title: A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease

summary: This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

design_allocation: Non-Randomized

location_country:
Italy
United States
Netherlands
Germany
France
Czechia
Poland
Israel
Slovakia
Norway
Hungary
Belgium
Romania
New Zealand
Spain
Denmark
Canada
United Kingdom

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 149870

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 149871

location_facility: Universitair Medisch Centrum Utrecht /ID# 149933

location_facility: Nature Coast Clinical Research - Inverness /ID# 149975

location_facility: Lovisenberg Diakonale Sykehus /ID# 149967

location_facility: Investigative Clinical Research /ID# 149886

location_facility: Centrum Medyczne Szpital Swietej Rodziny /ID# 149979

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 149963

location_facility: Options Health Research, LLC /ID# 150010

location_facility: Virginia Mason Medical Center /ID# 150042

location_facility: Cabinet Particular Policlinic Algomed /ID# 149993

location_facility: University of Florida - Archer /ID# 150033

location_facility: Manchester University NHS Foundation Trust /ID# 150006

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996

location_facility: Washington University-School of Medicine /ID# 149899

location_facility: Toronto Digestive Disease Asso /ID# 149877

location_facility: CHU Amiens-Picardie Site Sud /ID# 149921

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 149900

location_facility: NYU Langone Long Island Clinical Research Associates /ID# 149976

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 149863

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 149897

location_facility: Assaf Harofeh Medical Center /ID# 149943

location_facility: Kansas City Research Institute /ID# 149888

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 149882

location_facility: University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 149876

location_facility: Hospital Universitario La Paz /ID# 149997

location_facility: The Chaim Sheba Medical Center /ID# 149945

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890

location_facility: The Ctr for Gastro Disorders /ID# 150012

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 149958

location_facility: GIRI Gastrointestinal Research Institute /ID# 149878

location_facility: Texas Digestive Disease Consultants - Southlake /ID# 149869

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 149896

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149978

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 149930

location_facility: University of Alberta - Zeidler Ledcor Centre /ID# 149873

location_facility: Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907

location_facility: Univ California, San Francisco /ID# 149987

location_facility: Texas Digestive Disease Consultants - Southlake /ID# 149989


title: Mechanisms of Very Late Bioresorbable Scaffold Thrombosis Assessed by Optical Coherence Tomography: Insights From the International INVEST Registry

acronym: INVEST

summary:
Bioresorbable vascular scaffold (BVS, ABSORB BVS1.1, Abbott Vascular) has been approved (CE mark) and is used in daily clinical practice. While recent randomized controlled trials comparing BVS versus metallic drug-eluting stent showed higher risk of definite or probable device thrombosis after BVS implantation, the causes underlying thrombotic events occurring beyond one year after scaffold implantation remain unclear and require investigation in an independent manner.

The INVEST registry is a world-wide, multi-center, observational, retrospective, investigator-initiated registry, which will include any patients who suffered from very late (>1 year) scaffold thrombosis, underwent optical coherence tomography (OCT) at the time of thrombosis and provided informed consent for the further use of their health related data for this registry.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Serruys PW, Chevalier B, Sotomi Y, Cequier A, Carrié D, Piek JJ, Van Boven AJ, Dominici M, Dudek D, McClean D, Helqvist S, Haude M, Reith S, de Sousa Almeida M, Campo G, Iñiguez A, Sabaté M, Windecker S, Onuma Y. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016 Nov 19;388(10059):2479-2491. doi: 10.1016/S0140-6736(16)32050-5. Epub 2016 Oct 30. Erratum in: Lancet. 2017 Feb 25;389(10071):804.

ReferenceCitation: Kimura T, Kozuma K, Tanabe K, Nakamura S, Yamane M, Muramatsu T, Saito S, Yajima J, Hagiwara N, Mitsudo K, Popma JJ, Serruys PW, Onuma Y, Ying S, Cao S, Staehr P, Cheong WF, Kusano H, Stone GW; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015 Dec 14;36(47):3332-42. doi: 10.1093/eurheartj/ehv435. Epub 2015 Sep 1.

ReferenceCitation: Onuma Y, Sotomi Y, Shiomi H, Ozaki Y, Namiki A, Yasuda S, Ueno T, Ando K, Furuya J, Igarashi K, Kozuma K, Tanabe K, Kusano H, Rapoza R, Popma JJ, Stone GW, Simonton C, Serruys PW, Kimura T. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial. EuroIntervention. 2016 Oct 20;12(9):1090-1101. doi: 10.4244/EIJY16M09_01.

ReferenceCitation: Räber L, Brugaletta S, Yamaji K, O'Sullivan CJ, Otsuki S, Koppara T, Taniwaki M, Onuma Y, Freixa X, Eberli FR, Serruys PW, Joner M, Sabaté M, Windecker S. Very Late Scaffold Thrombosis: Intracoronary Imaging and Histopathological and Spectroscopic Findings. J Am Coll Cardiol. 2015 Oct 27;66(17):1901-14. doi: 10.1016/j.jacc.2015.08.853.

ReferenceCitation: de Jaegere P, Mudra H, Figulla H, Almagor Y, Doucet S, Penn I, Colombo A, Hamm C, Bartorelli A, Rothman M, Nobuyoshi M, Yamaguchi T, Voudris V, DiMario C, Makovski S, Hausmann D, Rowe S, Rabinovich S, Sunamura M, van Es GA. Intravascular ultrasound-guided optimized stent deployment. Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study). Eur Heart J. 1998 Aug;19(8):1214-23.

ReferenceCitation: Taniwaki M, Radu MD, Zaugg S, Amabile N, Garcia-Garcia HM, Yamaji K, Jørgensen E, Kelbæk H, Pilgrim T, Caussin C, Zanchin T, Veugeois A, Abildgaard U, Jüni P, Cook S, Koskinas KC, Windecker S, Räber L. Mechanisms of Very Late Drug-Eluting Stent Thrombosis Assessed by Optical Coherence Tomography. Circulation. 2016 Feb 16;133(7):650-60. doi: 10.1161/CIRCULATIONAHA.115.019071. Epub 2016 Jan 13.

ReferenceType: derived

ReferenceCitation: Yamaji K, Ueki Y, Souteyrand G, Daemen J, Wiebe J, Nef H, Adriaenssens T, Loh JP, Lattuca B, Wykrzykowska JJ, Gomez-Lara J, Timmers L, Motreff P, Hoppmann P, Abdel-Wahab M, Byrne RA, Meincke F, Boeder N, Honton B, O'Sullivan CJ, Ielasi A, Delarche N, Christ G, Lee JKT, Lee M, Amabile N, Karagiannis A, Windecker S, Räber L. Mechanisms of Very Late Bioresorbable Scaffold Thrombosis: The INVEST Registry. J Am Coll Cardiol. 2017 Nov 7;70(19):2330-2344. doi: 10.1016/j.jacc.2017.09.014.

family: Yamaji

full_name: Kyohei Yamaji

given: Kyohei

sequence: first

family: Ueki

full_name: Yasushi Ueki

given: Yasushi

sequence: additional

family: Souteyrand

full_name: Geraud Souteyrand

given: Geraud

family: Daemen

full_name: Joost Daemen

given: Joost

family: Wiebe

full_name: Jens Wiebe

given: Jens

family: Nef

full_name: Holger Nef

given: Holger

family: Adriaenssens

full_name: Tom Adriaenssens

given: Tom

family: Loh

full_name: Joshua P. Loh

given: Joshua P.

family: Lattuca

full_name: Benoit Lattuca

given: Benoit

family: Wykrzykowska

full_name: Joanna J. Wykrzykowska

given: Joanna J.

family: Gomez-Lara

full_name: Josep Gomez-Lara

given: Josep

family: Timmers

full_name: Leo Timmers

given: Leo

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Hoppmann

full_name: Petra Hoppmann

given: Petra

family: Abdel-Wahab

full_name: Mohamed Abdel-Wahab

given: Mohamed

family: Byrne

full_name: Robert A. Byrne

given: Robert A.

family: Meincke

full_name: Felix Meincke

given: Felix

family: Boeder

full_name: Niklas Boeder

given: Niklas

family: Honton

full_name: Benjamin Honton

given: Benjamin

family: O’Sullivan

full_name: Crochan J. O’Sullivan

given: Crochan J.

family: Ielasi

full_name: Alfonso Ielasi

given: Alfonso

family: Delarche

full_name: Nicolas Delarche

journal_name: Journal of the American College of Cardiology

location_country:
Italy
Austria
Hong Kong
Netherlands
Switzerland
France
Singapore
Belgium
Spain
Germany

location_facility: Deutsches Herzzentrum München, Technische Universität München,

location_facility: Department of Cardiology, CH F Mitterand, Pau Université Cedex, France.

location_facility: Department of Cardiology, University Hospital Leuven

location_facility: Academic Medical Center, University of Amsterdam

location_facility: Cardiology Division, Department of Medicine, Pamela Youde Nethersole Eastern Hospital

location_facility: Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.

location_facility: Hospital Universitari de Bellvitge, Institut d' Investigació Biomèdica de Bellvitge, Universitat de Barcelona, L' Hospitalet de Llobregat, Spain.

location_facility: Cardiology Division, Department of Medicine, Queen Elizabeth Hospital

location_facility: Department of Cardiology, University Hospital Caremeau

location_facility: 5th Medical Department with Cardiology, Kaiser Franz Josef Hospital

location_facility: Department of Cardiology, University of Giessen

location_facility: Heart Center, Segeberger Kliniken GmbH, Academic Teaching Hospital of the Universities of Kiel

location_facility: Department of Cardiology, Stadtspital Triemli

location_facility: Department of Cardiology, University Medical Centre Utrecht

location_facility: Department of Cardiology, Asklepios Klinik St. Georg

location_facility: Cardiology Department, CHU Clermont-Ferrand

location_facility: Department of Cardiovascular Medicine, Hypertension and Heart Failure Unit, Health Innovation Lab (Hi-Lab) Clinique Pasteur

location_facility: Cardiac Department, National University Heart Centre


design_allocation: Randomized

intervention_type: Drug

study_type: Interventional

lead_sponsor: Boehringer Ingelheim

primary_purpose: Treatment

location_country:
Italy
Guatemala
Mexico
France
Korea, Republic of
Poland
Russian Federation
United States
Canada

location_facility: 1218.56.48004 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.50202 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.82001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.82002 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.70006 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.70004 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.70001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.70003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52002 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.48001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52004 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.82005 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.48002 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.82003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.39005 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.01004 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.33003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.01006 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.52008 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.33006 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.48003 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.11001 Boehringer Ingelheim Investigational Site

location_facility: 1218.56.50203 Boehringer Ingelheim Investigational Site

type: EudraCT Number

source: euctr

title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Dose-finding Study of Linagliptin (1 and 5 mg Administered Orally Once Daily) Over 12 Weeks in Children and Adolescents, From 10 to 17 Years of Age, With Type 2 Diabetes Mellitus

summary:
The main objective of this study is to identify the dose of linagliptin in paediatric patients.

Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting plasma glucose (FPG) observed after 12 wk of treatment.

Furthermore, the study will investigate the pharmacokinetics (PK), the pharmacodynamics (PD) and the PK/PD relationship of linagliptin in the paediatric population.

lead_sponsor_type: industriel

status_simplified: Completed


status: Recruiting

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

enrollment_type: Anticipated

primary_purpose: Prevention

location_country:
Austria
India
Lebanon
Croatia
France
Israel
Hungary
Egypt
Spain
Turkey
United States
United Kingdom
Canada
Ukraine

location_facility: Wake Forest University Baptist Medical Center

location_facility: Vynnitsa Regional Children Clinical Hospital Policlinic Dept

location_facility: Novant Health Heart and Vascular institute

location_facility: University of California-San Francisco Department of Pediatrics - Hematology/Oncology

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

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Erciyes University Medical Faculty, Department of Children Hospital

location_facility: University of Florida College of Medicine

location_facility: Ege University Faculty of Medicine Department of Child Health and Diseases

location_facility: Alexandria Clinical Research Center, Faculty of Medicine

location_facility: Pediatric Cardiology Department, Hospital Necker Enfants Malades, APHP, Université Paris Descartes

location_facility: Children's Heart Centre at the American University of Beirut Medical Center

location_facility: Pediatric and Congenital Cardiology and Pulmonology Department; Arnaud De Villeneuve University Hospital

location_facility: McGill University Health Centre/Glen Site/Montreal Children's Hospital

location_facility: Kasr Elainy School of Medicine, Abo Elreesh Hospital (Japanese Hospital), Ali Basha Ibrahim ST Faculty of Medicine Cairo University

location_facility: Izmir-Dr. Behçet Uz. Pediatric Diseases and Surgery Training and Research Hospital- Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Communal Healthcare Institution Regional Pediatric Clinical Hospital, Kharkiv National Medical University

location_facility: Communal Institution Dnipropetrovsk Regional Pediatric Clinical Hospital of Dnipropetrovsk Regional Council, State Institution Dnipropetrovsk Medical Academy of MoH of Ukraine

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Kepler Universitätsklinikum Med Campus IV

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

ipd_sharing: Yes

study_completion_date_type: Anticipated

title: An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events

summary:
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).

All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.

The study will find out if edoxaban is safer and more effective than the standard of care.

status_simplified: Ongoing


ReferenceCitation: Tiddens HA, De Boeck K, Clancy JP, Fayon M, H G M A, Bresnik M, Derchak A, Lewis SA, Oermann CM; ALPINE study investigators. Open label study of inhaled aztreonam for Pseudomonas eradication in children with cystic fibrosis: The ALPINE study. J Cyst Fibros. 2015 Jan;14(1):111-9. doi: 10.1016/j.jcf.2014.06.003. Epub 2014 Aug 1.

family: Tiddens

full_name: H.A.W.M. Tiddens

family: De Boeck

full_name: K. De Boeck

given: K.

family: Clancy

full_name: J.P. Clancy

family: Fayon

full_name: M. Fayon

given: M.

full_name: Arets H.G.M.

given: Arets

family: Bresnik

full_name: M. Bresnik

family: Derchak

full_name: A. Derchak

given: A.

family: Lewis

full_name: S.A. Lewis

family: Oermann

full_name: C.M. Oermann

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Cystic Fibrosis

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Gilead Sciences

location_country:
Italy
Austria
Netherlands
Germany
France
Poland
Belgium
Spain
United States

acronym: ALPINE

location_facility: Klinik fur Kinder- und Jugendmedizinim St Josef-Hopsital

location_facility: Universitaetsklinikum Bonn-Zentrum fuer Kinderheikunde

location_facility: Centre hospitalier Robert Bissons CRCM - service pédiatrie

location_facility: Medizinische Universität Innsbruck Abt. für Kinder- und Jugendheilkunde, Pädiatrie III (Zystische Fibrose)

location_facility: Hospital Materno-Infantil Carlos Haya, Servicio de Neumología Pediatrica

location_facility: Service pédiatrie II Hôpital Necker Enfants Malades

location_facility: PennState Milton S. Hershey Medical Center

location_facility: Christiane Herzog CF-Center, Goethe University Hospital

location_facility: Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunolgie Prof. Wahn

location_facility: Azienda Ospedaliero-Universitaria di Catania, Dipartimento di Pediatria, UO Broncopneumologia Pediatrica

location_facility: Universitätsklinikum Essen, Zentrum für Kinderheilkunde - Abteilung Allg. Kinderheilkunde/Neuropaediatrie

location_facility: Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem, Poradnia Leczenia Mukowiscydozy

location_facility: Division of Respiratory Medicine and Allergology, Department of Pediatrics, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands

location_facility: Pediatric Respiratory Department, Ghent University Hospital

location_facility: CHU de Boredaux Hôpital des Enfants - Pellegrin CEDRE

location_facility: Centre de Ressources et de Compétences sur la Mucoviscidose ( CRCM), Roscoff, France

location_facility: Instytut Gruźlicy i Chorób Płuc, Klinki Pneumologii i Mukowiscydozy

location_facility: Instytut Matki i Dziecka Klinika Pediatrii

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Fondazione IRCCS, Ospedale Pediatrico, Bambino Gesu' di Roma

location_facility: Pediatric Pulmonology, Dept Pediatrics University Hospital Gasthuisberg

location_facility: Hospital Vall D' Hebron Pediatric Pneunmonology and Cystic Fibrosis Clinic

location_facility: Hospital infantil Universitario Niño Jesus, Servicio de Neumología Pediatrica

location_facility: Hôpital Universitaire des Enfants Reine Fabiola Brussels

location_facility: Paediatrics, University Hospital Brussels (UZB)

location_facility: Cystic Fibrosis Centre Paediatric Department, A. Meyer Children Hospital Florence

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Longziekten Universitair Medisch (PEDIATRIC), Ultrecht

location_facility: Centro Fibrosi Cistica di Verona, Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Toledo Children's Hospital CF Research Center

title: Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas Aeruginosa (PA)

summary:
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection. All eligible participants will be treated with a 28-day course of Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug, subjects will be followed up through Day 196 for safety and recurrence of PA.

The primary objective is to evaluate the proportion of participants with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).


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.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Holostem Terapie Avanzate s.r.l.

location_country: Italy Germany France

location_facility: Universitätsklinikum Erlangen Kinder- und Jugendklinik

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


title: Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation. The PREVENTION Randomized Multicenter Study

acronym: PREVENTION

summary: Tracheal intubation (TI) is associated with a high risk of adverse events in critically ill patients and peri-intubation hemodynamic collapse is the most commonly observed. The primary aim of the PREVENTION trial is to compare the effect of the pre-emptive use of noradrenaline versus no peri-intubation use of noradrenaline on incidence of cardiovascular collapse following TI in adult critically ill patients. Patients with absolute indication or contraindication to vasopressor support will be excluded from this trial. Patients will be randomized 1:1 to a continuous infusion of noradrenaline started before induction titrated to the goal of MAP 100 mmHg. The primary outcome will be the incidence of cardiovascular collapse. Secondary outcomes will include lowest systolic blood pressure within 30 minutes, ICU and in-hospital mortality.

ReferenceType: result

ReferenceCitation: Russotto V, Myatra SN, Laffey JG, Tassistro E, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Pelosi P, Sorbello M, Higgs A, Greif R, Putensen C, Agvald-Öhman C, Chalkias A, Bokums K, Brewster D, Rossi E, Fumagalli R, Pesenti A, Foti G, Bellani G; INTUBE Study Investigators. Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries. JAMA. 2021 Mar 23;325(12):1164-1172. doi: 10.1001/jama.2021.1727. Erratum in: JAMA. 2021 May 24;:null.

name: School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

name: Department of Emergency and Intensive Care, University Hospital San Gerardo, Monza, Italy

family: Russotto

full_name: Vincenzo Russotto

given: Vincenzo

name: Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India

family: Myatra

full_name: Sheila Nainan Myatra

given: Sheila Nainan

name: Regenerative Medicine Institute at CURAM Centre for Medical Devices, School of Medicine, National University of Ireland Galway, Galway, Ireland

name: Anesthesia and Intensive Care Medicine, University Hospital Galway, Galway, Ireland

family: Laffey

full_name: John G. Laffey

given: John G.

name: Bicocca Center of Bioinformatics, Biostatistics and Bioimaging (B4 center), University of Milano-Bicocca, Monza, Italy

family: Tassistro

full_name: Elena Tassistro

given: Elena

family: Antolini

full_name: Laura Antolini

given: Laura

name: Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota

family: Bauer

full_name: Philippe Bauer

given: Philippe

name: Médecine Intensive Réanimation, University Hospital Center, Nantes, France

family: Lascarrou

full_name: Jean Baptiste Lascarrou

given: Jean Baptiste

name: Department of Interdisciplinary Intensive Care, Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland

family: Szuldrzynski

full_name: Konstanty Szuldrzynski

given: Konstanty

name: Health Centre for Human and Applied Physiological Sciences, Department of Adult Critical Care, Guy's and St Thomas’ NHS Foundation Trust, London, United Kingdom

family: Camporota

full_name: Luigi Camporota

given: Luigi

name: Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neuroscience, Genoa, Italy

family: Pelosi

full_name: Paolo Pelosi

given: Paolo

name: Anesthesia and Intensive Care, Policlinico Vittorio Emanuele San Marco University Hospital, Catania, Italy

family: Sorbello

full_name: Massimiliano Sorbello

given: Massimiliano

name: Anaesthesia and Intensive Care Medicine, Warrington and Halton Hospitals NHS Foundation Trust, Warrington, United Kingdom

family: Higgs

full_name: Andy Higgs

given: Andy

name: Department of Anaesthesiology and Pain Therapy, Bern University Hospital, University of Bern, Bern, Switzerland

name: School of Medicine, Sigmund Freud University Vienna, Vienna, Austria

family: Greif

full_name: Robert Greif

given: Robert

name: Department of Anesthesiology and Intensive Care Medicine, University Hospital Bonn, Bonn, Germany

family: Putensen

full_name: Christian Putensen

given: Christian

name: Anaesthesiology and Intensive Care, Karolinska University Hospital Huddinge, Stockholm, Sweden

family: Agvald-Öhman

full_name: Christina Agvald-Öhman

given: Christina

name: University Hospital of Larissa, Larissa, Greece

family: Chalkias

full_name: Athanasios Chalkias

given: Athanasios

name: University Hospital Duesseldorf, Duesseldorf, Germany

family: Bokums

full_name: Kristaps Bokums

given: Kristaps

name: Intensive Care Unit, Cabrini Hospital, Malvern, Victoria, Australia

name: Central Clinical School, Monash University, Clayton, Victoria, Australia

family: Brewster

full_name: David Brewster

given: David

family: Rossi

full_name: Emanuela Rossi

given: Emanuela

name: Department of Anesthesiology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy

family: Fumagalli

full_name: Roberto Fumagalli

given: Roberto

name: Dipartimento di Anestesia, Rianimazione ed Emergenza-Urgenza, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy

family: Pesenti

full_name: Antonio Pesenti

given: Antonio

family: Foti

full_name: Giuseppe Foti

given: Giuseppe

family: Bellani

full_name: Giacomo Bellani

given: Giacomo

ReferenceCitation: Russotto V, Myatra SN, Laffey JG. What's new in airway management of the critically ill. Intensive Care Med. 2019 Nov;45(11):1615-1618. doi: 10.1007/s00134-019-05757-0. Epub 2019 Sep 16.

