title: Nomogram Control of Predictive Factors of Early Withdrawal After Gynecologic Oncology Surgery in the Enhanced Recovery After Surgery (ERAS) Protocol and Assessment of Practices

acronym: NomogramGyneco

summary: Validation of a predictive nomogram of a short hospital stay (less than two days after surgery) on a prospective cohort of patients.

ReferenceCitation: Chapman JS, Roddy E, Ueda S, Brooks R, Chen LL, Chen LM. Enhanced Recovery Pathways for Improving Outcomes After Minimally Invasive Gynecologic Oncology Surgery. Obstet Gynecol. 2016 Jul;128(1):138-144. doi: 10.1097/AOG.0000000000001466.

ReferenceCitation: Nicholson A, Lowe MC, Parker J, Lewis SR, Alderson P, Smith AF. Systematic review and meta-analysis of enhanced recovery programmes in surgical patients. Br J Surg. 2014 Feb;101(3):172-88. doi: 10.1002/bjs.9394. Review.

ReferenceCitation: Yoong W, Sivashanmugarajan V, Relph S, Bell A, Fajemirokun E, Davies T, Munro K, Chigwidden K, Evan F, Lodhi W; Enhanced Recovery After Surgery (ERAS) Team for Gynaecology and Anaesthesia. Can enhanced recovery pathways improve outcomes of vaginal hysterectomy? Cohort control study. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):83-9. doi: 10.1016/j.jmig.2013.06.007. Epub 2013 Jul 10.

ReferenceCitation: Kroon UB, Rådström M, Hjelthe C, Dahlin C, Kroon L. Fast-track hysterectomy: a randomised, controlled study. Eur J Obstet Gynecol Reprod Biol. 2010 Aug;151(2):203-7. doi: 10.1016/j.ejogrb.2010.04.001. Epub 2010 May 10.

ReferenceCitation: Borendal Wodlin N, Nilsson L, Kjølhede P; GASPI study group. The impact of mode of anaesthesia on postoperative recovery from fast-track abdominal hysterectomy: a randomised clinical trial. BJOG. 2011 Feb;118(3):299-308. doi: 10.1111/j.1471-0528.2010.02697.x. Epub 2010 Sep 14.

ReferenceCitation: Minig L, Chuang L, Patrono MG, Fernandez-Chereguini M, Cárdenas-Rebollo JM, Biffi R. Clinical outcomes after fast-track care in women undergoing laparoscopic hysterectomy. Int J Gynaecol Obstet. 2015 Dec;131(3):301-4. doi: 10.1016/j.ijgo.2015.06.034. Epub 2015 Sep 8.

ReferenceCitation: Bruneau L, Randet M, Evrard S, Damon A, Laurent FX. [Total laparoscopic hysterectomy and same-day discharge: Satisfaction evaluation and feasibility study]. J Gynecol Obstet Biol Reprod (Paris). 2015 Nov;44(9):870-6. doi: 10.1016/j.jgyn.2015.02.003. Epub 2015 Mar 13. French.

ReferenceCitation: Chase DM, Lopez S, Nguyen C, Pugmire GA, Monk BJ. A clinical pathway for postoperative management and early patient discharge: does it work in gynecologic oncology? Am J Obstet Gynecol. 2008 Nov;199(5):541.e1-7. doi: 10.1016/j.ajog.2008.04.037. Epub 2008 Jun 2.

ReferenceCitation: Wijk L, Franzén K, Ljungqvist O, Nilsson K. Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. Gynecol Obstet Invest. 2016;81(5):461-7. doi: 10.1159/000443396. Epub 2016 Jan 23.

ReferenceCitation: Lindemann K, Kok PS, Stockler M, Jaaback K, Brand A. Enhanced Recovery After Surgery for Advanced Ovarian Cancer: A Systematic Review of Interventions Trialed. Int J Gynecol Cancer. 2017 Jul;27(6):1274-1282. doi: 10.1097/IGC.0000000000000981. Review.

ReferenceCitation: Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, Engel AF, Gerhards MF, van Wagensveld BA, van der Zaag ES, van Geloven AA, Sprangers MA, Cuesta MA, Bemelman WA; LAFA study group. Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg. 2011 Dec;254(6):868-75. doi: 10.1097/SLA.0b013e31821fd1ce.

ReferenceCitation: Schlaerth AC, Abu-Rustum NR. Role of minimally invasive surgery in gynecologic cancers. Oncologist. 2006 Sep;11(8):895-901. Review.

ReferenceCitation: Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18.

ReferenceCitation: Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3.

ReferenceCitation: Miralpeix E, Nick AM, Meyer LA, Cata J, Lasala J, Mena GE, Gottumukkala V, Iniesta-Donate M, Salvo G, Ramirez PT. A call for new standard of care in perioperative gynecologic oncology practice: Impact of enhanced recovery after surgery (ERAS) programs. Gynecol Oncol. 2016 May;141(2):371-378. doi: 10.1016/j.ygyno.2016.02.019. Epub 2016 Mar 9. Review.

ReferenceCitation: Kalogera E, Dowdy SC. Enhanced Recovery Pathway in Gynecologic Surgery: Improving Outcomes Through Evidence-Based Medicine. Obstet Gynecol Clin North Am. 2016 Sep;43(3):551-73. doi: 10.1016/j.ogc.2016.04.006. Review.

ReferenceCitation: Bauchat JR, Habib AS. Evidence-based anesthesia for major gynecologic surgery. Anesthesiol Clin. 2015 Mar;33(1):173-207. doi: 10.1016/j.anclin.2014.11.011. Epub 2014 Dec 31. Review.

ReferenceCitation: Touijer K, Scardino PT. Nomograms for staging, prognosis, and predicting treatment outcomes. Cancer. 2009 Jul 1;115(13 Suppl):3107-11. doi: 10.1002/cncr.24352. Review.

ReferenceCitation: Potters L, Roach M 3rd, Davis BJ, Stock RG, Ciezki JP, Zelefsky MJ, Stone NN, Fearn PA, Yu C, Shinohara K, Kattan MW. Postoperative nomogram predicting the 9-year probability of prostate cancer recurrence after permanent prostate brachytherapy using radiation dose as a prognostic variable. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):1061-5. doi: 10.1016/j.ijrobp.2009.03.031. Epub 2009 Jun 18.

ReferenceCitation: Nixon IJ, Ganly I, Hann LE, Lin O, Yu C, Brandt S, Shah JP, Shaha A, Kattan MW, Patel SG. Nomogram for predicting malignancy in thyroid nodules using clinical, biochemical, ultrasonographic, and cytologic features. Surgery. 2010 Dec;148(6):1120-7; discussion 1127-8. doi: 10.1016/j.surg.2010.09.030.

ReferenceCitation: Barsoum WK, Murray TG, Klika AK, Green K, Miniaci SL, Wells BJ, Kattan MW. Predicting patient discharge disposition after total joint arthroplasty in the United States. J Arthroplasty. 2010 Sep;25(6):885-92. doi: 10.1016/j.arth.2009.06.022. Epub 2009 Sep 2.

ReferenceCitation: Kelly DM, Bennett R, Brown N, McCoy J, Boerner D, Yu C, Eghtesad B, Barsoum W, Fung JJ, Kattan MW. Predicting the discharge status after liver transplantation at a single center: a new approach for a new era. Liver Transpl. 2012 Jul;18(7):796-802. doi: 10.1002/lt.23434.

ReferenceCitation: Wan KM, Carter J, Philp S. Predictors of early discharge after open gynecological surgery in the setting of an enhanced recovery after surgery protocol. J Obstet Gynaecol Res. 2016 Oct;42(10):1369-1374. doi: 10.1111/jog.13045. Epub 2016 Jun 29.

ReferenceCitation: Schiavone MB, Herzog TJ, Ananth CV, Wilde ET, Lewin SN, Burke WM, Lu YS, Neugut AI, Hershman DL, Wright JD. Feasibility and economic impact of same-day discharge for women who undergo laparoscopic hysterectomy. Am J Obstet Gynecol. 2012 Nov;207(5):382.e1-9. doi: 10.1016/j.ajog.2012.09.014. Epub 2012 Sep 17.

lead_sponsor: Institut Paoli-Calmettes


type: Other Identifier

title: Efficacity of a Sustained Weekly Psychological Intervention for Adolescents and Young Adults Attending to Local Missions for Reinsertion, on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion Compared to Usual Care

acronym: MLADO

summary:
Suicide is the third leading cause of death in adolescents and young adults in the United States and the second leading cause in European countries.

Depressive disorders are consistently the most prevalent psychiatric disorder among adolescents who attempt suicide with a prevalence ranging from 49% to 64%. Depression in adolescent and young adults is a multifactorial phenomenon, as is the risk of suicidal attempt. To address such problems, effective and accessible treatment is needed, as recommended by the French Health Authority (HAS).

Our primary objective is to demonstrate that a weekly psychotherapeutic intervention reduces the depression level.

The primary assessment criterion is the variation of the clinician Adolescent Depression Rating Scale (ADRSc) from randomisation to month 6.

The study also aims comparing in the 2 randomised groups

ADRS depression global score (clinician and subject) at 0, 3, 9 and 12 months
Number of suicidal attempts and self-harm attempts at 6 and 12 months
Number of drop-out at 6 and 12 months
Beck's Hopelessness Scale at 0, 3, 6, 9 and 12 months
Global score on the GHQ-28 and scores on the 4 subscales (Somatization, Anxiety and Insomnia, Social dysfunction, Depressive mood) at 0, 3, 6, 9 and 12 months.
Working AIliance Inventory (WAI) score at 0, 3, 6, 9 and 12 months

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Unicentric Retrospective Analysis of a Cohort of 602 Young Adult and Adolescent Patients (AJA), Aged 15 to 30 Years, With Haematological Malignancies, and Managed Between 2000 and 2016

acronym: HEMAJA

summary: Unicentric retrospective analysis of a cohort of 602 young adult and adolescent patients, aged 15 to 30 years, with haematological malignancies, and managed between 2000 and 2016

study_type: Observational

time_perspective: Retrospective

ipd_sharing: No

intervention_type: Drug


title: Iontophoresis of Treprostinil to Enhance Wound Healing in Diabetic Foot Skin Ulcers

acronym: InTREPiD

summary:
Assess the effect of iontophoresis of treprostinil on wound closure over 12 weeks, in patients with DFU.

