title: A Randomised,Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy

acronym: MIMOSA

summary: The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy.

ReferenceCitation: Reinartz S, Kohler S, Schlebusch H, Krista K, Giffels P, Renke K, Huober J, Mobus V, Kreienberg R, DuBois A, Sabbatini P, Wagner U. Vaccination of patients with advanced ovarian carcinoma with the anti-idiotype ACA125: immunological response and survival (phase Ib/II). Clin Cancer Res. 2004 Mar 1;10(5):1580-7. doi: 10.1158/1078-0432.ccr-03-0056.

ReferenceCitation: Wagner U, Kohler S, Reinartz S, Giffels P, Huober J, Renke K, Schlebusch H, Biersack HJ, Mobus V, Kreienberg R, Bauknecht T, Krebs D, Wallwiener D. Immunological consolidation of ovarian carcinoma recurrences with monoclonal anti-idiotype antibody ACA125: immune responses and survival in palliative treatment. See The biology behind: K. A. Foon and M. Bhattacharya-Chatterjee, Are solid tumor anti-idiotype vaccines ready for prime time? Clin. Cancer Res., 7:1112-1115, 2001. Clin Cancer Res. 2001 May;7(5):1154-62.

ReferenceCitation: Pfisterer J, du Bois A, Sehouli J, Loibl S, Reinartz S, Reuss A, Canzler U, Belau A, Jackisch C, Kimmig R, Wollschlaeger K, Heilmann V, Hilpert F. The anti-idiotypic antibody abagovomab in patients with recurrent ovarian cancer. A phase I trial of the AGO-OVAR. Ann Oncol. 2006 Oct;17(10):1568-77. doi: 10.1093/annonc/mdl357.

ReferenceCitation: Sabbatini P, Dupont J, Aghajanian C, Derosa F, Poynor E, Anderson S, Hensley M, Livingston P, Iasonos A, Spriggs D, McGuire W, Reinartz S, Schneider S, Grande C, Lele S, Rodabaugh K, Kepner J, Ferrone S, Odunsi K. Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Clin Cancer Res. 2006 Sep 15;12(18):5503-10. doi: 10.1158/1078-0432.CCR-05-2670.

ReferenceCitation: Buzzonetti A, Fossati M, Catzola V, Scambia G, Fattorossi A, Battaglia A. Immunological response induced by abagovomab as a maintenance therapy in patients with epithelial ovarian cancer: relationship with survival-a substudy of the MIMOSA trial. Cancer Immunol Immunother. 2014 Oct;63(10):1037-45. doi: 10.1007/s00262-014-1569-0. Epub 2014 Jun 21.

ReferenceCitation: Sabbatini P, Harter P, Scambia G, Sehouli J, Meier W, Wimberger P, Baumann KH, Kurzeder C, Schmalfeldt B, Cibula D, Bidzinski M, Casado A, Martoni A, Colombo N, Holloway RW, Selvaggi L, Li A, del Campo J, Cwiertka K, Pinter T, Vermorken JB, Pujade-Lauraine E, Scartoni S, Bertolotti M, Simonelli C, Capriati A, Maggi CA, Berek JS, Pfisterer J. Abagovomab as maintenance therapy in patients with epithelial ovarian cancer: a phase III trial of the AGO OVAR, COGI, GINECO, and GEICO--the MIMOSA study. J Clin Oncol. 2013 Apr 20;31(12):1554-61. doi: 10.1200/JCO.2012.46.4057. Epub 2013 Mar 11.

lead_sponsor: Menarini Group

location_country:
Germany
Italy
Poland
Hungary
Belgium
United States
Spain
Czech Republic
France

location_facility: Hackensack University Medical Center, Obstetrics and Gynecology Oncology

location_facility: Dipartimento di Ginecologia ed Ostetricia Policlinico Universitario Gemelli

location_facility: Azienda Ospedaliera San Martino - Padiglione Malattie Complesse, Dipartimento di Oncologia Medica

location_facility: Krajska nemocnice Liberec, oddeleni gynekologicko porodnicke

location_facility: Semmelweis Egyetem, I sz. Szülészeti és Nőgyógyászati Klinika

location_facility: "Centrum Onkologii, Instytut im. M. Skłodowskiej-Curie, Oddział w Krakowie,

location_facility: Women and Infants Hospital of Rhode Island

location_facility: Wojskowy Instytut Medyczny; Klinika Onkologii Centralnego Szpitala Klinicznego MON

location_facility: Azienda Ospedaliera - Universitaria Careggi

location_facility: Komárom-Esztergom Megyei Onkormanyzat Szent Borbála Kórház, Szülészet-Nőgyógyászati Osztály

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny Nr 3, Oddzial Onkologii

location_facility: Hospital Clinico San Carlos, Servicio de Oncología Medica

location_facility: Policlinico Umberto I D.H. Oncologico Oncologia Medica

location_facility: Hospital Son Dureta, Servicio de Oncología

location_facility: Klinikum der Stadt Wolfsburg-FrauenklinikWolfsburg

location_facility: Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät

location_facility: AZ Sint Augustinus, Oncologisch Centrum GVA

location_facility: Arcispedale Santa Maria Nuova, Oncologia Medica

location_facility: Universtita' Cattolica del Sacro Cuore Dipartimento di Oncologia

location_facility: Azienda Ospedaliera San Carlo - Oncologia Medica

location_facility: Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica

location_facility: Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica

location_facility: Klinikum der Universität München-Innenstadt

location_facility: Oddzial Chemioterapii ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: Wojewodzkie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Ospedale S. Orsola Malpighi, Oncologia Medica

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Harry and Jeanette Weinberg Cancer Institute at Franklin Square

location_facility: Hospital General Universitario de Valencia

location_facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészetl es Nőgyógyászatl Klinika

location_facility: Policlinico di Modena, Dipartimento di Oncologia ed Ematologia

location_facility: Pécsi Tudományegyetem, ÁOK Szülészeti és Nőgyógyászati Klinika

location_facility: Oncologia Medica Ospedale di Faenza - AUSL di Ravenna

location_facility: Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworów Narządów Płciowych Kobiecych

location_facility: Centralny Szpital Kliniczny MSWiA, Klinika Onkologii, Hematologii i Chorob Wewnetrznych

location_facility: Istituto Europeo di Oncologia - Divisione di Ginecologia

location_facility: Unità Operativa Ginecologia e Ostetricia 2^, Università degli studi di Bari, Policlinico

location_facility: Klinikum Südstadt der Hansestadt Rostock

location_facility: DH Oncologico U.O. Medicina Oncologica Ospedale Ramazzini

location_facility: Klinika Onkologii, Oddzial Chemioterapii Akademii Medycznej w Poznaniu

location_facility: Fővárosi Önkormányzat Szent Margit Kórháza, Onkológia

location_facility: Hospital Vall d'Hebrón, Servicio de Oncologia

location_facility: Semmelweis Egyetem II. sz. Szülészeti és Nőgyógyászati Klinika

location_facility: Klinikum der Stadt Villingen-Schwenningen GmbH

location_facility: Dipartimento di Discipline Ginecologiche e Ostetriche - Universita degli Studi di Torino - Azienda ospedaliera O.I.R.M.-S'Anna

location_facility: Hospital Clinico de Malaga. Servicio de Oncologia

location_facility: Petz Aladar Megyei Oktató Kórház, Onkoradiológia

location_facility: Instituto Catalán de Oncología - Hospital Universitari de Girona "Dr. Josep Trueta". Oncologia Medica

location_facility: University of California, Los Angeles (UCLA)

location_facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Kórháza, Szülészet-Nőgyógyászati Osztály

location_facility: Ospedale Casa Sollievo della Sofferenza - Unita' Operativa di Ostetricia e Ginecologia

location_facility: Oddzial Onkologii Wojewódzki Szpital Specjalistyczny

location_facility: Wojewodzki Szpital Zespolony, Oddzial Onkologii Klinicznej

location_facility: Universitair Ziekenhuis Gent Medische Oncologie 4B-Z

location_facility: Curtis and Elizabeth Anderson Cancer Institute

location_facility: Ospedali Riuniti Bianchi-Melacrino-Morelli - Oncologia Medica

location_facility: Hospital Universitario Arnau de Vilanova, Servicio de Oncologia

location_facility: Gynekologicko-porodnicka klinika FN Plzen

location_facility: Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel


title: A Multicenter, Double-blind, Randomized, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 mg as Compared to Amlodipine/Valsartan 5/40 mg or to Amlodipine 5 mg Once Daily in Elderly Patients With Essential Hypertension Not Adequately Controlled After Four Weeks on Amlodipine 5 mg Once Daily

summary: To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Germany
Italy
Poland
Slovakia
Hungary
Sweden
Spain
Czech Republic
France

location_facility:
Investigative site Italy
Investigative site Sweden
Investigative site Hungary
Investigative sites Czech Republic
Investigative sites Czech Repbulic
Sites in Czech Republic
Investigative site Spain
Investigative site Czech Republic
Investigative site Finland
Investigative site Czech Repbulic
Investigative site Germany
Investigative site Poland
Investigative site France
Novartis Investigative site
Investigative site Slovakia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses

summary: 89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.

