title: Divided Drug Delivery : a Way to Prevent Repeated Volutary Drug Intoxications.

summary: This study will evaluate the efficacy of an advice with a weekly divided drug delivery, compared to an usual monthly delivery in the prevention of voluntary drug intoxications repeated.

ReferenceCitation: Alonso J, Angermeyer MC, Bernert S, Bruffaerts R, Brugha TS, Bryson H, de Girolamo G, Graaf R, Demyttenaere K, Gasquet I, Haro JM, Katz SJ, Kessler RC, Kovess V, Lépine JP, Ormel J, Polidori G, Russo LJ, Vilagut G, Almansa J, Arbabzadeh-Bouchez S, Autonell J, Bernal M, Buist-Bouwman MA, Codony M, Domingo-Salvany A, Ferrer M, Joo SS, Martínez-Alonso M, Matschinger H, Mazzi F, Morgan Z, Morosini P, Palacín C, Romera B, Taub N, Vollebergh WA; ESEMeD/MHEDEA 2000 Investigators, European Study of the Epidemiology of Mental Disorders (ESEMeD) Project. Psychotropic drug utilization in Europe: results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatr Scand Suppl. 2004;(420):55-64.

ReferenceCitation: Aouba, A., Péquignot, F., Camelin, L., Laurent, F., Jougla, E. La mortalité par suicide en France en 2006. Etudes et résultats. 2009 ; (702) : 1-8.

ReferenceCitation: Beck, F., Guignard, R., Du Roscoät, E., Saïas, T. Tentatives de suicide et pensées suicidaires en France en 2010. Bulletin épidémiologique hebdomadaire. 2011 ; 47-48 : 488-492.

ReferenceCitation: Camidge DR, Wood RJ, Bateman DN. The epidemiology of self-poisoning in the UK. Br J Clin Pharmacol. 2003 Dec;56(6):613-9.

ReferenceCitation: Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge: 24-month outcomes of a randomised controlled trial for hospital-treated self-poisoning. Br J Psychiatry. 2007 Dec;191:548-53.

ReferenceCitation: Chan-Chee, C., & Jezewski-Serra, D. Hospitalisations pour tentatives de suicide entre 2004 et 2007 en France métropolitaine. Analyse du PMSI-MCO. Bulletin épidémiologique hebdomadaire. 2011 ; 47-48 : 492-496.

ReferenceCitation: Coben JH, Davis SM, Furbee PM, Sikora RD, Tillotson RD, Bossarte RM. Hospitalizations for poisoning by prescription opioids, sedatives, and tranquilizers. Am J Prev Med. 2010 May;38(5):517-24. doi: 10.1016/j.amepre.2010.01.022. Erratum in: Am J Prev Med. 2010 Dec;39(6):613.

ReferenceCitation: Dumesnil, S., Grandfils, N., Le Fur, P., Mizrahi, A. Mizrahi, A. Santé, Soins et protection Sociale en France en 1996. CREDES (en ligne). Novembre 1997, (consulté le 3/4/12).

ReferenceCitation: Fedyszyn IE, Harris MG, Robinson J, Edwards J, Paxton SJ. Characteristics of suicide attempts in young people undergoing treatment for first episode psychosis. Aust N Z J Psychiatry. 2011 Oct;45(10):838-45. doi: 10.3109/00048674.2011.595687. Epub 2011 Aug 23.

ReferenceCitation: Florentine JB, Crane C. Suicide prevention by limiting access to methods: a review of theory and practice. Soc Sci Med. 2010 May;70(10):1626-32. doi: 10.1016/j.socscimed.2010.01.029. Epub 2010 Feb 12. Review. Erratum in: Soc Sci Med. 2010 Dec;71(11):2046.

ReferenceCitation: Fournet, N., Caillère, N., Fouillet, A., Caserio-Schönemann, C., Josseran, L. Le système français de surveillance sanitaire des urgences et des décès (Sur-SaUD®). Saint-Maurice : Institut de veille sanitaire : 2011. 12p.

ReferenceCitation: Gasquet I, Nègre-Pagès L, Fourrier A, Nachbaur G, El-Hasnaoui A, Kovess V, Lépine JP. [Psychotropic drug use and mental psychiatric disorders in France; results of the general population ESEMeD/MHEDEA 2000 epidemiological study]. Encephale. 2005 Mar-Apr;31(2):195-206. French.

ReferenceCitation: Hovda KE, Bjornaas MA, Skog K, Opdahl A, Drottning P, Ekeberg O, Jacobsen D. Acute poisonings treated in hospitals in Oslo: a one-year prospective study (I): pattern of poisoning. Clin Toxicol (Phila). 2008 Jan;46(1):35-41. doi: 10.1080/15563650601185969.

ReferenceCitation: Kapur N, Cooper J, Hiroeh U, May C, Appleby L, House A. Emergency department management and outcome for self-poisoning: a cohort study. Gen Hosp Psychiatry. 2004 Jan-Feb;26(1):36-41.

ReferenceCitation: Lamprecht HC, Pakrasi S, Gash A, Swann AG. Deliberate self-harm in older people revisited. Int J Geriatr Psychiatry. 2005 Nov;20(11):1090-6.

ReferenceCitation: Large MM, Nielssen OB. Suicide in Australia: meta-analysis of rates and methods of suicide between 1988 and 2007. Med J Aust. 2010 Apr 19;192(8):432-7. Review.

ReferenceCitation: Le Pont F, Letrilliart L, Massari V, Dorléans Y, Thomas G, Flahault A. Suicide and attempted suicide in France: results of a general practice sentinel network, 1999-2001. Br J Gen Pract. 2004 Apr;54(501):282-4.

ReferenceCitation: Manchikanti L, Whitfield E, Pallone F. Evolution of the National All Schedules Prescription Electronic Reporting Act (NASPER): a public law for balancing treatment of pain and drug abuse and diversion. Pain Physician. 2005 Oct;8(4):335-47.

ReferenceCitation: Mann JJ, Apter A, Bertolote J, Beautrais A, Currier D, Haas A, Hegerl U, Lonnqvist J, Malone K, Marusic A, Mehlum L, Patton G, Phillips M, Rutz W, Rihmer Z, Schmidtke A, Shaffer D, Silverman M, Takahashi Y, Varnik A, Wasserman D, Yip P, Hendin H. Suicide prevention strategies: a systematic review. JAMA. 2005 Oct 26;294(16):2064-74. Review.

ReferenceCitation: Mateos Rodríguez, A.A, Huerta Arroyo, A., Benito Vellisca, M.A. The epidemiology of suicide attempts using drugs. Emergencias. 2007 ; 19 : 251-254.

ReferenceCitation: Mauri MC, Cerveri G, Volonteri LS, Fiorentini A, Colasanti A, Manfré S, Borghini R, Pannacciulli E. Parasuicide and drug self-poisoning: analysis of the epidemiological and clinical variables of the patients admitted to the Poisoning Treatment Centre (CAV), Niguarda General Hospital, Milan. Clin Pract Epidemiol Ment Health. 2005 Apr 28;1(1):5.

ReferenceCitation: Michel, G., Aquaviva, E., Aubron, V., Purper-ouakil, D. Suicides : mieux comprendre, pour prévenir avec plus d'efficacité. In : Beck F, Guilbert P, Gautier A (dir). Baromètre santé 2005. Saint-Denis : Inpes. 2007 ; 487-506.

ReferenceCitation: Mouquet, M.C., & Bellamy, V. Suicides et tentatives de suicide en France. Etudes et Résutlats. 2006 ; 488 :1-8.

ReferenceCitation: Nordentoft M. Prevention of suicide and attempted suicide in Denmark. Epidemiological studies of suicide and intervention studies in selected risk groups. Dan Med Bull. 2007 Nov;54(4):306-69. Review.

ReferenceCitation: Owens D, Horrocks J, House A. Fatal and non-fatal repetition of self-harm. Systematic review. Br J Psychiatry. 2002 Sep;181:193-9. Review.

ReferenceCitation: Prescott K, Stratton R, Freyer A, Hall I, Le Jeune I. Detailed analyses of self-poisoning episodes presenting to a large regional teaching hospital in the UK. Br J Clin Pharmacol. 2009 Aug;68(2):260-8. doi: 10.1111/j.1365-2125.2009.03458.x.

ReferenceCitation: Rodríguez, A.A.M., Arroyo, A.H., and Vellisca, M.A.B. (2007). The epidemiology of suicide attempts using drugs. Emergencias. 2007 ; 19 : 251-254.

ReferenceCitation: Saviuc, P., Bedry, R., Flesch, F. Epidémiologie des intoxications médicamenteuses volontaires. Médecine Thérapeutique. 1999; 5(1): 45-8.

ReferenceCitation: Staikowsky F, Theil F, Candella S. [Trends in the pharmaceutical profile of intentional drug overdoses seen in the emergency room]. Presse Med. 2005 Jul 2;34(12):842-6. French.

ReferenceCitation: Simoni-Wastila L, Tompkins C. Balancing diversion control and medical necessity: the case of prescription drugs with abuse potential. Subst Use Misuse. 2001 Jul-Aug;36(9-10):1275-96.

ReferenceCitation: Theil, F. Evolution qualitative des médicaments incriminés dans les intoxications médicamenteuses sur une période de 10 ans. Créteil (Paris XII). 64 pages. 2007. (Thèse de médecine).

ReferenceCitation: Tournier M, Grolleau A, Cougnard A, Molimard M, Verdoux H. Factors associated with choice of psychotropic drugs used for intentional drug overdose. Eur Arch Psychiatry Clin Neurosci. 2009 Mar;259(2):86-91. doi: 10.1007/s00406-008-0839-2. Epub 2008 Sep 19.

ReferenceCitation: Vaiva G, Vaiva G, Ducrocq F, Meyer P, Mathieu D, Philippe A, Libersa C, Goudemand M. Effect of telephone contact on further suicide attempts in patients discharged from an emergency department: randomised controlled study. BMJ. 2006 May 27;332(7552):1241-5.

