acronym: COVIDAXIS

title: Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers : A Randomized Double-blind Placebo-controlled Clinical Trial

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Rouen
CHU de Nantes
CHU d'Angers
CHU de Clermont-Ferrand
CHU de Bordeaux
CHU de Saint-Etienne
CHU de Montpellier
CHU de Nancy
CHU de Rennes

summary:
Since December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan in China has been responsible for a major epidemic of respiratory infections, including severe pneumonia. Within weeks, COVID-19 became a pandemic.

In the absence of specific antiviral treatment, a special attention should be given to prevention. Personal protection equipments may be insufficiently protective, including in healthcare workers, a significant proportion of whom (around 4%) having been infected in the outbreaks described in China and more recently in Italy. Infection in healthcare workers could result from the contact with COVID-19 people in community or with infected colleagues or patients.

As it will take at least a year before vaccines against SARS-CoV-2 becomes available, chemoprophylaxis is an option that should be considered in this setting where prevention of SARS-CoV-2 infection in Health Care Workers.

The COVIDAXIS trial evaluates a chemoprophylaxis of SARS-CoV-2 infection in Health Care Workers. This trial is divided into two distinct studies that could start independently each with its own randomization process: COVIDAXIS 1 will study Hydroxychloroquine (HCQ) versus placebo; COVIDAXIS 2 will study Lopinavir/ritonavir (LPV/r) versus placebo.

Upon randomization healthcare workers (HCWs) involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:


title: A Randomized, Prospective, Post-market, Multicenter Study to Evaluate the Potential Benefit of Side Branch Ballooning, in the Setting of Single Stenting With Systematic Proximal Optimization Technique, in the Treatment of Bifurcation Lesion

acronym: KISS

summary: KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation PCI procedures for Side Branch protection

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Ceric Sàrl

location_country:
Portugal
Spain
Italy
United Kingdom
Switzerland
France

location_facility: Freeman Hospital Newcastle Newcastle Upon Tyne, Tyne and Wear

location_facility: CHUV Centre Hospitalier Universitaire Vaudois

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Unknown


title: Liver and Metabolic Effects of Insulin Pump Therapy in a Population of Type 2 Diabetics With Non-alcoholic Hepatic Steatosis

acronym: STEATO-POMPE

summary:
The prevalence of fatty liver disease (NAFLD: Non-Alcoholic Fatty Liver Disease or to a more severe degree NASH: Non-Alcoholic SteatoHepatitis) reached 40-70% in subjects with type 2 diabetes (T2D). NAFLD can be easily detected by performing a hepatic ultrasonography. The presence of a NAFLD is positively correlated with the severity of insulin resistance and dysglycemia in this population. The presence of NAFLD worsens the prognosis of T2D with an increased cardiovascular risk. This hepatic impairment would also increase the risk of microvascular complications, especially nephropathy. Conversely, T2D increases the risk of transition from NAFLD to NASH and then to hepatic fibrosis and its related complications (cirrhosis, hepatocellular carcinoma). The risk of progression of liver steatosis to fibrosis is also more important as diabetes and insulin resistance are more severe.

In addition to diabetes and insulin resistance, other risk factors are associated with more severe liver damage such as changes in microbiota. Indeed, it has already been described a smaller amount of bacteroides in the microbiota of subjects with T2D and the most severe hepatic impairment. The treatment of NAFLD/NASH is poorly codified without approved drugs in this indication, while many phase 3 trials with candidate drugs are undergoing. Life-style measures (physical activity and low carbohydrate/calorie diet) can limit the progression from NAFLD to more severe liver fibrosis. Some bariatric surgery studies have also shown good results in this situation. Pharmacological interventions are also reported with proven efficacy of pioglitazone, vitamin E and orlistat.

The OPT2MISE study has recently shown the superiority of insulin pump (or continuous sub-cutaneous insulin infusion: CSII) compared to multiple daily insulin injections (MDI) to improve glycemic control in a population of patients with T2D in failure of well-titrated MDI. In addition, treatment with CSII showed a 45% decrease in insulin resistance (assessed by HOMA-IR) in a population of newly diagnosed T2D.

In light of these data, investigators hypothesize that the introduction of insulin pump treatment in a population of subjects with T2D and NAFLD, by improving insulin sensitivity, could reduce fatty liver content compared to standard MDI treatment.

study_start_date_type: Actual

status: Recruiting

primary_purpose: Other

lead_sponsor: Nantes University Hospital

location_facility:
CHU
CHU de Rennes
Hospices Civils
Nantes UH

lead_sponsor_type: academique

status_simplified: Ongoing


title: Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy in a Randomized Trial for 3 Months Followed by an Extension Period

acronym: DIABELOOP SP8

summary:
This clinical trial is a randomized trial including a 3-month single-arm part and a 6-month extension phase.

Following randomization between the 1st group and 2nd group, a 2-week baseline period in open-loop for 148 adults and 30 adolescents will be performed. Patients will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6.

Then, a 3-month study phase will be performed during 12 weeks:

1st group (111 adults randomized from 148 adults and 30 adolescents) will receive the treatment via the Closed-loop System (closed-loop condition).
2nd group (37 adult controls randomized from 148 adults) will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6 (open loop condition).
An extension period of 6 months with the Closed-loop System (closed-loop condition) will be performed at the end of the study phase for all patients enrolled.

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility: Marseille - La Conception University Hospital

location_facility: Necker-Enfants Malades University Hospital

intervention_type: Device


title: Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration

acronym: ESOLANE

summary:
DESIRIAL® PLUS is a CE-marketed hyaluronic acid (since 2011) whose registered indications are moderate hypotrophy, severe hypotrophy or atrophy of the vulvar Labia Majora by subcutaneous injections. The aim is to restore volume, rehydrate and add tone and tension to connective tissue areas by filling.

In this study, 71 female subjects above or equal to 18 years old at inclusion, who have moderate hypotrophy or severe hypotrophy or atrophy of the vulvar Labia Majora (according to investigator's judgement), who have given her informed consent and meet all the eligibility criteria, will be enrolled. Subjects will come to a total of 6 visits over a period of 12 months. An optional screening visit may be done before injection (additional visit). Proportion of patients having an improved perception of aesthetics (GAIS score after mirror self-examination) after baseline injection will be assessed. Global Aesthetic Improvement, Sexual function, subject's satisfaction, subject's symptoms, pain at injection and safety will be also assessed.

status: Completed

lead_sponsor: Laboratoires Vivacy

location_facility:
CHU Croix-Rousse
Clinique de l'Europe
Centre de la femme
Private office
Chu Henri Mondor

status_simplified: Completed


title: MOdalities of Use, effectiveNEss and TOlerability of Eqwilate® a Balanced combInatiON of VWF and FVIII in Von WillEbrand Patients in Real-life Conditions: the ONE-TO-ONE Study

summary: MOdalities of use, effectiveNEss and TOlerability of Eqwilate® a balanced combInatiON of VWF and FVIII in von WillEbrand patients in real-life conditions: the ONE-TO-ONE study

study_type: Observational

time_perspective: Prospective

lead_sponsor: Octapharma

location_facility:
Rouen Study Site
Saint Denis Study Site
Saint Denis Study Site - Pediatrie
Saint-Etienne Study Site
Clamart Study Site
Paris Study Site - Lariboisiere
Rennes Study Site
Caen Study Site
Paris Study Site - Necker

intervention_type: Biological


type: Other Identifier

title: Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease

acronym: COMADHAA

summary: Alcoholic hepatitis carries a risk of high mortality at short term, especially in its severe form. Its diagnosis is confirmed by liver biopsy. The prevalence of alcoholic hepatitis, severe or not severe, is poorly known and prospective data are needed. The present observational study aims to define the prevalence of alcoholic hepatitis among patients admitted for jaundice and determine their outcome according to the severity. Survival and markers of liver dysfunction will be assessed. A biobank including genetic samples will be created to identify the disease profile in terms of inflammation and regeneration. The performance of non-invasive criteria for diagnosis will also be studied.

lead_sponsor: University Hospital, Lille

location_facility: Association Hopital Saint Joseph - Marseille

location_facility: Hu Est Parisien Site St Antoine Aphp - Paris 12


title: Low-voltage Areas Defragmentation in Sinus Rhythm for Radiofrequency Ablation of Persistent Atrial Fibrillation

acronym: SCAR-AF

summary: This is a study evaluating the value of defragmentation of sinus rhythmic low voltage areas in addition to isolation of pulmonary veins in the removal of recurrent atrial fibrillation. The invasive procedure will be performed according to the procedures chosen by the rhythmologist and will in no way be modified by the patient's enrollment in the study. Similarly, the frequency of consultations, date and nature of the additional examinations will be defined by the physician, with the purpose of monitoring the patient.

status: Active, not recruiting

lead_sponsor: French Cardiology Society

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Saint Joseph Saint Luc

location_facility: Clinique de l'Infirmerie Protestante de Lyon


title: A GINECO Phase II Trialo Assessing the Safety and the Efficacy of the Bevacizumab, Olaparib and Durvalumab (MEDI 4736) Combination in Patients With Advanced Epithelial Ovarian Cancer in Relapse

acronym: BOLD

summary: Assessing the safety and efficacy of the bevacizumab, Olaparib and Durvalumab (MEDI 4736) combination in patient with high grade serous or high grade endometrioid or other high grade epithelial non mucinous ovarian tumor, with at least one previous line of platinum-taxane chemotherapy, and present with platinum resistant disease (PRR) or platinum-sensitive relapse (PSR), whatever the line of chemotherapy given at relapse.

ipd_sharing: Undecided

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Groupe Hospitalier des Diaconesses Croix Saint-Simon

intervention_type: Drug


title: CABRAMET: A Phase 2 Study of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases

acronym: CABRAMET

summary: This is a multicenter, open-label, exploratory, single-arm, prospective phase II study to assess the efficacy and safety profile of cabozantinib in patients with brain metastases from metastatic renal cell carcinoma (mRCC).

lead_sponsor: Centre Leon Berard

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

location_facility: Institut de Cancérologie de l'Ouest-site René Gauducheau


title: A Multicentric Phase II Trial of Stereotactic Radiotherapy Plus Durvalumab Continuation for Patients With NSCLC Metachronous Oligometastatic Disease Under Durvalumab Consolidation Following Chemoradiation

acronym: SILK BM

summary:
This study is a single-arm phase II, multicenter study designed to evaluate the activity of stereotactic radiotherapy plus the continuation of durvalumab for 12 more months for patients presenting with NSCLC metachronous oligometastatic disease during post-chemoradiotherapy durvalumab consolidation.

Fifty patients will have to be enrolled in this phase II trial.

Total duration of treatment will be 12 months.

