title: Performance of the Dosage of Plasma 1, 3-β-D-glucan (BDG) for the Diagnosis of Candidemia in Intensive Care Patients: A Prospective, Multicenter Study

acronym: BDG-REA

summary:
Systematic and repeated dosing (3 times weekly) of 1,3-β-D-glucan (BDG), associated with blood cultures and fungal mapping (twice a week) for the patients hospitalized in intensive care. The diagnosis of candidemia is defined as the 1st positive blood culture for Candida spp.

The dosage of BDG will be considered positive if the value is at least or equal to 80 pg/ml.

ReferenceCitation: Lortholary O, Renaudat C, Sitbon K, Madec Y, Denoeud-Ndam L, Wolff M, Fontanet A, Bretagne S, Dromer F; French Mycosis Study Group. Worrisome trends in incidence and mortality of candidemia in intensive care units (Paris area, 2002-2010). Intensive Care Med. 2014 Sep;40(9):1303-12. doi: 10.1007/s00134-014-3408-3. Epub 2014 Aug 6.

ReferenceCitation: Clancy CJ, Nguyen MH. Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care. Clin Infect Dis. 2013 May;56(9):1284-92. doi: 10.1093/cid/cit006. Epub 2013 Jan 11. Review.

ReferenceCitation: Morrell M, Fraser VJ, Kollef MH. Delaying the empiric treatment of candida bloodstream infection until positive blood culture results are obtained: a potential risk factor for hospital mortality. Antimicrob Agents Chemother. 2005 Sep;49(9):3640-5.

ReferenceCitation: Posteraro B, De Pascale G, Tumbarello M, Torelli R, Pennisi MA, Bello G, Maviglia R, Fadda G, Sanguinetti M, Antonelli M. Early diagnosis of candidemia in intensive care unit patients with sepsis: a prospective comparison of (1→3)-β-D-glucan assay, Candida score, and colonization index. Crit Care. 2011;15(5):R249. doi: 10.1186/cc10507. Epub 2011 Oct 22.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hopital Avicenne
Hôpital Louis Mourier


type: EudraCT Number

title: A Single-arm Dose Finding Phase Ib Multicenter Study of the Oral Smoothened Antagonist LDE255 in Combination With Azacitidine for High Risk Myelodysplastic Syndrome Patients

summary: This study is a phase Ib add-on study of the combination of LDE255 to azacitidine in patients without marrow response after at least 6 cycles of azacitidine.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Hôpital Saint-Louis - Service d'hématologie AJA

location_facility: Hôpital Saint Louis - Service Hématologie Sénior

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: What Are the Predictive Factors for Preeclampsia in Oocyte Recipients? - PREROVE

acronym: PREROVE

summary: The main goal is to determine which risk factors develop preeclampsia in this specific group of oocyte recipients.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

lead_sponsor: Rennes University Hospital

location_facility:
Clinique de la sagesse
CHU de Rennes

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Risk Factors in Sudden Unexpected Death in Epilepsy of the Adults and Children: A Matched Case-control Study

acronym: PRERIES

summary:
Numerous studies over the past decade have shown without any doubt that there is a higher mortality risk in patients with epilepsy than in the general population. The cause of death may be related to the cause of epilepsy, being directly related to a seizure (status epilepticus or sudden unexpected death in epilepsy; SUDEP), a consequence of seizures (accidents, etc), other associated pathologies (cancer, cardiovascular disease, ischemic heart disease, pneumonia, etc) or an associated disorder (depression or suicide). A SUDEP is defined as a sudden, non-traumatic, unexpected death in a patient with epilepsy, not necessarily in the presence of witnesses, that is not due to drowning, with or without evidence of a seizure, excluding documented status epilepticus and in which a post-mortem autopsy reveals no anatomical or toxicological cause of death. Little is known about SUDEP and its mechanisms and risk factors.

This epidemiological study is based on the RSME. The Main objective of this study to identify risk factors of SUDEP, in particular night-time supervision and the risks associated with anti-epileptic drugs including compliance and drug interactions.

ReferenceType: background

ReferenceCitation: Donner EJ, Waddell B, Osland K, Leach JP, Duncan S, Nashef L, Picot MC. After sudden unexpected death in epilepsy: Lessons learned and the road forward. Epilepsia. 2016 Jan;57 Suppl 1:46-53. doi: 10.1111/epi.13235.

ipd_sharing: Yes

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Wide Awake Local Anesthesia No Tourniquet

acronym: WALANT

summary: The main objective is to assess patient's satisfaction regarding pure local anaesthesia and without use of a tourniquet (WALANT Technique) for trigger finger release surgery.

time_perspective: Prospective

location_facility:
Centre Hospitalier Privé de Plérin
CHU de Rennes

intervention_type: Procedure


title: Multicenter Randomized Phase 2 Trial of Gemcitabine - Platinum With or Without Trastuzumab in Advanced or Metastatic Urothelial Carcinoma With HER2 Overexpression

summary: A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of association of trastuzumab with combination chemotherapy in advanced or metastatic bladder cancer patients. Combining monoclonal antibody therapy with combination chemotherapy may improve treatment efficacy on tumours overexpressed HER 2.

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Oudard S, Culine S, Vano Y, Goldwasser F, Théodore C, Nguyen T, Voog E, Banu E, Vieillefond A, Priou F, Deplanque G, Gravis G, Ravaud A, Vannetzel JM, Machiels JP, Muracciole X, Pichon MF, Bay JO, Elaidi R, Teghom C, Radvanyi F, Beuzeboc P. Multicentre randomised phase II trial of gemcitabine+platinum, with or without trastuzumab, in advanced or metastatic urothelial carcinoma overexpressing Her2. Eur J Cancer. 2015 Jan;51(1):45-54. doi: 10.1016/j.ejca.2014.10.009. Epub 2014 Nov 15.

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_country: France Belgium

location_facility: Centre Hospitalier Départemental de la Vendée

location_facility: Cliniques saint Luc - Université Catholique de Louvain

intervention_type: Biological


title: Glucose Disorders Induced by Tacrolimus on Pre Transplantation Endstage Renal Disease Patients

acronym: GLITTER

summary:
Diabetes after kidney transplantation is a frequent complication, the incidence of which varies from 7 to 45% depending on the studies and on the diagnostic criteria used. Post-transplant diabetes is an early complication, most often occurring in the first month after transplantation.

In addition to the additional health costs generated by the appearance of post-transplant diabetes, the risk of graft loss is increased by 60% and the overall mortality risk by 90%. Similarly, the development of glucose intolerance after transplantation is associated with higher mortality.

Tacrolimus treatment is therefore currently one of the most important risk factors for diabetes at the time of transplantation.

Indeed, several in vitro and in vivo animal studies have shown that tacrolimus alters pancreatic endocrine function.

In the final stage, this cellular toxicity leads to diabetes, most often diagnosed on the rise in capillary or venous blood sugar levels after transplantation. This diabetes often requires hypoglycemic treatment with insulin or oral anti-diabetic drugs. for a variable period. The pro-diabetogenic effect of tacrolimus is sometimes irreversible, justifying preventive treatment.

No clinical studies have looked at "sub-clinical" changes in insulin secretion or insulin resistance under tacrolimus prior to the onset of diabetes. The static indices HOMA-β% and HOMA-IR (Homeostasis Model Accessment of insulin resistance) make it possible to estimate insulin secretion and insulin resistance in fasting patients respectively, while the oral glucose disposition index (IDO) makes it possible to study insulin secretion and action dynamically (after a 75 g glucose load), and are calculated as follows:

HOMA IR= Fasting blood glucose (mmol/L) x Fasting insulin (mU/L)/ 22.5 HOMAβ% = 20 x fasting insulinemia (mU/L) / fasting plasma glucose (mmol/L) - 3.5 IDO = (delta insulinemia T30-T0/ delta blood glucose T30-T0)/insulinemia T0

These indices have already been studied in dialysis patients (diabetic and non-diabetic) and may allow a more detailed study of pancreatic response and insulin resistance under tacrolimus in patients prior to renal transplantation. Determining the "pancreatic response" to tacrolimus in patients prior to transplantation would prevent diabetes by adapting immunosuppressive treatment and post-transplant screening modalities in the event of pre-transplant subclinical abnormalities identified in our study. The development of tacrolimus-induced diabetes in pre-transplantation in our study will be a contraindication to tacrolimus at the time of transplantation and ciclosporin therapy will be preferred.

status: Recruiting

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Centre Hospitalier Universitaire Nantes
Centre Hospitalier Départemental Vendée

status_simplified: Ongoing


title: Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent (Development Code TCD-10023) With Biodegradable Polymer at 1, 2 and 3 Months

summary: Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES), coverage of the stent struts by new tissue. The evaluation will be performed by means of intravascular imaging technology (optical frequency domain imaging, OFDI). Renewed tissue coverage over the implanted stent struts prevents direct contact between blood and metal/polymer, which could lead to adverse events: patients need to take blood-thinning drugs to prevent these events. Ous new stent has drug and polymer only on the outside of the stent, and the polymer is degraded by the body leaving a bare metal stent after 3-4 months. This should allow fast coverage of the struts, and might allow to reduce duration of the supportive medical treatment. Our hypothesis is that <20% of the struts remain uncovered at 3 months after implantation, as assessed by OFDI.

