title: Kinetics of Physiological and Symptomatic Responses to CardioPulmonary Exercise Testing (CPET) in Subjects With Persistent Exercise Intolerance After COVID-19: an Open-Source Exercise Network

summary:
This retrospective collaborative study on persistent exercise intolerance after COVID-19 offers to perform a large descriptive analysis of CPET performed in real-life by pulmonologists, cardiologists and physiologists. Indeed, these practicians are regularly consulted for a persistent intolerance to exercise expressed by dyspnea and/or frank fatigability sometimes associated with muscular or thoracic pain. When these complaints persist beyond 3 months after the first symptoms, it is legitimate to perform a CPET:

Either to evaluate the functional impact of an identified organ deficiency (e.g. myocarditis, pulmonary fibrosis, etc.),
Or, in the absence of formal arguments for an identified organ deficiency, to observe possible abnormalities in physiological responses during an incremental exercise test, likely to explain the persistence of symptoms and intolerance to exercise. Indeed, the recent literature highlights the presence of non-specific ventilatory and cardio-circulatory abnormalities leading to various physio-pathological observations. Unfortunately, these reports now concern relatively small numbers of patients with very diverse clinical forms of Covid, comorbidities and habitus.

In order to improve the understanding of persistent symptoms and in particular the diversity of physiological response presentations, the investigators propose to collect a very large amount of data through a web-based platform designed to collect the measurements made throughout the exercise test directly from the ergospirometer.

The relevant data covers the period from January 2, 2020 to May 31, 2022 (i.e. 29 months), The retrospective data collection will be carried out from September 19, 2022 to June 1, 2023.

The descriptive analysis will focus on the kinetics of all the variables measured and calculated on subgroups defined a priori on age, sex, comorbidities, acute covid severity, persistent symptoms post covid, regular habitual physical activity level, etc. according to the sample.

The study is expected to collect data from around 600 patients and to involve around 40 French-speaking investigators. However, this collaborative study is open on request to all centers wishing to participate, as the web platform has been developed for data collection in English.

time_perspective: Retrospective

ReferenceCitation: Gao Y, Chen R, Geng Q, Mo X, Zhan C, Jian W, Li S, Zheng J. Cardiopulmonary exercise testing might be helpful for interpretation of impaired pulmonary function in recovered COVID-19 patients. Eur Respir J. 2021 Jan 28;57(1). pii: 2004265. doi: 10.1183/13993003.04265-2020. Print 2021 Jan.

ReferenceCitation: Cortés-Telles A, López-Romero S, Figueroa-Hurtado E, Pou-Aguilar YN, Wong AW, Milne KM, Ryerson CJ, Guenette JA. Pulmonary function and functional capacity in COVID-19 survivors with persistent dyspnoea. Respir Physiol Neurobiol. 2021 Jun;288:103644. doi: 10.1016/j.resp.2021.103644. Epub 2021 Feb 27.

ReferenceCitation: Gervasi SF, Pengue L, Damato L, Monti R, Pradella S, Pirronti T, Bartoloni A, Epifani F, Saggese A, Cuccaro F, Bianco M, Zeppilli P, Palmieri V. Is extensive cardiopulmonary screening useful in athletes with previous asymptomatic or mild SARS-CoV-2 infection? Br J Sports Med. 2021 Jan;55(1):54-61. doi: 10.1136/bjsports-2020-102789. Epub 2020 Oct 5.

ReferenceCitation: Mohr A, Dannerbeck L, Lange TJ, Pfeifer M, Blaas S, Salzberger B, Hitzenbichler F, Koch M. Cardiopulmonary exercise pattern in patients with persistent dyspnoea after recovery from COVID-19. Multidiscip Respir Med. 2021 Jan 25;16(1):732. doi: 10.4081/mrm.2021.732. eCollection 2021 Jan 15.

ReferenceCitation: Townsend L, Moloney D, Finucane C, McCarthy K, Bergin C, Bannan C, Kenny RA. Fatigue following COVID-19 infection is not associated with autonomic dysfunction. PLoS One. 2021 Feb 25;16(2):e0247280. doi: 10.1371/journal.pone.0247280. eCollection 2021.

ReferenceCitation: Motiejunaite J, Balagny P, Arnoult F, Mangin L, Bancal C, d'Ortho MP, Frija-Masson J. Hyperventilation: A Possible Explanation for Long-Lasting Exercise Intolerance in Mild COVID-19 Survivors? Front Physiol. 2021 Jan 18;11:614590. doi: 10.3389/fphys.2020.614590. eCollection 2020.

ReferenceCitation: Debeaumont D, Boujibar F, Ferrand-Devouge E, Artaud-Macari E, Tamion F, Gravier FE, Smondack P, Cuvelier A, Muir JF, Alexandre K, Bonnevie T. Cardiopulmonary Exercise Testing to Assess Persistent Symptoms at 6 Months in People With COVID-19 Who Survived Hospitalization: A Pilot Study. Phys Ther. 2021 Jun 1;101(6). pii: pzab099. doi: 10.1093/ptj/pzab099.

ReferenceCitation: Dorelli G, Braggio M, Gabbiani D, Busti F, Caminati M, Senna G, Girelli D, Laveneziana P, Ferrari M, Sartori G, Dalle Carbonare L, Crisafulli E, On Behalf Of The Respicovid Study Investigators. Importance of Cardiopulmonary Exercise Testing amongst Subjects Recovering from COVID-19. Diagnostics (Basel). 2021 Mar 12;11(3). pii: 507. doi: 10.3390/diagnostics11030507.

ipd_sharing: Undecided

lead_sponsor: Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie

location_country: Canada Martinique France

location_facility: SSR Marguerite Boucicaut Croix-Rouge française

location_facility: Hôpital St Philibert GH Institut catholique Lille

location_facility: AP-HP Hop. Universitaires Pitié Salpêtrière


title: EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs

acronym: EVART

summary: The purpose of this study is to determine the prevalence and risk factors, at the time of the diagnosis of PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Institut de l'Atherothrombose

location_country: France Belgium

location_facility: Office-based Specialist in vascular medecine

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study

acronym: SURVEILLANCE

summary:
RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA assessment, may help monitor a patient's response to surgery. It is not yet known which follow-up regimen is more effective in patients who have undergone surgery for colorectal cancer.

PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or without CEA assessments to see how well they work in patients who have undergone surgery for stage II or stage III colorectal cancer.

study_start_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Lepage C, Phelip JM, Cany L, Faroux R, Manfredi S, Ain JF, Pezet D, Baconnier M, Deguiral P, Terrebone E, Adenis A, Le Malicot K, Bedenne L, Bouché O. Effect of 5 years of imaging and CEA follow-up to detect recurrence of colorectal cancer: The FFCD PRODIGE 13 randomised phase III trial. Dig Liver Dis. 2015 Jul;47(7):529-31. doi: 10.1016/j.dld.2015.03.021. Epub 2015 Apr 2.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_country: France Martinique Belgium

location_facility: Clinique du Cléret et Clinique Saint Joseph

location_facility: Centre d'oncologie et de radiothérapie du Pays Basque

location_facility: Centre de Radiothérapie et d'oncologie médicale

location_facility: Clinique Mutualiste de l'Estuaire - Cité Sanitaire

location_facility: Centre Médical National MGEN Alfred Leune

intervention_type: Procedure


title: Observational Prospective Multi-center International Study on the Use of Injectable Calcium Phosphate Cements for the Treatment of Bone Defects in Adults.

acronym: CPC

summary: CPC REGISTRY is a multi-center, international, prospective, open-label, observational study on the use of injectable calcium phosphate cements for the treatment of bone defects in adults. All patients will be treated with any of the two injectable calcium phosphate bone substitutes (GRAFTYS®HBS/GRAFTYS®Quickset or their private labels) according to standard clinical practice and according to the information provided by GRAFTYS manufacturer in respective device Instructions For Use (IFU).

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Graftys SA

location_country: Italy Switzerland Martinique France Germany

status_simplified: Unknown


title: Efficacy of Adjuvant Mitotane Treatment in Prolonging Recurrence-free Survival in Patients With Adrenocortical Carcinoma at Low-intermediate Risk of Recurrence

acronym: ADIUVO

summary:
Study Rationale Adrenocortical carcinoma (ACC) is a very rare disease with a high risk of relapse after radical surgery. The efficacy of adjuvant mitotane treatment is suggested by a retrospective multicenter international study showing that postoperative mitotane treatment was associated with a significant reduction of the risk of relapse and death. However, these promising results need confirmation in a randomized prospective study. Caution should be adopted particularly in patients with low risk of disease relapse, in whom the benefit of therapy should be weighted against the side effects. Even if an adjuvant treatment seems justified in patients at high risk of relapse, a randomised prospective study is needed to assess whether such a treatment is efficacious in patients at low-intermediate risk.

The purpose of the present study is to determine whether adjuvant mitotane treatment is effective in prolonging the disease free survival in patients with adrenocortical carcinoma at low-intermediate risk of progression who underwent radical resection

primary_purpose: Treatment

ReferenceCitation: Terzolo M, Angeli A, Fassnacht M, Daffara F, Tauchmanova L, Conton PA, Rossetto R, Buci L, Sperone P, Grossrubatscher E, Reimondo G, Bollito E, Papotti M, Saeger W, Hahner S, Koschker AC, Arvat E, Ambrosi B, Loli P, Lombardi G, Mannelli M, Bruzzi P, Mantero F, Allolio B, Dogliotti L, Berruti A. Adjuvant mitotane treatment for adrenocortical carcinoma. N Engl J Med. 2007 Jun 7;356(23):2372-80.

ipd_sharing: No

lead_sponsor: University of Turin, Italy

location_country:
United Kingdom
Italy
Netherlands
Canada
United States
France
Germany

location_facility: Dept. of Internal Medicine Maxima Medisch Centrum

location_facility: Endocrinologie - CHU Besançon Hôpital Jean Minjoz

location_facility: A.O.Universitaria Arcispedale S.Anna Ferrara

location_facility: University Hospital Campus Mitte Charitè, Berlin

location_facility: Department of Clinical and Biological Sciences, University of Turin, Internal Medicine 1

location_facility: Endocrinologie - Centre hospitalier de l'Université de Montréal (CHUM)

location_facility: Endocrine Oncology - University of Michigan Comprehensive Cancer Center

location_facility: Endocrinologie - CHU Toulouse Hôpital Larrey

location_facility: Endocrinologie - Institut de Cancérologie Gustave Roussy

location_facility: Endocrinologie - CHU Lyon Hôpital Pierre Wertheimer

location_facility: University Hospital Wuerzburg, Endocrinology

location_facility: Medical Oncology Branch - Center for Cancer Research - National Cancer Institute

location_facility: A.O.U. San Giovanni Battista - Molinette

location_facility: Cancer Research UK Clinical Trials Unit (CRCTU) - School of Cancer Sciences - University of Birmingham

intervention_type: Drug

lead_sponsor_type: academique


title: Study of a Scale Predicting the Feasibility of Chemotherapy in Patients Aged 75 Years or Older With Solid Tumour

acronym: OLD

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating older patients with solid tumour.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospitalier Villeneuve Saint Georges

location_facility: Centre Radiotherapie Oncologie Moyenne Garonne

location_facility: Centre Hospitalier d'Ardeche Meridionale

location_facility: Centre Hospitalier Intercommunal des Alpes du Sud

location_facility: Centre Medico-Chirurgical et Obstetrique d'Evry


type: Other Identifier

title: Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).

summary:
The Increlex® Global Registry is a descriptive, multicenter, observational, prospective, open-ended, non interventional, post-authorisation surveillance registry.