Patients will be followed for a maximum of 2 years following the date of inclusion.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Centre Hospitalier Universitaire Lyon Sud

location_facility: Institut de Cancérologie de Bourgogne - Auxerre

intervention_type: Combination Product


title: Evaluation of an Optimization Protocol for Diuretics in the Decompensation of Chronic Heart Failure: Randomized Trial in Clusters With Sequential Permutation

acronym: ProDUCT-HF

summary: The main objective of the study is to determine if a diuretic adaptation protocol in the decompensation of chronic heart failure is more effective but also safer than the current non-protocolized practice.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Ch Lyon Sud
CH RIOM
Ch Annecy
CHU de GRENOBLE
Chu Clermont-Ferrand
CH PUY
Ch Moulins
Ch Issoire
Infirmerie Protestante de Lyon


title: Vaginal Native Tissues Repair for Pelvic Organ Prolapse

acronym: TAPP

summary: The aim of the study is to assess at one year the effectiveness of the vaginal patch plastron in comparison of the anterior colporraphy through a combined definition of success: anatomic and functional.

ReferenceType: derived

ReferenceCitation: Lacorre A, Vidal F, Campagne-Loiseau S, Marin B, Aubard Y, Siegerth F, Mesnard C, Chantalat E, Hocke C, Gauthier T. Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial. Trials. 2020 Jul 8;21(1):624. doi: 10.1186/s13063-020-04512-x.

lead_sponsor: University Hospital, Limoges

location_facility:
CH de Gueret
CHU de Toulouse - Rangueil
CHU de Clermont Ferrand
CH de Tulle
CHU de Bordeaux
CHU de Toulouse - Paule de Viguier
CHU de Limoges
CHU de Saint-Etienne
CH de Brive


title: A Prospective Multicenter, Comparative, Randomized, Double-blind, Non-inferiority Study of Eyestil® Plus Multidose Versus Vismed Multi® in Patients With Moderate to Severe Dry Eye Syndrome

summary:
SIFI SpA had developed Eyestil Plus®. It is sterile eyedrops without preservatives with a physiological pH containing sodium hyaluronate. Its intended purpose is to moisturize, lubricate and protect the ocular surface and gives temporary relief to burning, irritation and dry eye-related discomfort, and other complaints induced, for example, by: prolonged use of either soft, semi rigid or rigid contact lenses; exposure to environmental factors (air conditioning, exposure to solar radiation, wind, smoke, pollution, severe climatic conditions, dust); ocular fatigue caused by studying, working, driving or prolonged exposure to electronic devices.

Eyestil Plus® is CE marked but not available yet in all European countries. Considering the European regulatory change on medical devices - from a Directive (Directive 1993/42/EEC) to a Regulation (MDR 2017/745) that now requires clinical evidence of device performance and safety; SIFI Spa decided to implement the present clinical comparative performance study. The choice of Vismed Multi® as the comparator has been done since it is the current French standard of care treatment for patients with moderate to severe dry eyes.

lead_sponsor: SIFI SpA

location_country: France Spain

location_facility:
CHU de Nice - Hôpital Pasteur
CHU François Mitterand
Chu Morvan
Instituto Oftalmologico Fernandez-Vega
Hospital Universitario Virgen Macarena
Hôpital de la Croix Rousse
CHU Saint Etienne/Hôpital Nord
Centre Monticelli
CHU de Bordeaux - Hôpital Pellegrin
Hopital La Timone Adultes
Hopital Bretonneau
Hospital Recoletas Campo Grande


title: Nal-IRI/LV5-FU VERSUS PACLITAXEL AS SECOND-LINE THERAPY IN PATIENTS WITH METASTATIC OESOPHAGEAL SQUAMOUS CELL CARCINOMA A Multi-centre, Randomized, Non-comparative Phase II Study

acronym: OESIRI

summary:
The aim of our study is to evaluate the efficacy and safety of NALIRI plus 5FU versus paclitaxel as a second-line therapy in patients with locally advanced or metastatic ESCC who had failed to cisplatin- or oxaliplatin-based first-line chemotherapy.

The hypotheses are as follows:

H0: the percentage of patients alive at 9 months of 40% is not useful. H1: the percentage of patients alive at 9 months of 60% is expected.

ReferenceType: background

ReferenceCitation: Randrian V, Adenis A, Desrame J, Barbier E, Di Fiore F, Lièvre A, Dahan L, Laurent-Puig P, Mineur L, Breysacher G, Roquin G, Louafi S, Lopez A, Louvet C, Borg C, Metges JP, Faroux R, Gaba L, Manfredi S, Tougeron D. Nal-IRI/LV5-FU versus paclitaxel as second-line therapy in patients with metastatic esophageal squamous cell carcinoma (OESIRI)-PRODIGE 62: A multicentre, randomised, non-comparative phase II study. Dig Liver Dis. 2020 Mar;52(3):347-350. doi: 10.1016/j.dld.2019.11.014. Epub 2019 Dec 30.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Chu Amiens
Chu de Poitiers
Ch Duchenne
Chu Saint Louis
Chu Rouen
Ch Perpignan
Ch Le Raincy
Hopital Européen
Institut Sainte Catherine


type: EudraCT Number

title: Elderly Cancer PatIents Treated for Advanced or Metastatic Melanoma or NSCLC, Safety and qualiTy of Life Under immunOtheraPies: a Phase IV Trial

summary: The co-primary objectives will be to assess the safety and quality of life under treatment.

ReferenceCitation: Balducci L, Extermann M. Management of cancer in the older person: a practical approach. Oncologist. 2000;5(3):224-37.

ReferenceCitation: Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006 Nov;7(11):903-9.

ReferenceCitation: Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhäufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crinò L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.

ReferenceCitation: Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.

ReferenceCitation: Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Arén Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.

ReferenceCitation: Cella D, Grünwald V, Nathan P, Doan J, Dastani H, Taylor F, Bennett B, DeRosa M, Berry S, Broglio K, Berghorn E, Motzer RJ. Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):994-1003. doi: 10.1016/S1470-2045(16)30125-5. Epub 2016 Jun 6. Erratum in: Lancet Oncol. 2016 Jul;17 (7):e270.

ReferenceCitation: Champiat S, Dercle L, Ammari S, Massard C, Hollebecque A, Postel-Vinay S, Chaput N, Eggermont A, Marabelle A, Soria JC, Ferté C. Hyperprogressive Disease Is a New Pattern of Progression in Cancer Patients Treated by Anti-PD-1/PD-L1. Clin Cancer Res. 2017 Apr 15;23(8):1920-1928. doi: 10.1158/1078-0432.CCR-16-1741. Epub 2016 Nov 8.

ReferenceCitation: Daste A, Domblides C, Gross-Goupil M, Chakiba C, Quivy A, Cochin V, de Mones E, Larmonier N, Soubeyran P, Ravaud A. Immune checkpoint inhibitors and elderly people: A review. Eur J Cancer. 2017 Sep;82:155-166. doi: 10.1016/j.ejca.2017.05.044. Epub 2017 Jul 6. Review.

ReferenceCitation: Du-Thanh A, Lesage C, Ferreira E, Dereure O, Guillot B. [Innovative therapies for metastatic melanoma in elderly patients]. Ann Dermatol Venereol. 2015 Oct;142(10):549-56. doi: 10.1016/j.annder.2015.03.022. Epub 2015 May 16. Review. French.

ReferenceCitation: Extermann M. Measurement and impact of comorbidity in older cancer patients. Crit Rev Oncol Hematol. 2000 Sep;35(3):181-200. Review.

ReferenceCitation: Fitzsimmons D, Gilbert J, Howse F, Young T, Arrarras JI, Brédart A, Hawker S, George S, Aapro M, Johnson CD. A systematic review of the use and validation of health-related quality of life instruments in older cancer patients. Eur J Cancer. 2009 Jan;45(1):19-32. doi: 10.1016/j.ejca.2008.07.036. Epub 2008 Sep 25. Review.

ReferenceCitation: Greenhalgh J. The applications of PROs in clinical practice: what are they, do they work, and why? Qual Life Res. 2009 Feb;18(1):115-23. doi: 10.1007/s11136-008-9430-6. Epub 2008 Dec 23.

ReferenceCitation: Helissey C, Vicier C, Champiat S. The development of immunotherapy in older adults: New treatments, new toxicities? J Geriatr Oncol. 2016 Sep;7(5):325-33. doi: 10.1016/j.jgo.2016.05.007. Epub 2016 Jun 16. Review.

ReferenceCitation: Hjermstad MJ, Fayers PM, Bjordal K, Kaasa S. Using reference data on quality of life--the importance of adjusting for age and gender, exemplified by the EORTC QLQ-C30 (+3). Eur J Cancer. 1998 Aug;34(9):1381-9.

ReferenceCitation: Hua C, Boussemart L, Mateus C, Routier E, Boutros C, Cazenave H, Viollet R, Thomas M, Roy S, Benannoune N, Tomasic G, Soria JC, Champiat S, Texier M, Lanoy E, Robert C. Association of Vitiligo With Tumor Response in Patients With Metastatic Melanoma Treated With Pembrolizumab. JAMA Dermatol. 2016 Jan;152(1):45-51. doi: 10.1001/jamadermatol.2015.2707.

ReferenceCitation: Ishida Y, Agata Y, Shibahara K, Honjo T. Induced expression of PD-1, a novel member of the immunoglobulin gene superfamily, upon programmed cell death. EMBO J. 1992 Nov;11(11):3887-95.

ReferenceCitation: Khoja L, Day D, Wei-Wu Chen T, Siu LL, Hansen AR. Tumour- and class-specific patterns of immune-related adverse events of immune checkpoint inhibitors: a systematic review. Ann Oncol. 2017 Oct 1;28(10):2377-2385. doi: 10.1093/annonc/mdx286. Review.

ReferenceCitation: Lafage-Pochitaloff M, Costello R, Couez D, Simonetti J, Mannoni P, Mawas C, Olive D. Human CD28 and CTLA-4 Ig superfamily genes are located on chromosome 2 at bands q33-q34. Immunogenetics. 1990;31(3):198-201.

ReferenceCitation: Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31. Erratum in: N Engl J Med. 2018 Nov 29;379(22):2185.

ReferenceCitation: Manoussakis MN, Tzioufas AG, Silis MP, Pange PJ, Goudevenos J, Moutsopoulos HM. High prevalence of anti-cardiolipin and other autoantibodies in a healthy elderly population. Clin Exp Immunol. 1987 Sep;69(3):557-65.

ReferenceCitation: Michelson H, Bolund C, Brandberg Y. Multiple chronic health problems are negatively associated with health related quality of life (HRQoL) irrespective of age. Qual Life Res. 2000;9(10):1093-104.

ReferenceCitation: Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.

ReferenceCitation: Naidoo J, Page DB, Li BT, Connell LC, Schindler K, Lacouture ME, Postow MA, Wolchok JD. Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. Ann Oncol. 2015 Dec;26(12):2375-91. doi: 10.1093/annonc/mdv383. Epub 2015 Sep 14. Review. Erratum in: Ann Oncol. 2016 Jul;27(7):1362.

ReferenceCitation: Nghiem PT, Bhatia S, Lipson EJ, Kudchadkar RR, Miller NJ, Annamalai L, Berry S, Chartash EK, Daud A, Fling SP, Friedlander PA, Kluger HM, Kohrt HE, Lundgren L, Margolin K, Mitchell A, Olencki T, Pardoll DM, Reddy SA, Shantha EM, Sharfman WH, Sharon E, Shemanski LR, Shinohara MM, Sunshine JC, Taube JM, Thompson JA, Townson SM, Yearley JH, Topalian SL, Cheever MA. PD-1 Blockade with Pembrolizumab in Advanced Merkel-Cell Carcinoma. N Engl J Med. 2016 Jun 30;374(26):2542-52. doi: 10.1056/NEJMoa1603702. Epub 2016 Apr 19.

