title: ProGene: Etude Genetique et Epidemiologique du Cancer de la Prostate Familial

summary:
The aims of the study are:

to identify genetic and molecular factors (rare mutations, polymorphisms) involved in the natural history of prostate cancers and their response to treatment,
to evaluate and deduce their medical applications for screening and therapeutic management of these tumors.

ReferenceCitation: Berthon P, Valeri A, Cohen-Akenine A, Drelon E, Paiss T, Wohr G, Latil A, Millasseau P, Mellah I, Cohen N, Blanche H, Bellane-Chantelot C, Demenais F, Teillac P, Le Duc A, de Petriconi R, Hautmann R, Chumakov I, Bachner L, Maitland NJ, Lidereau R, Vogel W, Fournier G, Mangin P, Cussenot O, et al. Predisposing gene for early-onset prostate cancer, localized on chromosome 1q42.2-43. Am J Hum Genet. 1998 Jun;62(6):1416-24. doi: 10.1086/301879.

ReferenceCitation: Correa-Cerro L, Wohr G, Haussler J, Berthon P, Drelon E, Mangin P, Fournier G, Cussenot O, Kraus P, Just W, Paiss T, Cantu JM, Vogel W. (CAG)nCAA and GGN repeats in the human androgen receptor gene are not associated with prostate cancer in a French-German population. Eur J Hum Genet. 1999 Apr;7(3):357-62. doi: 10.1038/sj.ejhg.5200298.

ReferenceCitation: Correa-Cerro L, Berthon P, Haussler J, Bochum S, Drelon E, Mangin P, Fournier G, Paiss T, Cussenot O, Vogel W. Vitamin D receptor polymorphisms as markers in prostate cancer. Hum Genet. 1999 Sep;105(3):281-7. doi: 10.1007/s004390051102.

ReferenceCitation: Valeri A, Fournier G, Morin V, Morin JF, Drelon E, Mangin P, Teillac P, Berthon P, Cussenot O. Early onset and familial predisposition to prostate cancer significantly enhance the probability for breast cancer in first degree relatives. Int J Cancer. 2000 Jun 15;86(6):883-7. doi: 10.1002/(sici)1097-0215(20000615)86:63.0.co;2-f.

ReferenceCitation: Cancel-Tassin G, Latil A, Valeri A, Mangin P, Fournier G, Berthon P, Cussenot O. PCAP is the major known prostate cancer predisposing locus in families from south and west Europe. Eur J Hum Genet. 2001 Feb;9(2):135-42. doi: 10.1038/sj.ejhg.5200592.

ReferenceCitation: Latil AG, Azzouzi R, Cancel GS, Guillaume EC, Cochan-Priollet B, Berthon PL, Cussenot O. Prostate carcinoma risk and allelic variants of genes involved in androgen biosynthesis and metabolism pathways. Cancer. 2001 Sep 1;92(5):1130-7. doi: 10.1002/1097-0142(20010901)92:53.0.co;2-b.

ReferenceCitation: Cormier L, Guillemin F, Valeri A, Fournier G, Cussenot O, Mangin P, Litwin MS. Impact of prostate cancer screening on health-related quality of life in at-risk families. Urology. 2002 Jun;59(6):901-6. doi: 10.1016/s0090-4295(02)01552-2.

ReferenceCitation: Valeri A, Cormier L, Moineau MP, Cancel-Tassin G, Azzouzi R, Doucet L, Baschet F, Cussenot I, L'Her J, Berthon P, Mangin P, Cussenot O, Morin JF, Fournier G. Targeted screening for prostate cancer in high risk families: early onset is a significant risk factor for disease in first degree relatives. J Urol. 2002 Aug;168(2):483-7. doi: 10.1016/s0022-5347(05)64663-0.

ReferenceCitation: Azzouzi AR, Cochand-Priollet B, Mangin P, Fournier G, Berthon P, Latil A, Cussenot O. Impact of constitutional genetic variation in androgen/oestrogen-regulating genes on age-related changes in human prostate. Eur J Endocrinol. 2002 Oct;147(4):479-84. doi: 10.1530/eje.0.1470479.

ReferenceCitation: Cancel-Tassin G, Latil A, Rousseau F, Mangin P, Bottius E, Escary JL, Berthon P, Cussenot O. Association study of polymorphisms in the human estrogen receptor alpha gene and prostate cancer risk. Eur Urol. 2003 Oct;44(4):487-90. doi: 10.1016/s0302-2838(03)00319-1.

ReferenceCitation: Fromont G, Joulin V, Chantrel-Groussard K, Vallancien G, Guillonneau B, Validire P, Latil A, Cussenot O. Allelic losses in localized prostate cancer: association with prognostic factors. J Urol. 2003 Oct;170(4 Pt 1):1394-7. doi: 10.1097/01.ju.0000083329.89215.91.

ReferenceCitation: Latil A, Chene L, Mangin P, Fournier G, Berthon P, Cussenot O. Extensive analysis of the 13q14 region in human prostate tumors: DNA analysis and quantitative expression of genes lying in the interval of deletion. Prostate. 2003 Sep 15;57(1):39-50. doi: 10.1002/pros.10272.

ReferenceCitation: Valeri A, Briollais L, Azzouzi R, Fournier G, Mangin P, Berthon P, Cussenot O, Demenais F. Segregation analysis of prostate cancer in France: evidence for autosomal dominant inheritance and residual brother-brother dependence. Ann Hum Genet. 2003 Mar;67(Pt 2):125-37. doi: 10.1046/j.1469-1809.2003.00022.x.

ReferenceCitation: Roumier X, Azzouzi R, Valeri A, Guillemin F, Fournier G, Cussenot O, Mangin P, Cormier L. Adherence to an annual PSA screening program over 3 years for brothers and sons of men with prostate cancer. Eur Urol. 2004 Mar;45(3):280-5; author reply 285-6. doi: 10.1016/j.eururo.2003.09.022.

ReferenceCitation: Thuret R, Chantrel-Groussard K, Azzouzi AR, Villette JM, Guimard S, Teillac P, Berthon P, Houlgatte A, Latil A, Cussenot O. Clinical relevance of genetic instability in prostatic cells obtained by prostatic massage in early prostate cancer. Br J Cancer. 2005 Jan 31;92(2):236-40. doi: 10.1038/sj.bjc.6602311.

ReferenceCitation: Fromont G, Chene L, Vidaud M, Vallancien G, Mangin P, Fournier G, Validire P, Latil A, Cussenot O. Differential expression of 37 selected genes in hormone-refractory prostate cancer using quantitative taqman real-time RT-PCR. Int J Cancer. 2005 Mar 20;114(2):174-81. doi: 10.1002/ijc.20704.

ReferenceCitation: Roupret M, Fromont G, Bitker MO, Gattegno B, Vallancien G, Cussenot O. Outcome after radical prostatectomy in young men with or without a family history of prostate cancer. Urology. 2006 May;67(5):1028-32. doi: 10.1016/j.urology.2005.11.035.

ReferenceCitation: Azzouzi AR, Stoppa-Lyonnet D, Roupret M, Larre S, Mangin P, Cussenot O. BRCA2 mutation screening is clinically relevant in breast and early prostate cancer families. Int J Urol. 2007 May;14(5):445-6. doi: 10.1111/j.1442-2042.2006.01712.x.

ReferenceCitation: Cussenot O, Azzouzi AR, Nicolaiew N, Mangin P, Cormier L, Fournier G, Valeri A, Cancel-Tassin G. Low-activity V89L variant in SRD5A2 is associated with aggressive prostate cancer risk: an explanation for the adverse effects observed in chemoprevention trials using 5-alpha-reductase inhibitors. Eur Urol. 2007 Oct;52(4):1082-7. doi: 10.1016/j.eururo.2007.04.008. Epub 2007 Apr 13.

ReferenceCitation: Yeager M, Orr N, Hayes RB, Jacobs KB, Kraft P, Wacholder S, Minichiello MJ, Fearnhead P, Yu K, Chatterjee N, Wang Z, Welch R, Staats BJ, Calle EE, Feigelson HS, Thun MJ, Rodriguez C, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Giovannucci E, Willett WC, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Gelmann EP, Tucker M, Gerhard DS, Fraumeni JF Jr, Hoover R, Hunter DJ, Chanock SJ, Thomas G. Genome-wide association study of prostate cancer identifies a second risk locus at 8q24. Nat Genet. 2007 May;39(5):645-9. doi: 10.1038/ng2022. Epub 2007 Apr 1.

ReferenceCitation: Roupret M, Hupertan V, Yates DR, Catto JW, Rehman I, Meuth M, Ricci S, Lacave R, Cancel-Tassin G, de la Taille A, Rozet F, Cathelineau X, Vallancien G, Hamdy FC, Cussenot O. Molecular detection of localized prostate cancer using quantitative methylation-specific PCR on urinary cells obtained following prostate massage. Clin Cancer Res. 2007 Mar 15;13(6):1720-5. doi: 10.1158/1078-0432.CCR-06-2467.

ReferenceCitation: Cussenot O, Azzouzi AR, Bantsimba-Malanda G, Gaffory C, Mangin P, Cormier L, Fournier G, Valeri A, Jouffe L, Roupret M, Fromont G, Sibony M, Comperat E, Cancel-Tassin G. Effect of genetic variability within 8q24 on aggressiveness patterns at diagnosis and familial status of prostate cancer. Clin Cancer Res. 2008 Sep 1;14(17):5635-9. doi: 10.1158/1078-0432.CCR-07-4999.

ReferenceCitation: Ahn J, Berndt SI, Wacholder S, Kraft P, Kibel AS, Yeager M, Albanes D, Giovannucci E, Stampfer MJ, Virtamo J, Thun MJ, Feigelson HS, Cancel-Tassin G, Cussenot O, Thomas G, Hunter DJ, Fraumeni JF Jr, Hoover RN, Chanock SJ, Hayes RB. Variation in KLK genes, prostate-specific antigen and risk of prostate cancer. Nat Genet. 2008 Sep;40(9):1032-4; author reply 1035-6. doi: 10.1038/ng0908-1032. No abstract available.

ReferenceCitation: Fromont G, Yacoub M, Valeri A, Mangin P, Vallancien G, Cancel-Tassin G, Cussenot O. Differential expression of genes related to androgen and estrogen metabolism in hereditary versus sporadic prostate cancer. Cancer Epidemiol Biomarkers Prev. 2008 Jun;17(6):1505-9. doi: 10.1158/1055-9965.EPI-07-2778.