The main purpose of this global registry is to collect, analyse and report safety data during and up to at least 5 years after the end of treatment in children and adolescents receiving Increlex® therapy for SPIGFD according to the locally approved product information.

status: Recruiting

time_perspective: Other

ReferenceType: derived

ReferenceCitation: Bang P, Polak M, Perrot V, Sert C, Shaikh H, Woelfle J. Pubertal Timing and Growth Dynamics in Children With Severe Primary IGF-1 Deficiency: Results From the European Increlex(®) Growth Forum Database Registry. Front Endocrinol (Lausanne). 2022 Feb 18;13:812568. doi: 10.3389/fendo.2022.812568. eCollection 2022.

ReferenceCitation: Bang P, Woelfle J, Perrot V, Sert C, Polak M. Effectiveness and safety of rhIGF1 therapy in patients with or without Laron syndrome. Eur J Endocrinol. 2021 Feb;184(2):267-276. doi: 10.1530/EJE-20-0325.

lead_sponsor: Ipsen

location_country:
Poland
Spain
Italy
Austria
United Kingdom
Martinique
United States
France
French Guiana
Germany

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Universitätsklinikum Erlangen Kinder- und Jugendklinik

location_facility: Universitätskliniken des Saarlandes Kinderklinik

location_facility: Klinikum der Otto von Guericke Universität

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Uniwersytecki Szpital Dziecięcy w Lublinie

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

status_simplified: Ongoing


acronym: ANRS 143

title: An Open-label Randomised Two-year Trial Comparing Two First-line Regimens in HIV-infected Antiretroviral naïve Subjects: Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir (ANRS 143/NEAT 001)

lead_sponsor: ANRS, Emerging Infectious Diseases

type: EudraCT Number

source: euctr

ReferenceCitation: Esteban-Cantos A, Rodriguez-Centeno J, Barruz P, Alejos B, Saiz-Medrano G, Nevado J, Martin A, Gaya F, De Miguel R, Bernardino JI, Montejano R, Mena-Garay B, Cadinanos J, Florence E, Mulcahy F, Banhegyi D, Antinori A, Pozniak A, Wallet C, Raffi F, Rodes B, Arribas JR; NEAT001/ANRS143 Study Group. Epigenetic age acceleration changes 2 years after antiretroviral therapy initiation in adults with HIV: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV. 2021 Apr;8(4):e197-e205. doi: 10.1016/S2352-3018(21)00006-0. Erratum In: Lancet HIV. 2021 Dec;8(12):e734.

ReferenceCitation: Ammassari A, Stöhr W, Antinori A, Molina JM, Schwimmer C, Domingo P, Thalme A, Di Pietro M, Wallet C, Pozniak A, Richert L, Raffi F; NEAT001/ANRS143 Trial Study Group. Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial. J Acquir Immune Defic Syndr. 2018 Dec 1;79(4):481-490. doi: 10.1097/QAI.0000000000001834.

ReferenceCitation: Bernardino JI, Mocroft A, Mallon PW, Wallet C, Gerstoft J, Russell C, Reiss P, Katlama C, De Wit S, Richert L, Babiker A, Buño A, Castagna A, Girard PM, Chene G, Raffi F, Arribas JR; NEAT001/ANRS143 Study Group. Bone mineral density and inflammatory and bone biomarkers after darunavir-ritonavir combined with either raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults with HIV-1: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV. 2015 Nov;2(11):e464-73. doi: 10.1016/S2352-3018(15)00181-2. Epub 2015 Sep 30.

ReferenceCitation: Raffi F, Babiker AG, Richert L, Molina JM, George EC, Antinori A, Arribas JR, Grarup J, Hudson F, Schwimmer C, Saillard J, Wallet C, Jansson PO, Allavena C, Van Leeuwen R, Delfraissy JF, Vella S, Chêne G, Pozniak A; NEAT001/ANRS143 Study Group. Ritonavir-boosted darunavir combined with raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults infected with HIV-1: 96 week results from the NEAT001/ANRS143 randomised non-inferiority trial. Lancet. 2014 Nov 29;384(9958):1942-51. doi: 10.1016/S0140-6736(14)61170-3. Epub 2014 Aug 4.

location_country:
Denmark
Poland
Portugal
Spain
Greece
Austria
Ireland
Italy
Netherlands
United Kingdom
Sweden
Hungary
France
Belgium
Germany

location_facility: Istituto Naziona e per le Malattie "Lazzaro Spallanzani"

location_facility: Hospital General Universitario de Alicante

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: Klinikum der Johann Wolfgang Goethe Universität

location_facility: Hospital of Infectious Diseases of Warsaw

location_facility: Hospital Universitario Virgen de la Victoria

summary:
The triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant first-line treatment option in the years to come. The dual combination of boosted darunavir + raltegravir is an innovative treatment option that combines two potent new antiretroviral drugs, one of which belongs to a new drug class (integrase inhibitor). The expected efficacy profile of this combination is promising. Moreover, this combination might have a better tolerance profile and has the advantage of sparing the NRTI class.

In the context of tenofovir/emtricitabine currently being a reference backbone in first-line antiretroviral regimens, we hypothesise that, in combination with darunavir/r, raltegravir may be an alternative option if its efficacy is non-inferior to tenofovir/emtricitabine.


acronym: REGENCY

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10.

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Mexico
United Kingdom
Argentina
Canada
United States
France
Israel
Peru
Colombia
South Africa
Germany

location_facility: Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex

location_facility: Washington University School of Medicine

location_facility: SPSK nr 2 Pomorskiej AM w Szczecinie; Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych

location_facility: Hospital Italiano de Buenos Aires; Rheumatology department

location_facility: Hospital Nacional Cayetano Heredia; Rheumatology

location_facility: Winelands Medical Research; Medical Research

location_facility: Hospital Universitario Reina Sofia; Servicio de Nefrologia

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: Szpital Specjalistyczny im Jozefa Dietla; Centrum Reumatologii, Immunologii i Rehabilitacji, I Oddzi

location_facility: Arizona Arthritis and Rheumatology Research PLLC

location_facility: Szpital Kliniczny Dzieciatka Jezus; Klinika Med. Transplantacyjnej, Nefrologii i Chorob Wew

location_facility: Ospedale ARNAS - P.O."Civico e Benfratelli; UOC Nefrologia e Dialisi

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: University of Alabama at Birmingham Medical Center

location_facility: Medyczne Centrum Hetmanska; Rheumatology

location_facility: Servicio de Inmuno Reumatologia; Hospital Nacional Arzobispo Loayza

location_facility: Hospital Regional Universitario de Malaga; Servicio de Reumatologia

location_facility: Hopital Claude Huriez; Internal Medicine

location_facility: University of Utah Health Science center; Department of Pediatrics

location_facility: Ser Servicos Especializados Em Reumatologia

location_facility: Hospital Universitari de Bellvitge; Servicio de Nefrologia

location_facility: Hospital Universitario; Dr. Jose Eleuterio Gonzalez

location_facility: Clínica San Juan Bautista CSJB; UNIDAD DE INVESTIGACION EN REUMATOLOGIA E INMUNOLOGIA CSJB

location_facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*

location_facility: Royal Free Hospital; Centre for Nephrology

location_facility: Panaroma Medical Center; Clinical Trials Department

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

location_facility: Centro de Investigación y Tratamiento Reumatológico S.C.

location_facility: SIH Kemerovo Regional Clinical Hospital; Neurology department

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: SPSK Slaskiego UM w Katowicach; Katedra i Klinika Nefrologii, Endokryn.I Chorob Przemiany Materii

location_facility: Arizona arthritis and Rheumatology Research PLLC

location_facility: NYU Langone Medical Center; Seligman Center for Advanced Therapeutics

location_facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; Nefrologia

location_facility: Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM; Oddzial Reumat Rehab i Chorob Wewnetrznych

location_facility: Universitaetsmedizin Johannes Gutenberg; Rheumatologie

location_facility: Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

location_facility: Sociedad de Cirugia de Bogota Hospital San Jose

location_facility: Chaim Sheba Medical Center; Rheumatology

location_facility: Städtisches Klinik Dresden-Friedrichstadt; I. Medizinische Klinik

location_facility: Hopital Universitaire; Nephrologie Clinique Medicale B

location_facility: Universitätskrankenhaus Tübingen; Innere Medizin / Hämatologie und Internistische Onkologie

location_facility: Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov; Rheumatology Department

location_facility: Hospital Universitario 12 de Octubre; Servicio de Reumatologia

location_facility: Uniwersytecki Szpital Kliniczny Nr 2 Im. Wam; Centralny Szpital Weteranow

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Servicio de Reumatología

location_facility: CHAPEL ALLERTON HOSPITAL; Unit of Musculoskeletal Disease

location_facility: Asst Degli Spedali Civili Di Brescia; Reumatologia Ed Immunologia Clinica

location_facility: Hospital General De Mexico; Rheumatology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

location_facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

location_facility: SBIH of Moscow "City Clinical Hospital #20 of Moscow Healthcare Department"

location_facility: SPZOZ Centralny Szpital Klin; UM w Lodzi

location_facility: Kaiser Permanente - San Francisco Medical Center

location_facility: Hopital Bichat Claude Bernard; Nephrologie

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Reumatologia

location_facility: Hospital de Basurto; Servicio de Reumatologia

location_facility: Instituto del Cerebro y la Columna Vertebral SAC

location_facility: SP Szpital Kliniczny nr 1 Pomorskiej Akademii Medycznej im. prof. Tadeusza Sokolowskiego

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Medicina Interna

location_facility: The Ohio State University Wexner Medical Center

location_facility: Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii

location_facility: "Kazan (Privolzhsky) Federal University"; Academic Hospital

location_facility: Hospital das Clinicas - FMUSP Ribeirao Preto; Reumatologia

location_facility: Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova

location_facility: Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique

location_facility: Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin

location_facility: Limited Liability Company "Centre of Medical Common Practice"

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: University of Miami Miller School of Medicine

location_facility: ASST Monza - Ospedale San Gerardo; Clinica Nefrologica

location_facility: Republican Hospital Named After V.A. Baranov

location_facility: Groote Schuur Hospital and University of Cape Town; E13 Renal Unit & J46 Dept of Medicine

location_facility: CHU de Martinique- Hôpital P. Zobda-Quitman; Service de Rhumatlogie- Médecine interne 5D

location_facility: Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie

location_facility: Hospital Universitario Araba; Servicio de Reumatologia

location_facility: University of Wisconsin School of Medicine and Public Health

location_facility: Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna

location_facility: HOPITAL HENRI MONDOR; SERVICE DE Nephrologie

location_facility: Azienda Ospedaliera di Padova; Dipartimento di Medicina - UOC di Reumatologia

location_facility: Hospital Ramon y Cajal ; Servicio de Reumatologia

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher

location_facility: Hospital Clinic i Provincial; Servicio de Nefrologia

location_facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

location_facility: AD-CARE, University of Rochester Medical Center

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.


acronym: The 'EMBRACE' Trial

title: The "EMBRACE" Trial: Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389. A Phase III Open-Label, Randomized, Parallel, Two-arm, Multi-center Study of E7389 Versus "Treatment of Physician's Choice" in Patients With Locally Recurrent, Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

lead_sponsor: Eisai Inc.

