title: Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.

summary:
Non-small cell lung cancer (NSCLC) is a major public health problem. New treatments as immunotherapy can improve prognosis of patients with NCLC tumors. Nevertheless, no robust biomarker is actually available.

The hypothesis of the trial is to realize a longitudinal molecular monitoring of NSCLC patients treated by immunotherapy using a quantitative analysis of cell-free DNA.

The primary purposes is to study the predictive value of quantification of cell-free DNA at the first reevaluation time, on the clinical benefit, in NSCLC patients treated by immunotherapy (regardless of line, or associated treatments) The secondary purposes in this population of patients is to study the earlier predictive value (before the second treatment by immunotherapy ) of quantification of cell-free DNA, and its relationship with refractory disease and pseudo-progressive disease.

location_facility: CHU de Besancon - Service de pneumologie

location_facility: GHR Mulhouse Sud-Alsace - Service de Pneumologie

location_facility: Hopitaux Civils de Colmar - service de Pneumologie

intervention_type: Genetic


title: Validation of the RADIAL Algorithm for Diagnosis of Autosomal Recessive Cerebellar Ataxia

acronym: RADIAL-VALID

summary: RADIAL is an algorithm which has been developed following a review of the literature on 67 autosomal recessive cerebellar ataxias (ARCA) and personal clinical experience. Frequency and specificity of each feature were defined for each autosomal recessive cerebellar ataxia, and corresponding prediction scores were assigned. Clinical and paraclinical features of patients are entered into the algorithm, and a patient's total score for each ARCA is calculated, producing a ranking of possible diagnoses. Sensitivity and specificity of the algorithm were assessed by blinded analysis of a multinational cohort of 834 patients with molecularly confirmed autosomal recessive cerebellar ataxia. The performance of the algorithm was assessed versus a blinded panel of autosomal recessive cerebellar ataxia experts. The correct diagnosis was ranked within the top 3 highest-scoring diagnoses at a sensitivity and specificity of >90% for 84% and 91% of the evaluated genes, respectively. Mean sensitivity and specificity of the top 3 highest-scoring diagnoses were 92% and 95%, respectively. Our aim is now to validate in a prospective cohort of ARCA, the performance of RADIAL to predict the correct genetic diagnosis.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Strasbourg, France

location_facility: CHRU de Strasbourg - Neurology/Pediatrics

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Program for Improved Family Screening for Colorectal Cancer

summary: A first- degree family history of colorectal cancer (CRC) or adenoma before age 65 is associated with a high risk of CRC. For these high-risk subjects, the French 2013 recommendations advise colonoscopy screening, but participation is insufficient (26-54%).The purpose of this project is to propose, through association of multidisciplinary research teams (public health, sociology, linguistic), actors on the field (physicians, organized screening facilities), and decision makers, relevant and effective interventions in the framework of a public health program, enabling increased participation of relatives of patients with CRC or adenoma before age 65 in targeted screening for CRC by colonoscopy.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Butterworth AS, Higgins JP, Pharoah P. Relative and absolute risk of colorectal cancer for individuals with a family history: a meta-analysis. Eur J Cancer. 2006 Jan;42(2):216-27. Epub 2005 Dec 9. Review.

ReferenceCitation: Ingrand I, Defossez G, Richer JP, Tougeron D, Palierne N, Letard JC, Beauchant M, Ingrand P. Colonoscopy uptake for high-risk individuals with a family history of colorectal neoplasia: A multicenter, randomized trial of tailored counseling versus standard information. Medicine (Baltimore). 2016 Aug;95(33):e4303. doi: 10.1097/MD.0000000000004303.

ReferenceCitation: Taouqi M, Ingrand I, Beauchant M, Migeot V, Ingrand P. Determinants of participation in colonoscopic screening by siblings of colorectal cancer patients in France. BMC Cancer. 2010 Jul 6;10:355. doi: 10.1186/1471-2407-10-355.

ReferenceCitation: Ingrand I, Dujoncquoy S, Beauchant M, Letard JC, Migeot V, Ingrand P. General practitioner and specialist views on colonoscopic screening of first-degree relatives of colorectal cancer patients. Cancer Epidemiol. 2009 Oct;33(3-4):223-30. doi: 10.1016/j.canep.2009.07.002. Epub 2009 Aug 3.

ReferenceCitation: Ingrand I, Dujoncquoy S, Migeot V, Ghadi V, Beauchant M, Ingrand P. Interactions among physicians, patients, and first-degree relatives in the familial screening of colorectal cancer in France. Patient Prefer Adherence. 2008 Feb 2;2:47-55.

ReferenceCitation: Ng SC, Lau JY, Chan FK, Suen BY, Tse YK, Hui AJ, Leung-Ki EL, Ching JY, Chan AW, Wong MC, Ng SS, To KF, Wu JC, Sung JJ. Risk of Advanced Adenomas in Siblings of Individuals With Advanced Adenomas: A Cross-Sectional Study. Gastroenterology. 2016 Mar;150(3):608-16; quiz e16-7. doi: 10.1053/j.gastro.2015.11.003. Epub 2015 Nov 14.

lead_sponsor: Poitiers University Hospital

intervention_type: Behavioral


title: Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test

acronym: HeMO

summary: Colorectal cancer screening by faecal occult blood test (FOBT) is a high public health priority. The interest of guaiac tests (G-FOBT) is limited by their poor sensitivity, while the superiority of I-FOBT in comparison with G-FOBT is now established. Nevertheless automated quantitative I-FOBTs have not been compared, and the optimal number of samples and threshold is not yet fixed. The aim of this study is to compare the performances of the 2 more well-known I-FOBTs with automated analyzers (magstream by Fujirebio, and OC Sensor by Eiken) for different positivity thresholds and numbers of samples in general average risk population. Patients will performed a two samples Magstream, a two samples OC Sensor and Hemoccult II. In case of a positive test, a colonoscopy will be performed. Sensitivity and specificity for detection of cancer and advanced neoplasias will be compared between tests using ratio of sensitivities (RSN) and ratio of false positives (RFP) according to number of samples and positivity threshold.

status: Completed

study_completion_date_type: Actual

primary_purpose: Screening

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Raginel T, Puvinel J, Ferrand O, Bouvier V, Levillain R, Ruiz A, Lantieri O, Launoy G, Guittet L. A population-based comparison of immunochemical fecal occult blood tests for colorectal cancer screening. Gastroenterology. 2013 May;144(5):918-25. doi: 10.1053/j.gastro.2013.01.042. Epub 2013 Feb 1.

family: Raginel

full_name: Thibaut Raginel

given: Thibaut

sequence: first

family: Puvinel

full_name: Josette Puvinel

given: Josette

sequence: additional

family: Ferrand

full_name: Olivier Ferrand

given: Olivier

family: Bouvier

full_name: Veronique Bouvier

given: Veronique

family: Levillain

full_name: Romuald Levillain

given: Romuald

family: Ruiz

full_name: Angela Ruiz

given: Angela

family: Lantieri

full_name: Olivier Lantieri

family: Launoy

full_name: Guy Launoy

given: Guy

family: Guittet

full_name: Lydia Guittet

given: Lydia

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Gastroenterology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: A Population-based Comparison of Immunochemical Fecal Occult Blood Tests for Colorectal Cancer Screening

lead_sponsor: University Hospital, Caen

location_facility:
ADECA
Adoc18 - Irsa

intervention_type: Other

status_simplified: Completed


type: Other Grant/Funding Number

type: Other Identifier

title: Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications

acronym: PRESTIGE

summary: The primary purpose of the trial is to evaluate coagulation activator markers in patients with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with the severity of the pathology.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Lille


title: Effects of EXEnatide on Glycemic Control and Weight Over 26 Weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients With Type 2 Diabetes : a Phase 2/3 Double Blind randoMized Placebo-controlled Trial.

acronym: EXEPUMP

summary: The purpose of this study is to determine whether exenatide is effective to improve glycemic control among type 2 diabetic patients treated by insulin pump therapy.

status: Unknown status

design_allocation: Randomized

primary_purpose: Treatment

location_facility: Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen

intervention_type: Drug

status_simplified: Unknown


title: Epidemiological, Immunological, Pathological and Pharmacogenetic Study of Cancers Occuring After Solid Organs Transplants

acronym: K-GREF

summary:
About 1500 solid organs transplants are performed each year in the Paris agglomeration.

Cancer risk in the transplanted is about three times higher than in a population of the same age without any organ transplant. Thus cancer is an important problem for organ transplant.

These cancers can be related to many factors :

Post-transplant cancers are due in part to the non specific immunosuppression, which leads to oncogenic viruses replication, and then produces virus inducted cancers (as lymphoma due to EBV virus).
Post-transplant cancers can also be due to the carcinogenic factors of the immunosuppressive drugs (as cyclosporine or tacrolimus, which can cause the appearance of metastases). However, a new type of immunosuppressive drugs (mTOR inhibitors) appear to have anti-cancer properties.
Post-transplant cancers which are not virus-inducted can be relied to genetic factors of the transplanted patient and/or the transplant donor.

There are 4 axes in this study :

Axis 1 : Epidemiological, clinical and biological study of the incident cancers in transplanted patients.
Axis 2 : Qualitative and quantitative immunological study of lymphocyte cells by the transplanted patient (determine their characteristics when a cancer appears).
Axis 3 : Pathological and genetic study of the post-transplant cancer cells (see if the cancer is caused by the donor or the recipient). Creation of a biobank.
Axis 4 : Pharmacogenetic study of the immunosuppressive drugs (determine the impact of patient genetic variability on tolerance and efficiency of the immunosuppressive drugs).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Bicêtre - Assistance Publique-Hôpitaux de Paris


title: Physiologic Effects of High Flow Nasal Therapy in Patients With Acute Hypoxemic Respiratory Failure

summary: The aim of the study is to assess, in patients with acute hypoxemic respiratory failure, the short term physiologic effects of the high flow oxygen nasal therapy (Optiflow), in term of inspiratory muscle effort, gas exchange, comfort and dyspnea

ReferenceCitation: Vargas F, Saint-Leger M, Boyer A, Bui NH, Hilbert G. Physiologic Effects of High-Flow Nasal Cannula Oxygen in Critical Care Subjects. Respir Care. 2015 Oct;60(10):1369-76. doi: 10.4187/respcare.03814. Epub 2015 May 5.

family: Vargas

full_name: F. Vargas

given: F.

family: Saint-Leger

full_name: M. Saint-Leger

given: M.

family: Boyer

full_name: A. Boyer

given: A.

family: Bui

full_name: N. H. Bui

given: N. H.

family: Hilbert

full_name: G. Hilbert

given: G.

journal_name: Respiratory Care

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Daedalus Enterprises

publisher_dissemination: Daedalus Enterprises

publisher_group: Daedalus Enterprises

publisher_normalized: Daedalus Enterprises

lead_sponsor: University Hospital, Bordeaux

intervention_type: Procedure


title: Randomized Double-Blind Study of Food Supplement Phytalgic on Symptoms of Osteoarthritis

summary: The objective of the study is to test the effects of a herbal supplement, Phytalgic, on the symptoms of osteoarthritis of the knee or hip, in patients with OA using NSAIDs or analgesics on a regular basis.

