title: Génomique de la résistance à la Prise de Poids Dans la Maigreur Constitutionnelle

summary: The purpose of this study is to evaluate the molecular differences between a group of Constitutionally Thin (CT) subjects and a group of controls.

ReferenceCitation: Cominetti O, Nunez Galindo A, Corthesy J, Carayol J, Germain N, Galusca B, Estour B, Hager J, Gheldof N, Dayon L. Proteomics reveals unique plasma signatures in constitutional thinness. Proteomics Clin Appl. 2022 Sep;16(5):e2100114. doi: 10.1002/prca.202100114. Epub 2022 May 26.

ReferenceCitation: Bailly M, Germain N, Feasson L, Costes F, Estour B, Hourde C, N Merlet A, Thomas T, Hager J, Pereira B, Thivel D, Courteix D, Galusca B, Verney J. Skeletal muscle of females and males with constitutional thinness: a low intramuscular lipid content and oxidative profile. Appl Physiol Nutr Metab. 2020 Nov;45(11):1287-1298. doi: 10.1139/apnm-2020-0068. Epub 2020 Jun 1.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

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

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

publisher_dissemination: Canadian Science Publishing

ReferenceCitation: Ling Y, Galusca B, Martin FP, Bartova S, Carayol J, Moco S, Epelbaum J, Grouselle D, Boirie Y, Montaurier C, Cuenco J, Minnion JS, Thomas T, Mure S, Hager J, Estour B, Gheldof N, Germain N. Resistance to lean mass gain in constitutional thinness in free-living conditions is not overpassed by overfeeding. J Cachexia Sarcopenia Muscle. 2020 Oct;11(5):1187-1199. doi: 10.1002/jcsm.12572. Epub 2020 Apr 10.

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

ReferenceCitation: Ling Y, Carayol J, Galusca B, Canto C, Montaurier C, Matone A, Vassallo I, Minehira K, Alexandre V, Cominetti O, Nunez Galindo A, Corthesy J, Dayon L, Charpagne A, Metairon S, Raymond F, Descombes P, Casteillo F, Peoc'h M, Palaghiu R, Feasson L, Boirie Y, Estour B, Hager J, Germain N, Gheldof N. Persistent low body weight in humans is associated with higher mitochondrial activity in white adipose tissue. Am J Clin Nutr. 2019 Sep 1;110(3):605-616. doi: 10.1093/ajcn/nqz144.

repositories_concat: PubMed Central;pdfs.semanticscholar.org


type: Other Identifier

title: Interest of Dynamic Measures of the Pupil in Optic Neuritis

acronym: PCT-NORB

summary: The investigators' hypothesis is that measuring the PCTdynamics would be an easy and reliable symptom to evaluate in pathologies affecting the optic nerve

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: Effect of an Induction Dose of Non Depolarizing Neuro Muscular Blocking Agents (NMBA) on Ultrasound Bowel Peristalsis.

acronym: CURARES

summary:
Phase III prospective randomised study : curare vs placebo, comparing bowel peristalsis (abdominal echography) in the first minutes of after general anesthesia induction.

Primary End Point: proportion of patients with a score of motion = 0

status: Terminated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

sponsor_collaborators: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Drug

status_simplified: Unknown


type: Registry Identifier

title: Pilot Prospective Study on Interest of Functional MRI in Early Assessment of Radioembolization Efficiency in Patients Suffering From Hepatocellular Carcinoma

acronym: ICY

summary: For patients who are suffering from hepatocellular carcinoma and are treated with radioembolization, the purpose of this study is to analyse parameters of functional MRIs that are modified early and to detect parameters that vary significantly after treatment.

primary_purpose: Diagnostic

lead_sponsor: Center Eugene Marquis


title: Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)

acronym: AMIS

summary: The objective is determine the strain measured at the bedside could be a dynamic prognostic marker of during Acute respiratory Distress Syndrome (ARDS).

study_start_date_type: Actual

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Réanimation Médicale CHU de Nice - Hôpital de l'Archet

lead_sponsor_type: academique


title: Effects of Viral Reactivation on Outcomes of Brain-injured Patients ( IBIS-VIRUS)

acronym: IBIS-VIRUS

summary: Morbidity and mortality of ICU patients is increased by the development of a "immunosuppression" systemic (IS). This IS develops in the early hours of hospitalization and is responsible for severe infections, including viral reactivations (Cytomegalovirus or Herpes Simplex Virus). Viral reactivation was associated with increased morbidity and mortality in intensive care units. In clinical practice, they are searched at the onset of organ failure or unexplained fever. The investigators wish to conduct this research in the stroke patients to assess the predictive power of these viral reactivations on the duration of mechanical ventilation.

time_perspective: Prospective

lead_sponsor: Nantes University Hospital


acronym: HYPNOART

summary: The purpose of this study is to compare the clinical benefits that can be expected by the Embryo transfert procedure with hypnosis to the usual embryo transfer procedure

lead_sponsor: University Hospital, Angers

intervention_type: Procedure


title: Chronic Pain and Vitamin D: a Randomized Pilot Study in General Practice

acronym: DOVID

summary: Non-systematized chronic musculoskeletal pains are a frequent reason for consulting in general practice. The possible causes are numerous and sometimes nonspecific. In some cases, the etiologic investigation of patients with non-systematized and chronic musculoskeletal pain can not highlight any organic cause. Several studies have shown a link between these symptoms and vitamin D deficiency, characterized by a blood level of 25 (OH) vitamin D < 20.8ng/ml. This deficit is easy to identify and to correct through proper vitamin D supplementation with few side effects. Nevertheless, it remains unknown and vitamin D deficiency is rarely considered as a possible etiology in patients with chronic pain. We hypothesize that vitamin D supplementation in patients with non-systematized musculoskeletal pain and deficient in vitamin D could improve painful symptoms. We aim to perform a double-blind randomized controlled trial, vitamin D versus placebo, to assess the pain improvement after vitamin D supplementation.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon


title: Comparison of Both Metabolic and Functional Effects Induced by Two Neuromuscular Electrical Stimulation Protocols: A Comprehensive Approach Using Magnetic Resonance Imaging and Spectroscopy

summary: Neuromuscular electrical stimulation (NMES) has emerged as a suitable tool for restoring, maintaining and/or enhancing muscular performance. From a practical point of view, NMES can elicit contractions either by direct activation of motor axons (i.e. peripheral mechanism) or by the recruitment of motoneurons in the spinal cord through the depolarization of sensory axons (central mechanism). It is noteworthy that NMES parameters widely affect the balance between transmission along these two pathways. Conventional NMES is usually delivered using short pulse duration (0.05-0.4 ms), low stimulation frequency (15-40 Hz) and high stimulus intensities so that the large antidromic volley in motor axons ensures that the evoked contraction will be driven largely by the direct depolarization of motor axons beneath the stimulation site with no or little involvement of central nervous system. On the contrary, when NMES is delivered using wide pulse widths (1 ms) and high frequency (up to 100 Hz) (WP-HF NMES), a portion of the evoked contraction arises from a central mechanism and the corresponding force (recently referred to as "extra force") is significantly (three times) larger than the conventional NMES-induced force. This extra force is supposed to represent the central contribution from the recruitment of spinal motoneurons by the evoked afferent volley given that no additional force was observed during a complete anesthetic block of the nerve proximal to the stimulation site. Despite the obvious differences in terms of activation of the neuromuscular system between conventional and WP-HF NMES, the functional, metabolic and cortical responses associated to both protocols remain to be determined

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Device


title: Abilities of Dynamic Preload Dependence Indicators to Predict Fluid Responsiveness During Neurosurgery in Sitting Position

summary: Intraoperative optimization of cardiac output using goal directed fluid challenge is associated with better outcome. Dynamic preload dependence indicators are well validated during surgery in supine position. Positioning from supine to sitting position under anesthesia is responsible of several hemodynamic changes. Predictability and cut-off values of dynamic preload dependence indicators during surgery in sitting position are unknown. The objective of this prospective study is to evaluate ability of three dynamic preload dependence indicators, i.e. PPV (Pulse Pressure Variation), SVV (Stroke Volume Variation) and PVI (Plethysmographic Variability Index), during neurosurgery in sitting position.

location_facility: Fédération d'anesthésie réanimation Hôpital Pierre Wertheimer


title: Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People

acronym: REFLEX-IR

summary: The study aim is to Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People.

lead_sponsor: Institut Pasteur de Lille

sponsor_collaborators:
Institut Pasteur de Lille
Luxomed


title: Interest of a Geriatric Intervention Plan Associated to a Comprehensive Geriatric Assessment on Autonomy, Quality of Life and Survival of Patients Aged 70 Years Old and More Surgically Treated for a Resectable Cancer (Thoracic, Digestive or Urologic). Randomized Multicentric Study

acronym: epigac

summary:
The curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic, hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical resection. For patients aged of 70 years old and more, this surgery is associated to an increased morbid-mortality especially because of more frequent co-morbidities. Comprehensive geriatric assessment (CGA) allows distinguishing patients for whom a resection surgery can be complicated by high morbid-mortality or a loss of autonomy. It has been proved that for old patient population without cancer, CGA associated with a geriatric intervention plan (GIP) allows autonomy preservation, decrease of institution admission, and survival improvement. The reference study showed that a CGA associated to a GIP improves survival of old patients who had a cancer surgery. However this study included patients from 60 years old and the GIP consisted in 3 home visits and 5 phone calls during the 4 weeks following hospital discharge.

We propose to perform a prospective and randomized study to evaluate the impact of a CGA with GIP in 70 years old and more patients with a thoracic, digestive or urologic cancer resection, respectively 1, 3, 6 and 12 months after discharge. CGA and GIP will focus on 8 distinct fields: autonomy, co-morbidities, co-medication, mobility, nutritional status, depression, cognitive function and social status. The impact of such a strategy on autonomy and survival has never been studied.

primary_purpose: Supportive Care

sponsor_collaborators: Assistance Publique Hopitaux De Marseille


title: Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo

summary:
Atrial fibrillation remains a major cause of morbidity following cardiac surgery with cardiopulmonary bypass. Many mechanisms have been implicated. Among then, adenosine, a strong endogenous vasodilating agent has been involved in cardiac surgery-induced atrial fibrillation, via A2A receptors modulation.

The effects of caffeine on the inducibility of atrial fibrillation are actually well-known, leading then to a significant reduction of atrial fibrillation. Moreover, a recent clinical study has demonstrated that coffee drinking was inversely associated with total and cause-specific mortality.

The investigators therefore examined the preventive effects of oral caffeine on valvular surgery with cardiopulmonary bypass-induced atrial fibrillation. The investigators also evaluated prospectively the influence of caffeine on adenosine plasma levels and A2A adenosine receptors modulation.

