title: Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer

summary:
One of the treatments generally used to treat this disease is a chemotherapy called FOLFIRI. The purpose of this study is to improve the efficacy of the chemotherapy by adding a protein, similar to immunoglobulins, aflibercept, and to assess their tolerance.

Aflibercept is a protein that has already been studied in the treatment of metastatic colorectal cancers, in combination with a chemotherapy involving irinotecan in addition to 5FU (fluoropyrimidine) ( (FOLFIRI) as 2nd line treatment. It is marketed in Europe and it is authorized in the United States. Its addition to this chemotherapy combination has in fact brought about a benefit in terms of progression-free survival and overall survival.

The purpose of the study is to evaluate the efficacy and tolerance of this combination rather in the initial approach to the treatment of metastatic colorectal cancers and hence to evaluate it as 1st line treatment

ReferenceCitation: Lapeyre-Prost A, Pernot S, Sigrand J, Le Malicot K, Mary F, Aparicio T, Dahan L, Caroli-Bosc FX, Lecomte T, Doat S, Marthey L, Desrame J, Lepage C, Taieb J. Aflibercept in Combination With FOLFIRI as First-line Chemotherapy in Patients With Metastatic Colorectal Cancer (mCRC): A Phase II Study (FFCD 1302). Clin Colorectal Cancer. 2020 Dec;19(4):285-290. doi: 10.1016/j.clcc.2020.06.003. Epub 2020 Jun 12.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Hôpital Européen Geaorge Pompidou (HEGP)


title: A Randomized, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL According to the Delivery Device: Injections Using Pump or Rapid Push.

summary: The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Bienvenu B, Cozon G, Mataix Y, Lachaud D, Alix A, Hoarau C, Antier D, Hachulla E, Brice S, Viallard JF, Tamisier S, Fauchais AL, Renon-Carron F, Clerson P, Fardini Y, Crave JC, Miossec P. Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients. J Clin Immunol. 2018 May;38(4):503-512. doi: 10.1007/s10875-018-0507-x. Epub 2018 May 31.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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: hybrid

publisher_dissemination: Springer-Nature

lead_sponsor: Octapharma

location_facility:
University Hospital of Lille
Clinique Mutualiste
University Hospital of Toulouse
University Hospital of Tours
University Hospital of Caen
University Hospital of Reims
Hospital Dupuytren
Haut-Leveque Hospital

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


title: Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke: An Observational, Prospective and Multicenter Study

acronym: Re-ACT

summary: The main objective of this study is to assess the safety and effectiveness of the ReVive SE (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy when used according to its Instruction for use (IFU).

study_start_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Codman & Shurtleff

location_facility:
CHU Lille
CHU La Timone
CHU de Colmar
CHU Bordeaux
CHU Dijon
CHU Clermont Ferrand
CHU St Etienne
Hôpital Bretonneau


title: Evaluation of the Benefits Associated With Pre-emptive Kidney Transplantation. Prospective, Multicenter and Controlled Study of Quality of Life, Psychological Adjustment Processes and Medical Outcomes of Patients Receiving a Pre-emptive Kidney Transplant Compared to a Similar Population of Recipients After a Dialysis Period of Less Than Three Years

acronym: PreKiTQoL

summary: The main objective is to assess the psychological impact of pre-emptive kidney transplantation on patients' quality of life taking into account psychological adjustment (response shift), compared to patients who have experienced a short pre-transplant dialysis period of less than 36 months.

status: Unknown status

study_completion_date_type: Anticipated

ReferenceCitation: Sebille V, Hardouin JB, Giral M, Bonnaud-Antignac A, Tessier P, Papuchon E, Jobert A, Faurel-Paul E, Gentile S, Cassuto E, Morelon E, Rostaing L, Glotz D, Sberro-Soussan R, Foucher Y, Meurette A. Prospective, multicenter, controlled study of quality of life, psychological adjustment process and medical outcomes of patients receiving a preemptive kidney transplant compared to a similar population of recipients after a dialysis period of less than three years--The PreKit-QoL study protocol. BMC Nephrol. 2016 Jan 19;17:11. doi: 10.1186/s12882-016-0225-7.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_normalized: HAL

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

lead_sponsor: Nantes University Hospital

location_facility: AP-HP - Hôpital St Louis - Service de Néphrologie et Transplantation Rénale

location_facility: CHU MARSEILLE - Hôpital de la Conception - Santé Publique

location_facility: CHU TOULOUSE - Hôpitalt Rangueil - Service de Néphrologie

location_facility: CHU MONTPELLIER - Hôpital Lapeyronie - Service de Néphrologie

location_facility: CHU NANTES - Hôtel Dieu-Jean Monnet - ITUN

location_facility: CHU LYON - Hôpitla E. Herriot - Médecine de transplantation et immunoclinique

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown

appel_a_projets: PHRCN

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

type_etablissement: CH

acronyme: PreKiTQoL

titre: Evaluation des bénéfices associés à une greffe rénale préemptive. Etude prospective observationnelle multicentrique et contrôlée de la qualité de vie, des processus d'adaptation psychologique et de l'évolution clinique de patients recevant une greffe préemptive par rapport à une population comparable de patients greffés après une période de dialyse inférieure à un an.

discipline_principale: néphrologie

nom_porteur: SEBILLE

prenom_porteur: Véronique


title: Longitudinal Study Comparing Markers of Frailty in Geriatric Assessment to Detect Vulnerability to Chemotherapy in Patients Aged 70 Years or Older With Colon Cancer

acronym: MOST

summary: MOST is a longitudinal study whose aim is to test the hypothesis that frailty markers are better at detecting vulnerable patients and that they are a better "Adverse Events" predictive tool than the CGA (Comprehensive Geriatric Assessment) in older cancer patients referred for chemotherapy. The second hypothesis is that a brief screening tool based on a combination of some frailty markers and some used in the CGA would help the oncologist detect patients requiring a more complete geriatric assessment

ReferenceType: background

ReferenceCitation: Retornaz F, Seux V, Sourial N, Braud AC, Monette J, Bergman H, Soubeyrand J. Comparison of the health and functional status between older inpatients with and without cancer admitted to a geriatric/internal medicine unit. J Gerontol A Biol Sci Med Sci. 2007 Aug;62(8):917-22. doi: 10.1093/gerona/62.8.917.

ReferenceCitation: Retornaz F, Monette J, Batist G, Monette M, Sourial N, Small D, Caplan S, Wan-Chow-Wah D, Puts MT, Bergman H. Usefulness of frailty markers in the assessment of the health and functional status of older cancer patients referred for chemotherapy: a pilot study. J Gerontol A Biol Sci Med Sci. 2008 May;63(5):518-22. doi: 10.1093/gerona/63.5.518.

lead_sponsor: Association Sud pour la Recherche en Oncogériatrie

location_facility: Centre Hospitalier Universitaire Intercommunal des Alpes du Sud

location_facility: Hôpital de Pontoise Centre Hospitalier René Dubos

location_facility: Pôle de Gérontologie, Service de Gériatrie Aigue et Thérapeutique


title: ADVATE 2 mL (Reconstituted in 2 mL SWFI) POST-AUTHORIZATION SAFETY SURVEILLANCE STUDY

summary: This is a Post-Authorization Safety Surveillance (PASS) study designed to collect data on the safety and effectiveness of ADVATE reconstituted in 2 mL Sterile water for injection (SWFI) during routine clinical practice in children until 12 years of age. This surveillance study is a post-licensure commitment for ADVATE reconstituted in 2 mL SWFI.

ipd_sharing: Yes

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Baxalta now part of Shire

location_country:
Germany
Hungary
United Kingdom
France

location_facility: CRTH Laboratoire d'Hématologie CHRU - Hôpital du Bocage

location_facility: American Memorial Hospital, Service de Pédiatrie

location_facility: Borsod-Abaúj-Zemplén County Hospital, Pediatric Dep

location_facility: Josa Andras Egyetemi Oktatokorhaz, Department of Pediatrics

location_facility: Birmingham Children's Hospital NHS Trust

location_facility: Universitätskliniken des Saarlandes, Klinik für pädiatrische Onkologie und Hämatologie

location_facility: Heim Pál Children's Hospital, Department of Oncology

location_facility: Klinikum Stuttgart, Olgahospital, Pädiatrie 5

location_facility: Great Ormond Street Hospital for Children NHS Trust

location_facility: Mohacsi Korhaz, Department of Pediatrics

location_facility: CHU de Nancy - Hôpital de Brabois- CRTH - Laboratoire Hémato-Hémostase


title: Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes

acronym: REPLACE

summary: To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 2 diabetes using insulin.

design_allocation: Randomized

primary_purpose: Other

ReferenceCitation: Rayman G, Kroger J, Bolinder J. Could FreeStyle Libre sensor glucose data support decisions for safe driving? Diabet Med. 2018 Apr;35(4):491-494. doi: 10.1111/dme.13515. Epub 2017 Oct 14.

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: Wiley

ReferenceCitation: Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes. Diabetes Ther. 2017 Jun;8(3):573-586. doi: 10.1007/s13300-017-0255-6. Epub 2017 Apr 11.

ReferenceCitation: Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2017 Feb;8(1):55-73. doi: 10.1007/s13300-016-0223-6. Epub 2016 Dec 20.

evidence: oa repository (via OAI-PMH title and first author match)

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

lead_sponsor: Abbott Diabetes Care

location_country:
Germany
United Kingdom
France

location_facility: St. James University Hospital, Leeds Teaching Hospitals NHS Trust

location_facility: FRCPath Life and Health Sciences, Aston University

location_facility: Diabetes Research, Linda McCartney Centre, Royal Liverpool University Hospital

location_facility: The Diabetes Centre, Ipswich Hospital NHS Trust

intervention_type: Device


title: Medico-economic Evaluation of a Telemedicine System for the Management of Chronic Renal Failure

acronym: eNephro

summary:
The main objective of this study is to demonstrate the efficiency ( cost-effectiveness ) of a telemedicine system : eNephro Application , compared with traditional care in the management of chronic renal failure in different populations :

population 1 : Patients with CKD stage 3B- 4 , the combined endpoint achievement of target blood pressure and proteinuria .
population 2 : Patients with ESRD treated by ambulatory dialysis , the cumulative duration of hospitalization in short-stay
population 3 : Patients with ESRD treated with Renal Transplantation , the cumulative duration of unplanned short stay

Two statistical analysis will be done :

a main analysis for the one year initial follow-up for each patient
a secondary analysis for the one year initial follow-up estended by one year (proposed to each patient at the end of the initial follow-up), that is a 2 years period.