ReferenceCitation: Jacquet A, Girodet PO, Pariente A, Forest K, Mallet L, Moore N. Phytalgic, a food supplement, vs placebo in patients with osteoarthritis of the knee or hip: a randomised double-blind placebo-controlled clinical trial. Arthritis Res Ther. 2009;11(6):R192. doi: 10.1186/ar2891. Epub 2009 Dec 16.

family: Jacquet

full_name: Alain Jacquet

given: Alain

family: Girodet

full_name: Pierre-Olivier Girodet

given: Pierre-Olivier

family: Pariente

full_name: Antoine Pariente

given: Antoine

family: Forest

full_name: Karelle Forest

given: Karelle

family: Mallet

full_name: Laurent Mallet

given: Laurent

family: Moore

full_name: Nicholas Moore

given: Nicholas

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Phytalgic®, a food supplement, vs placebo in patients with osteoarthritis of the knee or hip: a randomised double-blind placebo-controlled clinical trial

lead_sponsor: Université Victor Segalen Bordeaux 2

intervention_type: Dietary Supplement


title: Early Assessment of Anthracycline-induced Cardiotoxicity: Usefulness of Biochemical Markers and Ventricular Function Assessment.

summary:
Anthracycline-based chemotherapy is a key point of the treatment of patients with Hodgkin's and non-Hodgkin's lymphomas. However, cumulative doses are limited by cardiotoxicity, resulting in a marked left ventricular function impairment that may lead to heart failure.

The standard clinical approach to monitoring for anthracycline cardiotoxicity is based on cardiac function monitoring using echocardiography or radionuclide angiography. The aim of this study is to evaluate the usefulness of biochemical markers of cardiac injury (troponin and NT-proBNP) and structural changes on cardiac MR in predicting anthracycline cardiotoxicity.

status: Terminated

ReferenceCitation: Cardinale D, Sandri MT, Martinoni A, Borghini E, Civelli M, Lamantia G, Cinieri S, Martinelli G, Fiorentini C, Cipolla CM. Myocardial injury revealed by plasma troponin I in breast cancer treated with high-dose chemotherapy. Ann Oncol. 2002 May;13(5):710-5.

ReferenceCitation: Singal PK, Iliskovic N. Doxorubicin-induced cardiomyopathy. N Engl J Med. 1998 Sep 24;339(13):900-5. Review.

ReferenceCitation: Okumura H, Iuchi K, Yoshida T, Nakamura S, Takeshima M, Takamatsu H, Ikeno A, Usuda K, Ishikawa T, Ohtake S, Matsuda T. Brain natriuretic peptide is a predictor of anthracycline-induced cardiotoxicity. Acta Haematol. 2000;104(4):158-63.

ReferenceCitation: Mitani I, Jain D, Joska TM, Burtness B, Zaret BL. Doxorubicin cardiotoxicity: prevention of congestive heart failure with serial cardiac function monitoring with equilibrium radionuclide angiocardiography in the current era. J Nucl Cardiol. 2003 Mar-Apr;10(2):132-9.

lead_sponsor: Centre Henri Becquerel

location_facility:
Centre Henri Becquerel
University Hospital of Rouen

lead_sponsor_type: industriel


title: Efficacy of Rotational Atherectomy System Associated With Drug Coated Balloon Angioplasty (With or Without Stent Placement) in the Management of Lower Limb Ischemia (ELLIPSE): "Real Life" Observational Study

acronym: ELLIPSE

summary:
Lower extremity peripheral artery disease (PAD) is a major health problem leading to significant morbidity and even mortality. Patients with superficial femoral artery stenosis make up an important proportion of patients with PAD, and since this type of involvement was reported to be most commonly associated with intermittent claudication, this patient population has been subject to intensive research on methods to prevent disease progression and further complications.

Endovascular treatment has become the first-line treatment for low-complexity femoropopliteal (FP) lesions classified as TASC (Trans Atlantic Inter-Societal Consensus) A and B. Conversely, in case of more extensive lesions (TASC C), this treatment is still under debate because of a primary permeability that is difficult to maintain over time. Recently, studies have shown the interest of drug eluting technologies in the treatment of TASC A & B femoral-popliteal lesions, by significantly improving patency rates compared to uncoated balloons or stents.

In this context, the endovascular treatment of FP complex lesions (TASC C) continues to develop widely.

During endovascular treatment, the quality of the artery preparation has recently been identified as a factor improving outcomes. The dilatation of the artery with an uncoated balloon or POBA (Plain Old Balloon Angioplasty) is the reference method performed before stent placement or drug-coated balloons. However, some new alternatives to prepare the artery have emerged, using no more dilatation but atherectomy (Jetstream™ system).

Atherectomy appears to reduce the risk of dissections and bailout stenting and improve the acute procedural results. Its long term outcome, when associated with drug coated balloons (DCB), has recently been demonstrated in the USA to be superior to angioplasty in a single center study JET-SCE.

The purpose of this study is to evaluate the efficacy and the feasibility of atherectomy, using the Jetstream™ artery preparation associated to DCB treatment (Ranger™ Paclitaxel-Coated balloon), in symptomatic patients with claudication (Rutherford 2 and 3) and with complex de novo FP arterial lesions (TASC C).

lead_sponsor: Hospital St. Joseph, Marseille, France

location_facility:
Clinique Les Franciscaines
Clinique Saint Georges
Polyclinique Les Fleurs
Clinique Rhône Durance
Hôpital Saint Joseph
Hopital Prive de Provence
Hopital Europeen
Polyclinique Notre Dame

intervention_type: Device


title: Blood Activation During Cardiopulmonary Bypass Using Roller or Centrifugal Pumps

summary: Blood activation induced by cardiopulmonary bypass may compromise the postoperative outcome. The goal of this study is to compare blood activation induced by cardiopulmonary bypass performed with centrifugal pump or roller pump in patients undergoing coronary artery surgery.

lead_sponsor: University Hospital, Angers


title: National Study on the Quality of Life of Patients With Anorectal Malformation (MARQOL)

acronym: MARQOL

summary:
Anorectal malformations, occurring approximately 1 in 5000 live births, mainly involve the distal anus and rectum, but also sometimes the urinary and genital tracts. Defects range from the minor and easily treated with an excellent functional prognosis, to those that are complex and often associated with a poor functional prognosis.

Despite the better knowledge of the anatomy and physiology and the improvement of surgical management after birth, fecal and urinary incontinence can occur, due mainly to deficient nerve supply.

The quality of life of such patients is largely unknown in this country. The aim of the investigators study is to propose specific and generic questionnaires to the patients registered in the national database, correlated to their anatomical and functional status. A better understanding of such correlations should allow improvements in their medical and social management.

time_perspective: Cross-Sectional

ReferenceCitation: Clermidi P, Podevin G, Crétolle C, Sarnacki S, Hardouin JB. The challenge of measuring quality of life in children with Hirschsprung's disease or anorectal malformation. J Pediatr Surg. 2013 Oct;48(10):2118-27. doi: 10.1016/j.jpedsurg.2013.03.071.

ReferenceCitation: Mantoo S, Meurette G, Wyart V, Hardouin J, Cretolle C, Capito C, Sarnacki S, Podevin G, Lehur PA. The impact of anorectal malformations on anorectal function and social integration in adulthood: report from a national database. Colorectal Dis. 2013 Jun;15(6):e330-5. doi: 10.1111/codi.12186.

ReferenceCitation: Podevin G, Petit T, Mure PY, Gelas T, Demarche M, Allal H, Becmeur F, Varlet F, Philippe P, Weil D, Heloury Y. Minimally invasive surgery for anorectal malformation in boys: a multicenter study. J Laparoendosc Adv Surg Tech A. 2009 Apr;19 Suppl 1:S233-5. doi: 10.1089/lap.2008.0137.

ReferenceCitation: Fleury J, Picherot G, Cretolle C, Podevin G, David A, Caillon J, Roze JC, Gras-le Guen C. Currarino syndrome as an etiology of a neonatal Escherichia coli meningitis. J Perinatol. 2007 Sep;27(9):589-91.

lead_sponsor: Nantes University Hospital

location_facility:
CH Le Mans
AP-HP Hôpital Robert Debré
AP-HM La Timone
CHU Poitiers
CHU Clermont-Ferrand
AP-HP Hôpital Bicêtre
CHU Montpellier
AP-HM Hôpital Nord
CHU Amiens
CHRU Lille
CHU Reims
CHU Pointe-à-Pitre
CH Saint Brieuc
CHU Dijon
CHU Brest
Hospices Civils de Lyon
CHU Limoges
CHU Toulouse
CHU de Nantes
CHU Bordeaux
CHU Besançon
CHU Nancy
AP-HP Hôpital Trousseau
CHU Angers
CHU Fort-de-France
AP-HP Hôpital Necker
CHRU Tours
Hôpitaux Civils de Colmar
CHU Caen
CHR Orléans
CHU Saint Etienne
CHRU Strasbourg
CHU Grenoble
CHU Nice
CHU Rouen
CHU Rennes
CHR La Réunion


title: A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients: The TOP UP Trial (Pilot)

acronym: TOP-UP

summary:
The specific aim of the proposed study is to conduct a pilot study involving 160 critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of America, Belgium and France in order to:

Specific Aims

Confirm that we can achieve a clinically significant difference in calorie and protein intake between the two intervention groups.
Estimate recruitment rate i.e. number of eligible and enrolled patients per month per site.

Evaluate the safety, tolerance, and logistics around providing supplemental PN in the study population in the context of a multicenter trial, e.g.

To ensure adequate glycemic control in both groups.
To ensure that the other metabolic consequences of the feeding strategies are minimized.
To establish adequate compliance with study protocols and completion of case report forms

A secondary aim of this pilot study will be:

• To explore the effect of differential effects of calorie and protein delivery on muscle and mass function.