study_start_date_type: Actual

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Telix International Pty Ltd

location_country:
United Kingdom
Australia
Netherlands
Belgium
United States
Turkey
Canada
France

location_facility: CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec

location_facility: Advanced Molecular Imaging & Therapy, LLC

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: SEATTLE CANCER CARE ALLIANCE, University of Washington

location_facility: CHU de Bordeaux, Groupe hospitalier Pellegrin

location_facility: University of California, Los Angeles Campus,

location_facility: Centre De Recherche Centre hospitalier de l/Universite de Montreal (CrCHUM )

location_facility: Hacettepe University Faculty of Medicine

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Ankara University Medical Faculty Hospital

intervention_type: Diagnostic Test


title: Open-Label Study to Determine How Prior Therapy With Alendronate or Risedronate in Postmenopausal Women With Osteoporosis Influences the Clinical Effectiveness of Teriparatide

summary: To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of the study is to compare the teriparatide (human, recombinant PTH[1-34])-associated change from baseline in a marker of bone formation, N-terminal propeptide of type I collagen (P1NP), between subjects previously treated with risedronate and those previously treated with alendronate.

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Miller PD, Delmas PD, Lindsay R, Watts NB, Luckey M, Adachi J, Saag K, Greenspan SL, Seeman E, Boonen S, Meeves S, Lang TF, Bilezikian JP; Open-label Study to Determine How Prior Therapy with Alendronate or Risedronate in Postmenopausal Women with Osteoporosis Influences the Clinical Effectiveness of Teriparatide Investigators. Early responsiveness of women with osteoporosis to teriparatide after therapy with alendronate or risedronate. J Clin Endocrinol Metab. 2008 Oct;93(10):3785-93. doi: 10.1210/jc.2008-0353. Epub 2008 Aug 5.

lead_sponsor: Sanofi

sponsor_collaborators:
Sanofi
Procter and Gamble

location_country:
United Kingdom
Australia
Netherlands
Belgium
United States
Canada
France

location_facility:
sanofi-aventis, Belgium
sanofi-aventis, France
sanofi-aventis, Australia
sanofi-aventi, UK
sanofi-aventis, Netherlands
sanofi-aventis, US
sanofi-aventis, Canada


title: Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by IVUS (IntraVascular UltraSounds), in Overweight Patients With Clustering Risk Factors

summary: The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome.

ReferenceType: result

ReferenceCitation: Nissen SE, Nicholls SJ, Wolski K, Rodes-Cabau J, Cannon CP, Deanfield JE, Despres JP, Kastelein JJ, Steinhubl SR, Kapadia S, Yasin M, Ruzyllo W, Gaudin C, Job B, Hu B, Bhatt DL, Lincoff AM, Tuzcu EM; STRADIVARIUS Investigators. Effect of rimonabant on progression of atherosclerosis in patients with abdominal obesity and coronary artery disease: the STRADIVARIUS randomized controlled trial. JAMA. 2008 Apr 2;299(13):1547-60. doi: 10.1001/jama.299.13.1547. Epub 2008 Apr 1.

location_country:
Italy
Poland
Australia
Netherlands
Belgium
United States
Spain
Canada
France

location_facility:
sanofi-aventis, Belgium
sanofi-aventis, France
sanofi-aventis Italy
sanofi-aventis Spain
sanofi-aventis, Australia
sanofi-aventis Poland
sanofi-aventis, Netherlands
The Cleveland Clinic Foundation
Sanofi-Aventis Administrative Office


title: Safety and Efficacy of Orally Administered Fx-1006A in Patients With Familial Amyloid Polyneuropathy (FAP): A Randomized, Double-blind, Placebo-controlled Study

summary:
This study will examine whether Fx-1006A is effective in halting the progression of Familial Amyloid Polyneuropathy (FAP).

Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the condition called FAP.

The prevention of the formation of amyloid by stabilization of the TTR native state should constitute an effective therapy for amyloid diseases. Therapeutic intervention with a TTR stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP patients. FAP is a uniformly fatal disease and Fx-1006A is intended to halt the relentless neurological deterioration FAP patients experience.

This Phase 2/3 study will enroll early to mid-stage FAP patients in order to interrupt and stabilize the disease at a point in time where progression of motor and autonomic dysfunction can be maximally effected. Male and female patients with FAP with documented V30M TTR mutation will receive Fx-1006A or placebo once daily for a period of eighteen (18) months.

ReferenceCitation: Merlini G, Coelho T, Waddington Cruz M, Li H, Stewart M, Ebede B. Evaluation of Mortality During Long-Term Treatment with Tafamidis for Transthyretin Amyloidosis with Polyneuropathy: Clinical Trial Results up to 8.5 Years. Neurol Ther. 2020 Jun;9(1):105-115. doi: 10.1007/s40120-020-00180-w. Epub 2020 Feb 27.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Centro Hospitalar do Porto - Repositório Científico do Centro Hospitalar do Porto

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central;repositorio.chporto.pt

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Huber P, Flynn A, Sultan MB, Li H, Rill D, Ebede B, Gundapaneni B, Schwartz JH. A comprehensive safety profile of tafamidis in patients with transthyretin amyloid polyneuropathy. Amyloid. 2019 Dec;26(4):203-209. doi: 10.1080/13506129.2019.1643714. Epub 2019 Jul 27.

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Informa

ReferenceCitation: Amass L, Li H, Gundapaneni BK, Schwartz JH, Keohane DJ. Influence of baseline neurologic severity on disease progression and the associated disease-modifying effects of tafamidis in patients with transthyretin amyloid polyneuropathy. Orphanet J Rare Dis. 2018 Dec 17;13(1):225. doi: 10.1186/s13023-018-0947-7.

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

ReferenceCitation: Gundapaneni BK, Sultan MB, Keohane DJ, Schwartz JH. Tafamidis delays neurological progression comparably across Val30Met and non-Val30Met genotypes in transthyretin familial amyloid polyneuropathy. Eur J Neurol. 2018 Mar;25(3):464-468. doi: 10.1111/ene.13510. Epub 2017 Dec 26.

oa_colors: green hybrid

publisher_dissemination: Wiley

ReferenceCitation: Keohane D, Schwartz J, Gundapaneni B, Stewart M, Amass L. Tafamidis delays disease progression in patients with early stage transthyretin familial amyloid polyneuropathy: additional supportive analyses from the pivotal trial. Amyloid. 2017 Mar;24(1):30-36. doi: 10.1080/13506129.2017.1301419. Epub 2017 Apr 10.