ReferenceCitation: Chevalier B, Smits PC, Carrié D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamié D, Kraaijeveld AO, Hovasse T, Vlachojannis GJ. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months). Circ Cardiovasc Interv. 2017 Dec;10(12). pii: e004801. doi: 10.1161/CIRCINTERVENTIONS.116.004801.

lead_sponsor: Terumo Europe N.V.

location_country: Germany France Netherlands

location_facility: Cardiovascular Institute Paris Sud (ICPS)

intervention_type: Device


title: Study of the Efficacy and Safety of Perampanel in Combination in Glioma-refractory Epilepsy

summary:
Gliomas are primitive brain tumors frequently associated with epilepsy. In a significant number of these patients epilepsy is resistant to antiepileptic drugs. There are currently no recommendations for the management of these drug-resistant epilepsies associated with glioma. In addition, few studies have addressed the subject and no treatment appears to be superior to others in the literature for this indication. In addition, many antiepileptic drugs pose problems of tolerance or interaction with chemotherapy in these patients.

Fundamental studies on glioma-associated epilepsies have shown that there is a major dysregulation of glutamatergic systems involved in epileptogenesis and tumor growth. Targeting this glutamatergic system seems particularly interesting from a physiopathological point of view. Perampanel is a recent antiepileptic treatment with a novel mode of action targeting AMPA glutamate receptors. It has been shown to be effective in patients with drug-resistant epilepsies. He has demonstrated his tolerance in these patients. He has obtained a marketing authorization and is therefore used in routine epileptology without serious problems of tolerance being reported. It is neither an inducer nor an enzyme inhibitor, avoiding the problems of interaction with chemotherapy and is used in a daily dose facilitating compliance.

Therefore, there may be specific antiepileptic efficacy of perampanel in patients with glioma. Nevertheless, the only current data is limited to a retrospective study of 12 patients.

The objective of this protocol is to evaluate the efficacy and safety of perampanel in patients with glioma with drug-resistant epilepsy.

a prospective randomized study with two parallel arms: antiepileptic combination therapy with perampanel and antiepileptic combination therapy without perampanel (free choice of the practitioner). The main criterion of judgment will be the decrease of the monthly frequency of crisis. Secondary endpoints will assess tolerance, efficacy on responder rate (at least 50% decrease in seizure frequency), seizure severity (secondary generalization, loss of consciousness), and quality. patients' lives (quality of life questionnaires, side effects and anxiety / depression). The duration of participation per patient will be 23 weeks (6 weeks of baseline, 5 weeks of titration and 12 weeks of maintenance). The recruitment period will be 3 years. Investigators plan to recruit 120 patients.

In the context of no recommendation in the management of these patients, superior efficacy of perampanel compared with other antiepileptic drugs is expected. This would allow targeted treatment in this population and confirm the tolerance of this treatment in these patients.

status: Withdrawn

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille

location_facility: Department of Epileptology and Cerebral Rhythmology, Hôpital La Timone, APHM


title: Randomized Phase III Study Evaluating the Non-inferiority of a Treatment Adapted to the Early Response Evaluated With 18F-FDG PET Compared to a Standard Treatment, for Patients Aged From 18 to 80 Years With Low Risk (aa IPI = 0) Diffuse Large B-cells Non Hodgkin's Lymphoma CD 20+

summary:
In this study, the investigators purpose is to evaluate the adaptation of treatment with early response based on PET scan results after 2 cycles of chemotherapy, for patient aged from 18 to 80 years, with low IPI DLBCL.

This is an open randomized study.

The primary endpoint is to evaluate the 3 years PFS with the aim to demonstrate the non inferiority of the experimental arm in comparison to standard arm:

In standard arm, the patients will receive 6 cycles of R-CHOP 21 without taking into account of PET scan results after 2 cycles.

In experimental arm, early good responder patients (defined as having a negative PET scan after 2 cycles, confirmed after 4 cycles) will receive only 4 cycles of R-CHOP 21.

In both arms, if the PET scan remains positive after 4 cycles of chemotherapy, a biopsy exam is needed to confirm the failure and an intensive chemotherapy is then recommended.

All of the patients, in both arms, will have an early evaluation with PET scan. All PET scan will be reviewed by a group of expert according to Deauville criteria defined by Meignan et al to adapt the decision after the 2nd cycle in experimental arm and after the 4th cycle for all patients. The final evaluation of response will be made according to 2007 Cheson's criteria.

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: CH de Saint-Brieuc - Hôpital Yves Le Foll

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: Centre Hospitalier de Wallonie Picarde - CHwapi

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Université Catholique de Louvain Saint Luc

location_facility: Hôpital Saint Antoine, Service d'hématologie du Pr Marie


title: Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors

acronym: ProTool

summary: The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.

lead_sponsor: University Hospital, Grenoble

location_facility:
CLINATEC
Sainte-Anne Hospital
Henri Mondor University Hospital
Angers University Hospital
Grenoble University Hospital


type: Other Identifier

title: Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization

summary: The management of pelvic gynecological cancers (PGC) is based on the determination of extension to guide treatments. The biology of the CGP is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing ovarian tumors can select patients who can benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify the factors predictive of recurrence of these cancers. The results obtained are very promising. This study will permit to collect biological samples and detailed clinical data that would allow to test hypotheses and develop a personalized medicine based on clinical and biological characteristics of patients.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CHI Creteil
CHU Tenon


title: Use of Botulinum Toxin (BTX) for the Treatment of Peripheral Painful Traumatic Trigeminal Neuropathy (PPTTN)

acronym: TRIGTOX

summary: Peripheral painful traumatic trigeminal neuropathy (PPTTN) are poorly relieved by existing treatments which in addition induce many adverse effects. BTX, which blocks the exocytosis of neurotransmitters, can be captured by axonal retrograde transport in primary nociceptive neurons. Injected in the painful area, it might therefore inhibit the release of algogenic neurotransmitters, at both the peripheral and central levels and thus reduce pain. One study reported such an effect in neuropathic spinal pain. A recent study reported an analgesic effect in trigeminal neuralgia.

status: Active, not recruiting

ReferenceCitation: Moreau N, Dieb W, Descroix V, Svensson P, Ernberg M, Boucher Y. Topical Review: Potential Use of Botulinum Toxin in the Management of Painful Posttraumatic Trigeminal Neuropathy. J Oral Facial Pain Headache. 2017 Winter;31(1):7-18. doi: 10.11607/ofph.1753. Review.


title: Conservative Treatments of Retinoblastoma

summary:
Conservative treatments of retinoblastoma (RETINO 2011)

-Multicentric non randomised, phase II study for the patients treated by chemoreduction (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8
-Multicentric non randomised, phase II study for the patients with bilateral very asymmetric dis-ease (Group D eye on one of the eye) or unilateral presentation groups B/C/D according to the age and vitreous seeding
- Multicentric non randomised, phase II study for the patients treated by 6 cycles of three drugs regimen and local treatments for bilateral group D eyes or on the only eye.

design_allocation: Non-Randomized

lead_sponsor: Institut Curie

intervention_type: Radiation


title: A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions

summary: The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

ReferenceCitation: Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439.