ReferenceCitation: Alberda C, Gramlich L, Jones N, Jeejeebhoy K, Day AG, Dhaliwal R, Heyland DK. The relationship between nutritional intake and clinical outcomes in critically ill patients: results of an international multicenter observational study. Intensive Care Med. 2009 Oct;35(10):1728-37. doi: 10.1007/s00134-009-1567-4. Epub 2009 Jul 2. Erratum in: Intensive Care Med. 2009 Oct;35(10):1821.

ReferenceCitation: Villet S, Chiolero RL, Bollmann MD, Revelly JP, Cayeux R N MC, Delarue J, Berger MM. Negative impact of hypocaloric feeding and energy balance on clinical outcome in ICU patients. Clin Nutr. 2005 Aug;24(4):502-9.

ReferenceCitation: Krishnan JA, Parce PB, Martinez A, Diette GB, Brower RG. Caloric intake in medical ICU patients: consistency of care with guidelines and relationship to clinical outcomes. Chest. 2003 Jul;124(1):297-305.

ReferenceCitation: Hise ME, Halterman K, Gajewski BJ, Parkhurst M, Moncure M, Brown JC. Feeding practices of severely ill intensive care unit patients: an evaluation of energy sources and clinical outcomes. J Am Diet Assoc. 2007 Mar;107(3):458-65.

ReferenceCitation: Dhaliwal R, Jurewitsch B, Harrietha D, Heyland DK. Combination enteral and parenteral nutrition in critically ill patients: harmful or beneficial? A systematic review of the evidence. Intensive Care Med. 2004 Aug;30(8):1666-71. Epub 2004 Jun 8. Review.

ReferenceCitation: Wischmeyer PE, Hasselmann M, Kummerlen C, Kozar R, Kutsogiannis DJ, Karvellas CJ, Besecker B, Evans DK, Preiser JC, Gramlich L, Jeejeebhoy K, Dhaliwal R, Jiang X, Day AG, Heyland DK. A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial. Crit Care. 2017 Jun 9;21(1):142. doi: 10.1186/s13054-017-1736-8.

family: Wischmeyer

full_name: Paul E. Wischmeyer

given: Paul E.

family: Hasselmann

full_name: Michel Hasselmann

given: Michel

family: Kummerlen

full_name: Christine Kummerlen

given: Christine

family: Kozar

full_name: Rosemary Kozar

given: Rosemary

family: Kutsogiannis

full_name: Demetrios James Kutsogiannis

given: Demetrios James

family: Karvellas

full_name: Constantine J. Karvellas

given: Constantine J.

family: Besecker

full_name: Beth Besecker

given: Beth

family: Evans

full_name: David K. Evans

given: David K.

family: Preiser

full_name: Jean-Charles Preiser

given: Jean-Charles

family: Gramlich

full_name: Leah Gramlich

given: Leah

family: Jeejeebhoy

full_name: Khursheed Jeejeebhoy

given: Khursheed

family: Dhaliwal

full_name: Rupinder Dhaliwal

given: Rupinder

family: Jiang

full_name: Xuran Jiang

given: Xuran

family: Day

full_name: Andrew G. Day

given: Andrew G.

family: Heyland

full_name: Daren K. Heyland

given: Daren K.

journal_name: Critical Care

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

repository_institution: Duke University - DukeSpace

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

lead_sponsor: Clinical Evaluation Research Unit at Kingston General Hospital

location_facility: University of Texas Health Science Center

location_facility: The Ohio State Univsersity Medical Center

location_facility: Washington University School of Medicine in St. Louis

location_facility: Cleveland Clinic Lerner College of Medicine


title: Study of Human Locomotion With Global Positioning System. Application to Patients With Peripheral Arterial Disease

acronym: Starter-GPS

summary: The maximal walking distance (MWD) performed on treadmill (TT) remains the gold standard in estimating the walking capacity of patients suffering from peripheral arterial disease (PAD) with intermittent claudication, although treadmills are not accessible to most physicians. We hypothesized that global positioning system (GPS) recordings could monitor community-based outdoor walking and provide valid information on walking capacity in PAD patients.

ReferenceCitation: Noury-Desvaux B, Abraham P, Mahé G, Sauvaget T, Leftheriotis G, Le Faucheur A. The accuracy of a simple, low-cost GPS data logger/receiver to study outdoor human walking in view of health and clinical studies. PLoS One. 2011;6(9):e23027. doi: 10.1371/journal.pone.0023027. Epub 2011 Sep 13.

family: Noury-Desvaux

full_name: Bénédicte Noury-Desvaux

given: Bénédicte

family: Abraham

full_name: Pierre Abraham

given: Pierre

family: Mahé

full_name: Guillaume Mahé

given: Guillaume

family: Sauvaget

full_name: Thomas Sauvaget

given: Thomas

family: Leftheriotis

full_name: Georges Leftheriotis

given: Georges

family: Le Faucheur

full_name: Alexis Le Faucheur

given: Alexis

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: PLoS ONE

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: The Accuracy of a Simple, Low-Cost GPS Data Logger/Receiver to Study Outdoor Human Walking in View of Health and Clinical Studies

ReferenceCitation: Le Faucheur A, Noury-Desvaux B, Mahé G, Sauvaget T, Saumet JL, Leftheriotis G, Abraham P. Variability and short-term determinants of walking capacity in patients with intermittent claudication. J Vasc Surg. 2010 Apr;51(4):886-92. doi: 10.1016/j.jvs.2009.10.120.

family: Saumet

full_name: Jean Louis Saumet

given: Jean Louis

journal_name: Journal of Vascular Surgery

evidence: open (via crossref license)


lead_sponsor: Centre Hospitalier Universitaire, Amiens

acronym: Xeladys

location_facility:
CHRU Lille
CHU Strasbourg
CHU Limoges
CHU Toulouse
AP-HM Hopital de la Timone
CHU Poitiers
CHRU de Nimes
CH Aix en Provence
CHU Caen
CHU Clermont-Ferrand
CHU Bordeaux
CH des Charpennes
CHU Montpellier
CHU Nantes
CHU Nice
CHU de Rennes
CHU Rouen
CHU Amiens
CHU Saint Antoine

type: EudraCT Number

source: euctr

title: Study of Efficacy and Acceptability of Tetrabenazine in the Late Dyskinetic Syndrome With Neuroleptics: A Randomized, Parallel Group, Double-blind Placebo Controlled Multicentre Trial

summary:
Late dyskinetic syndrome with neuroleptics, or tardive dyskinesia, is the appearance of abnormal involuntary movements (AIM) in patients treated with antipsychotics for at least three months. This important public health issue arises for 15-20% of patients treated with neuroleptics, the most prescribed psychotropic drugs in mental disorders in France, and seriously impacts the patients' quality of life. In over 50% of cases, it is irreversible-that is to say that he will persist despite discontinuation of the offending drug.

Risk factors have been described: the age and female gender are established, a higher dosage of antipsychotic, a long-term treatment, a psychiatric condition other than schizophrenia are likely risk factors, intermittent treatment, previous acute dyskinesia, neuroleptics or powerful, longer term use of corrective treatments including anticholinergics are still discussed.

Apart from preventive treatment, which consists in using antipsychotics as being coerced, support is disappointing: the etiological treatment, which is to stop the offending antipsychotic, is effective only in less than 50% of cases, the syndrome is most often late irreversible. Must still have the possibility to interrupt the treatment, which is usually impossible in the risk of decompensation of the mental illness for which the neuroleptic was prescribed. Remains symptomatic treatment: functional neurosurgery is only for extreme cases, because it is not without risk, in terms of morbidity and mortality. So it's the medication that is most often offered: many drugs have been proposed, a direct result of the multiplicity of neurotransmitter systems implicated.

However, in the vast majority of cases, this approach is disappointing not to say ineffective. The only exception is the tetrabenazine, marketed under the name of Xenazine®. Empirically, neurologists specializing in pathology of the movement are almost unanimous: its efficiency is very good, with good tolerance. Some preliminary studies have reinforced this impression. However, their level of evidence remains low and that is why the investigators propose to implement a prospective multicenter clinical trial, double-blind with placebo which will include two groups of 27 patients.


title: Quality of Life for Patients With Chronic Paediatric Onset Inflammatory Bowel Disease (IBD)

acronym: QALY-ECOPED

summary: The main objective of the present study is to describe the quality of life of patients under 25 years of age with pediatric-onset IBD. The quality of life will be described according to the age and the activity of the disease in order to make it possible to associate with the different states of health a measure of quality of life (utility score) from utility values established in the French context. These data are essential for the realization of medico-economic models.


title: Efficacy of a Combination of Amlodipine / Valsartan on Blood Pressure Control, With One Nocturnal or Diurnal Intake a Day, in Ambulatory Blood Pressure Monitoring Setting, in Essential Uncontrolled Hypertensive Patients With Amlodipine 5mg ; The ExPERT Study

summary: This study was a multicenter, randomized, PROBE-type (prospective, randomized, open label, blinded end-point) study of 12 weeks duration comprising four visits, carried out in patients with essential arterial hypertension not controlled on four weeks treatment with amlodipine 5 mg alone.

lead_sponsor: Novartis Pharmaceuticals

location_country: Tunisia France

location_facility:
Investigative sites in Tunisia
Investigative sites in France


type: Registry Identifier

title: Prospective Study Evaluating the Combination of Positron Emission Tomography (PET) With 18F-FDG and 18 F-Fluorocholine for Optimization of Staging and Treatment Modification in Patients With Hepatocellular Carcinoma

summary: The objective of this protocol is to obtain a better match between the actual staging and the proposed treatment in order to avoid inadequate treatments at risk of complications. In patients with HCC classified as BCLC A to C, the combination of 18F-FDG and 18F-Fluorocholine PET- TomoDensitoMetry (TDM) with conventional imaging would clinically significantly modify the therapeutic strategy initially planned by conventional imaging alone. This change in therapeutic strategy would be from curative to palliative treatment or from loco-regional palliative to systemic palliative treatment. 18F-FDG and 18F-Fluorocholine PET-CT scans will be performed after inclusion of the patient in the study and prior to multidisciplinary consultation meeting for treatment discussion.

ReferenceCitation: Nault JC, Sutter O, Nahon P, Ganne-Carrié N, Séror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13. Review.

ReferenceCitation: Cadier B, Bulsei J, Nahon P, Seror O, Laurent A, Rosa I, Layese R, Costentin C, Cagnot C, Durand-Zaleski I, Chevreul K; ANRS CO12 CirVir and CHANGH groups. Early detection and curative treatment of hepatocellular carcinoma: A cost-effectiveness analysis in France and in the United States. Hepatology. 2017 Apr;65(4):1237-1248. doi: 10.1002/hep.28961. Epub 2017 Feb 8.

