title: Tracheobronchitis May Constitute the Main Sign of Respiratory Involvement on the Lung SPECT/CT Images of COVID-19 Patients

summary: Tracheobronchitis signs may be observed on ventilation lung scintigraphy during COVID-19 infection. This case report study aimed to analyze the rates and associated factors of such tracheobronchitis in COVID-19 patients referred to ventilation/perfusion lung scintigraphy with shortness of breath, suspected of pulmonary embolism.

lead_sponsor: Pierre Yves MARIE


title: OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs

acronym: OBSTINATE

summary: This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Dufrost V, Risse J, Reshetnyak T, Satybaldyeva M, Du Y, Yan XX, Salta S, Gerotziafas G, Jing ZC, Elalamy I, Wahl D, Zuily S. Increased risk of thrombosis in antiphospholipid syndrome patients treated with direct oral anticoagulants. Results from an international patient-level data meta-analysis. Autoimmun Rev. 2018 Oct;17(10):1011-1021. doi: 10.1016/j.autrev.2018.04.009. Epub 2018 Aug 11. Review.

ReferenceCitation: Dufrost V, Risse J, Wahl D, Zuily S. Direct Oral Anticoagulants Use in Antiphospholipid Syndrome: Are These Drugs an Effective and Safe Alternative to Warfarin? A Systematic Review of the Literature: Response to Comment. Curr Rheumatol Rep. 2017 Aug;19(8):52. doi: 10.1007/s11926-017-0676-2.

ipd_sharing: Undecided

lead_sponsor: Stéphane Zuily

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: Impact of an Adapted Physical Activity Program on Event-free Survival in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line

acronym: PHARAOM

summary:
Diffuse large B cell lymphoma is the most common histology of non-Hodgkin's malignant lymphomas (31% of lymphomas), with an incidence of between 15 and 20 new cases per year per 100,000 inhabitants in France. The median age is 65 and a third of patients are over 75 years old. 60% of patients are cured after a standard regimen of chemotherapy with RCHOP; 40% of patients will, however, relapse. No other regimen has shown improvement in overall survival, but poor prognosis factors have been identified. Beyond these factors, other prognostic factors can impact overall and progression-free survival: sarcopenia, nutritional status disorders Sarcopenia is defined by the reduction of muscle mass and strength. It was first described in the elderly and classified as geriatric syndrome such as dementia, falls or frailty. It varies from 5 to 13% between 60 and 70 years and between 11 and 50% beyond 80 years and is classified as primitive, that is to say related to age It can however be secondary to neoplasia. This event has been described in patients with hematologic malignancies during chemotherapy and can reach 55% of patients in the elderly. It is proportional to the intensity of the treatments. It emerges as an independent prognostic factor which is detrimental to survival in these patients. Physical exercise combined with nutritional support could reduce it.

The positive impact of adapted physical activity has been shown in numerous publications on reducing the incidence and risk of relapse for certain cancers (breast, colon prostate). It is less obvious in hematology in view of studies published on adapted physical activity . Adapted physical activity seems to provide a survival benefit in diffuse large cell B lymphoma however the number remains too low in this histology.

Sarcopenia is an often-underestimated event and is associated with older age, co-morbidities, increased infectious complications, and early mortality.

Correcting sarcopenia through appropriate physical activity could reduce its negative prognostic impact.

The aim of the study is to increase the event-free survival of patients in the RCHOP and adapted physical activity arm by 15% compared to the standard arm.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: Weprom

location_facility: Clinique Victor Hugo / Centre Jean Bernard

intervention_type: Other


title: Pharmaco-economic Cost-effective Prospective Randomized Trial Evaluating the Open Interest Caphosol ® Mouthwashes in the Prevention and Treatment of Severe Oral Mucositis in Patients Receiving High-dose Chemotherapy in Hematology

acronym: Caphosol

summary: The purpose of the study is to determine whether the use of mouthwashes Caphosol ™ in addition to standard oral care (strategy A) is cost-effective in the prevention and treatment of severe mucositis in adult patients with auto or allograft packaging without ICT versus mouthwashes standard bicarbonates with an antiseptic (strategy B).

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Nantes University Hospital

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Tolerance of "on Line" Hemodiafiltration and Impact on Morbidity and Cardiovascular Risk Factors in Chronic Renal Failure Patients

acronym: on-line-HDF

summary: The aim of this study is to appreciate the tolerance of "on line" hemodiafiltration and its impact on morbidity and cardiovascular risk factors in chronic renal failure patient.

primary_purpose: Treatment

lead_sponsor: University Hospital, Montpellier

intervention_type: Procedure


title: Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer

summary: An Expanded Access Program for IMM-101 for patients with advanced pancreatic cancer.

status: No longer available

study_type: Expanded Access

ReferenceCitation: Costa Neves M, Giakoustidis A, Stamp G, Gaya A, Mudan S. Extended Survival after Complete Pathological Response in Metastatic Pancreatic Ductal Adenocarcinoma Following Induction Chemotherapy, Chemoradiotherapy, and a Novel Immunotherapy Agent, IMM-101. Cureus. 2015 Dec 26;7(12):e435. doi: 10.7759/cureus.435.

ReferenceType: result

ReferenceCitation: Dalgleish AG, Stebbing J, Adamson DJ, Arif SS, Bidoli P, Chang D, Cheeseman S, Diaz-Beveridge R, Fernandez-Martos C, Glynne-Jones R, Granetto C, Massuti B, McAdam K, McDermott R, Martín AJ, Papamichael D, Pazo-Cid R, Vieitez JM, Zaniboni A, Carroll KJ, Wagle S, Gaya A, Mudan SS. Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer. Br J Cancer. 2016 Oct 25;115(9):e16. doi: 10.1038/bjc.2016.342. Epub 2016 Oct 11.

lead_sponsor: Impatients N.V. trading as myTomorrows

location_country:
France
United Kingdom

location_facility: France UK

intervention_type: Biological

status_simplified: Unknown


title: Frequency and Characteristics of Rehospitalizations During One Year After Percutaneous Coronary Intervention and Coronary Angiography - Results of the ACIRA Registry, Aquitaine Region

acronym: ACIRA-REHOSP

summary: Hospital readmission rate following percutaneous coronary interventions (PCI) or coronary angiographies (CAG) is a main indicator of quality of care and addresses economic issues. The aim of this study is to quantify the frequency and analyse the types of rehospitalizations and repeat revascularizations during one year after a PCI or a CAG. This information is needed to organize the health care pathway and to identify preventable rehospitalizations.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CH de Mont de Marsan
CH de Pau
CH de Perigueux
Clinique de St Augustin
Hôpital privé St Martin
Clinique de Caudéran les pins-francs
GCS Bayonne
CH de Libourne
Clinique Esquirol St Hilaire
CHU de Bordeaux
Clinique cardiologique d'Aressy


title: Randomized, Comparative Study to Assess the Effects of Cosmetic Lotion on Telogen Effluvium in Women Compared to a Control Group

summary:
Telogen effluvium (TE) is one of the most common causes of non-scarring diffuse hair loss, defined as global diminution of hair with no formation of areas completely bald.

Premature termination of anagen into catagen and telogen hair follicle is the main mechanism observed in TE. It results in increased, synchronized telogen shedding leading to a decrease in global hair density.

Acute telogen effluvium (ATE) has an abrupt onset and generalized scalp hair loss occurring 2-3 months after a triggering event, which could be unidentifiable in up to 33% cases.

The degree of effluvium depends on the severity, duration of exposure and the type of agent, that can be: emotional stress, hormonal changes in the postpartum period, high fever, surgery, surgical/accidental trauma, severe haemorrhage, chronic systemic illness, or immense psychological stress, changes in medication or crash-diets. A summer effect possibly ultraviolet (UV) light induced, manifesting itself in autumn can cause ATE. The incidence of TE is not known, although it is likely that most women will experience at least 1 episode of TE during a lifetime.

ATE can be diagnosed based on relevant medical and personal history and examination subjective complaints, clinical and physical exams or relevant investigations (hair pull test, phototrichogram, blood test…). ATE generates a lot of anxiety in the patient: significant impact on quality of life, self-esteem impairment, and stress increase. Thus, stress may act as a primary inducer; an aggravating factor or be a response to hair loss.

ATE usually remits within few months (3-4 to 6 months) in 95% of cases if the trigger is removed or treated. Complete recovery may take until 1 year. A resolving TE is characterized by the absence of hair shedding, a negative hair pull test and synchronized hair growth.

In this study, our aim is to assess the effects of the RV3466F lotion on hair growth, compared to a control group, with clinical and biometrological non- invasive methods on an adult female population with telogen effluvium.

primary_purpose: Supportive Care

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_facility:
Centre de santé SABOURAUD C.E.P.C
INTERTEK


title: Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication and Adherence in Emergency Ward

acronym: EDIFIP

summary: The purpose of this "before-after" prospective multicenter study is to assess the impact of six Patient Information Leaflets (PILs) on Doctor Patient Communication scale (DPC) and adherence scale for common acute illnesses in emergency ward.

design_allocation: Non-Randomized

ReferenceCitation: Sustersic M, Jeannet E, Cozon-Rein L, Maréchaux F, Genty C, Foote A, David-Tchouda S, Martinez L, Bosson JL. Impact of information leaflets on behavior of patients with gastroenteritis or tonsillitis: a cluster randomized trial in French primary care. J Gen Intern Med. 2013 Jan;28(1):25-31. doi: 10.1007/s11606-012-2164-8. Epub 2012 Jul 25.

ReferenceCitation: Sustersic M, Meneau A, Drémont R, Paris A, Laborde L, Bosson JL. [Developing patient information sheets in general practice. Proposal for a methodology]. Rev Prat. 2008 Dec 15;58(19 Suppl):17-24. French.

ReferenceCitation: Little P, Moore M, Kelly J, Williamson I, Leydon G, McDermott L, Mullee M, Stuart B; PIPS Investigators. Delayed antibiotic prescribing strategies for respiratory tract infections in primary care: pragmatic, factorial, randomised controlled trial. BMJ. 2014 Mar 6;348:g1606. doi: 10.1136/bmj.g1606.

ReferenceCitation: Coudeyre E, Tubach F, Rannou F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting. PLoS One. 2007 Aug 8;2(8):e706.

ReferenceCitation: Grime J, Blenkinsopp A, Raynor DK, Pollock K, Knapp P. The role and value of written information for patients about individual medicines: a systematic review. Health Expect. 2007 Sep;10(3):286-98. Review.

ReferenceCitation: Gauchet A, Tarquinio C, Fischer G. Psychosocial predictors of medication adherence among persons living with HIV. Int J Behav Med. 2007;14(3):141-50.

ReferenceCitation: Nicolson D, Knapp P, Raynor DK, Spoor P. Written information about individual medicines for consumers. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD002104. doi: 10.1002/14651858.CD002104.pub3. Review.