ReferenceCitation: Généreux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5). pii: e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.

lead_sponsor: Abbott Medical Devices

location_country:
Spain
Italy
United Kingdom
Venezuela
Belgium
South Africa
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Norway
Malaysia
Brazil
Switzerland
Hungary
China
Germany
Denmark
Greece
Latvia
France
Netherlands

location_facility: A.O. Universitaria Tor Vergata, Cardiologia

location_facility: INCOR/SP Instituto do Coração - Hospital das Clinicas - FMUSP

location_facility: Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II

location_facility: Hosital Italiano de Buenos Aires - Cardiologia

location_facility: Semmelweis University, Department of Cardiovascular Surgery

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Latvian Center of Cardiology, P. Stradina University Hospital

location_facility: Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud

location_facility: Technische Universität Dresden, Medizinische Klinik II - Kardiologie

location_facility: H. Miguel Servet. Zaragoza, Cardiology Service

location_facility: Escorts Heart Institute & Research Centre

location_facility: Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena

location_facility: Polsko Amerykanskie-Kliniki Serca American Heart

location_facility: L'Azienda di Rilievo Nazionale di Alta Specializzazione (A.R.N.A.S.) Civico e Benfratelli

location_facility: Hospital Moinhos de Ventos-Centro de Cardiologia

location_facility: Centre Cardio-Pneumologique - Hôpital Pontchaillou - CHU

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Instituto Cardiovascular de Buenos Aires-ICBA

location_facility: Medizinische Hochschule Hannover Abteilung Kardiologie Und Angiologie

location_facility: Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO

location_facility: Klinikum der Johannes Gutenberg-Universität II. Medizinische Klinik und Poliklinik

location_facility: China People Liberation Army (PLA) General Hospital

location_facility: Universitäres Herzzentrum, Medizinische Klinik III

location_facility: Max Devki Devi Heart & Vascular Insititute, Department of Cardiology

location_facility: Hospital Clinico San Carlos, Hemodynamics Department

location_facility: Kardiologische Klinik Herz- und Diabeteszentrum

location_facility: Bakulev Scientific Center for Cardiovascular Surgery

location_facility: University of Pécs/Medical School/Heart Institute

location_facility: Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

location_facility: Cardiology Clinic of Papageorgiou Hospital

location_facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences


title: Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting

acronym: HIPEOS

summary: The authors hypothesize that a pelvic kinematic disorder, demonstrated by a significant decrease in sacral slope, is associated with the risk of instability of total hip prosthesis, the sacral slope being measured by an EOS imaging system during the transition to sitting in unstable patients versus patients with no history of instability.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Lapeyronie de Montpellier
CHU Nimes


title: Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve

acronym: ROUTE

summary: This is an international multi-center, prospective, observational registry with consecutive patient enrollment intended to determine outcome Parameters within 30 days after transaortic transcatheter aortic valve replacement.

ReferenceCitation: Cocchieri R, Petzina R, Romano M, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Rein KA, Verhoye JP, Gerosa G, Bapat V, Baumbach H, Sims H, Deutsch C, Bramlage P, Kurucova J, Thoenes M, Frank D. Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE†. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):737-743. doi: 10.1093/ejcts/ezy333.

ReferenceCitation: Romano M, Frank D, Cocchieri R, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Arne Rein K, Verhoye JP, Gerosa G, Baumbach H, Deutsch C, Bramlage P, Thoenes M, Bapat V. Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry. Interact Cardiovasc Thorac Surg. 2017 Nov 1;25(5):757-764. doi: 10.1093/icvts/ivx159.

ReferenceCitation: Bonaros N, Petzina R, Cocchieri R, Jagielak D, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Bapat V, Arne Rein K, Verhoye JP, Gerosa G, Baumbach H, Kofler M, Bramlage P, Deutsch C, Thoenes M, Frank D, Romano M. Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry. Eur J Cardiothorac Surg. 2017 May 1;51(5):919-926. doi: 10.1093/ejcts/ezw406.

ReferenceCitation: Bapat V, Frank D, Cocchieri R, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Rein KA, Verhoye JP, Gerosa G, Baumbach H, Bramlage P, Deutsch C, Thoenes M, Romano M. Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry. JACC Cardiovasc Interv. 2016 Sep 12;9(17):1815-22. doi: 10.1016/j.jcin.2016.06.031.

ReferenceCitation: Bramlage P, Romano M, Bonaros N, Cocchieri R, Jagielak D, Frank D, Bapat V. Transaortic transcatheter aortic valve implantation - rationale and design of the multicenter, multinational prospective ROUTE registry. BMC Cardiovasc Disord. 2014 Nov 1;14:152. doi: 10.1186/1471-2261-14-152.

lead_sponsor: Institut für Pharmakologie und Präventive Medizin

location_country:
Poland
United Kingdom
Italy
Austria
Netherlands
Finland
France
Norway
Germany

location_facility: Division of Cardiology, Helsinki University Central Hospital

location_facility: St. Thomas Hospital Cardiothoracic surgery dept

location_facility: Cardiac Surgery dpt., Innsbruck Medical University Hospital

location_facility: Universitätsklinikum Kiel - Kardiologie u. Angiologie

location_facility: Westdeutsches Herzzentrum Essen - Uniklinikum -

location_facility: Hopital Cardio-Vasculaire et Pneumologie Louis Pradel

location_facility: Univ. Padova, Azienda Ospedaliera di Padova

location_facility: James Cook Hospital - Cardiothoracic Division

location_facility: Städt. Klinikum München GmbH Herzchirurgie Bogenhausen

location_facility: Policlinico San Matteo/Department of Cardiac Surgery


title: To Assess Hemodynamic Disturbances to the Ostia of the Renal Arteries Generated by the Implantation of EVAR With a Suprarenal Fixation

acronym: IFIXEAR

summary: The investigators conducted a bicentric prospective study to quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation EVAR with suprarenal fixation immediately postoperatively.

ReferenceCitation: Salomon du Mont L, Parmentier AL, Puyraveau M, Mauny F, Guillon B, Rinckenbach S, Costa P. To assess hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of EVAR with a suprarenal fixation. Medicine (Baltimore). 2020 May;99(18):e19917. doi: 10.1097/MD.0000000000019917.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Centre Hosptalier Universitaire
Centre Hospitalier Universitaire


title: First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma (PPGL)

acronym: FIRSTMAPPP

summary: The FIRSTMAPPP study is a randomized, double-blind, phase II, international, multicenter study which aims to determine the efficacy of Sunitinib on the progression-free survival at 12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated with sunitinib at a starting dose of 37.5 mg daily (continuous dosing).

ReferenceCitation: Fankhauser M, Bechmann N, Lauseker M, Goncalves J, Favier J, Klink B, William D, Gieldon L, Maurer J, Spöttl G, Rank P, Knösel T, Orth M, Ziegler CG, Aristizabal Prada ET, Rubinstein G, Fassnacht M, Spitzweg C, Grossman AB, Pacak K, Beuschlein F, Bornstein SR, Eisenhofer G, Auernhammer CJ, Reincke M, Nölting S. Synergistic Highly Potent Targeted Drug Combinations in Different Pheochromocytoma Models Including Human Tumor Cultures. Endocrinology. 2019 Nov 1;160(11):2600-2617. doi: 10.1210/en.2019-00410.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country: Germany France Netherlands Italy

location_facility: Radboud University Nijmegen Medical Centre


title: A Multicentric, Open-Label, Single Arm Phase II Study To Evaluate The Efficacy And Safety Of The Combination Of PEmbrolizumab And Lenvatinib In Pre-Treated Thymic Carcinoma PaTIents. PECATI.

acronym: PECATI

summary: This is a multicentric, open-label, single arm phase II study to evaluate the efficacy and safety of the combination of pembrolizumab and lenvatinib in pre-treated thymic carcinoma patients who have progressed after at least one line of platinum-based chemotherapy for advanced disease without having received any previous immunotherapy (previous bevacizumab allowed, but not sunitinib), and not amenable to curative-intent radical surgery and/or radiotherapy, regardless of PD-L1 status.

lead_sponsor: MedSIR

location_country: France Spain Italy

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hôpitaux Universitaires de Marseille - Hôpital Nord

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC)

location_facility: Centre Hospitalier Universitaire de Toulouse


title: Study of the Expression of Angiotensin-converting Enzyme 2 (ACE2), a Cell Membrane Receptor for SARS-CoV-2 and the TMPRSS2 Serine Protease in Tonsils and Adenoids of Children and Adults

summary: The objective of the research is to study the expression of the ACE 2 receptor and the TMPRSS2 serine protease in the tonsils and adenoids of children and adults.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Bicêtre
Hôpital Necker-Enfants Malades
Hôpital Pitié Salpêtrière
Hôpital Armand Trousseau
Hôpital Tenon
Hôpital Mondor
Hôpital Lariboisière
HEGP
Hôpital Bichat


title: Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound (HIFU). A Prospective, Multicenter, Open-label, Safety and Efficacy Study of the Treatment With the EYEOP Medical Device in Patients With Refractory Glaucoma

summary: The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment using High Intensity Focused Ultrasound in refractory glaucoma patients.