The intervention tested in this study is a telemedicine system which is a collaborative and expert system, consisting of:

A dynamic shared medical record for the collection of administrative , medical, biological and clinical data for each patient. All health professionals can access the folder and fill in the support. It is the same for patients treated at home.
A secure messaging for communication between health professionals and between patients and health professionals
Expert systems analyzing data from each patient
A management tool of therapeutic education

Each patient and whatever the group will perform as part of its monitoring of the CKD assessments at baseline , 6 months, 12 months, 18 months (Populations 1 and 2) and end of study (24 months). These evaluations are about compliance, quality of life, anxiety - depression state. To enhance costs the point of view retained will be health insurance's point of view. Among the various costs, only direct costs are considered: disease management, hospitalizations, consultations in hospitals and private practice, prescribed medical transportation , home visits by health professionals, additional assessments related to the evaluated intervention. A probabilistic matching with the data bases of the National Information System of the Social Insurance will be performed. In addition, the acceptability of the system of telemedicine by patients in the intervention and health professionals will be also evaluated.

ReferenceCitation: Thilly N, Chanliau J, Frimat L, Combe C, Merville P, Chauveau P, Bataille P, Azar R, Laplaud D, Noel C, Kessler M. Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design. BMC Nephrol. 2017 Apr 5;18(1):126. doi: 10.1186/s12882-017-0529-2.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - TEL - Thèses en ligne

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université d'Artois

ipd_sharing: No

lead_sponsor: Pharmagest Interactive

location_facility:
TELECOM Bretagne
AURAD Aquitaine
CH Boulogne sur Mer
ALTIR
CHU Bordeaux
CHU Lille
CHU Nancy
CH Dunkerque


title: A European, Randomised, Double-blind, Active Comparator Controlled, Cross-over, Efficacy and Safety Study of a New 10% Ready To-use Liquid Human Intravenous Immunoglobulin (I10E) Versus Kiovig® in Patients With Multifocal Motor Neuropathy

acronym: LIME

summary: The aim of this study is to evaluate the efficacy and safety of I10E (LFB 10% ready-to-use liquid human intravenous immunoglobulin) compared to Kiovig® for the maintenance treatment of MMN in a randomized, double-blind, active comparator-controlled, cross-over trial.

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

location_country:
Italy
United Kingdom
Spain
France

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista

location_facility: CHU Créteil - Groupe Hospitalier Henri Mondor

location_facility: Università di Genova - Ospedale San Martino

location_facility: Hospital Clinico Universitario de Santiago de Compostela

intervention_type: Drug


title: Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.

acronym: HORTOCI

summary: It has been reported that around 40% of GCA patients are able to decrease the prednisone dose until 0.1 mg/Kg/d or less after 6 months of treatment. In this study, we hypothesized that adding 3 months of tocilizumab to prednisone could increase the percentage from 40 to 70%.

ReferenceCitation: Samson M, Devilliers H, Ly KH, Maurier F, Bienvenu B, Terrier B, Charles P, Guillevin L, Besancenot JF, Liozon E, Fauchais AL, Loffroy R, Binquet C, Audia S, Seror R, Mariette X, Bonnotte B. Tocilizumab as an add-on therapy to glucocorticoids during the first 3 months of treatment of Giant cell arteritis: A prospective study. Eur J Intern Med. 2018 Nov;57:96-104. doi: 10.1016/j.ejim.2018.06.008. Epub 2018 Jul 24.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Hôpitaux privés de Metz - Site Sainte Blandine


title: Frequency and Risk Factors of the Lung High Blood Pressure Post-embolique in the Fall of a First Episode of Idiopathic Pulmonary Embolism. Study " PADIS HTP "

acronym: PADIS-HTP

summary: Forward-looking troop established(constituted) by the patients having been included in the study " PADIS EP ", PHRC on 2006 and 2009, randomized checked(controlled), double-blind, comparing an anticoagulating treatment(processing) extended by coumadine versus placebo during 18 months at patients having had a first episode of EP idiopathique treated(handled) initially 6 months by anti-vitamin K.

status: Terminated

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Brest

location_facility: Hôpital de Bellevue - CHU de Saint-Etienne


type: EudraCT Number

title: A Randomized Assessor-blinded Multicenter International Study Investigating Efficacy Patients Acceptance Safety and Tolerability of Sodium Phosphate Tablets Compared to Split Dose Polyethylene Glycol for Colon Cleansing Prior to Colonoscopy

summary: The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to colonoscopy.

ReferenceCitation: Chaussade S, Schmocker C, Toulemonde P, Munoz-Navas M, O'Mahony V, Henri F. Phosphate tablets or polyethylene glycol for preparation to colonoscopy? A multicentre non-inferiority randomized controlled trial. Surg Endosc. 2017 May;31(5):2166-2173. doi: 10.1007/s00464-016-5214-1. Epub 2016 Nov 18.

lead_sponsor: Laboratoires Mayoly Spindler

location_country: Germany Spain France

location_facility: Hospital Universitarion Gregorio Maranon

location_facility: Groupe Hospitalier Intercommunal Le Raincy-Montfermeil

location_facility: Medizinische Klinik und Poliklinik II Munchen


title: OPTIMOX-aflibercept as First-line Therapy in 49 Patients With Unresectable Metastatic Colorectal Cancer. A GERCOR Feasibility Single-arm Phase II Study.

acronym: VELVET

summary: Evaluation of feasibility of adding aflibercept to an oxaliplatin-based regimen rather than a continuous administration of chemotherapy until progression, in order to decrease the risk of severe toxicities.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
CHU Dupuytren
Hôpital Henri Mondor
Institut Mutualiste Montsouris
Hôpital Pitié Salpêtrière
Hôpital Privé Jean Mermoz
CH Mont de Marsan
Hôpital Saint-Antoine
Polyclinique de Bordeaux Nord


title: Phase 1-2 Study of the Combination of Escalated Total Bone Marrow Irradiation (TBMI) by Helicoidal Tomotherapy and a Fixed High-dose Melphalan (140 mg/m²) Followed by Peripheral Stem Cell Rescue (PSC) in First Relapsed Multiple Myeloma.

acronym: TOMMY

summary: In Multiple Myeloma, an adult hematological malignancy, mainly located in the Bone Marrow (BM), dramatic recent progresses have been observed, thanks to new agents (proteasome inhibitors and IMIDs). However, at time of first relapse, high-dose therapy followed by Stem Cell Rescue (SCR) is frequently mandatory as a consolidation in minimal residual disease, to healthy patients under 65 yo, combining Melphalan (MPH) and/or Total Body Irradiation. Modern irradiation modalities are now available by the use of HI-ART Tomotherapy system to realize a Total Bone Marrow Irradiation (TBMI), in order both to limit the dose administered to Organ at Risk (lungs, oral cavity) and to focus efficacy on BM. In this phase-1 study, the conditioning regimen before SCR will combine a fixed high-dose MPH (140 mg/m²) and a dose escalated TBMI, so as to define its Maximal Tolerated Dose (MTD) and the Dose Limiting Toxicities (DLT). An extended cohort will further in a phase-2 setting.

ReferenceCitation: Wong JY, Rosenthal J, Liu A, Schultheiss T, Forman S, Somlo G. Image-guided total-marrow irradiation using helical tomotherapy in patients with multiple myeloma and acute leukemia undergoing hematopoietic cell transplantation. Int J Radiat Oncol Biol Phys. 2009 Jan 1;73(1):273-9. doi: 10.1016/j.ijrobp.2008.04.071. Epub 2008 Sep 9.

ReferenceCitation: Somlo G, Spielberger R, Frankel P, Karanes C, Krishnan A, Parker P, Popplewell L, Sahebi F, Kogut N, Snyder D, Liu A, Schultheiss T, Forman S, Wong JY. Total marrow irradiation: a new ablative regimen as part of tandem autologous stem cell transplantation for patients with multiple myeloma. Clin Cancer Res. 2011 Jan 1;17(1):174-82. doi: 10.1158/1078-0432.CCR-10-1912. Epub 2010 Nov 3.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: CLCC Oscar Lambret, service de radiothérapie

location_facility: CLCC Paul Strauss, service de radiothérapie

location_facility: CHU Claude Huriez, service d'hématologie


type: Other Identifier

title: Validation of a French Version of the Confusion Assessment Method (CAM): a Diagnostic Tool for Acute Confusion Among the Elderly

summary:
To validate the French version of the CAM, a multicenter diagnostic study will be conducted. The principle of this study is identical to the study of Inouye which initially validated the CAM in 1990. This is to verify the diagnostic properties of the CAM (French version) compared to the gold standard represented by the confused state of psychiatric diagnosis using the DSM.

A representative sample of geriatric patients for whom a delirium is suspected, will be recruited in the various participating centers, patients will undergo two consecutive visits:

A visit by a geriatrician, during which the confused state of the patient will be evaluated using the French version of the CAM.
A visit by a psychiatrist during which the diagnosis of confusional state will be evaluated using the gold standard criteria of the DSM IV.

These two evaluations will be conducted on the same day and blinded from each other.

The order of these two procedures will be balanced within each center. This process will allow the calculation of diagnostic parameters of the CAM French version (validation competitive): sensitivity, specificity, positive and negative predictive values .

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHU de Rouen - Hôpital de Bois-Guillaume

location_facility: CHU de Montpellier - Centre Antonin Balmes


title: A Randomized Proof-of-concept Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer.

acronym: SHIVA

summary:
SHIVA is a proof of concept randomized phase II trial which compares two treatment strategies for patients with refractory cancer.

From a tumor biopsy, a molecular profile of the disease is established (mutations, amplifications, hormone receptor status). If a molecular abnormality is identified for which an approved targeted agent is available, patients are randomized randomized between two arms:

Targeted therapy based on the molecular profile
Conventional therapy based on investigator's choice.

A cross-over is proposed at disease progression.