ReferenceCitation: Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5:CD011220. doi: 10.1002/14651858.CD011220.pub2.

ReferenceCitation: Miyoshi Y, Yoshimura Y, Saito K, Muramoto K, Sugawara M, Alexis K, Nomoto K, Nakamura S, Saeki T, Watanabe J, Perez-Garcia JM, Cortes J. High absolute lymphocyte counts are associated with longer overall survival in patients with metastatic breast cancer treated with eribulin-but not with treatment of physician's choice-in the EMBRACE study. Breast Cancer. 2020 Jul;27(4):706-715. doi: 10.1007/s12282-020-01067-2. Epub 2020 Mar 5.

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

ReferenceCitation: Twelves C, Cortes J, Kaufman PA, Yelle L, Awada A, Binder TA, Olivo M, Song J, O'Shaughnessy JA, Jove M, Perez EA. "New" metastases are associated with a poorer prognosis than growth of pre-existing metastases in patients with metastatic breast cancer treated with chemotherapy. Breast Cancer Res. 2015 Dec 9;17(1):150. doi: 10.1186/s13058-015-0657-1.

ReferenceCitation: Muss H, Cortes J, Vahdat LT, Cardoso F, Twelves C, Wanders J, Dutcus CE, Yang J, Seegobin S, O'Shaughnessy J. Eribulin monotherapy in patients aged 70 years and older with metastatic breast cancer. Oncologist. 2014 Apr;19(4):318-27. doi: 10.1634/theoncologist.2013-0282. Epub 2014 Mar 28.

ReferenceCitation: Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Diéras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.

ReferenceCitation: Twelves C, Cortes J, Vahdat LT, Wanders J, Akerele C, Kaufman PA. Phase III trials of eribulin mesylate (E7389) in extensively pretreated patients with locally recurrent or metastatic breast cancer. Clin Breast Cancer. 2010 Apr;10(2):160-3. doi: 10.3816/CBC.2010.n.023.

location_country:
Croatia
Poland
Brazil
Spain
Italy
Austria
Australia
Russian Federation
Argentina
Canada
Switzerland
Hungary
United States
France
South Africa
Belgium
Czechia

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: Clinica Universitaria Privada Reina Fabiola

location_facility: Instituto Nacional do Cancer-Unidade III (INCA III)

location_facility: Centro Regional Integrado de Oncologia-CRIO

location_facility: CEPHO-Centro de Estudos e Pesquisa de Hematologia e oncologia

location_facility: Instituto de Oncologia y Especialidades Medicas

location_facility: Szpital Kiniczny Przemienienia Panskiego Uniwersyteu Medycznego im Karola Marcinkowskiego w Poznaniu

location_facility: Centrum Onkologii Instytut M Sklodowskiej Curie, Oddzial w Krakowie

location_facility: Centre Hospitalier Notre-Dame - Reine Fabiola

location_facility: Szpital Morski im PCK w Gdyni Gdynskie Centrum Onkologii

location_facility: McGill University Health Centre, Department of Oncology, Gerald Bronfman Center

location_facility: Peachtree Hematology/Oncology Consultants, PC

location_facility: State Institution of Healthcare Stavropol Region clinical Oncology dispensary

location_facility: Salzburger Landeskliniken Universitatsklinik fur Innere medizin III

location_facility: Markusovszky Teaching Hospital, Dept. of Oncoradiology, Sec. Med. Oncology

location_facility: The Ottawa Hospital Regional Cancer Center

location_facility: GUZ YO Regional Clinical Oncology Hospital

location_facility: Centrum Onkologii Instytut M. Sklodowskiej Curie w Warszawie Oddzial Gilwice

location_facility: Krasnodar Territory Clinical Oncology Center

location_facility: NN Petrov Research Institute of Oncology

location_facility: North Shore Hematology/Oncology Associates

location_facility: Debrecen Medical University, Department of Oncology

location_facility: Eastern Cape Oncology Centre, GVI, St Georges Hospital

location_facility: Centro de Pesquisas e Estudios do Centro Goiano

location_facility: Akademickie Centrum Kliniczne Szpital Akademii Medycznej w

location_facility: Hosptial Interzonal General de Mar del Plata

location_facility: Centrum Onkologii Instytut im M. Sklodowskiej Curie w Warszawie

location_facility: Hospital Universitario de Girona Dr. Josep Trueta

location_facility: Semmelweis Medical University, III. Dep. of Internal Med.

location_facility: AZ Groeninge, Campus Maria's Voorzienigheid

location_facility: US Oncology St. Vincent's Hospital - Bruno Cancer Center

location_facility: Royal Perth Hospital, Department of Medical Oncology

summary: The purpose of this study is to compare Overall Survival (OS), Progression Free Survival (PFS), objective tumor response rate, duration of response, and safety in patients treated with E7389 versus the Treatment of Physician's Choice (TPC) in patients with locally recurrent or metastatic breast cancer.


title: A Multicenter, Open-Label, Extension Study to Evaluate the Long-term Safety and Efficacy of Patisiran in Patients With Familial Amyloidotic Polyneuropathy Who Have Completed a Prior Patisiran Clinical Study

summary: The purpose of this study is to evaluate the safety and efficacy of long-term dosing with ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).

ReferenceCitation: Adams D, Polydefkis M, González-Duarte A, Wixner J, Kristen AV, Schmidt HH, Berk JL, Losada López IA, Dispenzieri A, Quan D, Conceição IM, Slama MS, Gillmore JD, Kyriakides T, Ajroud-Driss S, Waddington-Cruz M, Mezei MM, Planté-Bordeneuve V, Attarian S, Mauricio E, Brannagan TH 3rd, Ueda M, Aldinc E, Wang JJ, White MT, Vest J, Berber E, Sweetser MT, Coelho T; patisiran Global OLE study group. Long-term safety and efficacy of patisiran for hereditary transthyretin-mediated amyloidosis with polyneuropathy: 12-month results of an open-label extension study. Lancet Neurol. 2021 Jan;20(1):49-59. doi: 10.1016/S1474-4422(20)30368-9. Epub 2020 Nov 16. Erratum in: Lancet Neurol. 2021 Feb;20(2):e2.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Japan
Portugal
Australia
Argentina
Turkey
Mexico
Sweden
Malaysia
Cyprus
Brazil
Canada
Germany
Bulgaria
Taiwan
Korea, Republic of
France
Netherlands


title: European Real Life Study on NSAIDs Treated Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS): Assessment of Pain Relieve, Gastrointestinal (GI) Symptoms, Adherence and Health Resource Consumption

acronym: EVIDENCE

summary: The aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving NSAID-therapy are treated and managed by their doctor in usual clinical practice, how patients comply with their treatment and how satisfied they are with their treatment.

ReferenceCitation: Lanas A, Boers M, Nuevo J. Gastrointestinal events in at-risk patients starting non-steroidal anti-inflammatory drugs (NSAIDs) for rheumatic diseases: the EVIDENCE study of European routine practice. Ann Rheum Dis. 2015 Apr;74(4):675-81. doi: 10.1136/annrheumdis-2013-204155. Epub 2013 Dec 18.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
Greece
Netherlands
United Kingdom
Switzerland
Sweden
France
Turkey
Belgium
Norway
Germany


title: Survey on the Expectations of Adolescents With Juvenile Idiopathic Arthritis (JIA) Regarding Knowledge and Communication With Health Care Professionals in the Field of Sexual Health, and Their Parents' Views on the Subject.

acronym: SNAPS-JIA

summary:
Sexual health is a legitimate area to explore in the care of these patients, as it has such an impact on quality of life. However, addressing sexual health in a situation of chronic disease confronts the double societal taboo of disease and sexuality. Health professionals are uncomfortable because they are not trained to talk about the subject, especially in the presence of parents and with a teenager they have watched grow up.

In this context, a needs survey among juvenile idiopathic arthritis (JIA) patients and the point of view of their parents in the field of sexual health seems necessary.

Main objective: To determine the expectations of adolescents (aged 10-19 years) with juvenile idiopathic arthritis regarding knowledge and communication with health care professionals in the field of sexual health.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: CHU de Strasbourg - Hôpital de Hautepierre

location_facility: Association Nationale de Défense contre l'Arthrite Rhumatoïde

location_facility: Centre Hospitalier Universitaire de Nantes


title: Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Study of Brexpiprazole as Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

summary: To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.

status: Terminated

lead_sponsor: H. Lundbeck A/S

location_country:
Poland
Serbia
Italy
Estonia
Finland
United States
France
South Africa
Sweden


title: A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe

acronym: DrEW

summary:
Following the initiation of Doravirine (DOR) regimen among people living with HIV (PLWH), the study will aim to assess effectiveness, discontinuation, and resistance over the 12-month period.

Retrospective data from 400 patients, 100 treatment naïve and 300 virally suppressed patients switching from a 1st or second line treatment, is planned to be collected from 6 - 10 European sites.