ReferenceType: result

ReferenceCitation: Denis P, Aptel F, Rouland JF, Nordmann JP, Lachkar Y, Renard JP, Sellem E, Baudouin C, Bron A. Cyclocoagulation of the ciliary bodies by high-intensity focused ultrasound: a 12-month multicenter study. Invest Ophthalmol Vis Sci. 2015 Jan 20;56(2):1089-96. doi: 10.1167/iovs.14-14973.

lead_sponsor: EyeTechCare

location_facility:
University Hospital
Clinique du Parc - Private Hospital
Saint-Joseph Hospital
Croix Rousse Hospital
XV-XX National Ophthalmologic Hospital
Val de Grace Hospital
XV-XX Ophthalmologic Hospital
University Hospital - Cl Huriez


title: Prediction of the Severity of Female SUI by Measuring New Static and Dynamic Ultrasound Parameters of the Urethra

acronym: PRESIUS

summary: This study aims to evaluate the correlation of the ultrasonic functional length of the urethra and the incontinence urinary disorder (IUD). The goal is to predict the severity of the IU by measuring new static and dynamic ultrasound parameters of the urethra.

lead_sponsor: CMC Ambroise Paré

location_facility:
Centre Echographie Obstétricale
CMC Hartmann


type: Other Grant/Funding Number

title: Development and Evaluation of a Virtual Reality Application for Eliciting Craving and Its Physiological Arousal in Cocaine Users

acronym: RVCOC

summary: Our study main objective is to test whether virtual reality exposure could elicit cocaine craving and its physiological arousal in cocaine users. Investigators aim to compare self-reported cocaine craving, self-efficacy to cope with craving and emotional states levels in 11 voluntary and adults cocaine users in 3 consecutive 10-mins conditions: Neutral VR (virtual reality exposure to neutral stimuli), Cocaine VR (virtual reality exposure to cocaine use-related stimuli) and Relaxation (respiratory relaxation).

primary_purpose: Basic Science

location_facility: Laboratoire de Psychologie des Cognitions (Strasbourg University)

intervention_type: Behavioral


title: Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation and Interest of the Isochron Map

acronym: Isochrone-AFAn

summary: This study is an ancillary study to Isochrone-AF. The investigators hypothesize that patients eligible but non-included in the primary study (patients classified as non-reducible or non-inducible) will have different prognosis and electro-physiclogical characteristics to the patients included and randomized into the Isochrone AF study.

location_facility:
CHU Montpellier
CHU Nimes


title: Ketamine's Efficiency in the Treatment of Chronic Pain With an Added Inflammatory Component Exploring the Kynurenin Pathway. A Randomized, Double Blind, Placebo-controlled Trial

lead_sponsor: Redar

type: Registry Identifier

source: euctr

summary:
The kynurenine pathway is involved in hyperalgesia. This pathway is activated by inflammation. Ketamine would interact with the kynurenine pathway and inflammation. Our working hypotheses are: the clinical effects of ketamine on neuropathic pain are greater in the presence of systemic inflammation and the mechanism of action involves an interaction on the kynurenine pathway.

Study design: Interventional randomized placebo-controlled clinical trial.

￼Main goals:

To show a better clinical efficacy of ketamine in chronic pain in patients with an inflammatory component.
Explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.


title: ANRS HIV CONTROLLERS NATIONAL OBSERVATORY

acronym: ANRS CO18

summary: The investigators have previously described a limited group of HIV-1-infected patients, we called HIV controllers (HIC), who have been infected for more than 10 years, in whom viral replication is spontaneously controlled without any treatment. These patients are defined according to virological criteria: more than 90% of the quantifications of plasma viral load should be less than 400 RNA copies/mL. The purpose of the ANRS EP36 study was to characterize these patients.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis


title: Essais Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie de la Prostate

acronym: PERSEE II

summary: This multicenter study aimed at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during Robotic-Assisted Radical Prostatectomy or Laparoscopic Radical Prostatectomy for intra-operative characterisation of surgical margins.

lead_sponsor: Mauna Kea Technologies

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon


title: Phase III Open-label Randomized Multicenter Trial to Assess the Non-inferiority of Raltegravir Compared With EFavirenz, Both in Combination With LAmivudine and TEnofovir, in ART-naïve HIV-1-infected Patients Receiving Rifampin for Active TuBerculosis

acronym: REFLATE TB2

summary: Phase III trial evaluating raltegravir as an alternative to efavirenz for antiretroviral treatment of HIV-infected patients with tuberculosis.

ReferenceCitation: De Castro N, Marcy O, Chazallon C, Messou E, Eholié S, N'takpe JB, Bhatt N, Khosa C, Timana Massango I, Laureillard D, Chau GD, Domergue A, Veloso V, Escada R, Wagner Cardoso S, Delaugerre C, Anglaret X, Molina JM, Grinsztejn B; ANRS 12300 Reflate TB2 study group. Standard dose raltegravir or efavirenz-based antiretroviral treatment for patients co-infected with HIV and tuberculosis (ANRS 12 300 Reflate TB 2): an open-label, non-inferiority, randomised, phase 3 trial. Lancet Infect Dis. 2021 Jun;21(6):813-822. doi: 10.1016/S1473-3099(20)30869-0. Epub 2021 Mar 2.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_country:
Mozambique
Brazil
Vietnam
Côte D'Ivoire
France

location_facility: Laboratory of clinical research on STD/AIDS - IPEC/FIOCRUZ

location_facility: PACCI / CePReF Centre de Prise en charge de Recherche et de Formation

location_facility: Instituto Nacional de Saude / Hospital Geral de Machava


title: Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis

summary: It aims to demonstrate the superiority of a 6-week supplementation with Lactibiane Buccodental compared to placebo, as adjunctive therapy in chronic periodontitis in patients with generalized chronic periodontitis

lead_sponsor: PiLeJe

location_facility:
CHU Hôtel Dieu de Nantes
CHU Service d'Odontologie


title: Assessment of Sexual Health of Obese Men Before and After Paresis Bariatric Surgery. Prospective Multicentre Study.

acronym: BARIASSO

summary: Compare Male Health Sexual Questionnaire (MHSQ) before and after bariatric surgery to assess the sexual health of the obese men with a recommended and exhaustive tool. There are few data that evaluate the sexual health of this population.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Haut-Lévêque - groupe hospitalier Sud


title: Comparison of the Cardiopulmonary and Gaz-exchange Response Between the Six-minute Stepper Test and the Incremental Cardiopulmonary Exercise Testing in Patients With Chronicle Obstructive Pulmonary Disease

summary:
Chronicle obstructive pulmonary disease is a worldwide cause of mortality and morbidity. This systemic disease progressively leads to dyspnea, muscle wasting and exercise capacity impairment.

Pulmonary rehabilitation is a cornerstone in the management of these systemic effects. Unfortunately, access to pulmonary rehabilitation is limited for many people who would benefit from it, primarily because of a lack of pulmonary rehabilitation and assessment centers. Optimal assessment should include an incremental cardiopulmonary exercise testing. This test allows to evaluate the factors contributing to exercise intolerance by linking performance and physiological parameters to the underlying metabolism. Moreover, it is the standard test to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this test is not available in most centers and when it is, consultations are limited. Therefore, pulmonary rehabilitation is often delayed for several weeks and patients can lose motivation.

In order to promote pulmonary rehabilitation, the incremental cardiopulmonary exercise testing could be replaced by field tests to individualize pulmonary rehabilitation prescription.

The six-minute stepper test is a new field tool. Its sensitivity and reproducibility have previously been reported in patients with chronicle obstructive pulmonary disease. It is easy to set up in the clinical setting and could be used to individualize pulmonary rehabilitation.

The main drawback when using field test is that they only provide a non specific assessement of the functional capacity because cardiopulmonary parameters and gaz exchanges are not monitored.