ReferenceCitation: Le Tourneau C, Delord JP, Goncalves A, Gavoille C, Dubot C, Isambert N, Campone M, Tredan O, Massiani MA, Mauborgne C, Armanet S, Servant N, Bieche I, Bernard V, Gentien D, Jezequel P, Attignon V, Boyault S, Vincent-Salomon A, Servois V, Sablin MP, Kamal M, Paoletti X; SHIVA investigators. Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): a multicentre, open-label, proof-of-concept, randomised, controlled phase 2 trial. Lancet Oncol. 2015 Oct;16(13):1324-34. doi: 10.1016/S1470-2045(15)00188-6. Epub 2015 Sep 3.

lead_sponsor: Institut Curie

location_facility: Centre régional de lutte contre le cancer de Bourgogne Georges François Leclerc

location_facility: Institut de cancérologie de l'Ouest Centre René Gauducheau


title: Open-label, Randomized, Parallel-Group, Exploratory Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Steatohepatitis (NASH) and Non-treated Matched Healthy Volunteers as Control Group

acronym: EXPO

summary: Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty Liver Disease and non-treated matched healthy volunteers as control group

lead_sponsor: Abbott

sponsor_collaborators: Abbott PPD

location_country:
Germany
Poland
Russian Federation
France

location_facility:
Site Reference ID 93918
Site reference ID ORG-000920
Site Reference ID 93975
Site Reference ID 93914
Site Reference ID 93973
Site Reference ID 93894
Site Reference ID 93957
Site Reference ID 93935
Site Reference ID 93896
Site Reference ID 93917
Site reference ID ORG-000906
Site reference ID ORG-000907
Site Reference ID 93958
Site Reference ID 93955
Site reference ID ORG-000904
Site Reference ID 93933
Site Reference ID 94015
Site Reference ID 93893
Site Reference ID 93954
Site Reference ID 93956
Site reference ID ORG-000900
Site reference ID/Investigator # 109455
Site reference ID ORG-000905
Site Reference ID 93915
Site Reference ID 93913
Site reference ID ORG-000903
Site Reference ID 93916
Site Reference ID 93953
Site Reference ID 94014
Site Reference ID 93895
Site reference ID ORG-000901
Site Reference ID 93974


title: Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients With KCNQ1 or KCNH2 Mutation Without Long QT Interval in Rest ECG

acronym: QT long

summary: The aim of the study is to evaluate the best stress exam to unmask long QT in patient with KCNQ1 or KCNH2 mutation without long QT interval in rest electrocardiogram.

design_allocation: Non-Randomized

location_facility:
CHU Montpellier
CHU Toulouse
Nantes Universitary Hospital
CHU Rouen
Rennes Universitary Hospital
CHU Tours
Bordeaux Universitary Hospital
Marseille Universitary Hospital


title: Effectiveness of a Balance Rehabilitation Program With Sensory Recalibration After Stroke: A Randomized Controlled Trial.

acronym: AVCPOSTIM

summary: The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration and/or prism adaptation in patients with left hemiplegia on balance.

ReferenceType: result

ReferenceCitation: Leplaideur S, Moulinet-Raillon A, Duche Q, Chochina L, Jamal K, Ferre JC, Bannier E, Bonan I. The Neural Bases of Egocentric Spatial Representation for Extracorporeal and Corporeal Tasks: An fMRI Study. Brain Sci. 2021 Jul 22;11(8):963. doi: 10.3390/brainsci11080963.

oa_host_type: repository

repository_institution: MDPI AG - MDPI

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

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

repositories:
HAL
PubMed Central
mdpi.com

repositories_concat: HAL;PubMed Central;mdpi.com

unpaywall_oa_status: green

publisher_dissemination: MDPI

ReferenceCitation: Jamal K, Leplaideur S, Rousseau C, Cordillet S, Raillon AM, Butet S, Cretual A, Bonan I. The effects of repetitive neck-muscle vibration on postural disturbances after a chronic stroke. Neurophysiol Clin. 2020 Sep;50(4):269-278. doi: 10.1016/j.neucli.2020.01.005. Epub 2020 Mar 31.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: open (author manuscript)

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

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

repositories_concat: HAL

lead_sponsor: Rennes University Hospital

location_facility:
CHU Grenoble
Centre de Rééducation de Kerpape
CHU Reims
CHU Rennes-Pontchaillou
IRF Nancy
CHU Lariboisière-Saint Louis Paris
CHU Lyon
CHU Lille


title: Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials

acronym: IPSY

summary: This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.

primary_purpose: Supportive Care

lead_sponsor: Centre Oscar Lambret

location_facility:
François Baclesse Center
CHOLET Hospital
Val D'AURELLE Center
Georges-François LECLERC Center
Léon BERARD Center
Jean GODINOT Institut
Paul PAPIN Center
Oscar Lambret Center


title: Impact of the Absence of Steroids on the Evolution of Renal Function and on the Progression of Graft Fibrosis, Quantified by Numerical Method, in Patients With Renal Transplant

acronym: Astronef

summary: The main objective of this study is to demonstrate that the absence of post-transplantation corticosteroids does not induce a larger increase of renal graft fibrosis (by numerical reading) on biopsy at one year post-transplantation than immunosuppressive treatment strategy that includes standard oral corticosteroids.The secondary objectives of the study consist to compare on various parameters (fibrosis progression, renal function, dialysis, ratio of proteinuria/creatinuria, acute rejection, donor-specific antibody, graft survival, clinical and biological tolerance) therapy with no corticosteroids post-transplantation in comparison to standard immunosuppressive treatment strategies including oral corticosteroids. Secondary objectives of the study consist also to compare the two techniques for assessing fibrosis by numerical reading and by centralized blinded reading of the treatment group (by 2 anatomical pathologists).

location_facility:
AP-HP - Hôpital Bicêtre
CHU de Saint-Etienne
Nantes University Hospital
CHU de Lyon
CHU de Nice
CHU de Toulouse
CHRU de Tours
AP-HP - Hôpital Necker


title: Assessment of the Safety and Efficacy of the Danubio Paclitaxel-Eluting Balloon for the Treatment of In-Stent Restenosis Lesions in Native Coronary Arteries.

acronym: DEBREST

summary: The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries.

lead_sponsor: MINVASYS

sponsor_collaborators:
MINVASYS
European Cardiovascular Research Center

location_facility:
Clinique Saint-Pierre
Centre Hospitalier privé Saint-Martin
Hôpital Privé d'Antony
Centre Hospitalier d'Haguenau
Polyclinique les Fleurs
Les Franciscaines
Clinique Saint-Martin
Centre cardiologique d'Evecquemont


type: Registry Identifier

title: Evaluation of the Oncoral® Test in Epidermoid Carcinomas of the Upper Aerodigestive Tract

summary:
This is a multicentric feasibility study aimed to evaluate the Oncoral® test. The study includes 2 steps. The first one aims to validate the algorithm defined at the time when the test was developed in patients with different tumour stages. Patients will be enrolled before any treatment. They will immediately undergo the test. No follow-up will be realized. In total, 100 patients will be included in this first step. The estimated period of inclusion is 6 months.

If the algorithm is validated, the second step of the study will start. The purpose is to determine the characteristics of the test. Enrollment will concern smokers and alcohol drinkers at high risk of developing an epidermoid carcinoma of the upper aerodigestive tract. Patient follow-up will vary with both the result of the test and the biopsy, up to a maximum of one year. In total, 385 patients will be enrolled in this step during an estimated period of 18 months.

ReferenceCitation: Castellsague X, Quintana MJ, Martinez MC, Nieto A, Sanchez MJ, Juan A, Monner A, Carrera M, Agudo A, Quer M, Munoz N, Herrero R, Franceschi S, Bosch FX. The role of type of tobacco and type of alcoholic beverage in oral carcinogenesis. Int J Cancer. 2004 Feb 20;108(5):741-9. doi: 10.1002/ijc.11627.

ReferenceCitation: Lingen MW, Kalmar JR, Karrison T, Speight PM. Critical evaluation of diagnostic aids for the detection of oral cancer. Oral Oncol. 2008 Jan;44(1):10-22. doi: 10.1016/j.oraloncology.2007.06.011. Epub 2007 Sep 6.

ReferenceCitation: Nagler R, Bahar G, Shpitzer T, Feinmesser R. Concomitant analysis of salivary tumor markers--a new diagnostic tool for oral cancer. Clin Cancer Res. 2006 Jul 1;12(13):3979-84. doi: 10.1158/1078-0432.CCR-05-2412.

ReferenceCitation: Tavassoli M, Brunel N, Maher R, Johnson NW, Soussi T. p53 antibodies in the saliva of patients with squamous cell carcinoma of the oral cavity. Int J Cancer. 1998 Oct 29;78(3):390-1. doi: 10.1002/(SICI)1097-0215(19981029)78:33.0.CO;2-9. No abstract available.

ReferenceCitation: Peng G, Hakim M, Broza YY, Billan S, Abdah-Bortnyak R, Kuten A, Tisch U, Haick H. Detection of lung, breast, colorectal, and prostate cancers from exhaled breath using a single array of nanosensors. Br J Cancer. 2010 Aug 10;103(4):542-51. doi: 10.1038/sj.bjc.6605810. Epub 2010 Jul 20.

ReferenceCitation: Mager DL, Haffajee AD, Devlin PM, Norris CM, Posner MR, Goodson JM. The salivary microbiota as a diagnostic indicator of oral cancer: a descriptive, non-randomized study of cancer-free and oral squamous cell carcinoma subjects. J Transl Med. 2005 Jul 7;3:27. doi: 10.1186/1479-5876-3-27.

ReferenceCitation: Li Y, St John MA, Zhou X, Kim Y, Sinha U, Jordan RC, Eisele D, Abemayor E, Elashoff D, Park NH, Wong DT. Salivary transcriptome diagnostics for oral cancer detection. Clin Cancer Res. 2004 Dec 15;10(24):8442-50. doi: 10.1158/1078-0432.CCR-04-1167.

ReferenceCitation: El-Naggar AK, Mao L, Staerkel G, Coombes MM, Tucker SL, Luna MA, Clayman GL, Lippman S, Goepfert H. Genetic heterogeneity in saliva from patients with oral squamous carcinomas: implications in molecular diagnosis and screening. J Mol Diagn. 2001 Nov;3(4):164-70. doi: 10.1016/S1525-1578(10)60668-X.

ReferenceCitation: Liao PH, Chang YC, Huang MF, Tai KW, Chou MY. Mutation of p53 gene codon 63 in saliva as a molecular marker for oral squamous cell carcinomas. Oral Oncol. 2000 May;36(3):272-6. doi: 10.1016/s1368-8375(00)00005-1.

ReferenceCitation: Anker P, Lyautey J, Lederrey C, Stroun M. Circulating nucleic acids in plasma or serum. Clin Chim Acta. 2001 Nov;313(1-2):143-6. doi: 10.1016/s0009-8981(01)00666-0.

