title: Effects of Mode of Contraction on Neuromuscular Fatigue in Young People Aged 18 to 35, Aged 60 to 80 and Very Old People Aged Over 80

acronym: DYN-AGING

summary: Aging is associated with multiple deteriorations of the neuromuscular system. Given the increase in life expectancy, the investigators can now distinguish old adults (>60 years old) who conserve their neuromuscular capacities with regular physical activity and very old adults (>80 years old) who suffer from an inexorable decline, even if the number of octogenarians and their quality of life are progressively increasing. However, the most part of the literature on fatigue and neuromuscular capacity with aging focused on isometric tasks. The results showed a significant decrease in maximal force production capacity and a greater resistance to fatigue for old people compared to the young population. When fatigue is induced trough dynamic contractions, greater fatigability was observed in old adults compared to young adults. Investigations performed on the population aged over 80 years old are rare, showing greater fatigability in octogenarians than old men (aged 60-80 years old) during isometric tasks. The knowledge about the effects of dynamic contractions in this population are limited, and performed uniquely in single leg isokinetic mode. Evaluations that require the use of both legs and higher muscle mass involved in the task (cycloergometer) are needed. Understanding neuromuscular fatigue and fatigability across different exercise modalities is necessary to set adapted physical activity programs aimed to maintain autonomy in older individuals.


title: Evaluation of the Prevalence of Pelvic Static Disorders in Women Treated for Localized Breast Cancer During Adjuvant Hormone Therapy.

acronym: STATICBREAST

summary: In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Cowppli-Bony A, Colonna M, Ligier K, Jooste V, Defossez G, Monnereau A; le Réseau Francim; Réseau des registres de cancer Francim. [Descriptive epidemiology of cancer in metropolitan France: Incidence, survival and prevalence]. Bull Cancer. 2019 Jul - Aug;106(7-8):617-634. doi: 10.1016/j.bulcan.2018.11.016. Epub 2019 Mar 2. Review. French.

ReferenceCitation: Jones SE, Cantrell J, Vukelja S, Pippen J, O'Shaughnessy J, Blum JL, Brooks R, Hartung NL, Negron AG, Richards DA, Rivera R, Holmes FA, Chittoor S, Whittaker TL, Bordelon JH, Ketchel SJ, Davis JC, Ilegbodu D, Kochis J, Asmar L. Comparison of menopausal symptoms during the first year of adjuvant therapy with either exemestane or tamoxifen in early breast cancer: report of a Tamoxifen Exemestane Adjuvant Multicenter trial substudy. J Clin Oncol. 2007 Oct 20;25(30):4765-71.

ReferenceCitation: Kelley C. Estrogen and its effect on vaginal atrophy in post-menopausal women. Urol Nurs. 2007 Feb;27(1):40-5. Review.

ReferenceCitation: Chin SN, Trinkaus M, Simmons C, Flynn C, Dranitsaris G, Bolivar R, Clemons M. Prevalence and severity of urogenital symptoms in postmenopausal women receiving endocrine therapy for breast cancer. Clin Breast Cancer. 2009 May;9(2):108-17. doi: 10.3816/CBC.2009.n.020.

ReferenceCitation: Sousa MS, Peate M, Jarvis S, Hickey M, Friedlander M. A clinical guide to the management of genitourinary symptoms in breast cancer survivors on endocrine therapy. Ther Adv Med Oncol. 2017 Apr;9(4):269-285. doi: 10.1177/1758834016687260. Epub 2017 Jan 31. Review.

ReferenceCitation: Robinson PJ, Bell RJ, Christakis MK, Ivezic SR, Davis SR. Aromatase Inhibitors Are Associated With Low Sexual Desire Causing Distress and Fecal Incontinence in Women: An Observational Study. J Sex Med. 2017 Dec;14(12):1566-1574. doi: 10.1016/j.jsxm.2017.09.018. Epub 2017 Oct 21.

ReferenceCitation: Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057.

ReferenceCitation: Islam RM, Oldroyd J, Rana J, Romero L, Karim MN. Prevalence of symptomatic pelvic floor disorders in community-dwelling women in low and middle-income countries: a systematic review and meta-analysis. Int Urogynecol J. 2019 Dec;30(12):2001-2011. doi: 10.1007/s00192-019-03992-z. Epub 2019 Jun 4.

ReferenceCitation: Weintraub AY, Glinter H, Marcus-Braun N. Narrative review of the epidemiology, diagnosis and pathophysiology of pelvic organ prolapse. Int Braz J Urol. 2020 Jan-Feb;46(1):5-14. doi: 10.1590/S1677-5538.IBJU.2018.0581. Review.

ReferenceCitation: Ramaseshan AS, Felton J, Roque D, Rao G, Shipper AG, Sanses TVD. Pelvic floor disorders in women with gynecologic malignancies: a systematic review. Int Urogynecol J. 2018 Apr;29(4):459-476. doi: 10.1007/s00192-017-3467-4. Epub 2017 Sep 19. Review.

ReferenceCitation: Rutledge TL, Heckman SR, Qualls C, Muller CY, Rogers RG. Pelvic floor disorders and sexual function in gynecologic cancer survivors: a cohort study. Am J Obstet Gynecol. 2010 Nov;203(5):514.e1-7. doi: 10.1016/j.ajog.2010.08.004. Epub 2010 Sep 24.

ReferenceCitation: Neron M, Bastide S, Tayrac R, Masia F, Ferrer C, Labaki M, Boileau L, Letouzey V, Huberlant S. Impact of gynecologic cancer on pelvic floor disorder symptoms and quality of life: an observational study. Sci Rep. 2019 Feb 19;9(1):2250. doi: 10.1038/s41598-019-38759-5.

ReferenceCitation: Wiegersma M, Panman CM, Berger MY, De Vet HC, Kollen BJ, Dekker JH. Minimal important change in the pelvic floor distress inventory-20 among women opting for conservative prolapse treatment. Am J Obstet Gynecol. 2017 Apr;216(4):397.e1-397.e7. doi: 10.1016/j.ajog.2016.10.010. Epub 2016 Oct 15.

ReferenceCitation: Fallowfield LJ, Bliss JM, Porter LS, Price MH, Snowdon CF, Jones SE, Coombes RC, Hall E. Quality of life in the intergroup exemestane study: a randomized trial of exemestane versus continued tamoxifen after 2 to 3 years of tamoxifen in postmenopausal women with primary breast cancer. J Clin Oncol. 2006 Feb 20;24(6):910-7.

ipd_sharing: No

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: Efficacy of Pre-operative Prehabilitation in Patients With Limb Sarcoma

acronym: EPOP-SARCOMA

summary:
This Phase II feasibility study, prospective, interventional, monocentric aiming to assess the interest of pre-operative rehabilitation in patients treated for bone or soft-tissue sarcoma of the limbs.

This protocol will be based on the realisation of a surgical prehabilitation program adapted to the patient. This strategy will involve a team of several health professionals: rehabilitation doctor, physiotherapist, occupational therapist, specialised nurse, dietician and adapted physical activity teacher.

The aim of an adapted surgical prehabilitation program is to improve the functional recovery of the treated limb and the patient's autonomy after surgery.

Each patient will be followed until 24 months post surgery.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

status_simplified: Ongoing


title: AN EXPLORATORY FOLLOW-UP STUDY OF LONG TERM ANTI-TELOMERASE IMMUNE RESPONSE AFTER INVAC-1 VACCINATION IN PATIENTS WITH LONG TERM SURVIVAL. Addendum to INVAC1-CT-101 PROTOCOL - EUDRACT NUMBER : 2013-004369-15

summary: This study will be an exploratory study of long term immunogenicity of INVAC-1 in patients who participated in the INVAC1-CT-101 phase I study (between 2014 and 2018).

lead_sponsor: Invectys

intervention_type: Drug


title: Interest of the Second Phase of the Oral Challenge Test in Patients With Suspected Long-standing Penicillin Allergy

acronym: PENI

summary:
The most common drug allergy reported is penicillin allergy, approximately 10% of the world's population. According to the latest studies, only 1-2% of them have a proven hypersensitivity to penicillins. Being wrongly labeled "allergic" leads to a loss of chance for patients to be treated with a molecule of less efficacy than penicillins, an increase in bacterial resistance by broadening the spectrum of action of the molecules prescribed as an alternative and ultimately a additional financial cost. There are several forms of hypersensitivity: the two most classic: immediate hypersensitivity (type I according to Gell and Combs) with a reaction within an hour of taking and non-immediate hypersensitivity with a reaction occurring several days later (type IV according to Gell and Combs). A large majority of patients report a history of allergy in childhood that is poorly described and most often absent from health records. In most cases, this may be a viral rash concomitant with a febrile episode mistakenly mistaken for an allergic skin reaction. Patients are then tested for several decades, in adulthood, after their initial reaction. This latency of time involves a risk of negativation of the allergic tests and it is not excluded that the skin tests or drug reintroductions re cause sensitization to the antibiotic tested and that ultimately the patient reacts when taking the future drug. In fact, it is recommended to optimally explore patients approximately 6 months after an allergic reaction (except for severe drug eruptions).