ReferenceCitation: Fox R. Informed choice in screening programmes: do leaflets help? A critical literature review. J Public Health (Oxf). 2006 Dec;28(4):309-17. Epub 2006 Oct 23. Review.

ReferenceCitation: Graham W, Smith P, Kamal A, Fitzmaurice A, Smith N, Hamilton N. Randomised controlled trial comparing effectiveness of touch screen system with leaflet for providing women with information on prenatal tests. BMJ. 2000 Jan 15;320(7228):155-60.

ReferenceCitation: Kenny T, Wilson RG, Purves IN, Clark J Sr, Newton LD, Newton DP, Moseley DV. A PIL for every ill? Patient information leaflets (PILs): a review of past, present and future use. Fam Pract. 1998 Oct;15(5):471-9. Review.

ReferenceCitation: Little P, Dorward M, Warner G, Moore M, Stephens K, Senior J, Kendrick T. Randomised controlled trial of effect of leaflets to empower patients in consultations in primary care. BMJ. 2004 Feb 21;328(7437):441. Epub 2004 Feb 13.

ReferenceCitation: Raynor DK, Blenkinsopp A, Knapp P, Grime J, Nicolson DJ, Pollock K, Dorer G, Gilbody S, Dickinson D, Maule AJ, Spoor P. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess. 2007 Feb;11(5):iii, 1-160. Review.

ReferenceCitation: Paris A, Cornu C, Auquier P, Maison P, Radauceanu A, Brandt C, Salvat-Melis M, Hommel M, Cracowski JL. French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical research. Fundam Clin Pharmacol. 2006 Feb;20(1):97-104.

ReferenceCitation: Zapata LB, Steenland MW, Brahmi D, Marchbanks PA, Curtis KM. Patient understanding of oral contraceptive pill instructions related to missed pills: a systematic review. Contraception. 2013 May;87(5):674-84. doi: 10.1016/j.contraception.2012.08.026. Epub 2012 Oct 4. Review.

ReferenceCitation: Ziegler A, Hadlak A, Mehlbeer S, König IR. Comprehension of the description of side effects in drug information leaflets: a survey of doctors, pharmacists and lawyers. Dtsch Arztebl Int. 2013 Oct;110(40):669-73. doi: 10.3238/arztebl.2013.0669. Epub 2013 Oct 4.

ReferenceCitation: Talen MR, Muller-Held CF, Eshleman KG, Stephens L. Patients' communication with doctors: a randomized control study of a brief patient communication intervention. Fam Syst Health. 2011 Sep;29(3):171-83. doi: 10.1037/a0024399.

ReferenceCitation: Macfarlane J, Holmes W, Gard P, Thornhill D, Macfarlane R, Hubbard R. Reducing antibiotic use for acute bronchitis in primary care: blinded, randomised controlled trial of patient information leaflet. BMJ. 2002 Jan 12;324(7329):91-4.

ReferenceCitation: Francis NA, Butler CC, Hood K, Simpson S, Wood F, Nuttall J. Effect of using an interactive booklet about childhood respiratory tract infections in primary care consultations on reconsulting and antibiotic prescribing: a cluster randomised controlled trial. BMJ. 2009 Jul 29;339:b2885. doi: 10.1136/bmj.b2885.

ReferenceCitation: Johnson A, Sandford J. Written and verbal information versus verbal information only for patients being discharged from acute hospital settings to home: systematic review. Health Educ Res. 2005 Aug;20(4):423-9. Epub 2004 Nov 30. Review.

ReferenceCitation: Johnson A, Sandford J, Tyndall J. Written and verbal information versus verbal information only for patients being discharged from acute hospital settings to home. Cochrane Database Syst Rev. 2003;(4):CD003716. Review.

ReferenceCitation: Little P, Rumsby K, Kelly J, Watson L, Moore M, Warner G, Fahey T, Williamson I. Information leaflet and antibiotic prescribing strategies for acute lower respiratory tract infection: a randomized controlled trial. JAMA. 2005 Jun 22;293(24):3029-35.

ReferenceCitation: Allenet B, Baudrant M, Lehmann A, Gauchet A, Roustit M, Bedouch P, Golay A. [How can we evaluate medication adherence? What are the methods?]. Ann Pharm Fr. 2013 Mar;71(2):135-41. doi: 10.1016/j.pharma.2012.10.001. Epub 2012 Nov 6. Review. French.

ReferenceCitation: DiMatteo MR. Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004 Mar;42(3):200-9.

ReferenceCitation: Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54.

ReferenceCitation: Wells FO. Patient information--the present and the future. J R Soc Med. 1990 May;83(5):300-2.

ReferenceCitation: Finnie RK, Felder TM, Linder SK, Mullen PD. Beyond reading level: a systematic review of the suitability of cancer education print and Web-based materials. J Cancer Educ. 2010 Dec;25(4):497-505. doi: 10.1007/s13187-010-0075-0. Review.

ReferenceCitation: Carré PC, Roche N, Neukirch F, Radeau T, Perez T, Terrioux P, Ostinelli J, Pouchain D, Huchon G. The effect of an information leaflet upon knowledge and awareness of COPD in potential sufferers. A randomized controlled study. Respiration. 2008;76(1):53-60. doi: 10.1159/000115947. Epub 2008 Feb 5.

ReferenceCitation: Heaney D, Wyke S, Wilson P, Elton R, Rutledge P. Assessment of impact of information booklets on use of healthcare services: randomised controlled trial. BMJ. 2001 May 19;322(7296):1218-21.

ReferenceCitation: Yardley L, Barker F, Muller I, Turner D, Kirby S, Mullee M, Morris A, Little P. Clinical and cost effectiveness of booklet based vestibular rehabilitation for chronic dizziness in primary care: single blind, parallel group, pragmatic, randomised controlled trial. BMJ. 2012 Jun 6;344:e2237. doi: 10.1136/bmj.e2237.

ReferenceCitation: Smith SK, Trevena L, Simpson JM, Barratt A, Nutbeam D, McCaffery KJ. A decision aid to support informed choices about bowel cancer screening among adults with low education: randomised controlled trial. BMJ. 2010 Oct 26;341:c5370. doi: 10.1136/bmj.c5370.

ReferenceCitation: Turpin G, Downs M, Mason S. Effectiveness of providing self-help information following acute traumatic injury: randomised controlled trial. Br J Psychiatry. 2005 Jul;187:76-82.

ReferenceCitation: Cunningham JA, Neighbors C, Wild C, Humphreys K. Ultra-brief intervention for problem drinkers: results from a randomized controlled trial. PLoS One. 2012;7(10):e48003. doi: 10.1371/journal.pone.0048003. Epub 2012 Oct 24.

ReferenceCitation: Felley C, Perneger TV, Goulet I, Rouillard C, Azar-Pey N, Dorta G, Hadengue A, Frossard JL. Combined written and oral information prior to gastrointestinal endoscopy compared with oral information alone: a randomized trial. BMC Gastroenterol. 2008 Jun 3;8:22. doi: 10.1186/1471-230X-8-22.

ReferenceCitation: Galaal K, Bryant A, Deane KH, Al-Khaduri M, Lopes AD. Interventions for reducing anxiety in women undergoing colposcopy. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD006013. doi: 10.1002/14651858.CD006013.pub3. Review.

ReferenceType: derived

ReferenceCitation: Sustersic M, Tissot M, Tyrant J, Gauchet A, Foote A, Vermorel C, Bosson JL. Impact of patient information leaflets on doctor-patient communication in the context of acute conditions: a prospective, controlled, before-after study in two French emergency departments. BMJ Open. 2019 Feb 20;9(2):e024184. doi: 10.1136/bmjopen-2018-024184.

lead_sponsor: Floralis

location_facility: Groupe Hospitalier Mutualiste, service des urgences


title: Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention (MBRP) and Unguided Meditative Relaxation in Patients With Alcohol Use Disorder

acronym: MBRP

summary: Alcohol use disorder (AUD) is the second highest preventable cause of death in France. Only 3% of patients are prescribed approved drugs for reducing alcohol consumption or maintenance of abstinence. Increasing evidence supports the efficacy of psychotherapies such as cognitive and behavioral therapies (CBT) in AUD. However, some patients are resistant to CBT and the positive effects of CBT could wane over time, resulting in mid- and long-term relapses. Mindfulness practice is increasingly widespread in the United States and its efficacy in various fields appears very promising. The study investigators hypothesize that the Mindfulness Based Relapse Prevention (MBRP) program will be more efficient than a relaxation/meditation without guidance control program in AUD.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Ssra Les Eumenides
CHU de Nantes
Hôpital Corentin-Celton
Le CSAPA - Association Charonne
Hopital Paul Brousse
CHU de Nimes

intervention_type: Behavioral


title: Impact of the Arrival on the French Market of New First Line Oral Treatments on the Delay Between MS Onset and First Disease Modifying Treatment (DMTs) Administration

acronym: PREMISEP

summary:
The study design matches with a multicenter observational ambispective study. A first pilot study will be undertaken in Caen center and is expected to be extended to Rouen and Lille center. So patients from Normandy and North-West areas will be included.

In order to include patients in this observational study historical data about first line injectable treatments (interferons and glatiramer acetate) are used. As well as the data on patients treated with oral first line therapies (teriflunomide and dimethyl fumarate) began to be collected ahead of the study start (Retrospective phase). During the course of the study, new patients under teriflunomide or dimethyl fumarate will be included (Prospective phase).

time_perspective: Other

lead_sponsor: University Hospital, Caen

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille (HICL)


title: Protocol of Herceptin Adjuvant With Reduced Exposure, a Randomised Comparison of 6 Months vs 12 Months in All Women Receiving Adjuvant Herceptin [PHARE]

summary:
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving trastuzumab for 6 months is as effective as giving trastuzumab for 1 year in treating patients with breast cancer.

PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works when given for 6 months compared to 12 months in treating women with nonmetastatic breast cancer that can be removed by surgery.

ReferenceCitation: Pivot X, Romieu G, Debled M, Pierga JY, Kerbrat P, Bachelot T, Lortholary A, Espié M, Fumoleau P, Serin D, Jacquin JP, Jouannaud C, Rios M, Abadie-Lacourtoisie S, Venat-Bouvet L, Cany L, Catala S, Khayat D, Gambotti L, Pauporté I, Faure-Mercier C, Paget-Bailly S, Henriques J, Grouin JM; PHARE trial investigators. 6 months versus 12 months of adjuvant trastuzumab in early breast cancer (PHARE): final analysis of a multicentre, open-label, phase 3 randomised trial. Lancet. 2019 Jun 29;393(10191):2591-2598. doi: 10.1016/S0140-6736(19)30653-1. Epub 2019 Jun 6.