Although the performance during the 6-minute stepper test is moderately related with the maximal oxygen consumption during the incremental cardiopulmonary exercise testing performed on a cycloergometer, a direct comprehensive comparison of cardiopulmonary parameters and gaz exchanges during these two tests have never been performed.

Moreover, stepping is more closely related with activities of daily life (requiring a repetitive transition from rest to submaximal exercise intensity) than the maximal incremental exercise on cycloergometer and could provide further insight on the disability of patients during their usual activities, such as stair climbing (which is frequently avoided). Additionally, on-transient phase two oxygen consumption kinetic is particularly relevant because it evaluation is independent of the patient's motivation or criteria used to terminate exercise.

Therefore, the aim of this study is to compare the cardiorespiratory parameters, the gaz exchanges and the maximality between the six-minute stepper test and the incremental cardiopulmonary exercise testing performed on a cycloergometer.

The secondary objective was to compare the on-transient oxygen consumption phase two kinetic parameters (time constant, span and steady state) according to the severity of the disease.

lead_sponsor: ADIR Association

location_facility: Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil


title: Pilot Study to Identify the Benefits CAREGIVERSPRO-MMD Platform Use Based on the Information and Communications Technology, Dedicated to the Support and Assistance of Dyads Living With Neurocognitive Diseases Including Persons Living With Mild Cognitive Impairment or Mild to Moderate Dementia and Their Primary Caregivers

acronym: CAREGIVERSPRO

summary:
Our main goal is to test a web platform accessible by computers, smartphones and tablets, addressed specifically to caregivers and people with mild cognitive deterioration or mild to moderate dementia providing added value services based on social networks, adapted interventions, clinic strategies and gamification to improve the quality of life of caregivers and people living with dementia (dyads) and permitting to leave in the community as long as possible.

To evaluate the platform effectiveness and impact in dementia type disease affected people and caregivers a randomized, controlled, parallel, longitudinal is proposed. The objective will be to assess during 18 months aspects related to health of individuals (general aspect of health, neuropsychological, daily living functionalities, quality of life, treatment adherence, comorbidities ...), social aspects (improving dyad relationship…) and economics (cost-effectiveness of platform utilization), as well as satisfaction degree and usability of platform.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Rouen

location_facility: Centre Hospitalier Intercommunal Elbeuf Louviers


title: Excision and Reconstruction of the Natal Cleft With a Parasacral Perforator Flap Versus Open Excision With Secondary Healing, in the Management of Sacrococcygeal Pilonidal Disease. A Randomized Controlled Study.

acronym: PILOPERFO

summary:
Chronic sacrococcygeal pilonidal disease is a common acquired condition associated with hirsutism that predominantly affects young male patients. Morbidity from this disease results in pain, embarrassment and loss of normal activities, causing absenteeism from work and school.

Various surgical procedures have been described for the treatment of both primary and recurrent pilonidal disease counting: open excision and healing by secondary intention, marsupialization, excision and primary closure (midline or off-midline), excision and repair by flap.

No single method has been accepted as the "gold standard", and none of them cancels the risk of recurrence.

The optimal therapy for pilonidal sinus disease should be simple, with good aesthetic outcomes and a low recurrence rate. It must allow the return to normal activities quickly.

The parasacral perforator flap seems to answer these entire requirements. No study compares this flap repair with the most common procedure, which is the open excision with secondary healing. The aim of this study is to assess the efficacy and the security of the reconstruction of the natal cleft with the perforator parasacral flap versus open excision with secondary healing in the treatment of sacrococcygeal pilonidal sinus.

status: Suspended

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital
University hospital


title: Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care

acronym: REVEH

summary:
The management of hematological malignancies justifies the completion of a complete assessment before the start of treatment. This assessment includes imaging tests (computed tomography, position emission tomography, cavitary scintigraphy), biology and very often an exploration of the bone marrow by anterior or posterior iliac biopsy. Pains related to the disease (node compression, invasion of solid organs) are taken care of at the diagnosis and often relieved by the start of the specific treatment.

However, pain related to medical procedure is often overlooked and can lead to psychological trauma in some patients who may refuse to repeat these essential actions to assess the response to treatment.

Anxiety contributes to pain and various relaxation techniques have already proven their effectiveness. The goal of the protocol is to reduce the pain and anxiety associated with medical procedure by using virtual reality with a helmet proposed at the time of the gesture.

lead_sponsor: Weprom

location_facility: Centre Jean Bernard - Clinique Victor Hugo


title: Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy

acronym: MINER

summary:
This trial is a translational, open-label, multi-site, prospective cohort study of 520 patients aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of advanced (unresectable and/or metastatic) solid cancers.

The study will be conducted on a population of patients receiving ICB (anti-PD-1 or anti-PD-L1 or anti-CTLA4, alone or in combination) in the context of either routine care or a clinical study protocol.

Patients with any of the following tumor types may be enrolled in the trial:

Non-Small Cell Lung Cancer (NSCLC),
Head and neck cancer,
Melanoma,
Bladder cancer,
Other tumor types when Immuno-Oncology agent is expected to be efficient or when a clinical trial is an option.

For each included patient, tumor biopsy specimens and blood samples will be collected at different time points.

All included patients will be followed-up until progression. After this date, survival data will be collected.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole


title: Congestive Heart Failure Atrial Arrhythmia Monitoring and Pacing (CHAMP)

summary: The purpose of the study is to characterize atrial arrhythmias in patients indicated for Cardiac Resynchronization Therapy (CRT) and to monitor changes in atrial arrhythmias while CRT is provided.

ReferenceCitation: Remme WJ, Swedberg K; Task Force for the Diagnosis and Treatment of Chronic Heart Failure, European Society of Cardiology. Guidelines for the diagnosis and treatment of chronic heart failure. Eur Heart J. 2001 Sep;22(17):1527-60. Erratum in: Eur Heart J 2001 Dec;22(23):2217-8.

ReferenceCitation: Mosterd A, de Bruijne MC, Hoes AW, Deckers JW, Hofman A, Grobbee DE. Usefulness of echocardiography in detecting left ventricular dysfunction in population-based studies (The Rotterdam Study). Am J Cardiol. 1997 Jan 1;79(1):103-4.

ReferenceCitation: Rihal CS, Davis KB, Kennedy JW, Gersh BJ. The utility of clinical, electrocardiographic, and roentgenographic variables in the prediction of left ventricular function. Am J Cardiol. 1995 Feb 1;75(4):220-3.

ReferenceCitation: Wheeldon NM, MacDonald TM, Flucker CJ, McKendrick AD, McDevitt DG, Struthers AD. Echocardiography in chronic heart failure in the community. Q J Med. 1993 Jan;86(1):17-23.

ReferenceCitation: SOLVD Investigators, Yusuf S, Pitt B, Davis CE, Hood WB Jr, Cohn JN. Effect of enalapril on mortality and the development of heart failure in asymptomatic patients with reduced left ventricular ejection fractions. N Engl J Med. 1992 Sep 3;327(10):685-91. Erratum in: N Engl J Med 1992 Dec 10;327(24):1768.

ReferenceCitation: Køber L, Torp-Pedersen C, Carlsen JE, Bagger H, Eliasen P, Lyngborg K, Videbaek J, Cole DS, Auclert L, Pauly NC. A clinical trial of the angiotensin-converting-enzyme inhibitor trandolapril in patients with left ventricular dysfunction after myocardial infarction. Trandolapril Cardiac Evaluation (TRACE) Study Group. N Engl J Med. 1995 Dec 21;333(25):1670-6.

ReferenceCitation: Flather MD, Yusuf S, Køber L, Pfeffer M, Hall A, Murray G, Torp-Pedersen C, Ball S, Pogue J, Moyé L, Braunwald E. Long-term ACE-inhibitor therapy in patients with heart failure or left-ventricular dysfunction: a systematic overview of data from individual patients. ACE-Inhibitor Myocardial Infarction Collaborative Group. Lancet. 2000 May 6;355(9215):1575-81.

ReferenceCitation: Bayliss J, Norell M, Canepa-Anson R, Sutton G, Poole-Wilson P. Untreated heart failure: clinical and neuroendocrine effects of introducing diuretics. Br Heart J. 1987 Jan;57(1):17-22.

ReferenceCitation: Dargie HJ. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet. 2001 May 5;357(9266):1385-90.

