Third-blind, Controlled Trial of Superiority (Versus Sequential Dressings Recommended by the HAS) of an Electrode Dressing (WoundEL® Electrostimulation Device) on the Healing of Venous Ulcers

acronym: ELEXICA

summary:
Several studies have suggested that the endogenous electric field and its polarity stimulate the proliferation and migration of epithelial cells and therefore promote wound healing. WoundEL® will reproduce the endogenous electrical current to stimulate all the factors contributing to healing.

Electrostimulation of wounds, including the WoundEL® device, is a therapy listed but not yet reimbursed in France. The aim of this study is to show that the WoundEL® electrostimulation device is superior to the reference treatments recognized by the HAS.

lead_sponsor: CEN Biotech


title: Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving Continuous Positive Airway Pressure (CPAP) Compliance in Low Cardiovascular Risk Sleep Apnea Patients

summary:
Targeted population:

Sleep apnea patients at low cardiovascular risk newly treated by CPAP

Hypothesis:

Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP care.

Main goal:

To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.

lead_sponsor: Fédération Française de Pneumologie

location_facility: Respiratory physician in private practice


title: Influence of Peri-procedural Management of Direct Oral Anticoagulants on the Incidence of Pocket Hematoma in Patients Undergoing Cardiac Rhythm Device Implantation

acronym: StimAOD

summary:
Each year, tens of thousands of cardiac rhythm devices including pacemaker (PM) or implantable cardioverter-defibrillator (ICD) are implanted in France. More than 25% of patients undergoing cardiac device implantation receive long-term anticoagulation therapy, that increases the incidence of pocket hematoma with potential serious consequences for patients. Although more and more patients receive direct oral anticoagulants (DOACs), limited data currently exist on the perioperative management of DOAC-treated patients undergoing cardiac device implantation and the optimal strategy remains unclear. Especially, the time of DOAC resumption after the procedure is controversial.

We hypothesize that the time of DOAC resumption is the main risk factor of bleeding event in DOAC-treated patients undergoing cardiac device implantation, that is to say that a delayed DOAC resumption > 48 hours following the procedure will reduce pocket hematoma incidence compared with an early resumption, ≤ 48 hours, without increasing thromboembolic events. We propose here an observational multicentre national study to find out the optimal strategy.

lead_sponsor: Institut Necker Enfants Malades


title: Assessement of Capacity to Consent in Depressed Patients

summary:
Any patient can request euthanasia in many of our neighbouring European countries as long as informed consent is given. Psychiatric evaluation is not always mandatory.

Faced with the increasing emergence of euthanasia requests in different countries from patients under psychiatric care in France for severe depressive episodes, question arises of a possible alteration in the capacity to give consent in the context of a severe depressive episode.

This is a Social and Human Sciences study which does not aim to modify the usual management of patients.

ipd_sharing_description: NC


title: Reduction of no Flow Time During Out of Hospital Cardiac Arrest by Using Laryngeal Tube for Airway Management by Nurses.

acronym: FLOWERS

summary:
International recommendations stress on the importance of no flow time reduction in cardiac arrest management. In fact, no flow time is an independent factor of morbidity and mortality.

In France, cardiac arrests are treated by first responders (including emergency nurses) before the arrival of a mobile intensive care unit. Those first responders use bag-valve-mask for ventilation and therefore practice conventional CPR (30 chest compression / 2 ventilation rhythm). Laryngeal tube is a safe and efficient device in cardiac arrest ventilation. The purpose of our study is to compare the no flow time between two strategies of out of hospital cardiac arrest management by first responders: conventional CPR with bag-valve-mask ventilation vs. compression only CPR with Laryngeal Tube ventilation.

ReferenceCitation: Nolan JP, Deakin CD, Soar J, Böttiger BW, Smith G; European Resuscitation Council. European Resuscitation Council guidelines for resuscitation 2005. Section 4. Adult advanced life support. Resuscitation. 2005 Dec;67 Suppl 1:S39-86. Review.

ReferenceCitation: Eftestøl T, Sunde K, Steen PA. Effects of interrupting precordial compressions on the calculated probability of defibrillation success during out-of-hospital cardiac arrest. Circulation. 2002 May 14;105(19):2270-3.

ReferenceCitation: Eftestøl T, Wik L, Sunde K, Steen PA. Effects of cardiopulmonary resuscitation on predictors of ventricular fibrillation defibrillation success during out-of-hospital cardiac arrest. Circulation. 2004 Jul 6;110(1):10-5. Epub 2004 Jun 21.

ReferenceCitation: Adrie C, Cariou A, Mourvillier B, Laurent I, Dabbane H, Hantala F, Rhaoui A, Thuong M, Monchi M. Predicting survival with good neurological recovery at hospital admission after successful resuscitation of out-of-hospital cardiac arrest: the OHCA score. Eur Heart J. 2006 Dec;27(23):2840-5. Epub 2006 Nov 2. Erratum in: Eur Heart J. 2007 Mar;28(6):774.

ReferenceCitation: Edelson DP, Abella BS, Kramer-Johansen J, Wik L, Myklebust H, Barry AM, Merchant RM, Hoek TL, Steen PA, Becker LB. Effects of compression depth and pre-shock pauses predict defibrillation failure during cardiac arrest. Resuscitation. 2006 Nov;71(2):137-45. Epub 2006 Sep 18.

ReferenceCitation: Abella BS, Sandbo N, Vassilatos P, Alvarado JP, O'Hearn N, Wigder HN, Hoffman P, Tynus K, Vanden Hoek TL, Becker LB. Chest compression rates during cardiopulmonary resuscitation are suboptimal: a prospective study during in-hospital cardiac arrest. Circulation. 2005 Feb 1;111(4):428-34.

ReferenceCitation: Wiese CH, Bahr J, Bergmann A, Bergmann I, Bartels U, Graf BM. [Reduction in no flow time using a laryngeal tube: comparison to bag-mask ventilation]. Anaesthesist. 2008 Jun;57(6):589-96. doi: 10.1007/s00101-008-1358-2. German.

ReferenceCitation: Odegaard S, Pillgram M, Berg NE, Olasveengen T, Kramer-Johansen J. Time used for ventilation in two-rescuer CPR with a bag-valve-mask device during out-of-hospital cardiac arrest. Resuscitation. 2008 Apr;77(1):57-62. doi: 10.1016/j.resuscitation.2007.11.005.

ReferenceCitation: Wik L, Kramer-Johansen J, Myklebust H, Sørebø H, Svensson L, Fellows B, Steen PA. Quality of cardiopulmonary resuscitation during out-of-hospital cardiac arrest. JAMA. 2005 Jan 19;293(3):299-304.