ReferenceType: derived

ReferenceCitation: Lagier D, Nee L, Guieu R, Kerbaul F, Fenouillet E, Roux N, Giorgi R, Theron A, Grisoli D, Gariboldi V, Collart F, Bruder N, Velly L, Guidon C. Peri-operative oral caffeine does not prevent postoperative atrial fibrillation after heart valve surgery with cardiopulmonary bypass: A randomised controlled clinical trial. Eur J Anaesthesiol. 2018 Dec;35(12):911-918. doi: 10.1097/EJA.0000000000000824.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health


title: Evaluation of Microdialysis to Monitor Postoperative Outcomes After Proctectomy

acronym: MTM-COLON-II

summary: The aim of this study is to monitor by microdialysis the postoperative outcomes in order to identify anastomotic leaks after rectal surgery.

ReferenceType: background

ReferenceCitation: Solligard E, Juel IS, Spigset O, Romundstad P, Gronbech JE, Aadahl P. Gut luminal lactate measured by microdialysis mirrors permeability of the intestinal mucosa after ischemia. Shock. 2008 Feb;29(2):245-51. doi: 10.1097/SHK.0b013e3180cab3ce.

ReferenceCitation: Cibicek N, Zivna H, Zadak Z, Kulir J, Cermakova E, Palicka V. Colon submucosal microdialysis: a novel in vivo approach in barrier function assessment - a pilot study in rats. Physiol Res. 2007;56(5):611-617. doi: 10.33549/physiolres.931004. Epub 2006 Dec 19.

ReferenceCitation: Krejci V, Hiltebrand L, Buchi C, Ali SZ, Contaldo C, Takala J, Sigurdsson GH, Jakob SM. Decreasing gut wall glucose as an early marker of impaired intestinal perfusion. Crit Care Med. 2006 Sep;34(9):2406-14. doi: 10.1097/01.CCM.0000233855.34344.29.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Determinants of Intensity of Care of Lung Cancer Patients With Organ Failure

acronym: CBP-DO

summary: Investigators will evaluate determinants of the patients' care type : palliative, medical or intensive care. The place of patient or family on care's decision will be noticed. Investigators will evaluate 3 month-survival and patients' feelings (visit with a psychologist) according to type of care they benefited.

lead_sponsor: University Hospital, Grenoble


title: Pilot Study of the Efficacy and Tolerance of the Adjunction of a Fish Oil Emulsion to Daunorubicin and Cytarabine Chemotherapy for the Treatment of Acute MYeloblastic Leukemia of Younger Patients With High-risk Cytogenetics

acronym: FAMYLY

summary: Pilot study of the efficacy and tolerance of the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients (under 61 years) with high-risk cytogenetics.

ReferenceCitation: Gyan E, Pigneux A, Hunault M, Peterlin P, Carre M, Bay JO, Bonmati C, Gallego-Hernanz MP, Lioure B, Bertrand P, Vallet N, Ternant D, Darrouzain F, Picou F, Bene MC, Recher C, Herault O. Adjunction of a fish oil emulsion to cytarabine and daunorubicin induction chemotherapy in high-risk AML. Sci Rep. 2022 Jun 13;12(1):9748. doi: 10.1038/s41598-022-13626-y.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Picou F, Debeissat C, Bourgeais J, Gallay N, Ferrie E, Foucault A, Ravalet N, Maciejewski A, Vallet N, Ducrocq E, Haddaoui L, Domenech J, Herault O, Gyan E. n-3 Polyunsaturated fatty acids induce acute myeloid leukemia cell death associated with mitochondrial glycolytic switch and Nrf2 pathway activation. Pharmacol Res. 2018 Oct;136:45-55. doi: 10.1016/j.phrs.2018.08.015. Epub 2018 Aug 22.

publisher_dissemination: Elsevier

ReferenceCitation: Gyan E, Raynard B, Durand JP, Lacau Saint Guily J, Gouy S, Movschin ML, Khemissa F, Flori N, Oziel-Taieb S, Bannier Braticevic C, Zeanandin G, Hebert C, Savinelli F, Goldwasser F, Hebuterne X; NutriCancer2012 Investigator Group. Malnutrition in Patients With Cancer: Comparison of Perceptions by Patients, Relatives, and Physicians-Results of the NutriCancer2012 Study. JPEN J Parenter Enteral Nutr. 2018 Jan;42(1):255-260. doi: 10.1177/0148607116688881. Epub 2017 Dec 11.

publisher_dissemination: Wiley

ipd_sharing: No

lead_sponsor: French Innovative Leukemia Organisation

sponsor_collaborators:
French Innovative Leukemia Organisation
Fresenius Kabi


title: Phenotype/Genotype Correlation in a Family With Early Onset Osteoarthritis: Contribution of Genetic in the Diagnosis and Early Management of Patients.

acronym: Exorhum

summary:
This study will investigate the genes responsible for osteoarthritis. Individuals with osteoarthritis known or suspected to be caused by a gene mutation (change) may be eligible for this study. Family members may also participate.

Patients will talk with investigators who will explain the study and its possible implications for the patient and family and answer questions. The patient's medical records will be reviewed, a personal and family history will be taken, and a physical examination will be done. Two procedures may be done including blood sampling (which will be used for DNA (genetic) studies) and X-rays (to define osteoarthritis grade).

If no known mutations responsible for osteoarthritis will be detected, participating family members will be interviewed by telephone about their personal and family health history and will have a blood sample drawn for DNA testing, and X-rays.

lead_sponsor: University Hospital, Caen

intervention_type: Genetic


title: Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site

acronym: ROPI

summary:
The aim of the study is to Evaluate of the analgesic effect of ropivacaine in topical use at the thin skin graft donor site.

For Patient needing a thin skin graft < 320 cm2, randomization will be done in 2 groups, one receiving the standard treatment (20 mL of physiologic serum) during the surgical intervention in topical use to recover an alginate dressing (Algosteril)and the other receive 20 mL of Naropein during the surgical intervention on alginate dressing.

The hypothesis of the study is the administration of ropivacaine will decrease the post-operative pain compared to physiologic serum

lead_sponsor: University Hospital, Rouen


title: Hypertension of Our Patients: Knowledge, Control, Comorbidity

summary:
Numerous studies highlight the insufficiency of blood pressure control in treated hypertensive population [1].

As shown in the MONICA study, increased cardiovascular mortality is found in Alsace compared to other french regions. The incidence and prevalence of diabetes and obesity are likely explanatory factors leading to this excess mortality [2].

Furthermore, the incidence and prevalence of alsacian patients with end-stage renal failure (ESRD) is also higher than the national average. The high prevalence of diabetes, hypertension and obesity in this population is also probably responsible for the high prevalence of ESRD [3].

Opportunities to prevent the progression of kidney disease involve an optimal control of treatable evolutionary factors.

Beyond control of diabetes and obesity, optimization of blood pressure control are an important factor to consider, as national and international guidelines recommend lower blood pressure targets in this population [4]. Knowledge of the disease and treatment goals are a key component of hypertensive patient management. Studies have shown that the knowledge of hypertensive disease and therapeutic targets were correlated with treatment compliance and with the rate of blood pressure control [5]. Patient education and participation of non-medical actors (nurses, pharmacists, …) are likely to improve the management and treatment compliance of these patients [6]. To our knowledge, no investigation has been performed in our region to determine the epidemiological characteristics, the knowledge level and blood pressure control in the population of hypertensive patients. The main objectives of this observational study are to evaluate, in a treated hypertensive population:

the knowledge level of the blood pressure treatment goals, the impact of patient knowledge on this blood pressure control, the potential impact of the patient's comorbidities on his blood pressure control.

Such a study should provide the basis for the feasibility of a large survey.

ReferenceCitation: Mancia G, Sega R, Milesi C, Cesana G, Zanchetti A. Blood-pressure control in the hypertensive population. Lancet. 1997 Feb 15;349(9050):454-7. doi: 10.1016/s0140-6736(96)07099-7.

ReferenceCitation: Berard E, Bongard V, Arveiler D, Amouyel P, Wagner A, Dallongeville J, Haas B, Cottel D, Ruidavets JB, Ferrieres J. Ten-year risk of all-cause mortality: assessment of a risk prediction algorithm in a French general population. Eur J Epidemiol. 2011 May;26(5):359-68. doi: 10.1007/s10654-010-9541-6. Epub 2010 Dec 28.

ReferenceCitation: Registre REIN Rapport annuel 2010

ReferenceCitation: Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, Cifkova R, Clement D, Coca A, Dominiczak A, Erdine S, Fagard R, Farsang C, Grassi G, Haller H, Heagerty A, Kjeldsen SE, Kiowski W, Mallion JM, Manolis A, Narkiewicz K, Nilsson P, Olsen MH, Rahn KH, Redon J, Rodicio J, Ruilope L, Schmieder RE, Struijker-Boudier HA, Van Zwieten PA, Viigimaa M, Zanchetti A. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. Blood Press. 2009;18(6):308-47. doi: 10.3109/08037050903450468. No abstract available.

ReferenceCitation: Atallah A, Papouin G, Mimran C, Braunstein C, Ganty J, Larifla L, Djaballah K, Inamo J. [Knowledge of hypertension among hypertensive patients in general practice, and its relation to achieving therapeutic goals: The Co-HACT study, French West Indies]. Ann Cardiol Angeiol (Paris). 2011 Feb;60(1):21-6. doi: 10.1016/j.ancard.2010.06.001. Epub 2010 Jul 16. French.

ReferenceCitation: M Ashok Kumar. Improving medication adherence and clinical outcomes of hypertensive patients through patient counseling. Research Journal of Pharmaceutical, Biological and Chemical Sciences 2011; 2: 232-241

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace


title: Predictive Factors of the Reduction of Emotional Eating After a Behavior Change Program Among Individuals With Obesity of Class II and Class III.

summary: Recent studies show that overweight people have a greater sensitivity to the rewarding aspect of food due to the disturbance of the dopaminergic system. These perturbations lead to a greater amount of food to satisfy this rewarding aspect. Then, this rewarding aspect to food would also facilitate food intake related to emotions, whether they are positive or negative. However, the food intake in response to emotions can be modulated by physical activity. But, there are no interventional studies in the literature examining the behavioral and biological factors related to emotional eating together with the fact, there are few data on the explanatory mechanisms. The purpose of the study is to evaluate the predictive factors of emotional eating 6 months after a behavior change program adapted to the motivational state and to identify the its underlying mechanisms

primary_purpose: Basic Science

lead_sponsor: University Hospital, Montpellier

location_facility: University Hospital of Montpellier-Hopital La colombière


title: Immunologic Profile of Children and Teenagers With Severe Allergy to Peanuts and Nuts After Induction of Tolerance: a Pilot Project

acronym: TOY

summary:
Many authors propose the strict avoidance of allergenic food as the only treatment for children known to be allergic to certain food. However, it has been observed an increase of the frequency and severity of the allergic accidents in these children in the long term. Other teams have suggested treating these allergies (in particular peanut allergies) by controlled and progressive reintroduction of the allergenic food. A good tolerance and a prevention of allergic reactions consecutive to the ingestion of the same allergenic food were observed. The immunological mechanisms of this type of treatment are not well known.