ReferenceCitation: Packer M, Bristow MR, Cohn JN, Colucci WS, Fowler MB, Gilbert EM, Shusterman NH. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996 May 23;334(21):1349-55.

ReferenceCitation: Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999 Sep 2;341(10):709-17.

ReferenceCitation: Khand AU, Rankin AC, Kaye GC, Cleland JG. Systematic review of the management of atrial fibrillation in patients with heart failure. Eur Heart J. 2000 Apr;21(8):614-32. Review.

ReferenceCitation: Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med. 1997 Feb 20;336(8):525-33.

ReferenceCitation: Cazeau S, Ritter P, Lazarus A, Gras D, Backdach H, Mundler O, Mugica J. Multisite pacing for end-stage heart failure: early experience. Pacing Clin Electrophysiol. 1996 Nov;19(11 Pt 2):1748-57.

ReferenceCitation: Auricchio A, Stellbrink C, Block M, Sack S, Vogt J, Bakker P, Klein H, Kramer A, Ding J, Salo R, Tockman B, Pochet T, Spinelli J. Effect of pacing chamber and atrioventricular delay on acute systolic function of paced patients with congestive heart failure. The Pacing Therapies for Congestive Heart Failure Study Group. The Guidant Congestive Heart Failure Research Group. Circulation. 1999 Jun 15;99(23):2993-3001.

ReferenceCitation: Gras D, Mabo P, Tang T, Luttikuis O, Chatoor R, Pedersen AK, Tscheliessnigg HH, Deharo JC, Puglisi A, Silvestre J, Kimber S, Ross H, Ravazzi A, Paul V, Skehan D. Multisite pacing as a supplemental treatment of congestive heart failure: preliminary results of the Medtronic Inc. InSync Study. Pacing Clin Electrophysiol. 1998 Nov;21(11 Pt 2):2249-55.

ReferenceCitation: Stellbrink C, Auricchio A, Diem B, Breithardt OA, Kloss M, Schöndube FA, Klein H, Messmer BJ, Hanrath P. Potential benefit of biventricular pacing in patients with congestive heart failure and ventricular tachyarrhythmia. Am J Cardiol. 1999 Mar 11;83(5B):143D-150D.

ReferenceCitation: Saxon LA, Boehmer JP, Hummel J, Kacet S, De Marco T, Naccarelli G, Daoud E. Biventricular pacing in patients with congestive heart failure: two prospective randomized trials. The VIGOR CHF and VENTAK CHF Investigators. Am J Cardiol. 1999 Mar 11;83(5B):120D-123D. Review.

ReferenceCitation: Cazeau S, Ritter P, Bakdach S, Lazarus A, Limousin M, Henao L, Mundler O, Daubert JC, Mugica J. Four chamber pacing in dilated cardiomyopathy. Pacing Clin Electrophysiol. 1994 Nov;17(11 Pt 2):1974-9.

ReferenceCitation: Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53.

ReferenceCitation: Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood GA, Santini M, Bailleul C, Daubert JC; Multisite Stimulation in Cardiomyopathies (MUSTIC) Study Investigators. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med. 2001 Mar 22;344(12):873-80.

ReferenceCitation: Daubert JC, Ritter P, Le Breton H, Gras D, Leclercq C, Lazarus A, Mugica J, Mabo P, Cazeau S. Permanent left ventricular pacing with transvenous leads inserted into the coronary veins. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 2):239-45.

ReferenceCitation: Gurley J, Lamba S, Moulton K, Miller B, Mullin J, Hine D, MIRACLE and InSync III investigators. Does the availability of multiple left heart lead and delivery systems matter for cardiac resynchronization therapy? Eur Heart J 2002; 4:Abstr Suppl: 51

ReferenceCitation: Auricchio A, Sack S, Stellbrink C, Neuzner J, Tockman B, Hoersch W, Klein H. Transvenous left ventricular pacing using a new over the wire coronary venous lead. Pacing Clin Electrophysiol 1999; 22: 717

ReferenceCitation: Achtelik M, Bocchiardo M, Trappe HJ, Gaita F, Lozano I, Niazi I, Gold M, Yong P, Duby C; VENTAK CHF/CONTAK CD Clinical Investigation Study Group. Performance of a new steroid-eluting coronary sinus lead designed for left ventricular pacing. Pacing Clin Electrophysiol. 2000 Nov;23(11 Pt 2):1741-3.

ReferenceCitation: Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H, Levine JH, Saksena S, Waldo AL, Wilber D, Brown MW, Heo M. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med. 1996 Dec 26;335(26):1933-40.

ReferenceCitation: Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 1999 Dec 16;341(25):1882-90. Erratum in: N Engl J Med 2000 Apr 27;342(17):1300.

ReferenceCitation: Salukhe TV, Francis DP, Sutton R. Comparison of medical therapy, pacing and defibrillation in heart failure (COMPANION) trial terminated early; combined biventricular pacemaker-defibrillators reduce all-cause mortality and hospitalization. Int J Cardiol. 2003 Feb;87(2-3):119-20.

ReferenceCitation: Walker S, Levy TM, Rex S, Brant S, Allen J, Ilsley CJ, Paul VE. Usefulness of suppression of ventricular arrhythmia by biventricular pacing in severe congestive cardiac failure. Am J Cardiol. 2000 Jul 15;86(2):231-3.

ReferenceCitation: Higgins SL, Yong P, Sheck D, McDaniel M, Bollinger F, Vadecha M, Desai S, Meyer DB. Biventricular pacing diminishes the need for implantable cardioverter defibrillator therapy. Ventak CHF Investigators. J Am Coll Cardiol. 2000 Sep;36(3):824-7.

ReferenceCitation: Ehrlich JR, Nattel S, Hohnloser SH. Atrial fibrillation and congestive heart failure: specific considerations at the intersection of two common and important cardiac disease sets. J Cardiovasc Electrophysiol. 2002 Apr;13(4):399-405. Review.

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ReferenceCitation: Leclercq C, Walker S, Linde C, Clementy J, Marshall AJ, Ritter P, Djiane P, Mabo P, Levy T, Gadler F, Bailleul C, Daubert JC. Comparative effects of permanent biventricular and right-univentricular pacing in heart failure patients with chronic atrial fibrillation. Eur Heart J. 2002 Nov;23(22):1780-7.

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ReferenceCitation: Carson PE, Johnson GR, Dunkman WB, Fletcher RD, Farrell L, Cohn JN. The influence of atrial fibrillation on prognosis in mild to moderate heart failure. The V-HeFT Studies. The V-HeFT VA Cooperative Studies Group. Circulation. 1993 Jun;87(6 Suppl):VI102-10.

ReferenceCitation: Crijns HJ, Van den Berg MP, Van Gelder IC, Van Veldhuisen DJ. Management of atrial fibrillation in the setting of heart failure. Eur Heart J. 1997 May;18 Suppl C:C45-9. Review.

ReferenceCitation: Mahoney P, Kimmel S, DeNofrio D, Wahl P, Loh E. Prognostic significance of atrial fibrillation in patients at a tertiary medical center referred for heart transplantation because of severe heart failure. Am J Cardiol. 1999 Jun 1;83(11):1544-7.

ReferenceCitation: Dries DL, Exner DV, Gersh BJ, Domanski MJ, Waclawiw MA, Stevenson LW. Atrial fibrillation is associated with an increased risk for mortality and heart failure progression in patients with asymptomatic and symptomatic left ventricular systolic dysfunction: a retrospective analysis of the SOLVD trials. Studies of Left Ventricular Dysfunction. J Am Coll Cardiol. 1998 Sep;32(3):695-703.

ReferenceCitation: Middlekauff HR, Stevenson WG, Stevenson LW. Prognostic significance of atrial fibrillation in advanced heart failure. A study of 390 patients. Circulation. 1991 Jul;84(1):40-8.

ReferenceCitation: Opasich C, Tavazzi L, Lucci D, Gorini M, Albanese MC, Cacciatore G, Maggioni AP. Comparison of one-year outcome in women versus men with chronic congestive heart failure. Am J Cardiol. 2000 Aug 1;86(3):353-7.

ReferenceCitation: van den Berg MP, van Gelder IC, van Veldhuisen DJ. Impact of atrial fibrillation on mortality in patients with chronic heart failure. Eur J Heart Fail. 2002 Oct;4(5):571-5. Review.