ReferenceCitation: Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. Epub 2016 Oct 8.

ReferenceCitation: Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, Gadgeel SM, Hida T, Kowalski DM, Dols MC, Cortinovis DL, Leach J, Polikoff J, Barrios C, Kabbinavar F, Frontera OA, De Marinis F, Turna H, Lee JS, Ballinger M, Kowanetz M, He P, Chen DS, Sandler A, Gandara DR; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. doi: 10.1016/S0140-6736(16)32517-X. Epub 2016 Dec 13. Erratum in: Lancet. 2017 Apr 8;389(10077):e5.

ReferenceCitation: Robert C, Karaszewska B, Schachter J, Rutkowski P, Mackiewicz A, Stroiakovski D, Lichinitser M, Dummer R, Grange F, Mortier L, Chiarion-Sileni V, Drucis K, Krajsova I, Hauschild A, Lorigan P, Wolter P, Long GV, Flaherty K, Nathan P, Ribas A, Martin AM, Sun P, Crist W, Legos J, Rubin SD, Little SM, Schadendorf D. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015 Jan 1;372(1):30-9. doi: 10.1056/NEJMoa1412690. Epub 2014 Nov 16.

ReferenceCitation: Robert C, Thomas L, Bondarenko I, O'Day S, Weber J, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011 Jun 30;364(26):2517-26. doi: 10.1056/NEJMoa1104621. Epub 2011 Jun 5.

ReferenceCitation: Solana R, Tarazona R, Gayoso I, Lesur O, Dupuis G, Fulop T. Innate immunosenescence: effect of aging on cells and receptors of the innate immune system in humans. Semin Immunol. 2012 Oct;24(5):331-41. doi: 10.1016/j.smim.2012.04.008. Epub 2012 May 4. Review.

ReferenceCitation: Wheelwright S, Darlington AS, Fitzsimmons D, Fayers P, Arraras JI, Bonnetain F, Brain E, Bredart A, Chie WC, Giesinger J, Hammerlid E, O'Connor SJ, Oerlemans S, Pallis A, Reed M, Singhal N, Vassiliou V, Young T, Johnson C. International validation of the EORTC QLQ-ELD14 questionnaire for assessment of health-related quality of life elderly patients with cancer. Br J Cancer. 2013 Aug 20;109(4):852-8. doi: 10.1038/bjc.2013.407. Epub 2013 Jul 18.

ReferenceCitation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56.

ReferenceCitation: Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8.

ReferenceCitation: Bandeen-Roche K, Xue QL, Ferrucci L, Walston J, Guralnik JM, Chaves P, Zeger SL, Fried LP. Phenotype of frailty: characterization in the women's health and aging studies. J Gerontol A Biol Sci Med Sci. 2006 Mar;61(3):262-6.

ReferenceCitation: Davis HS, MacPherson K, Merry HR, Wentzel C, Rockwood K. Reliability and validity of questions about exercise in the Canadian Study of Health and Aging. Int Psychogeriatr. 2001;13 Supp 1:177-82.

ReferenceCitation: Cornali C, Franzoni S, Frisoni GB, Trabucchi M. Anorexia as an independent predictor of mortality. J Am Geriatr Soc. 2005 Feb;53(2):354-5.

ReferenceCitation: Cheng ST, Chan AC. Comparative performance of long and short forms of the Geriatric Depression Scale in mildly demented Chinese. Int J Geriatr Psychiatry. 2005 Dec;20(12):1131-7.

ReferenceCitation: Clément JP, Nassif RF, Léger JM, Marchan F. [Development and contribution to the validation of a brief French version of the Yesavage Geriatric Depression Scale]. Encephale. 1997 Mar-Apr;23(2):91-9. French.

ReferenceCitation: Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011 Mar 15;173(6):676-82. doi: 10.1093/aje/kwq433. Epub 2011 Feb 17.

ReferenceCitation: Borson S, Scanlan JM, Chen P, Ganguli M. The Mini-Cog as a screen for dementia: validation in a population-based sample. J Am Geriatr Soc. 2003 Oct;51(10):1451-4.

ReferenceCitation: Borson S, Scanlan J, Brush M, Vitaliano P, Dokmak A. The mini-cog: a cognitive 'vital signs' measure for dementia screening in multi-lingual elderly. Int J Geriatr Psychiatry. 2000 Nov;15(11):1021-7.

ReferenceCitation: Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86.

ReferenceCitation: Barberger-Gateau P, Dartigues JF, Letenneur L. Four Instrumental Activities of Daily Living Score as a predictor of one-year incident dementia. Age Ageing. 1993 Nov;22(6):457-63.

ReferenceCitation: KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9.

lead_sponsor: Institut Paoli-Calmettes

location_facility: Assistance Publique des Hôpitaux de Marseille


title: Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department: a Multicenter Randomized Controlled Double-blind Non-inferiority Trial

acronym: ADAMOPA

summary: In emergency medicine, acute pain is a common reason for consultation. It is recommended that patients in moderate to severe pain should receive a combination of intravenous acetaminophen and morphine. However, the data are sparse to support this strategy. Thus, the purpose of our research is to test non-inferiority of IV morphine alone versus IV acetaminophen and morphine in a multicenter, randomized, controlled double blind trial in ED patients with moderate to severe acute pain.

location_facility: La Pitié-Salpêtrière University Hospital


title: Impact of Early Debriefing and Enhanced Educative Components on Direct Oral Anticoagulant Adherence After Venous Thromboembolism. The DEBRIEF-VTE Study

acronym: DEBRIEF-VTE

summary:
Venous thromboembolism (VTE) is a frequent multifactorial and potential life-threatening disease. Once VTE has been diagnosed, anticoagulation should be started and prolonged for at least three to six months in order to reduce the risk of fatal and non-fatal recurrences and long-term sequelae. The development of direct oral anticoagulants (DOACs) has represented a major advance in patients' care as there is evidence that DOACs are associated with a decreased risk of bleeding without loss in efficacy and as it simplifies treatment modalities for the patients and the physician. However, as DOACs do not require laboratory monitoring, adherence of anticoagulation is difficult to evaluate and traditional programs built on patients receiving VKA may no longer be applicable to patients on DOAC. In order to increase treatment adherence in patients on DOAC for an acute VTE and to improve the quality of life, the impact of specific educational programs on DOACs, taking in account both therapeutic (DOAC) and medical illness (VTE) dimensions needs to be investigated.

In patients with an acute episode of VTE treated for at least 6 months, the main hypothesis is that early debriefing and educative components added to a standardized visit one month after an acute VTE has the potential to improve patient's adherence to APIXABAN therapy at 6 months of follow-up.

lead_sponsor: University Hospital, Brest

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel Montpied

location_facility: CHU de Grenoble - Hôpital Nord Michallon

intervention_type: Other


title: Concordance and Accuracy of Magnetic Resonance Imaging in the Detection of Meningiomas: Optimizing Sequences With Low Doses of Gadolinium

acronym: CAMOMILLE

summary:
Meningioma, an extra-axial brain tumor developed at the expense of meninges, accounts for 35% of central nervous system tumors, and its incidence is estimated at 3% in large autopsy series.

The current gold standard for screening and monitoring cerebral meningiomas is MRI with injection of gadoline-contrast product. However, the use of some of these products is problematic, due to gadolinium deposits observed in patients who have had several injections during their lifetime, especially in patients followed for multiple sclerosis.

Recently, the French National Agency for the Safety of Medicines and Health Products (ANSM) issued recommendations concerning the screening of meningiomas in patients at risk, particularly in people treated with cyproterone acetate. It is a synthetic progestogen steroid with anti-androgenic properties. It is used to treat hyperandrogenic syndromes in women or in the palliative treatment of prostate cancer in men. Its long-term use seems to be associated with a significant over-risk of developing meningiomas, brain tumours affecting meninges. This increased risk is multiplied by 7 in women exposed to high doses of cyproterone acetate, and by 20 over a cumulative dose of 60 grams, or about 5 years of treatment at 50 mg/day or 10 years at 25 mg/day. The ANSM recommends that a cerebral MRI be performed at the beginning of treatment for all patients, as well as a control MRI renewed at 5 years and then every 2 years if the MRI at 5 years is normal. These recommendations will lead to a large number of MRIs involving an injection of contrast agent in this population, with potential immediate or delayed serious adverse effects.

New techniques, such as Arterial Spin Labelling (ASL), or black blood sequences optimized for contrast detection, have been developed. These could detect meningeal anomalies and more particularly meningiomas without contrast injection, or with a significantly lower dose of contrast agent.

These techniques have not been specifically studied for screening or monitoring meningeal lesions, but it seems relevant and important to be able to validate protocols that reduce gadolinium doses given the high number of screening and follow-up MRIs in the general population.

Patients presenting for brain MRI screening or meningioma follow-up will have the usual MRI sequences for their management, and the sequences performed at 1/6th of the standard dose of Gadolinium that are added for research. These new sequences will add approximately 6 minutes of additional examination time.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild


title: A Multicenter, Randomized, Open-label, Phase II Trial Aiming to Evaluate the Impact of Pegfilgrastim on Trastuzumab Anti-tumor Effect and ADCC in Operable HER2 Positive Breast Cancer Patients

source: euctr

ReferenceCitation: Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.

ReferenceCitation: Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF; American Society of Clinical Oncology; College of American Pathologists. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013 Nov 1;31(31):3997-4013. doi: 10.1200/JCO.2013.50.9984. Epub 2013 Oct 7.

ReferenceCitation: Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, Dowsett M, Fitzgibbons PL, Hanna WM, Langer A, McShane LM, Paik S, Pegram MD, Perez EA, Press MF, Rhodes A, Sturgeon C, Taube SE, Tubbs R, Vance GH, van de Vijver M, Wheeler TM, Hayes DF; American Society of Clinical Oncology/College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med. 2007;131(1):18-43. doi: 10.1043/1543-2165(2007)131[18:ASOCCO]2.0.CO;2.

ReferenceCitation: Zhou BP, Hung MC. Dysregulation of cellular signaling by HER2/neu in breast cancer. Semin Oncol. 2003 Oct;30(5 Suppl 16):38-48. Review.

ReferenceCitation: Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383.

ReferenceCitation: Untch M, Rezai M, Loibl S, Fasching PA, Huober J, Tesch H, Bauerfeind I, Hilfrich J, Eidtmann H, Gerber B, Hanusch C, Kühn T, du Bois A, Blohmer JU, Thomssen C, Dan Costa S, Jackisch C, Kaufmann M, Mehta K, von Minckwitz G. Neoadjuvant treatment with trastuzumab in HER2-positive breast cancer: results from the GeparQuattro study. J Clin Oncol. 2010 Apr 20;28(12):2024-31. doi: 10.1200/JCO.2009.23.8451. Epub 2010 Mar 22.