A decrease of specific IgE and an increase of IgG4 have been observed in the case of egg allergies after this kind of treatment. Certain experiments realized in mice models testing the allergenic stimulation challenge showed an increase of lymphocytes T regulators (foxp3+ , CD4+, CD25+), stimulated by dendritic cells, and also an increase of interleukin 10, leading to the modification of the balance between Th1 and Th2.Our hypothesis is that after treating allergies by the reintroduction of the allergenic food, the immunological mechanism of acquisition of tolerance is associated to variations in populations of lymphocytes and in the activation or decrease of pro and anti-inflammatory cytokines. This reaction will be studied in two groups: 1. Children with a confirmed allergy to peanuts or nuts and 2. Children without antecedents of allergy or familiar atopy.

lead_sponsor: Lille Catholic University

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille


title: The Proposed Study is to Validate a New Non-invasive Imaging Technique for Evaluation of Cardiac Microciculation in Coronary Artery Disease With a Comparison With Validated Technique Invasive, Which is Measure of Index of Myocardial Resistance

acronym: EVACORY

summary: The proposed study is to validate a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease with a comparison with validated technique invasive, which is measure of index of myocardial resistance.


title: Effects of Physical Activity Program on the Emotional and Cognitive Dynamics in Major Depressive Disorder Patients

summary: The main objective of this study is to evaluate the effect of a 12 weeks adapted physical activity program (active walking) on depression by analyzing the dynamics of emotional and cognitive functioning. The secondary objectives are to test the effects of a physical activity on functional performance and to highlight psychological mechanisms.

primary_purpose: Health Services Research

ReferenceCitation: Deschamps T, Thomas-Ollivier V, Sauvaget A, Bulteau S, Fortes-Bourbousson M, Vachon H. Balance characteristics in patients with major depression after a two-month walking exercise program: A pilot study. Gait Posture. 2015 Oct;42(4):590-3. doi: 10.1016/j.gaitpost.2015.07.057. Epub 2015 Jul 31.

lead_sponsor: Laboratory Motricité, Interactions, Performance


title: A Smartphone Application to Evaluate Energy Expenditure and Duration of Moderate-intensity Activities

summary: The aim of this study was to find functions for estimating energy expenditure in free-living conditions. This method was based on accelerometry data acquired from a smartphone worn in a trouser pocket. The developed functions have been compared to the estimations provided by two research devices named Armband and Actiheart.

primary_purpose: Prevention

lead_sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

location_facility: Centre de Recherche en Nutrition Humaine Auvergne


title: A Smartphone Application to Evaluate Energy Expenditure and Duration of Moderate-intensity Activities in Free-living Conditions (eMouve 2)

summary: The aim of this study was to validate functions for estimating energy expenditure in free-living conditions. This method was based on accelerometry data acquired from a smartphone worn in a trouser pocket. The developed functions have been compared to the estimations provided by two research devices named Armband and Actiheart.

sponsor_collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement


title: A Cohort to Quantify and to Predict Treatment Related Chronic Toxicities in Patients With Non-metastatic Cancer - Breast and Lung.

acronym: CANTO

summary:
The aims of the cohort will be to quantify impact of cancer treatments toxicities , and to generate predictors of chronic toxicity in patients with non-metastatic cancer. Study of the original cohort will be focused on localized breast cancer patients, other localisation in non-metastatic setting will be explored furtherwise, fist of all in lung cancer.

The project will include four specific aims :

To develop a database of chronic treatment related toxicity in a cohort of 14750 women with stage I-III breast cancer (= non metastatic), whatever these treatments are (surgery; radiation therapy; chemotherapy …)
To describe incidence, clinical presentation, and outcome of chronic toxicities.
To describe the psychological, the social and the economic impacts of chronic toxicities.
To generate predictors for chronic toxicities in order to prevent them, based upon biological criteria.

The expected impact of these toxicities, when identified, will be to improve quality of life and to decrease health cost, by the early identification of patients at high risk of toxicity. Such early identification could lead to prevent toxic effect by: a. developing prevention strategies, b. substituting toxic treatment by a non (less) toxic one.

Also, such cohort will offer a quantification of the impact of treatment toxicity, that could be further used to quantify medical usefulness of strategies that aim at decreasing treatment toxicities (implementation of predictive biomarker for resistance, cytotoxic-free regimen etc…)

status: Recruiting

ReferenceCitation: Soldato D, Havas J, Crane TE, Presti D, Lapidari P, Rassy N, Pistilli B, Martin E, Del Mastro L, Martin AL, Jacquet A, Coutant C, Cottu P, Merimeche A, Lerebours F, Tredan O, Vanlemmens L, Andre F, Vaz-Luis I, Di Meglio A. Coffee and tea consumption, patient-reported, and clinical outcomes in a longitudinal study of patients with breast cancer. Cancer. 2022 Oct 1;128(19):3552-3563. doi: 10.1002/cncr.34401. Epub 2022 Aug 1.

oa_colors: green hybrid

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unpaywall_oa_status: hybrid

ReferenceCitation: Presti D, Havas J, Soldato D, Lapidari P, Martin E, Pistilli B, Jouannaud C, Emile G, Rigal O, Fournier M, Soulie P, Mouret-Reynier MA, Tarpin C, Campone M, Guillermet S, Martin AL, Everhard S, Di Meglio A. Factors associated with enrolment in clinical trials among women with early-stage breast cancer. ESMO Open. 2022 Jun;7(3):100513. doi: 10.1016/j.esmoop.2022.100513. Epub 2022 Jun 17.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Baker JL, Di Meglio A, Gbenou AS, El Mouhebb M, Iyengar NM, Michiels S, Cottu P, Lerebours F, Coutant C, Lesur A, Tredan O, Vanlemmens L, Jouannaud C, Hrab I, Everhard S, Martin AL, Arveux P, Fabrice A, Vaz-Luis I, Jones LW. Association between physical activity and neoadjuvant chemotherapy completion and pathologic complete response in primary breast cancer: the CANTO study. Br J Cancer. 2022 Sep;127(5):886-891. doi: 10.1038/s41416-022-01870-y. Epub 2022 Jun 17.

oa_host_type: repository

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

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: green

ReferenceCitation: Di Meglio A, Havas J, Gbenou AS, Martin E, El-Mouhebb M, Pistilli B, Menvielle G, Dumas A, Everhard S, Martin AL, Cottu PH, Lerebours F, Coutant C, Lesur A, Tredan O, Soulie P, Vanlemmens L, Joly F, Delaloge S, Ganz PA, Andre F, Partridge AH, Jones LW, Michiels S, Vaz-Luis I. Dynamics of Long-Term Patient-Reported Quality of Life and Health Behaviors After Adjuvant Breast Cancer Chemotherapy. J Clin Oncol. 2022 Sep 20;40(27):3190-3204. doi: 10.1200/JCO.21.00277. Epub 2022 Apr 21.

evidence: open (via page says license)

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

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

repository_normalized: HAL

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

repository_institution: California Digital Library - eScholarship

repositories:
HAL
PubMed Central
escholarship.org

repositories_concat: HAL;PubMed Central;escholarship.org

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Vaz-Luis I, Di Meglio A, Havas J, El-Mouhebb M, Lapidari P, Presti D, Soldato D, Pistilli B, Dumas A, Menvielle G, Charles C, Everhard S, Martin AL, Cottu PH, Lerebours F, Coutant C, Dauchy S, Delaloge S, Lin NU, Ganz PA, Partridge AH, Andre F, Michiels S. Long-Term Longitudinal Patterns of Patient-Reported Fatigue After Breast Cancer: A Group-Based Trajectory Analysis. J Clin Oncol. 2022 Jul 1;40(19):2148-2162. doi: 10.1200/JCO.21.01958. Epub 2022 Mar 15.

ReferenceCitation: Di Meglio A, Charles C, Martin E, Havas J, Gbenou A, Flaysakier JD, Martin AL, Everhard S, Laas E, Chopin N, Vanlemmens L, Jouannaud C, Levy C, Rigal O, Fournier M, Soulie P, Scotte F, Pistilli B, Dumas A, Menvielle G, Andre F, Michiels S, Dauchy S, Vaz-Luis I. Uptake of Recommendations for Posttreatment Cancer-Related Fatigue Among Breast Cancer Survivors. J Natl Compr Canc Netw. 2022 Feb 7;20(13). doi: 10.6004/jnccn.2021.7051.

ReferenceCitation: Di Meglio A, Havas J, Soldato D, Presti D, Martin E, Pistilli B, Menvielle G, Dumas A, Charles C, Everhard S, Martin AL, Coutant C, Tarpin C, Vanlemmens L, Levy C, Rigal O, Delaloge S, Lin NU, Ganz PA, Partridge AH, Andre F, Michiels S, Vaz-Luis I. Development and Validation of a Predictive Model of Severe Fatigue After Breast Cancer Diagnosis: Toward a Personalized Framework in Survivorship Care. J Clin Oncol. 2022 Apr 1;40(10):1111-1123. doi: 10.1200/JCO.21.01252. Epub 2022 Jan 21.

ReferenceCitation: Caumette E, Vaz-Luis I, Pinto S, Havas J, Bovagnet T, Ruiz de Azua G, Di Meglio A, Martin AL, Everhard S, Cottu P, Vanlemmens L, Jouannaud C, Lerebours F, Dumas A, Menvielle G. The Challenge of Return to Work after Breast Cancer: The Role of Family Situation, CANTO Cohort. Curr Oncol. 2021 Oct 1;28(5):3866-3875. doi: 10.3390/curroncol28050330.

ReferenceCitation: Di Meglio A, Gbenou AS, Martin E, Pistilli B, Ligibel JA, Crane TE, Flaysakier JD, Minvielle E, Vanlemmens L, Guenancia C, Rigal O, Fournier M, Soulie P, Mouret-Reynier MA, Tarpin C, Boiffard F, Guillermet S, Everhard S, Martin AL, Giacchetti S, Petit T, Dalenc F, Rouanet P, Arnaud A, Andre F, Vaz-Luis I. Unhealthy behaviors after breast cancer: Capitalizing on a teachable moment to promote lifestyle improvements. Cancer. 2021 Aug 1;127(15):2774-2787. doi: 10.1002/cncr.33565. Epub 2021 Apr 22.

ReferenceCitation: Di Meglio A, Menvielle G, Dumas A, Gbenou A, Pinto S, Bovagnet T, Martin E, Ferreira AR, Vanlemmens L, Arsene O, Ibrahim M, Wassermann J, Martin AL, Lemonnier J, Del Mastro L, Jones LW, Partridge AH, Ligibel JA, Andre F, Michiels S, Vaz Luis I. Body weight and return to work among survivors of early-stage breast cancer. ESMO Open. 2020 Nov;5(6):e000908. doi: 10.1136/esmoopen-2020-000908.