ReferenceCitation: Thomas G, Jacobs KB, Yeager M, Kraft P, Wacholder S, Orr N, Yu K, Chatterjee N, Welch R, Hutchinson A, Crenshaw A, Cancel-Tassin G, Staats BJ, Wang Z, Gonzalez-Bosquet J, Fang J, Deng X, Berndt SI, Calle EE, Feigelson HS, Thun MJ, Rodriguez C, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Giovannucci E, Willett WC, Cussenot O, Valeri A, Andriole GL, Crawford ED, Tucker M, Gerhard DS, Fraumeni JF Jr, Hoover R, Hayes RB, Hunter DJ, Chanock SJ. Multiple loci identified in a genome-wide association study of prostate cancer. Nat Genet. 2008 Mar;40(3):310-5. doi: 10.1038/ng.91. Epub 2008 Feb 10.

ReferenceCitation: Lou H, Yeager M, Li H, Bosquet JG, Hayes RB, Orr N, Yu K, Hutchinson A, Jacobs KB, Kraft P, Wacholder S, Chatterjee N, Feigelson HS, Thun MJ, Diver WR, Albanes D, Virtamo J, Weinstein S, Ma J, Gaziano JM, Stampfer M, Schumacher FR, Giovannucci E, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Crawford ED, Anderson SK, Tucker M, Hoover RN, Fraumeni JF Jr, Thomas G, Hunter DJ, Dean M, Chanock SJ. Fine mapping and functional analysis of a common variant in MSMB on chromosome 10q11.2 associated with prostate cancer susceptibility. Proc Natl Acad Sci U S A. 2009 May 12;106(19):7933-8. doi: 10.1073/pnas.0902104106. Epub 2009 Apr 21.

ReferenceCitation: Nicolaiew N, Cancel-Tassin G, Azzouzi AR, Grand BL, Mangin P, Cormier L, Fournier G, Giordanella JP, Pouchard M, Escary JL, Valeri A, Cussenot O. Association between estrogen and androgen receptor genes and prostate cancer risk. Eur J Endocrinol. 2009 Jan;160(1):101-6. doi: 10.1530/EJE-08-0321. Epub 2008 Oct 24.

ReferenceCitation: Yeager M, Chatterjee N, Ciampa J, Jacobs KB, Gonzalez-Bosquet J, Hayes RB, Kraft P, Wacholder S, Orr N, Berndt S, Yu K, Hutchinson A, Wang Z, Amundadottir L, Feigelson HS, Thun MJ, Diver WR, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Crawford ED, Haiman CA, Henderson B, Kolonel L, Le Marchand L, Siddiq A, Riboli E, Key TJ, Kaaks R, Isaacs W, Isaacs S, Wiley KE, Gronberg H, Wiklund F, Stattin P, Xu J, Zheng SL, Sun J, Vatten LJ, Hveem K, Kumle M, Tucker M, Gerhard DS, Hoover RN, Fraumeni JF Jr, Hunter DJ, Thomas G, Chanock SJ. Identification of a new prostate cancer susceptibility locus on chromosome 8q24. Nat Genet. 2009 Oct;41(10):1055-7. doi: 10.1038/ng.444. Epub 2009 Sep 20.

ReferenceCitation: Prokunina-Olsson L, Fu YP, Tang W, Jacobs KB, Hayes RB, Kraft P, Berndt SI, Wacholder S, Yu K, Hutchinson A, Spencer Feigelson H, Thun MJ, Diver WR, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Crawford ED, Haiman CA, Henderson BE, Kolonel L, Le Marchand L, Siddiq A, Riboli E, Travis R, Kaaks R, Isaacs WB, Isaacs SD, Gronberg H, Wiklund F, Xu J, Vatten LJ, Hveem K, Kumle M, Tucker M, Hoover RN, Fraumeni JF Jr, Hunter DJ, Thomas G, Chatterjee N, Chanock SJ, Yeager M. Refining the prostate cancer genetic association within the JAZF1 gene on chromosome 7p15.2. Cancer Epidemiol Biomarkers Prev. 2010 May;19(5):1349-55. doi: 10.1158/1055-9965.EPI-09-1181. Epub 2010 Apr 20.

ReferenceCitation: Cussenot O, Azzouzi AR, Nicolaiew N, Fromont G, Mangin P, Cormier L, Fournier G, Valeri A, Larre S, Thibault F, Giordanella JP, Pouchard M, Zheng Y, Hamdy FC, Cox A, Cancel-Tassin G. Combination of polymorphisms from genes related to estrogen metabolism and risk of prostate cancers: the hidden face of estrogens. J Clin Oncol. 2007 Aug 20;25(24):3596-602. doi: 10.1200/JCO.2007.11.0908.

lead_sponsor: Centre de Recherche sur les Pathologies Prostatiques

location_facility: Department of Urology, Hopital Pitié-Salpetriere

location_facility: Department of Urology, Hopital de la Cavale Blanche


title: Evaluation of IL-6 and IL-8 Interleukin Rates to Diagnose Spontaneous Bacterial Peritonitis

summary:
Spontaneous bacterial peritonitis (SBP), an infection of ascitic fluid in the absence of localized intra-abdominal infection, is one of the main potentially fatal complications of cirrhosis. In the case of SBP, early diagnosis and rapid therapeutic care can improve patient survival (Garcia-Tsao, 2001).

The diagnosis of SBP is based on the detection of a polymorphonuclear neutrophils count equal to or greater than 250 /mm3 in the ascitic fluid (method of reference). However, obtaining an ascitic cell count is sometimes difficult because it can not always be performed in emergency especially outside the opening hours of the laboratory of Bacteriology. This raises the necessity of developing quick and easy alternative approaches of diagnosis.

Few groups have proposed the use of urinary reagent strip for rapid diagnosis of SBP. Nevertheless, the investigators clinical teams have shown that the sensitivity of this test was low in a large national multicenter prospective study involving more than a thousand patients (Nousbaum et al., 2007). The use of Multistix strips test is thus not recommended for the routine application of diagnosis of SBP due to its lack of sensitivity.

Although performed on small groups of patients, several studies have reported that IL-8 or IL-6 might be used as markers of ascitic fluid infections. Based on these data and confirmed by the investigators preliminary results the investigators propose to study on a broad recruitment of patients estimated to about 500 inclusions (about 45 infected patients) the interest of using IL-8 and IL-6 as predictive markers of SBP. The investigators propose to use an ELISA method, standardized, rapid and automated, applicable in the context of emergency (7 days a week and 24 hours a day) as previously described in the work conducted to exclude the urinary tract infection (Oregioni et al., 2005).

During the preliminary experiments conducted for this project, the investigators also found systematic variation of another marker, leptin. This is a protein hormone involved in the inflammatory and immune responses (Otero et al., 2005). It appears necessary to include the study of this marker in the analysis of differential protein response between patients suffering or not suffering from SBP.

The investigators therefore propose a diagnostic study, non-interventional, prospective, multicenter trial conducted over 2 years.

The main objective is to establish the diagnostic performance (sensitivity, specificity, positive predictive value and negative) of IL-8 and IL-6, assayed in the ascites fluid by an automated ELISA in the early diagnosis of SBP.
The secondary objectives are to confirm the interest of the measurement of leptin in the SBP and to establish the diagnostic performance of IL-8 and IL-6 or leptin according to different clinical features in patients (score Child-Pugh classification and history of SBP, ascitic fluid infection with positive bacterial culture).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Hepato-gastro-enterology and bacteriology department

location_facility: Hepato-gastro-enterology and Bacteriology department

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: An Open Label Dose Escalation and Pharmacokinetic Phase I Study With Pazopanib in Combination With Cisplatin (CDDP) Every Three Weeks in Patients With Advanced Solid Tumors

acronym: PACIFIK

summary:
The aim of this research is to evaluate the potential interest of an association of Pazopanib, a multi-tyrosine kinase inhibitor, and cisplatin.

As cisplatin has marketing approval for several cancers (ovarian, testicle, bladder, esophagus, endometrium, lung, stomach, head and neck cancer (HNC)), and in order to have a rapid evaluation of this combination, we will evaluate the combination in any patient whose tumors is known to be sensible to cisplatin (except tumors at risk of bleeding).

This study is a classical phase 1 trial of pazopanib and 3-weekly cisplatin association. It will allow for optimal dose selection and pharmacokinetic analysis. It is planed to include around 38 patients, enriching the optimal tolerated regimen (OTR) level only with a cohort of triple negative breast cancer patients. If the association is proven to be feasible, we will then move to a specific phase II study in triple negative breast cancer patients.

study_type: Interventional

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Dieras V, Bachelot T, Campone M, Isambert N, Joly F, Le Tourneau C, Cassier P, Bompas E, Fumoleau P, Noal S, Orsini C, Jimenez M, Imbs DC, Chatelut E. A Phase I, Dose-Escalation Trial of Pazopanib in Combination with Cisplatin in Patients with Advanced Solid Tumors: A UNICANCER Study. Oncol Ther. 2016;4(2):211-223. doi: 10.1007/s40487-016-0027-x. Epub 2016 Aug 18.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: UNICANCER

location_facility:
Centre François BACLESSE
Centre Léon Berard
Centre Georges François LECLERC
Centre René Gauducheau
Institut Curie

intervention_type: Drug

lead_sponsor_type: industriel


acronym: MEOPA

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

summary: The purpose of this study is to determine whether or not the use of an equimolar mixture of oxygen and nitrous oxide during the physical therapy for patients suffering from frozen shoulder (adhesive shoulder capsulitis) results in a gain in shoulder amplitude (Constant Score) and less pain as compared to patients undergoing physical therapy without this treatment.

ReferenceCitation: Dupeyron A, Denarie M, Richard D, Dobija L, Castelli C, Petiot S, Tavares I, Gelis A, Coudeyre E. Analgesic gas for rehabilitation of frozen shoulder: Protocol for a randomized controlled trial. Ann Phys Rehabil Med. 2019 Jan;62(1):43-48. doi: 10.1016/j.rehab.2018.07.007. Epub 2018 Aug 9.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

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

repository_normalized: HAL

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

location_facility: Unité Rééducation Réadaptation Locomotrice

location_facility: Centre Hospitalier Universitaire de Nîmes

title: Comparative Study of the Effectiveness of an Equimolar Oxygen-nitrous Oxide Mixture During Physical Therapy for Adhesive Shoulder Capsulitis

type: EudraCT Number

source: euctr

design_allocation: Randomized


title: A Phase I/II Multicenter Study of IV Clofarabine in Patients With High-Risk Myelodysplastic Syndrome Who Have Failed Therapy With Azacitidine: the NIDEVOL Study

summary: This study aims to determine the maximal tolerated dose (MTD) and dose limiting toxicities (DLTs) of low dose IV clofarabine for MDS patients after treatment failure of azacitidine.

design_allocation: Non-Randomized

lead_sponsor: Groupe Francophone des Myelodysplasies

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Genzyme, a Sanofi Company

location_facility:
Hôpital Avicenne
Hôpital Saint-Louis
Institut Paoli-Calmettes
Hopital Cochin Service d'Hématologie
Centre Henri Becquerel


type: Other Identifier

title: Post Authorization Safety Study of the Intramuscular Inactivated, Split Virion Pandemic A/H1N1 Influenza Vaccines in Children Aged Over 2 Months and in Adult Populations

summary:
This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring.