ReferenceCitation: Abella BS, Alvarado JP, Myklebust H, Edelson DP, Barry A, O'Hearn N, Vanden Hoek TL, Becker LB. Quality of cardiopulmonary resuscitation during in-hospital cardiac arrest. JAMA. 2005 Jan 19;293(3):305-10.

ReferenceCitation: Valenzuela TD, Kern KB, Clark LL, Berg RA, Berg MD, Berg DD, Hilwig RW, Otto CW, Newburn D, Ewy GA. Interruptions of chest compressions during emergency medical systems resuscitation. Circulation. 2005 Aug 30;112(9):1259-65. Epub 2005 Aug 22.

ReferenceCitation: Kern KB, Hilwig RW, Berg RA, Ewy GA. Efficacy of chest compression-only BLS CPR in the presence of an occluded airway. Resuscitation. 1998 Dec;39(3):179-88.

ReferenceCitation: Berg RA, Sanders AB, Kern KB, Hilwig RW, Heidenreich JW, Porter ME, Ewy GA. Adverse hemodynamic effects of interrupting chest compressions for rescue breathing during cardiopulmonary resuscitation for ventricular fibrillation cardiac arrest. Circulation. 2001 Nov 13;104(20):2465-70.

ReferenceCitation: Yu T, Weil MH, Tang W, Sun S, Klouche K, Povoas H, Bisera J. Adverse outcomes of interrupted precordial compression during automated defibrillation. Circulation. 2002 Jul 16;106(3):368-72.

ReferenceCitation: Bowman FP, Menegazzi JJ, Check BD, Duckett TM. Lower esophageal sphincter pressure during prolonged cardiac arrest and resuscitation. Ann Emerg Med. 1995 Aug;26(2):216-9.

ReferenceCitation: Gabrielli A, Wenzel V, Layon AJ, von Goedecke A, Verne NG, Idris AH. Lower esophageal sphincter pressure measurement during cardiac arrest in humans: potential implications for ventilation of the unprotected airway. Anesthesiology. 2005 Oct;103(4):897-9.

ReferenceCitation: Wenzel V, Idris AH, Banner MJ, Kubilis PS, Williams JL Jr. Influence of tidal volume on the distribution of gas between the lungs and stomach in the nonintubated patient receiving positive-pressure ventilation. Crit Care Med. 1998 Feb;26(2):364-8.

ReferenceCitation: Wenzel V, Idris AH, Banner MJ, Kubilis PS, Band R, Williams JL Jr, Lindner KH. Respiratory system compliance decreases after cardiopulmonary resuscitation and stomach inflation: impact of large and small tidal volumes on calculated peak airway pressure. Resuscitation. 1998 Aug;38(2):113-8.

ReferenceCitation: Lawes EG, Baskett PJ. Pulmonary aspiration during unsuccessful cardiopulmonary resuscitation. Intensive Care Med. 1987;13(6):379-82.

ReferenceCitation: Sayre MR, Sakles JC, Mistler AF, Evans JL, Kramer AT, Pancioli AM. Field trial of endotracheal intubation by basic EMTs. Ann Emerg Med. 1998 Feb;31(2):228-33.

ReferenceCitation: Bradley JS, Billows GL, Olinger ML, Boha SP, Cordell WH, Nelson DR. Prehospital oral endotracheal intubation by rural basic emergency medical technicians. Ann Emerg Med. 1998 Jul;32(1):26-32.

ReferenceCitation: Katz SH, Falk JL. Misplaced endotracheal tubes by paramedics in an urban emergency medical services system. Ann Emerg Med. 2001 Jan;37(1):32-7.

ReferenceCitation: Dörges V, Wenzel V, Schumann T, Neubert E, Ocker H, Gerlach K. Intubating laryngeal mask airway, laryngeal tube, 1100 ml self-inflating bag-alternatives for basic life support? Resuscitation. 2001 Nov;51(2):185-91.

ReferenceCitation: Ocker H, Wenzel V, Schmucker P, Steinfath M, Dörges V. A comparison of the laryngeal tube with the laryngeal mask airway during routine surgical procedures. Anesth Analg. 2002 Oct;95(4):1094-7, table of contents.

ReferenceCitation: Bein B, Carstensen S, Gleim M, Claus L, Tonner PH, Steinfath M, Scholz J, Dörges V. A comparison of the proseal laryngeal mask airway, the laryngeal tube S and the oesophageal-tracheal combitube during routine surgical procedures. Eur J Anaesthesiol. 2005 May;22(5):341-6.

ReferenceCitation: Genzwuerker HV, Finteis T, Slabschi D, Groeschel J, Ellinger K. Assessment of the use of the laryngeal tube for cardiopulmonary resuscitation in a manikin. Resuscitation. 2001 Dec;51(3):291-6.

ReferenceCitation: Figueredo E, Martínez M, Pintanel T. A comparison of the ProSeal laryngeal mask and the laryngeal tube in spontaneously breathing anesthetized patients. Anesth Analg. 2003 Feb;96(2):600-5, table of contents.

ReferenceCitation: Mihai R, Knottenbelt G, Cook TM. Evaluation of the revised laryngeal tube suction: the laryngeal tube suction II in 100 patients. Br J Anaesth. 2007 Nov;99(5):734-9. Epub 2007 Sep 14.

ReferenceCitation: Genzwuerker HV, Dhonau S, Ellinger K. Use of the laryngeal tube for out-of-hospital resuscitation. Resuscitation. 2002 Feb;52(2):221-4.

ReferenceCitation: Kette F, Reffo I, Giordani G, Buzzi F, Borean V, Cimarosti R, Codiglia A, Hattinger C, Mongiat A, Tararan S. The use of laryngeal tube by nurses in out-of-hospital emergencies: preliminary experience. Resuscitation. 2005 Jul;66(1):21-5.

ReferenceCitation: Dörges V, Ocker H, Wenzel V, Sauer C, Schmucker P. Emergency airway management by non-anaesthesia house officers--a comparison of three strategies. Emerg Med J. 2001 Mar;18(2):90-4.

ReferenceCitation: Dörges V, Wenzel V, Neubert E, Schmucker P. Emergency airway management by intensive care unit nurses with the intubating laryngeal mask airway and the laryngeal tube. Crit Care. 2000;4(6):369-76. Epub 2000 Oct 13.

ReferenceCitation: Asai T, Hidaka I, Kawachi S. Efficacy of the laryngeal tube by inexperienced personnel. Resuscitation. 2002 Nov;55(2):171-5.