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

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: Waddington Cruz M, Amass L, Keohane D, Schwartz J, Li H, Gundapaneni B. Early intervention with tafamidis provides long-term (5.5-year) delay of neurologic progression in transthyretin hereditary amyloid polyneuropathy. Amyloid. 2016 Sep;23(3):178-183. doi: 10.1080/13506129.2016.1207163. Epub 2016 Aug 5.

repository_institution: University of Illinois at Chicago - INDIGO

location_country:
Germany
Portugal
United Kingdom
Argentina
Brazil
Sweden
United States
Spain
France

location_facility: Serviço de Neurologia-Hospital de Santa Maria

location_facility: Hospital Universitário Prof. Clementino Fraga Filho-UFRJ

location_facility: Unidade Clinica de Paramiloidose-Hospital Santo Antonio

location_facility: Universitatsklinikum Munster, Transplant Hepatology

location_facility: FLENI-Hepatology and Organ Transplant Dept.


title: Quality of Life in Patients With Congenital Afibrinogenemia

acronym: QualyAFIB

summary: The aim of this observational study is to evaluate the quality of life in patients with congenital afibrinogenemia using the Haemo-QoL SF for kids and the Haem-A-QoL for adult patients.

study_type: Observational

time_perspective: Cross-Sectional

ReferenceCitation: Casini A, von Mackensen S, Santoro C, Djambas Khayat C, Belhani M, Ross C, Dorgalaleh A, Naz A, Unal E, Abdelwahab M, Lozeron ED, Trillot N, Susen S, Peyvandi F, de Moerloose P; QualyAfib Study Group. Clinical phenotype, fibrinogen supplementation, and health-related quality of life in patients with afibrinogenemia. Blood. 2021 Jun 3;137(22):3127-3136. doi: 10.1182/blood.2020009472.

oa_colors: green other

evidence: open (via free article)

repository_institution: University of Geneva - Archive ouverte UNIGE

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

lead_sponsor: University Hospital, Geneva

location_country:
Germany
Poland
Algeria
Japan
Kuwait
Turkey
Pakistan
Canada
Serbia
France
Slovakia
Switzerland
United States
Morocco
India
Tunisia
Lebanon
Egypt
Italy
Netherlands
Spain

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: National Institute Of Blood Disease and Bone Marrow Transplantation

location_facility: National Centre of Hemostasis and Thrombosis

location_facility: Institute of Hematology and Transfusion Medicine

intervention_type: Other

lead_sponsor_type: academique


title: A Randomized Phase II-III Multicenter Trial of Docetaxel Plus Cisplatin and Docetaxel Plus 5-FU Versus Cisplatin Plus 5-FU in 1st Line Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.

summary: The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

location_country:
Germany
Guadeloupe
Argentina
Australia
Brazil
Canada
France
Hungary
Switzerland
United States
Belgium
Italy
Réunion
Austria
Uruguay
Spain
Greece
South Africa
Russian Federation
Israel

location_facility:
Sanofi-Aventis
Sanofi-Aventis Hungaria
sanofi-aventis, Belgium
sanofi-aventis Germany
sanofi-aventis Greece
sanofi-aventis Israel
sanofi-aventis US
sanofi-aventis, France
sanofi-aventis Italy
sanofi-aventis South Africa
sanofi-aventis Canada
sanofi-aventis, Australia
sanofi-aventis Switzerland


type: EudraCT Number

title: Double-blind, Randomised, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Levocetirizine 5 mg for the Treatment of Chronic Idiopathic Urticaria

summary: The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic Idiopathic Urticaria.

ReferenceType: background

ReferenceCitation: Church MK. Safety and efficacy of bilastine: a new H(1)-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Saf. 2011 Sep;10(5):779-93. doi: 10.1517/14740338.2011.604029. Epub 2011 Aug 11. Erratum In: Expert Opin Drug Saf. 2012 Jan;11(1):175.

ReferenceCitation: Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P, Antepara I, Jauregui I, Valiente R; Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy. 2010 Apr;65(4):516-28. doi: 10.1111/j.1398-9995.2009.02217.x. Epub 2009 Oct 23.

lead_sponsor: Faes Farma, S.A.

location_country: Germany Poland Argentina Romania Belgium Spain France

location_facility:
Centre nº 506
Centre nº 407
Centre nº 106
Centre nº 404
Centre nº 805
Centre nº 203
Centre nº 411
Centre nº 704
Centre nº 400
Centre nº 501
Centre nº 800
Centre nº 107
Centre nº 804
Centre nº 105
Centre nº 204
Centre nº 410
Centre nº 701
Centre nº 200
Centre nº 705
Centre nº 308
Centre nº 303
Centre nº 505
Centre nº 109
Centre nº 104
Centre nº 703
Centre nº 201
Centre nº 302
Centre nº 503
Centre nº 307
Centre nº 707
Centre nº 806
Centre nº 108
Centre nº 305
Centre nº 301
Centre nº 502
Centre nº 101
Centre nº 100
Centre nº 801
Centre nº 406
Centre nº 706
Centre nº 702
Centre nº 802
Centre nº 102
Centre nº 500
Centre nº 504
Centre nº 803
Centre nº 103
Centre nº 202
Centre nº 700
Centre nº 507


lead_sponsor: Sarepta Therapeutics, Inc.

summary: This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability, efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with deletions amenable to exon 53 skipping.

ReferenceCitation: Frank DE, Schnell FJ, Akana C, El-Husayni SH, Desjardins CA, Morgan J, Charleston JS, Sardone V, Domingos J, Dickson G, Straub V, Guglieri M, Mercuri E, Servais L, Muntoni F; SKIP-NMD Study Group. Increased dystrophin production with golodirsen in patients with Duchenne muscular dystrophy. Neurology. 2020 May 26;94(21):e2270-e2282. doi: 10.1212/WNL.0000000000009233. Epub 2020 Mar 5. Erratum In: Neurology. 2023 May 9;100(19):936.

ReferenceCitation: Servais L, Mercuri E, Straub V, Guglieri M, Seferian AM, Scoto M, Leone D, Koenig E, Khan N, Dugar A, Wang X, Han B, Wang D, Muntoni F; SKIP-NMD Study Group. Long-Term Safety and Efficacy Data of Golodirsen in Ambulatory Patients with Duchenne Muscular Dystrophy Amenable to Exon 53 Skipping: A First-in-human, Multicenter, Two-Part, Open-Label, Phase 1/2 Trial. Nucleic Acid Ther. 2022 Feb;32(1):29-39. doi: 10.1089/nat.2021.0043. Epub 2021 Nov 17.

evidence: open (via page says license)

repository_institution: Newcastle Univesity - Newcastle University ePrints

version: submittedVersion

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

repository_normalized: HAL

repository_institution: University of Liège - Open Repository and Bibliography

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

publisher_dissemination: Mary Ann Liebert Inc

sponsor_collaborators: Consultants for Research in Imaging and Spectroscopy

sponsor_collaborators: Great Ormond Street Hospital for Children NHS Foundation Trust

title: A 2-Part, Randomized, Double-Blind, Placebo-Controlled, Dose-Titration, Safety, Tolerability, and Pharmacokinetics Study (Part 1) Followed by an Open-Label Efficacy and Safety Evaluation (Part 2) of SRP-4053 in Patients With Duchenne Muscular Dystrophy Amenable to Exon 53 Skipping

source: euctr

location_country:
United States
Italy
United Kingdom
France


title: A Phase 1, Multinational Study of MCLA-117 in Acute Myelogenous Leukemia

summary: This is a First-in-Human, single arm, open-label, multi-national study designed to determine the safety, tolerability and preliminary efficacy of MCLA 117.

status: Unknown status

study_completion_date_type: Anticipated

lead_sponsor: Merus N.V.

location_country:
Italy
Netherlands
Belgium
United States
France

location_facility: Ziekenhuis Netwerk Antwerpen Campus Stuivenberg

location_facility: Georgia Cancer Center, Augusta University

location_facility: The University of Texas, MD Anderson Cancer Center

status_simplified: Unknown


type: Other Identifier

title: Asymptomatic Sexually Transmitted Infections (STI) : Comparison of Two Screening Strategies Routine Screening Versus Screening as Reported by the Risks Taken by the Patient, in a Cohort of HIV Outpatients Men Who Have Sex With Men

acronym: DRIVER

summary: Comparison of two screening strategies of asymptomatic sexually transmitted infections : routine screening versus screening as reported by the risks taken by the patient, in a cohort of HIV outpatients men who have sex with men. The aim of this study will be create and validate a simple tool for clinicians. A digital tool will be developed will allowed empowerment of HIV-positive men who have sex with men.

primary_purpose: Screening

lead_sponsor: Hopital Foch

sponsor_collaborators:
Hopital Foch
Saint-Louis Hospital, Paris, France
Bicetre Hospital
Hotel Dieu Hospital
European Georges Pompidou Hospital
Hôpital Necker-Enfants Malades
Hôpital Franco-Britannique
Institut Mutualiste Montsouris
Hôpital Lagny Marne la Vallée
Hôpital Raymond Poincaré
Centre Hospitalier Argenteuil
Hôpital Louis Mourier
Hospital Ambroise Paré Paris

location_facility: Hôpital Mignot-centre hospitalier de versailles


title: Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Adolescents (12 to Less Than 18 Years) With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-13)

summary: This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).

status: Active, not recruiting

ReferenceCitation: Reijman MD, Schweizer A, Peterson ALH, Bruckert E, Stratz C, Defesche JC, Hegele RA, Wiegman A. Rationale and design of two trials assessing the efficacy, safety, and tolerability of inclisiran in adolescents with homozygous and heterozygous familial hypercholesterolaemia. Eur J Prev Cardiol. 2022 Jul 20;29(9):1361-1368. doi: 10.1093/eurjpc/zwac025.