ReferenceCitation: Jacquinot Q, Paget-Bailly S, Fumoleau P, Romieu G, Pierga JY, Espié M, Lortholary A, Nabholtz JM, Mercier CF, Pauporté I, Henriques J, Pivot X. Fluctuation of the left ventricular ejection fraction in patients with HER2-positive early breast cancer treated by 12 months of adjuvant trastuzumab. Breast. 2018 Oct;41:1-7. doi: 10.1016/j.breast.2018.06.001. Epub 2018 Jun 15.

ReferenceCitation: Curtit E, Pivot X, Henriques J, Paget-Bailly S, Fumoleau P, Rios M, Bonnefoi H, Bachelot T, Soulié P, Jouannaud C, Bourgeois H, Petit T, Tennevet I, Assouline D, Mathieu MC, Jacquin JP, Lavau-Denes S, Darut-Jouve A, Ferrero JM, Tarpin C, Lévy C, Delecroix V, Trillet-Lenoir V, Cojocarasu O, Meunier J, Pierga JY, Kerbrat P, Faure-Mercier C, Blanché H, Sahbatou M, Boland A, Bacq D, Besse C, Thomas G, Deleuze JF, Pauporté I, Romieu G, Cox DG. Assessment of the prognostic role of a 94-single nucleotide polymorphisms risk score in early breast cancer in the SIGNAL/PHARE prospective cohort: no correlation with clinico-pathological characteristics and outcomes. Breast Cancer Res. 2017 Aug 22;19(1):98. doi: 10.1186/s13058-017-0888-4.

ReferenceCitation: Pivot X, Fumoleau P, Pierga JY, Delaloge S, Bonnefoi H, Bachelot T, Jouannaud C, Bourgeois H, Rios M, Soulié P, Jacquin JP, Lavau-Denes S, Kerbrat P, Cox D, Faure-Mercier C, Pauporte I, Gligorov J, Curtit E, Henriques J, Paget-Bailly S, Romieu G. Superimposable outcomes for sequential and concomitant administration of adjuvant trastuzumab in HER2-positive breast cancer: Results from the SIGNAL/PHARE prospective cohort. Eur J Cancer. 2017 Aug;81:151-160. doi: 10.1016/j.ejca.2017.05.020. Epub 2017 Jun 16.

ReferenceCitation: Pivot X, Suter T, Nabholtz JM, Pierga JY, Espie M, Lortholary A, Khayat D, Pauporte I, Romieu G, Kramar A, Fumoleau P. Cardiac toxicity events in the PHARE trial, an adjuvant trastuzumab randomised phase III study. Eur J Cancer. 2015 Sep;51(13):1660-6. doi: 10.1016/j.ejca.2015.05.028. Epub 2015 Jul 7.

ReferenceCitation: Kramar A, Bachelot T, Madrange N, Pierga JY, Kerbrat P, Espié M, Fumoleau P, Pauporté I, Khayat D, Romieu G, Pivot X. Trastuzumab duration effects within patient prognostic subgroups in the PHARE trial. Ann Oncol. 2014 Aug;25(8):1563-70. doi: 10.1093/annonc/mdu177. Epub 2014 May 14.

ReferenceCitation: Pivot X, Romieu G, Debled M, Pierga JY, Kerbrat P, Bachelot T, Lortholary A, Espié M, Fumoleau P, Serin D, Jacquin JP, Jouannaud C, Rios M, Abadie-Lacourtoisie S, Tubiana-Mathieu N, Cany L, Catala S, Khayat D, Pauporté I, Kramar A; PHARE trial investigators. 6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial. Lancet Oncol. 2013 Jul;14(8):741-8. doi: 10.1016/S1470-2045(13)70225-0. Epub 2013 Jun 11.

lead_sponsor: National Cancer Institute, France

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

location_facility: Centre de Radiologie et de Traitement des Tumeurs

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre de Radiotherapie et Oncologie Saint-Faron

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Hospital General Robert Ballanger

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Intercommunal de Poissy


title: Predictive Factors Associated With Impairment in Functional Autonomy in a Regional Real-life Cohort of Patients With Alzheimer's Disease or Related Disorders (ADRD)

acronym: MEM-AURA

summary:
The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The Investigators aim at developing a regional database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative staff and with the University hospital computer science departments.

The main objective is to study the predictive factors associated with change in functional autonomy level, measured every 6 to 12 months in centres across Region Auvergne Rhone-Alpes in France.

The real-life study population will consist in about 5400 patients with ADRD. The inclusion period will be of 3 years, the length of follow-up of each patient will be of 10 years max for a total study length of 13 years.

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de neuro-cognition et neuro-ophtalmologie du Groupement Hospitalier Est

location_facility: Centre Mémoire de Ressources et de Recherche de Lyon


title: Prospective, Controlled, Multicenter Cohort Study Evaluating the Benefit of Allogeneic Haematopoietic Stem Cells in Cutaneous T-cell Lymphomas Epidermotropic With Advanced Stage and Poor Prognosis

acronym: CUTALLO

summary: Epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant, Sézary syndrome, are the most frequent subtypes of cutaneous T-cell lymphomas. MF typically runs an indolent course in its early stages. By contrast, advanced-stage ETCLs share a very bad prognosis: Patients usually show early relapses after chemotherapy, prolonged complete remissions exceptionally occur and quality of life is severely affected. Several publications have reported durable responses following allogeneic hematopoietic stem cell transplantation (HSCT) in advanced-stage ETCLs. This study aims to investigate the role of allogeneic HSCT in treating advanced-stage ETCLs. An observational, prospective, multicenter, controlled study will compare the outcomes of patients who receive reduced-intensity conditioned allogeneic HSCT from a sibling or 10/10 HLA-matched unrelated donor to those of patients who receive standard of care in patients with advanced-stage ETCL with poor prognostic features, will be performed. Patients are included at the time of donor search irrespective of the results, and compared on a donor versus no donor basis. It is an observational study since no intervention is made except the comparison of outcomes of groups that receive usual care (HSCT if donor available, or not).

status: Active, not recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evaluation of Predictive Factors for Ruptures of Meije Duo ™ Size 1 and 2 Femoral Stems in Hip Replacement Surgery

acronym: MEIJE

summary:
A normative development concerning the mechanical resistance tests of the the femoral stems led to contraindicate, in September 2014, to implant Meije Duo ™ femoral stems size 1 or 2 in patients weighing more than 60 kg due to an assumed risk of femoral stem breakage.

This contraindication is based on standardized mechanical tests which may have not taken into account the changes in patient weight that may occur after the intervention.

To date, investigators have not been aware of any Meije Duo ™ size 1/2 brakeage in our patients implanted with this type of prosthesis regardless of their weights before 2014. However, it is possible that some of them have had a prostheses failure and consulted another hospital. In the absence of a clinical study on this problem, investigators decided to set up a health care assessment study collecting retrospective and prospective information from our patients.

ReferenceCitation: Wroblewski BM, Siney PD, Fleming PA. Increasing patients' body mass. Are the criteria for testing stemmed femoral components in total hip arthroplasty still valid? Proc Inst Mech Eng H. 2007 Nov;221(8):959-61.

ReferenceCitation: Silva M, Shepherd EF, Jackson WO, Dorey FJ, Schmalzried TP. Average patient walking activity approaches 2 million cycles per year: pedometers under-record walking activity. J Arthroplasty. 2002 Sep;17(6):693-7.

ReferenceCitation: Westerman AP, Moor AR, Stone MH, Stewart TD. Hip stem fatigue: : The implications of increasing patient mass. Proc Inst Mech Eng H. 2018 May;232(5):520-530. doi: 10.1177/0954411918767200. Epub 2018 Apr 2.

lead_sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Groupe Hospitalier Diaconesses Croix saint Simon

location_facility: Groupe Hospitalier Dianconesses croix saint Simon


type: Registry Identifier

title: A Multi-center, Prospective, Randomized Crossover Study With the NightBalance SPT Compared to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)

acronym: SOS

summary: Comparison of the NightBalance Sleep Position Trainer (SPT) to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA). Primary Objective: Efficacy and Adherence of the SPT over 3 months of use compared to PAP for the treatment of POSA. The study is run from centers in France, the UK and Germany.

status: Suspended

lead_sponsor: Philips Clinical & Medical Affairs Global

location_country:
Germany
France
United Kingdom

location_facility: Hôpital Universitaire Pitié - Salpêtrière (UPMC)

location_facility: Guy's and St Thomas' NHS Foundation Trust (GSTT)

location_facility: Centre Hospitalier Universitaire Bordeaux


title: Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition

summary:
The therapeutic management of patients with cancer often requires the establishment of a chamber implantable catheter. Infections are the main complication of these catheters. These infections may be responsible for a significant impairment of quality of life for patients, and may increase the frequency and duration of hospitalizations. The rate of mortality from these infections is about 17%. The objective of this study is to evaluate the efficacy of a 1.35% taurolidine lock / 4% citrate (TauroLock®) in the primary prevention of infections related to chambers implantable catheter (IRCIC) in cancer patients receiving parenteral nutrition.

This is a, randomized, double-blind clinical trial comparing the incidence of IRCIC in patients receiving Taurolidine lock or concession the usual procedure of rinsing with saline (placebo) (pulsed rinsing with 20 mL of serum physiological and clamping catheter positive pressure). The lock will be instilled after the end of the session IV treatment (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. The primary endpoint will be the rate IRCIC in both groups.

status: Unknown status

location_facility:
Groupement Hospitalier Lyon Sud
Hôpital Edouard Herriot
Hôpital de la Croix Rousse


title: Optimization of the Preservation of Muscle Mass and / or Its Recovery by a Protein-energy Chrononutrition Approach Dissociated From Meals

acronym: CARBOPTIMUS

summary:
Muscle wasting has a multifactorial origin, including decreased physical activity, malnutrition, loss of post-incident muscle recovery abilities, and decreased ability to regenerate muscle. Among the strategies tested to improve the production of proteins and thus muscle is the supplementation of whey proteins. However this strategy does not seem sufficient and optimal to avoid muscle wasting and it must be complemented by a complementary action.