ReferenceCitation: Asai T, Kawachi S. Use of the laryngeal tube by paramedic staff. Anaesthesia. 2004 Apr;59(4):408-9.

ReferenceCitation: Kurola J, Harve H, Kettunen T, Laakso JP, Gorski J, Paakkonen H, Silfvast T. Airway management in cardiac arrest--comparison of the laryngeal tube, tracheal intubation and bag-valve mask ventilation in emergency medical training. Resuscitation. 2004 May;61(2):149-53.

ReferenceCitation: Kurola JO, Turunen MJ, Laakso JP, Gorski JT, Paakkonen HJ, Silfvast TO. A comparison of the laryngeal tube and bag-valve mask ventilation by emergency medical technicians: a feasibility study in anesthetized patients. Anesth Analg. 2005 Nov;101(5):1477-1481. doi: 10.1213/01.ANE.0000182330.54814.70.

ReferenceCitation: Wiese CH, Bartels U, Schultens A, Steffen T, Torney A, Bahr J, Graf BM. Influence of airway management strategy on "no-flow-time" during an "advanced life support course" for intensive care nurses - a single rescuer resuscitation manikin study. BMC Emerg Med. 2008 Apr 10;8:4. doi: 10.1186/1471-227X-8-4.

ReferenceCitation: Gueugniaud PY, David JS, Chanzy E, Hubert H, Dubien PY, Mauriaucourt P, Bragança C, Billères X, Clotteau-Lambert MP, Fuster P, Thiercelin D, Debaty G, Ricard-Hibon A, Roux P, Espesson C, Querellou E, Ducros L, Ecollan P, Halbout L, Savary D, Guillaumée F, Maupoint R, Capelle P, Bracq C, Dreyfus P, Nouguier P, Gache A, Meurisse C, Boulanger B, Lae C, Metzger J, Raphael V, Beruben A, Wenzel V, Guinhouya C, Vilhelm C, Marret E. Vasopressin and epinephrine vs. epinephrine alone in cardiopulmonary resuscitation. N Engl J Med. 2008 Jul 3;359(1):21-30. doi: 10.1056/NEJMoa0706873.

ReferenceCitation: Gueugniaud PY, Mols P, Goldstein P, Pham E, Dubien PY, Deweerdt C, Vergnion M, Petit P, Carli P. A comparison of repeated high doses and repeated standard doses of epinephrine for cardiac arrest outside the hospital. European Epinephrine Study Group. N Engl J Med. 1998 Nov 26;339(22):1595-601.

ReferenceCitation: Asai T, Moriyama S, Nishita Y, Kawachi S. Use of the laryngeal tube during cardiopulmonary resuscitation by paramedical staff. Anaesthesia. 2003 Apr;58(4):393-4.

ReferenceCitation: Asai T, Shingu K. The laryngeal tube. Br J Anaesth. 2005 Dec;95(6):729-36. Review.

ReferenceCitation: Cummins RO, Chamberlain DA, Abramson NS, Allen M, Baskett P, Becker L, Bossaert L, Delooz H, Dick W, Eisenberg M, et al. Recommended guidelines for uniform reporting of data from out-of-hospital cardiac arrest: the Utstein Style. Task Force of the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, and the Australian Resuscitation Council. Ann Emerg Med. 1991 Aug;20(8):861-74. Review.

ReferenceCitation: Lemaire F, Bion J, Blanco J, Damas P, Druml C, Falke K, Kesecioglu J, Larsson A, Mancebo J, Matamis D, Pesenti A, Pimentel J, Ranieri M; ESICM Task Force on Legislation Affecting Clinical Research in the Critically Ill Patient. The European Union Directive on Clinical Research: present status of implementation in EU member states' legislations with regard to the incompetent patient. Intensive Care Med. 2005 Mar;31(3):476-9. Epub 2005 Feb 15.

lead_sponsor: University Hospital, Grenoble

location_facility:
SDIS
Samu Smur


title: Follow-up Study in French Practice to Evaluate the Improvement of Gait and Pain Relief in Patients Treated With Endovascular Endovascular Treatment of de Novo Lesions of the Femoropopliteal Artery Above the Knee With LUTONIX®035 or RANGER TM Active Ballon

acronym: EQUATEUR

summary:
This study is part of the subordination for the renewal of the registration of the LUTONIXR035 or RANGERTM drug coated balloon catheter by the CNEDiMTS following the transmission of the results of a French study on quality of life (evaluation of pain relief and walking evaluation criteria) for patients treated for de novo lesions of the femoropopliteal artery above the knee by endovascular treatment with LUTONIXR035 or RANGERTM drug-coated balloon catheters.

In accordance with the HAS practical guide on the approval of medical devices in France (November 2017), the protocol for this study was submitted in advance to the HAS and its suggestions were taken into account when drafting the objectives relative to the population to be included.

A second exhaustive study will be conducted in parallel using SNDS data to complete the CNEDiMTS application in order to evaluate, in the context of this registration renewal, the interest of the technique by documenting limb preservation, overall survival, the rate of re-interventions and the number of stents implanted.


title: Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH

summary:
Recent epidemiological studies in France showed a high prevalence of obesity (14.5%) and its strong increase in the last 20 years. Among the many complications associated with obesity, liver complications (steatosis and steatohepatitis [NASH]) are among the most common. Semaphorins were described in the early 1990. More than 20 types of these proteins have been reported to date. These proteins were used for neural development. Since many functions have also been described. The semaphorins are involved in numerous physiological or physiopathological processes (cardiac morphogenesis, vascular growth, tumor progression), the regulation of immune cells and liver fibrosis. Preliminary studies have allowed to show that dendritic cells infiltrate adipose tissue and initiate the activation of T cells and inflammation. Immune semaphorin are new players in the regulation of inflammation and immune reactions.

The role of immune semaphorin in regulating inflammation in the two compartments (liver and adipose tissue) could be a crucial step that could lead to more severe liver damage. Its dysregulation could explain NASH injuries. The goal is to identify a new mode of regulation of cellular homeostasis in the fatty liver disease. These factors may serve as diagnostic markers or future therapeutic targets.