In the present study the investigators aim at establishing the proof-of-concept of iontophoresis of treprostinil as a potential treatment of diabetic foot ulcers in humans. The main hypothesis is that in patients with DFUs, the pharmacodynamic effect of a PGI2 analogue potentiates the effect of low-intensity current on microvascular function, tissue oxygenation and healing.

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: University Hospital, Grenoble

intervention_type: Device

status_simplified: Ongoing


title: Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated With Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)

acronym: CABRI

summary: Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated with Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)

status: Unknown status

ReferenceType: background

ReferenceCitation: Hodgson K, Ferrer G, Montserrat E, Moreno C. Chronic lymphocytic leukemia and autoimmunity: a systematic review. Haematologica. 2011 May;96(5):752-61. doi: 10.3324/haematol.2010.036152. Epub 2011 Jan 17. Review.

ReferenceCitation: Dierickx D, Kentos A, Delannoy A. The role of rituximab in adults with warm antibody autoimmune hemolytic anemia. Blood. 2015 May 21;125(21):3223-9. doi: 10.1182/blood-2015-01-588392. Epub 2015 Mar 31. Review.

ReferenceCitation: D'Arena G, Laurenti L, Capalbo S, D'Arco AM, De Filippi R, Marcacci G, Di Renzo N, Storti S, Califano C, Vigliotti ML, Tarnani M, Ferrara F, Pinto A. Rituximab therapy for chronic lymphocytic leukemia-associated autoimmune hemolytic anemia. Am J Hematol. 2006 Aug;81(8):598-602.

ReferenceCitation: Reynaud Q, Durieu I, Dutertre M, Ledochowski S, Durupt S, Michallet AS, Vital-Durand D, Lega JC. Efficacy and safety of rituximab in auto-immune hemolytic anemia: A meta-analysis of 21 studies. Autoimmun Rev. 2015 Apr;14(4):304-13. doi: 10.1016/j.autrev.2014.11.014. Epub 2014 Dec 9.

ReferenceCitation: Kaufman M, Limaye SA, Driscoll N, Johnson C, Caramanica A, Lebowicz Y, Patel D, Kohn N, Rai K. A combination of rituximab, cyclophosphamide and dexamethasone effectively treats immune cytopenias of chronic lymphocytic leukemia. Leuk Lymphoma. 2009 Jun;50(6):892-9. doi: 10.1080/10428190902887563.

ReferenceCitation: Rossignol J, Michallet AS, Oberic L, Picard M, Garon A, Willekens C, Dulery R, Leleu X, Cazin B, Ysebaert L. Rituximab-cyclophosphamide-dexamethasone combination in the management of autoimmune cytopenias associated with chronic lymphocytic leukemia. Leukemia. 2011 Mar;25(3):473-8. doi: 10.1038/leu.2010.278. Epub 2010 Dec 3.

ReferenceCitation: Quinquenel A, Willekens C, Dupuis J, Royer B, Ysebaert L, De Guibert S, Michallet AS, Feugier P, Guieze R, Levy V, Delmer A. Bendamustine and rituximab combination in the management of chronic lymphocytic leukemia-associated autoimmune hemolytic anemia: a multicentric retrospective study of the French CLL intergroup (GCFLLC/MW and GOELAMS). Am J Hematol. 2015 Mar;90(3):204-7. doi: 10.1002/ajh.23909. Epub 2015 Jan 16.

ReferenceCitation: Maura F, Visco C, Falisi E, Reda G, Fabris S, Agnelli L, Tuana G, Lionetti M, Guercini N, Novella E, Nichele I, Montaldi A, Autore F, Gregorini A, Barcellini W, Callea V, Mauro FR, Laurenti L, Foà R, Neri A, Rodeghiero F, Cortelezzi A. B-cell receptor configuration and adverse cytogenetics are associated with autoimmune hemolytic anemia in chronic lymphocytic leukemia. Am J Hematol. 2013 Jan;88(1):32-6. doi: 10.1002/ajh.23342. Epub 2012 Oct 31.

ReferenceCitation: Byrd JC, Furman RR, Coutre SE, Burger JA, Blum KA, Coleman M, Wierda WG, Jones JA, Zhao W, Heerema NA, Johnson AJ, Shaw Y, Bilotti E, Zhou C, James DF, O'Brien S. Three-year follow-up of treatment-naïve and previously treated patients with CLL and SLL receiving single-agent ibrutinib. Blood. 2015 Apr 16;125(16):2497-506. doi: 10.1182/blood-2014-10-606038. Epub 2015 Feb 19.

ReferenceCitation: Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.

ReferenceCitation: Burger JA, Tedeschi A, Barr PM, Robak T, Owen C, Ghia P, Bairey O, Hillmen P, Bartlett NL, Li J, Simpson D, Grosicki S, Devereux S, McCarthy H, Coutre S, Quach H, Gaidano G, Maslyak Z, Stevens DA, Janssens A, Offner F, Mayer J, O'Dwyer M, Hellmann A, Schuh A, Siddiqi T, Polliack A, Tam CS, Suri D, Cheng M, Clow F, Styles L, James DF, Kipps TJ; RESONATE-2 Investigators. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med. 2015 Dec 17;373(25):2425-37. doi: 10.1056/NEJMoa1509388. Epub 2015 Dec 6.

ReferenceCitation: St Bernard R, Hsia CC. Safe utilization of ibrutinib with or without steroids in chronic lymphocytic leukemia patients with autoimmune hemolytic anemia. Ann Hematol. 2015 Dec;94(12):2077-9. doi: 10.1007/s00277-015-2487-8. Epub 2015 Sep 3.

ReferenceCitation: Manda S, Dunbar N, Marx-Wood CR, Danilov AV. Ibrutinib is an effective treatment of autoimmune haemolytic anaemia in chronic lymphocytic leukaemia. Br J Haematol. 2015 Sep;170(5):734-6. doi: 10.1111/bjh.13328. Epub 2015 Feb 25.

ReferenceCitation: Rogers KA, Ruppert AS, Bingman A, Andritsos LA, Awan FT, Blum KA, Flynn JM, Jaglowski SM, Lozanski G, Maddocks KJ, Byrd JC, Woyach JA, Jones JA. Incidence and description of autoimmune cytopenias during treatment with ibrutinib for chronic lymphocytic leukemia. Leukemia. 2016 Feb;30(2):346-50. doi: 10.1038/leu.2015.273. Epub 2015 Oct 7.

ReferenceCitation: Vitale C, Ahn IE, Sivina M, Ferrajoli A, Wierda WG, Estrov Z, Konoplev SN, Jain N, O'Brien S, Farooqui M, Keating MJ, Wiestner A, Burger JA. Autoimmune cytopenias in patients with chronic lymphocytic leukemia treated with ibrutinib. Haematologica. 2016 Jun;101(6):e254-8. doi: 10.3324/haematol.2015.138289. Epub 2016 Mar 24.

ReferenceCitation: Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn I, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Stilgenbauer S, Cramer P, Aiello M, Johnson DM, Miller LL, Li D, Jahn TM, Dansey RD, Hallek M, O'Brien SM. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014 Mar 13;370(11):997-1007. doi: 10.1056/NEJMoa1315226. Epub 2014 Jan 22.

status_simplified: Unknown


type: EudraCT Number

title: Essai de Phase II Multicentrique évaluant le Pembrolizumab Dans le Traitement de la Maladie de Kaposi Classique ou endémique

acronym: KAPKEY

summary:
Classic and endemic Kaposi's sarcoma (KS) are lymphangio-proliferations associated with human herpes virus 8 (HHV8), which treatment is poorly codified. Chemotherapies give at best 30-60% of transient responses. While interferon responses are frequent, this drug is often poorly tolerated in elderly patients. Therefore new therapies are needed. Classic KS represents an ideal model for evaluating new drugs since patients do not receive concomitant immunosuppressive regimens nor antiviral therapies.

Pembrolizumab, an anti-PD1 monoclonal antibody has recently been shown to improve survival in several solid tumors. In KS few data are available on the role of PD1-PD-L1 axis. A significant PD-L1 expression on HHV8-associated pleural effusion lymphomas and on KS samples have been recently reported. Our experience in classical and endemic KS supports the role of this pathway with expression of PD-L1 by subpopulations of T cells but also NK cells in peripheral blood cells from these patients and expression of PD-L1 by tumor cells in KS lesions.

In this study we will evaluate the benefit and safety profile of pembrolizumab in classic and endemic KS.

ReferenceType: derived

ReferenceCitation: Delyon J, Biard L, Renaud M, Resche-Rigon M, Le Goff J, Dalle S, Heidelberger V, Da Meda L, Toullec L, Carcelain G, Mourah S, Caillat-Zucman S, Allain V, Battistella M, Lebbe C. PD-1 blockade with pembrolizumab in classic or endemic Kaposi's sarcoma: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2022 Apr;23(4):491-500. doi: 10.1016/S1470-2045(22)00097-3. Epub 2022 Mar 10.


title: Evaluation of the Diagnostic Contribution of High-throughput Exome Sequencing for Patients With Convulsive Encephalopathy of Unknown Etiology: Pilot Study to Improve Genetic Counselling

acronym: SHD-EE

summary:
Congenital epileptic encephalopathies (EE) are predominantly genetic in origin. Their diagnosis is hampered by the large number of genes involved and their low recurrence. Genetic study in routine diagnosis is limited by the existing techniques and the development costs. The routine diagnostic implementation of high throughput sequencing pushes these limits. High throughput exome sequencing (ES) showed superior diagnostic performance in all diagnostic settings studied.