oa_host_type: closed

publisher_dissemination: Oxford University Press

ReferenceCitation: Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.

publisher_dissemination: Wolters Kluwer Health

ipd_sharing: Yes

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Netherlands
Lebanon
United States
Greece
Malaysia
Turkey
Canada
France

location_facility: American University of Beirut Medical Center

status_simplified: Ongoing


title: Acute Care For Patients Exposed to a Chemical, Biological, Radiological, Nuclear, Explosive: Attack: Protocol For An International Multicentric Observational Study

acronym: CBRNEObs

summary: Observation study measuring medical response in contaminated environment.

status: Enrolling by invitation

time_perspective: Retrospective

enrollment_type: Anticipated

ReferenceCitation: Bourassa S, Noebert D, Dauphin M, Rambaud J, Kawaguchi A, Leger F, Beijer D, Fortier Y, Dligui M, Ivanovski H, Simard S, Jouvet P, Leclerc J. Acute care for patients exposed to a chemical attack: protocol for an international multicentric observational study. BMJ Open. 2022 Sep 29;12(9):e065015. doi: 10.1136/bmjopen-2022-065015.

publisher_dissemination: British Medical Journal

ipd_sharing: Undecided

ipd_sharing_description: At this stage, we do have any plan. However, for the interest of pursuing the research, that matter will require to be addressed in due time.

lead_sponsor: St. Justine's Hospital

collaborators: Quebec Heart and Lung Institute, Quebec City, Canada

collaborators: Medical Intelligence CBRNE inc.; Quebec City, Canada

collaborators: Department of Intensive Care Medicine, Tokyo, Japan

collaborators: Centre for Defence and Security Studies, University of Manitoba, Winnipeg, Canada

collaborators: Biomedical Telematics Laboratory, Quebec Respiratory Health Research Network, Sherbrooke, Canada

location_country:
United States
Canada
Japan
France

location_facility: Biomedical Telematics Laboratory Platform of the Quebec Respiratory Health Research Network

location_facility: Research Centre, Quebec Heart and Lung Institute, Laval University

location_facility: Department of Critical care, Miyagi Children's Hospital

location_facility: Tokyo Women's Medical University, Department of Intensive Care Medicine

location_facility: Research Center of the CHU St-Justine, University of Montreal

location_facility: Department of Disaster Medical Management, The University of Tokyo Hospital

location_facility: Director, Unconventional Weapons & Technology Division, National Consortium for the Study of Terrorism and Responses to Terrorism University of Maryland

intervention_type: Procedure


lead_sponsor: Merck Sharp & Dohme LLC

summary: The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men and who are at high risk of HIV-1 infection with 48 or 96 weeks of treatment and a minimum follow-up of 42 days.

location_facility: Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 0151)

location_facility: Midway Immunology and Research Center ( Site 0014)

location_facility: The Crofoot Research Center ( Site 0025)

location_facility: Perinatal HIV Research Unit (PHRU)-HIV Prevention CRS ( Site 0203)

location_facility: Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 0052

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 0101)

location_facility: Centro de Referência e Treinamento DST/AIDS ( Site 0351)

location_facility: Rutgers New Jersey Medical School-Clinical Research Center ( Site 0017)

location_facility: Central Texas Clinical Research ( Site 0002)

location_facility: Bridge HIV - San Francisco Department of Public Health ( Site 0003)

location_facility: University of Miami Miller School of Medicine-Infectious Disease ( Site 0029)

location_facility: The University of North Carolina at Chapel Hill ( Site 0019)

location_facility: The University of Mississippi Medical Center ( Site 0012)

location_facility: Chulalongkorn University-Pediatrics ( Site 0051)

location_facility: Wits Reproductive Health and HIV Institute (WRHI)-Research Center ( Site 0201)

location_facility: UCLA Center for Clinical AIDS Research and Education ( Site 0011)

location_facility: University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0007)

location_facility: Desmond Tutu HIV Foundation ( Site 0202)

location_facility: Ponce De Leon Center Grady Health ( Site 0032)

location_facility: HIV Netherlands Australia Thailand Research Collaboration ( Site 0056)

location_facility: The GW Medical Faculty Associates-Medicine ( Site 0033)

title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Men and Transgender Women Who Have Sex With Men, and Are at High Risk for HIV-1 Infection

primary_purpose: Prevention

type: Registry Identifier

location_country:
Japan
Brazil
United States
Thailand
South Africa
Peru
France


acronym: STOP PIV - Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects

lead_sponsor: Ansun Biopharma, Inc.

summary:
This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection.

It also contains a sub-study to enroll patients with severe COVID-19.

location_facility: University of California San Diego Medical Center

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of California Davis Health System

location_facility: Seoul National University Bundang Hospital

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Froedtert Medical College Pulmonary Clinic

status: Recruiting

title: A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

location_country:
Hong Kong
Denmark
Australia
United States
China
Korea, Republic of
Taiwan
France


acronym: Hubble Zoom

lead_sponsor: Takeda

summary: The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.

sponsor_collaborators: Takeda Development Center Americas, Inc.

location_facility: Nemours Childrens Specialty Care - Jacksonville

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Kharkiv Regional Clinical Children's Hospital

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Schneider Children's Medical Center of Israel

location_facility: Children's Center for Digestive Healthcare

location_facility: BAZ Megyei Korhaz es Egyetemi Oktatokorhaz

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: The Edmond and Lily Safra Children's Hospital - Sheba Medical Center

location_facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnicki

location_facility: Hopital Necker-Enfants Malades - Service de Gastroenterologie-Hepatologie-Nutrition Pediatriques

location_facility: Tel Aviv Sourasky Medical Center - Dept. of Gastroenterology and Hepatology

location_facility: Barts and The London NHS Trust - Children's Clinical Research Facility

location_facility: Hopital Universitaire des Enfants Reine Fabiola

title: A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
France
Poland
Hungary
United Kingdom
Belgium
United States
Ukraine
Israel


title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

summary: This is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.

ReferenceCitation: Ray U, Pathoulas CL, Thirusangu P, Purcell JW, Kannan N, Shridhar V. Exploiting LRRC15 as a Novel Therapeutic Target in Cancer. Cancer Res. 2022 May 3;82(9):1675-1681. doi: 10.1158/0008-5472.CAN-21-3734.

publisher_dissemination: American Association for Cancer Research

lead_sponsor: AbbVie

location_country:
United States
Spain
France

location_facility: Washington University-School of Medicine /ID# 151348

location_facility: Mary Crowley Cancer Research /ID# 148580

location_facility: University of California, Los Angeles /ID# 148586

location_facility: Dana-Farber Cancer Institute /ID# 143782

location_facility: South Texas Accelerated Research Therapeutics /ID# 141715

location_facility: Carolina BioOncology Institute /ID# 148583

location_facility: Hosp Univ Madrid Sanchinarro /ID# 146039

location_facility: Univ of Colorado Cancer Center /ID# 148581


title: A Multicenter, Prospective, Randomized, Open-label, Intra-subject Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated With Generalized Epidermolysis Bullosa

summary:
The purpose of this study is to evaluate the efficacy and safety of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing.