ReferenceCitation: Sans A, Bailly L, Anty R, Sielezenef I, Gugenheim J, Tran A, Gual P, Iannelli A. Baseline Anthropometric and Metabolic Parameters Correlate with Weight Loss in Women 1-Year After Laparoscopic Roux-En-Y Gastric Bypass. Obes Surg. 2017 Nov;27(11):2940-2949. doi: 10.1007/s11695-017-2720-8. Erratum in: Obes Surg. 2017 Jul 5;:.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Service d'Hépato-Gastroentérologie - Hôpital de l'Archet


title: Natural History of Anal Human Papillomavirus Infection and Associated Disease in HIV-infected Men Who Have Sex With Men: Towards an Evidence Base for the Prevention of Anal Cancer.

acronym: APACHES

summary:
Multicentric epidemiological non-comparative study in France characterising evolution of anal Human papillomavirus (HPV) infection and related lesions and evaluating markers associated with the observed evolution.

Estimated enrolment: 500

Principal Outcomes

Detection of high-grade cytological and histological anal lesions by high resolution anoscopy
Spontaneous regression of high-grade anal lesions
Detection of anal HPV infection

Intervention (procedure):

Patient medical interview (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
Standard proctologic examination with digital rectal examination and 2 anal swabs (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
High resolution anoscopy (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)

Only if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High Resolution Anoscopy (HRA):

- anal biopsy(ies) during HRA

Only if high-grade lesion:

- HRA biannually

lead_sponsor: ANRS, Emerging Infectious Diseases


summary: The exploration of evocative symptoms of esophageal reflux disease or dyspepsia is based on a relatively invasive endoscopic examination, often badly tolerated, and which, in France, is carried out in 50% of the cases under general anaesthesia. The development of a Capsule Endoscopy, of single use, of esophageal exploration (PILLCAM OESO), could allow a painless exploration of the oesophagus, without infectious risk.The aim of this study is to validate the information provided by the Esophageal Capsule Endoscopy compared to upper endoscopy in the screening of patients with gastroesophageal reflux disease or dyspepsia . For that these patients, after being informed and to have given their signed assent, will initially have an exploration by Esophageal Capsule Endoscopy and then, the very same day or within 3 days maximum, a upper endoscopy'. The information provided by the Esophageal Capsule Endoscopy then by the upper endoscopy will be analyzed by investigators different. This study should make it possible to evaluate the parameters of specificity, sensitivity and predictive values of Esophageal Capsule Endoscopy in this indication.

lead_sponsor: Nantes University Hospital


title: The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists

summary: The RATIO registry is a French registry designed by a multidisciplinary group to collect data on opportunistic and severe bacterial infections and lymphoma in patients treated with TNF-a antagonists ( infliximab, etanercept and adalimumab). A total of 486 medical units in metropolitan France participate in the RATIO registry. All diagnosis are retained after validation by 2 qualified infectious disease or haematologist physicians (on the basis of the standardized case report form, the hospitalisation summary, and the microbiological and radiological results). Risk factors for developing these conditions when treated by TNF-a antagonists will be identified in a case control study. Incidence of these diseases will be calculated.

ReferenceCitation: Lanternier F, Tubach F, Ravaud P, Salmon D, Dellamonica P, Bretagne S, Couret M, Bouvard B, Debandt M, Gueit I, Gendre JP, Leone J, Nicolas N, Che D, Mariette X, Lortholary O; Research Axed on Tolerance of Biotherapies Group. Incidence and risk factors of Legionella pneumophila pneumonia during anti-tumor necrosis factor therapy: a prospective French study. Chest. 2013 Sep;144(3):990-998. doi: 10.1378/chest.12-2820.

ReferenceCitation: Tubach F, Salmon D, Ravaud P, Allanore Y, Goupille P, Bréban M, Pallot-Prades B, Pouplin S, Sacchi A, Chichemanian RM, Bretagne S, Emilie D, Lemann M, Lortholary O, Mariette X; Research Axed on Tolerance of Biotherapies Group. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry. Arthritis Rheum. 2009 Jul;60(7):1884-94. doi: 10.1002/art.24632. Erratum in: Arthritis Rheum. 2009 Aug;60(8):2540. Lorthololary, O [corrected to Lortholary, O].

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: All French departments of rheumatology, internal medicine, gastro-enterology, dermatology, infectious diseases, intensive care unit, oncology and haematology, paediatrics and chest medicine


title: Phase II Study of Broncho-Alveoscopy Using Fibered Confocal Fluorescence Microscopy

acronym: ALVEOLE

summary:
Fibered confocal fluorescence microscopy (FCFM), also referred to as Cell-Vizio® (MaunaKea Technologies, France) is a new technique that produces microscopic imaging in a living tissue, through a 1 mm fiberoptic miniprobe that can be introduced into the working channel of the bronchoscope. The system produces real-time imaging of endogenous fluorophores with a 5 µm lateral resolution and a field of view of 600 x 600 µm. FCFM is able to produce dynamic, high-resolution microimaging of the respiratory bronchiolar walls, alveolar ducts and sacs in vivo during endoscopy (a procedure termed as alveoscopy).

The hypothesis of this study is that an alveoscopy makes it possible to analyze the microstructure of the distal airways in vivo and to collect specific morphologic information in patients with interstitial lung diseases.

The goals of this French Phase II trial are:

to evaluate the tolerance of the alveoscopy
to describe the normal appearance of the bronchoalveolar system in spontaneous ventilation in normal subjects
to describe specific alterations of the bronchoalveolar microstructure in focal or diffuse interstitial lung diseases

ReferenceCitation: Salaün M, Guisier F, Dominique S, Genevois A, Jounieaux V, Bergot E, Thill C, Piton N, Thiberville L. In vivo probe-based confocal laser endomicroscopy in chronic interstitial lung diseases: Specific descriptors and correlation with chest CT. Respirology. 2019 Aug;24(8):783-791. doi: 10.1111/resp.13507. Epub 2019 Feb 27.

lead_sponsor: University Hospital, Rouen


title: Developing Guidelines for Parental Involvement in the Emergency Care of Suicidal Adolescents and Young Adults: a Qualitative Study

acronym: S-Urg-Quali

summary:
Parents occupy a central place in the emergency care of suicidal adolescents and young adults. However, from 15 to 25yo, three different administrative situations exist in France:

<16yo: admission to a child ED by a team trained to receive the youngest patients.
16-18yo: admission to an adult ED by team devoted to adult care, no exit without parents' authorization.
>18yo: admission to an adult ED by team.