This pilot study is dedicated to evaluating the diagnostic performance of high throughput ES in EE, with an implementation and analysis strategy allowing for a direct transfer to routine diagnostics. This novel approach should improve the diagnostic rate while reducing the diagnostic cost per patient.

time_perspective: Other

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Study of Innate Host Immune Response to C. Glabrata Clinical Isolates Resistant to Echinocandins: Impact on the Management of Candidemia in High-risk Patients

acronym: CAHOHR

summary:
In the context of Candida yeast infections, a large number of studies have been published over the past two decades specifying the molecular mechanisms of antifungal resistance in different Candida species. However, few of these studies have explored how these mechanisms influence host immune response to this opportunistic pathogen. Recent advances in understanding how the host's immune system responds to Candida have initiated the emergence of a new research theme aimed at better understanding Candida's intrinsic and adaptive resistance mechanisms to antifungals can modulate "escape to" or "recognition by" the host's immune system. This knowledge could lead to (i) a better understanding of the predominance of certain Candida species with antifungal resistance in certain patient populations, (ii) a better understanding of why high levels of in vitro resistance are not necessarily correlated with in vivo therapeutic failure, and (iii) effective immunotherapeutic strategies to control Candida resistance to antifungals.

It is therefore crucial to investigate the impact of Candida's resistance to antifungals on the host's innate immune response. Indeed, most antifungal resistance mechanisms have a direct or indirect structural modification of the fungal wall. However, it is the composition of this wall that is involved in the recognition of Candida by the host cell via the pattern recognition receptors (PRRs). We therefore put forward the very probable hypothesis that changes in the fungal wall, induced by the appearance of resistance, could alter the recognition of Candida by PRRs and thus trigger a different immune response, either qualitatively (type of cytokines secreted) or quantitatively (amplitude and duration of the immune response). However, even if initial experimental data support the hypothesis of a possible link between resistance and a modulation of the innate immune response in digestive mucosa (the most frequent starting point for disseminated candidiasis), many questions remain regarding (i) the proteins and mechanisms of the modulated immune cascade, (ii) the modification of the immune response according to the Candida species in question and (iii) the modification of the immune response according to the resistance phenotype in question.


title: Influence of the "Atelier du rêve" (Dream Workshop) on the Quality of Falling Asleep in the Operating Room.

acronym: REVA

summary: A "dream workshop" is organized for the children by nurses specialized in anesthesia in the CHI Creteil. During this workshop, the anesthesia process is explained to the children using games, drawings, songs, etc. The impact of this workshop on the child stress and acceptance of the mask during induction is studied in this research.

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Prevention of Sequelae Pain After Breast Cancer Surgery by Daily Self Massages and Self Stretching of Serratus Anterior Muscle, Pectoralis Major Muscle, Infraspinatus Muscle and Latissimus Dorsi Muscle: Impact of Learning Workshops Performed by a Multidisciplinary Team.

acronym: ESTAUVAL

summary:
Myofascial pain syndrome is a common cause of chronic pain characterized by myofascial pain and trigger points. Recommendations regarding management of pain after breast cancer don't mention myofascial syndrome despite a study suggests possible myofascial syndrome with roughly 75% of patients in pain.

144 patients having a local breast cancer requiring surgery will be randomized in this study, ratio 1:1 standard and experimental groups.

Every patients (standard and experimental groups) will attend 4 specific consultations during which standard recommendations will be given, pain, quality of life, shoulder range of motion, global upper limbs force will be assessed.

In addition, patient randomized in experimental group will attend self massages and self stretching workshops, one before surgery and one after surgery. Patients will be encouraged to performed daily self massages and self stretching.

The aim of the study is to assess impact of self massages and self stretching workshops on sequelae pain further surgery for breast cancer.

lead_sponsor: Center Eugene Marquis

lead_sponsor_type: industriel


title: Mobile and Interactive Robot's Social Acceptability for Balance and Gait

acronym: ROBO-K

summary:
The recovery of a balance and gait is a primary objective for geriatric, neurological or orthopedic rehabilitation. Since the 80s, many walking robots were proposed.

Despite encouraging results, the use of robotic equipment for gait training remains limited, even if they meet a strong social demand. The reasons for this situation are economic, but also related to the non consideration of the context of utilization . It is therefore important to involve the users of the innovation in the development process because it is the latter that will broadcast. Psychosocial perspective of the acceptability of the technology meets this need by including the users' perceptions toward device (s).

The ROBO-K project aimed at developping a mobile and interactive robot, dedicated to the rehabilitation of balance and gait at an early stage. It was intended for patients with impaired walking vascular neurological, traumatic or associated with chronic neurological disease. The first step for its developement was conducted with the psychosocial approach of Technology acceptability which has required specific methods for collecting the views of users and analysis of the activity. This process allowed the design and the development of robot prototypes.

The aim of the present study is now to establish the degree of social acceptability of the robot and to analyze balance and gait training activity.

primary_purpose: Screening

ReferenceCitation: Davis, F.D. (1989). Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS Quartely, 13 (3) : 319-340.

ReferenceCitation: Venkastesh, V., Morris, M.G., Davis, G.B. & Davis, F.D. (2003). User acceptance of information technology: toward a unified view. Mis Quartely, 27 (3), 425-478

ReferenceCitation: Heerink, M., Kröse, B., Evers, V., & Wielinga, B. (2010). Assessing acceptance of assistive social agent technology by older adults: the Almere Model. International Journal of Social Robotics, 2(4), 361-375

ReferenceCitation: Hamner, M. & Qazi, R. (2008). Expanding the technology acceptance model to examine personal computing technology utilization in government agencies in developing countries. Government Information Quaterly, 26(1), 128-136

ReferenceCitation: King, W.R., & He, J. (2006). A meta-analysis of the technology acceptance model. Information and Management, 43(6), 740-755

ReferenceCitation: Legris, P., Ingham, J., & Collerette, P. (2003). Why do people use information technology? A critical review of the technology acceptance model. Information and Management, 40(3), 191-204

lead_sponsor: Rennes University Hospital


title: Apnea Treatment in Premature Infants Using an Automatic Vibro-tactile Stimulator Triggered by the Detection of Apnea-bradycardia.

acronym: SENSITACT

summary: The goal of the SENSITACT system is to activate an adaptive kinesthetic stimulation to treat apnea-bradycardia events on preterm infants, while minimizing deleterious effects, in particular arousals that can be due either to respiratory efforts or to kinesthetic stimulation itself. This novel system will provide an alternative treatment to apnea-bradycardia, with improved patient comfort and autonomy. In particular, it may become a complementary solution for the current treatments (Manual stimulation by caregivers, continuous or intermittent nasal positive pressure ventilation and methylxanthine therapies) that do not appear to be optimal and usually only allow a partial reduction in the number and severity of apneas.


type: Registry Identifier

title: Personalized Targeted Therapies in Inflammatory Complex Multi Organ Disease

acronym: PIMOC

summary: Inflammatory diseases may display atypical features making such patients impossible to classify. Management of these cases in daily practice cannot rely on the results of clinical trials nor on guidelines. DNA and RNA mapping have become major tools to understand and sometimes direct the treatment strategy in oncology. This study aims to test whether a precise analysis of molecular pathways in inflammatory, non classified diseases, can constitute a predictive tool of therapeutic efficiency


title: Research Into the Molecular Bases of a New Phenotype Combining Premature White Hair, Polycystic Kidney Disease, Aortic Dilation/Dissection and Lymphopenia

summary:
This study involves a single family, including 1 patient, father, mother and sister. The patient presented with a new phenotype associating premature white hair, renal polycystosis, aortic dilation/dissection and lymphopenia. Samples were taken in order to identify the origin of the symptomatology highlighted in the index case.

In addition, it was observed that mice invalidated for bcl-2, normal at birth and indistinguishable from control mice, showed, after one week, a phenotype similar to that observed in this patient.

The overlap between the patient's main clinical signs (lymphopenia, white hair and polycystic renal disease) and the manifestations presented by the invalidated murine model for BCL2 suggests that its phenotype may be secondary to a Bcl-2 expression defect.


title: Linking Optic Nerve Lesion Length at MRI and the Retinal Axonal Loss at 12 Months From a Clinical Episode of Optic Neuritis

acronym: IRMANO

summary: This study evaluates the length of optic nerve lesion on 3D-DIR sequence as an imaging biomarker predictive of retinal axonal loss and visual disability, 12 months after the occurence of a first clinical episode of optic neuritis.

ReferenceCitation: Hadhoum N, Hodel J, Defoort-Dhellemmes S, Duhamel A, Drumez E, Zéphir H, Pruvo JP, Leclerc X, Vermersch P, Outteryck O. Length of optic nerve double inversion recovery hypersignal is associated with retinal axonal loss. Mult Scler. 2016 Apr;22(5):649-58. doi: 10.1177/1352458515598021. Epub 2015 Jul 30.

ReferenceCitation: Hodel J, Outteryck O, Bocher AL, Zéphir H, Lambert O, Benadjaoud MA, Chechin D, Pruvo JP, Vermersch P, Leclerc X. Comparison of 3D double inversion recovery and 2D STIR FLAIR MR sequences for the imaging of optic neuritis: pilot study. Eur Radiol. 2014 Dec;24(12):3069-75. doi: 10.1007/s00330-014-3342-3. Epub 2014 Aug 23.

ReferenceCitation: Miller DH, Newton MR, van der Poel JC, du Boulay EP, Halliday AM, Kendall BE, Johnson G, MacManus DG, Moseley IF, McDonald WI. Magnetic resonance imaging of the optic nerve in optic neuritis. Neurology. 1988 Feb;38(2):175-9.