The exploration of drug hypersensitivity to penicillins therefore involves a strict questioning of the circumstances of the so-called allergic reaction allowing the reaction to be classified as immediate or delayed, then skin tests (prick test, IDR and Patch test according to the immediate profile or delayed) and finally the hospital provocation test. While provocation tests are carried out conventionally most often within one day, it has been shown that some patients react several days after taking penicillin repeatedly: 6.1% have a reaction in their protocol of taking for 5 days at home in the context of a delayed allergy.

In the allergology service at hôpital Paris Saint-Joseph, the protocol corresponds to 2 successive reintroductions.

This study is to evaluate the protocol for reintroducing Amoxicillin or Augmentin carried out over two stages: a first with 100 mg (i.e. 1 / 10th of a dose) then a second with a dose of 1200 mg 1 month later. It would be a question of seeing if with the second reintroduction, one could not catch up with allergic people who would have presented a false negative during the first reintroduction because of explorations too far away from their initial reaction.

status: Active, not recruiting

time_perspective: Retrospective

ReferenceCitation: Solensky R, Earl HS, Gruchalla RS. Lack of penicillin resensitization in patients with a history of penicillin allergy after receiving repeated penicillin courses. Arch Intern Med. 2002 Apr 8;162(7):822-6.

ReferenceCitation: Marwood J, Aguirrebarrena G, Kerr S, Welch SA, Rimmer J. De-labelling self-reported penicillin allergy within the emergency department through the use of skin tests and oral drug provocation testing. Emerg Med Australas. 2017 Oct;29(5):509-515. doi: 10.1111/1742-6723.12774. Epub 2017 Apr 5.

ReferenceCitation: Shenoy ES, Macy E, Rowe T, Blumenthal KG. Evaluation and Management of Penicillin Allergy: A Review. JAMA. 2019 Jan 15;321(2):188-199. doi: 10.1001/jama.2018.19283. Review.

ReferenceCitation: de Haan P, Bruynzeel DP, van Ketel WG. Onset of penicillin rashes: relation between type of penicillin administered and type of immune reactivity. Allergy. 1986 Jan;41(1):75-8.

ReferenceCitation: Blanca M, Romano A, Torres MJ, Férnandez J, Mayorga C, Rodriguez J, Demoly P, Bousquet PJ, Merk HF, Sanz ML, Ott H, Atanasković-Marković M. Update on the evaluation of hypersensitivity reactions to betalactams. Allergy. 2009 Feb;64(2):183-93. doi: 10.1111/j.1398-9995.2008.01916.x. Review.

ReferenceCitation: Hjortlund J, Mortz CG, Skov PS, Bindslev-Jensen C. Diagnosis of penicillin allergy revisited: the value of case history, skin testing, specific IgE and prolonged challenge. Allergy. 2013 Aug;68(8):1057-64. doi: 10.1111/all.12195. Epub 2013 Jul 29.

ReferenceCitation: Devillers L, Sicsic J, Delbarre A, Le Bel J, Ferrat E, Saint Lary O. General Practitioner trainers prescribe fewer antibiotics in primary care: Evidence from France. PLoS One. 2018 Jan 25;13(1):e0190522. doi: 10.1371/journal.pone.0190522. eCollection 2018.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

lead_sponsor_type: academique


title: Efficacy of a Multi-faceted Intervention Combining an Educational Outreach Visit to General Practitioners and Patient Education Material to Deprescribe Proton Pump Inhibitors (PPI): a Population-based, Pragmatic, Cluster-randomized Controlled Trial

acronym: DeprescrIPPDAM

summary:
Deprescribing is defined as "the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing the polypharmacy and improving outcomes". Inappropriate use of proton pump inhibitors (PPI) is associated with severe adverse drug reactions and a major economic impact. Deprescribing should be considered when inappropriate prescription of PPI is identified.

DeprescrIPP DAM is a pragmatic trial, population-based, designed in clusters. It wil assess the efficacy of a multi-faceted intervention (an educational outreach visit to general practitioners associated with the sending of patient education material to their patients) to deprescribe PPI.

design_allocation: Randomized

primary_purpose: Health Services Research

lead_sponsor: Nantes University Hospital


type: Other Identifier

title: Evaluation of the Impact of Lock Down and End of Lock Down on the Management of Patients With Inflammatory and Dysimmune Diseases Followed in the Context of IMMINeNT FHU (Rheumatology, Dermatology, Internal Medicine, Pneumology, Gastroenterology, Neurology).

acronym: CONFIMID

summary:
This questionnaire is distributed via a mailing list (e-mail) of patients treated within the framework of the FHU for pathologies including chronic inflammatory bowel diseases or IBD (Crohn's disease and ulcerative colitis), inflammatory rheumatic diseases (such as rheumatoid arthritis and ankylosing spondylitis), but also asthma, psoriasis, atopic dermatitis as well as systemic autoimmune (such as scleroderma, lupus, angioedema) and neurological (multiple sclerosis) diseases.

A two-step analysis will be conducted: impact of lock down(March 17, 2020 - May 11, 2020) and a 2-month assessment of end of lock down (from May 11, 2020) on issues addressing: overall impact, impact on the disease, treatment and follow-up, and access to information related to the epidemic during these periods.

lead_sponsor: University Hospital, Lille


title: Phase II Study Aiming to Evaluate the Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

acronym: HYPNOMUSE

summary:
This phase II, randomized, non-comparative and monocentric study aims to evaluate the interest of medical hypnosis in the management of anxiety in patients who are moderately anxious, anxious or very anxious during their radiotherapy treatment.

45 patients will be randomized into the following arms:

Arm A (standard): relaxation with music listening during radiotherapy treatment
Arm B (experimental): relaxation with music listening and hypnosis during radiotherapy treatment

For the study each patient will be followed during 2 months.

primary_purpose: Supportive Care


title: Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?

acronym: SAMHY SARCOME

summary:
Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating "cancer cell/macrophage" hybrid cells in the peripheral blood.

The study will be conducted on a population of patients with sarcoma and treated in the context of routine care.

For each included patient, blood samples will be collected during baseline visit and after the initiation therapy.

At the end of the 2nd blood collection, the patient will have completed his participation in the study.


title: Evaluation of Clonal Heterogeneity and Tumor Evolution Using Liquid Biopsy in Newly Diagnosed Patients With High Grade Adenocarcinoma of Ovarian Origin, Fallopian Tubes or Primary Peritoneal

acronym: BOVARY CE

summary:
BOVARY-CE is a monocentric, pilot, longitudinal, real-life study with a total duration of 36 months. The purpose of this study is to assess the feasibility of using liquid biopsy as a substitute for tissue multisampling, in order to describe clonal heterogeneity and tumor evolution in patients with ovarian cancer. The method involves the inclusion of 20 patients with high-grade ovarian adenocarcinoma, fallopian tubes or primary peritoneal origin, not pretreated, newly diagnosed, and eligible for treatment who will participate in the research. These patients will have several samples throughout their treatment for a period of 2 years: blood samples which will be taken at each therapeutic moment of interest.

Tissue samples which will be taken at the time of the diagnostic laparoscopy and at the time of surgery.