The study will be conducted through collaboration with the NEAT ID Network, a well-established network of clinical sites across Europe.

lead_sponsor: NEAT ID Foundation

location_country:
France
United Kingdom

location_facility:
CHU de Nantes
St Louis Hospital
Hopital Universitaire Pitie-Salpetriere
Guy's Hospital


type: Registry Identifier

title: Observational Multicenter Prospective Clinical Study on the Total Ankle Prosthesis, EasyMove®, Evaluating Safety and Performance up to 5 Years of Follow-up

summary: This study is a post-market clinical follow-up conducted in order to collect long-term data on safety and performance of the EasyMove prosthesis, which is intended to be implanted in case of total ankle replacement, when used in real life conditions according to the instructions for use.

lead_sponsor: FH ORTHO

location_country: France Switzerland

location_facility: Centre hospitalier universitaire vaudois

intervention_type: Device


title: Randomized Placebo-controlled Double-blinded Study of the Effect of TOTUM-070 on Lipid Metabolism in Moderate Hypercholesterolemic Subjects

acronym: HEART

summary: This clinical study aims to assess the efficacy of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism in moderate hypercholesterolemic subjects. The hypothesis is that TOTUM-070, daily consumed, is superior to placebo for decrease of fasting blood LDL-cholesterol concentration (determined by ultracentrifugation method) after 24 weeks of consumption.

lead_sponsor: Valbiotis

location_country: Germany France

location_facility: Unité d'Investigation Clinique Biofortis Mérieux NutriSciences

intervention_type: Dietary Supplement


title: A Phase 1 Dose Escalation and Expansion Study of CID-103, an Anti-CD38 Antibody, in Patients With Previously Treated Relapsed or Refractory Multiple Myeloma

summary: Patients with relapsed/refractory multiple myeloma will be enrolled in a dose-escalation phase receiving monotherapy CID-103. Once the recommended CID-103 dose and infusion duration is known, additional patients will be enrolled in an expansion phase consisting of two cohorts (anti-CD38 pretreated, and anti-CD38 treatment naïve). Patients will be treated until disease progression or unacceptable toxicities.

design_allocation: Non-Randomized

lead_sponsor: CASI Pharmaceuticals, Inc.

location_facility:
Sarah Cannon
CHU Rennes - Pontchaillou
Gustave Roussy Cancer Center
CHU de Nantes - Hôpital Hôtel-Dieu


title: Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study

acronym: HaWPYC

summary: HaWPYC is an international Post-Market Clinical Follow-up (PMCF) to collect post-market safety and performance data on commercially available Pyrocarbon (PyC) hand and wrist implants used in this study. Data may be used for Post-Market Surveillance, and regulatory requirements.

lead_sponsor: Stryker Trauma GmbH

location_facility: Orthopedic Surgeon (Dr. med. Dietmar Bignion)


title: Prospective, Multi Centre Evaluation of AVANTAGE® RELOAD Double Mobility Acetabular Cup - Clinical and Radiographic Outcomes

summary: This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.

status: Active, not recruiting

primary_purpose: Other

lead_sponsor: Zimmer Biomet

location_country: France Slovenia

location_facility:
CHU Cote de Nacre
CHU Lapeyronie
Hôpital Renée Sabran
Hospital Novo Mesto


title: Effect of Starter Formula With Symbiotic on Microbiota Balance

summary: The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of Bifidobacteria species in comparison with a formula non-supplemented with pre and probiotics.

lead_sponsor: Nestlé

location_country: Poland France

location_facility:
Hôpital de la Conception
The Medical University of Warsaw
Hôpital Saint Joseph
Hôpital Nord


title: Study of Prognosis Value of Protein S100Beta and Copeptine in Seizure in the Emergency Department

acronym: BISTRO

summary: We study the hypothesis that combination of Proteine S100 beta and Copeptin within normal ranges can rule out seizure recurrences and severe outcome, and allow early discharge from the emergency department

lead_sponsor: Bistro Study Group

location_facility: Royal London Hospital, Barts Health NHS Trust


title: Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open-label Phase I/II Clinical Trial - The AIMM Study (AMEP In Metastatic Melanoma)

acronym: AIMM

summary:
The objective of the present trial is:

to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma.
to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP
to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP

status: Withdrawn

lead_sponsor: Onxeo

location_facility: Hôpital Saint Louis. Service de dermatologie

intervention_type: Biological


title: Open Label Study of the Anti Insulin-like Growth Factor 1 Receptor (IGF-1R) Monoclonal Antibody, AVE1642, as Single Agent (Dose Escalation, Part 1) and in Combination With Velcade® (Combination, Part 2) in Patients With Recurrent, Refractory Multiple Myeloma (MM)

summary:
Primary Objectives:

Study Part 1: Determine the selected dose of AVE1642 administered every 3 weeks based on pharmacokinetic (PK) (Clearance of AVE1642), pharmacodynamic (PD) (insulin-like growth factor 1 [IGF-1] serum level) parameters, and eventual dose limiting toxicities (DLTs) in patients with recurrent, refractory multiple myeloma (MM).

Study Part 2: Assess the safety of the combination of the selected dose of AVE1642 with the recommended dose of Velcade®.

Secondary Objectives :

Study Part 1:

To assess the safety profile: type, incidence and intensity of drug related adverse events (AEs)
To assess the biological activity of AVE1642 (saturation of the receptors and down-regulation) on malignant plasma cells and on peripheral blood mononuclear cells (PBMC) and granulocytes
To assess the biological activity of AVE1642 on the signalization pathway of the IGF-1 system (phosphorylated akt [pAkt], phosphorylated erk [pErk]) on malignant plasma cells when technically possible
To define PK profile of AVE1642, and its PD effects on serum IGF 1, GF 2 and IGFBP-3
To assess clinical efficacy (complete response [CR], partial response [PR], minimal response [MR] and stabilization) based on the European group for Blood and Marrow Transplantation (EBMT) criteria, when possible
To assess potential immunogenicity by detection of human antihumanized antibodies (HAHA) anti-AVE1642

Study Part 2:

To detect any PK or PD interaction between AVE1642 and Velcade®
To assess clinical efficacy (CR, PR, MR, no change [NC]) according to EBMT criteria when appropriate
To assess biological activity of AVE1642 in combination with Velcade® on malignant plasma cells collected from bone marrow aspirates: saturation and down-regulation of the insulin-like growth factor 1 receptor (IGF-1R) and activity on the signalization pathway of the IGF-1 system (pAkt, pErk) when feasible
To detect immunogenicity reaction (HAHA)
To characterize PK and PD profile of a low dose (0.5 mg/kg) of AVE1642 expected to be non biologically active

lead_sponsor: Sanofi

location_country: France Italy

location_facility: Sanofi-Aventis Investigational Site Number 380001

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 250002


title: Characterization of the Mechanisms of Action of Resistance to Azacitidine in High-risk Myelodysplastic Syndromes and Acute Myeloid Leukemia With Multilineage Dysplasia

summary:
Myelodysplastic syndromes (MDS) are frequent diseases in elderly patients (median age: 71 years). IPSS classification defines low risk (Low and Intermediate 1), and high risk (Intermediate 2 and High) MDS. High-risk MDS (MDS-HR) have a high risk of transformation into acute leukemia with multilineage dysplasia (AML-DML). The success of Azacitidine has been mainly achieved through a rigorous empirical and clinical research, but the molecular mechanisms by which this molecule exerts its effects remain poorly characterized. The primary mode of action of Azacytidine is through DNA demethylation, and integration in to mRNA that favor traduction inhibition. The impact of this molecule on various cell death programs involved in the elimination of leukemic cells : apoptosis and autophagy is currently poorly known.

The research program and clinical studies we proposed focus on two major aspects:

- Main objective: Molecular mechanism of action and resistance to Azacitidine: Role of apoptosis versus autophagy.

- Secondary Objective: Reversion of Azacytidine resistance using different drugs targeting apoptosis and/or autophagy. Our laboratory has identified new molecules to selectively induce different types of cell death (apoptosis or autophagy).

ReferenceCitation: Cluzeau T, Robert G, Mounier N, Karsenti JM, Dufies M, Puissant A, Jacquel A, Renneville A, Preudhomme C, Cassuto JP, Raynaud S, Luciano F, Auberger P. BCL2L10 is a predictive factor for resistance to azacitidine in MDS and AML patients. Oncotarget. 2012 Apr;3(4):490-501.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_country: France Monaco

location_facility:
CHU de Nice - Hôpital de l'Archet
Centre Antoine Lacassagne
CH d'Antibes
CH Princesse Grace


title: Study of Congestive Heart Failure Through the Evaluation of Cardiac Resynchronization Non-responders and Mechanical Assistance Therapy

acronym: CHECKMATE

summary:
The prognosis for heart failure patients is bleak for the advanced stages of the disease, with a reported 6-month mortality rate of almost 50% in patients treated with chronic inotropic therapy. As well as its very severe prognosis, heart failure is a costly disease. Heart transplantation remains the reference treatment for the terminal stage of the disease but although this is an effective therapy, it does engender ethical, social, economic and legal problems. It also requires irreproachable and costly logistics, immuno-suppressor treatment and a lifetime of follow-ups. In particular, the number of donors has been going down steadily for several years in most countries which offer a heart transplant programme and some patients cannot take advantage of being added to a waiting list for a graft (age, co-morbidities…).

It is in this context that, alongside the medical treatments for cardiac insufficiency, other therapeutic strategies were developed, including resynchronization and long-term mechanical circulatory support. The progress made in resynchronization is at several levels: better understanding of the action mechanisms, the development and improvement of equipment specifically dedicated to resynchronization and prospective and randomized clinical trials which have scientifically validated this technique.

Simultaneously, many studies were published evaluating long term support with mechanical circulatory support (MCS), excluding light devices, as a bridge to transplant or an alternative to a transplant. It is also recognized that mechanical circulatory support with a new generation of continuous flow assist device improved the quality of life and functional capacity, with a reduced risk of device failure and infrequent need for replacement.

The "Achilles heel" of cardiac resynchronization remains the 20 to 40% of patients who respond barely or not at all. Among this population of patients, some are not candidates for a transplantation and long-term mechanical circulatory support by axial pump is an alternative to be considered. We elaborated an original randomized pilot study for these patients in order to evaluate their survival and their quality of life, to define if they should be proposed a left ventricular assist device (LVAD)or not.

lead_sponsor: Rennes University Hospital

location_facility: Klinik für Herz- und Thoraxchirurgie Martin-Luther-Universität


title: A Prospective Multicenter, Study to Evaluate the Safety and Effectiveness of the Presbyopia Algorithm for Hyperopia and Hyperopic Astigmatism Using LASIK

acronym: PresbyLASIK

summary: The Presbyopia Algorithm subject to this study has been specifically developed to prospectively generate a treatment file for the Technolas 217z100 laser that will provide Presbyopia correction among eyes with primary hyperopia or hyperopic astigmatism (distance correction). The treatment algorithm provides a bilateral, multifocal ablation with a center near addition, thereby allowing good focus over a range of object distances.

lead_sponsor: Technolas Perfect Vision GmbH

location_country: France Spain

location_facility:
Vision Future Nice
Clinique de la Vision Paris
Dr. Roure
Instituo Oftalmologico Casteanera


title: A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients With Multiple System Atrophy or Parkinson's Disease

acronym: Foehn

summary: The purpose of this study is to determine whether Fipamezole is effective in the treatment of orthostatic hypotension and related symptoms in multiple system atrophy and Parkinson's disease.

lead_sponsor: Juvantia Pharma Ltd

location_country: France Portugal

location_facility: Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa

location_facility: Hôpital du Haut Lévêque, CHU de Bordeaux


title: An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

lead_sponsor: Astellas Pharma Global Development, Inc.