ReferenceCitation: Li Y, Zhou X, St John MA, Wong DT. RNA profiling of cell-free saliva using microarray technology. J Dent Res. 2004 Mar;83(3):199-203. doi: 10.1177/154405910408300303.

ReferenceCitation: Rieger-Christ KM, Mourtzinos A, Lee PJ, Zagha RM, Cain J, Silverman M, Libertino JA, Summerhayes IC. Identification of fibroblast growth factor receptor 3 mutations in urine sediment DNA samples complements cytology in bladder tumor detection. Cancer. 2003 Aug 15;98(4):737-44. doi: 10.1002/cncr.11536. Erratum In: Cancer. 2003 Nov 1;98(9):2000.

ReferenceCitation: Phillips M, Gleeson K, Hughes JM, Greenberg J, Cataneo RN, Baker L, McVay WP. Volatile organic compounds in breath as markers of lung cancer: a cross-sectional study. Lancet. 1999 Jun 5;353(9168):1930-3. doi: 10.1016/S0140-6736(98)07552-7.

ReferenceCitation: Miekisch W, Schubert JK, Noeldge-Schomburg GF. Diagnostic potential of breath analysis--focus on volatile organic compounds. Clin Chim Acta. 2004 Sep;347(1-2):25-39. doi: 10.1016/j.cccn.2004.04.023.

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
Clinident Institute

location_facility: Groupement Hospitalier Pitié Salpêtrière

location_facility: CHU Bordeaux - Groupe Hospitalier Pellegrin


title: Efficacy and Safety of Xenon Anaesthesia Compared to Sevoflurane Anaesthesia and Total Intravenous Anaesthesia for On-pump Coronary Artery Bypass Graft Surgery: a Randomised, Three-arm, Single-blind, International Study

summary:
Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction.

This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients.

The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). The second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.

lead_sponsor: Air Liquide Santé International

sponsor_collaborators:
Air Liquide Santé International
Orion Corporation, Orion Pharma

location_country: Germany Italy Netherlands France

location_facility: Hôpital Cardiovasculaire et Pneumologique Louis Pradel

location_facility: Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes

location_facility: Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil

location_facility: Klinikum Links der Weser - Senator-Wessling-Str. 1

location_facility: Academic Medical Center - University of Amsterdam


title: A Phase IB/II Study of Escalating Doses of Romidepsin (Istodax®) in Association With CHOP (Ro-CHOP) in the Treatment of Peripheral T-Cell Lymphomas

acronym: Ro-CHOP

summary:
This study is an open label, multicenter study with two phases:

A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell lymphoma.
An expansion phase in order to assess the safety and the efficacy of the association of the recommended dose of Romidepsin associated with CHOP in a population of patients with T-cell lymphoma.

ReferenceCitation: Dupuis J, Morschhauser F, Ghesquieres H, Tilly H, Casasnovas O, Thieblemont C, Ribrag V, Bossard C, Le Bras F, Bachy E, Hivert B, Nicolas-Virelizier E, Jardin F, Bastie JN, Amorim S, Lazarovici J, Martin A, Coiffier B. Combination of romidepsin with cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated patients with peripheral T-cell lymphoma: a non-randomised, phase 1b/2 study. Lancet Haematol. 2015 Apr;2(4):e160-5. doi: 10.1016/S2352-3026(15)00023-X. Epub 2015 Mar 17.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
Centre Léon Bérard
Hôpital Henri Mondor
CHU de Dijon
Hôpital St Louis
Centre Henri Becquerel
Institut Gustave Roussy
Centre Hospitalier Lyon Sud
Hôpital Claude Huriez


lead_sponsor: GlaxoSmithKline

summary:
The purpose of the study is to evaluate the persistence of the immune response of GSK134612 vaccine up to 68 months after vaccination in the primary vaccination study (NCT number = NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary vaccination study with either GSK134612 vaccine or Menjugate®.

This protocol posting deals with objectives & outcome measures of the persistence and booster epochs. The objectives & outcome measures of the primary epoch are presented in a separate protocol posting (NCT number = NCT00674583)

title: Persistence of Antibodies After Vaccination With a Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Children and Safety and Immunogenicity of a Booster Dose at 68 Months Post-primary Vaccination

primary_purpose: Prevention

source: euctr

location_country: Germany France


title: Médulloblastome of the Child and After-effects Cognitive: Study Anatomo-functional by IRM of the Working Memory

acronym: MEDIR

summary:
The medulloblastome is a tumour of the child relatively frequent usually sitting in the cerebellum and treated by surgery, radiotherapy and chemotherapy. After the treatment, these children present cognitive disorders and in particular disorders of the working memory associated with a fall with the school performances. By studying a troop of 32 children, we could show that the disorders of the working memory prevail during the handling of information presented visually and with verbal contents. However, the specific engagement of the cerebellum in the tasks of working memory according to the sensory method of presentation (visual or auditive) and the nature (verbal or not verbal) of information to treat vague remainder. Moreover, the anatomical attacks associated with these disorders remain ignored in these children. The best comprehension of the bases anatomo-functional calculuses which underlie their cognitive deficits is essential to develop new strategies of treatment and rehabilitation.

Objectives:

To describe in IRMf of the common and specific networks engaged during the execution of the tasks of working memory according to the sensory type and the nature of information to be memorized.
To describe in IRMf the cortical reorganizations necessary to the execution of the mnemic tasks among patients.
To describe in anatomical IRM and of the tensor of diffusion lesions cérébelleuses and cerebral, cortical and subcortical associated with these disorders.
To study the correlations radio-private clinics between data IRM and the data neurological and neuropsychological of the children explored according to protocol ONCORAP

lead_sponsor: University Hospital, Grenoble

location_facility: Hôpital Frédéric Joliot Orsay - Hôpital Necker

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique


title: Randomized Controlled Trial Comparing the Metabolic Efficiency of Allogeneic Pancreatic Islet Transplantation to Intensive Insulin Therapy for the Treatment of Type 1 Diabetes

acronym: TRIMECO

summary: Efficacy of pancreatic islet transplantation at 6 months compared to an intensive insulin therapy for 2 categories of patients: patients with unstable diabetes and patients who underwent kidney transplantation.

ReferenceCitation: Alejandro R, Barton FB, Hering BJ, Wease S; Collaborative Islet Transplant Registry Investigators. 2008 Update from the Collaborative Islet Transplant Registry. Transplantation. 2008 Dec 27;86(12):1783-8. doi: 10.1097/TP.0b013e3181913f6a.

ReferenceCitation: Shapiro AM, Ricordi C, Hering BJ, Auchincloss H, Lindblad R, Robertson RP, Secchi A, Brendel MD, Berney T, Brennan DC, Cagliero E, Alejandro R, Ryan EA, DiMercurio B, Morel P, Polonsky KS, Reems JA, Bretzel RG, Bertuzzi F, Froud T, Kandaswamy R, Sutherland DE, Eisenbarth G, Segal M, Preiksaitis J, Korbutt GS, Barton FB, Viviano L, Seyfert-Margolis V, Bluestone J, Lakey JR. International trial of the Edmonton protocol for islet transplantation. N Engl J Med. 2006 Sep 28;355(13):1318-30. doi: 10.1056/NEJMoa061267.

ReferenceCitation: Badet L, Benhamou PY, Wojtusciszyn A, Baertschiger R, Milliat-Guittard L, Kessler L, Penfornis A, Thivolet C, Renard E, Bosco D, Morel P, Morelon E, Bayle F, Colin C, Berney T; GRAGIL Group. Expectations and strategies regarding islet transplantation: metabolic data from the GRAGIL 2 trial. Transplantation. 2007 Jul 15;84(1):89-96. doi: 10.1097/01.tp.0000268511.64428.d8.

ReferenceCitation: Vantyghem MC, Kerr-Conte J, Arnalsteen L, Sergent G, Defrance F, Gmyr V, Declerck N, Raverdy V, Vandewalle B, Pigny P, Noel C, Pattou F. Primary graft function, metabolic control, and graft survival after islet transplantation. Diabetes Care. 2009 Aug;32(8):1473-8. doi: 10.2337/dc08-1685.

ReferenceCitation: Ryan EA, Paty BW, Senior PA, Lakey JR, Bigam D, Shapiro AM. Beta-score: an assessment of beta-cell function after islet transplantation. Diabetes Care. 2005 Feb;28(2):343-7. doi: 10.2337/diacare.28.2.343.

ReferenceCitation: Bahougne T, Olagne J, Munch M, Braun-Parvez L, Chenard MP, Fremeaux-Bacchi V, Caillard S, Baltzinger P, Greget M, Kessler L, Moulin B. Atypical hemolytic and uremic syndrome due to C3 mutation in pancreatic islet transplantation: a case report. BMC Nephrol. 2020 Sep 19;21(1):405. doi: 10.1186/s12882-020-02062-7.

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

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

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

repositories:
HAL
PubMed Central
univOAK

repositories_concat: HAL;PubMed Central;univOAK

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

ReferenceCitation: Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.

ReferenceCitation: Lablanche S, Vantyghem MC, Kessler L, Wojtusciszyn A, Borot S, Thivolet C, Girerd S, Bosco D, Bosson JL, Colin C, Tetaz R, Logerot S, Kerr-Conte J, Renard E, Penfornis A, Morelon E, Buron F, Skaare K, Grguric G, Camillo-Brault C, Egelhofer H, Benomar K, Badet L, Berney T, Pattou F, Benhamou PY; TRIMECO trial investigators. Islet transplantation versus insulin therapy in patients with type 1 diabetes with severe hypoglycaemia or poorly controlled glycaemia after kidney transplantation (TRIMECO): a multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2018 Jul;6(7):527-537. doi: 10.1016/S2213-8587(18)30078-0. Epub 2018 May 15.

location_country: Switzerland France

location_facility: University Hospital, Department of General Surgery and Endocrinology

location_facility: Hopitaux Universitaires de Genève, Department of Visceral Surgery and Transplant

location_facility: University Hospital Besançon, Department of Endocrinology

location_facility: University Hospital, Department of Endocrinology

location_facility: University Hospital Gabriel Montpied, Department of Endocrinology


title: Chimiodiet Study:Impact of Early and Active Nutritional and Dietary Management on grade3 or More Toxicities Induced by Chemotherapy and Targeted Therapies Administered to Patients as First Intention for Non Surgical Metastatic Colorectal Cancer.

acronym: CHIMIODIET

summary:
Description of active nutritional support: Early and active nutritional support is mainly concerned with maintaining protein and energy intake levels despite chemotherapy. A part-time nutritionist will be assigned to each research centre. She will cover active nutritional support during a one-hour consultation and assist the investigating oncologist in filling out the e-CRF data. A two-day meeting prior to the beginning of the study will enable the standardization of active nutritional support strategy across all research centres:

The nutritionist will explain the consequences of the side effects of chemotherapy on appetite levels and nutritional status.
Spontaneous oral intake and eating habits will be assessed based on a qualitative and quantitative 3-day food record.
Then the nutritionist will explain to patients how to adapt their diet (fortification, portion control etc.) according to personal preferences and dietary habits, appetite fluctuation and side effects.
A booklet containing an overview of the nutritional counsel, recipe ideas, an example of a daily menu, energy equivalence tables and specific diet and hygiene tips for each possible side effects of chemotherapy will be given to all patients.
During each consultation, patients will be weighed, appetite and food intake will be evaluated (24-hour record except for prospective 3-day record of V0, V3, V6, V9, V12, V13 and V14 consultations), chemotherapy side effects will be recorded and nutritional counsel will be adapted to each patient's individual situation. In case of decrease in food intake and/or weight loss, a protein- and energy-rich oral supplement will be given.