Primary objective:

To describe the incidence of serious adverse events and adverse events of special interest (AESIs) after HUMENZA or PANENZA administration throughout the study in different age groups.

Secondary objective:

To describe the incidence of non-serious cutaneous allergic reactions after HUMENZA or PANENZA administration in different age groups up to 21 days after the last vaccination.This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring.

lead_sponsor: Sanofi Pasteur, a Sanofi Company


acronym: RACCOSA

lead_sponsor: University Hospital, Limoges

summary: The purpose of this study is to evaluate the safety of non small cell lung cancer (NSCLC) treatment with cisplatin and oral vinorelbine administered weekly associated with concomitant radiotherapy in elderly patients.

sponsor_collaborators:
University Hospital, Limoges
Pierre Fabre Laboratories

location_facility: Département de Pathologie Respiratoire du CHU de Limoges

title: Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC


title: A Long-Term Safety and Immunogenicity Follow-up of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)

summary:
The purpose of this study is to provide long-term follow-up immunogenicity and safety data on participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).

Primary Objectives:

Immunogenicity: To yearly describe the vaccinia antibody persistence up to 5 years post-vaccination.

Safety: To follow-up the long-term safety up to 5 years post-vaccination.

lead_sponsor: Sanofi


title: SORAFENIB (NEXAVAR®) in Combination With Irinotecan in the Second Line Treatment or More of Metastatic Colorectal Cancer With K-RAS Mutation : a Multicentre Two-part Phase I/II Study.

acronym: NEXIRI

summary: A multicentre two-part phase I/II study evaluating response and safety of SORAFENIB in combination with irinotecan in the second line treatment or more of metastatic colorectal cancer with K-RAS mutation.

ReferenceCitation: Samalin E, Bouche O, Thezenas S, Francois E, Adenis A, Bennouna J, Taieb J, Desseigne F, Seitz JF, Conroy T, Galais MP, Assenat E, Crapez E, Poujol S, Bibeau F, Boissiere F, Laurent-Puig P, Ychou M, Mazard T. Sorafenib and irinotecan (NEXIRI) as second- or later-line treatment for patients with metastatic colorectal cancer and KRAS-mutated tumours: a multicentre Phase I/II trial. Br J Cancer. 2014 Mar 4;110(5):1148-54. doi: 10.1038/bjc.2013.813. Epub 2014 Jan 9.

evidence: open (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

publisher_dissemination: Springer

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

location_facility:
Hopital Saint Eloi
Centre Rene Gauducheau
Centre Antoine Lacassagne
CHU Robert Debre
Centre Oscar Lambret


intervention_type: Biological

acronym: FLU D-PAN H1N1-022

lead_sponsor: GlaxoSmithKline

summary: The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.

ReferenceType: background

ReferenceCitation: Duval X, Caplanusi A, Laurichesse H, Deplanque D, Loulergue P, Vaman T, Launay O, Gillard P. Flexibility of interval between vaccinations with AS03A-adjuvanted influenza A (H1N1) 2009 vaccine in adults aged 18-60 and >60 years: a randomized trial. BMC Infect Dis. 2012 Jul 23;12:162. doi: 10.1186/1471-2334-12-162.

title: Safety and Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2340272A in Adults Aged 18 Years and Above

primary_purpose: Prevention

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

ipd_sharing: Yes


title: Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)

summary:
Dystrophic epidermolysis bullosa hereditaria are genodermatosis responsible for formation of cutaneous bullous lesion arising spontaneously or after mechanical trauma.

These lesions are due to mutation on gene COL7A1 coding for collagen VII. There is no treatment available. Cares are consisting to dress lesions and to protect the skin.

The investigators have recently observed on patients having residual expression of collagen VII that phenotype severity is modulated by activation degree of dermic metalloproteinase. The investigators have also observed that epigallocatechin-3-gallate (Polyphenon E®) could be regulated this activity.

The primary purpose of this study is to assessing the efficacity of Polyphenon E to decrease the number of cutaneous bullosa after four month of treatment.

The primary outcome measure is the rate of patient presenting a decrease of 20% or more of the number of cutaneous bullosa.

Secondary outcomes are: severity of mucosa impairment, affected cutaneous surface, the average duration of cicatrisation and treatment tolerance.

This study foresees the inclusion of 22 patients older than 2 years old in 5 centers.

When patients are included, they will be randomized and receive the treatment (or placebo) for 4 months.

ReferenceCitation: Chiaverini C, Roger C, Fontas E, Bourrat E, Bourdon-Lanoy E, Labreze C, Mazereeuw J, Vabres P, Bodemer C, Lacour JP. Oral epigallocatechin-3-gallate for treatment of dystrophic epidermolysis bullosa: a multicentre, randomized, crossover, double-blind, placebo-controlled clinical trial. Orphanet J Rare Dis. 2016 Mar 25;11:31. doi: 10.1186/s13023-016-0411-5.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: Toulouse University Hospital, Dermatology Department

location_facility: Dermatology Department, Saint Louis Hospital, APHP

location_facility: Dijon University Hospital, Dermatology Department

location_facility: Dermatology Department, Necker Enfants Malades, APHP

location_facility: Dermatology Department, Bordeaux University Hospital


title: Comparison of SEPTal and Apical Pacing Sites in PerManent Right Ventricular Pacing

acronym: SEPTAL-PM

summary: The SEPTAL-PM study is aimed to compare the right ventricular apical and right ventricular septal position of the right ventricular lead in patients implanted with a pacemaker for conventional anti-bradycardia pacing indications requiring permanent right ventricular pacing ; the primary endpoint is the evolution of the left ventricular ejection fraction assessed by contrast echocardiography at 18-months follow-up.

ReferenceType: result

ReferenceCitation: Galand V, Martins RP, Donal E, Behar N, Crocq C, Soulie GG, Degand B, Garcia R, Solnon A, Lande G, Probst V, Marjaneh F, Mansourati J, Dupuis JM, Laviolle B, Leclercq C. Septal versus apical pacing sites in permanent right ventricular pacing: The multicentre prospective SEPTAL-PM study. Arch Cardiovasc Dis. 2022 May;115(5):288-294. doi: 10.1016/j.acvd.2021.12.007. Epub 2022 Feb 19.

oa_host_type: publisher

repositories_concat: closed

lead_sponsor: Rennes University Hospital

location_facility:
CHU de Poitiers
Service de cardiologie-CHU de Brest
CHU d'Angers
CHU de Rennes
Service de cardiologie-CHU de Nantes

intervention_type: Device


title: Evaluation of Hemodynamic Effects of Cascade Hemofiltration in Septic Shock

acronym: Cascade

summary:
Septic shock is a major cause of mortality and morbidity in critically ill patients. Septic Shock is associated with an overwhelming, systemic overflow of pro inflammatory and anti-inflammatory mediators, which leads to generalized endothelial damage, multiple organ failure, and altered cellular immunological responsiveness. Although our understanding of the complex pathophysiological alterations that occur in septic shock has increased greatly as a result of recent clinical and preclinical studies, mortality associated with the disorder remains unacceptably high, ranging from 30% to 50%. To date, attempts to improve survival with innovative, predominantly anti-inflammatory therapeutic strategies have been disappointing. A standard hemofiltration rate of 35 ml/kg/hour has been successfully used to treat acute renal failure. However, this dose does not alter plasma levels of inflammatory mediators, suggesting that its ability to clear these mediators is suboptimal. Higher doses of hemofiltration (up to 120 ml/kg per hour) have been demonstrated to improve cardiac function and hemodynamics in several animal models of sepsis. High-volume hemofiltration (HVHF) was thus conceived and applied in patients with septic shock, showing an improvements in hemodynamics with decreased vasopressor requirements and improved survival in patients admitted after a cardiac arrest.

The main benefit described with high volume hemofiltration is a hemodynamic improvement (e.g reduction in catecholamines' requirement). This improvement seems to be due to the removal of a badly defined network of middle molecular weight peptides. To remove efficiently these middle molecular peptides, a high filtration rate is needed. However, with high filtration rates, there is also a high clearance for smaller molecules, including antibiotics, electrolytes, vitamins, trace elements and amino acids.

The cascade hemofiltration system has been designed for a more efficient removal of middle molecular weight peptides with a limited solute consumption.

The goal of this study is the evaluation of the hemodynamic improvement using cascade hemofiltration in patients treated for septic shock.

lead_sponsor: Baxter Healthcare Corporation

sponsor_collaborators:
Baxter Healthcare Corporation
Gambro Lundia AB

location_facility:
CHU hospital
Hopital Delafontaine
Centre Hospitalier Marc JACQUET
Hopital Le Bocage
Hopital Tenon


title: Analysis of the Proteomic Signature in Breast Cancer Correlated With Tumor Response in Patients Necessitating a Neo-adjuvant Chemotherapy

acronym: SPAM

summary: The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.

lead_sponsor: Centre Oscar Lambret

location_facility:
Intercommunal Hospital
Hopital Saint Vincent
Centre Oscar Lambret
Geroges PIANTA Hospital
Centre Henri Becquerel

intervention_type: Procedure


lead_sponsor: Lymphoma Study Association

summary: The purpose of the study is to determine the recommended dose (RD) of lenalidomide (Revlimid) when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone).

location_facility:
CHU Lyon Sud
CHU Brabois
CHU de Dijon
CHRU Lille
Centre Henri Becquerel

title: A Phase IB Study of Escalating Doses of REVLIMID in Association With R-CHOP (R2-CHOP) in the Treatment of B-cell Lymphoma


title: A Multicenter Prospective Randomized Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation

summary:
This study is a prospective comparison between 2 popular regimens based on reduced intensity or non-myeloablative approaches to define the optimal myeloablative and/or immu-nonsuppressive association for reduced intensity conditionings (RIC).

Flu-Bu-ATG (Study A) associated Fludarabine (30mg/m²/5 days), Oral Busulfan (8 mg/kg over 2 days) and Thymoglobuline (2.5 mg/m²/1day).

Flu-TBI (Study B) consisted of Fludarabine (25mg/m²/ 3 days) and 2 Gy total body irradiation (TBI).