ReferenceCitation: Hoimes CJ, Flaig TW, Milowsky MI, Friedlander TW, Bilen MA, Gupta S, Srinivas S, Merchan JR, McKay RR, Petrylak DP, Sasse C, Moreno BH, Yu Y, Carret AS, Rosenberg JE. Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer. J Clin Oncol. 2022 Aug 30:JCO2201643. doi: 10.1200/JCO.22.01643. [Epub ahead of print]

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Turkey
Singapore
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Thailand
Korea, Republic of
France
Netherlands

location_facility: Hillman Cancer Center / University of Pittsburgh Medical Center

location_facility: University of California Irvine - Newport

location_facility: Louisiana State University/ East Jefferson General Hospital

location_facility: University of Colorado Hospital / University of Colorado

location_facility: Saint Francis Hospital / Bon Secours - South Carolina

location_facility: Eastern CT Hematology and Oncology Associates

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Ironwood Cancer & Research Centers - Chandler

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Georgia Cancer Specialists / Northside Hospital Cancer Institute

location_facility: New York University (NYU) Cancer Institute

location_facility: University of Texas Southwestern Medical Center

location_facility: Lombardi Cancer Center / Georgetown University Medical Center

location_facility: University of California Los Angeles Medical Center

summary: This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.


title: Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients

summary: Primary objective of TELEDIAB-3 study is to demonstrate that the use of Meos Telemedicine ePortal for sharing information between diabetologist and type 1 diabetic patient is not inferior to a conventional care regarding metabolic results at 12 months.

ReferenceCitation: Chase HP, Pearson JA, Wightman C, Roberts MD, Oderberg AD, Garg SK. Modem transmission of glucose values reduces the costs and need for clinic visits. Diabetes Care. 2003 May;26(5):1475-9.

ReferenceCitation: Farmer AJ, Gibson OJ, Dudley C, Bryden K, Hayton PM, Tarassenko L, Neil A. A randomized controlled trial of the effect of real-time telemedicine support on glycemic control in young adults with type 1 diabetes (ISRCTN 46889446). Diabetes Care. 2005 Nov;28(11):2697-702.

ReferenceCitation: Montori VM, Helgemoe PK, Guyatt GH, Dean DS, Leung TW, Smith SA, Kudva YC. Telecare for patients with type 1 diabetes and inadequate glycemic control: a randomized controlled trial and meta-analysis. Diabetes Care. 2004 May;27(5):1088-94.

ReferenceCitation: Benhamou PY, Melki V, Boizel R, Perreal F, Quesada JL, Bessieres-Lacombe S, Bosson JL, Halimi S, Hanaire H. One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study. Diabetes Metab. 2007 Jun;33(3):220-6. Epub 2007 Mar 28.

ReferenceCitation: Boizel R, Benhamou PY, Renard E; Accu-Chek Pocket Compass Study Group. Glucose monitoring and pump data management software operated on a personal digital assistant can contribute to improve diabetes control in CSII-treated patients. Diabetes Metab. 2007 Sep;33(4):314-5. Epub 2007 May 1.

ReferenceCitation: Young RJ, Taylor J, Friede T, Hollis S, Mason JM, Lee P, Burns E, Long AF, Gambling T, New JP, Gibson JM. Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: a randomized controlled trial. Diabetes Care. 2005 Feb;28(2):278-82.

ReferenceCitation: Ralston JD, Revere D, Robins LS, Goldberg HI. Patients' experience with a diabetes support programme based on an interactive electronic medical record: qualitative study. BMJ. 2004 May 15;328(7449):1159.

ReferenceCitation: Cho JH, Chang SA, Kwon HS, Choi YH, Ko SH, Moon SD, Yoo SJ, Song KH, Son HS, Kim HS, Lee WC, Cha BY, Son HY, Yoon KH. Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system. Diabetes Care. 2006 Dec;29(12):2625-31.

ReferenceCitation: Tate DF, Jackvony EH, Wing RR. Effects of Internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial. JAMA. 2003 Apr 9;289(14):1833-6.

ReferenceCitation: Trief PM, Sandberg J, Izquierdo R, Morin PC, Shea S, Brittain R, Feldhousen EB, Weinstock RS. Diabetes management assisted by telemedicine: patient perspectives. Telemed J E Health. 2008 Sep;14(7):647-55. doi: 10.1089/tmj.2007.0107.

lead_sponsor: University Hospital, Grenoble

location_facility: University Hospital of Besancon - Hospital Jean Minjoz

location_facility: University Hospital, Department of Endocrinology

location_facility: University Hospital of Lyon (HCL Lyon sud)

location_facility: University Hospital of Caen (Hospital Côte de nacre)


title: Longitudinal Follow-up of Patients With Defibrillator Threshold Testing During Implantable Cardioverter Defibrillator (ICD) Replacement

acronym: T-DEF

summary: This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.

lead_sponsor: CMC Ambroise Paré

location_facility: Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu-CHU de Nancy-Hôpitaux de Brabois

intervention_type: Diagnostic Test


title: Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI: a Randomized Study

acronym: EASY TAVI

summary: The purpose of this study is to determine whether a left ventricular rapid pacing using the valve delivery guide-wire in transcatheter aortic valve implantation (TAVI) reduces the overall procedure duration in comparison with the conventional method.

ReferenceCitation: Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.

ReferenceCitation: Arnold SV, Reynolds MR, Wang K, Magnuson EA, Baron SJ, Chinnakondepalli KM, Reardon MJ, Tadros PN, Zorn GL, Maini B, Mumtaz MA, Brown JM, Kipperman RM, Adams DH, Popma JJ, Cohen DJ; CoreValve US Pivotal Trial Investigators. Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk: Results From the CoreValve US Pivotal Trial. JACC Cardiovasc Interv. 2015 Aug 17;8(9):1207-1217. doi: 10.1016/j.jcin.2015.04.018.

ReferenceCitation: Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8.

ReferenceCitation: Cribier A, Eltchaninoff H, Tron C, Bauer F, Agatiello C, Sebagh L, Bash A, Nusimovici D, Litzler PY, Bessou JP, Leon MB. Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis. J Am Coll Cardiol. 2004 Feb 18;43(4):698-703.

ReferenceCitation: Eggebrecht H, Mehta RH, Kahlert P, Schymik G, Lefèvre T, Lange R, Macaya C, Mandinov L, Wendler O, Thomas M. Emergent cardiac surgery during transcatheter aortic valve implantation (TAVI): insights from the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry. EuroIntervention. 2014 Dec;10(8):975-81. doi: 10.4244/EIJV10I8A165.

ReferenceCitation: Faurie B, Abdellaoui M, Wautot F, Staat P, Champagnac D, Wintzer-Wehekind J, Vanzetto G, Bertrand B, Monségu J. Rapid pacing using the left ventricular guidewire: Reviving an old technique to simplify BAV and TAVI procedures. Catheter Cardiovasc Interv. 2016 Nov 15;88(6):988-993. doi: 10.1002/ccd.26666. Epub 2016 Aug 11.

ReferenceCitation: Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrié D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. doi: 10.1056/NEJMoa1114705.

ReferenceCitation: Karagöz T, Aypar E, Erdoğan I, Sahin M, Ozer S, Celiker A. Congenital aortic stenosis: a novel technique for ventricular pacing during valvuloplasty. Catheter Cardiovasc Interv. 2008 Oct 1;72(4):527-30. doi: 10.1002/ccd.21695.

ReferenceCitation: Lefèvre T, Kappetein AP, Wolner E, Nataf P, Thomas M, Schächinger V, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, Romano M, Serruys P, Wimmer-Greinecker G; PARTNER EU Investigator Group. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J. 2011 Jan;32(2):148-57. doi: 10.1093/eurheartj/ehq427. Epub 2010 Nov 12.

ReferenceCitation: Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

ReferenceCitation: Navarini S, Pfammatter JP, Meier B. Left ventricular guidewire pacing to simplify aortic balloon valvuloplasty. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):426-7. doi: 10.1002/ccd.21810.

ReferenceCitation: Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014 May 20;63(19):1972-81. doi: 10.1016/j.jacc.2014.02.556. Epub 2014 Mar 19.

ReferenceCitation: Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

ReferenceCitation: Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, Eggebrecht H, Rubino P, Colombo A, Lange R, Schwarz RR, Wendler O. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011 Jul 26;124(4):425-33. doi: 10.1161/CIRCULATIONAHA.110.001545. Epub 2011 Jul 11.

ReferenceCitation: Walther T, Hamm CW, Schuler G, Berkowitsch A, Kötting J, Mangner N, Mudra H, Beckmann A, Cremer J, Welz A, Lange R, Kuck KH, Mohr FW, Möllmann H; GARY Executive Board. Perioperative Results and Complications in 15,964 Transcatheter Aortic Valve Replacements: Prospective Data From the GARY Registry. J Am Coll Cardiol. 2015 May 26;65(20):2173-80. doi: 10.1016/j.jacc.2015.03.034. Epub 2015 Mar 15.

ReferenceCitation: Wenaweser P, Pilgrim T, Roth N, Kadner A, Stortecky S, Kalesan B, Meuli F, Büllesfeld L, Khattab AA, Huber C, Eberle B, Erdös G, Meier B, Jüni P, Carrel T, Windecker S. Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes. Am Heart J. 2011 Jun;161(6):1114-24. doi: 10.1016/j.ahj.2011.01.025. Epub 2011 May 11.

ReferenceCitation: Vogel R, Meier B. Emergent mechanical and electrical guidewire pacing of the right ventricle for aystole in the cardiac catheterization laboratory. J Invasive Cardiol. 2005 Sep;17(9):490.

ReferenceCitation: Faurie B, Souteyrand G, Staat P, Godin M, Caussin C, Van Belle E, Mangin L, Meyer P, Dumonteil N, Abdellaoui M, Monségu J, Durand-Zaleski I, Lefèvre T; EASY TAVI Investigators. Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2449-2459. doi: 10.1016/j.jcin.2019.09.029. Epub 2019 Sep 28.

lead_sponsor: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Groupement Hospitalier Mutualiste de Grenoble


title: Long-Term Observational Study of Translarna Safety and Effectiveness in Usual Care

summary: This study is being performed as a post-approval safety study (PASS), per the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), to gather data on Translarna (ataluren) safety, effectiveness, and prescription patterns in routine clinical practice.