In both groups, if a patient exhibits signs of malnutrition (weight loss >5% over a one-month period or > 10% in total) and/or food intake less than 50% of estimated daily requirements, an oral supplement will be given after approval of the oncologist. If this measure is insufficient, artificial nutrition (enteral or parenteral) will be considered.

ReferenceCitation: 1. Situation du cancer en France en 2007 - Synthèses rapports INCa - http://www.e-cancer.fr 2.Dewys et al.,Pronostic effect of weight loss prior to CT in cancer patient. Am J.Med 1980; 69 (4): 491-7; 3. Étude Nutricancer 2005, Hébuterne et al, Nutr Clin Metabol 2006.4.Gupta D, Lis CG, Granick J, Grutsch JF, Vashi PG, Lammersfeld CA. Malnutrition associated with poor quality of life in CR cancer:retrospective analysis.J Clin Epidemiol 2006 Jul;59(7):704-9. Epub 2006 Apr 19. 5. Andreyev et al., Why do patients with weight loss have a worse outcome when undergoing CT for gastrointestinal malignancies, Eur J Cancer 1998 Mar; 34(4): 503-9;6. Schneider et al, Malnutrition is an independant factor associated with nosocomial infections, Br J Nutr 2004 Jul; 92(1): 105-11. 7.Tucker HN, Miquel SG. : cost containment through nutrition intervention. Nutr Rev 1996 Apr; 54: 111-21.8. Colucci G, Gebbia V, Paoletti G, Giuliani F, Caruso M, Gebbia N et al . Gruppo Oncologico Dell'Italia Meridionale. Phase III randomized trial of FOLFIRI VS FOLFOX4 in the treatment of advanced CCR: a multicenter study of the Gruppo Oncologico Dell'Italia Meridionale. J Clin Oncol. 2005 Aug 1;23(22):4866-75. Epub 2005 Jun 6.9. Douillard JY, Sobrero A, Carnaghi C, Comella P, Díaz-Rubio E, Santoro A et al. Metastatic CR cancer: integrating irinotecan into combination and sequential CT. Ann Oncol. 2003;14 Suppl 2:ii7-12. Review.10. Hurwitz HI, Fehrenbacher L, Hainsworth JD, Heim W, Berlin J, Holmgren E et al. Bevacizumab in combination with fluorouracil and leucovorin: an active regimen for first-line metastatic colorectal cancer.J Clin Oncol. 2005 May 20;23(15):3502-8.11. Saltz LB, Meropol NJ, Loehrer PJ Sr, Needle MN, Kopit J, Mayer RJ. Phase II trial of cetuximab in patients with refractory CR cancer that expresses the epidermal growth factor receptor. J Clin Oncol. 2004 Apr 1;22(7):1201-8. Epub 2004 Mar 1

lead_sponsor: Centre Hospitalier Universitaire de Nice

collaborators: Assistance Publique Hopitaux De Marseille

location_facility: The digestive oncology departement of the Archet Hospital of the Nice University Hospital Centre

location_facility: Assistance Publique des hopitaux de Marseille


title: Effects of an Early Wheelchair Reconditionong Program on Functional Independence in Spinal Cord-inured Individuals

summary: Reconditioning program during the chronic phase of the spinal cord-injury is well known for its beneficial effects, but there is no investigation in early rehabilitation consequences. Nevertheless, it may be justified : to increase oxygen uptake; to decrease the risks of medical complications; or to improve the mobility. The restrictive autonomy is due to different factors: firstly wheelchair users reduce their movement because they need technical or human help to achieve transfers; and secondly, locomotion is performed by the upper limbs. Without specific practice, the upper limbs mechanical and physiological properties do not permit exercises that are long and intense. Then, the purpose of this research is to evaluate the effects of an 8 weeks interval training program on wheelchair independance during inpatient early rehabilitation for spinal cord injury (3 to 6 months post injury) compared to a control group (classical rehabilitation program in a physical medicine and rehabilitation department).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

location_facility: Centre de Réadaptation fonctionnelle - UGECAM

location_facility: Service MPR des Kermes - Hôpital René Sabran

location_facility: Centre de Rééducation de la Tour de Gassie

location_facility: Groupe Hospitalier Raymond Poincaré - APHP


title: Multicenter Prospective Study for a Rational Management of Appendicitis in Children

acronym: ALGAP

summary: Despite the fact that appendicitis is one of the most frequent surgical pathology in children, its clinical management is still debated. Previous reports have shown rate of appendectomy in children without appendicitis up to 30 %. Morbidity, due to infectious complications or intestinal obstruction, is often between 5 and 10 % of published cases, and increase medical and social costs. Evidence-based medicine concept could therefore be worthwhile in that context, in order to promote rational diagnosis and treatment of that frequent medical condition.An algorithm describing management of children with suspicion of appendicitis was established, based on recent published data, in order to reduce delay between first clinical signs and confirmation of the diagnosis, and to define therapeutic indication such as conservative management and interval appendectomy or patient requiring laparoscopic approach. The main objective of the study is to decrease morbidity and unnecessary appendectomy rates, and secondly to decrease costs, by the use of that algorithm.

lead_sponsor: Nantes University Hospital

location_facility:
GARIGNON Cynthia
PODEVIN Guillaume
DE VRIES Philine
WEIL Dominique
AZZIS Olivier
LARDY Hubert
MCHEIK Jiad
PETIT Thierry

intervention_type: Procedure


title: Population Pharmacokinetics of Fondaparinux Administered at Prophylactic Doses After Major Orthopedic Surgery in Everyday Practice

acronym: POP-A-RIX

summary: Fondaparinux is a synthetic antithrombotic agent with specific anti-factor Xa activity. A population pharmacokinetic model of fondaparinux, based on data obtained in patients included in phase II/III trials, has been described. However, the validity of this model in everyday practice needed to be confirmed. This study was a multicenter, prospective cohort study in consecutive orthopedic patients treated with 2.5 mg of fondaparinux. Anti-Xa activities were recorded in 809 patients. Population parameters and inter-individual variability were estimated using NONMEM VI software. A two-compartment model with first-order absorption best described fondaparinux pharmacokinetics. Covariates partly explaining inter-individual variability were body weight, age and creatinine clearance estimated by the simplified Modification of Diet in Renal Disease formula. A body weight less than 50 kg and moderate renal failure increased drug exposure. These results suggest that fondaparinux pharmacokinetics need to be confirmed in patient populations not fully assessed in phase II/III studies

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
ROSENCHER Nadia
PETIT Pierre-Yves
CHARRET Françoise
PEGOIX Michel
MAITRE Anne-Marie
BAYLOT Denis
ZUFFEREY Paul
BARRE Jeanne


title: An Open-label, Dose Escalating Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion

summary: The purpose of the study is to evaluate the safety and tolerability of a single administration of FOV2302 (ecallantide) in patients with macular edema associated with central retinal vein occlusion.

lead_sponsor: Fovea Pharmaceuticals SA

location_facility: Centre Hospitalier National d'Ophthalmologies des XV-XX


lead_sponsor: Pfizer

summary: The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, in subjects with mild to moderate Alzheimer's disease.

sponsor_collaborators: JANSSEN Alzheimer Immunotherapy Research & Development, LLC

location_facility: Universitatsklinikum und Poliklinik der Uni Bonn

location_facility: Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin

location_facility: Zentralinstitut fuer Seelische Gesundheit Mannheim

location_facility: Klinikum der Albert-Ludwigs-Universitaet Freiburg

location_facility: Groupe Hospitalier Broca-La Rochefoucauld

title: A PHASE IIA, MULTICENTER, RANDOMIZED, THIRD-PARTY UNBLINDED, LONG -TERM EXTENSION STUDY TO DETERMINE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF ACC-001 WITH QS-21 ADJUVANT IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.


title: A Double Blind, Placebo Controlled Study of the Effect of 330 mg QD of TRO19622 in the Treatment of Chemotherapy Induced Peripheral Neuropathy

acronym: CIPN

summary: The purpose of this study is to test the effect of TRO19622 on peripheral neuropathy scores after 6 weeks treatment and is based on the separate assessment of pain and dysesthesia scores.

lead_sponsor: Hoffmann-La Roche

location_facility: Centre Oscar Lambret Département de Sénologie

location_facility: Hôpital Privé de l'Ouest Parisien Service d'Oncologie

location_facility: Centre Hospitalier de Versailles Hôpital André Mignot Service d'Hématologie-Oncologie

location_facility: Centre Léon Bérard Département de Soins de Support

location_facility: C.R.L.C Val d'Aurelle Service d'Oncologie Médicale

location_facility: Hôpital Nord CHU Saint Etienne Centre de la douleur


lead_sponsor: Ipsen

summary: The aim of the study is to evaluate the effect of EGb761®, in comparison to placebo, on cerebral glucose metabolism, in three groups of elderly patients: newly diagnosed mild Alzheimer's disease (AD), memory complaint patients with cognitive impairment (MC) and memory complaint patients cognitively normal (CNE). The first phase includes four weeks treatment with EGb761® for all groups, with change in brain glucose metabolism at month 1 using 18 FDG-PET, as primary endpoint which will be followed by an open 17 months follow-up (FU) period with EGb761® treatment in MC and CNE patients.

