title: Assessment of Renal and Cervical Artery DysplasIA

acronym: ARCADIA

summary:
ARCADIA is a national registry designed to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia (FMD).

FMD is a group of arterial diseases that most commonly involve renal and carotid arteries. Patients with FMD may present with renovascular hypertension and/or with cerebrovascular symptoms. Angiographic classification includes the multifocal type and the focal type. FMD may affect one or more vascular beds and progress to more severe stenosis and to renal or cerebrovascular complications. FMD may be familial (OMIM #135580).

Our main objective is to create a FMD registry that will collect standardized information from all consenting patients diagnosed with the condition in 16 participating centers. This registry, along with a collection of leukocyte DNA, will constitute a resource for further clinical research on FMD. The first application will be the assessment of the frequency of multi-site FMD, i.e. the frequency of cervical artery FMD in patients presenting with renal artery FMD and vice-versa. The second application will be a case-control study to identify susceptibility genes for FMD.

Patients are eligible in the registry if: (a) they have renal or cervical artery FMD with either multifocal or focal lesions at CT-angiography, MR-angiography, or intra-arterial angiography; (b) they give informed consent to leukocyte DNA analysis and to the collection of bioclinical and morphologic information. Phenotypic assessment will be performed in accordance with current recommendations and best clinical practice.

Given the multicenter nature of the study and the recruitment capacity of each centre, enrollment of 500 FMD cases is expected over 5 years. This number will 1) allow an accurate estimation of the frequency of multi-site FMD: when the sample size is 500, a two-sided 95% confidence interval will extend 0.035 from the observed proportion for an expected proportion of 0.20 based on a previous report and from our unpublished data. 2) In addition to a collection of 400 renal FMD already collected at HEGP, give sufficient power for a genome-wide association study seeking for susceptibility genes

ReferenceCitation: Arnaud C, Boulanger M, Lorthioir A, Amar L, Azarine A, Boyer L, Chatellier G, Di Monaco S, Jeunemaitre X, Kastler A, Mousseaux E, Oppenheim C, Thony F, Persu A, Olin JW, Azizi M, Touzé E; ARCADIA Co-investigators †. Male Sex Is Associated With Cervical Artery Dissection in Patients With Fibromuscular Dysplasia. J Am Heart Assoc. 2021 Jun;10(11):e018311. doi: 10.1161/JAHA.120.018311. Epub 2021 May 17.

ReferenceCitation: Plouin PF, Baguet JP, Thony F, Ormezzano O, Azarine A, Silhol F, Oppenheim C, Bouhanick B, Boyer L, Persu A, Hammer F, Gosse P, Mounier-Vehier C, Le Hello C, Jeunemaitre X, Azizi M, Amar L, Chatellier G, Mousseaux E, Touzé E; ARCADIA Investigators. High Prevalence of Multiple Arterial Bed Lesions in Patients With Fibromuscular Dysplasia: The ARCADIA Registry (Assessment of Renal and Cervical Artery Dysplasia). Hypertension. 2017 Sep;70(3):652-658. doi: 10.1161/HYPERTENSIONAHA.117.09539. Epub 2017 Jul 17.

ipd_sharing_description: Controlled access


title: Efficacy and Tolerance of EGb 761® 120mg Two Times a Day on Dementia of Alzheimer Type's Onset in Patients Suffering From Memory Complaints. A Randomised, Double-blind, Multicentre, Parallel Groups, Placebo Controlled Phase IIIb/IV Study in Elderly Over 70

summary: The purpose of this study is to determine whether Tanakan® is effective at slowing the progression from memory complaint to dementia of Alzheimer's type.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Vellas B, Coley N, Ousset PJ, Berrut G, Dartigues JF, Dubois B, Grandjean H, Pasquier F, Piette F, Robert P, Touchon J, Garnier P, Mathiex-Fortunet H, Andrieu S; GuidAge Study Group. Long-term use of standardised Ginkgo biloba extract for the prevention of Alzheimer's disease (GuidAge): a randomised placebo-controlled trial. Lancet Neurol. 2012 Oct;11(10):851-9. doi: 10.1016/S1474-4422(12)70206-5. Epub 2012 Sep 6. Review.

lead_sponsor: Ipsen

location_facility: 22 avenue du Général Leclerc Les Bougainvillées

location_facility: Hôpital Charles Nicolle Department de Neurologie 1, rue de Germont

location_facility: Centre Hospitalier Jacques Coeur Hopital Taillegrain Centre de Gerontologie des Pres Fichaux 6 rue Taillegrain

location_facility: Hôtel les Cordeliers place des Cordeliers

location_facility: 136 av. Ambroise Croizat Saint Martin d'Heres

location_facility: Centre Commercial La Verriere place Beauval

location_facility: 5 rue Daniel Casanova Le Parc des Amandiers

location_facility: Immeuble Athéna 62 bis rue Aristide Briand

location_facility: Centre Commercial Tertifume 9 rue de Montreuil

location_facility: Cabinet de Neurologie 4 av Charles Tillon

location_facility: Centre Hospitalier des Pyrenees Department de Psychogeriatrie 29 av du Marechal Leclerc

location_facility: Centre Hospitalier Pellegrin-Tripode Service de Neurologie Place Amelie Raba-Leon

location_facility: Hopital Gui de Chauliac 80 rue Augustin Fliche

location_facility: 34 avenue de l'Europe Immeuble le Trident A1er etage

location_facility: Centre Hospitalier de Purpan Service de Neurologie place du Docteur Baylac

location_facility: Centre de Prevention des Alpes 3 place de Metz

location_facility: Résidence Mozart- Apt 56, 2 rue Jean Artus

location_facility: Residence le Paradis Bat 17, 74-78 rue Volney

location_facility: Hopital Bellier Service de Geronotologie 41 rue Curie

location_facility: Hopital de Cimiez Pavillon Mossa 4 avenue de la Reine Victoria

location_facility: Hopital St Joseph Service de Neurologie 26 boulevard Louvain

location_facility: Hopital STe Marguerite Unite de Neurologie 270 boulevard de STe Marguerite

location_facility: Centre Hospitalier Jacques Coeur Hôpital Taillegrain

location_facility: Hôpital Felix Marechal 1 rue Xavier Roussel

location_facility: Hotel les Cordeliers place des Cordeliers

location_facility: Hopital Roger Salengro Service de Neurologie C rue Emile Laine

location_facility: 1 rue Franz Schubert Saint Martin d'Hères

location_facility: Espace Vénitien 1 av Pres Salvador Allende

location_facility: Maison de retraite publique Centre de Memoire Route de Nimes

location_facility: 117, avenue du Maréchal de Lattre de Tassigny

location_facility: Hopital Cote de Nacre Service de Neurologie avenue de la cote de Nacre

location_facility: Residence Le Gaughin Bat 1 68 rue Borely

location_facility: Impasse Mérite, Résidence Lamiot rue L'ecalier

location_facility: Groupe Medical de Mazargues 1 av de la Martheline

location_facility: Centre Raymond Ruffi 12 rue Alexandre Ducros

location_facility: Hôpital Broca - Service de Gérontologie Clinique 54-56 rue Pascal

location_facility: Centre Hospitalier Universitaire Hotel Dieu Gerontologie Clinique 4 rue Larrey

location_facility: Résidence Emeraude 71 av Adolphe Geeraert

location_facility: 9, Résidence Haut Rivage, Rue Jean Xxiii

location_facility: Hopital Charles Foix Service de Gerontologie 37 avenue de la Republique

location_facility: 7 rue Raymond Boulogne Batiment C- apt 23

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas

acronym: CHIRACIC

summary: The general objective is to evaluate the consequences of surgical removal of SCSI on hypertension and cardiovascular risk factors in order to determine on an evidence-based basis if surgical excision of SCSI is preferable to an intensive medical regimen in patients with hypertension.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: University Hospital, Bordeaux

location_country: Germany France Italy

location_facility: Service Endocrinologie, Diabétologie, maladies métaboliques - CHU de Bordeaux

location_facility: Endokrinologie, Diabetes und Ernährungsmedizin, Campus Mitte, Medizinische Klinik - Charité - Universitätsmedizin Berlin

location_facility: Service d'Endocrinologie et Maladies Métabolique - CHU de Toulouse

location_facility: Service d'Endocrinologie et des Maladies de la Reproduction- Assistance Publique - Hôpitaux de Paris - Hôpial Bicêtre

location_facility: Assistance Publique - Hôpitaux de Paris - Hôpital COCHIN

location_facility: Service d'Endocrinologie, Diabète et Maladies Métaboliques - Assistance publique - Hôpitaux de Marseille

location_facility: Department of Internal Medicine I, Endocrine and Diabetes Uni -University Hospital Würzburg

location_facility: Service d'Endocrinologie, Diabétologie et Métabolisme - CHRU de LILLE

location_facility: Endocrinologie, Diabète et Maladies Métaboliques - CHU de Rouen

location_facility: Service d'Endocrinologie, Diabétologie, Nutrition - CHU d'Amiens

location_facility: CIC Endocrinologie-Nutrition - CHU de Nantes

location_facility: Département Endocrinologie-Diabétologie -Nutrition - CHU d'ANGERS

location_facility: Service de Médecine Interne, Endocrinologie et Nutrition - CHU de Strasbourg

location_facility: Service d'Hypertension et de Médecine Vasculaire - Assistance Publique - Hôpitaux de Paris - Hôpital européen Georges Pompidou

location_facility: Service d'Endocrinologie - Niveau 18 - Caen CHU Côte de Nacre

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Medico-economic Evaluation of the Care by Serious Games in Outpatient Units and at Home for Children With Autism Spectrum Disorders

acronym: e-GOLIAH-ECO

summary:
Randomized open-label study comparing children aged 3 to 6 years with autism and normal cognitive development or mild cognitive impairment receiving the usual treatment plus intensive use of eGOLIAH (experimental group) with children receiving only the usual treatment (control group).

eGOLIAH (Gaming Open Library for Intervention in Autism at Home) is an accessible online platform for digital games inspired by the principles of the Early Start Denver Model (ESDM), one of the care programs validated in the management of young ASD.