title: What’s new in airway management of the critically ill

ReferenceCitation: Janz DR, Casey JD, Semler MW, Russell DW, Dargin J, Vonderhaar DJ, Dischert KM, West JR, Stempek S, Wozniak J, Caputo N, Heideman BE, Zouk AN, Gulati S, Stigler WS, Bentov I, Joffe AM, Rice TW; PrePARE Investigators; Pragmatic Critical Care Research Group. Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial. Lancet Respir Med. 2019 Dec;7(12):1039-1047. doi: 10.1016/S2213-2600(19)30246-2. Epub 2019 Oct 1.

lead_sponsor: Azienda Ospedaliera San Gerardo di Monza

location_facility:
Galway University Hospitals
University Hospital San Gerardo
CHU de Nantes


title: Association Between Premature Birth and Its Comorbidities With NO and the HPG Activation at Minipuberty

acronym: miniNO

summary: Case-control study of inhaled Nitric Oxide (iNO) treatment of full-term and preterm infants. The main objective of this study is to investigate the association between premature birth and its later comorbidities (neuroendocrine, metabolic, cognitive, etc) with iNO treatment and the maturation of the HPG axis during minipuberty.

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: National and Kapodistrian University of Athens

location_country: France Switzerland Greece

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Regional Et Universitaire de Lille

lead_sponsor_type: academique


title: Computed Tomography Targets for Efficient Guidance of Catheter Ablation in Ventricular Tachycardia (MAP-IN-HEART)

acronym: MAP-IN-HEART

summary: The hypothesis of MAP IN HEART is that catheter ablation for post-infarction ventricular tachycardia (VT) can be largely improved through a direct definition of primary ablation targets from pre-operative CT scan imaging. The objective of is to demonstrate that catheter ablation of post-infarction VT targeting left ventricular wall thickness channels as defined from CT scan is feasible and associated with favorable efficacy, efficiency and safety profiles. A single-arm prospective cohort study will be conducted, including 40 patients over 3 European centres. Baseline, procedural and 6-month follow-up data will be analyzed

lead_sponsor: University Hospital, Bordeaux

location_country: Germany France Switzerland

location_facility: Department of Electrophysiology, Rhön-Klinikum AG

location_facility: Department of Cardiac Pacing and Electrophysiology, CHU Bordeaux

intervention_type: Device


title: Evaluation of the Daily Intake of 0.5 L of Water Saturated With Molecular Hydrogen for 21 Days in COVID-19 Patients Treated in Ambulatory Care. Double-blind, Randomized, Comparative Study

acronym: HYDRO COVID

summary:
Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect in preventing the runaway inflammatory reactions that lead to complications of Covid-19.

This hypothesis is supported by numerous preclinical and theoretical arguments, as well as by some Chinese clinical studies (the Chinese guidelines for the management of Covid-19 recommend the inhalation of hydrogen), a recommendation whose interest has just been confirmed by a publication describing the very positive results of a clinical study in China.

Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect in preventing the runaway inflammatory reactions that lead to complications of Covid-19.

The ingestion of water saturated with molecular hydrogen has been the subject of several clinical studies in other indications than Covid-19, and no side effects of this ingestion have been reported. A recent publication recommends initiating clinical trials using a hydrogen fortified beverage.

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

family: Zhou

full_name: Fei Zhou

given: Fei

family: Yu

full_name: Ting Yu

given: Ting

family: Du

full_name: Ronghui Du

given: Ronghui

family: Fan

full_name: Guohui Fan

given: Guohui

family: Liu

full_name: Ying Liu

given: Ying

full_name: Zhibo Liu

given: Zhibo

family: Xiang

full_name: Jie Xiang

given: Jie

family: Wang

full_name: Yeming Wang

given: Yeming

family: Song

full_name: Bin Song

given: Bin

family: Gu

full_name: Xiaoying Gu

given: Xiaoying

family: Guan

full_name: Lulu Guan

given: Lulu

family: Wei

full_name: Yuan Wei

given: Yuan

family: Li

full_name: Hui Li

given: Hui

family: Wu

full_name: Xudong Wu

given: Xudong

family: Xu

full_name: Jiuyang Xu

given: Jiuyang

family: Tu

full_name: Shengjin Tu

given: Shengjin

family: Zhang

full_name: Yi Zhang

given: Yi

family: Chen

full_name: Hua Chen

given: Hua

family: Cao

full_name: Bin Cao

journal_name: The Lancet

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

license_normalized: no license

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

host_type: repository

license: implied-oa

license_normalized: implied-oa

ReferenceCitation: Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16.

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

repository_institution: University College London - UCL Discovery

ReferenceCitation: Thompson BT, Chambers RC, Liu KD. Acute Respiratory Distress Syndrome. N Engl J Med. 2017 Aug 10;377(6):562-572. doi: 10.1056/NEJMra1608077. Review.

ReferenceCitation: TY - JOUR AU - Russell, Grace AU - Veal, David AU - Rehman, Mubasher AU - Adukwu, Emmanuel AU - LeBaron, Tyler AU - Hancock, John PY - 2020/06/22 SP - T1 - An Overview of SARS-CoV-2 (COVID-19) Infection and the Importance of Molecular Hydrogen as an Adjunctive Therapy DO - 10.20455/ros.2020.829 JO - Reactive Oxygen Species ER -

ReferenceCitation: Dole M, Wilson FR, Fife WP. Hyperbaric hydrogen therapy: a possible treatment for cancer. Science. 1975 Oct 10;190(4210):152-4.

ReferenceCitation: Ohsawa I, Ishikawa M, Takahashi K, Watanabe M, Nishimaki K, Yamagata K, Katsura K, Katayama Y, Asoh S, Ohta S. Hydrogen acts as a therapeutic antioxidant by selectively reducing cytotoxic oxygen radicals. Nat Med. 2007 Jun;13(6):688-94. Epub 2007 May 7.

ReferenceCitation: Itoh T, Hamada N, Terazawa R, Ito M, Ohno K, Ichihara M, Nozawa Y, Ito M. Molecular hydrogen inhibits lipopolysaccharide/interferon γ-induced nitric oxide production through modulation of signal transduction in macrophages. Biochem Biophys Res Commun. 2011 Jul 22;411(1):143-9. doi: 10.1016/j.bbrc.2011.06.116. Epub 2011 Jun 23.

ReferenceCitation: Manaenko A, Lekic T, Ma Q, Zhang JH, Tang J. Hydrogen inhalation ameliorated mast cell-mediated brain injury after intracerebral hemorrhage in mice. Crit Care Med. 2013 May;41(5):1266-75. doi: 10.1097/CCM.0b013e31827711c9.

ReferenceCitation: Xie K, Yu Y, Zhang Z, Liu W, Pei Y, Xiong L, Hou L, Wang G. Hydrogen gas improves survival rate and organ damage in zymosan-induced generalized inflammation model. Shock. 2010 Nov;34(5):495-501. doi: 10.1097/SHK.0b013e3181def9aa.

ReferenceCitation: Xie K, Fu W, Xing W, Li A, Chen H, Han H, Yu Y, Wang G. Combination therapy with molecular hydrogen and hyperoxia in a murine model of polymicrobial sepsis. Shock. 2012 Dec;38(6):656-63. doi: 10.1097/SHK.0b013e3182758646.

ReferenceCitation: Xie K, Yu Y, Huang Y, Zheng L, Li J, Chen H, Han H, Hou L, Gong G, Wang G. Molecular hydrogen ameliorates lipopolysaccharide-induced acute lung injury in mice through reducing inflammation and apoptosis. Shock. 2012 May;37(5):548-55. doi: 10.1097/SHK.0b013e31824ddc81.

ReferenceCitation: LeBaron TW, Kura B, Kalocayova B, Tribulova N, Slezak J. A New Approach for the Prevention and Treatment of Cardiovascular Disorders. Molecular Hydrogen Significantly Reduces the Effects of Oxidative Stress. Molecules. 2019 May 31;24(11). pii: E2076. doi: 10.3390/molecules24112076. Review.

ReferenceCitation: Ohta S. Molecular hydrogen as a preventive and therapeutic medical gas: initiation, development and potential of hydrogen medicine. Pharmacol Ther. 2014 Oct;144(1):1-11. doi: 10.1016/j.pharmthera.2014.04.006. Epub 2014 Apr 24. Review.

ReferenceCitation: Ono H, Nishijima Y, Adachi N, Sakamoto M, Kudo Y, Kaneko K, Nakao A, Imaoka T. A basic study on molecular hydrogen (H2) inhalation in acute cerebral ischemia patients for safety check with physiological parameters and measurement of blood H2 level. Med Gas Res. 2012 Aug 23;2(1):21. doi: 10.1186/2045-9912-2-21.

ReferenceCitation: Abraini JH, Gardette-Chauffour MC, Martinez E, Rostain JC, Lemaire C. Psychophysiological reactions in humans during an open sea dive to 500 m with a hydrogen-helium-oxygen mixture. J Appl Physiol (1985). 1994 Mar;76(3):1113-8.