A randomization of 2 phase study according to the methodology developed by Liu et al (Liu, 1993 and 2001) for the evaluation of multiple innovative approaches.

Primary endpoint is one year overall survival (OS). Stopping rules included excessive engraftment failure and trans-plant related mortality ratio. Data are yearly reviewed by an independent safety review board (ISRB).

Inclusion criteria are patients presenting a hematological malignancy, eligible for non myeloablative allo stem cell transplantation (SCT), aged between 18 and 65, with a suitable HLA identical sibling. All patients and donors are included after giving written informed consent.

Protocol was submitted and accepted by the ethical committee and the AFFSSAPS cellular therapies committee (national agency).

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Institut Paoli-Calmettes
CHU


title: Non-comparative, Opened Study, Evaluating in HIV-1 Infected Patients With Undetectable Viral Load, Treated by an Antiretroviral Combination Including a Protease Inhibitor Boosted With Ritonavir and Administered by Oral Route Twice a Day, the Substitutability of the Current Protease Inhibitor Regimen by the Association Darunavir/Ritonavir 800/100 mg Once a Day to Maintain the Viral Load Under the 50 Copies/ml Limit of Detection After 24 Weeks of Treatment.

acronym: RADAR

summary:
Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir/r strain.

Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

location_facility: Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales

location_facility: Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne

location_facility: Hôpital Tenon - Service des Maladies Infectieuses et Tropicales

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales


title: Superficial Thrombophlebitis and Venous Thromboembolism: A Large Prospective Epidemiological Study

acronym: POST

summary: We performed a national cross-sectional and prospective large epidemiological cohort study in patients with ST. Office- and hospital-based vascular medicine French practitioners enrolled all consecutive patients with a symptomatic ST of the lower limbs at least 5 cm long documented by compression ultrasonography. Follow-up was three months. All events were adjudicated by a central committee.

time_perspective: Cross-Sectional

ReferenceCitation: Galanaud JP, Bosson JL, Genty C, Presles E, Cucherat M, Sevestre MA, Quere I, Decousus H, Leizorovicz A. Superficial vein thrombosis and recurrent venous thromboembolism: a pooled analysis of two observational studies. J Thromb Haemost. 2012 Jun;10(6):1004-11. doi: 10.1111/j.1538-7836.2012.04704.x.

ReferenceCitation: Decousus H, Quere I, Presles E, Becker F, Barrellier MT, Chanut M, Gillet JL, Guenneguez H, Leandri C, Mismetti P, Pichot O, Leizorovicz A; POST (Prospective Observational Superficial Thrombophlebitis) Study Group. Superficial venous thrombosis and venous thromboembolism: a large, prospective epidemiologic study. Ann Intern Med. 2010 Feb 16;152(4):218-24. doi: 10.7326/0003-4819-152-4-201002160-00006.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: GILLET Guenneguez CHANUT LEANDRI Barrelier


lead_sponsor: Boehringer Ingelheim

summary: Progression-free rate after 16 weeks of BIBW 2992 administration in association with letrozole

ReferenceCitation: Gunzer K, Joly F, Ferrero JM, Gligorov J, de Mont-Serrat H, Uttenreuther-Fischer M, Pelling K, Wind S, Bousquet G, Misset JL. A phase II study of afatinib, an irreversible ErbB family blocker, added to letrozole in patients with estrogen receptor-positive hormone-refractory metastatic breast cancer progressing on letrozole. Springerplus. 2016 Jan 19;5:45. doi: 10.1186/s40064-015-1601-7. eCollection 2016.

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

location_facility: 1200.5.3302A Boehringer Ingelheim Investigational Site

location_facility: 1200.5.3304A Boehringer Ingelheim Investigational Site

location_facility: 1200.5.3301A Boehringer Ingelheim Investigational Site

location_facility: 1200.5.3305A Boehringer Ingelheim Investigational Site

location_facility: 1200.5.3306A Boehringer Ingelheim Investigational Site

title: A Phase II Study of BIBW 2992 Administration in Patients With Hormone Refractory Metastatic Breast Cancer


title: Evaluation of the Long-term Effects of Amantadine in Parkinsonian's Suffering From Dyskinesia Induced by Levodopa: Study Randomised Double-blind, Placebo - Cessation of a Chronic Prescription. STUDY AMANDYSK.

acronym: AMANDYSK

summary:
This is a French national trial, conducted using a double-blind, placebo-controlled, randomised design involving 7 centers and 80 patients of both sexes.

The primary objective of the trial is to evaluate the effects of the interruption of a long term treatment (ex. Greater than 6 months) with Amantadine (prescribed as an antidyskinetic) in patients suffering from Parkinson disease being treated with Levodopa and suffering from mid dose dyskinesias.

Secondary objectives of the trial are the evaluation of the other effects of withdrawal of Amantadine on the same group of patients: motor fluctuations, vigilance, apathy, fatigue, certain cognitive aspects, the disappearance or development of undesirable side effects and quality of life.

enrollment_type: Anticipated

ReferenceCitation: Alves G, Wentzel-Larsen T, Larsen JP. Is fatigue an independent and persistent symptom in patients with Parkinson disease? Neurology. 2004 Nov 23;63(10):1908-11. doi: 10.1212/01.wnl.0000144277.06917.cc.

ReferenceCitation: Bibbiani F, Oh JD, Kielaite A, Collins MA, Smith C, Chase TN. Combined blockade of AMPA and NMDA glutamate receptors reduces levodopa-induced motor complications in animal models of PD. Exp Neurol. 2005 Dec;196(2):422-9. doi: 10.1016/j.expneurol.2005.08.017. Epub 2005 Oct 3.

ReferenceCitation: Chapuis S, Ouchchane L, Metz O, Gerbaud L, Durif F. Impact of the motor complications of Parkinson's disease on the quality of life. Mov Disord. 2005 Feb;20(2):224-30. doi: 10.1002/mds.20279.

lead_sponsor: University Hospital, Toulouse

location_facility:
Hôpital d'Aix en Provence
CHU Timone
CHU de Clermont-Ferrand
Hôpital Haut-Lévêque
CHU Pitié-Salpêtrière


title: Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux

summary: The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility:
Centre hospitalier Annecy
Centre hospitalier de Bretagne Sud
Institut Gustave Roussy
Centre Guillaume Le Conquerant
Centre Jean Perrin


type: Other Grant/Funding Number

title: Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients

acronym: RenforcHémi

summary: Gait impairment remain one of the main problem for hemiplegic stroke patients. After the 6 first months, stroke patients are classically described with moderate or no improvement. Here, we want to compare the effectiveness of a flexor and extensor paretic knee muscular strengthening program with conventional physiotherapy delivered by the local physiotherapist of the patient, in a very ecological way.

sponsor_collaborators:
University Hospital, Toulouse
University Hospital, Bordeaux
University Hospital, Limoges

location_facility: Service de Médecine Physique et de Réadaptation, Hôpital Rangueil, CHU de Toulouse, TSA 50032

location_facility: Centre Mutualiste de Rééducation Fonctionnelle, rue Angély Cavlié

location_facility: Service de Médecine Physique et de Réadaptation, Hôpital Jean Rebeyrol, CHU de Limoges,

location_facility: Service de Médecine Physique et de Réadaptation, Hôpital de Salies du Salat

location_facility: Service de Médecine Physique et de Réadaptation, Hôpital Pellegrin, CHU de Bordeaux,


title: Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients

summary: Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients .

lead_sponsor: Société des Produits Nestlé (SPN)

location_facility: Hopital Saint Antoine- Service des Brules

intervention_type: Dietary Supplement


title: Prediction of the Response to Chemotherapy by Tomoscintigraphie the MIBI in the Balance Sheet Pre Hodgkin's Disease and Lymphoma Malins High Grade

acronym: MIBI

summary:
Predicting response to chemotherapy in patients with Hodgkin's disease or lymphoma high-grade malignant de novo or recurrence.

The non-Hodgkin's lymphoma and high-grade Hodgkin's disease may show resistance to chemotherapy, regardless of their initial extension. The failure of treatment is most often correlated with an incomplete answer or lack of response to chemotherapy as a result chemoresistance. This drug, which may involve the gene MDR1 (multidrug resistance) encoding the protein PGP, can be studied in vivo by MIBI scan. The MIBI is behind a tracer perfusionnel used routinely to explore myocardial perfusion, but it has other characteristics of fixing, which can be used in oncological imaging (fixation by glial tumors of high grade).Prospective Study, which includes conducting a tomoscintigraphie 30 minutes after injection of 20 mCi of 99mTc-MIBI in initial stock or relapse of high-grade lymphoma and Hodgkin's disease any stage (I-IV). Fixing the MIBI is compared with morphological abnormalities detected by CT and the setting of lesions by 18FDG. Patients will be treated in a traditional way, without changes in treatment protocols used in routine. Patients with a negative MIBI scan, will be watched with particular attention in order to detect insufficient response to chemotherapy. The only change, the care of patients, only for the achievement of an initial consideration of non-invasive imaging, further, which is the tomoscintigraphie the MIBI. Of the tumor samples, will be evaluated by immunohistochemistry, the expression of PGP and the MRP1 (two proteins associated with the drug). On blood, may be carried out genotyping of MDR1, MRP1 and MRP2 to the patient.

primary_purpose: Diagnostic

location_facility:
Pharmacology
Anatomo-pathology
Nuclear Medicine
Hematology
Radiology


title: Phase I Study Evaluating the Combination of Lapatinib + Vinorelbine in Patients With Locally Advanced or Metastatic Breast Cancer Overexpressing HER2

summary:
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with vinorelbine may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib and vinorelbine in treating women with HER2-overexpressing locally advanced or metastatic breast cancer.

lead_sponsor: UNICANCER

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


title: Efficacy Study of Oral Glutamine Supplementation in Duchenne Muscular Dystrophy

acronym: MDB-GLN

summary: The purpose of this study is to determine whether long-term oral glutamine supplementation is effective in improving muscle mass and function in children with Duchenne muscular dystrophy (DMD).

ReferenceCitation: Mok E, Eleouet-Da Violante C, Daubrosse C, Gottrand F, Rigal O, Fontan JE, Cuisset JM, Guilhot J, Hankard R. Oral glutamine and amino acid supplementation inhibit whole-body protein degradation in children with Duchenne muscular dystrophy. Am J Clin Nutr. 2006 Apr;83(4):823-8. doi: 10.1093/ajcn/83.4.823.

ReferenceCitation: Hankard R, Mauras N, Hammond D, Haymond M, Darmaun D. Is glutamine a 'conditionally essential' amino acid in Duchenne muscular dystrophy? Clin Nutr. 1999 Dec;18(6):365-9. doi: 10.1016/s0261-5614(99)80017-x.