ReferenceCitation: Gianni L, Eiermann W, Semiglazov V, Manikhas A, Lluch A, Tjulandin S, Zambetti M, Vazquez F, Byakhow M, Lichinitser M, Climent MA, Ciruelos E, Ojeda B, Mansutti M, Bozhok A, Baronio R, Feyereislova A, Barton C, Valagussa P, Baselga J. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet. 2010 Jan 30;375(9712):377-84. doi: 10.1016/S0140-6736(09)61964-4.

ReferenceCitation: Gianni L, Eiermann W, Semiglazov V, Lluch A, Tjulandin S, Zambetti M, Moliterni A, Vazquez F, Byakhov MJ, Lichinitser M, Climent MA, Ciruelos E, Ojeda B, Mansutti M, Bozhok A, Magazzù D, Heinzmann D, Steinseifer J, Valagussa P, Baselga J. Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet Oncol. 2014 May;15(6):640-7. doi: 10.1016/S1470-2045(14)70080-4. Epub 2014 Mar 20. Erratum in: Lancet Oncol. 2018 Dec;19(12):e667.

ReferenceCitation: Kute T, Stehle JR Jr, Ornelles D, Walker N, Delbono O, Vaughn JP. Understanding key assay parameters that affect measurements of trastuzumab-mediated ADCC against Her2 positive breast cancer cells. Oncoimmunology. 2012 Sep 1;1(6):810-821.

ReferenceCitation: Deauvieau F, Ollion V, Doffin AC, Achard C, Fonteneau JF, Verronese E, Durand I, Ghittoni R, Marvel J, Dezutter-Dambuyant C, Walzer T, Vie H, Perrot I, Goutagny N, Caux C, Valladeau-Guilemond J. Human natural killer cells promote cross-presentation of tumor cell-derived antigens by dendritic cells. Int J Cancer. 2015 Mar 1;136(5):1085-94. doi: 10.1002/ijc.29087. Epub 2014 Aug 6.

ReferenceCitation: Hernandez-Ilizaliturri FJ, Jupudy V, Ostberg J, Oflazoglu E, Huberman A, Repasky E, Czuczman MS. Neutrophils contribute to the biological antitumor activity of rituximab in a non-Hodgkin's lymphoma severe combined immunodeficiency mouse model. Clin Cancer Res. 2003 Dec 1;9(16 Pt 1):5866-73.

ReferenceCitation: Cornet S, Mathé D, Chettab K, Evesque A, Matera EL, Trédan O, Dumontet C. Pegfilgrastim Enhances the Antitumor Effect of Therapeutic Monoclonal Antibodies. Mol Cancer Ther. 2016 Jun;15(6):1238-47. doi: 10.1158/1535-7163.MCT-15-0759. Epub 2016 Mar 17.

ReferenceCitation: Cartron G, Zhao-Yang L, Baudard M, Kanouni T, Rouillé V, Quittet P, Klein B, Rossi JF. Granulocyte-macrophage colony-stimulating factor potentiates rituximab in patients with relapsed follicular lymphoma: results of a phase II study. J Clin Oncol. 2008 Jun 1;26(16):2725-31. doi: 10.1200/JCO.2007.13.7729. Epub 2008 Apr 21.

ReferenceCitation: Bossuyt V, Provenzano E, Symmans WF, Boughey JC, Coles C, Curigliano G, Dixon JM, Esserman LJ, Fastner G, Kuehn T, Peintinger F, von Minckwitz G, White J, Yang W, Badve S, Denkert C, MacGrogan G, Penault-Llorca F, Viale G, Cameron D; Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration. Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration. Ann Oncol. 2015 Jul;26(7):1280-91. doi: 10.1093/annonc/mdv161. Epub 2015 May 27. Review.

ReferenceCitation: Lin Y, Kikuchi S, Obata Y, Yagyu K; Tokyo Research Group on Prevention of Gastric Cancer. Serum levels of transforming growth factor beta1 are significantly correlated with venous invasion in patients with gastric cancer. J Gastroenterol Hepatol. 2006 Feb;21(2):432-7.

ReferenceCitation: Tas F, Yasasever CT, Karabulut S, Tastekin D, Duranyildiz D. Serum transforming growth factor-beta1 levels may have predictive and prognostic roles in patients with gastric cancer. Tumour Biol. 2015 Mar;36(3):2097-103. doi: 10.1007/s13277-014-2817-9. Epub 2014 Nov 13.

ReferenceCitation: Lin Y, Kikuchi S, Tamakoshi A, Obata Y, Yagyu K, Inaba Y, Kurosawa M, Kawamura T, Motohashi Y, Ishibashi T; JACC Study Group. Serum transforming growth factor-beta1 levels and pancreatic cancer risk: a nested case-control study (Japan). Cancer Causes Control. 2006 Oct;17(8):1077-82.

ReferenceCitation: Zhao J, Liang Y, Yin Q, Liu S, Wang Q, Tang Y, Cao C. Clinical and prognostic significance of serum transforming growth factor-beta1 levels in patients with pancreatic ductal adenocarcinoma. Braz J Med Biol Res. 2016 Jul 25;49(8). pii: S0100-879X2016000800705. doi: 10.1590/1414-431X20165485.

ReferenceCitation: Tas F, Karabulut S, Yasasever CT, Duranyildiz D. Serum transforming growth factor-beta 1 (TGF-β1) levels have diagnostic, predictive, and possible prognostic roles in patients with melanoma. Tumour Biol. 2014 Jul;35(7):7233-7. doi: 10.1007/s13277-014-1984-z. Epub 2014 Apr 27.

ReferenceCitation: Xu S, Yang S, Sun G, Huang W, Zhang Y. Transforming growth factor-beta polymorphisms and serum level in the development of osteosarcoma. DNA Cell Biol. 2014 Nov;33(11):802-6. doi: 10.1089/dna.2014.2527. Epub 2014 Aug 6.

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre de Lutte contre le Cancer Jean Perrin

summary: First preclinical data suggest that pegfilgrastim could constitute a potent adjuvant for immunotherapy with mAb possessing ADCC/ADCP properties as trastuzumab. Combined treatment of pegfilgrastim and trastuzumab should translate into an increased rate of pathological clinical response. Therefore the investigators' proposal is to evaluate the clinical and biological impact of pegfilgrastim in combination with trastuzumab + paclitaxel in HER2-positive early stage breast cancer patients. Breastimmune02 is a multicenter, randomized, open-label, Phase II trial. Operable HER2+ breast cancer patients previously treated with 4 cycles of standard adriamycine/cyclophosphamide (AC) chemotherapy will be randomized (1:1) to receive in the neoadjuvant setting:Arm A: weekly paclitaxel + trastuzumab (every 3 weeks, Q3W) + pegfilgrastim (Q3W) versus Arm B: weekly paclitaxel + trastuzumab (Q3W).Stratification criteria will be: cN0 versus cN1.


title: Medical-economic Evaluation of the Care of Refractory Ascites by Implantation of Alfapump® Device in Cirrhotic Patients

acronym: ARIAPUMP

summary:
The hypothesis is that the Alfapump® strategy would be more effective in terms of QALYs generated , and that the cost of Alfapump® device and its implantation will be totally or partially offset by the reduction in the number of evacuating parentheses performed and the reduction in the number of complications in patients with refractory ascites awaiting liver transplantation or not. On the other hand, given the difference in the clinical profiles of these two populations (whether or not they are awaiting transplantation), these two populations will be study separately

Evaluation of the medical-economic impact at 1 year of the two therapeutic strategies: implantation of Alfapump® versus repeated evacuating paracentesis in cirrhotic patients with refractory ascites without scheduled liver transplantation.

ReferenceCitation: Bellot P, Welker MW, Soriano G, von Schaewen M, Appenrodt B, Wiest R, Whittaker S, Tzonev R, Handshiev S, Verslype C, Moench C, Zeuzem S, Sauerbruch T, Guarner C, Schott E, Johnson N, Petrov A, Katzarov K, Nevens F, Zapater P, Such J. Automated low flow pump system for the treatment of refractory ascites: a multi-center safety and efficacy study. J Hepatol. 2013 May;58(5):922-7. doi: 10.1016/j.jhep.2012.12.020. Epub 2013 Jan 11.

ReferenceCitation: Bureau C, Adebayo D, Chalret de Rieu M, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rosi S, MacDonald S, Malago M, Stepanova M, Younossi ZM, Trepte C, Watson R, Borisenko O, Sun S, Inhaber N, Jalan R. Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study. J Hepatol. 2017 Nov;67(5):940-949. doi: 10.1016/j.jhep.2017.06.010. Epub 2017 Jun 21. Erratum in: J Hepatol. 2018 Jan 29;:. J Hepatol. 2020 Mar;72(3):595-596.

ReferenceCitation: Stirnimann G, Berg T, Spahr L, Zeuzem S, McPherson S, Lammert F, Storni F, Banz V, Babatz J, Vargas V, Geier A, Stallmach A, Engelmann C, Trepte C, Capel J, De Gottardi A. Treatment of refractory ascites with an automated low-flow ascites pump in patients with cirrhosis. Aliment Pharmacol Ther. 2017 Nov;46(10):981-991. doi: 10.1111/apt.14331. Epub 2017 Sep 21.

ReferenceCitation: Solà E, Solé C, Ginès P. Management of uninfected and infected ascites in cirrhosis. Liver Int. 2016 Jan;36 Suppl 1:109-15. doi: 10.1111/liv.13015. Review.

ReferenceCitation: Thomas MN, Sauter GH, Gerbes AL, Stangl M, Schiergens TS, Angele M, Werner J, Guba M. Automated low flow pump system for the treatment of refractory ascites: a single-center experience. Langenbecks Arch Surg. 2015 Dec;400(8):979-83. doi: 10.1007/s00423-015-1356-1. Epub 2015 Nov 13.

ReferenceCitation: Stepanova M, Nader F, Bureau C, Adebayo D, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rossi S, MacDonald S, Capel J, Jalan R, Younossi ZM. Patients with refractory ascites treated with alfapump® system have better health-related quality of life as compared to those treated with large volume paracentesis: the results of a multicenter randomized controlled study. Qual Life Res. 2018 Jun;27(6):1513-1520. doi: 10.1007/s11136-018-1813-8. Epub 2018 Feb 19.

lead_sponsor: University Hospital, Grenoble

location_facility:
Amiens-Picardie University Hospital
Toulouse University Hospital
LA PITIE SALPETRIERE Univesity Hospital
Chu Angers
Jean MINJOZ Univesity Hospital
Haut-Lévêque Hospital
Beaujon Hospital
Chu Pontchaillou
Grenoble University Hospital


title: Dexmedetomidine After Cardiac Surgery for Prevention of Delirium: The Exactum Study a Randomised Double Blind Controlled Trial

acronym: EXACTUM

summary: We designed a prospective, double blind, randomized, controlled versus placebo study to evaluate the efficacy of nightly low dose of Dexmedetomidine infusion to promote sleep and lower delirium in a population of post cardiac surgery patients. This population is characterized by longer ICU stay, more physical restraints such as catheters and drains, pain and sleep deprivation. It is associated with higher prevalence of Delirium and agitation leading to exposure to severe agitation related adverse events.