ReferenceCitation: Bertagna F, Bertoli M, Bosio G, Biasiotto G, Sadeghi R, Giubbini R, Treglia G. Diagnostic role of radiolabelled choline PET or PET/CT in hepatocellular carcinoma: a systematic review and meta-analysis. Hepatol Int. 2014 Oct;8(4):493-500. doi: 10.1007/s12072-014-9566-0. Epub 2014 Sep 3.

intervention_type: Radiation


title: Prevention of pneumonIA in Nursing hOme

acronym: PIANO

summary: Infections in nursing home are associated with high morbidity and mortality. Pulmonary infections are known to be the most problematic. In our INCUR observational study of 773 residents, 20.13% of residents had pneumonia during the year of follow-up. On average, the extra cost of pneumopathies was 4,467 euros / patient for the long-term care facility and 3,044 euros for the hospital.

lead_sponsor: University Hospital, Toulouse


title: Impact of Joint Crisis Plan on the Duration of Isolation Measures in Psychiatry.

acronym: PLANCO-ISO

summary:
For some patients in department psychiatric, isolation measures are put in place. But the measures is not pleasant for the patient or for the care team.

That's why care team are trying to find ways to improve patient care, including asking them how they would like to be treated.

One of the solutions is called the Joint Crisis Plan. A Joint Crisis Plan is a personalized procedure for a patient. It describes the attitude, the care, the measures in case of crisis with the patient and his family. Patients indicate their wishes regarding their care. However, there is no real scientific proof of the effectiveness of this Joint Crisis Plan, especially to reduce isolation measures.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Biomechanical Analysis, Complementary Examinations and Rehabilitative Management of Chronic Ankle Instability

acronym: CAIDiag

summary: Chronic ankle instability is a common condition in the active adult population and characterized by the occurrence of repeated giving way and/or recurrent ankle sprains. Multiple underlying deficits have been proposed, among which ankle muscle strength deficits, proprioception deficits, ( static and dynamic balance disorders, and articular laxity. Unfortunately, no consensus exists on which clinical tests should be realized to determine if one of these underlying deficits is predominant and as a result could guide the rehabilitation process. The study hypothesis is that people with chronic ankle instability might be heterogenous and could be divided in different subgroups as a function of underlying deficits. Therefore, this study aims to evaluate the capacity of different clinical tests to differentiate people with chronic ankle instability from healthy people as well as between each other.

location_facility: CH Saint-Omer, institut audomarois de la chirurgie orthopédique et du sport


title: Evaluation Genotypic, Phenotypic and Prognosis Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED) Syndrome

acronym: APECED

summary: The objective of the study will define the mutational spectrum in this French cohort, in patients with APECED syndrome genetically authenticated


title: Electromyography Study of Lip Muscles During Auditory Verbal Hallucinations Without Subvocalization in Patients With Schizophrenia

acronym: HAV

summary:
Auditory verbal hallucinations (AVHs) are speech perceptions in the absence of a relevant external stimulation. Some accounts of AVHs claim that a deficit in inner speech monitoring would cause the verbal thoughts of the patient to be perceived as external voices resulting in AVHs.

In order to examine whether AVHs correspond to self-generated inner speech, the present study aims at collecting speech muscle activity during covert AVHs (without articulation), overt speech and rest. Surface electromyography (sEMG) is used on schizophrenia patients and control subjects to detect any speech muscle activity during AVH.

lead_sponsor: University Hospital, Grenoble


title: Central Sleep Apneas Syndrome and Ventricular Function in Patients With Heart Failure, After Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion

summary: The aim of this clinical trial is to evaluate the effect of an early treatment of sleep-disordered breathing by adaptive servo-ventilation in heart failure patient following coronary artery bypass graft surgery or other coronary reperfusion.

ReferenceType: result

ReferenceCitation: Vazir A, Hastings PC, Dayer M, McIntyre HF, Henein MY, Poole-Wilson PA, Cowie MR, Morrell MJ, Simonds AK. A high prevalence of sleep disordered breathing in men with mild symptomatic chronic heart failure due to left ventricular systolic dysfunction. Eur J Heart Fail. 2007 Mar;9(3):243-50. Epub 2006 Oct 6.


title: Prevention of Central Venous Catheter Infections : Comparison of the Efficacy of Skin Disinfection With 5% Povidone Iodine in Alcoholic Solution Versus 0.25% Chlorhexidine, 0.025 Benzalkonium and 4% Benzylic Alcohol

summary:
The best antiseptic solution for cateheter care remains unknown.High concentration in aquous solution or low concentration in alcoholic solution of chlorhexidine actbetter than povidone iodine in aquous solutions. No study has compare alcoholic formulations of low concentration of chlorhexidine and povidone iodine for skin disinfection prior to insertion of central venous catheters.

To compare the incidence of central venous catheter colonization after skin disinfection with either an alcoholic solution of povidone iodine or a combination of 0.5% chlorhexidine, 0.025% Benzalkonium and 4% benzylic alcohol.

To compare the incidence of catheter related bacteremia in the to study groups. To compare the local and general tolerance of the two antiseptic formulations

ReferenceCitation: Mimoz O, Villeminey S, Ragot S, Dahyot-Fizelier C, Laksiri L, Petitpas F, Debaene B. Chlorhexidine-based antiseptic solution vs alcohol-based povidone-iodine for central venous catheter care. Arch Intern Med. 2007 Oct 22;167(19):2066-72.


title: Impact of Timing of Surgery on Outcome of Severely Ill Burn Patients

acronym: EARLYBURN

summary: Prognosis of burn patients has improved over the last decades. Early excision of full thickness burns is thought to be one of the key factors which have led to prognostic improvement. Best timing for burn excision remain uncertain however. In this multicenter observational study, we aim at exploring the impact of timing of surgery on outcome in severely ill patients using a propensity analysis.

location_facility: Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital, University Paris Diderot


title: MOther-Child Interaction Assessment TRAINING for Pediatricians

acronym: MOCITRAINING

summary: The originality of the MOCITRAINING study lies in the integration of infant and maternal care during the pediatric consultation and the assessment of the impact of this type of care in the short and medium term on The MOCITRAINING program could contribute to improving the quality of parent-child interactions.

primary_purpose: Supportive Care


title: Determinants of Patients' Uptake of Therapeutic Education Programme

acronym: UTEP

summary:
Therapeutic Patient Education (TPE) refers to programs that help patients to manage life with a chronic disease in the best possible way. In spite of the effectiveness of Therapeutic Patient Education, few patients uptake TPE when it is proposed to them. Therefore, our main aim was to identify patients' beliefs that will predict patients' uptake of TPE. According to the Health Belief Model, patient will participate in TPE if they perceive their disease as a serious threat (with possible serious complications), but which can be controlled however, and that TPE is efficient and represents little burden.

Secondary aims are as follows:

To test whether the way TPE is presented to patients impact patients' decision to uptake TPE. The way TPE is presented comprises the time between diagnosis and the proposal of TPE, whether patient is a remission or crisis period in the disease, the time between the proposal and the next TPE session, and what is said by healthcare professionals to present TPE.
To test whether healthcare professionals' empathy impact patients' decision to participate in TPE
To test whether patients' intention to participate in TPE will predict their actual participation.

The ultimate goal of the study is to identify patients whose beliefs will not favor participation in TPE in order to accompany those patients more carefully. Best practices will be proposed according the results.


title: Antenatal Detection by Array CGH Genomic Rearrangements Unbalanced Front Uninsulated Thick Neck or a Combination of Two Signs of Ultrasound Calling Normal Karyotype

acronym: CGH Array

summary:
This is the first study with a real diagnostic and prognostic focus in prenatal. In addition to this innovative aspect, the identification of cryptic imbalances in fetuses with malformative syndrome would be an invaluable resource for the identification of new genes involved in development, as is already the case for postnatal studies.

This research aims to:

to test the feasibility of this protocol, ie the practical application of this new technology in the context of prenatal diagnosis,
demonstrate and evaluate the possible involvement of cryptic chromosomal abnormalities in fetuses with a thick neck associated with other malformations and recruited on the strict criteria mentioned above,
assist in the diagnosis of these fetuses and genetic information for their families,
identify new regions of the genome potentially involved in the occurrence of congenital malformations.

location_facility: Hôpital Jeanne de Flandre - CHRU de Lille


title: Image Transmission Applied to Organ Transplant: Before-after Study of the Device of the Effectiveness

summary:
In the complex process of organ transplant, two of the major steps are:

evaluation of the organs of potential donors in health institutions:
proposing grafts to the transplant teams, according to rules defined at the national level.

In the absence of the possibility of transmitting the images between the deceased donor sites and the transplant teams, the visualization of these examinations does not take part in the decision-making of the transplant team. This leads in the displacement of the transplant team in order to verify the grafts after acceptance of the graft proposal.

The "Cristal Image" project is a visualisation project for the transplant teams, in real time, at the time of the proposal of the graft so that they can give an opinion (acceptance, refusal) in less than 20 minutes (legal delay for a vital organ) after analyzing the medical records provided and the imaging data (scanner, ultrasound (s), coronary angiography, etc.).

The hypothesis of the project is that the implementation of a secure image transmission (complete anonymisation of the data of the donor) before the acceptance by the team, will allow an optimization of the use of the qualified organs by reducing risks, unnecessary displacement of transplant surgical teams, and securing the allocation of organs to recipient patients.

ReferenceCitation: Reddy MS, Bhati C, Neil D, Mirza DF, Manas DM. National Organ Retrieval Imaging System: results of the pilot study. Transpl Int. 2008 Nov;21(11):1036-44. doi: 10.1111/j.1432-2277.2008.00720.x.

ReferenceCitation: Rosenkrantz AB, Campbell N, Wehrli N, Triolo MJ, Kim S. New OPTN/UNOS classification system for nodules in cirrhotic livers detected with MR imaging: effect on hepatocellular carcinoma detection and transplantation allocation. Radiology. 2015 Feb;274(2):426-33. doi: 10.1148/radiol.14140069. Epub 2014 Oct 7.

ReferenceCitation: Furlow B. Solid organ donation and transplantation. Radiol Technol. 2012 Mar-Apr;83(4):371-89. Review. Erratum in: Radiol Technol. 2012 May-Jun;83(5):446.

ReferenceCitation: Fregeville A, De Bazelaire C, Zagdanski A, Albiter M, Desgrandchamps F, De Kerviler E. [Value of whole body CTA in the management of brain-dead patients]. J Radiol. 2010 Jan;91(1 Pt 1):37-44. French.