ReferenceCitation: Hankard RG, Hammond D, Haymond MW, Darmaun D. Oral glutamine slows down whole body protein breakdown in Duchenne muscular dystrophy. Pediatr Res. 1998 Feb;43(2):222-6. doi: 10.1203/00006450-199802000-00011.

ReferenceCitation: Hankard RG, Haymond MW, Darmaun D. Effect of glutamine on leucine metabolism in humans. Am J Physiol. 1996 Oct;271(4 Pt 1):E748-54. doi: 10.1152/ajpendo.1996.271.4.E748.

ReferenceCitation: Hankard RG, Darmaun D, Sager BK, D'Amore D, Parsons WR, Haymond M. Response of glutamine metabolism to exogenous glutamine in humans. Am J Physiol. 1995 Oct;269(4 Pt 1):E663-70. doi: 10.1152/ajpendo.1995.269.4.E663.

ReferenceCitation: Mok E, Beghin L, Gachon P, Daubrosse C, Fontan JE, Cuisset JM, Gottrand F, Hankard R. Estimating body composition in children with Duchenne muscular dystrophy: comparison of bioelectrical impedance analysis and skinfold-thickness measurement. Am J Clin Nutr. 2006 Jan;83(1):65-9. doi: 10.1093/ajcn/83.1.65.

ReferenceCitation: Mok E, Letellier G, Cuisset JM, Denjean A, Gottrand F, Alberti C, Hankard R. Lack of functional benefit with glutamine versus placebo in Duchenne muscular dystrophy: a randomized crossover trial. PLoS One. 2009;4(5):e5448. doi: 10.1371/journal.pone.0005448. Epub 2009 May 6.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Neuropédiatrie, Hôpital Roger Salengro, CHR&U de Lille

location_facility: Pédiatrie Multidisciplinaire et Nutrition de l'Enfant, Centre Hospitalier Universitaire de Poitiers

location_facility: Centre d'Investigation Clinique, Hôpital Cardiologique, CHR&U de Lille

location_facility: Service d'Hépato Gastro Entérologie, Hôpital Jeanne de Flandre, CHR&U de Lille

location_facility: Centre d'Investigation Clinique (CIC9202), Hôpital Robert Debré, Assistance Publique-Hôpitaux de Paris


title: Multicenter Phase 2 Study of Efficacy and Safety of Pegylated Interferon-alfa 2a in Polycythemia Vera Patients

summary: Interferon alfa is an effective treatment of polycythemia vera (PV), but about 20% of patients discontinue their treatment because of side effects and treatment schedule (three times per week administration). The pegylated form of interferon alfa-2a has shown a better tolerance in hepatitis patients and is administered only once a week. The purpose of this study is to determine efficacy and safety of pegylated interferon alfa-2a in the treatment of PV patients.

ReferenceCitation: Berk PD, Goldberg JD, Donovan PB, Fruchtman SM, Berlin NI, Wasserman LR. Therapeutic recommendations in polycythemia vera based on Polycythemia Vera Study Group protocols. Semin Hematol. 1986 Apr;23(2):132-43.

ReferenceCitation: Fruchtman SM, Mack K, Kaplan ME, Peterson P, Berk PD, Wasserman LR. From efficacy to safety: a Polycythemia Vera Study group report on hydroxyurea in patients with polycythemia vera. Semin Hematol. 1997 Jan;34(1):17-23. No abstract available.

ReferenceCitation: Kiladjian JJ, Bernard JF, Fenaux P. Is life expectancy of polycythemia vera patients clearly different from that of the general population? Am J Med. 2005 May;118(5):565; author reply 565-6. doi: 10.1016/j.amjmed.2004.12.026. No abstract available.

ReferenceCitation: Lengfelder E, Berger U, Hehlmann R. Interferon alpha in the treatment of polycythemia vera. Ann Hematol. 2000 Mar;79(3):103-9. doi: 10.1007/s002770050563.

ReferenceCitation: Streiff MB, Smith B, Spivak JL. The diagnosis and management of polycythemia vera in the era since the Polycythemia Vera Study Group: a survey of American Society of Hematology members' practice patterns. Blood. 2002 Feb 15;99(4):1144-9. doi: 10.1182/blood.v99.4.1144.

ReferenceCitation: Kiladjian JJ, Cassinat B, Chevret S, Turlure P, Cambier N, Roussel M, Bellucci S, Grandchamp B, Chomienne C, Fenaux P. Pegylated interferon-alfa-2a induces complete hematologic and molecular responses with low toxicity in polycythemia vera. Blood. 2008 Oct 15;112(8):3065-72. doi: 10.1182/blood-2008-03-143537. Epub 2008 Jul 23.

ReferenceCitation: Kiladjian JJ, Cassinat B, Turlure P, Cambier N, Roussel M, Bellucci S, Menot ML, Massonnet G, Dutel JL, Ghomari K, Rousselot P, Grange MJ, Chait Y, Vainchenker W, Parquet N, Abdelkader-Aljassem L, Bernard JF, Rain JD, Chevret S, Chomienne C, Fenaux P. High molecular response rate of polycythemia vera patients treated with pegylated interferon alpha-2a. Blood. 2006 Sep 15;108(6):2037-40. doi: 10.1182/blood-2006-03-009860. Epub 2006 May 18.

lead_sponsor: PV-Nord

location_facility:
Hopital Lariboisiere
Hopital Saint-Louis
Hopital Avicenne
Hopital Huriez
Hopital Dupuytren


summary: Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma

ReferenceCitation: Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42. doi: 10.1200/JCO.1998.16.12.3832.

ReferenceCitation: Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.

location_facility:
Rhumatologie, CHU Rangueil
Rhumatologie, CHU Purpan
Service d'hématologie, CHU Purpan
Médecine Interne, CHU Purpan
Médecine Interne, Hôpital Rangueil


title: PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study

summary:
The follow up of colorectal cancer after curative surgery has to find loco-regional relapses or synchronous metastases, and to detect adenomas and new cancer on the rest of the colon.

The increase of survival after relapse of the colorectal cancer depends on the possibility of curative action or after chemotherapy response.

This is a Phase III open-labeled, multicenter, multidisciplinary, randomised study, comparing 2 arms of 188 patients (i.e. 376 total patients).

Study Period (date of first inclusion/last inclusion): 3 years.

Follow Up: 3 years.

The primary objective is the evaluation of PET performance in the earlier relapse detection of the colorectal cancer relapse in comparison with conventional control (including carcinoembryonic [CEA] levels and other classic radiological exams).

ReferenceCitation: Monteil J, Le Brun-Ly V, Cachin F, Zasadny X, Seitz JF, Mundler O, Selvy M, Smith D, Rullier E, Lavau-Denes S, Lades G, Labrunie A, Lecaille C, Valli N, Leobon S, Terrebonne E, Deluche E, Tubiana-Mathieu N. Comparison of 18FDG-PET/CT and conventional follow-up methods in colorectal cancer: A randomised prospective study. Dig Liver Dis. 2021 Feb;53(2):231-237. doi: 10.1016/j.dld.2020.10.012. Epub 2020 Nov 2.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

version: submittedVersion

lead_sponsor: University Hospital, Limoges


title: Open Multicenter Phase II Study in Second-Line Metastatic Colorectal Cancer Patients: Combination of ALIMTA and Irinotecan Administered Every Two-Weeks

summary: A non-randomized phase II study to determine the efficacy and safety of the combination of Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.

ReferenceCitation: Louvet C, Andre T, Gamelin E, Hebbar M, Mabro M, Bennamoun M, Rassam H, de Gramont A. Phase II Study of Biweekly Pemetrexed Plus Irinotecan as Second-Line Therapy for Metastatic Colorectal Cancer. J Oncol. 2010;2010:785934. doi: 10.1155/2010/785934. Epub 2010 Apr 8.

lead_sponsor: Eli Lilly and Company

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.


title: Phase II Study Evaluating The Role Of Exemestane On Clinical And Pathologic Response Rates, And Its Aromatase Activity As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients.

summary: To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)

lead_sponsor: Pfizer


title: A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis

summary: The purpose of the study is to demonstrate that antibiotic therapy is as safe and effective as appendectomy for the treatment of acute non complicated appendicitis. Two hundred fifty patients will be included in a prospective multicentric randomized trial. The primary endpoint is the rate of intra abdominal infections in both therapeutic strategies. Other criteria will be studied including duration of hospital stay and absence from work during a follow up period of one year, parietal and abdominal complications and recurrent appendicitis after antibiotic therapy.

ReferenceCitation: Vons C, Barry C, Maitre S, Pautrat K, Leconte M, Costaglioli B, Karoui M, Alves A, Dousset B, Valleur P, Falissard B, Franco D. Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011 May 7;377(9777):1573-9. doi: 10.1016/S0140-6736(11)60410-8.

location_facility: Cochin Hospital, Department of Digestive Surgery

location_facility: Antoine Béclère Hospital - Department of Surgery

location_facility: Hotel Dieu Hospital, Department of Digestive Surgery

location_facility: Lariboisière Hospital, Department of Digestive Surgery


title: Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel and oxaliplatin and to see how well they work in treating patients with stage III or stage IV ovarian epithelial cancer.

status: Unknown status

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Polyclinique De Courlancy
Intercommunal Hospital
Hopital Tenon
C.H. Senlis
Hopital Saint Antoine

status_simplified: Unknown


title: Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients who have recurrent and/or unresectable meningioma.

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

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours


title: Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation

acronym: NEwTON AF

summary: The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation.

ipd_sharing: No

ipd_sharing_description: No request for study data has been made at this time. However, Boston Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
United Kingdom
Hong Kong
Japan
Netherlands
Austria
Belgium
United States
Monaco
Taiwan
Canada
France

location_facility: Chippenham and Johnston-Willis Hospital (CJW)

location_facility: Christus Trinity Mother Frances Health System

location_facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: St. Mary's Duluth Clinic Regional Heart Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Wake Forest University School of Medicine


title: Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

acronym: FROZEN-AF

summary: To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).

ipd_sharing_description: No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

location_country:
Germany
Italy
Hong Kong
Netherlands
Belgium
United States
Taiwan
Canada
France

location_facility: Virginia Commonwealth University Health System

location_facility: Erasmus MC- University Medical Center Rotterdam


title: A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis

summary: The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.

ReferenceCitation: Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available.

oa_host_type: closed

publisher_dissemination: Oxford University Press

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country: Germany Italy Poland Hungary Romania Netherlands Austria Belgium Spain France


title: The Acute Optic Neuritis Network (ACON): a Non-interventional Prospective Multicenter Study on Diagnosis and Treatment of Acute Optic Neuritis

acronym: ACON

summary:
The goal of this observational study is to longitudinally investigating subjects with inaugural acute optic neuritis (ON).