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ReferenceCitation: Ansalone G, Giannantoni P, Ricci R, Trambaiolo P, Laurenti A, Fedele F, Santini M. Doppler myocardial imaging in patients with heart failure receiving biventricular pacing treatment. Am Heart J. 2001 Nov;142(5):881-96.

ReferenceCitation: Ansalone G, Giannantoni P, Ricci R, Trambaiolo P, Fedele F, Santini M. Doppler myocardial imaging to evaluate the effectiveness of pacing sites in patients receiving biventricular pacing. J Am Coll Cardiol. 2002 Feb 6;39(3):489-99.

ReferenceCitation: Bax JJ, Molhoek SG, van Erven L, Voogd PJ, Somer S, Boersma E, Steendijk P, Schalij MJ, Van der Wall EE. Usefulness of myocardial tissue Doppler echocardiography to evaluate left ventricular dyssynchrony before and after biventricular pacing in patients with idiopathic dilated cardiomyopathy. Am J Cardiol. 2003 Jan 1;91(1):94-7.

ReferenceCitation: Garrigue S, Jaïs P, Espil G, Labeque JN, Hocini M, Shah DC, Haïssaguerre M, Clementy J. Comparison of chronic biventricular pacing between epicardial and endocardial left ventricular stimulation using Doppler tissue imaging in patients with heart failure. Am J Cardiol. 2001 Oct 15;88(8):858-62.

ReferenceCitation: Yu CM, Chau E, Sanderson JE, Fan K, Tang MO, Fung WH, Lin H, Kong SL, Lam YM, Hill MR, Lau CP. Tissue Doppler echocardiographic evidence of reverse remodeling and improved synchronicity by simultaneously delaying regional contraction after biventricular pacing therapy in heart failure. Circulation. 2002 Jan 29;105(4):438-45.

ReferenceCitation: Adamson PB, St John Sutton MG, Plappert TJ, Abraham WT, Hilpisch KE, Hill MR. Echo-Defined Ventricular Dysynchrony predicts magnitude of response o Cardiac Resynchronization Abstract presented during AHA Scientific Session 2002.

ReferenceCitation: St John Sutton MG, Plappert TJ, Hilpisch KE, Chinchoy E. Baseline Aortic Pre-Ejection Interval (bAPEI) as a predictor of response to Cardiac Resynchronization Therapy (CRT) Abstract presented during AHA Scientific Session 2002.

ReferenceCitation: Pitzalis MV, Iacoviello M, Romito R, Massari F, Rizzon B, Luzzi G, Guida P, Andriani A, Mastropasqua F, Rizzon P. Cardiac resynchronization therapy tailored by echocardiographic evaluation of ventricular asynchrony. J Am Coll Cardiol. 2002 Nov 6;40(9):1615-22.

lead_sponsor: Medtronic BRC

location_country:
Serbia
United Kingdom
Italy
Czech Republic
France
Netherlands
Slovakia

location_facility: Institut Klinické A Experimentální Medicíny

location_facility: Fakultní Nemocnice S Poliklinikou Ostrava

location_facility: Slovenský Ústav Srdcových A Cievnych Chorôb

location_facility: Hôpital Cardiologique Du Haut-Levêque - Chu


title: Predictive Platform for PEople aGed and Requiring ASsistancE

summary: The study aim is to assess the capacity of a technological solution for analyzing older person's functional and cognitive autonomy at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to detect early infra-clinical disability.

primary_purpose: Prevention

ReferenceCitation: Piau A, Lepage B, Bernon C, Gleizes MP, Nourhashemi F. Real-Time Detection of Behavioral Anomalies of Older People Using Artificial Intelligence (The 3-PEGASE Study): Protocol for a Real-Life Prospective Trial. JMIR Res Protoc. 2019 Nov 18;8(11):e14245. doi: 10.2196/14245.

location_facility:
University Hospital, Toulouse
CHU Toulouse


title: The Inclined Position in Case of Respiratory Discomfort in the One Year Less Infant : Study on the Profits and the Risks in the Home

acronym: PROCLIVE

summary:
The inclined position at 30 ° in case of transient respiratory discomfort is recommended since the consensus conference of September 2000. This recommendation is based on a low level of evidence (grade C). This advice is found in the health book, and in many tips for parents. However, it does not comply with the recommendations of the American Academy of Pediatrics for sleeping on the back, on a firm mattress and without other objects in the bed.

70% of pediatricians advise this position in a specific medical context according to a study of Bellaïche conducted in 2013. 40% of parents use it for no particular reason.

Anatomically, the upper airways of infants are of reduced caliber, and therefore at risk of obstruction.

A study by Bergougnioux on the cases of MIN in infants wearing a wrap-around sling shows that the flexion of the neck causes the chin to be positioned against the chest and contributes to the suffocation of the infant. This is especially important in infants under 3 months whose neck muscles do not yet support the weight of the head.

The 2009 InVS national survey of unexpected infant deaths shows that bed crashes accounted for 11.1% of all deaths reported. Among unexplained deaths, maladaptive bedding was a contributing factor, including the use of a pillow in the bed in 24.3% of cases.

It was observed in the study by Kornhauser Cerar et al in 2009 that half-sitting in a car seat for an extended duration was at the origin of a significant desaturations rate, which was also found in the car bed group. The control group "hospital bed" was not subject to these desaturations. These results support the fact that only an adapted bedding that complies with the recommendations protects against asphyxiation.

Since 2016, INPES recommends in its advice sheet on bronchiolitis for parents, a flat bed on the back.

Hypothesis :

The inclined position in infants under one year of age is at risk of unexpected death of the infant by obstruction of the upper airways, because of the changes of position that it entails, including a risk of slipping at the bottom of the bed and of asphyxiation under the covers.

study_start_date_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Accueil des urgences pédiatriques - Hôpital Nord-Ouest Villefranche sur Saône


title: Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)

acronym: DETECT

summary:
The main objective of this project is to demonstrate the feasability of an endomicroscopic biomarker of efficacy of vedolizumab and adalimumab, in Ulcerative colitis (UC) by coupling vedolizumab to a fluorescent component, FITC (Fluorescein isothiocyanate) , and adalimumab to rhodamine.

This project should allow the development of a biomarker of therapeutic efficacy for vedolizumab and adalimumab that can be used in a single time-frame in vivo in humans, while respecting manufacturing standards and Good manufacturing procedures.

status: Terminated

lead_sponsor: Nantes University Hospital

location_facility:
Chd Vendee
Chu Nantes
Chu Angers
Chu Rennes


title: MILAR, is a Controlled, Randomised, Comparative, Prospective, Multi-center, Superiority French Clinical Trial Comparing the MacGrath MAC Videolaryngoscope and the MacIntosh Laryngoscope for Oro-tracheal Intubation by Patients With Less Than 2 Criteria of Difficult Intubation in Elective Surgery.

acronym: MILAR

summary: The MILAR trial is a multicenter randomised , prospective, controlled, single-blind, superiority French clinical trial, with a 1: 1 distribution of patients to compare intubation during the first laryngoscopy between the MacGrath MAC videolaryngoscope and the MacIntosh laryngoscope for patients with less than 2 criteria of difficult intubation in elective surgery.

ReferenceCitation: Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.

ReferenceCitation: Hasegawa K, Shigemitsu K, Hagiwara Y, Chiba T, Watase H, Brown CA 3rd, Brown DF; Japanese Emergency Medicine Research Alliance Investigators. Association between repeated intubation attempts and adverse events in emergency departments: an analysis of a multicenter prospective observational study. Ann Emerg Med. 2012 Dec;60(6):749-754.e2. doi: 10.1016/j.annemergmed.2012.04.005. Epub 2012 Apr 28.

ReferenceCitation: Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents.

ReferenceCitation: Sakles JC, Javedani PP, Chase E, Garst-Orozco J, Guillen-Rodriguez JM, Stolz U. The use of a video laryngoscope by emergency medicine residents is associated with a reduction in esophageal intubations in the emergency department. Acad Emerg Med. 2015 Jun;22(6):700-7. doi: 10.1111/acem.12674. Epub 2015 May 20.

ReferenceCitation: Kaplan A, Göksu E, Yıldız G, Kılıç T. Comparison of the C-MAC Videolaryngoscope and Rigid Fiberscope with Direct Laryngoscopy in Easy and Difficult Airway Scenarios: A Manikin Study. J Emerg Med. 2016 Mar;50(3):e107-14. doi: 10.1016/j.jemermed.2015.06.070. Epub 2015 Dec 22.