ReferenceCitation: Fontanari P, Badier M, Guillot C, Tomei C, Burnet H, Gardette B, Jammes Y. Changes in maximal performance of inspiratory and skeletal muscles during and after the 7.1-MPa Hydra 10 record human dive. Eur J Appl Physiol. 2000 Mar;81(4):325-8.

ReferenceCitation: Zhou ZQ, Zhong CH, Su ZQ, Li XY, Chen Y, Chen XB, Tang CL, Zhou LQ, Li SY. Breathing Hydrogen-Oxygen Mixture Decreases Inspiratory Effort in Patients with Tracheal Stenosis. Respiration. 2019;97(1):42-51. doi: 10.1159/000492031. Epub 2018 Sep 18.

ReferenceCitation: Hu Y, Sun J, Dai Z, Deng H, Li X, Huang Q, Wu Y, Sun L, Xu Y. Prevalence and severity of corona virus disease 2019 (COVID-19): A systematic review and meta-analysis. J Clin Virol. 2020 Jun;127:104371. doi: 10.1016/j.jcv.2020.104371. Epub 2020 Apr 14.

ReferenceCitation: Verity R, Okell LC, Dorigatti I, Winskill P, Whittaker C, Imai N, Cuomo-Dannenburg G, Thompson H, Walker PGT, Fu H, Dighe A, Griffin JT, Baguelin M, Bhatia S, Boonyasiri A, Cori A, Cucunubá Z, FitzJohn R, Gaythorpe K, Green W, Hamlet A, Hinsley W, Laydon D, Nedjati-Gilani G, Riley S, van Elsland S, Volz E, Wang H, Wang Y, Xi X, Donnelly CA, Ghani AC, Ferguson NM. Estimates of the severity of coronavirus disease 2019: a model-based analysis. Lancet Infect Dis. 2020 Jun;20(6):669-677. doi: 10.1016/S1473-3099(20)30243-7. Epub 2020 Mar 30. Erratum in: Lancet Infect Dis. 2020 Apr 15;:. Lancet Infect Dis. 2020 May 4;:.

ReferenceCitation: Chow SC, Shao J, Wang H. A note on sample size calculation for mean comparisons based on noncentral t-statistics. J Biopharm Stat. 2002 Nov;12(4):441-56.

ReferenceCitation: LeBaron, T. W., McCullough M. L. and Ruppman Sr K. H., A novel functional beverage for COVID-19 and other conditions: Hypothesis and preliminary data, increased blood flow, and wound healing, Journal of Translational Science, 6(2020), pp 1-6, doi: 10.15761/JTS.1000380

ReferenceCitation: Guan WJ, Wei CH, Chen AL, Sun XC, Guo GY, Zou X, Shi JD, Lai PZ, Zheng ZG, Zhong NS. Hydrogen/oxygen mixed gas inhalation improves disease severity and dyspnea in patients with Coronavirus disease 2019 in a recent multicenter, open-label clinical trial. J Thorac Dis. 2020 Jun;12(6):3448-3452. doi: 10.21037/jtd-2020-057. Erratum in: J Thorac Dis. 2020 Aug;12(8):4591-4592.

ReferenceCitation: Haute Autorité de Santé. Réponses rapides dans le cadre de la Covid-19 - Prise en charge de premier recours des patients suspectés de Covid-19. Paris,18 juin 2020. Mise à jour en nov. 2020

location_facility:
Public Health Center
Casablanca center
Timc-Imag (Umr5525 Uga-Cnrs)


title: Integrated Care of Co-morbidities vs Standard Care After Acute Hypercapnic Respiratory Failure in the Intensive Care Unit: a Randomized Controlled Trial

acronym: TMIRA

summary: The study will assess the potential benefit of implementing a complex bundle of interventions to treat important - often unrecognized - comorbidities in patients surviving an episode of Acute Hypercapnic Respiratory Failure (AHRF). This study will also provide a comparative analysis of the costs and health consequences of two alternative strategies to inform decision making about healthcare. All interventions are individually evidence-based and seem sound to hypothesize that implementing such interventions might improve patient's outcome and reduce the financial burder of repeated hospitalization in AHRF survivors.

ipd_sharing: No

lead_sponsor: Dan Adler

location_country: France Switzerland

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

intervention_type: Other


title: A Prospective, Randomized, Multicentric Clinical Evaluation Comparing a Monofocal Extended Depth of Focus IOL With a Monofocal IOL

acronym: MonoeDOF

summary:
Post-market, prospective, randomized, single-masked, multi-center clinical study investigating the safety and effectiveness of the Monofocal Extended Depth of Focus Intraocular Lens (Mono-EDoF IOL) when compared to a Standard Monofocal Intraocular Lens.

Primary Objectives:

To evaluate the distance VA of the study IOLs
To evaluate the intermediate VA of the study IOLs
To explore the safety profile with regards to visual disturbances

ReferenceCitation: Black S. Successful Restoration of Visual Acuity with an Extended Range of Vision Intraocular Lens after Multifocal Laser Ablation. Case Rep Ophthalmol. 2016 Oct 11;7(3):193-197. doi: 10.1159/000450675. eCollection 2016 Sep-Dec.

ReferenceCitation: Bostanci Ceran B, Takmaz T, Can İ, Demirok G, Uysal BS. Clinical outcomes and optical performance of four differentmultifocal intraocular lenses. Turk J Med Sci. 2016 Apr 19;46(3):597-603. doi: 10.3906/sag-1403-24.

ReferenceCitation: Cillino S, Casuccio A, Di Pace F, Morreale R, Pillitteri F, Cillino G, Lodato G. One-year outcomes with new-generation multifocal intraocular lenses. Ophthalmology. 2008 Sep;115(9):1508-16. doi: 10.1016/j.ophtha.2008.04.017. Epub 2008 Jun 5.

ReferenceCitation: Cochener B; Concerto Study Group. Clinical outcomes of a new extended range of vision intraocular lens: International Multicenter Concerto Study. J Cataract Refract Surg. 2016 Sep;42(9):1268-1275. doi: 10.1016/j.jcrs.2016.06.033.

ReferenceCitation: Davison JA, Simpson MJ. History and development of the apodized diffractive intraocular lens. J Cataract Refract Surg. 2006 May;32(5):849-58.

ReferenceCitation: de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016 Dec 12;12:CD003169. doi: 10.1002/14651858.CD003169.pub4. Review.

ReferenceCitation: Harman FE, Maling S, Kampougeris G, Langan L, Khan I, Lee N, Bloom PA. Comparing the 1CU accommodative, multifocal, and monofocal intraocular lenses: a randomized trial. Ophthalmology. 2008 Jun;115(6):993-1001.e2. Epub 2007 Nov 26.

ReferenceCitation: Hashemi H, Khabazkhoob M, Soroush S, Shariati R, Miraftab M, Yekta A. The location of incision in cataract surgery and its impact on induced astigmatism. Curr Opin Ophthalmol. 2016 Jan;27(1):58-64. doi: 10.1097/ICU.0000000000000223. Review.

ReferenceCitation: Kaymak H, Höhn F, Breyer DR, Hagen P, Klabe K, Gerl RH, Mueller M, Auffarth GU, Gerl M, Kretz FT. [Functional Results 3 Months after Implantation of an "Extended Range of Vision" Intraocular Lens]. Klin Monbl Augenheilkd. 2016 Aug;233(8):923-7. doi: 10.1055/s-0042-104064. Epub 2016 Jul 6. German.

ReferenceCitation: Lan J, Huang YS, Dai YH, Wu XM, Sun JJ, Xie LX. Visual performance with accommodating and multifocal intraocular lenses. Int J Ophthalmol. 2017 Feb 18;10(2):235-240. doi: 10.18240/ijo.2017.02.09. eCollection 2017.

ReferenceCitation: Pedrotti E, Bruni E, Bonacci E, Badalamenti R, Mastropasqua R, Marchini G. Comparative Analysis of the Clinical Outcomes With a Monofocal and an Extended Range of Vision Intraocular Lens. J Refract Surg. 2016 Jul 1;32(7):436-42. doi: 10.3928/1081597X-20160428-06.

ReferenceCitation: Prasher P, Sandhu JS. Prevalence of corneal astigmatism before cataract surgery in Indian population. Int Ophthalmol. 2017 Jun;37(3):683-689. doi: 10.1007/s10792-016-0327-z. Epub 2016 Aug 27.

ReferenceCitation: TECNIS Symfony DFU

ReferenceCitation: Ruiz-Mesa R, Abengózar-Vela A, Aramburu A, Ruiz-Santos M. Comparison of visual outcomes after bilateral implantation of extended range of vision and trifocal intraocular lenses. Eur J Ophthalmol. 2017 Jun 26;27(4):460-465. doi: 10.5301/ejo.5000935. Epub 2017 Jan 28.

ReferenceCitation: Weeber HA, Meijer ST, Piers PA. Extending the range of vision using diffractive intraocular lens technology. J Cataract Refract Surg. 2015 Dec;41(12):2746-54. doi: 10.1016/j.jcrs.2015.07.034.

ReferenceCitation: Attia MSA, Auffarth GU, Kretz FTA, Tandogan T, Rabsilber TM, Holzer MP, Khoramnia R. Clinical Evaluation of an Extended Depth of Focus Intraocular Lens With the Salzburg Reading Desk. J Refract Surg. 2017 Oct 1;33(10):664-669. doi: 10.3928/1081597X-20170621-08.

family: Attia

full_name: Mary S. A. Attia

given: Mary S. A.

family: Auffarth

full_name: Gerd U. Auffarth

given: Gerd U.

family: Kretz

full_name: Florian T. A. Kretz

given: Florian T. A.

family: Tandogan

full_name: Tamer Tandogan

given: Tamer

family: Rabsilber

full_name: Tanja M. Rabsilber

given: Tanja M.

family: Holzer

full_name: Mike P. Holzer

given: Mike P.

family: Khoramnia

full_name: Ramin Khoramnia

given: Ramin

journal_name: Journal of Refractive Surgery

publisher: SLACK, Inc.

publisher_dissemination: SLACK, Inc.

publisher_group: SLACK, Inc.

publisher_normalized: SLACK, Inc.