ReferenceCitation: Dunker S, Wiegand W. Prognostic value of magnetic resonance imaging in monosymptomatic optic neuritis. Ophthalmology. 1996 Nov;103(11):1768-73.

ReferenceCitation: Kallenbach K, Simonsen H, Sander B, Wanscher B, Larsson H, Larsen M, Frederiksen JL. Retinal nerve fiber layer thickness is associated with lesion length in acute optic neuritis. Neurology. 2010 Jan 19;74(3):252-8. doi: 10.1212/WNL.0b013e3181ca0135.

ReferenceCitation: Trip SA, Schlottmann PG, Jones SJ, Altmann DR, Garway-Heath DF, Thompson AJ, Plant GT, Miller DH. Retinal nerve fiber layer axonal loss and visual dysfunction in optic neuritis. Ann Neurol. 2005 Sep;58(3):383-91.

lead_sponsor: University Hospital, Lille


title: Therapeutic Drug Monitoring of Gentamicin and Vancomycin, in Neonates, Using Dried Blood Spot Sampling.

acronym: MIDOMEN

summary:
Gentamicin and vancomycin, widely used in neonatology, are antibiotics with a narrow therapeutic index and a risk of nephrotoxicity and ototoxicity. For these drugs, therapeutic drug monitoring (TDM) is required, to optimize the efficacy and tolerance of these antibiotics.

In newborns, the TDM of these antibiotics is really available, because of physiological features, such as renal elimination and hepatic metabolism which are both very dependent on age and maturation. Thus, in newborn, there is a large interindividual variability of pharmacokinetic parameters, making the dosage adjustment of antibiotics very difficult.

Unfortunately, because of a limited blood mass, the TDM of these antibiotics is very rarely practiced in these children. The introduction of a Died blood spot (DBS), which uses only a single drop of blood (<50 μL) preserved in dried form, thus makes it possible to reduce the blood volume taken and avoid the venous intrusion. The dosage needs the use of liquid chromatography coupled with tandem mass spectrometry (LC-MSMS), the only sensitive technique to work with such a low blood volume.

We therefore wish to develop this approach coupling DBS and LC-MSMS, in neonatology, to evaluate the concentration of these nephrotoxic antibiotics (gentamicin and vancomycin), as TDM. The blood concentrations of the antibiotic, per 100 new-born term or premature (50 gentamicin, 50 vancomycin), are compared to the physiological state of the child (premature or not, intrauterine growth retardation or not), its hemodynamic status (shock or not) and its efficacy / toxicity, evaluated by the clinician using a questionnaire.

The use of this new sampling method, as an alternative to conventional blood sampling, makes it possible to better monitor the concentrations of gentamicin and vancomycin in neonatalogy, thus reducing the risk of toxicity of these antibiotics.

lead_sponsor: University Hospital, Caen

intervention_type: Diagnostic Test


title: Vertebral Bone Quality and Prediction of Screw Loosening in Spine Fusion

acronym: QOAR

summary: Finding a way to use Vertebral CT scan will help to predict screw loosing risk in spinal fusion for degenerative spine disease. Patients who will undergo at least two spine fusion levels for degenerative spine disease will be enrolled in. Before surgery, patients will undergo a spinal QCT scan with a calibrated phantom. The calibrated bone density, at bone-implant interface, will be assessed using dual energy CT scan immediately after surgery, and six months later. The primary outcomes will be the difference between the two values of the bone implant interface. The difference between density values will be correlated to the pre-op bone density value.

status: Active, not recruiting


title: An Open Label Non Randomized Access Study of Trametinib for Patients With Advanced Unresectable (Stage IIIc) or Distant Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

summary: This is a single arm open label, multicenter, non randomized, access study of trametinib for subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV). Trametinib may be given as monotherapy or in combination since first line metastatic melanoma as per inclusion criteria. Subjects who received prior BRAF inhibitor may be included if they have not progressed under such treatment or if they have presented limited progression as per eligibility criteria. It is estimated that between 250 and 400 subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV) will be enrolled.

status: No longer available

study_type: Expanded Access

lead_sponsor: GlaxoSmithKline


title: Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (ATLANTIS)

acronym: ATLANTIS

summary: Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line.

ReferenceCitation: Aix SP, Ciuleanu TE, Navarro A, Cousin S, Bonanno L, Smit EF, Chiappori A, Olmedo ME, Horvath I, Grohé C, Farago AF, López-Vilariño JA, Cullell-Young M, Nieto A, Vasco N, Gómez J, Kahatt C, Zeaiter A, Carcereny E, Roubec J, Syrigos K, Lo G, Barneto I, Pope A, Sánchez A, Kattan J, Zarogoulidis K, Waller CF, Bischoff H, Juan-Vidal O, Reinmuth N, Dómine M, Paz-Ares L. Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial. Lancet Respir Med. 2022 Oct 14. pii: S2213-2600(22)00309-5. doi: 10.1016/S2213-2600(22)00309-5. [Epub ahead of print]

lead_sponsor: PharmaMar

location_country:
Poland
Brazil
Portugal
Romania
Greece
Austria
Italy
Lebanon
Argentina
Canada
Netherlands
Spain
United Kingdom
Hungary
United States
France
Belgium
Germany
Bulgaria
Czechia

location_facility: The Center for Cancer and Blood Disorders

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"

location_facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment. EOOD, Sofia; Clinic of Medical Oncology

location_facility: Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály

location_facility: Vivantes Klinikum am Urban, Hämatologie und Onkologie

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Corporació Sanitaria Parc Taulí-Hospital de Sabadell

location_facility: Centro Hospitalar Lisboa Norte, EPE- Hospital Pulido Valente

location_facility: General Hospital of Thessaloniki "G. Papanikolaou", Pulmonary Clinic, Aristotle University of Thessaloniki

location_facility: Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Presidio G. Rodolico

location_facility: Centre intégré de santé et de services sociaux de la Montérégie Centre

location_facility: Medical Oncology Associates PS (dba Summit Cancer Centers)

location_facility: University of Munich LMU, Dpt. of Medicine V

location_facility: Hospital Universitario La Fe de Valencia

location_facility: SC Centrul de Oncologie Sf. Nectarie SRL, Departament Oncologie Medícala

location_facility: East Jefferson Hematology-Oncology Metairie Physicians Services, Inc

location_facility: Center for Pneumology and Thoracic Surgery

location_facility: Medizinische Universität Wien / AKH Wien, Universitätsklinik für Innere Medizin I, Abteilung für klinische Onkologie

location_facility: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

location_facility: Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte

location_facility: Bristol Cancer Institute, UHB NHS Foundation Trust

location_facility: Hôpital Nord - Service Oncologie Multidisciplinaire et Innovations Thérapeutiques

location_facility: Hospital Universitari Germans Trias i Pujol ICO

location_facility: Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály

location_facility: Hospital General Universitario de Valencia

location_facility: lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu, Oddzial Chemioterapii

location_facility: Instituto Médico Especializado Alexander Fleming

location_facility: MultiCare Institute for Research & Innovation

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Departament Oncologie Medicala

location_facility: Hospital Universitario Clínico San Carlos

location_facility: Anne Arundel Medical Center Oncology and Hematology

location_facility: Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie und Palliativmedizin

location_facility: Uniklinikum Mannheim, TTZ, Medizinische Fakultät Mannheim

location_facility: Innovative Clinical Research Institute (ICRI)

location_facility: CORI - Centro Oncológico Riojano Integral

location_facility: ASST della Valtellina e dell' Alto Lario P.O. Di Sondrio

location_facility: General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Internal Medicine-Oncology Clinic

location_facility: Centre Hospitalier Universitaire Notre Dame de Secours

location_facility: Southlake Regional Health Centre - Stronach Regional Cancer Centre

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie; Oddzial Onkologii Klinicznej im. dr Ewy Pileckiej z pododdzialem

location_facility: American University of Beirut Medical Center

location_facility: Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Sectia Oncologic Medicala

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: AOU Maggiore della Carità - SC Oncologia

location_facility: Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

location_facility: Hammoud Hospital University Medical Center

location_facility: University General Hospital of Heraklion - General Hospital "Venizeleio"

location_facility: Mazowieckie Centrum Leczenia Chorób Pluc i Gruźlicy Oddzial III Chorób Pluc z Pododdzialem Onkologicznym

location_facility: St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare

location_facility: Städtisches Krankenhaus München Neuperlach

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály

location_facility: Centro Hospitalar do Porto, EPE - Hospital de Santo António

location_facility: Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii Klinicznej, Oddzial Onkologii i Radioterapii

location_facility: Szent Borbála Kórház, Pulmonológiai osztály

location_facility: Katholisches Klinikum Koblenz-Montabaur, Marienhof Koblenz

location_facility: Klinikum Bogenhausen, Städt. Klinikum München GmbH, Klinik für Pneumologie und Pneumologische Onkologie

location_facility: Froedtert Hospital & the Medical College of Wisconsin

location_facility: IRCCS CROB (Istituto di Ricovero e Cura a Carattere Scientifico)

location_facility: Universitätsklinik für Innere Medizin III der PMU

location_facility: Klinikum Nürnberg Nord - Pneumologische Onkologie

location_facility: Centre Hospitalier Lyon Sud - Service de Pneumologie

location_facility: Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia

location_facility: Krajska zdravotni a.s. Masarykova nemocnice o.z.

location_facility: Uniklinik Freiburg, Hämatologie, Onkologie & Stammzellransplantation

location_facility: Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia

location_facility: The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Instituto COl de Pesquisa, Educação e Gestão

location_facility: Centro Clínico Champalimaud - Fundação Champalimaud

location_facility: Complejo hospitalario regional virgen rocío

location_facility: Worcestershire Acute Hospitals NHS Trust

location_facility: Hospital Regional Universitario de Malaga

location_facility: Associates in Hematology and Oncology, P.C.