The duration per patient will be one year. The exposure to e-GOLIAH for the experimental group will be done with the recommendation of intensive exposure to the game (5 sessions> ½ hour per week).

Clinical variables will be assessed at entry, 6 months and 1 year (end of study).

The EQ5D questionnaires will be collected by the supervising therapist during the follow-up visit and at the same time as the clinical variables.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Other

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Dawson G, Rogers S, Munson J, Smith M, Winter J, Greenson J, Donaldson A, Varley J. Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model. Pediatrics. 2010 Jan;125(1):e17-23. doi: 10.1542/peds.2009-0958. Epub 2009 Nov 30.

ReferenceCitation: Jouen AL, Narzisi A, Xavier J, Tilmont E, Bodeau N, Bono V, Ketem-Premel N, Anzalone S, Maharatna K, Chetouani M, Muratori F, Cohen D; MICHELANGELO Study Group. GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study. Child Adolesc Psychiatry Ment Health. 2017 Mar 22;11:17. doi: 10.1186/s13034-017-0154-7. eCollection 2017.

ReferenceCitation: Bieleninik L, Geretsegger M, Mössler K, Assmus J, Thompson G, Gattino G, Elefant C, Gottfried T, Igliozzi R, Muratori F, Suvini F, Kim J, Crawford MJ, Odell-Miller H, Oldfield A, Casey Ó, Finnemann J, Carpente J, Park AL, Grossi E, Gold C; TIME-A Study Team. Effects of Improvisational Music Therapy vs Enhanced Standard Care on Symptom Severity Among Children With Autism Spectrum Disorder: The TIME-A Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):525-535. doi: 10.1001/jama.2017.9478. Erratum in: JAMA. 2021 Apr 13;325(14):1473.

ReferenceCitation: Billeci L, Narzisi A, Tonacci A, Sbriscia-Fioretti B, Serasini L, Fulceri F, Apicella F, Sicca F, Calderoni S, Muratori F. An integrated EEG and eye-tracking approach for the study of responding and initiating joint attention in Autism Spectrum Disorders. Sci Rep. 2017 Oct 19;7(1):13560. doi: 10.1038/s41598-017-13053-4.

ReferenceCitation: Bono V, Narzisi A, Jouen AL, Tilmont E, Hommel S, Jamal W, Xavier J, Billeci L, Maharatna K, Wald M, Chetouani M, Cohen D, Muratori F; MICHELANGELO Study Group. GOLIAH: A Gaming Platform for Home-Based Intervention in Autism - Principles and Design. Front Psychiatry. 2016 Apr 28;7:70. doi: 10.3389/fpsyt.2016.00070. eCollection 2016.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier de Versailles - André Mignot

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Fondation Lenval - Hôpitaux Pédiatriques de Nice- CHU Lenval

location_facility: Centre Hospitalier Sainte-Anne / GHU Paris Psychiatrie et Neurosciences

location_facility: Assistance Publique - Hôpitaux de Paris, Site de la Pitié-Salpêtrière

location_facility: Assistance Publique - Hôpitaux de Paris, Site de Necker

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Paris - Centre Hospitalier d'Henri Laborit

intervention_type: Behavioral


title: A Phase III Randomised, Double Blind, Placebo Controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of Continuing IRESSA 250 mg in Addition to Chemotherapy Versus Chemotherapy Alone in Patients Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and Have Progressed on First Line IRESSA

acronym: IMPRESS

summary: The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.

ReferenceCitation: Soria JC, Wu YL, Nakagawa K, Kim SW, Yang JJ, Ahn MJ, Wang J, Yang JC, Lu Y, Atagi S, Ponce S, Lee DH, Liu Y, Yoh K, Zhou JY, Shi X, Webster A, Jiang H, Mok TS. Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. Lancet Oncol. 2015 Aug;16(8):990-8. doi: 10.1016/S1470-2045(15)00121-7. Epub 2015 Jul 6.

lead_sponsor: AstraZeneca

location_country:
Taiwan
Hong Kong
Spain
Italy
Russian Federation
Hungary
Korea, Republic of
France
China
Japan
Germany

intervention_type: Drug


title: OpT2mise Glucose Control in Type 2 DM With Insulin Pump Therapy

summary: The purpose of this study is to evaluate the comparative effectiveness of insulin pump therapy versus multiple daily injections in insulin-taking type 2 Diabetes Mellitus who are sub optimally controlled with multiple daily injections (MDI).

ReferenceCitation: Chlup R, Runzis S, Castaneda J, Lee SW, Nguyen X, Cohen O. Complex Assessment of Metabolic Effectiveness of Insulin Pump Therapy in Patients with Type 2 Diabetes Beyond HbA1c Reduction. Diabetes Technol Ther. 2018 Feb;20(2):153-159. doi: 10.1089/dia.2017.0283. Epub 2017 Dec 7.

ReferenceCitation: Metzger M, Castañeda J, Reznik Y, Giorgino F, Conget I, Aronson R, de Portu S, Runzis S, Lee SW, Cohen O. Factors associated with improved glycemic control following continuous subcutaneous insulin infusion therapy in patients with type 2 diabetes uncontrolled with bolus-basal insulin regimens: An analysis from the OpT2mise randomized trial. Diabetes Obes Metab. 2017 Oct;19(10):1490-1494. doi: 10.1111/dom.12960. Epub 2017 Jul 25.

ReferenceCitation: Reznik Y, Cohen O, Aronson R, Conget I, Runzis S, Castaneda J, Lee SW; OpT2mise Study Group. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014 Oct 4;384(9950):1265-72. doi: 10.1016/S0140-6736(14)61037-0. Epub 2014 Jul 2.

ipd_sharing: No

lead_sponsor: Medtronic Diabetes

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: McGill University, McGill Nutrition and Food Science Centre

location_facility: Canadian Centre for Research on Diabetes

location_facility: IJsselland Ziekenhuis Poli Interne geneeskunde

location_facility: Zentrum für Diabetes und Gefäßerkrankungen

location_facility: Chaim Sheba Medical center Endocrinology unit

location_facility: Endocrinologist, 202-301 Columbia Street East

location_facility: Clinic for Endocrinology, Diabetes and Metabolic Diseases

location_facility: Clinical Professor Department of Medicine University of Calgary

location_facility: Péterfy Hospital and Emergency Center Diabetes Outpatient Clinic

location_facility: Università degli Studi di Bari - Policlinico Universitario

location_facility: Universita di Perugia - Ospedale S.M. Della Misericordia

intervention_type: Device


title: A National, Multicenter, Randomized Open-Label Study of Proctological Surgery Efficacy on Anoperineal Fistulas Healing in Crohn's Disease Patients Treated With Adalimumab. (Official French Title: "Étude Nationale, Multicentrique, randomisée et en Ouvert de l'efficacité de la Chirurgie Proctologique Sur la Cicatrisation Des Fistules anopérinéales de la Maladie de Crohn Chez Des Patients traités Par Adalimumab")

acronym: FACC

summary: The purpose of this study is to demonstrate, in patients treated with adalimumab, the efficacy of proctological surgery in anoperineal fistula healing after the removal of seton drain.

status: Unknown status

ReferenceCitation: Abramowitz L, Brochard C, Pigot F, Roumeguere P, Pillant H, Vinson Bonnet B, Faucheron JL, Senéjoux A, Bonnaud G, Meurette G, Fayette JM, Train C, Staumont G, Siproudhis L, Bouchard D. Surgical closure, mainly with glue injection and anti-tumour necrosis factor α, in fistulizing perianal Crohn's disease: A multicentre randomized controlled trial. Colorectal Dis. 2022 Feb;24(2):210-219. doi: 10.1111/codi.15947. Epub 2021 Oct 23.

lead_sponsor: French Society of Coloproctology

location_facility: CHU Pontchaillou - Department of Digestive Diseases

location_facility: Hôpital Nord de Marseille - Gastroenterology Department

location_facility: Polyclinique de Franche-Comté - Department of Proctological Surgery

location_facility: Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology

location_facility: Clinique Saint Jean Languedoc - Department of Gastroenterology

location_facility: Institut Mutualiste Montsouris - Proctology Unit

location_facility: CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology

location_facility: Clinique des Cèdres - Hepato-Gastroenterology Department

location_facility: Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit

location_facility: Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology

location_facility: CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition

location_facility: Hôpital Louis Mourier - Department of Hepato-Gastroentérologie

location_facility: Hôpital Bichat-Claude Bernard - Gastro-enterology Department

status_simplified: Unknown


title: European Phase-IIb Clinical Trial Evaluating Efficacy of Low Dose rhIL-2 in Patients With Recently-diagnosed Type 1 Diabetes DIABIL-2

summary:
Type 1diabetes (T1D) is caused by autoimmune destruction of the pancreatic islet ß-cells, leading to an absolute deficiency in insulin.