ReferenceCitation: Gargadennec T, Oilleau JF, Rozec B, Nesseler N, Lasocki S, Futier E, Amour J, Durand M, Bougle A, Kerforne T, Consigny M, Eddi D, Huet O. Dexmedetomidine after Cardiac Surgery for Prevention of Delirium (EXACTUM) trial protocol: a multicentre randomised, double-blind, placebo-controlled trial. BMJ Open. 2022 Apr 8;12(4):e058968. doi: 10.1136/bmjopen-2021-058968.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
Hôpital Privé Jacques Cartier
Angers university hospital
CHU la Pitié Salpétrière
CHU de Nantes
CHU Poitiers
CHU de Grenoble
CHRU de Brest
Clermont Ferrand university hospital
CHU de Rennes


title: A European, Multicenter, Prospective Clinical Study to Evaluate Cysteamine Toxicity on Human Osteoclasts. The CYSTEA-BONE Clinical Study.

acronym: CYSTEA-BONE

summary:
Nephropathic Cystinosis (NC) is an orphan inherited autosomal recessive disease characterised as a generalized lysosomal storage disease due to a deficiency of the cystine lysosomal transport protein, cystinosin.

Patients with NC usually receive cysteamine. Bone impairment was recently recognized as a late complication of NC, occurring at adolescence or early adulthood. Even though the exact underlying pathophysiology is unclear, at least six hypotheses are discussed, and mainly cysteamine toxicity and/or direct bone effect of the Cystinosin (CTNS) mutation. Because of the potential dramatic impact on quality of life of this novel complication, research should aim to better understand bone disease in NC.

The primary objective of this study is to evaluate the action of cysteamine on osteoclastic differentiation and resorption activity of NC patients, depending on the underlying genotype. The Secondary objective is to describe the clinical bone status of NC patients depending on their underlying genotype.

lead_sponsor: Hospices Civils de Lyon

location_country: Germany France Turkey Italy

location_facility: CHU Bordeaux - Hôpital Pellegrin tripode

location_facility: Hacettepe University Faculty of Medicine

location_facility: CHU Paris - Hôpital Necker-Enfants Malades

location_facility: Klinik für Pädiatrische Nieren-, Leber- und Stoffwechselerkrankungen


title: Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.

acronym: FASCE

summary:
Acne vulgaris of adult woman has increased over the past 10 years; it affects currently 20% to 30% of adult women.

The physiopathology of adult woman acne is distinguished from the teenager one by essentially 2 factors:

hormonal factor with a peripheral hyperandrogenism coupled with an hypersensibility of cutaneous androgens receptors of these women. But this point is still at the stage of hypothesis.
inflammatory factor linked with Propionibacterium Aces ; indeed these women received most of the time many cures of local and systematic antibiotics at the origin of resistant Propionibacterium Aces strains which lead to a chronical activation of cutaneous innate immunity.

On a therapeutic plan, four types of systemic treatment, approved in this indication are:

Tetracyclines which are problematic for the bacterial resistance and consequently constant relapse when they are stopped.
Zinc salts which target only the inflammatory lesions and were shown less effective than cycline
Antiandrogens, with acetate of cyproterone associated with risks of phlebitis and pulmonary embolism, and increase risk of triglycerides, cholesterol and hepatic balance.
The last alternative is represented by isotretinoin but the use in women of childbearing potential is binding because of the teratogen risks and the hyperandrogenism represents an identified risk of relapse.

In this context, the spironolactone could represent an interesting alternative. It blocks the 5-alpha-reductase receptors at sebaceous gland and inhibits Luteinizing hormone (LH) production at the pituitary level. It is not submitted to isotretinoin constraints, does not lead to bacterial resistance and targets the peripheral hyperandrogenism.

Currently, very few studies have been performed and on a weak number of patients but they showed that at low doses (lower than 200mg/day), spironolactone can be effective against acne.

In that context, it seemed clearly interesting to perform the first double-blind randomized study spironolactone vs cyclines which remains the moderate acne reference treatment and to demonstrate the superiority of spironolactone's efficacy in order to establish it as alternative way to cycline.

ReferenceCitation: Poinas A, Lemoigne M, Le Naour S, Nguyen JM, Schirr-Bonnans S, Riche VP, Vrignaud F, Machet L, Claudel JP, Leccia MT, Hainaut E, Beneton N, Dert C, Boisrobert A, Flet L, Chiffoleau A, Corvec S, Khammari A, Dréno B. FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial. Trials. 2020 Jun 25;21(1):571. doi: 10.1186/s13063-020-04432-w.

lead_sponsor: Nantes University Hospital

location_facility:
CHRU Tours
CHU Caen
CHU Poitiers
CH Le Mans
CHU Grenoble
Cabinet du Dr Jean-Paul Claudel
Chru Brest
CHU de Nantes - Dermatologie
CH La Rochelle


title: ADOPT-PRESTAGE: Randomized Controlled Trial on Acceptability, Diffusion and Impact on Treatment Adherence and Persistence of the PRESTAGE Program (Program for Education and Support for Oral Cancer Treatments in the Elderly) - Randomized Controlled Study Evaluating the Impact of the Program PRESTAGE

acronym: ADOPT-PRESTAGE

summary:
As the proportion of oral anticancer treatments is continuously increasing, adherence appears as a major issue for patients' outcomes. Poor adherence affects particularly geriatric patients due among others to polypharmacy or cognitive impairment. Thus, the need for educational programs in this population has been regularly emphasized.

PRESTAGE educational program was built after an external and internal analysis of educational needs in elderly patients treated with oral cancer treatments. It implicates a multidisciplinary educational team (nurses, physicians, pharmacists, psychologists, physiologists, social workers...). Six educational workshops were designed with the following endpoints: disease and treatment understanding, treatment management, nutrition and psychological as well as physical well being.

ADOPT-PRESTAGE is a clinical, prospective, interventional, open-label, multicenter, randomized, controlled trial designed to evaluate the impact of PRESTAGE program. It is, to the investigators' knowledge, the first randomized controlled trial evaluating the acceptability and impact (adherence, clinical benefit) of an educational program in an elderly cancer population. The primary endpoint of this trial will be to evaluate adherence using an indirect objective adherence measure: the Medication Event Monitoring System (MEMS). Secondary endpoints include quality of life and evaluation of changes in patients' behaviors.

primary_purpose: Supportive Care

location_facility: Service d'oncologie, Centre Hospitalier Annecy Genevois

location_facility: Service de Gériatrie, Centre Hospitalier de Givors

location_facility: Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL

location_facility: Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole

location_facility: Service d'oncologie médicale, Cnetre Léon Bérard

location_facility: Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)

location_facility: Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL

location_facility: Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL

location_facility: service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne

intervention_type: Behavioral


title: A Multicenter Pilot Study to Determine Criteria for Evaluating the Effectiveness of Two Comparative Monitoring Methods in the Management of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Receiving Home-based Treatment With IVIg (Privigen®)

acronym: HELIPAD 1

summary:
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a chronic demyelinating polyneuropathy of autoimmune origin with a progressive or relapsing course.

Diagnosis is based on clinical presentation and electrophysiological findings in accordance with the EFNS/PNS consensus guidelines. IVIg is the first line treatment witch has been shown to be effective in several placebo-controlled trials.

Once IVIg therapy produces a response and is well tolerated, some patients are able to continue their treatment in the home setting. The HOME LINK system offers an integrated, global solution based on telemonitoring technology providing continuous, remote monitoring of Privigen® infusions administered at home.

lead_sponsor: CSL Behring

location_facility: Hôpital Gui de Chauliac - Montpellier University Hospital (CHU)

location_facility: Hôpital Nord - Saint Etienne University Hospital (CHU)

location_facility: Hôpital Pellegrin, Bordeaux University Hospital (CHU)

location_facility: Hôpital Pasteur 2 - Nice University Hospital (CHU)


title: Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non-Alcoholic Fatty Liver Disease (NAFLD)

acronym: FibroMR

summary: The main objective is to compare the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD.

lead_sponsor: Rennes University Hospital

location_facility:
CHU de Nantes
CHU d'Angers
CHU de Toulouse
CHD Vendée
Groupe Hospitalier Bretagne Sud
CHU de Bordeaux
CH de Saint Brieuc
Centre Hospitalier Bretagne Atlantique
CHU de Rennes


acronym: EMBRACE

title: A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Subjects With Manifestations of Plaque Psoriasis and Impaired Quality of Life

lead_sponsor: Amgen

type: Registry Identifier

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Spain
Italy
United Kingdom
Switzerland
France
Germany

summary: The primary objective of the study is to assess the impact of treatment with apremilast 30 mg twice daily for 16 weeks, compared to placebo, on health-related quality of life (QOL) in adults with manifestations of plaque psoriasis and impaired quality of life.


title: Characteristics and Evolution of Hospitalized Patients in Post-Resuscitation Rehabilitation Care Units (SRPR)

acronym: Cohorte-SRPR

summary:
Non-interventional cohort study (on data), prospective national multicenter. Inclusion of patients as they enter in a post-intensive care rehabilitation unit (SRPR) .

Collection of data after inclusion, from patients' records during their stay (weekly follow-up) to the SRPR and at their discharge, to D28, D90 and at 1 year after their hospitalization from hospital reports or call of the attending physician.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Raymond Poincaré de Garches - SRPR neurologique

location_facility: Hôpital Raymond Poincaré - SRPR pédiatrique

location_facility: Hôpital d'instruction des armées - Percy


title: Double Bind Randomized Placebo-controlled Cross-over Study to Evaluate Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease

acronym: APOMORPHEE

summary: The purpose of the study is to demonstrate that continuous apomorphine treatment during the night compared with placebo improves sleep quality in insomniac patient with Parkinson's disease.