location_facility: General Hospital of Chest Diseases of Athens "Sotiria"

location_facility: Multiprofile Hospital for Active Treatment of Women Health - "Nadezhda", Sofia; Clinic of Medical Oncology

location_facility: Coordenação de Pesquisa Clínica / Instituto Nacional de Câncer

location_facility: Universitätsklinikum Ulm - Klinik für Innere Medizin II, Pneumologie

location_facility: Boca Raton Regional Hospital Lynn Cancer Institute

location_facility: Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Dcpartamentul Oncologie Medicala

location_facility: Centro para la Atención Integral del Paciente Oncológico (CAIPO)

location_facility: R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health

location_facility: Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia

location_facility: Joliet Oncology-Hematology Associates, Ltd.

location_facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris", Sectia Oncologie Medicala

location_facility: lrmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Fundação PlO XII - Hospital de Câncer de Barretos

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Vitkovicka nemocnice, a.s., Plicni oddeleni

location_facility: Klinik Löwenstein gGmbH, Med. Klinik II Onkologie


acronym: Doxo

title: Phase II Pharmacokinetic Study to Assess the Age-dependency in the Clearance of Doxorubicin in Paediatric Patients With Solid Tumours and Leukaemia

lead_sponsor: University Hospital Muenster

source: euctr

location_country:
Germany
France
United Kingdom
Italy

location_facility: Royal Victoria Infirmary, Sir James Spence Institute of Child Health

location_facility: Great Ormond Street Hospital for Children

location_facility: Prof. Maurizio D'Incalci, National Study Manager Italy

location_facility: MD Nicolas Andre, National Study Manager France

location_facility: Prof. Alan Boddy, National Study Manager UK

summary: Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity .


title: A Randomized Phase II Study of Pazopanib and Weekly Paclitaxel in Patients With Platinum Resistant/Refractory Ovarian Cancer Who Relapse During Bevacizumab Maintenance

acronym: TAPAZ

summary: Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.

ReferenceCitation: Joly F, Fabbro M, Berton D, Lequesne J, Anota A, Puszkiel A, Floquet A, Vegas H, Bourgeois H, Bengrine Lefevre L, You B, Pommeret F, Lortholary A, Spaeth D, Hardy-Bessard AC, Abdeddaim C, Kaminsky-Forrett MC, Tod M, Kurtz JE, Del Piano F, Meunier J, Raban N, Alexandre J, Mouret-Reynier MA, Ray-Coquard I, Provansal Gross M, Brachet PE. Paclitaxel with or without pazopanib for ovarian cancer relapsing during bevacizumab maintenance therapy: The GINECO randomized phase II TAPAZ study. Gynecol Oncol. 2022 Sep;166(3):389-396. doi: 10.1016/j.ygyno.2022.06.022. Epub 2022 Jul 26.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: "Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie"

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: ICL Institut de Cancérologie de Lorraine

location_facility: Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Cochin

location_facility: Centre Hospitalier Universitaire Bretonneau

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Centre ONCOGARD - Institut de Cancérologie du Gard

location_facility: Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble


acronym: SYMPTOMS

title: Prevention of Symptomatic Venous Thromboembolism by Low Molecular Weight Heparin in Hospitalized Medical Patients Aged 70 Years and Older : a Randomized Placebo-Controlled Study The SYMPTOMS (SYstematic Elderly Medical Patients Thromboprophylaxis : Efficacy on Symptomatic OutcoMeS) Study

lead_sponsor: University Hospital, Brest

location_country: France Switzerland

location_facility: CHU Strasbourg - Service de Médecine Interne

location_facility: CHRU Strasbourg- Service HTA et Maladies Vasculaires

location_facility: CH Intercommunal Toulon La Seyne sur Mer

location_facility: Clinique Mutualiste Médico-chirurgical "Beau Soleil"

summary:
Venous thromboembolism (VTE) is a frequent condition, affecting 1.8 per 1,000 people every year. Admission to hospital is one of the main risk factors for VTE, and could account for up to 20% of all VTE, making VTE prevention in admitted patients an appealing option to reduce VTE global burden.

The landmark MEDENOX trial and others demonstrated the efficacy of low molecular weight heparins (LMWH) in reducing a composite outcome of symptomatic and asymptomatic events, the latter accounting for the vast majority of events.

Publication of these trials led to the implementation of thromboprophylaxis policies in hospitals, which acceptance has been variable. More recently, the use of thromboprophylaxis has been challenged after the publication of 1) a negative trial that used 'death from any cause' as main outcome, 2) a systematic review showing the lack of a clear efficacy on the risk of pulmonary embolism or death, 3) negative trials using new oral anticoagulants, 4) the last version of the American College of Chest Physicians Guidelines, focusing on symptomatic events only, downgraded its recommendation for thromboprophylaxis in medical patients to a 1B recommendation, restricting its use to patients 'at increased risk of thrombosis' and recommending against the use of thromboprophylaxis in patients at low risk of thrombosis, patients bleeding or at high risk of bleeding.

However, a limitation of this interpretation of the data is that in most trials, patients with screened asymptomatic events were treated with anticoagulants, preventing the occurrence of symptomatic events during follow-up. Moreover, subgroup analyses showed that elderly patients were at high risk of thrombosis in these trials, and that LMWH could be particularly efficient in this subgroup of patients. Conversely, their risk of bleeding is also higher than in younger patients and the current trials were not powered to detect a difference in the bleeding risk between groups. Finally, the diagnostic and therapeutic management of VTE is more challenging in the elderly. Therefore, we planned a randomized controlled trial on the efficacy of LMWH for the prevention of symptomatic VTE in elderly patients.


title: Consultations Reason for Genital, Urinary or Psychological Humans in General Practice

acronym: GETUP

summary: Many male patients complain about their ejaculation: 21-30% of men aged between 18 and 59 have admitted suffering from a decrease in, or loss of control of, their ejaculation. The quality of life of patients and their partners is impaired compared to men not suffering from premature ejaculation. Economically, the impact of the disease are significant. In the year preceding the detection of premature ejaculation patients visit twice their physician. The majority of men interviewed anonymously, in their General Practitioner's ( GP's) waiting room, considered it important to talk with their GP about their sexual concerns. Almost half of them preferred that their GP initiate any discussions about sexuality. More than two thirds of the respondents would have liked their GP to signal his or her open-mindedness by directly addressing sexual topics during the consultation. In 2008 a qualitative study brought to the fore the strategies used by GPs to initiate the discussion on premature ejaculation . GPs who mentioned premature ejaculation with their patient described three attitude-related strategies and three investigative strategies.

status: Terminated

primary_purpose: Diagnostic

ReferenceCitation: Barais M, Vaillant Roussel H, Costa D, Derriennic J, Pereira B, Cadier S. Premature ejaculation in primary care: communication strategies versus usual care for male patients consulting for a sexual, urogenital or psychological reason - GET UP: study protocol for a cluster randomised controlled trial. Trials. 2018 Nov 12;19(1):622. doi: 10.1186/s13063-018-2947-2.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

location_facility: Cabinet médical du 5 Descente des Oliviers

location_facility: Cabinet médical - 89 Bis Rue de la Calade

location_facility: Cabinet médical - Esplanade Mitterrand 5

location_facility: Cabinet médical - 39 rue Saint Philibert


acronym: BEVABEL

title: Prospective Phase II Study of Gemcitabine Plus Platinum Salt in Combination With Bevacizumab (Avastin®) for Metastatic Collecting Duct Carcinoma

lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie de l'Ouest-Site Paul Papin

location_facility: Institut de cancérologie de l'Ouest - Site René Gauducheau

location_facility: Gustave Roussy, Cancer Campus, Grand Paris

summary: Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinum salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma.


title: A 6-month Randomised, Double-blind, Placebo Controlled Multicentre Parallel Group Study to Evaluate Efficacy and Safety of Bumetanide 0.5mg Twice a Day Followed by an Open Label Active 6-month Treatment Period With Bumetanide (0.5mg Twice a Day) and a 6 Weeks Discontinuation Period After Treatment Stop.

lead_sponsor: Institut de Recherches Internationales Servier

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

location_country:
Poland
Brazil
Portugal
Spain
Italy
United Kingdom
Netherlands
Hungary
France
Germany

location_facility: Neuro Riabilitazione/Psicopatologia dell'età evolutiva Istituto Scientifico Medea - Bosisio Parini

location_facility: Centrum Badań Klinicznych PI-House sp. z o.o

location_facility: NAVICULA Centrum Diagnozy i Terapii Autyzmu w Łodzi

location_facility: Programma Interdipartimentale "Autismo 0-90" A.O.U. Policlinico "Gaetano Martino"

location_facility: Hospital General Universitario de Alicante

location_facility: Universidade Federal de São Paulo, Escola Paulista de Medicina

location_facility: U.O. di Neuropsichiatria Infantile Fondazione Istituto Neurologico Nazionale Casimiro Mondino Istituto di Ricovero e Cura a Carattere Scientifico

location_facility: Centre Hospitalier Charles Perrens CRA Aquitaine

location_facility: Centre Hospitalier du Rouvray Centre de Ressources pour l'Autisme

location_facility: Universitätsklinikum Freiburg, Zentrum für Psychische Erkrankungen, Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter

location_facility: Unità Semplice di Psichiatria Infantile Policlinico Universitario di Napoli - Università Federico II

location_facility: Bekes Megyei Kozponti Korhaz Gyermek es ifjusagpszichiatriai osztaly

location_facility: Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

location_facility: Szegedi Tudományegyetem Szent-Gyorgy Albert Klinikai Kozpont Gyermekgyógyászati Klinika Gyermek es Ifjusagpszichiátriai o

location_facility: Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters am Zentralinstitut für Seelische Gesundheit

location_facility: Forward Thinking Birmingham_Birmingham Women's and Children's NHS Foundation Trust

location_facility: Centro Hospitalar e Universitario de Coimbra Hospital Pediatrico

location_facility: Hôpitaux Universitaires de Strasbourg Service de Psychiatrie de l'Enfant et de l'Adolescent

location_facility: Samodzielny Publiczny Dziecięcy Szpital Kliniczny w Warszawie Oddział Kliniczny Psychiatrii Wieku Rozwojowego

location_facility: U.O. di Neuropsichiatria Infantile Azienda Ospedaliera Universitaria Senese

location_facility: Trial Tech em Pesquisas com Medicamentos Ltda

location_facility: Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza Ospedale Pediatrico-Microcitemico