It is hypothesized that ABH001 may initiate and continue wound healing in patients with epidermolysis bullosa.

status: Terminated

lead_sponsor: Shire Regenerative Medicine, Inc.

location_country:
Germany
Poland
Portugal
Austria
United States
Spain
Canada
France

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der Paracelsus Medizinischen Privatuniversität

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Rady Children's Hospital - San Diego/UCSD, Pediatric and Adolescent Dermatology

location_facility: University of Freiburg (Studiensekretariat Hautklinik Universitätsklinikum Freiburg - Hautklinik)

location_facility: Warszawki Uniwersytet Medyczny Katedra I Klinika Dermatologiczna

location_facility: Lucile Packard Children's Hospital at Stanford University


title: Validation of HWA10 With Withings ECG-app for the Detection of Atrial Fibrillation

summary: The aim of the study is to evaluate the performance of Withings HWA10 with embedded Withings ECG-app in the automatic detection of atrial fibrillation

primary_purpose: Basic Science

lead_sponsor: Withings

sponsor_collaborators: Withings Syntactx

location_country:
United States
France

location_facility:
Texas Heart Institute
FWD Clinical Research
Diverse Clinical Research
American Institute of Therapeutics
The Angel Medical Research
Cambridge Medical Trials
Heartbeat Health
Henri-Mondor Hospital
Florida Cardiovascular Research
LINQ Research LLC

intervention_type: Device


title: Validation of WBS08 With Withings ECG Monitor for the Detection of Atrial Fibrillation

summary: The aim of the study is to evaluate the performance of Withings WBS08 with embedded Withings ECG Monitor in the automatic detection of atrial fibrillation


acronym: SURPASS-CVOT

lead_sponsor: Eli Lilly and Company

summary: The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

ReferenceCitation: Kaneko S. Tirzepatide: A Novel, Once-weekly Dual GIP and GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes. touchREV Endocrinol. 2022 Jun;18(1):10-19. doi: 10.17925/EE.2022.18.1.10. Epub 2022 Jun 16.

publisher_dissemination: Touch Medical Media, Ltd.

location_facility: Tianjin Medical University General Hospital

location_facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

location_facility: First City Clinical Hospital E.E. Volosevich

location_facility: Diabetes and Thyroid Center of Ft. Worth

location_facility: UCSD - Altman Clinical and Translational Research Institute (ACTRI)

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: Cotton O'Neil Clinical Research Center - Central Office

location_facility: The Second Affiliated Hospital of Nanjing Medical University

location_facility: Centro de Estudios Clínicos de Querétaro (CECLIQ)

location_facility: Reinier de Graaf Ziekenhuis, locatie Delft

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: Russian Cardiology Research and Production Complex

location_facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi

location_facility: Norcal Endocrinology & Internal Medicine

location_facility: Centro de Investigacion Cardiovascular y Metabólica

location_facility: Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos

location_facility: Vinnytsia Regional Clinical Endocrinology Dispensary

location_facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

location_facility: L.T. Mala National Institute of Therapy of NAMS of Ukraine

location_facility: University of Alabama at Birmingham Medical Center

location_facility: Topiwala National Medical College & B. Y. L. Nair Charitable Hospital

location_facility: Private Practice - Dr. Osvaldo A. Brusco

location_facility: IBPClin - Instituto Brasil de Pesquisa Clínica

location_facility: General Hospital of Ningxia Medical University

location_facility: The Institute for Adult Disease, Asahi Life Foundation

location_facility: Zentrum für klinische Studien Dr Hanusch Gmbh

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Praxis für Inner Medizin - Diabetologische Schwerpunktpraxis

location_facility: Academy of Diabetes, Thyroid and Endocrine

location_facility: First Moscow State Medical University I.M. Sechenov

location_facility: Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: First Huai'an Hospital Affiliated to Nanjing Medical University

location_facility: Yaroslavl State Med Acad Clinical Hospital

location_facility: Hull and East Yorkshire Hospitals NHS Trust

location_facility: PMG Research Inc., d/b/a PMG of Piedmont Healthcare

location_facility: SN ZOZ Lege Artis Poradnia Diabetologiczna

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Universität zu Lübeck - Institut für Endokrinologie und Diabetes

location_facility: Regional Clinical Hospital of the Saratov Region

location_facility: M. F. Vladimirskiy Moscow Regional Research Clinical Institute

location_facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

location_facility: National Medical Research Center for therapy and preventive medicine

location_facility: Riverside University Health System - Medical Center

location_facility: Medizinisches Versorgungszentrum am Bahnhof Spandau

location_facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Institut für Diabetesforschung GmbH Münster

location_facility: Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen

location_facility: NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

location_facility: Dr. Sadi Konuk Egitim ve Arastirma Hastanesi

location_facility: Fundación Cardiovascular de Aguascalientes A.C.

location_facility: Ryazan Regional Clinical Cardiological Dispensary

location_facility: Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Institut für klinische Forschung und Entwicklung

location_facility: Private Practice - Dr. Arechavaleta Granell Maria del Rosario

location_facility: Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels

location_facility: Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council

location_facility: Ukrainian State Research Institute Of Medical And Social Problems Of Disability

location_facility: Università degli Studi Gabriele D' Annunzio

location_facility: Instituto de Investigaciones Clínicas Bahia Blanca

location_facility: Chernivetsky Oblasny Endokrynologichny Centr, Oblasna Komunalna Ustanova

location_facility: Cardiology Partners Clinical Research Institute - Wellington

location_facility: Cardiology Partners Clinical Research Institute - Palm Beach Gardens

location_facility: Instituto de Diabetes, Obesidad y Nutricion

location_facility: John Muir Medical Center - Concord Campus

location_facility: Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

location_facility: ISPEM - Instituto São José dos Campos em Pesquisas Médicas

location_facility: Clalit Health Services Diabetes and Endocrinology Clinic Jerusalem

location_facility: Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien

location_facility: North York Diagnostic and Cardiac Centre

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: The First Hospital of Lanzhou University

location_facility: Practice Dr.med. Denger and Dr.med. Pfitzner

location_facility: Yonsei University-Wonju Severance Christian Hospital

location_facility: Municipal Non-Profit Enterprise "City clinical hospital №8" of Kharkiv city council

location_facility: CIDIM-Centro Integral de Diagnostico por Imagenes Marchegiani

location_facility: Cardiology Consultants of Philadelphia Yardley

location_facility: Asociación de Beneficencia Hospital Sirio Libanés

location_facility: Pesquisa Clínica em Diabetes - Dra Rosângela Réa

location_facility: Diabetologische Schwerpunktpraxis und Praxis für Allgemeinmedizin Dr. Veronika Wenzl-Bauer null Josef Wenzl

location_facility: Alliance for Multispecialty Research, LLC

location_facility: The University of Kansas - Clinical Research Center

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: Instituto de Cardiología "Juana F. Cabral"

location_facility: Centro de Investigacion Medica Aguascalientes

location_facility: Fondazione Salvatore Maugeri Clinica del lavoro

location_facility: Pirogov Russian National Research Medical University

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia

location_facility: Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob, Dr. med. Frohmut Jacob

location_facility: Centro Universitario de Investigación en Farmacologia Clínic

location_facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital

location_facility: CIMS Hospital - Care Institute of Medical Sciences

location_facility: Diabetologische Schwerpunktpraxis Diabetologikum Speyer

location_facility: Private Practice - Dr. Claus Busch, Dr. Christian Busch & Dr. Christopher Cramer

location_facility: Dnipropetrovsk City Clinical Hospital No. 9

location_facility: Milan Kvapil s.r.o., Diabetologicka ambulance

location_facility: Instituto de Investigaciones Clinicas Rosario

location_facility: PMG Research, Inc. d/b/a PMG Research of Knoxville

location_facility: Albany Medical College, Division of Community Endocrinology

location_facility: Monterey Endocrine & Diabetes Institute, Inc.

location_facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej

location_facility: "Fatebenefratelli Isola Tiberina - Gemelli Isola"

location_facility: Private Practice - Dr. Ilka Simon-Wagner

location_facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul

location_facility: Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Osrodek Diabetologiczny Popula Spolka Cywilna

location_facility: VA Nebraska-Western Iowa Health Care System

location_facility: Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut

location_facility: Encore Research Group- Jacksonville Center for Clinical Research

location_facility: North Hills Family Medicine/North Hills Medical Research

location_facility: G.B. Pant Institute of Postgraduate Medical Education & Research

location_facility: Centro Medico Privado San Vicente Diabetes

location_facility: Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho

location_facility: Endocrinology Research Center of Rosmedtechnologies

location_facility: Batra Hospital and Medical Research Centre

location_facility: Institute of Endocrinology and Metabolism named after Komissarenko

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Chang Gung Medical Foundation-Linkou Branch

title: The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT)

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Slovakia
Hungary
United States
Ukraine
India
Belgium
China
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


summary: The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and to evaluate the safety, antitumor activity and pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as Diffuse Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced solid tumors for whom no further effective standard treatment is available.

location_facility: Uni of TX MD Anderson Cancer Cntr Dept of Onc

title: A Phase I/II, Multicenter, Open-label Study of MAK683 in Adult Patients With Advanced Malignancies

location_country:
Germany
Italy
Hong Kong
Singapore
Japan
United States
China
Spain
Canada
France


lead_sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

summary:
This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.

This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks).

This trial will determine if the benefit of using either study product outweighs the risks.