ReferenceCitation: Bellucci R. Multifocal intraocular lenses. Curr Opin Ophthalmol. 2005 Feb;16(1):33-7. Review.

lead_sponsor: Advanced Vision Science, Inc.

location_country:
United Kingdom
France
Portugal

location_facility:
University Hospital Pellegrin
Hospital de Braga
Oxford Eye Hospital

intervention_type: Procedure


title: Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Ophthalmic Gel Administered in Patients Affected by Moderate Dry Eye Disease (DED): a Randomized, Cross Over, Double Blind Study

summary: This is a post-market, european multicenter study. This is a randomized, cross-over, double blind study with competitive enrolment, aimed to enroll a total of 90 patients with a diagnosis of moderate dry eye disease (DED).

status: Active, not recruiting

lead_sponsor: VISUfarma SpA

location_country: Italy France Spain

location_facility: ASST-Santi Paolo e Carlo-Presidio San Paolo


title: Phase II, Multicenter, Open-label, Rct With an Adaptive Design, to Assess Efficacy of Intravenous Administration of Oxytocin in Hospitalized Patients Affected by COVID-19

summary:
Introduction There are currently no treatments with demonstrated efficacy for COVID-19 infection. Epidemiological evidence points to the existence of intrinsic protection factors which make young persons and women more resistant to the infection, whereas older patients with multiple illnesses, above all with heart disease, are at greatest risk. This trial proposes treatment initiated in the early stages of the disease, when clinical worsening is most likely, with intravenous Oxytocin (OT), an endogenous hormone currently safely used in clinical practice. The selection of this molecule is based on numerous experimental and clinical observations, which show its activity in modulating resistance to pathogens, in mitigating overall cardiovascular risk, and in acting on the production of Nitric Oxide (ON) in the lungs, which is emerging as a key therapeutic factor for the improvement of respiratory function in patients with SARS-COVID 19. Finally, OT is physiologically produced by the human body, especially in the female sex and in the age ranges that coincide with most resistant patients. In routine clinical practice, OT exhibits an excellent therapeutic index, in absence of significant adverse effects.

Primary aim To assess the effects of Oxytocin in addition to standard therapy, with respect to Standard of Care (SoC), in reducing the number of patients who enter a critical stage Secondary aim

To describe:

Mortality 28 days after randomization
Time to mechanical ventilation during the study
Duration of dependency on oxygen supply
Length of stay
Temporal trend of clinical improvement (7-category ordinal scale)
Safety analysis

status: Withdrawn

lead_sponsor: Azienda Ospedaliero-Universitaria di Parma

location_country: Italy France

location_facility: Azienda Ospedaliero Universitaria di Parma

status_simplified: Unknown


title: Phase II Study on TSR-042 in Advanced Clear Cell Sarcoma

acronym: ACCeSs

summary: Phase II,single arm study designed to explore the activity of TSR-042, an immunotherapy agent, in patients with a diagnosis of advanced or metastatic clear cell sarcoma (CCS).

ReferenceCitation: Granter SR, Weilbaecher KN, Quigley C, Fletcher CD, Fisher DE. Clear cell sarcoma shows immunoreactivity for microphthalmia transcription factor: further evidence for melanocytic differentiation. Mod Pathol. 2001 Jan;14(1):6-9.

ReferenceCitation: Antonescu CR, Tschernyavsky SJ, Woodruff JM, Jungbluth AA, Brennan MF, Ladanyi M. Molecular diagnosis of clear cell sarcoma: detection of EWS-ATF1 and MITF-M transcripts and histopathological and ultrastructural analysis of 12 cases. J Mol Diagn. 2002 Feb;4(1):44-52.

ReferenceCitation: Stacchiotti S, Grosso F, Negri T, Palassini E, Morosi C, Pilotti S, Gronchi A, Casali PG. Tumor response to sunitinib malate observed in clear-cell sarcoma. Ann Oncol. 2010 May;21(5):1130-1. doi: 10.1093/annonc/mdp611. Epub 2010 Jan 21.

ReferenceCitation: Tazzari M, Palassini E, Vergani B, Villa A, Rini F, Negri T, Colombo C, Crippa F, Morosi C, Casali PG, Pilotti S, Stacchiotti S, Rivoltini L, Castelli C. Melan-A/MART-1 immunity in a EWS-ATF1 translocated clear cell sarcoma patient treated with sunitinib: a case report. BMC Cancer. 2015 Feb 14;15:58. doi: 10.1186/s12885-015-1044-0.

lead_sponsor: Italian Sarcoma Group

location_facility: Fondazione IRCSS Istituto Nazionale dei Tumori


title: Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Single Oral Administration of MD1003 100 mg in Hepatic Impaired Patients and Healthy Subjects With Normal Hepatic Function

summary:
This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in hepatic impaired patients and healthy subjects with normal hepatic function.

The planned enrollment is 16 subjects (8 impaired patients and 8 healthy subjects).

status: Terminated

primary_purpose: Other

lead_sponsor: MedDay Pharmaceuticals SA

location_country: Hungary France

location_facility:
Eurofins Optimed
DRC Drug Research Center Ltd.
Clinical Research Units Hungary Ltd.


title: Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders

acronym: FIBRINOGEST

summary: The aim of this observational study is to evaluate the prevalence of uncomplicated pregnancies in women suffering from congenital fibrinogen disorders (i.e, hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) as well as to describe pregnancies outcomes in such diseases.

time_perspective: Retrospective

lead_sponsor: University Hospital, Geneva

location_country: Slovakia France Switzerland

location_facility: Jessenius Faculty of Medicine and University Hospital


title: A Phase I/II Safety and Dose Evaluation Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral Idiopathic Parkinson's Disease (SUNRISE-PD)

acronym: SUNRISE-PD

summary: This study consists of two parts. Part A will evaluate the safety and tolerability of multiple doses of OXB-102 (AXO-Lenti-PD) in participants with Parkinson's disease. Part B will assess the safety and efficacy of the selected dose of OXB-102 in participants with Parkinson's disease.

ReferenceCitation: McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS: 1. GENE THERAPY FOR PARKINSON'S, 2. PHASE 3 STUDY IN FOCUS - INTEC PHARMA'S ACCORDION PILL, 3. CLINICAL TRIALS RESOURCES. J Parkinsons Dis. 2019;9(2):251-264. doi: 10.3233/JPD-199001.

name: Parkinson’s Advocate, Innovation Fixer Ltd, Oxford, UK. kevin.mcfarthing@googlemail.com

family: McFarthing

full_name: Kevin McFarthing

given: Kevin

name: Parkinson’s Disease and Movement Disorders Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

family: Prakash

full_name: Neha Prakash

given: Neha

name: Parkinson's Disease and Movement Disorders Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

family: Simuni

full_name: Tanya Simuni

given: Tanya

journal_name: Journal of Parkinson's Disease

oa_colors: green other

evidence: open (via page says Open Access)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: CLINICAL TRIAL HIGHLIGHTS: 1. GENE THERAPY FOR PARKINSON’S, 2. PHASE 3 STUDY IN FOCUS - INTEC PHARMA’S ACCORDION PILL, 3. CLINICAL TRIALS RESOURCES

lead_sponsor: Sio Gene Therapies

location_country:
United Kingdom
France

location_facility: University of Cambridge, Centre for Brain Repair

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Service de Neurochirurgie, Hôpital Henri Mondor


title: An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Rich Tumors of Bone

summary: An open-label, multi-center, phase 2 study of the efficacy of denosumab in subjects with giant cell rich tumors of bone. The population will consist of subjects with the following tumor types: aneurysmal bone cysts (ABC), giant cell granuloma (GCG) and other giant cell rich lesions (primary bone, non-malignant).

lead_sponsor: Leiden University Medical Center

location_country: Italy France Netherlands

location_facility:
Istituto Ortopedico Rizzoli
Centre Léon Bérard
Leiden University Medical Center


type: Other Identifier

title: Delivery of Audiovisual Information on Early Medical Abortion to Women in Europe Via Digital Technology: is it Acceptable and Informative?

acronym: EMAVID

summary:
The majority of abortions in the United Kingdom (UK) are performed before 9 weeks (63 days) gestation using a method known as Early Medical Abortion (EMA). EMA involves an assessment visit and provision of two types of medication .

The assessment visit usually involves Ultrasound to confirm gestation, detailed personal history, safeguarding assessment and contraception planning, before arranging treatment and follow up.

The process is long and lots of information is given to women attending the service. In NHS Lothian (National Health Service, Lothian Health Board), the average appointment length for combined assessment and provision of the first part of treatment is 3 hours.

Despite how common abortion is ( 1 in 3), many women presenting for abortion care are not aware of what the procedure will involve. This may in part to the social stigma surrounding abortion and unintended pregnancy in general. This stigma can in turn result in feelings of anxiety and shame about the decision to terminate a pregnancy.

There is evidence that short videos shown to patients prior to abortion or contraception consultations can improve their ability to recall information and can make them feel more confident about the procedure.

Additionally, abortion care providers have found patients who have seen videos to be better prepared and informed and this allows consultations to progress more easily and allow greater time for discussion of contraceptive methods.

We have prepared a video approximately 3 minutes in length to provide information about EMA. It summarises the process described above using simple language and animated characters. The video has been translated into French, Portuguese and Swedish and has been adapted to reflect subtle differences in practice and law in these countries. We have partners in services in these three countries who will be conducting the trial there in accordance with this protocol and their own local ethics and clinical governance requirements.

primary_purpose: Health Services Research

ReferenceCitation: Michie L, Cameron ST, Glasier A, Johnstone A. Giving information about the contraceptive implant using a DVD: is it acceptable and informative? A pilot randomised study. J Fam Plann Reprod Health Care. 2016 Jul;42(3):194-200. doi: 10.1136/jfprhc-2015-101186. Epub 2015 Aug 6.

ReferenceCitation: Powell-Jackson R, Glasier A, Cameron ST. Benefits of using a digital video disk for providing information about abortion to women requesting termination of pregnancy. Contraception. 2010 Jun;81(6):537-41. doi: 10.1016/j.contraception.2010.01.015. Epub 2010 Feb 19.