Muscle protein degradation also occurs during the nocturnal fasting periods to provide amino acids for energy purposes and to produce glucose, essential for vital organs. The preservation of the benefit of whey intake during meals could therefore be optimized by reducing the use of muscle proteins for energy purposes during the night.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
EHPAD Cité des Aînés
EHPAD L'Adret
EHPAD Valbenoite
EHPAD Les Tilleuls
EHPAD Le Soleil
EHPAD Bernadette
EHPAD Le Val Dorlay
EHPAD Les Myosotis
Chu Saint-Etienne
EHPAD Bellevue
EHPAD La Cerisaie

intervention_type: Dietary Supplement


title: Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM

acronym: RAPID XT

summary:
Post Marketing study, Interventional, Prospective, non randomised

Describe how the MD is using the information of the ICM in addition of standard FU(clinical exam and holter 24h)post AF ablation(1 year FU).

lead_sponsor: Dr Ange FERRACCI


title: Underreporting of Occupational Blood Exposure (OBE) Among Medical Staff at an University Hospital Center (UHC) in 2017

summary: Regarding 30 to 50% of occupational blood exposure (OBE) are underreporting among health professionals, it's to highlight that the part of medical professionals in OBE reporting is among the lowest (1996 to 2016). The current study is aiming to evaluate the underreporting of this specific occupational accident among medical staff for the year 2017. The investigators are supposing this is declining and the part of OBE reporting is better than before. So the current situation concerning OBE underreporting for medical staff in an University Hospital Center (UHC), 20 years after the first study, is our main purpose.

time_perspective: Cross-Sectional

location_facility:
CHU Grenoble Alpes
CHU de Saint-Etienne
CHU Clermont-Ferrand
Groupement Hospitalier Sud


title: Effects of Mesenchymal Stem Cells Administration on Organ Failure During Septic Shock: Phase II Randomized Comparator-controlled Study

acronym: CHOCMSC

summary: The main purpose at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group. The secondary purpose is to assess the role of heterologous mesenchymal stem cells on the occurrence and duration of failure of each organ and on the mortality at day 28 and day 90. The safety of administration will be also assessed.

study_start_date_type: Anticipated

lead_sponsor: Central Hospital, Nancy, France

location_facility: Hôpital Hautepierre, Service de réanimation médicale

location_facility: Service de Réanimation Médicale, Hôpital Central

location_facility: Service de Réanimation Médicale, Hôpital Bocage


title: European Ambispective Cohort of Rectal Cancer Patient Who Underwent Robotic Low Anterior Resection

summary: The laparoscopic approach for total mesorectal excision (L-TME) results improved short-term outcomes. However this approach has technical limitations when the pelvis is narrow and deep. Indeed there is a limited mobility of straight laparoscopic instruments and associated loss of dexterity, unstable camera view and compromised ergonomics for the surgeon. Robotic technology was developed to reduce these limitations and offers the advantages of intuitive manipulation of laparoscopic instruments with wrist articulation, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement and an ergonomic operating environment. A major advantage of the robotic approach is the surgeon's simultaneous control of the camera and of the two or three additional instruments. This advantage facilitates traction and counter-traction. The technological advantages of robotic surgery should also allow a finer dissection in a narrow pelvic cavity.

primary_purpose: Other

ReferenceCitation: Green BL, Marshall HC, Collinson F, Quirke P, Guillou P, Jayne DG, Brown JM. Long-term follow-up of the Medical Research Council CLASICC trial of conventional versus laparoscopically assisted resection in colorectal cancer. Br J Surg. 2013 Jan;100(1):75-82. doi: 10.1002/bjs.8945. Epub 2012 Nov 6.

ReferenceCitation: van der Pas MH, Haglind E, Cuesta MA, Fürst A, Lacy AM, Hop WC, Bonjer HJ; COlorectal cancer Laparoscopic or Open Resection II (COLOR II) Study Group. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013 Mar;14(3):210-8. doi: 10.1016/S1470-2045(13)70016-0. Epub 2013 Feb 6.

ReferenceCitation: Rouanet P, Mourregot A, Azar CC, Carrere S, Gutowski M, Quenet F, Saint-Aubert B, Colombo PE. Transanal endoscopic proctectomy: an innovative procedure for difficult resection of rectal tumors in men with narrow pelvis. Dis Colon Rectum. 2013 Apr;56(4):408-15. doi: 10.1097/DCR.0b013e3182756fa0.

ReferenceCitation: Fernández-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Díaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865.

ReferenceCitation: Sylla P, Rattner DW, Delgado S, Lacy AM. NOTES transanal rectal cancer resection using transanal endoscopic microsurgery and laparoscopic assistance. Surg Endosc. 2010 May;24(5):1205-10. doi: 10.1007/s00464-010-0965-6. Epub 2010 Feb 26.

ReferenceCitation: Atallah S, Martin-Perez B, Albert M, deBeche-Adams T, Nassif G, Hunter L, Larach S. Transanal minimally invasive surgery for total mesorectal excision (TAMIS-TME): results and experience with the first 20 patients undergoing curative-intent rectal cancer surgery at a single institution. Tech Coloproctol. 2014 May;18(5):473-80. doi: 10.1007/s10151-013-1095-7. Epub 2013 Nov 23.

ReferenceCitation: D'Annibale A, Pernazza G, Monsellato I, Pende V, Lucandri G, Mazzocchi P, Alfano G. Total mesorectal excision: a comparison of oncological and functional outcomes between robotic and laparoscopic surgery for rectal cancer. Surg Endosc. 2013 Jun;27(6):1887-95. doi: 10.1007/s00464-012-2731-4. Epub 2013 Jan 5.

ReferenceCitation: Kwak JM, Kim SH, Kim J, Son DN, Baek SJ, Cho JS. Robotic vs laparoscopic resection of rectal cancer: short-term outcomes of a case-control study. Dis Colon Rectum. 2011 Feb;54(2):151-6. doi: 10.1007/DCR.0b013e3181fec4fd.

ReferenceCitation: Park JS, Choi GS, Lim KH, Jang YS, Jun SH. Robotic-assisted versus laparoscopic surgery for low rectal cancer: case-matched analysis of short-term outcomes. Ann Surg Oncol. 2010 Dec;17(12):3195-202. doi: 10.1245/s10434-010-1162-5. Epub 2010 Jun 30.

ReferenceCitation: Patel CB, Ragupathi M, Ramos-Valadez DI, Haas EM. A three-arm (laparoscopic, hand-assisted, and robotic) matched-case analysis of intraoperative and postoperative outcomes in minimally invasive colorectal surgery. Dis Colon Rectum. 2011 Feb;54(2):144-50. doi: 10.1007/DCR.0b013e3181fec377.

ReferenceCitation: Bianchi PP, Ceriani C, Locatelli A, Spinoglio G, Zampino MG, Sonzogni A, Crosta C, Andreoni B. Robotic versus laparoscopic total mesorectal excision for rectal cancer: a comparative analysis of oncological safety and short-term outcomes. Surg Endosc. 2010 Nov;24(11):2888-94. doi: 10.1007/s00464-010-1134-7. Epub 2010 Jun 5.

ReferenceCitation: Popescu I, Vasilescu C, Tomulescu V, Vasile S, Sgarbura O. The minimally invasive approach, laparoscopic and robotic, in rectal resection for cancer. A single center experience. Acta Chir Iugosl. 2010;57(3):29-35.

ReferenceCitation: Lin S, Jiang HG, Chen ZH, Zhou SY, Liu XS, Yu JR. Meta-analysis of robotic and laparoscopic surgery for treatment of rectal cancer. World J Gastroenterol. 2011 Dec 21;17(47):5214-20. doi: 10.3748/wjg.v17.i47.5214.

ReferenceCitation: Trastulli S, Farinella E, Cirocchi R, Cavaliere D, Avenia N, Sciannameo F, Gullà N, Noya G, Boselli C. Robotic resection compared with laparoscopic rectal resection for cancer: systematic review and meta-analysis of short-term outcome. Colorectal Dis. 2012 Apr;14(4):e134-56. doi: 10.1111/j.1463-1318.2011.02907.x. Review.

ReferenceCitation: Memon S, Heriot AG, Murphy DG, Bressel M, Lynch AC. Robotic versus laparoscopic proctectomy for rectal cancer: a meta-analysis. Ann Surg Oncol. 2012 Jul;19(7):2095-101. doi: 10.1245/s10434-012-2270-1. Epub 2012 Feb 16.

ReferenceCitation: Yang Y, Wang F, Zhang P, Shi C, Zou Y, Qin H, Ma Y. Robot-assisted versus conventional laparoscopic surgery for colorectal disease, focusing on rectal cancer: a meta-analysis. Ann Surg Oncol. 2012 Nov;19(12):3727-36. doi: 10.1245/s10434-012-2429-9. Epub 2012 Jul 3.

ReferenceCitation: González Fernández AM, Mascareñas González JF. [Total laparoscopic mesorectal excision versus robot-assisted in the treatment of rectal cancer: a meta-analysis]. Cir Esp. 2012 Jun-Jul;90(6):348-54. doi: 10.1016/j.ciresp.2012.03.004. Epub 2012 Apr 24. Spanish.

ReferenceCitation: Ortiz-Oshiro E, Sánchez-Egido I, Moreno-Sierra J, Pérez CF, Díaz JS, Fernández-Represa JÁ. Robotic assistance may reduce conversion to open in rectal carcinoma laparoscopic surgery: systematic review and meta-analysis. Int J Med Robot. 2012 Sep;8(3):360-70. doi: 10.1002/rcs.1426. Epub 2012 Mar 22. Review.

ReferenceCitation: Xiong B, Ma L, Zhang C, Cheng Y. Robotic versus laparoscopic total mesorectal excision for rectal cancer: a meta-analysis. J Surg Res. 2014 May 15;188(2):404-14. doi: 10.1016/j.jss.2014.01.027. Epub 2014 Jan 22.

ReferenceCitation: Son GM, Kim JG, Lee JC, Suh YJ, Cho HM, Lee YS, Lee IK, Chun CS. Multidimensional analysis of the learning curve for laparoscopic rectal cancer surgery. J Laparoendosc Adv Surg Tech A. 2010 Sep;20(7):609-17. doi: 10.1089/lap.2010.0007.

ReferenceCitation: Kim HJ, Choi GS, Park JS, Park SY. Multidimensional analysis of the learning curve for robotic total mesorectal excision for rectal cancer: lessons from a single surgeon's experience. Dis Colon Rectum. 2014 Sep;57(9):1066-74. doi: 10.1097/DCR.0000000000000174.

ReferenceCitation: Jiménez-Rodríguez RM, Díaz-Pavón JM, de la Portilla de Juan F, Prendes-Sillero E, Dussort HC, Padillo J. Learning curve for robotic-assisted laparoscopic rectal cancer surgery. Int J Colorectal Dis. 2013 Jun;28(6):815-21. doi: 10.1007/s00384-012-1620-6. Epub 2012 Dec 15.

ReferenceCitation: Kuo LJ, Lin YK, Chang CC, Tai CJ, Chiou JF, Chang YJ. Clinical outcomes of robot-assisted intersphincteric resection for low rectal cancer: comparison with conventional laparoscopy and multifactorial analysis of the learning curve for robotic surgery. Int J Colorectal Dis. 2014 May;29(5):555-62. doi: 10.1007/s00384-014-1841-y. Epub 2014 Feb 23.

ReferenceCitation: Baek JH, Pastor C, Pigazzi A. Robotic and laparoscopic total mesorectal excision for rectal cancer: a case-matched study. Surg Endosc. 2011 Feb;25(2):521-5. doi: 10.1007/s00464-010-1204-x. Epub 2010 Jul 7.