In health, regulatory T cells (Tregs) suppress immune responses against normal tissues, and likewise prevent autoimmune diseases. Tregs are insufficient in T1D.

The investigators previously showed that administration of low doses of IL-2 induces selective expansion and activation of Tregs in mice and humans.

The investigators hypothesize that Tregs expansion and activation with low doses of IL2 could block the ongoing autoimmune destruction of insulin producing cells in patients with recently diagnosed T1D.

location_country: Netherlands Switzerland Sweden France Belgium Germany

location_facility: UZ - Diabetes voor Kinderen en Adolescenten-Leuven

location_facility: Service d' Endocrinologie Diabétologie CHRU DE RENNES

location_facility: Center for Pediatric and Adolescent Diabetes Care and Research

location_facility: Service d' Endocrinologie, maladies métaboliques HOPITAL NORD

location_facility: CIC Paris-Est (Adultes), Hôpitaux Universitaires Pitié-Salpêtrière, Charles Foix

location_facility: Structure d'Endocrinologie-Diabète-Nutrition et Addictologie HOPITAUX UNIVERSITAIRES NHC

location_facility: Service d'Endocrinologie pédiatrique - HFME

location_facility: Service d' Endocrinologie HOPITAL CAVALE BLANCHE

location_facility: Service d'Endocrinologie Pédiatrique, Hôpital d'enfants Robert Debré

location_facility: Institute of Diabetes Research, Helmholtz Zentrum München

location_facility: Dept. of Clinical Sciences Lund University, Skåne University Hospital.

location_facility: CIC Pédiatrique, Hôpital d'enfants Robert Debré

location_facility: Pediatric Department, Centre Hospitalier Régional de la Citadelle

location_facility: Service de pédiatrie 1CHU de HAUTEPIERRE

location_facility: Service Diabétologie -Endocrinologie, CHU Jean Minjoz

location_facility: Endocrinologie gynécologie diabétologie pédiatriques, Hôpital Universitaire Necker Enfants Malades.

location_facility: Service de Nutrition - Maladies Métaboliques - Endocrinologie HOPITAL DE LA CONCEPTION

location_facility: Hopital G&R Laënnec , Endocrinologie, Maladies Métaboliques et Nutrition

location_facility: Service d'endocrinologie, diabétologie, maladies métaboliques, et nutrition, CHU de Bordeaux, Hôpital Haut Levêque

location_facility: Division of Endocrinology, Diabetology and Metabolic Diseases, University Hospital of Freiburg, Department for children and adolescents

location_facility: Service Pédiatrie - Gastro-entérologie, Hépatologie, Nutrition, Diabétologie, Hôpital des Enfants Pôle Enfants

location_facility: Centre d'Investigations Cliniques, CHU-HOPITAL HAUTEPIERRE

location_facility: Endocrinologie-Diabétologie-Maladies de la nutrition, Centre Hospitalier Lyon-Sud

location_facility: Centre d'Investigations Cliniques, HÔPITAL CIVIL

location_facility: Unité d'Endocrinologie et Diabétologie Pédiatriques, CHU de Marseille, Hôpital La Timone Enfants

location_facility: CIC pédiatrique Hôpital Necker Enfants Malades

location_facility: Division of Endocrinology and Diabetology, Department of Internal Medicine II, University Hospital of Freiburg

location_facility: CHRU de Lille, Hôpital Claude Huriez Service d'endocrinologie

location_facility: Endocrinology and Diabetes department, University Hospital of Basel


time_perspective: Prospective

title: A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection

lead_sponsor: Gilead Sciences

type: EudraCT Number

source: euctr

study_type: Observational

ReferenceCitation: Younossi ZM, Stepanova M, Racila A, Afendy A, Lawitz EJ, Schwabe C, Ruane PJ, Lalezari J, Reddy KR, Jacobson IM, Muir AJ, Gaggar A, Myers RP, Younossi I, Nader F. Long-term Benefits of Sustained Virologic Response for Patient-Reported Outcomes in Patients With Chronic Hepatitis C Virus Infection. Clin Gastroenterol Hepatol. 2020 Feb;18(2):468-476.e11. doi: 10.1016/j.cgh.2019.07.047. Epub 2019 Jul 31.

location_country:
Poland
Spain
Italy
Austria
Australia
Estonia
Canada
Netherlands
New Zealand
United Kingdom
Sweden
Puerto Rico
United States
France
Belgium
Germany
Czechia

location_facility: University of North Carolina at Chapel Hill

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliera-universitaria Policlinico P. Giaccone

location_facility: Advanced Clinical Research Institute, LLC

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Weill Cornell Medical College of Cornell Univeristy

location_facility: University of Pennsylvania School of Medicine

location_facility: PraxisZentrum für Gastroenterologie und Endokrinologie

location_facility: Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie

location_facility: Community Research Initiative of New England

location_facility: Hospital General Universitario de Valencia

location_facility: Université Libre de Bruxelles Hôpital Erasme

location_facility: Hospital Clínico Universitario Virgen de la Victoria

location_facility: University of Birmingham and Queen Elizabeth Hospital Birmingham

location_facility: University of Florida Hepatology Research at CTRB

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: St. Luke's Health Baylor College of Medicine Medical Center

location_facility: Centre Hospitalier Universitaire Bordeaux Hôpital Haut-Lévêque

location_facility: Instituto Nationale Per Le Malattie Infettive "Lazzaro Spallanzani"

location_facility: Slezska nemocnice v Opave, Infekcni oddeleni

location_facility: Lehigh Valley Health Network, Network Office of Research and Innovation

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Centre Hospitalier de L'Universite de Montreal (CHUM)

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: University of Texas Health Science Center at Houston

location_facility: The Gastroenterology Group of South Jersey

location_facility: Universitair Medisch Centrum Sint Radboud

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: Ospedale San Raffaele-IRCCS, Centro San Luigi - San Raffaele Turro, Unità Operativa di Malattie Infettive

location_facility: Schleinitz Research and Gastroenterology LLC

location_facility: Ente Ospedaliero Ospedali Galliera di Genova

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Spzoz Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego W Lodzi

location_facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Inova Fairfax Hospital Center for Liver Diseases

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Southwest Infectious Disease Clinical Research, Inc

location_facility: Gastroenterologische Gemeinschaftspraxis Kiel Preetzer

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hôpital-Saint Joseph, Service D'Hépato-Gastroentérologie

location_facility: Guy's and Saint Thomas NHS Foundation Trust

location_facility: Columbia Presbyterian Hospital, Columbia University

location_facility: Azienda Ospedaliera Padova, U.O.C. Cardiologia

location_facility: Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankhen

location_facility: Veterans Administration Wadsworth Medical Center

location_facility: Ziekenhuis Netwerk Antwerpen Campus Stuivenberg

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Virginia Commonwealth University Medical Center

location_facility: Azienda Ospedaliera S. Orsola - Malpighi

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Sahlgrenska Universitetssjukhuset, Östra Sjukhus

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Veterans Affairs Pittsburgh Healthcare System

location_facility: The North Texas Clinical Research Institute

location_facility: University of California Davis Medical Center

location_facility: Digestive Health Specialists of the Southeast, PA

location_facility: Azienda Ospedaliera - Polo Universitario Luigi Saco

location_facility: South Florida Center of Gastroenterology, P.A.

location_facility: Wojewódzki Szpital Specjalistyczny im. Kazimierza Dluskiego w Bialymstoku

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

location_facility: Binghamton Gastroenterology Associates, PC

location_facility: Southampton University Hospitals NHS Trust, Southampton General Hospital

location_facility: Infectious Disease Specialists of Atlanta, PC

summary: This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.


ipd_sharing: Undecided

acronym: PROOF 302

title: Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations (PROOF 302)

lead_sponsor: QED Therapeutics, Inc.