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

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

ReferenceCitation: Pistilli B, Paci A, Ferreira AR, Di Meglio A, Poinsignon V, Bardet A, Menvielle G, Dumas A, Pinto S, Dauchy S, Fasse L, Cottu PH, Lerebours F, Coutant C, Lesur A, Tredan O, Soulie P, Vanlemmens L, Jouannaud C, Levy C, Everhard S, Arveux P, Martin AL, Dima A, Lin NU, Partridge AH, Delaloge S, Michiels S, Andre F, Vaz-Luis I. Serum Detection of Nonadherence to Adjuvant Tamoxifen and Breast Cancer Recurrence Risk. J Clin Oncol. 2020 Aug 20;38(24):2762-2772. doi: 10.1200/JCO.19.01758. Epub 2020 Jun 22.

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

ReferenceCitation: Kabore EG, Guenancia C, Vaz-Luis I, Di Meglio A, Pistilli B, Coutant C, Cottu P, Lesur A, Petit T, Dalenc F, Rouanet P, Arnaud A, Arsene O, Ibrahim M, Wassermann J, Boileau-Jolimoy G, Martin AL, Lemonnier J, Andre F, Arveux P. Association of body mass index and cardiotoxicity related to anthracyclines and trastuzumab in early breast cancer: French CANTO cohort study. PLoS Med. 2019 Dec 23;16(12):e1002989. doi: 10.1371/journal.pmed.1002989. eCollection 2019 Dec.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

ReferenceCitation: Ferreira AR, Di Meglio A, Pistilli B, Gbenou AS, El-Mouhebb M, Dauchy S, Charles C, Joly F, Everhard S, Lambertini M, Coutant C, Cottu P, Lerebours F, Petit T, Dalenc F, Rouanet P, Arnaud A, Martin A, Berille J, Ganz PA, Partridge AH, Delaloge S, Michiels S, Andre F, Vaz-Luis I. Differential impact of endocrine therapy and chemotherapy on quality of life of breast cancer survivors: a prospective patient-reported outcomes analysis. Ann Oncol. 2019 Nov 1;30(11):1784-1795. doi: 10.1093/annonc/mdz298.

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.


title: Analysis of Osteoimmune Interactions Linking Inflammation and Bone Destruction in Aggressive Periodontitis

acronym: PAG

summary: Periodontitis are inflammatory diseases characterized by the destruction of the tooth-supporting bone due to increased bone resorption by osteoclasts (OCLs). Two forms are described: chronic periodontitis (CP) and aggressive periodontitis (AP) that differ by the severity and rapidity of bone loss, much more important for AP than CP. In both forms, the link with uncontrolled activation of the immune system is largely admitted. Despite the physiopathology of CP is fairly well studied, very few data are available regarding AP. The investigators aim is to understand the severity of AP by analyzing the proportion and action of immune and mesnchymal cells potentially involved in bone destruction, on biopsies of periodontal granulation tissue (surgical waste) and blood. Three groups of 20 patients will be included: affected with AP, CP or controls (necessitating an extraction of wisdom teeth).

design_allocation: Non-Randomized

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: Odontology Department, Nice Unversity Hospital


title: Experimental Pain Sensitivity of Subjects With Fibromyalgia Before and After rTMS Treatment in Relation to the Clinical Improvement

summary: The principal study aims at evaluating the efficiency of rTMS maintenance sessions on the clinical effect of a rTMS cure in fibromyalgic subjects. This complementary study consists in the evaluation of the experimental sensitivity to mechanical pain (pressure application on the forearm) of subjects presenting fibromyalgia before and after rTMS treatment (21 days), and to put the results in relation to the clinical improvement and the psychometric evaluations (depression,fibromyalgia impact questionnaire, catastrophism).

lead_sponsor: Centre Hospitalier Esquirol


title: Evaluation of Cardiac Arrest Recognition by Non-physicians Dispatchers in the Paris Fire Brigade Emergency Call Dispatch Center

acronym: OCAR

summary: The purpose of this study is to measure an improvement in the detection rate of cardiac arrest (CA) in the Dispatch Center as a result of debriefings and repeated trainings for non-medical operators who receive emergency calls.

lead_sponsor: Fire Brigade Of Paris Emergency Medicine Dept


title: Etude de l'Expression Des Micro-RNA Comme Biomarqueur Diagnostic et Pronostic Dans la Sclérose Latérale Amyotrophique

acronym: MIRSLA

summary: The principal goal is to demonstrate that a specific pattern of microRNA (miRNA) expression can be correlated with the definite diagnostic of Amyotrophic Lateral Sclerosis (ALS). The investigators will use biological sample (from muscle biopsy, Cerebrospinal Fluid (CSF) and blood sample) collected in three control populations: definite ALS patients according to El Escorial diagnostic criterion, control patients without any neurological disease having an orthopedic surgery for shoulder disease, and control patient explored for peripheral neuropathy and myopathy. A second goal will correlate the miRNA pattern to the severity and/or progression rate of the motor neurons define as the progression rate of the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) score/year.

lead_sponsor: University Hospital, Bordeaux


title: Targeted High Throughput Sequencing in the Diagnosis of Pediatric Acute Leukemia

summary:
Acute leukemias are a heterogeneous group of hematologic malignancies. They result from clonal expansion of immature cells whose number is greater than 20% in bone marrow. Childhood acute leukemias are the most common pediatric malignancies. In Europe and the United states, they represent about 35% of childhood cancers. 80% of them are acute lymphoblastic leukemia (ALL) and 15-20% of acute myeloid leukemia (AML). Current treatments allow a cure in about 80% of ALL, while this level is only 50% in AML.Acute leukemia diagnosis is based on the multidisciplinary exploration of leukemia cells by different techniques:

Cellular: cytology, immunophenotyping and cytochemistry
Cytogenetic: conventional (karyotype) and molecular (FISH) cytogenetic
Molecular: RT-PCR and RQ-PCR

Cytogenetic studies are performed at time of acute leukemia diagnosis. Indeed, the WHO 2008 classification of acute leukemia is based largely on the presence of recurrent cytogenetic and molecular abnormalities. The most frequent chromosomal aberrations have been associated with specific clinical and biological characteristics and are now used as diagnosis and prognostic markers. These chromosomal abnormalities affect genes involving in the leukemogenesis process. These rearrangements are of several types:

Fusion genes causing :

Repression of transcriptional activity of genes involved in differentiation of hematopoietic cells (AML1-ETO, PML-RARA…)
Deregulation of signal transduction pathway (eg BCR-ABL chimeric protein with constitutive tyrosine kinase activity)
Changing in the state of chromatin condensation resulting changes of transcription (MLL gene rearrangements in 11q23, MOZ en 8p11…)
Deregulation of genes expression: chromosomal rearrangements can sometimes induce deregulation of adjacent genes to the breakpoint. For example, inv(3)(q21q26) or t(3;3)(q21;q26) induce over expression of transcriptional factor EVI-1.
Loss of function due to deletion of variable size in genomic regions containing genes with a role in the differentiation, apoptosis, or cell proliferation (eg IKZF1, PAX5…)

In addition to the karyotype, which allows to have a global view of the genome; FISH, a targeted technique, is used to highlight invisible abnormalities on karyotype (cryptic abnormalities) or the time of karyotype failure. However, conventional and molecular cytogenetic techniques do not highlight any abnormalities (eg different partners involved in the formation of fusion genes in particular for MLL gene rearrangement, mutations) hence our interest in next generation sequencing.Indeed, the high throughput targeted sequencing messenger RNAs (RNA-seq) has the avantage of allow identification of different types of mutations in a single test, with exception of epigenetic mutations. The importance of RNAs sequencing rather than DNA genomic is the one hand, a very significant decrease in the volume of sequences to analyze because transcribed mRNA genes represent about 5% of the genome size and secondly, a better identification of chimeric genes. The RNA-seq has used as a research tool in hematologic malignancies. The purpose of this project is to use innovative technology to develop a new diagnostic and prognostic new tool in hematological malignancies. 50 acute leukemias will be tested and results will be analyzed according to three criteria:

Quantity, quality and relevance of information provided for the diagnosis, monitoring and therapeutic management compared to a conventional strategy
Period required to obtain results and methods to decrease the analysis time so that results can be integrated into therapeutic decisions.
Economic evaluation, which will calculate the cost of this diagnosis option and assess the cost/benefit ratio In future, other innovative approaches will be implemented (study of imbalances genomic abnormalities by array-CGH, transcriptome analysis with micro-array, and study of methylome) to identify the "molecular signature" of each leukemia and set of informative abnormalities for diagnosis, prognosis and treatment of disease and monitoring of residual disease.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Effect of Sleep Restriction on Decision Making and Inflammation

summary:
hypothesis: sleep restriction in healthy subject trigger alteration of decision making associated with immuno-inflammatory changes
inclusion criterias: healthy subjects, men, under 35 years, BMI<26, no sleep troubles, intermediate chronotype
design: 12 subjects, longitudinal study 2 days of baseline, 7 night of sleep restriction (4h sleep/night), recovery (1, 2, 3 and 9 normal sleep nights).
parameters: decision making tests, reaction time, wakefulness test, biological parameters (cathecholamines, pro-inflammatory cytokines...), heart rate, blood pressure
control of sleep restriction: continuous polysomnographic survey

ReferenceCitation: Rabat A, Gomez-Merino D, Roca-Paixao L, Bougard C, Van Beers P, Dispersyn G, Guillard M, Bourrilhon C, Drogou C, Arnal PJ, Sauvet F, Leger D, Chennaoui M. Differential Kinetics in Alteration and Recovery of Cognitive Processes from a Chronic Sleep Restriction in Young Healthy Men. Front Behav Neurosci. 2016 May 23;10:95. doi: 10.3389/fnbeh.2016.00095. eCollection 2016.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Frontiers

ReferenceCitation: Sauvet F, Drogou C, Bougard C, Arnal PJ, Dispersyn G, Bourrilhon C, Rabat A, Van Beers P, Gomez-Merino D, Faraut B, Leger D, Chennaoui M. Vascular response to 1 week of sleep restriction in healthy subjects. A metabolic response? Int J Cardiol. 2015;190:246-55. doi: 10.1016/j.ijcard.2015.04.119. Epub 2015 Apr 16.

lead_sponsor: Institut de Recherche Biomedicale des Armees

location_facility: Institut de recherche biomédicale des armées


title: Body Posture Assessment Considering Jaws Position Before and After Orthognathic Surgery on Adult Patient.

summary:
Postural balance on both feet, characteristic of the human species, is possible by the tension of muscle of the whole body from toes to head.

Body position depends on many inputs such as vision, vestibule, skin receptors, states of muscle tension receptors. Information is integrated in a complex nervous system via the ascending and descending pathways. The information is then analyzed to provide feedback on body position. Any variation of body position, induces a variation of the center of pressure. Impaired body positioncan cause pain (back pain, neck pain) or long-term deformation (including scoliosis or kyphosis).