ReferenceCitation: Reynolds-Wright JJ, Belleuvre F, Daberius A, Faucher P, Gemzell-Danielsson K, Cameron ST. Information on early medical abortion for women using an audiovisual animation vs face-to-face consultation: A consortium randomized and quasi-randomized trial. Acta Obstet Gynecol Scand. 2020 Dec;99(12):1611-1617. doi: 10.1111/aogs.13944. Epub 2020 Jul 12.

name: MRC Center for Reproductive Healthcare University of Edinburgh Edinburgh UK

family: Reynolds‐Wright

full_name: John J. Reynolds‐Wright

given: John J.

name: Public Assistance Hospitals of Paris (APHP) Paris France

family: Belleuvre

full_name: Florence Belleuvre

given: Florence

name: Department of Women’s and Children’s Health Karolinska Institutet, and Karolinska University Hospital Stockholm Sweden

family: Daberius

full_name: Anette Daberius

given: Anette

family: Faucher

full_name: Philippe Faucher

given: Philippe

family: Gemzell‐Danielsson

full_name: Kristina Gemzell‐Danielsson

given: Kristina

name: Chalmers Center NHS Lothian Edinburgh UK

family: Cameron

full_name: Sharon T. Cameron

given: Sharon T.

journal_name: Acta Obstetricia et Gynecologica Scandinavica

license: cc-by

license_normalized: cc-by

repository_institution: University of Edinburgh - Edinburgh Research Explorer

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Information on early medical abortion for women using an audiovisual animation vs face‐to‐face consultation: A consortium randomized and quasi‐randomized trial

ipd_sharing_description: Only anonymised responses to questionnaire will be shared between sites.

lead_sponsor: NHS Lothian

location_country:
Sweden
United Kingdom
France

location_facility: Chalmers Centre for Sexual and Reproductive Health


title: PULsecath mechanicaL Support Evaluation (PULSE) - Trial

acronym: PULSE

summary: The objective of this study is to determine ventricular loading conditions during and after PulseCath® iVAC2L support, and assess its impact on specific load dependent humoral factors and cardiac enzymes. These specific patterns are so far unknown and will be evaluated invasively.

ReferenceCitation: Dedic A, Bastos MB, Van Mieghem NM. Pressure-Volume Loop Analysis in Percutaneous Coronary Intervention-Induced Shock. JACC Case Rep. 2020 Sep 23;2(12):1882-1883. doi: 10.1016/j.jaccas.2020.07.026. eCollection 2020 Oct.

family: Dedic

full_name: Admir Dedic

given: Admir

family: Bastos

full_name: Marcelo B. Bastos

given: Marcelo B.

family: Van Mieghem

full_name: Nicolas M. Van Mieghem

given: Nicolas M.

currency_apc_doaj: USD

journal_name: JACC: Case Reports

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Erasmus University, Rotterdam - RePub

lead_sponsor: Erasmus Medical Center

location_country:
United Kingdom
France
Netherlands

location_facility: Kings College London, St. Thomas' Hospital


title: Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation

acronym: DIRECT-DBS

summary: The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.

lead_sponsor: Boston Scientific Corporation

location_country: Germany France Netherlands

location_facility:
Universitaetsklinikum Wuerzburg
Academisch Medisch Centrum
CHU Grenoble - Hopital Michallon


title: SEMEiotic Oriented Technology for Individual's CardiOmetabolic Risk Self- assessmeNt and Self-monitoring

acronym: SEMEOTICONS

summary:
Cardio-metabolic risk factors include obesity, physical inactivity, smoke, alcohol abuse, high blood lipids or sugar and arterial hypertension. Systems for self-learning and self-monitoring may help people improve and maintain a healthy lifestyle through tailored suggestions about diet, weight control, physical activity, fatigue,stress.

SEMEOTICONS exploits the human face as an indicator of individual's health status and translates signs obtained from the face using contactless sensors into measures and descriptors to be automatically evaluated by a an interactive smart mirror. This "Wize Mirror" extracts descriptors from videos, images and gas concentration signals and integrates them in a virtual model used to compute and trace the evolution of an individual's wellness index. A health diary enables each individual to evaluate and personally relate his/her lifestyle to his/her well-being. Coaching messages are provided, in relation to the evolution of the wellness index and of each descriptor, to provide useful suggestions on correct lifestyle self-monitoring.

The purpose of this study is assess the accuracy of the information derived from the Wize Mirror in expressing the health status of the individual.

The reproducibility and repeatability study will evaluate whether measurements are stable over short time spans and whether they are influenced by meals light and temperature conditions.

To verify whether the Wize Mirror is able to detect variations in physical and emotional health status with appropriate lifestyle changes, the validation study will cross-check measurements from the Wize Mirror against reference clinical tests at enrolment and after 3 months of personalized suggestions for healthy behavior.

Reference tests include

Physician visit
Measurement of blood oxygen content and skin end products of sugar metabolism,body composition, energy expenditure, vascular function
Laboratory profile and exhaled gas composition
Questionnaires on quality of life and lifestyle (food, sleep, physical activity, smoking, alcohol, stress).

Wize Mirror measures include

3D reconstruction of face images for roundness, color, stress and fatigue
Heart and respiratory rate
Detection of skin sugar metabolism end-products and of eye lipid deposits
Small vessel vasodilating ability with local heating The results will allow to assess whether the Wize Mirror is easy to use and helpful for self-monitoring of cardio-metabolic risk.

lead_sponsor: Istituto di Fisiologia Clinica CNR

location_facility: Istituto di Fisiologia Clinica del CNR UOS Milano

location_facility: Centre de Recherche en Nutrition Humaine


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

summary: This is a Phase I, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously. The eligible patient population will be patients with advanced solid tumours. At any time during the trial, it will not be permitted to escalate to a dose which does not fulfil the escalation with overdose control (EWOC) criterion

lead_sponsor: Boehringer Ingelheim

location_country: Germany France

location_facility:
Universitätsklinikum Freiburg
Universitätsklinikum Augsburg
INS Curie


title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-part Study of Orally Administered JNJ-54257099 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (Part 1) and Food-effect (Part 2) in Healthy Subjects, and Multiple Doses in Subjects With Chronic Hepatitis C Infection (Part 3)

summary:
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human, 3-part study in which the safety, tolerability, and pharmacokinetics of orally administered AL-704 will be assessed in healthy adult subjects and in adult subjects with CHC infection.

Part 1: Healthy adult subjects will receive one of 5 single ascending oral doses (SAD) of AL-704 ranging from 100 mg to 1,500 mg (Cohorts 1 to 5). Within each cohort subjects will be randomized to receive either AL-704 or placebo (n=8 per cohort; 6 assigned to AL-704 and 2 assigned to placebo), in a fasted state.

The planned dose-escalation scheme may be changed based on the emerging PK and safety data. Two additional cohorts (Cohorts 6 and 7) may be enrolled for evaluation of additional doses at the discretion of the Sponsor and Investigator, based on the emerging pharmacokinetic (PK) profile, and the presence of an acceptable safety profile.

Part 2: To assess the food effect on pharmacokinetics, 8 healthy subjects from one full Part 1 cohort who received a single dose of AL-704 or placebo in a fasted state, will receive the same single dose of AL-704 or placebo in a fed state in Part 2 after a washout period of 7-14 days (depending on PK results). It is expected that Cohort 3 of Part 1 (600 mg dose) will be selected, however this depends on the evaluation of available PK and safety data from Part 1 of the study.

Part 3: The following cohorts of 10 adult subjects each, with CHC infection, will be evaluated. Subjects with CHC genotype 1 infection (Cohorts 8 to 10) and subjects with CHC genotype 3 infection (Cohort 11) will be randomized to receive AL-704 or placebo for 7 consecutive days (n=10 per cohort, 8 assigned to AL-704 and 2 assigned to placebo) in a fed state. The treatment is anticipated to be administered in a once daily dose regimen or a twice daily dose regimen. The dose and dose regimen to be administered will be determined by the Sponsor depending on the PK and safety outcomes of previous cohorts.

lead_sponsor: Alios Biopharma Inc.

location_country:
Georgia
Moldova, Republic of
France

location_facility: Arensia Biotrial


title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3 Part Study of Orally Administered AL-335 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects With Chronic Hepatitis C Genotype 1 Infection

summary: This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered AL-335 in healthy volunteers (HV) and subjects with CHC infection.

ReferenceCitation: McClure MW, Berliba E, Tsertsvadze T, Streinu-Cercel A, Vijgen L, Astruc B, Patat A, Westland C, Chanda S, Zhang Q, Kakuda TN, Vuong J, Khorlin N, Beigelman L, Blatt LM, Fry J. Safety, tolerability, and pharmacokinetics of AL-335 in healthy volunteers and hepatitis C virus-infected subjects. PLoS One. 2018 Oct 16;13(10):e0204974. doi: 10.1371/journal.pone.0204974. eCollection 2018.

family: McClure

full_name: Matthew W. McClure

given: Matthew W.

family: Berliba

full_name: Elina Berliba

given: Elina

family: Tsertsvadze

full_name: Tengiz Tsertsvadze

given: Tengiz

family: Streinu-Cercel

full_name: Adrian Streinu-Cercel

given: Adrian

family: Vijgen

full_name: Leen Vijgen

given: Leen

family: Astruc

full_name: Béatrice Astruc

given: Béatrice

family: Patat

full_name: Alain Patat

given: Alain

family: Westland

full_name: Christopher Westland

given: Christopher

family: Chanda

full_name: Sushmita Chanda

given: Sushmita

family: Zhang

full_name: Qingling Zhang

given: Qingling

family: Kakuda

full_name: Thomas N. Kakuda

given: Thomas N.

family: Vuong

full_name: Jennifer Vuong

given: Jennifer

family: Khorlin

full_name: Nick Khorlin

given: Nick

family: Beigelman

full_name: Leonid Beigelman

given: Leonid

family: Blatt

full_name: Lawrence M. Blatt

given: Lawrence M.

family: Fry

full_name: John Fry

given: John

journal_name: PLOS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

evidence: oa repository (semantic scholar lookup)

location_facility: Arensia, Research Institute of Clinical Medicine


title: A Randomised, Assessor-blinded, Multi-centre Trial Comparing the Efficacy, Safety and Tolerability of the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy

acronym: OPTIMA

summary: This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy.