ReferenceCitation: Vlad IA, Fatovich DM, Fenner SG, Daly FF, Soderstrom JH, Burrows SA. Patient perceptions of the potential lethality associated with deliberate self-poisoning. Emerg Med Australas. 2011 Oct;23(5):580-6. doi: 10.1111/j.1742-6723.2011.01434.x. Epub 2011 Jun 15.

lead_sponsor: University Hospital, Grenoble


title: Impact of a Training-action About Projects Leading for the Improvement of Care Quality in Managing Practice of Health Executive

acronym: ImpactFA

summary: The present study focuses on the quality of care and how the health executives can bring it to a central place in their management. A training-action has been set-up at the Health Executive training institute (University Hospital Grenoble) to improve care quality. Reports prepared by students (tutored projects) related to operational diagnosis and action plans about care quality improvement are given to health executives. The objective is to evaluate how the health executive will use the tutored project to improve care quality and set-up actions.The hypothesis is that the health executive will use the tutored project to improve project management.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Institut Paoli Calmettes Thyroid Cancer Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with thyroid cancer

status: Recruiting

ipd_sharing: No

lead_sponsor: Institut Paoli-Calmettes

status_simplified: Ongoing


title: Institut Paoli Calmettes Breast Cancer Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with breast cancer

ReferenceType: derived

ReferenceCitation: Houvenaeghel G, de Nonneville A, Cohen M, Chopin N, Coutant C, Reyal F, Mazouni C, Gimbergues P, Azuar AS, Chauvet MP, Classe JM, Daraï E, Martinez A, Rouzier R, de Lara CT, Lambaudie E, Barrou J, Goncalves A. Lack of prognostic impact of sentinel node micro-metastases in endocrine receptor-positive early breast cancer: results from a large multicenter cohort(☆). ESMO Open. 2021 Jun;6(3):100151. doi: 10.1016/j.esmoop.2021.100151. Epub 2021 May 10.


title: Institut Paoli Calmettes Prostate Cancer Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with prostate cancer


title: Institut Paoli-Calmettes Pancreatic Neoplasms Database

summary: Database of Institut Paoli Calmettes diagnosed with Pancreatic neoplasms


summary: Database of Institut Paoli-Calmettes patients diagnosed with ovarian cancer


title: Institut Paoli Calmettes Multiple Myeloma Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with multiple myeloma


summary: Database of Institut Paoli-Calmettes patients diagnosed with lymphoma


title: Institut Paoli Calmettes Chronic Lymphatic Leukemia Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with chronic lymphatic leukemia


title: Institut Paoli Calmettes Acute Leukemia Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with Acute Leukemia


title: Institut Paoli Calmettes Colorectal Cancer Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with colorectal cancer


summary: Database of Institut Paoli-Calmettes patients diagnosed with cervical cancer


title: Institut Paoli Calmettes Cardia Cancer Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with cardia cancer


title: TUDY OF THE EXPRESSION OF CIRCULATING AND INTRA-TUMORAL

acronym: CHEMOPROST

summary: Multicentric, observational, prospective, non-interventional study with occasional biological sample collection (serum bank, urine bank and tumor bank)

lead_sponsor: Institut Bergonié

lead_sponsor_type: industriel


title: Interest of the Injection of Morphine, in Addition to a Local Anesthetic When Performing a Combined Spinal-epidural for Labor Analgesia

acronym: MASEA

summary: The addition of morphine to a local anesthetic when performing an epidural analgesia during labor analgesia has improved the efficiency and the action duration of analgesia. One limitation of this technique is the time of installation of the analgesic effect (about 30 minutes) when using the only epidural. Therefore, the technique of sequential combined spinal epidural was introduced. This is to shorten the installation time by direct injection into the cerebrospinal fluid. This allows a good efficiency in less than 10 minutes. It has been shown that low doses of sufentanil (strong opioid) in spinal anesthesia could potentiate the effect of the local anesthetic.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: CHU de Reims

intervention_type: Drug

status_simplified: Completed


title: Interest of Serum Periostin Dosage in Patients With Bone Fibrous Dysplasia

acronym: PERIOSTINE

summary: Fibrous dysplasia is a rare bone disease which can cause pain and fractures. It has been shown that periostin is over expressed in fibrous component in patients bones ; but periostin has never been measured out in serum of patients, although it is easy to assess. This study aims to show whether serum periostin is elevated in serum of patients with fibrous dysplasia, and if it is more elevated in patients with severe forms of the disease.

study_start_date_type: Actual

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de rhumatologie Pavillon F - Hôpital Edouard Herriot

intervention_type: Biological


title: Binge Eating Disorder and Obesity : Reward System Abnormalities in Response to Food Stimuli and Research Operability by Deep Brain Stimulation Criteria: Functional MRI Study

acronym: BED

summary: Obesity, defined as BMI> 30kg / m2, is a major public health problem, with devastating medical and psychological consequences. 30% of obese suffer from BED type of eating disorders. The optimal treatment of obesity remains bariatric surgery, failed in 20% of cases. Many arguments are in favor of the involvement of the reward circuitry, with the central role of NAc in the pathophysiology of BED and obesity. The recent application and effectiveness of DBS (Deep Brain Stimulation) in refractory psychiatric disorders suggest that DBS may be of interest in treating obesity and BED with potential target for the NAc. This project propose to study fMRI activation of the reward system in response to food stimuli to better direct the DBS targets. This is a pilot study to define indication criteria based on fMRI to obese BED patients are potential candidates for treatment with DBS.

ReferenceCitation: Charroud C, Poulen G, Sanrey E, Menjot de Champfleur N, Deverdun J, Coubes P, Le Bars E. Task- and Rest-based Functional Brain Connectivity in Food-related Reward Processes among Healthy Adolescents. Neuroscience. 2021 Mar 1;457:196-205. doi: 10.1016/j.neuroscience.2021.01.016. Epub 2021 Jan 21.

ReferenceCitation: Charroud C, Menjot de Champfleur N, Sanrey E, Pfeuffer J, Deverdun J, Le Bars E, Coubes P. Differential effects of hunger on cerebral blood flow in healthy adolescents. Behav Brain Res. 2020 Apr 6;383:112505. doi: 10.1016/j.bbr.2020.112505. Epub 2020 Jan 23.

lead_sponsor: University Hospital, Montpellier


type: Other Identifier

acronym: MENINGITE

summary: The primary purpose of this study is to assess the contribution of a non-invasive sampling (pharyngeal swab) in the diagnosis of community based meningitis or meningo-encephalitis.

primary_purpose: Diagnostic

ipd_sharing: Undecided

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Assessment of Pharyngeal Carriage of Microorganisms Responsible for Transmissible Acute Respiratory Infections in HAJJ Pilgrims

acronym: EMIRATH

summary:
The objective of this project is to study the prevalence of viruses and bacteria responsible for transmissible acute respiratory infections in the respiratory tract of pilgrims returning from the trip. The patients included, will be the consultant pilgrims to the traveler health center, and before leaving for Hajj. Based on the results obtained in previous studies, it is estimated that 200 pilgrims will be included each year, 600 in total (inclusion period of 3 years). Respiratory secretions are then collected by nasal swab and throat (swab) prior to departure for the hajj. In return, patients will be reconvened systematic consultation to record medical events potentially encountered during the trip, and it will again be performed the same nasal swabs and throat. It will then be performed on these samples' return from hajj "molecular detection (PCR and RT-PCR) of 35 viruses and bacteria respiratory tropism: influenza (3), RSV (2), metapneumovirus (1), Coronavirus (4), Parainfluenzavirus (4), enteroviruses (4), rhinovirus (1), adenovirus (6) bocavirus, polyomavirus (2), pneumococcus, Bordetella pertussis, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Haemophilus influenzae, Neisseria meningitidis and Coxiella burnetii. Samples "return of hajj" positive should be cultured for the isolation of the strain. For patients positive return, it will be done further research of these 35 viruses and bacteria on samples "start of hajj," the same method described above. In addition to this systematic consultation, and if symptoms return, the pilgrims will be seen in consultation for a diagnosis evaluation and therapeutic management.

This study will shed light on the acquisition of microorganisms respiratory tropism during the stay and on the potential risks associated with the circulation of these pathogens after the trip.


acronym: WHIPPLE

summary:
In 2012, a previous work showed that T. whipplei is a common bacterium detected in various situations. A large part of the population is therefore exposed to a T. whipplei but there is that some people probably with immunological and genetic factors predisposing which develop a disease. The association teams with experience in HLA-typing will allow us to better identify patients with a risk of chronic complication.

The main aim of this study is to evaluate if the HLA-DRB13 and/or HLA-DQB106 typing in patients are risk factors of chronic infection with T. whipplei (defined by classic Whipple disease and/ or, endocarditis and/or encephalitis).

location_facility: Assistance Publique Hôpitaux de Marseille


title: Determinants of Health Status and Quality of Life in Patients With Primary Immunodeficiencies Inhereted Diagnosed During Childhood

acronym: CEREDIH

summary:
Background: Most children with primary immune deficiency (PID) now reach adulthood. However, few studies have evaluated their health status and health related quality of life (HRQoL).

Objective: To investigate long-term morbidity, the French Reference Center for PIDs initiated a prospective multicenter cohort: the F-CILC (French Childhood Immune deficiency Long-term Cohort). The data collected will be used to assess the physical health condition of patients who reached adulthood and the impact on their quality of life.

Methods: Patients are asked to complete health status questionnaires. A severity score (grade1 ["mild"] to grade 4 ["life-threatening"]) is assigned to each health condition. The HRQoL of patients is compared to age- and sex-matched French normal values using the SF36 HRQoL questionnaire.

Capsule summary. This will be the first study of adult survivors of childhood PID describing how the burden of health conditions affect their quality of life.

ReferenceCitation: Barlogis V, Mahlaoui N, Auquier P, Fouyssac F, Pellier I, Vercasson C, Allouche M, De Azevedo CB, Moshous D, Neven B, Pasquet M, Jeziorski E, Aladjidi N, Thomas C, Gandemer V, Mazingue F, Picard C, Blanche S, Michel G, Fischer A. Burden of Poor Health Conditions and Quality of Life in 656 Children with Primary Immunodeficiency. J Pediatr. 2018 Mar;194:211-217.e5. doi: 10.1016/j.jpeds.2017.10.029. Epub 2017 Dec 6.


acronym: SCHIFT

summary:
Quality of life (QoL) measurements have become an important way to evaluate the treatments and care provided to patients with schizophrenia. Understanding determinants of QoL in schizophrenia is of importance for developing effective interventions that would improve patient functional and subjective well-being. A challenge in the interpretation of QoL measures, especially in longitudinal studies, is that QoL is self-reported by the patient and might be influenced by psychological phenomena such as adaptation to illness. An important mediator of this adaptation process is a "response shift" (RS), which involves changing internal standards, values and the conceptualization of QoL. RS can be divided into three phases 1) reconceptualization (i.e., a redefinition of QoL), 2) reprioritization (i.e., a change in the importance attributed to component domains constituting QoL) and 3) recalibration (i.e., a change in a patient's internal standards of measurements). Patients may change their frame of reference, rendering scores from different measurement occasions incomparable. An RS is a potential explanation when the QoL of an individual who has experienced a serious health event or chronic condition is similar to the QoL of a healthy individual. With an RS, the concept of QoL changes over time and cannot be compared longitudinally because of changes in internal standards, values, and/or concepts. True change may be over- or underestimated when a RS is present, leading to biased estimates of the magnitude of change.The objective is to examine whether a response shift, a change in the internal standards of a patient, occurs in patients suffering from schizophrenia and in their caregivers.