Laying on qualitative observational protocol and a Delphi approach, this study will explore the perspective of adolescents and young adults following a suicidal attempt, the perspective of their parents, and the perspective of their healthcare professionals to build guidelines for parental involvement in care of suicidal youths.

status: Not yet recruiting

time_perspective: Cross-Sectional


title: Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: A Pilot Study of an APA Muscle Rendorcement Program

acronym: REMUSCLON

summary:
Colon cancer is a real public health problem with more than 46,000 new cases diagnosed per year in France and about 650 cases in Burgundy. Muscle deconditioning (MD), which is characterized by a loss of muscle mass and function, is a frequent consequence in cancer patients and conditions the prognosis. Therefore, it is essential to understand its complex etiology in oncology in order to address the real need for therapeutic countermeasures in clinical practice. DM is a multifactorial process that is exacerbated by therapies. It induces neurogenic and muscular alterations that can profoundly affect patients' quality of life.

Currently, analyses of this phenomenon in oncology have been limited essentially to a global evaluation of physical performance, neglecting the muscular and nervous nature of the adaptations responsible for it.

Most studies analyzing the therapeutic effects of physical activity (PA) have shown numerous physiological and psychological benefits of aerobic exercise. However, this form of PA is still not very effective in preserving muscle mass.

Only muscle strengthening can have an anabolic effect by accelerating the rate of protein synthesis.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Biological


title: Recognizing Pain Intensity in Alzheimer's Disease: Autonomic Nervous System Variations and Facial Emotion

acronym: DOMASNA

summary:
The most common form of dementia is Alzheimer's disease, with 900,000 people affected in France in 2015 and a forecast of 1.3 million in 2020. As a consequence of their advanced age, dementia patients often suffer from pain, mainly musculoskeletal or neuropathic pain. However, the exact prevalence of pain in dementia is underestimated. Indeed, several studies indicate that people suffering from dementia report less pain. This phenomenon is all the more true as the stage of dementia is advanced. In addition, people with dementia receive less pain medication than people without cognitive impairment in similarly painful conditions. Hetero-evaluation alone also seems insufficient, with the result that pain is under-treated compared to patients without cognitive impairment. Better pain screening is a major challenge and self-assessment tools should be favoured as a first line of treatment, even for patients with cognitive impairment. suffering from dementia.

The investigators propose in this work to evaluate the variation of vegetative parameters that accompany a painful stimulus. These variations can be recorded at the cardiac, vascular, pupillary or skin conductance level.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Ambulatory Measurement of Physical Activity in Pancreatic Cancer Patients

acronym: ARABICA

summary: Pancreatic cancer is the 5th leading cause of death from cancer in France. When chemotherapy can be proposed, the choice of treatment is currently based on the patient's profile and expected tolerance. The endpoints currently used in trials, such as time to therapeutic failure, do not take into account the patient's experience of the disease. The use of quality of life questionnaires is often proposed, but frequent missing data and filling time can be a problem. In oncology, some studies have demonstrated, through questionnaires, the link between physical activity and quality of life. In this situation, ambulatory measurement of physical activity by wrist actimetry could be an integrative reflection of the impact of the disease and treatment (efficacy, tolerance) on patients. This type of evaluation, if accepted by patients, could usefully complement the measurement of quality of life in this population. No study has specifically looked at the use of devices of this type in the context of digestive cancer. The investigators propose to evaluate the acceptance of this type of device by pancreatic cancer patients receiving chemotherapy before evaluating its potential interest.


title: Awareness on Cancer in Persons With Intellectual Disabilities

acronym: ONCODEFI

summary:
Context People with intellectual disability (PWIDs), nearly 1,300,000 adults and children in France, develop as many cancers as persons in the general population. However, their tumors are different by their particular organ distribution, the age of onset, the biological background (2,000 genetic conditions are associated with an intellectual disability) and above all the unusual clinical presentation. These cancers are not well known from physicians, carers and families, and often discovered late. A recent review of the literature shows many inequalities in the prevention, monitoring, screening, diagnosis and treatment of cancer in these patients. Currently, no population study on clinical features and stage at diagnosis of cancer in PWIDs is available. No interventional research study has been conducted on this subject.

Hypothesis Investigators hypothesize that inequalities in cancer care of PWIDs do not result from a direct link between intellectual disability and cancer, but are related to diagnosis difficulties of these tumors which are not well known, and to difficulties of communication with these patients who do not express easily their symptoms, particularly pain.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique


title: Immune Response and Risk of Serious Infection to SARS-Cov2

summary:
To date, nearly 2 million people, including at least 100,000 in France, have been infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). This infection is very heterogeneous in nature, ranging from asymptomatic forms to acute respiratory distress syndrome patterns in 6.1% of cases, leading to an estimated overall mortality of 5.2%.

Apart from age, few risk factors for a pejorative evolution have been identified: arterial hypertension, diabetes, cardiovascular history, obesity and chronic respiratory pathology in particular. The median incubation period is 5 days and the median time between the appearance of the first symptoms and the onset of hypoxia requiring admission to intensive care is 7 to 12 days. The mechanisms involved in the occurrence of these secondary worsening patterns are unclear. One hypothesis is that it is related to an inappropriate inflammatory response rather than a direct cytopathic effect of the virus. The objective of this study is to measure the intensity of the T lymphocyte response in patients hospitalized for Cov2 SARS infection in order to determine whether the intensity of the response is associated with worsening of symptoms.


title: Psychometric Validation of an Oral Health-related Scale for Quality of Life and Coping in People With Schizophrenia

acronym: QUALITY BIS

summary:
Schizophrenia is a severe and persistent psychological disorder affecting 0.7 to 1% of the world's population and 600,000 people in France. Schizophrenic patients are exposed to excess mortality and a life expectancy that is 10 to 15 years lower than the general population (excluding causes of suicide) and to numerous co-morbidities, including oral diseases.

To improve this public health problem, concrete action must be undertaken and evaluated in both quantitative and qualitative terms. While there are many quantitative indicators, there are no reliable and valid tools for the perceived oral health of these individuals in the context of their real and/or imagined world.

The results of a qualitative study previously carried out by our team (QUALITY Study: NCT02730832) made it possible to develop two hypothetical questionnaires for evaluating quality of life related to oral health, the Schizophrenia Oral Health Profile (SOHP), and a questionnaire for evaluating coping strategies with regard to oral health, the Schizophrenia Coping Oral Health Profile (SCOOHP).

However, before these questionnaires can be used in clinical practice, their psychometric properties must be validated.


title: Study of the Determinants Associated With Sustained Changes in Physical Activity Behaviors, and Their Effects on the Prevention and Treatment of Chronic Diseases, in Individuals Enrolled in an Adapted Physical Activity Program

acronym: SESAME

summary:
Introduction: Regular practice of exercise or physical activity (PA) is a recognized intervention as a determinant of good health acquisition, maintenance, or recovery for a large number of chronic pathologies. Nevertheless, few studies have evaluated adherence to an initial health-adapted PA (APA) program, and persistence of active behavior over the time in individuals with a chronic disease.