ReferenceCitation: Blume-Peytavi U, Shapiro J, Messenger AG, Hordinsky MK, Zhang P, Quiza C, Doshi U, Olsen EA. Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study. J Drugs Dermatol. 2016 Jul 1;15(7):883-9.

location_facility: Klinik für Dermatologie, Venerologie und Allergologie, Clinical Research Center for Hair and Skin Science

title: A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5 % Minoxidil Foam vs. 2 % Minoxidil Solution in Females for the Treatment of Female Pattern Hair Loss - Androgenetic Alopecia (MINALO3004, NCT01145625)

location_country:
Germany
United Kingdom
United States
Canada
France


title: Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial

summary:
The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment.

The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient's tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER

collaborators: Cancer Research UK & UCL Cancer Trials Centre

collaborators: GlaxoSmithKline Research & Development Limited

location_country:
United Kingdom
Belgium
France

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: GCS UNICANCER SIEGE

type_etablissement: GCS

titre: Sélection moléculaire des cancers biliaires avancés pour une médecine de précision.

discipline_principale: cancer

nom_porteur: MALKA

prenom_porteur: David


title: Chronic Myeloid Leukemia (CML) Real-Life Database

summary: Establish the largest possible real-life cohort collecting long-term follow-up of a maximum number of CML patients in order to carry out observational studies: epidemiological, identification of subgroups according to their response to treatment, evaluation of new molecules in real life, therapeutic discontinuations, impact of the evolution of recommendations, etc.

time_perspective: Other

ReferenceCitation: Saugues S, Lambert C, Daguenet E, Ansah HJ, Turhan A, Huguet F, Guerci-Bresler A, Tchirkov A, Hamroun D, Hermet E, Pereira B, Berger MG. Real-world therapeutic response and tyrosine kinase inhibitor discontinuation in chronic phase-chronic myeloid leukemia: data from the French observatory. Ann Hematol. 2022 Oct;101(10):2241-2255. doi: 10.1007/s00277-022-04955-z. Epub 2022 Aug 30.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: A Six-month Double-blind, Randomized, Placebo-controlled Study Investigating the Safety and Tolerability of Deferiprone in Patients With Friedreich's Ataxia

summary:
The primary objective of this study is to demonstrate the safety and tolerability of deferiprone in subjects with Friedreich's ataxia (FRDA).

The secondary objective is to evaluate the efficacy of deferiprone for the treatment of FRDA, as assessed by a 9-Hole Peg Test (9HPT), Timed 25-Foot Walk (T25FW), Low-Contrast Letter Acuity test (LCLA), International Cooperative Ataxia Rating Scale (ICARS), and Friedreich's Ataxia Rating Scale (FARS).

The tertiary objectives are to evaluate the effect of deferiprone on:

cardiac function as measured by changes in Left Ventricular Shortening Fraction (LVSF), Left Ventricular Ejection Fraction (LVEF) and Left Ventricular (LV) mass using echocardiogram (ECHO),
quality of life using quality-of-life surveys, and
functional status using Activities of Daily Living (ADL).

lead_sponsor: ApoPharma

location_country: Italy Australia Belgium Spain Canada France

location_facility: Fondazione IRCCS Istituto Neurologico "C. Besta"

location_facility: La Fundacion Para la Investigacion Biomedica


title: Randomized Clinical Trial to Evaluate the Interest of a Down-scaled Treatment Strategy Using Dual Therapy (Nucleoside Analogs) in HIV Infected Patients Already Being Treated Using Triple Therapy, Who Present With a Successful Virological Control and for Which the HIV Reservoir is Low to Moderate

acronym: TRULIGHT

summary:
In the early 2000s, the "TRILEGE©" study was realized to determine if the reductive anti retroviral strategy from an initial triple therapy (based on a protease inhibitor as the third agent) towards a dual therapy of nucleoside analogs (in particular the association of "zidovudine +lamivudine") for patients infected by HIV and stabilized for at least 3 months at a threshold value of 400 copies/ml, would allow to obtain a well-controlled plasmatic viral load, with an aim to reduce the long-term side effects of the treatment.

The afore mentioned study showed that the reductive anti retroviral strategy was a failure. No study has as yet to revaluate this strategy, in particular in the current context of antiretroviral treatments.

Indeed, modern nucleoside inhibitors (Kivexa®, Truvada®) have extended half-lives as well as a superior intrinsic power as compared to treatments proposed in the initial "TRILEGE©" study. Furthermore, the better quality of current triple therapy (as compared to that used 10 years ago) has lead to substantial viral reservoir reduction.

Currently, a small number of patients is being successfully treated in the long-term (viral load < 20 copies/ml) using nucleoside analog dual therapy. The particular characteristics of these patients have yet to be thoroughly investigated.

The patients concerned were all treated prematurely before ever passing below 200 lymphocytes T CD4/mm3. It occurred that all these patients presented a low viral reservoir as measured by HIV DNA quantification (< 2,7 log copies/106 PBMC).

Therefore, by targeting patients who have (1) a strong immune restoration, (2) a low HIV DNA value and (3) a very good observance, the investigators emit the hypothesis that, reductive anti retroviral strategy that would consist in changing from a conventional triple therapy towards a Nucleoside reverse-transcriptase inhibitors dual therapy, could allow for durable control of viral replication with the concomitant benefice of reduced antiretroviral side effects and cost.

ReferenceCitation: Prazuck T, Verdon R, Le Moal G, Ajana F, Bernard L, Sunder S, Roncato-Saberan M, Ponscarme D, Etienne M, Viard JP, Pasdeloup T, Darasteanu I, Pialoux G, de la Blanchardiere A, Avettand-Fenoel V, Parienti JJ, Hocqueloux L; TRULIGHT Study Team. Tenofovir disoproxil fumarate and emtricitabine maintenance strategy in virologically controlled adults with low HIV-1 DNA: 48 week results from a randomized, open-label, non-inferiority trial. J Antimicrob Chemother. 2021 May 12;76(6):1564-1572. doi: 10.1093/jac/dkab038.

ReferenceCitation: Hocqueloux L, Gubavu C, Prazuck T, De Dieuleveult B, Guinard J, Seve A, Mille C, Gardiennet E, Lopez P, Rouzioux C, Lefeuvre S, Avettand-Fenoel V. Genital Human Immunodeficiency Virus-1 RNA and DNA Shedding in Virologically Suppressed Individuals Switching From Triple- to Dual- or Monotherapy: Pooled Results From 2 Randomized, Controlled Trials. Clin Infect Dis. 2020 Apr 15;70(9):1973-1979. doi: 10.1093/cid/ciz511.

lead_sponsor: University Hospital, Tours

sponsor_collaborators:
University Hospital, Tours
HOSPITAL, ORLEANS
Poitiers University Hospital
Centre Hospitalier de La Rochelle
HOSPITAL, SAINTES
HOSPITAL, FOCH
HOSPITAL, CAEN
Henri Mondor University Hospital
HOSPITAL, HOTEL DIEU
HOSPITAL, CHARTRES
HOSPITAL, SAINT LOUIS
Tourcoing Hospital
Central Hospital, NIORT
Tenon Hospital, Paris
Central Hospital, Nancy, France
University Hospital, Rouen

location_facility: Service des Maladies Infectieuses et tropicales, APHP SAINT LOUIS

location_facility: Service de Medecine Interne et Maladies Infectieuses, CHRU BRETONNEAU, TOURS CEDEX9

location_facility: Service des maladies Infectieuses et tropicales, CH GEORGES RENON

location_facility: Service Universitaire des Maladies Infectieuses et du Voyageur, CH DRON

location_facility: Service de Pneumologie, centre Hospitalier Fontenoy, CH de CHARTRES

location_facility: Service de Médecine Interne, CH de SAINTONGE- BP 326

location_facility: Centre de diagnostic et thérapeutique, Hopital Hotel Dieu

location_facility: Service de Médecine Interne et Maladies Infectieuses, Groupe Hospitalier La Rochelle, Cedex 01

location_facility: Unité des Maladies Infectieuses, CHU de CAEN

location_facility: Service des Maladies Infectieuses, CHR Orléans La Source, ORLEANS CEDEX 2

location_facility: Service d'Immunologie Clinique centre de Vaccination anti- VIH ANRS Hopital Henri- Mondor

location_facility: Consultation Maladies Infectieuses, Chu de Poitiers, Cedex


title: Personalized Spacing of Eculizumab Infusions Based on Therapeutic Pharmacological Monitoring: Prospective Health-economic Evaluation in Patients in Remission With Atypical Hemolytic Uraemic Syndrome Requiring Long-term Treatment.