ReferenceCitation: Park YA, Kim JM, Kim SA, Min BS, Kim NK, Sohn SK, Lee KY. Totally robotic surgery for rectal cancer: from splenic flexure to pelvic floor in one setup. Surg Endosc. 2010 Mar;24(3):715-20. doi: 10.1007/s00464-009-0656-3. Epub 2009 Aug 18.

ReferenceCitation: Speicher PJ, Englum BR, Ganapathi AM, Nussbaum DP, Mantyh CR, Migaly J. Robotic Low Anterior Resection for Rectal Cancer: A National Perspective on Short-term Oncologic Outcomes. Ann Surg. 2015 Dec;262(6):1040-5. doi: 10.1097/SLA.0000000000001017.

ReferenceCitation: Tuech JJ, Karoui M, Lelong B, De Chaisemartin C, Bridoux V, Manceau G, Delpero JR, Hanoun L, Michot F. A step toward NOTES total mesorectal excision for rectal cancer: endoscopic transanal proctectomy. Ann Surg. 2015 Feb;261(2):228-33. doi: 10.1097/SLA.0000000000000994.

ReferenceCitation: Wolthuis AM, de Buck van Overstraeten A, D'Hoore A. Dynamic article: transanal rectal excision: a pilot study. Dis Colon Rectum. 2014 Jan;57(1):105-9. doi: 10.1097/DCR.0000000000000008.

ReferenceCitation: Dumont F, Goéré D, Honoré C, Elias D. Transanal endoscopic total mesorectal excision combined with single-port laparoscopy. Dis Colon Rectum. 2012 Sep;55(9):996-1001. doi: 10.1097/DCR.0b013e318260d3a0.

ReferenceCitation: Zorron R, Phillips HN, Coelho D, Flach L, Lemos FB, Vassallo RC. Perirectal NOTES access: "down-to-up" total mesorectal excision for rectal cancer. Surg Innov. 2012 Mar;19(1):11-9. doi: 10.1177/1553350611409956. Epub 2011 Jul 7.

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

location_country: France Monaco Belgium

location_facility: Institut régional du cancer de Montpellier


title: Phase III Study Evaluating Two Strategies of Maintenance, One With Pemetrexed in Continuous Strategy and One According to the Response of Induction Chemotherapy, in Non Squamous Non Small Cell Lung Cancer of Advanced Stage

summary:
In France, lung cancer is responsible for more than 30000 each year. Progress was made in treatment of lung cancer in the last five years due to targeted therapies and to strategical evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of this strategical evolution. It is based on maintaining continuous therapeutical pression in order to preserve the therapeutical benefit obtained by the first line (induction chemotherapy). Several clinical trials showed that maintenance strategies increase the duration of controlled disease.

There is two types of maintenance strategies:

Continuous maintenance : prolongation of the treatment initially associated with platin until progression
Switch maintenance : introduction of a new treatment after the end of induction chemotherapy

The aim of this study is to compare two maintenance strategies

A continuous maintenance by pemetrexed
A switch maintenance or a continuous maintenance according to the response of induction chemotherapy.

ReferenceCitation: Souquet PJ, Audigier-Valette C, Molinier O, Cortot A, Margery J, Moreau L, Gervais R, Barlesi F, Pichon E, Zalcman G, Dumont P, Girard N, Poudenx M, Mazieres J, Cadranel J, Debieuvre D, Dauba J, Langlais A, Morin F, Moro-Sibilot D, Westeel V, Perol M. Tailoring maintenance chemotherapy upon response to induction chemotherapy as compared with pemetrexed continuation maintenance in advanced non-squamous NSCLC patients: Results of the IFCT-GFPC-1101 multicenter randomized phase III trial. Lung Cancer. 2022 Feb;164:84-90. doi: 10.1016/j.lungcan.2021.11.014. Epub 2021 Nov 30.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques


title: A Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose Escalation Trial to Explore the Potential Antidyskinetic Properties of Safinamide in Patients With Parkinson's Disease Suffering From Levodopa Induced Dyskinesias

acronym: Safinamide-LID

summary: Approximately twenty four (24) subjects will participate in this research trial. The research trial will be conducted in approximately twelve (12) medical centers in the following countries: Germany, France, South Africa, Austria and Canada. The research trial will last until December 2011.

lead_sponsor: Newron Pharmaceuticals SPA

location_country:
Austria
Canada
France
South Africa
Germany

location_facility: St. Josef Hospital, Klinik für Neurologie

location_facility: Quebec Memory and Motor Skills Disorders

location_facility: Medical University Innsbruck, Dept. of Neurology

location_facility: Medical University Graz, Klinische Abteilung für Spezielle Neurologie


title: Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients

acronym: DIACOBHR

summary:
The propias, and more recently the update of the recommendations relating to the control of the spread of bacteria highly resistant to emerging antibiotics issued by the High Council of Public Health (December 2019), recommend the implementation of measures to maintain the rate of Carbapenemase-producing Enterobacteriaceae (EPC) such as Klebsiella pneumoniae (K. pneumoniae) isolated from bacteremia in healthcare establishments in France at less than 1%, and that of Vancomycin Resistant Enterococcus (VRE) belonging to Enterococci Resistant to Glycopeptides (ERG) such as Enterococcus faecium isolated from bacteremia in health establishments in France at less than 1% also. At the same time, the prevalence of colonized patients is increasing. One of the recommended measures concerns the fight against cross transmission.

Due to the high technicality of the treatments, the risks of cross-transmission are very high and present at each stage of the dialysis procedure. Screening and isolation of patients colonized with emerging Highly Resistant Bacteria (BHRe) is essential to avoid their spread and the risk of infection with these germs.

Screening is done using rectal swabs. If the patient is found to be a carrier of BHRe, he should be isolated. Isolation is made more difficult in the hemodialysis room due to their architectural configuration, the organization of care and the chronicity of the patients. Patients have a monthly sample.

The isolation is allowed after obtaining six consecutive negative rectal swabs, the number of which has been arbitrarily defined. Indeed, the negativation of the samples does not confirm the disappearance of the carriage (that is to say the presence of BHRe), hence the need to repeat them. Persistence of colonization at a rate below the detection limit is possible. With for corollaries:

Isolation which could be lifted more quickly in the event of real disappearance of the strain since the investigators know that a prolonged period of isolation can lead to a loss of opportunity for the patient and the investigators know its impact for the patient, on the operation of the service and its cost, with in particular the increase in withdrawals.
Isolation lifted too early in the event of persistent carriage with risk of secondary transmission.

The interest of this study is to determine the clearance of the carriage of BHRe, i.e. their disappearance, in the chronic dialysis patient and to define, secondly, the factors associated with the prolonged carriage corresponding to the presence of bacteria for more than 3 months. , and elements of answer concerning the early disappearance of the EPC in the event of co-colonization by ERG and EPC. The follow-up of this carriage for 1 year will make it possible to evaluate the relapse corresponding to the reappearance of the bacteria previously identified, the recolonization corresponding to the acquisition of a new BHR, or the reinfection corresponding to an infection with a new highly resistant bacterium.

ReferenceCitation: Fournier S, Brossier F, Fortineau N, Gillaizeau F, Akpabie A, Aubry A, Barbut F, Chedhomme FX, Kassis-Chikhani N, Lucet JC, Robert J, Seytre D, Simon I, Vanjak D, Zahar JR, Brun-Buisson C, Jarlier V. Long-term control of vancomycin-resistant Enterococcus faecium at the scale of a large multihospital institution: a seven-year experience. Euro Surveill. 2012 Jul 26;17(30). pii: 20229.

ReferenceCitation: Davido B, Moussiegt A, Dinh A, Bouchand F, Matt M, Senard O, Deconinck L, Espinasse F, Lawrence C, Fortineau N, Saleh-Mghir A, Caballero S, Escaut L, Salomon J. Germs of thrones - spontaneous decolonization of Carbapenem-Resistant Enterobacteriaceae (CRE) and Vancomycin-Resistant Enterococci (VRE) in Western Europe: is this myth or reality? Antimicrob Resist Infect Control. 2018 Aug 13;7:100. doi: 10.1186/s13756-018-0390-5. eCollection 2018.

ReferenceCitation: Zahar JR, Garrouste-Orgeas M, Vesin A, Schwebel C, Bonadona A, Philippart F, Ara-Somohano C, Misset B, Timsit JF. Impact of contact isolation for multidrug-resistant organisms on the occurrence of medical errors and adverse events. Intensive Care Med. 2013 Dec;39(12):2153-60. doi: 10.1007/s00134-013-3071-0. Epub 2013 Aug 31.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility:
AURA Paris Site de Saint Ouen
Groupe Hospitalier Paris Saint-Joseph
AURA Bichat
AURA Corentin Celton
AURA Paris Plaisance


title: Comparison of Efficacity of Simple Aspiration Versus Standard Drainage in the Management of Large Size Primary Spontaneous Pneumothorax

acronym: EXPRED

summary: Management of primary spontaneous pneumothorax (PSP) remains unclear. Primary therapeutic goals for PSP include removal of air from the pleural space an prevention of recurrences. The absence of generally accepted and methodologically sound recommendations may account for the extensive variation in practice for air evacuation techniques. Air evacuation may be achieved by simple aspiration (exsufflation) or conventional chest tube drainage. Chest tube thoracotomy remains the most popular technique.Aspiration is a more simple technique, that allows possibility of ambulatory management. The purpose of the present study is to compare simple aspiration performed with a specific thoracentesis device, versus conventional chest tube drainage. Comparison will be performed on immediate efficacity of resolution of the pneumothorax.The hypothesis is that simple aspiration performed with a specific device is not inferior to chest tube drainage for management of a first episode of large size primary spontaneous pneumothorax. A second goal is to measure the efficacy at one week, and the recidive at one year. The trial is randomized, controlled and will include 200 patients for each group. The patients will be enrolled in 29 hospitals in France. Emergency department, thoracic surgery and pulmonary departments of each hospital were primarily contacted for agreement to participate to the study.

ReferenceCitation: Desmettre T, Meurice JC, Kepka S, Dalphin JC. [Treatment of first spontaneous pneumothorax: drainage or exsufflation?]. Rev Mal Respir. 2011 Jan;28(1):5-8. doi: 10.1016/j.rmr.2010.10.028. Epub 2011 Jan 12. Review. French.

ReferenceCitation: Desmettre T, Meurice JC, Mauny F, Woronoff MC, Tiffet O, Schmidt J, Ferretti G, Dalphin JC. [Comparison of simple aspiration versus standard drainage in the treatment of large primary spontaneous pneumothorax]. Rev Mal Respir. 2011 Mar;28(3):336-43. doi: 10.1016/j.rmr.2010.10.030. Epub 2011 Mar 10. French.