The concentration of cfDNA and tumor heterogeneity will be used to predict disease-related events defined as relapse, progression or death.

primary_purpose: Diagnostic

ipd_sharing: Undecided

lead_sponsor: Institut de Cancérologie de Lorraine


title: Difference in Central Fatigue During Two Ultra-endurance Practices: Running vs. Cycling

acronym: FAT-CENTR

summary: The mechanisms contributing to muscle fatigue in extreme long-duration exercise bouts are poorly understood. Ultra-endurance exercise is an excellent model for the study of adaptive responses to extreme loads and stress and it is an especially useful model for documenting the origins of central fatigue. This protocol will compare fatigue during and after ultra-endurance exercise bouts that result in moderate lower-limb tissue damage (i.e. cycling) or significant damage (i.e. running). The results of this protocol will allow us to further understanding of the reasons for major central fatigue, i.e. within the central nervous system, in ultra-endurance.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: The "Great Live and Move Challenge": a Program to Promote Physical Activity Among Children Aged 7-11 Years. Design and Implementation of a Cluster-randomized Controlled Trial.

summary: The Great Live and Move Challenge (GLMC) study is a 2-year cluster-randomized controlled trial designed to evaluate a multilevel and theory-based intervention to promote PA practice in children aged 7-11 years from French primary schools.

primary_purpose: Prevention

location_facility: Institut régional di Cancer de Montpellier (ICM)

intervention_type: Behavioral


title: Comparative Study of Differences in Food Preferences and Sensory Perceptions Between People With Obesity With or Without Bariatric Surgery

acronym: BariaTaste 2

summary: Several studies report changes in food preferences in favor of low energy density foods after bariatric surgery and changes in scores of liking and desire to eat, as well as changes in hedonic evaluation certain foods. However, only one study was held in a more realistic condition of consumption by using real food, looking at some aspects of food preferences and giving contradictory results. We hypothesise that food preferences are different between obese people with and without a bariatric surgery. The main objective of this study is to compare the differences in food quality (proportion of total energy intake from foods with high energy density versus foods with low energy density), evaluated during a standardized and validated buffet between adult women with severe complicated or morbid obesity and women who have undergone bariatric surgery in the last 12 months.

status: Unknown status

time_perspective: Cross-Sectional

lead_sponsor: Hospices Civils de Lyon

location_facility: : Center for Research in Human Nutrition Rhône-Alpes, Institut Paul Bocuse Research Center

status_simplified: Unknown


title: Evaluation of a ddPCR Technology for the SARS-CoV-2 Detection in Symptomatic Patients With Suspicion of COVID-19

summary: Evaluation of the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection using an IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard (FDA validated commercial serologic test).

lead_sponsor: Centre Leon Berard

intervention_type: Diagnostic Test


title: Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)

acronym: CISCO

summary: The objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients.

lead_sponsor: Rennes University Hospital


title: Comparative Study of Human Growth Hormone Measurements: Impact on Clinical Interpretation

summary: Human growth hormone (hGH) provocation test is an essential tool to assess growth hormone deficiency in children and young adults. It is important to have a robust and reliable method to determine the hGH peak of stimulation. This work aimed to compare three common automated immunoassays for hGH measurements and to assess whether there are still result-related differences influencing clinical decision.

ReferenceType: derived

ReferenceCitation: Lotierzo M, Olaru-Soare F, Dupuy AM, Plawecki M, Paris F, Cristol JP. Comparative study of human growth hormone measurements: impact on clinical interpretation. Clin Chem Lab Med. 2021 Dec 2;60(2):191-197. doi: 10.1515/cclm-2021-1109. Print 2022 Jan 27.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Access to Maternity and Risk Factors in a Non-consultant Population - Longitudinal and Prospective Exploratory Study (PROXIMA)

summary: Characterize the psychic and medical disorders related to pregnancy and motherhood in a group of primiparous and primigratic women.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Prevalence of Eating Disorders in Adult Patients With Type I Diabetes and Insulin Pump Treatment

acronym: Diaboulimia

summary: The purpose of this study is to determine the prevalence of eating disorders in type 1 insulin-dependent diabetes patients

ipd_sharing: Yes

ipd_sharing_description: Contact icadom@agiradom.com for any data request. The researcher will be invited to complete a form (data sharing agreement) explaining the reasons and the aim of the data requests. The data will be de-identified.

lead_sponsor: Icadom


title: Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation

acronym: BKSEREIN

summary: Due to the increasing importance of BKV infection on the survival of kidney transplants, a better knowledge, in the pretransplant phase, of the risk factors leading to viral reactivation could allow the follow-up physician to be more vigilant and better prevent this pathology. There are no commercial tests for BKV serology. In the virology laboratory, the investigators have developed the technique for producing "Virus-like particles" (VLP) that mimics the antigenic structure of the BK virus. The investigators plan to evaluate seroreactivity to the five BK virus serotypes in the recipient of a kidney transplant as a pretransplant and to compare this data with the detection or not of viral reactivation in the recipient during the first post-transplant year.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Prospective, Single Center Study for the Clinical Evaluation of the Safety and Performance of a Dermal Filler in Correction of Mid-face Age-related Volume Deficit

summary: Prospective, single center study, on healthy subjects to evaluate the aesthetic improvement of facial volume, effect on the restoration and/or augmentation in subjects with mid-face age-related volume deficit after injection of a filler with lidocaine.

primary_purpose: Treatment

lead_sponsor: Relife S.r.l.

intervention_type: Device


title: Real Time Molecular Analysis of Breast Cancer Receiving Neo-adjuvant Chemotherapy: Identification of Preclinical Models Predictive for Therapeutic Resistance

acronym: NEO-R

summary: The present project aims at identifying robust candidates for drug resistance in BC patients eligible for NAC. Its originality lies upon the combination of three different and complementary prospective approaches: from the molecular analyses of biopsies sampled before and after NAC, from in vitro BC Patient-Derived Organoids (PDO) mimicking patient's response to NAC, and from Circulating Tumor Cells (CTCs) isolated before/during/after NAC.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Institut Paoli-Calmettes


title: ASYMMETRIC LACK OF KNEE FLEXION AS A SYMPTOM OF DLM IN CHILDREN

summary:
Highlighted during the clinical examination of a knee flexion asymmetry, and related to the intraoperative meniscal observations on DLM.

Search for a link between asymmetric bending defect and posterior shift in MCA-type DLM.

Analysis of all patients with symptomatic DLM.

location_facility: Paediatric orthopaedic - Femme Mère Enfant Hospital (HFME)


title: Pilot Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer

acronym: EUTACAM

summary:
This is a pilot, prospective, interventional, monocentric study designed to evaluate, in a real-life situation, adherence to tamoxifen treatment as a function of the taking of alternative and complementary therapies in patients with localized hormone-dependent breast cancer.

200 patients will be included in the study.

Each patient will be followed for one day.


title: Interest of Systematic PPI Therapy After POEM vs Symptomatic Use of PPI Therapy in Prevention of Gastroesophageal Reflux Disease After POEM for Esophageal Achalasia. A Comparative Retrospective Analysis.

acronym: IPPOEM-Retro

summary:
POEM is a minimally invasive endoscopic therapy that is highly efficacy in the treatment of achalasia of any type. POEM has an increased risk of GERD. Systematic PPI therapy has never been studied for the prevention of post-POEM GERD.

The investigators wish to retrospectively compare patients who have received routine PPI therapy vs. patients who don't.

ipd_sharing_description: nc


title: Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity.

summary: The aim of the present study is to compare the effect of iso-energetic energy deficits induced by exercise or dietary restriction on energy intake and appetite feelings in adolescents with obesity

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evaluation of the Therapeutic Benefit of Rehabilitation With Computerized Mirror Therapy for Patients Suffering From Motor Neurological Disorder (FND) of the Upper Limb.

acronym: FND-mirror

summary:
Motor functional neurological disorders (FND) correspond to motor symptoms that are unexplained by an organic lesion but are due to cerebral dysfunction. Patients with these disorders have high rates of disability and health care utilization, and their quality of life is as impaired as that of patients with an "organic" disease. Accompanying these patients in their often-complex health journey represents a socio-economic and human challenge that demands interdisciplinary collaboration. Rehabilitation is seen as an important part of the therapy for motor FND. However, further research is needed to refine appropriate interventions and to create evidence-based recommendations. In this study, patients suffering from a functional neurological motor disorder of the upper limb will be included in a novel rehabilitation protocol that includes computerized mirror therapy. The study will used a multiple baseline, across subjects, single-case experimental design (SCED). In this type of design, each subject is his own control, with individual parameters being repeatedly measured in the presence and absence of the intervention of interest (computerized mirror therapy). Computerized mirror therapy could restore the coherence between the motor program and its execution. The investigators hypothesize that this process could re-normalize upper-limb motor activity and that this will have a beneficial impact on manual dexterity, quality of life, and mental representation capacities of the upper limb.

The objective of this project is to use the single case experimental design method to investigate the efficacy of rehabilitation with computerized mirror therapy for patients suffering from motor neurological disorders (FND) of the upper limb.

location_facility: Hôpital Henry Gabrielle - Hospices Civils de Lyon


title: ARTHEMIRS: Assessment of Brain Activation During Different Mirror Therapy Tasks Using fNIRS Technology

acronym: ARTHEMIRS

summary: The purpose of this study is to investigate the cerebral activation during Classic Mirror Therapy (TMC) and especially during Virtual Mirror Therapy (TMV) in healthy subjects. It seems that the precuneus is involved in the effectiveness of mirror therapy. One goal of this study is to determine if there is a better activation of the precuneus during TMV than during TMC. Others goals are to compare cerebral activation during three different tasks (TMV, TMC and a simple motor task), to study the intra-subjects reproducibility of the measurement and the correlation between cerebral activation and feelings of the participants about the efficacity of the tasks.