acronym: EspacECU

summary: Eculizumab is an anti-C5 monoclonal antibody approved for rare diseases including atypical haemolytic-uraemic syndrome. The maintenance phase dosing regimen is identical for all adult patients but several studies have shown a high interindividual kinetics variability. A tailored administration of eculizumab based on therapeutic drug monitoring will be compared with real-life administration in adults suffering from an atypical haemolytic uraemic syndrome. The objective is to improve efficiency of eculizumab administration.

collaborators: Centre Hospitalier Universitaire, Amiens

collaborators: Centre Hospitalier Universitaire de Besancon

collaborators: Centre Hospitalier Universitaire de Nice

collaborators: Assistance Publique Hopitaux De Marseille

location_facility:
Hotel Dieu
Hôpital Tenon
Hôpital Gabriel Montpied
Hôpital Maison Blanche
Hôpital Pontchaillou
Hôpital de la Côte de Nacre
Hopital Necker
Hopital Pasteur 2
CHU Besançon
Hopital de la conception
Nouvel Hôpital Civil
CHU d'Angers
Hospices Civils de Lyon
Hôpital de la Milétrie
Hôpitaux de Brabois
CHU Amiens Picardie
Hôpital de Bois-Guillaume
Hôpital Louis Pasteur

appel_a_projets: PRME

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

type_etablissement: CHUR

acronyme: EspacECU

titre: Espacement personnalisé des perfusions d'éculizumab basé sur un suivi thérapeutique pharmacologique : Evaluation médico-économique prospective multicentrique chez les patients en rémission atteints d'un syndrome hémolytique et urémique atypique nécessitant un traitement au long cours.

discipline_principale: néphrologie

nom_porteur: GATAULT

prenom_porteur: Philippe


title: Safety & Efficacy of Neoadjuvant Immunotherapy With Durvalumab (MEDI 4736) Combined With Neoadjuvant Chemotherapy (Gemcitabine/Cisplatin or Gemcitabine/Carboplatin) in Patients With Operable, High-risk, Localized Urothelial Carcinoma of the Upper Urinary Tract

acronym: iNDUCT

summary:
Following radical nephrectomy (RNU) for upper tract urothelial carcinoma (UTUC) most patients face a poor prognosis. Indeed, patients who have undergone RNU for UTUC have 5-year recurrence-free and cancer specific survival probabilities of 69% and 73% respectively.

The primary objective of this study is to assess the pathological complete response rate to combination therapy with neoadjuvant durvalumab and chemotherapy (Gemcitabine/Cisplatin) before surgery in patients with high-risk, localized, non-metastatic urothelial carcinomas of the upper tract.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

collaborators: Hôpital Bichat-Claude Bernard, 75018 Paris

location_facility:
Hôpital Européen Georges Pompidou
Institut Paoli Calmette
Hôpital Bichat-Claude Bernard
Centre hospitalier Lyon Sud
Hôpital Saint Louis
Hôpital Foch
Hôpital Pitié Salpétrière
Iuct Oncopole
Centre Eugène Marquis


title: Safety and Efficacy of Endovascular Treatment of Unruptured Intracranial Aneurysms in the Prevention of Aneurysmal Haemorrhages: A Randomized Comparison With Indefinite Deferral of Treatment in 2002 Patients Followed for 10 Years

acronym: TEAM

summary: The management of patients with unruptured aneurysms is controversial. Patients with unruptured aneurysms may suffer intracranial hemorrhage, but the incidence of this event is still debated. Endovascular treatment can prevent rupture, but involves immediate risks; furthermore, successful treatment does not eliminate all risks. A randomized trial may be the best way to demonstrate the potential benefits of endovascular over conservative management of unruptured aneurysms.

ReferenceCitation: Raymond J, Meder JF, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; Trial on Endovascular Aneurysm Management (TEAM) collaborative group. Trial on endovascular treatment of unruptured aneurysms (TEAM): study monitoring and rationale for trial interruption or continuation. J Neuroradiol. 2007 Mar;34(1):33-41. doi: 10.1016/j.neurad.2007.01.011.

ReferenceCitation: Raymond J, Meder JF, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; Trial On Endovascular Aneurysm Management Team Collaborative Group. Unruptured intracranial aneurysms: the unreliability of clinical judgment, the necessity for evidence, and reasons to participate in a randomized trial. J Neuroradiol. 2006 Oct;33(4):211-9. doi: 10.1016/s0150-9861(06)77266-2. No abstract available.

ReferenceCitation: Raymond J, Guilbert F, Weill A, Roy D. Unruptured intracranial aneurysms: a call for a randomized clinical trial. AJNR Am J Neuroradiol. 2006 Feb;27(2):242-3. No abstract available.

ReferenceCitation: Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A, Lamoureux J, Chagnon M, Roy D. Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke. 2003 Jun;34(6):1398-403. doi: 10.1161/01.STR.0000073841.88563.E9. Epub 2003 May 29.

ReferenceCitation: Raymond J, Chagnon M, Collet JP, Guilbert F, Weill A, Roy D. A randomized trial on the safety and efficacy of endovascular treatment of unruptured intracranial aneurysms is feasible. Interv Neuroradiol. 2004 Jun 29;10(2):103-12. doi: 10.1177/159101990401000202. Epub 2004 Oct 22.

ReferenceCitation: Raymond J, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; TEAM Collaborative Group. The TEAM trial: safety and efficacy of endovascular treatment of unruptured intracranial aneurysms in the prevention of aneurysmal hemorrhages: a randomized comparison with indefinite deferral of treatment in 2002 patients followed for 10 years. Trials. 2008 Jul 16;9:43. doi: 10.1186/1745-6215-9-43.

ReferenceCitation: Naggara O, Raymond J, Guilbert F, Roy D, Weill A, Altman DG. Analysis by categorizing or dichotomizing continuous variables is inadvisable: an example from the natural history of unruptured aneurysms. AJNR Am J Neuroradiol. 2011 Mar;32(3):437-40. doi: 10.3174/ajnr.A2425. Epub 2011 Feb 17.

ReferenceCitation: Raymond J. Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009 Feb;22(1):96-102. doi: 10.1097/wco.0b013e32831fee91.

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

collaborators: Canadian Institutes of Health Research (CIHR)

location_country:
United States
United Kingdom
Canada
France

location_facility: TEAM France Coordination Unit - CHU Reims CRICAM

location_facility: TEAM European Coordination Centre NVRU- Radcliffe Infirmary

location_facility: CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office)


title: Clinical Trial Comparing Two Electroconvulsive Therapy (ECT) Application Schemas in Ultra-resistant Schizophrenia

acronym: SURECT

summary: The effects of the ECT in schizophrenia ultra-resistant were studied in short times (4-6 months in most studies with follow-up). The literature identified a high relapse rate of 32% in the weeks to months after ECT discontinuation. The use of the ECT in the prevention of the relapse is partially known. In an empirical way, experts recommend protocols of prevention of the relapse going from 6 to 12 months. Nevertheless, the profit of a long cure (12 months) compared with a short cure (6 months) was never determined. Therefore, the investigators decided to lead a prospective randomized controlled study in order to compare the response rates between the two strategies of clozapine and ECT combinations applied to URS patients. The treatment consisted either in a short therapy of six months or a longer course of therapy of twelve months. To the investigators' knowledge, it is the first study which compares two ECT strategies (both the short duration and the longer one) for the treatment of URS patients.