The aim of the study is to determine the brakes and levers associated with motivation and long-term compliance. In addition, the investigators aim to evaluate the cost-effectiveness of such program in term of care consumption. Finally, the investigators complete their interest for APA prescription from practitioners agreeing to enroll their patients in the present study.

Method: The investigators perform a prospective monocentric cohort, of 2024 patients affected of a chronic disease or long-term illness (LTI), enrolled from 2021 to 2024 (4 years, 506 per year), for a 16-week APA program, and followed 5 years with an annual fitness and habits of life and care consumption evaluation.

lead_sponsor: Mon Stade Sports Medicine Centre


title: Perioperative Collection of Temperatures and Hypothermia (Recueil périOpératoire Des Températures et de l'Hypothermie - ROTHY)

acronym: ROTHY

summary:
Accidental perioperative hypothermia is a frequent complication of anesthesia that favors the occurrence of infections, bleeding and perioperative cardiovascular accidents, and is responsible for perioperative excess mortality. Although preventive measures are widely used, it remains very frequent in France. This observation led a group of experts to draft, under the aegis of the Société Française d'Anesthésie et de Réanimation (SFAR), several recommendations aimed at improving the prevention of perioperative accidental hypothermia.

Perioperative hypothermia is defined as a core body temperature below 36.0 ° Celsius.

This study aims to evaluate the impact of hypothermia prevention training on the proportion of hypothermic patients in the operating room.

ReferenceCitation: Sari S, Aksoy SM, But A. The incidence of inadvertent perioperative hypothermia in patients undergoing general anesthesia and an examination of risk factors. Int J Clin Pract. 2021 Jun;75(6):e14103. doi: 10.1111/ijcp.14103. Epub 2021 Feb 28.

lead_sponsor: Centre Leon Berard


title: Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema

acronym: BESQAOH

summary:
8 years after the establishment of the therapeutic education program and 14 years after the creation of the National Reference Center for Angioedemas (CREAK), it is necessary to make an inventory in 2021 on the disease experienced by the patient with an assessment the needs and expectations of HAE patients. This assessment would make it possible to see the evolution of these needs and to adjust the price for the overall cost of children and adults in France. It may also allow a comparison of the requests expressed during a similar survey in another French-speaking region such as Quebec.

Main objective is to know the needs and the current satisfaction of the needs, with regard to the disease and the treatment of the targeted patients of hereditary angioedema (HAE)


title: Interactive Care Assessment of Risk Factors and Emergency Levels

acronym: iCare

summary: The investigators conceived a computerized interactive tool for Emergency Triage, based on a patient's symptoms, medical history and background. Using this tool, the patient (alone or helped by a nurse / supporting person) presenting to an ophthalmologic ER, should be able to detect and prioritize his most urgent symptoms (A,B), in opposition to less urgent (C) or non urgent symptoms (D). To test the validity of this tool, each patient presenting at the Rothschild Foundation ER (Paris, France) with an ophthalmological problem should be included and sorted by the algorithm before the medical consultation. Neither the patient nor the practitioner are aware of the scoring (A,B,C,D) defined by the algorithm. The practitioner should then give his own emergency scoring (A,B,C,D) after patient examination. A total of 1000 patients is expected.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty - Ankle Go Study

summary:
Ankle injuries are the 2nd most common reason for admission to trauma emergency rooms. It is estimated that the number of sprains occurring per day in France. These injuries are mainly caused by by sports activities. Chronic instability is the most frequent complication that can occur in up to 40% of cases up to 40% of cases. In case of failure of conservative treatment for a minimum of 6 months, surgical management is surgical management is indicated to limit the risk of tibiotalar osteoarthritis, which increases with each episode of instability instability episode.

The main hypothesis of this study is that the Ankle Go Test composite score would to validate in a global way all the criteria of scores of 4 tests and 2 questionnaires, carried out in current practice.

ReferenceCitation: Lopes R, Andrieu M, Cordier G, Molinier F, Benoist J, Colin F, Thès A, Elkaïm M, Boniface O, Guillo S, Bauer T; French Arthroscopic Society. Arthroscopic treatment of chronic ankle instability: Prospective study of outcomes in 286 patients. Orthop Traumatol Surg Res. 2018 Dec;104(8S):S199-S205. doi: 10.1016/j.otsr.2018.09.005. Epub 2018 Sep 21.

ReferenceCitation: Lopes R, Noailles T, Brulefert K, Geffroy L, Decante C. Anatomic validation of the lateral malleolus as a cutaneous marker for the distal insertion of the calcaneofibular ligament. Knee Surg Sports Traumatol Arthrosc. 2018 Mar;26(3):869-874. doi: 10.1007/s00167-016-4250-7. Epub 2016 Aug 6.

ReferenceCitation: Juré D, Blache Y, Degot M, Vigne G, Nové-Josserand L, Godenèche A, Collotte P, Franger G, Borel F, Rogowski I, Neyton L. The S-STARTS Test: Validation of a Composite Test for the Assessment of Readiness to Return to Sport After Shoulder Stabilization Surgery. Sports Health. 2022 Mar-Apr;14(2):254-261. doi: 10.1177/19417381211004107. Epub 2021 Apr 9.

ReferenceCitation: Blakeney WG, Ouanezar H, Rogowski I, Vigne G, Guen ML, Fayard JM, Thaunat M, Chambat P, Sonnery-Cottet B. Validation of a Composite Test for Assessment of Readiness for Return to Sports After Anterior Cruciate Ligament Reconstruction: The K-STARTS Test. Sports Health. 2018 Nov/Dec;10(6):515-522. doi: 10.1177/1941738118786454. Epub 2018 Jul 19.

ReferenceCitation: Carcia CR, Martin RL, Drouin JM. Validity of the Foot and Ankle Ability Measure in athletes with chronic ankle instability. J Athl Train. 2008 Apr-Jun;43(2):179-83. doi: 10.4085/1062-6050-43.2.179.

ReferenceCitation: Borloz S, Crevoisier X, Deriaz O, Ballabeni P, Martin RL, Luthi F. Evidence for validity and reliability of a French version of the FAAM. BMC Musculoskelet Disord. 2011 Feb 8;12:40. doi: 10.1186/1471-2474-12-40.

ReferenceCitation: Docherty CL, Arnold BL, Gansneder BM, Hurwitz S, Gieck J. Functional-Performance Deficits in Volunteers With Functional Ankle Instability. J Athl Train. 2005 Mar;40(1):30-34.