ReferenceType: background

ReferenceCitation: Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, Ramachandran VS. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999 Jun 12;353(9169):2035-6.

ReferenceCitation: Bae SJ, Jang SH, Seo JP, Chang PH. The Optimal Speed for Cortical Activation of Passive Wrist Movements Performed by a Rehabilitation Robot: A Functional NIRS Study. Front Hum Neurosci. 2017 Apr 20;11:194. doi: 10.3389/fnhum.2017.00194. eCollection 2017.

ReferenceCitation: Bai Z, Fong KNK, Zhang J, Hu Z. Cortical mapping of mirror visual feedback training for unilateral upper extremity: A functional near-infrared spectroscopy study. Brain Behav. 2020 Jan;10(1):e01489. doi: 10.1002/brb3.1489. Epub 2019 Dec 5.

ReferenceCitation: Brunetti M, Morkisch N, Fritzsch C, Mehnert J, Steinbrink J, Niedeggen M, Dohle C. Potential determinants of efficacy of mirror therapy in stroke patients--A pilot study. Restor Neurol Neurosci. 2015;33(4):421-34. doi: 10.3233/RNN-140421.

ReferenceCitation: Calautti C, Jones PS, Naccarato M, Sharma N, Day DJ, Bullmore ET, Warburton EA, Baron JC. The relationship between motor deficit and primary motor cortex hemispheric activation balance after stroke: longitudinal fMRI study. J Neurol Neurosurg Psychiatry. 2010 Jul;81(7):788-92. doi: 10.1136/jnnp.2009.190512. Epub 2010 Apr 14.

ReferenceCitation: Chang CS, Lo YY, Chen CL, Lee HM, Chiang WC, Li PC. Alternative Motor Task-Based Pattern Training With a Digital Mirror Therapy System Enhances Sensorimotor Signal Rhythms Post-stroke. Front Neurol. 2019 Nov 22;10:1227. doi: 10.3389/fneur.2019.01227. eCollection 2019.

ReferenceCitation: Darbois N, Guillaud A, Pinsault N. Do Robotics and Virtual Reality Add Real Progress to Mirror Therapy Rehabilitation? A Scoping Review. Rehabil Res Pract. 2018 Aug 19;2018:6412318. doi: 10.1155/2018/6412318. eCollection 2018. Review.

ReferenceCitation: Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. Neuroimage. 2012 Nov 1;63(2):921-35. doi: 10.1016/j.neuroimage.2012.03.049. Epub 2012 Mar 28. Review.

ReferenceCitation: Giraux P, Sirigu A. Illusory movements of the paralyzed limb restore motor cortex activity. Neuroimage. 2003 Nov;20 Suppl 1:S107-11.

ReferenceCitation: Harmsen WJ, Bussmann JB, Selles RW, Hurkmans HL, Ribbers GM. A Mirror Therapy-Based Action Observation Protocol to Improve Motor Learning After Stroke. Neurorehabil Neural Repair. 2015 Jul;29(6):509-16. doi: 10.1177/1545968314558598. Epub 2014 Nov 21.

ReferenceCitation: Inagaki Y, Seki K, Makino H, Matsuo Y, Miyamoto T, Ikoma K. Exploring Hemodynamic Responses Using Mirror Visual Feedback With Electromyogram-Triggered Stimulation and Functional Near-Infrared Spectroscopy. Front Hum Neurosci. 2019 Feb 26;13:60. doi: 10.3389/fnhum.2019.00060. eCollection 2019.

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ReferenceCitation: Lee HM, Li PC, Fan SC. Delayed mirror visual feedback presented using a novel mirror therapy system enhances cortical activation in healthy adults. J Neuroeng Rehabil. 2015 Jul 11;12:56. doi: 10.1186/s12984-015-0053-1.

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lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Analysing the French COVID-19 Epidemic Using a National SARS-CoV-2 RT-PCR Database : CovPCR

acronym: CovPCR

summary: Analysing ths spread of COVID-19 epidemics in a timely manner is key to implementing public health control strategies. The investigators propose to analyse a large set of laboratory SARS-CoV-2 RT-PCR data to explore potential links between Ct values and epidemic parameters.


title: Evaluation of the Antalgic Effect of Puressentiel Joints and Muscles - Gel with14 Essential Oils on Joint Pain of the Knee

acronym: EVAPURGEL

summary: This clinical trial aims to evaluate the antalgic effect of Puressentiel Joints and Muscles - Gel with 14 essential oils for 12 weeks on knee joint pain in 45 patients suffering from chronic pain related to arthritis of the knee. The evaluation of the puressentiel antalgic effect Joints and Muscles - Gel with 14 essential oils will be done by an algo-functional score of WOMAC based on items of pain, joint stiffness and locomotor function (main criterion), a visual analog scale EVA (graduated from 1 to 10) of the pain by self-assessment of the patient during the consultation and the number of daily analgesics and anti-inflammatory drugs (secondary criteria).

lead_sponsor: Marco Pacchioni


title: Study of the Influence of Proprioceptive Reweighting Ability on the Lower-extremity Biomechanics During Functional Tasks and Unplanned Sidestep Cutting Manoeuvre

acronym: NEURIBIO

summary:
Anterior cruciate ligament (ACL) injuries are frequent in handball especially among young players. Recent investigations highlighted the implication of the central nervous system as a potential risk factor for ACL rupture.

The ability to dynamically reweight proprioceptive signals according to postural conditions is crucial for balance control.

The aim of this study is therefore to investigate the influence of proprioceptive reweighting on biomechanical determinants of ACL loads during functional tasks and unplanned side cutting manoeuvers.

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ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Multi-omic Longitudinal Characterization of Pulmonary Microbiome in Cystic Fibrosis Patients

acronym: SPutOM-CF

summary:
The composition and role of the pulmonary microbiota is not yet well described in cystic fibrosis patients.

The objective of our longitudinal follow-up of primary colonised patients is to show the presence of a link between the composition of the microbiota and the effectiveness of antibiotic therapy.

All patients followed at the Montpellier CF center will be asked to participate in this cohort. All patients have a regular follow-up every 1 to 6 months and will be asked at each visit to keep their sputum sample in excess of the analyses requested for their follow-up


title: Prospective Study on the Contribution of Fluorescence in the Guidance of Lymphadenectomy and in Peroperative Evaluation of Pre-anastomotic Tissue Perfusion in Laparoscopic Esogastric Oncologic Resections

acronym: FOREGUT

summary: A high number of resected lymph nodes is an independent prognostic factor for improved survival after esophagectomy or gastrectomy for cancer. The quality of the lymphadenectomy is operator-dependent, as is the evaluation of the vascularization of the digestive structures that are anastomosed to restore digestive continuity after esophago-gastric resection. The aim of the study is to evaluate the impact of Indocyanine Green (ICG) and near infra-red (NIR) fluorescence imaging guidance in terms of number of lymph nodes resected and quality of gastrointestinal tract anastomoses in esophagogastric cancer surgery.

ReferenceCitation: Rosenthal EL, Warram JM, Bland KI, Zinn KR. The status of contemporary image-guided modalities in oncologic surgery. Ann Surg. 2015 Jan;261(1):46-55. doi: 10.1097/SLA.0000000000000622. Review.

ReferenceCitation: van der Werf LR, Dikken JL, van Berge Henegouwen MI, Lemmens VEPP, Nieuwenhuijzen GAP, Wijnhoven BPL; Dutch Upper GI Cancer Audit group. A Population-based Study on Lymph Node Retrieval in Patients with Esophageal Cancer: Results from the Dutch Upper Gastrointestinal Cancer Audit. Ann Surg Oncol. 2018 May;25(5):1211-1220. doi: 10.1245/s10434-018-6396-7. Epub 2018 Mar 9.

ReferenceCitation: Tachimori Y. Pattern of lymph node metastases of squamous cell esophageal cancer based on the anatomical lymphatic drainage system: efficacy of lymph node dissection according to tumor location. J Thorac Dis. 2017 Jul;9(Suppl 8):S724-S730. doi: 10.21037/jtd.2017.06.19. Review.