ReferenceCitation: Moulier V, Krir MW, Dalmont M; SURECT Group; Guillin O, Rotharmel M. A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study). Trials. 2021 Apr 15;22(1):284. doi: 10.1186/s13063-021-05227-3.

lead_sponsor: Centre Hospitalier du Rouvray

collaborators: Centre hospitalier de Ville-Evrard, France

location_facility:
Montpellier University Hospital
EPS Ville Evrard
CHU de Caen
Centre Hospitalier Charles Perrens
Centre Hospitalier Henri Laborit
CHU de Toulouse
Centre Hospitalier de Cadillac
Clermont-Ferrand Hospital
CHU de Nantes
Centre Hospitalier Saint Anne

appel_a_projets: PHRCN

region: Normandie

nom_etablissement: CHS DU ROUVRAY SOTTEVILLE-LES-ROUEN

type_etablissement: EPSM

acronyme: SURECT

titre: ECT dans la schizophrénie Ultra-Résistante

discipline_principale: psychiatrie / addictologie

nom_porteur: GUILLIN

prenom_porteur: Olivier


title: Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

acronym: ZERO-AF

summary: The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Portugal
United Kingdom
Australia
Sweden
United States
Spain
Czechia
France

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: University of North Carolina Medical Center

location_facility: University of Texas Health Science Center

location_facility: Hospital of the University of Pennsylvania

location_facility: Strong Memorial Hospital of the University of Rochester


title: FREnch Data on Outcomes in HR+/HER2- Early Breast Cancer Patients With oncotypeDX Recurrence Score-guided Therapy

summary: The aim of this study is to assess the clinical outcomes in real-life setting of early breast cancer RH+ HER2- patients with systemic therapy guided by Oncotype DX (ODX) Breast Recurrence Score®.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU Besançon
Centre Catalan d'Oncologie
Clinique Tivoli Ducos
AP-HP - Hôpital Tenon
Polyclinique Bordeaux Nord Aquitaine


title: Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis Indicated for the Treatment of Primary and Secondary First Line Gonarthrosis and Revision Arthroplasty - 2 Years Follow-up - A Pilot Study

acronym: FHK-CK

summary:
The life expectancy worldwide is increasing and leading to an increase of knee arthroplasty. Also, as millions of people around the world are currently living with a Total Knee Arthroplasty (TKA), the need for revision surgery represents a large public health burden. In this context, FH ORTHO company develops FHK®-CK (prosthesis + ancillary equipment) which is a knee prosthesis for complex first intention and revision knee arthroplasty. This new medical device complements the FHK® standard first-line range (CE marked).

The FHK®-CK ancillary equipment were designed by expert knee surgeons and is simple, reliable and reproducible. It allows for maximum versatility while remaining compact.

By completing the FHK® range of first intention prostheses, the FHK®-CK allows the surgeon to be on the same level as the competitors by having a first intention and semi-constrained prosthesis. This prosthetic arsenal allows the surgeon to opt for the best solution for his patient so that he can regain mobility and a satisfactory quality of life. Also, in case of failure of the FHK® first-line prosthesis, it will provide the surgeon and the patient with a simple alternative to prosthesis replacement. As it has been developed in line with the first intention, inter-compatibility between the two systems is possible, which simplifies the surgical procedure and reduces the risks for the patient.

primary_purpose: Other

lead_sponsor: FH ORTHO

sponsor_collaborators:
FH ORTHO
Slb Pharma

location_facility: Groupe Hospitalier Pitié Salpêtrière AP-HP

location_facility: Centre Hospitalier Régional Universitaire de Nancy


title: Clinical and Medico-economic Study to Validate the Performance of a Digital and Personalized Solution (HEPHAÏ) to Support the Use of Inhaled Treatments for Asthma and COPD

acronym: VAL-HEPHAI

summary:
In a context where the use of inhalation devices for respiratory medications is associated with a high frequency of critical errors, our primary hypothesis is that the use of the HEPHAÏ solution reduces this frequency compared to standard care.

The objective of this clinical study is to evaluate the performance of the HEPHAÏ solution as a tool for improving the administration of inhaled treatments in patients undergoing pulmonary care for asthma and/or COPD, who are receiving treatment with Innovair® or Trimbow®. These two inhalers were chosen for reasons of feasibility and compatibility with the version of the HEPHAÏ software provided as part of the clinical investigation

lead_sponsor: Hephai

location_facility:
Hôpital Arnaud de Villeneuve
CHU de Dijon
Hôpital BICHAT
Pitié-Salpêtrière Hospital
Hôpital COCHIN


title: Study of Families With an Hemopathies Predisposition Related to the DDX41 Gene.

acronym: LUCID

summary:
This is a multicenter, interventional, historico-prospective cohort pilot study aimed at specifying the phenotype of subjects carrying a constitutional familial DDX41 mutation, with a view to eventually publishing oncogenetic recommendations for carriers of this mutation.

The main objective of the LUCID project is to assess the cumulative risk of hematological diseases (Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) or cytopenia) as a function of age in DDX41 germline mutation carriers.

This study will be carried out in two stages:

Stage 1: Inclusion of index cases in an oncogenetic consultation (salivary test, completion of an health self-questionnaire and collection of contact details for the related cases).

Stage 2: Proposition of participation to family members, by correspondence, and determination of carrier or non-carrier status of the constitutional familial DDX41 mutation (based on a salivary test).

A maximum of 210 index case patients and 700 family member will be included in this study.

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Paoli-Calmettes
Chu de Bordeaux
Chu de Montpellier
Chu de Limoges
IUCT-O

intervention_type: Genetic


title: Evaluation of a New Microprocessor-Controlled Prosthetic Knee : A Prospective, Multicentered, Randomized Cross-over Trial

summary: The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK. Subjects will also run functional tests and questionnaires to compare performances and feedback with each prosthetic knee.

lead_sponsor: Proteor Group

location_facility:
Clinique du Dr Ster
Centre Mutualiste de Kerpape
UGECAM Nord-Est IRR
Hôpital Léon Bérard
UGECAM La Tourmaline


title: Evaluation of Multisite Sampling to Detect C. Trachomatis or N. Gonorrheae Compared With Vaginal Sampling in Women at Risk for Sexually Transmitted Infections (STI)

acronym: SIST'RS

summary:
Screening for STIs in MSM is based on multisite samples: urine, anal and oral for PCR targeting C. trachomatis, N. gonorrhoeae, M. genitalium and T. vaginalis, whereas only vaginal self-sampling is recommended in women.

Recent publications and observations suggest that a substantial number of STIs are under diagnosed with the current recommendations.

The main objective of the study is to assess the number and percentage of additional C. trachomatis and N. gonorrhoeae infections diagnosed by a multiple sampling strategy in women, particularly when the vaginal sampling is negative The secondary objective will assess the acceptability of anal and oropharyngeal self-sampling relative to vaginal self-sampling in women.

ReferenceCitation: Prazuck T, Lanotte P, Le Moal G, Hocqueloux L, Sunder S, Catroux M, Garcia M, Perfezou P, Gras G, Plouzeau C, Leveque N, Beby-Defaux A. Pooling Rectal, Pharyngeal, and Urine Samples to Detect Neisseria gonorrhoeae, Chlamydia trachomatis, and Mycoplasma genitalium Using Multiplex Polymerase Chain Reaction Is as Effective as Single-Site Testing for Men Who Have Sex With Men. Open Forum Infect Dis. 2022 Oct 31;9(10):ofac496. doi: 10.1093/ofid/ofac496. eCollection 2022 Oct.

ReferenceCitation: Verougstraete N, Verbeke V, De Canniere AS, Simons C, Padalko E, Coorevits L. To pool or not to pool? Screening of Chlamydia trachomatis and Neisseria gonorrhoeae in female sex workers: pooled versus single-site testing. Sex Transm Infect. 2020 Sep;96(6):417-421. doi: 10.1136/sextrans-2019-054357. Epub 2020 May 13.

ReferenceCitation: Lunny C, Taylor D, Hoang L, Wong T, Gilbert M, Lester R, Krajden M, Ogilvie G. Self-Collected versus Clinician-Collected Sampling for Chlamydia and Gonorrhea Screening: A Systemic Review and Meta-Analysis. PLoS One. 2015 Jul 13;10(7):e0132776. doi: 10.1371/journal.pone.0132776. eCollection 2015.

repository_institution: Monash University - Monash University Research Portal

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Public Library of Science

ReferenceCitation: Alexander S, Ison C, Parry J, Llewellyn C, Wayal S, Richardson D, Phillips A, Smith H, Fisher M; Brighton Home Sampling Kits Steering Group. Self-taken pharyngeal and rectal swabs are appropriate for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in asymptomatic men who have sex with men. Sex Transm Infect. 2008 Nov;84(6):488-92. doi: 10.1136/sti.2008.031443.

ReferenceCitation: Wayal S, Llewellyn C, Smith H, Hankins M, Phillips A, Richardson D, Fisher M; Home Sampling Kit Project Steering Group. Self-sampling for oropharyngeal and rectal specimens to screen for sexually transmitted infections: acceptability among men who have sex with men. Sex Transm Infect. 2009 Feb;85(1):60-4. doi: 10.1136/sti.2008.032193. Epub 2008 Aug 15.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHU de STRASBOURG
CeGIDD
CH de Saint Nazaire
CHU de Tours
CHRU de POITIERS