This is a monocentric and propective design study, with inclusion of patients and caregivers on a 12-month period, and a follow up on a 12-month period.

100 patients with schizophrenia and 100 caregivers

Test approach (Response shift (RS) (pre-test - then-test), unadjusted effect (post-test - pre-test), and adjusted effect (post-test - then-test scores)) will be completed with other statistical approaches such as confirmatory factorial analysis, multilevel models and CART method.

primary_purpose: Supportive Care

intervention_type: Behavioral


acronym: REPERM-OCT

summary: The treatment of neovascular age-related macular degeneration (ARMD) is a major issue of public health. The therapeutic arsenal has widely grown throughout the years with the emergence of intra-vitreous anti-angiogenic treatments, under different surveillance protocols. The "PRN" surveillance (pro re nata: an on-demand treatment with monthly follow-up) allows a faster re-injection in case of neovascular relapse in order to maintain the best visual acuity. This therapeutic protocol is guided by the sub-retinal neovascular signs of activity. The monitoring is done during common practice via OCT B scans showing indirect signs of neovascular activity (exudation signs). OCT retinal imaging has been recently enriched with new programs allowing the visualization of sub-retinal neovessels without the use dyes (OCT angiography). The OCT angiography is automatically done by a program using standard OCT sections. During the monitoring of a patient using the OCT A, the signs of renewed neovascular activity are represented by an "arterialization" or the development of an arteriole network of the neovessel with the reappearance of a hyper reflective flow after a neovascular regressive phase. Indeed, the visualization of neovessels during the monitoring by Angio-OCT may lead to therapeutical modifications (anticipation of the injections). Knowing that the injection time-table of ARMD patients treated with anti-angiogenics is determined by sub-retinal neovascular signs of activity. This activity is evaluated during routine clinical practice by very specific signs, observable on OCT B scans. The hypothesis of this study is that the search of activity sins on the Angio-OCT, a new technic of image analysis performed on the OCT, may modify this injection time-table, with an impact of the patient's visual acuity.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rotchschild

intervention_type: Device


acronym: Botox shoulder

summary:
Botulinum toxin is used in musculoskeletal therapy routinely for 15 years. This is one of the most potent neurotoxins. It comes in 7 serotypes (A to G).Therapeutic application of botulinum toxin are mainly based on its ability to block the neuromuscular transmission by preventing the release of acetylcholine, creating paralysis muscle relative and reversible.

It has been used in the treatment of cervical dystonia, migraine headaches, and an antinociceptive effect. The analgesic effect occurred even prior to the release muscular. Several randomized studies have been published about it. The investigators assume that intramuscular injection of botulinum toxin is effective in the treatment of tendinopathy rotator cuff.

lead_sponsor: Versailles Hospital


title: Multiple Fields Radiotherapy Versus Intravenous Rituximab in the Treatment of Indolent Cutaneous Lymphomas B-cell With Multiple or Recurrent Lesions

acronym: RADIO-LYMPH

summary:
Cutaneous lymphomas are the most frequent extranodal lymphomas after digestive lymphomas. A quarter are B-cell lymphomas. 80% of cutaneous B cell lymphomas are indolent cutaneous B cell lymphomas. These indolent cutaneous B cell lymphomas are characterized by good prognosis (survival rate at 5 years: 90%), but also by the frequency of cutaneous recurrences. The radiotherapy is currently the most widely used treatment, with complete response rate close to 100% for a lesion treated. However, it has limits when there are outset multiple lesions inaccessible to a single radiotherapy field (concerning one case in three), or during recurrences. In these situations, conventional chemotherapy is not recommended and multi-field radiotherapy is often used empirically, but its effectiveness has never been studied prospectively.

Recently, retrospective studies with small numbers patients (totaling sixty patients) reported complete response rates of 80 to 100% with rituximab (anti-cluster of differentiation antigen 20 (CD20) antibodies) used as monotherapy in non-standardized treatment by intravenous with a recurrence rate of less than one case in three. These data suggest that rituximab by intravenous with a standardized initial cycle followed by a maintenance therapy could improve the prognosis of indolent cutaneous B cell lymphomas with multiple lesions or of recurrent lesions.

intervention_type: Radiation


title: Comparison of Endoscopy and Diffusion-weighted Enterography-MRI for the Diagnosis of Crohn's Disease Recurrence Following Ileocolic Resection: a Pilot Study

acronym: MRI-CROHN

summary:
Nearly three-quarters of patients with Crohn's disease have small bowel involvement and 80% of them will have complications that will require a surgical procedure, usually an ileocolonic resection with ileocolonic anastomosis. The rate of recurrence at the anastomosis site and in the ileum after surgery, whether symptomatic or not, is high, at least 60% in one year and 80% within three years. The gold standard for monitoring being ileocolonoscopy, endoscopic surveillance is recommended in these patients, once between 6 to 12 months after surgery and then every 2 years.

The MRI enterography is a validated technique for the assessment of small bowel Crohn's disease. The enterography MRI is a validated technique for the assessment of small bowel Crohn's disease. The MRI enteroclysis was evaluated in two studies compared to endoscopy, with excellent performance in terms of recurrence detection sensitivity and suggested as an alternative to it to avoid an invasive procedure repeated in these patients. The MRI enterography (without enteroclysis) does not provide as good distension of the bowel loops as MRI enteroclysis because it relies on the principle of oral ingestion prior to the examination of large amounts of liquid. However, it is much better tolerated by the patient, does not involve radiation that exists with enteroclysis, is much simpler to use and requires no special equipment to magnetic fields.


title: Prospective Constitution of Database Gathering Data of Patients Suffering From Glaucoma Followed at University Hospital of Grenoble

summary: Few publications provide information on the natural history of glaucoma, outside of clinical trials do not always reflect what is observed in common situation for various reasons (specific selection criteria and sometimes restrictive, stronger motivations patients and physicians to comply with follow-up visits and prescribed treatments, etc.). Therefore, much information on the natural history of glaucoma are unknown to date (degradation rate of visual field and visual function over time, risk of blindness in the years following diagnosis, effects of various treatments to reduce intraocular pressure and preserving visual field deterioration, etc.). Obtaining such important data to improve the management of glaucoma patients (choice of treatment methods, identification of predictors of rapid change that can make choosing more aggressive treatment and more regular monitoring, etc.) requires the establishment of cohort of patients followed and treated with the methods usually used in current practice, and besides therapeutic trial.

status: Active, not recruiting


title: Physical Activity in Patients With Cancer: Epidemiological Study of Patients' Beliefs and Promotional Messages Efficiency

acronym: RESCA

summary:
Study 1:

The investigator hypothesizes that the level of knowledge about the benefits of physical activity, physical activity level and physical fatigue level observed in cancer patients, would influence their beliefs about physical activity and their intention to engage in AP.

lead_sponsor: Centre Antoine Lacassagne


title: Information Consultation by a Manipulator Radiotherapy: Impact on Information to Patients Treated With Radiotherapy for Cancer

acronym: INFORTH

summary:
The medical teams are increasingly sought by patients to get the most possible information, probably expressed in a different form and thereby supplementing the information already received. Coulter et al. reached similar conclusions in their study of the writings of patient information documents. They point out, moreover, the best adaptation of the patients better informed compared to those with less or no information.

This need for information varies over time. It is present before treatment begins, continues during treatment and persists after treatment. Given the specific features of radiotherapy, the manipulators are important interlocutors to participate in the accompanying caregiver time.

In conclusion, the quality of information delivered to the patient has been poorly evaluated, let alone with validated tools in this area.

The impact of information on the tolerance of the treatment also needs to be confirmed, knowing that an informed patient seems less anxious and better prepared for future treatment.


title: PHASE II STUDY : Hypofractionated Radiation by CyberKnife as a Mean of Radiation of the Tumor Site After Conventional Breast Radiation.

acronym: CYBERBOOST

summary:
The CyberKnife (CK) has been developed recently. This is a linear accelerator carried by an industrial robot. It has, due to its tumor tracking capabilities and high accuracy, an interest in irradiation (boost) of tumor site after conventional irradiation. The radiation boost is currently issued by electrons, protons or brachytherapy. These techniques require several fractions and are associated with cutaneous toxicities and aesthetic problems. CK has an interest in reducing the number of fractions and a reduction of dose delivered to the skin.

CK has been used in a phase I protocol (CYBERNEO) with concomitant chemotherapy for inoperable breast tumors and has proven its effectiveness and safety of treatments.

The investigator is considering conducting a Phase II protocol to a single dose of 8 Grays issued by CK for boost to the tumor site after conventional breast irradiation.

The results, in terms of local control, will be evaluated on clinical monitoring.


title: Phase I Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer

acronym: PROSTIRNA

summary:
This is a single site, open-label, non-randomized, dose escalation phase I study designed to evaluate the safety, the tolerability and the Recommended Phase II Dose (RP2D) of SXL01, a synthetic small interfering ribonucleic acid (RNA) targeting the androgen receptor messenger RNA (mRNA), in patients with metastatic castration-resistant prostate cancer.

A standard method "3+3" will be used for dose escalation. A maximum of 30 patients will complete the dose-escalation phase of the study; 12 additional patients will be included at the RP2D in the expansion phase.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Institut Claudius Regaud


title: Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy

acronym: BioConnect

summary:
Patients should receive a chemotherapy regimen with an overall risk of febrile neutropenia ≥ 20%. The use of the web-application their will be proposed .

They will be informed of the risk of neutropenia, fever and bleeding which may occur beyond the fifth day of each chemotherapy cycle (to eliminate fevers related to treatment).

The temperature measurement is performed at home by an infrared forehead thermometer provided as part of the study, in a systematic manner once daily at the same time of day and in case of unexplained fatigue or chills.