ReferenceCitation: Desmettre T, Meurice JC, Tapponnier R, Pretalli JB, Dalphin JC. [The EXPRED study: where are we?]. Rev Mal Respir. 2013 Jan;30(1):18-21. doi: 10.1016/j.rmr.2012.09.019. Epub 2012 Nov 13. French.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Intercommunal de la Haute Saône


title: Assessment of the Comparative Effect of Donepezil 10mg/d and Placebo on Clinical and Radiological Markers in Patients With Mild Cognitive Disorders

summary: The purpose of this study is to demonstrate that donepezil slows the progression of Alzheimer's disease (AD) using magnetic resonance imaging (MRI) of the brain to measure the volume of the hippocampus in patients with pre-dementia Alzheimer's disease.

ReferenceCitation: Cavedo E, Dubois B, Colliot O, Lista S, Croisile B, Tisserand GL, Touchon J, Bonafe A, Ousset PJ, Rouaud O, Ricolfi F, Vighetto A, Pasquier F, Galluzzi S, Delmaire C, Ceccaldi M, Girard N, Lehericy S, Duveau F, Chupin M, Sarazin M, Dormont D, Hampel H; Hippocampus Study Group. Reduced Regional Cortical Thickness Rate of Change in Donepezil-Treated Subjects With Suspected Prodromal Alzheimer's Disease. J Clin Psychiatry. 2016 Dec;77(12):e1631-e1638. doi: 10.4088/JCP.15m10413.

ReferenceCitation: Teipel SJ, Cavedo E, Grothe MJ, Lista S, Galluzzi S, Colliot O, Chupin M, Bakardjian H, Dormont D, Dubois B, Hampel H; Hippocampus Study Group. Predictors of cognitive decline and treatment response in a clinical trial on suspected prodromal Alzheimer's disease. Neuropharmacology. 2016 Sep;108:128-35. doi: 10.1016/j.neuropharm.2016.02.005. Epub 2016 Feb 10.

lead_sponsor: Eisai Inc.


title: Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer

acronym: PreToxE

summary: In order to assess the important issue of the safety of antiangiogenic TKI in geriatric population we set up this project which aims to identify, among clinical, biological, pharmacokinetic data, predictive factors for severe toxicity of antiangiogenic TKI (sunitinib, sorafenib, pazopanib, regorafenib, axitinib) in patients over 70 year-old.

ReferenceCitation: Lebreton C, Cantarel C, Toulza E, Desgrippes R, Bozec L, Saada E, Ducoulombier A, Tardy M, Paillaud E, Lalet C, Bellera C, Italiano A. Incidence and prognostic factors of clinically meaningful toxicities of kinase inhibitors in older patients with cancer: The PreToxE study. J Geriatr Oncol. 2021 May;12(4):668-671. doi: 10.1016/j.jgo.2020.09.020. Epub 2020 Sep 23.

lead_sponsor: Institut Bergonié

location_facility:
Institut Bergonié
Centre Léon Bérard


title: Autosomal Dominant Retinitis Pigmentosa: Prevalence of Known Genes Identification of New Loci / Genes

summary: Identify new genes responsible for autosomal dominant retinitis pigmentosa (ADRP), one of the most common causes of hereditary diseases of the retina, and thus better understand the mechanisms involved of the disease."

primary_purpose: Diagnostic

ReferenceCitation: Audo I, Manes G, Mohand-Saïd S, Friedrich A, Lancelot ME, Antonio A, Moskova-Doumanova V, Poch O, Zanlonghi X, Hamel CP, Sahel JA, Bhattacharya SS, Zeitz C. Spectrum of rhodopsin mutations in French autosomal dominant rod-cone dystrophy patients. Invest Ophthalmol Vis Sci. 2010 Jul;51(7):3687-700. doi: 10.1167/iovs.09-4766. Epub 2010 Feb 17.

lead_sponsor: University Hospital, Montpellier

intervention_type: Genetic


title: "EVALUATION CLINIQUE D'UNE CAPSULE A GUIDAGE MAGNETIQUE POUR L'EXPLORATION GASTRIQUE "Capsule Dirigée Versus Gastroscopie à Haute Définition""

summary: A capsule steered by magnetic field force developed by Siemens and Olympus has recently been evaluated in a pilot series in man with encouraging results (Rey JF, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo S, Tajiri H. Feasibility of stomach exploration with a guided capsule endoscope. Endoscopy. 2010;42:541-5. Epub 2010 Jun 30.18). This blinded prospective study investigates the accuracy of the magnetically guided capsule (MGCE) compared to gastroscopy in patients with focal lesions and / or gastric symptoms and indication for upper GI Endoscopy.

ReferenceCitation: Rey JF, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo SE, Tajiri H. Blinded nonrandomized comparative study of gastric examination with a magnetically guided capsule endoscope and standard videoendoscope. Gastrointest Endosc. 2012 Feb;75(2):373-81. doi: 10.1016/j.gie.2011.09.030. Epub 2011 Dec 9.

ReferenceCitation: Rey JF, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo S, Tajiri H. Feasibility of stomach exploration with a guided capsule endoscope. Endoscopy. 2010 Jul;42(7):541-5. doi: 10.1055/s-0030-1255521. Epub 2010 Jun 30.

ReferenceCitation: Denzer UW, Rösch T, Hoytat B, Abdel-Hamid M, Hebuterne X, Vanbiervielt G, Filippi J, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Kudo SE, Tajiri H, Treszl A, Wegscheider K, Greff M, Rey JF. Magnetically guided capsule versus conventional gastroscopy for upper abdominal complaints: a prospective blinded study. J Clin Gastroenterol. 2015 Feb;49(2):101-7. doi: 10.1097/MCG.0000000000000110.

lead_sponsor: Universitätsklinikum Hamburg-Eppendorf

location_facility: Institut Arnault Tzanck , Avenue du Docteur Maurice Donat


title: TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis

acronym: TOTEM-RRMS

summary:
Centra nervous system (CNF) damage in multiple sclerosis (MS), are mainly attributed to myelin destruction, axonal abnormalities and subsequent degeneration, and are responsible for serious deficiencies. Current therapies are focused on the treatment of inflammation with several types of anti-inflammatory agents. However, there is an urgent need for innovative therapies promoting neuroregeneration and particularly myelin repair.

It has been demonstrated that testosterone can act through neural androgen receptors to promote proliferation and differentiation of oligodendrocyte precursors into mature oligodendrocytes in a cuprizone-induced animal model of demyelination. The rare clinical trials on testosterone are mainly exploratory. Here, we sought to demonstrate an effect of testosterone supplementation in testosterone-deficient patients in a multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 2 trial.

The main objective will be to determine the neuroprotective and remyelinating effects of testosterone using tensor diffusion imaging techniques and thalamic atrophy analyzes.

As secondary objectives, we would like to study the impact of testosterone supplementation on other conventional and unconventional MRI parameters and on clinical outcomes (cognition, fatigue, quality of life, impact on work / activity and anxiety / depression).

ReferenceCitation: Metzger-Peter K, Kremer LD, Edan G, Loureiro De Sousa P, Lamy J, Bagnard D, Mensah-Nyagan AG, Tricard T, Mathey G, Debouverie M, Berger E, Kerbrat A, Meyer N, De Seze J, Collongues N. The TOTEM RRMS (Testosterone Treatment on neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis) trial: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2020 Jun 29;21(1):591. doi: 10.1186/s13063-020-04517-6.

lead_sponsor: University Hospital, Strasbourg, France

location_facility:
CHU Nancy
CHRU de Strasbourg
CHU de Besançon
CHU de Rennes/Pontchaillou


title: Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors

acronym: iALTE

summary: Apparent Life-Threatening Events (ALTE) in infants often lead to severe neurological complications or to sudden death. In such situations, cardio-pediatricians and intensive care physicians have no specific diagnosis or treatment. In a recent translational research (INSERM-DHOS), our team has reported a myocardiac abnormality in a rabbit model of vagal hyperreactivity which is also present in the human hearts of infants deceased from sudden death, i.e. increased M2 muscarinic receptors (M2R) density associated with compensative increased enzymatic activity and overexpression of acetylcholine esterase (AchE). In a recent PHRC-I study (article in preparation), these abnormalities have also been observed in the blood of patients, infants as well as adults, exhibiting severe vagal syncopes. We observed, even more importantly, similar abnormalities in infants under 1 year of age with very severe idiopathic ALTE (iALTE) compared with normal subjects and with patients who presented ALTE with identified etiologies (JAMA Pediatric, 2016 May). The aim of this present study is to validate the overexpression of M2R as a marker of risk of iALTE in infant under 1 year.

primary_purpose: Basic Science

location_facility: Pediatric unit - Maison Blanche Hospital - Reims University Hospital

location_facility: Pediatric Intensive Care unit/Emergency unit - Besançon University Hospital

location_facility: Pediatric intensive care unit/ Pediatric unit- Strasbourg University Hospital - Hautepierre Hospital

location_facility: Pediatric Intensive Care Unit - Brabois Hospital - Nancy University Hospital


title: Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed

acronym: IBADEPIF

summary:
The knowledge of encephalitis associated with antibodies targeting intracellular antigens, and neuronal surface antibody syndromes has expanded considerably in recent times.

The primary purpose of the investigators protocole is to determine the incidence of anti-neuronal antibodies (blood and CSF) in a population of patients suffering from focal epilepsy of unknown cause to guide the management of these patients.

The investigators hypothesis is that dysimmune encephalitis is more common than is suggested by the current literature, and that sometimes forms of encephalitis dysimmune "at minimum" can be observed only in the form of focal epilepsy without further manifestation associated.

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Clinical Implication of the Molecular Diagnostic Retinitis Pigmentosa Molecular Diagnostic Using High Throughput Sequencing (RP-SEQ-HD)

acronym: RP-SEQ-HD

summary:
The retinitis pigmentosa (RP) are genetic conditions that cause retinal degeneration leading to severe low vision and is the leading cause of consultation in reference centers dedicated to the ophthalmic genetics. These rare diseases are characterized by a triple heterogeneity (clinical, genetic and molecular), which made them unreachable by traditional molecular diagnostic sequencing technology by the large number of genes to be tested (> 190).

The advent of high-throughput sequencing (NGS) and targeted capture has opened unexpected possibilities of investigation and ultimately to improve the care of patients. This project aims to study the genetic and molecular epidemiology of an interregional french (grand EST) cohort of patients. Patients receive a detailed retinal phenotype (visual acuity, visual field, photographs of the fundus and ERG). Their DNA will be analyzed by NGS targets the 190 known genes (https://sph.uth.edu/retnet/).

This research will provide a molecular epidemiological cohort study compared to prior publications on the frequency of genes involved. The benefit for patients is important to: establish a mode of transmission of the disease and optimize genetic counseling (currently very empirical); establish phenotype-genotype correlations in the French population (very few studies to date) and from the data of international literature; identify patients likely to be included in future therapeutic protocols of research; identify patients with significant potential for future projects to identify new genes.