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Gdańskie Centrum Zdrowia Sp. z o.o.

location_facility: Hôpital Robert Debré Service de Psychiatrie de l'enfant et de l'adolescent

location_facility: U.O.C. Psichiatria dello Sviluppo IRCCS Fondazione Stella Maris

location_facility: Faculdade de Medicina da Universidade de São Paulo - Departamento de Psiquiatria

location_facility: Hôpital Le Vinatier CRA Rhône-Alpes, Bat 211

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden, Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und

summary: The purpose of this study was to evaluate the efficacy and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.


title: APEX-AMI - Pexelizumab in Conjunction With Angioplasty

summary: In the setting of reperfusion therapy in an acute myocardial infarction using primary percutaneous intervention (PCI), the body's own inflammatory system involving the complement cascade may be harmful. This study will test the safety and efficacy of a novel complement inhibitor, pexelizumab to reduce mortality at 30 days.

ReferenceCitation: Bagai A, Armstrong PW, Stebbins A, Mahaffey KW, Hochman JS, Weaver WD, Patel MR, Granger CB, Lopes RD. Prognostic implications of left ventricular end-diastolic pressure during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: Findings from the Assessment of Pexelizumab in Acute Myocardial Infarction study. Am Heart J. 2013 Nov;166(5):913-9. doi: 10.1016/j.ahj.2013.08.006. Epub 2013 Sep 24.

ReferenceCitation: Guptill JT, Mehta RH, Armstrong PW, Horton J, Laskowitz D, James S, Granger CB, Lopes RD. Stroke after primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction: timing, characteristics, and clinical outcomes. Circ Cardiovasc Interv. 2013 Apr;6(2):176-83. doi: 10.1161/CIRCINTERVENTIONS.112.000159. Epub 2013 Apr 2.

ReferenceCitation: Westerhout CM, Pieper KS, James SK, Mahaffey KW, de Werf FV, Califf RM, Granger CB, Armstrong PW. Dynamic modeling of 90-day mortality in ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention. Am Heart J. 2013 Mar;165(3):354-62.e2. doi: 10.1016/j.ahj.2012.12.001. Epub 2013 Jan 15.

ReferenceCitation: Patel MR, Westerhout CM, Granger CB, Brener SJ, Fu Y, Siha H, Kim RJ, Armstrong PW. Aborted myocardial infarction after primary percutaneous coronary intervention: magnetic resonance imaging insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2013 Feb;165(2):226-33. doi: 10.1016/j.ahj.2012.10.028. Epub 2012 Nov 24.

ReferenceCitation: Truffa AA, Granger CB, White KR, Newby LK, Mehta RH, Hochman JS, Patel MR, Pieper KS, Al-Khalidi HR, Armstrong PW, Lopes RD. Serious infection after acute myocardial infarction: incidence, clinical features, and outcomes. JACC Cardiovasc Interv. 2012 Jul;5(7):769-76. doi: 10.1016/j.jcin.2012.03.018.

ReferenceCitation: Martel C, Granger CB, Ghitescu M, Stebbins A, Fortier A, Armstrong PW, Bonnefoy A, Theroux P. Pexelizumab fails to inhibit assembly of the terminal complement complex in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Insight from a substudy of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2012 Jul;164(1):43-51. doi: 10.1016/j.ahj.2012.04.007. Epub 2012 Jun 15.

ReferenceCitation: van Diepen S, Widimsky P, Lopes RD, White KR, Weaver WD, Van de Werf F, Ardissino D, van't Hof AW, Armstrong PW, Granger CB. Transfer times and outcomes in patients with ST-segment-elevation myocardial infarction undergoing interhospital transfer for primary percutaneous coronary intervention: APEX-AMI insights. Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):437-44. doi: 10.1161/CIRCOUTCOMES.112.965160. Epub 2012 May 15.

ReferenceCitation: Hudson MP, Armstrong PW, O'Neil WW, Stebbins AL, Weaver WD, Widimsky P, Aylward PE, Ruzyllo W, Holmes D, Mahaffey KW, Granger CB. Mortality implications of primary percutaneous coronary intervention treatment delays: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction trial. Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):183-92. doi: 10.1161/CIRCOUTCOMES.110.945311. Epub 2011 Feb 8.

ReferenceCitation: Huber K, Holmes DR Jr, van 't Hof AW, Montalescot G, Aylward PE, Betriu GA, Widimsky P, Westerhout CM, Granger CB, Armstrong PW. Use of glycoprotein IIb/IIIa inhibitors in primary percutaneous coronary intervention: insights from the APEX-AMI trial. Eur Heart J. 2010 Jul;31(14):1708-16. doi: 10.1093/eurheartj/ehq143. Epub 2010 May 25.

ReferenceCitation: Alhadramy O, Westerhout CM, Brener SJ, Granger CB, Armstrong PW; APEX AMI Investigators. Is visual interpretation of coronary epicardial flow reliable in patients with ST-elevation myocardial infarction undergoing primary angioplasty? Insights from the angiographic substudy of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2010 May;159(5):899-904. doi: 10.1016/j.ahj.2010.02.028.

ReferenceCitation: Patel MR, Worthley SG, Stebbins A, Dill T, Rademakers FE, Valeti US, Barsness GW, Van de Werf F, Hamm CW, Armstrong PW, Granger CB, Kim RJ. Pexelizumab and infarct size in patients with acute myocardial infarction undergoing primary percutaneous coronary Intervention: a delayed enhancement cardiac magnetic resonance substudy from the APEX-AMI trial. JACC Cardiovasc Imaging. 2010 Jan;3(1):52-60. doi: 10.1016/j.jcmg.2009.09.014. Epub 2010 Jan 12. Erratum in: JACC Cardiovasc Imaging. 2010 Jul;3(7):796. Velleti, Uma S [corrected to Valeti, Uma S].

ReferenceCitation: Trendelenburg M, Theroux P, Stebbins A, Granger C, Armstrong P, Pfisterer M. Influence of functional deficiency of complement mannose-binding lectin on outcome of patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Eur Heart J. 2010 May;31(10):1181-7. doi: 10.1093/eurheartj/ehp597. Epub 2010 Jan 19.

ReferenceCitation: Brener SJ, Westerhout CM, Fu Y, Todaro TG, Moliterno DJ, Wagner GS, Granger CB, Armstrong PW; APEX-AMI Investigators. Contribution of angiographic and electrocardiographic parameters of reperfusion to prediction of mortality and morbidity after acute ST-elevation myocardial infarction: Insights from the Assessment of Pexelizumab in Acute Myocardial Infarction trial. Am Heart J. 2009 Nov;158(5):755-60. doi: 10.1016/j.ahj.2009.09.009. Epub 2009 Oct 3.

ReferenceCitation: Armstrong PW, Fu Y, Westerhout CM, Hudson MP, Mahaffey KW, White HD, Todaro TG, Adams PX, Aylward PE, Granger CB. Baseline Q-wave surpasses time from symptom onset as a prognostic marker in ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention. J Am Coll Cardiol. 2009 Apr 28;53(17):1503-9. doi: 10.1016/j.jacc.2009.01.046.

ReferenceCitation: Buller CE, Fu Y, Mahaffey KW, Todaro TG, Adams P, Westerhout CM, White HD, van 't Hof AW, Van de Werf FJ, Wagner GS, Granger CB, Armstrong PW. ST-segment recovery and outcome after primary percutaneous coronary intervention for ST-elevation myocardial infarction: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Circulation. 2008 Sep 23;118(13):1335-46. doi: 10.1161/CIRCULATIONAHA.108.767772. Epub 2008 Sep 8.

ReferenceCitation: APEX AMI Investigators, Armstrong PW, Granger CB, Adams PX, Hamm C, Holmes D Jr, O'Neill WW, Todaro TG, Vahanian A, Van de Werf F. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial. JAMA. 2007 Jan 3;297(1):43-51.

lead_sponsor: Procter and Gamble

location_country:
Denmark
Poland
Portugal
Spain
Italy
Austria
Australia
Netherlands
Canada
Czech Republic
New Zealand
Switzerland
Sweden
United States
France
Belgium
Germany

location_facility: Ciutat Sanitaria i Universitaria de Bellvitge

location_facility: Hospital of the University of Pennsylvania

location_facility: South Texas Veterans Health Care System Audie L. Murphy Division

location_facility: Saint John Regional Hospital - New Brunswick Heart Centre

location_facility: Hospital Garcia de Orta - Servico de Cardiologia

location_facility: I. Interni klinika, Fakultni nemocnice Plzen

location_facility: A.O. della Regione Lombardia Presidio Ospedaliero Sant'Anna

location_facility: Kardiocentrum, Fakultni nemocnice Kralovske Vinohrady

location_facility: Kardiologicke odd. Nemocnice Ceske Budejovice as

location_facility: Health First Holmes Regional Medical Center

location_facility: Interni kardiologicka klinika, Fakultni nemocnice Brno

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Kardiologicke odd., Krajska neocnice Liberec