Before any fever reported to the physician via the web-application (alert), a questionnaire will be completed by the patient to the search for gravity criteria to assess his condition at home. The patient will be hospitalized immediately if it shows signs of severity in order to document the infection and provide intravenous antibiotics adapted to the clinical condition; in the absence of these signs, the patient will make a count to the nearest lab and will receive oral antibiotics if indicated. The subsequent strategy will be defined by the web-application algorithm to optimize the care of patients.

The ability to use a web-application could allow early detection of complications of post-chemotherapy haematological toxicity and offer a taking over guided by a decision-making algorithm managed by the physician.

The aim is to favour the taking over at home.

status: Terminated

lead_sponsor: Institut Cancerologie de l'Ouest


title: Prevalence and Factors Associated With the Occurrence of Depression Six Months After an Endovascular Treatment of Intracranial Aneurysm

acronym: DEP-AIC

summary:
During the last decade, the embolization has become the treatment of choice for ruptured intracranial aneurysms, to improve the neurological outcome of patients. At the same time, for his safety, she also became the technique allowing prophylactic treatment of unruptured intracranial aneurysms discovered incidentally during imaging exams.

Regarding patients with ruptured intracranial aneurysms, patients who survive often have a reduced quality of life while one in two has a good neurological outcome after embolization. Depression, anxiety and fatigue, whose the psycho-social impact is important, are often cited. This description has often been done without considering the realized type of treatment (surgery or embolization) and mostly of neurological and functional status of the patient remotely (disability or not in daily activities).

Regarding patients with unruptured intracranial aneurysms, they are mostly asymptomatic and embolization is programmed. They would present an cognitive impairment in one case in five at 1 month of treatment.

If depression, fatigue and difficult return to working life are logically found in patients with severe sequelae (disability in daily activities) of their ruptured intracranial aneurysms, the question arises for patients with a ruptured intracranial aneurysms with a favorable evolution and for asymptomatic patients with unruptured intracranial aneurysms.

A precise status of these populations is necessary, especially as the discovery and treatment of their intracranial aneurysms is often early (between 40 and 60 years) and that their good neurological status should allow "a priori" to return easily at the active life.

primary_purpose: Basic Science


title: Assessment of the Efficacy and Tolerance of Sub-cutaneous Re-injection of Autologous

acronym: REGENDER

summary:
Diabetic foot ulcer (DFU) is a major complication and the leading cause of hospitalization among people with diabetes mellitus. It occurs in 15% of all patients with diabetes and precedes 84% of all lower leg amputations. Despite many therapeutic advances over the past decades, including dressings (hydrocolloids, alginate, skin substitutes) and growth factors, healing rates of DFU remain low.

Mechanisms of faulty wound healing in diabetic patients are complex, related to both intrinsic and extrinsic factors. The main reasons for impaired healing appears to be: 1/exhaustion of local cell populations that promote wound healing; 2/excessive production of matrix metalloproteases (MMPs) coupled with reduced expression of the tissue inhibitors of MMPs; 3/impaired neovascularisation coupled with reduced numbers of endothelial progenitor cells and impairment of their functioning. These imbalances may result in excessive degradation of extracellular matrix components, as well as an inappropriate local inflammatory response .

Adipose-derived stroma vascular fraction provides a rich and easily accessible source of autologous cells for regenerative medicine applications. Il contains multipotent stem cells and progenitors called adipose-derived regenerative cells (ADRCs) able to stimulate wound healing. There are attracted to the wound site where they supplement the wound bed with similar cell types, secrete numerous growth factors and cytokines, increase macrophage recruitment, enhance granulation tissue, and improve vascularisation . The reparative capabilities coupled with good safety of ADRCs have been illustrated in a study for treating severe and irreversible radiation-induced lesions, and in a study for treating sclerodactyly in patients with diffuse scleroderma. Numerous case reports showing healing of refractory wounds following treatment with autologous ADRCs have also been reported.

Based on these previous reports, the present study aims to assess the efficacy and tolerance of injection of ADRCs for the local treatment of neuropathic or neuro-ischemic DFU.

status: Not yet recruiting


acronym: SCLERADECIII

summary:
Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis. As a result, patients suffer from everyday disability, with consequences on their occupational activities and social contact, sometimes severely altering their quality of life. To date, no anti-fibrosis treatment has proven effective; existing vasodilation treatments are unfortunately not very effective, and are associated with adverse effects or restrictions. It is consequently of utmost importance that an effective treatment for sclerodermic hands be developed. The injection of adipose autologous tissue is a common practice in plastic surgery, and has been known for over a century. Adipose tissue, originally used to increase volume, is also characterized by trophic properties associated to stromal vascular fraction (SVF), which contain multipotent stem cells, capable of tissue repair. Interestingly, some SVF cells can be angiogenic and anti-inflammatory, which could improve damage seen with SSc. The injection of SVF into the fingers would also make it possible to control the production of the extracellular matrix and to improve the balance between fibrosis and fibrolysis, resulting in an improvement of cutaneous sclerosis

The main purpose is to evaluate the efficacy of SVF injections in the fingers of patients suffering from SSc on the Cochin hand functional scale evaluated at 12 months, in comparison to the control group.


title: Incidence of High Levels of Transpulmonary Pressure During the Use of Airway Pressure Release Ventilation.

summary:
Mechanical ventilation can induce pulmonary lesions called ventilator induced lung injury (VILI). High levels of Transpulmonary pressure is one of the most important mechanism of VILI during the use of mechanical ventilation. The use of bilevel pressure ventilator modes like APRV could generate high levels of transpulmonary pressure.

The aim of this study is to evaluate the variations of transpulmonary pressure during the use of APRV by clinicians

location_facility: Assistance Publique Hôpitaux de Marseille hôpital de la Timone


title: Efficacy of the Implementation of a Food and Nutritional Support Strategy Adapted to Dependent Elderly Subjects: Controlled Trial.

acronym: RENES+

summary:
Malnutrition particularly affects people who delegate the preparation of their meals with 46% of persons living at home and using a meals-on-wheels service, or those in old people's homes (Etablissement d'Hebergement pour Personnes Agees Dependantes - EHPAD) at risk of malnutrition, compared with 16% in persons who have help, but not for their meals, and 8% in independent persons (Aupalesens Survey). This proportion, which is particularly high, is essentially due to the absence or insufficient level of individual monitoring of the nutritional status of these "dependent" populations despite the different recommendations. EHPAD (old people's homes) are invited to respect meal rhythms, to adapt the nutritional and gustatory qualities of the food, to propose a pleasant environment (Survey CLCV 2012: data collection in 2012); in parallel, few professionals are really trained in the needs of the elderly. In meals-on-wheels services, apart from the distribution of meals, no nutritional follow-up is proposed (Guide 2012).

Symmetrically, the constant search to control costs in western healthcare systems has led managers to systematically reduce care costs, in particular those that are not directly related to medico-pharmaceutical or care personnel expenditure in the strictest sense. In the collective catering services, there is, for example, a systematic effort to reduce daily "costs/materials", without measuring the global cost related to the efficacy of care.

The present work is part of the RENESSENS project: these studies will be conducted in two elderly populations, one living at home and receiving meals on wheels daily and a regular visit of a dietician, who will propose individual nutritional follow-up and the second living in an old people's home (EHPAD) that will benefit from the improved management of its catering service (good culinary practices, including specific training for personnel and meals adapted to the needs of residents). The principal aim of these two studies will be common and will be to evaluate the efficacy of this specific type of management of meals and nutrition compared with a reference meals-on-wheels service and a reference EHPAD.

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Dietary Supplement


title: Postoperative Oxycodone Consumption After Spinal Surgery in Pregabalin-treated Patients Compared to a 48-h Perioperative Administration: a Prospective, Observational Study

acronym: PREGAB

summary: Spinal surgery is associated with intense pain and associated to a history of preoperative chronic pain. Pregabalin is licensed to treat chronic neuropathic pain, particularly when high dose of opioid are required. Preoperative pain is associated with high postoperative pain scores and opioid requirement promoting persistent hyperalgesic state. The investigators will evaluate the postoperative opioid consumption and pain scores in patients scheduled for lumbar surgery and taking pregabalin since more than 15 days and compare with preoperative pregabalin-free patient that will receive pregabalin only during surgery.

lead_sponsor: Christophe Aveline, MD


title: Identification of the Molecular Bases of Syndromic Congenital Neutropenia With Development Anomalies

acronym: neutropenias

summary:
Syndromic congenital neutropenia (SCN) includes a heterogeneous group of diseases characterized by congenital neutropenia associated with the involvement of other organs. Most patients have syndromic congenital neutropenia, which does not correspond, either clinically or genetically, to any other previously described form. A large number of genes still have to be identified in these syndromic forms.

The aim of this study is to identify the molecular bases of congenital neutropenias that have not yet been classified, by taking advantage of high-throughput exome sequencing.

intervention_type: Genetic


title: Prospective Study to Evaluate Ultrasound Verification of the Correct Position of Gastric Tubes in Intensive Care

acronym: SNG echo

summary: There are several ways to verify the correct positioning of a gastric tube. Radiography is considered the reference method. The use of ultrasonography could diminish the number of radiographies necessary. The hypothesis of this research is that gastric ultrasonography performed during insertion of the tube is a reliable examination to check the correct positioning of gastric tubes in intensive care.


summary:
Laparoscopic surgery is gaining currency in the field of oncologic care, particularly for colorectal and gynecologic cancers. This innovation could be used either for staging purpose and therefore could steer global therapeutic options or for surgical management only.

Increase knowledge and skills lead to an increase in the number and rate of the women this innovation could be offered. The project team observed a shift from traditional surgical management (abdominal radical surgery) towards laparoscopic with a focus on lymphadenectomy.

This innovation however increases some costs (the surgical stage) but decrease some others (the post surgical stage).

Foreseeing the pace of the dissemination needs to have objective and reliable data about who had access to laparoscopic surgery and who didn't (and why) and accurate assessment of related costs.

This program will focus on uterine cancer (both cervix and corpus).

intervention_type: Procedure


title: Effect of Bladder Distension on Organs at Risk Doses in PDR 3D Image-guided Brachytherapy of Cervical Cancer

acronym: VESICOL

summary: The purpose of this study is to compare, for each patient, dosimetry of organs at risk (bladder, rectum, sigmoid, small bowel) in two bladder distension procedures (emptied by a urinary catheter or filled with 120cc) during PDR 3D image-guided brachytherapy of cervical cancer.

lead_sponsor: Institut de Cancérologie de Lorraine


acronym: EFIMED

summary:
Breast MRI is performed in prone position which causes a number of questions. Indeed, the correlation with mammography and echography and the identification of preoperative lesions can be complex as echography and surgery are carried in supine position while mammography is performed in standing position.