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

family: Charrier

full_name: Nathanael Charrier

given: Nathanael

name: the ARS Ile de France telemedicine group

family: Zarca

full_name: Kevin Zarca

given: Kevin

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

family: Calinaud

full_name: Christine Calinaud

given: Christine

journal_name: BMC Health Services Research

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Zarca K, Dupont JK, Jacoud L, Bulsei J, Huot O, Logerot H, Durand-Zaleski I. Effectiveness and efficiency of teleimaging in the transplantation process: a mixed method protocol. BMC Health Serv Res. 2019 Sep 18;19(1):672. doi: 10.1186/s12913-019-4488-0.

family: Dupont

full_name: Jean-Claude K. Dupont

given: Jean-Claude K.

family: Jacoud

full_name: Lorène Jacoud

given: Lorène

family: Bulsei

full_name: Julie Bulsei

given: Julie

family: Huot

full_name: Olivier Huot

given: Olivier

family: Logerot

full_name: Hélène Logerot

given: Hélène

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod


title: Evaluation of the Impact of Locoregional Treatment of Soft Tissue Sarcoma on the Functional Status of Patients Aged 70 Years and Over

acronym: SARCOLD

summary: In order to describe functional impact of surgery in elderly patients treated for lower-limb soft-tissue sarcoma, the investigators set up this project which aims to identify prognostic factors among geriatric and functional assessment.

lead_sponsor: Institut Bergonié


title: Randomized Phase 2 Study Evaluating the Interest of Mid-position Strategy Versus ITV (Internal Target Volume) Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-resected Non-small Cell Lung Carcinoma (NSCLC).

acronym: midP

summary: The purpose of this study is to establish on the market and to clinically evaluate a new strategy of treatment for patients with locally advanced non-small cell lung cancer using deformable repositioning of 4D imaging.

lead_sponsor: Centre Leon Berard


title: Effect of Fluconazole on the Levels of Anti-Saccharomyces Cerevisiae Antibodies (ASCA) After Surgical Resection for Crohn's Disease. Multicenter, Randomized, and Controlled in Two Parallel Groups Versus Placebo

acronym: AscaMC

summary: This was prospective study randomized in two controlled parallel groups verum versus placebo. The objectives were to assess the influence of antifungal treatment with Fluconazole (FCZ) on the rate of ASCA and endoscopic recurrence at 6 months. The rational was based on our previous research having established i) a link between intestinal inflammation and the opportunistic fungal pathogen C. albicans -a yeast colonizing the human digestive tract- ii) the demonstration that this yeast species could be at the origin of ASCA, a prominent serological marker of CD. It was therefore hypothesized that the FCZ could lower the rate of ASCA and/or reduce the occurrence of recurrences.

ReferenceCitation: Sendid B, Salvetat N, Sarter H, Loridant S, Cunisse C, François N, Aijjou R, Gelé P, Leroy J, Deplanque D, Jawhara S, Weissmann D, Desreumaux P, Gower-Rousseau C, Colombel JF, Poulain D. A Pilot Clinical Study on Post-Operative Recurrence Provides Biological Clues for a Role of Candida Yeasts and Fluconazole in Crohn's Disease. J Fungi (Basel). 2021 Apr 22;7(5). pii: 324. doi: 10.3390/jof7050324.

family: Sendid

full_name: Boualem Sendid

given: Boualem

family: Salvetat

full_name: Nicolas Salvetat

given: Nicolas

family: Sarter

full_name: Helène Sarter

given: Helène

family: Loridant

full_name: Severine Loridant

given: Severine

family: Cunisse

full_name: Catherine Cunisse

given: Catherine

family: François

full_name: Nadine François

given: Nadine

family: Aijjou

full_name: Rachid Aijjou

given: Rachid

family: Gelé

full_name: Patrick Gelé

given: Patrick

family: Leroy

full_name: Jordan Leroy

given: Jordan

family: Deplanque

full_name: Dominique Deplanque

given: Dominique

family: Jawhara

full_name: Samir Jawhara

given: Samir

family: Weissmann

full_name: Dinah Weissmann

given: Dinah

family: Desreumaux

full_name: Pierre Desreumaux

family: Gower-Rousseau

full_name: Corinne Gower-Rousseau

given: Corinne

family: Colombel

full_name: Jean Frédéric Colombel

given: Jean Frédéric

family: Poulain

full_name: Daniel Poulain

given: Daniel

currency_apc_doaj: CHF

journal_name: Journal of Fungi

publisher: MDPI AG

publisher_dissemination: MDPI

publisher_group: MDPI

publisher_normalized: MDPI

title: A Pilot Clinical Study on Post-Operative Recurrence Provides Biological Clues for a Role of Candida Yeasts and Fluconazole in Crohn’s Disease


title: Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery - ePPOP Study

acronym: ePPOP-ID

summary: The purpose of this study is to assess the efficacy of an electronic-based intervention to help pregnant overweight and obese women gain an appropriate amount of weight and improve their delivery i.e. to reduce the rate of labour procedures and interventions. We chose a composite outcome including instrumental delivery and Caesarean section, as clinically relevant outcomes because the mode of delivery is one of the major goals of the obstetrical management and is is strongly associated with body mass index and gestational weight gain.

ReferenceCitation: Deruelle P, Lelorain S, Deghilage S, Couturier E, Guilbert E, Berveiller P, Sénat MV, Vayssière C, Sentilhes L, Perrotin F, Gallot D, Chauleur C, Sananes N, Roth E, Luton D, Caputo M, Lorio E, Chatelet C, Couster J, Timbely O, Doret-Dion M, Duhamel A, Pigeyre M. Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for obesity in pregnancy to improve delivery. BMC Pregnancy Childbirth. 2020 Oct 7;20(1):602. doi: 10.1186/s12884-020-03288-x.

family: Deruelle

full_name: Philippe Deruelle

given: Philippe

family: Lelorain

full_name: Sophie Lelorain

given: Sophie

family: Deghilage

full_name: Sylvie Deghilage

given: Sylvie

family: Couturier

full_name: Emmanuelle Couturier

given: Emmanuelle

family: Guilbert

full_name: Elodie Guilbert

given: Elodie

family: Berveiller

full_name: Paul Berveiller

given: Paul

family: Sénat

full_name: Marie Victoire Sénat

given: Marie Victoire

family: Vayssière

full_name: Christophe Vayssière

given: Christophe

family: Sentilhes

full_name: Loïc Sentilhes

given: Loïc

family: Perrotin

full_name: Franck Perrotin

given: Franck

family: Gallot

full_name: Denis Gallot

given: Denis

family: Chauleur

full_name: Céline Chauleur

given: Céline

family: Sananes

full_name: Nicolas Sananes

family: Roth

full_name: Emmanuel Roth

given: Emmanuel

family: Luton

full_name: Dominique Luton

family: Caputo

full_name: Marie Caputo

given: Marie

family: Lorio

full_name: Elodie Lorio

family: Chatelet

full_name: Carla Chatelet

given: Carla

family: Couster

full_name: Julien Couster

given: Julien

family: Timbely

full_name: Oumar Timbely

given: Oumar

family: Doret-Dion

full_name: Muriel Doret-Dion

given: Muriel

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Pigeyre

full_name: Marie Pigeyre


title: Comparison of Rates DMBT1 ( Glycoprotein) in Sputum of CF Patients Colonized Patients Between Chronic and Non-chronic Patients Colonized With Pseudomonas Aeruginosa

summary: Rates of DMBT1 (Glycoprotein like) in Sputum of CF Patients with or without may be different according to their Pseudomonas Aeruginosa chronic colonization status. The aim of this study is to compare rates of DMBT1 (Glycoprotein like) in Sputum of CF patients with or without a Pseudomonas Aeruginosa chronic colonization.


title: EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest With no Obvious Non Cardiac Cause of Arrest

acronym: EMERGE

summary:
Sudden cardiac death (SCD) remains a major public health issue with a low survival rate. The most common cause of SCD is acute coronary artery occlusion. Several registry based studies suggest that coronary angiography (CA) performed at admission followed if necessary by coronary angioplasty improves in-hospital and long term survival. Recent guidelines recommend performing an immediate CA in all survivors of SCD with no obvious non cardiac cause of arrest. However there is a lack of randomized data on this topic.

Several retrospective studies have shown that if the post-resuscitation electrocardiogram (ECG) shows ST segment elevation, the probability of finding an acute coronary artery lesion during the CA is high (70-80%). In contrast, if no ST segment elevation is present the probability is low (15-20%).

Performing an immediate CA in all survivors of SCD can be challenging. It requires admitting these patients to centers with an intensive care unit and facilities allowing 24/24 7/7 CA. It may increase the delay of performing other therapeutic modalities such as CT brain or thorax scan to determine the cause of SCD. Performing the CA 48 to 96 hours after admission would facilitate the management of these difficult patients. However if the cause of the arrest is a coronary artery occlusion and there is a delay in reperfusion, the rate of post-arrest shock and the mortality may increase. Therefore a randomized study comparing immediate versus delayed (between 48 to 96 hours) CA in survivors of SCD with no obvious non-cardiac cause of arrest is warranted.


acronym: ACTICAS

title: A Randomized Crossover TrIal to Compare Recombinant Human rhPTH(1-34) to the ASsociation Alfacalcidol/Hydrochlorothiazide in the Treatment of Severe Primary Hypoparathyroidism

summary:
Hypoparathyroidism is a rare condition in which the parathyroid glands fail to produce sufficient amount of parathyroid hormone or the parathyroid hormone produced lacks biologic activity. The most common cause of hypoparathyroidism is damage to or removal of the parathyroid glands due to neck surgery for another condition. Occurrence of hypercalciuria under treatment is a frequent concern in primary hypoparathyroidism, limiting correction of hypocalcemia.