ReferenceCitation: Mercuri E, Muntoni F, Osorio AN, Tulinius M, Buccella F, Morgenroth LP, Gordish-Dressman H, Jiang J, Trifillis P, Zhu J, Kristensen A, Santos CL, Henricson EK, McDonald CM, Desguerre I; STRIDE; CINRG Duchenne Natural History Investigators. Safety and effectiveness of ataluren: comparison of results from the STRIDE Registry and CINRG DMD Natural History Study. J Comp Eff Res. 2020 Apr;9(5):341-360. doi: 10.2217/cer-2019-0171. Epub 2020 Jan 30.

lead_sponsor: PTC Therapeutics

location_country:
Brazil
Portugal
Slovenia
Greece
Austria
Italy
Latvia
United Kingdom
Sweden
Hungary
France
Israel
Romania
Norway
Germany
Czechia

location_facility: Sheba Medical Center The Joseph Sagol EMG, Neuroscience Center

location_facility: Children's Hospital Alder Hey Children's Hospital NHS Trust

location_facility: Centro Hospitalar e Universitário de coimbra EPE - Hospital Pediátrico de Coimbra

location_facility: Hospital das Clínicas da Universidade de São Paulo

location_facility: Klinik und Poliklinik f. Kinder- und Jugendmedizin

location_facility: Centro Hospitalar do Porto EPE - Hospital Geral de Santo António

location_facility: UCL Great Ormond Street Institute of Child Health

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: IRCSS Istituto delle Scienze Neurologiche

location_facility: CHU de Nancy Hôpital de Brabois-Enfants Rue du Morvan

location_facility: Semmelweis Egyetem II (Semmelweis University II)

location_facility: CHU de Toulouse Hôpital Pierre Paul Riquet

location_facility: University Children's Hospital University Medical Centre Ljubljana

location_facility: Göteborgs Universitet Avdelningen för pediatrik vid institutionen för kliniska vetenskaper

location_facility: The John Walton Muscular Dystrophy Research Centre

location_facility: II Policlinico Neurofisiopatologia (Edificio 11 G)

location_facility: CHU de Martinique - Hôpital P. Zobda-Quitman

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria

location_facility: CHU de Clermont-Ferrand, hôpital Estaing

location_facility: CHU de Bordeaux Hôpital Pellegrin Enfant

location_facility: Children Hospital - Children's Neurosciences Leeds TEACHING HOSPITALS NHS Trust

location_facility: CHU de la Réunion - GHSR - GH Sud-Réunion

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospices Civils de Lyon Groupement Hospitalier Est - Bâtiment "Les Tilleuls"

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Szent László Kórház Gyermekneurológiai szakrendelés

location_facility: Cardiomiologia e Genetica Medica Primo Policlinico

location_facility: St. Olavs hospital University children's clinical hospital

location_facility: NIHR Lancashire Clinical Research Facility Royal Preston Hospital

location_facility: Sozialmedizinisches Zentrum Süd Kaiser-Franz-Josef Spital mit Gottfried von Preyer´schen Kinderspital

location_facility: Schneider Medical Center Tel Aviv University

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Spitalul Clinic de Copii "Dr. Victor Gomoiu" Sectia Clinica Neurologie Pediatrica

location_facility: Ospedale Molinette SCDU Neuropsichiatria Infantile AO Città della Salute e della Scienza di Torino

location_facility: Sozialpädiatrisches Zentrum (SPZ) Charité Berlin


title: Effectiveness and Organizational Conditions of Effectiveness of Telemedicine in Establishments Providing Care for the Dependent Elderly

acronym: EFFORT

summary: Study of interest of Telemedicine in establishments providing care for the dependent elderly (EHPAD in french) is a strategy for improving the course of care of residents, including the number not programmed hospitalizations, and a multidimensional analysis of the conditions of effectiveness of telemedicine will identify the keys to optimize its use.

ReferenceType: result

ReferenceCitation: Han JH, Morandi A, Ely EW, Callison C, Zhou C, Storrow AB, Dittus RS, Habermann R, Schnelle J. Delirium in the nursing home patients seen in the emergency department. J Am Geriatr Soc. 2009 May;57(5):889-94. doi: 10.1111/j.1532-5415.2009.02219.x.

ReferenceCitation: Morandi A, Han JH, Callison C, Ely EW, Schnelle JF. Delirium in nursing home residents across care transitions: a preliminary report. J Am Geriatr Soc. 2009 Oct;57(10):1956-8. doi: 10.1111/j.1532-5415.2009.02472.x.

ReferenceCitation: Vellas B. Integrating Frailty into Clinical Practice to Prevent the Risk of Dependency in the Elderly. Nestle Nutr Inst Workshop Ser. 2015;83:99-104. doi: 10.1159/000382092. Epub 2015 Oct 20. Review.

ReferenceCitation: Graverholt B, Forsetlund L, Jamtvedt G. Reducing hospital admissions from nursing homes: a systematic review. BMC Health Serv Res. 2014 Jan 24;14:36. doi: 10.1186/1472-6963-14-36. Review.

ReferenceCitation: Salles N, Saillour-Glénisson F, Sibe M, Langlois E, Kret M, Durrieu J, Arditi N, Abraham M, Perry F. Effectiveness and organizational conditions of effectiveness of telemedicine in nursing homes. A study protocol of a comparative prospective cohort (EFFORT study). Digit Health. 2021 Jan 24;7:2055207620982422. doi: 10.1177/2055207620982422. eCollection 2021 Jan-Dec.

lead_sponsor: University Hospital, Bordeaux

location_facility:
EHPAD Résidence La berge du lac
EHPAD Residence Aime Cesaire
EHPAD Villa Bontemps
EHPAD Résidence les Carmes
EHPAD Le home medocain Arsac
EHPAD Cos villa Pia
EHPAD Le rétou
EHPAD résidence du Tertre
EHPAD Henry Dunant
EHPAD Fontaudin
EHPAD Villa presentine
EHPAD Le parc du Bequet
EHPAD Jacqueline Auriol
EHPAD Manon Cormier
EHPAD Home Marie Curie
Résidence de Médicis
EHPAD Le Clos Serena
EHPAD Douceur de France
EHPAD Résidence l'Arousiney
EHPAD Grand Bon Pasteur
EHPAD Le Platane du Grand Parc
EHPAD Les coteaux
EHPAD CHU Bordeaux
EHPAD Seguin


title: Comparative Assessment of Methods to Analyze MGMT as a Predictive Factor of Response to Temozolomide in Glioblastomas.

acronym: ECOM

summary: Treatment for newly diagnosed glioblastomas currently involves surgical resection followed by Temozolomide chemotherapy with concomitant radiotherapy, and then 6 cycles of Temozolomide in adjuvant. According to many studies, only those patients not expressing the enzyme repair MGMT benefit from the adjunction of Temozolomide. Therefore, many patients receive unnecessary treatment. The aim of this project is to compare different techniques for analysis of MGMT in order to choose the approach with the best cost/utility ratio, which will allow the selection of patients likely to respond to TMZ chemotherapy during the first course of GBM treatment.

ReferenceCitation: Hegi ME, Diserens AC, Gorlia T, Hamou MF, de Tribolet N, Weller M, Kros JM, Hainfellner JA, Mason W, Mariani L, Bromberg JE, Hau P, Mirimanoff RO, Cairncross JG, Janzer RC, Stupp R. MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med. 2005 Mar 10;352(10):997-1003.

ReferenceCitation: Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96.

lead_sponsor: Center Eugene Marquis

location_facility:
CHU La Timone
CHRU Hautepierre
CHU de Lyon
Center Eugene Marquis
CHU de Grenoble
CHU de Poitiers
CHU de Bordeaux
CHU Cote de Nacre
CHRU de Lille
CHU La Salpetriere

intervention_type: Radiation


title: A Prospective, Multi-center, Randomized, Double-blind Trial to Assess the Effectiveness and Safety of 12 Versus 30 Months of Dual Antiplatelet Therapy in Subjects Undergoing Percutaneous Coronary Intervention With Either Drug-eluting Stent or Bare Metal Stent Placement for the Treatment of Coronary Artery Lesions

summary: The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.

ReferenceCitation: Berg DD, Yeh RW, Mauri L, Morrow DA, Kereiakes DJ, Cutlip DE, Gao Q, Jarolim P, Michelson AD, Frelinger AL 3rd, Cange AL, Sabatine MS, O'Donoghue ML. Biomarkers of platelet activation and cardiovascular risk in the DAPT trial. J Thromb Thrombolysis. 2021 Apr;51(3):675-681. doi: 10.1007/s11239-020-02221-5.

ReferenceCitation: Stefanescu Schmidt AC, Steg PG, Yeh RW, Kereiakes DJ, Tanguay JF, Hsieh WH, Massaro JM, Mauri L, Cutlip DE; DAPT Investigators. Interruption of Dual Antiplatelet Therapy Within Six Months After Coronary Stents (from the Dual Antiplatelet Therapy Study). Am J Cardiol. 2019 Dec 15;124(12):1813-1820. doi: 10.1016/j.amjcard.2019.09.006. Epub 2019 Sep 26.

ReferenceCitation: Berry NC, Kereiakes DJ, Yeh RW, Steg PG, Cutlip DE, Jacobs AK, Abbott JD, Hsieh WH, Massaro JM, Mauri L; DAPT Study Investigators. Benefit and Risk of Prolonged DAPT After Coronary Stenting in Women. Circ Cardiovasc Interv. 2018 Aug;11(8):e005308. doi: 10.1161/CIRCINTERVENTIONS.117.005308.

ReferenceCitation: Yeh RW, Kereiakes DJ, Steg PG, Cutlip DE, Croce KJ, Massaro JM, Mauri L; DAPT Study Investigators. Lesion Complexity and Outcomes of Extended Dual Antiplatelet Therapy After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2017 Oct 31;70(18):2213-2223. doi: 10.1016/j.jacc.2017.09.011.

ReferenceCitation: Secemsky EA, Yeh RW, Kereiakes DJ, Cutlip DE, Cohen DJ, Steg PG, Cannon CP, Apruzzese PK, D'Agostino RB Sr, Massaro JM, Mauri L; Dual Antiplatelet Therapy (DAPT) Study Investigators. Mortality Following Cardiovascular and Bleeding Events Occurring Beyond 1 Year After Coronary Stenting: A Secondary Analysis of the Dual Antiplatelet Therapy (DAPT) Study. JAMA Cardiol. 2017 May 1;2(5):478-487. doi: 10.1001/jamacardio.2017.0063.