Moreover, the prone position is often considered as uncomfortable by the patients. However, there is few publications in the literature on breast MRI in decubitus position.


title: Comparison of the Clinical Efficacy of 2 Paravertebral Block Strategies in Thoracic Surgery by Thoracotomy: : by the Anesthetist (Paravertebral Block Guided by Ultrasound) and by the Thoracic Surgeon (Paravertebral Block Visual)

acronym: PVBS-USguided

summary:
Post-thoracotomy pain is one of the most severe. The local analgesia allows its effective control and a reduction of postoperative morbidity and mortality.

The gold standard for local analgesia is the thoracic epidural. However, this technique can be dangerous with severe complications.

The paravertebral block showed comparable efficacy to the thoracic epidural for local analgesia . In addition, it has a better safety profile. There are several installation techniques. The difference in efficiency of these laying techniques is unknown.


title: Predictive Value of the Aβ Peptides Salivary Dosage for Alzheimer's Disease Diagnosis

acronym: SalivALZ

summary: Although saliva is not generally regarded as one of the most interesting biological fluids, the fact that it can be sampled using simple, noninvasive methods makes it an interesting alternative to cerebrospinal fluid (CSF) or blood for diagnostic purposes. The use of salivary diagnostics is moreover increasing these past 10 years, as shown with the abundant literature as well as various clinical trials. Saliva collection which is now well standardized has the major advantage of being simple and non-invasive. An original study had already discussed possible changes in the salivary composition in Alzheimer's disease (AD). The feasibility and the potential interest of measuring saliva concentration of the amyloid peptides was reported in an article published recently. The prospect of using saliva for early diagnosis and monitoring of AD is thus of major interest and the objective of the current trial.


title: Association Between High-risk HPV Genome Integration Detected by Molecular Combing and Cervical Lesions Severity and/or Evolution

acronym: IDAHO

summary: High-risk human papillomavirus (HR-HPV) are involved in cervical cancer development. Integration of HR-HPV DNA in cellular genomes is considered as a major event in the cervical cancer development. The aim of this study is to validate the integration of the HPV-HR as an appropriate biomarker of the severity of precancerous lesions and progression of cervical lesions towards cervical cancer. HR-HPV integration status will be analyzed by Molecular Combing technology, which allows direct and high-resolution visualization of the integration of high-risk HPV genomes.

primary_purpose: Screening


title: From the Characterization of the Cholesterol-epoxide Pathway Deregulation to New Therapeutic Perspectives in Breast Cancers

acronym: BREASTEROL

summary: The main objective of our project is to further characterize the deregulation of CE (Cholesterol Epoxides) metabolism in different moleculars subtypes of BC (BC=Breast Cancer) (luminal A and B, HER2+ and triple negative). We will study not only the level of expression of the enzymes involved in this pathway by immuno-histochemistry, all the enzymes involved were identified in our preclinical work (GSTA1 (Glutathione S-Transferase A1 ), DHCR7, D8D7I, 11βHSD2 (11β-hydroxysteroid dehydrogenase of type 2 )), but also the metabolite rates of CE (hydrolyses cholesterols-5,6-epoxide ), CT (into cholestane-3β, 5α, 6β triol ), DDA (Dendrogenin A)and OCDO (6-oxo-cholestan-3β, 5α-diol ). Our preliminary results demonstrate the feasibility of these dosages. We will also establish whether these deregulations are i) correlated with different histo-prognostic parameters (pN (N= Node), pT (T= Tumor) , EV, TIL…) but also clinical ii) an independent prognostic parameter of BC in terms of disease-free survival, metastasis-free survival and overall survival. The cohort consists of 350 cases of BC, treated between 2009 and 2011 as well as all relevant clinical informations. In parallel, we will continue our preclinical work by characterizing the targets and mechanisms of action of OCDO. Our preliminary results indicate that OCDO is a modulator of the glucocorticoid receptor (GR), which could be target to inhibit this pathway. On the other hand, we will characterize in the same manner as in human tumors, the deregulations of the CE metabolism in vitro and in vivo (including xenografts in mice of human tumors, in collaboration with Roman-Roman S) on a representative panel of BC molecular subtypes, sensitive or not usually administered in clinical treatment and study the anti-tumor effect of various "anti-OCDO" therapies (therapies preventing its production such as Tam (tamoxifen) or DDA, inhibitor of the enzyme producing OCDO, or an inhibitor of the GR (glucocorticoid receptor )), alone or in combination with conventional therapies


acronym: PARM

summary:
Age related macular degeneration (ARMD) is a major and irreversible cause of blindness among the elderly. The sub-retinal space, located between the retinal pigmentary epithelium (RPE) and the external segments of the retinal photoreceptors, plays a crucial role in this pathology. A recent epidemiologic study in the US, unpublished yet, has shown that patients treated with the L-DOPA, developed only later an ARMD when compared to the untreated patients.

The L-Dopa is an endogenous ligand of the GPR43 receptor, located on the RPE's cell's apical pole.

This receptor, via several intracellular mechanisms, regulates the cell's exosomal and endosomal pathways: it would appear that the L-DOPA, by stimulating this receptor, decreases significantly the RPE's exosome release.

The contents of the exosomes is still uncertain, however in addition to their signalization role, it seems they transport pro-inflammatory components, possibly helping the cellular recruitment due to the mononuclear phagocytic systems, particularly toxic for the photoreceptors.

The aim of this study is to validate the hypothesis stating that he L-DOPA would play a protective role against age related macular degeneration.

time_perspective: Retrospective


title: What Care Pathways for Newborns Consulting Pediatric Emergencies? Prospective Study Over One Year Newborn Pediatric Emergencies (NNUP)

acronym: NNUP

summary: This study will evaluate the course of care of newborns, to understand why some newborns have improper care pathways, particularly as regards the first medical consultation at the exit of motherhood. It is also to organize a better quality care network to hospital discharge to avoid unnecessary use of pediatric emergencies, which represents a real public health problem.

ReferenceCitation: Tran A, Hérissé AL, Isoardo M, Valo P, Maillotte AM, Haas H, Donzeau D, Freyssinet E, Pradier C, Gentile S. Evaluation of compliance with early postbirth follow-up and unnecessary visits to the paediatric emergency department: a prospective observational study at the Lenval Children's Hospital in Nice. BMJ Open. 2022 Jan 6;12(1):e056476. doi: 10.1136/bmjopen-2021-056476.

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-LENVAL


title: Efficacy of the Use of a Refrigerant Helmet to Prevent Alopecia in Patients Treated With Eribulin for Locally Advanced or Metastatic Breast Cancer Pretreated With Anthracyclines and Taxanes

summary: HALACAP-1406 is a prospective single-centre non-interventional study assessing the refrigerant helmet use as medical device to prevent alopecia induced by eribulin (Halaven®) in the conditions of use specified in its marketing authorization. Eribulin will be used alone for the treatment of the patients having a locally advanced or metastatic breast cancer which have progressed after at least 1 chemotherapy regimen for their advanced stage.

lead_sponsor: Centre Oscar Lambret


title: Use of a Heating Cable to Obtain Hyperthermia During Intraperitoneal Chemotherapy

acronym: CHIPOFIL

summary:
The investigator will study the possibility of in situ heating of the liquid containing the chemotherapy, so as to avoid the need for an external pumping system with its complexity, and its associated risks and costs.

The use of a heating cable (prototype hereinafter called Thermowire, made by the company EFS, which is in charge of its development) was patented and tested in pigs in two studies that included 15 animals altogether (in 7 of which the heating cable was used). The aim of the first study was the purely safety aspects, while the efficacy to obtain hyperthermia, the quality and the homogeneity of the hyperthermia and its effect on the tissue penetration of the chemotherapy were evaluated in a second study. The results obtained justify transfer to use in humans in the context of a clinical trial so as to obtain CE certification.


title: Study of the Effect of Beta-3 Adrenergic Receptor Agonists on Oxidative Stress and Signalling Pathways Implicated in Remodelling of the Uteroplacental Space: Experimental in Vitro Approach on Myometrial Tissue Explants

acronym: STRESSOX

summary:
CHRONOLOGICAL DESCRIPTION OF THE STUDY

Information provided to study participants
Collection of written informed consent
Harvesting of myometrial biopsies
Creation of tissue explants using myometrial biopsies
Stimulation of the explants with LPS
Study of the effect of SAR150640 (beta3-adrenergic agonist) on LPS-induced oxidative stress Moreover, demonstrating the ability of beta3-adrenergic receptor agonists to prevent the appearance of oxidative stress and its consequences on tissues, as a complement to previous studies, is an additional argument for the clinical development of this class of pharmaceuticals in the management of threatened premature delivery and labour induction.


title: Iinterest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section: Double-blind Randomized Controlled Single-centre Study

acronym: ZORA

summary:
The intravenous injection of 8mg of ondansetron (a serotonin type 3 receptor antagonist) before spinal anaesthesia for caesarean section, leads to a smaller reduction in systolic arterial pressure (SAP).

The expected results are a decrease in the frequency and severity of hypotension, thus leading to improved comfort for the mother and decreased maternal and foetal morbidity. Indeed, episodes of hypotension are responsible for impaired foeto-placental circulation, with sometimes severe consequences for neonates.

It has been established that episodes of hypotension alter foetal pH. Investigators therefore hope to see a smaller reduction in SAP in the ondansetron group, and show a benefit for the infant.

One of the objectives of this study is also to observe a decrease in the quantity of vasopressors used and thus to avoid the adverse effects of their use in high doses.

The expected results are thus an improvement in haemodynamic stability during spinal anaesthesia for caesarean section.

The originality of this project lies in the use of a CNAP monitor (Continuous Non-invasive Arterial Pressure) as the collection of haemodynamic data will allow greater precision with the continuous measurement of AP, as well as a study of maternal cardiac output.

primary_purpose: Prevention


title: Influence of Glycaemic Variability on Oxidative Stress and High-density Lipoprotein (HDL) Function in Type-1 Diabetes

acronym: Holter Gly

summary:
As glycaemic variability on the one hand and hypoglycaemia on the other are associated with oxidative stress and inflammation, they are likely, in type-1 diabetic patients, to affect the oxidation of lipoproteins and HDL function, by altering their anti-atherogenic properties.