Hypoparathyroidism can also be caused by an autoimmune process. In rare cases, hypoparathyroidism may occur as a genetic disorder inherited as an autosomal recessive, autosomal dominant or X-linked recessive trait. The autosomal dominant hypocalcemia (ADH) is mainly caused by heterozygous activating mutations in the CASR gene encoding CaSR). As other severe presentation of primary hypothyroidism, ADH is characterized by the increased risk to develop hypercalciuria and nephrolithiasis. The purpose of the study is to compare two therapeutic approaches in severe hypoparathyroidism in order to limit the risk of nephrocalcinosis and renal failure when attempting to correct hypocalcemia: rhPTH(1-34) vs association of active vitamin D and hydrochlorothiazide. The European Society of Endocrinology Clinical has indeed recently published guidelines for the treatment of chronic hypoparathyroidism in adults. These guidelines suggest considering treatment with a thiazide diuretic In a patient with hypercalciuria and replacement therapy with PTH in patients who do not stably and safely maintain their serum and urinary calcium in the target range.


lead_sponsor: Centre Hospitalier Annecy Genevois

acronym: DENIVOS

location_facility: Groupe Hospitalier Sud Réunion - CHU de la Réunion

location_facility: Ch Intercommunal Elbeuf Louvier Val de Reuil

location_facility: CHU Morvan - Institut de Cancérologie et d'Hématologie

location_facility: Hôpital André Mignot Centre Hospitalier de Versailles

location_facility: Hôpital d'Instruction des Armées Saint-Anne

ipd_sharing: Undecided

title: A Multicenter Phase II Study Evaluating Denosumab (XGEVA®) in Combination With Nivolumab (OPDIVO®) as Second-line Therapy for Patients With Stage IV Non-small-Cell Lung Cancer (Squamous and Non-squamous) With Bone Metastases: DENIVOS STUDY

summary:
Bone metastases are common in Non-Small Cell Lung Cancer (NSCLC). They most often occur during disease progression. It is thought that more than half of the patients with bone metastases will have at least 1 skeletal-related event (SRE, i.e. pathological fractures, medullary compression, analgesic radiotherapy, preventive and/or analgesic surgery and hypercalcemia).

Expert and medical Society guidelines, notably European Society for Medical Oncology in 2014, then in 2016, recommended using anti-resorptive agents (bisphosphonates or denosumab) to prevent SREs, attenuate pain and improve the quality of life, and decrease the medical-economic impact of this major metastatic site. Denosumab was accorded marketing authorization in France in 2011 as an anti-resorptive agent for bone metastases to delay the occurrence of SREs in lung-cancer patients.

Immunotherapy, notably immune-checkpoint inhibitors, like nivolumab (anti-programed death-1), has recently become an integral part of the therapeutic arsenal against NSCLCs. Nivolumab was accorded marketing authorization based on the phase III CHECKMATE 017 (squamous cell NSCLCs) and CHECKMATE 057 (non-squamous cell NSCLCs) trials versus docetaxel, after the phase II CHECKMATE 063 trial.

The denosumab-nivolumab combination is commonly used in current practice but has not been evaluated prospectively. The aim of this trial is to evaluate the combination of denosumab and nivolumab in second line of NSCLC with bone metastases.


title: Cerebral Functional Modifications After Low Frequency Repetitive Transcranial Magnetic Stimulation in Refractory Depression. Assessment With 18F-FDG-PET Imaging.

acronym: SMTr-METAB

summary: Biological markers of depressive states have been studied, but their usefulness to predict the therapeutic response is unknown. This issue is major in all depressive states which have not remitted after several lines of treatment. rTMS (repetitive transcranial magnetic stimulation) is a non-pharmacological alternative in the treatment of depression, but its effects on cerebral functioning are not known in episodes which have resist to conventional treatments. The investigators will include 50 depressive patients who have failed to respond to two successive antidepressant medication, and propose them a treatment with low frequency rTMS during 3 to 6 weeks. Cerebral functional imaging with 18FDG-PET (positon emission tomography) with be assessed at the beginning and at the end of rTMS acute treatment, in order to measure induced metabolic changes and their correlation with clinical states. Patients who have responded to rTMS acute treatment may continue this therapeutic for six months, and the investigators will assess if efficacy maintenance is related with cerebral metabolic variations

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_country: Monaco France

location_facility:
Hôpital Princesse Grace
CHU de Nice


title: Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 836880 Administered by Weekly Repeated Intravenous Infusions in Patients With Advanced Solid Tumors.

summary:
This is a Phase I, multi-centre, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously once a week. The eligible patient population will be patients with advanced solid tumors.

The primary objective of this trial is to determine the maximum tolerated dose (MTD) and recommended Phase II doses for BI 836880 in patients with solid tumors. Preliminary safety data will be evaluated as secondary objectives.

Subsequently, pharmacokinetic profile, pharmacodynamic changes in circulating biomarkers and Dynamic Contrast-Enhanced Magnetic Resonance Imaging ( DCE-MRI), anti-tumor activity and the immunogenicity of BI 836880 will be explored up to a total of 40 patients with advanced solid tumors.

Dose escalation will be guided by a Bayesian logistic regression model with over dose control (EWOC) using at least 2 patients per dose cohorts.

Safety criteria will be followed, including adverse events according to Common Terminology Criteria (CTCAE version 4.03), incidence of dose limiting toxicities, physical examination, vital signs, safety laboratory parameters and Eastern Cooperative Oncology Group (ECOG).

lead_sponsor: Boehringer Ingelheim

location_country: France Spain

location_facility:
CTR Georges-François Leclerc
Hospital Vall d'Hebron


title: Post-Marketing Clinical Follow-up (PMCF) Study for Skin Closure to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material. A Multicenter, International, Prospective, Observational Study

acronym: SKINNOQ

summary: The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for skin closure. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature.

ReferenceCitation: Gfroerer S, Baumann P, Schwalbach AK, Smirnoff A. Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ). BMC Surg. 2019 May 2;19(1):47. doi: 10.1186/s12893-019-0506-8.

family: Gfroerer

full_name: Stefan Gfroerer

given: Stefan

family: Baumann

full_name: Petra Baumann

given: Petra

family: Schwalbach

full_name: Anne-Kathrin Schwalbach

given: Anne-Kathrin

family: Smirnoff

full_name: Alexandre Smirnoff

given: Alexandre

journal_name: BMC Surgery

lead_sponsor: Aesculap AG

location_country: Germany France

location_facility: Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology


title: Cognitive Behavioural Therapy for Anxiety Disorders in Patients With Parkinson's Disease: a Randomized, Controlled Trial of the Clinical Effectiveness and Changes in Cerebral Connectivity

summary: Anxiety disorders occur in up to 35% of patients with Parkinson's disease (PD) and have a negative effect on gait, dyskinesia, freezing, on/off fluctuations, and quality of life. With this Randomized Controlled Trial the investigators intend to 1) develop a Cognitive Behavioural Therapy (CBT) module for anxiety in PD 2) assess the effectiveness of this module in reducing anxiety symptoms, and 3) study the effects of CBT on cerebral connectivity. Effective CBT treatment of anxiety will provide patients with behavioural and anxiety management techniques that can give lasting benefits, not only on anxiety symptoms, but potentially also on motor symptoms.

ReferenceCitation: Mulders AEP, Moonen AJH, Dujardin K, Kuijf ML, Duits A, Flinois B, Handels RLH, Lopes R, Leentjens AFG. Cognitive behavioural therapy for anxiety disorders in Parkinson's disease: Design of a randomised controlled trial to assess clinical effectiveness and changes in cerebral connectivity. J Psychosom Res. 2018 Sep;112:32-39. doi: 10.1016/j.jpsychores.2018.04.002. Epub 2018 Apr 10.

family: Mulders

full_name: A.E.P. Mulders

family: Moonen

full_name: A.J.H. Moonen

family: Dujardin

full_name: K. Dujardin

given: K.

family: Kuijf

full_name: M.L. Kuijf

family: Duits

full_name: A. Duits

given: A.

family: Flinois

full_name: B. Flinois

given: B.

family: Handels

full_name: R.L.H. Handels

family: Lopes

full_name: R. Lopes

given: R.

family: Leentjens

full_name: A.F.G. Leentjens

journal_name: Journal of Psychosomatic Research

oa_host_type: repository

repository_institution: Maastricht University - Research Publications

ipd_sharing: Yes

ipd_sharing_description: Treatment module will be made available for public use. Study data will be published in peer-reviewed journals.

lead_sponsor: Maastricht University Medical Center

location_country: France Netherlands

location_facility: Neurology and Movement Disorders Unit, Lille University Hospital


title: Cost-effectiveness and Cost-utility of Liberal vs Restrictive Red Blood Cell Transfusion Strategies in Patients With Acute Myocardial Infarction and Anaemia. The REALITY (REstrictive And LIberal Transfusion Strategies in Patients With Acute mYocardial Infarction) Randomized Trial.

acronym: REALITY

summary:
Anemia in patients with myocardial infarction (MI) is a relatively frequent issue, resulting in poorer outcome. There is equipoise regarding which transfusion strategy is best, and there is an international consensus on the urgent need for a randomized trial.

The investigators hypothesize that a "restrictive" transfusion strategy is at least non-inferior to a "liberal" transfusion strategy on 30-day outcomes of MI patients with anemia. Given the costs and risks of transfusion, a cost-effectiveness and cost-utility analysis becomes key to determining the role of each strategy.

ReferenceCitation: Sabatine MS, Morrow DA, Giugliano RP, Burton PB, Murphy SA, McCabe CH, Gibson CM, Braunwald E. Association of hemoglobin levels with clinical outcomes in acute coronary syndromes. Circulation. 2005 Apr 26;111(16):2042-9. Epub 2005 Apr 11.

ReferenceCitation: Hanssen M, Cottin Y, Khalife K, Hammer L, Goldstein P, Puymirat E, Mulak G, Drouet E, Pace B, Schultz E, Bataille V, Ferrières J, Simon T, Danchin N; FAST-MI 2010 Investigators. French Registry on Acute ST-elevation and non ST-elevation Myocardial Infarction 2010. FAST-MI 2010. Heart. 2012 May;98(9):699-705. doi: 10.1136/heartjnl-2012-301700.

family: Hanssen

full_name: Michel Hanssen

given: Michel

family: Cottin

full_name: Yves Cottin

given: Yves

family: Khalife

full_name: Khalife Khalife

given: Khalife

family: Hammer

full_name: Laure Hammer

given: Laure

family: Goldstein

full_name: Patrick Goldstein

given: Patrick

family: Puymirat

full_name: Etienne Puymirat

given: Etienne

family: Mulak

full_name: Geneviève Mulak

given: Geneviève

family: Drouet

full_name: Elodie Drouet

given: Elodie

family: Pace

full_name: Benoit Pace

given: Benoit

family: Schultz

full_name: Eric Schultz

given: Eric

family: Bataille

full_name: Vincent Bataille

given: Vincent

family: Ferrières

full_name: Jean Ferrières

given: Jean

family: Simon

full_name: Tabassome Simon

given: Tabassome

family: Danchin

full_name: Nicolas Danchin

given: Nicolas

journal_name: Heart

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Silvain J, Pena A, Cayla G, Brieger D, Bellemain-Appaix A, Chastre T, Vignalou JB, Beygui F, Barthelemy O, Collet JP, Montalescot G. Impact of red blood cell transfusion on platelet activation and aggregation in healthy volunteers: results of the TRANSFUSION study. Eur Heart J. 2010 Nov;31(22):2816-21. doi: 10.1093/eurheartj/ehq209. Epub 2010 Jun 29.