Maxillas position, via the activity of masseter and temporal muscles, acts on the muscle chain that controls posture. Incorrect positioning of the jaw in the three directions of space seems to create an asymmetric masticatory muscles activity and thus destabilize the muscle chain responsible for body position. Repositioning maxillas by orthognathic surgery could alter the body posture via changing the activity of the masticatory muscles.

However, nowadays no clear link has been demonstrated between maxillas repositioning and body posture modification.

The purpose of this study is to highlight the link between posture and jaws position, by analyzing the variation of the masticatory muscles activity and, the changes in body center of pressure before and after orthognathic surgery of jaws standardization.

In this study each patient will be evaluated in terms of occlusion and body posture before surgery and after surgery (2 months) by the same protocol. The surgery will be performed in the Maxillofacial Surgery service - Pr BLANC and assessment will take place in the dentistry department - Prof. Salvadori La Timone Hospital, Marseille.

The assessment includes the body posture study with a stabilometric platform (eyes open / eyes closed and with / without tooth contact), and analysis of the head orientation relative to the vertical. Electromyographic muscle masseter assessment (jaw with/without contact ) are devoted to check the evolution of the developed forces, and hand strength will be recorded using a dynamometer.

All these data will be recorded for all the patients. Patients will be divided into four subgroups: (1) maxillary endognathia, (2) mandibular prognathism , (3) mandibular retrognathia and (4 mandible repositioning.

Statistical analysis is aimed at validating or not the hypothesis of changes in body posture caused by surgical maxillas repositioning.


title: Prospective Non-randomized Comparative Study Evaluating the Effectiveness of Osteopathy in the Preoperative Treatment of Postoperative Pain in Patients Undergoing Total Knee Replacement in Osteoarthritis Indication

summary: Osteopathy is an alternative healthcare that seems effective in relieving the pain of patients. The main purpose of this study is to evaluate the efficacy of preoperative osteopathic care in patients undergoing total knee arthroplasty (TKA) for osteoarthritis. The secondary objectives are to assess pain during the first postoperative month on a VAS and knee function and quality of life at 6 months and 1 year. Our hypothesis is that osteopathy will decrease postoperative pain and increase knee function.

lead_sponsor: Hospital Ambroise Paré Paris


title: Impact de la Vaccination Sur la Distribution Des génotypes de Papillomavirus (HPV) et Suivi de la Dynamique Intra-individuelle de l'Infection et Des Co-infections Dans Une Population d'étudiantes âgées de 18 à 20 Ans

acronym: DyPAVIR

summary:
Human papillomavirus (HPV) infection is the most common sexually transmitted infection. The high risk oncogenic types, HPV-16 and -18 are responsible for 70% of cervical cancers. The introduction of vaccination against two major oncogenic genotypes of HPV raises questions about genotype replacement because of the existence of other oncogenic types not targeted by the vaccine. A better understanding of natural history of HPV infection and interaction (competition, synergy) between genotypes are required in order to anticipate this phenomenon.

The aims of this study are to characterize HPV infection in young female students and to follow up HPV infection and co-infection dynamics with different genotypes, taking into account both vaccination status and immunity to HPV 16 and 18. The study also focuses on the determination of factors influencing the development of persistent cervical HPV infections.

The DyPAVIR-ISHARE study is based on the participation of 5000 young female students, from 18 to 20 years-old, all registered at the Universities of Bordeaux or Versailles Saint-Quentin (UVSQ). The 3-years follow-up includes completion of a self-administrated questionnaire regarding sexual behaviour, socio-demographic characteristics, access to health-care services and, for a sub-group of 1000 students, the taking of genital and oral self-taken samples for the detection and genotyping of HPV (every 3 months). Previously, a pilot phase study (2 visits in 3 months of interval) is set up on 50 young female students from UVSQ in order to test feasibility.

This study will provide data to gain insight into the possibility of type replacement. Moreover, this study would provide an overview of HPV vaccine coverage and effectiveness HPV incidence and factors associated with HPV infection and co-infection ; Partners recruitment would allow us to follow HPV transmission dynamics among couples, and in particular, HPV exposure in young adult women. The HPV research won't be limited to virus detection in samples but will indicate the presence or absence of HPV infection.

Finally, additional genetic studies could be conducted in order to study genetic susceptibility to HPV infection, to chronic HPV infection and to co-infection.

This research project is part of the i-Share program funded by the "Investissement d'Avenir" cohort call.

ipd_sharing: Undecided

lead_sponsor: Institut Pasteur

collaborators: centre national de référence pour les Papillomavirus Humains

location_facility: Service Universitaire de Médecine Préventive et de Promotion de la Santé (SUMPPS)


title: Clinical Assessment of Innovative Procedure Using Image-guided Surgery to Avoid Sinus Lift

acronym: SINIMAGE

summary: The objective of this study is to compare two surgical procedure to place implant in severely resorbed posterioir part of the maxilla.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires


title: French Digestive Polyposis Cohorte

summary: French cohorte about polyposis digestive diseases

time_perspective: Retrospective

lead_sponsor: Hôpital Edouard Herriot


type: EudraCT Number

title: DRESS - Setting of Corticosteroid Treatment.

acronym: DRESSCODE

summary:
Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare and severe multiorgan adverse drug reaction occurring within 2 to 6-8 weeks after a new drug intake. DRESS syndrome is defined by the combination of clinical manifestations, cutaneous, visceral and biological disturbances. Its prognosis is directly linked to severity of visceral involvement, with a mortality evaluated above 10%.

Considering curative treatment, there is no consensus. Until now, no controlled trial has been performed. Systemic steroids are mainly used in first intention, in particular for management of visceral involvements, whatever their severity. From clinical practice, topical steroids are often used and could be helpful in the therapeutic management of DRESS.

We propose to evaluate systemic steroids versus very potent topical steroids in a multicentric randomized controlled trial including defined moderate DRESS, ie the non-inferiority of very potent topical steroids in terms of remission of visceral involvement at Day30 and the superiority of very potent topical steroids in terms of delay to remission of skin involvement.

ReferenceCitation: Eshki M, Allanore L, Musette P, Milpied B, Grange A, Guillaume JC, Chosidow O, Guillot I, Paradis V, Joly P, Crickx B, Ranger-Rogez S, Descamps V. Twelve-year analysis of severe cases of drug reaction with eosinophilia and systemic symptoms: a cause of unpredictable multiorgan failure. Arch Dermatol. 2009 Jan;145(1):67-72. doi: 10.1001/archderm.145.1.67.

ReferenceCitation: Mardivirin L, Valeyrie-Allanore L, Branlant-Redon E, Beneton N, Jidar K, Barbaud A, Crickx B, Ranger-Rogez S, Descamps V. Amoxicillin-induced flare in patients with DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms): report of seven cases and demonstration of a direct effect of amoxicillin on Human Herpesvirus 6 replication in vitro. Eur J Dermatol. 2010 Jan-Feb;20(1):68-73. doi: 10.1684/ejd.2010.0821. Epub 2009 Oct 12.

ReferenceCitation: Funck-Brentano E, Duong TA, Bouvresse S, Bagot M, Wolkenstein P, Roujeau JC, Chosidow O, Valeyrie-Allanore L. Therapeutic management of DRESS: a retrospective study of 38 cases. J Am Acad Dermatol. 2015 Feb;72(2):246-52. doi: 10.1016/j.jaad.2014.10.032.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Advantage of Detection of phIGFBP-1 to Reduce Hospitalization Time for Stable Patients With a Risk of Preterm Labour.

summary:
It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total duration of hospitalization for patients with a risk of preterm labor before 32 weeks of gestation without increasing the number of preterm labour.

Methods Patient with a risk of preterm labor (ultrasound cervical length < 25 mm +/- described or recorded uterine contractions) before 32 weeks of gestation will be hospitalized to receive tocolytic drugs and antenatal corticosteroid therapy according to our gold standard protocol. After 48 hours, they will be assessed by examination, external tocodynamometry and the measure of cervical length by ultrasound. Stabilized patients will be included and randomized into 2 groups of 210 patients each. The first group "A" will benefit from the standard protocol (extended hospitalization of 2 or 4 days according to the clinical and ultrasound assessment); whereas the second group, "B", will have the benefit of the detection of phIGFBP-1.If the result proves negative, patients could be discharged early at day 2. In the case of a positive result, patients will follow the standard procedure because of the low positive predictive value of the test. The main outcome is the total duration of hospitalization.

Study duration The trial period will be 36 months.

Expected results The use of detection of IGFBP-1 would enable us to select patients at risk and to decrease the duration of hospitalization in the case of a negative result.

Perspectives The negative predictive value of phIGFBP-1 test could be useful to select patients with stabilized risk of preterm labor, who could be discharged early. Moreover it could be used, in the Perinat Sud network, to decide if patients with a risk of preterm labor would benefit from hospitalization in a level II or III maternity ward.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Prevalence of Digestive Carriage of Integrons to Resistance in Two Populations in Limousin

acronym: APIHA

summary: Bacterial resistance to antimicrobials is an increasing problem. Doctors occasionally face genuine therapeutic dead-ends, when attempting to cure nosocomial infections and, more and more frequently, community-acquired infections. Mastering antimicrobial resistance diffusion is nowadays a major Public Health issue.

lead_sponsor: University Hospital, Limoges


title: Prospective and Multicentre Evaluation of 3 Different Doses of IV Busulfan Associated With Fludarabine and Thymoglobuline in the Conditioning of Allogeneic Stem Cell Transplantation (SCT) From a Matched Related or Unrelated Donor in Patients With Poor Prognosis Myeloid Malignancies

acronym: AAA

summary:
Albeit the safety of the stem cell transplantation procedure has been greatly improved, further refining the intensity of the conditioning is an important issue to explore, especially in patients with poor prognosis, the goal being to maintain the very favorable safety profile and improve the disease control. This is the goal our prospective trial; we aim to prospectively evaluate in a prospective multicenter trial the efficacy of different conditioning regimens in patients with high-risk myeloid malignancies.

The study is a phase II trial randomizing patients between a prospective active control arm (BX2) and two experimental arms (BX3 and BX4). A standard group was kept in this clinical trial in order to avoid the limitations induced by the comparison with historical controls in the context of continuously improving practice. Each experimental arm will be conducted in parallel according to a standard phase II trial design.