The primary purpose of the protocol is to use high throughput sequencing to identify pathogenic variants in genes involved in RP.

The secondary purposes will be the following:

Determining the diagnostic yield
Study the genotype-phenotype correlation.

The secondary purposes will be the following:

Determining the diagnostic yield
Study the genotype-phenotype correlation

location_facility: Service d'Ophtalmologie CHU Hôpital Général

location_facility: Service d'Ophtalmologie, Hôpital Robert Debré, CHR

location_facility: Affections Rares en Génétique Ophtalmologique (CARGO) Hôpital Civil, Hôpitaux Universitaires de Strasbourg


title: Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota

summary: D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The study aim to determine if the carriage of the intestinal parasite D.fragilis is associated to changes of gut microbiota in subjects presenting with or without intestinal symptoms.

status: Terminated

location_facility: Service de Médecine Interne - Diabète et Maladies métaboliques Hôpital Civil

location_facility: Laboratoire de Parasitologie et de Mycologie Médicale du Plateau Technique de Microbiologie des Hôpitaux Universitaires de Strasbourg

location_facility: Médecine interne, maladies tropicales et infectieuses Hôpital Civil

location_facility: Service d'hépato gastro-entérologie et assistance nutritive Hôpital Hautepierre


title: Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients

acronym: DRONE

summary: This is a multi-center prospective study. The primary objective of DRONE study is to investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48 (W48) in participants treated by DTG-based regimen. Secondary objectives include: DTG pharmacokinetic and analysis of biomarkers of immune activation from baseline to W48.

location_facility: Centre hospitalier de Belfort-Montbéliard


title: Metabolomic Analysis of Systemic Sclerosis

acronym: SCLEROMICS

summary:
Currently investigators do not have diagnostic and prognostic markers for SSc which almost always starts with a vascular disease (Raynaud's disease) isolated for several years.

The primary purpose is to highlight discriminating metabolic profiles depending on the characteristics of the disease, allowing early diagnosis of SSc at the onset of vascular lesions, by comparing the profiles of SSc beginners (<3 years) to established forms (> 3 years).

Secondary purposes:

Prognosis: to study the metabolomics profile of SSc when a visceral complication occurs
Diagnosis: to compare the metabolomics profile of SSc to undifferentiated connective tissue disease (UCDT), Raynaud's disease (RD), vascular disease (VD) and healthy controls
Exploratory: to compare the metabolomics profile of blood, urine and skin of SSc patients

location_facility:
CHU
Hôpitaux privés de Metz


title: Protective Effects of Ischemic Preconditioning on Cardiac, Renal, Pulmonary and Muscular Functions After Aortic Clamping

summary: Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful in order to decrease these complications. The investigators would like to use an ischemic preconditioning protocol during open surgery of aortic aneurysm in order to decrease these complications.

location_facility: Service de Chirurgie Vasculaire, Hôpitaux Privés de Metz, Site de Mercy

location_facility: Service de Chirurgie Vasculaire, CHU le Bocage

location_facility: Service de Chirurgie Vasculaire, CH Jean Minjoz

location_facility: Service de Chirurgie vasculaire et transplantation rénale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg


title: Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study

summary: Blood loss was reported as a prognostic risk factor of morbidity and overall survival after hepatic resection. The aim of this study prospective randomized was compare the efficacy of the administration of tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy (> 3 hepatic segments).

location_facility: Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg

location_facility: Chirurgie digestive et transplantation, Hôpital de Besançon

location_facility: CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André)


title: Effects of Early Rehabilitation in Chronic Obstructive Pulmonary Disease Patients Under Mechanical Ventilation for Acute Respiratory Failure in Intensive Care Unit.

summary: Twenty per cent of the intensive care patients mechanically ventilated suffer from chronic obstructive pulmonary disease (COPD). These patients stay longer in Intensive Care which is more costly and they are more prone to nosocomial infection.In addition, they are longer bedridden and they develop muscular weakness.Prolonged inactivity results in respiratory and skeletal muscle weakness which curtails simple daily activity.The principal purpose of this study is to compare two types of muscular rehabilitation (electrical stimulation of the thigh and/or cycloergometer training) to classic passive mobilization of the leg.The second purpose is to analyse the effects of each type of rehabilitation on muscular fiber (structural and functional analysis) by muscular biopsies.Two hundred forty COPD patients admitted in the intensive care unit for acute respiratory failure will be randomized in 4: 1 fashion to receive passive mobilization of the legs(group 1, n=60), electrical stimulation of the thigh (group 2, n=60), cycloergometer training (group 3, n=60) or electrical stimulation of the thigh and cycloergometer training(group 4, n=60).The rehabilitation program will last 4 weeks with 5 sessions per week.In each group of patients, muscular biopsies will be done under local anaesthesia at the beginning and end of the rehabilitation programme and when they are discharged from the service.

location_facility: Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg


title: Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE

summary:
The aim of this study is to confirm that URAPIDIL is as efficient and as safe as NICARDIPINE to correct severe hypertension in pre-eclamptic patients.

efficacy endpoint : mean arterial blood pressure corrected to 105-125 mmHg after 120 min of study drug administration.
safety endpoints : clinical, biological and ultrasound observation for any side effect.All infants will be observed in the neonatology unit (during 48h).

ReferenceCitation: Diemunsch P, Garcia V, Lyons G, Pottecher J, Emmanuel S. Urapidil versus nicardipine in preeclamptic toxaemia: A randomised feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):822-3. doi: 10.1097/EJA.0000000000000303.

location_facility: Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg


title: Comparison of Cliavist Enhancement in Infectious and Degenerative Diseases of the Spine

summary: USPIO contrast enhancement results from intracellular trapping of the iron particles in reactive cells, especially macrophages. 17FDG-PET studies have demonstrated that macrophages are present in spine infectious diseases but are absent in spine degenerative diseases. The aim of this work is to compare the enhancement induced by CLIAVIST in both diseases. The absence of macrophages in degenerative lesions should help to differentiate them from infectious lesions, who should present contrast enhancement in relation to the presence of macrophages.

location_facility: Service de Rhumatologie - Hôpital de Hautepierre

location_facility: Service de Neuroradiologie - Hôpital Central

location_facility: Service de Radiologie 2 - Hôpital de Hautepierre


title: TWIST Human Gene and Cleft Lips and Palates

summary: This study uses a sequence analysis for TWIST and other craniofacial development genes, among patients presenting with facial clefting.

location_facility: Centre d'Investigations Cliniques, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Centre de Soins , d'Enseignement et de Recherche Dentaire (CESRD), Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Consultation de la Face, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg


title: Evaluation of the Long-term Efficacy and Safety of the Omega Loop Bypass Versus the Roux-en-Y Gastric Bypass on the Cohort of Patients Included in the Randomized Trial YOMEGA (DGOS 13-0037)

acronym: YOMEGA 5-7y

summary: Over the last 40 years, the Roux-en-Y Gastric Bypass (RYGB) has been the gold standard in the surgical management of morbid obesity. and is a validated bariatric procedure in France. Nevertheless, the RYGB remains a technically demanding procedure; thus and in order to overcome the complexity of this intervention, a simpler technique based on a single anastomosis at 200cm from the Treitz angle creating an omega loop (Mini Gastric Bypass - MGB or One Anastomosis Gastric Bypass-OAGB) has gradually spread around the worl without prior evaluation, . In 2018, the MGB was officially recognized by the International Federation of Bariatric Surgery (IFSO) as a standard procedure but not by the ASMBS American Society for Metabolic and Bariatric Surgery ; indeed, the OAGB remains controversial because considered by many surgeons at risk of biliary reflux and malnutrition.

lead_sponsor: Hospices Civils de Lyon

location_facility: Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière

location_facility: Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye

location_facility: Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche

location_facility: Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille

location_facility: Service de Chirurgie Digestive Hôpital Edouard Herriot

location_facility: Service de Chirurgie Générale - Hôpital Privé de la Loire

location_facility: Service de Chirurgie Digestive, Générale et Cancérologique - HEGP

location_facility: Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire


title: Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients at Risk.

acronym: OPTIVACC

summary: In France, Streptococcus pneumoniae is the leading agent bacterial involved in community lung disease and meningitis. The frequency of these infections and their mortality increase significantly in those at risk such as patients with certain chronic diseases, immunocompromised or on immunosuppressive therapy. This population, despite regular monitoring, has a limited pneumococcal vaccine coverage of around 20%. By carrying out a reconciliation of treatments upon admission to hospital, the clinical pharmacist can detect those without up to date pneumococcal vaccination status. The goal of this management is to make the patient aware of the need for vaccination and organization upon return home. Thus, this limited pneumococcal vaccination coverage would benefit from intervention by regional clinical pharmacy activities. The study investigators want to study the impact of a structured medico-pharmaceutical collaboration on pneumococcal vaccination of patients with risk on discharge from hospital. The investigators hypothesize that this collaboration in patients at risk of infection with pneumococcus could significantly increase their anti-pneumococcal vaccination coverage

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CH de Montauban
CH Comminges Pyrénées
CH du Bassin de Thau
CHU de Toulouse
CHU de Montpellier
CH Alès Cévennes
CHU de Nimes
CH de Perpignan
CH de Bagnols sur Cèze


title: Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease

acronym: CALMET

summary:
Chronic alcoholic and metabolic liver diseases are the two main liver diseases in France. The long-term prognosis of these two diseases are not well known because main studies are retrospective and with only alcoholic patients. The knowledge of the natural history of these diseases should improve the management of patients with such diseases.

The aim of this prospective cohort is to describe the natural history of patients with chronic liver disease due to alcohol or metabolic disease and to identify factors associated with complications of these liver diseases (cirrhosis, hepatocellular carcinoma, ascites. ..).

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Brest - Hôpital La Cavale Blanche

location_facility: CHRU de Strasbourg - Nouvel Hôpital Civil

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: CHU de Bordeaux - Hôpital du Haut-Lévêque


title: Etude Comparative Multicentrique Prospective évaluant la Prise en Charge Chirurgicale associée à Une cautérisation Chimique Par Acide TCA Par Rapport à la Prise en Charge Chirurgicale Standard Dans le Traitement de l'Ongle incarné

summary:
Ingrown toenail is a very common disease in the general population that touches young adults. There are lots of treatments from local care of pedicure to surgery with matricectomy. Gold standard of symptomatic and painful ingrown toenail is the simple surgery with matricectomy and with suture or directed healing pad.

For many years chemical cauterisation with phenolic acid is used, a method with very few relapses and with a more simple pad. However, because of a lack of information about this phenolic acid, the pharmaceutical laboratory withdrew it from the market.

The new method to replace phenolic acid is trichloroacetic acid, used mainly in cosmetics for peeling. This method was already compared to phenolic acid and showed equal results with fewer laps of application and a low cost. The comparison between acid trichloroacetic method and the gold standard surgery was never done and will be the goal of this study.