ReferenceCitation: Franck F, Saithna A, Vieira TD, Pioger C, Vigne G, Le Guen M, Rogowski I, Fayard JM, Thaunat M, Sonnery-Cottet B. Return to Sport Composite Test After Anterior Cruciate Ligament Reconstruction (K-STARTS): Factors Affecting Return to Sport Test Score in a Retrospective Analysis of 676 Patients. Sports Health. 2021 Jul-Aug;13(4):364-372. doi: 10.1177/1941738120978240. Epub 2021 Feb 6.

ReferenceCitation: Gribble PA, Delahunt E, Bleakley C, Caulfield B, Docherty CL, Fourchet F, Fong D, Hertel J, Hiller C, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino B, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Orthop Sports Phys Ther. 2013 Aug;43(8):585-91. doi: 10.2519/jospt.2013.0303. Epub 2013 Jul 31.

ReferenceCitation: Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83.

ReferenceCitation: Rosen AB, Needle AR, Ko J. Ability of Functional Performance Tests to Identify Individuals With Chronic Ankle Instability: A Systematic Review With Meta-Analysis. Clin J Sport Med. 2019 Nov;29(6):509-522. doi: 10.1097/JSM.0000000000000535.

ReferenceCitation: Sigonney F, Lopes R, Bouché PA, Kierszbaum E, Moslemi A, Anract P, Stein A, Hardy A. The ankle ligament reconstruction-return to sport after injury (ALR-RSI) is a valid and reproducible scale to quantify psychological readiness before returning to sport after ankle ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2020 Dec;28(12):4003-4010. doi: 10.1007/s00167-020-06020-6. Epub 2020 Apr 30.

lead_sponsor: Elsan


title: Stopping Cognitive Decline and Dementia by Fighting Covert Cerebral Small Vessel Disease

acronym: SHIVA

summary: Cerebral small Vessel Disease (cSVD), characterized by an alteration of the structure and function of small penetrating brain arteries, is highly prevalent in older persons from the general population and represents a leading cause of stroke and a major contributor to cognitive decline and dementia risk. In France >4 million persons aged 60+ are estimated to have moderate to extensive covert cSVD (ccSVD), i.e. features of SVD on brain imaging without a history of clinical stroke. Better detection and management of covert cSVD would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. However, there are no specific mechanistic treatments for cSVD and hardly any recommendations worldwide on how to prevent and treat cSVD and related cognitive impairment. The aim of the present study, through the identification of novel cutting-edge multimodal biomarkers, is to develop innovative diagnostic and risk prediction tools for cSVD and its complications and to contribute to accelerating the discovery of novel drug targets and therapeutics strategies for cSVD.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Broca Hospital
Bordeaux Hospital


title: Non-invasive Screening of Fetal Trisomy 21 by Digital PCR

summary:
In France, as in many countries of the world, trisomy 21 or Down syndrome (DS) is the subject of an antenatal screening based on a risk calculation (R) including the assay of biochemical markers in the maternal blood, and the measurement of a fetal ultrasound parameter (nuchal translucency). In the population of pregnant women said to be at high risk (R> 1/250), confirmation of the diagnosis of DS is made by invasive sampling (trophoblast biopsy or amniocentesis), which allows the establishment of fetal karyotype. In addition to limited sensitivity (80 to 85% depending on the techniques), this screening is an anxiety factor (8% false positives), and miscarriages of euploid fetuses (normal karyotype) in 1% of cases (procedures invasive).

The plasma of a pregnant woman contains a mixture of free DNA of maternal (90%) and fetal origin (cffDNA for cell free fetal DNA) (about 10%, but this proportion increases in cases of fetal trisomy 21. The proportion of cffDNA is sufficient to qualitatively and quantitatively study specific genetic markers of a pair of chromosomes. It is therefore possible to evaluate the quantity of markers chromosome of interest relative to a reference chromosome marker, and to calculate a marker / marker ratio of interest, theoretically identical for all autosomes (chromosomes 1 to 22) during euploid pregnancy. In case of fetal aneuploidy (for example, trisomy 21), this ratio is unbalanced for the chromosomal pair involved.

Advances in technology, such as high-throughput mass sequencing (MPS) and digital PCR (dPCR), now make it possible to consider the diagnosis of fetal maternal DS through the study of cffDNA. Several teams have already published on this subject with the MPS technique, applied directly to free DNA from maternal plasma, or after a cffDNA isolation step. This involves sequencing the DNA fragments present in the sample and placing them back on their original chromosome. In case of trisomy 21 fetal, one seeks to put in evidence of an excess of sequences from chromosome 21. These techniques require expensive equipment (sequencer, bioinformatic platform, servers) and a technical time and important analysis (often several days for a single run). Concerning the research of aneuploidies by digital PCR (dPCR), few publications are today due to the absence of sufficiently powerful instruments until recently. DPCR is less expensive.

lead_sponsor: University Hospital, Caen


title: Comparative Study of Two Embryo Culture Systems: Randomization of Attempts at In Vitro Fertilization With ICSI at the Centre for Medically Assisted Procreation at Dijon CHU

acronym: INCUBATE

summary:
The centre for Medically-Assisted Procreation (MAP) of Dijon CHU has two high-technology embryo culture systems, with incubation characteristics that are potentially superior to those provided by classical culture systems. Indeed, these two systems, available in only two MAP centres in France, make it possible to maintain a stable temperature and gaseous environment during the in-vitro development of the embryos.

It is necessary to observe the development of the embryos to determine which embryos have the highest implantation potential. These observations are done from time to time by microscope for one system and continuously using an incorporated video camera for the other (cinematographic study). The MAP centre in Dijon wishes to compare the interest of these two systems.