In addition, this trial will associate four ancillary studies to the main clinical objective: 1/ a prospective assessment of the quality of life of the patients over a period of 2 years 2/ an analysis of the cost effectiveness of the procedure, assessed over a period of 2 years 3/ an observational busulfan pharmacokinetic study 4/ a busulfan pharmacogenomic study

ReferenceCitation: Wanquet A, Crocchiolo R, Furst S, Granata A, Faucher C, Devillier R, Harbi S, Lemarie C, Calmels B, Vey N, Weiller PJ, Chabannon C, Castagna L, Blaise D, El-Cheikh J. The efficacy and safety of a new reduced-toxicity conditioning with 4 days of once-daily 100 mg/m(2) intravenous busulfan associated with fludarabine and antithymocyte globulins prior to allogeneic stem cell transplantation in patients with high-risk myelodysplastic syndrome or acute leukemia. Leuk Lymphoma. 2016 Oct;57(10):2315-20. doi: 10.3109/10428194.2016.1146948. Epub 2016 Feb 17.

publisher_dissemination: Informa

lead_sponsor: Institut Paoli-Calmettes


title: Characterisation of Circadian Rhythm in Autistic Spectrum Disorder : a Clinical, Biochemical and Genetic Study

summary: Autism spectrum disorders (ASDs) are complex neurodevelopmental conditions characterized by deficits in social communication, delay in language and repetitive behaviors. Results from genetic studies reveal one pathway associated with susceptibility to ASDs, which includes synaptic cell adhesion molecules. Among the factors that could modulate this pathway are the genes controlling circadian rhythms. Sleep disorders and low melatonin levels are frequently observed in ASDs. Thus investigator will characterize the circadian rhythms of patients with ASD and search for circadian rhythms genes polymorphisms.

collaborators: Albert Chenevier Hospital (Department of Psychiatry)

collaborators: Pasteur Institute (Cognitive Function and Human Genetic)


title: Exploratory Study of Prognostic Factors in Aortic Dissection Type B: Role of Imaging (18F-FDG PET-Scan and Angioscan) and Biomarkers

acronym: TEDAC

summary:
Clinical outcomes of chronic type B aortic dissections are unknown, especially in case of false lumen expansion and risk of rupture. Data of literature give us some indications about prognosis. The 1-year survival rate is about 80%, but we deplore the 25% rate of mortality at 3 years despite follow-up.The only known predictive factors are the initial diameter of more than 4 cm and the persistence of a false lumen patent.However, actual means of follow-up do not allow to predict severe complications. The aim of the sudy is to propose a diagnostic and preventive strategy for the follow-up of chronic type B aortic dissections treated medically.

The primary objective is then to evaluate the prognostic role of 18-FDG-PET Scan in such patients in order to predict the risk of aortic diameter growth of more than 5 mm in 1 year and/or of an aortic dissections extension at 1 year. The secondary objectives are to evaluate the link between fibrosis biomarkers MMP et TIMP) and the results of imaging results (evolution of diameter and extension and results of PET-Scan imaging) Methods: 100 patients to be included in 3 years History of chronic type B aortic dissection, treated medically, evolving since more than 1 month and less than 5 years.

Expected results: Prognostic contribution of 18FDG-PET-Scan and biomarkers for the identification of patients at high risk of evolution. Elaboration of a decisional algorithm about follow-up modalities of chronic aortic dissections. Demonstration of a correlation between aortic diameter growth or aortic dissection extension and intensity of marker fixation with 18-FDG-PET-Scan.

lead_sponsor: University Hospital, Caen


title: One Year Change in Caloric Compensation and Eating in the Absence of Hunger in French Preschool Children

summary:
Objectives: The aims were to measure one year change in caloric compensation (CC) and eating in the absence of hunger (EAH) in 3 to 6 year-old French children in their regular eating context and to link these change with individual characteristics (adiposity, age, gender) and maternal feeding practices.

Three series of measurements of caloric compensation (CC) and eating in the absence of hunger (EAH) were conducted: at baseline, and 3 (FU3M) and 15 (FU15M) months later. Each serie of measurement was composed of three consecutive weeks an identical lunch was served in four preschool canteens reaching 236 children. The first lunch was a control session. For the CC situation (week 2), thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to palatable foods (430 kcal). Food intake was measured at the individual level. Maternal eating behaviour and feeding practices were measured by questionnaires. Child's height and weight were measured by a medical doctor.

lead_sponsor: Centre des Sciences du Goût et de l'Alimentation


title: Monocentric Prospective Pilot Study Evaluating the Value of Indocyanine Green (ICG, Indocyanine Green) During a Surgical Resection of Cancerous Lesions Peritoneal Colorectal Origin.

summary:
Between 30% and 40% of patients with colorectal cancer develop metastatic disease intraperitoneally. The optimal treatment of this disease combines surgery and chemotherapy but requires resection of all lesions larger than 2mm.

Indocyanine green has an affinity for tumor tissues and the interest of its use has been demonstrated for the detection of sentinel lymph node and some liver surgeries.

The ability of indocyanine green to detect peritoneal carcinomatosis in humans has never been evaluated.

This study aims to evaluate the diagnostic performance of fluorescence in the detection of malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological analysis.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Effects of Whole Body Vibration (WBV) on Musculoskeletal System of Aged Women

acronym: VIBROS

summary:
A controlled, non-randomized trial will be carried out in 240 postmenopausal women, aged 55-75 years, over a 18-month period. The group 1 received a physical intervention, consisting of whole body vibration (WBV) over 12 months followed by training arrest during 6 months. The group 2 served as sedentary control. WBV training is performed 2 or 3 times per week, with each session lasting 20 minutes. The training included light squats at 35-50 Hz and ended up by stretching and relaxation exercises at 50 Hz. Bone, muscle and postural evaluations will be performed at the beginning, 6, 12 and 18 months in each group with evaluation of bone micro-architectural trabecular and cortical compartments, at the weight bearing tibia and the non weight bearing radius.

The primary outcome of the project is the pre, mid, and post evaluations of bone. Bone exploration included dual x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HR-pQCT). Bone Mass Density (BMD) will be evaluated by DXA at lumbar, femoral levels and humeral, macro and micro-architectures of the cortical and trabecular compartments will be evaluated in distal radius and tibia by HR-pQCT and bone markers will be analyzed longitudinally. The secondary aim is to assess muscle performance and proprioception. Finally will be assessed markers of cartilage degradation and synthesis, no study has been published on this tissue.

collaborators: Association pour le Développement de la Recherche sur l'Appareil Locomoteur dans la Loire

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function

acronym: FFSI

summary: Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.

ReferenceCitation: Quero G, Fiorillo C, Dallemagne B, Mascagni P, Curcic J, Fox M, Perretta S. The Causes of Gastroesophageal Reflux after Laparoscopic Sleeve Gastrectomy: Quantitative Assessment of the Structure and Function of the Esophagogastric Junction by Magnetic Resonance Imaging and High-Resolution Manometry. Obes Surg. 2020 Jun;30(6):2108-2117. doi: 10.1007/s11695-020-04438-y.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil


title: The Cognitive and Cardiovascular Health in the Elderly Study

acronym: COACHES

summary: The main objective of this study is to look for the interest forecast of the IPS as infra-clinical cardiovascular marker in the prediction of a change of the cognitive functions (MCI) at the elderly of 70 and more years old without clinical cardiovascular pathology.


title: Predictive Clinical and Biological Parameters in Gynecological Cancer - GC-BIO-IPC 2013-010

acronym: GC-BIO

summary: Research of predictive clinical and biological factors in breast cancer : genomic, proteomic, mutation

status_simplified: Ongoing


title: Procalcitonin and Threatened Premature Delivery

acronym: MAPPRO

summary:
Among all patients hospitalized for Threatened Premature Delivery (TPD), the rate of premature birth (PB) before 37 weeks is about 42%, which reflects the inability to accurately identify patients at high risk of PB. Currently, no clinical or biological marker is recognized as the most reliable in predicting the real risk of AP in case of MAP.

The purpose of this study is to improve the knowledge of predictors of preterm delivery compared with conventional blood markers by estimating serum procalcitonin according to premature delivery or not in patients hospitalized for preterm labor .

ReferenceCitation: Ducarme G, Desroys du Roure F, Le Thuaut A, Grange J, Vital M, Dimet J. Efficacy of serum procalcitonin to predict spontaneous preterm birth in women with threatened preterm labour: a prospective observational study. BMC Pregnancy Childbirth. 2018 Mar 7;18(1):65. doi: 10.1186/s12884-018-1696-2.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Effect of the Physiological Angular Position of the Resting Knee on Pressure at the Heel/Surface Interface

acronym: FlessCare

summary: The main objective of this study is to evaluate the relationship between the angle of knee flexion in a supine position with joint relaxation (DDPD) and the maximum interface pressure at the heel area (PtAl).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Glycemic Instability of Non-diabetic Patients After Spine Surgery: a Prospective Observational Cohort Study

acronym: GLYRACH

summary: Analyzing peri operative changes in blood glucose levels from non-diabetic patients undergoing spine surgery

ReferenceCitation: Pili-Floury S, Mitifiot F, Penfornis A, Boichut N, Tripart MH, Christophe JL, Garbuio P, Samain E. Glycaemic dysregulation in nondiabetic patients after major lower limb prosthetic surgery. Diabetes Metab. 2009 Feb;35(1):43-8. doi: 10.1016/j.diabet.2008.06.007. Epub 2008 Nov 26.

ReferenceCitation: Lipshutz AK, Gropper MA. Perioperative glycemic control: an evidence-based review. Anesthesiology. 2009 Feb;110(2):408-21. doi: 10.1097/ALN.0b013e3181948a80.

ReferenceCitation: Pull ter Gunne AF, Cohen DB. Incidence, prevalence, and analysis of risk factors for surgical site infection following adult spinal surgery. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1422-8. doi: 10.1097/BRS.0b013e3181a03013.

lead_sponsor: Beaujon Hospital


title: First Evaluation of Morphine Hydrochloride by Nebulisation Compared to Intravenous Route in Healthy Volunteers: Preliminary Study Dose

summary:
Acute pain relief in emergency setting is still a public health priority. Pain is the primary reason for emergency room use, but the situation of "oligo-analgesia" persists in all countries. Intravenous morphine titration has become the standard method for severe acute pain management in the emergency department, but it is still insufficiently implemented. Deviations from the recommended protocol are common: initial additional loading doses, unusually extended intervals between bolus, premature discontinuation. Several factors contribute to these difficulties: heaviness of its setting up, especially in overcrowding case, procedure rigidity, high consumption of nursing time. This method requires a systematic intravenously route, which has several inconvenients: algogenic procedures, coupled initial diagnostic venous sampling (delay for analgesia), excessive "medicalization" of ambulatory patients (risk of infection and less mobility in the emergency department). An alternative to reduce the analgesic latency in emergency department, without losing the benefits of tolerance and safety should be welcome. The inhaled route looks promising, but has yet not been enough evaluated in adults, and even less in the emergency room. Aerosol techniques change from one study to another (molecules, materials, doses, painful intensities included, judgment criteria and assessment times). A morphine titration by aerosol therapy could be an interesting alternative to the standard method disadvantages, using faster, painless and easier procedures, leading to "demedicalization".