location_facility: Centre Hospitalier d'Orsay 4 place du Général Leclerc

location_facility: Hôpital Corentin Celton 4 parvis Corentin Celton

location_facility: Hôpital Paul Brousse 12 av Paul-Vaillant-Couturier

title: Effect of Oral EGb761® on Brain Glucose Metabolism in Three Groups of Elderly With Memory Complaint, Mild Alzheimer's Disease, and Cognitively Normal Elderly. Phase II, Randomised, Double-blind, Parallel Groups, Placebo-controlled Study


title: A Prospective, Comparative, Multicenter, Randomized Study to Compare the Safety and Efficacy of Sirolimus (Rapamune) to Tacrolimus (Advagraf) Associated to Mycophenolate Mofetil (CellCept) Between 12 and 36 Months After Kidney Transplantation

acronym: EPARGNE

summary: The use of tacrolimus in the long term as part of the immunosuppressive regimen after transplantation is associated to complications such as chronic nephrotoxicity, impaired glucose metabolism (diabetes mellitus) and an increase of the incidence of neoplasia. The conversion from a tacrolimus based therapy to a sirolimus based therapy associated with mycophenolate mofetil could improve the incidence of such complications. The aim of this study is to assess the risk/benefit ratio of this switch performed in stable renal transplant recipient between 12 months and 36 months after transplantation. The incidence of a composite endpoint (worsening of GFR evaluated by MDRD formula, incidence of cancer and diabetes) will be assessed 24 months after conversion.

lead_sponsor: University Hospital, Rouen

location_facility: UHNecker UHAngers UHRouen UHAmiens UHCaen UHTours UHRennes UHLimoges


title: Post-Authorization Safety Study to Evaluate the Long-Term Safety and Tolerability of Vimpat® (Lacosamide) as Add-On Therapy in Epilepsy Patients With Partial-Onset Seizures Who Are Uncontrolled on Current Therapy

acronym: PASS

summary: SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in patients with Epilepsy 16 years and older with partial-onset seizures who are uncontrolled on current therapy. Using reported adverse events, the incidence of certain cardiovascular and psychiatric events will be evaluated.

lead_sponsor: UCB Pharma

location_country:
Germany
United Kingdom
Netherlands
Spain
France


title: Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study

summary:
Venous thromboembolism (VTE) remains a major cause of maternal morbidity and mortality in developed countries. Objective diagnosis of pulmonary embolism (PE) and/or deep vein thrombosis (DVT) in pregnancy is crucial. Failure to identify PE or/or DVT will place the mother's life at risk, and unnecessary treatment will not only expose her to anticoagulants but will also label her as having had VTE. Thus, this diagnosis has serious implications for the management of her present pregnancy, and for other aspects of her life ranging from contraception to thromboprophylaxis in future pregnancies and hormone replacement therapy in later life. It is therefore critical that all women with symptoms or signs that suggest venous thromboembolism have appropriate investigation and diagnosis based on objective diagnostic tests.

The current diagnostic approach in suspected PE is based on sequential diagnostic tests: 1) assessment of clinical probability, 2) fibrin D-dimer measurement, 3) compression ultrasonography of lower limb veins and 4) multi-slice computed tomography (MSCT). However, physicians are reluctant to perform MSCT in pregnant women because of potential adverse effect of radiation exposure to the fetus. For this reason, ventilation/perfusion or perfusion-only lung scan has been the cornerstone of PE diagnosis in pregnant women. Indeed, perfusion lung scan was assumed to be associated with less radiation than computed tomography (CT). However, this technique is now widely abandoned in the usual diagnostic strategy of PE for the following reasons: it is not widely available; its interpretation may be difficult and the test may be inconclusive in the presence of other chest abnormalities. Moreover, recent data convincingly show that the radiation exposure associated with single-slice or multi-slice CT exposes the fetus to less radiation than perfusion lung scan.

However, the use of CT has never been adequately validated in pregnant women with clinically suspected PE. The investigators, therefore, plan to set up a prospective management study in which pregnant women with suspected PE will undergo a sequential diagnostic strategy based on 1) assessment of clinical probability 2) D-dimer measurement 3) compression ultrasonography, and 4) MSCT.

Nowadays, the overestimated fear of radiation exposure for the fetus leads to an irrational attitude and inadequate investigations in pregnant women with suspected PE, even though both European [3, 4] and North-American guidelines [5] suggest that only objective testing may accurately rule out the disease. The proposed study should lead to an increased awareness of the risks and benefits of appropriate imaging in pregnant women suspected of PE and should result in a more rational management of this under-studied patient group.

lead_sponsor: University Hospital, Geneva

sponsor_collaborators:
University Hospital, Geneva
Swiss National Science Foundation
University Hospital, Brest

location_facility:
Caroline BOHEC
Antoine ELIAS
Florence PARENT
Pierre-Marie ROY
Isabelle QUERE
Grégoire LE GAL
Guy MEYER
Marc Righini
Jean-Christophe GRIS


title: Reformulated BeneFIX Efficacy and Safety After Conversion From a pdFIX

summary: The purpose of this study is to collect data around the period of the conversion from plasma-derived Factor IX (pdFIX) to BeneFIX. The main information collected will be: a retrospective history of the bleedings in the 3-month period before the conversion, the recovery with pdFIX just before the conversion and with BeneFIX just after the conversion, and a prospective history of the bleedings in the 3 month period following the conversion.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_facility:
Dr. Borg
Dr. Lambert
Pr Chambost
Dr. Rothschild
Pr Schved
Dr. Duillet
Dr. Hassoun
Pr Gruel


title: A Phase II Trial Evaluating the Safety and the Efficacy of Trastuzumab in Relapsed/Refractory HER2 Positive B-acute Lymphoblastic Leukemia Patients.

summary: This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till progression. Response and HER2 expression are assessed each month by bone marrow aspirate.

ReferenceCitation: Chevallier P, Robillard N, Charbonnier A, Raffoux E, Maury S, Carras S, Chabrot C, Fohrer C, Bernard M, Blade JS, Etienne A, Talmant P, Delaunay J, Guillaume T, Mohty M, Bene MC, Ifrah N, Dombret H. Trastuzumab for treatment of refractory/relapsed HER2-positive adult B-ALL: results of a phase 2 GRAALL study. Blood. 2012 Mar 15;119(11):2474-7. doi: 10.1182/blood-2011-11-390781. Epub 2012 Jan 20.

location_facility:
Clermont-Ferrand University Hospital
St Louis Hospital
Mondor Hospital
CHU
Rennes University Hospital
Strasbourg University Hospital
Grenoble Hospital
Institut Paoli Calmettes


title: Improving the Management of Non-ST Elevation Acute Coronary Syndrome: Systematic Evaluation of a Quality Improvement Programme

acronym: EQUIP-ACS

summary: The main hypothesis to be tested is that the use of a quality improvement programme will lead to measurable improvements in the management of care and use of evidence based treatments for patients presenting to hospital with non-ST elevation acute coronary syndromes.

primary_purpose: Health Services Research

ReferenceCitation: Flather MD, Babalis D, Booth J, Bardaji A, Machecourt J, Opolski G, Ottani F, Bueno H, Banya W, Brady AR, Bojestig M, Lindahl B. Cluster-randomized trial to evaluate the effects of a quality improvement program on management of non-ST-elevation acute coronary syndromes: The European Quality Improvement Programme for Acute Coronary Syndromes (EQUIP-ACS). Am Heart J. 2011 Oct;162(4):700-707.e1. doi: 10.1016/j.ahj.2011.07.027.

ReferenceCitation: Flather MD, Booth J, Babalis D, Bueno H, Steg PG, Opolski G, Ottani F, Machecourt J, Bardaji A, Bojestig M, Brady AR, Lindahl B. Improving the management of non-ST elevation acute coronary syndromes: systematic evaluation of a quality improvement programme European QUality Improvement Programme for Acute Coronary Syndrome: the EQUIP-ACS project protocol and design. Trials. 2010 Jan 14;11:5. doi: 10.1186/1745-6215-11-5.

lead_sponsor: Royal Brompton & Harefield NHS Foundation Trust

collaborators:
Uppsala University
GlaxoSmithKline

location_country:
Italy
Poland
United Kingdom
Spain
France

location_facility: Centre Hospitalier de la region d'Annecy

location_facility: Cardiology dept. B, CHU Hopital G. Montpied

location_facility: Ospedale Generale Provinciale di Macerata

intervention_type: Behavioral


acronym: RADHER

lead_sponsor: UNICANCER

summary:
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving everolimus together with trastuzumab is more effective than giving trastuzumab alone in treating women with breast cancer.

PURPOSE: This randomized phase II trial is studying trastuzumab and everolimus to see how well they work compared to trastuzumab alone before surgery in treating patients with breast cancer that can be removed by surgery.

ReferenceCitation: Campone M, Bachelot T, Treilleux I, Pistilli B, Salleron J, Seegers V, Arnedos M, Loussouarn D, Wang Q, Vanlemmens L, Jimenez M, Rios M, Dieras V, Leroux A, Paintaud G, Rezai K, Andre F, Lion M, Merlin JL. A phase II randomised study of preoperative trastuzumab alone or combined with everolimus in patients with early HER2-positive breast cancer and predictive biomarkers (RADHER trial). Eur J Cancer. 2021 Oct 19;158:169-180. doi: 10.1016/j.ejca.2021.09.017. Online ahead of print.

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

title: A Phase II, Randomized, Multi-center Study, Assessing Value of Adding Everolimus (RAD001) to Trastuzumab as Preoperative Therapy of HER-2 Positive Primary Breast Cancer Amenable to Surgery.


lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

summary:
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells.