ReferenceCitation: Stefanescu Schmidt AC, Kereiakes DJ, Cutlip DE, Yeh RW, D'Agostino RB Sr, Massaro JM, Hsieh WH, Mauri L; DAPT Investigators. Myocardial Infarction Risk After Discontinuation of Thienopyridine Therapy in the Randomized DAPT Study (Dual Antiplatelet Therapy). Circulation. 2017 May 2;135(18):1720-1732. doi: 10.1161/CIRCULATIONAHA.116.024835. Epub 2017 Feb 22.

ReferenceCitation: Resor CD, Nathan A, Kereiakes DJ, Yeh RW, Massaro JM, Cutlip DE, Gabriel Steg P, Hsieh WH, Mauri L; Dual Antiplatelet Therapy Study Investigators. Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study. Circulation. 2016 Oct 4;134(14):989-998. Epub 2016 Aug 30.

ReferenceCitation: Kereiakes DJ, Yeh RW, Massaro JM, Cutlip DE, Steg PG, Wiviott SD, Mauri L; DAPT Study Investigators. DAPT Score Utility for Risk Prediction in Patients With or Without Previous Myocardial Infarction. J Am Coll Cardiol. 2016 May 31;67(21):2492-502. doi: 10.1016/j.jacc.2016.03.485. Epub 2016 Apr 1.

ReferenceCitation: Yeh RW, Secemsky EA, Kereiakes DJ, Normand SL, Gershlick AH, Cohen DJ, Spertus JA, Steg PG, Cutlip DE, Rinaldi MJ, Camenzind E, Wijns W, Apruzzese PK, Song Y, Massaro JM, Mauri L; DAPT Study Investigators. Development and Validation of a Prediction Rule for Benefit and Harm of Dual Antiplatelet Therapy Beyond 1 Year After Percutaneous Coronary Intervention. JAMA. 2016 Apr 26;315(16):1735-49. doi: 10.1001/jama.2016.3775. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

ReferenceCitation: Meredith IT, Tanguay JF, Kereiakes DJ, Cutlip DE, Yeh RW, Garratt KN, Lee DP, Steg PG, Weaver WD, Holmes DR Jr, Brindis RG, Trebacz J, Massaro JM, Hsieh WH, Mauri L; DAPT Study Investigators. Diabetes Mellitus and Prevention of Late Myocardial Infarction After Coronary Stenting in the Randomized Dual Antiplatelet Therapy Study. Circulation. 2016 May 3;133(18):1772-82. doi: 10.1161/CIRCULATIONAHA.115.016783. Epub 2016 Mar 18. Erratum in: Circulation. 2016 May 31;133(22):e671.

ReferenceCitation: Hermiller JB, Krucoff MW, Kereiakes DJ, Windecker S, Steg PG, Yeh RW, Cohen DJ, Cutlip DE, Massaro JM, Hsieh WH, Mauri L; DAPT Study Investigators. Benefits and Risks of Extended Dual Antiplatelet Therapy After Everolimus-Eluting Stents. JACC Cardiovasc Interv. 2016 Jan 25;9(2):138-47. doi: 10.1016/j.jcin.2015.10.001.

ReferenceCitation: Mauri L, Elmariah S, Yeh RW, Cutlip DE, Steg PG, Windecker S, Wiviott SD, Cohen DJ, Massaro JM, D'Agostino RB Sr, Braunwald E, Kereiakes DJ; DAPT Study Investigators. Causes of late mortality with dual antiplatelet therapy after coronary stents. Eur Heart J. 2016 Jan 21;37(4):378-85. doi: 10.1093/eurheartj/ehv614. Epub 2015 Nov 18.

ReferenceCitation: Kereiakes DJ, Yeh RW, Massaro JM, Driscoll-Shempp P, Cutlip DE, Steg PG, Gershlick AH, Darius H, Meredith IT, Ormiston J, Tanguay JF, Windecker S, Garratt KN, Kandzari DE, Lee DP, Simon DI, Iancu AC, Trebacz J, Mauri L; DAPT Study Investigators. Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy. JACC Cardiovasc Interv. 2015 Oct;8(12):1552-62. doi: 10.1016/j.jcin.2015.05.026. Erratum in: JACC Cardiovasc Interv. 2015 Dec 21;8(14):1913.

ReferenceCitation: Yeh RW, Kereiakes DJ, Steg PG, Windecker S, Rinaldi MJ, Gershlick AH, Cutlip DE, Cohen DJ, Tanguay JF, Jacobs A, Wiviott SD, Massaro JM, Iancu AC, Mauri L; DAPT Study Investigators. Benefits and Risks of Extended Duration Dual Antiplatelet Therapy After PCI in Patients With and Without Acute Myocardial Infarction. J Am Coll Cardiol. 2015 May 26;65(20):2211-21. doi: 10.1016/j.jacc.2015.03.003. Epub 2015 Mar 15.

ReferenceCitation: Kereiakes DJ, Yeh RW, Massaro JM, Driscoll-Shempp P, Cutlip DE, Steg PG, Gershlick AH, Darius H, Meredith IT, Ormiston J, Tanguay JF, Windecker S, Garratt KN, Kandzari DE, Lee DP, Simon DI, Iancu AC, Trebacz J, Mauri L; Dual Antiplatelet Therapy (DAPT) Study Investigators. Antiplatelet therapy duration following bare metal or drug-eluting coronary stents: the dual antiplatelet therapy randomized clinical trial. JAMA. 2015 Mar 17;313(11):1113-21. doi: 10.1001/jama.2015.1671. Erratum in: JAMA. 2015 Jun 2;313(21):2185. JAMA. 2016 Jul 5;316(1):105. JAMA. 2016 Jul 5;316(1):105.

ReferenceCitation: Yeh RW, Czarny MJ, Normand SL, Kereiakes DJ, Holmes DR Jr, Brindis RG, Weaver WD, Rumsfeld JS, Roe MT, Kim S, Driscoll-Shempp P, Mauri L. Evaluating the generalizability of a large streamlined cardiovascular trial: comparing hospitals and patients in the dual antiplatelet therapy study versus the National Cardiovascular Data Registry. Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):96-102. doi: 10.1161/CIRCOUTCOMES.114.001239. Epub 2014 Nov 16.

ReferenceCitation: Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM; DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155-66. doi: 10.1056/NEJMoa1409312. Epub 2014 Nov 16.

ReferenceCitation: Matteau A, Yeh RW, Kereiakes D, Orav EJ, Massaro J, Steg PG, Normand SL, Cutlip DE, Mauri L. Frequency of the use of low- versus high-dose aspirin in dual antiplatelet therapy after percutaneous coronary intervention (from the Dual Antiplatelet Therapy study). Am J Cardiol. 2014 Apr 1;113(7):1146-52. doi: 10.1016/j.amjcard.2013.10.015. Epub 2013 Nov 8.

ReferenceCitation: Mauri L, Kereiakes DJ, Normand SL, Wiviott SD, Cohen DJ, Holmes DR, Bangalore S, Cutlip DE, Pencina M, Massaro JM. Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous coronary intervention with either drug-eluting stent or bare metal stent placement for the treatment of coronary artery lesions. Am Heart J. 2010 Dec;160(6):1035-41, 1041.e1. doi: 10.1016/j.ahj.2010.07.038.

lead_sponsor: Baim Institute for Clinical Research

location_country:
Poland
United Kingdom
Australia
New Zealand
Hungary
United States
France
Romania
Germany
Czechia

location_facility: California Cardiovascular Consultants/ Washington Hospital

location_facility: Institutul de Boli Cardiovasculare si Transplant Targu Mures

location_facility: UMDNJ - Robert Wood Johnson Medical School

location_facility: SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie

location_facility: Veteran's Affairs Medical Center- Dallas

location_facility: Bay Area Cardiology Associates/ Brandon Regional Hospital

location_facility: Capital Cardiovascular Research Institute

location_facility: Heartland Education and Research Foundation

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Klinikai Kozpont

location_facility: St. Luke's Hospital Mid America Heart Institute

location_facility: Great Lakes Heart & Vascular Institute, PC

location_facility: Instytut Kardiologii im. Kardynala St. Wyszynskiego

location_facility: Midwest Cardiovascular Research and Education Foundation

location_facility: Centrul Clinic de Urgenta de Boli Cardiovasculare al Armatei

location_facility: University of Oklahoma Health Sciences Center

location_facility: Inst. Urgenta Boli Cardiovasculare Prof. Dr. C.C. Iliescu

location_facility: Wielospecj. Szpital Miejski im.dr.E.Warminskiego-SPZOZ

location_facility: University of Arkansas (Central VA) for Medical Science

location_facility: St. Vincent Heart Center of Indiana, LLC

location_facility: Spitalul Clinic Universitar de Urgenta Bucuresti

location_facility: Institutul de Urgenta pentru Boli Cardiovasculare Prof. Dr.

location_facility: Donald Guthrie Foundation for Education and Research

location_facility: University Hospital of Leicester Glenfield Hospital

location_facility: Methodist DeBakey Heart & Vascular Center

location_facility: The Foundation for Cardiovascular Medicine

location_facility: Frederick C Smith Clinic dba Smith Clinic

location_facility: Torrance Memorial Medical Center / Vasek Polak Research Program

location_facility: University Hospital of Coventry and Warwickshire

location_facility: Institutul Inimii Niculae Stancioiu Cluj-Napoca

location_facility: Central Minnesota Heart Center at St. Cloud Hospital

location_facility: Cardiovascular Associates of the Delaware Valley, PA

location_facility: Oregon Health & Sciences University Hospital

location_facility: Universitaetsklinikum Schleswig-Holstein - PS

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

location_facility: St. Vincent Hospital/ Providence Heart Hospital

location_facility: Polsko-Amerykanskie Kliniki Serca.American Heart of Poland S

location_facility: Black Hills Research- Rapid City Regional

location_facility: Uniwersyteck Szpital Klin. w Bialymstoku

location_facility: Henry Ford Hospital Heart & Vascular Institute

location_facility: Northwest Indiana Cardiovascular Physicians, P.C.


title: Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation

acronym: QDA-UE

summary: The aim of the study is to demonstrate the performance of Withings WBS08 in the automatic identification of atrial fibrillation and sinus rhythm.

primary_purpose: Diagnostic

lead_sponsor: Withings

location_country: France Belgium

location_facility: Cliniques Universitaires de Bruxelles - Hôpital Erasme


title: Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

acronym: CALLIOPE

summary: The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.

lead_sponsor: MicroPort CRM

location_facility:
Hôpital Louis Pasteur
Clinique Saint Joseph
CHU Bordeaux
Hôpital de la Timone


title: PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.

summary: PREG2 is a randomized controlled trial that aims to evaluate efficacy in preventing intrauterine adhesion recurrence after hysteroscopic adhesiolysis of a novel intrauterine barrier film named Womed Leaf

ipd_sharing: Yes

ipd_sharing_description: Individual participant data that underlie the result that will be reported in an article and study protocol may be made available to researchers who provide a methodologically sound proposal, immediately after article publication and during 5 years

lead_sponsor: Womed

location_facility:
CHU Lariboisière
Hopital La Conception
Gent UZ
CHU Bicêtre


title: Dilatation Versus Endoscopic Laser Resection in Simple Benign Tracheal Stenosis : a Randomized Controlled Trial

acronym: AERATE

summary: Multicenter randomized controlled trial comparing endoscopic laser resection vs dilatation in benign tracheal stenosis.