ReferenceCitation: Silvain J, Abtan J, Kerneis M, Martin R, Finzi J, Vignalou JB, Barthélémy O, O'Connor SA, Luyt CE, Brechot N, Mercadier A, Brugier D, Galier S, Collet JP, Chastre J, Montalescot G. Impact of red blood cell transfusion on platelet aggregation and inflammatory response in anemic coronary and noncoronary patients: the TRANSFUSION-2 study (impact of transfusion of red blood cell on platelet activation and aggregation studied with flow cytometry use and light transmission aggregometry). J Am Coll Cardiol. 2014 Apr 8;63(13):1289-1296. doi: 10.1016/j.jacc.2013.11.029. Epub 2013 Dec 18.

ReferenceCitation: Yeh RW, Wimmer NJ. Blood transfusion in myocardial infarction: opening old wounds for comparative-effectiveness research. J Am Coll Cardiol. 2014 Aug 26;64(8):820-2. doi: 10.1016/j.jacc.2014.05.041.

ReferenceCitation: Carson JL, Grossman BJ, Kleinman S, Tinmouth AT, Marques MB, Fung MK, Holcomb JB, Illoh O, Kaplan LJ, Katz LM, Rao SV, Roback JD, Shander A, Tobian AA, Weinstein R, Swinton McLaughlin LG, Djulbegovic B; Clinical Transfusion Medicine Committee of the AABB. Red blood cell transfusion: a clinical practice guideline from the AABB*. Ann Intern Med. 2012 Jul 3;157(1):49-58. doi: 10.7326/0003-4819-157-1-201206190-00429. Review.

ReferenceCitation: Carson JL, Carless PA, Hébert PC. Outcomes using lower vs higher hemoglobin thresholds for red blood cell transfusion. JAMA. 2013 Jan 2;309(1):83-4. doi: 10.1001/jama.2012.50429.

ReferenceCitation: Wu WC, Rathore SS, Wang Y, Radford MJ, Krumholz HM. Blood transfusion in elderly patients with acute myocardial infarction. N Engl J Med. 2001 Oct 25;345(17):1230-6.

ReferenceCitation: Chatterjee S, Wetterslev J, Sharma A, Lichstein E, Mukherjee D. Association of blood transfusion with increased mortality in myocardial infarction: a meta-analysis and diversity-adjusted study sequential analysis. JAMA Intern Med. 2013 Jan 28;173(2):132-9. doi: 10.1001/2013.jamainternmed.1001.

ReferenceCitation: Salisbury AC, Reid KJ, Marso SP, Amin AP, Alexander KP, Wang TY, Spertus JA, Kosiborod M. Blood transfusion during acute myocardial infarction: association with mortality and variability across hospitals. J Am Coll Cardiol. 2014 Aug 26;64(8):811-9. doi: 10.1016/j.jacc.2014.05.040.

ReferenceCitation: Rao SV, Sherwood MW. Isn't it about time we learned how to use blood transfusion in patients with ischemic heart disease? J Am Coll Cardiol. 2014 Apr 8;63(13):1297-1299. doi: 10.1016/j.jacc.2013.11.028. Epub 2013 Dec 18.

ReferenceCitation: Cooper HA, Rao SV, Greenberg MD, Rumsey MP, McKenzie M, Alcorn KW, Panza JA. Conservative versus liberal red cell transfusion in acute myocardial infarction (the CRIT Randomized Pilot Study). Am J Cardiol. 2011 Oct 15;108(8):1108-11. doi: 10.1016/j.amjcard.2011.06.014. Epub 2011 Jul 24.

ReferenceCitation: Carson JL, Brooks MM, Abbott JD, Chaitman B, Kelsey SF, Triulzi DJ, Srinivas V, Menegus MA, Marroquin OC, Rao SV, Noveck H, Passano E, Hardison RM, Smitherman T, Vagaonescu T, Wimmer NJ, Williams DO. Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease. Am Heart J. 2013 Jun;165(6):964-971.e1. doi: 10.1016/j.ahj.2013.03.001. Epub 2013 Apr 8.

ReferenceCitation: Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26.

ReferenceCitation: Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24.

ReferenceCitation: Hébert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. Erratum in: N Engl J Med 1999 Apr 1;340(13):1056.

ReferenceCitation: Hébert PC, Yetisir E, Martin C, Blajchman MA, Wells G, Marshall J, Tweeddale M, Pagliarello G, Schweitzer I; Transfusion Requirements in Critical Care Investigators for the Canadian Critical Care Trials Group. Is a low transfusion threshold safe in critically ill patients with cardiovascular diseases? Crit Care Med. 2001 Feb;29(2):227-34.

ReferenceCitation: Villanueva C, Colomo A, Bosch A, Concepción M, Hernandez-Gea V, Aracil C, Graupera I, Poca M, Alvarez-Urturi C, Gordillo J, Guarner-Argente C, Santaló M, Muñiz E, Guarner C. Transfusion strategies for acute upper gastrointestinal bleeding. N Engl J Med. 2013 Jan 3;368(1):11-21. doi: 10.1056/NEJMoa1211801. Erratum in: N Engl J Med. 2013 Jun 13;368(24):2341.

ReferenceCitation: Sherwood MW, Rao SV. Acute coronary syndromes: Blood transfusion in patients with acute MI and anaemia. Nat Rev Cardiol. 2013 Apr;10(4):186-7. doi: 10.1038/nrcardio.2013.14. Epub 2013 Feb 5.

ReferenceCitation: Perkins HA, Busch MP. Transfusion-associated infections: 50 years of relentless challenges and remarkable progress. Transfusion. 2010 Oct;50(10):2080-99. doi: 10.1111/j.1537-2995.2010.02851.x. Review.

ReferenceCitation: Williamson LM, Devine DV. Challenges in the management of the blood supply. Lancet. 2013 May 25;381(9880):1866-75. doi: 10.1016/S0140-6736(13)60631-5. Review.

ReferenceCitation: Bernard AC, Davenport DL, Chang PK, Vaughan TB, Zwischenberger JB. Intraoperative transfusion of 1 U to 2 U packed red blood cells is associated with increased 30-day mortality, surgical-site infection, pneumonia, and sepsis in general surgery patients. J Am Coll Surg. 2009 May;208(5):931-7, 937.e1-2; discussion 938-9. doi: 10.1016/j.jamcollsurg.2008.11.019. Epub 2009 Mar 26.

ReferenceCitation: Vincent JL, Baron JF, Reinhart K, Gattinoni L, Thijs L, Webb A, Meier-Hellmann A, Nollet G, Peres-Bota D; ABC (Anemia and Blood Transfusion in Critical Care) Investigators. Anemia and blood transfusion in critically ill patients. JAMA. 2002 Sep 25;288(12):1499-507.

ReferenceCitation: Frank SM, Abazyan B, Ono M, Hogue CW, Cohen DB, Berkowitz DE, Ness PM, Barodka VM. Decreased erythrocyte deformability after transfusion and the effects of erythrocyte storage duration. Anesth Analg. 2013 May;116(5):975-981. doi: 10.1213/ANE.0b013e31828843e6. Epub 2013 Feb 28.

ReferenceCitation: Vamvakas EC, Blajchman MA. Transfusion-related mortality: the ongoing risks of allogeneic blood transfusion and the available strategies for their prevention. Blood. 2009 Apr 9;113(15):3406-17. doi: 10.1182/blood-2008-10-167643. Epub 2009 Feb 2. Review.

ReferenceCitation: Murray CJ, Richards MA, Newton JN, Fenton KA, Anderson HR, Atkinson C, Bennett D, Bernabé E, Blencowe H, Bourne R, Braithwaite T, Brayne C, Bruce NG, Brugha TS, Burney P, Dherani M, Dolk H, Edmond K, Ezzati M, Flaxman AD, Fleming TD, Freedman G, Gunnell D, Hay RJ, Hutchings SJ, Ohno SL, Lozano R, Lyons RA, Marcenes W, Naghavi M, Newton CR, Pearce N, Pope D, Rushton L, Salomon JA, Shibuya K, Vos T, Wang H, Williams HC, Woolf AD, Lopez AD, Davis A. UK health performance: findings of the Global Burden of Disease Study 2010. Lancet. 2013 Mar 23;381(9871):997-1020. doi: 10.1016/S0140-6736(13)60355-4. Epub 2013 Mar 5.

ReferenceCitation: Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, Augustovski F, Briggs AH, Mauskopf J, Loder E; CHEERS Task Force. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. BMJ. 2013 Mar 25;346:f1049. doi: 10.1136/bmj.f1049.

ReferenceCitation: Briggs AH, O'Brien BJ. The death of cost-minimization analysis? Health Econ. 2001 Mar;10(2):179-84. Review.

ReferenceCitation: Kaiser C, Brunner-La Rocca HP, Buser PT, Bonetti PO, Osswald S, Linka A, Bernheim A, Zutter A, Zellweger M, Grize L, Pfisterer ME; BASKET Investigators. Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitäts Trial (BASKET). Lancet. 2005 Sep 10-16;366(9489):921-9. Erratum in: Lancet. 2005 Dec 17;366(9503):2086.

ReferenceCitation: Caruba T, Katsahian S, Schramm C, Charles Nelson A, Durieux P, Bégué D, Juillière Y, Dubourg O, Danchin N, Sabatier B. Treatment for stable coronary artery disease: a network meta-analysis of cost-effectiveness studies. PLoS One. 2014 Jun 4;9(6):e98371. doi: 10.1371/journal.pone.0098371. eCollection 2014.

ReferenceCitation: Greiner W, Weijnen T, Nieuwenhuizen M, Oppe S, Badia X, Busschbach J, Buxton M, Dolan P, Kind P, Krabbe P, Ohinmaa A, Parkin D, Roset M, Sintonen H, Tsuchiya A, de Charro F. A single European currency for EQ-5D health states. Results from a six-country study. Eur J Health Econ. 2003 Sep;4(3):222-31.