ReferenceCitation: Kiesslich R, Schubert S, Mross M, Klugmann T, Klemt-Kropp M, Behnken I, Bonnaud G, Keulen E, Groenen M, Blaker M, Ponchon T, Landry W, Stoltenberg M. Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study. Endosc Int Open. 2017 Apr;5(4):E282-E290. doi: 10.1055/s-0043-102433.

apc_source: doaj

name: Klinikdirektor ZIM II, Sprecher ZIM (Zentrum für Innere Medizin), Helios Dr. Horst Schmidt Kliniken Wiesbaden, Germany

family: Kiesslich

full_name: Ralf Kiesslich

given: Ralf

name: Gastroenterologie am Bayerischen Platz, Berlin, Germany

family: Schubert

full_name: Stefan Schubert

given: Stefan

name: Praxis Dr. med. Michael R Mross, Berlin, Germany

family: Mross

full_name: Michael Mross

given: Michael

name: Internistische Gemeinschaftspraxis, Leipzig, Germany

family: Klugmann

full_name: Tobias Klugmann

given: Tobias

name: Medisch Centrum, Alkmaar, the Netherlands

family: Klemt-Kropp

full_name: Michael Klemt-Kropp

name: Internistisches Facharztzentrum Dr M Scholz, Langen, Germany

family: Behnken

full_name: Imke Behnken

given: Imke

family: Bonnaud

full_name: Gillaume Bonnaud

given: Gillaume

name: Orbis Medisch Centrum, Sittard, the Netherlands

family: Keulen

full_name: Eric Keulen

given: Eric

name: Rijnstate Arnhem, Wagnerlaan, the Netherlands

family: Groenen

full_name: Marcel Groenen

given: Marcel

name: Gastroenterologie Eppendorfer Baum, Hamburg, Germany

family: Blaker

full_name: Michael Blaker

family: Ponchon

full_name: Thierry Ponchon

given: Thierry

family: Landry

full_name: Wilfred Landry

given: Wilfred

name: Ferring Pharmaceuticals, Kay Fiskers Plads 11 Copenhagen S, Denmark

family: Stoltenberg

full_name: Meredin Stoltenberg

given: Meredin

currency_apc_doaj: EUR

journal_name: Endoscopy International Open

version: submittedVersion

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

lead_sponsor: Ferring Pharmaceuticals

location_facility: Ed Herriot Hopital (there may be other sites in this country)

location_facility: Medisch Centrum Alkmaar (there may be other sites in this country)

location_facility: Gastroenterologie am Bayerischen Platz (there may be other sites in this country)


title: Assessment of Hybrid Use of an Artificial Pancreas in a Home Setting for Two Months in Patients With Type 1 Diabetes

acronym: AP Hybrid

summary: The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients

ReferenceCitation: Renard E, Farret A, Kropff J, Bruttomesso D, Messori M, Place J, Visentin R, Calore R, Toffanin C, Di Palma F, Lanzola G, Magni P, Boscari F, Galasso S, Avogaro A, Keith-Hynes P, Kovatchev B, Del Favero S, Cobelli C, Magni L, DeVries JH; AP@home Consortium. Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home. Diabetes Care. 2016 Jul;39(7):1151-60. doi: 10.2337/dc16-0008. Epub 2016 May 5.

family: Renard

full_name: Eric Renard

family: Farret

full_name: Anne Farret

given: Anne

family: Kropff

full_name: Jort Kropff

given: Jort

family: Bruttomesso

full_name: Daniela Bruttomesso

given: Daniela

family: Messori

full_name: Mirko Messori

given: Mirko

family: Place

full_name: Jerome Place

given: Jerome

family: Visentin

full_name: Roberto Visentin

given: Roberto

family: Calore

full_name: Roberta Calore

given: Roberta

family: Toffanin

full_name: Chiara Toffanin

given: Chiara

family: Di Palma

full_name: Federico Di Palma

given: Federico

family: Lanzola

full_name: Giordano Lanzola

given: Giordano

family: Magni

full_name: Paolo Magni

given: Paolo

family: Boscari

full_name: Federico Boscari

family: Galasso

full_name: Silvia Galasso

given: Silvia

family: Avogaro

full_name: Angelo Avogaro

given: Angelo

family: Keith-Hynes

full_name: Patrick Keith-Hynes

given: Patrick

family: Kovatchev

full_name: Boris Kovatchev

given: Boris

family: Del Favero

full_name: Simone Del Favero

given: Simone

family: Cobelli

full_name: Claudio Cobelli

given: Claudio

full_name: Lalo Magni

given: Lalo

family: DeVries

full_name: J. Hans DeVries

given: J. Hans

journal_name: Diabetes Care

repository_institution: University of Padova - Padua Research Archive

ReferenceCitation: Kropff J, Del Favero S, Place J, Toffanin C, Visentin R, Monaro M, Messori M, Di Palma F, Lanzola G, Farret A, Boscari F, Galasso S, Magni P, Avogaro A, Keith-Hynes P, Kovatchev BP, Bruttomesso D, Cobelli C, DeVries JH, Renard E, Magni L; AP@home consortium. 2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial. Lancet Diabetes Endocrinol. 2015 Dec;3(12):939-47. doi: 10.1016/S2213-8587(15)00335-6. Epub 2015 Sep 30.

location_facility:
University of Padova
CHU Montpellier
University of Amsterdam


title: Open-label, Single-dose, Multi-center Study, Investigating the Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment

summary: The purpose of this study is to assess the pharmacokinetics (PK) of BIA 9-1067 in patients with moderate chronic hepatic impairment and in matched healthy subjects.

lead_sponsor: Bial - Portela C S.A.

location_country:
Russian Federation
France

location_facility:
City clinical Hospital N°3
City clinical Hospital N°64
Biotrial, 7-9 rue Jean-Louis Bertrand


title: A Phase I, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K Delta/Gamma Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies

summary: The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with hematologic malignancies.

lead_sponsor: Rhizen Pharmaceuticals SA

location_facility:
Rhizen Trial Site
Rhizen Trial Site 1
Rhizen Trial Site 2


title: Technical Evaluation of a Whole Blood Rapid Test Measuring Procalcitonin (BRAHMS PCT Direct)

summary: Validation of the technical performance of the BRAHMS PTC direct point-of-care assay under routine conditions with native patient samples. The clinical validation is planned as a method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT). The study hypothesis is to show a highest correlation between the new product and the reference methods.

lead_sponsor: Philipp Schuetz

location_facility: Pitié Salpetrière. Groupement hospitalière universitaire Est

location_facility: Klinikum Ernst von Bergmann, gemeinnützige GmbH Akademisches Lehrkrankenhaus der Humboldt-Universität Berlin (Charité)


title: A Randomised, Open-label, Multi-centre Trial Investigating the Intra-subject Variability of ROTEM® and TEG® Parameters Following Two Intravenous Administrations of the Same Dose of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Haemophilia Patients in a Non-bleeding State

summary:
This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state.

The TEG® parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM® parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT).

lead_sponsor: Novo Nordisk A/S

location_country: Israel Germany France


title: A Multiple Center, Open-label, Single Dose, Parallel-group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of RO4917838

summary: This open-label, single-dose, parallel-group study will investigate the pharmacokinetics and safety of RO4917838 in healthy and renal impaired subjects. Subjects will receive a single dose of RO4917838.

lead_sponsor: Hoffmann-La Roche


summary: This open-label, single-dose, parallel group study will assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment. Patients and healthy volunteers will receive a single oral dose of RO4917838.


title: ETAMI-Study: Early Thienopyridine Treatment to Improve Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction

acronym: ETAMI

summary: Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted myocardium.

ReferenceCitation: Zeymer U, Mochmann HC, Mark B, Arntz HR, Thiele H, Diller F, Montalescot G, Zahn R. Double-blind, randomized, prospective comparison of loading doses of 600 mg clopidogrel versus 60 mg prasugrel in patients with acute ST-segment elevation myocardial infarction scheduled for primary percutaneous intervention: the ETAMI trial (early thienopyridine treatment to improve primary PCI in patients with acute myocardial infarction). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):147-154. doi: 10.1016/j.jcin.2014.09.007. Epub 2014 Nov 4.

family: Zeymer

full_name: Uwe Zeymer

given: Uwe

family: Mochmann

full_name: Hans-Christian Mochmann

given: Hans-Christian

family: Mark

full_name: Bernd Mark

given: Bernd

family: Arntz

full_name: Hans-Richard Arntz

given: Hans-Richard

family: Thiele

full_name: Holger Thiele

given: Holger

family: Diller

full_name: Frank Diller

given: Frank

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

family: Zahn

full_name: Ralf Zahn

given: Ralf

journal_name: JACC: Cardiovascular Interventions

title: Double-Blind, Randomized, Prospective Comparison of Loading Doses of 600 mg Clopidogrel Versus 60 mg Prasugrel in Patients With Acute ST-Segment Elevation Myocardial Infarction Scheduled for Primary Percutaneous Intervention

lead_sponsor: Stiftung Institut fuer Herzinfarktforschung

location_facility: Charité Campus Benjamin Franklin, Med. Klinik II


summary:
The aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound.

This is a multi-centre study on 60 patients who have a lower limb ulcer.

lead_sponsor: Integra LifeSciences Services

location_country: Italy France Greece

location_facility: Aristotle University of Thessaloniki - Papageorgiou General Hospital


title: Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate

summary:
In case of deformities of the forefoot (Hallux-valgus, Hallux-varus), the basal osteotomy may be more indicated than the distal osteotomy as it allows to achieve a greater degree of correction.

However, weight bearing forces on the head of the first metatarsal acting at a distance from the osteotomy site subject the construct to an important dorsiflexion stress. Fixation strength being the important consideration led to design the B-BOP® Lock plate, specifically dedicated to basal osteotomy of the first metatarsal, with the following characteristics:

plantar positioning to obtain the best stability and resistance while reducing the implant bulkiness;
anatomical shape adapted to the plantar curve of the first metatarsal. Taking advantages of the most appropriated anatomical site to implant the B-BOP® Lock plate directly on tension, it offers an innovative and unique basal osteotomy fixation solution.

The B-BOP® Lock osteosynthesis plate benefits now of the Surfix locking screws technology.

The purpose of this study is to collect and publish data from several centers, several users.

location_country:
United Kingdom
France
Lebanon

location_facility: Centre Hospitalier universitaire Notre Dame de secours


title: Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence: a Multi-center, Randomized, Placebo Controlled Study

summary:
Background of the study:

Fecal incontinence is a complex problem. The social consequences of this problem result in a lower quality of life. The exact prevalence of FI is unknown, literature reports vary from 13-19%. There are variable treatment options depending on the patient and the etiology of the FI. Dietary manipulation, pharmacological intervention, pelvic floor physiotherapy, as well as surgical interventions are currently used to treat FI.

A promising current treatment is Percutaneous Tibial Nerve Stimulation (PTNS). The nerves in the spine that control bowel function also have branches which go to the ankle. Stimulating these nerves in the ankle has shown to be an effective treatment for FI in the short-term. The treatment has been shown to be safe and well tolerated by subjects with almost no morbidity in prior urology trials.

Objective of the study:

The objective of this study is to show that the results of PTNS are based on the treatment of electrical stimulation and not on a placebo effect with a sham treatment.

Study design:

This study is a multicenter, single-blinded, randomized, placebo-controlled trial.

Primary study parameters/outcome of the study:

The percentage of patients experiencing a ≥ 50% decrease in incontinence episodes from baseline after 9 weeks of treatment.