ReferenceCitation: Pal SK, Somford DM, Grivas P, Sridhar SS, Gupta S, Bellmunt J, Sonpavde G, Fleming MT, Lerner SP, Loriot Y, Hoffman-Censits J, Valderrama BP, Andresen C, Schnabel MJ, Cole S, Daneshmand S. Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial. Future Oncol. 2022 Jul;18(21):2599-2614. doi: 10.2217/fon-2021-1629. Epub 2022 May 24. Review.

location_country:
Spain
Greece
Italy
Netherlands
United Kingdom
Canada
United States
France
Belgium
Germany
Bulgaria

location_facility: Universitatsklinikum des Saarlandes Klinik fur Urologie & Kinderurologie

location_facility: Institut de Cancerologie Strasbourg Europe

location_facility: Institut De Cancerologie De L'ouest - Site Saint-Herblain

location_facility: Saint Louis University- SLUCare Academic Pavilion

location_facility: Loma Linda University Faculty Medical Clinics

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD

location_facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari

location_facility: Albany Medical Center - Division of Urology

location_facility: UChicago Medicine Duchossois Center for Advanced Medicine (DCAM) - Hyde Park

location_facility: Lakeland Regional Health Hollis Cancer Center

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: The Ohio State University College of Medicine

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Winship Cancer Institute of Emory University

location_facility: Harold C. Simmons Comprehensive Cancer Center

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Policlinico Universitario Campus Biomedico

location_facility: A.O.U.C. Polclinico di Bari U.O. Oncologia Medica Universitaria

location_facility: Hospital Universitario Puerta Hierro-Majadahonda

location_facility: Caritas-Krankenhaus St. Josef Klinik für Urologie

location_facility: Althaia Xarxa Assistencial Universitària de Manresa

location_facility: Associated Medical Professionals - Syracuse

location_facility: Centre de Lutte Contre le Cancer - Centre Léon Bérard

location_facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga

location_facility: Universitätsklinikum des Saarlandes Klinik für Urologie & Kinderurologie

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Ospedale di Trento - Presidio Ospedaliero Santa Chiara

location_facility: Marien Hospital Herne - Universitätsklinikum der Ruhr-Universität Bochum

location_facility: Multiprofile Hospital For Active Treatment "Sveta Sofia"

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: Houston Methodist Hospital- Department of Urology

location_facility: Citta Della Salute e Della Scienz - Torino

location_facility: Tulane University/Southeastern Louisiana VA Health Care

location_facility: University Multiprofile Hospital For Active Treatment Deva Maria

location_facility: Indiana University Melvin and Bren Simon Cancer Center

summary: This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer.


title: A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase 3 Study Evaluating Long-term Efficacy and Safety of Lanifibranor in Adult Patients With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) and Fibrosis 2 (F2)/Fibrosis 3 (F3) Stage of Liver Fibrosis

summary: This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3

status: Recruiting

lead_sponsor: Inventiva Pharma

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
South Africa
Czechia
Poland
Portugal
Australia
Puerto Rico
Israel
Mexico
Brazil
Canada
Hungary
Germany
Bulgaria
France
Chile
Netherlands

location_facility: South Texas Research Institute - Edinburg

location_facility: Digestive Health Research of Central Texas

location_facility: Charlotte Gastroenterology and Hepatology - Randolph Road Office

location_facility: SSM Health Saint Louis University Hospital

location_facility: Sefako Makgatho Health Sciences University

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych

location_facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: University Multiprofile Hospital for Active Treatment St. Ivan Rilski

location_facility: ARcare Center for Clinical Research - Conway

location_facility: Diagnostic Consultative Center Aleksandrovska

location_facility: Centor for Advanced Gastroenterology - Main Office - Maitland

location_facility: Metropolitan Gastroenterology Associates - Metairie

location_facility: Gastrointestinal Associates & Endoscopy Center - Flowood

location_facility: Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen

location_facility: Gastroenterology Associates of Northern Virginia

location_facility: Amsterdam Universitair Medische Centra - Vrije Universiteit Medisch Centrum

location_facility: Gastro One - Germantown Office - Wolf Park Drive

location_facility: Hospital Clínico Universitario de Valencia

location_facility: California Pacific Medical Center Research Institute

location_facility: Digestive Health Associates of Texas - Rockwall

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Hôpitaux Universitaires Paris Nord Val-de-Seine - Hôpital Beaujon

location_facility: Digestive Disease Associates - Catonsville

location_facility: Synexus - Helderberg Clinical Research Centre - Somerset West

location_facility: Consorci Hospital General Universitari de València

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: PanAmerican Clinical Research - US Headquarters

location_facility: Hospital Clínico Universitario de Santiago

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: Kansas Medical Clinic - Gastroenterology

location_facility: The Institute For Liver Health - Chandler

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Synexus Clinical Research SA- Watermeyer

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku

location_facility: Debreceni Egyetem Klinikai Központ Kenézy Gyula Campus

location_facility: Del Sol Research Management - Tucson East

location_facility: William Osler Health System - Brampton Civic Hospital

location_facility: Beth Israel Deaconess Medical Center - Liver Center

location_facility: MNGI Digestive Health - Northeast Minneapolis Clinic

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Regional Infectious Diseases and Infusion Center

location_facility: Texas Liver Institute/American Research Corporation

location_facility: Gastroenterology Associates - Baton Rouge

location_facility: Consultants for Clinical Research - Montgomery Office

location_facility: Royal Surrey County Hospital NHS Foundation Trust

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: SYNEXUS Magyarország Egészségügyi Szolgáltató KFT

location_facility: Pinnacle Clinical Research - San Antonio

location_facility: Synexus - Mediclinic Southern Africa - Constantiaberg

location_facility: Centro Hospitalar Universitário De São João

location_facility: National Research Institute - Huntington Park

location_facility: Hospital Universitario Doctor José Eleuterio Gonzalez

location_facility: Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Centro De Investigaciones Clínicas Viña Del Mar

location_facility: Unidade Local Saúde Alto Minho - Hospital de Santa Luzia

location_facility: Fundación de Investigación de Diego Clinical Research

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Digestive Health Specialist of the Southeast

location_facility: University of Kansas Medical Center Research Institute

location_facility: National Research Institute - Panorama City

location_facility: Objective Health - Birmingham Gastroenterology Associates

location_facility: Washington University School of Medicine in St. Louis

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Covenant Metabolic Specialists LLC - Sarasota

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Investigative Clinical Research - Annapolis

location_facility: Ziekenhuis Oost-Limburg - Campus Sint-Jan

location_facility: South Texas Research Institute - Brownsville

location_facility: Research and Education Foundation of Atlanta Medical Center

location_facility: Centre Hospitalier Universitaire de Liège Site Sart Tilman

location_facility: Bon Secours Liver Institute of Hampton Roads

location_facility: USPA Advance Concept Medical Research Group

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Digestive Health Research of North Texas

location_facility: State University of New York - University at Buffalo

location_facility: Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

location_facility: Medical Center Center of Family Medicine Plus, LLC

location_facility: Hôpitaux Universitaires Paris-Sud - Hôpital Paul Brousse

location_facility: Gastroenterology Consultants - Ellington

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Centro de Investigación y Gastroenterología

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Consorci Corporació Sanitària Parc Taulí de Sabadell

location_facility: Diagnostic Consulting Center 20 - Sofia Еооd


title: A Non-interventional Study to Assess the Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Patients Not in Dialysis Treated With Mircera®

summary: This prospective, multicenter, observational study will evaluate the impact of comorbidity factors on the hemoglobin level in participants with chronic kidney disease who are not on dialysis and initiated on treatment with methoxy polyethylene glycol-epoetin beta (Mircera). Data will be collected for 9 months after initiation of methoxy polyethylene glycol-epoetin beta treatment.