The aim of this study is thus to determine, in patients with Type 1 Diabetic (T1D) who will wear a glycaemic Holter for 1 week, the glycaemia parameters (mean glycaemia, duration of hypoglycaemia, duration of hyperglycaemia, mean amplitude of glycaemic excursions) associated with proatherogenic alterations in lipoproteins, in particular:

LDL oxidation
HDL oxidation and alterations of HDL function (anti-inflammatory capacity, antioxidant capacity)


title: Towards an Improvement in Diagnosis and Genetic Counselling in Syndromic Poikiloderma

acronym: poikiloderma

summary:
In the context of this study, the investigators wish to take advantage of high-throughput genetic techniques (microarray and high-throughput exome sequencing) to identify new genes implicated in syndromic poikiloderma so as to improve the diagnostic decision tree in these syndromes, opportunities for genetic counselling for patients and their families and the follow-up of patients, notably with regard to the risk of tumours.

This study will make it possible to identify new genes implicated in syndromic poikiloderma and improve the diagnostic strategy proposed to patients with these syndromes, and to propose to patients a confirmed diagnosis, appropriate follow-up, notably with regard to the risk of tumours, genetic counselling to families and eventually an antenatal diagnosis to couples who would like to have one for future pregnancies.

The identification of new genetic causes of syndromic poikiloderma will also make it possible to complete the current classification of these syndromes


title: Molecular Diagnosis of Syndromic or Isolated Severe Intellectual Disability Using Whole Exome Sequencing : a Pilot Study

acronym: SHD-DI

summary: Evaluation of diagnostic whole exome sequencing in patients with syndromic or isolated severe intellectual disability without a molecular diagnostic, with suspected autosomal recessive inheritance, allowing accurate genetic counseling in this high risk of recurrence group of diseases

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms

acronym: ACET

summary: Endovascular treatment of ruptured and unruptured intracranial aneurysms presents complications, mainly the thrombo-embolic complication. No specific studies have been conducted to study factors associated with the occurrence of thromboembolic complications (symptomatic or not) post endovascular treatment of intracranial aneurysms.


title: Molecular Characterization of Advanced Stage Melanoma by Blood Sampling

acronym: MELCIRC

summary:
Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies.

In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.


title: Predictive Value of Diffusion-weighted MRI Performed in Early Post-treatment in the Occurrence of Tumor Recurrence or Progression in Head and Neck Squamous Cell Carcinoma Treated With Chemoradiotherapy: a Pilot Study

acronym: ORODIFF

summary: Head and neck squamous cell carcinoma are frequent. The chemoradiotherapy protocols are part of the reference treatment of locally advanced stage tumors. Diffusion-weighted MRI (DW-MRI) is a non radiating imaging, not requiring injection of gadolinium, giving informations on tumor activity, based on the brownian motion of water molecules. The differences in motion are expressed by the apparent diffusion coefficient (ADC). The ADC variations reflect changes in water molecules motion and redistribution between the intra- and extracellular compartments. Several studies have shown that malignant lesions have an ADC coefficient lowered as compared to benign lesions.


title: Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children

acronym: THROMBLEUKEMIA

summary:
Acute lymphoblastic leukemia is the most common malignancy of the child. Current therapeutic strategies allow healing of over 80% of children. However these treatments are associated with toxicity, with a mortality of 1-2%. The most frequent complications, occuring during treatment initiation, are the thromboembolic complications.

The most commonly accepted explanation is that of an anti-thrombin depletion by chemotherapy used in the treatment, L-asparaginase. But the anti-thrombin supplementation showed no efficacy in the prevention of these thromboembolic complications. Therefore most authors consider that a multifactorial mechanism is behind these events, involving both treatment and malignant cells. The interaction of these two factors participate in the damage of the vascular endothelium.

The microparticles are membrane fragments derived from budding from the membrane of activated cells or apoptosis. Their thrombogenic role is linked to the expression of coagulation activators such as tissue factor. It is also associated with their role in the modulation of signaling pathways involved in the invasiveness and angiogenesis in endothelial cells.

In acute lymphoblastic leukemia, the presence and role of microparticles have not been studied. Our hypothesis is that of production of microparticles upon lysis of blasts then upon activation of endothelial cells induced by the induction therapy, participating in a procoagulant phenotype.


title: Efficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip

acronym: VISCOSUPP-HIP

summary:
The current management of osteoarthritis is based on non-pharmacological and pharmacological means which include intra-articular injections.

The recommendations on the management of hip osteoarthritis stipulate that intra-articular injections of corticosteroid may be considered in patients with an exacerbation not responding to oral treatments. Several recent studies show the effectiveness of intra-articular corticosteroids compared with anesthetics. The intra-articular injection of viscosupplementation alone has never been validated in this indication since controlled studies did not show efficacy over placebo. At present, viscosupplementation is considered an anti-osteoarthritic symptomatic slow-acting and its interest is not yet established in hip osteoarthritis.


acronym: PSY-DIA-MUM

summary: The incidence of type one diabetes is still rising, especially in children under 5 years old. Mothers often are the primary caregivers of these children. To take care of a young child with diabetes is a great responsibility and mothers must be constantly vigilant. This study aims to assess the psychological state of these mothers (in term of depression, anxiety, stress, coping, fear of hypoglycemia) and factors which influence this state.


title: Evaluation of a Personalized Rehabilitation Program for Elderly Patients That Fall : Impact on the Fear of Falling

acronym: CHUTE

summary:
The risk of falling affects more than one third of people over 65 years old and over 50% of persons over 80 years. These falls have important consequences for the autonomy of the elderly patient and also increase the risk of sequelae and death.

The goal of this study is to evaluate a personalized rehabilitation program for elderly patients that fall for the first time and to measure the impact on the fear of falling of these patients. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors.

lead_sponsor: Lille Catholic University


title: Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic

acronym: TITIM

summary:
The drug immune thrombocytopenia (TIM) are the most common drug cytopenias. They result from a peripheral destruction of platelets in the presence of the drug only. They usually involve immunoglobulin G (IgG) directed against either the drug molecule bound to a carrier protein or, by autoimmunity, against a hidden epitope newly exposed as a result of treatment. The most common drugs involved are quinine, some antibiotics, nonsteroidal anti-inflammatory drugs or anticonvulsants but the list is not exhaustive.

in the case of new-onset thrombocytopenia and after eliminating other possible causes, a TIM is suspected but the offending drug is difficult to identify in generally poly-medicated patients.

Several drugs may be suspected and the clinician uses biology for rapid assistance to the "de-prescription" and reduces unnecessary therapeutic substitutions in an always difficult clinical situation.

The Immunology Laboratory of the University Hospital of Saint-Etienne has developed a biological test of thrombocytopenia induction in the presence of the drug and the patient's serum that is to say its antibodies and complement fractions with cytometry reading flow. This Induction Test in vitro TIM (TITIM) is simple, fast, inexpensive, easy to transfer in hospital laboratories. But this test must be validated on well-documented clinical cases.

The purpose of this pilot project is to validate the technical and assess the clinical specificity of the test TITIM for hard imputability drugs validated by a committee of experts combining a posteriori of clinical and biological criteria of routine.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Study of the Involvement of 15q11 - q13 Chromosome Region and CYFIP1 Gene in Autism. Attempt a Genotype-phenotype Correlation

summary:
Autism, ranked among the '' pervasive developmental disorders' (ASD), is characterized by disturbances in the areas of reciprocal social interaction, communication and behavior, interests and activities restricted, repetitive. Various studies indicate that autistic disorder is subjected to a genetic predisposition, most likely polygenic and heterogeneous. However, no major gene responsible for this disorder has yet been identified. Given the link between the Fragile X syndrome (the most common form of mental retardation (MR) hereditary) and autistic behavior, it seems interesting to look, also, a possible link to the molecular level. Among the proteins interacting with FMRP (absent protein in fragile X patients), the investigators were interested to CYFIP1, protein encoded by the gene CYFIP1 appears to be a good candidate gene involved in the RM and autism by its chromosomal position and function. As FMR1, CYFIP1 is expressed in the brain cortex, hippocampus and Purkinje cells of the cerebellum. This protein co-localizes and interacts with Rac and FMRP, which are both involved in neurogenesis and cognitive development. In humans, the gene encoding CYFIP1 is located in the 15q11-q13. Now, the only autosomal abnormalities most frequently observed in autism are those involving the proximal 15q region, including duplications or 15q11-q13 triplications interstitial, of maternal origin.

These data suggest that an / or more autism genes responsible are probably present in the 15q11-q13 chromosomal region, although no gene has yet been identified. Thus, the study of the role of CYFIP1 gene in patients with autism spectrum disorders would most likely contributory.

The investigators wish to study the involvement of the 15q11-q13 chromosomal region and CYFIP1 gene in autistic disorder in a hundred patients from the Autism Resource Centre (ARC) Nice PACA antenna, over a two year period.

The diagnosis and assessment report of children likely to be included in this study will be conducted at ARC Nice. Balance sheets are made according to the recommendations of the High Authority of Health for diagnosis of infantile autism and PDD. These children are then sent to the Genetic Consultation Nice Hospital where an analysis of the background and a specific morphological examination will be realized..

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Intravenous Dexamethasone Versus Placebo for Ultrasound Guided Axillary Brachial Plexus Block With Ropivacaine: Randomised, Controlled, Clinical Trial

acronym: ADEXA

summary: Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after ultrasound guided axillary brachial plexus block

ReferenceCitation: Clement JC, Besch G, Puyraveau M, Grelet T, Ferreira D, Vettoretti L, Pili-Floury S, Samain E, Berthier F. Clinical effectiveness of single dose of intravenous dexamethasone on the duration of ropivacaine axillary brachial plexus block: the randomized placebo-controlled ADEXA trial. Reg Anesth Pain Med. 2019 Mar;44(3). pii: e100035. doi: 10.1136/rapm-2018-100035.


acronym: PROPASPI

summary:
There is actually no consensus in place defining for which patients with suspected inhalation pneumonia antibiotic treatment should be initiated and what the duration of this antibiotic treatment should be.

This absence of recommendations results in excessive use of antibiotics, in emergence of multi-resistant strains and increase of costs. Several studies have been performed investigating antibiotic treatment based on procalcitonin values and have demonstrated a decreased use of antibiotics without change in mortality rates, in duration of hospitalization, in occurrence of super-infections or in infection relapse rate. Of the studies performed in an intensive care setting, none has specifically studied inhalation pneumonia.