PURPOSE: This phase II clinical trial is studying how well cetuximab given together with combination chemotherapy works in treating patients with stage III or stage IV oropharynx cancer that can be removed by surgery.

location_facility:
Hopital Europeen Georges Pompidou
Centre René Huguenin
Hopital Bichat - Claude Bernard
Hopital Tenon
centre Hospitalier Lyon Sud
Hôpital Simone Veil
Hôpital Privé St Joseph
Hopital Foch

title: Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF) in Patient With Resectable Stage III-IV Squamous Cell Carcinoma of the Oropharynx


title: Evaluation of the Benefit of Antithymocyte Induction Therapy on Hepatic Fibrosis in de Novo Hepatitis C Virus Liver Transplant Patients.

acronym: BEFIRTH

summary: An open-label randomized multicenter clinical study comparing three regimes of immunosuppression : (A) tacrolimus and steroids, (B) antithymocyte induction therapy and full dose of tacrolimus, (C) antithymocyte induction therapy with mycophenolate mofetil and a reduced dose of tacrolimus.

lead_sponsor: University Hospital, Toulouse

location_facility:
Hôpital Cochin
La CONCEPTION hospital
Hôpital Pontchaillou
Hopital Paul Brousse
Hopital de L'Archet
University Hospital
Hopital Pellegrin Tripode
Hopital Saint-Eloi


title: To Assess Whether Type 1 Diabetic Patients Treated With M D I and in Poor Metabolic Control Can Improve Using the Paradigm® Real Time System Compared to Self-Monitoring Blood Glucose and Continuous Subcutaneous Insulin Infusion

acronym: RTD

summary: In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6 months.

ReferenceCitation: Raccah D, Sulmont V, Reznik Y, Guerci B, Renard E, Hanaire H, Jeandidier N, Nicolino M. Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study. Diabetes Care. 2009 Dec;32(12):2245-50. doi: 10.2337/dc09-0750. Epub 2009 Sep 18.

lead_sponsor: Medtronic Diabetes

location_facility:
Hôpital Universitaire Debrousse
American Memorial Hospital
Hôpital Sainte Marguerite
Hôpitaux Universitaires de Strasbourg
CHU Côte de Nacre
Hôpital Jeanne D'Arc
CH La Peyronie
CHU Rangueil


title: A Prospective Multicentric Randomized Study of Glivec® in Patients With Advanced Gastrointestinal Stromal Tumors Expressing C-kit Comparing Treatment Interruption After 5 Years vs Treatment Maintenance

summary: Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. Virtually all malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec® inhibits KIT and exerts a major antitumor efficacy in vivo in patients with advanced GIST. Glivec® is generally pursued until progression or intolerance. The optimal duration of treatment with Glivec® remains unknown. The objective of this study is to determine the feasibility of Glivec® treatment interruption with reintroduction at progression in GIST patients.

ReferenceCitation: Le Cesne A, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Cioffi A, Emile JF, Chabaud S, Perol D, Blay JY; French Sarcoma Group. Discontinuation of imatinib in patients with advanced gastrointestinal stromal tumours after 3 years of treatment: an open-label multicentre randomised phase 3 trial. Lancet Oncol. 2010 Oct;11(10):942-9. doi: 10.1016/S1470-2045(10)70222-9. Epub 2010 Sep 21.

ReferenceCitation: Blay JY, Le Cesne A, Ray-Coquard I, Bui B, Duffaud F, Delbaldo C, Adenis A, Viens P, Rios M, Bompas E, Cupissol D, Guillemet C, Kerbrat P, Fayette J, Chabaud S, Berthaud P, Perol D. Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group. J Clin Oncol. 2007 Mar 20;25(9):1107-13. doi: 10.1200/JCO.2006.09.0183.

ReferenceCitation: Patrikidou A, Chabaud S, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Domont J, Perol D, Blay JY, Le Cesne A; French Sarcoma Group. Influence of imatinib interruption and rechallenge on the residual disease in patients with advanced GIST: results of the BFR14 prospective French Sarcoma Group randomised, phase III trial. Ann Oncol. 2013 Apr;24(4):1087-93. doi: 10.1093/annonc/mds587. Epub 2012 Nov 21.

ReferenceCitation: Blesius A, Cassier PA, Bertucci F, Fayette J, Ray-Coquard I, Bui B, Adenis A, Rios M, Cupissol D, Perol D, Blay JY, Le Cesne A. Neoadjuvant imatinib in patients with locally advanced non metastatic GIST in the prospective BFR14 trial. BMC Cancer. 2011 Feb 15;11:72. doi: 10.1186/1471-2407-11-72.

ReferenceCitation: Blay JY, Perol D, Le Cesne A. Imatinib rechallenge in patients with advanced gastrointestinal stromal tumors. Ann Oncol. 2012 Jul;23(7):1659-65. doi: 10.1093/annonc/mdr622. Epub 2012 Feb 21.

ReferenceCitation: Patrikidou A, Domont J, Chabaud S, Ray-Coquard I, Coindre JM, Bui-Nguyen B, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Perol D, Emile JF, Blay JY, Le Cesne A; French Sarcoma Group. Long-term outcome of molecular subgroups of GIST patients treated with standard-dose imatinib in the BFR14 trial of the French Sarcoma Group. Eur J Cancer. 2016 Jan;52:173-80. doi: 10.1016/j.ejca.2015.10.069. Epub 2015 Dec 11.

lead_sponsor: Centre Leon Berard

collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Institut Bergonié
Hopitaux de La Timone
Institut Paoli Calmette
Centre Leon Berard
Institut Gustave Roussy
Centre Oscar Lambret
Hopital Edouard Herriot
Centre Alexis Vautrin


title: The Effect of Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) on Quality of Life in Comparison to Best Medical Treatment in Patients With Complicated Parkinson's Disease and Preserved Psychosocial Competence (EARLYSTIM-study)

acronym: EARLYSTIM

summary:
Earlystim Study: Patients are randomized either to medical treatment or subthalamic stimulation. The observation period was 2 years. The primary outcome criterium: PDQ-39.

Post study Follow up studies: After the 24 months observation period also BMT patients could be operated and all patients will be observed for 10 years or longer to elucidate whether earlier stimulation has advantages (or drawbacks) compared to later stimulation.

ReferenceCitation: Schuepbach WM, Rau J, Knudsen K, Volkmann J, Krack P, Timmermann L, Halbig TD, Hesekamp H, Navarro SM, Meier N, Falk D, Mehdorn M, Paschen S, Maarouf M, Barbe MT, Fink GR, Kupsch A, Gruber D, Schneider GH, Seigneuret E, Kistner A, Chaynes P, Ory-Magne F, Brefel Courbon C, Vesper J, Schnitzler A, Wojtecki L, Houeto JL, Bataille B, Maltete D, Damier P, Raoul S, Sixel-Doering F, Hellwig D, Gharabaghi A, Kruger R, Pinsker MO, Amtage F, Regis JM, Witjas T, Thobois S, Mertens P, Kloss M, Hartmann A, Oertel WH, Post B, Speelman H, Agid Y, Schade-Brittinger C, Deuschl G; EARLYSTIM Study Group. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. 2013 Feb 14;368(7):610-22. doi: 10.1056/NEJMoa1205158.

evidence: open (via free article)

repository_institution: University of Bern - Bern Open Repository and Information System

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Deuschl G, Schade-Brittinger C, Agid Y; EARLYSTIM Study Group. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. 2013 May 23;368(21):2038. doi: 10.1056/NEJMc1303485. No abstract available.

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

ReferenceCitation: Dams J, Balzer-Geldsetzer M, Siebert U, Deuschl G, Schuepbach WM, Krack P, Timmermann L, Schnitzler A, Reese JP, Dodel R; EARLYSTIM-investigators. Cost-effectiveness of neurostimulation in Parkinson's disease with early motor complications. Mov Disord. 2016 Aug;31(8):1183-91. doi: 10.1002/mds.26740.

ReferenceCitation: Lhommee E, Wojtecki L, Czernecki V, Witt K, Maier F, Tonder L, Timmermann L, Halbig TD, Pineau F, Durif F, Witjas T, Pinsker M, Mehdorn M, Sixel-Doring F, Kupsch A, Kruger R, Elben S, Chabardes S, Thobois S, Brefel-Courbon C, Ory-Magne F, Regis JM, Maltete D, Sauvaget A, Rau J, Schnitzler A, Schupbach M, Schade-Brittinger C, Deuschl G, Houeto JL, Krack P; EARLYSTIM study group. Behavioural outcomes of subthalamic stimulation and medical therapy versus medical therapy alone for Parkinson's disease with early motor complications (EARLYSTIM trial): secondary analysis of an open-label randomised trial. Lancet Neurol. 2018 Mar;17(3):223-231. doi: 10.1016/S1474-4422(18)30035-8.

ReferenceCitation: Schupbach WM, Rau J, Houeto JL, Krack P, Schnitzler A, Schade-Brittinger C, Timmermann L, Deuschl G. Myths and facts about the EARLYSTIM study. Mov Disord. 2014 Dec;29(14):1742-50. doi: 10.1002/mds.26080. Epub 2014 Nov 14.

ReferenceCitation: Deuschl G, Schupbach M, Knudsen K, Pinsker MO, Cornu P, Rau J, Agid Y, Schade-Brittinger C. Stimulation of the subthalamic nucleus at an earlier disease stage of Parkinson's disease: concept and standards of the EARLYSTIM-study. Parkinsonism Relat Disord. 2013 Jan;19(1):56-61. doi: 10.1016/j.parkreldis.2012.07.004. Epub 2012 Jul 28.

evidence: open (via free pdf)