It's an open, non randomised, comparative, multicentric (2 centers) study with two groups : common surgery and surgery with chemical cauterisation For this study the investigators will compare between the two groups : gain of quality of life at one month after surgery, difference of pain between before, one week and one month after surgery, the occurrence of adverse events and number of relapses at one year.

lead_sponsor: University Hospital, Caen

location_facility: Centre hospitalier universitaire de CAEN

location_facility: Centre hospitalier Mémorial France Etats Unis


title: A Randomized Study of Fludarabine in Part of Induction and Postremission Treatment for de Novo Acute Myeloid Leukaemia in Elderly Patients

summary: In this study, patients were randomly assigned to either receive fludarabine or not (20 mg/m2/d) in addition to induction chemotherapy, consolidation chemotherapy and the 3 subsequent re-induction courses during maintenance.

lead_sponsor: French Innovative Leukemia Organisation


title: Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to Sars-covid-2: a Randomized Crossover Trial.

acronym: DeCOPO

summary:
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.

Prone positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation.

Early PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu.

Our hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.

ipd_sharing: Yes

ipd_sharing_description: Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures, and appendices).

lead_sponsor: Hospital St. Joseph, Marseille, France

location_facility:
Hopital La Timone
Hopital Saint Joseph
Hopital Européen
Hopital Nord


title: Real World Effectiveness of Natalizumab Extended Interval Dosing in Relapsing-Remitting Multiple Sclerosis in a French Cohort

acronym: RELEVANT

summary:
Natalizumab (NTZ) use in Multiple Sclerosis (MS) in highly active patients has been largely established during the last Rationale 10 years in both clinical trials and real-world practice. Along with its efficacy, NTZ use has been limited by potential risk of progressive multifocal leukoencephalopathy (PML). Thus, several studies have tried to assess how to minimize this risk.

One suggested approach is to move from the standard interval dose (SID) of 4 weeks to an extended interval dose (EID) of 5 weeks or longer. Extending the dosing interval of NTZ has been practiced by some physicians with the intention of improving the benefit/risk of the treatment by reducing the exposure-dependent risk of progressive multifocal leukoencephalopathy (PML) while maintaining efficacy. We propose to retrospectively analyze data from clinical records coming from RRMS patients treated in France at 5 different centers; Caen, Nice, Bobigny and Toulouse hospitals as well as Percy Military Hospital, to evaluate the effectiveness of natalizumab EID in subjects who have previously been treated with natalizumab SID for 12 months, in relation to continued SID treatment. In the clinical practice of these centers, patients are shifted after minimum 12 months under SID to an EID of 6 weeks regardless antibody JC serum status. Clinical, magnetic resonance imaging (MRI) and serum anti-JCV antibody status data are collected when available.

The objective of this study is to assess the efficacy in term of ARR and safety.

time_perspective: Retrospective

location_facility: Department of Neurology, Percy Military Hospital

location_facility: Department of Neurology, CHU Toulouse Purpan

location_facility: Department of Neurology, CHU Bobigny-Avicenne


title: Randomized Controlled Trial Evaluating the Efficacy of an Adapted Physical Activity Program Using a Connected Device With Activity Trackers and a Therapeutic Education Program Among Women With Localized Breast Cancer

acronym: DISCO

summary: The 3-year DISCO study aims to systematically implement physical activity in breast cancer patients. The primary objective is to investigate the efficacy of a connected device (personalized non-supervised exercise program including a wristband as activity tracker, a smartphone application, and a website) and the efficacy of a therapeutic education program on the physical activity level of patients at the end of the 6-month programs. The research hypothesis is that patients participating in the intervention with the connected device or in the therapeutic education program will achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.

ReferenceCitation: Beasley JM, Kwan ML, Chen WY, Weltzien EK, Kroenke CH, Lu W, Nechuta SJ, Cadmus-Bertram L, Patterson RE, Sternfeld B, Shu XO, Pierce JP, Caan BJ. Meeting the physical activity guidelines and survival after breast cancer: findings from the after breast cancer pooling project. Breast Cancer Res Treat. 2012 Jan;131(2):637-43. doi: 10.1007/s10549-011-1770-1. Epub 2011 Sep 21.

ReferenceCitation: Beg MS, Gupta A, Stewart T, Rethorst CD. Promise of Wearable Physical Activity Monitors in Oncology Practice. J Oncol Pract. 2017 Feb;13(2):82-89. doi: 10.1200/JOP.2016.016857. Review.

ReferenceCitation: Cadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women. Am J Prev Med. 2015 Sep;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. Epub 2015 Jun 10.

ReferenceCitation: Ferguson T, Rowlands AV, Olds T, Maher C. The validity of consumer-level, activity monitors in healthy adults worn in free-living conditions: a cross-sectional study. Int J Behav Nutr Phys Act. 2015 Mar 27;12:42. doi: 10.1186/s12966-015-0201-9.

ReferenceCitation: Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

ReferenceCitation: Ibrahim EM, Al-Homaidh A. Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies. Med Oncol. 2011 Sep;28(3):753-65. doi: 10.1007/s12032-010-9536-x. Epub 2010 Apr 22.

ReferenceCitation: Lahart IM, Metsios GS, Nevill AM, Carmichael AR. Physical activity, risk of death and recurrence in breast cancer survivors: A systematic review and meta-analysis of epidemiological studies. Acta Oncol. 2015 May;54(5):635-54. doi: 10.3109/0284186X.2014.998275. Epub 2015 Mar 9. Review.

ReferenceCitation: Sullivan AN, Lachman ME. Behavior Change with Fitness Technology in Sedentary Adults: A Review of the Evidence for Increasing Physical Activity. Front Public Health. 2017 Jan 11;4:289. doi: 10.3389/fpubh.2016.00289. eCollection 2016. Review.

ReferenceCitation: Thariat J, Creisson A, Chamignon B, Dejode M, Gastineau M, Hébert C, Boissin F, Topfer C, Gilbert E, Grondin B, Guennoc H, Mari V, Buzzo S, Saja D, Duboue N, Boulahssass R, Tosi A, Verne S, Ducray J, Benard-Thiery I, Ferrero JM. [Integrating patient education in your oncology practice]. Bull Cancer. 2016 Jul-Aug;103(7-8):674-90. doi: 10.1016/j.bulcan.2016.04.007. Epub 2016 Jun 7. Review. French.

ReferenceCitation: Tudor-Locke C, Hatano Y, Pangrazi RP, Kang M. Revisiting "how many steps are enough?". Med Sci Sports Exerc. 2008 Jul;40(7 Suppl):S537-43. doi: 10.1249/MSS.0b013e31817c7133.

ReferenceCitation: Touillaud M, Fournier B, Pérol O, Delrieu L, Maire A, Belladame E, Pérol D, Perrier L, Preau M, Leroy T, Fassier JB, Fillol F, Pascal S, Durand T, Fervers B. Connected device and therapeutic patient education to promote physical activity among women with localised breast cancer (DISCO trial): protocol for a multicentre 2×2 factorial randomised controlled trial. BMJ Open. 2021 Sep 13;11(9):e045448. doi: 10.1136/bmjopen-2020-045448.

lead_sponsor: Centre Leon Berard

location_facility:
Institut Sainte-Catherine
Centre Léon Bérard
CHRU Besançon


title: Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

summary: This is an observational, multicenter study in participants treated with nivolumab for the approved indications of melanoma and Lung cancer in Australia, the EU, Switzerland, the United Kingdom (UK), and the United States (US). The targeted countries in the EU for study participation include Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, and Spain. Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Spain
Italy
Austria
Australia
United Kingdom
Switzerland
Hungary
Puerto Rico
United States
France
Belgium
Germany
Czechia

location_facility:
Local Institution - 1413
Local Institution - 1304
Local Institution - 1006
Local Institution - 1307
Local Institution - 1102
Local Institution - 1909
Local Institution - 1421
Local Institution - 2106
Local Institution - 1426
Local Institution - 1915
Local Institution - 2002
Local Institution - 1503
Local Institution - 1910
Local Institution - 2201
Local Institution - 1603
Local Institution - 1411
Local Institution - 1904
Local Institution - 1804
Local Institution - 1002
Local Institution - 1005
Local Institution - 1101
Local Institution - 1802
Local Institution - 1202
Local Institution - 1412
Local Institution - 1501
Local Institution - 1417
Local Institution - 1502
Local Institution - 1427
Local Institution - 1301
Local Institution - 1407
Local Institution - 1424
Local Institution - 1506
Local Institution - 1434
Local Institution - 1303
Local Institution - 1410
Local Institution - 1436
Local Institution - 1425
Local Institution - 1302
Local Institution - 2103
Local Institution - 1435
Local Institution - 1906
Local Institution - 1433
Local Institution - 1414
Local Institution - 1419
Local Institution - 1428
Local Institution - 2203
Local Institution - 1907
Local Institution - 1607
Local Institution - 1402
Local Institution - 1422
Local Institution - 1406
Local Institution - 1003
Local Institution - 1401
Local Institution - 1423
Local Institution - 1602
Local Institution - 2101
Local Institution - 1420
Local Institution - 1103
Local Institution - 1504
Local Institution - 1416
Local Institution - 1415
Local Institution - 1201
Local Institution - 1405
Local Institution - 1902
Local Institution - 1505
Local Institution - 1001
Local Institution - 1430
Local Institution - 1803
Local Institution - 1905
Local Institution - 1605
Local Institution - 1408
Local Institution - 1901
Local Institution - 1908
Local Institution - 2107
Local Institution - 1601
Local Institution - 1305
Local Institution - 1702
Local Institution - 1913
Local Institution - 1432
Local Institution - 2102
Local Institution - 1409
Local Institution - 1203
Local Institution - 1429
Local Institution - 1703
Local Institution - 1604
Local Institution - 1801
Local Institution - 1403
Local Institution - 1912
Local Institution - 1431
Local Institution - 1911
Local Institution - 1404
Local Institution - 2202
Local Institution - 1606
Local Institution - 1418


title: A 3-month, Prospective, Multicentre, Investigator-masked, Parallel-group, Active-controlled, Randomised, Non-inferiority Study to Compare the Efficacy & Tolerability of CATIONORM PRO® & VISMED® in Patients With Mod-to-severe Dry Eye Disease

acronym: PROSIKA

summary:
This study is a prospective, multicentre, parallel-group, active-controlled, non-inferiority study conducted in adult patients with moderate-to-severe dry eye disease (DED) related to keratitis or keratoconjunctivitis. This study is to be conducted in France, Poland and Spain.

The patients will be randomised to receive Cationorm Pro® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion

lead_sponsor: Santen SAS

location_country: Poland France Spain

location_facility: 5th MILITARY CLINICAL HOSPITAL IN KRAKOW

location_facility: Klinika Okulistyki i Onkologii Okulistycznej

location_facility: El Instituto Ofalmológico Quirónsalud Zaragoza