ReferenceCitation: De Cock VC, Dodet P, Leu-Semenescu S, Aerts C, Castelnovo G, Abril B, Drapier S, Olivet H, Corbillé AG, Leclair-Visonneau L, Sallansonnet-Froment M, Lebouteux M, Anheim M, Ruppert E, Vitello N, Eusebio A, Lambert I, Marques A, Fantini ML, Devos D, Monaca C, Benard-Serre N, Lacombe S, Vidailhet M, Arnulf I, Doulazmi M, Roze E. Safety and efficacy of subcutaneous night-time only apomorphine infusion to treat insomnia in patients with Parkinson's disease (APOMORPHEE): a multicentre, randomised, controlled, double-blind crossover study. Lancet Neurol. 2022 May;21(5):428-437. doi: 10.1016/S1474-4422(22)00085-0.

lead_sponsor: Clinique Beau Soleil

location_facility:
Clinique Beau Soleil
CHU de NIMES
CHU de NANTES - HOPITAL NORD
Chu Ponchaillou
Hôpital de la TIMONE
Hôpital CIVIL
Hôpital de HAUTEPIERRE
Chu Gabriel Montpied
Centre hospitalier JACQUES LACARIN


title: Written Advice to Improve Compliance With Early Detection of Melanoma in First-degree Relatives: a Multicenter, Cluster-randomized Intervention Trial to Evaluate the Impact of Specific Incentives and Study Psychological Determinants of Early Melanoma Detection Behavior in First-degree Relatives

acronym: FADEMELA

summary: First-degree relatives of patients with melanoma have a greater risk of developing melanoma. Patients are advised orally to inform their first-degree relatives that they should protect their skin from UV radiation and ask for a skin examination from a general practitioner or dermatologist. The study will evaluate the effectiveness of a written sheet in addition to the usual oral counselling to increase acceptance of skin examination by the first-degree relatives. If effective, written counselling provided to the patient for relatives should be recommended and generalized.

primary_purpose: Screening

lead_sponsor: University Hospital, Tours

location_facility: CHRU BREST Hôpital du Morvan, Institut de Cancérologie et d'Hématologie

location_facility: CHU -RENNES -Service de Dermatologie-CHU Pontchaillou

location_facility: University Hospital of Tours, Service de Dermatologie

location_facility: CHU-Poitiers _LA MILETRIE POLE MEDIPOOL-DERMATO-ALLERGOLOGIE

location_facility: GH La Rochelle Ré Aunis-Service de Dermatologie

location_facility: Centre Eugène Marquis -Service d'Oncologie médicale


acronym: SEAT

title: Impact of the Use of Biomarkers on Early Discontinuation of Empirical Antifungal Therapy in Critically Ill Patients: a Randomized Controlled Study.

lead_sponsor: University Hospital, Lille

location_facility:
CH Dunkerque
CHU de Rouen
CH ARRAS
CH de DOUAI
Ch Dr.Schaffner de Lens
Ch Tourcoing
Centre hospitalier de valenciennes
Hôpital Roger Salengro, CHU
Centre Hospitalier Dr Schaffner
CH Roubaix

summary:
Empirical antifungal therapy (EAT) is frequently prescribed to septic critically ill patients with risk factors for invasive Candida infections (ICI). However, among patients without subsequent proven ICI, antifungal discontinuation is rarely performed, resulting in unnecessary antifungal overuse.

The investigators postulate that the use of fungal biomarkers could increase the percentage of early discontinuation of EAT among critically ill patients suspected of ICI, as compared with a standard strategy, without negative impact on day 28-mortality.

To test this hypothesis, the investigators designed a randomized controlled open-label parallel-group study.


title: A Study to Assess Efficacy and Safety of Pioglitazone as Add-On Therapy to Imatinib Mesylate in CP-CML Patients in Major Molecular Response

acronym: ACTIM

summary:
This project is a Phase II clinical trial that aims at evaluating efficacy and tolerance of the combination of pioglitazone (Actos®) and imatinib mesylate (STI571, CGP57148, Gleevec®) in patients with Chronic Myelogenous Leukemia (CML) in stable major molecular response (i.e. a BCRABL/ABL ratio assessed by RTQ-PCR equal to or lower than 0.1% according to the European Leukemia Net recommendations) after at least 2 years of therapy with imatinib.

Imatinib mesylate (Gleevec®) is the gold standard for the treatment of CML in chronic phase (O Brian et al. 2003, Druker et al. 2006). Despite a high efficacy of the drug, CML is not eradicated by imatinib alone in almost any of the patients.

Treatment discontinuation in patients treated by imatinib and in complete molecular remission for more than 2 years yield molecular relapses within 6 months in half of the patients,indicating the persistence of CML progenitor cells. STAT5 expression is required for CML stem cell engraftment and expansion in mouse models. STAT5 is the target of the dysregulated activity of BCR-ABL in CML.

Recently, Stephane Prost et al. demonstrated that PPAR-γ is a negative regulator of STAT5A and STAT5B gene expression. Data obtained suggest that PPAR-γ agonists may have potential therapeutic value in reversing myeloproliferative disorders. On the basis of our preclinical studies, we went ahead and administered pioglitazone to one patient who suffered from both diabetes type II and CML with residual disease after continuous treatment with Gleevec. The amount of BCR-ABL transcript detected by QPCR decreased dramatically during the first 3 months of combined (Gleevec + ACTOS) therapy to become undetectable thereafter until 9 months post-treatment, the latest time point assessed. This striking anecdotal result now forms the rationale for filing this formal Phase II clinical trial application.

lead_sponsor: Versailles Hospital

location_facility:
Institut Bergonié
CHU Purpan
CHU archet 1
CH Versailles
IPC
CHU Lille
CHU Poitiers
St Louis
CHR Annecy


title: Comparaison de la Douleur Lors de la Pose Des DIU et SIU Entre la méthode Classique et la méthode Directe

acronym: KIDDS

summary:
The so-called "direct" method of intrauterine device (IUD) and intraintuerine system (IUS) insertion is increasingly used. A study has shown that it is technically simpler and assumes less painful than the classic pose.

It seems interesting to compare the pain felt by the patients during IUD / IUS insertion in these two methods of placement and also to confirm that there is no more malposition with the direct method.

ReferenceCitation: Golightly E, Gebbie AE. Low-lying or malpositioned intrauterine devices and systems. J Fam Plann Reprod Health Care. 2014 Apr;40(2):108-12. doi: 10.1136/jfprhc-2013-100684. Epub 2014 Jan 6. Review.

ReferenceCitation: Heinemann K, Reed S, Moehner S, Minh TD. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contraception.2015.01.007. Epub 2015 Jan 16.

ReferenceCitation: Braaten KP, Benson CB, Maurer R, Goldberg AB. Malpositioned intrauterine contraceptive devices: risk factors, outcomes, and future pregnancies. Obstet Gynecol. 2011 Nov;118(5):1014-1020. doi: 10.1097/AOG.0b013e3182316308.

ReferenceCitation: Teal SB, Romer SE. Awareness of long-acting reversible contraception among teens and young adults. J Adolesc Health. 2013 Apr;52(4 Suppl):S35-9. doi: 10.1016/j.jadohealth.2013.01.013. Review.

location_facility:
Centre de Santé Gatineau Saillant
Liberal Cabinet Midwife
CIVG Hôpital Avicenne
Medical Office Gynecology
Hôpital Trousseau
ACSBE-La place santé
CIVG Hôpital Louis Mourier
Medical Practice General Practice
CPEF


title: Doppler Flow Classification of Saint-Bonnet : A Non Interventional Clinical Trial

acronym: Saint-Bonnet

summary: Observational Study that evaluates the interest of Doppler waveforms classification in Peripheral Artery disease

location_facility:
CHU de Caen
CH de Vichy
CHU Brest
CHU de Grenoble
CHU de Toulouse
CHU de Bordeaux
CHU de Limoges
CHU de Saint-Etienne
CHU Amiens
CHU de Rennes


title: RNASARC - Molecular Screening Program of Soft Tissue Sarcomas With Complex Genomic Profile to Detect NTRK1/2/3, ROS1 or ALK Gene Fusions.

acronym: RNASARC

summary: This trial is a multicenter, prospective cohort study aiming to describe molecular profiles of soft tissue sarcoma (STS) with complex genomic profiles in particular to assess the incidence of NTRK1/2/3, ROS1 or ALK gene fusions to direct such patients through an ongoing clinical trial with entrectinib when appropriate. An exploratory translational program is also correlated to this trial in order to analyse immune gene expression.

ReferenceCitation: Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, Adkins D, Agulnik M, Cooney MM, Livingston MB, Pennock G, Hameed MR, Shah GD, Qin A, Shahir A, Cronier DM, Ilaria R Jr, Conti I, Cosaert J, Schwartz GK. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016 Jul 30;388(10043):488-97. doi: 10.1016/S0140-6736(16)30587-6. Epub 2016 Jun 9. Erratum in: Lancet. 2016 Jul 30;388(10043):464.

ReferenceCitation: Jain S, Xu R, Prieto VG, Lee P. Molecular classification of soft tissue sarcomas and its clinical applications. Int J Clin Exp Pathol. 2010 Apr 23;3(4):416-28. Review.

ReferenceCitation: Fleitas T, Ibarrola-Villava M, Ribas G, Cervantes A. MassARRAY determination of somatic oncogenic mutations in solid tumors: Moving forward to personalized medicine. Cancer Treat Rev. 2016 Sep;49:57-64. doi: 10.1016/j.ctrv.2016.07.007. Epub 2016 Jul 29. Review.

ReferenceCitation: Schmidt KT, Chau CH, Price DK, Figg WD. Precision Oncology Medicine: The Clinical Relevance of Patient-Specific Biomarkers Used to Optimize Cancer Treatment. J Clin Pharmacol. 2016 Dec;56(12):1484-1499. doi: 10.1002/jcph.765. Epub 2016 Jun 17. Review.

ReferenceCitation: Nakagawara A. Trk receptor tyrosine kinases: a bridge between cancer and neural development. Cancer Lett. 2001 Aug 28;169(2):107-14. Review.

ReferenceCitation: Pulciani S, Santos E, Lauver AV, Long LK, Aaronson SA, Barbacid M. Oncogenes in solid human tumours. Nature. 1982 Dec 9;300(5892):539-42.

ReferenceCitation: Martin-Zanca D, Hughes SH, Barbacid M. A human oncogene formed by the fusion of truncated tropomyosin and protein tyrosine kinase sequences. Nature. 1986 Feb 27-Mar 5;319(6056):743-8.

ReferenceCitation: Shaw AT, Ou SH, Bang YJ, Camidge DR, Solomon BJ, Salgia R, Riely GJ, Varella-Garcia M, Shapiro GI, Costa DB, Doebele RC, Le LP, Zheng Z, Tan W, Stephenson P, Shreeve SM, Tye LM, Christensen JG, Wilner KD, Clark JW, Iafrate AJ. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Nov 20;371(21):1963-71. doi: 10.1056/NEJMoa1406766. Epub 2014 Sep 27.

ReferenceCitation: Shaw AT, Kim DW, Mehra R, Tan DS, Felip E, Chow LQ, Camidge DR, Vansteenkiste J, Sharma S, De Pas T, Riely GJ, Solomon BJ, Wolf J, Thomas M, Schuler M, Liu G, Santoro A, Lau YY, Goldwasser M, Boral AL, Engelman JA. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Mar 27;370(13):1189-97. doi: 10.1056/NEJMoa1311107.

ReferenceCitation: Vaishnavi A, Le AT, Doebele RC. TRKing down an old oncogene in a new era of targeted therapy. Cancer Discov. 2015 Jan;5(1):25-34. doi: 10.1158/2159-8290.CD-14-0765. Epub 2014 Dec 19. Review.

ReferenceCitation: Doebele RC, Davis LE, Vaishnavi A, Le AT, Estrada-Bernal A, Keysar S, Jimeno A, Varella-Garcia M, Aisner DL, Li Y, Stephens PJ, Morosini D, Tuch BB, Fernandes M, Nanda N, Low JA. An Oncogenic NTRK Fusion in a Patient with Soft-Tissue Sarcoma with Response to the Tropomyosin-Related Kinase Inhibitor LOXO-101. Cancer Discov. 2015 Oct;5(10):1049-57. doi: 10.1158/2159-8290.CD-15-0443. Epub 2015 Jul 27.