ReferenceCitation: Schuepbach WMM, Tonder L, Schnitzler A, Krack P, Rau J, Hartmann A, Halbig TD, Pineau F, Falk A, Paschen L, Paschen S, Volkmann J, Dafsari HS, Barbe MT, Fink GR, Kuhn A, Kupsch A, Schneider GH, Seigneuret E, Fraix V, Kistner A, Chaynes PP, Ory-Magne F, Brefel-Courbon C, Vesper J, Wojtecki L, Derrey S, Maltete D, Damier P, Derkinderen P, Sixel-Doring F, Trenkwalder C, Gharabaghi A, Wachter T, Weiss D, Pinsker MO, Regis JM, Witjas T, Thobois S, Mertens P, Knudsen K, Schade-Brittinger C, Houeto JL, Agid Y, Vidailhet M, Timmermann L, Deuschl G; EARLYSTIM study group. Quality of life predicts outcome of deep brain stimulation in early Parkinson disease. Neurology. 2019 Mar 5;92(10):e1109-e1120. doi: 10.1212/WNL.0000000000007037. Epub 2019 Feb 8. Erratum In: Neurology. 2019 Jun 11;92(24):1166.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: Forschungszentrum Jülich - JuSER

publisher_dissemination: Wolters Kluwer Health

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

lead_sponsor: German Parkinson Study Group (GPS)

sponsor_collaborators:
German Parkinson Study Group (GPS)
University Hospital Schleswig-Holstein
Assistance Publique - Hôpitaux de Paris
KKS Netzwerk

location_facility: Service de Neurologie C, Hôpital Neurologique et neurochirurgical Pierre Wertheimer , 59 Bd Pinel 69677 BRON Cedex

location_facility: Michallon Hospital, CHU Grenoble, Service de Neurologie, BP217

location_facility: Neurologische Klinik der Universität, Moorenstr. 5

location_facility: Neurologische Universitätsklinik Freiburg, Breisacher Str. 64

location_facility: Klinik und Poliklinik für Neurologie, Charite

location_facility: Hôpital La Milétrie, Tour Jean Bernard, 350 Av Jacques Cœur, BP 577

location_facility: Klinikum der Universität München Neurologische Klinik und Poliklinik - Großhadern, Marchioninistr. 15

location_facility: "Hôpital Nord Laënnec Boulevard Jacques-Monod - Saint-Herblain

location_facility: Centre d'investigation Clinique, Pavillon Riser, Hôpital Purpan,Place du Dr Baylac TSA 40031

location_facility: Paracelsus-Elena-Klinik, Kassel, Klinikstrasse 16

location_facility: CIC, CHU Pitié-Salpêtrière, 47-83 Bd de l'Hôpital

location_facility: Centre Hospitalo-Universitaire de Rouen, Charles Nicolle, bat. DV, 1 rue de Germont

location_facility: Universitätsklinikum Tübingen, Klinik für Neurochirurgie, Hoppe-Seyler-Str.3

location_facility: Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Schittenhelmstr. 10

location_facility: Centre hospitalier La Timone, Service de neurologie et pathologie du mouvement,Boulevard Jean Moulin


title: Phase 3 Study of Corticotherapy (Hydrocortisone Alone Versus Hydrocortisone Plus Fludrocortisone) Versus Corticotherapy Plus Intensive Insulin Therapy for Septic Shock

acronym: COIITSS

summary: This study will compare, in adults with septic shock, the safety and efficacy of a combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticosteroids. In addition, this study will compare the efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone

ReferenceCitation: COIITSS Study Investigators; Annane D, Cariou A, Maxime V, Azoulay E, D'honneur G, Timsit JF, Cohen Y, Wolf M, Fartoukh M, Adrie C, Santre C, Bollaert PE, Mathonet A, Amathieu R, Tabah A, Clec'h C, Mayaux J, Lejeune J, Chevret S. Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomized controlled trial. JAMA. 2010 Jan 27;303(4):341-8. doi: 10.1001/jama.2010.2. Erratum In: JAMA. 2010 May 5;303(17):1698.

lead_sponsor: University of Versailles

sponsor_collaborators:
University of Versailles
Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Avicenne
CHU Grenoble
Hôpital Jean Verdier
Hôpital Saint Louis
hôpital Cochin
Hôpital Bichat Claude Bernard
Hôpital Delafontaine
Hôpital central


title: Adjuvant Treatment of Fully Resected Stage III Colon Cancer With FOLFOX-4 Versus FOLFOX-4 Plus Cetuximab

summary:
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, or fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without cetuximab after surgery may kill any remaining tumor cells and keep colon cancer from coming back. It is not yet known whether giving combination chemotherapy together with cetuximab is more effective than giving combination chemotherapy alone in treating colon cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone in treating patients with stage III colon cancer that was completely removed by surgery.

ReferenceCitation: Taieb J, Puig PL, Bedenne L. Cetuximab plus FOLFOX-4 for fully resected stage III colon carcinoma: scientific background and the ongoing PETACC-8 trial. Expert Rev Anticancer Ther. 2008 Feb;8(2):183-9. doi: 10.1586/14737140.8.2.183.

ReferenceCitation: Taieb J, Tabernero J, Mini E, Subtil F, Folprecht G, Van Laethem JL, Thaler J, Bridgewater J, Petersen LN, Blons H, Collette L, Van Cutsem E, Rougier P, Salazar R, Bedenne L, Emile JF, Laurent-Puig P, Lepage C; PETACC-8 Study Investigators. Oxaliplatin, fluorouracil, and leucovorin with or without cetuximab in patients with resected stage III colon cancer (PETACC-8): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Jul;15(8):862-73. doi: 10.1016/S1470-2045(14)70227-X. Epub 2014 Jun 11.

repository_institution: University of Turin - Institutional Research Information System University of Turin

version: submittedVersion

ReferenceCitation: Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Cohen R, Taieb J, Fiskum J, Yothers G, Goldberg R, Yoshino T, Alberts S, Allegra C, de Gramont A, Seitz JF, O'Connell M, Haller D, Wolmark N, Erlichman C, Zaniboni A, Lonardi S, Kerr R, Grothey A, Sinicrope FA, Andre T, Shi Q. Microsatellite Instability in Patients With Stage III Colon Cancer Receiving Fluoropyrimidine With or Without Oxaliplatin: An ACCENT Pooled Analysis of 12 Adjuvant Trials. J Clin Oncol. 2021 Feb 20;39(6):642-651. doi: 10.1200/JCO.20.01600. Epub 2020 Dec 23.

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

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

ReferenceCitation: Salem ME, Yin J, Goldberg RM, Pederson LD, Wolmark N, Alberts SR, Taieb J, Marshall JL, Lonardi S, Yoshino T, Kerr RS, Yothers G, Grothey A, Andre T, De Gramont A, Shi Q. Evaluation of the change of outcomes over a 10-year period in patients with stage III colon cancer: pooled analysis of 6501 patients treated with fluorouracil, leucovorin, and oxaliplatin in the ACCENT database. Ann Oncol. 2020 Apr;31(4):480-486. doi: 10.1016/j.annonc.2019.12.007. Epub 2020 Jan 16.

ReferenceCitation: Taieb J, Shi Q, Pederson L, Alberts S, Wolmark N, Van Cutsem E, de Gramont A, Kerr R, Grothey A, Lonardi S, Yoshino T, Yothers G, Sinicrope FA, Zaanan A, Andre T. Prognosis of microsatellite instability and/or mismatch repair deficiency stage III colon cancer patients after disease recurrence following adjuvant treatment: results of an ACCENT pooled analysis of seven studies. Ann Oncol. 2019 Sep 1;30(9):1466-1471. doi: 10.1093/annonc/mdz208.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Hopital Duffaut
Hopital Robert Boulin
CHU de Caen
CHU Pitie-Salpetriere
Hopital Bichat - Claude Bernard
Centre Hospitalier Yves Le Foll
Hopital Tenon
Nouvelle Clinique Generale


title: Open-label, Uncontrolled, Prospective Long-term Observation of Ventavis Inhalation Therapy in the Treatment of Patients With Primary Pulmonary Hypertension up to 4 Years

summary: This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from around 30 study sites in Europe will be included in the study. This observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. Ventavis is used to treat moderate cases of primary pulmonary hypertension.

lead_sponsor: Bayer

location_country:
Germany
Italy
Portugal
United Kingdom
Spain
France


title: A Multicentre Study on the Capacity of the IGF-1 Stimulation Test to Predict the Growth Promoting Effect of Standard and High Doses of Genotonorm® in Prepubertal Children With Growth Hormone Deficiency.

acronym: CAREL

summary: To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH deficiency.

lead_sponsor: Pfizer


title: Development of Targeted RNA-Seq for Amyotrophic Lateral Sclerosis Diagnosis

acronym: ROSA

summary:
Genetic diagnosis of Amyotrophic Lateral Sclerosis (ALS) could identify the origin of the disease, potentially allowing the patient to pursue targeted/gene therapy. However, many familial forms of ALS are genetically undiagnosed, either because no variant has been detected in the genes of interest, or because the detected variant(s) have uncertain significance. Currently, molecular diagnosis takes place in two stages: 1) Search for the GGGGCC expansion in the C9ORF72 gene by RP-PCR; 2) Analysis of the coding regions by high-throughput sequencing of a panel of 30 genes involved in ALS.

Many of these variants of uncertain significance affect splicing. Their impact can be predicted using in silico tools, but only an analysis of the patient's RNA can confirm their pathogenic nature. Currently, the analysis of transcripts is only done a posteriori, when a variant predicted to impact splicing is detected on the patient's DNA. RT-PCR followed by Sanger sequencing then verifies the impact of the splice variants. This method confirmed the impact of certain splice variants in patients. However, this method is time-consuming and requires custom development, and is mutation/gene/patient-dependent. In contrast, high-throughput RNA sequencing (RNA-Seq) simultaneously analyzes the splicing of numerous genes, with a global approach, applicable to all patients. This approach avoids the custom design of primers, which can be biased by the interpretation of splicing predictions, while RNA-Seq systematically captures and sequences all the transcripts. Finally, RNA-Seq provides additional information compared to DNA sequencing such as the detection of exon skipping, intron inclusion, and the creation of fusion transcripts.

In the GTEx project (GTEx Consortium, 2013), expression levels of human genome transcripts were quantified by RNA-Seq. Using these results, the study investigators measured expression of transcripts of known ALS genes in whole blood. Applying a threshold value of 0.5 transcripts per million reads (TPM), 25 of the 30 ALS genes currently analyzed by NGS in routine diagnostics at Nîmes University Hospital could be eligible for a complete analysis by RNA-Seq. None of the French laboratories carrying out genetic analyzes of ALS has yet developed RNA-Seq as a routine diagnostic tool. The study laboratory receives more than 600 requests for genetic diagnosis of ALS patients per year. The aim of this study is therefore to develop a global method for analyzing RNA transcripts of ALS genes to categorize the mutations to improve the diagnostic management of patients.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

collaborators: Association pour la Recherche sur la Sclérose Latérale Amyotrophique et autres maladies du motoneurones

location_facility:
La Timone
CHU de Lyon
CHU de Clermont-Ferrand
CHU de Nîmes
CHU de Toulouse
CHU de Montpellier
CHU de Bordeaux

status_simplified: Ongoing


type: Other Grant/Funding Number

title: Evaluation of a Training and Support Intervention for General Practitioners Managing Patients With Persistent Symptoms Following a COVID-19 Episode

acronym: EMPATY

summary: Evaluation of the effectiveness of a training and support intervention for general practitioners treating patients with persistent symptoms after a COVID-19 episode on the patients'quality of life at 3 months.

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

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
ANRS, Emerging Infectious Diseases

location_facility:
Paris Ouest (CPTS 15e)
DAC 93
Paris Sud (CPTS 13-14e)
DAC 75
DAC 92
Paris Est (CPTS 12e et 20e)
Paris Nord (CPTS 10e)