The objective of this study is to determine whether use of a decisional algorithm based on procalcitonin values allows reducing antibiotics exposure in patients who are intubated because of coma in comparison with standard care according to actual guidelines and clinical experience with respect to ventilator-acquired pneumonia.

The study has a prospective, multi-centre, comparative, randomized, open design. It is a superiority study, with as primary parameter the duration of antibiotic therapy during the first 15 days after admission in the intensive care unit (ICU).

Patients can be included in this study if they are intubated for coma (Glasgow Coma Scale (GCS) ≤ 8) within 48 hours following admission to the hospital and with a foreseen duration of ventilation exceeding 48 hours.

There will be two treatment groups, stratified by centre and randomised in blocs of 4: one group for which treatment initiation and discontinuation will be guided by a procalcitonin-based decisional algorithm and a control group to whom antibiotics will be administered according to the standard protocols of each participating centre.

Based on an estimated duration of antibiotic treatment of 6.2 days, a risk -significance α level- of 5%, a power of 90% and a reduction of antibiotic treatment duration of 25% in the treatment arm guided by procalcitonin values, the number of patients to be included is 83 per treatment arm. Taking into account a loss of 10% for patients lost to follow-up, 166 patients should be included.

ReferenceCitation: Labro G, Aptel F, Puyraveau M, Paillot J, Pili Floury S, Merdji H, Helms J, Piton G, Ecarnot F, Kuteifan K, Quenot JP, Capellier G; PROPASPI (PROcalcitonin Pneumonia/pneumonitis Associated with ASPIration) trial investigators. Impact on antimicrobial consumption of procalcitonin-guided antibiotic therapy for pneumonia/pneumonitis associated with aspiration in comatose mechanically ventilated patients: a multicenter, randomized controlled study. Ann Intensive Care. 2021 Oct 12;11(1):145. doi: 10.1186/s13613-021-00931-4.


title: Epigenetic Evaluation of HAT/HDAC Activity in Peripheral Blood Mononuclear Cells From Patients With Clinically Isolated Syndrome and Analysis of the Relationship With the Pathophysiology and Disease Activity

acronym: EPIC

summary: The aim of the study is to compare the enzymatic activity of HATs and HDACs in peripheral blood mononuclear cell (PBMC) of patients with a clinically isolated syndrome (CIS group) and healthy controls (control group).


title: Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.

acronym: TherMO

summary: The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety of microwave ablation in the treatment of malignant bone, lung and renal tumors.


title: Measuring the Effects of Therapeutic Education Program "Caratif" Patient Under Strong Opioids Versus Standard Taking Charge of Patient Pain Receiving Opioid Therapy in Medical Oncology.

summary:
A first empirical evidence on the difficulties of observance of morphine in cancer patients invited a multidisciplinary team to initiate an innovative quality approach. It shows the lack of transcript of a comprehensive care causing a problem for monitoring actions undertaken for the relief of pain. In addition, two exploratory studies targeting the expectations and needs of the Patient Therapeutic Education (E.T.P) receiving strong opioids.

The E.T.P, public health priority, provides a framework for action and improving care. In oncology, the involvement of the patient in pain relief and management of opioids represents an axis of intervention more appropriate. Yet, it is not found in literature. In our department, we conduct an experimental therapeutic education program type "caratif" and a nurse consultation FTE receiving opioids on the model of nursing "care" of J. Watson (humanist emphasis promoting interpersonal teaching-learning mobilizing the patient experience). The ETP folder and its tools have been continuously validated with patients. The heart of the educational process is in the patient's complex path neat oncology and relies on interaction and creativity between patient and caregivers.

location_facility: Assistance Publique Hôpitaux de Marseille Hôpital de la Timone


title: Réponse à l'Application d'Une Pression Locale en Laser Speckle Imaging Locally Applied Pressure-induced Vasodilatation

acronym: LAV

summary: Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle).

ReferenceCitation: Henni S, Hersant J, Loufrani L, Duval G, Humeau-Heurtier A; SIMS Group, Riou J, Abraham P; SOCOS Group. Painless local pressure application to test microvascular reactivity to ischemia. Microvasc Res. 2019 Mar;122:13-21. doi: 10.1016/j.mvr.2018.10.013. Epub 2018 Nov 3.

lead_sponsor: University Hospital, Angers


title: Effects of NMES on Muscle Function of Patients With FSHD: a Double-blind Randomized Controlled Clinical Trial

acronym: NEMS and FSHD

summary: Facioscapulohumeral muscular dystrophy (FSHD) is an autosomal dominant disease characterized by progressive weakness and atrophy of specific skeletal muscles. One of the major problems of patients affected by FSHD is the limitation in performing daily activities induced by the progressive muscle weakness. This sedentary lifestyle can cause a "debilitative cycle," and neuromuscular deconditioning can even aggravate the muscular deficiencies. Recent studies have indicated the safety and the effectiveness of moderate aerobic training programs in patients with FSHD. However, these training programs have limited applicability in patients with more severe muscular weakness. Artificial strength training by means of neuromuscular electrical stimulation (NMES) appears to be a promising rehabilitation strategy for FSHD patients suffering from neuromuscular disorders. Therefore we propose to investigate the feasibility, safety, and effectiveness of NMES strength training to counteract quadriceps muscle weakness in patients affected by FSHD.

lead_sponsor: University Hospital, Montpellier


summary:
This is a first care research focuses on the study of adaptation strategies implemented by cancerous wound patients. Today, advances in treatment generally increases the life expectancy of a patient with cancer. the patients thus live longer with their wound. How to live then? The literature review shows that there is research on adaptation strategies in cancer pathology and that different factors seem to interact with these strategies. However the investigators have not found written on the theme cancerous wound and adaptation strategies.

the investigators conducted a pilot study of this research in medical oncology, Prof. service Duffaud CHU Timone, which allowed us to highlight patient adherence and motivation centers contacted but also areas for improvement. Indeed, the investigators now were doing a study of adaptation strategies implemented by the patient time T of his life. However, adaptation is a process in constant motion, the investigators want to identify two different time patients coping strategies following a specific charge nurse taking.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille Hôpital de Timone


title: Study of New Determinants of Type 2 Diabetes in Severe Obesity

acronym: COMET

summary:
This project aims at identifying new determinants of type 2 diabetes in severe obesity. To do so, a biological collection, including tissues of interest in the field of metabolism, will be collected during bariatric surgery in obese patients. Three different groups of metabolic status of patients, corresponding to different stages of evolution of the disease, will be constituted: type 2 diabetes, insulin resistance, insulin sensitivity.

The main objective is to compare, between these 3 groups of patients, several biological processes that may be involved in the pathophysiology of type 2 diabetes and disorders associated with obesity, including:

Abnormalities of the transcriptome, proteome, metabolome in all target tissues (plasma, serum, muscle, subcutaneous and visceral adipose tissue, omental artery, liver)
Identification of metabolic signatures, protein and miRNA in plasma
Immunoinflammatory response in adipose tissue
Polymorphisms SNP from whole blood
Histological analysis of tissue sections This main objective will be studied on samples taken at the time of surgery Secondary objectives will be to study the changes in metabolites, proteins and miRNA in plasma level 3 and 12 months after the completion of surgery, according to the initial metabolic state.


type: Registry Identifier

title: Improving the Diagnostic of Tuberculosis

summary:
The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.

Hypothesis 10% of patients infected by M. tuberculosis are carrier of M. tuberculosis pharyngeal.

Secondary

Measure the time to diagnosis of pulmonary TB by comparing the sample versus noninvasive pharyngeal samples taken routinely.
Evaluation of the direct cost of the diagnosis of M. tuberculosis by comparing the sample versus noninvasive pharyngeal samples taken routinely.
Beijing genotype prevalence among patients with pulmonary tuberculosis.


summary: Acute erythroid leukemia (AEL) is a morphologically distinct, infrequent (o5%) acute myeloid leukemia (AML) designed as M6 in the French- American-British (FAB) classification. The World Health Organization classification recognizes two subclasses, M6a, a leukemia with myeloid blast cells, and M6b, a very rare, purely erythroid AML. It may be difficult to distinguish between a myelodysplastic syndrome and AEL because of the erythroblastic proliferation, which is increased when dysplasia is present. No recurrent cytogenetic abnormality is specific of AEL and the prognosis is poor with a median survival of 17 months. A study of 14 genes in a series of 92 cases has shown that mutations are frequent in AEL and somewhat differ from the other AMLs by the lower and higher proportion of FLT3-ITD and TP53 mutations, respectively. Only three cases of AEL are reported in the TCGA database. To further characterize AEL, determine whether it constitutes a distinct class of AML and document the reasons for its poor prognosis, the investigators will search for molecular alterations in 40 M6a-AMLs using array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation.

lead_sponsor: Institut Paoli-Calmettes


title: Study of the Interest of Proprioceptive Therapy as a Complement to Speech Therapy in Children With Reading Difficulties

summary:
Before proposing this observational study protocol, a randomized study was attempted. This consisted in proposing to families of children with difficulties in learning to read, via the speech therapists who were treating them, to take part in a randomized trial that compared speech therapy alone with a combination of speech therapy and proprioceptive therapy. If parents agreed in principle with the study, the child underwent a complementary speech therapy examination and was referred to the nearest investigating doctor for inclusion. However, this study had to be abandoned because of insufficient recruitment (2 patients included in 1 year). Despite the motivation and training of participating speech therapists, proposing a study based on randomization to families often in distress proved to be extremely difficult, as their conviction of the interest of proprioceptive therapy was greater than the available scientific evidence suggested. Direct recruitment by investigating ophthalmologists was not possible because they were consulted directly by the families so as to obtain proprioceptive therapy. The principle of randomization would thus not have been accepted.

In light of the above, we decided to turn towards a non-randomized study comparing outcomes in two groups of children:

children who consulted an ophthalmologist who proposed proprioceptive therapy in Côte d'Or
children managed by one of the four speech therapists who do not propose proprioceptive therapy and who accepted the principle of the study.


title: Development and Validation of a Prognostic Score for Early Death in Head Injury Patients in the Traumatic Brain Injury Intensive Care Unit of Dijon CHU

acronym: SCORE TC

summary:
Traumatic brain injury (TBI) is a serious condition with high morbidity and mortality. The Glasgow score alone, assessed at the initial phase, is not enough to determine the prognosis.

The aim of this study is to define and to evaluate a prognostic score for early death based on clinical and CT-scan findings in an observational retrospective derivation cohort of patients hospitalized for traumatic brain injury.