ReferenceCitation: Nafteux P, Depypere L, Van Veer H, Coosemans W, Lerut T. Principles of esophageal cancer surgery, including surgical approaches and optimal node dissection (2- vs. 3-field). Ann Cardiothorac Surg. 2017 Mar;6(2):152-158. doi: 10.21037/acs.2017.03.04.

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ReferenceCitation: Woo Y, Goldner B, Ituarte P, Lee B, Melstrom L, Son T, Noh SH, Fong Y, Hyung WJ. Lymphadenectomy with Optimum of 29 Lymph Nodes Retrieved Associated with Improved Survival in Advanced Gastric Cancer: A 25,000-Patient International Database Study. J Am Coll Surg. 2017 Apr;224(4):546-555. doi: 10.1016/j.jamcollsurg.2016.12.015. Epub 2016 Dec 23.

ReferenceCitation: Vahrmeijer AL, Hutteman M, van der Vorst JR, van de Velde CJ, Frangioni JV. Image-guided cancer surgery using near-infrared fluorescence. Nat Rev Clin Oncol. 2013 Sep;10(9):507-18. doi: 10.1038/nrclinonc.2013.123. Epub 2013 Jul 23. Review.

ReferenceCitation: Herrera-Almario G, Patane M, Sarkaria I, Strong VE. Initial report of near-infrared fluorescence imaging as an intraoperative adjunct for lymph node harvesting during robot-assisted laparoscopic gastrectomy. J Surg Oncol. 2016 Jun;113(7):768-70. doi: 10.1002/jso.24226. Epub 2016 Mar 29.

ReferenceCitation: Kwon IG, Son T, Kim HI, Hyung WJ. Fluorescent Lymphography-Guided Lymphadenectomy During Robotic Radical Gastrectomy for Gastric Cancer. JAMA Surg. 2019 Feb 1;154(2):150-158. doi: 10.1001/jamasurg.2018.4267.

ReferenceCitation: Kim TH, Kong SH, Park JH, Son YG, Huh YJ, Suh YS, Lee HJ, Yang HK. Assessment of the Completeness of Lymph Node Dissection Using Near-infrared Imaging with Indocyanine Green in Laparoscopic Gastrectomy for Gastric Cancer. J Gastric Cancer. 2018 Jun;18(2):161-171. doi: 10.5230/jgc.2018.18.e19. Epub 2018 Jun 28.

ReferenceCitation: Turner SR, Molena DR. The Role of Intraoperative Fluorescence Imaging During Esophagectomy. Thorac Surg Clin. 2018 Nov;28(4):567-571. doi: 10.1016/j.thorsurg.2018.07.009. Review.

ReferenceCitation: Hachey KJ, Gilmore DM, Armstrong KW, Harris SE, Hornick JL, Colson YL, Wee JO. Safety and feasibility of near-infrared image-guided lymphatic mapping of regional lymph nodes in esophageal cancer. J Thorac Cardiovasc Surg. 2016 Aug;152(2):546-54. doi: 10.1016/j.jtcvs.2016.04.025. Epub 2016 Apr 11.

ReferenceCitation: Park SY, Suh JW, Kim DJ, Park JC, Kim EH, Lee CY, Lee JG, Paik HC, Chung KY. Near-Infrared Lymphatic Mapping of the Recurrent Laryngeal Nerve Nodes in T1 Esophageal Cancer. Ann Thorac Surg. 2018 Jun;105(6):1613-1620. doi: 10.1016/j.athoracsur.2018.01.083. Epub 2018 Mar 5.

ReferenceCitation: Kaburagi T, Takeuchi H, Oyama T, Nakamura R, Takahashi T, Wada N, Saikawa Y, Kamiya S, Tanaka M, Wada T, Kitagawa Y. Intraoperative fluorescence lymphography using indocyanine green in a patient with chylothorax after esophagectomy: report of a case. Surg Today. 2013 Feb;43(2):206-10. doi: 10.1007/s00595-012-0391-6. Epub 2012 Oct 30.

ReferenceCitation: Kim M, Son SY, Cui LH, Shin HJ, Hur H, Han SU. Real-time Vessel Navigation Using Indocyanine Green Fluorescence during Robotic or Laparoscopic Gastrectomy for Gastric Cancer. J Gastric Cancer. 2017 Jun;17(2):145-153. doi: 10.5230/jgc.2017.17.e17. Epub 2017 Jun 9.

ReferenceCitation: Zehetner J, DeMeester SR, Alicuben ET, Oh DS, Lipham JC, Hagen JA, DeMeester TR. Intraoperative Assessment of Perfusion of the Gastric Graft and Correlation With Anastomotic Leaks After Esophagectomy. Ann Surg. 2015 Jul;262(1):74-8. doi: 10.1097/SLA.0000000000000811.

ReferenceCitation: Campbell C, Reames MK, Robinson M, Symanowski J, Salo JC. Conduit Vascular Evaluation is Associated with Reduction in Anastomotic Leak After Esophagectomy. J Gastrointest Surg. 2015 May;19(5):806-12. doi: 10.1007/s11605-015-2794-3. Epub 2015 Mar 20.

ReferenceCitation: Agzarian J, Visscher SL, Knight AW, Allen MS, Cassivi SD, Nichols FC 3rd, Shen KR, Wigle D, Blackmon SH. The cost burden of clinically significant esophageal anastomotic leaks-a steep price to pay. J Thorac Cardiovasc Surg. 2019 May;157(5):2086-2092. doi: 10.1016/j.jtcvs.2018.10.137. Epub 2018 Nov 15.

ReferenceCitation: Carrott PW, Markar SR, Kuppusamy MK, Traverso LW, Low DE. Accordion severity grading system: assessment of relationship between costs, length of hospital stay, and survival in patients with complications after esophagectomy for cancer. J Am Coll Surg. 2012 Sep;215(3):331-6. doi: 10.1016/j.jamcollsurg.2012.04.030. Epub 2012 Jun 8.

ReferenceCitation: Wang S, Xu L, Wang Q, Li J, Bai B, Li Z, Wu X, Yu P, Li X, Yin J. Postoperative complications and prognosis after radical gastrectomy for gastric cancer: a systematic review and meta-analysis of observational studies. World J Surg Oncol. 2019 Mar 18;17(1):52. doi: 10.1186/s12957-019-1593-9.

ReferenceCitation: Carus T, Dammer R. Laparoscop fluorescence angiography with indocyanine green to control the perfusion of gastrointestinal anastomoses intraoperatively. Surg Technol Int. 2012 Dec;22:27-32.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne, NHC

intervention_type: Procedure


title: Appetite Response to Exercise- Versus Mixed (Exercise + Dietary Restriction)-Induced Energy Deficit in Adolescents With Obesity

summary: The aim of the present study is to compare the effect of iso-energetic energy deficits induced by energy restriction alone or exercise + dietary restriction (Mixed deficit) on energy intake and appetite feelings in adolescents with obesity.


title: Persistent Eosinopenia is Associated With In-hospital Mortality Among Elderly Patients : Revisiting and Old Forgotten Marker of Infection

summary:
No biological marker is highly specific of infection and currently available, especially for bacterial infection. The ideal marker would be easy to perform, rapidly, inexpensive, and correlated with the severity and prognosis of the infection.

decreased in eosinophil count (EC) is unspecific of a particular clinical picture and may support a systemic inflammation, whereas the deeper the eosinopenia is, the darker is the prognosis in ICU.

The duration of eosinopenia is not clearly documented, but it has been recently shown that EC tends to normalization, rapidly after appropriate and effective antimicrobial therapy in case of bacterial infection among adults patients hospitalized in a medicine ward. In the light of this findings, Terradas et al. described that EC returned back to normal between the day 2 or day 3 in survivors, indicating a potential interest as a predictive marker of the evolution among hospitalized patients.

To the best of our knowledge, no work has studied eosinopenia as a prognostic marker of mortality during bacterial infections in the elderly patients in a hospital setting. Our study aims to evaluate the prognosis value of the EC in a geriatric unit of tertiary care hospital.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

intervention_type: Biological


title: Role of Selective Attention for Sound Modulations in the Listening Effort of Patients With Cochlear Implants

acronym: EffICAtt

summary:
Cochlear implant users perceive mainly sound amplitude modulation cues. Processing of these amplitude modulations can be subject to interferences, so that the perception of a modulation in a target sound can be impaired by a superimposed sound if this sound contains a similar modulation. Such phenomenon, which is observed both in subjects with normal-hearing and in cochlear-implant users, could be explained by difficulties to direct attention to relevant information in complex sound signals. Selective auditory attention also plays a crucial role in speech comprehension in cocktail-party situations where the speech of multiple talkers get mixed at the ear of a listener. Cochlear implant users typically struggle in these cocktail-party situations and report intense listening effort.