ReferenceType: result

ReferenceCitation: Judson I, Verweij J, Gelderblom H, Hartmann JT, Schöffski P, Blay JY, Kerst JM, Sufliarsky J, Whelan J, Hohenberger P, Krarup-Hansen A, Alcindor T, Marreaud S, Litière S, Hermans C, Fisher C, Hogendoorn PC, dei Tos AP, van der Graaf WT; European Organisation and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014 Apr;15(4):415-23. doi: 10.1016/S1470-2045(14)70063-4. Epub 2014 Mar 5.

ReferenceCitation: Ryan CW, Merimsky O, Agulnik M, Blay JY, Schuetze SM, Van Tine BA, Jones RL, Elias AD, Choy E, Alcindor T, Keedy VL, Reed DR, Taub RN, Italiano A, Garcia Del Muro X, Judson IR, Buck JY, Lebel F, Lewis JJ, Maki RG, Schöffski P. PICASSO III: A Phase III, Placebo-Controlled Study of Doxorubicin With or Without Palifosfamide in Patients With Metastatic Soft Tissue Sarcoma. J Clin Oncol. 2016 Nov 10;34(32):3898-3905. doi: 10.1200/JCO.2016.67.6684. Epub 2016 Sep 30.

lead_sponsor: Centre Leon Berard

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

intervention_type: Genetic


title: Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera

acronym: RETICERA

summary: Patients under hemodialysis treatment are mostly treated by erythropoietin (EPO) through erythropoiesis stimulating agents (ESA). The objective of ESA treatments is to maintain the hemoglobin level in a therapeutic target around 11g/dl. The EPO dose that is necessary to reach this target depends on numerous and imbricated factors such as age, associated pathologies, iron status, inflammation. As of today, there is no marker to predict the EPO response and Hemoglobin (Hb) level is currently the only and late tool to assess the efficacy.

location_facility:
CH Bretagne Sud
CHRU de Poitiers
AUB Brest
CHU Angers
CHU Pontchaillou
CH Yves LE FOLL
CHRU La Cavale Blanche
Ch Broussais
CH Cornouaille


title: Application of Telemedicine to the Management of Aggressive Lymphomas: a Regional Comparative Study

acronym: AMA

summary: The purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the duration without progression. The study covers 350 patients recruited from 10 regional centers.

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: University Hospital, Toulouse

location_facility:
Clinique Marzet
Tarbes Hospital
Clinique Saint Jean
Rodez Hospital
University Hospital of Toulouse
Bayonne Hospital
University Hospital Bordeaux
Hospital
Clinique Claude Bernard


title: Efficiency Clinical Study of NOVATEX MEDICAL Compression Garments in Patients With Ehlers-Danlos Syndrome

acronym: NOVASED

summary:
Objective of this study is to assess the efficiency of NOVATEX MEDICAL compression garments in patients with an Ehlers-Danlos syndrome (EDS).

To answer this objectif a comparison before/after use of compression garments will be performed for all patients.

lead_sponsor: Novatex Medical

location_facility: Chu de Marseille - Hôpital de La Conception


title: Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer

summary: This prospective, multicenter, observational study aims to explore a comprehensive approach to the care of early breast cancer patients in a regional health territory (including 1.5 million women and characterized by a breast cancer incidence and mortality higher than national ranges), incorporating all healthcare actors inside and outside the hospital.

ReferenceCitation: Arfi A, Baffert S, Soilly AL, Huchon C, Reyal F, Asselain B, Neffati S, Rouzier R, Héquet D. Determinants of return at work of breast cancer patients: results from the OPTISOINS01 French prospective study. BMJ Open. 2018 May 18;8(5):e020276. doi: 10.1136/bmjopen-2017-020276.

lead_sponsor: Institut Curie

location_facility:
René Dubos Hospital
Victor Dupouy Hospital
Poissy Interegional Hospital Center
Institut Curie - René Huguenin Hospital
Louis Mourier Hospital
André Mignot Hospital - Versailles
Bichat Beaujon University Hospital
Antoine Béclère Hospital
Institut Curie


title: Conduct of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure: a Multicentre Observational Study

acronym: DECIPHEROBS

summary: Although many studies have investigated the clinical benefits of nasal high flow during acute hypoxemic respiratory failure, there is no data (and even less so recommendations) on how to best conduct this technique, including its initiation and its weaning periods. Investigators will assess in a multicenter, observational study, the way clinicians use nasal high flow therapy in patients with acute respiratory failure in order to try identify one or more strategies that may be then compared in an interventional study.

time_perspective: Other

ReferenceCitation: Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Béduneau G, Delétage-Métreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

ReferenceCitation: Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.

ReferenceCitation: Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.

ReferenceCitation: Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.

ReferenceCitation: Roca O, Messika J, Caralt B, García-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31.

lead_sponsor: Hôpital Louis Mourier

location_facility: Service de Réanimation Médicale et Resiratoire

location_facility: Service de Réanimation Médico-Chirurgicale


title: Evaluation of the Initial Prescription of Ketamine and Milnacipran Forin Depression in Patients With a Progressive Disease

acronym: KETAPAL

summary: KetaPal is a placebo-controlled randomized trial designed to demonstrate the antidepressant action of ketamine in palliative care situations. Half of participants will receive Ketamine and Milnacipran in combination, while the other half will receive a Placebo and Milnacipran in combination.

ReferenceCitation: Temel JS, Greer JA, Admane S, Gallagher ER, Jackson VA, Lynch TJ, Lennes IT, Dahlin CM, Pirl WF. Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care. J Clin Oncol. 2011 Jun 10;29(17):2319-26. doi: 10.1200/JCO.2010.32.4459. Epub 2011 May 9.

ReferenceCitation: Lépine JP, Gasquet I, Kovess V, Arbabzadeh-Bouchez S, Nègre-Pagès L, Nachbaur G, Gaudin AF. [Prevalence and comorbidity of psychiatric disorders in the French general population]. Encephale. 2005 Mar-Apr;31(2):182-94. French.

ReferenceCitation: Mitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, Meader N. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011 Feb;12(2):160-74. doi: 10.1016/S1470-2045(11)70002-X. Epub 2011 Jan 19.

ReferenceCitation: Atassi N, Cook A, Pineda CM, Yerramilli-Rao P, Pulley D, Cudkowicz M. Depression in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2011 Mar;12(2):109-12. doi: 10.3109/17482968.2010.536839. Epub 2010 Nov 24.

ReferenceCitation: Rutledge T, Reis VA, Linke SE, Greenberg BH, Mills PJ. Depression in heart failure a meta-analytic review of prevalence, intervention effects, and associations with clinical outcomes. J Am Coll Cardiol. 2006 Oct 17;48(8):1527-37. Epub 2006 Sep 26.

ReferenceCitation: Araujo SM, de Bruin VM, Daher Ede F, Almeida GH, Medeiros CA, de Bruin PF. Risk factors for depressive symptoms in a large population on chronic hemodialysis. Int Urol Nephrol. 2012 Aug;44(4):1229-35. doi: 10.1007/s11255-011-0032-9. Epub 2011 Jul 22.

ReferenceCitation: Koenig HG, George LK, Peterson BL, Pieper CF. Depression in medically ill hospitalized older adults: prevalence, characteristics, and course of symptoms according to six diagnostic schemes. Am J Psychiatry. 1997 Oct;154(10):1376-83.

ReferenceCitation: Lloyd-Williams M, Friedman T, Rudd N. A survey of antidepressant prescribing in the terminally ill. Palliat Med. 1999 May;13(3):243-8.

ReferenceCitation: Goldberg RJ, Mor V. A survey of psychotropic use in terminal cancer patients. Psychosomatics. 1985 Sep;26(9):745-8, 751.

ReferenceCitation: Rumsfeld JS, Havranek E, Masoudi FA, Peterson ED, Jones P, Tooley JF, Krumholz HM, Spertus JA; Cardiovascular Outcomes Research Consortium. Depressive symptoms are the strongest predictors of short-term declines in health status in patients with heart failure. J Am Coll Cardiol. 2003 Nov 19;42(10):1811-7.

ReferenceCitation: Cubo E, Bernard B, Leurgans S, Raman R. Cognitive and motor function in patients with Parkinson's disease with and without depression. Clin Neuropharmacol. 2000 Nov-Dec;23(6):331-4.

ReferenceCitation: Lyketsos CG, Steele C, Baker L, Galik E, Kopunek S, Steinberg M, Warren A. Major and minor depression in Alzheimer's disease: prevalence and impact. J Neuropsychiatry Clin Neurosci. 1997 Fall;9(4):556-61.

ReferenceCitation: Aimonino N, Tibaldi V, Barale S, Bardelli B, Pilon S, Marchetto C, Zanocchi M, Molaschi M. Depressive symptoms and quality of life in elderly patients with exacerbation of chronic obstructive pulmonary disease or cardiac heart failure: preliminary data of a randomized controlled trial. Arch Gerontol Geriatr. 2007;44 Suppl 1:7-12.

ReferenceCitation: Newport DJ, Nemeroff CB. Assessment and treatment of depression in the cancer patient. J Psychosom Res. 1998 Sep;45(3):215-37. Review.

ReferenceCitation: Rhondali W, Perceau E, Berthiller J, Saltel P, Trillet-Lenoir V, Tredan O, Coulon JP, Bruera E, Filbet M. Frequency of depression among oncology outpatients and association with other symptoms. Support Care Cancer. 2012 Nov;20(11):2795-802. doi: 10.1007/s00520-012-1401-3. Epub 2012 Feb 17.

ReferenceCitation: Onitilo AA, Nietert PJ, Egede LE. Effect of depression on all-cause mortality in adults with cancer and differential effects by cancer site. Gen Hosp Psychiatry. 2006 Sep-Oct;28(5):396-402.

ReferenceCitation: Satin JR, Linden W, Phillips MJ. Depression as a predictor of disease progression and mortality in cancer patients: a meta-analysis. Cancer. 2009 Nov 15;115(22):5349-61. doi: 10.1002/cncr.24561.

ReferenceCitation: Lloyd-Williams M, Shiels C, Taylor F, Dennis M. Depression--an independent predictor of early death in patients with advanced cancer. J Affect Disord. 2009 Feb;113(1-2):127-32. doi: 10.1016/j.jad.2008.04.002. Epub 2008 Jun 16.

ReferenceCitation: DiMatteo MR, Lepper HS, Croghan TW. Depression is a risk factor for noncompliance with medical treatment: meta-analysis of the effects of anxiety and depression on patient adherence. Arch Intern Med. 2000 Jul 24;160(14):2101-7.

ReferenceCitation: Blank K, Robison J, Doherty E, Prigerson H, Duffy J, Schwartz HI. Life-sustaining treatment and assisted death choices in depressed older patients. J Am Geriatr Soc. 2001 Feb;49(2):153-61.

ReferenceCitation: Rosenfeld KE, Wenger NS, Phillips RS, Connors AF, Dawson NV, Layde P, Califf RM, Liu H, Lynn J, Oye RK. Factors associated with change in resuscitation preference of seriously ill patients. The SUPPORT Investigators. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. Arch Intern Med. 1996 Jul 22;156(14):1558-64.