lead_sponsor: Hoffmann-La Roche

location_facility: Association Pour L'Aide Des Uremiques de Bretagne

location_facility: Fondation Transplantation; Ctirc De Drevon

location_facility: Hopital Saint Louis; Service de Nephrologie - Transplantation

location_facility: Polyclinique De La Louviere; Nephrologie

location_facility: Centre Hospitalier General; Service de Nephrologie-Hemodialyse

location_facility: Centre De Sante Medical; Centre De Sante Republique

location_facility: Ch Germon Et Gauthier; Medecine Interne Nephrologie

location_facility: Centre Hospitalier De Sens; Nephrologie-Dialyse

location_facility: Hopital Civil; Nephrologie Clinique Medicale B

location_facility: Clinique de Tournan; Service de Nephrologie

location_facility: Ch Pitie Salpetriere; Nephrologie Hemodialyse

location_facility: Ch Lyon Sud; Nephrologie Sect Jules Courmont

location_facility: Hopital Europeen Georges Pompidou; Service de Nephrologie

location_facility: Chic Cote Basque Bayonne; Nephrologie Hemodialyse

location_facility: Hopital Bretonneau; Nephrologie Transplantations

location_facility: Hopital Pellegrin; Departement Nephrologie

location_facility: Centre D'Hemodialyse Arnaud Tzanck; Service Nephrologie - Hemodialyse

location_facility: Hopital Albert Michallon; Clinique De Nephrologie

location_facility: Hopital Rangueil; Nephrologie Hemodialyse

location_facility: Centre Hemodialyse St Augustin; Nephrologie

location_facility: Ch de Brive la Gaillarde; Nephrologie Hemodialyse

location_facility: Chu La Miletrie;Nephrologie Transplantation

location_facility: Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique

location_facility: Ctre Hosp St Joseph Et St Luc; Nephrologie Hemodialyse

location_facility: Centre de Dialyse Atirra; Service Nephrologie - Hemodialyse

location_facility: Ch De Beauvais; Neph Endocrino Dialyse Diabeto

location_facility: Ch Henri Duffaut; Nephrologie Hemodialyse

location_facility: Chi Poissy Saint Germain En Laye; Hemodialyse

location_facility: Ch Bretagne Atlantique De Vannes; Nephrologie

location_facility: Association Aurad Aquitaine; Aurad Gradignan

location_facility: Hopital Clemenceau; Nephrologie Hemodialyse

location_facility: Hopital Hotel Dieu; Medecine Geriatrique Nephrologie

location_facility: Hopital Prive De L Estuaire; Nephrologie Hemodialyse

location_facility: Chi Du Val D Ariege; Gastro Enterologie Nephrologie

location_facility: Hopital Edouard-Herriot; Nephrologie - Hemodialyse

location_facility: Hopital de La Source; Service de Nephrologie & Hemodialyse

location_facility: Ch Antoine Gayraud; Nephrologie Hemodialyse

location_facility: Hopitaux Du Leman Site Thonon;Nephrologie

location_facility: Hopital Hotel Dieu Et Hme; Hemodialyse Chronique

location_facility: HOPITAL NORD; NEPH Transplantation Reanimation


title: A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection

ReferenceCitation: Younossi ZM, Stepanova M, Jacobson I, Muir AJ, Pol S, Zeuzem S, Younes Z, Herring R, Lawitz E, Younossi I, Racila A. Not Achieving Sustained Viral Eradication of Hepatitis C Virus After Treatment Leads to Worsening Patient-reported Outcomes. Clin Infect Dis. 2020 Feb 3;70(4):628-632. doi: 10.1093/cid/ciz243.

location_country:
Poland
Spain
Italy
Austria
Australia
Estonia
Canada
Netherlands
New Zealand
United Kingdom
Sweden
Puerto Rico
United States
France
Germany
Czechia

location_facility: Infectious Disease Specialists of Atlanta

location_facility: University of North Carolina at Chapel Hill

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: Washington University School of Medicine

location_facility: University of Manitoba, Health Sciences Center

location_facility: Azienda Ospedaliera-universitaria Policlinico P. Giaccone

location_facility: Advanced Clinical Research Institute, LLC

location_facility: Universitätsklinikum Würzburg - Med Klinik und Poliklinik

location_facility: UT Southwestern Medical Center at Dallas

location_facility: SP ZOZ Wojewodzki Szpital Zakazny w Warszawie

location_facility: C.H.U. Strasbourg - Hôpital Hautpierre - Hématologie

location_facility: University of Pennsylvania School of Medicine

location_facility: Sahlgrenska Universitetssjukhuset, Östra sjukhuset

location_facility: Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum

location_facility: Gastroenterology Center of the MidSouth, P.C.

location_facility: Los Angeles BioMedical Institute at Harbor-UCLA Medical Center

location_facility: Alfred Hospital - Infectious Disease Unit

location_facility: Liver Institute of Virginia, Bon Secours Health System

location_facility: Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie

location_facility: Community Research Initiative of New England

location_facility: Nashville Gastrointestinal Specialists, Inc

location_facility: Hospital General Universitario de Valencia

location_facility: University of Birmingham and Queen Elizabeth Hospital Birmingham

location_facility: Gordon & Leslie Diamond Health Care Centre

location_facility: Institut für interdisziplinäre Medizin Studien GmbH an der Asklepiosklinik Saint Georg

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Kaiser Permanente Institute for Health Research

location_facility: St. Luke's Health Baylor College of Medicine Medical Center

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

location_facility: Lehigh Valley Health Network, Network Office of Research and Innovation

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Hôpital Saint Louis, Services des Maladies Infectieuses

location_facility: University of Utah Pediatric Pulmonology

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Dipartimento Polispecialistico - Malattie Infetive

location_facility: Remedis, s.r.o., Nestátní zdravotnické zarízení, Vladimírova 10

location_facility: Kansas City Gastroenterology and Hepatology

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Universitair Medisch Centrum Sint Radboud

location_facility: The Gastroenterology Group of South Jersey

location_facility: Medizinisches Zentrum - Klinik für Gastroenterologie und Hepatologie

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: Ospedale San Raffaele-IRCCS, Centro San Luigi - San Raffaele Turro, Unità Operativa di Malattie Infettive

location_facility: Schleinitz Research and Gastroenterology LLC

location_facility: University of California, San Francisco School of Medicine

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Ente Ospedaliero Ospedali Galliera di Genova

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Klinikum der Johann Wolfgang-Goethe-Universität

location_facility: Service des Maladies de l'Appareil Digestif et de la nutrition

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

location_facility: Inova Fairfax Hospital Center for Liver Diseases

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hôpital-Saint Joseph, Service D'Hépato-Gastroentérologie

location_facility: Weill Medical College of Cornell Univeristy

location_facility: Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases

location_facility: Guy's and Saint Thomas NHS Foundation Trust

location_facility: Azienda Ospedaliera Padova, U.O.C. Cardiologia

location_facility: Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankhen

location_facility: Veterans Administration Wadsworth Medical Center

location_facility: Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy

location_facility: University of Miami Miller School of Medicine

location_facility: Waikato Hospital (District Health Board)

location_facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

location_facility: Virginia Commonwealth University Medical Center

location_facility: Azienda Ospedaliera S. Orsola - Malpighi

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Sahlgrenska Universitetssjukhuset, Östra Sjukhus

location_facility: Research Center at Affiliates in Gastroenterology

location_facility: Veterans Affairs Pittsburgh Healthcare System

location_facility: Hôpital La Pitié Salpétrière, Service des Maladies Infectieuses

location_facility: Hospital Moncloa, Servicio de Enfermedades Infecciosas

location_facility: South Florida Center of Gastroenterology, P.A.

location_facility: Wojewódzki Szpital Specjalistyczny im. Kazimierza Dluskiego w Bialymstoku

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Southampton University Hospitals NHS Trust, Southampton General Hospital

summary: This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.


type: Registry Identifier

title: An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura

acronym: MAYARI

summary:
This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline therapeutic plasma exchange (TPE) with primary endpoint of remission in male and female participants aged 18 to 80 years with immune-mediated thrombotic thrombocytopenic purpura (iTTP).

The anticipated study duration per participant without a recurrence while on therapy is maximum 24 weeks (ie, approximately 1 day for screening + maximum 12 weeks of treatment for the presenting episode + 12 weeks of follow-up). Participants will have daily assessments during hospitalization and weekly visits for assessments during ongoing treatment with caplacizumab and IST. There will be 3 outpatient visits for assessments during the follow-up period. There will be two additional follow-up visits for participants who do not have ADAMTS13 activity levels of ≥50% at the time of caplacizumab discontinuation.

ipd_sharing: Yes

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

lead_sponsor: Sanofi

location_country: Germany France

location_facility:
Investigational Site Number :2760006
Investigational Site Number :2500001

intervention_type: Biological


title: Randomized, Double-blind, Placebo-controlled, Multi-center Phase IIb Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HSCT

acronym: MO-TRANS

summary: This is a multi-center, randomized, double-blinded, placebo controlled trial.

lead_sponsor: Priothera SAS

location_country:
France
United Kingdom

location_facility:
Imperial College, London
Hospital Saint Antoine


title: An International Prospective Natural History Study in Children With a Type II Collagen Disorder With Short Stature

acronym: ROCKET

summary:
There are relatively few data available on type II collagen disorders, and evidence is lacking on the disease course in relation to symptoms and development of complications, the level of actual disease burden over time as well as data to support identification of possible risk factors.

This study aims to build a natural history data set through collection of a number of clinical, imaging, and laboratory assessments that may be specific predictors of type II collagen disorder progression and clinical outcome. Having a type II collagen disorder natural history data set can inform potential efficacy endpoints and biomarkers for future clinical trials.

This natural history study will follow up to 60 individuals diagnosed with a type II collagen disorder for up to 3 years. Visits will be conducted every 3 months for the first year and then every 6 months, during which several assessments will be performed in order to learn about the natural course of the disease, including changes in clinical and functional outcomes, imaging and biofluid biomarkers. Some of the study activities include: a physical exam, height measurements, vision and breathing tests and x-ray. A blood sample will be collected once or twice each year.