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: A.O. SS. Antonio e Biagio e Cesare Arrigo

location_facility: Hospital General Universitario de Alicante

location_facility: Centre Hospitale de'Universite de Montreal (Pav Notre-Dame)_

location_facility: MultiCare Medical Center (Tacoma General Hospital)

location_facility: SPZOZ Dolnoslaski Szpital Specjalistyczny

location_facility: Hopital d'adultes de Brabois (CHU de Nancy)

location_facility: Universitiy of Virginia Health Science Center

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: I. Interni klinika, Fakultni nemocnice Hradec

location_facility: II. Interni klinika, Vseobecna fakultni nemocnice

location_facility: Montreal Heart Institute/Research Centre

location_facility: Kardiologicke oddeleni, Masarykova nemocnice

location_facility: University of Missouri Health Sciences Center

location_facility: Universitatsklinik der Ruhr-Universitat Bochum

location_facility: I. interni kardioangiologicka klinika, Fakultni nemocnice u Sv. Anny

location_facility: Azienda Ospedaliera di Parma - Ospedale Maggiore

location_facility: Kardiologicke odd., Nemocnice Na Homoice

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Oklahoma Health Sciences Center

location_facility: Sunnybrook & Women's Health Sciences Centre

location_facility: Kardio-Troll sro and Krajska nemocnice Pardubice

location_facility: Hospital Sao Joao - Servico de Cardiologia


title: A Phase II Study of Cetuximab Rechallenge in Combination With Irinotecan in Advanced Metastatic Colorectal Cancer Without KRAS or NRAS or BRAF Mutation (All Wild Type) for Patients Pretreated With FOLFIRI and Cetuximab in First Line With Stopping Cetuximab for Progressive Disease After a Previous Response (Partial Response or Complete Response) and After Treatment With a Fluoropyrimidine, Oxaliplatin Plus Bevacizumab Regimen

acronym: REGAIN

summary:
The main objective of this study is to evaluate the objective response rate at two months (complete disappearance of the disease and partial disappearance of the disease) obtained after administration of combination therapy with cetuximab and irinotecan in the patients with metastatic colorectal cancer.

Secondaries objectives will be assessed progression-free survival, overall survival, toxicity, quality of life.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre de radiothérapie - Clinique Sainte Anne

location_facility: Groupe hospitalier Public du Sud de l'Oise -site de Senlis


title: Therapeutic Nipple Areola Skin-sparing Mastectomy.

summary:
This is a phase III, multicentric, single arm study with a sequential design using the exact conditional Poisson test.

The primary objective of this prospective study is to evaluate whether selected breast carcinoma patients could be treated with nipple sparing mastectomy (NSM) with an acceptable low local recurrence rates.

450 patients will be included over a period of 4 years and will be followed for a 5 years period (twice a year).

All patients must have a complete preoperative evaluation (bilateral mammography, bilateral breast ultrasonography +/- MRI), and a histopathological diagnostic proof of carcinoma (invasive or in situ, all histopathological types, first treatment or relapse).

The study procedure is represented by nipple areola skin-sparing mastectomy followed by immediate breast reconstruction.

After surgery, early and late complications, including specific complications (suffering of the nipple-areolar complexe and suffering of the skin flaps), will be evaluate.

An esthetic evaluation (by patient and clinician) and a quality of life evaluation will be realized throughout the study.

A complementary study, prospective, non-interventional, will be proposed to patients who will benefit from the same surgical technique (NSM) followed by immediate reconstruction, but in the context of preventive surgery (prophylactic surgery for patients mutated or high genetic risk). The aim of this complementary study, which will include a maximum of 60 patients, is to evaluate associated morbidity in prophylactic NSM.

Data will be collected over a 3 months period after surgery.

ReferenceCitation: Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.

lead_sponsor: Institut Claudius Regaud

location_facility: Etablissement Rennais du Sein - CHP St Grégoire

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Hôpital Européen Georges Pompidou, Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure


acronym: FLIRT

title: A Randomized Phase III Trial Evaluating Two Strategies of Rituximab Administration for the Treatment of First Line/Low Tumor Burden Follicular Lymphoma (Follicular Lymphoma IV/SC Rituximab Therapy)

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Institut de Cancérologie du Gard Hématologie clinique

location_facility: Hôpital Haut Lévêque - Centre François Magendie

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau

summary:
Patient will receive either one infusion of rituximab IV and seven administrations of rituximab SC (experimental arm) or four infusions of rituximab IV (standard arm).

The hypothesis is that the use of rituximab by sub cutaneous route and the scheme of administration could:

optimize rituximab exposure leading to improve response rate
increase adaptative response and then improve long-term control disease.


title: Long Term Follow-up of Twisted Fallopian Tubes Among Young Girl. International Study

acronym: Tubes

summary:
Isolated tubal torsion is a very rare event already in adults (1: 1.5 million women), it remains exceptional in children without being able to find a prevalence in the literature. The causes can be malformative or idiopathic, but even that remains unknown.

Because of the scarcity, surgical treatment is not standardized and left to the good care of the surgeon in charge.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Hospices Civils de Lyon

location_country: Italy Lebanon France Turkey Romania

location_facility: APHM, Hôpital La Timone Enfants et Hôpital Nord

location_facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo

location_facility: Ege University Faculty of Medicine Children's Hospital

location_facility: Centre Hospitalier Universitaire de Angers

location_facility: Institute for Maternal and Child Health IRCCS G. Gaslini, Genova

location_facility: ASP Trapani - presidio ospedaliero "S. Antonio Abate

location_facility: Azienda Ospedaliera Universitaria di Padova


title: A Phase IIIb, Multicentre, Open-label Study of Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome and/or BCR-ABL Positive CML in Chronic Phase

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Gullaksen SE, Skavland J, Gavasso S, Tosevski V, Warzocha K, Dumrese C, Ferrant A, Gedde-Dahl T, Hellmann A, Janssen J, Labar B, Lang A, Majeed W, Mihaylov G, Stentoft J, Stenke L, Thaler J, Thielen N, Verhoef G, Voglova J, Ossenkoppele G, Hochhaus A, Hjorth-Hansen H, Mustjoki S, Sopper S, Giles F, Porkka K, Wolf D, Gjertsen BT. Single cell immune profiling by mass cytometry of newly diagnosed chronic phase chronic myeloid leukemia treated with nilotinib. Haematologica. 2017 Aug;102(8):1361-1367. doi: 10.3324/haematol.2017.167080. Epub 2017 May 18.

ReferenceCitation: Thielen N, Richter J, Baldauf M, Barbany G, Fioretos T, Giles F, Gjertsen BT, Hochhaus A, Schuurhuis GJ, Sopper S, Stenke L, Thunberg S, Wolf D, Ossenkoppele G, Porkka K, Janssen J, Mustjoki S. Leukemic Stem Cell Quantification in Newly Diagnosed Patients With Chronic Myeloid Leukemia Predicts Response to Nilotinib Therapy. Clin Cancer Res. 2016 Aug 15;22(16):4030-8. doi: 10.1158/1078-0432.CCR-15-2791. Epub 2016 Mar 22.

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
Romania
Belgium
Poland
Portugal
Slovenia
Austria
Norway
Sweden
Slovakia
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Latvia
Estonia
Finland
Czech Republic
France
Netherlands

summary: This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.


title: Randomized Control Study : Evaluation of the Benefits of Glucose Drinks During Childbirth

acronym: SOLISO

summary:
Fear of full stomach when emergency general anaesthesia is required is the origin of fastening when giving birth. This behaviour does not warranty perfect security for the general anaesthesia. In addition, well being for women and new born is affected. Giving birth is finally compared to a sportive competition with high-energy needs. As Intravenous energy intake is not regulated by physiologic digestion, it can induce metabolic disorders for the mother that can be amplified for the foetus.

Oral glucose drinks could offer some benefits:

gastric acidity would be decreased without significant increase in volumes.
energy intake would further more active and more efficiency labour
an increase in foetus well being

However, it has never been shown yet that such behaviour could offer those benefits. Also, it seems that there is not more vomiting, but most of the studies compared oral glucose intake to waterborne intake with the same volumes The expected efficacy is a reduction in labour duration and a reduction in percentage of extraction. Previous studies said that the lack of statistical power due to small number of subjects caused the absence of statistical significant relationship.

In addition, even though newborn have less acidosis, there is no clinical relationship proven.

The investigators propose a randomised multicentre study to assess efficacy of oral glucose drinks in comparison to traditional fastening when giving birth.

Main objective is to significantly reduce instrumental extraction rates. 5400 women will be included in the study in 2 years.

location_facility: Centre Hospitalier Mémorial France Etats-Unis


intervention_type: Radiation

title: Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II Hodgkin's Lymphoma and FDG-PET Positivity After 2 Cycles of ABVD

location_facility:
Clinique Victor Hugo
CHU Pontchaillou
Hôpital Cochin
CH Sud Francilien
Hôpital André Mignot
Centre François Baclesse
Hôpital Haut Lévêque
CH Victor Dupouy
CHU de Dijon - Hôpital le Bocage
CHU de Strasbourg
Centre Léon Bérard
CHU Bretonneau
I.U.C.T Oncopole
CHU Montpellier - Saint ELOI
CH Perpignan
Institut Paoli Calmette
CHU Robert Debre
Hôpital Saint Louis
CHU de Brabois
CHRU Lille - Hôpital Claude Huriez
Polyclinique Bordeaux Nord
CH de Chambéry
Hôpital de la Conception
Gustave Roussy Cancer Campus
CHU Lyon Sud
CHU de Nantes
Hôpital de la Pitié Salpétrière
Centre Henri Becquerel
CHU de Limoges
Hôpital Henri Mondor

summary: This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).


title: Efficacy of Captopril Nebulization in Covid-19 Patients Suffering of SARS CoV-2 Pneumonia. A Randomized Phase II Study

acronym: CAPTOCOVID

summary: Captopril being an effective drug available in liquid preparation, administration by nebulization could be of interest for maximizing lung action and minimizing systemic side effects. Such a treatment might be used for "Covid-19" patients with pneumonia in order to avoid ARDS.