This cohort will allow us to carry out a uni- and then multi-variate analysis so as to create a prognostic score for early death.

We will subsequently test this score in a prospective validation cohort.


title: Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology

acronym: UNMASK

summary: Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for non metastatic colon cancer.


title: Economic Evaluation of the Use of Plerixafor for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma

acronym: PLERIXAFOR

summary: This study aims to realize an economic evaluation of the introduction of Plerixafor in addition to G-CSF and alternative options, in patients with multiple myeloma (MM) who failed or insufficiently mobilize peripheral blood stem and progenitor cells in response to G-CSF alone.


title: Antibiotic-related Serious Adverse Events in Obese Patients Treated for Bone and Joint Infection

summary:
It exists recommendations to get an optimal antibiotic treatment for bone and joint infection and prescription of antibiotics in the bone and joint infections on material meets certain obligations: the micro-organism must be known, the antibiotic therapy must be started in association, obtaining high plasma levels, use of molecules having good bone circulation. It is recommended to initially administer treatment with intravenous route and to propose an oral relay, under conditions. It is recommended to administer the antibiotic treatment for at least 6 weeks.

The dosages of antibiotics are adapted to the weight of patients in order to respond to those recommendations. But little is known about the optimal dose of treatment to give to obese patients (BMI>=30) and the frequency of serious adverse events in these patients in which the dosage is then higher can be more important compared to non-obese patients. The aim of the study is then to evaluate the risk of occurrence of serious adverse events in obese patients and to identify risks factors.

This study consists in a retrospective cohort of obese patients treated for a bone or joint infection and having had a serious adverse event. Several data are collected concerning: demographics data, treatment responsible of the serious adverse event (molecules, dosage, route), description of the serious adverse event, residual rate for vancomycin.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de référence des infections ostéo-articulaires, Hôpital de la Croix-Rousse, 103 Grande Rue de la Croix-Rousse,


title: Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?

acronym: MICI

summary:
The chronic fatigue is observed in approximately 40 % of the patients with a chronic quiet inflammatory bowel disease (IBD) and impacts the quality of life of the patients. The beneficial role of a regular physical activity on the quality of life of patients having an IBD was demonstrated in 5 studies including only 1 controlled one [Bilski, on 2013]. The mechanism by which the physical activity could improve the quality of life of the patients remains unknown (stress decreased, reduction of the inflammatory process) [Bilski, on 2014]. Several studies concerning other chronic pathologies such as fibromyalgia, have demonstrated the beneficial effect of a regular physical exercise to reduce the fatigue of patients. It was recently demonstrated that the chronic fatigue observed in patients with IBD came along with a physical reduction in the performances during the exercise test and a reduction in the physical activity of the patients [Vogelaar, 2015].

Our hypothesis is that a regular moderate physical activity could improve physical performance during an effort et could reduce the chronic fatigue and improve their quality of life.

lead_sponsor: University Hospital, Rouen


title: Using Infrared Spectroscopy for Diagnosis Severity of Nonalcoholic Fatty Liver Disease

acronym: NASH

summary: The main objective of this study is to evaluate the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH

lead_sponsor: Rennes University Hospital

location_facility: Centre hospitalier universitaire de Rennes


title: Use of Infrared Spectroscopy in Septic Arthritis Diagnosis

acronym: SynoFAST

summary: The main objective of this study is to assess the ability of Fiber-optic Evanescent Wave Spectroscopy (FEWS) to discriminate synovial fluids samples of septic arthritis patients from other causes of joint effusion by analyzing ex vivo joint fluid samples collected during routine clinical care.

ReferenceCitation: Albert JD, Le Corvec M, Berthoud O, David C, Guennoc X, Hoppe E, Jousse-Joulin S, Le Goff B, Tariel H, Sire O, Jolivet-Gougeon A, Coiffier G, Loréal O. Ruling out septic arthritis risk in a few minutes using mid-infrared spectroscopy in synovial fluids. Rheumatology (Oxford). 2021 Mar 2;60(3):1158-1165. doi: 10.1093/rheumatology/keaa373.


title: Role of PTK-7 in Acute Myeloid Leukemias: Impact of PTK7 Serum Marker and ex Vivo Studies to Decipher the Role of PTK7

summary:
The pseudo tyrosine kinase receptor 7 (PTK7) is an orphan tyrosine kinase receptor assigned to the planar cell polarity pathway. PTK7 is expressed in normal myeloid progenitors and CD34(+) CD38(-) bone marrow cells in humans. It is also expressed in acute myeloid leukemia (AML) and is mostly assigned to granulocytic lineage differentiation. In AML, PTK7 seems to convey promigratory and antiapoptotic signals into the cell and represents an independent prognosis factor of survival in patients treated with induction chemotherapy. This study aims at:

evaluating the impact of PTK7 expression on primary AML cells ex vivo
evaluating the diagnostic and prognostic value of a soluble form of PTK7


title: Clinical Observatory of the Prescription of Erythropoietin as Treatment of Anemia Induced by Chemotherapy or Allograft Conditioning Among the Patients With a Haematological Malignancy

acronym: EPREX/LAM-ALLO

summary:
Anemia concerns a lot of patients with cancer and affects their quality of life (QOL). Numerous studies in oncology have demonstrated the benefit of erythropoiesis-stimulating agents (ESA) in the treatment of anemia. ESAs allow the improvement of QOL,of the hemoglobin level (Hb) and is a validated alternative to transfusion.

However, in hematology, if there are some specific recommendations for the use of ESAs in lymphoid pathology, there are none for myeloid disorders and in the context of autografts and allogeneic hematopoietic stem-cell transplantation (HSCT). Thus, the investigators are in particular interested in both indications: treatment of anemia in acute myeloid leukemia (AML) patients treated with chemotherapy, and the in patients receiving a myeloablative or a non-myeloablative conditioning before allogeneic HSCT, whatever type of donor and cell source.


acronym: BREAST-HDCT

summary: The objective of this study was to evaluate the outcome of patients affected with different subtypes of metastatic breast cancer following treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation.


acronym: EVEROST

title: Topical Everolimus Versus Placebo for the Treatment of Facial Angiofibromas in Patients With Tuberous Sclerosis Complex. A Phase II/III, Multicentre, Randomized, Double-blind, Placebo-controlled Study of 3 Doses of Topical Everolimus.

type: EudraCT Number

source: euctr

summary: Tuberous sclerosis complex (TSC) is a rare genetic multisystem disorder characterized by the development of hamartomas in several organs (e.g. brain, heart, kidney, liver, lung), and skin in more than 90% of cases. Facial angiofibromas (FA), present in about 80% of patients, are a stigmatizing hallmark of the disease. Everolimus could be a candidate for use as a topical formulation to treat FA. This adaptive seamless Phase II/III study primary objective is to determine the dose of topical everolimus for treatment of FA and evaluate the efficacy and safety of topical everolimus versus placebo in patients with angiofibromas.


title: Role of Pulse Co-oximetry in Prehospital Emergency Medical Service Management of Suspected Carbon Monoxide Poisoning : A Prospective Multicenter Study.

acronym: CO-OX

summary:
The RAD-57 pulse CO-oximeter is a lightweight device allowing non-invasive measurement of blood carboxyhemoglobin. Previous studies comparing RAD-57 measurements (SpCO) to standard laboratory blood gas analysis (COHb) have reported contradictory results.

the RAD-57 pulse CO-oximeter could be useful as a first-line screening test for acute CO poisoning, enabling rapid detection and management of patients with suspected CO poisoning in the prehospital emergency setting This study assesses the diagnostic value of pulse CO-oximetry, comparing SpCO to standard laboratory blood measurement for prehospital management of patients with suspected carbon monoxide (CO) poisoning.

location_facility: Montpellier University hospital - Emergency department


title: Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia

summary: Single center, pilot study, to evaluate the influence of Motor Imagery (MI) on functional rehabilitation and cerebral plasticity through the qualitative and quantitative mental practice approach. For this, the investigators will use magnetoencephalography (MEG) but also physiological and behavioral indicators developed by the Laboratoire de la Performance Motrice, Mentale et du Matériel (P3M) of Université Claude Bernard Lyon 1 and its partners.

ReferenceType: result

ReferenceCitation: Mateo S, Reilly KT, Collet C, Rode G. Descriptive pilot study of vividness and temporal equivalence during motor imagery training after quadriplegia. Ann Phys Rehabil Med. 2018 Sep;61(5):300-308. doi: 10.1016/j.rehab.2018.06.003. Epub 2018 Jun 23.

location_facility: Hôpital Henry Gabrielle - Médecine physique et Réadaptation, Hospices Civils de Lyon, 20 Route de Vourles,


title: Evaluation of Systemic Leakage When a Heparin or Citrate Lock is Injected and Biological and Clinical Repercussions: Ancillary Study of the VERROU-REA Randomized Controlled Trial

acronym: VERROU HEMOST

summary: In the VERROUREA study, there were two cases of an abnormal increase in TCA. In theory no leakage of the lock into the bloodstream should have been seen. Lock leakage could have particularly serious, and especially clinical, repercussions in these patients who already have a high risk of haemorrhage given the numerous associated comorbidities. The aim of this study is to investigate the leakage of locks into the bloodstream by measuring, before and after injection of the lock, the evolution of haemostasis tests and calcaemia. The findings will complete safety data already collected in the VERROU REA study.


title: Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke: Effect of Intravenous Fibrinolysis With Rt-PA

acronym: BDNF

summary:
The aim of this study is to show for the first time that treatment with intravenous fibrinolysis using rt-PA in patients with recent ischemic stroke is accompanied by increases in circulating levels of BDNF, which may reflect an increase in BDNF synthesis in the brain.

The analysis of the recovery of functional and cognitive abilities as well as mood at 3 months will allow us to study the impact of BDNF on these parameters. Thus, depending on the results obtained, circulating BDNF could serve as an early marker of these.


title: Mechanical Characterization of Ascending Aorta in Patients With Acute Type A Dissection and in Healthy Control Group Combined to Structural and Ultrastructural Analysis of Aortic Tissue

summary: Acute type A aortic dissection is a frequent (3 cases per 100 000 people per year) and severe (spontaneous mortality 70%), needing an emergency surgical treatment. Surgical outcomes have improved with the development of surgical techniques, but the postoperative mortality remains high (15-30% at 30 days). Endovascular approach with the deployment of endoprosthesis sealing the proximal intimal tear is an attractive minimally invasive technique, which can represent an alternative to surgical repair especially in high risk patients.