ReferenceCitation: Breitbart W, Rosenfeld B, Pessin H, Kaim M, Funesti-Esch J, Galietta M, Nelson CJ, Brescia R. Depression, hopelessness, and desire for hastened death in terminally ill patients with cancer. JAMA. 2000 Dec 13;284(22):2907-11.

ReferenceCitation: Haverkate I, Onwuteaka-Philipsen BD, van Der Heide A, Kostense PJ, van Der Wal G, van Der Maas PJ. Refused and granted requests for euthanasia and assisted suicide in the Netherlands: interview study with structured questionnaire. BMJ. 2000 Oct 7;321(7265):865-6.

ReferenceCitation: Meier DE, Emmons CA, Litke A, Wallenstein S, Morrison RS. Characteristics of patients requesting and receiving physician-assisted death. Arch Intern Med. 2003 Jul 14;163(13):1537-42.

ReferenceCitation: Buiting HM, Gevers JK, Rietjens JA, Onwuteaka-Philipsen BD, van der Maas PJ, van der Heide A, van Delden JJ. Dutch criteria of due care for physician-assisted dying in medical practice: a physician perspective. J Med Ethics. 2008 Sep;34(9):e12. doi: 10.1136/jme.2008.024976.

ReferenceCitation: Rietjens JA, van der Maas PJ, Onwuteaka-Philipsen BD, van Delden JJ, van der Heide A. Two Decades of Research on Euthanasia from the Netherlands. What Have We Learnt and What Questions Remain? J Bioeth Inq. 2009 Sep;6(3):271-283. Epub 2009 Jul 28.

ReferenceCitation: Emanuel LL. Facing requests for physician-assisted suicide: toward a practical and principled clinical skill set. JAMA. 1998 Aug 19;280(7):643-7.

ReferenceCitation: Rayner L, Price A, Hotopf M, Higginson IJ. The development of evidence-based European guidelines on the management of depression in palliative cancer care. Eur J Cancer. 2011 Mar;47(5):702-12. doi: 10.1016/j.ejca.2010.11.027. Epub 2011 Jan 4. Review.

ReferenceCitation: Rayner L, Price A, Evans A, Valsraj K, Hotopf M, Higginson IJ. Antidepressants for the treatment of depression in palliative care: systematic review and meta-analysis. Palliat Med. 2011 Jan;25(1):36-51. doi: 10.1177/0269216310380764. Epub 2010 Oct 8. Review.

ReferenceCitation: Ujeyl M, Müller-Oerlinghausen B. [Antidepressants for treatment of depression in palliative patients : a systematic literature review]. Schmerz. 2012 Sep;26(5):523-36. doi: 10.1007/s00482-012-1221-x. Review. German.

ReferenceCitation: Willner P, Scheel-Krüger J, Belzung C. The neurobiology of depression and antidepressant action. Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 1):2331-71. doi: 10.1016/j.neubiorev.2012.12.007. Epub 2012 Dec 19. Review.

ReferenceCitation: Mion G, Villevieille T. Ketamine pharmacology: an update (pharmacodynamics and molecular aspects, recent findings). CNS Neurosci Ther. 2013 Jun;19(6):370-80. doi: 10.1111/cns.12099. Epub 2013 Apr 10.

ReferenceCitation: Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64.

ReferenceCitation: Li N, Lee B, Liu RJ, Banasr M, Dwyer JM, Iwata M, Li XY, Aghajanian G, Duman RS. mTOR-dependent synapse formation underlies the rapid antidepressant effects of NMDA antagonists. Science. 2010 Aug 20;329(5994):959-64. doi: 10.1126/science.1190287.

ReferenceCitation: Li N, Liu RJ, Dwyer JM, Banasr M, Lee B, Son H, Li XY, Aghajanian G, Duman RS. Glutamate N-methyl-D-aspartate receptor antagonists rapidly reverse behavioral and synaptic deficits caused by chronic stress exposure. Biol Psychiatry. 2011 Apr 15;69(8):754-61. doi: 10.1016/j.biopsych.2010.12.015. Epub 2011 Feb 3.

ReferenceCitation: Monteggia LM, Gideons E, Kavalali ET. The role of eukaryotic elongation factor 2 kinase in rapid antidepressant action of ketamine. Biol Psychiatry. 2013 Jun 15;73(12):1199-203. doi: 10.1016/j.biopsych.2012.09.006. Epub 2012 Oct 11. Review.

ReferenceCitation: Beurel E, Song L, Jope RS. Inhibition of glycogen synthase kinase-3 is necessary for the rapid antidepressant effect of ketamine in mice. Mol Psychiatry. 2011 Nov;16(11):1068-70. doi: 10.1038/mp.2011.47. Epub 2011 Apr 19.

ReferenceCitation: Li X, Jope RS. Is glycogen synthase kinase-3 a central modulator in mood regulation? Neuropsychopharmacology. 2010 Oct;35(11):2143-54. doi: 10.1038/npp.2010.105. Epub 2010 Jul 28. Review.

ReferenceCitation: Akinfiresoye L, Tizabi Y. Antidepressant effects of AMPA and ketamine combination: role of hippocampal BDNF, synapsin, and mTOR. Psychopharmacology (Berl). 2013 Nov;230(2):291-8. doi: 10.1007/s00213-013-3153-2. Epub 2013 Jun 4.

ReferenceCitation: Autry AE, Adachi M, Nosyreva E, Na ES, Los MF, Cheng PF, Kavalali ET, Monteggia LM. NMDA receptor blockade at rest triggers rapid behavioural antidepressant responses. Nature. 2011 Jun 15;475(7354):91-5. doi: 10.1038/nature10130.

ReferenceCitation: Koike H, Iijima M, Chaki S. Involvement of AMPA receptor in both the rapid and sustained antidepressant-like effects of ketamine in animal models of depression. Behav Brain Res. 2011 Oct 10;224(1):107-11. doi: 10.1016/j.bbr.2011.05.035. Epub 2011 Jun 6.

ReferenceCitation: Rasmussen KG, Lineberry TW, Galardy CW, Kung S, Lapid MI, Palmer BA, Ritter MJ, Schak KM, Sola CL, Hanson AJ, Frye MA. Serial infusions of low-dose ketamine for major depression. J Psychopharmacol. 2013 May;27(5):444-50. doi: 10.1177/0269881113478283. Epub 2013 Feb 20.

ReferenceCitation: Price RB, Nock MK, Charney DS, Mathew SJ. Effects of intravenous ketamine on explicit and implicit measures of suicidality in treatment-resistant depression. Biol Psychiatry. 2009 Sep 1;66(5):522-6. doi: 10.1016/j.biopsych.2009.04.029. Epub 2009 Jul 9.

ReferenceCitation: Thakurta RG, Das R, Bhattacharya AK, Saha D, Sen S, Singh OP, Bisui B. Rapid response with ketamine on suicidal cognition in resistant depression. Indian J Psychol Med. 2012 Apr;34(2):170-5. doi: 10.4103/0253-7176.101793.

ReferenceCitation: Glue P, Gulati A, Le Nedelec M, Duffull S. Dose- and exposure-response to ketamine in depression. Biol Psychiatry. 2011 Aug 15;70(4):e9-10; author reply e11-2. doi: 10.1016/j.biopsych.2010.11.031. Epub 2011 Apr 8.

ReferenceCitation: Loo CK, Katalinic N, Garfield JB, Sainsbury K, Hadzi-Pavlovic D, Mac-Pherson R. Neuropsychological and mood effects of ketamine in electroconvulsive therapy: a randomised controlled trial. J Affect Disord. 2012 Dec 15;142(1-3):233-40. doi: 10.1016/j.jad.2012.04.032. Epub 2012 Aug 2.

ReferenceCitation: Thakurta RG, Ray P, Kanji D, Das R, Bisui B, Singh OP. Rapid Antidepressant Response with Ketamine: Is it the Solution to Resistant Depression? Indian J Psychol Med. 2012 Jan;34(1):56-60. doi: 10.4103/0253-7176.96161.

ReferenceCitation: Murrough JW, Perez AM, Pillemer S, Stern J, Parides MK, aan het Rot M, Collins KA, Mathew SJ, Charney DS, Iosifescu DV. Rapid and longer-term antidepressant effects of repeated ketamine infusions in treatment-resistant major depression. Biol Psychiatry. 2013 Aug 15;74(4):250-6. doi: 10.1016/j.biopsych.2012.06.022. Epub 2012 Jul 27.

ReferenceCitation: Cusin C, Hilton GQ, Nierenberg AA, Fava M. Long-term maintenance with intramuscular ketamine for treatment-resistant bipolar II depression. Am J Psychiatry. 2012 Aug;169(8):868-9. doi: 10.1176/appi.ajp.2012.12020219.

ReferenceCitation: Paslakis G, Gilles M, Meyer-Lindenberg A, Deuschle M. Oral administration of the NMDA receptor antagonist S-ketamine as add-on therapy of depression: a case series. Pharmacopsychiatry. 2010 Jan;43(1):33-5. doi: 10.1055/s-0029-1237375. Epub 2009 Dec 11.

ReferenceCitation: Murrough JW, Iosifescu DV, Chang LC, Al Jurdi RK, Green CE, Perez AM, Iqbal S, Pillemer S, Foulkes A, Shah A, Charney DS, Mathew SJ. Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial. Am J Psychiatry. 2013 Oct;170(10):1134-42. doi: 10.1176/appi.ajp.2013.13030392.

ReferenceCitation: Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpää M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7. Review.

ipd_sharing_description: Undecided yet

location_facility: Groupt Hopitaux Instit Catho de Lille - Lomme


title: Early Post Hospital Discharge Psychomotor Therapy Intervention Program: Effect on the Development in Very Preterm Infants at 2-years Corrected Age

acronym: VPI

summary: Our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive disorders and unbalanced between brain and brainstem maturation of the neonatal period involve an early deviant development for immature infants that will be cascaded through the brain scaffolding and later development. The primary purpose is to determine whether the Early Psychomotor Therapy Intervention Program improves development and behavior in very preterm infants (VPI) at 24-month corrected age (CA).

ReferenceCitation: Shevell MI, Bodensteiner JB. Cerebral palsy: defining the problem. Semin Pediatr Neurol. 2004 Mar;11(1):2-4. Review.

ReferenceCitation: Hagberg B, Hagberg G, Beckung E, Uvebrant P. Changing panorama of cerebral palsy in Sweden. VIII. Prevalence and origin in the birth year period 1991-94. Acta Paediatr. 2001 Mar;90(3):271-7.

ReferenceCitation: Nelson KB. Can we prevent cerebral palsy? N Engl J Med. 2003 Oct 30;349(18):1765-9.

ReferenceCitation: Jacobsson B, Hagberg G. Antenatal risk factors for cerebral palsy. Best Pract Res Clin Obstet Gynaecol. 2004 Jun;18(3):425-36. Review.

ReferenceCitation: Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23.

ReferenceCitation: Weisglas-Kuperus N, Koot HM, Baerts W, Fetter WP, Sauer PJ. Behaviour problems of very low-birthweight children. Dev Med Child Neurol. 1993 May;35(5):406-16. Review.

location_facility: CHIVA centre hospitalier du val d'Ariège