ReferenceCitation: Fearon WF, Shilane D, Pijls NH, Boothroyd DB, Tonino PA, Barbato E, Jüni P, De Bruyne B, Hlatky MA; Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 2 (FAME 2) Investigators. Cost-effectiveness of percutaneous coronary intervention in patients with stable coronary artery disease and abnormal fractional flow reserve. Circulation. 2013 Sep 17;128(12):1335-40. doi: 10.1161/CIRCULATIONAHA.113.003059. Epub 2013 Aug 14.

name: From the Division of Cardiovascular Medicine (W.F.F., M.A.H.) and the Department of Health Research and Policy (D.S., D.B.B., M.A.H.), Stanford University School of Medicine, Stanford, CA; Catharina Hospital, Eindhoven, The Netherlands (N.H.J.P., P.A.L.T.); Cardiovascular Center Aalst, Aalst, Belgium (E.B., B.D.B.); and Institute of Social and Preventive Medicine (ISPM), University of Bern, Switzerland and CTU Bern, Department of Clinical Research, University of Bern, Switzerland (P.J.).

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

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Cost-Effectiveness of Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease and Abnormal Fractional Flow Reserve

ReferenceCitation: Wijeysundera HC, Tomlinson G, Ko DT, Dzavik V, Krahn MD. Medical therapy v. PCI in stable coronary artery disease: a cost-effectiveness analysis. Med Decis Making. 2013 Oct;33(7):891-905. doi: 10.1177/0272989X13497262. Epub 2013 Jul 25.

ReferenceCitation: Magnuson EA, Farkouh ME, Fuster V, Wang K, Vilain K, Li H, Appelwick J, Muratov V, Sleeper LA, Boineau R, Abdallah M, Cohen DJ; FREEDOM Trial Investigators. Cost-effectiveness of percutaneous coronary intervention with drug eluting stents versus bypass surgery for patients with diabetes mellitus and multivessel coronary artery disease: results from the FREEDOM trial. Circulation. 2013 Feb 19;127(7):820-31. doi: 10.1161/CIRCULATIONAHA.112.147488. Epub 2012 Dec 31.

ReferenceCitation: Raikou M, Briggs A, Gray A, McGuire A. Centre-specific or average unit costs in multi-centre studies? Some theory and simulation. Health Econ. 2000 Apr;9(3):191-8.

ReferenceCitation: Hollingworth W, McKell-Redwood D, Hampson L, Metcalfe C. Cost-utility analysis conducted alongside randomized controlled trials: are economic end points considered in sample size calculations and does it matter? Clin Trials. 2013 Feb;10(1):43-53. doi: 10.1177/1740774512465358. Epub 2012 Dec 11.

ReferenceCitation: Mauskopf JA, Sullivan SD, Annemans L, Caro J, Mullins CD, Nuijten M, Orlewska E, Watkins J, Trueman P. Principles of good practice for budget impact analysis: report of the ISPOR Task Force on good research practices--budget impact analysis. Value Health. 2007 Sep-Oct;10(5):336-47.

ReferenceCitation: Robinson SD, Janssen C, Fretz EB, Berry B, Chase AJ, Siega AD, Carere RG, Fung A, Simkus G, Klinke WP, Hilton JD. Red blood cell storage duration and mortality in patients undergoing percutaneous coronary intervention. Am Heart J. 2010 May;159(5):876-81. doi: 10.1016/j.ahj.2010.02.018.

ReferenceCitation: Ducrocq G, Gonzalez-Juanatey JR, Puymirat E, Lemesle G, Cachanado M, Durand-Zaleski I, Arnaiz JA, Martínez-Sellés M, Silvain J, Ariza-Solé A, Ferrari E, Calvo G, Danchin N, Avendaño-Solá C, Frenkiel J, Rousseau A, Vicaut E, Simon T, Steg PG; REALITY Investigators. Effect of a Restrictive vs Liberal Blood Transfusion Strategy on Major Cardiovascular Events Among Patients With Acute Myocardial Infarction and Anemia: The REALITY Randomized Clinical Trial. JAMA. 2021 Feb 9;325(6):552-560. doi: 10.1001/jama.2021.0135.

name: Université de Paris, AP-HP, French Alliance for Cardiovascular Trials (FACT), INSERM U1148, Paris, France

name: Cardiology Department, University Hospital, IDIS, CIBERCV, University of Santiago de Compostela, Santiago de Compostela, Spain

name: Université de Paris, AP-HP, Hôpital Européen Georges Pompidou, French Alliance for Cardiovascular Trials (FACT), Paris, France

name: Institut Cœur Poumon, Centre Hospitalier Universitaire de Lille, Faculté de Médecine de Lille, Université de Lille, Institut Pasteur de Lille, Inserm U1011, Lille, France

name: Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris (URC-CRC-CRB), AP-HP, Hôpital St Antoine, Paris, France

name: AP-HP Health Economics Research Unit, Hotel Dieu Hospital, INSERM UMR 1153 CRESS, Paris, France

name: Clinical Trials Unit, Clinical Pharmacology Department, Hospital Clinic, Barcelona, Spain

name: Servicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, Universidad Europea, Universidad Complutense, Madrid, Spain

name: Sorbonne Université, ACTION Study Group, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), INSERM UMRS 1166, Paris, France

name: University Hospital Bellvitge, Heart Disease Institute, Barcelona, Spain

name: Université Côte d’Azur, CHU de Nice, Hôpital Pasteur 1, Service de Cardiologie, Nice, France

name: Àrea del Medicament, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain

name: Clinical Pharmacology Service, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain

name: AP-HP, Department of Biostatistics, Université Paris-Diderot, Sorbonne-Paris Cité, Fernand Widal Hospital, France

name: Department of Clinical Pharmacology-Clinical Research Platform (URCEST-CRB-CRCEST), AP-HP, Hôpital Saint Antoine, French Alliance for Cardiovascular Trials (FACT), Sorbonne-Université, Paris, France

name: Royal Brompton Hospital, Imperial College, London, United Kingdom

location_facility:
Hôpital Bichat
Hospital Clinic of Barcelona


title: Fiber Tolerability in Children

acronym: FITIC

summary: Assessment of the digestive tolerability of the PROMITOR® .

lead_sponsor: Nestlé

location_country: France Switzerland

location_facility: Metabolic Unit, Clinical Development Unit Nestec


title: Evaluation of the Parkinson's KinetiGraph Data Logger (PKG) as a Tool to Measure Motor Fluctuations and Support the DBS Eligibility Assessment of Parkinson's Disease Patients.

acronym: KITE

summary:
The purpose of the study is to investigate the feasibility of using the commercially available Parkinson's KinetiGraph Data Logger (PKG) to quantitatively assess motor fluctuations in Parkinson's Disease (PD) patients. A reliable and objective assessment of motor fluctuations would support the general neurologists in the referral of PD patients to the Deep Brain Stimulation (DBS) surgical centers and facilitate the DBS eligibility evaluation of PD patients usually done by the DBS specialists at the DBS surgical centers.

As part of the routine clinical practice, PD patients are referred to the DBS surgical center (clinical site) to optimize their PD treatment and potentially receive a DBS therapy, and the Principal Investigator (PI), a DBS specialist, assesses their DBS eligibility following published expert evaluation criteria and assigns the patient to one of the following two groups (PI assessment):

DBS ready, if the patient presents severe motor fluctuations and/or clear dyskinesia history.
DBS not-ready, if the patient presents neither severe motor fluctuations, nor clear dyskinesia history.

As part of routine clinical practice, the PKG responsible physician will provide the patient with the PKG to be worn for 6 to 10 days.

Based on the Global Kinetics Corporation (GKC) algorithm applied on the data recorded by the PKG, a GKC representative assigned the patients to one of the above mentioned groups: DBS ready or DBS not-ready.

The primary objective is to evaluate whether the GKC algorithm can differentiate DBS ready from DBS not-ready patients as assessed during the visit at the clinical site by the DBS specialist. The primary endpoint is therefore the percentage of agreement between the PI assessment and the GKC assessment (DBS ready or DBS not-ready) about the DBS eligibility of the PD patients.

ReferenceCitation: Horne MK, McGregor S, Bergquist F. An objective fluctuation score for Parkinson's disease. PLoS One. 2015 Apr 30;10(4):e0124522. doi: 10.1371/journal.pone.0124522. eCollection 2015.

lead_sponsor: Medtronic Bakken Research Center

location_facility: Centre Hospitalier Universitaire de Grenoble


title: A Phase I/II Multi Centre Single Arm, Open Label Study of Intraparenchymal Therapy With Irinotecan Hydrochloride Drug-eluting Beads (CM-BC2) as a Adjunct Therapy to Best Standard of Care in Patients With Recurrent, Surgically Resectable High Grade Glioma

acronym: IDEB-glioma

summary: A study to demonstrate safety, and feasibility for intraparenchymal injection of irinotecan hydrochloride drug-eluting beads in the treatment of recurrent high grade glioma (HGG).

lead_sponsor: Boston Scientific Corporation

location_facility: Centre Hopsitalier Universitaire d'Angers


title: Rivaroxaban Evaluation in Real Life Settings

acronym: RIVER

summary: To discover outcomes of patients treated with Rivaroxaban with atrial fibrillation with at least one additional investigator-determined risk factor for stroke in real-life practice.

ReferenceCitation: Waldo AL, Becker RC, Tapson VF, Colgan KJ; NABOR Steering Committee. Hospitalized patients with atrial fibrillation and a high risk of stroke are not being provided with adequate anticoagulation. J Am Coll Cardiol. 2005 Nov 1;46(9):1729-36. Epub 2005 Oct 10.

ReferenceCitation: Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation: a major contributor to stroke in the elderly. The Framingham Study. Arch Intern Med. 1987 Sep;147(9):1561-4.

ReferenceCitation: Rockson SG, Albers GW. Comparing the guidelines: anticoagulation therapy to optimize stroke prevention in patients with atrial fibrillation. J Am Coll Cardiol. 2004 Mar 17;43(6):929-35. Review.

ReferenceCitation: Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5.

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family: Beyer-Westendorf

full_name: Jan Beyer-Westendorf

given: Jan

family: Camm

full_name: A. John Camm

given: A. John

family: Fox

full_name: Keith A. A. Fox

given: Keith A. A.

family: Le Heuzey

full_name: Jean-Yves Le Heuzey

given: Jean-Yves

family: Haas

full_name: Sylvia Haas

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family: Turpie

full_name: Alexander G. G. Turpie

given: Alexander G. G.

family: Virdone

full_name: Saverio Virdone

given: Saverio

family: Kakkar

full_name: Ajay K. Kakkar

given: Ajay K.

journal_name: Thrombosis Journal

repository_institution: Università degli Studi di Milano - Institutional Research Information System

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repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

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license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repository_institution: Technische Universität München - mediaTUM Gesamtbestand

repository_institution: University College London - UCL Discovery

repository_institution: St George's University of London - St George's Online Research Archive

location_facility: Prof. Jean-Yues LeHeuzey, National Coordinating Investigator, Hopital Europeen Georges Pompidou