To the need for stronger fundamentals, an additional study was designed in healthy volunteers. The objective is to compare the titration of intravenous morphine titration aerosol in moderate acute pain caused by electrostimulation.

To purchase this aim, we first need to determine accurately the smallest dose of effective and well tolerated inhaled morphine, to provide the "bolus" dose we have to repeat by titration, which is still currently unknown. This dose is called ED50, it's the effective dose for at least 50% of healthy volunteers relieved. ED50 for intravenous morphine is also needed to be established, unknown in this indication. The determination of these two parallel ED50 would allow a reliable conversion factor between the two routes of administration for morphine "bolus", which can then be tested in comparative titrations. To validate our induced pain model in healthy volunteers, we also have chosen to fix in these conditions the ED50 of fentanyl that the effective dose by nebulization is better known. This study would also describe the pharmacokinetics of inhaled morphine and its derivatives after a single spray.

ReferenceCitation: Lvovschi V, Aubrun F, Bonnet P, Bouchara A, Bendahou M, Humbert B, Hausfater P, Riou B. Intravenous morphine titration to treat severe pain in the ED. Am J Emerg Med. 2008 Jul;26(6):676-82. doi: 10.1016/j.ajem.2007.10.025.

ReferenceCitation: Blum CA, Velly L, Brochet C, Ziegler F, Tavolacci MP, Hausfater P, Lvovschi VE. Relevance of cortisol and copeptin blood concentration changes in an experimental pain model. Sci Rep. 2022 Mar 19;12(1):4767. doi: 10.1038/s41598-022-08657-4.

lead_sponsor: University Hospital, Rouen


title: Relationship Between Sperm Parameters and Metabolic Syndrome in a Infertile Couple Partner Man

acronym: Metasperme

summary: Multidisciplinary, multicentric, cross-sectional study on men in infertile couples who conduct their sperm test through their diagnosis of infertility

ReferenceCitation: Sermondade N, Faure C, Fezeu L, Shayeb AG, Bonde JP, Jensen TK, Van Wely M, Cao J, Martini AC, Eskandar M, Chavarro JE, Koloszar S, Twigt JM, Ramlau-Hansen CH, Borges E Jr, Lotti F, Steegers-Theunissen RP, Zorn B, Polotsky AJ, La Vignera S, Eskenazi B, Tremellen K, Magnusdottir EV, Fejes I, Hercberg S, Levy R, Czernichow S. BMI in relation to sperm count: an updated systematic review and collaborative meta-analysis. Hum Reprod Update. 2013 May-Jun;19(3):221-31. doi: 10.1093/humupd/dms050. Epub 2012 Dec 12.

ReferenceCitation: Hammoud AO, Gibson M, Peterson CM, Meikle AW, Carrell DT. Impact of male obesity on infertility: a critical review of the current literature. Fertil Steril. 2008 Oct;90(4):897-904. doi: 10.1016/j.fertnstert.2008.08.026.

ReferenceCitation: Sermondade N, Faure C, Fezeu L, Levy R, Czernichow S; Obesity-Fertility Collaborative Group. Obesity and increased risk for oligozoospermia and azoospermia. Arch Intern Med. 2012 Mar 12;172(5):440-442. doi: 10.1001/archinternmed.2011.1382.

ReferenceCitation: Michalakis K, Mintziori G, Kaprara A, Tarlatzis BC, Goulis DG. The complex interaction between obesity, metabolic syndrome and reproductive axis: a narrative review. Metabolism. 2013 Apr;62(4):457-78. doi: 10.1016/j.metabol.2012.08.012. Epub 2012 Sep 20.

ReferenceCitation: Saget S, Kappeler L, Grandjean V, Leneuve P, Berthaut I, Faure C, Czernichow S, Racine C, Levy R, Dupont C; Metasperme Collaboratif group. Association between metabolic disorders and seminal plasma miRNA levels: a pilot study. Basic Clin Androl. 2022 Jun 7;32(1):9. doi: 10.1186/s12610-022-00159-7.


title: Improvement of Chronic Stroke Patients Gait Pattern Following Repetitive Multifocal Botulinum Toxin Injection Sessions in Paretic Lower Limb: an Observational Study.

summary:
Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved kinematic gait parameters(GP) but surprisingly none of them assessed the effects of repetitive multifocal BTI on patient's gait pattern and their duration.

The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic stroke patients. To that end, gait of patients has been compared using 3D-gait analysis after at least 2 consecutive BTI sessions.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Non Invasive Ventilation After Abdominal Surgery in Postoperative Acute Respiratory Failure: a Multicenter Randomized Controlled Trial.

acronym: NIVAS

summary: Acute respiratory failure may occur early in the postoperative course, requiring endotracheal intubation and mechanical ventilation in selected patients, thus increasing morbidity and mortality and prolonging intensive care unit (ICU) and hospital stay.We will perform a multicenter, prospective, randomized clinical trial to compare the efficacy of non invasive ventilation (NIV) which associated pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O) with standard oxygen therapy in the treatment of postoperative acute respiratory failure. We also set out to examine the hypothesis that early application of NIV may prevent intubation and mechanical ventilation in patients who develop acute respiratory failure after abdominal surgery.

ReferenceCitation: Jaber S, Lescot T, Futier E, Paugam-Burtz C, Seguin P, Ferrandiere M, Lasocki S, Mimoz O, Hengy B, Sannini A, Pottecher J, Abback PS, Riu B, Belafia F, Constantin JM, Masseret E, Beaussier M, Verzilli D, De Jong A, Chanques G, Brochard L, Molinari N; NIVAS Study Group. Effect of Noninvasive Ventilation on Tracheal Reintubation Among Patients With Hypoxemic Respiratory Failure Following Abdominal Surgery: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1345-53. doi: 10.1001/jama.2016.2706.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

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

repository_normalized: univOAK

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

repositories: HAL univOAK

repositories_concat: HAL;univOAK

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

lead_sponsor: University Hospital, Montpellier

location_facility: Department of Anesthesiology & Critical Care, St Eloi University Hospital


title: Protection of Arteritic Patients by Remote Preconditioning

acronym: PARADIS

summary: Prospective, monocentric, randomised, double-blind study with 20 patients enrolled to be explored twice through a Cross-over strategy to determine whether remote preconditioning improves arteritic patients' ability to walk.

lead_sponsor: University Hospital, Angers

location_facility: Service de Médecine du Sport, CHU d'Angers


title: Clinical, Genetic and Epigenetic Characterization of Patients With FSHD Type 1 and FSHD Type 2

summary:
The aim of the study was to compare the severity of illness between groups of patients (Facio-Scapulo-Humeral Dystrophy = FHSD1, FSHD2 and patients both FSHD1 and FSHD2).

Despite advances in research on the subject, answers are still needed on these diseases.

We also aim to determine whether the chromosomal genetic abnormality is involved in other diseases and the frequency of this mutation in the population of patients FSHD.

This study will increase our knowledge of the two forms of FSHD who present a common pathophysiological mechanism and may occur together in the same family with a worsening of the clinical phenotype worsening . In addition, epigenetic differences between FSHD type 1 and type 2 seems to have clinical consequences requiring appropriate management

ReferenceCitation: Sacconi S, Briand-Suleau A, Gros M, Baudoin C, Lemmers RJLF, Rondeau S, Lagha N, Nigumann P, Cambieri C, Puma A, Chapon F, Stojkovic T, Vial C, Bouhour F, Cao M, Pegoraro E, Petiot P, Behin A, Marc B, Eymard B, Echaniz-Laguna A, Laforet P, Salviati L, Jeanpierre M, Cristofari G, van der Maarel SM. FSHD1 and FSHD2 form a disease continuum. Neurology. 2019 May 7;92(19):e2273-e2285. doi: 10.1212/WNL.0000000000007456. Epub 2019 Apr 12.

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Biological


title: An Observational, Prospective, Single-center Study of Placement and Confirmation of Peripheral Inserted Central Catheters Tip Position Using a New Electrocardiographic Method

acronym: SHERLOCK 3CG

summary:
This is a prospective, single center, observational study. Patients who require a Peripheral Inserted Central Catheters (PICC) will constitute the study population.

The purpose of the study is to determine whether Sherlock 3CG, is adequate means for the total placement of PICC and confirmation of tip of PICC placement and if this method can be conducted safely and efficiently.

Patients will be included during a 6-month period as well as they are ambulatory or hospitalized. The patient's routine care will not be modified and only PICC will be assessed in the present study.

PICC placement will be performed using the Site Rite guidance and tip position will be confirmed using the Sherlock 3CG.

The procedure is the same as the routine habits of the operator (nurse or anesthesiologist); the vascular access team already uses the previous device for CVC placement.

Patients won't be followed up in the study.

lead_sponsor: Centre Leon Berard


title: Lipophilic Organic Polluants and Morbid Obesity: Kinetic of the Release and Impact on the Metabolic Syndrome Before and After Bariatric Surgery

acronym: POLOB

summary:
To study the kinetics of release after bariatric surgery of selected polluants stored in adipose tissue, looking for clinical and/or predictive factors
To test the hypothesis of a deleterious effect of this release on the expected improvement of insulin-resistance and on the liver inflammation.
To determine the level of contamination of morbidly obese patients, with or without metabolic syndrome, compared to a control, non obese population, with special attention to clinical (age, gender, reproductive history, pregnancy, nursing) and biological parameters (insulin-resistance, inflammation).


title: Intravenous Exenatide (Byetta®) Versus Insulin for Perioperative Glycemic Control in Cardiac Surgery: the Open-labeled Randomized Phase II/III ExStress Study

acronym: ExSTRESS

summary:
Stress hyperglycemia is a common phenomenon in cardiac surgery that concerns diabetic and non diabetic patients.

It has been shown that perioperative hyperglycemia is an independent risk factor of postoperative mortality and morbidity.

The Leuven et al.'s study suggested that strict glycemic perioperative control using an intensive insulin therapy could reduce mortality and morbidity in surgical intensive care's patients. This study included a majority of cardiac surgery patients. Others studies have suggested that the beneficial effect of insulin-based tight perioperative glycemic control might be hampered by iatrogenic hypoglycemia. Moreover, insulin therapy failed to obtain perioperative glycemic stability in most patients.

Exenatide (Byetta ®) is an incretin mimetic, characterized by an anti-hyperglycemic effect that depends on the blood glucose level.

We hypothesize that continuous intravenous infusion of exenatide could improve perioperative glycemic control and stability and could reduce the risk of iatrogenic hypoglycemia compared to a conventional insulin therapy during the perioperative period of cardiac surgery.

ReferenceCitation: Goldberg PA, Sakharova OV, Barrett PW, Falko LN, Roussel MG, Bak L, Blake-Holmes D, Marieb NJ, Inzucchi SE. Improving glycemic control in the cardiothoracic intensive care unit: clinical experience in two hospital settings. J Cardiothorac Vasc Anesth. 2004 Dec;18(6):690-7. doi: 10.1053/j.jvca.2004.08.003.