ReferenceCitation: Gurwitz D. Angiotensin receptor blockers as tentative SARS-CoV-2 therapeutics. Drug Dev Res. 2020 Aug;81(5):537-540. doi: 10.1002/ddr.21656. Epub 2020 Mar 4.

ReferenceType: result

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

ReferenceCitation: Li F, Li W, Farzan M, Harrison SC. Structure of SARS coronavirus spike receptor-binding domain complexed with receptor. Science. 2005 Sep 16;309(5742):1864-8.

ReferenceCitation: Imai Y, Kuba K, Rao S, Huan Y, Guo F, Guan B, Yang P, Sarao R, Wada T, Leong-Poi H, Crackower MA, Fukamizu A, Hui CC, Hein L, Uhlig S, Slutsky AS, Jiang C, Penninger JM. Angiotensin-converting enzyme 2 protects from severe acute lung failure. Nature. 2005 Jul 7;436(7047):112-6.

ReferenceCitation: Zhang H, Penninger JM, Li Y, Zhong N, Slutsky AS. Angiotensin-converting enzyme 2 (ACE2) as a SARS-CoV-2 receptor: molecular mechanisms and potential therapeutic target. Intensive Care Med. 2020 Apr;46(4):586-590. doi: 10.1007/s00134-020-05985-9. Epub 2020 Mar 3.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital de Tours
Hôpital Antoine Béclère
Groupe hospitalier Sud Ile de France
Hôpital Avicenne,
CH de Compiègne-Noyon
Hôpital Tenon
Hôpital Avicenne
Hôpital de la Pitié- Salpêtrière
CH Victor Dupuy- Argenteuil
CHRU de Tours, Hôpital Bretonneau


summary: This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months.

lead_sponsor: Hoffmann-La Roche

location_facility: Cmc De Tronquieres;Chimiotherapie Et Radiotherapie

location_facility: Centre Catherine de Sienne; Chimiotherapie

location_facility: Clinique Armoricaine Radiologie; Cons Externes

location_facility: Chi Emile Durkheim Site Epinal; Oncologie

location_facility: Ch Georges Renon; Oncologie Radiotherapie

location_facility: Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire

location_facility: Chi De Cornouaille; Oncologie Hospitalisation

location_facility: Clinique Tivoli; Chimiotherapie Radiotherapie

location_facility: CH de Saint Jean De Maurienne; Had St Jean De Maurienne

location_facility: Polyclinique Du Languedoc; Chimiotherapie

location_facility: Hopitaux Du Leman Site Thonon; Maternite Gynecologie

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Ch De Montlucon; Hematologie Cancerologie

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: Centre Hospitalier De Sens; Medecine Generale Oncologie

location_facility: C H Du Pays D'Aix En Provence; Hopital De Jour

location_facility: Hopital De Falconaja Furiani; Hopital De Jour

location_facility: Centre Mistral; Chirurgie Cancerologie Gynecologiques

location_facility: Clinique Medico Chir Charcot; Chir Cancerologie

location_facility: Clinique Claude Bernard; Onco Hematologie

location_facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Clinique De L Estree; Oncologie Medicale

location_facility: Polyclinique Francheville; Med Chimiotherapie Radiotherapie

location_facility: CH Carcassonne; Service Onco Hematologie

location_facility: Hopital Louis Pasteur; Oncologie Hematologie

location_facility: Clinique Francois 1er; Service De Chimiotherapie

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

location_facility: Medipole De Savoie; Departement Oncologie

location_facility: Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie

location_facility: Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie

location_facility: Ch De Longjumeau; Hopital De Jour Et Semaine

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Ctre Hosp Prive Beauregard; Hop De Jour Chimiotherapie

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: CH Annecy Genevois site Annecy; Oncologie

location_facility: Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie

location_facility: Ghi Le Raincy Montfermeil; Oncologie Medicale

location_facility: Hopital Antoine Beclere; Hopital De Jour

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: Centre De Radiotherapie Et D'Oncologie; Oncologie

location_facility: Clinique Saint Jean Languedoc; Oncologie Medicale

location_facility: CH de Marne la vallee; Oncologie Medicale

location_facility: Hopital Bretonneau; Clinique D'Oncologie & de Radiotherapie

location_facility: Ch Pitie Salpetriere; Oncologie Medicale

location_facility: Clinique De La Sauvegarde; Chimiotherapie

location_facility: Clinique Saint Faron; Sce Oncologie Radiotherapie

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

location_facility: Hopital Henri Mondor; Oncologie Medicale

location_facility: Ch Francois Mitterrand; Medecine Oncologie

location_facility: Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie


title: Medical and Economic Evaluation of an External Beam Radiotherapy Combined With a Brachytherapy Boost Compared With an Exclusive External Beam Radiotherapy for Intermediate-risk Prostate Cancer

summary:
The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment.

The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.

location_facility: Centre d'oncologie et de radiothérapie Mâcon

location_facility: Institut de Cancerologie de Lorraine Alexis Vautrin

location_facility: Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard


title: Follow-up of HBsAg Inactive Carriers Study

acronym: PIBAC

summary: The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We spoke first from HBsAg" healthy carrier ", then from " asymptomatic carrier ", last from HBsAg" inactive carrier ". This definition continue to be not totally consensual. A very low viral load (< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40 UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg quantification for the prognosis of such events or, in contrary HBs seroconversion; will evaluate the influence of B genotype on HBsAg level; will evaluate the influence of comorbidities on unexpected arrival of such events.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Chi Villeneauve Saint Georges
Ch de Lagny Marne La Valee
Ch D'Hyeres
Ch de Meaux
Clinique Du Palais
Ch de Pau
Medical Center La Sauvegarde
Clinical Center Bourgoin Jallieu
Ch de Vannes
Ch Saint Brieuc
Hopital Sainte Camille
Ch Montelimar
CHR d'ORLEANS
Medical Center Besancon
Ch de Creteil
Ch de Saint Denis
Ch General Du Pays D'Aix
CH CREIL
Ch Sud Fracilien Jean Jaures
Ch Du Mans
Ch de Montfermeil
Chd Vendee
CH de GONESSE
Medical Center Nanterre
Clinical Center Montpellier
Clinique de La Chataigneraie
Hopital Saint Jean
Ch de Caen
Medical Center Paris 7
CH d'AVIGNON
Ch de La Region Annnecienne
CH MELUN


title: Evaluation of the Clinical Utility and Cost Effectiveness Ratio of Generalized Neonatal Screening for Severe Combined Immunodeficiencies (SCID) by Quantification of TRECs on Guthrie Cards

acronym: DEPISTREC

summary:
Severe combined Immunodeficiencies ( SCID ) are a group of inherited diseases of the immune system by characterised profound abnormalities of T cell development . Infants with SCID require prompt clinical response to Prevent life -threatening infection and studies show significantly improved survival in babies Diagnosed at birth as a result of previous family history . SCID follows criteria for population -based newborn screening since it is asymptomatic at birth and fatal within the first year of life, the confirmation of the disease is easy, there is a curative treatment , and it is known that early stem cell transplantation improves survival . Quantification of TRECs (T- cell receptor excision circles ) in DNA extracted from Guthrie samples is a sensitive screening test for Specific and SCID .

The investigators propose in this study to perform a neonatal screening of SCID , in a population of 200,000 babies over a period of two years .

The investigators propose to study the clinical utility and cost effectiveness ratio, and SCID screening to demonstrate that could result in a broad benefit to Individuals detected , making screening relatively cost-effective in spite of the low incidence of the disease .

design_allocation: Non-Randomized

ReferenceCitation: Thomas C, Durand-Zaleski I, Frenkiel J, Mirallié S, Léger A, Cheillan D, Picard C, Mahlaoui N, Riche VP, Roussey M, Sébille V, Rabetrano H, Dert C, Fischer A, Audrain M. Clinical and economic aspects of newborn screening for severe combined immunodeficiency: DEPISTREC study results. Clin Immunol. 2019 May;202:33-39. doi: 10.1016/j.clim.2019.03.012. Epub 2019 Apr 1.

ReferenceCitation: Audrain MAP, Léger AJC, Hémont CAF, Mirallié SM, Cheillan D, Rimbert MGM, Le Thuaut AM, Sébille-Rivain VA, Prat A, Pinel EMQ, Divry E, Dert CGL, Fournier MAG, Thomas CJC. Newborn Screening for Severe Combined Immunodeficiency: Analytic and Clinical Performance of the T Cell Receptor Excision Circle Assay in France (DEPISTREC Study). J Clin Immunol. 2018 Oct;38(7):778-786. doi: 10.1007/s10875-018-0550-7. Epub 2018 Sep 24.

lead_sponsor: Nantes University Hospital

location_facility: Toulouse Private Hospital Clinique Sarrus Teinturiers

location_facility: Marseille University Hospital La Conception

location_facility: Nantes Private Hospital Clinique Jules Verne

location_facility: Rennes Private Hospital Clinique Mutualiste La Sagesse

location_facility: Paris University Hospital Armand-Trousseau

location_facility: Bordeaux Maison de Santé Protestante Bordeaux Bagatelle

location_facility: Poissy Hospital CHI Poissy-Saint-Germain

location_facility: Saint-Herblain Private Hospital Polyclinique de l'Atlantique

location_facility: Aulnay-sous-Bois Hospital CHI Robert Ballanger

location_facility: Bordeaux Private Hospital Polyclinique Bordeuax Nord Aquitaine

location_facility: Corbeil Essonnes Hospital Sud Francilien

location_facility: Saint-Martin-d'Hère Private Hospital Clinique Belledonne

location_facility: Toulouse University Hospital P. DE VIGUIER

location_facility: Strasbourg Private Hospital Clinique Adassa

location_facility: Paris University Hospital La Pitié Salpétrière

location_facility: Angers Private Hospital Clinique de l'Anjou

intervention_type: Biological