Most of the information collected, the tests done, and the schedule of visits in this study are the same as recommended for regular care of children with a type II collagen disorder.

ReferenceCitation: Savarirayan R, Bompadre V, Bober MB, Cho TJ, Goldberg MJ, Hoover-Fong J, Irving M, Kamps SE, Mackenzie WG, Raggio C, Spencer SS, White KK; Skeletal Dysplasia Management Consortium. Best practice guidelines regarding diagnosis and management of patients with type II collagen disorders. Genet Med. 2019 Sep;21(9):2070-2080. doi: 10.1038/s41436-019-0446-9. Epub 2019 Jan 30.

ReferenceCitation: Oh CW, Thacker MM, Mackenzie WG, Riddle EC. Coxa vara: a novel measurement technique in skeletal dysplasias. Clin Orthop Relat Res. 2006 Jun;447:125-31.

ReferenceCitation: Dhiman N, Albaghdadi A, Zogg CK, Sharma M, Hoover-Fong JE, Ain MC, Haider AH. Factors associated with health-related quality of life (HRQOL) in adults with short stature skeletal dysplasias. Qual Life Res. 2017 May;26(5):1337-1348. doi: 10.1007/s11136-016-1455-7. Epub 2016 Nov 19.

ReferenceCitation: Graham HK, Harvey A, Rodda J, Nattrass GR, Pirpiris M. The Functional Mobility Scale (FMS). J Pediatr Orthop. 2004 Sep-Oct;24(5):514-20.

lead_sponsor: Innoskel

location_country: France Spain

location_facility:
Hopital Necker-Enfants Malades
Hospital Universitario La Paz


title: Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access

acronym: RADIANCY

summary: The primary objective of this clinical investigation is to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ Nitinol Stent, in the treatment of patients with obstructive iliac or femoropopliteal arterial disease via radial artery access.

lead_sponsor: Cordis Corporation

location_facility:
CHU Ambroise Paré
University Hospital of Guadalajara


title: A Phase I, Open-label, Multi-center Study of PIT565 in Patients With Relapsed and/or Refractory B-cell Malignancies

summary: This is an open-label, multicenter, phase I study, which primary objective is to characterize the safety and tolerability of PIT565 and to identify maximal tolerated doses (MTDs) and/or recommended doses (RDs), schedule and route of administration in relapsed and/or refractory B-cell Non-Hodgkin lymphoma (R/R B-NHL) and relapsed and/or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).

design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country: France Israel


title: Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction

acronym: PREVENT

summary: The objective of this study is to collect post-market clinical safety and performance data on the robotic assisted prophylactic Nipple Sparing Mastectomy (R-NSM) surgery performed with the da Vinci Xi/X Surgical System as part of a PMCF Plan.

lead_sponsor: Intuitive Surgical

location_country: France Italy

location_facility:
Gustave Roussy Cancer Campus
Istituto Europeo di Oncologia


acronym: SAkuraSun

title: A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm

location_country: Poland France

location_facility: Centre Hospitalier Universitaire de Bicêtre

summary: This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.


title: Multicentre, Open-label, Uncontrolled, Pivotal Clinical Trial to Confirm the Efficacy and Safety of Autologous Fibrin-cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified for Restoration of Epidermis in Patients With Junctional Epidermolysis Bullosa

acronym: HOLOGENE 5

summary: Prospective, multicenter and multinational, open-label, uncontrolled clinical study to assess the safety and efficacy of autologous cultured epidermal grafts containing epidermal stem cells genetically modified transduced with a LAMB3-gamma retroviral vector. The purpose of this study is to demonstrate the safety and efficacy after one or more treatments with genetically corrected cultured epidermal autograft (Hologene 5) for restoration of the epidermis in patients with generalized intermediate LAMB3-dependent Junctional Epidermolysis Bullosa.

lead_sponsor: Holostem Terapie Avanzate s.r.l.

location_facility: Struttura Complessa di Dermatologia Azienda Ospedaliero Universitaria Policlinico di Modena


title: Study Evaluating the Performance and Safety in the Medium Term of Implant-prosthetic Systems Including Ranges of Dental Implants and Prosthetic Components Global D: In-Kone® U,In-Kone® P,3.0,twinKon® U,EVL® S,EVL® K,EVL® C

summary: This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety in the medium term of implant-prosthetic systems including Global D dental implants: In-Kone® UNIVERSAL, In-Kone® PRIMO, 3.0, twinKon® UNIVERSAL, EVL® S, EVL® K and EVL® C.

time_perspective: Other

lead_sponsor: Global D

location_country: France Greece


type: Other Grant/Funding Number

title: Exploratory Multicenter Observational Study to Assess the Outcome of Infants With Perinatal SARS-COV-2 Infection and Its Link With the NO Pathway: the Minipuberty Hypothesis

acronym: miniNO-COVID

summary: Some evidence exists that SARS-COV-2 may infect pituitary axis, and therefore may alter hypothalamic function. Whether perinatal COVID-19 is associated with alterations in the maturation of the Hypothalamic-Pituitary-Gonadal (HPG) axis, and specifically with its transient activation occurring during infancy, namely minipuberty, is a major concern. Among the various pathogenic features related to COVID-19, altered minipuberty could be a key factor underlying many multimorbidities later in life, suggesting that they could involve a common causative mechanism that occurs within this short and critical period of time following birth. Altered minipuberty together with NO deficiency seem to be key factors underlying many of these multimorbidities, suggesting that they involve a common causative mechanism that occurs within this short and critical period of time following birth

lead_sponsor: University Hospital, Lille

location_facility: Uri-National and Kapodistrian University of Athens


title: A Phase I/II Study of Brigatinib in Pediatric and Young Adult Patients With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors

acronym: Briga-PED

summary: This is an open-label, phase I-II dose-escalation and expansion study designed to define the recommended dose of brigatinib as monotherapy in pediatric and young adult patients with ALK+ ALCL, IMT or other solid tumors and to evaluate the pharmacokinetics (PK), (long-term) safety, and efficacy of brigatinib in these children.

ipd_sharing_description: all IPD that underlie results in a publication

lead_sponsor: Princess Maxima Center for Pediatric Oncology

location_country: Netherlands France

location_facility: Princess Máxima Center for Pediatric Oncology


title: Prospective Registry of Transarterial Chemoembolization of Metastatic Colorectal Cancer to the Liver With HepaSphere™ Microspheres Loaded With Irinotecan

acronym: mCRC

summary:
HepaSphere™ Microspheres loaded with irinotecan received CE mark for the indication of use in embolization of metastatic colorectal cancer (mCRC) to the liver in 2015.

The purpose of this registry is to demonstrate the safety and efficacy of HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal liver metastasis and add to the understanding of the use and value of this treatment in 'real life' usage conditions.

lead_sponsor: Merit Medical Systems, Inc.

location_facility:
European Hospital Georges Pompidou
Evgenidio Hospital/ATTIKO Hospital


title: Effectiveness and Safety of STYLAGE® L Lidocaïne in the Treatment of Nasolabial Folds

acronym: NICE

summary: STYLAGE® L Lidocaine is a CE-marked hyaluronic acid gel intended to fill skin depressions on the face by dermal injection. In this study, 50 healthy subjects between the age of 30 and 65, with moderate to severe nasolabial folds as assessed in live, who have given their informed consent and met all eligibility criteria, will be enrolled. Subjects will randomly receive injection of STYLAGE® L Lidocaine on one nasolabial fold and injection of an active comparator on the other nasolabial fold. A touch-up is possible if required one month after. Subjects will come to a total of 7 visits over a period of 12 months. Variation in severity score of nasolabial folds will be assessed in live and on photographs by independent evaluators. Variation in nasolabial fold depth, global aesthetic improvement, subject satisfaction, pain at injection site and safety will also be assessed.

lead_sponsor: Laboratoires Vivacy

location_facility:
Eurofins Dermscan Pharmascan
Eurofins Dermscan Poland


title: SMILE Study: Effectiveness and Safety of STYLAGE® M Lidocaïne for Lips' Volume Augmentation and/or Redefinition of the Outline of the Lips

acronym: SMILE

summary:
STYLAGE® M Lidocaine is a hyaluronic acid injectable gel CE (conformité européenne)-marketed since 2009 . It is indicated for the outline of the lips and/or for lips augmentation in lips mucosa. It is also indicated to fill skin depressions on the face. Lidocaine is intended to reduce the pain associated with the injection.

The aim of SMILE study is to demonstrate that STYLAGE® M Lidocaine is non-inferior to an active comparator that has shown its effectiveness in lips' volume augmentation and restoration in improving the aesthetic appearance of the lips evaluated by subjects.