ReferenceCitation: Barberet J, Chammas J, Bruno C, Valot E, Vuillemin C, Jonval L, Choux C, Sagot P, Soudry A, Fauque P. Randomized controlled trial comparing embryo culture in two incubator systems: G185 K-System versus EmbryoScope. Fertil Steril. 2018 Feb;109(2):302-309.e1. doi: 10.1016/j.fertnstert.2017.10.008. Epub 2017 Nov 23.


title: Effects of Oral Glutamine Supplementation on Insulin Resistance and Functional Intestinal Disorders in Obese Patients.

acronym: OBEGLUT

summary: Obesity, which has a prevalence at 15% in France, is a major public health concern. Altered glycemic control and irritable bowel syndrome (IBS) are frequently observed in obese patients and lead to reduce the quality of life. In the last decades, the role of gut microbiota and intestinal permeability has been underlined in obesity, glycemic control and IBS. Interestingly, experimental and clinical data show that glutamine, an amino acid, is able to maintain or restore intestinal permeability in different conditions. We thus hypothesize that oral glutamine supplementation may restore gut barrier function contributing to improve glycemic control and IBS-symptoms. Our project will thus aim to evaluate the effects of 8 weeks - oral glutamine supplementation on glycemic control and IBS symptoms in obese patients in a blinded randomized controlled trial. Placebo group will received protein powder. 55 obese patients will enrolled in each arm and will received oral glutamine supplementation or protein powder (10g t.i.d.) during 8 weeks. Blood and feces samples and intestinal permeability assays will be performed at baseline (w0), after 8 weeks of supplementation (w8) and then after 8 weeks of a wash-out period (w16).

intervention_type: Dietary Supplement


title: Signature of the Host Response to a Respiratory Viral Infection, in the Prediction of Bronchiolitis Obliterans

acronym: ALLOPIV

summary: Bronchiolitis obliterans (BO) is the well-known manifestation of the chronic pulmonary graft-versus-host disease(GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). The pathophysiology of BO is, however, poorly known. The available data strongly support the role of respiratory viruses, in particular paramyxoviruses (parainfluenzae virus (PIV), respiratory syncytial virus, metapneumovirus). It is likely that the alloimmune response triggered by the respiratory virus is inadequate and leads to the peribronchiolar fibrotic process. The objective is to analyze the kinetics of profiles of the blood and respiratory host responses resulting from a high or low parainfluenza respiratory infection, in order to evaluate if the occurrence of a BO is associated with a specific signature We will evaluate the predictive signature of a BO after a parainfluenza virus infection by characterizing the differences between the patients evolving and those not evolving to a BO at 2 months after the infection.


title: Brainstem Dysfunction Involvement in the Pathogenesis of Pierre Robin Sequence

acronym: DYSROBIN

summary:
Introduction Pierre Robin Sequence, PRS, incidence is about one hundred births per year in France. The main neonatal clinical manifestations are secondary to airway obstruction and food difficulties related to swallowing disorders. Despite recent progress, the pathogenesis of PRS is not fully understood.

The hypothesis is that brainstem dysfunction, BSD, plays a central role in the pathogenesis of PRS.

The purpose of the study is to achieve a complete evaluation of BSD to specify its role in the pathogenesis of PRS.

The primary objective is to compare central apnea index (CAI) of infants with PRS with those of infants with isolated airway obstruction (AWO) and those of healthy infants in order to clarify the direct role of BSD.

Material and Methods This prospective interventional study will be carried out in Lyon at the Hôpital Femme-Mère-Enfant and in Paris at the Hôpital Necker-Enfants Malades for 2 years. 3 groups of patients will be studied: PRS, 50 patients, AWO, 50 patients and healthy, 30 patients, included before 2 months of life. Infants will be followed for a maximum of 10 months. The evaluations will be carried out for 48 hours between birth and 2 months of life and then for 24 hours between 6 and 10 months of life for PRS and AWO group. Concerning the healthy group, the evaluation will be carried out during 48h during a single hospitalization before 2 months. Polysomnography, holter-ECG, 24h gas exchange, impedance-pH monitoring and mental region EEG will be performed. The central apnea index (mean number per hour), obstructive apnea index, non-nutritive swallowing index (NNS), gastroesophageal reflux and NNS-respiration coordination will be assessed for each stage of sleep and compared between the three groups of patients.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hopital Femme Mère Enfant
APHP-Necker


title: Bioavailability of Protein and Amino Acids From Oilseeds in Healthy Volunteers

acronym: PRODIGE

summary:
The study aims to determine in healthy subjects the bioavailability of protein and amino acids of 4 protein sources: sunflower, rapeseed, lupin, flax. For this purpose, the investigators will compare two methods:

the standard method consisting in measuring the ileal digestibility using ileal tubes
an alternative method that has been proposed by an Food and Agriculture Organization (FAO) expert group: the dual isotope method

ReferenceCitation: Tessier R, Calvez J, Airinei G, Khodorova N, Kapel R, Quinsac A, Galet O, Piedcoq J, Benamouzig R, Tomé D, Gaudichon C. The True Amino Acid Digestibility of 15N-Labelled Sunflower Biscuits Determined with Ileal Balance and Dual Isotope Methods in Healthy Humans. J Nutr. 2022 Mar 3;152(3):698-706. doi: 10.1093/jn/nxab423.

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre de Recherche sur Volontaires (CRV), Hospital Avicenne


title: Concussion in French Amateur Rugby: Descriptive Cross-sectional Survey About the Management and Knowledge of Players Over the 2019/2021 Seasons

acronym: RUGBY-COM

summary: Rugby is a popular contact sport in France the majority of whom are amateur players. Concussion is one of the main risks given its potential severity and frequency (between 2.78 and 10 per 1,000 player hours). Faced with a concussion, stop sport activity, medical evaluation and a progressive resumption of activity are simple things to do to avoid an over-risk of injury and better recovery of the player. For this purpose, the rugby federation implement the blue card and the concussion declaration by clubs. A recent study showed that the directives of the federation are not sufficiently respected. The non-declaration problem is added knowing that around 50% of concussions are not declared. In professional rugby, the presence of a medical staff makes possible to optimize care as much as possible. In the amateur world, there are not always medical or paramedical personnel trained for this problem at the edge of the field when all the participants (player, coach, coaching) lack of knowledge on the subject and that the general practicer remains the referent for the concussion management. We will reach a dozen amateur rugby club to complete a questionnaire about concussions and conduct un formation session about this issue.


title: Assessment of the Relevance of a Medico-social Care of Elderly Patients, in Relay Between Hospital and Home: Experimentation of TEMPORARY HERBERGEMENT in Retirement Home " EHPAD " in Seine-et-Marne Department

summary: The main objective is to study the impact of Temporary Hebergement (TH), as a medico-social care link between hospital and home, on the length of hospitalization in the referral services.

lead_sponsor: Gérond'if


title: Identification of Susceptibility Loci and Genes for Systemic Vasculitis Risk, by Analyzing Whole Exome Sequencing of Familial and Pediatric Forms of Vasculitis (FAMILYVASC Study)

acronym: FAMILYVASC

summary: The FAMILYVASC study is a prospective observational study which will aim to identify susceptibility loci and genes for systemic vasculitis risk in patients with familial or pediatric forms of vasculitis. Genetic analysis based on whole exome sequencing will be carried out through salivary DNA.

lead_sponsor: Benjamin Terrier

location_facility: Hôpital Cochin - Department of Internal Medicine