Secondary study parameters/outcome of the study (if applicable):

Mean change in the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FI Score)

Mean change in Quality of Life scores in validated QoL questionnaires (SF-36, Digestive Health Status Instrument (DHSI), and Fecal Incontinence Quality of life)

Subject's and Physician's Global Impression

ReferenceCitation: van der Wilt AA, Giuliani G, Kubis C, van Wunnik BPW, Ferreira I, Breukink SO, Lehur PA, La Torre F, Baeten CGMI. Randomized clinical trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in patients with faecal incontinence. Br J Surg. 2017 Aug;104(9):1167-1176. doi: 10.1002/bjs.10590.

name: Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands

family: van der Wilt

full_name: A A van der Wilt

given: A A

name: Department of Surgery, Università degli Studi di Roma ‘Sapienza’, Rome, Italy

family: Giuliani

full_name: G Giuliani

given: G

name: Department of Surgery, Institut des Maladies de l'Appareil Digestiv, University Hospital of Nantes, Nantes, France

family: Kubis

full_name: C Kubis

given: C

family: van Wunnik

full_name: B P W van Wunnik

given: B P W

name: Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, The Netherlands

name: Division of Epidemiology and Biostatistics, School of Public Health, Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia

family: Ferreira

full_name: I Ferreira

given: I

family: Breukink

full_name: S O Breukink

given: S O

family: Lehur

full_name: P A Lehur

given: P A

family: La Torre

full_name: F La Torre

given: F

family: Baeten

full_name: C G M I Baeten

given: C G M I

journal_name: British Journal of Surgery

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Maastricht University Medical Center

location_facility: Università degli Studi di Roma "La Sapienza"


lead_sponsor: Novartis Pharmaceuticals

location_country: Italy Germany France

title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Multiple-dose, 4-way Crossover Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Salts (Maleate, Xinafoate, and Acetate) in Patients With Persistent Asthma

summary: This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate, xinafoate and acetate) in patients with asthma.


title: Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases A Case Matched Control Study

summary: Hypothesis of the study: Neoadjuvant chemotherapy with Bevacizumab impairs postoperative outcome after resection of colorectal liver metastases.

lead_sponsor: University of Zurich

location_country: France Switzerland Spain

location_facility: Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital

location_facility: Division of hepato-biliary-pancreatic surgery. Department of surgery, "Josep Tureta" Hospital


title: Comparison of the Safety and Efficacy of Volinanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties. A 4 Week,Randomized, Double-blind, Comparative, Parallel-group Study.

acronym: REST

summary:
The primary objective is to compare the potential for next-day residual effects of volinanserin 2 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties.

Secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.

lead_sponsor: Sanofi

location_country: Sweden France Spain


title: An Open Label Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO5126766, a Dual Raf and MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors

summary: This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors. In the first part of the study, groups of patients will by sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with selected tumor types will be randomized to receive either the optimal biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

location_country:
United Kingdom
France
Spain


title: An Open-label, Non-randomized, Dose Evaluation, Safety and Pharmacokinetics Phase I Study of AVE8062 in Combination With Platinum Salts (Cisplatin or Carboplatin) and Taxanes (Docetaxel or Paclitaxel), Every 3 Weeks, in Patients With Advanced Solid Tumors.

summary: The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care.

ReferenceCitation: Bahleda R, Sessa C, Del Conte G, Gianni L, Capri G, Varga A, Oprea C, Daglish B, Hospitel M, Soria JC. Phase I clinical and pharmacokinetic study of ombrabulin (AVE8062) combined with cisplatin/docetaxel or carboplatin/paclitaxel in patients with advanced solid tumors. Invest New Drugs. 2014 Dec;32(6):1188-96. doi: 10.1007/s10637-014-0119-0. Epub 2014 Jun 6.

family: Bahleda

full_name: Rastislav Bahleda

given: Rastislav

family: Sessa

full_name: Cristiana Sessa

given: Cristiana

family: Del Conte

full_name: Gianluca Del Conte

given: Gianluca

family: Gianni

full_name: Luca Gianni

given: Luca

family: Capri

full_name: Giuseppe Capri

given: Giuseppe

family: Varga

full_name: Andrea Varga

given: Andrea

family: Oprea

full_name: Corina Oprea

given: Corina

family: Daglish

full_name: Byzance Daglish

given: Byzance

family: Hospitel

full_name: Marie Hospitel

given: Marie

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

journal_name: Investigational New Drugs

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

location_country: Italy France Switzerland

location_facility:
Investigational Site Number 250001
Investigational Site Number 380001
Investigational Site Number 756001


title: A Multi-centre, Randomized, Double-blind, Placebo Controlled, Two-period, Crossover Proof-of-concept Study in Male Patients With Fragile X Syndrome to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of AFQ056

summary: This study will evaluate the safety, tolerability and efficacy of multiple doses of AFQ056 in patients with Fragile X Syndrome. The dose range will be 50 to 150 mg b.i.d. The primary read-out of efficacy is reduction in Aberrant-Behavior Checklist score.

ReferenceCitation: Jacquemont S, Curie A, des Portes V, Torrioli MG, Berry-Kravis E, Hagerman RJ, Ramos FJ, Cornish K, He Y, Paulding C, Neri G, Chen F, Hadjikhani N, Martinet D, Meyer J, Beckmann JS, Delange K, Brun A, Bussy G, Gasparini F, Hilse T, Floesser A, Branson J, Bilbe G, Johns D, Gomez-Mancilla B. Epigenetic modification of the FMR1 gene in fragile X syndrome is associated with differential response to the mGluR5 antagonist AFQ056. Sci Transl Med. 2011 Jan 5;3(64):64ra1. doi: 10.1126/scitranslmed.3001708.

family: Jacquemont

full_name: S. Jacquemont

given: S.

family: Curie

full_name: A. Curie

given: A.

family: des Portes

full_name: V. des Portes

given: V.

family: Torrioli

full_name: M. G. Torrioli

given: M. G.

family: Berry-Kravis

full_name: E. Berry-Kravis

given: E.

family: Hagerman

full_name: R. J. Hagerman

given: R. J.

family: Ramos

full_name: F. J. Ramos

given: F. J.

family: Cornish

full_name: K. Cornish

given: K.

family: He

full_name: Y. He

given: Y.

family: Paulding

full_name: C. Paulding

given: C.

family: Neri

full_name: G. Neri

given: G.

family: Chen

full_name: F. Chen

given: F.

family: Hadjikhani

full_name: N. Hadjikhani

given: N.

family: Martinet

full_name: D. Martinet

given: D.

family: Meyer

full_name: J. Meyer

given: J.

family: Beckmann

full_name: J. S. Beckmann

given: J. S.

family: Delange

full_name: K. Delange

family: Brun

full_name: A. Brun

family: Bussy

full_name: G. Bussy

family: Gasparini

full_name: F. Gasparini

family: Hilse

full_name: T. Hilse

given: T.

family: Floesser

full_name: A. Floesser

family: Branson

full_name: J. Branson

family: Bilbe

full_name: G. Bilbe

publisher: American Association for the Advancement of Science (AAAS)

title: Epigenetic Modification of the FMR1 Gene in Fragile X Syndrome Is Associated with Differential Response to the mGluR5 Antagonist AFQ056


title: An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients.

summary: The primary objective of this study is to assess the proportion of schizophrenic patients and the proportion of bipolar patients who discontinue olanzapine within 12 months of treatment in outpatient, ambulatory or community settings

lead_sponsor: Eli Lilly and Company

location_country: Germany France Greece

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


title: "Heptovax" - A Phase II, Open-Label Trial Evaluating the Safety and Efficacy of GV1001 in Advanced Hepatocellular Carcinoma.

summary: The purpose of this study is to investigate the efficacy of GV1001 in locally advanced or metastatic HCC. Also the safety of GV1001 and immunogenicity will be evaluated.

ReferenceCitation: Greten TF, Forner A, Korangy F, N'Kontchou G, Barget N, Ayuso C, Ormandy LA, Manns MP, Beaugrand M, Bruix J. A phase II open label trial evaluating safety and efficacy of a telomerase peptide vaccination in patients with advanced hepatocellular carcinoma. BMC Cancer. 2010 May 17;10:209. doi: 10.1186/1471-2407-10-209.

family: Greten

full_name: Tim F Greten

given: Tim F

family: Forner

full_name: Alejandro Forner

given: Alejandro

family: Korangy

full_name: Firouzeh Korangy

given: Firouzeh

family: N'Kontchou

full_name: Gisele N'Kontchou

given: Gisele

family: Barget

full_name: Nathalie Barget

given: Nathalie

family: Ayuso

full_name: Carmen Ayuso

given: Carmen

family: Ormandy

full_name: Lars A Ormandy

given: Lars A

family: Manns

full_name: Michael P Manns

given: Michael P

family: Beaugrand

full_name: Michel Beaugrand

given: Michel

family: Bruix

full_name: Jordi Bruix

given: Jordi

currency_apc_doaj: GBP

journal_name: BMC Cancer

lead_sponsor: Pharmexa A/S

location_country: Germany France Spain

location_facility:
Tim F. Greten
Michel Beaugrand
Jordi Bruix

intervention_type: Biological


title: Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women

summary: Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing products may be a potential alternative to HRT for preventing bone loss during the menopausal transition. We investigated whether one-year consumption of isoflavone-enriched foods affected bone mineral density, bone metabolism and hormonal status in early postmenopausal women in a randomized double-blind, placebo controlled parallel multi-centre trial.

ReferenceCitation: Brink E, Coxam V, Robins S, Wahala K, Cassidy A, Branca F; PHYTOS Investigators. Long-term consumption of isoflavone-enriched foods does not affect bone mineral density, bone metabolism, or hormonal status in early postmenopausal women: a randomized, double-blind, placebo controlled study. Am J Clin Nutr. 2008 Mar;87(3):761-70.

lead_sponsor: TNO

location_country: Italy France Netherlands

location_facility: National Institute for Research on Food an Nutrition

location_facility: Institute National de la Recherche Agronomique


title: Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.

acronym: GREAT

summary: The primary objective of this study is to compare the safety and performance of the Palmaz Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosis, measured at 6 months follow up via angiography.

ReferenceCitation: Zähringer M, Sapoval M, Pattynama PM, Rabbia C, Vignali C, Maleux G, Boyer L, Szczerbo-Trojanowska M, Jaschke W, Hafsahl G, Downes M, Bérégi JP, Veeger NJ, Stoll HP, Talen A. Sirolimus-eluting versus bare-metal low-profile stent for renal artery treatment (GREAT Trial): angiographic follow-up after 6 months and clinical outcome up to 2 years. J Endovasc Ther. 2007 Aug;14(4):460-8.

lead_sponsor: Cordis Corporation

location_facility:
Universitätskliniken Köln
Erasmus MC Rotterdam
Hopital Européen Georges Pompidou