The present clinical trial aims at evaluating the contribution of selective auditory attention for sound modulations to the listening effort of patients with cochlear implants and of healthy volunteers with normal-hearing during speech perception under cocktail-party-like conditions.

Selective auditory attention abilities of patients and controls will be assessed using a psychoacoustical test whereby their ability to detect a target sound amplitude modulation will be measured both in the absence and in the presence of an interfering (i.e. distracting) amplitude modulation occurring in a distant spectral region from that of the target. The effect of this distractor's presence on modulation detection performance will serve as a behavioural index of the subject's auditory attention capacities.

The attentional capacity index will then be tested as a predicting factor for the listening effort of the subject during a speech-in-noise consonant identification task. Listening effort will be measured from the pupil dilation response to the presented speech units (pseudowords).

This study will enhance our understanding of cochlear implant user's perception and listening effort and will serve as a basis for prognostic tests of listening effort and of implantation success for cochlear implant candidates, based on a simple measurement of auditory attentional abilities.

design_allocation: Non-Randomized

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Treatment of Corneal Wounds Emergencies During the COVID-19 Shutdown: Absorbable 10-0 Vicryl Sutures as a Valuable Strategy.

summary:
Vicryl (polyglactin) 10-0 resorbable suture is rarely used, little known to ophthalmologists but may offer therapeutic and practical advantages in eligible cases of corneal trauma, particularly during a COVID-19 pandemic.

This has imposed new sanitary restrictions : limited access to the operating room in ophthalmology only for functional emergencies and a drastically reduced capacity for external consultations in favor of teleconsultation. The aim of this study is to evaluate the Vicryl 10-0 (polyglactin 910) resorbable monofilament suture in corneal trauma, rather than classic Nylon 10-0: structural and functional results, and adaptation of postoperative follow-up during a sanitary crisis period.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Effects of Delayed Growth on the Quality of Life of Children Treated for a Chronic Disease and Quality of Life Study of Their Parents and Siblings

acronym: CROQUIE

summary:
Chronic childhood diseases have sometimes strong repercussions on the everyday life of patients and their families, because of strict daily treatment regimens, physical limitation or effects on social life for instance In children, chronic diseases can lead to poor growth, which can of itself affect the child's quality of life.

Our proposal is therefore to study the effects of short stature on the quality of life of children with chronic diseases treated in our multidisciplinary paediatrics department.

The quality of life of the patients' relatives will also be considered.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital Heart Disease

acronym: CINC

summary: We propose a prospective observational study whose main objective will be to determine whether there is an association between age at surgery (days of life) and neurodevelopmental outcome in patients with CCHD. Secondly, we will study the relationship between age at surgery and (i) the incidence of WMI observed on pre- and post-operative cerebral MRI (ii) post-operative morbidity as defined by the occurrence of post-operative complications (haemodynamic, infectious, neurological, surgical) and (iii) the length of hospital stay.

location_facility: Assistance Publique Des Hopitaux de Marseille


title: Pronostic Value of Type I ANTi-Interferon Antibodies in Patients With COVID-19 Acute Respiratory Failure: a Multicenter Observational Study

acronym: ANTICOV

summary:
Severe SARS-CoV-2 infections are frequently associated with the acute respiratory distress syndrome (ARDS), which leads to a mortality of 30-40%. An altered type I interferon (IFN) response has been demonstrated in patients with severe COVID-19, together with a high viral load.

The aim of the current work is, in a large cohort of patients with severe COVID-19 admitted in the ICU, to determine the prevalence of patients with positive anti-IFN antibodies and to determine their outcome, as compared to patients having negative anti-IFN antibodies.

time_perspective: Other

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR


title: Prospective Study of the Safety and Efficacy of the Use of a Lipiodol Emulsion for the Embolization of Inflammatory Hypervascularizations Observed in Patients With Joint or Abarticular Knee Pain

type: EudraCT Number

source: euctr

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

summary: Knee osteoarthritis is a common cause of disability in patients who are often young and active. Surgery being an option only for the most severe cases, there is little alternative in case of failure of recommended medication. Inflammatory hypervascularization of the joint is a known source of pain. Temporary embolization of intra-arterial inflammatory hypervascularization has been used since 2012 with good results on pain relief to treat patients with musculoskeletal disorders that are resistant to conventional treatments. Lipiodol® has transient embolizing properties when in emulsion with a contrast agent. It has been used as an emulsion with chemotherapy for the treatment of metastases and primary intra-arterial liver cancer (chemo-embolization) for many years without serious side effects. We hypothesized that Lipiodol® in emulsion could serve as a temporary embolization agent for the treatment of inflammatory hypervascularization responsible for musculoskeletal disorders in humans.


title: Maintenance of Physical Activity at One Year After Cardiac Rehabilitation Program

acronym: APA&Co

summary:
Maintaining physical activity after cardiac rehabilitation has a major role in disease progression and patient prognosis. 6 months after the cardiac rehabilitation, we find during a nursing interview that many patients do not maintain regular physical activity.

1 year after cardiac rehabilitation, between 30% and 60% of patients do not maintain the recommendations in terms of physical activity. However during the follow-up at 6 months, distance is maintened on the 6-minute walk test.

These results suggest that maintaining distances on the 6-minute walk test is possible without maintaining regular physical activity.

Data are lacking on maintenance beyond 6 months. Currently, we do not identify any studies evaluating maintenance to physical activity at 1 year cardiac rehabilitation by a 6-minute walk test.

lead_sponsor: Centre Hospitalier de Cholet


title: Impact of a Dynamic Dressing in the Management of Unoperated Hallux Valgus With Theoretical Indication for Surgery: Randomized Open Trial

acronym: DYNHALLUX

summary:
Hallux Valgus (HV) is a lateral deviation of the big toe. HV is a deformity of the forefoot centered on the 1st radius (1st metatarsal and big toe). This deformation is characterized by:

a big toe (hallux) deviated outwards (valgus greater than 12 °)
a first metatarsal moved medially (varus) (angle M1 / M2> 10 °). We also note the existence of an exostosis formed by the apex of the angle between the 1st metatarsal deviated inwards and the big toe deported outwards. This exostosis corresponds to the head of the 1st metatarsal.

In addition to the pain and the unaesthetic nature induced by this deviation, the modifications of the skeletal axes of the foot cause disorders of its function but also of the joints of the lower limb during standing, walking and running. Axis defects of the lower limbs in varum or valgum also cause deformities in the rearfoot, midfoot and forefoot.

There is no non-surgical curative treatment for this deformity. Different conservative treatment options have been offered for first-line treatment, including different types of physiotherapy, wearing rigid insoles or splints.

Wearing rigid insoles is indicated to "counter" the valgic pressure, thereby reducing pain and high plantar pressure, in patients with HV. Their hardness, expressed in SHORE units, must be greater than 65. By countering the valgic pressure (rearfoot and midfoot), the rigid soles make it possible to contain the development of deformation and stabilize the axis of the first spoke. The speed of hallux deformation is therefore greatly reduced if the soles are worn diligently. But there is little or no impact on the correction of the deformity, but it is stabilized as it is without rapid and major worsening. Indeed, soles with a hardness greater than or equal to 65 SHORE make it possible to avoid the valgum of the hindfoot and midfoot under load and when walking.