In this study, 92 healthy volunteers between 18 and 65 years old, who expressed the wish for augmentation or restoration of the volume of the lips and/or lips' outline redefinition, confirmed by investigators at inclusion, who have given his/her informed consent and who met all the eligibility criteria, will be enrolled.

Subjects will randomly receive STYLAGE® M Lidocaïne or the active comparator (ratio 1:1) injection in the lips at first visit on Day 0. At second visit, one month after Day 0, an optional touch-up injection could be performed according to subject's and investigator's opinions and if the subject is still eligible.

Subjects will have a total of 6 visits over a 12 months follow-up period and a screening visit prior to first injection.

Proportion of subjects having a global aesthetic improvement of their lips (blinded self-evaluation), 3 months after treatment initiation will be assessed and compared between the two groups. This will also be done during the other visits (1, 6, 9 and 12 months after treatment initiation). Global aesthetic improvement according to blinded independent evaluator, subjects' satisfaction, pain during injection and safety parameters will also be assessed during the study period.


title: A Phase 1/2, Multicenter, Open-label, Dose-confirmation Trial to Evaluate the Safety and Preliminary Efficacy of DYN101 in Participants 2 to 17 Years of Age With Centronuclear Myopathy Caused by Mutations in MTM1 or DNM2

acronym: DyNaMic

summary: There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety and tolerability as well as pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of DYN101 in participants 2 to 17 years of age with CNM caused by mutations in DNM2 or MTM1.The trial will consist of a pre-screening consent, a screening period, a run-in period (if applicable), and a Part 1 of 12 weeks with weekly infusion of DYN101 to evaluate safety and tolerability as well as PK, PD and preliminary efficacy. The dose level may need adjustment based on the Part 1 results of the current study and available data from the Unite-CNM study (DYN101-C101, NCT04033159). If a dose adjustment is needed, Part 2 will be conducted in the same participants and the newly selected dose level will be used to assess whether efficacy is seen after an additional 12 weeks of treatment. As this trial is investigational, there is no defined, expected benefit for subjects who participate in this trial except a better knowledge of their disease.

status: Withdrawn

ReferenceCitation: Tasfaout H, Buono S, Guo S, Kretz C, Messaddeq N, Booten S, Greenlee S, Monia BP, Cowling BS, Laporte J. Antisense oligonucleotide-mediated Dnm2 knockdown prevents and reverts myotubular myopathy in mice. Nat Commun. 2017 Jun 7;8:15661. doi: 10.1038/ncomms15661.

lead_sponsor: Dynacure

location_facility:
Universitätsklinikum Essen
I-Motion Institute - Trousseau Hospital


title: A Study on Genetic Alterations (Polymorphism) in Key Genes in the Kynurenine Pathway on Suicidal Behavior

acronym: SuiKYN

summary: Current research has shown that an imbalance in the Kinurenine pathway plays a role in the physiopathology of neurogenerative and mental disorders (with a decrease in neuroprotective metabolites and an increase in neurotoxic products). So far the research has concentrated on the enzymes IDO, KAT, KMO, 3HAO and QPRT which are the key players in this pathway. Several polymorphisms affecting these enzymes have been associated with certain disorders characterized by a deregulation of the inflammation and immune response (McCauley et al 2009,Tardito et al 2013, Lee et al 2014), but no studies have ever tried to find a link between these enzymes and suicidal behavior. The investigators hypothesize that people who have attempted to commit suicide will have pro-inflammatory genetic variations affecting the kynurenine pathway.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes

intervention_type: Genetic


title: Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.

acronym: SCEI

summary: The aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : Implant Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close Relationship Scale (ECRS).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre de Recherche et d'Innovation Clinique

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

intervention_type: Diagnostic Test


title: Role of Nasal Dysbiosis in Parkinson Disease

acronym: SMELLPARK

summary: Olfactory dysfunction is frequent in Parkinson Disease (PD) and may be present years before the motor symptoms appear. The early olfactory dysfunction could result from environmental factors acting through the nasal cavity such as microbial communities. In across-sectional bicentric study, groups of 160 PD patients and 160 controls will be compared for nasal microbiota composition according to their geographical origin. We will search an association between microbiota and the presence of an olfactory deficit, cognitive deficit and thymic disorder.

time_perspective: Cross-Sectional

lead_sponsor: Institut Pasteur

location_country: France Guadeloupe

location_facility:
Pitie-Salpetriere Hospital
Centre Hospitalier Universitaire


title: Simulation of Stent-graft Deployment in Aortic Arch Aneurysms

summary: Total endovascular repair of the aortic arch represents a promising option for patients ineligible to open surgery. Custom-made design of stent-grafts (SG), such as the Terumo Aortic® RelayBranch device (DB), requires complex preoperative measures. Accurate SG deployment is required to avoid intraoperative or postoperative complications, which is extremely challenging in the aortic arch. In that context, our aim is to develop a computational tool able to predict SG deployment in such highly complex situations. Four patient-specific cases will be performed with complete deployment of the DB and its bridging stents in aneurysmal aortic arch. Deviations of our simulation predictions from actual stent positions will be estimated based on post-operative scan and a sensitivity analysis will be performed to assess the effects of material parameters. If good agreement between simulation and reality is obtained, numerical simulations will show their ability to successfully predict the DB deployment in complex anatomy. The results will emphasize the potential of computational simulations to assist practitioners in planning and performing complex and secure interventions.

location_facility:
Rinjstate Hopital
CHU Saint-Etienne


title: Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study

acronym: DORAVIPEP

summary: Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.

primary_purpose: Prevention

lead_sponsor: David Garcia Cinca

location_facility: Department and HIV & HCV Clinical Research Unit University Hospital Nantes


title: Clinical Application of the European Horizon 2020 Research Project "BRIDGES" - Study of the Psychological Impact of Breast Cancer Risk Communication in Cancer Genetics Based on the Personalized Estimation of the BOADICEA V5/PLUS Model

summary: Study of the psychological impact of breast cancer risk communication in Cancer Genetics based on the personalized estimation of the BOADICEA V5/PLUS model ("Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm-version 5 or PLUS").

lead_sponsor: Institut Curie

location_facility:
University Hospital of Cologne
Institut Curie


title: MOdified DIagnostic strateGy to Safely ruLe-out Pulmonary Embolism In the Emergency depArtment: A Non-Inferiority Cluster Cross-over Randomized Trial

acronym: MODIGLIA-NI

summary:
Because a missed PE could be potentially lethal, several researches reported that PE is both overinvestigated and overdiagnosed. The diagnostic gold standard for PE is the computed tomographic pulmonary angiogram (CTPA) and has been shown to have clear risks and other downsides. To limit the use of CTPA, two rules were recently reported to be safe to exclude PE: the PERC rule and the YEARS rule. PERC is an 8 item block of clinical criteria that has recently been validated to safely exclude PE in low risk patients. YEARS is a clinical rule that allow to raise the threshold of D-dimer for the order of CTPA. However, whether a modified diagnostic algorithm that includes these two rules combined could safely reduce imaging study use in the ED is unknown.

This is a non-inferiority, cluster cross-over randomized, international trial.

Each center will be randomized on the sequence of period intervention: 4 months intervention (MOdified Diagnostic Strategy: MODS) followed by 4 months control (usual care), or 4 months control followed by 4 months intervention with 1 month of "wash-out" between the two periods.

All centers will recruit adult emergency patients with a suspicion of PE.

In the control group (usual strategy), patients will be tested for D-dimer, followed if positive by a CTPA.

In the intervention group (MODS) :

All included patients will be tested with quantitative D-dimer. The MODS work-up will be based on YEARS rule :

- If all YEARS criteria are absent, the threshold of D-Dimer for ordering a CTPA will be raised.

If at least one criterion of YEARS is present, then the D-dimer threshold for ordering a CTPA will be as usual.

primary_purpose: Diagnostic

ReferenceCitation: Freund Y, Chauvin A, Jimenez S, Philippon AL, Curac S, Fémy F, Gorlicki J, Chouihed T, Goulet H, Montassier E, Dumont M, Lozano Polo L, Le Borgne P, Khellaf M, Bouzid D, Raynal PA, Abdessaied N, Laribi S, Guenezan J, Ganansia O, Bloom B, Miró O, Cachanado M, Simon T. Effect of a Diagnostic Strategy Using an Elevated and Age-Adjusted D-Dimer Threshold on Thromboembolic Events in Emergency Department Patients With Suspected Pulmonary Embolism: A Randomized Clinical Trial. JAMA. 2021 Dec 7;326(21):2141-2149. doi: 10.1001/jama.2021.20750.