The main questions it aims to answer are:

Does the time to corticosteroid treatment affect the visual outcome at 6 months in subjects with acute multiple sclerosis (MS)-, aquaporin 4-IgG positive (AQP4-IgG+) and myelin-oligodendrocyte-glycoprotein-IgG positive (MOG-IgG+) ON?
How differ clinical, structural, and laboratory biomarkers in subjects with acute ON, including clinical isolated syndrome (CIS), MS-ON, AQP4-IgG+ON, MOG-IgG+ON and seronegative non-MS-ON? Participants will undergo
clinical examination, including clinical history, neurovisual and neurological tests
serum and cerebrospinal fluid examination
optical coherence tomography (OCT)
magnetic resonance imaging (MRI)
assessment of depression, pain, quality of life through validated questionnaires Researchers will compare subjects with MS-ON, AQP4-IgG+ON, MOG-IgG+ON and other ON (CIS, seronegative non-MS-ON) to detect diagnostic and predictive markers for the disease course.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing_description: The datasets generated and/or analyzed during the current study are not publicly available but are available from the corresponding author upon reasonable request

lead_sponsor: Experimental and Clinical Research Center, a cooperation between the Max Delbrück Center for Molecul

location_country:
Germany
Italy
Colombia
India
Israel
Argentina
Denmark
Australia
Brazil
Japan
United Kingdom
United States
Korea, Republic of
Botswana
Spain
Zambia
France

location_facility: Institute for Clinical Neuroimmunology, LMU Clinic of Ludwig-Maximilians Universität in Munich

location_facility: Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital

location_facility: Department of Neurology, Concord Hospital, Faculty of Medicine and Health

location_facility: Departments of Neurology and Ophthalmology, Mayo Clinic

location_facility: Sackler School of Medicine and Rabin Medical Center

location_facility: Department of Neurology, Slagelse, Institute for Health Research, University of Southern Denmark

location_facility: Federal University of Minas Gerais, Belo Horizonte

location_facility: Experimental and Clinical Research Center, Charité - Universitätsmedizin Berlin, Germany, Department of Neurology

location_facility: Fukushima Medical University School of Medicine

location_facility: Department of Ophthalmology, Oftlamo-Sanitas Eye Institute, School of Medicine, Fundación Universitaria Sanitas

location_facility: University of Colorado School of Medicine

status_simplified: Ongoing


title: NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™

summary: The purpose of this study is to evaluate outcomes following electromagnetic navigation bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.

ReferenceCitation: Bowling MR, Folch EE, Khandhar SJ, Kazakov J, Krimsky WS, LeMense GP, Linden PA, Murillo BA, Nead MA, Pritchett MA, Teba CV, Towe CW, Williams T, Anciano CJ. Fiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study. Ther Adv Respir Dis. 2019 Jan-Dec;13:1753466619841234. doi: 10.1177/1753466619841234.

repository_institution: East Carolina University - The Scholarship East Carolina University's Institutional Repository

publisher_dissemination: SAGE Publications

ReferenceCitation: Khandhar SJ, Bowling MR, Flandes J, Gildea TR, Hood KL, Krimsky WS, Minnich DJ, Murgu SD, Pritchett M, Toloza EM, Wahidi MM, Wolvers JJ, Folch EE; NAVIGATE Study Investigators. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulm Med. 2017 Apr 11;17(1):59. doi: 10.1186/s12890-017-0403-9.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

ReferenceCitation: Folch EE, Bowling MR, Gildea TR, Hood KL, Murgu SD, Toloza EM, Wahidi MM, Williams T, Khandhar SJ. Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy. BMC Pulm Med. 2016 Apr 26;16(1):60. doi: 10.1186/s12890-016-0228-y.

location_country:
Italy
United Kingdom
Denmark
Austria
United States
Spain
France

location_facility: Pulmonary and Critical Care Associates of Baltimore

location_facility: University Hospitals of Saint Etienne France

location_facility: University Hospitals of Case Medical Center

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Pulmonary Medicine Center of Chattanooga - Memorial Health

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino - IST

location_facility: Gundersen Lutheran Medical Foundation, Inc

location_facility: University of Cincinnati Physicians Company LLC


title: A Phase 2/3 Prospective, Multicentre Randomized, Double-blind Trial, Comparing Intra-discal Allogeneic Adult BM-MSC Therapy and Sham-treated Controls in Subjects With Chronic LBP Due to Lumbar DDD Unresponsive to Conventional Therapy

acronym: RESPINE

summary:
This will be a multicenter, prospective, double blind, randomized phase 2/3 trial comparing culture-expanded allogeneic adult BM-MSCs with sham-treated controls.

This trial will evaluate the efficacy of intradiscal injection of BM-MSCs in chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive to conventional therapy .

Visual analog scale (VAS) and functional status (by Oswestry Disability Index - ODI) will be evaluated 12 months after treatment, defining responders in case of improvement of VAS for pain of at least 20% and 20 mm between baseline and month 12, or improvement of ODI of 20% between baseline and month 12.

status: Active, not recruiting

lead_sponsor: University Hospital, Montpellier

collaborators: Interdisziplinäres Zentrum Klinische Studien (IZKS)

collaborators: European Clinical Research Infrastructure Network

collaborators: Département de l'information médicale, CHU de Montpellier

collaborators: Centre National de la Recherche Scientifique, France

collaborators: National University of Ireland, Galway, Ireland

collaborators: BG Klinikum Bergmannstrost, Halle, Germany

collaborators: Institut de Terapia Regenerativa Tissular

location_country: Germany Italy Spain France

location_facility: Institut de Teràpia Regenerativa Tissular


title: A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation

summary: Demonstrate a larger proportion of subjects with healed fractures among subjects treated with InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed, locked intramedullary nailing alone.

sponsor_collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Finland
Italy
Germany
Poland
Norway
United Kingdom
Romania
Netherlands
Belgium
Spain
South Africa
France


title: A Phase IIIB, Multicentre, Multinational, Randomized, Open-label Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® Day 1 to Day 5 Followed by Pergoveris® Starting Day 6 to Pergoveris® Starting Day 1 in Women Between 36 and 40 Years of Age Undergoing Assisted Reproductive Technique (ART)

acronym: PERSIST

summary:
This is a multicenter, multi-national, randomized, open-label comparative trial. After screening, the subjects will start down-regulation treatment on Day 21-22 of the cycle. Down-regulation treatment will start within 2 months following the screening visit. The routine long luteal phase protocol for gonadotropin-releasing hormone (GnRH) agonist treatment will be followed. Once down-regulation has been confirmed, a pregnancy test will be performed just before randomization and start of recombinant human follicle-stimulating hormone (r-hFSH) treatment to rule out any pre-existing pregnancy. If the result is negative, the subject will be randomly assigned to one of the two treatment arms of the trial:

GONAL-f®: (Liquid Pen; 300 international unit [IU] of per day) stimulation Day 1-5 followed by Pergoveris® (vial/powder, 300 IU per day) from stimulation Day 6 and until required recombinant human chorionic hormone (r-hCG) criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Pergoveris®: (vial/powder, 300 IU per day) from stimulation Day 1 and until required r-hCG criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.

Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Follicular development will be monitored according to the center's standard practice by ultrasound (US) and/or estradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least one follicle greater than or equal to [>=] 18 millimeter [mm] and two follicles >=16 mm). After this, a single injection of r-hCG will be administered in order to induce final oocyte maturation.

At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-5 days after oocyte recovery. Ovum pick up (OPU), in vitro fertilization (IVF), embryo transfer (ET) and luteal support will be performed as per center's standard practice.

A post-treatment safety visit will be performed for all subjects who received r-hCG (pregnant and non- pregnant) on Day 15-20 post-hCG. For subjects who have withdrawn from treatment (i.e. after starting Pergoveris® or Gonal-f® but before hCG is given) this visit will take place 20-30 days after their first Pergoveris® or Gonal-f® treatment injection (excluding pregnancy testing).

ReferenceCitation: H Behre, C Howles, S Longobardi. Luteinizing hormone supplementation from Day 1 versus 6 of ovarian stimulation in women aged 36-40 years: results from an open-label, randomized, multicentre, multinational trial. Human Reproduction. 2013;28(suppl 1)

ReferenceCitation: Behre HM, Howles CM, Longobardi S; PERSIST Study Investigators. Randomized trial comparing luteinizing hormone supplementation timing strategies in older women undergoing ovarian stimulation. Reprod Biomed Online. 2015 Sep;31(3):339-46. doi: 10.1016/j.rbmo.2015.06.002. Epub 2015 Jun 15.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

lead_sponsor: Merck KGaA, Darmstadt, Germany

sponsor_collaborators:
Merck KGaA, Darmstadt, Germany
Merck Serono S.A., Geneva
Merck A/S, Denmark
Merck OY, Finland
Merck Serono S.A.S, France
Merck Serono GmbH, Germany
Merck A.E., Greece
Merck B.V., Netherlands
Merck SP. Z.O.O., Poland
Merck Serono S.P.A., Italy
Merck Services U.K. Ltd, UK
LLC Merck, Russia
Merck spol. s r.o., Slovakia
Merck Pharma, K.S., Slovakia

location_country:
Finland
Germany
Italy
Poland
Slovakia
United Kingdom
Denmark
Netherlands
Greece
Russian Federation
France


title: A Prospective, Multicentre, International, Post-marketing, Longitudinal, Observational Cohort Study to Monitor the Performances of GMK Sphere Cementless Knee Prosthesis

summary: This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.

lead_sponsor: Medacta International SA

location_country: Switzerland France

location_facility:
Clinique des Acacias
Clinique du Parc
Hôpitaux Civils de Colmar
Clinique Saint Vincent de Paul
Hôpital de la Tour


title: Study of the Impact of DPD Activity on the Efficacy of Capecitabine

acronym: DPDMAX

summary: This study evaluates the Impact of DihydroPyrimidine Dehydrogenase (DPD) activity on the efficacy of Capecitabine in patients with metastatic breast cancer. The DPD phenotype before the initiation of treatment will be assess and then the patient will be follow up during the treatment with Capecitabine up to 24 month.

primary_purpose: Other

lead_sponsor: Centre Antoine Lacassagne

sponsor_collaborators:
Centre Antoine Lacassagne
Cerbaliance

location_country: Monaco France

location_facility:
Clinique Saint Jean
Centre Antoine Lacassagne
Clinique St Georges
Centre Azuréen de Cancérologie
Hôpital Princesse Grâce

appel_a_projets: PHRCI

region: Provence-Alpes-Côte d'Azur

nom_etablissement: CENTRE ANTOINE LACASSAGNE

type_etablissement: CLCC

acronyme: DPDmax

titre: Etude de l'impact de l'activité DPD sur l'efficacité de la capecitabine.