Wearing a dynamic splint was studied in a recently published prospective randomized study conducted between 2011 and 2013. This study, concluding that the dynamic splint is not effective in reducing the angle of deformation of the HV, nevertheless shows the reduction in pain during walking and running. The limits of the study lie in the pace of wearing the splint, left to the discretion of patients, during their rest period, and in the duration of the operation, which is not precisely described.

status: Terminated

lead_sponsor: Centre Hospitalier Annecy Genevois


title: Educational Interventions to Integrate Surgical Staff Within Medical Units During the COVID-19 Pandemic: EDUCOVID Cross-sectional, E-survey

acronym: EDUCOVID

summary: The coronavirus disease 2019 (COVID-19) pandemic required a rapid surge of healthcare capacity to face a growing number of critically ill patients. For this reason, a support reserve of physicians, including surgeons, were required to be reassigned to offer support. Given the time shortage for trainers and trainees, time and cost-efficient programs to gain maximal benefit from short rotations for several physicians at one time are required 8. In case of pandemics, blending face-to-face education to e-learning seems sustainable, with online resources being scalable and more cost effective than other methods 9.

location_facility: Assistance Publique Hôpitaux de Paris - GHU AP-HP Hôpitaux Universitaires Henri-Mondor


title: Efficacy of a Smartphone App Designed to Manage Craving and Individual Predictors of Substance Use / Addictive Behavior Among Individuals With Addictive Disorders

acronym: CRAVINGMANAGER

summary: Test the Efficacy of a smartphone application designed to manage craving and individual predictors of substance use / addictive behavior among individuals with addictive disorders

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux


title: Evaluation of Corrected Carotid Flow Time Variations During Passive Leg Lift to Predict Response to Filling

acronym: CAROT

summary: Patients hospitalized in intensive care often require intravenous administration of fluid in order to optimize the functioning of the heart and thus ensure perfusion of vital organs such as the kidneys, the brain or the digestive tract. However, it is necessary to find the right balance in fluid intake because it has been shown that excessive administration has a negative impact on patient survival, the length of their stay in intensive care or the duration of invasive mechanical ventilation.The passive leg lifting maneuver is regularly used to determine which patients should be infused with these large volumes (the patient's chest is placed in a horizontal position and the legs are elevated at 30 ° by tilting the bed for 2 minutes ). To be interpreted, this maneuver requires the presence of invasive devices (bloody arterial pressure catheter, PICCO monitor) or an operator experienced in cardiac ultrasound.Our study aims to evaluate an easy-to-use, non-invasive tool widely available in intensive care and emergency departments (carotid vascular doppler ultrasound) to assess the response to a passive leg lifting maneuver. . The measurements are taken before and after a passive leg lifting maneuver and then before and after a filling decided before inclusion by the doctor responsible for the patient.

lead_sponsor: Centre Hospitalier de Cornouaille


title: Impact of Formal Home Help on Quality of Life for Caregivers of Elderly Patients With Neurocognitive Impairment: a Prospective Monocenter Study

acronym: PIAF-QVA

summary: The purpose of this prospective monocenter observational study is to assess the impact of the first introduction of formal home help (personalized autonomy allowance for seniors) on the quality of life of home caregivers of elderly patients with neurocognitive impairment.

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


title: Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir - STEP 1

ReferenceCitation: Faure Bardon V, Peytavin G, Lê MP, Guilleminot T, Elefant E, Stirnemann J, Leruez-Ville M, Ville Y. Placental transfer of Letermovir & Maribavir in the ex vivo human cotyledon perfusion model. New perspectives for in utero treatment of congenital cytomegalovirus infection. PLoS One. 2020 Apr 30;15(4):e0232140. doi: 10.1371/journal.pone.0232140. eCollection 2020.

summary:
In the model of the perfused cotyledon, Letermovir crosses the placenta to reach appropriate fetal concentration. The cotyledon model can only be performed in the third trimester placenta. Although it is probable that the transplacental passage in the second trimester is in the same range than the one found in the 2th trimester, it needs to be confirmed. The study will be divided in 2 steps: step 1 will study the Letermovir transplacental transfer in the second trimester and step 2 will test the efficacy of letermovir to inhibit replication in infected fetuses.

Main objective To measure the Letermovir transplacental transfer in the second trimester and its accumulation in the amniotic fluid and the placenta in the second trimester

Primary end point:

Concentrations reached in fetal blood relative to EC50 of letermovir.


title: Orange Juice, Hesperidin and Their Role in Vascular Health Benefit: a Human Double Blind, Randomized, Controlled, Cross Over Study

acronym: HESPER-HEALTH

summary: Although epidemiological studies have associated the consumption of sugary beverages with adverse health effects, experimental studies have demonstrated that the metabolic response of the human body to fruit juice as compared to artificial beverages is substantially different. Fruit juices do not just provide sugars and related calories, but they are rich sources of bioactive compounds especially of flavonoids. Flavanones constitute a class of flavonoids that are specifically and abundantly found in citrus fruits, with hesperidin being the major compound in orange. From prospective cohort studies, higher intakes of flavanones are associated with a lower incidence of mortality by cardiovascular disease (CVD). This relation is supported by results from a number of animal studies demonstrating a slowdown in atherosclerosis development and vascular protective effects in dietary interventions with flavanones. Randomized, controlled clinical trials to corroborate the suggested vasculo-protective effects of orange juice presumably mediated by the flavanones are scarce and available data do not allow to draw firm conclusions about their efficacy. To fill this gap, the "HESPER-HEALTH study" conducted in humans will assess the vascular protective effects of 100% orange juice consumption and evaluate the contribution of hesperidin in these effects.

ReferenceCitation: Verny MA, Milenkovic D, Macian N, Pereira B, Evrard R, Gilcher C, Steingass CB, Mosoni P, Gladine C, Monfoulet LE, Schweiggert R, Pickering G, Morand C. Evaluating the role of orange juice, HESPERidin in vascular HEALTH benefits (HESPER-HEALTH study): protocol for a randomised controlled trial. BMJ Open. 2021 Nov 30;11(11):e053321. doi: 10.1136/bmjopen-2021-053321.


title: Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.

acronym: REVDOU

summary:
Marie Lannelongue Hospital is a hospital specialized in lung transplantation. Lung transplant patients require regular check-ups by bronchial fibroscopy. This examination is known to be anxious, stressful and sometimes painful. These patients take many medications (immunosuppressants, antibiotics....) that may interact with analgesic or anxiolytic drugs.

The objective is to propose to HML lung transplant patients a virtual reality solution containing visual and auditory 3D experiences to fight against anxiety and pain during repetitive and anxiogenic examinations such as bronchial fibroscopies.

Translated with www.DeepL.com/Translator (free version)

lead_sponsor: Centre Chirurgical Marie Lannelongue


title: Effect on the Quality of Life of a Therapeutic Education Program in Patients With Marfan Syndrome: an Observational, Prospective and Multicenter Study

acronym: MYLIFE

summary: This is a before-after, observational, prospective, multicenter cohort study. The study will consist of 2 phases: an initial observational phase of a minimum of 3 months before the Therapeutic Education Program (TEP) intervention, then a phase of evolution analysis of at least 3 months.

lead_sponsor: University Hospital, Toulouse


title: Efficacy of the Sit to Stand Test (STST) in the Decision to Hospitalize a Patient Consulting the Emergency Department for COVID 19 (Coronavirus Infectious Disease)

acronym: SITCOV

summary:
As part of the Coronavirus Infectious Disease 2019 (COVID19) pandemic, the hospital care system is facing a major strain. Patients with SARS-Cov2 (severe acute respiratory syndrome coronavirus 2 ) infection can worsen very quickly, possibly presenting, within hours, severe respiratory failure requiring urgent specialized care. Therefore, it is essential to develop emergency assessment tools to assess relevant criteria to decide which patients must be kept under hospital monitoring and which patients can be treated on outpatient care.

The aim of this study is to assess the efficacy of STST in the decision to hospitalize patients consulting emergency department for a SARS-Cov2 infection. The investigators wish to show that the addition of this test to the usual hospitalization criteria reduces the proportion of patients hospitalized 48 hours after their first visit to the emergency department.

primary_purpose: Screening

lead_sponsor: University Hospital, Rouen


title: A Retrospective Observational Study of Hernias Reparation in Patients Who Have Received a Kidney Transplant

acronym: HEREKT

summary: Correlation between hernias reparation in patients who have received a kidney transplant. The investigators will analyze the data of patients who have been treated for reparation of incisional hernia after kidney transplantation with or without the placement of a prosthesis.

lead_sponsor: University Hospital, Montpellier


title: Exploratory Study to Assess the Impact of a Cosmetic Product (Lactibiane Topic AD) on Skin Flora and Skin Reinforcement Barrier in Mild to Moderate Atopic Dermatitis

summary: This exploratory study aims to evaluate the impact of a cosmetic product (Lactibiane Topic AD) vs placebo on skin flora and skin reinforcement barrier in mild to moderate atopic dermatitis using biometrological, biological and clinical parameters.

lead_sponsor: PiLeJe

location_facility: Unité de Recherche Clinique en Immunologie - Lyon Sud


title: Evaluation of miRNAs in Endometriosis

acronym: ENDOmiARN

summary: We therefore propose a research project based on the prospective evaluation of miRNAs (blood and salivary) in patients with endometriosis diagnosed (by clinical examination and imaging) or suspected of endometriosis (clinical/radiological discordance) and in need of management in routine care (surgical or medical PMA) in the Endometriosis Expert Center Hospital.

lead_sponsor: Groupe expert en endometriose-6 centre expert en endometriose


title: Smartphone and Smartwatch Based ECG for Patients With Congenital Long QT Syndrome

acronym: SMART-QT

summary:
Congenital long QT syndrome (LQTS) is a rare genetic disorder characterized by prolongation of the corrected QT interval (QTc) on the electrocardiogram. LQTS is associated with a risk of syncope or sudden death from ventricular arrhythmia.