ReferenceCitation: Philippon AL, Dumont M, Jimenez S, Salhi S, Cachanado M, Durand-Zaleski I, Simon T, Freund Y. MOdified DIagnostic strateGy to safely ruLe-out pulmonary embolism In the emergency depArtment: study protocol for the Non-Inferiority MODIGLIANI cluster cross-over randomized trial. Trials. 2020 Jun 3;21(1):458. doi: 10.1186/s13063-020-04379-y.

ipd_sharing_description: Yes, upon request, after approval by the primary investigator and clinical research platform of East Paris. For the purpose of IPD meta-analysis, or secondary analysis. Unidentifying data will be shared.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Emergency department Hospital Pitié-Salpêtrière


title: FENIX™ Continence Restoration System Registry

summary: The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety through the use of a bowel diary, fecal incontinence quality-of-life measures and adverse event reporting. Up to 25 sites will participate in the Registry. Sites to enroll consecutive eligible patients into the Registry. Registry will enroll approximately 200 FENIX patients.

lead_sponsor: Torax Medical Incorporated

location_facility:
University Hospital of Nantes
Kliniken Essen-Mitte


title: Tailored Intervention on Nutrition and Exercise for Obstructive Sleep Apnea Patients Treated With CPAP

acronym: TINE

summary: This study evaluates the addition of a comprehensive lifestyle program including dietary management and exercise to continuous positive airway pressure (CPAP) therapy in overweighted adults with obstructive sleep apnea. Half of the participants will receive CPAP therapy while the other half will have diet consultations, nordic walking sessions and CPAP.

lead_sponsor: Raphael Heinzer

location_country: France Switzerland

location_facility: Centre Hospitalier Universitaire Saint-Etienne

location_facility: Centre Hospitalier Universitaire Vaudois


title: Biomechanics and Motor Control of the First 6 Months of Independent Walking for Children With Unilateral Cerebral Palsy

acronym: BB-AQM

summary: This study will focus the gait analysis, using an optoelectronic system, of children with unilateral cerebral palsy compared to typically developed children in the first 6 months of independent walking.

lead_sponsor: University Hospital, Brest

location_country: France Romania

location_facility: Centrul National Clinic Recuperare Copii "Dr. N. Robanescu"


title: Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Single Oral Administration of Elafibranor 120 mg in Renal Impaired Patients and Healthy Subjects With Normal Renal Function

summary: This study is being conducted in order to assess the need for dose adjustment for elafibranor in participants with renal impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in severe renal impaired participants (eGFR<15mL/mn/1.73m^2) versus healthy participants after a single oral administration of elafibranor 120 mg

primary_purpose: Basic Science

lead_sponsor: Genfit

location_facility: ARENSIA Exploratory Medicine Unit, Nephrology Hospital Dr. Carol Davilla


title: Controlled Randomized Clinical Trial to Assess Efficacy of Deep Brain Stimulation (DBS) of the slMFB in Patients With Treatment Resistant Major Depression

acronym: FORESEE III

summary: The primary objective of this multicenter, randomized, sham-controlled, double blind (patient and observer blinded) clinical trial is to assess the antidepressant effect of Deep Brain Stimulation (DBS) in patients with treatment resistant major depression using the Boston Scientific implantable Vercise™ GEVIA™ DBS system compared to sham.

lead_sponsor: University Hospital Freiburg

location_facility:
Université Grenoble Alpes
University Hospital Freiburg


title: Feasibility of Implementing a Cohort of People Living With Hepatitis C in the Viet Tiep Hospital in Hai Phong, Vietnam

acronym: CoViet-C

summary: The purpose of this study is to evaluate the feasibility of implementing a cohort of patients with Hepatitis C in order to generate a larger cohort for future studies

location_country: France Vietnam

location_facility:
CHU Nimes
Hospital Viet Tiep


title: Evaluation of MDW for Early Detection of Sepsis In the Emergency Department

summary: The purpose of this study is to confirm the clinical validity and the performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of Emergency Department (ED) adults who have blood draw including Complete Blood Count with differential (CBC-DIFF) ordered upon presentation in a Spanish & French hospital and to verify cut-off for Tri-potassium ethylenediaminetetraacetic acid (K3EDTA).

ReferenceCitation: Hausfater P, Robert Boter N, Morales Indiano C, Cancella de Abreu M, Marin AM, Pernet J, Quesada D, Castro I, Careaga D, Arock M, Tejidor L, Velly L. Monocyte distribution width (MDW) performance as an early sepsis indicator in the emergency department: comparison with CRP and procalcitonin in a multicenter international European prospective study. Crit Care. 2021 Jun 30;25(1):227. doi: 10.1186/s13054-021-03622-5.

lead_sponsor: Beckman Coulter, Inc.

location_facility: Hospital Universitari Germans Trias I Pujol


title: A Non-interventional Patient Study to Demonstrate Medical Utility of the lncRNA to Predict HF in AMI Patients

acronym: HeartLinc

summary: HeartLinc is a non-interventional patient study to demonstrate medical utility of the lncRNA to predict HF in AMI patients. 300 patients are expected to be recruited.

lead_sponsor: Firalis SA

location_country:
Korea, Republic of
France

location_facility:
CHU de TOULOUSE
SNUH


title: Le rôle de la Cryobiopsie Transbronchique Dans le Diagnostic Des Maladies Pulmoniares Interstitielles

acronym: CryoPID

summary: Pathological comparisons of surgical open lung biopsies and cryobiopsies in non-IPF ILD. Patients with non-IPF ILD eligible for an open lung biopsy will undergo cryobiopsy in the same time. Between observers agreement will be assessed for each pairs of samples.

ReferenceCitation: Romagnoli M, Colby TV, Suehs CM, Vachier I, Molinari N, Bourdin A. Cryobiopsy Compared with Surgical Lung Biopsy in ILD: Reply to Maldonado et al., Froidure et al., Bendstrup et al., Agarwal et al., Richeldi et al., Rajchgot et al., and Quadrelli et al. Am J Respir Crit Care Med. 2019 Oct 1;200(7):944-946. doi: 10.1164/rccm.201906-1252LE.

ReferenceCitation: Bourdin A, Suehs CM, Colby TV, Vachier I, Molinari N, Romagnoli M. Reply to Wand et al.: Role of Transbronchial Cryobiopsy in Interstitial Lung Diseases: An Ongoing Tale. Am J Respir Crit Care Med. 2020 Jan 15;201(2):260-261. doi: 10.1164/rccm.201909-1736LE.

ReferenceCitation: Bourdin A, Romagnoli M, Gamez AS, Hireche K, Berthet JP, Mallet JP, Vachier I, Nava S, Reynaud P, Molinari N, Suehs C. Careful consideration of the bleeding caused by transbronchial lung cryobiopsies. Eur Respir J. 2020 May 21;55(5). pii: 1902415. doi: 10.1183/13993003.02415-2019. Print 2020 May.

ReferenceType: result

ReferenceCitation: Romagnoli M, Colby TV, Berthet JP, Gamez AS, Mallet JP, Serre I, Cancellieri A, Cavazza A, Solovei L, Dell'Amore A, Dolci G, Guerrieri A, Reynaud P, Bommart S, Zompatori M, Dalpiaz G, Nava S, Trisolini R, Suehs CM, Vachier I, Molinari N, Bourdin A. Poor Concordance between Sequential Transbronchial Lung Cryobiopsy and Surgical Lung Biopsy in the Diagnosis of Diffuse Interstitial Lung Diseases. Am J Respir Crit Care Med. 2019 May 15;199(10):1249-1256. doi: 10.1164/rccm.201810-1947OC.

ReferenceCitation: Suehs C, Bourdin A, Vachier I, Molinari N, Romagnoli M. Transbronchial cryobiopsy in the diagnosis of interstitial lung diseases: methodologies and perspectives from the Cryo-PID and COLDICE studies. Ann Transl Med. 2020 Oct;8(20):1330. doi: 10.21037/atm-20-2814.

ReferenceCitation: Reynaud P, Ahmed E, Serre I, Knabe L, Bommart S, Suehs C, Vachier I, Berthet JP, Romagnoli M, Vernisse C, Mallet JP, Gamez AS, Bourdin A. Club Cell Loss as a Feature of Bronchiolization in ILD. Front Immunol. 2021 Feb 26;12:630096. doi: 10.3389/fimmu.2021.630096. eCollection 2021.

lead_sponsor: University Hospital, Montpellier

location_facility: Arnaud de Villeneuve University Hospital


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

acronym: SMTr-METAB

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

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_country: France Monaco

location_facility:
Hôpital Princesse Grace
CHU de Nice


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

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

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

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

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

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

ReferenceCitation: Le Tourneau C, Becker H, Claus R, Elez E, Ricci F, Fritsch R, Silber Y, Hennequin A, Tabernero J, Jayadeva G, Luedtke D, He M, Isambert N. Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors. ESMO Open. 2022 Oct;7(5):100576. doi: 10.1016/j.esmoop.2022.100576. Epub 2022 Sep 13.

lead_sponsor: Boehringer Ingelheim

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


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

acronym: SKINNOQ

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

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

lead_sponsor: Aesculap AG

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


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

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

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

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

lead_sponsor: Maastricht University Medical Center

location_facility: Neurology and Movement Disorders Unit, Lille University Hospital