discipline_principale: cancer oncologie

nom_porteur: CREISSON

prenom_porteur: Anne


title: A Prospective, Multicenter, Randomised Study to Evaluate the Fixation of Cemented and Cementless Design of GMK-UNI Anatomical Knee Prosthesis.

summary: Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the total knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current comparative randomized study aims to evaluate the fixation of cemented and cementless designs of GMK-UNI unicompartmental knee prosthesis over a 5-year time period.

ipd_sharing: Undecided

location_facility:
Dr. Näder Helmy
Clinique du Mail
CHP Saint-Grégoire
Clinique Saint Vincent de Paul
Centre Orthéo, Espace Fauriel


type: Registry Identifier

title: Measurement of Pharyngeal Sensitivity With the SENSITEST Device: Validation of the Diagnosis Algorithm for Sleep Disordered Breathing

acronym: SENSITEST

summary: Pharyngeal sensitivity is a determinant parameter of pharyngeal functioning, particularly regarding protective dilator reflexes of upper airway. Preliminary results have suggested that the use of this parameter in diagnosis algorithm such as linear discriminant analysis and random forest could predict the presence of sleep apnea syndrome in almost 98% of patients. Our study aims at validating a new diagnosis method of sleep disordered breathing which will be compared with nocturnal polysomnography, the reference method to diagnose sleep disordered breathing. Pharyngeal sensitivity will be measured using the SENSITEST device which allows an automatic measurement of the pharyngeal sensation. The use of this parameter in diagnosis algorithm will be compared with polysomnographic results.

ReferenceCitation: Dematteis M, Levy P, Pepin JL. A simple procedure for measuring pharyngeal sensitivity: a contribution to the diagnosis of sleep apnoea. Thorax. 2005 May;60(5):418-26. doi: 10.1136/thx.2003.015032.

ReferenceCitation: Larsson H, Carlsson-Nordlander B, Lindblad LE, Norbeck O, Svanborg E. Temperature thresholds in the oropharynx of patients with obstructive sleep apnea syndrome. Am Rev Respir Dis. 1992 Nov;146(5 Pt 1):1246-9. doi: 10.1164/ajrccm/146.5_Pt_1.1246.

ReferenceCitation: Kimoff RJ, Sforza E, Champagne V, Ofiara L, Gendron D. Upper airway sensation in snoring and obstructive sleep apnea. Am J Respir Crit Care Med. 2001 Jul 15;164(2):250-5. doi: 10.1164/ajrccm.164.2.2010012.

ReferenceCitation: Guilleminault C, Li K, Chen NH, Poyares D. Two-point palatal discrimination in patients with upper airway resistance syndrome, obstructive sleep apnea syndrome, and normal control subjects. Chest. 2002 Sep;122(3):866-70. doi: 10.1378/chest.122.3.866.

ReferenceCitation: Woodson BT, Garancis JC, Toohill RJ. Histopathologic changes in snoring and obstructive sleep apnea syndrome. Laryngoscope. 1991 Dec;101(12 Pt 1):1318-22. doi: 10.1002/lary.5541011211.

ReferenceCitation: Friberg D. Heavy snorer's disease: a progressive local neuropathy. Acta Otolaryngol. 1999;119(8):925-33. doi: 10.1080/00016489950180306.

ReferenceCitation: Boyd JH, Petrof BJ, Hamid Q, Fraser R, Kimoff RJ. Upper airway muscle inflammation and denervation changes in obstructive sleep apnea. Am J Respir Crit Care Med. 2004 Sep 1;170(5):541-6. doi: 10.1164/rccm.200308-1100OC. Epub 2004 May 19.

ReferenceCitation: Mayer P, Dematteis M, Pepin JL, Wuyam B, Veale D, Vila A, Levy P. Peripheral neuropathy in sleep apnea. A tissue marker of the severity of nocturnal desaturation. Am J Respir Crit Care Med. 1999 Jan;159(1):213-9. doi: 10.1164/ajrccm.159.1.9709051.

ReferenceCitation: Deegan PC, McNicholas WT. Pathophysiology of obstructive sleep apnoea. Eur Respir J. 1995 Jul;8(7):1161-78. doi: 10.1183/09031936.95.08071161.

ReferenceCitation: Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
University of Liege
Poitiers University Hospital
University Hospital, Geneva

location_facility:
Clinic of Louvière
University Hospital of Geneva
Annemasse-Bonneville Hospital
Poitiers University Hospital
University Hospital of Grenoble


title: A Placebo-controlled, Single-blind, Multi-center Study to Explore the Photoparoxysmal Response in Photosensitive Epileptic Subjects After One Single Oral Dose of Brivaracetam in Capsules.

summary: to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive epileptic subjects

lead_sponsor: UCB Pharma

location_country: Germany France


title: Persona Outcomes Led Assessment Research in Total Knee Arthroplasty (POLAR - TKA)

summary:
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include:

Implant survivorship based on removal of a study device.
Safety based on incidence and frequency of adverse events.
Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.

ReferenceCitation: Mathijssen NMC, Verburg H, London NJ, Landsiedl M, Dominkus M. Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up. BMC Musculoskelet Disord. 2019 Mar 4;20(1):97. doi: 10.1186/s12891-019-2470-y.

lead_sponsor: Zimmer, GmbH

location_country:
Germany
United Kingdom
Netherlands
Austria
Spain
France

location_facility: Centre Hospitalier régional Universitaire de Montpellier

location_facility: Stichting Research Orthopedie & Reinier de Graaf Groep


title: Phase IV, Multi-center, Randomized, Cross-over Study to Demonstrate the Efficacy of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder

acronym: ACCEPTANCE

summary: The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.

status: Terminated

lead_sponsor: MedtronicNeuro

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
France

location_facility: National Hospital for Neurology and Neurosurgery

location_facility: Marienhospital Herne, Klinikum der Ruhr-Universitaet Bochum

location_facility: Centre Hospitalier Universitaire de Lyon-Sud


title: COVID-19 And Lingering Symptoms In Primary Care Patients

acronym: CALIP

summary: The ongoing corona virus disease 2019 (COVID-19) is a viral acute respiratory tract infection caused by server acute respiratory syndrom coronavirus typ 2 (SARS-CoV-2). The signs and symptom of SARS-CoV-2 infection vary and most people with COVID-19 experience illness of mild or moderate severity and recover with symptomatic treatment outside of hospital. Studies have found that some people experience lingering/long-lasting symptoms and only a minority of patients were completely free from COVID-19 related symptoms after two months. About one third still had up to two residual symptoms and 55% had three or more. As far as we know no study on lingering symptoms has been published in patients after a mild or moderate infection managed in primary care settings. The aim of this study is to explore the course of disease over a one year period and describe lingering symptoms and their impact on well-being and daily activities in adult non-hospitalized patients with previous established COVID-19 infection.

lead_sponsor: Katarina Hedin

collaborators: Research Unit of General Practice, Aalborg

sponsor_collaborators: National University of Ireland, Galway, Ireland

location_country: Germany Ireland Italy Poland Denmark Romania Sweden Netherlands Belgium Georgia France

location_facility: School of Medicine, National University of Ireland

location_facility: Julius Center, University Medical Center Utrecht

location_facility: Département de Santé Publique, Université Côte d'Azur, Centre Hospitalier Universitaire de Nice, Nice, France

location_facility: Center for General Practice at Aalborg University

location_facility: Covid-19 primary care special unit Sassuolo, Azienda Unità Sanitaria locale di Modena, Modena, Italy

location_facility: Institut für Allgemeinmedizin Universitätsklinikum Würzburg Josef-Schneider-Str. 2/D7 97080 Würzburg

location_facility: the Academic Centre for General Practice (ACHG), Department of Public Health and Primary Care, KU Leuven

location_facility: R. Lugar Center for Public Health Research

location_facility: Centre for General Practice, Department of Family Medicine & Population Health (FAMPOP), Faculty of Medicine and Health Sciences, University of Antwerp


title: A Muliticenter, Open Label Safety Study of 2 Doses of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed GERD

summary: The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.

location_country:
Germany
Italy
Poland
Australia
Netherlands
Switzerland
Belgium
United States
South Africa
Canada
France


title: A Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline Versus Ertapenem for the Treatment of Foot Infections in Subjects With Diabetes

summary: The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.

ReferenceCitation: Lauf L, Ozsvar Z, Mitha I, Regoly-Merei J, Embil JM, Cooper A, Sabol MB, Castaing N, Dartois N, Yan J, Dukart G, Maroko R. Phase 3 study comparing tigecycline and ertapenem in patients with diabetic foot infections with and without osteomyelitis. Diagn Microbiol Infect Dis. 2014 Apr;78(4):469-80. doi: 10.1016/j.diagmicrobio.2013.12.007. Epub 2013 Dec 16.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Turkey
Croatia
Chile
Canada
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
Ukraine
India
Romania
Belgium
China
Peru
Estonia
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
Panama
South Africa
Taiwan
Russian Federation
Sweden


title: A Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD

summary: The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.


title: Comparison Between MostCare and Echo-Doppler for Cardiac Output Measurement: an Observational Study

acronym: PRAM

summary: Recently, an uncalibrated minimally invasive Pulse-code Modulator (PCM) has been developed: the MostCare system. This monitoring system is powered by Pressure Recording Analytical Method (PRAM), which is based on the mathematical analysis of the arterial pressure profile changes. It allows beat-to-beat Stroke Volume (SV) assessment from the pressure signal recorded invasively in radial, brachial, or femoral arteries. The most innovative features of this method are: 1) the lack of a calibration requirement, 2) the analysis of the arterial wave signal is performed at 1000 Hz, 3) a dedicated arterial catheter-transducer is unnecessary. MostCare is powered by PRAM (Pressure Recording Analytical Method) algorithm. The investigators primary end-point was to evaluate the relationship between Cardiac Output (CO) measured by MostCare with CO calculated with Echo-Doppler in Intensive Care Unit (ICU) patients under different clinical conditions. As a secondary end-point the investigators evaluated the relationship between CO measured by MostCare with CO obtained with thermodilution techniques (standard bolus thermodilution or transpulmonary thermodilution, i.e. PiCCO system). This is a prospective multicentre observational study.