ReferenceCitation: Ruetzler K, Imach S, Weiss M, Haas T, Schmidt AR. [Comparison of five video laryngoscopes and conventional direct laryngoscopy : Investigations on simple and simulated difficult airways on the intubation trainer]. Anaesthesist. 2015 Jul;64(7):513-9. doi: 10.1007/s00101-015-0051-5. Epub 2015 Jul 15. German.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Chartres Hospital Center
Orleans Hospital Center


title: European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

acronym: ESMART

summary:
The first molecular profiling protocols have been launched in Europe (MOSCATO-01 (Geoerger 2014), MAPPYACTS, INFORM, iTHER, SM-PAEDS, etc.) determining multiple actionable alterations in pediatric recurrent cancers. Increasingly, stratified approaches are being implemented to enrich clinical trials of molecularly targeted agents and possibly improve outcomes in specific populations i.e. a molecularly enriched/predictive biomarker-driven approach. The diversity and heterogeneity of the detected molecular alterations and the low number of pediatric patients mandate an adapted, innovative trial design for the attributed treatment options in order to satisfy the current unmet medical need.

This basket trial is designed to cover the targeting of several survival pathways in oncogenesis that are currently not adequately employed for pediatric patients in Europe.

ReferenceCitation: Berlanga P, Pierron G, Lacroix L, Chicard M, Adam de Beaumais T, Marchais A, Harttrampf AC, Iddir Y, Larive A, Soriano Fernandez A, Hezam I, Chevassus C, Bernard V, Cotteret S, Scoazec JY, Gauthier A, Abbou S, Corradini N, André N, Aerts I, Thebaud E, Casanova M, Owens C, Hladun-Alvaro R, Michiels S, Delattre O, Vassal G, Schleiermacher G, Geoerger B. The European MAPPYACTS Trial: Precision Medicine Program in Pediatric and Adolescent Patients with Recurrent Malignancies. Cancer Discov. 2022 May 2;12(5):1266-1281. doi: 10.1158/2159-8290.CD-21-1136.

ReferenceCitation: Morscher RJ, Brard C, Berlanga P, Marshall LV, André N, Rubino J, Aerts I, De Carli E, Corradini N, Nebchi S, Paoletti X, Mortimer P, Lacroix L, Pierron G, Schleiermacher G, Vassal G, Geoerger B. First-in-child phase I/II study of the dual mTORC1/2 inhibitor vistusertib (AZD2014) as monotherapy and in combination with topotecan-temozolomide in children with advanced malignancies: arms E and F of the AcSé-ESMART trial. Eur J Cancer. 2021 Nov;157:268-277. doi: 10.1016/j.ejca.2021.08.010. Epub 2021 Sep 17.

ReferenceCitation: Bautista F, Paoletti X, Rubino J, Brard C, Rezai K, Nebchi S, Andre N, Aerts I, De Carli E, van Eijkelenburg N, Thebaud E, Corradini N, Defachelles AS, Ducassou S, Morscher RJ, Vassal G, Geoerger B. Phase I or II Study of Ribociclib in Combination With Topotecan-Temozolomide or Everolimus in Children With Advanced Malignancies: Arms A and B of the AcSé-ESMART Trial. J Clin Oncol. 2021 Nov 10;39(32):3546-3560. doi: 10.1200/JCO.21.01152. Epub 2021 Aug 4.

ReferenceCitation: Pasqualini C, Rubino J, Brard C, Cassard L, André N, Rondof W, Scoazec JY, Marchais A, Nebchi S, Boselli L, Grivel J, Aerts I, Thebaud E, Paoletti X, Minard-Colin V, Vassal G, Geoerger B. Phase II and biomarker study of programmed cell death protein 1 inhibitor nivolumab and metronomic cyclophosphamide in paediatric relapsed/refractory solid tumours: Arm G of AcSé-ESMART, a trial of the European Innovative Therapies for Children With Cancer Consortium. Eur J Cancer. 2021 Jun;150:53-62. doi: 10.1016/j.ejca.2021.03.032. Epub 2021 Apr 20.

ReferenceCitation: Rossoni C, Bardet A, Geoerger B, Paoletti X. Sequential or combined designs for Phase I/II clinical trials? A simulation study. Clin Trials. 2019 Dec;16(6):635-644. doi: 10.1177/1740774519872702. Epub 2019 Sep 20.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
France
Germany

location_facility: Unidad de Oncología Pediátrica Hospital Niño Jesús

location_facility: Pediatric and Adolescent Oncology The Royal Marsden Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori


title: Medico-economic Evaluation of a "IsereADOM" Package of Services Versus Conventional Health and Social Monitoring, in the Care of a Population of People With Heart Failure in Isère.

acronym: CardIC

summary:
The goal of this study is to evaluate the health and social benefit of innovative management - IsereADOM - versus conventional follow-up in patients with heart failure.

There is a medico-economic goal too, is to perform a cost-utility analysis of the service bundle (IsereADOM) versus conventional 6-month community-based follow-up in a population with heart failure.

primary_purpose: Health Services Research

ReferenceCitation: Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442.

ReferenceCitation: Desai AS, Stevenson LW. Rehospitalization for heart failure: predict or prevent? Circulation. 2012 Jul 24;126(4):501-6. doi: 10.1161/CIRCULATIONAHA.112.125435.

ReferenceCitation: McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Böhm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Køber L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Rønnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology, Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, McDonagh T, Sechtem U, Bonet LA, Avraamides P, Ben Lamin HA, Brignole M, Coca A, Cowburn P, Dargie H, Elliott P, Flachskampf FA, Guida GF, Hardman S, Iung B, Merkely B, Mueller C, Nanas JN, Nielsen OW, Orn S, Parissis JT, Ponikowski P; ESC Committee for Practice Guidelines. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2012 Aug;14(8):803-69. doi: 10.1093/eurjhf/hfs105. Erratum in: Eur J Heart Fail. 2013 Mar;15(3):361-2.

ReferenceCitation: Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735.

ReferenceCitation: Takeda A, Taylor SJ, Taylor RS, Khan F, Krum H, Underwood M. Clinical service organisation for heart failure. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD002752. doi: 10.1002/14651858.CD002752.pub3. Review. Update in: Cochrane Database Syst Rev. 2019 Jan 08;1:CD002752.

ReferenceCitation: Krumholz HM, Merrill AR, Schone EM, Schreiner GC, Chen J, Bradley EH, Wang Y, Wang Y, Lin Z, Straube BM, Rapp MT, Normand SL, Drye EE. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009 Sep;2(5):407-13. doi: 10.1161/CIRCOUTCOMES.109.883256. Epub 2009 Jul 9.

ReferenceCitation: Powell LH, Calvin JE Jr, Richardson D, Janssen I, Mendes de Leon CF, Flynn KJ, Grady KL, Rucker-Whitaker CS, Eaton C, Avery E; HART Investigators. Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. JAMA. 2010 Sep 22;304(12):1331-8. doi: 10.1001/jama.2010.1362.

ReferenceCitation: Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96.

lead_sponsor: University Hospital, Grenoble

location_facility:
Groupe Hospitalier Mutualiste
CHU Grenoble-Alpes


title: Evaluation of the Frequency of Occurrence of Joint Pain With Bevacizumab in Patients With Ovarian, Colorectal or Bronchopulmonary Cancer

summary:
Self-administered questionnaire survey to determine the presence or absence of joint pain during bevacizumab treatment for lung, ovarian, colorectal cancers.

The principal end-point is the frequency of arthralgia after 6 months of treatment with Bevacizumab.

ReferenceCitation: Vauléon E, Behal H, Lebellec L, Desbarbieux R, Baldacci S, Simon N, Pannier D, Vieillard MH, Turpin A. Does bevacizumab increase joint pain in patients with cancer? Results of the prospective observational BEVARTHRALGIA study. Cancer Chemother Pharmacol. 2021 Apr;87(4):533-541. doi: 10.1007/s00280-020-04226-6. Epub 2021 Jan 12.

lead_sponsor: University Hospital, Lille

location_facility:
Centre Oscar Lambret
Hôpital Huriez. CHRU


title: Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas

acronym: PEMBROCABOSARC

summary: Phase II trial with three independent strata to independently assess the effects of the association of pembrolizumab and cabozantinib in advanced sarcomas.

lead_sponsor: Institut Bergonié

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