The increase in the duration of the corrected QT interval and / or changes in the morphology of the T wave on the electrocardiogram are markers of an increased risk of sudden death and syncope.

Recently, a personal portable 6-lead device (DI, DII, DIII, aVF, aVL and aVR) connected to the patient's smartphone has entered the market (KARDIA MOBILE 6L, AliveCor, Mountain View, CALIFORNIA, USA). The APPLE WATCH Series 6 (Apple, Cupertino, CA, USA) can also record an ECG. If the device is designed to record a single lead (DI), several works have shown that it is possible to record 9 leads (DI, DII, DIII, V1, V2, V3, V4, V5 and V6) by moving simply the device (Spaccarotella CAS et al. JAMA Cardiology 2020).

These devices were originally designed to screen for atrial fibrillation, but they produce accurate 6- and 9-lead ECGs and could potentially allow ambulatory ECG monitoring of patients with LQTS.

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of Motor-Related Beta-Activity in Relation to Naturalistic Movement in Healthy Adult Subjects

acronym: MOBETA

summary:
The whole body's voluntary movements are controlled by the brain. One of the brain areas most involved in controlling these voluntary movements is the motor cortex and it is often viewed as the primary 'output' region of the neocortex. Motor cortical activity in the beta frequency range (13-30Hz) is a hallmark signature of healthy and pathological movement, but its behavioral relevance remains unclear. Such uncertainty confounds the development of treatments for diseases of movement which are associated with pathophysiological beta activity, including Parkinson's, therefore furthering understanding on the behavioral significance of activity in this range is now vital. Recently, it has become apparent that oscillatory beta activity actually occurs in discrete transient bursts, and that the summation of short-lasting, high-powered bursts of activity only appear to be sustained oscillations when averaged over multiple trials.

In this study we will use neurophysiological and neuroimaging techniques such as electroencephalography (EEG), magnetoencephalography (MEG), and magnetic resonance imaging (MRI). All of these techniques have been identified as non-invasive techniques. By applying these methods, we will be able to analyze beta burst activity in order to determine how beta bursts influence naturalistic motor behavior.

This project also encompasses the study of auditory and motor interactions doing an experimental task.

The aim of the project is to get a better understanding of the role of motor-related beta activity during the preparation and generation of reach and grasp actions. These findings may inform novel treatments for pathophysiological disorders characterized by aberrant beta signaling, utilizing causal manipulation of the neural circuits implicated in the generation of beta activity. This project also has expected methodological repercussions. It will make it possible to validate the use of individualized head-casts worn during MEG acquisition for the study of the cortical control of naturalistic actions, and to create new analysis tools that allow an increase in the spatial resolution of MEG data.

location_facility: Institut des Sciences Cognitives, Marc Jeannerod, UMR 5229 CNRS


title: Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal: a Multicenter Randomized Controlled Trial

acronym: BIOPANS

summary: European guidelines recommend the use of cold snare polypectomy (CSP) for removal of diminutive colorectal polyps (DCP)(5 mm or less). However, for DCP < 4 mm cold biopsy forceps (CBF) may be optional. Moreover, CBF remains the endoscopist's technique of choice for polyp resection and CSP is associated with a failure of specimen retrieval for histology in up to 6.8% of cases. In this study, the investigators aimed to compare the efficacy of CSP with CBF for removal of DCP in routine colonoscopy

ReferenceCitation: Perrod G, Perez-Cuadrado-Robles E, Coron E, Pioche M, Becq A, Etchepare N, Danan D, Musquer N, Dray X, Laquiere A, Jais B, Broudin C, Benosman H, Cellier C, Rahmi G. Comparison of cold biopsy forceps vs cold snare for diminutive colorectal polyp removal: A multicenter non-inferiority randomized controlled trial. Clin Res Hepatol Gastroenterol. 2022 Mar;46(3):101867. doi: 10.1016/j.clinre.2022.101867. Epub 2022 Jan 14.

lead_sponsor: Gabriel RAHMI

location_facility: Hôpital Européen Georges Pompidou 20, rue Leblanc


title: First-in-human Pilot Study for the Safety Assessment of DXM Gel in Patients With Painful Lumbar Degenerative Disc Disease

acronym: DXM gel

summary: The purpose of this study is to assess the safety and the efficacy of an hydrogel (double cross-link microgel - DXM) injection into the intervertebral disc (IVD) space in patients with painful lumbar degenerative disc disease (DDD) over 24 to 48 weeks.

lead_sponsor: Gelmetix

location_facility: Polyclinique Bordeaux Nord Aquitaine Centre Vertebra


title: Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer

acronym: IMMUN VESSIE

summary:
Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence (60 to 70%) and progression (20 to 30%) to muscle-invasive bladder cancer (MIBC).

The local immunotherapy (intra-vesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor (TURBT)) reduces significantly the risk of recurrence and progression as compared to observation or to intra-vesical chemotherapy.

Systemic immunotherapy with programmed death ligand-1 (PD-L1) or Programmed cell Death 1 (PD1) inhibitors has shown major efficacy in the treatment of patients with advanced/metastatic urothelial carcinoma who have progressed on platinum-based regimens of chemotherapy, or even in front line setting. In the field of NMIBC, immunotherapy using PD-L1 or PD1 inhibitors is under investigation but the frequency of PD-L1 expression has rarely been precisely described in the different subtypes.

The aim of this retrospective study is to investigate the expression of PD-L1 by different types of NMIBC.

The secondary objective is to characterize the immune contexture of NMIBC.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Observatory of Psychiatric Symptoms and Their Somatic Causes in Urgent Medical Care (OPOSSUM)

acronym: OPOSSUM

summary:
Use of emergency department for psychiatric symptoms always addresses the question of a potential somatic cause to the symptoms. Despite the wide-spread use of standard biology test and systematic brain imaging (for a first episode), there are still up to 5% of patients sent in psychiatric wards that actually have a somatic explanation to their symptoms which induces an important delay in the diagnostic assessement We hypothesized that simple neurological clinical examination along with fast psychometric screening tests in the Emergency Room (ER) could help the physicians to better screen the patients and thus prevent inaccurate post-emergency orientation.

Every patient visiting the ER for psychiatric symptoms will be included. The usual physical examination by the ER physician will be associated with two psychometric tests (namely the Clock-drawing test and Frontal Assessment Battery test).

The follow up will be made after 3 months in order to have the final diagnosis. Neurological data and data from the FAB test and the Clock-drawing test will be compared between patients who were finally given a psychiatric diagnosis versus patients with a somatic diagnosis at the end of the follow up period.

location_facility: Service Accueil des Urgences, Hopital Edouard Herriot


title: COVID-19 and Pregnancy: Placental and Immunological Impacts

acronym: MaterCov

summary: The aim of this study is to compare placental pathologies in patients with COVID 19 infection at the time of childbirth or a history of COVID 19 during pregnancy versus control patients

lead_sponsor: Hopital Foch


type: Registry Identifier

title: Pertinence Clinique de l'échographie Thoracique Pour le Diagnostic précoce de la Pneumopathie Interstitielle Diffuse de la sclérodermie systémique - Etude Pilote

acronym: PRECOSS

summary:
Diffuse interstitial lung disease (PID) is the leading cause of death in systemic scleroderma (SSc). Major progress has recently been made in its therapeutic management. Early diagnosis is essential to optimize this management. Current diagnostic techniques are based on high-resolution computed tomography on the thorax (HRCT) and pulmonary functional tests (PFT). However, these explorations have their limitations. Thus, there is a need for new techniques for a very early diagnosis of PID-SSc.

Thoracic ultrasound (TUS) is an innovative, easily accessible, non-irradiating, inexpensive and painless tool. It is an emerging technique for the diagnosis of PID and has already proven its sensitivity for the detection of interstitial damage, as defined by HRCT.

The main objective of the PRECOSS study is to describe the prevalence of an ultrasound interstitial syndrome in patients with SSc, free of PID-SSc (defined by the Goh criteria) detectable by HRCT.

lead_sponsor: University Hospital, Tours


title: Relevance of the Activ'Dos App for Chronic Low Back Pain Patients - Randomized Trial

acronym: ACTIV'DOS

summary: The purpose of this study is to compare a self rehabilitation program using ACTIV'DOS app versus using a standard sheet of paper.

lead_sponsor: University Hospital, Brest