lead_sponsor: Azienda Ospedaliera Universitaria Senese

location_country:
Italy
United Kingdom
Spain
France

location_facility: Department of Anaesthesia and Intensive Care, Siena University Hospital

location_facility: Department of Anaesthesia and Intensive Care, Pisa University Hospital

location_facility: Cardio-Thoracic-Vascular Anaesthesia and Intensive Care, San Raffaele University Hospital

location_facility: Department of Cardiovascular Anesthesia and Intensive Care, Careggi University Hospital, Italy

location_facility: of Anesthesia, Critical Care and Pain Medicine, Hospital Universitario de la Ribera

location_facility: (Cardiothoracic Anaesthesia, Heart and Lung Centre, New Cross Hospital

location_facility: Anaesthesia and Intensive Care Unit, S. Giovanni di Dio - Torregalli Hospital

location_facility: Department of Anaesthesia and Intensive Care, Torrette University Hospital

location_facility: Cardiovascular Anesthesia, Policlinico Umberto I°

location_facility: Department of Anaesthesia and Intensive Care, Ospedali Riuniti Foggia University Hospital

location_facility: Intensive Care Unit, Santa Maria Annunziata Hospital

location_facility: Department of Anesthesiology & Intensive Care - Lariboisière University Hospital University Paris 7 Diderot. France


title: A Phase II Study Evaluating the Efficacy and Safety of Imetelstat in Patients With HR Myelodysplastic Syndromes or AML Failing HMA-based Therapy

acronym: IMpress

summary: The purpose of this study is to evaluate the efficacy, in terms of hematologic improvement, and safety of imetelstat in participants with high-risk (HR) myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that is relapsed/refractory to hypomethylating agents (HMAs) treatment. Responding patients are eligible to continue treatment until loss of response/disease progression.

lead_sponsor: GCP-Service International West GmbH

collaborators: QIMR Berghofer Medical Research Institute

collaborators: Australasian Leukaemia and Lymphoma Group

collaborators: German Myelodysplastic Syndrome Study Group

location_country: Germany Australia France

location_facility: Universität Leipzig, Medizinische Fakultät


title: The Bacteriuria in Renal Transplantation (BiRT) Study: A Prospective, Randomized, Parallel-group, Multicenter, Open-label, Superiority Trial Comparing Antibiotics Versus no Treatment in the Prevention of Symptomatic Urinary Tract Infection in Kidney Transplant Recipients With Asymptomatic Bacteriuria

acronym: BiRT

summary: The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant recipients with asymptomatic bacteriuria.

lead_sponsor: Erasme University Hospital

collaborators: Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP, France

collaborators: Centre Hospitalier Universitaire Brugmann

collaborators: Centre Hospitalier Universitaire de Charleroi

location_country: Belgium France

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel

location_facility: Department of Kidney Transplantation, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP

location_facility: Groupe Henri Mondor-Albert Chenevier, Assistance Publique-Hôpitaux de Paris

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Saint-Étienne

location_facility: Hôpital Tenon, Assistance Publique-Hôpitaux de Paris

location_facility: Centre Hospitalier Universitaire Rangueil


lead_sponsor: Transgene

summary: This is a Phase I/IIa, multicenter, open-label, consecutive cohorts, dose-escalation study of BT-001 with repeated IT administrations alone and in combination with IV infusions of pembrolizumab.

sponsor_collaborators:
Transgene
BioInvent International AB
Merck Sharp & Dohme LLC

location_facility:
Hôpital Saint-Louis AP-HP
Institut Bergonié
Clinique Universitaire Saint-Luc
Centre Léon Bérard
Institut Gustave Roussy

title: A Phase I/IIa Study of Intra-tumoral BT-001 (TG6030) Administered Alone and in Combination With Pembrolizumab in Patients With Cutaneous or, Subcutaneous Lesions or Easily Injectable Lymph Nodes of Metastatic/Advanced Solid Tumors.


title: Automatic Oxygen Administration in Early and Late Postoperative Hypoxaemia Prevention After Major Abdominal and Thoracic Surgery

summary:
The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in the post anesthesia care unit in a patient population admitted for major abdominal and thoracic surgery.

The investigators' hypothesis is that FreeO2 system will provide a better control of the oxygen saturation and reduce postoperative hypoxaemia.

ReferenceCitation: L'Her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Consigny M, Lellouche F. Automated closed-loop versus standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study. Eur Respir J. 2021 Jan 5;57(1):2000182. doi: 10.1183/13993003.00182-2020. Print 2021 Jan.

oa_colors: green other

evidence: open (via free pdf)

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

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

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

unpaywall_oa_status: bronze

publisher_dissemination: European Respiratory Society

ReferenceCitation: L'her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Gouillou M, Nowak E, Lellouche F. Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study. BMJ Open. 2019 Jan 17;9(1):e023833. doi: 10.1136/bmjopen-2018-023833.

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

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Brest

location_country: Canada France

location_facility:
Hôpital Laval - Québéc
CHU Montpellier
Brest, University Hospital
CHU Clermont-Ferrand
CHU Poitiers


title: FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden

summary: The purpose of this study is to assess in a prospective multicentric study (Phase III) the introduction of a monoclonal antibody directed against B-cells associated with a standard therapy including chemotherapy and alpha-interferon in first line treatment of patients with a large tumor burden follicular lymphoma.

ReferenceCitation: Solal-Celigny P, Lepage E, Brousse N, Reyes F, Haioun C, Leporrier M, Peuchmaur M, Bosly A, Parlier Y, Brice P, et al. Recombinant interferon alfa-2b combined with a regimen containing doxorubicin in patients with advanced follicular lymphoma. Groupe d'Etude des Lymphomes de l'Adulte. N Engl J Med. 1993 Nov 25;329(22):1608-14. doi: 10.1056/NEJM199311253292203.

ReferenceCitation: McLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33. doi: 10.1200/JCO.1998.16.8.2825.

ReferenceCitation: Salles G, Mounier N, de Guibert S, Morschhauser F, Doyen C, Rossi JF, Haioun C, Brice P, Mahe B, Bouabdallah R, Audhuy B, Ferme C, Dartigeas C, Feugier P, Sebban C, Xerri L, Foussard C. Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study. Blood. 2008 Dec 15;112(13):4824-31. doi: 10.1182/blood-2008-04-153189. Epub 2008 Sep 17.

lead_sponsor: Lymphoma Study Association

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud


acronym: TRACE

lead_sponsor: Prof. Tobias Feuchtinger

summary: Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults.

sponsor_collaborators: Simbec-Orion Group Ltd, Merthyr Tydfil, UK

sponsor_collaborators: Miltenyi Biotec B.V. & Co. KG, Bergisch Gladbach, Germany

sponsor_collaborators: Leiden University Medical Center, LUMC, Leiden, The Netherlands

sponsor_collaborators: Centre Hospitalier Universitaire de Nancy, CHU, Vandoeuvre-Lès-Nancy, France

sponsor_collaborators: Ghent University Hospital, UZG, Ghent, Belgium

sponsor_collaborators: Ospedale Pediatrico Bambino Gesù, OPBG, Rome, Italy

sponsor_collaborators: Newcastle University, UNEW, Newcastle, UK

sponsor_collaborators: Vall d'Hebron Institute of Oncology (VHIO) and Banc de Sang I Teixits (BST), Barcelona, Spain

location_facility: Institut d'Hématologie et Oncologie Pédiatrique (IHOPe)

location_facility: Hospital Universitario Politécnico La Fe

location_facility: Universitäsklinikum Leipzig - Medizinische Klinik und Poliklinik I

location_facility: Universitätsklinikum Würzburg - Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation

location_facility: Klinikum rechts der Isar der Technischen Universität - Kinderklinik Schwabing

location_facility: LMU Klinikum - Dr. v. Haunersches Kinderspital

location_facility: Centre Hospitalier Régional Universitaire de Nancy (CHRU)

location_facility: Medizinische Hochschule Hannover - Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Universitätsklinikum Regensburg - Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation

location_facility: Ospedale Infantile Regina Margherita - Oncoematologie Pediatrica

location_facility: Universitätsklinikum Freiburg - Klinik für Pädiatrische Hämatologie und Onkologie

location_facility: Klinikum rechts der Isar der Technischen Universität - Klinik und Poliklinik für Innere Medizin III

location_facility: Universitätsklinikum Essen - Pädiatrische Hämatologie-Onkologie

location_facility: LMU Klinikum - Medizinische Klinik und Poliklinik III

location_facility: Universitätsklinikum Düsseldorf - Klinik für Kinder-Onkologie, -Hämatologie und klinische Immunologie

location_facility: Universitätsklinikum Tübingen, Center for Pediatric Clinical Studies (CPCS)

location_facility: Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II & Zentrum Innere Medizin (ZIM)

location_facility: Leiden University Medical Centre (LUMC) - Department of Hematology

location_facility: Charité Berlin (Campus Virchow-Klinikum) - Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie

title: Treatment of Chemo-refractory Viral Infections After Allogeneic Stem Cell Transplantation With Multispecific T Cells Against CMV, EBV and AdV: A Phase III, Prospective, Multicentre Clinical Trial

location_country: Germany Italy Netherlands Belgium Spain France


title: An Open Label Study to Determine the Safety and Tolerability of 12 Weeks Treatment With Oral REN001 in Subjects With Fatty Acid Oxidation Disorders (FAOD)

summary: The purpose of this Phase 1b study is to assess REN001 safety in subjects with fatty acid oxidation disorders.

lead_sponsor: Reneo Pharma Ltd

location_country:
United States
Spain
France

location_facility: Servicio de Neurología - Unidad de Neuromuscular Centro de Referencia Nacional de Enfermedades Neuromusculares raras Instituto de Investigación i+12

location_facility: Division of Medical Genetics, University Utah

location_facility: Neurology department, Raymond-Poincaré Teaching Hospital, Nord/Est/Ile de France Neuromuscular Reference Center


title: A Phase 1B Dose Escalation, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-hodgkin's Lymphoma

summary:
CC-95775-ST-001 is an open-label, Phase 1B, dose escalation and expansion study of CC-95775 in subjects with advanced or unresectable solid tumors, including laBCC, and relapsed/ refractory non-Hodgkin's lymphoma (NHL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-95775 administered on a 4d on/24d off schedule to estimate the MTD of CC-95775. A mTPI-2 will help guide CC-95775 dose escalation decisions with the final decisions made by an SRC. Approximately 20 subjects will be enrolled.

The expansion cohort (Part B) will evaluate the safety, PK, PD safety and preliminary activity of CC-95775 in advanced solid tumors, including laBCC. Approximately 20 subjects will be enrolled.

lead_sponsor: Celgene

location_country: Spain France

location_facility:
Hopital Saint Louis
Clinica Universidad de Navarra
Centre Eugene Marquis
Hospital de Madrid Norte- Sanchinarro
Institut Curie