ReferenceCitation: Studer C, Sankou W, Penfornis A, Pili-Floury S, Puyraveau M, Cordier A, Etievent JP, Samain E. Efficacy and safety of an insulin infusion protocol during and after cardiac surgery. Diabetes Metab. 2010 Feb;36(1):71-8. doi: 10.1016/j.diabet.2009.05.008. Epub 2010 Jan 25.

ReferenceCitation: Galiatsatos P, Gibson BR, Rabiee A, Carlson O, Egan JM, Shannon RP, Andersen DK, Elahi D. The glucoregulatory benefits of glucagon-like peptide-1 (7-36) amide infusion during intensive insulin therapy in critically ill surgical patients: a pilot study. Crit Care Med. 2014 Mar;42(3):638-45. doi: 10.1097/CCM.0000000000000035.

ReferenceCitation: Besch G, Perrotti A, Salomon du Mont L, Puyraveau M, Ben-Said X, Baltres M, Barrucand B, Flicoteaux G, Vettoretti L, Samain E, Chocron S, Pili-Floury S. Impact of intravenous exenatide infusion for perioperative blood glucose control on myocardial ischemia-reperfusion injuries after coronary artery bypass graft surgery: sub study of the phase II/III ExSTRESS randomized trial. Cardiovasc Diabetol. 2018 Nov 1;17(1):140. doi: 10.1186/s12933-018-0784-y.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators:
AstraZeneca
Eli Lilly and Company

location_facility: Post operative intensive care unit of the cardiac surgery department


title: Diaphragm Function in Patients Acquired Weakness and Neuromyopathy in ICU: Impact on Weaning and Outcome (DIAPH-WEAK ICU)

summary:
Critical illness neuromyopathy is a common disease acquired during ICU stay leading to a deep weakness involving the respiratory muscle work which result in a delayed weaning of mechanical ventilation.

The main objective is to quantify the loss of diaphragm function by measuring the diaphragm force (using the non invasive method by phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion) in a selected population of patients with critical illness neuromyopathy (defined as a MRC score < 48).

The second end points are to evaluate its incidence, the consequences on the patients outcome (extubation success or failure; ICU stay) and to evaluate the relations between diaphragm function (twitch airway pressure during airway occlusion, maximal inspiratory pressure and diaphragm thickness evaluated by ultrasound) and peripheral limbs force (evaluated by the Medical Research Council - MRC score).

location_facility: Department of Anesthesiology & Critical Care, St Eloi University


title: Prospective Evaluation of Iron Status in Cancer Patients Beginning Chemotherapy

acronym: CANFER

summary:
In cancerology, anemia is a frequently-found situation, with a prevalence ranging from 30% to 90%, according to the series, disease stages, primary tumor locations and age (Scotte, Launay-Vacher et al. 2012). Although very probably a major cause of anemia, iron deficiency (ID) has been seldom investigated in the field of cancer. Its prevalence and incidence have never been assessed in a prospective study. It is well-known that anemia in the cancer setting is a source of asthenia and deterioration of quality of life, and can even reduce the efficacy of anticancer treatments such as radiotherapy. Correcting anemia therefore constitutes a daily challenge. Before 2004-2005, a very large proportion of patients were treated with erythropoietin (EPO). However, prescriptions for EPO appear to have considerably declined since the warnings issued by various scientific societies and governments on account of the possible increase in death rates and a higher incidence of thromboembolic events, as reported in 8 studies published to date (NCCN 2012). Simultaneously, the transfusion rate augmented from 3.4% to 8.7% and the median hemoglobin level fell from 10.8 to 8.9 g/dL (Feinberg, Bruno et al. 2012). The use of injectable iron appears to have improved the correction of anemia by EPO, as reported in several concordant studies versus oral iron and placebo (Pedrazzoli, Rosti et al. 2009; Steensma, Sloan et al. 2011). However, no monotherapy study has been conducted to evaluate the impact of injectable iron, alone without EPO, for the correction of ID (with or without anemia) in cancer treatment. Consequently, there exists a wide variety of practices, with an injectable iron prescription rate which, a priori, does not match the number of patients with iron deficiency. There exist other iron-based parameters to characterize ID but these are not yet used routinely during chemotherapy and need to be validated in the cancer field.

These parameters include:

An assay of reticulocyte hemoglobin content (rHC)
An assay of soluble transferrin receptor (sTfR) Soluble transferrin receptors are mainly located on red blood line cells receiving iron delivered by transferrin.

In this study, we propose to make a prospective assessment of the iron status of cancer patients beginning chemotherapy. The aim is to determine the proportion of patients who might benefit from injectable iron treatment. All ID will be covered prospectively over a 2-year period.

lead_sponsor: Centre Antoine Lacassagne


title: Salvage Chemotherapy for Poor Prognosis Germ Cell Tumors - A Phase I-II Sequential Chemotherapy Protocol of Bevacizumab (Avastin) Plus High-dose ICE (Ifosfamide - Carboplatin - Etoposide) Intensification

acronym: TAXIFIII

summary:
High-dose chemotherapy with autologous hematopoietic stem-cell transplantation is a standard salvage treatment used in adults with germ cell tumors (Einhorn et al, J Clin Oncol 2007).

Disease prognosis following 1 to 2 intensified combinations of etoposide - carboplatin +/- ifosfamide depends on the patient's performance status (PS) at inclusion and the prior sensitivity of the disease to cisplatin. A poor PS and/or being refractory to cisplatin suggest a higher toxicity and a bad prognosis.

However, predictive factors of response to high-dose chemotherapy do not include a chemo-sensitivity phase with a semi-intensive chemotherapy excluding a platinum compound (epirubicin - paclitaxel), which still allows stem-cell harvest. The use of this chemotherapy combination induced a response in more than one third of the patients treated during disease progression in the TAXIF I study. The same strategy was tested in the TAXIF II study, which completed the inclusion of 45 patients and was closed in May 2008. Results of the TAXIF II study, are currently being analyzed; they support the hypothesis to prioritarily treat patients with a sensitive relapsed disease at the time of the high-dose administration.

A combination of a semi-intensive sequential ICE type chemotherapy plus bevacizumab was used on a highly refractory patient. A 5 months nearly complete response was achieved. Indeed, the overexpression of VEGF (Vascular Endothelial Growth Factor) has been identified as an independent risk factor in patients with germ cell tumor. Therefore, a treatment strategy using an inductive chemotherapy followed, in case of response, by a double intensification therapy in combination with a VEGF treatment, could be an interesting approach in patients with poor prognosis germ cell tumors.

The aim of this phase I/II trial is to assess the feasibility of a Bevacizumab - ICE (Ifosfamide-Carboplatin-Etoposide) high dose combination with the support of autologous hematopoietic stem cell for two intensive consecutive cycles ("tandem" intensification) in patients with a poor prognosis germ cell tumor non refractory to a front-line mobilization chemotherapy using two half intensified consecutive combinations of Epirubicin-Paclitaxel.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Phase 2 Study of SERCA2a Gene Transfer in Patients With Severe Heart Failure

acronym: AGENT-HF

summary: The purpose of this study is to determine the effect of intracoronary SERCA2a Gene transfer on cardiac volumes and function using multimodality cardiac imaging.

ReferenceType: result

ReferenceCitation: Hulot JS, Salem JE, Redheuil A, Collet JP, Varnous S, Jourdain P, Logeart D, Gandjbakhch E, Bernard C, Hatem SN, Isnard R, Cluzel P, Le Feuvre C, Leprince P, Hammoudi N, Lemoine FM, Klatzmann D, Vicaut E, Komajda M, Montalescot G, Lompre AM, Hajjar RJ; AGENT-HF Investigators. Effect of intracoronary administration of AAV1/SERCA2a on ventricular remodelling in patients with advanced systolic heart failure: results from the AGENT-HF randomized phase 2 trial. Eur J Heart Fail. 2017 Nov;19(11):1534-1541. doi: 10.1002/ejhf.826. Epub 2017 Apr 10.

oa_host_type: publisher

evidence: open (via free article)

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Celladon Corporation


title: Basophil Activation Test (BAT) Sensitivity in Child Food Allergy

acronym: TAB-TPO

summary:
Child food allergy represent 6 to 8% of child in industrialised country. Within this allergy, peanuts and egg allergy are one of the most common.

Actually when there is a suspicion of food allergy, the OPT is the gold standard for the diagnosis. During the OPT we give increasing doses of the allergen to the patient and evaluate threshold causing a clinical reaction. This test is associated with a risk of strong allergic reaction and need a medical supervision.

Standard allergy test, like skin test or specific IgE test, can't be use for the diagnosis of these allergy. Some publications demonstrate that these tests lack sensibility and specificity for child food allergy diagnosis.

New tests have to be develop to diagnosis child food allergy without risks. The BAT is a cellular test able to evaluate the basophiles activation by specific allergen in vitro. This test allow us to evaluate more physiologically the sensitization of patients to an allergen. It is already used in drug allergy and it has been evaluated in infant milk allergy in an other clinical trial.

In this study we want to evaluate the sensitivity of BAT to the diagnosis of child food allergy compare to the gold standard test OPT. We will evaluate the BAT on 140 children with food allergy and compare this results with the OPT at the same time. If the BAT results can predict the sensitivity of children to food allergen, it could limit the use of the OPT and reduce the risk of this test.


title: A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies.

acronym: LYMPHCORD

summary:
Indication: Patients with advanced lymphoid malignancies in the absence of an HLA identical or mismatch donor.

Objectives: Overall survival at one year. Efficacy >60%, rejection rate <20%. Inclusion criteria: Age: 18-65 years old, no sibling or unrelated donor identified, low grade non-hodgkin lymphoma in third line (who already received at least one autologous transplantation); hodgkin lymphoma in early relapse (<1 year), who received at least one autologous transplantation and sensible to chemotherapy and CLL with 17p deletion or in relapse less than 2 year after a fludarabine nbased regimen or in relapse after one autologous transplantation.

Stem cell source: Two cord blood units containing both together more than 3x107 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients.


title: Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure

acronym: RCPBALSTAT

summary: Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflations and overinflations frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions. The aim of this study is to determine the efficiency of Mallinckrodt electronic device (Mallinckrodt electronic cuff pressure controller, VBM Medizintechnik GmbH, Sulz aN) in continuous control of tracheal cuff pressure.

ReferenceCitation: Rouze A, De Jonckheere J, Zerimech F, Labreuche J, Parmentier-Decrucq E, Voisin B, Jaillette E, Maboudou P, Balduyck M, Nseir S. Efficiency of an electronic device in controlling tracheal cuff pressure in critically ill patients: a randomized controlled crossover study. Ann Intensive Care. 2016 Dec;6(1):93. doi: 10.1186/s13613-016-0200-2. Epub 2016 Oct 4.

lead_sponsor: University Hospital, Lille

location_facility: ICU, Salengro Hospital, University Hospital of Lille