ReferenceCitation: Soumagne T, Guibert N, Atallah I, Lacasse Y, Dutau H, Fortin M. Dilation versus laser resection in subglottic stenosis: protocol for a prospective international multicentre randomised controlled trial (AERATE trial). BMJ Open. 2022 Mar 17;12(3):e053730. doi: 10.1136/bmjopen-2021-053730.

lead_sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_country: Canada France

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

location_facility: Hôpital Larrey, University Hospital of Toulouse

location_facility: Centre Hospitalier Universitaire Grenoble Alpes


title: A Prospective Single Arm Clinical Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation

acronym: FASTR-AF

summary: The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.

ReferenceCitation: Neuzil P, Poty H, de Chillou C, Petru J, Getman MK, Liu S, Funasako M, Durand-Dubief A, Combes S, Albenque JP. Radiofrequency ablation using the second-generation temperature-controlled diamond tip system in paroxysmal and persistent atrial fibrillation: results from FASTR-AF. J Interv Card Electrophysiol. 2022 May 18. doi: 10.1007/s10840-022-01234-9. [Epub ahead of print]

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country: France Czechia

location_facility:
CHRU de Nancy
Na Homolce
Clinique Pasteur
Clnique du Tonkin


title: An Open-label, First-in-human, Dose Escalation Study of SAR440234 Administered as Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), or High Risk Myelodysplasia (HR-MDS)

lead_sponsor: Sanofi

ReferenceCitation: Gerard E, Zohar S, Thai HT, Lorenzato C, Riviere MK, Ursino M. Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics. Biometrics. 2022 Mar;78(1):300-312. doi: 10.1111/biom.13433. Epub 2021 Feb 18.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
United States
France

location_facility:
Investigational Site Number 8400001
Investigational Site Number 2500003
Investigational Site Number 2500001
Investigational Site Number 2500004

summary:
Primary Objective:

Dose escalation: To determine the maximum tolerated dose (MTD) of SAR440234 administered as a single agent in participants with relapsed or refractory acute myeloid leukemia (R/R AML), high risk myelodysplastic syndrome (HR-MDS), or B-cell acute lymphoblastic leukemia (B-ALL), and determine the recommended phase 2 dose (RP2D) for the subsequent Expansion part.
Expansion part: To assess the activity of single agent SAR440234 at the RP2D in participants with R/R AML or HR-MDS.

Secondary Objective:

To characterize the safety profile including cumulative adverse drug reactions.
To evaluate the potential immunogenicity of SAR440234.
To assess any preliminary evidence of hematologic response in the Dose Escalation Part.


title: A Phase II Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumour (TET) Progressing After Primary Chemotherapy.

acronym: TET-SEL

summary:
The aim of the study is to determine the efficacy of selinexor in adults with TETs determined by overall response rate (RECIST 1.1) in two parallel cohorts of patients with advanced thymomas or thymic carcinomas. The study is an international, multicenter, open label phase II trial using Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with least one platinum containing chemotherapy regimen.

This study is comprised of 2 similar phase II tirals, one running in EU (25 patients) and one running in US (25 patients).

There are two study arms:

Arm A: Thymoma

Stage 1: 15 patients
Stage 2: 10 patients

Arm B: Thymic carcinoma

Stage 1: 15 patients
Stage 2: 10 patients

lead_sponsor: Morten Mau-Soerensen

location_country: Denmark France

location_facility:
Hospices Civils de Lyon
Rigshospitalet
Intitut Gustave Roussy
Intitut Curie


title: A Study to Investigate the Genetic Variation of Dopamine Pathway Associated With the Observed Effects of a New Treatment in Former Studies in Patients With Chronic Pain

summary: Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling for genotyping purposes. In addition they will compete the personality questionnaires they had completed in the former trial.

primary_purpose: Basic Science

location_facility:
ATC SA
CIC Clermont-Ferrand CHU G. Montpied
Institut Curie
Eurofins Optimed


title: IPS-II Study: Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) - A Pilot Study.

acronym: IPS-II

summary:
Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve targeted lung denervation and potentially improve breathing and quality of life for patients suffering from COPD.

Use of the IPS System will be technically feasible in accessing the target treatment location and delivering RF energy to the target treatment location.

lead_sponsor: Nuvaira, Inc.

location_country: Austria France

location_facility: Centre Hospitalier et Universitaire de Grenoble


title: A Phase 2 Pilot Study With a Randomized Double-Blind Treatment Phase to Evaluate the Pharmacodynamics and Safety of Alirocumab in Patients With Autosomal Dominant Hypercholesterolemia and Gain-of-Function Mutations in 1 or Both Alleles of the PCSK9 Gene or Loss-of-Function Mutations in 1 or More Alleles of the Loss-of-Function Mutations B Gene

lead_sponsor: Regeneron Pharmaceuticals

ReferenceCitation: Hopkins PN, Krempf M, Bruckert E, Donahue S, Yang F, Zhang Y, DiCioccio AT. Pharmacokinetic and pharmacodynamic assessment of alirocumab in patients with familial hypercholesterolemia associated with proprotein convertase subtilisin/kexin type 9 gain-of-function or apolipoprotein B loss-of-function mutations. J Clin Lipidol. 2019 Nov - Dec;13(6):970-978. doi: 10.1016/j.jacl.2019.10.007. Epub 2019 Oct 21.

ReferenceCitation: Hopkins PN, Defesche J, Fouchier SW, Bruckert E, Luc G, Cariou B, Sjouke B, Leren TP, Harada-Shiba M, Mabuchi H, Rabès JP, Carrié A, van Heyningen C, Carreau V, Farnier M, Teoh YP, Bourbon M, Kawashiri MA, Nohara A, Soran H, Marais AD, Tada H, Abifadel M, Boileau C, Chanu B, Katsuda S, Kishimoto I, Lambert G, Makino H, Miyamoto Y, Pichelin M, Yagi K, Yamagishi M, Zair Y, Mellis S, Yancopoulos GD, Stahl N, Mendoza J, Du Y, Hamon S, Krempf M, Swergold GD. Characterization of Autosomal Dominant Hypercholesterolemia Caused by PCSK9 Gain of Function Mutations and Its Specific Treatment With Alirocumab, a PCSK9 Monoclonal Antibody. Circ Cardiovasc Genet. 2015 Dec;8(6):823-31. doi: 10.1161/CIRCGENETICS.115.001129. Epub 2015 Sep 15.

summary: The primary objective of the study is to assess the pharmacodynamic (PD) effect of alirocumab on serum low density lipoprotein cholesterol (LDL-C) during 14 weeks of subcutaneous (SC) administered alirocumab in patients with autosomal dominant hypercholesterolemia (ADH) and gain-of-function mutation (GOFm) in 1 or both alleles of the proprotein convertase subtilisin/kexin type 9 (PCSK9) gene or with loss-of-function mutation (LOFm) in 1 or more alleles of the apolipoprotein (ApoB) gene.


title: An Open Label, Multicenter Phase 2 Study of Single-Agent Enzastaurin HCl in Previously Treated Waldenstrom's Macroglobulinemia or Multiple Myeloma

summary: To determine whether further study of single-agent enzastaurin is warranted in patients with previously treated Waldenstrom's Macroglobulinemia or Multiple Myeloma based on response.

lead_sponsor: Eli Lilly and Company

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


title: Open Label Multi-Centric Phase II Study of the Raf Kinase Inhibitor BAY 43-9006 in Chronic Myelogenous Leukemia (CML) Patients Resistant to Gleevec (Imatinib)

acronym: ORACLE

summary: The purpose of this study is to evaluate the anti-cancer activity and safety of Bay 43-006, in patients who have Chronic Myelogenous Leukemia that resisted to Gleevec treatment, one of the standard medication administered for these patients.

lead_sponsor: Bayer


title: Unruptured Cerebral Aneurysm: Prediction of Evolution

acronym: U-CAN

summary: The protocol has many assets. A prospective nationwide recruitment allows for the inclusion of a large cohort of patients with UIA. It will combine accurate clinical phenotyping and comprehensive imaging with CAWE screening. Besides, it will enable to exploit metadata and to explore new pathophysiological pathways of interest by crossing clinical, genetic, biological, and imaging information.

lead_sponsor: Nantes University Hospital

location_country: Netherlands France Switzerland

location_facility:
Rostchild Foundation Hospital
Creteil University Hospital
Amiens University Hospital
AP-HP La Pitié-Salpêtrière Hospital
InselHospital Bern
Reims University Hospital
UMC Utrecht
Tours University Hospital
Clairval's Hospital
Toulouse University Hospital
Brest University Hospital
AP-HP Le Kremlin Bicêtre Hospital
Limoges University Hospital
Rennes University Hospital
Bordeaux University Hospital
Ste Anne's Hospital
Angers University Hospital
Nancy University Hospital
Rouen University Hospital
Nantes University Hospital


title: ZEPHYR: Multicenter, Prospective, Randomized, Open-label Study in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube. This Study Compared Two Ventilation Modes: NAVA Mode and Spontaneous Breathing With Inspiratory Pressure Support (the Latter is Considered as the Reference Ventilation Mode).

summary: This is a multicenter, prospective, randomized, open-label study which compared two ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter is considered as the reference ventilatory mode) in patients admitted to the ICU for acute respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous ventilation.

primary_purpose: Supportive Care

ReferenceCitation: Demoule A, Clavel M, Rolland-Debord C, Perbet S, Terzi N, Kouatchet A, Wallet F, Roze H, Vargas F, Guerin C, Dellamonica J, Jaber S, Brochard L, Similowski T. Neurally adjusted ventilatory assist as an alternative to pressure support ventilation in adults: a French multicentre randomized trial. Intensive Care Med. 2016 Nov;42(11):1723-1732. Epub 2016 Sep 30.

lead_sponsor: Clinact

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Leveque - Maison du Haut-Leveque

location_facility: Hopital de la Cote de Nacre - CHU de CAEN